20-F - BDRX - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

¨	REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

x	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the fiscal year ended December 31, 2025

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the transition period from ______________ to _______________

¨	SHELL COMPANY PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	Date of event requiring this shell company report_________________

Commission File Number 001-37652

____________________________________________________________

BIODEXA PHARMACEUTICALS PLC

(Exact name of Registrant as specified in itscharter)

____________________________________________________________

England and Wales

(Jurisdiction of incorporation or organization)

1 Caspian Point

Caspian Way

Cardiff, CF10 4DQ

United Kingdom

(Address of principal executive offices)

Stephen Stamp, Chief Executive Officer

1 Caspian Point

Caspian Way

Cardiff, CF10 4DQ

United Kingdom

Tel: +44 29 2048 0180

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class	Trading Symbol	Name of each exchange on which<br><br>registered
Ordinary Shares, nominal value £0.000001 each	*	NASDAQ Capital Market
American Depositary Shares, each representing 100,000 ordinary shares	BDRX	NASDAQ Capital Market

* Not for trading, but only in connection with the registrationof the American Depositary Shares

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

(Title of Class)

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

None

(Title of Class)

____________________________________________________________

The number of outstanding

shares of each of the issuer’s classes of capital or common stock as of December 31, 2025 was: 225,817,808,922 Ordinary Shares

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes ¨ No x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer”, and “emerging growth company” in Rule 12b-2 of the Exchange Act (check one):

Large accelerated filer ¨	Accelerated filer ¨	Non-accelerated filer x
		Emerging growth company ¨

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal controls over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ¨

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ¨

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ¨

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ¨	International Financial Reporting Standards as issued by the International Accounting Standards Board x	Other ¨

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. Item 17 ¨ Item 18 ¨

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

TABLEOF CONTENTS

PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS	8
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE	8
ITEM 3. KEY INFORMATION	8
ITEM 4. INFORMATION ON THE COMPANY	51
ITEM 4A. UNRESOLVED STAFF COMMENTS	79
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS	79
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	88
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	97
ITEM 8. FINANCIAL INFORMATION	99
ITEM 9. THE OFFER AND LISTING	99
ITEM 10. ADDITIONAL INFORMATION	100
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	107
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	109
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	112
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	112
ITEM 15. CONTROLS AND PROCEDURES	112
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT	113
ITEM 16B. CODE OF ETHICS	113
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES	113
ITEM 16D. EXEMPTIONS FROM LISTING STANDARDS FOR AUDIT COMMITTEES	114
ITEM 16E. PURCHASE OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	114
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	114
ITEM 16G. CORPORATE GOVERNANCE	114
ITEM 16H. MINE SAFETY DISCLOSURE	114
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	115
ITEM 16J. INSIDER TRADING POLICIES	115
ITEM 16K. CYBERSECURITY	115
PART III
ITEM 17. FINANCIAL STATEMENTS	117
ITEM 18. FINANCIAL STATEMENTS	117
ITEM 19. EXHIBITS	118
SIGNATURES	122

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GENERAL INFORMATION

Biodexa Pharmaceuticals PLC is a public limited company organized under the laws of England and Wales under registered number 09216368. In this annual report, references to “we,” “us,” “our,” “the Group,” “Company,” “company” or “Biodexa” means Biodexa Pharmaceuticals PLC and our consolidated subsidiaries.

Our principal executive offices are located at 1 Caspian Point, Caspian Way, Cardiff, CF10 4DQ, United Kingdom. The telephone number at our principal executive office is +44 29 2048 0180.

We maintain an Internet website at www.biodexapharma.com. None of the information contained on our website, or on any other website linked to our website, will be incorporated in this annual report by reference or otherwise be deemed to be a part of this annual report.

The trademarks, trade names and service marks appearing in this annual report are the property of their respective owners.

PRESENTATION OF FINANCIAL AND OTHER INFORMATION

The consolidated financial statement data as of December 31, 2025, 2024 and 2023 and for the years ended December 31, 2025, 2024 and 2023 have been derived from our consolidated financial statements, as presented at the end of this annual report, which have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. We prepare our consolidated financial statements in British pounds sterling. Except as otherwise stated, all monetary amounts in this annual report are presented in British pounds sterling.

In this annual report, unless otherwise specified or the context otherwise requires:

·	“$” and “U.S. dollar” each refer to the United States dollar (or units thereof);<br> and
·	“£,” “pence” and “p” each refer to the British pound sterling (or<br> units thereof).
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References to a particular “fiscal” year are to our fiscal year ended December 31 of such year.

On March 27, 2023, following shareholder approval at a general meeting, we effected a one-for-20 reverse stock split of our Ordinary Shares, and our consolidated Ordinary Shares began trading on AIM, a market operated by the London Stock Exchange plc, or AIM, on a split-adjusted basis as of such date. No fractional shares were issued in connection with the reverse stock split. At the same general meeting, our shareholders approved the cancellation of admission of our Ordinary Shares on AIM and this cancellation became effective on April 26, 2023.

Concurrently with the reverse split, and in order to continue meeting The NASDAQ Stock Market LLC’s, or NASDAQ, minimum 500,000 publicly held shares requirement pursuant to Rule 5550(a)(4), on March 27, 2023 we effected a ratio change in the number of Ordinary Shares represented by the Depositary Shares from 25 Ordinary Shares per Depositary Share to five Ordinary Shares per Depositary Share.

On June 14, 2023, we held our annual general meeting of shareholders, or the June AGM, and our shareholders passed resolutions, among other procedural items, to approve the allotment of, and disapplication of pre-emption rights in respect of, up to 7.0 billion Ordinary Shares, or Shareholder Approval. On June 14, 2023, we also held a separate general meeting of shareholders, or June GM, and our shareholders passed resolutions to (x)(i) re-designate our deferred shares into A deferred shares, or the Re-Designation, and (ii) subdivide our Ordinary Shares of £0.02 nominal value each into one ordinary share of £0.001 nominal value and 19 B deferred shares of £0.001 nominal value each, each the Subdivision, and (y) adopt new articles of association, or the Articles of Association, which made consequential amendments to the existing Articles of Association of the Company to reflect the Re-Designation and the Subdivision, together with certain other changes to reflect that the Ordinary Shares were no longer admitted to trading on AIM. As is standard for deferred shares, each B deferred share has very limited rights and is effectively valueless. The B deferred shares have the rights and restrictions as set out in the Articles of Association and do not entitle the holder thereof to receive notice of or attend and vote at any general meeting of the Company or to receive a dividend or other distribution.

On July 5, 2023, and in an effort to bring our Depositary Share price into compliance with NASDAQ’s minimum bid price per share requirement, we effected a ratio change in the number of Ordinary Shares represented by our Depositary Shares from five Ordinary Shares per Depositary Share to 400 Ordinary Shares per Depositary Share. No fractional Depositary Shares were issued.

On October 4, 2024, and in an effort to bring our Depositary Share price into compliance with NASDAQ’s minimum bid price per share requirement, we effected a ratio change in the number of Ordinary Shares represented by our Depositary Shares from 400 Ordinary Shares per Depositary Share to 10,000 Ordinary Shares per Depositary Share. No fractional Depositary Shares were issued.

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On November 22, 2024, we held a general meeting of shareholders, or the November GM, and our shareholders passed resolutions to (i) subdivide our Ordinary Shares of £0.001 nominal value each into one ordinary share of £0.00005 nominal value and 19 C deferred shares of £0.00005 nominal value each, each the November Subdivision, and (y) adopt new Articles of Association, which made consequential amendments to the existing Articles of Association of the Company to reflect the November Subdivision. As is standard for deferred shares, each C deferred share has very limited rights and is effectively valueless. The C deferred shares have the rights and restrictions as set out in the Articles of Association and do not entitle the holder thereof to receive notice of or attend and vote at any general meeting of the Company or to receive a dividend or other distribution.

On June 11, 2025, we held a general meeting of shareholders, or June 2025 GM, and our shareholders passed resolutions to (i) subdivide our Ordinary Shares of £0.00005 nominal value each into one ordinary share of £0.000001 nominal value and 49 D deferred shares of £0.000001 nominal value each, each the June 2025 Subdivision, and (y) adopt new Articles of Association, which made consequential amendments to the existing Articles of Association of the Company to reflect the June Subdivision. As is standard for deferred shares, each D deferred share has very limited rights and is effectively valueless. The D deferred shares have the rights and restrictions as set out in the Articles of Association and do not entitle the holder thereof to receive notice of or attend and vote at any general meeting of the Company or to receive a dividend or other distribution.

The change in the number of Ordinary Shares resulting from the reverse stock split and change in the number of Depositary Shares (and the underlying Ordinary Shares) resulting from the change in ratio, including any changes resulting from fractional Depositary Shares not being issued to holders in connection with the Depositary Share ratio change, has been applied retroactively to all share and per share amounts presented in this annual report, to the extent applicable. As a result of retroactively applying changes resulting from fractional Depositary Shares not being issued to holders in connection with the Depositary Share ratio change, the amount of Ordinary Shares issued in prior transactions may not equal the amount of Depositary Shares such Depositary Shares are currently exercisable for.

INDUSTRY AND MARKET DATA

This annual report contains estimates, projections and other information concerning our industry, our business and the market for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we believe our internal company research as to such matters is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source.

In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Note Regarding Forward-LookingStatements.”

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This annual report contains certain forward-looking information about the Company that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995. These statements may be made directly in this annual report or may be incorporated into this annual report by reference to other documents. Our representatives may also make forward-looking statements. Forward-looking statements are statements that are not historical facts. Words such as “expect,” “believe,” “will,” “may,” “anticipate,” “plan,” “estimate,” “intend,” “should,” “can,” “likely,” “could” and similar expressions are intended to identify forward-looking statements. Forward-looking statements appear in a number of places throughout this annual report and include statements regarding our intentions, beliefs, assumptions, projections, outlook, analyses or current expectations concerning, among other things, our intellectual property position, research and development projects, results of operations, cash needs, capital expenditures, financial condition, liquidity, prospects, growth and strategies, regulatory approvals and clearances, the markets and industry in which we operate and the trends and competition that may affect the markets, industry or us.

These forward-looking statements are based on currently available competitive, financial and economic data together with management’s views and assumptions regarding future events and business performance as of the time the statements are made and are subject to risks and uncertainties. We wish to caution you that there are some known and unknown factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements, including but not limited to risks related to:

·	our requirement for additional financing and our ability to continue as a going concern;
·	our estimates regarding losses, expenses, future revenues, capital requirements and needs for additional financing;
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·	our ability to successfully develop, test and partner with a licensee to manufacture or commercialize products<br> for conditions using our technology platforms;
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·	the successful commercialization and manufacturing of our any future product we may commercialize or license;
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·	the success and timing of our preclinical studies and clinical trials;
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·	shifts in our business and commercial strategy;
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·	the filing and timing of regulatory filings, including Investigational New Drug applications, with respect to any of our product candidates<br> and the receipt of any regulatory approvals;
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·	the anticipated medical benefits of our product candidates;
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·	the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling<br> under any approval we may obtain;
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·	the success and timing of the potential commercial development of our product candidates and any product candidates<br> we may acquire in the future, including eRapa and tolimidone;
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·	our plans and ability to develop and commercialize our product candidates and any product candidates we may<br> acquire in the future;
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·	the ability to manufacture products in third-party facilities;
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·	the rate and degree of market acceptance of any of our product candidates;
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·	the successful development of our commercialization capabilities, including our internal sales and marketing<br> capabilities;
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·	obtaining and maintaining intellectual property protection for our product candidates and our proprietary<br> technology;
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·	the success of competing therapies and products that are or become available;
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·	the success of any future acquisitions or other strategic transactions;
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·	the difficulties of integrating the business of any future acquisitions into our own;
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| --- | | · | cybersecurity and other cyber incidents; | | --- | --- | | · | industry trends; | | --- | --- | | · | the impact of government laws and regulations; | | --- | --- | | · | regulatory, economic and political developments in the United Kingdom, the European Union, the United States and other foreign countries, including any impact from the United Kingdom leaving the European Union; | | --- | --- | | · | the difficulties doing business internationally; | | --- | --- | | · | the ownership of our Ordinary Shares and Depositary Shares; | | --- | --- | | · | our ability to continue to meet the listing criteria required to remain listed on the NASDAQ Capital Market; | | --- | --- | | · | our ability to recruit or retain key scientific or management personnel or to retain our senior management; | | --- | --- | | · | the impact and costs and expenses of any litigation we may be subject to now or in the future; | | --- | --- | | · | the performance of third parties, including joint venture partners, our collaborators, third-party suppliers and parties to our licensing agreements; and | | --- | --- | | · | other risks and uncertainties, including those described in “Risk Factors” in this annual report. | | --- | --- |

Any forward-looking statements that we make in this annual report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this annual report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data. You should, however, review the factors and risks we describe in the reports we will file from time to time with the U.S. Securities and Exchange Commission, or SEC, after the date of this annual report. See “Item 10. Additional Information—H. Documents on Display.”

You should also read carefully the factors described in “Item 3. Key Information—D. Risk Factors” and elsewhere in this annual report to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this annual report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all.

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PART I

ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS.

Not Applicable.

ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE.

Not Applicable.

ITEM 3.	KEY INFORMATION.
A.	[Reserved].
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B.	Capitalization and Indebtedness
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Not Applicable.

C.	Reasons for the Offer and Use of Proceeds

Not Applicable.

D.	Risk Factors

Our business has significantrisks. In addition to the other information included in this annual report, including the matters addressed in the section of the annualreport entitled “Cautionary Note Regarding Forward-Looking Statements” and in our financial statements and the related notes,you should consider carefully the risks described below. The risks and uncertainties described below are not the only risks and uncertaintieswe may face. Additional risks and uncertainties not presently known to us, or that we currently consider immaterial could also negativelyaffect our business, financial condition, results of operations, prospects, profits and stock prices. If any of the risks described belowactually occur, our business, financial condition, results of operations, prospects, profits and stock prices could be materially adverselyaffected.

Summary of Risk Factors

The occurrence of one or more of the events or circumstances described in this section titled “Risk Factors,” alone or in combination with other events or circumstances, may materially adversely affect our business, financial condition and operating results. In that event, the trading price of our securities could decline, and you could lose all or part of your investment. Such risks include, but are not limited to:

·	We have incurred significant losses since our inception and anticipate that we will continue to incur losses<br> in the future.
·	Our requirement for additional financing in the short-term represents a material uncertainty that raises substantial<br> doubt about our ability to continue as a going concern.
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·	If we require or seek to raise additional capital to fund our operations and we fail to obtain necessary financing,<br> we may be unable to complete the development of our product candidates.
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·	Our operations are in early-stage development with no sources of recurring revenue and there is no assurance<br> that we will successfully develop and license our product candidates or ever become profitable.
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·	We are exposed to political, regulatory, social and economic risk relating to the United Kingdom’s exit<br> from the European Union.
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·	We have undertaken in the past, and may in the future undertake, strategic acquisitions. Failure to integrate<br> acquisitions could adversely affect our value.
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·	Our future success is dependent on product development and the ability to successfully license our product<br> candidates to partners who can seek regulatory approval and commercialization of our product candidates.
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·	Our development efforts are in the early stages. All of our product candidates are in clinical development<br> or preclinical development phases. If we are unable to advance our product candidates through clinical development, obtain regulatory<br> approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially<br> harmed.
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| --- | | · | The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that we advance in clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval. | | --- | --- | | · | The regulatory approval processes in the United States and Europe are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business may be substantially harmed. | | --- | --- | | · | We seek to establish agreements with potential licensing partners and collaborators and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans. | | --- | --- | | · | If we enter into agreements with a licensing or collaboration partner for the development and commercialization of our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations. | | --- | --- | | · | The commercial success of any of our product candidates is not guaranteed. | | --- | --- | | · | The pharmaceutical and biotechnology industries are highly competitive. | | --- | --- | | · | Changes in healthcare policies, laws and regulations, including legislative measures aimed at reducing healthcare costs, may impact our ability to obtain approval for or commercialize any of our future product candidates, if approved. | | --- | --- | | · | Coverage and adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for us to sell profitably, if approved. | | --- | --- | | · | Our business may be adversely affected by economic conditions and current economic weakness. | | --- | --- |

·	Our business may be impacted by political events, war, terrorism, business interruptions and other geopolitical<br> events and uncertainties beyond our control.
·	We may in the future be unable to retain and recruit qualified scientists, key executives, key employees or key consultants, which may<br> delay our development efforts or otherwise harm our business.
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·	Public health crises, such as the COVID-19 pandemic, have had, and could in the future have, a negative effect<br> on our business.
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·	Our success depends in part on our ability to protect rights in our intellectual property, which cannot be<br> assured.
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·	We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully<br> carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our<br> product candidates and our business could be substantially harmed.
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·	We rely on third parties to manufacture our product candidates, and we expect to continue to rely on third<br> parties for the clinical as well as any future commercial supply of our product candidates and other future product candidates. The development<br> of our current and future product candidates, and the commercialization of any approved products, could be stopped, delayed or made less<br> profitable if any such third party fails to provide us with sufficient clinical or commercial quantities of such product candidates or<br> products, fails to do so at acceptable quality levels or prices or fails to achieve or maintain satisfactory regulatory compliance.
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·	We are dependent on third party suppliers, and if we experience problems with any of these third parties,<br> the manufacturing of our product candidates could be delayed, which could harm our results of operations.
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·	It is not possible to predict the actual number of Depositary Shares we will sell pursuant to the equity line<br> of credit, or the actual gross proceeds resulting from those sales or the dilution to you from those sales.
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·	If we cannot meet NASDAQ’s continued listing requirements, NASDAQ may delist our Depositary Shares,<br> which could have an adverse impact on the liquidity and market price of our Depositary Shares.
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| --- | | · | The price of our Depositary Shares may be volatile. | | --- | --- | | · | The liquidity of our Depositary Shares may have an adverse effect on share price. | | --- | --- | | · | Shareholder ownership interests in the Company may be diluted as a result of, among other things, future financings and/or additional acquisitions, including the ELOC (as defined below), and may have a material negative effect on the market price of our securities. | | --- | --- | | · | Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. | | --- | --- | | · | As a foreign private issuer, we are not required to comply with many of the corporate governance standards of NASDAQ applicable to companies incorporated in the United States. | | --- | --- | | · | Your right to participate in any future rights offerings may be limited, which may cause dilution to your holdings. | | --- | --- | | · | Protections found in provisions under the United Kingdom City Code on Takeovers and Mergers may delay or discourage a takeover attempt, including attempts that may be beneficial to holders of our Ordinary Shares and Depositary Shares. | | --- | --- |

Risks Related to Our Financial Operations and Capital Needs

We have incurred significant losses sinceour inception and anticipate that we will continue to incur losses in the future.

We are an early-stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because we entail substantial upfront capital expenditures and significant risk that a product candidate will fail in development, will fail to gain regulatory approval or otherwise fail to become commercially viable. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred substantial losses since our inception. For the years ended December 31, 2025, 2024 and 2023 we had a net loss of £6.25 million, £5.73 million and £7.08 million, respectively. For the year ended December 31, 2025, we had an accumulated deficit of £155.67 million.

We expect to continue to incur losses for the foreseeable future, and do not expect these losses to reduce as we continue our development of, and work with any licensing partners to seek regulatory approvals for, our product candidates.

We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If we fail to find licensing partners, if we abandon any development programs, or if any of our licensed product candidates fail in clinical trials or do not gain regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses and expected future losses have had and will continue to have an adverse effect on our shareholders’ equity and working capital.

Our requirement for additional financingin the short-term represents a material uncertainty that raises substantial doubt about our ability to continue as a going concern.

We have experienced net losses and significant cash outflows from cash used in operating activities over the past years as we develop our portfolio.

Our future viability is dependent on our ability to raise cash from financing activities to finance our development plans until milestones and/or royalties can be secured from partnering our assets, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of our development products. Our failure to raise capital as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies.

Our consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at December 31, 2025, we had cash and cash equivalents of £8.53 million.

We have prepared cash flow forecasts and considered the cash flow requirement for the next three years, including the period 12 months from the date of approval of the financial statements included in this annual report. Our forecasts show that further financing will be required before third quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. In January 2025, we entered into a $35.0 million equity line of credit agreement, or ELOC, with C/M Capital Master Fund LP, whereby we may direct such investor from time to time to purchase Depositary Shares (subject to certain limitations) and receive proceeds in accordance with a formula price. To date, we have sold $8.92 million of shares under the ELOC. However, there is no guarantee that we will be able to use the ELOC to the extent necessary to finance our operations.

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We believe the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, any attendant financing is likely to be dilutive. We and our advisors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to us, including fundraising and the partnering of assets and technologies of the Company. There can be no assurance that any of the courses of action to finance the Company, will be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast doubt upon our ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to us which are actionable before our cash resources run out, then we will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities.

We believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, we considered it appropriate to continue to adopt the going concern basis in preparing the financial information.

Our ability to continue as a going concern is dependent upon our ability to obtain additional capital and/or dispose of assets, for which there can be no assurance we will be able to do on a timely basis, on favorable terms or at all.

Our operations are in early-stage developmentwith no sources of recurring revenue and there is no assurance that we will successfully develop and license our product candidates orever become profitable.

We are at a relatively early stage of our commercial development. To date, we have generated a minimal amount of revenue from our product candidates. Our ability to generate revenue and become and remain profitable depends, in part, on our ability to successfully find a licensing partner for our product candidates, or other product candidates we may in-license or acquire, and have such candidates successfully commercialized. Our current strategy is, once proof-of-concept of our product candidates has been established, to generate revenue via a partner, thereby earning royalty and/or milestone income; however, this is not expected to materialize in the foreseeable future, and there can be no guarantee we will be able to find a licensing partner for our product candidates. Even if our product candidates were to successfully achieve regulatory approval, we do not know when any of the product candidates will generate revenue, if at all. Our ability to generate revenue from our product candidates also depends on a number of additional factors, including our ability, and the ability of any licensing partners, to:

·	successfully complete development activities;
·	complete and submit new drug applications to the European Medicines Agency, or the EMA, the Medicines and<br> Healthcare Products Regulatory Agency in the United Kingdom, or the MHRA, the United States Food and Drug Administration, or the FDA,<br> and any other foreign regulatory authorities, and obtain regulatory approval for products for which there is a commercial market;
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·	set a commercially viable price;
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·	obtain commercial qualities of the products at acceptable cost levels;
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·	develop and maintain a commercial organization capable of sales, marketing and distribution in the markets<br> where the product is to be sold; and
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·	obtain adequate reimbursement from third parties, including government, departments and healthcare payors.
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In addition, because of the numerous risks and uncertainties associated with product development, including that our product candidates may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able to complete the process described above, we anticipate incurring significant costs.

Even if we are able to generate royalty and/or milestone revenues from the sale of product candidates, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to cease or reduce our operations.

There can be no assurance that we will operate profitably, produce a reasonable return, if any, on investment, or remain solvent. If our strategy proves unsuccessful, stockholders could lose all or part of their investment.

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If we require or seek to raise additionalcapital to fund our operations and we fail to obtain necessary financing, we may be unable to complete the development of our productcandidates.

We expect to continue to spend substantial amounts of our cash resources going forward in order to advance the development of our product candidates. We believe we have sufficient funds to continue our operations until the third quarter of 2026, and we believe that we will need to raise additional capital to fund our operations thereafter.

Until such time as we can generate a sufficient amount of revenue from the product candidates we license, if ever, we expect that we may finance future cash needs through, among other things, public or private equity or debt offerings, including equity sales pursuant to our purchase agreement with the Investor. Such offerings may take place in the United Kingdom, the United States or other foreign countries. However, if we are unable to raise capital when needed, or on terms acceptable to us, our business could be significantly harmed. If we raise additional funds through the issuance of debt or additional equity securities, such issuance could result in dilution to our existing shareholders and/or increased fixed payment obligations. Furthermore, these securities may have rights senior to those of our Ordinary Shares and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

·	any acquisitions and the commercialization of other assets, including licensed assets;
·	the initiation, progress, timing, costs and results of clinical trials for any product candidates we advance<br> to clinical trials;
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·	the attainment of milestones and the need to make any royalty payments on any of our product candidates or<br> any other future product candidates;
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·	the number and characteristics of product candidates we in-license or acquire and develop;
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·	the outcome, timing and cost of regulatory approvals by the EMA, the MHRA, the FDA and any other comparable<br> foreign regulatory authorities, including the potential for such regulatory authorities to require that we perform more studies, or more<br> costly studies, than those we currently expect;
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·	the cost of filing, prosecuting, defending and enforcing any patent claims or other intellectual property<br> rights; and
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·	the effect of competing technological and market developments.
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Further, our forecast also does not reflect the possibility that we may not be able to access a portion of our existing cash, cash equivalents and investments due to market conditions. For example, if banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition.

If a lack of available capital means that we are unable to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected.

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Any failure by us to maintain an effectivesystem of internal controls or provide reliable financial and other information in the future, may cause investors to lose confidencein our financial statements and SEC filings and the market price of our securities may be materially and adversely affected.

The Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment includes disclosures of any material weaknesses identified by management in its internal control over financial reporting.

A material weakness is a control deficiency, or combination of control deficiencies, in internal control over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis. Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting. However, for as long as we remain a non-accelerated filer, we are not required to comply with the independent registered public accounting firm attestation requirement.

In previous years, we and our independent registered public accounting firm have identified material weaknesses in our internal controls over financial reporting. Although we have instituted remedial measures to address the material weaknesses identified and to continually review and evaluate our internal control systems to allow management to report on the sufficiency of our internal control over financial reporting, we cannot assure you that we will not discover additional weaknesses in our internal control over financial reporting. Any such additional weaknesses or failure to adequately remediate any existing weakness could materially and adversely affect our financial condition and results of operations, as well as our ability to accurately report our financial condition and results of operations in a timely and reliable manner.

Additionally, the material weaknesses previously identified, or other material weaknesses or significant deficiencies we may become aware of in the future, could result in our determining that our controls and procedures are not effective in future periods or could result in a material misstatement of the consolidated financial statements that would not be prevented or detected.

Any failure to maintain effective internal controls over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting once that firm begin its Section 404 reviews, we could lose investor confidence in the accuracy and completeness of our financial statements and reports, the market price of our Ordinary Shares and/or Depositary Shares could decline, and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Risks Related to Our Business, Strategy andIndustry

We have undertaken in the past, and may in the future undertake,strategic acquisitions. Failure to integrate acquisitions could adversely affect our value.

One of the ways we have grown our pipeline and business in the past is through strategic acquisitions of other businesses, product candidates, and technologies. We may, from time to time, evaluate additional acquisition opportunities, and may, in the future, strategically make further acquisitions of, and investments in, businesses, compounds, products and technologies when we believe the opportunity is advantageous to our prospects, such as the acquisition of eRapa and tolimidone. There can be no assurance that in the future we will be able to find appropriate acquisitions or investments. In connection with these acquisitions or investments, we may:

·	issue stock that would dilute our shareholders’ percentage of ownership;
·	be obligated to make milestone or other contingent or non-contingent payments;
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·	incur debt and assume liabilities; and/ or
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·	incur amortization expenses related to intangible assets or incur large and immediate write-offs.
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We also may be unable to find suitable acquisition candidates and may not be able to complete acquisitions on favorable terms, if at all, or obtain adequate financing for such acquisitions. If we do complete an acquisition, this may not ultimately strengthen our competitive position or ensure that we will not be viewed negatively by customers, financial markets or investors. Further, acquisitions could also pose numerous additional risks to our operations, including:

·	problems integrating the purchased business, products or technologies without substantial costs, delays or<br> other problems;
·	increases to our expenses;
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·	the failure to have discovered undisclosed liabilities of the acquired asset or company for which we may not<br> be adequately indemnified;
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·	diversion of management’s attention from their day-to-day responsibilities and our core business;
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·	inability to enforce indemnification and non-compete agreements;
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·	the failure to successfully incorporate acquired products or technologies into our business;
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·	the failure of the acquired business, products or technologies to perform as well as anticipated;
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·	the failure to realize expected synergies and cost savings;
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·	unexpected safety issues and/or clinical trial failure of the acquisition’s products;
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·	harm to our operating results or financial condition, particularly during the first several reporting periods<br> after the acquisition is completed;
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·	entrance into markets in which we have limited or no prior experience; and
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·	potential loss of key employees or customers, particularly those of the acquired entity.
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We may not be able to complete one or more acquisitions or effectively integrate the operations, products or personnel gained through any such acquisition without a material adverse effect on our business, financial condition and results of operations.

Our future success is dependent on productdevelopment and the ability to successfully license our product candidates to partners who can seek regulatory approval and commercializationof our product candidates.

We continue to conduct research and development for our product candidates and, to a lesser extent, clinical trials for certain of our product candidates; however there can be no assurance that any of our targeted developments will be successful. We must develop functional products that address specific market needs. We must therefore engage in new development activities, which may not produce innovative, commercially viable results in a timely manner or at all. In addition, we may not be able to develop new technologies or identify specific market needs that are addressable by our technologies, or technologies available to us. We may encounter delays and incur additional development and production costs and expenses, over and above those expected, in order to develop technologies and products suitable for licensing. If any of our development programs are curtailed, this may have a material adverse effect on our business and financial conditions.

Our business is dependent on our ability to complete the development of product candidates, and license our product candidates to partners who will seek to obtain regulatory approval for and commercialize our product candidates in a timely manner. Any licensing partner cannot commercialize a product without first obtaining regulatory approval from the appropriate regulatory authorities in a country. Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, it must be demonstrated with substantial evidence gathered in preclinical and well-controlled clinical studies that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate. The process of developing, obtaining regulatory approval for and commercializing product candidates is long, complex and costly. Even if a product candidate were to successfully obtain approval from the EMA, the MHRA, the FDA and/or comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for certain age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If our product candidates are unable to obtain regulatory approval in one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of any other product candidate. Furthermore, even if a product candidate obtains approval from the regulatory authorities, it is likely that, in order to obtain royalty and/or milestone revenue from any of our licensing partners, our licensing partners may need to expand their commercial operations, establish commercially viable pricing and obtain approval for adequate reimbursement from third parties and government departments and healthcare payors for such products. If our product candidates are unable to successfully be commercialized, we may not be able to earn sufficient revenues to continue our business.

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Our development efforts generally are inthe early stages. All of our product candidates are in clinical development or preclinical development phases. If we are unable to advanceour product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, orexperience significant delays in doing so, our business will be materially harmed.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of any preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, even after seeing promising results in earlier clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry, including many with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

With the exception of the Phase 3 trial of eRapa which, together with a company match is substantially funded by a grant from the Cancer Prevention and Research Institute of Texas, or CPRIT, we have determined generally not to conduct expensive, late-stage clinical trials in humans. Instead, we intend to focus our resources on smaller pilot trials designed to establish proof of concept. With the exception of eRapa, we expect our licensing partners to be responsible for late-stage clinical trials. We and any of our current or potential licensing partners may experience delays in ongoing or future clinical trials and we do not know whether planned clinical trials will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all.

There is no assurance that current or future clinical trials of our product candidates, will be successful or will generate positive clinical data and we or our licensing partners may not receive marketing approval from the FDA, European Commission, or other regulatory authorities for any of our product candidates. We have limited experience submitting NDAs, biologics license applications, or BLAs, and investigational new drug applications, or INDs, to the FDA, as well as clinical trial applications, or CTAs, or marketing authorization applications, or MAAs, to the EMA. MTX240 and tolimidone are both at a relatively early stage in their clinical development. There can be no assurance that the FDA will permit any of our or our licensing partners’ future NDAs, BLAs, or INDs, including the NDA for eRapa, MTX240 or tolimidone or any future INDs for our other product candidates, to go into effect in a timely manner or at all. Without an IND or CTA for a product candidate, we or our licensing partners will not be permitted to conduct clinical trials in the United States or the European Union, respectively, of such product candidate.

Drug or biological product development is a difficult, long, time-consuming, expensive and uncertain process, and delay or failure can occur at any stage. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing and marketing them. Clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:

·	delay or failure to complete preclinical studies;
·	insufficient financial and other resources to complete the necessary preclinical studies and clinical trials;
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·	delay or failure in reaching agreement with the applicable regulatory authorities on a trial design;
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·	delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed<br> by a regulatory authority regarding the scope or design of a clinical trial;
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·	delay or failure in reaching agreement on acceptable terms with prospective contract research organizations,<br> or CROs, and clinical trial providers and sites, the terms of which can be subject to extensive negotiation and may vary significantly<br> among different CROs and trial sites;
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·	delay or failure in obtaining institutional review board, or IRB, ethics committee approval or the approval<br> of other reviewing entities, including foreign regulatory authorities, to conduct a clinical trial at each site;
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·	failure to recruit, or subsequent withdrawal of, clinical trial sites from clinical trials as a result of<br> changing standards of care or the ineligibility of a site to participate in our clinical trials;
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·	delay or failure in recruiting and enrolling suitable subjects to participate in a trial;
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·	delay or failure in having subjects complete a trial or return for post-treatment follow-up;
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| --- | | · | clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial; | | --- | --- | | · | inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication; | | --- | --- | | · | failure of third party clinical trial managers or clinical sites to satisfy contractual duties or meet expected deadlines; | | --- | --- | | · | delay or failure in adding new clinical trial sites; | | --- | --- | | · | ambiguous or negative interim results, or results that are inconsistent with earlier results; | | --- | --- | | · | the need for clinical trial protocol modifications based on comments from the EMA, the MHRA, the FDA, a responsible IRB, a data safety monitoring board, or other regulatory authority, or on results from earlier stage or concurrent preclinical and clinical studies; | | --- | --- | | · | decisions by the EMA, the MHRA, the FDA, a responsible IRB, other regulatory authorities, or us, or recommendation by a data safety monitoring board, to suspend or terminate a clinical trial at any time for safety issues or for any other reason; | | --- | --- | | · | unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects; | | --- | --- | | · | failure to demonstrate a benefit from using our product candidate over existing marketed products or established standard of care treatment; | | --- | --- | | · | manufacturing issues, including problems with manufacturing or obtaining from third parties sufficient quantities of raw materials, active pharmaceutical ingredients, or API, or product candidates for use in clinical trials; and | | --- | --- | | · | changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. | | --- | --- |

Many of these factors are beyond our control. If we experience delays in the completion of, or termination of, any ongoing or future clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, any delays in completing clinical trials may slow down our product candidate development and approval process and jeopardize the ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. It is possible that none of our product candidates will ever complete successfully the clinical development process and obtain regulatory approval, even if we expend substantial time and resources seeking such approval.

Negative results in the development of our lead product candidates may also prevent or delay our ability to continue or conduct clinical programs or receive regulatory approvals for our other product candidates. For example, although we believe our preclinical studies and animal testing of eRapa and tolimidone demonstrate indications of acceptable safety and effectiveness profiles, future clinical trials may fail to demonstrate adequate levels of safety or effectiveness. Consequently, in order to obtain regulatory approval, we may have to reach agreement with the FDA on defining the optimal patient population, study design, and size, any of which may require significant additional resources and delay our clinical trials and ultimately the approval, if any, of any of our product candidates.

We may experience setbacks that could delay or prevent regulatory approval of, or our or our licensing partners’ ability to commercialize, our product candidates, including:

·	negative or inconclusive results from our preclinical studies or clinical trials or positive results from<br> the clinical trials of others for product candidates similar to ours leading to their approval, and evolving to a decision or requirement<br> to conduct additional preclinical testing or clinical trials or abandon a program;
·	product-related side effects experienced by patients or subjects in our clinical trials or by individuals using drugs or therapeutics<br> that we, the FDA, other regulators or others view as relevant to the development of to our product candidates;
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·	delays in submitting INDs or comparable foreign applications or delays or failure in obtaining the necessary<br> approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
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| --- | | · | conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials, including our clinical endpoints; | | --- | --- | | · | inability to maintain compliance with regulatory requirements, including current good manufacturing practices, or cGMP, and complying effectively with other procedures; | | --- | --- | | · | inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; | | --- | --- | | · | greater than anticipated clinical trial costs; | | --- | --- | | · | inability to compete with other therapies; | | --- | --- | | · | poor efficacy of our product candidates during clinical trials; | | --- | --- | | · | trial results taking longer than anticipated; | | --- | --- | | · | trials being subjected to fraud or data capture failure or other technical mishaps leading to the invalidation of our trials; | | --- | --- | | · | the results of our trials not supporting application for conditional approval in the EU; | | --- | --- | | · | unfavorable FDA or other regulatory agency inspection and review of a clinical trial site; | | --- | --- | | · | failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; | | --- | --- | | · | delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical development generally or with respect to our technology in particular; or | | --- | --- | | · | varying interpretations of data by the FDA and similar foreign regulatory agencies. | | --- | --- |

In addition, because we have limited financial and personnel resources and are focusing primarily on developing our lead product candidates, we may forgo or delay pursuit of other future product candidates that may prove to have greater commercial potential and may fail to capitalize on viable commercial products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a future product candidate, we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product candidates.

The results of preclinical studies and earlyclinical trials are not always predictive of future results. Any product candidate that we advance in clinical trials may not achievefavorable results in later clinical trials, if any, or receive marketing approval.

The research and development of drugs and biological products is expensive and extremely risky. Only a small percentage of product candidates that enter the development process ever receive marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. The outcome of clinical testing is uncertain. We may face unforeseen challenges in our product candidate development strategy, and we can provide no assurances that any of our clinical trials will be conducted as planned or completed on schedule, or at all, that we will ultimately be successful in our current and future clinical trials, or that our product candidates will be able to receive regulatory approval. A failure of one or more clinical trials can occur at any stage of testing, which may result from a multitude of factors, including, among other things, flaws in study design, dose selection issues, placebo effects, patient enrollment criteria and failure to demonstrate favorable safety or efficacy. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final results. For example, it is not uncommon for product candidates to exhibit unforeseen safety or efficacy issues when tested in humans despite promising results in preclinical animal model studies. Accordingly, we cannot assure you that any clinical trials that we may conduct will demonstrate consistent or adequate efficacy and safety to support marketing approval.

Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and early-stage clinical trials, and we cannot be certain that we will not face similar setbacks. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. Furthermore, the failure of any product candidates that we develop to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of other product candidates that we develop or cause regulatory authorities to require additional testing before approving any of our product candidates.

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If we are required to conduct additional clinical trials or other testing our product candidates, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, if there are safety concerns or if we determine that the observed safety or efficacy profile would not be competitive in the marketplace, we or our licensing partners may:

·	incur unplanned costs;
·	be delayed in obtaining marketing approval for product candidates we develop;
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·	not obtain marketing approval at all;
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·	obtain marketing approval in some countries and not in others;
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·	obtain approval for indications or patient populations that are not as broad as intended or desired;
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·	obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
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·	be subject to additional post-marketing testing requirements; or
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·	have the product removed from the market after obtaining marketing approval.
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Our product development costs will also increase if we experience delays in clinical trials or in obtaining marketing approvals. We do not know whether any of our clinical trials will continue or begin as planned, will need to be restructured or will be completed on schedule, or at all. We may also decide to change the design or protocol of one or more of our clinical trials, including to add additional patients or arms, which could result in increased costs and expenses or delays. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

We or our collaborators may experience delaysor difficulties in the enrollment and/or retention of patients in clinical trials, which could delay or prevent our receipt of necessaryregulatory approvals.

Successful and timely completion of clinical trials will require that we or our collaborators sponsoring trials for our product candidates enroll a sufficient number of patients. Patient enrollment, which is an important factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population and competition for patients eligible for our clinical trials with competitors, which may have ongoing clinical trials for product candidates that are under development to treat the same indications as one or more of our product candidates or approved products for the conditions for which we are developing our product candidates.

Trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patient withdrawal. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, EMA, or comparable foreign regulatory authorities. We cannot predict how successful we or our collaborators will be at enrolling subjects in future clinical trials. Trial subject enrollment is affected by other factors including:

·	the severity and difficulty of diagnosing the disease under investigation;
·	the eligibility and exclusion criteria for the trial in question;
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·	the size of the patient population and process for identifying patients;
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·	our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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·	the design of the trial protocol;
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·	the perceived risks and benefits of the product candidate in the trial in relation to other available therapies,<br> including any new products that may be approved for the indications we are investigating;
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| --- | | · | the availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation; | | --- | --- | | · | the willingness of patients to be enrolled in our clinical trials; | | --- | --- | | · | the risk that subjects enrolled in clinical trials will drop out of our trials before completion; | | --- | --- | | · | our ability to obtain and maintain clinical trial subject informed consents; | | --- | --- | | · | the efforts to facilitate timely enrollment in clinical trials; | | --- | --- | | · | the patient referral practices of physicians; | | --- | --- | | · | the ability to monitor patients adequately during and after treatment; and | | --- | --- | | · | the proximity and availability of clinical trial sites for prospective patients. | | --- | --- |

In addition, the U.S. Congress recently amended the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug or biologic to support marketing authorization, to design and submit a diversity action plan for such clinical trial. The action plan must describe appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. We or our licensing partners must submit a diversity action plan to the FDA by the time a Phase 3 trial, or pivotal study, protocol is submitted to the agency for review, such as for our Phase 3 trial of eRapa, unless we or our licensing partners are able to obtain a waiver for some or all of the requirements for a diversity action plan. Initiation of such trials may be delayed if the FDA objects to a proposed diversity action plans for any future Phase 3 trial of our product candidates. We or our licensing partners may experience difficulties recruiting a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.

Inability to enroll a sufficient number of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their performance.

We are exposed to political, regulatory,social and economic risk relating to the United Kingdom’s exit from the European Union.

Following the result of a referendum in 2016, the United Kingdom left the European Union on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom was subject to a transition period until December 31, 2020, during which European Union rules continued to apply. The Trade and Cooperation Agreement between the United Kingdom and the European Union, which outlines the future trading relationship between the United Kingdom and the European Union, was agreed in December 2020.

From a regulatory perspective, the United Kingdom’s withdrawal from the European Union has created significant complexity and potential risks. A basic requirement of European Union law relating to the grant of a marketing authorization for a medicinal product in the European Union is that the applicant is established in the European Union. Following the withdrawal of the United Kingdom from the European Union, marketing authorizations previously granted to applicants established in the United Kingdom are no longer valid for commercialization of the respective products in the European Union. Moreover, the scope of a marketing authorization for a medicinal product granted by the European Commission pursuant to the centralized procedure does not include the United Kingdom. In these circumstances, an authorization granted by competent United Kingdom authorities is required to place medicinal products on the United Kingdom market.

Any of these factors could significantly increase the complexity of our activities in the European Union and in the United Kingdom, could depress our economic activity and restrict our access to capital, which could have a material adverse effect on our business, financial condition and results of operations and reduce the price of our Ordinary Shares and Depositary Shares.

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The regulatory approval processes in the United States and Europeare lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our productcandidates, our business may be substantially harmed.

The time required to obtain approval for a product candidate by the EMA, the MHRA, the FDA and other comparable foreign regulatory authorities is unpredictable, and it typically takes many years following the commencement of preclinical studies and clinical trials, if approval is obtained at all, and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that we may never obtain regulatory approval for any product candidate we may seek to develop in the future. Neither we nor any current or future collaborator is permitted to market any drug product candidate in the United States until FDA grants regulatory approval of an NDA for such product candidate. Likewise, none of our product candidates may be marketed in the European Union, the United Kingdom, or any other country or jurisdiction until the applicable regulatory authority grants the product candidate marketing authorization approval as required under the laws of such country.

Our product candidates could fail to receive regulatory approval from the EMA, the MHRA, the FDA and other comparable foreign regulatory authorities for many reasons, including:

·	disagreement with the design or implementation of the clinical trials;
·	failure to demonstrate that a product candidate is safe and effective for its proposed indication;
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·	failure of clinical trial results to meet the level of statistical significance required for approval;
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·	failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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·	disagreement with our interpretation of data from preclinical studies or clinical trials;
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·	the insufficiency of data collected from clinical trials of our product candidates to support the submission<br> and filing of a NDA, BLA, MAA or other submission or to obtain regulatory approval;
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·	regulatory authorities may find deficiencies in good clinical practice, or GCP, compliance or may find our<br> record keeping, or the record keeping of our clinical trial sites, to be inadequate;
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·	disapproval of the manufacturing processes or facilities of third-party manufacturers with whom we or any<br> licensing partner contracts with for clinical and commercial supplies; or
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·	changes in approval policies or regulations that render the preclinical and clinical data insufficient for<br> approval.
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Of the large number of products in development, only a small percentage successfully complete the FDA, EMA, MHRA, or other comparable regulatory approval processes and are commercialized. The lengthy approval and marketing authorization process as well as the unpredictability of future clinical trial results may result in our or our licensing partners’ failing to obtain regulatory approval and marketing authorization to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects.

In addition, the EMA, the MHRA, the FDA and other comparable foreign regulatory authorities may require more information, including additional preclinical or clinical data to support approval, which may delay or prevent approval and any commercialization plans, or we or any licensing partner may decide to abandon the development program. If approval were to be obtained, regulatory authorities may approve any of our product candidates for fewer or more limited indications than is requested, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. In addition, if our product candidate produces undesirable side effects or safety issues, the regulatory authorities (the FDA, MHRA, EMA or a comparable foreign regulatory authority) may require the establishment of a specific risk management program, such as a Risk Evaluation and Mitigation Strategy, or REMS, which may, for instance, restrict distribution of the products and impose burdensome implementation requirements on us or any licensing partner. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

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Our product candidates may cause undesirableside effects or have other properties that could delay or prevent their regulatory approval and limit the commercial profile of an approvedlabel, and such side effects or other properties could result in significant negative consequences following any marketing approval ofany of our product candidates.

Undesirable side effects caused by any of our product candidates could cause us, our licensing partners, if any, or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the EMA, the MHRA, the FDA or other comparable foreign regulatory authority. Results of the clinical trials could reveal a high and unacceptable severity and prevalence of side effects or risks associated with a product candidate’s use. In such an event, our trials could be suspended or terminated and the regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment to clinical trials for our product candidates or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

Additionally, if undesirable side effects of our products are identified following marketing approval, a number of potentially significant negative consequences could result, including:

·	marketing of such product may be suspended;
·	a product recall or product withdrawal;
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·	regulatory authorities may withdraw approvals of such product or may require additional warnings on the label;
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·	the requirement to develop a REMS for each product or, if a strategy is already in place, to incorporate additional<br> requirements under the REMS, or to develop a similar strategy as required by a comparable foreign regulatory authority;
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·	the requirement to conduct additional post-market studies; and
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·	being sued and held liable for harm caused to subjects or patients.
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Consequently, our reputation and business operations may suffer.

Any of these events could prevent the achievement or maintaining of market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects.

Even if we receive regulatory approval of any product candidates,we will be subject to ongoing regulatory oversight and continued regulatory review, which may result in significant additional expenseand we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any ofour product candidates.

Our product candidates, if they receive regulatory approval, will be subject to the ongoing requirements of the EMA, the MHRA, the FDA and other regulatory agencies governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. These requirements include submissions of safety and other post-marketing information and reports, establishment registration, as well as continued compliance with cGMP for product manufacturing and GCP requirements for any clinical trials that we conduct post-approval. The safety profile of any product is closely monitored by the EMA, the MHRA, the FDA and other regulatory authorities after approval. If the EMA, the MHRA, the FDA or other regulatory authorities become aware of new safety information after approval of any of our products or product candidates, regulatory authorities may require labeling changes or establishment of a risk mitigation strategy or similar strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

In addition, manufacturers of drug and biological products and their facilities are subject to continual review and periodic inspections by the EMA, the MHRA, the FDA and other governmental regulatory authorities for compliance with cGMP and other applicable regulations. If a previously unknown problem with a product, such as adverse events of unanticipated severity or frequency, or a problem with the facility where the product is manufactured is discovered, a regulatory agency may impose restrictions on that product, the manufacturing facility or the party commercializing the product, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

·	issue warning letters or untitled letters;
·	mandate modifications to, or the withdrawal of, marketing and promotional materials or require corrective<br> information to be provided to healthcare professionals;
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·	require the violating party to enter into a consent decree, which can include the imposition of various fines,<br> reimbursements of inspection costs, required due dates for specific actions and penalties for non-compliance;
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| --- | | · | seek an injunction or impose civil or criminal penalties or monetary fines; | | --- | --- | | · | require revisions to the labeling, including limitations on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; | | --- | --- | | · | suspend, vary or withdraw regulatory approval; | | --- | --- | | · | require additional post-market clinical trials to assess the safety of the product; | | --- | --- | | · | suspend any ongoing clinical studies; | | --- | --- | | · | refuse to approve pending applications or supplements to applications filed by us or any licensing partner; | | --- | --- | | · | suspend or impose restrictions on operations, the products, manufacturing or ourselves; or | | --- | --- | | · | seize or detain products, refuse to permit the import or export of products or require a product recall. | | --- | --- |

In the European Union, the EMA may require an equivalent risk management plan, or RMP. Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

The occurrence of any of these events or penalties described above may inhibit our ability to generate revenue from product candidates that are commercialized by any of our licensing partners.

The FDA’s, EMA’s, MHRA’s, and other comparable foreign regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Obtaining and maintaining regulatory approvalof any of our other product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval ofour product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of our other product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, similar foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining similar foreign regulatory approvals and compliance with similar foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. We do not currently have any product candidates approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

We seek to establish agreements with potentiallicensing partners and collaborators and, if we are not able to establish them on commercially reasonable terms, we may have to alterour development and commercialization plans.

Our current development and commercialization strategy is to deploy our proprietary drug delivery technologies to formulate a compelling portfolio of novel first-in-class sustained release formulations of products with significant commercial potential for licensing to pharmaceutical company partners at proof-of-concept stage, which would potentially result in revenue generation from product royalty and/or milestone deals. We seek to work with licensing or collaboration partners for the development and commercialization of one or more of our product candidates. Future collaborators may include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies.

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We face significant competition in seeking appropriate licensing or collaboration partners. Whether we reach a definitive agreement will depend, among other things, upon our assessment of the partner’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed partner’s evaluation of a number of factors. Those factors may include the potential differentiation of our product candidate from competing product candidates, design or results of clinical trials, the likelihood of approval by the FDA or comparable foreign regulatory authorities and the regulatory pathway for any such approval, the potential market for the product candidate, the costs and complexities of manufacturing and delivering the product to patients and the potential of competing products. The partner may also consider alternative product candidates or technologies for similar indications that may be available for collaboration and whether such collaboration could be more attractive than the one with us for our product candidate.

These agreements are complex and time consuming to negotiate and document. Further, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future licensing and collaboration partners.

We may not be able to negotiate agreements with these potential partners on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs.

If we enter into agreements with a licensingor collaboration partner for the development and commercialization of our product candidates, our prospects with respect to those productcandidates will depend in significant part on the success of those collaborations.

We expect a material amount of our revenue in the future will be derived from licensing or collaboration agreements with other biopharmaceutical companies, research institutes and universities and similar agreements. We may enter into additional agreements with a licensing or collaboration partner for the development and commercialization of certain of our product candidates. If we enter into such agreements, we will have limited control over the amount and timing of resources that our partners will dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from these arrangements will depend on any future licensing partners’ ability to successfully perform the functions assigned to them in these arrangements. In addition, any future licensing or collaboration partner may have the right to abandon research or development projects and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed upon terms.

Agreements involving our product candidates pose a number of risks, including:

·	partners have significant discretion in determining the efforts and resources that they will apply to these<br> matters;
·	partners may not perform their obligations as expected;
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·	partners may not pursue development and commercialization of our product candidates or may elect not to continue<br> or renew development or commercialization programs, based on clinical trial results, changes in their strategic focus or available funding<br> or external factors, such as an acquisition, that divert resources or create competing priorities;
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·	partners may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial<br> or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical<br> testing;
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·	a partner with marketing and distribution rights to one or more products may not commit sufficient resources<br> to the marketing and distribution of such product or products;
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·	disagreements with partners, including disagreements over proprietary rights, contract interpretation or the<br> preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates,<br> might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any<br> of which would be time-consuming and expensive;
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·	partners may not properly maintain or defend our intellectual property rights or may use our proprietary information<br> in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose<br> us to potential litigation;
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·	partners may infringe the intellectual property rights of third parties, which may expose us to litigation<br> and potential liability; and
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·	agreements may be terminated and, if terminated, may result in a need for additional capital to pursue further<br> development or commercialization of the applicable product candidates.
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Agreements may not lead to development or commercialization of product candidates in the most efficient manner, or at all. If any future partners of ours is involved in a business combination, it could decide to delay, diminish or terminate the development or commercialization of any product candidate licensed to it by us.

The commercial success of any of our productcandidates is not guaranteed.

There can be no assurance that any of our product candidates currently in development will be successfully developed into any commercially viable product or products and/or be manufactured in commercial quantities at an acceptable cost or be marketed successfully and profitably. If we, or our partners, encounter delays at any stage, and fail successfully to address such delays, it may have a material adverse effect on our business, financial condition and prospects. In addition, our success will depend on the market’s acceptance of these products and there can be no guarantee that this acceptance will be forthcoming or that our technologies will succeed as an alternative to competing products. If a market fails to develop or develops more slowly than anticipated, we may be unable to recover the costs we may have incurred in the development of particular products and may never achieve profitable royalty or licensing revenues from that product.

The pharmaceutical and biotechnology industriesare highly competitive.

The development and commercialization of new drug products is highly competitive. Our business faces competition from a range of major and specialty pharmaceutical and biotechnology companies worldwide with respect to our product candidates, and will face competition in the future with respect to any product candidates that we may seek to develop or commercialize.

There are a number of pharmaceutical and biotechnology companies that currently market and sell products or are pursuing development of products that could compete with our product candidates. With respect to eRapa, there are no currently approved products with a familial adenomatous polyposis, or FAP, indication, though certain non-steroidal anti-inflammatory drugs may be prescribed off label. Tempest Therapeutics, Inc., Panbela Therapeutics, Inc. and Recursion Pharmaceuticals, Inc. are developing products for FAP. There are at least four products approved for the treatment of GIST, all of which are tyrosine kinase inhibitors, or TKIs. Cogent Biosciences, Inc. and GSK plc are developing new TKIs for the treatment of GIST. With respect to tolimidone, teplizumab, the first disease-modifying treatment of Type 1 diabetes, or T1D, has been approved for the delay of Stage 3 T1D and a number of companies are researching potentially disease-modifying approaches to T1D including stem cell therapies by Vertex Pharmaceuticals, Inc. and CRISPR Therapeutics AG and SAB Biotherapeutics, Inc. is developing an immunotherapeutic. In addition, the JDRF T1D Fund has invested in approximately 30 private companies working on a variety of approaches to the treatment of T1D.

Some of these competitive products and therapies are based on scientific approaches that are the same or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Our competitors in the biotechnology and pharmaceutical industries may have superior research and development capabilities, products, manufacturing capability or sales and marketing expertise. Many of our competitors may have significantly greater financial and human resources and may have more experience in research and development.

As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection of other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop products that are more effective, more widely used and less costly than our own product candidates, and may be more successful in commercializing their products.

We anticipate that we will face increased competition in the future as new companies enter our markets and alternative products and technologies become available. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, our programs.

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Changes in healthcare policies,laws and regulations, including legislative measures aimed at reducing healthcare costs, may impact our ability to obtain approval foror commercialize any of our future product candidates, if approved.

All aspects of our business, including research and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation and regulation. Changes in applicable U.S. federal and state laws and agency regulation, as well as foreign laws and regulations, could have a materially negative impact on our business. In the United States and in some other jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates or any potential future product candidates of ours, restrict or regulate post-approval activities, or affect our ability to profitably sell any product candidates for which we obtain marketing approval. Increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements. Congress also must reauthorize the FDA’s user fee programs every five years and often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA and industry stakeholders as part of this periodic reauthorization process. The next FDA user fee reauthorization package entered stakeholder negotiations in mid-2025, and any agreement is expected to be sent to Congress in early 2027 for purposes of initiating the legislative process. Reauthorization of the prescription drug user fee program must be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for NDAs and BLAs and other activities supported by user fees assessed against industry.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, Congress passed the ACA, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. We expect that changes or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard to health care access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States.

The Drug Supply Chain Security Act, or DSCSA, imposes obligations on manufacturers of pharmaceutical products related to product tracking and tracing. Other legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We are unsure whether additional legislative changes will be enacted, or whether the current regulations, guidance or interpretations will be changed, or whether such changes will have any impact on our business.

Additionally, there has been heightened governmental scrutiny in the United States of biopharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, state legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers, or PBMs, and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area. Then, in mid-2022, the Federal Trade Commission, or FTC, launched sweeping investigations into the practices of the PBM industry that appear to be contributing to additional federal and state legislative and regulatory proposals, as well as enforcement action and private litigation, targeting PBM operations, pharmacy networks, or financial arrangements. In February 2026, President Trump signed into law several PBM regulatory reforms as part of a federal budget package, including but not limited to requirements for PBMs to pass back 100% of rebates and fees to commercial health plan sponsors; to provide extensive informational disclosures related to patients’ coverage and benefits; and to accept only bona fide service fees from drug companies when providing services under Medicare Part D. The DOL also issued a proposed rule in January 2026 that would mandate specific PBM fee disclosures to self-insured plan fiduciaries under ERISA, which would allow plan fiduciaries to audit those PBM disclosures to confirm accuracy. In addition, in the last few years, several states have formed prescription drug affordability boards, or PDABs, with the authority to implement upper payment limits, or UPLs, on drugs sold in their respective jurisdictions. There are several pending federal lawsuits challenging the authority of states to impose UPLs, however.

In August 2022, the Inflation Reduction Act, or IRA, was signed into the law the IRA. The IRA includes multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the product’s price increases faster than the rate of inflation. This calculation is made on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. Any additional federal or state healthcare reform measures could limit the amounts that third-party payers will pay for future healthcare products and services, and, in turn, could significantly reduce the projected value of certain development projects and reduce our profitability.

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On May 12, 2025, the Trump Administration issued an Executive Order titled “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients”, outlining a plan to reduce prescription drug costs in the United States, which was followed by formal letters to major pharmaceutical companies in July 2025 outlining steps they must take to lower prescription drug costs to American patients and taxpayers. In the future, there will likely continue to be proposals relating to the reform of the United States healthcare system, some of which could further limit coverage and reimbursement of drug products, including our product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Our results of operations could be adversely affected by the ACA and by other health care reforms that may be enacted or adopted in the future.

Outside of the United States, particularly in the European Union, the coverage status and pricing of prescription pharmaceuticals and biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. Furthermore, the requirements may differ across the European Union Member States. To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed. Also, at national level, actions have been taken to enact transparency and anti-gift laws (similar to the U.S. Physician Payments Sunshine Act) regarding payments between pharmaceutical companies and healthcare professionals.

Coverageand adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for usto sell profitably, if approved.

Market acceptance and sales of any product candidates that we commercialize, if approved, will depend in part on the extent to which reimbursement for these products and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and private health insurers. Significant uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. Third-party payors decide which therapies they will pay for and establish reimbursement levels. Third-party payors in the United States often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis. One payor’s determination to provide coverage for a drug does not assure that other payors will also provide coverage for the drug. Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may incur significant costs to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our product candidates, in addition to the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost-effective.

Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier of its list of covered drugs, or formulary, it will be placed. The position on a payor’s formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products, and providers are unlikely to prescribe our products, unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products and their administration. Therefore, coverage and adequate reimbursement is critical to new medical product acceptance.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for our products can differ significantly from payor to payor. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product candidates, once approved.

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be available for any product that we may commercialize and, if reimbursement is available, what the level of reimbursement will be. Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug for which we obtain marketing approval. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop.

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We are subject to environmental laws andregulations that govern the use, storage, handling and disposal of hazardous materials and other waste products.

We are subject to environmental laws and regulations governing the use, storage, handling and disposal of hazardous materials and other waste products. We have health and safety policies and procedures in place to assess the risks associated with use of hazardous materials, and the assessment includes information for employees on how the substances should be used to avoid contamination of the environment and inadvertent exposure to themselves and their colleagues. Despite our precautions for handling and disposing of these materials, we cannot eliminate the risk of accidental contamination or injury. In the event of a hazardous waste spill or other accident, we could be liable for damages, penalties or other forms of censure. If we fail to comply with any laws or regulations, or if an accident occurs, we may have to pay significant penalties and may be held liable for any damages that result. This liability could exceed our financial resources and could harm our reputation. We may also have to incur significant additional costs to comply with current or future environmental laws and regulations. Our failure to comply with any government regulation applicable to our laboratory and the materials used in our laboratory may adversely affect our ability to develop, produce, market or partner any products we may commercialize or develop.

Our employees, principal investigators,consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standardsand requirements, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct by our employees, principal investigators, consultants and commercial partners. Misconduct by such parties could include intentional failures to comply with applicable regulations, provide accurate information to regulatory authorities, comply with manufacturing standards, comply with healthcare fraud and abuse laws and regulations, report financial information or data accurately, or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter employee misconduct, and the precautions we have taken to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

Unexpected facility shutdowns or system failures may occur andour disaster recovery plans may not be sufficient.

We depend on the performance, reliability and availability of our properties, machinery, and laboratory equipment and information technology systems. We may not be able to access our facilities as a result of events beyond our control, such as extreme weather conditions, quarantines, flood, fire, theft, terrorism and acts of God.

Further, any damage to or failure of our equipment and/or systems could also result in disruptions to our operations. A complete or partial failure of our information technology systems, or those of our CROs and other third parties on which we rely, or corruption of data could result in our inability to access information that we need in order to meet our obligations to our customers or a breach of confidentiality with respect to our or our customers’ proprietary information. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Our disaster recovery plans may not adequately address every potential event and our insurance policies may not cover any loss in full or in part (including losses resulting from business interruptions) or damage that we suffer fully or at all. The occurrence of one or more of these events could have a material adverse effect on our business, financial position, reputation or prospects, and might lead to a claim for damages.

Our business may be adversely affected by economic conditionsand current economic weakness.

Any economic downturn either globally, regionally or locally in any country in which we operate may have an adverse effect on the demand for any products derived from our product candidates. A more prolonged economic downturn may lead to an overall decline in our sales, limiting our ability to generate a profit and positive cash flow. The markets in which we expect the products to be offered are directly affected by many national and international factors that are beyond our control, such as political, economic, currency, social and other factors.

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Inadequatefunding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel,prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies fromperforming normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, its ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the FDA, the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Future legislative and regulatory proposals may materially impact the ability of the FDA and other regulatory agencies to operate as they have historically operated. We cannot be sure whether additional legislative changes or executive orders will be enacted, or whether any of the FDA’s regulations, guidances or interpretations will be changed, or what the impact of such changes on the agency and its scientific review staff, if any, may be. For example, the FDA has experienced significant and rapid fluctuations in leadership and scientific review personnel, which may be key contributing factors in multiple reported delays in agency decision making on marketing applications and agency requests for additional data that are inconsistent with prior regulatory feedback. Additionally, the next FDA user fee reauthorization package entered stakeholder negotiations in mid-2025, and any agreement will be sent to Congress in early 2027. Reauthorization of the prescription drug user fee program must be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for NDAs or BLAs, and to other activities supported by user fees assessed against industry.

Disruptions at the FDA and other agencies may slow the time necessary for clinical trial applications and/or marketing applications for new drugs to be reviewed or approved, which would adversely affect our business. For example, political disputes in Congress may result in a shutdown of the U.S. government and, in such cases, certain regulatory agencies, such as the FDA and the SEC, may have to furlough critical staff and stop critical activities during that period. Government shutdowns or slowdowns can increase the time needed for an agency to complete its review or make final approvals or other administrative decisions. If a prolonged government or slowdown shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Future government shutdowns or slowdowns could also result in delays in our interactions with the SEC and other government agencies, which could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Geopolitical risks could result in increasedmarket volatility and uncertainty, which could negatively impact our business, financial condition and results of operation.

The uncertain nature, scope, magnitude, and duration of hostilities stemming from geopolitical conflicts, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyberattacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain. Any disruption in our supply chain could reduce our revenue and adversely impact our financial results. Such a disruption could occur as a result of any number of events, including, but not limited to, military conflicts, geopolitical developments, war or terrorism, including the ongoing conflicts in Ukraine and Israel and Gaza, ongoing tensions with the Russian Federation and China, and disruptions in utility and other services. Any inability to obtain adequate deliveries or any other circumstance that would require us to seek alternative sources of supply or to manufacture, assemble, and test such components internally could significantly delay our ability to ship our products, which could damage relationships with current and prospective customers and could harm our reputation and brand and could adversely affect our business, financial condition, and results of operations.

We do not and cannot know if the ongoing conflicts and the economic sanctions imposed as a result of the conflicts, could escalate and result in broader economic and security concerns which could adversely affect our business. It is not possible to predict the broader consequences of these conflicts, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could have a material adverse effect on our business, financial condition and results of operations.

We are exposed to the risks of doing business internationally.

We currently, and may continue to operate outside of the United Kingdom. These international operations are subject to a number of risks inherent in operating in different countries. These include, but are not limited to, risks regarding:

·	currency exchange rate fluctuations;
·	restrictions on repatriation of earnings;
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| --- | | · | difficulty of effective enforcement of contractual provisions in local jurisdictions; | | --- | --- | | · | inadequate intellectual property (including confidentiality) protection in foreign countries; | | --- | --- | | · | public health epidemics or outbreaks, such as COVID-19; | | --- | --- | | · | trade-protection measures (including tariffs), import or export licensing requirements and fines, penalties or suspension or revocation of export privileges; and | | --- | --- | | · | changes in a specific country’s or a region’s political or economic conditions, including the implications of the United Kingdom’s withdrawal from the European Union. | | --- | --- |

The occurrence of any of these events or conditions could adversely affect our ability to increase or maintain our operations in various countries.

Tariff policies and potential countermeasures could increaseour costs and disrupt our supply chain, which could negatively impact the results of our operations.

U.S. President Trump has increased, and has indicated his willingness to continue to increase, the use of tariffs by the United States to accomplish certain United States policy goals. On April 2, 2025, a universal 10% tariff on all United States imports was announced, with higher tariffs ranging from 11% to 50% on imports from 57 countries. Tariff rates have since fluctuated as a result of bilateral negotiations and legal challenges, and product-specific tariffs have also been implemented. On February 20, 2026, the United States Supreme Court ruled against the Trump administration’s use of tariffs under the International Emergency Economic Powers Act, or IEEPA, and U.S. Customs and Border Protection halted collections of IEEPA tariffs on February 24, 2026. However, the decision creates uncertainty related to various aspects of the tariffs previously collected under the IEEPA, including whether, and if so, how, companies may be able to recover any portion of IEEPA tariffs previously paid. Additionally, in response to the U.S. Supreme Court ruling, the Trump administration imposed a new worldwide tariff effective for 150 days from February 24, 2026. These ongoing measures have led to retaliatory tariffs from affected countries and have contributed to increased trade tensions and economic uncertainty. Such tariffs and any countermeasures could increase the cost of raw materials and components necessary for our operations, disrupt our supply chain and create additional operational challenges. Further, it is possible that government policy changes and related uncertainty about policy changes could increase market volatility. Because of these dynamics, we cannot predict the impact of any future changes to the United States’ or other countries’ trading relationships or the impact of new laws or regulations adopted by the United States or other countries on our business. Such changes in tariffs and trade regulations could have a material adverse effect on our financial condition, results of operations and cash flows.

We are exposed to risks related to currencyexchange rates.

We currently conduct a portion of our operations outside of the United Kingdom. Because we use the British pound sterling as our financial statement reporting currency, changes in currency exchange rates have had and could have a significant effect on our operating results when our operating results are translated from the local currency into the British pound sterling. Exchange rate fluctuations between local currencies and the British pound sterling create risk in several ways, including the following: weakening of the British pound sterling, as seen, for example, following the results of the Brexit referendum, may increase the British pound sterling cost of overseas research and development expenses and the cost of sourced product components outside the United Kingdom; strengthening of the British pound sterling may decrease the value of our revenues denominated in other currencies; the exchange rates on non-sterling transactions and cash deposits can distort our financial results; and commercial pricing and profit margins are affected by currency fluctuations. Future changes in currency exchange rates could have a material adverse effect on our financial results.

We are subject to cybersecurity risks, includingthe misappropriation or compromise of our information, our information technology systems, and other cybersecurity incidents that mayresult in operational or service disruption, harm to our reputation, litigation, fines, penalties and liabilities, and the incurrenceof costs in an effort to minimize those risks.

In the normal course of conducting our business, we collect and store sensitive data on our networks and on networks and platforms of third parties upon which we rely, including intellectual property, personal information of our employees, and our proprietary business information and that of our customers, vendors and business partners. Despite the security measures we have in place and any additional measures we may implement in the future to safeguard our systems and to mitigate potential security risks, our facilities and systems, and those of our third-party service providers, could be vulnerable to cybersecurity incidents, computer viruses, lost or misplaced data, programming errors, human errors, acts of vandalism, viruses, bugs, worms, or other malicious codes, malware, including as a result of advanced persistent threat intrusions, and other attacks by computer hackers, cracking, application security attacks, social engineering, including through phishing attacks, supply chain attacks and vulnerabilities through our third-party service providers, denial-of-service attacks, such as credential stuffing, credential harvesting, personnel misconduct or error, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, and other similar threats. Any steps we take to deter, identify, and mitigate these risks may not be successful and may cause us to incur increasing costs.

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Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel, such as through theft or misuse, sophisticated nation states, and nation-state-supported actors. In particular, ransomware attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions, delays, or outages in our operations, loss of data, including sensitive customer information, loss of income, significant extra expenses to restore data or systems, reputational loss and the diversion of funds.

Some threat actors also now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors, for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we, the third parties upon which we rely, and our customers may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain and ability to produce, sell and distribute our goods and services.

While we take steps to detect and remediate vulnerabilities, we may not be able to detect and remediate all vulnerabilities because the threats and techniques used to exploit such vulnerabilities change frequently and are often sophisticated in nature. Therefore, such vulnerabilities could be exploited but may not be detected until after a cybersecurity incident has occurred, if at all. Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.

We rely on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud-based infrastructure, encryption and authentication technology, employee email, and other functions. We also rely on third-party service providers to assist with our clinical trials, provide other products or services, or otherwise to operate our business. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a cybersecurity incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems, including our services, or the third-party information technology systems that support us and our services.

Any of the previously identified or similar threats could cause a cybersecurity incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive data or our information technology systems, or those of the third parties upon whom we rely. A cybersecurity incident or other interruption could disrupt our ability, and that of third parties upon whom we rely, to provide our products and services and conduct clinical trials.

The costs related to significant cybersecurity incidents or disruptions could be material and cause us to incur significant expenses. If the information technology systems of our CROs, clinical sites, and other contractors and consultants become subject to disruptions or cybersecurity incidents, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.

If any such incidents were to occur and cause interruptions in our operations, it could result in a disruption of our business and development programs. For example, the loss of clinical trial data from completed or ongoing clinical trials for a product candidate could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data, or may limit our ability to effectively execute a product recall, if required in the future. To the extent that any disruption or cybersecurity incident were to result in the loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of any product candidates could be delayed. Applicable data privacy and security obligations may require us to notify relevant stakeholders, regulatory authorities, and other individuals of cybersecurity incidents, and take other remedial measures. Such disclosures and measures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences. Any such event could also result in legal claims or proceedings, liability under laws that protect the privacy of personal information and significant regulatory penalties, and damage to our reputation and a loss of confidence in us and our ability to conduct clinical trials, which could delay the clinical development of our product candidates.

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We may incur substantial costs in our effortsto comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such lawsand regulations may harm our business and operations.

We maintain a large quantity of sensitive information, including confidential business and personal information in connection with the conduct of our clinical trials and related to our employees, and we are subject to laws and regulations governing the privacy and security of such information. In the United States, there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure and protection of personal information, including federal and state health information privacy laws, federal and state security breach notification laws, and federal and state consumer protection laws. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues, including with respect to regulatory enforcement and private litigation, which may affect our business and is expected to increase our compliance costs and exposure to liability. In the United States, numerous federal and state laws and regulations could apply to our operations or the operations of our partners, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws and regulations, that govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH and regulations promulgated thereunder. Depending on the facts and circumstances, we could be subject to significant penalties if we obtain, use, or disclose, or are subject to an actual or alleged data breach regarding, individually identifiable health information in a manner that is not authorized or permitted by HIPAA.

In addition, various U.S. states have enacted privacy and security laws and regulations, and such laws and regulations vary from state to state, constantly evolve, and remain subject to significant change. In some cases, such laws and regulations can impose more restrictive requirements than HIPAA and other U.S. federal laws, thus complicating compliance efforts. By way of example, California has enacted the California Consumer Privacy Act, or CCPA, which went into effect in January of 2020. The CCPA established a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for California residents, requiring covered businesses to provide new disclosures to California residents, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for covered businesses that fail to implement reasonable security procedures and practices to prevent data breaches. Additionally in 2020, California voters passed the California Privacy Rights Act, or CPRA, which went into full effect on January 1, 2023. The CPRA significantly amends the CCPA, resulting in further complexity, additional costs and expenses relating to compliance efforts and additional potential for harm and liability for failure to comply. Among other things, the CPRA established a new regulatory authority, the California Privacy Protection Agency, which is tasked with enacting new regulations under the CPRA and has expanded enforcement authority. In addition to California, numerous other U.S. states have enacted or are considering enacting similar data privacy and consumer protection legislation, increasing compliance complexity, and increasing risks of failures to comply. While these enacted and pending state privacy laws, like the CCPA, also exempt some data processed in the context of clinical trials (and most also exempt employee and business personal data), these developments further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon whom we rely. The scope and enforcement of these laws is uncertain and subject to rapid change. For example, increasing concerns about health information privacy have recently prompted the federal government to take a newly expansive view of the scope of existing privacy laws and regulations. Congress and some states are considering (and in some cases have passed) new laws and regulations that further and more broadly protect the privacy and security of personal health information.

The interplay of federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and our clients and potentially exposing us to additional expense, adverse publicity and liability. Further, as regulatory focus on privacy issues continues to increase and laws and regulations concerning the protection of personal information expand and become more complex, these potential risks to our business could intensify.

In the European Union, the General Data Protection Regulation (EU) 2016/679, or GDPR, lays down the legal framework for data protection and privacy. The GDPR applies directly in all European Union member states (until December 31, 2020, this included the United Kingdom) and applies to companies with an establishment in the European Economic Area, or EEA, and to certain other companies not in the EEA that process personal data in relation to offering or providing goods or services to individuals located in the EEA, or monitor the behavior of individuals located in the EEA. In the United Kingdom, the GDPR has been implemented into United Kingdom domestic law, with effect from January 1, 2021, pursuant to the European Union (Withdrawal) Act 2018 and as adapted by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (as amended), which makes some minor technical amendments to ensure the GDPR, or the UK GDPR, is operable in the United Kingdom. The UK GDPR is also supplemented by the Data Protection Act 2018. United Kingdom and European Union data protection law is therefore generally aligned. The GDPR and UK GDPR implement stringent operational requirements for both controllers and processors of personal data, including, for example, expanded disclosure requirements about how personal information is to be used, limitations on retention of information, increased requirements pertaining to health data and pseudonymized (i.e., key-coded) data, increased cyber security requirements, new rights for individuals to be “forgotten” and rights to data portability, as well as enhanced existing rights (e.g., access requests), mandatory data breach notification requirements and higher standards for controllers to demonstrate that they have obtained a valid legal basis for certain data processing activities when compared against the previous legal framework for data protection and privacy which was replaced by GDPR when it came into effect on May 25, 2018. In particular, medical or health data, genetic data and biometric data are all classified as “special category” data under the GDPR and the UK GDPR, and afforded greater protection and require additional compliance obligations. Further, the GDPR provides that European Union member states may make their own further laws and regulations in relation to the processing of genetic, biometric or health data, which could result in differences between member states, limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial condition.

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The GDPR and the UK GDPR also regulate the overseas transfer of personal data subject to the GDPR or UK GDPR to so-called third countries that have not been found by the European Commission or the United Kingdom government, respectively, to provide an adequate level of data protection. The GDPR and UK GDPR only permit exports of personal data outside of the European Union and United Kingdom, respectively, to “non-adequate” countries where there is a suitable data transfer mechanism in place to safeguard personal data or where a derogation applies for a specific situation. As from 2020, legal developments in Europe have created complexity and uncertainty regarding such transfers. For instance, on July 16, 2020, the Court of Justice of the European Union, or CJEU, invalidated, the E.U.-U.S. Privacy Shield Framework, or the Privacy Shield, under which personal data could be transferred from the EEA to U.S. entities who had self-certified under the Privacy Shield scheme. However, on July 10, 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring data from the European Union to the United States – the E.U.-U.S. Data Privacy Framework, which provides E.U. individuals with several new rights, including the right to obtain access to their data, or obtain correction or deletion of incorrect or unlawfully handled data, and allows U.S. companies to self-certify to the U.S. Department of Commerce their compliance with a set of agreed privacy principles in order to freely receive E.U. personal data. The adequacy decision followed the signing of an executive order in the U.S. introducing new binding safeguards to address the points previously raised by the CJEU judgment. Notably, the new obligations were geared to ensure that data can be accessed by U.S. intelligence agencies only to the extent necessary and proportionate and to establish an independent and impartial redress mechanism to handle complaints from Europeans concerning the collection of their data for national security purposes. The UK-US Data Bridge (the United Kingdom extension to the Data Privacy Framework) came into force shortly after the E.U. – U.S. Data Privacy Framework, and provides UK individuals with similar rights. Organizations that have not certified under the under the E.U. – U.S. Data Privacy Framework (or the UK-US Data Bridge) may utilize another data transfer mechanism, such as the EU Commission approved Standard Contractual Clauses, or the United Kingdom equivalent, respectively. The European Commission and the UK government will continually review developments in the United States along with their adequacy decisions. Consequently, there is some risk of any data transfers from the European Union and United Kingdom being halted. In addition, in June of 2021, the European Commission issued a decision, which was subsequently renewed on December 19, 2025, that the United Kingdom ensures an adequate level of protection for personal data transferred under the E.U. GDPR from the European Union to the United Kingdom, meaning that organizations in the EEA can send personal data to the United Kingdom under the E.U. GDPR without additional safeguards. The amended adequacy decision has a limited duration of six years. Adequacy decisions can be adapted or even withdrawn in the event of developments affecting the level of protection in the applicable jurisdiction.

Failure to comply with European Union laws, or equivalent laws in the United Kingdom, including failure under the GDPR and UK GDPR, Data Protection Act 2018, ePrivacy Directive, as implemented into national law by European Union member states and the United Kingdom, and other laws relating to the security of personal data may result in fines up to €20 million (or £17.5 million under the UK GDPR) or up to 4% of the total worldwide annual turnover of the preceding financial year, if greater, and other administrative penalties including criminal liability, which may be onerous and adversely affect our business, financial condition, results of operations and prospects. The GDPR and UK GDPR also confer a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR and UK GDPR, respectively. Failure to comply with the GDPR, UK GDPR, and related laws may lead to increased risk of private actions from data subjects and consumer not-for-profit organizations, including a new form of class action that is available under the GDPR and UK GDPR. Further, if we have to rely on third parties to carry out services for us, which includes processing personal data on our behalf, we are required under GDPR and UK GDPR to enter into contractual arrangements containing contractual obligations prescribed by GDPR and UK GDPR, including to ensure, for example, that these third parties only process such data according to our instructions and have sufficient security measures in place. Any failure to do this, or any security breach or non-compliance with our contractual terms or breach of applicable law by such third parties could result in enforcement actions, litigation, fines and penalties or adverse publicity and could cause customers to lose trust in us, which would have an adverse impact on our reputation and business. Future customers or other service providers may respond to these evolving laws and regulations by asking us to make certain privacy or data-related contractual commitments that we are unable or unwilling to make. This could lead to the loss of future customers or other business relationships.

We may in the future be unable to retainand recruit qualified scientists, keyexecutives and directors, keyemployees or key consultants,may delay our development efforts or otherwise harm our business.

Our future development and prospects depend to a large degree on the experience, performance and continued service of our senior management team, including members of our Board of Directors. We have invested in our management team at all levels. We have entered into contractual arrangements with our directors and senior management team with the aim of securing the services of each of them. However, retention of these services or the identification of suitable replacements cannot be guaranteed. There can be no guarantee that the services of the current directors and senior management team will be retained, or that suitably skilled and qualified individuals can be identified and employed, which may adversely impact our ability to develop our technologies and/or provide our services at the time requested by our customers or our ability to market our services and technologies, and otherwise to grow our business, could be impaired. The loss of the services of any of the directors or other members of the senior management team and the costs of recruiting replacements may have a material adverse effect on us and our commercial and financial performance.

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The ability to continue to attract and retain employees with the appropriate expertise and skills also cannot be guaranteed. Finding and hiring any additional personnel and replacements could be costly and might require us to grant significant equity awards or other incentive compensation, which could adversely impact our financial results, and there can be no assurance that we will have sufficient financial resources to do so. Effective product development and innovation, upon which our success is dependent, is in turn dependent upon attracting and retaining talented technical and scientific personnel, who represent a significant asset and serve as the source of our technological and product innovations. If we are unable to hire, train and retain such personnel in a timely manner, the development and introduction of our products could be delayed and our ability to sell our products and otherwise to grow our business will be impaired and the delay and inability may have a detrimental effect upon our performance.

Artificial intelligence presents risks and challenges that canimpact our business including by posing security risks to confidential information, proprietary information, and personal data.

Issues in the development and use of artificial intelligence, combined with an uncertain regulatory environment, may result in reputational harm, liability, or other adverse consequences to our business operations. We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security. Our vendors may incorporate generative artificial intelligence tools into their offerings, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit us or our vendors’ ability to maintain an adequate level of service and experience. Additionally, artificial intelligence algorithms may be flawed, datasets may be insufficient or biased, and ineffective artificial intelligence development or deployment could lead to other compliance violations. If we, our vendors, or our third-party partners experience an actual or perceived violation of applicable privacy or data protection, intellectual property, or other laws or regulations, or a cybersecurity incident due to the use of generative artificial intelligence, we could be subject to regulatory fines, investigations, enforcement actions, penalties and other liabilities, claims for damages from affected individuals, and we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our privacy or cybersecurity measures could be harmed. Several jurisdictions around the globe, including Europe and the U.S., have already proposed or enacted laws governing artificial intelligence, and we may need to commit significant resources to maintain business practices that comply with the evolving regulatory landscape. Our competitors or other third parties may incorporate artificial intelligence into their products more quickly and successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.

Risks Related to Global Public Health Concerns

Public health crises, such as the COVID-19pandemic, have had, and could in the future have, a negative effect on our business.

Pandemics or disease outbreaks, such as the COVID-19 pandemic, have created and may continue to create significant volatility, uncertainty and economic disruption in the markets we operate in and may negatively impact business and healthcare activity globally. In response to the COVID-19 pandemic, governments around the world imposed measures designed to reduce the transmission of COVID-19 and individuals continue to respond to the fear of contracting COVID-19. It is not possible to accurately predict the extent of the adverse effects of the pandemic on our business. However, we have experienced certain impacts and may experience others which, if they continue for an extended period of time, could have material adverse effects on our operations and the execution of our business plans. Individuals defer seeking treatment, physicians have fewer in-person meetings to recruit and enroll patients, and recruited patients are hindered by restrictions in traveling to and accessing clinical sites. In addition, resources at hospitals have been diverted to dealing with the pandemic, causing delays in scheduling screening evaluations, implant procedures, and follow-up monitoring visits. As a result of the foregoing factors, the expected timeline for data readouts of our clinical trials may be negatively impacted, which would adversely affect our business.

The extent to which fear of exposure to or actual effects of COVID-19, new variants, disease outbreak, epidemic or a similar widespread health concern impacts our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the speed and extent of geographic spread of the disease, the duration of the outbreak, travel restrictions, the efficacy of vaccination and treatment; impact on the United States, United Kingdom and international healthcare systems, the United States, United Kingdom and worldwide economy; the timing, scope and effectiveness of United States, United Kingdom and international governmental response; and the impact on the health, well-being and productivity of our employees. To the extent that pandemics or disease outbreak, such the COVID-19 pandemic, adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

Risks Related to Our Intellectual Property

Our success depends in part on our abilityto protect rights in our intellectual property, which cannot be assured.

Our success and ability to compete effectively are in large part dependent upon exploitation of proprietary technologies and products that we have developed internally or have acquired or in-licensed. To date, we have relied on copyright, trademark and trade secret laws, as well as confidentiality procedures, non-compete and/or work for hire invention assignment agreements and licensing arrangements with our employees, consultants, contractors, customers and vendors, to establish and protect our rights to our technology and, to the best extent possible, control the access to and distribution of our technology, software, documentation and other proprietary information, all of which offer only limited protection. Where we have the right to do so under our agreements, we seek to protect our proprietary position by filing patent applications in the United States, the United Kingdom and worldwide related to our novel technologies and products that are important to our business. The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and have in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patents, including those patent rights licensed to us by third parties, are highly uncertain. There can be no assurance that:

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| --- | | · | the scope of our patents provides and will provide us with exclusivity with respect to any or all of our product candidates and technologies, as well as any other technologies and/or products that address the same problems as our technologies and product candidates by a different means, whether in the same manner as us or not; | | --- | --- | | · | pending or future patent applications will be issued as patents; | | --- | --- | | · | our patents, and/or those patents to which we are licensed, are and will remain valid and enforceable and will not be subject to invalidity or revocation proceedings and that such proceedings will not result in a complete or partial loss of rights; | | --- | --- | | · | our entitlement to exploit patents from time to time (including patents registered solely in our name or our affiliates’ name or in the joint names of us or an affiliate and a third party or patents which are licensed to us) is and will be sufficient to protect our core intellectual property rights against third parties, our commercial activities from competition or to support comprehensively our ability to develop and market our proposed products either now or in the future; | | --- | --- | | · | the lack of any particular patents or rights to exploit any particular patents, and the scope of our patents, will not have a material adverse effect on our ability to develop and market our proposed product candidates, either now or in the future; | | --- | --- | | · | we have or will have the resources to pursue any infringer of: (i) patents registered in our name (whether solely or jointly with a third party) from time to time; or (ii) patents licensed to us where we or an affiliate have the financial responsibility to bring such infringement actions pursuant to the relevant license agreement; | | --- | --- | | · | we will develop technologies or product candidates which are patentable, either alone or in conjunction with third parties; | | --- | --- | | · | the ownership, scope or validity of any patents registered in our name (either solely or jointly) from time to time will not be challenged by third parties, including parties with whom we, or any affiliate, have entered into collaboration projects or co-ownership arrangements and that any such challenge will not be successful; | | --- | --- | | · | any patent or patent application owned solely or jointly by us will not be challenged on grounds that we failed to identify the correct inventors or that we failed to comply with our duty of disclosure to the United States Patent and Trademark Office or any equivalent office in a foreign jurisdiction having a disclosure requirement; | | --- | --- | | · | any issued patent in our sole or joint name from time to time will not be challenged in one or more post-grant proceedings, including but not limited to inter partes review, derivation proceedings, interferences, and that like; and that any such challenge will not result in a complete or partial loss of rights to such issued patent or patents; | | --- | --- | | · | any patent applications in our sole or joint name from time to time will not be opposed by any third party, including parties to collaboration, co-existence and any other contractual relationship with us or any of its members; | | --- | --- | | · | the license agreements between us and third parties are and will be valid and subsisting in the future or until their expiry dates, and that we have complied with our contractual obligations under the license agreements; | | --- | --- | | · | all intellectual property capable of being commercialized that is or has been generated pursuant to collaboration agreements between us and third parties will be or has been identified; | | --- | --- | | · | all intellectual property generated pursuant to collaboration agreements and to which we have a contractual entitlement or generated by employees has been lawfully assigned into our sole name (or to one of our subsidiaries); | | --- | --- | | · | in respect of all intellectual property generated pursuant to a collaboration agreement between us and a third party to which we and that third party have a joint contractual entitlement, that such intellectual property has been lawfully assigned into joint names and the rights between us and that third party are properly regulated by a co-ownership agreement; and | | --- | --- | | · | beyond contractual warranties, the licensors of intellectual property to us or our affiliates own the relevant patents and that those patents have not and will not be the subject of, or subject to, infringement, invalidity or revocation actions. | | --- | --- |

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The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside of the United Kingdom and United States. The rights already granted under any of our currently issued patents and those that may be granted under future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking. If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and commercialize technology and products similar or superior to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

With respect to patent rights, we do not know whether any of the pending patent applications for any of our licensed compounds will result in the issuance of patents that protect our technology or products, or which will effectively prevent others from commercializing competitive technologies and products. Although we have a number of issued patents covering our technology, our pending applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Further, the examination process may require us to narrow the claims, which may limit the scope of patent protection that may be obtained. Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or have licensed from third parties may be challenged in the courts or patent offices in the European Union, United Kingdom, the United States and other foreign jurisdictions. Overall, such challenges may result in the loss of patent protection, the narrowing of claims in such patents, or the invalidity or unenforceability of such patents, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection for our technology and products. Protecting against the unauthorized use of our patented technology, trademarks and other intellectual property rights is expensive, difficult and may in some cases not be possible. In some cases, it may be difficult or impossible to detect third party infringement or misappropriation of our intellectual property rights, even in relation to issued patent claims, and proving any such infringement may be even more difficult.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of inventions made in the course of our development and commercialization activities before it is too late to obtain patent protection on them. Further, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions of patent terms where they are available in any countries where we are prosecuting patents. However, the applicable authorities, including the FDA in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. Changes in either the patent laws or interpretation of the patent laws in the European Union, the United Kingdom, the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United Kingdom or the United States, and these foreign laws may also be subject to change. Publication of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications typically are not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

Previously, in the United States, assuming the other requirements for patentability are met, the first to make the claimed invention was entitled to the patent. Outside the United States, the first to file a patent application is entitled to the patent. In March 2013, the United States transitioned to a “first to file” system in which the first inventor to file a patent application will be entitled to the patent. Under either the previous or current system, third parties will be allowed to submit prior art prior to the issuance of a patent by the United States Patent and Trademark Office, and may become involved in opposition, derivation, reexamination, inter-partes review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, which could adversely affect our competitive position with respect to third parties.

Our commercial success depends, in part, upon our not infringingintellectual property rights owned by others.

Although we believe that we have proprietary platforms for our technologies and product candidates, we cannot determine with certainty whether any existing third party patents or the issuance of any third party patents in the future would require us to alter our technology, obtain licenses or cease certain activities. We may become subject to claims by third parties that our technology infringes their intellectual property rights, in which case we will have no option other than to defend the allegation, which may be possible to resolve through negotiation or which might result in court proceedings. An adverse outcome in any of these circumstances is that we might be subject to significant liabilities, be required to cease using a technology or to pay license fees (both prospectively and retrospectively); and may be subject to the payment of significant damages. We could incur substantial costs in any litigation or other proceedings relating to patent rights, even if it is resolved in our favor. If the proceedings occur in the United States, it is likely that we will be responsible for our own legal costs, no matter the outcome of the litigation. In contrast, in the United Kingdom, the losing party typically is ordered to pay the winning party’s costs, although it is rare to have a complete recovery of all costs from the losing side. Some of our competitors may be able to sustain the costs of complex litigation more effectively or for a longer time than we can because of their substantially greater resources. In addition, uncertainties or threatened or actual disputes relating to any patent, patent application or other intellectual property right (including confidential information) could have a material adverse effect on our ability to market a product, enter into collaborations in respect of the affected products, or raise additional funds.

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The policing of unauthorized use of our patented technologies and product candidates is difficult and expensive. There can be no assurance that the steps we take will prevent misappropriation of, or prevent an unauthorized third party from obtaining or using, the technologies, know-how and products we rely on. In addition, effective protection may be unavailable or limited in some jurisdictions. Any misappropriation of our proprietary technology, product candidates and intellectual property could have a negative impact on our business and our operating results. Litigation may be necessary in the future to enforce or protect our rights or to determine the validity or scope of the proprietary rights of others. Litigation could cause us to incur substantial costs and divert resources and management attention away from our daily business and there can be no guarantees as to the outcome of any such litigation. In addition, a defendant in any such litigation may counterclaim against us, resulting in additional time and expense to defend against such a counterclaim, which defense may not be successful.

We may become involved in lawsuits to protector enforce our intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe on our patents or misappropriate or otherwise violate our intellectual property rights. To counter infringement or unauthorized use, litigation may be necessary in the future to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of our own intellectual property rights or the proprietary rights of others. This can be expensive and time consuming. Many of our current and potential competitors have the ability to dedicate substantially greater resources to defend our intellectual property rights than we can. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs and diversion of management resources, which could harm our business and financial results. In addition, in an infringement proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Third parties may initiate legal proceedingsalleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a materialadverse effect on the success of our business.

Our commercial success depends upon our ability and the ability of our collaborators and licensing partners to develop, manufacture, market and sell our product candidates, and to use our proprietary technologies without infringing the proprietary rights of third parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and commercializing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, in any such proceeding or litigation, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Any claims by third parties that we have misappropriated our confidential information or trade secrets could have a similar negative impact on our business.

We may be subject to claims that our employees have wrongfullyused or disclosed alleged trade secrets of their former employers.

Many of our employees, including our senior management, were previously employed at other biotechnology or pharmaceutical companies. Some of these employees, including members of our senior management, executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. We are not aware of any threatened or pending claims related to these matters or concerning the agreements with our senior management, but in the future litigation may be necessary to defend against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a potential distraction to management.

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If we are unable to protect the confidentiality of our tradesecrets, our business and competitive position could be harmed.

In addition to seeking patents for some of our technology and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. In addition, a court may determine that we failed to take adequate steps to protect our trade secrets, in which case it may not be possible to enforce our trade secret rights. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some may be less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.

We may face potential product liability,and, if successful claims are brought against us, we may incur substantial liability and costs. If the use of our product candidates harmspatients or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could berevoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.

In carrying out our activities, we may potentially face contractual and statutory claims, or other types of claims from customers, suppliers and/or investors. In addition, we are exposed to potential product liability risks that are inherent in the research, development, production and supply of products. Subjects enrolled in our clinical trials, consumers, healthcare providers or other persons administering or selling products based on our and our collaborators’ technology may be able to bring claims against us based on the use of such products. If we cannot successfully defend ourselves against claims that any product candidates commercialized caused injuries, we could incur substantial costs and liabilities. Irrespective of their merits or actual outcome, liability claims may result in:

·	decreased demand for any product candidates that we may develop;
·	withdrawal of clinical trial participants;
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·	termination of clinical trials;
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·	significant negative media attention and injury to our reputation;
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·	significant costs to defend the related litigation;
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·	substantial monetary awards to trial subjects or patients;
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·	loss of revenue;
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·	diversion of management and scientific resources from our business operations; and
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·	the inability to commercialize any products that we may develop.
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While we have obtained product liability coverage, our insurance coverage may not be sufficient to cover our entire product liability related expenses or losses and may not cover us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and, in the future, we may not be able to maintain insurance coverage at a reasonable cost, in sufficient amounts or upon adequate terms to protect us against losses due to product liability. If we determine that it is prudent to increase our product liability, we may be unable to obtain this increased product liability insurance on commercially reasonable terms or at all. Large judgments have been awarded in class action or individual lawsuits based on drugs that had unanticipated side effects, including side effects that may be less severe than those of our products. A successful product liability claim or series of claims brought against us could cause the price of the Ordinary Shares and/or Depositary Shares to decline and, if judgments exceed our insurance coverage, could decrease our cash and have a material adverse effect our business, results of operations, financial condition and prospects.

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Risks Related to our Relationships with ThirdParties

We rely on third parties to conduct ourpreclinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines,we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.

We are, and may continue to be, reliant on other parties for the successful development and commercialization of many of our product candidates. We have in the past, and continue to rely upon, CROs and clinical investigators for the conduct of our clinical trials and upon contract laboratories for execution of our preclinical studies, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs or collaboration partners does not relieve us of our regulatory responsibilities. We also rely on third parties to assist in conducting our preclinical studies in accordance with good laboratory practices, or GLP, and requirements with respect to animal welfare. We and our CROs or collaboration or licensing partners are required to comply with GCP, which are regulations and guidelines enforced by the MHRA, the FDA, the EMA and comparable foreign regulatory authorities for all of our products in clinical development. Regulatory authorities enforce GCP regulations, and other regulations applicable to clinical trials and investigational drug or biological products, through periodic inspections of trial sponsors, CROs, principal investigators and trial sites. If we or any of our CROs or partners fail to comply with applicable GCP regulations or other clinical trial regulations, the data generated in our clinical trials may be deemed unreliable and the EMA, the MHPA, the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot be assured that upon inspection by a given regulatory authority, that such regulatory authority will determine that any of our clinical trials comply with GCP requirements or other applicable regulations. In addition, our clinical trials must be conducted with product produced under cGMP requirements. Failure to comply with these regulations may require us to repeat preclinical and clinical trials, which would delay the regulatory approval process.

Our CROs and other contractors or collaborators are not our employees, and except for remedies available to us under such agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our on-going or future clinical or nonclinical programs, as applicable. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, then our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. Entering into arrangements with alternative CROs, clinical trial investigators or other third parties involves additional cost and requires management focus and time, in addition to requiring a transition period when a new CRO, clinical trial investigator or other third party begins work. If third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any clinical trials such third parties are associated with may be extended, delayed or terminated, and we may not be able to obtain marketing approval for or successfully commercialize our product candidates. As a result, we believe that our financial results and the commercial prospects for our product candidates in the subject indication would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Because we have relied on third parties, our internal capacity to perform these functions is limited. Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all. In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated. We currently have a small number of employees, which limits the internal resources we have available to identify and monitor our third-party providers. To the extent we are unable to identify and successfully manage the performance of third-party service providers in the future, or successfully transition such relationship to other third-party service providers, including CROs, our business may be adversely affected. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

We rely on third parties to manufactureour product candidates, and we expect to continue to rely on third parties for the clinical as well as any future commercial supply ofour product candidates and other future product candidates. The development of our current and future product candidates, and the commercializationof any approved products, could be stopped, delayed or made less profitable if any such third party fails to provide us with sufficientclinical or commercial quantities of such product candidates or products, fails to do so at acceptable quality levels or prices or failsto achieve or maintain satisfactory regulatory compliance.

We do not currently have, and we do not plan to build, the infrastructure or capability internally to manufacture current product candidates or any future product candidates for use in the conduct of our clinical trials or, if approved, for commercial supply. We rely on, and expect to continue to rely on, contract manufacturing organizations, or CMOs. Reliance on third-party contractors may expose us to more risk than if we were to manufacture our product candidates ourselves. Although our agreements with CMOs require them to perform according to certain cGMP requirements such as those relating to quality control, quality assurance, maintenance of production and testing records, and qualified personnel, we do not control the manufacturing processes of our CMOs, and we are dependent on such CMOs for the production of our product candidates in accordance with cGMP and other relevant applicable regulations.

In complying with the manufacturing regulations of the FDA and other comparable foreign regulatory authorities, we and our third-party manufacturers must spend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that the product candidates meet applicable specifications and other regulatory requirements. If either we or our CMOs fail to comply with these requirements, we may be subject to regulatory enforcement action, including the seizure of product candidates and shutting down of production.

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Even if we are able to establish and maintain agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

·	reliance on the third party for regulatory, compliance and quality assurance;
·	the possible breach of the manufacturing agreement by the third party;
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·	the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
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·	the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient<br> for us.
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We or our third-party manufacturers may encounter shortages in the raw materials or APIs necessary to produce our product candidates in the quantities needed for our clinical trials or, if our product candidates are approved, in sufficient quantities for commercialization or to meet an increase in demand, as a result of capacity constraints or delays or disruptions in the market for the raw materials or active pharmaceutical ingredients, including shortages caused by the purchase of such raw materials or APIs by our competitors or others. The failure by us or our third-party manufacturers to obtain the raw materials or APIs necessary to manufacture sufficient quantities of our product candidates, may have a material adverse effect on our business.

Our third-party manufacturers are subject to inspection and approval by regulatory authorities before we can commence the manufacture and sale of any of our product candidates, and thereafter are subject to ongoing inspection from time to time. Our third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in regulatory actions, such as the issuance of notices of inspectional observations, warning letters or sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or commercial products (if any), operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products. If any of our third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, our ability to develop and commercialize our product candidates could suffer significant interruptions.

Any disruption, such as a fire, natural hazards or vandalism at our CMOs, or any impacts on our CMOs due to health pandemics, could significantly interrupt our manufacturing capability. We currently do not have alternative production plans in place or disaster-recovery facilities available. In case of a disruption, we will have to establish alternative manufacturing sources. This would require substantial capital on our part, which we may not be able to obtain on commercially acceptable terms or at all. Additionally, we would likely experience months of manufacturing delays as we build facilities or locate alternative suppliers and seek and obtain necessary regulatory approvals. If this occurs, we will be unable to satisfy manufacturing needs on a timely basis, if at all. If changes to CMOs occur, then there also may be changes to manufacturing processes inherent in the setup of new operations for our product candidates and any products that may obtain approval in the future. Any such changes could require the conduct of bridging studies and regulatory approval before we can use any materials produced at new facilities or under new processes in clinical trials or, for any products reaching approval, in our commercial supply. Further, business interruption insurance may not adequately compensate us for any losses that may occur and we would have to bear the additional cost of any disruption. For these reasons, a significant disruptive event of any CMOs could have drastic consequences, including placing our financial stability at risk.

Our product candidates and any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities. There are no assurances we would be able to enter into similar arrangements, on acceptable terms, with other manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval.

If we were to experience an unexpected loss of supply of or if any supplier were unable to meet our clinical or commercial demand for any of our product candidates, we could experience delays in our planned clinical studies or commercialization. We could be unable to find alternative suppliers of acceptable quality and experience that can produce and supply appropriate volumes at an acceptable cost or on favorable terms. Moreover, our suppliers are often subject to strict manufacturing requirements and rigorous testing requirements, which could limit or delay production. The long transition periods necessary to switch manufacturers and suppliers, if necessary, would significantly delay our clinical trials and, for any product candidates that reach approval, the commercialization of our products, which would materially adversely affect our business, financial condition and results of operation.

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We are dependent on third party suppliers,and if we experience problems with any of these third parties, the manufacturing of our product candidates could be delayed, which couldharm our results of operations.

We are dependent upon certain qualified suppliers, of which there are a limited number, for the supply of raw materials, components, devices and manufacturing equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial pharmaceutical and biologics production. Additionally, these suppliers may also have upstream suppliers who supply materials, components, devices and manufacturing equipment, which may indirectly impact our business operations. Thus, the success of our business may be adversely affected by the underperformance of third parties, exploitation by third parties of our commercial dependence and by unforeseen interruptions to third parties’ businesses. Although the existence of several alternative suppliers for each function mitigates the risks associated with this dependence, as does the availability of commercial insurance in respect of the impact of accidental events, the failure of a third party to properly to carry out their contractual duties or regulatory obligations could be highly disruptive to our business. Supply chain failures can result in significant clinical or commercial supply interruptions which could materially hamper our ability to conduct clinical trials or to supply adequate commercial supplies (if any of our product candidates receive marketing authorization), and efforts to qualify new suppliers can be costly and time consuming. Further, any action taken by a third party that is detrimental to our reputation could have a negative impact on our ability to register our trademarks and/or market and sell our products, if any.

For some of these raw materials, components, devices and manufacturing equipment, we rely and may in the future rely on sole source vendors or a limited number of vendors. The supply of the reagents and other specialty materials and equipment that are necessary to produce our product candidates could be reduced or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all. Switching suppliers or manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If any of our product candidates receive marketing authorization and we change suppliers or manufacturers for commercial production, applicable regulatory agencies must approve such changes and may require us to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if the supply of the materials is diminished or discontinued, we may not be able to develop, manufacture and market our product candidates in a timely and competitive manner, or at all. An inability to continue to source product from any of these suppliers, which could be due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product approval or commercialization plans and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

As we continue to develop our product candidates and manufacturing processes, we expect that we will need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on our business. Even if we are able to alter our process so as to use other materials or equipment, such a change may lead to a delay in our clinical development and/or commercialization plans. If such a change occurs for product candidate that is already in clinical testing, the change may require us to perform both in vitro or in vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials. These factors could cause the delay of studies or trials, regulatory submissions, required approvals or commercialization of product candidates that we develop, cause us to incur higher costs and prevent us from commercializing our product candidates successfully.

Our counterparties may become insolvent.

There is a risk that parties with whom we trade or have other business relationships with (including partners, joint venturers, customers, suppliers, subcontractors and other parties) may become insolvent. This may be due to general economic conditions or factors specific to that company. In the event that a party with whom we trade becomes insolvent, this could have an adverse impact on our revenues and profitability.

Our relationships with customers, healthcareproviders, physicians, prescribers, purchasers, third party payors, charitable organizations and patients are subject to applicable anti-kickback,fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages,reputational harm and diminished profits and future earnings.

Although we do not currently have any products on the market, upon commercialization of any of our product candidates, if approved, we will be subject to additional healthcare statutory and regulatory requirements and oversight by federal and state governments in the United States as well as foreign governments in the jurisdictions in which we conduct our business. Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of drug and biological products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute, or AKS, and the False Claims Act, or FCA, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the research of any of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

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The healthcare laws that may affect us include: the federal fraud and abuse laws, including the AKS; false claims and civil monetary penalties laws, including the FCA and Civil Monetary Penalties Law; federal data privacy and security laws, including HIPAA, as amended by HITECH; and the federal Physician Payments Sunshine Act related to ownership and investment interests held by physicians and their immediate family members, as well as payments and/or other transfers of value made to physicians, certain advanced non-physician healthcare practitioners and teaching hospitals. In addition, many states have similar laws and regulations that may differ from each other and federal law in significant ways, thus complicating compliance efforts. Moreover, several states require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally, some state and local laws require the registration of pharmaceutical sales representatives in the jurisdiction.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from other aspects of its business.

It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, possible exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Risks Related to the ELOC

It is not possible to predict the actualnumber of Depositary Shares we will sell pursuant to the ELOC, or the actual gross proceeds resulting from those sales or the dilutionto you from those sales.

Pursuant to the ELOC, the Investor shall, subject to the restrictions and satisfaction of the conditions in the ELOC, purchase from us up to $35.0 million of Depositary Shares, upon the terms and subject to the conditions and limitations set forth in the ELOC, or the Commitment Amount. The Depositary Shares that may be issued under the ELOC may be sold, subject to the restrictions and satisfaction of the conditions in the ELOC, by us to the Investor at our discretion from time to time until the earliest to occur of (i) the first day of the month next following the 36-month anniversary of the date of effectiveness of the registration statement registering such shares for resale, (ii) the date on which the Investor shall have purchased the Commitment Amount, (iii) the ninetieth day after the date on which, pursuant to or within the meaning of any bankruptcy law, we commence a voluntary case or any person commences a proceeding against us, in each case that is not discharged or dismissed prior to such ninetieth day, and (iv) the date on which, pursuant to or within the meaning of any bankruptcy law, a custodian is appointed for us or for all or substantially all of our property, or we make a general assignment for the benefit of our creditors, or each, a Termination Event.

Over the 36-month period from and after the commencement of the ELOC program, we will generally have the right to control the timing and amount of any sales of our Depositary Shares to the Investor under the ELOC. Sales of our Depositary Shares to the Investor under the ELOC will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to the Investor all or some of the Depositary Shares that may be available for us to sell to the Investor pursuant to the ELOC. Accordingly, we cannot guarantee that we will be able to sell all of the Commitment Amount or how much in proceeds we may obtain under the ELOC. If we cannot sell securities under the ELOC, we may be required to utilize more costly and time-consuming means of accessing the capital markets, which could have a material adverse effect on our liquidity and cash position.

Because the purchase price per Depositary Share to be paid by the Investor for the Depositary Shares that we may elect to sell to the Investor under the ELOC, if any, will fluctuate based on the market prices of our Depositary Shares at the time we make such election, it is not possible for us to predict the total number of Depositary Shares that we will sell to the Investor under the ELOC, the purchase price per share that the Investor will pay for Depositary Shares purchased from us under the ELOC, or the aggregate gross proceeds that we will receive from those purchases the Investor under the ELOC.

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The actual number of Depositary Shares issuable will vary depending on the then current market price of our Depositary Shares sold to the Investor in the offering and the number of Depositary Shares we ultimately elect to sell to the Investor under the ELOC.

In addition, the Investor is not obligated to buy any Depositary Shares under the ELOC if such shares, when aggregated with all other securities then beneficially owned by the Investor and its affiliates (as calculated pursuant to Section 13(d) of the Exchange Act, and Rule 13d-3 promulgated thereunder), would result in the Investor beneficially owning Ordinary Shares in excess of the beneficial ownership limitation set forth in the ELOC. Our inability to access a portion or the full amount available under the ELOC, in the absence of any other financing sources, could have a material adverse effect on our business or results of operation.

As of the date hereof, we have sold 57,648,000,000 Ordinary Shares under the ELOC, for gross proceeds of approximately $8.9 million, and issued 1,840,460,000 Ordinary Shares to the Investor in satisfaction of a commitment fee.

The Investor will pay less than the then-prevailing market pricefor our Depositary Shares, which could cause the price of our Depositary Shares to decline.

The purchase price of our Depositary Shares to be sold to the Investor under the ELOC is derived from the market price of our Depositary Shares on NASDAQ. Shares to be sold to the Investor pursuant to the ELOC will be purchased at a discounted price.

For example, we may effect sales to the Investor at a purchase price equal to the lesser of 95% of (i) the volume weighted average price of the Depositary Shares for the five trading days immediately preceding the applicable purchase date for such purchase and (ii) the lowest sale price of a Depositary Share on the trading day preceding the applicable purchase date. As a result of this pricing structure, the Investor may sell the shares they receive immediately after receipt of such shares, which could cause the price of our Depositary Shares to decrease. ****

Investors who buy Depositary Shares from the Investor at differenttimes will likely pay different prices.

Pursuant to the ELOC, we have discretion (subject to the restrictions and satisfaction of the conditions in the ELOC) to vary the timing, price and number of Depositary Shares we sell to the Investor. If and when we elect to sell Depositary Shares to the Investor pursuant to the ELOC, after the Investor has acquired such shares, the Investor may resell all, some or none of such shares at any time or from time to time in its sole discretion and at different prices. As a result, investors who purchase shares from the Investor in the offering at different times will likely pay different prices for those shares, and so may experience different levels of dilution and in some cases substantial dilution and different outcomes in their investment results. Investors may experience a decline in the value of the shares they purchase from the Investor in the offering as a result of future sales made by us to the Investor at prices lower than the prices such investors paid for their shares in the offering. In addition, if we sell a substantial number of shares to the Investor under the ELOC, or if investors expect that we will do so, the actual sales of shares or the mere existence of our arrangements with the Investor may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.

Future resales and/or issuances of our DepositaryShares, including pursuant to the ELOC, or the perception that such sales may occur, may cause the market price of our shares to dropsignificantly.

The Depositary Shares that may be issued under the ELOC may be sold, subject to the restrictions and satisfaction of the conditions in the ELOC, by us to the Investor at our discretion from time to time until a Termination Event (as defined in the ELOC).

The purchase price for Depositary Shares that we may sell to the Investor under the ELOC will fluctuate based on the trading price of shares of our Depositary Shares. Depending on market liquidity at the time, sales of Depositary Shares may cause the trading price of Depositary Shares to decrease. We generally have the right to control the timing and amount of any future sales of Depositary Shares to the Investor. Additional sales of Depositary Shares, if any, to the Investor will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to the Investor all or some of the additional Depositary Shares that may be available for us to sell pursuant to the ELOC. If and when we do sell Depositary Shares to the Investor, after the Investor has acquired Depositary Shares, the Investor may resell all, some or none of Depositary Shares at any time or from time to time in its discretion and at different prices. Therefore, sales to the Investor by us could result in substantial dilution to the interests of other holders of Depositary Shares. In addition, if we sell a substantial number of shares of our Depositary Shares to the Investor under the ELOC, or if investors expect that we will do so, the shares held by the Investor will represent a significant portion of our public float and may result in substantial decreases to the price of our Depositary Shares. The actual sales of Depositary Shares or the mere existence of our arrangement with the Investor may also make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.

In addition, Depositary Shares issuable upon exercise or vesting of incentive awards under our incentive plans are, once issued, eligible for sale in the public market, subject to any lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144. Furthermore, Depositary Shares reserved for future issuance under our incentive plan may become available for sale in future. In addition, we also have outstanding warrants exercisable for Ordinary Shares. The Depositary Shares underlying such warrants will, upon issuance, be freely tradeable without restriction or further registration under the Securities Act.

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The market price of Depositary Shares could drop significantly if the holders described above sell or are perceived by the market as intending to sell. These factors could also make it more difficult for us to raise additional funds through future offerings of shares of our Depositary Shares or other securities.

Risks Related to Ownership of Our Securities and Our Status as aU.S. Listed Company

If we cannot meet NASDAQ’s continuedlisting requirements, NASDAQ may delist our Depositary Shares, which could have an adverse impact on the liquidity and market price ofour Depositary Shares.

Our Depositary Shares are currently listed on the NASDAQ Capital Market. We are required to meet certain qualitative and financial tests to maintain the listing of the Depositary Shares on the NASDAQ Capital Market. We cannot assure you that in the future we will remain in compliance with all applicable requirements for continued listing on the NASDAQ Capital Market, including NASDAQ’s minimum bid price requirement. If we fail to sustain compliance with all applicable requirements for continued listing on NASDAQ, our Depositary Shares may be subject to delisting by NASDAQ. This could inhibit the ability of our holders of Depositary Shares to trade their shares in the open market, thereby severely limiting the liquidity of such shares. Although holders may be able to trade their shares of Depositary Shares on the over-the-counter market, there can be no assurance that this would occur. Further, the over-the-counter market provides significantly less liquidity than NASDAQ and other national securities exchanges, is thinly traded and highly volatile, has fewer market makers and is not followed by analysts. As a result, your ability to trade or obtain quotations for these securities may be more limited than if they were quoted on NASDAQ or other national securities exchanges.

The price of our Depositary Shares may bevolatile.

The trading price of our Depositary Shares in the United States has fluctuated, and is likely to continue to fluctuate, substantially in response to various factors, some of which are beyond our control, including limited trading volume. The stock market in general, and the market for pharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has often been unrelated to the operating performance of these companies. As a result of this volatility, investors may not be able to sell their Depositary Shares at or above the price paid for the Depositary Shares. In addition, there is no current market for our Ordinary Shares and we do not expect to list our Ordinary Shares on any exchange or have them quoted for trading on any over-the-counter trading system in the foreseeable future.

In addition to the factors discussed in this “Risk Factors” section, the factors that could cause volatility in the market price of each Depositary Share include:

·	the success of competitive products or technologies;
·	regulatory actions;
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·	actual or anticipated changes in our growth rate relative to our competitors;
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·	announcements by us or our competitors of new products, significant acquisitions, strategic partnerships,<br> joint ventures, collaborations or capital commitments;
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·	the progress of preclinical development, laboratory testing and clinical trials of our product candidates<br> or those of our competitors;
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·	the results from our clinical programs and any future trials we may conduct;
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·	developments in the clinical trials of potentially similar competitive products;
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·	EMA, MHRA, FDA or international regulatory or legal developments;
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·	failure of any of our product candidates, if approved, to achieve commercial success;
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·	developments or disputes concerning patent applications, issued patents or other proprietary intellectual<br> property rights;
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·	the recruitment or departure of key personnel;
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| --- | | · | the level of expenses related to any of our product candidates or clinical development programs; | | --- | --- | | · | litigation or public concern about the safety of our products; | | --- | --- | | · | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; | | --- | --- | | · | actual and anticipated fluctuations in our operating results; | | --- | --- | | · | variations in our financial results or those of companies that are perceived to be similar to us; | | --- | --- | | · | share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; | | --- | --- | | · | announcements or expectations of additional financing efforts; | | --- | --- | | · | rumors relating to us or our competitors; | | --- | --- | | · | sales of our Depositary Shares by us, our insiders or our other shareholders; | | --- | --- | | · | changes in the structure of healthcare payment systems; | | --- | --- | | · | market conditions in the pharmaceutical and biotechnology sectors, or general volatility in the market due to other factors; | | --- | --- | | · | third party reimbursement policies; | | --- | --- | | · | Brexit and any resulting economic or currency volatility; | | --- | --- | | · | developments concerning current or future collaborations, strategic alliances, joint ventures or similar relationships; and | | --- | --- | | · | reviews of long-term values of our assets, which could lead to impairment charges that could reduce our earnings. | | --- | --- |

These and other market and industry factors may cause the market price and demand for our Depositary Shares to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from selling their Depositary Shares at or above the price paid for the Depositary Shares, and may otherwise negatively affect the liquidity of our Ordinary Shares and Depositary Shares. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our Depositary Shares.

The liquidity of our Depositary Shares mayhave an adverse effect on share price.

In July 2025, we changed the ratio of our Ordinary Shares to Depositary Shares, which had the effect of a one-for-10 reverse split of Depositary Shares and reduced the amount of Depositary Shares publicly traded. There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our securities. Our Depositary Shares have historically had limited trading volume, which may also result in volatility.

We may be subject to securities litigation, which is expensiveand could divert management attention.

The market price of our Depositary Shares may be volatile, and in the past, some companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms.

Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation is costly and time consuming, and could divert our management’s attention and our resources. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a negative effect on the market price of our Depositary Shares.

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Shareholder ownership interests in the Companymay be diluted as a result of, among other things, future financings, sales under the ELOC, and/or additional acquisitions, and may havea material negative effect on the market price of our securities.

We may seek to raise additional funds from time to time in public or private issuances of equity and such financings may take place in the near future or over the longer term. Sales of our securities offered through future equity offerings, including equity sales pursuant to the ELOC, may result in substantial dilution to the interests of our current shareholders. The sale of a substantial number of securities to investors, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

We may also issue Ordinary Shares (and Depositary Shares underlying such Ordinary Shares) or other securities convertible into Ordinary Shares from time to time for future acquisitions, including acquisitions of licenses. The issuance of the securities underlying these instruments, or perception that issuance may occur, will have a dilutive impact on other shareholders and could have a material negative effect on the market price of our Depositary Shares.

If equity research analysts do not publishresearch or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our securities will depend in part on the research and reports that equity research analysts publish about us or our business. If no or few equity research analysts cover our Company, the trading price for our securities would be negatively impacted. We do not have any control over the analysts or the content and opinions included in their reports. The price of our securities could decline if one or more equity research analysts downgrade our securities or issue other unfavorable commentary or research about us. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our securities could decrease, which in turn could cause the trading price or trading volume of our securities to decline.

The rights of holders of Depositary Sharesare not the same as the rights of holders of Ordinary Shares.

We are a public limited company incorporated under the laws of England and Wales. The Depositary Shares represent a beneficial ownership interest in our Ordinary Shares. The rights of holders of Depositary Shares are governed by English law, our constitutional documents, and the deposit agreement pursuant to which the Depositary Shares are issued. The rights and terms of the Depositary Shares are designed to replicate, to the extent reasonably practicable, the rights attendant to the Ordinary Shares, for which there is currently no active trading market in the United States. However, because of aspects of United Kingdom law, our constitutional documents and the terms of the deposit agreement, the rights of holders of Depositary Shares will not be identical to and, in some respects, may be less favorable than, the rights of holders of Ordinary Shares.

You may not have the same voting rightsas the holders of our Ordinary Shares and may not receive voting materials in time to be able to exercise your right to vote.

Holders of our Depositary Shares do not have the same rights as shareholders who hold our Ordinary Shares directly and may only exercise their voting rights with respect to the underlying Ordinary Shares in accordance with the provisions of the deposit agreement. Holders of the Depositary Shares will appoint the Depositary or its nominee as their representative to exercise the voting rights attaching to the Ordinary Shares represented by the Depositary Shares. When a general meeting is convened, if you hold Depositary Shares, you may not receive sufficient notice of a shareholders’ meeting to permit you to withdraw the Ordinary Shares underlying your Depositary Shares to allow you to vote with respect to any specific matter. Further, we cannot assure purchasers of Depositary Shares that they will receive voting materials in time to instruct the Depositary to vote, and it is possible that they, or persons who hold their Depositary Shares through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote. Furthermore, the Depositary will not be liable for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, purchasers of Depositary Shares may not be able to exercise their right to vote and they may lack recourse if their Depositary Shares are not voted as they request.

You may not receive distributions on Ordinary Shares representedby Depositary Shares or any value for them if it is illegal or impractical to make them available to holders of Depositary Shares.

The Depositary of the Depositary Shares has agreed to pay to you distributions with respect to cash or other distributions it or the custodian receives on Ordinary Shares or other deposited securities after deducting its agreed fees and expenses. You will receive these distributions in proportion to the number of Ordinary Shares your Depositary Shares represent. However, the Depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any holders of Depositary Shares. We have no obligation to take any other action to permit the distribution of our Depositary Shares, Ordinary Shares, rights or anything else to holders of our Depositary Shares. As a result, you may not receive the distributions made on Ordinary Shares or any value from them if it is illegal or impractical for us to make them available to you. These restrictions may have a material adverse effect on the value of your Depositary Shares.

You may be subject to limitations on transfer of your DepositaryShares.

Your Depositary Shares are transferable on the books of the Depositary. However, the Depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The Depositary may refuse to deliver, transfer or register transfers of your Depositary Shares generally when our books or the books of the Depositary are closed, or at any time if we or the Depositary deems it advisable to do so because of any requirement of law or government or governmental body, or under any provision of the deposit agreement, or for any other reason.

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We have no present intention to pay dividendson our Ordinary Shares in the foreseeable future and, consequently, your only opportunity to achieve a return on your investment duringthat time may be if the price of Depositary Shares appreciates.

We have no present intention to pay dividends on our Ordinary Shares in the foreseeable future. Any determination by our Board of Directors to pay dividends will depend on many factors, including our financial condition, results of operations, legal requirements and other factors. Accordingly, if the price of the Depositary Shares falls in the foreseeable future and you sell your Depositary Shares, you will lose money on your investment, without the likelihood that this loss will be offset in part or at all by cash dividends.

We are a non-accelerated filer, and the reduced reporting obligationsapplicable to non-accelerated filers may make our securities less attractive to investors.

We are a “non-accelerated filer” under the rules of the SEC. For as long as we remain a “non-accelerated filer,” our independent registered public accounting firm is not required to deliver an annual attestation report on the effectiveness of our internal control over financial reporting. We will cease to be a non-accelerated filer if (a) the aggregate market value of our outstanding Ordinary Shares held by non-affiliates as of the last business day of our most recently completed second fiscal quarter is $75 million or more and we reported annual net revenues of greater than $100 **** million for our most recently completed fiscal year or (b) the aggregate market value of our outstanding Ordinary Shares held by non-affiliates as of the last business day of our most recently completed second fiscal quarter is $700 **** million or more, regardless of annual net revenues. If we cease to be a non-accelerated filer, we would be subject to the requirement for an annual attestation report by our independent registered public accounting firm on the effectiveness of our internal control over financial reporting. We cannot predict whether investors will find our securities less attractive if we rely on this exemption. If some investors find our securities less attractive as a result, there may be a less active trading market for our securities and our stock price may be more volatile and may decline.

Our disclosure controls and procedures maynot prevent or detect all errors or acts of fraud.

We are subject to certain periodic reporting requirements of the Exchange Act. We design our disclosure controls and procedures to reasonably assure that information we are required to disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosure due to error or fraud may occur and we may not detect them.

Any failure to maintain effective internal controls and procedures over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows.

We are incurring increased costs as a resultof operating as a public company, and management will be required to devote substantial time to new compliance initiatives.

We are a public company, and as such we are incurring significant legal, accounting and other expenses that we did not incur as a private company. We are currently subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC and the NASDAQ. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we expect these rules and regulations to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the sufficient coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our Board of Directors, our board committees or as members of our senior management.

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Risks Related to Investing in a Foreign Private Issuer or UnitedKingdom Company

We are a “foreign private issuer”under the rules and regulations of the SEC and, as a result, are exempt from a number of rules under the Exchange Act and are permittedto file less information with the SEC than a company incorporated in the United States.

We are incorporated as a public limited company in England and Wales and are deemed to be a “foreign private issuer” under the rules and regulations of the SEC. As a foreign private issuer, we are exempt from certain rules under the Exchange Act that would otherwise apply if we were a company incorporated in the United States, including:

·	the requirement to file periodic reports and financial statements with the SEC as frequently or as promptly<br> as United States companies with securities registered under the Exchange Act;
·	the requirement to file financial statements prepared in accordance with U.S. GAAP;
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·	the proxy rules, which impose certain disclosure and procedural requirements for proxy or consent solicitations;<br> and
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·	the requirement to comply with Regulation FD, which imposes certain restrictions on the selective disclosure<br> of material information.
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In addition, our officers, directors and principal shareholders are currently exempt from the “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the related rules with respect to their purchases and sales of Ordinary Shares and Depositary Shares. Accordingly, you may receive less information about us than you would receive about a public company incorporated in the United States and may be afforded less protection under the United States federal securities laws than you would be if we were incorporated in the United States.

Additional reporting requirements may apply if we lose our statusas a foreign private issuer.

As a foreign private issuer, we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. In order to maintain our current status as a foreign private issuer, either (1) a majority of our voting securities must be either directly or indirectly owned of record by non-residents of the United States or (2)(a) a majority of our executive officers or directors cannot be U.S. citizens or residents, (b) more than 50% of our assets must be located outside the United States and (c) our business must be administered principally outside the United States.

If we lose our status as a foreign private issuer, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers. We may also be required to make changes in our corporate governance practices in accordance with various SEC and NASDAQ rules. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer may be significantly higher than the cost we would incur as a foreign private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time consuming and costly. We also expect that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our Board of Directors.

As a foreign private issuer, we are notrequired to comply with many of the corporate governance standards of NASDAQ applicable to companies incorporated in the United States.

Our Board of Directors is required to maintain an audit committee comprised solely of three or more directors satisfying the independence standards of NASDAQ applicable to audit committee members. As a foreign private issuer, however, we are not required to comply with most of the other corporate governance rules of NASDAQ, including the requirement to maintain a majority of independent directors, and nominating and compensation committees of our Board of Directors comprised solely of independent directors. Although United Kingdom corporate governance rules which we abide by have comparable requirements, holders of Depositary Shares may not be afforded the benefits of the corporate governance standards of NASDAQ to the same extent applicable to companies incorporated in the United States.

Your right to participate in any future rights offerings maybe limited, which may cause dilution to your holdings.

Under English law, shareholders usually have preemptive rights to subscribe on a pro rata basis in the issuance of new shares for cash. The exercise of preemptive rights by certain shareholders not resident in the United Kingdom may be restricted by applicable law or practice in the United Kingdom and overseas jurisdictions. We may from time to time distribute rights to our shareholders, including rights to acquire our securities. However, we cannot make rights available to shareholders in the United States unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available. Also, under the deposit agreement, the depositary bank will not make rights available to Depositary Share holders unless either both the rights and any related securities are registered under the Securities Act, or the distribution of them to Depositary Share holders is exempted from registration under the Securities Act. We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, we may not be able to establish an exemption from registration under the Securities Act. If the Depositary does not distribute the rights, it may, under the deposit agreement, either sell them, if possible, or allow them to lapse. Accordingly, Depositary Share holders may be unable to participate in our rights offerings and may experience dilution in their holdings. We are also permitted under English law to disapply preemptive rights (subject to the approval of our shareholders by special resolution or the inclusion in our articles of association of a power to disapply such rights) and thereby exclude certain shareholders, such as overseas shareholders, from participating in a rights offering (usually to avoid a breach of local securities laws).

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It may be difficult for you to bring anyaction or enforce any judgment obtained in the United States against us or members of our Board of Directors, which may limit the remediesotherwise available to you.

We are incorporated as a public limited company in England and Wales and nearly all of our assets are located outside the United States. In addition, all but one of the members of our Board of Directors are non-United States nationals and all members of our Board of Directors are residents of countries, including the United Kingdom, outside of the United States. Most or all of the assets of these individuals are located outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or to enforce judgments obtained in U.S. courts against them or us, including judgments predicated upon the civil liability provisions of the U.S. federal securities laws.

The United States and the United Kingdom do not currently have a treaty providing for the reciprocal recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in England and Wales. In addition, uncertainty exists as to whether the English and Welsh courts would entertain original actions brought in England and Wales against us or our directors or executive officers predicated upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite sum obtained against us in U.S. courts would be treated by the courts of England and Wales as a cause of action in itself and sued upon as a debt so that no retrial of the issues would be necessary, provided that certain requirements are met consistent with English law and public policy. Whether these requirements are met in respect of a judgment based upon the civil liability provisions of the U.S. securities laws is an issue for the English court making such decision. If an English court gives judgment for the sum payable under a U.S. judgment, the English judgment will be enforceable by methods generally available for this purpose.

As a result, U.S. investors may not be able to enforce against us or our executive officers, board of directors or certain experts named herein who are residents of the United Kingdom or countries other than the United States any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.

We intend to operate so as to be treatedexclusively as a resident of the United Kingdom for tax purposes, but the relevant tax authorities may treat us as also being a residentof another jurisdiction for tax purposes or having a permanent establishment for tax purposes in other jurisdictions.

Under current United Kingdom tax law, as a company incorporated in the United Kingdom, we should be treated as a resident for United Kingdom tax purposes in the United Kingdom unless (i) we were concurrently to be treated as resident in another jurisdiction (applying the tax residence rules of that jurisdiction) that has a double tax treaty with the United Kingdom and (b) our exclusive residence were to be determined under that tax treaty (either pursuant to a tiebreaker position or by agreement between the competent authorities) to reside in that other jurisdiction.

Even if, as expected, we are, and continue to be, treated as a resident of the United Kingdom for tax purposes, it would in principle be possible for the tax authorities of another jurisdiction to treat us either (a) being resident for tax purposes in that other jurisdiction or (b) having a permanent establishment for tax purposes in that jurisdiction. While we intent to operate in such a manner that this would not be the case, this analysis is highly factual and may depend on future changes in our management and organizational structure; accordingly, there can be no assurance regarding the final determination of our tax residence or where we may be treated as having a permanent establishment. Should we be treated as resident for tax purposes, or having a permanent establishment, in another jurisdiction other than the United Kingdom, we would be subject to taxation in such jurisdiction in accordance with such jurisdiction’s laws, which could result in additional costs and expenses. If we were to cease to be treated as a resident of the United Kingdom for tax purposes, this could result in exit charges and additional costs and expenses.

The rights of our shareholders may differ from the rights typicallyoffered to shareholders of a U.S. corporation.

We are incorporated under English law. The rights of holders of Ordinary Shares and, therefore, certain of the rights of holders of our Depositary Shares, are governed by English law, including the provisions of the Companies Act 2006 (as amended from time to time) of the United Kingdom, or the Companies Act, and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. See “Description of Share Capital—Differences in Corporate Law” for a description of the principal differences between the provisions of the Companies Act applicable to us and, for example, the Delaware General Corporation Law relating to shareholders’ rights and protections.

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Protections found in provisions under theCity Code on Takeovers and Mergers may delay or discourage a takeover attempt, including attempts that may be beneficial to holders ofour Ordinary Shares and Depositary Shares.

The City Code on Takeovers and Mergers, or the City Code, applies, among other things, to an offer for a public limited company whose registered office is in the United Kingdom and has its place of central management and control in United Kingdom, as determined by Panel on Takeovers and Mergers, or the Takeover Panel. The Takeover Panel has confirmed we are subject to the City Code.

The City Code provides a framework within which takeovers of certain companies organized in the United Kingdom, the Channel Islands or the Isle of Man are regulated and conducted. The following is a brief summary of some of the most important rules of the City Code:

·	In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the<br> company is “the subject of rumor or speculation” or there is an “untoward movement” in the company’s share<br> price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the<br> company to make a public announcement about its review of a potential offer.
·	Unless there is consent from the Takeover Panel, when the shares of any class under offering in the company<br> in which interests are acquired for cash by an offeror and any person acting in concert with it during the offer period and within 12<br> months prior to its commencement represent 10% or more of the shares of that class in issue, the offer must be in cash or be accompanied<br> by a cash alternative for all shareholders of that class at not less than the highest price paid by the offeror or any person acting in<br> concert with them in that period. Further, if an offeror or any person acting in concert with them acquires any interest in shares during<br> the offer period, the offer for the shares must be in cash or accompanied by a cash alternative at a price at least equal to the price<br> paid for such shares during the offer period.
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·	If after an announcement is made, the offeror or any person acting in concert with them acquires an interest<br> in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased to not less<br> than the highest price paid for the interest in shares so acquired accordingly.
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·	The board of directors of the offeree company must appoint a competent independent adviser whose advice on<br> the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the<br> offeree company.
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·	Favorable deals for selected shareholders are not permitted, except in certain circumstances where independent<br> shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the financial adviser to the<br> offeree.
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·	All shareholders must be given the same information.
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·	Those issuing documents in connection with a takeover must include statements taking responsibility for the<br> contents thereof.
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·	Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified<br> standards and must be reported on by professional advisers.
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·	Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected<br> immediately.
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·	Actions during the course of an offer by the offeree company, which might frustrate the offer are generally<br> prohibited unless shareholders approve these plans. Frustrating actions would include, for example, lengthening the notice period for<br> directors under their service contract or agreeing to sell off material parts of the target group.
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·	Stringent requirements are laid down for the disclosure of dealings in relevant securities during an offer,<br> including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested<br> (directly or indirectly) in 1% or more of any class of relevant securities.
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·	Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension<br> scheme must be informed about an offer. In addition, the offeree company’s employee representatives and pension scheme trustees<br> have the right to have a separate opinion on the effects of the offer on employment appended to the offeree board of directors’<br> circular or published on a website.
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If we are deemed or become a passive foreign investment company,or PFIC, for U.S. federal income tax purposes in 2025 or in any prior or subsequent year, this may result in adverse U.S. federal incometax consequences for U.S. taxpayers that are holders of our securities.

We will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which either (1) at least 75% of our gross income is “passive income” or (2) on average at least 50% of our assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the temporary investment of funds, including those raised in a public offering. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.

We do not believe we were a PFIC for 2025, but there can be no assurance that we will not be a PFIC for 2026 or for any other taxable year, as our operating results for any such years may cause us to be a PFIC. If we were to be characterized as a PFIC for U.S. federal income tax purposes in any taxable year during which a U.S. shareholder owns our securities, and such U.S. shareholder does not make an election to treat us as a “qualified electing fund,” or a QEF, or make a “mark-to-market” election, then “excess distributions” to a U.S. shareholder, and any gain realized on the sale or other disposition of our securities will be subject to special rules. Under these rules: (1) the excess distribution or gain would be allocated ratably over the U.S. shareholder’s holding period for the securities; (2) the amount allocated to the current taxable year and any period prior to the first day of the first taxable year in which we were a PFIC would be taxed as ordinary income; and (3) the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such other taxable year. In addition, if the United States Internal Revenue Service, or the IRS, determines that we are a PFIC for a year with respect to which we have determined that we were not a PFIC, it may be too late for a U.S. shareholder to make a timely QEF or mark-to-market election. U.S. shareholders who hold or have held our securities during a period when we were or are a PFIC will be subject to the foregoing rules, even if we cease to be a PFIC in subsequent years, subject to exceptions for U.S. shareholders who made a timely QEF or mark-to-market election. However, because we do not intend to prepare or provide the information that would permit the making of a valid QEF election, such an election will not be available to United States holders.

Changes to U.S. and non-U.S. tax laws could materially adverselyaffect our Company and holders of our Ordinary Shares and the Depositary Shares.

The Tax Cuts and Jobs Act, which was legislation bringing about broad changes in the existing U.S. corporate tax system, was enacted in the United States in December 2017. The Tax Cuts and Jobs Act made significant changes to the U.S. federal income tax laws. Certain provisions of the Tax Cuts and Jobs Act could have an adverse effect on the Company or holders of our Ordinary Shares or Depositary Shares. The U.S. Treasury Department and the IRS continue to interpret and issue guidance on how provisions of the Tax Cuts and Jobs Act will be applied and administered. The interpretations of many provisions of the Tax Cuts and Jobs Act are still unclear. We cannot predict when or to what extent any additional U.S. federal tax laws, regulations, interpretations, or rulings clarifying the Tax Cuts and Jobs Act will be issued or the impact of any such guidance on investors or the Company. Holders of Ordinary Shares and Depositary Shares are urged to consult their own tax advisors regarding the effect of the Tax Cuts and Jobs Act and other potential changes to the U.S. federal tax laws.

We are unable to predict what tax changes may be enacted in the future or what effect such changes would have on our business, but such changes could affect our effective tax rates in countries where we have operations and could have an adverse effect on our overall tax position in the future, along with increasing the complexity, burden and cost of tax compliance. In addition, such changes could impact the holders of Ordinary Shares or Depositary Shares.

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| --- | | ITEM 4. | INFORMATION ON THE COMPANY. | | --- | --- | | A. | History and Development of the Company | | --- | --- |

We were originally formed as a limited liability company under the laws of England and Wales in 2000 under the name Midatech Ltd, which acquired its base nanoparticle technology through an assignment of worldwide commercialization rights and joint ownership of patent rights from Consejo Superior de Investigaciones Cientificas in Madrid, Spain. Midatech Ltd was a research and development focused biotech company which subsequently advanced and developed this gold nanoparticle drug delivery platform technology to enhance the delivery of medicines for major therapeutic indications where clinical therapeutic options are limited, with a particular focus on certain cancers, such as liver and brain cancer.

To better be able to continue the commercial development of the research and development programs of Midatech Ltd, Midatech Pharma PLC was incorporated on September 12, 2014 under the laws of England and Wales, to be the public holding company of Midatech Ltd and Midatech Pharma (Wales) Limited under registered number 09216368. On December 8, 2014, we completed our initial public offering of our Ordinary Shares in the United Kingdom. On December 4, 2015, we acquired DARA Biosciences, Inc., and in connection therewith, listed our Depositary Shares on the NASDAQ Capital Market.

On March 24, 2023, we held a general meeting where our shareholders approved, among other things, a change of our name to “Biodexa Pharmaceuticals PLC” and the cancellation of admission of our Ordinary Shares from trading on AIM with effect from April 26, 2023. Additionally, the names of Midatech Ltd and Midatech Pharma (Wales) Limited were subsequently changed to Biodexa Ltd and Biodexa Pharmaceuticals (Wales) Ltd, respectively.

Our principal executive office and registered offices are located at 1 Caspian Point, Caspian Way Cardiff, United Kingdom CF10 4DQ, and our telephone number is +44 29 2048 0180. Our authorized representative in the United States is Donald J. Puglisi of Puglisi and Associates. Our agent for service in the United States is Donald J. Puglisi of Puglisi and Associates, located at 850 Library Avenue, Suite 204, Newark, Delaware 19711. Our Depositary Shares are traded on the NASDAQ Capital Market under the symbol “BDRX.”

We file reports and other information with the SEC. The SEC maintains an Internet website that contains reports, proxy and information statements, and other information regarding issuers, including us, that file electronically with the SEC. Our filings with the SEC are available to the public through the SEC’s website at http://www.sec.gov. Our corporate website is located at www.biodexapharma.com. Information contained on our website is not part of, or incorporated in, this annual report.

See “—B. BusinessOverview” for a discussion of additional significant events and developments relating to our business, and “Item 5B.—Liquidityand Capital Resources” for a discussion of our capital expenditures.

B.	Business Overview

Business Overview

We are a clinical stage biopharmaceutical company developing a pipeline of innovative products focused on the treatment or prevention of gastrointestinal cancers including gastrointestinal stromal tumors, or GIST and familial adenomatous polyposis, or FAP.

In April 2024 we licensed eRapa, a proprietary formulation of rapamycin, from Rapamycin Holdings, Inc. d/b/a Emtora Biosciences, Inc., or Emtora. Rapamycin is an mTOR inhibitor. As a central regulator of cell metabolism, growth, proliferation and survival, the mTOR pathway is activated during various cellular processes including tumor formation and angiogenesis. Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. A Phase 2 study of eRapa in NMIBC, now being conducted as an IIT by the University of Texas, San Antonio, is ongoing. On February 10, 2025, we announced that the FDA had granted fast track designation for eRapa. Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. In May 2025, we announced the receipt of an additional grant of $3.0 million from CPRIT to support the registrational Phase 3 program of eRapa in FAP, which, along with the prior grants received from CPRIT and the Company match, we expect will fund substantially all costs of the Phase 3 study.

The Phase 3 study of eRapa in FAP is a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo, conducted in approximately 30 clinical sites across the United States and Europe. On June 25, 2025, we announced the activation of the first clinical study site for our Phase 3 clinical study in patients with FAP, which is actively screening patients. On July 14, 2025, we announced the filing of a Clinical Trial Application, or CTA, with the European Medicines Agency, or EMA, for the Phase 3 study, which is required to begin a clinical trial in Europe, and on August 18, 2025, we announced the enrollment of the first two patients in the Phase 3 study by the Pan American Center for Oncology in San Juan, Puerto Rico. On November 3, 2025, we announced the approval of the CTA by the EMA for the Phase 3 study in Europe, and on December 1, 2025 we announced the enrollment of the first European patients into the study. As of March 16, 2026, there were 22 active clinical sites and 37 patients enrolled in the Phase 3 study.

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On February 4, 2026 we licensed MTX240, formerly known as OPB-171775, from Otsuka Pharmaceutical Co., Ltd, or Otsuka. MTX240 is a new chemical entity molecular glue which we intend to develop initially for GIST. Otsuka developed a comprehensive preclinical data package and gained approval for a Phase 1 study from the Pharmaceuticals and Medical Devices Agency in Japan. GIST is driven by activating mutations in the KIT receptor tyrosine kinase. While tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib are reported to have significantly improved outcomes for GIST patients, resistance typically develops through secondary KIT mutations or activation of alternative signaling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs.

MTX240 acts as a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT or PDGFR signaling. By triggering cell death through this alternative pathway, MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors. This novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs.

Our first priority with respect to MTX240 is to engage a contract manufacturer to manufacture clinical trial material, file an IND application and commence a Phase 1b / 2a dose escalation study to determine a maximum tolerated dose and preferred regimen followed by an extension component to assess potential efficacy signals in TKI-resistant patients.

Tolimidone is a selective activator of the enzyme lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signaling cascade initiated by the binding of insulin to its receptor. Lyn kinase modulates key intracellular functions such as proliferation, differentiation, apoptosis, migration and metabolism. In fat cells, lyn kinase increases utilization of insulin, thus decreasing blood sugar without having an effect on insulin production. In pancreatic islets, activation of lyn kinase promotes beta cell survival and proliferation, whereas its inhibition leads to cell death, prevents proliferation and precipitates diabetes. We are developing tolimidone for T1D initially in a Phase 2a dose confirming study. On June 4, 2025, we announced the recruitment of the first patient in the study. The study will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events initially in 12 patients across three dose groups.

Due to resource constraints, MTX110, a liquid formulation of the histone deacetylase, panobinostat, being studied in aggressive rare/orphan brain cancer indications, has been de-prioritized and is no longer a key program for the Company. In addition, we have closed our laboratory in Cardiff, Wales and are no longer investing in our drug delivery technologies, which included Q-Sphera, MidaSolve and MidaCore.

Revenue. Revenue for the whole of the Company for the years ended December 31, 2025, 2024 and 2023 is set out below.

	Year ended December 31,
(£ in thousands)	2025		2024		2023
Revenue (Europe, including United Kingdom)		--		--		381
Revenue (Rest of World)		--		--		--
Total Revenue from continuing and discontinued operations		--		--		381

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Recent Developments

MTX240 License. On February 3, 2026, we announced that we had entered into a license and collaboration agreement, or the Otsuka License Agreement, with Otsuka, pursuant to which Otsuka granted us an exclusive, worldwide (excluding Japan) license, or the MTX240 Licensed Territory, to develop manufacture and commercialize OPB-171755, to be designated MTX240, a Phase 1-ready molecular glue therapeutic candidate, for all human therapeutic uses. We intend to initially develop MTX240 for the treatment of gastrointestinal stromal tumors.

Pursuant to the Otsuka License Agreement, we will be responsible for all development, manufacturing and commercialization activities for MTX240 in the MTX240 Licensed Territory, and Otsuka will retain all rights to MTX240 in Japan. As consideration for the license, we made an upfront payment to Otsuka, and Otsuka is eligible to receive one-time development and regulatory milestones, as well as tiered royalties in the mid-single digits on the net sales of licensed products. We are also obligated to pay Otsuka a percentage of any sublicense income we receive, subject to certain exceptions.

Our Strategy

In early 2023, we decided to re-position the Company as therapeutics (as opposed to drug delivery) company and we began looking for additional assets. The delivery of proof-of-concept clinical data is the primary focus of our business model going forward.

Due to resource constraints our MTX110 programs in rare/orphan brain cancers and our proprietary drug delivery technologies are no longer priorities for the Company.

Development

Our intention is to build a balanced portfolio of clinical-stage development assets, ideally with a focus on rare / orphan indications in gastrointestinal / oncology. eRapa was in-licensed in April 2024 and is being developed for FAP and NMIBC. In the third quarter of 2025, we enrolled our first patients on the multi-center registrational Phase 3 trial in FAP branded ‘Serenta.’ The Phase 2 trial in NMIBC, now being conducted as an investigator initiated trial (IIT) by the University of Texas, San Antonio, has enrolled all 166 patients and is expected to read out in the third quarter of 2026. MTX240 was in-licensed from Otsuka in February 2026 and we intend to develop it for GIST. Our goal is to manufacture clinical trial supplies and dose the first patient in a Phase 1b/2a dose escalation and extension study by 2026 year end. Tolimidone, which was in-licensed in December 2023, is undergoing a Phase 2a IIT at the University of Alberta Diabetes Institute for T1D.

Our aim is generally to develop our clinical assets to proof-of-concept stage before securing partners to undertake the most expensive, later stage development. Because of $20.0 million of grant funding from CPRIT, we are developing eRapa through Phase 3 to potential registration.

Manufacturing

We do not intend to establish our own manufacturing capabilities. For clinical trial material we utilize GMP-certified contract manufacturers.

Commercialization

Once proof-of-concept has been established, we intend to seek to license our products to a partner who would complete the development, and subsequently market and sale, of the product in an agreed upon licensed territory. In addition to reimbursement of development costs, the partner would be expected to make milestone payments based on sales targets and royalty payments.

Pipeline

We are actively pursuing the development of eRapa in FAP, MTX240 in GIST and tolimidone in T1D. Due to resource constraints, MTX110 has been de-prioritized and is no longer a key program for the Company. Our development pipeline is as follows:

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Current Clinical Stage Assets

eRapa. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Rapamycin is approved in the United States for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin.

FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the United States and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the United States and we plan to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

Our open-label Phase 2 study was conducted in seven United States centers of excellence in 30 adult patients with a median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis, and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were the safety and tolerability of eRapa and percentage change from baseline in polyp burden, as measured by the aggregate of all polyp diameters.

On May 21, 2024, we announced six-month results of the Phase 2 clinical trial of eRapa in FAP, which were presented at the 2024 Digestive Disease Week annual meeting in Washington D.C. In the duodenum, 14 out of 18 patients, or 78%, were non-progressors, with 11 out of 18 of these patients, or 61%, with a partial response, or PR. In the colorectum, 25 out of 29 patients, or 86%, were non-progressors, including all with an intact colon; of these, 15 out of 29 patients, or 67%, demonstrated PR, including four with an intact colon. Only two drug-related Grade 3 serious adverse events, or SAEs, occurred during the trial (with no Grade 4 or 5 SAEs reported), and 97% of patients remained on treatment at six months. In summary, after six months’ treatment, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate.

On June 24, 2024, we announced 12-month results of the Phase 2 clinical trial which were presented at the 2024 InSIGHT bi-annual meeting in Barcelona. Overall, 21 out of 28 patients, or 75%, were deemed to be non-progressors at 12 months, with a median reduction in polyp burden of 17%. Over the course of 12 months, there were four related Grade 3 or higher and one related SAE reported during the trial, and a 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. In summary, after 12 months’ treatment, eRapa appeared safe and well-tolerated with a median 17% reduction in the total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. The 89% non-progression rate and 29% median reduction in polyp burden in Cohort 2 is likely to be the preferred dosage regimen for Phase 3.

The Phase 3 study of eRapa in FAP is a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo, conducted in approximately 30 clinical sites across the United States and Europe and with a primary endpoint being time to a defined progression free survival event. In May 2025, we announced the receipt of an additional grant of $3.0 million from the Cancer Prevention and Research Institute of Texas, or CPRIT, to support the registrational Phase 3 program of eRapa in FAP, which, along with the prior grants received from CPRIT and the Company match, we expect will fund substantially all costs of the Phase 3 study. On June 25, 2025, we announced the activation of the first clinical study site for our Phase 3 clinical study in patients with FAP, which is actively screening patients. On July 14, 2025, we announced the filing of a Clinical Trial Application, or CTA, with the European Medicines Agency, or EMA, for the Phase 3 study, which is required to begin a clinical trial in Europe, and on August 18, 2025, we announced the enrollment of the first two patients in the Phase 3 study by the Pan American Center for Oncology in San Juan, Puerto Rico. On November 3, 2025, we announced the approval of the CTA by the EMA for the Phase 3 study in Europe, and on December 1, 2025 we announced the enrollment of the first European patients into the study.

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On February 10, 2025, we announced that the FDA had granted fast track designation for eRapa. Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women. The multi-center, double-blind, placebo-controlled Phase 2 study in NMIBC, now being conducted as an IIT by the University of Texas, San Antonio, is expected to enroll up to 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported by a $2.8 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, is ongoing.

MTX240. MTX240 is a small molecule new chemical entity developed by, and licensed from, Otsuka in February 2026. It was originally coded OPB-171775 by Otsuka. It is a so-called molecular glue intended to be developed for the treatment of GIST. The compound also has the potential to be useful in additional indications. In our pipeline, OPB-171775 is coded as MTX240.

Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional kinase inhibitors for rare oncology indications. GIST is driven by activating mutations in the KIT receptor tyrosine kinase. While TKIs such as imatinib, sunitinib, and regorafenib are reported to have significantly improved outcomes for GIST patients, resistance typically develops through secondary KIT mutations or activation of alternative signaling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs.

MTX240 acts as a molecular glue, bringing two intracellular proteins, PDE3A and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signaling. By triggering cell death through this alternative pathway, MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors. This novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs.

In patient derived xenograft (PDX) mice, MTX240 has shown dose-dependent anti-tumor efficacy in imatinib and sunitinib resistant models irrespective of KIT mutation status as demonstrated by E.O. Takaki et al. in the following charts:

MTX240, referenced as OPB-171775 in the charts, and vehicle were administered once daily for 21 days. Imatinib was administered twice daily for 21 days. The values represent mean tumor volumes +/- standard error of the mean GS5107 (n=3), GS5108 (n=5), GS11353 (n=5).

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PDX models use actual tumor tissue harvested from patients, preserving the genetic complexity and treatment resistance patterns of real human cancers. This makes PDX studies far more predictive of human clinical outcomes because they bridge the gap between laboratory discovery and clinical trials.

GIST is a rare gastrointestinal malignancy affecting approximately 3,000-4,000 patients annually in the United States, with a significant unmet medical need for patients who develop TKI resistance. Approximately 10-15%. of GIST patients are either primarily refractory, or develop secondary resistance, to available TKIs, and options for these patients remain limited. MTX240’s novel mechanism represents a potentially differentiated therapeutic approach that circumvents conventional resistance pathways and aligns with our strategic focus on rare disease development and addressing important clinical gaps. The global GIST market is valued at approximately USD 1.3 billion and is expected to grow at 6-10% annually through 2032, driven by rising incidence and emerging therapeutic options targeting treatment-resistant disease.

GIST qualifies for orphan drug designation in major regulatory jurisdictions, offering potential regulatory advantages and incentives to support drug development.

Under the terms of the Otsuka License Agreement, we have the exclusive rights to develop and commercialize MTX240 globally with the exception of Japan, where Otsuka retains its rights. The Otsuka License Agreement includes an upfront fee and additional development and regulatory milestones. In addition, tiered royalties in the mid-single digit range are payable on net sales of MTX240. MTX240 benefits from composition of matter patents in the United States, Europe, Japan and various other countries extending through 2037 without any patent term extension.

As a first step, we plan to manufacture clinical trial supplies and then initiate a Phase 1b/2a trail to include a dose escalation followed by an extension with a view to establishing a safe and well tolerated doe and an efficacy signal.

Tolimidone. Tolimidone was originally discovered by Pfizer Inc., or Pfizer, and was developed through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in Phase 2. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signaling cascade initiated by the binding of insulin to its receptor.

We intend to develop tolimidone for the treatment of T1D. As a lyn kinase activator, tolimidone has been shown in preclinical experiments to have a role in beta cell survival and proliferation. If replicated in clinical studies, tolimidone could have the potential to be disease modifying and change the treatment paradigm for T1D. T1D affects approximately 8.4 million people worldwide and there are approximately 500,000 new diagnoses per annum.

As a first step in the planned continued clinical development of tolimidone, we initiated a Phase 2a dose confirmation study to establish the optimum dose of tolimidone in patients with T1D. The Phase 2a study will be open-label in approximately 12 patients with T1D treated over a period of three months with endpoints of change in C-peptide levels, HbA1c and number of hyperglycemic events. On June 4, 2025, we announced the recruitment of the first patient in the study.

Commercial Agreements, Strategic Partnerships and Collaborations

We are currently collaborating with biopharmaceutical companies, contract research organizations and universities on several of our development programs.

For more information on the Otsuka License Agreement, see “–Recent Developments.”

Emtora License Agreement. On April 25, 2024, we entered into a license and collaboration agreement, or the Emtora License Agreement, with Emtora, relating to the license of eRapa, an oral product formulation of rapamycin (sirolimus), or the Product, for use in the prevention, treatment, diagnosis, detection, monitoring and/or predisposition testing of all diseases, states or conditions in humans, or the Field, that includes the nanoparticle and enteric coated finished pharmaceutical formulations developed at any time by Emtora and its affiliates, or the License. Under the License, we obtained from Emtora an exclusive, worldwide, sublicensable right to develop, manufacture, commercialize, or otherwise exploit products containing rapamycin (sirolimus) in the Field. Pursuant to the terms of the License Agreement, the Company and Emtora established a joint development committee, consisting of two designees of the Company and two designees of Emtora.

As consideration for the License, we made an upfront payment to Emtora in the form of 1,512 of our Depositary Shares (equal to five percent (5%) of our outstanding Ordinary Shares, calculated on a fully-diluted basis (including in-the-money warrants) at the time). In addition, we are also responsible for up to $31.5 million in sales milestones within the first six months of commercial sale of a first-approved indication of eRapa in certain markets, with decreasing milestones for subsequent approvals for additional indications. There is also a one-time $10.0 million milestone payable upon cumulative net sales of $1.0 billion. Further, we are also obligated to pay Emtora single digit tiered royalties on net sales of eRapa, in addition to honoring Emtora’s legacy royalty obligations and paying Emtora fees related to income derived from sublicensing and the partnering of eRapa. In addition, effective as of the closing of the License Agreement, a promissory note previously issued by Emtora in favor of the Company in the amount of $250,000 was forgiven. We also made an additional $500,000 cash payment to Emtora to be used exclusively for a match to an advance from CPRIT.

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Upon any change of control of the Company (as defined in the Emtora License Agreement), we shall issue Emtora a warrant exercisable for 6,417 Depositary Shares, which may only be exercised upon such change of control.

The License Agreement also provides us with the exclusive option to acquire all of the capital stock of Emtora at a purchase price on commercially reasonable terms during the period beginning with the filing of a new drug application, or NDA, for the Product with the FDA and ending 90 days after acceptance of the filing of the NDA by the FDA.

Melior License. On November 22, 2023, we entered into the license agreement, or the Melior License Agreement, with Melior Pharmaceuticals I, Inc., or Melior, for the development and commercialization of tolimidone in most territories other than China, South Korea and a number of smaller Asian territories which Melior licensed to Bukwang Pharmaceutical Co. Ltd., or Bukwang. Under the Melior License Agreement, we obtained from Melior an exclusive, worldwide, sublicensable right to develop, manufacture, commercialize, or otherwise exploit products containing tolimidone for any field.

Pursuant to the terms of the License Agreement, we issued to Melior 1,417 Depositary Shares in upfront consideration, and agreed to issue the same to Bukwang. In addition, we are obligated to pay single digit tiered royalties on net sales of tolimidone to Melior, with Melior agreeing to pay to Bukwang 50% of such royalties pursuant to a royalty agreement.

Under the Melior License Agreement, we, at our own cost, have the right to control the prosecution, maintenance and enforcement of the tolimidone patents, while Melior has certain step-in rights if we elect not to prosecute and maintain such tolimidone patents. The Melior License Agreement may be terminated by Melior if we fail to meet various development diligence obligations.

In connection with the License Agreement, on November 22, 2023, Melior and Bukwang entered into an amendment to the license agreement with Bukwang, or the Bukwang License. Under the amendment, the Bukwang License terminated in its entirety and Bukwang transferred to Melior all rights, titles and interests to certain INDs, know-how and data, and patents relating to tolimidone.

Under the amendment, Melior and Bukwang entered into a royalty agreement pursuant to which Bukwang shall be entitled to 50% of all payments Melior receives under the License Agreement, including: (i) 50% of the equity issued by us under the License Agreement, and (ii) 50% of the royalties that we will pay to Melior. Further, under the royalty agreement, Bukwang will pay to Melior $100,000 in consideration for Melior’s waiver of Bukwang’s obligation to pay patent costs pursuant to the Bukwang License, and Melior will take back responsibility for all tolimidone patent prosecution and maintenance costs.

Sales and Marketing

We do not currently have any internal sales and marketing organization or distribution capabilities.

Research and Development

We have leased a laboratory in Cardiff, Wales in which we are able to undertake basic formulation and analytical work. During 2025 we decided to de-commission the laboratories as a result of its change in focus to clinical stage assets.

Intellectual Property

Our success depends in large part on our ability to obtain and maintain proprietary protection for our product candidates (and products derived therefrom), technology and know-how, to operate without infringing the proprietary rights of others and to prevent others from infringing our proprietary rights. We strive to protect the proprietary technology that we believe is important to our business by, among other methods, seeking and maintaining patents, where available, that are intended to cover our product candidates (and products derived therefrom), compositions and formulations, their methods of use and processes for their manufacture and any other inventions that are commercially important to the development of our business. We also rely on trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary and competitive position.

We have developed a strong intellectual property base globally, comprising patents, know-how, and trade secrets. Currently, we maintain an extensive intellectual property portfolio, intended to protect our key assets across all major jurisdictions. The portfolio comprises 13 patent families, 93 granted patents and 11 pending applications. Approximately 85% of the granted patents are associated with recently in-licensed assets and these are co-administered but not assigned to the Company. We continue to strengthen our patent portfolio by strategically submitting new patents and divisional patent applications based on our active research and development activities.

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Patent rights have been granted in all the major world markets, including Europe, the United States and Japan, or the Key Markets. The granted patents and pending patent applications in our patent families are owned solely by us, co-owned with other parties or in-licensed to us. These include patents related to methods of use of MTX240, eRapa, tolimidone and MTX110, as well as patents covering sustained release drug delivery, nano-inclusion technology and nanoparticle technology.

The term of individual patents depends upon the legal term for patents in the countries in which they are obtained. In most countries, including the United States, the patent term is 20 years from the filing date of a non-provisional patent application. In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent.

The term of a United States patent that covers a drug, biological product or medical device approved pursuant to a pre-market approval may also be eligible for patent term extension when FDA approval is granted, provided that certain statutory and regulatory requirements are met. The length of the patent term extension is related to the length of time the drug is under regulatory review while the patent is in force. The Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the expiration date set for the patent. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to each regulatory review period may be granted an extension and only those claims reading on the approved drug may be extended. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug, provided that statutory and regulatory requirements are met. Thus, in the future, if and when our product candidates receive approval by the FDA or foreign regulatory authorities, we expect to apply for patent term extensions on issued patents covering those products, depending upon the length of the clinical trials for each drug and other factors. The expiration dates of our patents and patent applications referred to above are without regard to potential patent term extension or other market exclusivity that may be available to us.

In addition to patents, we may rely, in some circumstances, on trade secrets to protect our technology and maintain our competitive position. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees, corporate and scientific collaborators, consultants, scientific advisors, contractors and other third parties. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

Government Regulations

Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union and the United Kingdom, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products. The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. As we have disclosed herein, we are seeking to license our product candidates and other formulations to licensing partners. While many of the rules and regulations set forth herein do and will apply to us, some are more applicable to any licensing partner who seeks to conduct clinical trials of, obtain regulatory approval for and commercialize any of our product candidates, which could have an impact on any licensing revenue received by us.

Review and Approval of Drugs in the United States

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations, and regulates biologics under the FDCA, the Public Health Services Act, or the PHSA, and their implementing regulations. Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of enforcement letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, exclusion from participation in government sponsored healthcare programs such as Medicare, or civil or criminal investigations and penalties brought by the FDA and the Department of Justice, or the DOJ, or other governmental entities.

An applicant seeking approval to market and distribute a new drug product in the United States must typically undertake the following:

·	completion of preclinical (or nonclinical) laboratory tests, animal studies and formulation studies in compliance with the FDA’s<br> good laboratory practice, or GLP, regulations;
·	submission to the FDA of an IND application, which must take effect before human clinical trials may begin;
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| --- | | · | approval of clinical protocols by an independent institutional review board, or IRB, or ethics committee representing each clinical site before each site may enroll subjects; | | --- | --- | | · | potential initiation and completion of successive clinical trials that establish safety dose ranges; | | --- | --- | | · | performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, and other clinical-trial related regulations to establish the safety and efficacy of the proposed drug product for each indication; | | --- | --- | | · | preparation and submission to the FDA of a new drug application, or NDA, or a biologics license application, or BLA; | | --- | --- | | · | review of the submission by an FDA advisory committee, where appropriate or if applicable; | | --- | --- | | · | satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity, for drugs, or safety, purity and potency for biologics; | | --- | --- | | · | satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCP regulations and the integrity of the clinical data; | | --- | --- | | · | payment of user fees and securing FDA approval of the NDA or BLA; | | --- | --- | | · | agree to comply with any post-approval requirements, including Risk Evaluation and Mitigation Strategies, or REMS, and post-approval studies required by the FDA; and | | --- | --- | | · | FDA review and approval of the NDA or licensure of the BLA. | | --- | --- |

Preclinical Studies

Preclinical studies include laboratory evaluation of the purity and stability of the manufactured drug substance or API and the formulated finished drug or drug product, as well as in vitro and animal studies to assess the safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GLP regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before human clinical trials may begin. Some long-term nonclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after the IND is submitted.

The Consolidated Appropriations Act for 2023 amended the FDCA and the Public Health Service Act to specify that nonclinical testing for drugs and biologics may, but is not required to, include in vivo animal testing. According to the amended language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or nonhuman biology-based tests (e.g., bioprinting), or in vivo animal tests.

Human Clinical Trials in Support of an NDA

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing before their participation in any clinical trial. Clinical trials are conducted under written study protocols detailing, among other things, the inclusion and exclusion criteria, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to a proposed clinical trial and places the clinical trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Accordingly, submission of an IND may not result in the FDA allowing clinical trials to commence. A separate submission to an existing IND must also be made for each successive clinical trial conducted during development of a product candidate, and the FDA must grant permission, either explicitly in writing or implicitly by not objecting, before each clinical trial can begin.

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Following commencement of a clinical trial, the FDA may also place a clinical hold or partial clinical hold on that trial. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is a delay or suspension of only part of the clinical work requested under the IND. No more than 30 days after imposition of a clinical hold or partial clinical hold, the FDA will provide the sponsor a written explanation of the basis for the hold. Following issuance of a clinical hold or partial clinical hold, an investigation may only resume after the FDA has notified the sponsor that the investigation may proceed.

In addition, an IRB representing each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must conduct a continuing review and reapprove the study at least annually. The IRB must review and approve, among other things, the study protocol and informed consent information to be provided to study subjects. An IRB must operate in compliance with FDA regulations.

Some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee, or DSMB. This group provides authorization as to whether or not a trial may move forward at designated check points based on access that only the group maintains to available data from the study.

Information about certain clinical trials, including details of the protocol and eventually study results, must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website. Information related to the product, patient population, phase of investigation, study site locations and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government. Both NIH and FDA have brought enforcement actions against non-compliant clinical trial sponsors.

Human clinical trials are typically conducted in three sequential phases, Phase 1, Phase 2 and Phase 3, which may overlap or be combined:

·	Phase 1. The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance,<br> absorption, metabolism, distribution and excretion. In the case of some product candidates for severe or life-threatening diseases, especially<br> when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often<br> conducted in patients.
·	Phase 2. The product candidate is evaluated in a limited patient population to identify possible adverse effects and safety<br> risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases and to determine dosage tolerance,<br> optimal dosage and dosing schedule.
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·	Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded<br> patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit<br> ratio of the product candidate and provide, if appropriate, an adequate basis for approval and product labeling. These trials may include<br> comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a<br> product during marketing.
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Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA.

Congress amended the FDCA in 2022 to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to submit a diversity action plan for such clinical trial. The action plan must include the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. A sponsor must submit a diversity action plan to FDA by the time the sponsor submits the trial protocol to the agency for review. The FDA may grant a waiver for some or all of the requirements for a diversity action plan. If the FDA objects to a sponsor’s diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.

Reports detailing the progress of, and safety date from, the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions; findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug; and any clinically important increase in the case of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. The FDA will typically inspect one or more clinical sites to assure compliance with GCP and the integrity of the clinical data submitted with an NDA or BLA.

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Submission of an NDA or BLA to the FDA

Assuming successful completion of required clinical testing and other requirements, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product candidate for one or more indications. Data may come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product, or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA. In particular, a BLA must contain proof of the biological product candidate’s safety, purity, potency and efficacy for its proposed indication or indications. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee, and the sponsor of an approved NDA is also subject to an annual program user fee. These fees are typically increased annually. Certain exceptions and waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver of the application fee for the first application filed by a qualifying small business.

The FDA conducts a preliminary review of an NDA within 60 days of its receipt and informs the sponsor by the 74th day after the FDA’s receipt of the submission whether the application is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA has agreed to specified performance goals in the review process of NDAs and BLAs. Most such applications are meant to be reviewed within ten months from the date of filing, and most applications for “priority review” products are meant to be reviewed within six months of filing. Despite these review goals, it is not uncommon for FDA review of an NDA or BLA to extend beyond the goal date. For instance, the review process may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.

The FDA may refer applications for novel drug or biological products or drug or biological products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes independent clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions and typically follows the advisory committee’s recommendations.

Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured. These pre-approval inspections cover all facilities associated with an NDA or BLA submission, including drug or biologic component manufacturing (such as APIs), finished product manufacturing, and control testing laboratories. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP.

Fast Track, Breakthrough Therapy and PriorityReview Designations and Commissioner’s National Priority Voucher

The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are fast track designation, breakthrough therapy designation, priority review designation and the Commissioner’s National Priority Voucher program.

Specifically, the FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs by providing a therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. For fast track products, sponsors may have more frequent interactions with the FDA and the FDA may initiate review of sections of a fast track product’s NDA or BLA before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective. The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees upon submission of the first section of the NDA or BLA. However, the FDA’s time period goal for reviewing a fast track application does not begin until the last section of the NDA is submitted. In addition, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

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The FDA may grant breakthrough therapy designation to a drug or biologic meeting certain statutory criteria upon a request made by the IND sponsor. A product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner. In addition, breakthrough therapies are eligible for accelerated approval of their respective marketing applications.

The FDA may designate a product for priority review if it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, at the time that the marketing application is submitted, on a case-by-case basis, whether the proposed drug represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, or evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months for an original BLA or for an NME NDA from the date of filing.

In 2025, the FDA created a new pilot program called the Commissioner’s National Priority Voucher, or CNPV, with the goal of radically expediting the drug and biological product review and approval process. The agency may award a CNPV to a company or a specific product candidate that demonstrates alignment with certain national health priorities. The FDA aims to take action on a marketing application for which a CNPV is used within one to two months after the filing date.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Furthermore, none of these programs changes the scientific or medical standards for approval or the quality of evidence necessary to support approval and may not ultimately expedite the development or review process.

Accelerated Approval Pathway

The FDA may grant accelerated approval to a drug or biologic for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination from well-controlled clinical trials that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a drug or biologic when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. Drugs and biologics granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug or biologic, such as an effect on IMM. The FDA has limited experience with accelerated approvals based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate clinical benefit of a drug or biologic.

The accelerated approval pathway is most often used in settings in which the course of a disease is long and an extended period of time is required to measure the intended clinical benefit of a drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. For example, accelerated approval has been used extensively in the development and approval of drugs for treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large clinical trials to demonstrate a clinical or survival benefit.

The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. As a result, a drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA. As part of the Consolidated Appropriations Act for 2023, Congress provided the FDA additional statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval. Under the act’s amendments to the FDCA, the FDA may require the sponsor of a product being considered for accelerated approval to have a confirmatory trial underway prior to approval. The sponsor must also submit progress reports on a confirmatory trial every six months until the trial is complete, and such reports are published on the FDA’s website. The amendments also give the FDA the option of using expedited procedures to withdraw product approval if the sponsor’s confirmatory trial fails to verify the claimed clinical benefits of the product.

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The FDA’s Decision on an NDA or BLA

The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. The approval process is lengthy and often difficult, and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. On the basis of the FDA’s evaluation of the NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A complete response letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. In September 2025, the FDA began publishing CRLs, with trade secret and confidential commercial information redacted, soon after issuing them to the respective sponsors, breaking with long standing agency tradition of publishing CRLs with approval documentation after the product is approved. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA or BLA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

If the FDA approves a product, it may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess the drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, such as REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. The FDA may also require an applicant to develop a REMS as a condition of approval to ensure that the benefits of the product outweigh its risks and to assure its safe use. REMS use risk minimization strategies beyond the professional labeling to ensure that the benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, seriousness of the disease, expected benefit of the product, expected duration of treatment, seriousness of known or potential adverse events, and whether the product is a new molecular entity. REMS can include medication guides, physician communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU may include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The FDA may require a REMS before approval or post-approval if it becomes aware of a serious risk associated with use of the product. If the FDA concludes a REMS is needed as a condition of approval, the sponsor must submit a proposed REMS during the application review process; the FDA will not approve the NDA without an approved REMS, if required. The requirement for a REMS can materially affect the potential market and profitability of a product. After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Post-Approval Requirements

Drugs or biologics manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fee requirements for any marketed products, as well as new application fees for supplemental applications with clinical data.

In addition, drug and biologic manufacturers and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments with the FDA and state agencies, and are subject to periodic prescheduled or unannounced inspections by the FDA and the relevant state agencies for compliance with cGMP and other regulatory requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

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Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

·	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the<br> market or product recalls;
·	fines, warning letters or holds on post-approval clinical trials;
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·	refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of<br> product license approvals;
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·	product seizure or detention, or refusal to permit the import or export of products; or
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·	injunctions or the imposition of civil or criminal penalties.
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The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market, and we must comply with the FDA’s advertising and promotion requirements, such as those related to direct-to-consumer advertising, industry-sponsored scientific and educational activities, and promotional activities involving the internet, as well as the prohibition on promoting products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label use”). Drugs and biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. Furthermore, the Drug Supply Chain Security Act, or DSCSA, was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United States, including most biological products. The DSCSA mandates resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers. The DSCSA also replaced certain provisions from the PDMA pertaining to wholesale distributions of prescription drugs with a more comprehensive statutory scheme, requiring uniform national standards for wholesale distribution and, for the first time, for third-party logistics providers. From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. It is impossible to predict whether further legislative or regulatory changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any, may be.

Abbreviated New Drug Applications for Generic Drugs

In 1984, with passage of the Hatch-Waxman amendments to the FDCA, Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the statute and also enacted Section 505(b)(2) of the FDCA. To obtain approval of a generic drug, an applicant must submit an abbreviated new drug application, or ANDA, to the agency. In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference listed drug, or RLD.

Specifically, in order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength of the drug. At the same time, the FDA must also determine that the generic drug is “bioequivalent” to the innovator drug. Under the statute, a generic drug is bioequivalent to a RLD if “the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug.”

Upon approval of an ANDA, the FDA indicates whether the generic product is “therapeutically equivalent” to the RLD in its publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred to as the “Orange Book.” Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully substitutable for the RLD. In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s designation of therapeutic equivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing physician or patient.

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In contrast, Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously approved product is scientifically appropriate. Unlike the ANDA pathway used by developers of bioequivalent versions of innovator drugs, which does not allow applicants to submit new clinical data other than bioavailability or bioequivalence data, the 505(b)(2) regulatory pathway does not preclude the possibility that a follow-on applicant would need to conduct additional clinical trials or nonclinical studies; for example, they may be seeking approval to market a previously approved drug for new indications or for a new patient population that would require new clinical data to demonstrate safety or effectiveness. The FDA may then approve the new product for all or some of the label indications for which the RLD has been approved, or for any new indication sought by the Section 505(b)(2) applicant, as applicable.

In addition, under the Hatch-Waxman amendments, the FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent exclusivity for the RLD has expired. These market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a period of five years of non-patent data exclusivity for a new drug containing a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. In cases where such exclusivity has been granted, an ANDA or 505(b)(2) NDA may not be filed with the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification (as described below), in which case the applicant may submit its application four years following the original product approval.

The FDCA also provides for a period of three years of data exclusivity for an NDA, 505(b)(2) NDA or supplement thereto if one or more new clinical investigations, other than bioavailability or bioequivalence studies, that were conducted by or for the applicant are deemed by the FDA to be essential to the approval of the application. This three-year exclusivity period often protects changes to a previously approved drug product, such as a new dosage form, route of administration, combination or indication. This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving follow-on applications for drugs containing the original active agent. Five-year and three-year exclusivity also will not delay the submission or approval of a traditional NDA filed under Section 505(b)(1) of the FDCA. However, an applicant submitting a traditional NDA would be required to either conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Hatch-Waxman Patent Certification and the 30-Month Stay

Upon approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product. Each of the patents listed by the NDA sponsor is published in the Orange Book. When an ANDA applicant files its application with the FDA, the applicant is required to certify to the FDA concerning any patents listed for the reference product in the Orange Book, except for patents covering methods of use for which the ANDA applicant is not seeking approval. To the extent that a Section 505(b)(2) NDA applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would.

Specifically, the applicant must certify with respect to each patent that:

I.	the required patent information has not been filed by the original applicant;
II.	the listed patent has expired;
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III.	the listed patent has not expired, but will expire on a particular date and approval is sought after patent<br> expiration; or
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IV.	the listed patent is invalid, unenforceable or will not be infringed by manufacture, use or sale of the new<br> product.
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If a Paragraph I or II certification is filed, the FDA may make approval of the application effective immediately upon completion of its review. If a Paragraph III certification is filed, the approval may be made effective on the patent expiration date specified in the application, although a tentative approval may be issued before that time. If an application contains a Paragraph IV certification, a series of events will be triggered, the outcome of which will determine the effective date of approval of the ANDA or 505(b)(2) application.

A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called a Paragraph IV certification. If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the follow-on application in question has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months after the receipt of the Paragraph IV notice, expiration of the patent or a decision in the infringement case that is favorable to the ANDA or 505(b)(2) applicant. Alternatively, if the listed patent holder does not file a patent infringement lawsuit within the required 45-day period, the follow-on applicant’s ANDA or 505(b)(2) NDA will not be subject to the 30-month stay.

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Reference Product Exclusivity for Biological Products

In March 2010, the Patient Protection and Affordable Care Act, or ACA, was enacted in the United States and included the Biologics Price Competition and Innovation Act of 2009, or the BPCIA. The BPCIA amended the PHSA to create an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. To date, the FDA has approved a number of biosimilars, and numerous biosimilars have been approved in Europe. The FDA has also issued several guidance documents outlining its approach to reviewing and approving biosimilars and interchangeable biosimilars, and has created a public database that contains information on all FDA-licensed biological products, including biosimilars, called the Purple Book.

A biosimilar product is defined as one that is highly similar to a reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product. An interchangeable product is a biosimilar product that can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times to an individual, that the product and the reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch. Upon licensure by the FDA, an interchangeable biosimilar may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

The biosimilar applicant must demonstrate that the product is biosimilar based on data from (1) analytical studies showing that the biosimilar product is highly similar to the reference product; (2) animal studies (including toxicity); and (3) one or more clinical studies to demonstrate safety, purity and potency in one or more appropriate conditions of use for which the reference product is approved. In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label, route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.

A reference biological product is granted 12 years of data exclusivity from the time of first licensure of the product, and the first approved interchangeable biologic product will be granted an exclusivity period of up to one year after it is first commercially marketed. As part of the Consolidated Appropriations Act for 2023, Congress amended the PHSA in order to permit multiple interchangeable products approved on the same day to receive and benefit from this one-year exclusivity period. If pediatric studies are performed and accepted by the FDA as responsive to a Written Request, the 12-year exclusivity period will be extended for an additional six months. In addition, the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a supplement for the reference product for a subsequent application filed by the same sponsor or manufacturer of the reference product (or licensor, predecessor in interest or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength or for a modification to the structure of the biological product that does not result in a change in safety, purity or potency. Therefore, one must determine whether a new product includes a modification to the structure of a previously licensed product that results in a change in safety, purity or potency to assess whether the licensure of the new product is a first licensure that triggers its own period of exclusivity. Whether a subsequent application, if approved, warrants exclusivity as the “first licensure” of a biological product is determined on a case-by-case basis with data submitted by the sponsor.

The BPCIA is complex and is still being interpreted and implemented by the FDA. In addition, recent government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of litigation. As a result, the ultimate impact, implementation and meaning of the BPCIA is subject to significant uncertainty.

Pediatric Studies and Exclusivity

Under the Pediatric Research Equity Act, or PREA, amendments to the FDCA, an NDA, BLA or supplement thereto must contain data that are adequate to assess the safety and effectiveness of the drug product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. With enactment of the FDASIA in 2012, PREA was made permanent and sponsors are required submit pediatric study plans to FDA prior to the assessment data. In particular, a sponsor that is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study. The initial PSP must contain an outline of the proposed pediatric study or studies the applicant plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs.

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The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. The law requires the FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA, have failed to seek or obtain a deferral or deferral extension or have failed to request approval for a required pediatric formulation. It further requires the FDA to publicly post the PREA Non-Compliance letter and sponsor’s response. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation, although FDA has taken steps to limit what it considers abuse of this statutory exemption in PREA by announcing that it does not intend to grant any additional orphan drug designations for rare pediatric subpopulations of what is otherwise a common disease.

In addition, pediatric exclusivity is another type of non-patent marketing exclusivity in the United States that, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity or listed patents. This six-month exclusivity may be granted if an NDA sponsor submits pediatric data that fairly respond to a Written Request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months, including orphan drug exclusivity. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. The FDA’s issuance of a Written Request does not require the sponsor to undertake the described studies.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may designate a drug product as an “orphan drug” if it is intended to treat a rare disease or condition (generally meaning that it affects fewer than 200,000 individuals in the United States, or more in cases in which there is no reasonable expectation that the cost of developing and making a drug product available in the United States for treatment of the disease or condition will be recovered from sales of the product). A company must request orphan product designation before submitting an NDA. If the request is granted, the FDA will disclose the identity of the therapeutic agent and its potential use. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a product with orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product generally will receive orphan product exclusivity. Orphan product exclusivity means that the FDA may not approve any other applications for the same product for the same indication for seven years, except in certain limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues. Competitors, however, may receive approval of either a different product for the same indication for which the orphan product has exclusivity or for the same product but for a different indication (which could then be used off-label in the orphan indication). If a drug or drug product designated as an orphan product ultimately receives marketing approval for an indication broader than what was designated in its orphan product application, it may not be entitled to exclusivity.

Patent Term Restoration and Extension

The term of a United States patent that covers a drug, biological product or medical device approved pursuant to a PMA may also be eligible for patent term extension when FDA approval is granted, provided that certain statutory and regulatory requirements are met. The length of the patent term extension is related to the length of time the product is under regulatory review while the patent is in force. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration date set for the patent. However, patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent applicable to an approved drug may be granted an extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trade Office reviews and approves the application for any patent term extension or restoration in consultation with the FDA. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug, provided that statutory and regulatory requirements are met.

Regulation Outside the United States

In order to market any product outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of drug products. Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries or jurisdictions. The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in a country or jurisdiction may negatively impact the regulatory process in others.

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Regulation and Marketing Authorization in the European Union

The process governing approval of medicinal products in the European Union follows essentially the same lines as in the United States and, likewise, generally involves satisfactorily completing each of the following:

·	preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable European Union good<br> laboratory practice regulations;
·	submission to the relevant national authorities of a clinical trial application, or CTA, which must be approved before human clinical<br> trials may begin;
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·	performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;
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·	submission to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting<br> safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed<br> labeling;
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·	satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those<br> of third parties, at which the product is produced to assess compliance with strictly enforced current cGMP;
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·	potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and
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·	review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
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Preclinical Studies

Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies, in order to assess the potential safety and efficacy of the product. The conduct of the preclinical tests and formulation of the compounds for testing must comply with the relevant European Union regulations and requirements. The results of the preclinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA.

Clinical Trial Approval

The new Clinical Trials Regulation, (EU) No 536/2014, which took effect on January 31, 2022, aims to simplify and streamline the approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined application procedure via a single entry point, the Clinical Trials Information System, or CTIS; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed by the appointed reporting Member State, whose assessment report is submitted for review by the sponsor and all other competent authorities of all European Union Member States in which an application for authorization of a clinical trial has been submitted (Concerned Member States). Part II is assessed separately by each Concerned Member State. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the Concerned Member State. However, overall related timelines will be defined by the Clinical Trials Regulation.

As in the United States, similar requirements for posting clinical trial information are present in the European Union (EudraCT) website: https://eudract.ema.europa.eu/ and other countries.

PRIME Designation in the European Union

In March 2016, the EMA launched an initiative to facilitate development of product candidates in indications, often rare, for which few or no therapies currently exist. The PRIority MEdicines, or PRIME, scheme is intended to encourage drug development in areas of unmet medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized procedure. Products from small- and medium-sized enterprises, or SMEs, may qualify for earlier entry into the PRIME scheme than larger companies. Many benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and accelerated marketing authorization application assessment once a dossier has been submitted. Importantly, a dedicated Agency contact and rapporteur from the Committee for Human Medicinal Products, or CHMP, or Committee for Advanced Therapies, or CAT, are appointed early in PRIME scheme facilitating increased understanding of the product at EMA’s Committee level. A kick-off meeting initiates these relationships and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies.

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Marketing Authorization

To obtain a marketing authorization for a product under European Union regulatory systems, an applicant must submit an MAA either under a centralized procedure administered by the EMA, or one of the procedures administered by competent authorities in the European Union Member States (decentralized procedure, national procedure or mutual recognition procedure). A marketing authorization may be granted only to an applicant established in the European Union. Regulation (EC) No 1901/2006 provides that prior to obtaining a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included in an EMA-approved Paediatric Investigation Plan, or PIP, covering all subsets of the pediatric population, unless the EMA has granted (1) a product-specific waiver, (2) a class waiver or (3) a deferral for one or more of the measures included in the PIP.

The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid across the European Economic Area (i.e., the European Union as well as Iceland, Liechtenstein and Norway). Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of cancer. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional. The centralized procedure may at the request of the applicant also be used in certain other cases.

Under the centralized procedure, the CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing marketing authorization. Under the centralized procedure in the European Union., the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops, when additional information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. If the CHMP accepts such request, the time limit of 210 days will be reduced to 150 days, but it is possible that the CHMP can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment. At the end of this period, the CHMP provides a scientific opinion on whether or not a marketing authorization should be granted in relation to a medicinal product. Within 15 calendar days of receipt of a final opinion from the CHMP, the European Commission must prepare a draft decision concerning an application for marketing authorization. This draft decision must take the opinion and any relevant provisions of European Union law into account. Before arriving at a final decision on an application for centralized authorization of a medicinal product the European Commission must consult the Standing Committee on Medicinal Products for Human Use. The Standing Committee is composed of representatives of the European Union Member States and chaired by a non-voting European Commission representative. The European Parliament also has a related “droit de regard.” The European Parliament's role is to ensure that the European Commission has not exceeded its powers in deciding to grant or refuse to grant a marketing authorization.

The European Commission may grant a so-called “marketing authorization under exceptional circumstances.” Such authorization is intended for products for which the applicant can demonstrate that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information. Consequently, marketing authorization under exceptional circumstances may be granted subject to certain specific obligations, which may include the following:

·	the applicant must complete an identified program of studies within a time period specified by the competent<br> authority, the results of which form the basis of a reassessment of the benefit/risk profile;
·	the medicinal product in question may be supplied on medical prescription only and may in certain cases be<br> administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized<br> person; and
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·	the package leaflet and any medical information must draw the attention of the medical practitioner to the<br> fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
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A marketing authorization under exceptional circumstances is subject to annual review to reassess the risk-benefit balance in an annual reassessment procedure. Continuation of the authorization is linked to the annual reassessment and a negative assessment could potentially result in the marketing authorization being suspended or revoked. The renewal of a marketing authorization of a medicinal product under exceptional circumstances, however, follows the same rules as a “normal” marketing authorization. Thus, a marketing authorization under exceptional circumstances is granted for an initial five years, after which the authorization will become valid indefinitely, unless the EMA decides that safety grounds merit one additional five-year renewal.

The European Commission may also grant a so-called “conditional marketing authorization” prior to obtaining the comprehensive clinical data required for an application for a full marketing authorization. Such conditional marketing authorizations may be granted for product candidates (including medicines designated as orphan medicinal products), if (i) the risk-benefit balance of the product candidate is positive, (ii) it is likely that the applicant will be in a position to provide the required comprehensive clinical trial data, (iii) the product fulfills an unmet medical need and (iv) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorization may contain specific obligations to be fulfilled by the marketing authorization holder, including obligations with respect to the completion of ongoing or new studies, and with respect to the collection of pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a conditional marketing authorization.

The European Union medicines rules expressly permit the European Union Member States to adopt national legislation prohibiting or restricting the sale, supply or use of any medicinal product containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells. While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain European Union Member States may prohibit or restrict us from commercializing our products, even if they have been granted a European Union marketing authorization.

Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the competent authorities of each European Union Member State in which the product is to be marketed. This application is identical to the application that would be submitted to the EMA for authorization through the centralized procedure. The reference European Union Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned European Union Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials. If a concerned European Union Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the European Commission, whose decision is binding on all European Union Member States.

The mutual recognition procedure similarly is based on the acceptance by the competent authorities of the European Union Member States of the marketing authorization of a medicinal product by the competent authorities of other European Union Member States. The holder of a national marketing authorization may submit an application to the competent authority of a European Union Member State requesting that this authority recognize the marketing authorization delivered by the competent authority of another European Union Member State.

In April 2023 the European Commission issued a legislative proposal to revise and replace the existing general pharmaceutical legislation, which was subsequently finalized and adopted in December 2025. The revisions will significantly change several aspects of drug development and approval in the European Union.

Regulatory Data Protection in the EuropeanUnion

In the European Union, innovative medicinal products approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity pursuant to Directive 2001/83/EC. Regulation (EC) No 726/2004 repeats this entitlement for medicinal products authorized in accordance with the centralized authorization procedure. Data exclusivity prevents applicants for authorization of generics of these innovative products from referencing the innovator’s data to assess a generic (abridged) application for a period of eight years. During an additional two-year period of market exclusivity, a generic marketing authorization application can be submitted and authorized, and the innovator’s data may be referenced, but no generic medicinal product can be placed on the European Union market until the expiration of the market exclusivity. The overall 10-year period will be extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. Even if a compound is considered to be a new chemical entity so that the innovator gains the prescribed period of data exclusivity, another company nevertheless could also market another version of the product if such company obtained marketing authorization based on an MAA with a complete independent data package of pharmaceutical tests, preclinical tests and clinical trials.

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Periods of Authorization and Renewals

A marketing authorization has an initial validity for five years in principle. The marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the European Union Member State. To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. The European Commission or the competent authorities of the European Union Member States may decide, on justified grounds relating to pharmacovigilance, to proceed with one further five-year period of marketing authorization. Once subsequently definitively renewed, the marketing authorization shall be valid for an unlimited period. Any authorization which is not followed by the actual placing of the medicinal product on the European Union market (in case of centralized procedure) or on the market of the authorizing European Union Member State within three years after authorization ceases to be valid (the so-called sunset clause).

Pediatric Studies

Prior to obtaining a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included in an EMA-approved Paediatric Investigation Plan, or PIP, covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. The respective requirements for all marketing authorization procedures are set forth in Regulation (EC) No 1901/2006, which is referred to as the Paediatric Regulation. This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorized. The Paediatric Committee of the EMA, or PDCO, may grant deferrals for some medicines, allowing a company to delay development of the medicine in children until there is enough information to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the elderly population.

Before a marketing authorization application can be filed, or an existing marketing authorization can be amended, the EMA determines that companies actually comply with the agreed studies and measures listed in each relevant PIP.

Regulatory Requirements after a Marketing Authorization has beenObtained

In case an authorization for a medicinal product in the European Union is obtained, the holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. These include:

·	Compliance with the European Union’s stringent pharmacovigilance or safety reporting rules must be ensured.<br> These rules can impose post-authorization studies and additional monitoring obligations.
·	The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory,<br> must also be conducted in strict compliance with the applicable European Union laws, regulations and guidance, including Directive 2001/83/EC,<br> Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements<br> include compliance with European Union cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including<br> the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import the active pharmaceutical<br> ingredients into the European Union.
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·	The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education<br> and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union notably<br> under Directive 2001/83EC, as amended, and European Union Member State laws. Direct-to-consumer advertising of prescription medicines<br> is prohibited across the European Union.
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Orphan Drug Designation and Exclusivity

The European Commission, following an evaluation by the EMA’s Committee for Orphan Medicinal Products, has designated MTX110 as an orphan medicinal product. Pursuant to Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000, the European Commission can grant orphan medicinal product designation to products for which the sponsor can establish that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 people in the European Union, or a life threatening, seriously debilitating or serious and chronic condition in the European Union and that without incentives it is unlikely that sales of the drug in the European Union would generate a sufficient return to justify the necessary investment. In addition, the sponsor must establish that there is no other satisfactory method approved in the European Union of diagnosing, preventing or treating the condition, or if such a method exists, the proposed orphan drug will be of significant benefit to patients.

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Orphan drug designation is not a marketing authorization. It is a designation that provides a number of benefits, including fee reductions, regulatory assistance, and the possibility to apply for a centralized European Union marketing authorization, as well as ten years of market exclusivity following a marketing authorization. During this market exclusivity period, neither the EMA, the European Commission nor the member states can accept an application or grant a marketing authorization for a similar medicinal product. A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances as those contained in an authorized orphan medicinal product and that is intended for the same therapeutic indication. The market exclusivity period for the authorized therapeutic indication may be reduced to six years if, at the end of the fifth year, it is established that the orphan designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. In addition, a competing similar medicinal product may in limited circumstances be authorized prior to the expiration of the market exclusivity period, including if it is shown to be safer, more effective or otherwise clinically superior to the already approved orphan drug. Furthermore, a product can lose orphan designation, and the related benefits, prior to us obtaining a marketing authorization if it is demonstrated that the orphan designation criteria are no longer met.

General Data Protection Regulation

As further discussed in “Risk Factors” under the heading “We may incur substantial costs in our efforts to comply with evolving global data protectionlaws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations,” the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union and United Kingdom, including personal health data, is subject to the GDPR and UK GDPR, respectively, which are wide-ranging in scope and impose numerous requirements on companies that process personal data, impose strict rules on the transfer of personal data to countries outside the European Union and United Kingdom, respectively, and permits data protection authorities to impose large penalties for violations. Compliance with the GDPR and UK GDPR is a rigorous and time-intensive process that may increase the cost of doing business or require companies to change their business practices to ensure full compliance.

Pricing Decisions for Approved Products

In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular product candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing approval. For example, the European Union provides options for its Member States to restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Member States may approve a specific price for a product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on the market. Other Member States allow companies to fix their own prices for products, but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. Recently, many countries in the European Union have increased the amount of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by many countries in the European Union. The downward pressure on health care costs in general, particularly prescription products, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various Member States, and parallel trade, i.e., arbitrage between low-priced and high-priced Member States, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.

Patent Term Extension

In order to compensate the patentee for delays in obtaining a marketing authorization for a patented product, a supplementary certificate, or SPC, may be granted extending the exclusivity period for that specific product by up to five years. Applications for SPCs must be made to the relevant patent office in each European Union member state and the granted certificates are valid only in the member state of grant. An application has to be made by the patent owner within six months of the first marketing authorization being granted in the European Union (assuming the patent in question has not expired, lapsed or been revoked) or within six months of the grant of the patent (if the marketing authorization is granted first). In the context of SPCs, the term “product” means the active ingredient or combination of active ingredients for a medicinal product and the term “patent” means a patent protecting such a product or a new manufacturing process or application for it. The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the first marketing authorization, minus five years, subject to a maximum term of five years.

A six-month pediatric extension of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information includes information on the results of the studies and the product is authorized in all member states of the European Union.

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United Kingdom Regulation

From January 1, 2021, European Union law no longer directly applies in the United Kingdom. The United Kingdom has adopted existing European Union medicines regulation as standalone United Kingdom legislation with some amendments to reflect procedural and other requirements with respect to marketing authorizations and other regulatory provisions.

The Medicines and Healthcare products Regulatory Agency, or MHRA, is responsible for regulating the United Kingdom medicinal products market (Great Britain and Northern Ireland). In order to market medicines in the United Kingdom, manufacturers must hold a United Kingdom authorization. On January 1, 2021, all European Union marketing authorizations were converted to United Kingdom marketing authorizations subject to a manufacturer opt-out. The United Kingdom has introduced a separate UK-specific processes for regulatory submissions and medicinal product MA, and MHRA guidance states that the United Kingdom will have the power to take into account marketing authorizations made under the European Union decentralized and mutual recognition procedures. On January 1, 2024, the MHRA launched the International Recognition Procedure, or IRP, which provides for an expedited authorization procedure for products that have received positive marketing authorization decisions from trusted partner agencies, such as the EMA or the FDA. There are two available routes for assessment and recognition under the IRP:

·	Recognition Route A – 60 days from validation of submission
·	Application must be based on a Reference Regulatory, or RR, MA within the previous two years
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·	Any significant differences from the quality dossier approved by the RR requires assessment under Recognition<br> Route B
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·	Evidence of GMP compliance for manufacturing sites should be provided with submission
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·	None of the Recognition Route B criteria are met
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·	Recognition Route B – 110 days from validation of submission with one planned clock stop (up to 60 days)<br> at day 70 to allow applicant to respond to issues identified during review
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·	Application must be based on a RR marketing authorization within the previous ten years.
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·	Criteria requiring Recognition Route B include, among other things:
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§	The RR granted a conditional or exceptional circumstances marketing authorization
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§	Additional manufacturing sites included in the application were not assessed by the RR or a manufacturing<br> site is not GMP certified
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§	There are substantial changes to the manufacturing process compared to the process approved by the RR
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§	Certain product types (e.g., advanced therapy medicinal products, orphan medicines, over-the-counter medicines)
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§	A Risk Management Plan was not assessed by the RR
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§	The RR required one or more post-authorization safety studies for the product
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§	A companion diagnostic is necessary for correct use of the product
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United Kingdom medicines legislation is subject to future regulatory change under the Medicines and Medical Devices Act 2021. This act sets out a new framework for the adoption of medicines regulation.

Different rules apply in Northern Ireland following implementation of the Northern Ireland Protocol, under which European Union central marketing applications continue to apply there. However, in March 2023, the United Kingdom government and the European Commission reached agreement on a regulatory framework to replace the Northern Ireland Protocol, referred to as the Windsor Framework. The Windsor Framework is effective as of January 1, 2025 and requires changes to the system that was previously in effect under the Northern Ireland Protocol, including the regulation of pharmaceutical products in the United Kingdom. Specifically, the MHRA will be responsible for approving all medicines intended to be marketed in the United Kingdom (i.e., Great Britain and Northern Ireland), while the EMA will no longer be involved in approving medicines intended for sale in Northern Ireland.

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The Trade and Cooperation Agreement, which sets forth a framework for partnership between the European Union and the United Kingdom, was applied provisionally as of January 1, 2021 and became effective as of May 1, 2021. The Trade and Cooperation Agreement between the European Union and the United Kingdom contains an Annex in relation to medicinal products with the objective of facilitating availability of medicines, promotion of public health and consumer protection in respect of medicinal products. The Annex provides for mutual recognition of good manufacturing practice (GMP) inspections and certificates, meaning that manufacturing facilities do not need to undergo duplicate inspections for the two markets. The Annex establishes a Working Group on Medicinal Products to deal with matters under the Trade and Cooperation Agreement, facilitate co-operation and for the carrying out of technical discussions. It is expected that further bilateral discussions will continue with respect to regulatory areas not the subject of the Trade and Cooperation Agreement, including pharmacovigilance. The Trade and Cooperation Agreement also does not include reciprocal arrangements for the recognition of batch testing certification. However, the United Kingdom has listed approved countries, including the EEA which will enable UK importers and wholesales to recognize certain certification and regulatory standards. The European Commission has not adopted such recognition procedures.

It is expected that the establishment of a separate United Kingdom authorization system, albeit with transitional recognition procedures in the United Kingdom, will lead to additional regulatory costs. In addition, additional regulatory costs may be incurred with respect to the lack of mutual recognition of batch testing and related regulatory measures.

Healthcare Law and Regulation

Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval. Arrangements with third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations. Such restrictions under applicable federal and state healthcare laws and regulations include the following:

·	the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting,<br> offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of<br> an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part,<br> under a federal healthcare program such as Medicare and Medicaid; A person or entity does not need to have actual knowledge of the Anti-Kickback<br> Statute or specific intent to violate it to have committed a violation;
·	the federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False<br> Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or<br> fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using or<br> causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money<br> to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay<br> money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government<br> payers if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual<br> acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share<br> in any monetary recovery;
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·	the Civil Monetary Penalties Law, which prohibits, among other things, the offering or giving of remuneration,<br> which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions),<br> to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of<br> a particular supplier of items or services reimbursable by a federal or state governmental program;
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·	the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil<br> liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
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·	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing<br> regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission<br> of individually identifiable health information;
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·	the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering<br> up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items<br> or services;
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·	the federal transparency requirements of the Physician Payment Sunshine Act, which requires manufacturers<br> of drugs, devices, biologics and medical supplies covered by Medicare, Medicaid or a state plans under CHIPs to report to the Centers<br> for Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, certain non-physician advanced<br> healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, the physicians<br> and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members; and
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| --- | | · | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. | | --- | --- |

Additionally, similar healthcare laws and regulations in the European Union, United Kingdom and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers and laws governing the privacy and security of certain protected information, such as GDPR and UK GDPR, which imposes obligations and restrictions on the collection and use of personal data (including health data) relating to individuals located in the European Union and the United Kingdom.

Finally, the majority of states also have statutes or regulations similar to the aforementioned federal laws, some of which are broader in scope and apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to clinicians and other healthcare providers or marketing expenditures. Some states and local jurisdictions require the registration of pharmaceutical sales representatives. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of their exceptions and safe harbors, it is possible that business activities can be subject to challenge under one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

Ensuring that business arrangements with third parties comply with applicable healthcare laws and regulations is costly and time consuming. If business operations are found to be in violation of any of the laws described above or any other applicable governmental regulations a pharmaceutical manufacturer may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of operations, any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its business and the results of its operations.

Coverage and Reimbursement

The future commercial success of our product candidate or any of our collaborators' abilities to commercialize any approved product candidate successfully will depend in part on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for our product candidate. Government health administration authorities, private health insurers and other organizations generally decide which drugs they will pay for and establish reimbursement levels for healthcare. In particular, in the United States, private health insurers and other third-party payors often provide reimbursement for products and services based on the level at which the government, through the Medicare or Medicaid programs, provides reimbursement for such treatments. In the United States, the United Kingdom, the European Union, and other potentially significant markets for our product candidate, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often has resulted in average selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United States and on country and regional pricing and reimbursement controls in the United Kingdom and European Union will put additional pressure on product pricing, reimbursement and usage, which may adversely affect our future product sales and results of operations. Recent U.S. federal actions include initiatives incorporating “most favored nation” (international reference pricing) concepts for certain prescription drugs, as well as agency testing of new payment models that could tie Medicare reimbursement or manufacturer rebates to prices in specified reference countries. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related to government health benefit programs and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.

Third-party payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products. For example, federal and state governments reimburse covered prescription drugs at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of healthcare services and products. Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drug products for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidate may not be considered medically necessary or cost-effective. A payor's decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our products and product candidates, if approved, or their exclusion from coverage. The cost containment measures that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of any of our product candidates for which we obtain regulatory approval. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for any of our product candidates, if approved, in whole or in part.

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Healthcare Reform

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product and therapeutic candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell product and therapeutic candidates that obtain marketing approval. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product and therapeutic candidates. In addition, future legislative and regulatory proposals may materially impact the ability of the FDA and other regulatory agencies to operate as they have historically operated. We cannot be sure whether additional legislative changes will be enacted, or whether any of the FDA’s regulations, guidances or interpretations will be changed, or what the impact of such changes on the agency and its scientific review staff, if any, may be. For example, negotiations on the next FDA user fee reauthorization package began in mid-2025, and the resulting agreement is expected to be sent to Congress in early 2027 for purposes of initiating the legislative process. Reauthorization of the prescription drug user fee program must be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for NDAs and other activities supported by user fees assessed against industry. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

In addition, the containment of healthcare costs has become a priority of federal and state governments and the prices of therapeutics have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement, and requirements for substitution of generic and biosimilar products for branded prescription medicines and biologics, respectively. In recent years, the U.S. Congress has considered reductions in Medicare reimbursement levels for medicines administered by physicians. CMS, the agency that administers the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage restrictions for most drugs and biologics. Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement for any approved products we may market in the future. While Medicare regulations apply only to pharmaceutical benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments from private payors.

The ACA, as amended by the Health Care and Education Affordability Reconciliation Act, was enacted in 2010 and substantially changed the way healthcare is financed by both governmental and private insurers in the United States, and significantly impacted the pharmaceutical industry. The ACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical manufacturers, and impose additional health policy reforms. With regard to biopharmaceutical products, the ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for therapeutics that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees on manufacturers of certain branded prescription medicines, created a new Medicare Part D coverage gap discount program, and expanded the 340B drug discount program. As another example, the 2021 Consolidated Appropriations Act signed into law on December 27, 2020 incorporated extensive healthcare provisions and amendments to existing laws, including a requirement that all manufacturers of medicines and biological products covered under Medicare Part B report the product’s average sales price, to the U.S. Department of Health and Human Services, subject to enforcement via civil money penalties.

Legislative and regulatory changes under the ACA remain possible, but it is unknown what form any such changes or any law would take and how or whether it may affect the biopharmaceutical industry as a whole or our business in the future. We expect that changes or additions to the ACA, the Medicare and Medicaid programs and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States.

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In addition, there has been heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products. Such scrutiny has resulted in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to medicine pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of medicines under Medicare, and reform government program reimbursement methodologies for pharmaceutical products. Notably, on December 20, 2019, the Further Consolidated Appropriations Act for 2020 became law (P.L. 116-94) and included a piece of bipartisan legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019, or the CREATES Act. The CREATES Act was enacted to address the concern articulated by both the FDA and others in the industry that some brand manufacturers had improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar product developers access to samples of brand products. Because generic and biosimilar product developers need samples of an RLD to conduct certain comparative testing required by the FDA, some attributed the inability to timely obtain samples as a cause of delay in the entry of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Although lawsuits have been filed under the CREATES Act since its enactment, those lawsuits have settled privately; therefore, to date no federal court has reviewed or opined on the statutory language and there continues to be uncertainty regarding the scope and application of the law

In August 2022, the IRA was signed into law. Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation. This calculation is made on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, CMS will negotiate drug prices annually for a select number of single-source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities announcing the first round of negotiated “maximum fair prices” for the first 10 drug products in August 2024, which will become applicable for payment year 2026. The second round of negotiated prices for 15 drug products was announced in November 2025, and CMS published the next group of drug products selected for negotiation in January 2026. However, the IRA’s impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints. Those lawsuits are currently ongoing.

Separately, the Trump Administration announced the creation of a government website called TrumpRx, which will allow consumers to purchase certain drugs at reduced prices as negotiated between the drug manufacturers and the administration. As of December 2025, the Trump Administration secured deals with five major drug manufacturers to offer certain drugs at most-favored-nation prices.

The Federal Trade Commission in mid-2022 also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its findings in mid-2024 and January 2025, that also appear to be contributing to additional federal and state legislative and regulatory proposals, as well as enforcement action and private litigation, targeting such entities’ operations, pharmacy networks, and financial arrangements. In February 2026, President Trump signed into law several PBM regulatory reforms as part of a federal budget package, including but not limited to requirements for PBMs to pass back 100% of rebates and fees to commercial health plan sponsors; to provide extensive informational disclosures related to patients’ coverage and benefits; and to accept only bona fide service fees from drug companies when providing services under Medicare Part D. The Department of Labor (DOL) also issued a proposed rule in January 2026 that would mandate specific PBM fee disclosures to self-insured plan fiduciaries under the Employment Retirement Income Security Act (ERISA). If finalized as proposed, the DOL rule would also allow plan fiduciaries to audit those PBM disclosures to confirm accuracy. Additional proposals and legislative changes aimed at PBMs and their business practices are likely to continue to be introduced and considered in Congress and by executive agencies. Significant efforts to change the PBM industry as it currently exists in the United States may affect the entire pharmaceutical supply chain and the business of other stakeholders, including biopharmaceutical developers like us. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

At the state level in the United States, legislatures have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing. For example, in recent years, several states have formed PDABs. Much like the IRA’s drug price negotiation program, these PDABs have attempted to implement UPLs on drugs sold in their respective states in both public and commercial health plans. In August 2023, Colorado’s PDAB announced a list of five prescription drugs that would undergo an affordability review. The effects of these efforts remain uncertain pending the outcomes of several federal lawsuits challenging state authority to regulate prescription drug payment limits. Furthermore, in December 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.

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We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

Competition

We also face competition from numerous sources including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Many of our competitors may have significantly greater research capabilities, as well as financial, product development, manufacturing, and marketing resources.

There are no currently approved products with an FAP indication although certain non-steroidal anti-inflammatory drugs may be prescribed off-label. Tempest Therapeutics, Inc., Panbela Therapeutics, Inc. and Recursion Pharmaceuticals, Inc. are developing products for FAP. Standard of care treatment for NMIBC usually involves transurethral resection of the tumor followed by intravesical Bacillus Calmette-Guérin therapy. A number of companies are developing therapeutics for NMIBC including Janssen Pharmaceuticals, CG Oncology, Inc. and Protara Therapeutics, Inc.

There are relatively few products available for the treatment of T1D. Exogenous insulin in its various forms is used to compensate for the lack of endogenous insulin common to all T1D patients. More recently, teplizumab, the first disease-modifying treatment of T1D, has been approved for the delay of Stage 3 T1D. A number of companies are researching potentially disease-modifying approaches to T1D including stem cell therapies by Vertex Pharmaceuticals, Inc. and CRISPR Therapeutics AG and SAB Biotherapeutics, Inc. is developing an immunotherapeutic. The JDRF T1D Fund has invested in approximately 30 private companies working on a variety of approaches to the treatment of T1D. There are over 400 studies listed as recruiting in T1D based on the clinicaltrials.gov website.

Manufacturing

We do not have our own manufacturing facilities and we rely on GMP-certified contract manufacturers for our clinical trial material.

Environmental Matters and Seasonality

We may from time to time be subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological materials and wastes and the cleanup of contaminated sites. We believe that our business, operations and facilities are being operated in compliance in all material respects with applicable environmental and health and safety laws and regulations. Based on information currently available to us, we do not expect environmental costs and contingencies to have a material adverse effect on it. The operation of our laboratory-scale manufacturing facility, however, entails risks in these areas. Significant expenditures could be required in the future if these facilities are required to comply with new or more stringent environmental or health and safety laws, regulations or requirements.

Our current business does not generally reflect any significant degree of seasonality.

Legal Proceedings

From time to time, we may be subject to various claims or legal proceedings that arise in the ordinary course of our business. Other than as disclosed in this annual report, we currently are not a party to any legal proceedings, which, in the opinion of management, is likely to have or could reasonably possibly have a material adverse effect on our business, financial condition or results of operations.

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| --- | | C. | Organizational Structure | | --- | --- |

We are organized under the laws of England and Wales. The following table sets forth a description of our current significant subsidiaries:

Subsidiaries	Country of Incorporation	Voting Interest
Biodexa Australia PTY<br> Ltd	Australia	100%
Biodexa<br> Ireland Ltd	Republic<br> of Ireland	100%
Biodexa<br> US, Inc.	United<br> States	100%
Biodexa<br> Pharma (Wales) Limited	England<br> and Wales	100%
Biodexa Ltd	England<br> and Wales	100%
D.	Property, Plant and Equipment
---	---

Our current headquarters is located at 1 Caspian Point, Caspian Way, Cardiff, Wales, where we also have our laboratories. We entered into the lease for these premises in April 2021. The premises comprise 754 square meters (approximately 8,118 square feet). The lease expires in August 2026. During 2025, we made the determination to de-commission our laboratories in Cardiff, Wales as a result of our change in focus to clinical stage assets.

ITEM 4A. UNRESOLVED STAFF COMMENTS.

Not applicable.

ITEM 5. OPERATING AND FINANCIAL REVIEW ANDPROSPECTS.

The following discussionand analysis of our financial condition and results of operations should be read together with our audited consolidated financial statementsand the accompanying notes thereto appearing at the of this annual report. We have prepared our consolidated financial statements in thisannual report in British pounds sterling and in accordance with IFRS, as issued by the InternationalAccounting Standards Board, which may differ in material respects from generally accepted accounting principles in other jurisdictions,including generally accepted accounting principles in the United States**. IFRS differs in some significant respects fromU.S. GAAP.

The following discussionand analysis contains forward-looking statements. Statements that are not statements of historical fact, including expression of management’sbeliefs and expectations, may be forward-looking in nature and based on current plans, estimates, projections and beliefs. Forward-lookingstatements are applicable only as of the date made, and we undertake no obligation to update any of them in light of new information orfuture events. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual resultsor outcomes to differ materially from those expressed in any forward-looking statement. These factors include those identified under theheadings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.”

This section begins with an overview of the principal factors and trends affecting our results of operations. The overview is followed by a discussion of the components of our income statement and our critical accounting policies and estimates that we believe are important to understanding the assumptions and judgments reflected in our reported financial results. We then present an analysis of our results of operations for the last two fiscal years. We contain one reportable segment, referred to as Pipeline Research and Development.

Recent Developments

For information regarding

our recent developments, please see “Item 4. Information on the Group—B. Business Overview—Recent Developments,” which is incorporated herein by reference.

Principal Factors Affecting Results of Operations

We consider the currency exchange rate between the British pound sterling, Euros and the United States dollar and certain other factors affecting the comparability of results of operations between periods as those most likely to influence our financial condition and results of operations.

Currency Exchange Rate

We report our financial results in British pounds sterling.

During the periods set forth in our financial statements, there has been considerable volatility in the British pound sterling against the Euro and the United States dollar. From time to time, we enter into transactions denominated in a currency other than our functional currency and this results in foreign exchange risk. At this time, we do not consider the exposure sufficient to utilize derivatives to manage the forward exchange risk.

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Components of Consolidated Statement of Comprehensive Income Items

Revenue

Our income streams comprise revenue derived from supply of services and from research and development contracts. Revenue is recognized in-line with that set out in Note 1 to our consolidated financial statements included elsewhere in this annual report.

Operating Expenses

We classify our operating expenses into two categories: (i) research and development, and (ii) administrative costs. These categories correspond to different functional areas within the Company.

Our operating expenses primarily consist of personnel costs, contract research and development costs, professional service fees and depreciation. Personnel costs for each category of operating expenses include salaries, bonuses, social security, health insurance, other employee benefits and share-based compensation for personnel in that category. We allocate share-based compensation expense resulting from the amortization of the fair value of options. Central overheads, such as rent, computer and other technology costs, are allocated out to departments.

Research and DevelopmentCost. Research and development, R&D, costs consist of costs that are directly attributable to our research and development programs associated with the products described herein. This includes costs of third party contract research organizations, research specialist professional services providers, chemicals and other consumables used in the research and manufacturing process, depreciation of assets related to the research and development function, and payroll costs of staff directly assigned to the research and manufacturing operations.

Administrative Costs. These primarily consist of personnel costs for our executive, finance, corporate development and administrative personnel, as well as legal, accounting and other professional service fees, other corporate expenses, merger and acquisition costs and public offering costs that are charged to the consolidated statement of comprehensive income. Administrative costs also include depreciation of administrative assets.

Finance Income

Finance income includes all interest receivable on cash deposits.

During the fiscal year ended December 31, 2025 and 2024, finance income also included a gain on an equity settled derivative financial liability. We issued warrants in fiscal years 2025, 2024, 2023, 2020 and 2019 in connection with equity offerings. In 2015, we assumed fully vested warrants and share options on the acquisition of DARA Biosciences, Inc. The number of Ordinary Shares to be issued when the warrants and options are exercised is fixed, however the exercise prices are denominated in United States dollars, which is different from the functional currency of the Company. Therefore, the warrants and share options are classified as equity settled derivative financial liabilities in the consolidated statement of financial position with any gains or losses being recognized through finance income or finance expense in the consolidated statement of comprehensive income. All remaining DARA Biosciences, Inc. warrants and share options lapsed in 2025.

Finance Expense

Finance expenses include all interest payable on borrowings and loan instruments. For the year ended December 31, 2025, and December 31, 2024, finance expenses were comprised primarily of interest payable on deferred consideration, interest payable on lease liabilities and on other loans.

Taxation

Taxation represents tax credits receivable by Group companies in respect of qualifying research and development costs incurred.

A.	Operating Results

In this section we discuss our operating results for the year ended December 31, 2025 as compared to our operating results for the year ended December 31, 2024. For a discussion and analysis of the year ended December 31, 2024 compared to December 31, 2023, please refer to “Item 5. Operatingand Financial Review and Prospects” in our Annual Report on Form 20-F for the year ended December 31, 2023, as filed with SEC on April 19, 2025.

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Year Ended December 31, 2025 Compared to Year Ended December31, 2024

The following table summarizes our consolidated results of operations for the years ended December 31, 2025 and 2024:

	Year Ended<br> December 31,
	2025		2024
	( in thousands)
Revenue				--
Total revenue				--
Other income				31
Research and development costs		)		(5,437	)
Administrative costs		)		(3,793	)
Loss from operations		)		(9,199	)
Finance income				3,385
Finance expense		)		(165	)
Loss before taxation		)		(5,979	)
Taxation				250
Loss from continuing operations		)		(5,729	)
Exchange gain/(losses) on translation of foreign operations				-
Loss for the year attributable to the owners of the parent		)		(5,729	)

All values are in British Pounds.

Revenue. Total revenue for the year ended December 31, 2025 was £Nil compared to £Nil in 2024.

Research and DevelopmentCosts. R&D costs analyzed by development project indication were as follows:

	Year Ended<br> December 31,
	2025		2024
	( in thousands)
MTX230 eRapa
Familial Adenomatous Polyposis (net of grant)				1,627
Non-muscle Invasive Bladder Cancer				284
Total eRapa				1,911
MTX228 Tolimidone
Type 1 Diabetes				1,093
Total Tolimidone				1,093
MTX110 Panobinostat
Diffuse Midline Glioma				(6	)
Recurrent Glioblastoma				635
Total MTX110				629
Other preclinical				102
R&D overheads				1,702
Total R&D				5,437
MTX230 eRapa Familial Adenomatous Polyposis costs are shown above net of grant<br> income. This is analyzed as follows:
Grant income		)		(1,215	)
Gross costs				2,842
Net charge to income statement				1,627
Percentage of costs allocated against CPRIT grant		%		43	%

All values are in British Pounds.

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R&D costs were £3.96 million, a reduction of £1.48 million, or 27% on 2024 (2024: £5.44 million). The percentage of R&D costs as a percentage of operating costs reduced to 45% from 59% in the prior year. The reduction in R&D costs in 2025 predominately reflects a reduction in spend of £0.71 million on pre-clinical studies and manufacturing costs on MTX228, £0.60 million on the MTX110 MAGIC-G1 study in rGBM and £0.44 million on MTX230 eRapa (net of CPRIT grant income). The percentage of MTX230 (eRapa) costs that were able to be offset against grant funding during the period was 77% compared to 43% in 2024. We anticipate that over the life of the grant this will be 67%.

Administrative costs. Administrative costs in the year increased by £1.04 million to £4.84 million (2024: £3.79 million), an increase of 27%. The increase in administrative costs in the year is driven by foreign exchange movement of £0.44 million, an increase in professional fees of £0.73 million offset by a reduction in share-based payments of £0.10 million.

In 2025, we expensed £1.72 million on legal and professional fees in connection with the successful financing transaction in December 2025, the acquisition of the license from Otsuka completed in 2026 and aborted acquisitions, and £0.37 million non- cash upfront commitment fee for the ELOC, which compares to £0.88m spent in 2024 on similar transactions.

Finance Income. Finance income in 2025 and 2024 included gains in respect of an equity settled derivative financial liability of £2.30 million (2024: £3.22 million). The gains arose as a result of the fall in our share price. In addition, we earned interest on cash deposits.

Finance Expense. Finance expense in the 2024 and 2025 related to lease liabilities, discounted interest on deferred consideration and interest on the promissory note issued in December 2024.

B.	Liquidity and Capital Resources

Overview

We have incurred significant net losses and have had negative cash flows from operations during each period from inception through December 31, 2025, and had an accumulated deficit of £155.81 million as of December 31, 2025. As of December 31, 2025, we had cash and cash equivalents of £8.53 million. We have yet to generate a profit and, excluding share issues, cash flows have been consistently negative from the date of incorporation. Management expects operating losses and negative cash flows to continue for the foreseeable future. We believe our existing balances of cash and cash equivalents will be insufficient to satisfy our working capital needs and other liquidity requirements associated with our existing operations over the next 12 months.

We have prepared cash flow forecasts and considered the cash flow requirement for the next three years, including the period 12 months from the date of approval of the financial statements included in this annual report. Our forecasts show that further financing will be required in the third quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. In January 2025, we entered into a $35.0 million ELOC with the Investor, whereby we may direct such investor from time to time to purchase Depositary Shares (subject to certain limitations) and receive proceeds in accordance with a formula price. However, there is no guarantee that we will be able to use the ELOC to the extent necessary to finance our operations. As of the date hereof, we have sold 57,648,000,000 Ordinary Shares under the ELOC, for gross proceeds of approximately $8.9 million, and issued 1,840,460,000 Ordinary Shares to the Investor in satisfaction of a commitment fee.

We believe there are adequate options and time available to secure additional financing for the Company, including equity sales pursuant to our ELOC with the Investor, and after considering the uncertainties, we consider it is appropriate to continue to adopt the going concern basis in preparing the financial information. We have a good fundraising history and a number of available financing options are currently being evaluated. Our consolidated financial information have therefore been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. With respect to equity sales pursuant to our ELOC with the Investor, we may ultimately decide to sell to the Investor all or some of the Depositary Shares that may be available for us to sell to the Investor pursuant to the ELOC. Accordingly, we cannot guarantee that we will be able to sell all of the amount available under the ELOC or how much in proceeds we may obtain under the ELOC. If we cannot sell securities under the ELOC, we may be required to utilize more costly and time-consuming means of accessing the capital markets, which could have a material adverse effect on our liquidity and cash position. There is no guarantee that we will be able to use the ELOC or raise other financing to the extent necessary to finance our operations. As at December 31, 2025, $26.08 million remains undrawn from the ELOC.

The consolidated financial information has been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

Our Depositary Shares are currently listed on the NASDAQ Capital Market. We have, in the past, received notifications from the Listing Qualifications Department of NASDAQ notifying us that we were not in compliance with certain qualitative and financial tests to maintain the listing of the Depositary Shares on the NASDAQ Capital Market. If, in the future, we fail to sustain compliance with all applicable requirements for continued listing on NASDAQ, our Depositary Shares may be subject to delisting by NASDAQ. This could inhibit the ability of our holders of Depositary Shares to trade their shares in the open market, thereby severely limiting the liquidity of such shares, and the price of our Depositary Shares could decline. Delisting may further impair our ability to raise capital.

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In our opinion, the environment for financing of small and micro-cap biotech companies continues to be challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by us are likely to be dilutive. We continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Company. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon our ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to us which are actionable before its cash resources run out then we will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities.

As noted herein, we believe there are adequate options and time available to secure additional financing for us and after considering the uncertainties, we consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements.

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected.

Cash Flows

The following table presents a summary of the primary sources and uses of cash from continuing activities for the years ended December 31, 2025 and 2024:

	Year Ended December 31,
	2025		2024
	( in thousands)
Cash used in operating activities		)		(12,261	)
Cash used in investing activities		)		(598	)
Cash generated from financing activities				8,557
Net increase/(decrease) increase in cash and equivalents				(4,302	)

All values are in British Pounds.

Operating Activities

The following table presents a summary of the cash used in operations as of the years ended December 31, 2025 and 2024:

	Year Ended<br> December 31,
	2025		2024
	( in thousands)
Cash flows from operating activities before <br> changes in working capital		)		(8,654	)
Changes in working capital				(3,736	)
Cash used in operations		)		(12,390	)

All values are in British Pounds.

Cash flows from OperatingActivities before Changes in Working Capital. Net cash outflow from operating activities before changes in working capital was £8.01 million in the year ended December 31, 2025, as opposed to £8.65 million during the same period in 2024.

This reduced cash outflow of £0.64 million was driven by increased losses attributable to the owners of the Company of £0.66 million offset by net finance income of £1.06 million .

Cash Used in Operations. Working capital reduced in cash flow terms by £1.72 million for the year ended December 31, 2025, compared to an increase of £3.74 million for 2024. The reduction in 2025 primarily comprised of a reduction in trade and other receivables of £2.73 million offset by a reduction in trade and other payables of £0.91 million. The net increase in working capital is driven by the accounting for the eRapa joint arrangement as set out in Note 1 to our consolidated financial statements included elsewhere in this annual report.

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Taxes Paid. Taxes paid in the years ended December 31, 2025 and 2024 were £nil.

Research and development tax credits of £0.71 million were received in 2025, as opposed to £0.13 million in 2024. This related to claims submitted in the prior financial year.

Investing Activities

Purchase of property, plant and equipment of £2,000 occurred in the year ended December 31, 2025, compared to £0.01 million in 2024. Capital expenditures in 2025 related to the purchase of IT equipment, during 2024 this related to laboratory equipment. In addition, in 2025 we made deferred consideration payments of £0.69 million in connection to the eRapa license acquired in 2024. These cash outflows are offset by interest income from bank deposits of £0.09 million.

Financing Activities

Amounts paid on lease liabilities. In 2025, we paid £0.25 million in respect of lease liabilities compared with £0.19 million in 2024, which related to rental payments on our facilities in Cardiff, Wales.

Share Issues IncludingWarrants, Net of Costs. We raised £13.75 million in net proceeds during the year ended December 31, 2025 in cash from a registered equity offering, as well as from the exercise of warrants, including a warrant inducement transaction in May 2025. We raised £8.31 million in net proceeds during the year ended December 31, 2024 in cash from a private placement of our securities and a registered direct offering, as well as from the exercise of warrants, including a warrant inducement transaction in May 2024.

Repayment/issuance of PromissoryNote. We received £0.43 million during December 2024 from the issuance of a promissory note to the Investor, which was repaid in 2025.

Cash and Cash Equivalents

Cash increased for the year ended December 31, 2025 by £6.87 million, before the impact of foreign exchange movements, compared to a decrease of £4.30 million in 2024. This increase was primarily due to continuing trading losses, offset by positive working capital movement and by financing activities. As of December 31, 2025, we had cash and cash equivalents of £8.53 million compared to £1.67 million as at December 31, 2024.

Cash Commitments

As of December 31, 2025, our cash requirements primarily relate to the following:

·	lease obligations, related to our office and research and development facility, which are recognized as lease<br> liabilities in the consolidated statement of financial position;
·	purchase obligations, under our commercial supply agreements and related activities; and
---	---
·	research and development activities related to preclinical and clinical trials for our product candidates<br> in development.
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The lease on our office and research and development facility commenced in August 2021 and expires in August 2026. Our cash requirements for our lease obligation (on a discounted basis) are £0.06 million, for the short-term (payable within twelve months after the reporting date). Our lease obligation includes ancillary contractual commitments in relation to utilities, maintenance and other services.

We expect only minimal capital expenditures in the foreseeable future.

As of December 31, 2025, we believed we have sufficient cash resources to fund our commitments and operations imto the 3^rd^ quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. To maintain operations beyond that date, additional funding will be required, which may include public or private equity or debt offerings. Additional capital may not be available on reasonable terms, if at all. In January 2025, we entered into a $35.0 million ELOC with the Investor, whereby we may direct such investor from time to time to purchase Depositary Shares (subject to certain limitations) and receive proceeds from the sale thereof. However, there is no guarantee that we will be able to use the ELOC to the extent necessary to finance our operations. As at December 31, 2025, $26.08 million remains undrawn from the ELOC. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us or the ELOC is not available to finance our operations, we may have to significantly delay, scale back or discontinue the development of our product candidates and formulations, as well as consider other strategic alternatives.

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| --- | | C. | Research and Development, Patents and Licenses, Etc. | | --- | --- |

For the years ended December 31, 2025 and 2024, our research and development expenses were £3.87 million and £5.44 million, respectively.

D.	Trend Information

Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material adverse effect on our revenues, profitability, liquidity or capital resources, or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.

E.	Critical Accounting Estimates

The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that can have a significant impact on the reported amounts of assets and liabilities, revenue and expenses and related disclosure of contingent assets and liabilities, at the respective dates of our financial statements. We base our estimates, assumptions and judgments on historical experience and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Management evaluates estimates, assumptions and judgments on a regular basis and makes changes accordingly, and discusses critical accounting estimates with the Board of Directors.

The following are considered to be critical accounting policies because they are important to the portrayal of our financial condition or results of operations and they require critical management estimates and judgments about matters that are uncertain.

Income taxes

Deferred tax assets are recognized for unused tax losses to the extent that it is probable that taxable profit will be available against which the losses can be utilized. Significant management judgment is required to determine the amount of deferred tax assets that can be recognized based upon the likely timing and the level of future taxable profits together with future tax planning strategies.

In 2025 and 2024, there were £82.2 million and £79.7 million of gross unutilized tax losses carried forward, respectively. No deferred tax asset has been provided in respect of losses, as there was insufficient evidence to support their recoverability in future periods. The losses do not have an expiry date.

Going Concern

We are subject to a number of risks similar to those of other development and early commercial stage pharmaceutical companies. These risks include, amongst others, generation of revenue from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of our pipeline products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfill our commercial and development activities and generating a level of revenue adequate to support our cost structure.

We have experienced net losses and significant cash outflows from cash used in operating activities over the past years as we develop our portfolio. As at December 31, 2025, we had total equity of £11.41 million (£8.32 million at December 31, 2024), incurred a net loss after tax for the year ended December 31, 2025 of £6.38 million (£5.73 million at December 31, 2024), and used cash in operating activities of £5.59 million (December 31, 2024: £12.26 million) for the same period.

Our future viability is dependent on our ability to raise cash from financing activities to finance our development plans until commercialization, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of our development products. Our failure to raise capital as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies.

Our consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

As of December 31, 2025, we had cash and cash equivalents of £8.53 million.

We have prepared cash flow forecasts and considered the cash flow requirement for the next three years, including the period 12 months from the date of approval of the financial statements included in this annual report. Our forecasts show that further financing will be required in the third quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. In January 2025, we entered into a $35.0 million ELOC with the Investor, whereby we may direct such investor from time to time to purchase Depositary Shares (subject to certain limitations) and receive proceeds in accordance with a formula price. However, there is no guarantee that we will be able to use the ELOC or raise from other financings to the extent necessary to finance our operations. As at December 31, 2025, $26.08 million remains undrawn from the ELOC.

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Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the timing of clinical trials. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. If we lack sufficient capital to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected.

If we raise additional funds through the issuance of debt securities or additional equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our Ordinary Shares (including the Depositary Shares) and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

In our opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by us are likely to be dilutive. We continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Company. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon our ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. As a result of the foregoing, our independent registered public accounting firm included an explanatory paragraph in their report on our financial statements as of and for the year ended December 31, 2025 with respect to this uncertainty.

The following are considered to be critical accounting estimates:

Impairment of Goodwill and Intangible Assets Not Yet Ready forUse

Intangible assets not yet ready for use are tested for impairment at the cash generating unit level on an annual basis at the year end and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a cash generating unit below its carrying value. These events or circumstances could include a significant change in the business climate, legal factors, operating performance indicators, competition, or sale or disposition of a significant portion of a reporting unit.

The fair value of each cash generating unit or asset is estimated using the income approach, on a discounted cash flow methodology. This analysis requires significant judgments, including estimation of future cash flows, which is dependent on internal forecasts, including for revenues and development costs, estimation of the long-term rate of growth for the business, estimation of the useful life over which cash flows will occur and determination of our weighted-average cost of capital.

The carrying value of our goodwill was £nil as of December 31, 2025 and 2024, and intangible assets not yet ready for use was £5.6 million (2024: £5.6 million) as at December 31, 2025.

The estimates used to calculate the fair value of a cash generating unit change from year to year based on operating results and market conditions. Changes in these estimates and assumptions could materially affect the determination of fair value and goodwill impairment for each such unit.

Share-based payments

We account for share-based payment transactions for employees in accordance with IFRS 2, Share-based Payment, which requires the measurement of the cost of employee services received in exchange for the options on our Ordinary Shares, based on the fair value of the award on the grant date.

We selected the Black-Scholes-Merton option pricing model as the most appropriate method for determining the estimated fair value of our share-based awards without market conditions.

The resulting cost of an equity incentive award is recognized as an expense over the requisite service period of the award, which is usually the vesting period. Compensation expense is recognized over the vesting period using the straight-line method and classified in the consolidated statements of comprehensive income.

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The assumptions used for estimating fair value for share-based payment transactions are disclosed in our annual financial statements and are estimated as follows:

·	volatility is estimated based on the average annualized volatility of a number of publicly traded peer companies<br> in the biotech sector;
·	the estimated life of the option is estimated to be until the first exercise period, which is typically the<br> month after the option vests; and
---	---
·	the dividend return is estimated by reference to our historical dividend payments. Currently, this is estimated<br> to be zero as no dividend has been paid in the prior periods.
---	---

We also issue warrants exercisable for Depositary Shares to certain professional advisors in connection with equity transactions that fall within the scope of IFRS 2 and are accounted for as share based payments. The fair value of the services received in exchange for the grant of warrants is recognized as an expense of the equity transaction. The total expense is recognized immediately.

Financial liabilities

Fair value through profitand loss (FVTPL)

We have outstanding warrants in the Ordinary Share capital of the company. The number of Ordinary Shares to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the parent company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognized at fair value through the profit and loss account.

The financial liability is valued using the either the Monte Carlo model or the Black-Scholes option pricing model. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognized in profit or loss. The net gain or loss recognized in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. Fair value is determined in the manner described in our annual financial statements.

Recently Issued and Adopted Accounting Pronouncements

See Note 1 to our consolidated financial statements included elsewhere in this annual report for recently adopted accounting pronouncements and recently issued accounting pronouncements not yet adopted as of the dates of the statement of financial position included in this report.

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ITEM 6. DIRECTORS, SENIOR MANAGEMENT ANDEMPLOYEES.

A.	Directors and Senior Management

The following table sets forth certain information about our current directors and senior management. The professional address of each of the directors and officers is care of Biodexa Pharmaceuticals PLC, Caspian Point, 1 Caspian Way, Cardiff, CF10 4DQ, United Kingdom.

Name (1)	Age at<br><br> <br>12/31/2025	Position/Title
Stephen Stamp	64	Chief Executive Officer and Director
Stephen Parker (3)(4)	67	Non-Executive Chairman of the Board of Directors
Simon Turton, Ph.D. (2)(3)(4)	58	Senior Independent Non-Executive Director
Sijmen (Simon) de Vries, M.D. (2)(4)	66	Non-Executive Director
Ann Merchant (2)(3)	60	Non-Executive Director
Fiona (Powell) Sharp	57	Chief Financial Officer and Director

__________________________

(1)	The term of the Board of Directors will expire immediately after the annual general meetings held in, 2026<br> for Mr. Stamp, Dr. Parker, Ms. Merchant and Ms. Sharp, 2027 for Dr. de Vries, and 2028 for Dr. Turton.
(2)	Remuneration Committee member
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(3)	Audit Committee member
---	---
(4)	Nominations Committee member
---	---

Stephen Stamp has served as our Chief Executive Officer since March 31, 2020, and our Chief Financial Officer and a member of our Board of Directors since September 2019. Prior to joining the Company, Mr. Stamp served as Chief Executive Officer of Ergomed plc (AIM: ERGO) from December 2017 until January 2019 and Chief Financial Officer from January 2016 to July 2018. From March 2013 until July 2015, Mr. Stamp served as the Chief Financial Officer of Assurex Health, Inc. Mr. Stamp served as Chief Financial Officer of EZCORP Inc. (NASDAQ: EZPW) and KV Pharmaceuticals Co. from November 2010 to October 2012 and March 2010 to June 2010. Mr. Stamp has also previously served as Chief Operating Officer of Xanodyne Pharmaceuticals, Inc., and Group Finance Director of Regus PLC (now IWG plc) (LON: IWG) and Shire plc (subsequently acquired by Takeda Pharmaceuticals Company Limited). Mr. Stamp is a Chartered Accountant and qualified with KPMG LLP. Mr. Stamp has a Bachelor’s degree in economics from the University of Manchester. We believe that Mr. Stamp possesses specific attributes that qualify him to serve as a member of our board of directors, including the perspective and experience he brings as our Chief Executive Officer and former Chief Financial Officer, which provides historical knowledge of the Company, operational expertise and continuity to our board of directors, and his significant experience in the biopharmaceutical industry in various positions of responsibility.

Stephen Parker has served as our Non-Executive Chairman of the Board of Directors and a director since June 2022. Dr. Parker has a career in the healthcare and pharma sector that spans over 30 years, including 10 years in advisory roles. Dr. Parker has served as Managing Director of sp2 Consulting Limited since September 2002. Dr. Parker has also served as Chairman of Sareum Holdings plc (AIM: SAR) since May 2016, Drishti Discoveries Limited since January 2021 and sp2 Asset Management Limited since September 2018. Previously, Dr. Parker served as a director of Albucasis Limited from September 2013 to September 2019, as Chairman of Liverpool Chirochem Limited from July 2017 to July 2018, as Senior Independent Director of MGC Pharmaceuticals Limited (ASX, LSE:MXC) from March 2019 to November 2023, as a director of Eternans Limited from July 2019 to October 2023 and as a director and Chairman of Silence Therapeutics plc (LSE: SLN) from November 2013 to April 2019. Dr. Parker also has corporate finance experience having been an investment banker focusing on pharma and biotechnology with Barings Brothers Limited, SBC Warburg Dillon Read, and Apax Partners LLP, and previously served as a director at subsidiaries of Celtic Pharma GP Limited and Chief Financial Officer of Oxford GlycoSciences. Dr. Parker received his D.Phil in Biochemistry from the University of Oxford, MBA in Business Administration from City University, London, and B.Sc. in Chemical Sciences from the University of East Anglia. We believe that Dr. Parker possesses specific attributes that qualify him to serve as a member of our board of directors, including his extensive leadership experience across public and private biopharmaceutical companies, his deep corporate finance and strategic advisory background, and his demonstrated ability to guide life sciences organizations through complex operational, transactional, and governance matters.

Simon Turton, Ph.D. has served as a non-executive member of our Board of Directors since December 2014. Dr. Turton served as Chairman of Q Chip and OpsiRx Pharmaceuticals from March 2014 until their acquisition by us in December 2014. Since January 2015, he has served as the Managing Director of Gensmile Limited. In 2002, Dr. Turton joined Warburg Pincus’, most recently as head of healthcare investing activities in Europe, until June 2011. Dr. Turton has previously served on the board of Archimedes Pharma, Eurand, ProStrakan Group plc and Tornier, Inc. Dr. Turton has a Master’s of Business Administration from INSEAD and a Ph.D. in Pharmacy from the University of London. Dr. Turton. We believe that Dr. Turton possesses specific attributes that qualify him to serve as a member of our board of directors, including his historical knowledge of the Company, his extensive experience in healthcare-focused investing, his leadership roles across multiple life sciences companies, and his strategic expertise in guiding growth-stage and acquisitive organizations.

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Sijmen de Vries, M.D. has served as a non-executive member of our Board of Directors since October 2004 (including his service to our predecessor entity). From November 2008 until March 2025, Dr. de Vries has served as of the Chief Executive Officer of Pharming Group NV (Euronext: PHARM). Prior to that, Dr. de Vries served as Chief Executive Officer of 4-Antibody and Morphochem AG. Prior to this he worked at Novartis Pharma, Novartis Ophthalmics and at SmithKline Beecham Pharmaceuticals Plc, where he held senior business and commercial positions. Dr. de Vries holds an M.D. degree from the University of Amsterdam and a Masters of Business Administration in General Management from Ashridge Management College (United Kingdom). We believe that Dr. de Vries possesses specific attributes that qualify him to serve as a member of our board of directors, including his historical knowledge of the Company, his extensive leadership experience as a chief executive in the biopharmaceutical industry, his proven track record in building and commercializing life-science companies, and his deep global operational and strategic expertise gained through senior roles at major pharmaceutical organizations.

Ann Merchant has served as a non-executive member of our Board of Directors since December 2023. Ms. Merchant has served as Vice President for MorphoSys AG (NASDAQ: MOR), a commercial stage biopharmaceutical company headquartered in Munich, Germany, since 2018, and as Head of Supply Chain and External Operations since January 2019 until April 2025. From September 2011 to August 2018, Ms. Merchant served as the President for Schreiner Medipharm, a business unit of the Schreiner Group Gmbh & Co. KG. Between 1994 and 2011, Ms. Merchant held various roles at Amgen Inc. (NASDAQ: AMGN), including Vice President, Head of International Supply Chain and Site Head as well as various roles in the Finance Organization between 2007 and 2011. Ms. Merchant currently serves on the board of directors of Alvotech S.A. (NASDAQ: ALVO), a biosimilar company. Ms. Merchant holds an MBA from the Henley Business School and a Bachelor of Science in Languages from Georgetown University. We believe that Ms. Merchant possesses specific attributes that qualify her to serve as a member of our board of directors, including her extensive leadership experience in finance, global supply chain and operations within the biopharmaceutical industry, her experience as a director of another NASDAQ-listed company, and her strategic insights gained from senior roles at both multinational and commercial stage life sciences companies.

Fiona (Powell) Sharp has served as Group Financial Controller of the Company since December 2019 and a member of our Board of Directors since January 2026. Prior to that, she served as Assistant Director of Finance for Hywell DDA University Health Board, a local health board of the National Health Service of Wales for western Wales, United Kingdom, from October 2018 to July 2019. From 1995 to June 2018, Ms. Sharp held various financial leadership roles with Chime Communications Limited, a London-based international communications and sports marketing group, including Group Tax Consultant and Group Finance Director. Ms. Sharp is a Chartered Certified Accountant. We believe that Ms. Sharp possesses specific attributes that qualify her to serve as a member of our board of directors, including her extensive financial leadership experience across both public-sector and multinational corporate environments, her deep expertise in accounting and tax oversight, and her long track record of directing complex financial operations within a variety of highly regulated industries. ****

B. Compensation

Compensation of Non-Executive Directors

Our non-executive directors receive a fee for their services as a director, which is approved by our Board of Directors, giving due consideration to the time commitment and responsibilities of their roles and of current market rates for comparable organizations and appointments. Non-executive directors are reimbursed for travelling and other incidental expenses incurred on our business in accordance with our expenses policy.

The following table summarizes the compensation paid to our non-employee directors during 2025.

Name	Fees Earned or<br> Paid in Cash<br> ()(1)	All other compensation<br> ()	Total<br> ()
Sijmen de Vries
Simon Turton
Stephen Parker
Ann Merchant

All values are in British Pounds.

______________

(1)	Includes annual fees, committee chairpersonship fees and meeting fees.

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The following table sets forth, as of December 31, 2025, the aggregate number of option awards, which options are exercisable for Ordinary Shares (issued in the form of Depositary Shares), held by those individuals who served as non-executive directors during 2025:

Name (1)		Grant <br> Date	Expiration<br><br> <br>Date
Sijmen de Vries, M.D.	28,800,000	1/23/2024	1/23/2034
Simon Turton, Ph.D.	28,800,000	1/23/2024	1/23/2034
Ann Merchant	28,800,000	1/23/2024	1/23/2034
Stephen Parker	57,600,000	1/23/2024	1/23/2034

All values are in British Pounds.

___________

(1)	The stock options vest in the following tranches: 25% of the options vest 12 months after the grant date,<br> and the remaining options have subsequently vested, or will vest, in 12 equal quarterly tranches over a subsequent three-year period.

All stock options were granted with an exercise price at or above market value on the date of grant.

Deed of Indemnity

Under a deed poll declared by the Company on August 5, 2015, or a Deed of Indemnity, the Board of Directors and our Company Secretary are indemnified against costs and liabilities incurred in connection with their office, other than any liability owed by such person to the Company itself (or any of its associated entities) and other than indemnification for liabilities in certain circumstances, which are prohibited by virtue of the Companies Act. The Deed of Indemnity provides that a director may also be lent sums to finance any relevant defense costs, provided that, in the event such proceedings involve criminal or civil matters in which the person is convicted or has a judgment made against him or her, then such loan must be repaid.

Letters of Appointment

Each non-executive director (other than Dr. Parker) has been appointed to serve on our Board of Directors pursuant to a letter of appointment. The initial term of appointment for each director is three years, unless terminated earlier by either party upon one month’s prior notice or in accordance with the terms of the letters of appointment. The appointment is subject to our articles of association, and is subject to confirmation at any annual general meeting of the Company.

Each non-executive director (other than Dr. Parker) was paid an annual fee of £40,000 in 2025, which covers all duties, including committee service or service on the board of a Biodexa subsidiary, with the exception of committee chairmanships and certain additional responsibilities, such as taking on the role of senior independent director. This amount may be changed from time to time. In addition, we reimburse each director for reasonable and properly documented expenses incurred in performing their duties. As noted above, we also grant each director a deed of indemnity against certain liabilities that may be incurred as a result of their service, to the extent permitted by the Companies Act.

In addition, without our prior written consent, for a period of six months following a director’s termination from service, such director will not, whether as a principal or agent and whether alone or jointly with, or as a director, manager, partner, shareholder, employee consultant of, any other person, carry on or be engaged, concerned or interested in any business which is similar to or which is (or intends to be) in competition with any business being carried on by Biodexa or any subsidiary, as applicable.

Dr. Parker Letter of Appointment

Pursuant to a term of appointment dated June 20, 2022, or the Appointment Agreement, Dr. Parker was appointed Non-Executive Chairman of the Board of Directors, effective as of the date thereof. The initial term of appointment for Dr. Parker expired on June 19, 2023 and has been subsequently renewed for one-year each year. His appointment may be terminated:

·	by either party giving at least three months prior written notice;
·	by the Board of Directors reasonably determining that Dr. Parker’s acceptance of any other employment,<br> engagement, appointment, interest or involvement with any business or person competes or conflicts with his appointment and would result<br> in a serious conflict of interest or Dr. Parker reasonably determines such interest would result in a serious conflict of interest, and<br> Dr. Parker accepts such employment, engagement, appointment, interest or involvement;
---	---
·	in accordance with our articles of association or applicable law; or
---	---
·	he is not re-elected to the Board of Directors.
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Pursuant to the terms of the Appointment Agreement, Dr. Parker is paid an annual fee of £82,000, plus an additional fee of £1,750 for every day in excess of 16 days worked.

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We also agreed to reimburse Dr. Parker for reasonable and documented expenses accrued in the course of performing his duties and provide him with up to £7,500 in professional advice in connection with performing his duties. The Appointment Agreement includes provisions related to the non-disclosure of information and assignment of inventions. Among other things, these provisions obligate Dr. Parker from disclosing any of our proprietary and confidential information received during the course of employment and to assign to us any inventions conceived or developed during the course of their employment.

In the event we terminate the agreement with Dr. Parker at any time in accordance with the provisions of the articles of association or applicable laws, Dr. Parker will have no right to damages or compensation if he:

·	is found guilty of any misconduct, gross negligence or dishonesty or acts in a manner which is materially<br> adverse to our interests;
·	commits any serious or repeated breach or non-observance of his obligations to the Company;
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·	becomes bankrupt, has an interim order made against him under the United Kingdom Insolvency Act 1986 or makes<br> any composition or enters into any deed of arrangement with his creditors or the equivalent of any of these under any other jurisdictions;
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·	becomes of unsound mind, becomes a patient under any statute relating to mental health or is unable, due to<br> any accident, illness or injury, to undertake his duties for the Company for a period of more than six consecutive months;
---	---
·	is convicted of a criminal offense (other than a motoring offense for which a non-custodial penalty is imposed);
---	---
·	is disqualified by law or an order of a court of competent jurisdiction from holding office; or
---	---
·	has failed to submit his resignation as Non-Executive Chairman and as a director of the Company when required<br> to so pursuant to the terms of the Appointment Agreement.
---	---

In the event we terminate the agreement at any time with immediate effect (other than pursuant to the preceding paragraph), we will pay to Dr. Parker all fees which are due to him for the following 12 months.

Dr. Parker may resign from his positions at any time if the Company (i) is guilty of any gross negligence which affects him or any dishonesty towards or concerning him or (ii) becomes insolvent, makes any composition or enters into any deed of arrangement with its creditors or the equivalent. If Dr. Parker resigns due to these reasons, we will pay to Dr. Parker all fees which are due to him for the following 12 months. Further, in the event that Dr. Parker is unable, due to an accident, illness or injury, to undertake his duties for the Company in accordance with the terms of the Appointment Agreement for a period of more than six consecutive months, he may resign at any time without any rights to damages or compensation. Dr. Parker is also required to resign in connection with the Board of Directors determination that his acceptance of any other employment, engagement, appointment, interest or involvement with any business or person competes or conflicts with his appointment and would result in a serious conflict of interest or Dr. Parker reasonably determines such interest would result in a serious conflict of interest, and Dr. Parker accepts such employment, engagement, appointment, interest or involvement, without any rights to damages or compensation. If Dr. Parker resigns for any other reason, he must provide 12 months written notice.

Compensation of Senior Management

The following table summarizes the compensation earned by our senior management during 2025 (including for any service on any our subsidiaries). On January 5, 2026, Fiona (Powell) Sharp was appointed as Chief Financial Officer. As such, compensation information for Ms. Sharp is not included in this annual report.

Name	Salary<br> ()	Bonus<br> ()(1)	All Other<br> Compensation<br> ()	Total<br> ()
Stephen Stamp
Chief Executive Officer

All values are in British Pounds.

_____________

(1)	Mr. Stamp has a bonus target of 33% of his annual base salary, which bonus is payable upon attainment of objectives<br> as determined in the subjective judgment of the Board of Directors or a committee thereof, taking into account various factors without<br> any preassigned weighting.

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Name			Grant Date	Expiration<br><br> <br>Date
Stephen Stamp	1,500	(1)	9/9/2019	9/9/2029
	15,000	(1)	6/17/2020	1/17/2030
	25,000	(1)	7/15/2021	7/14/2031
	85,922,000	(2)	7/10/2024	7/10/2034

All values are in British Pounds.

_________

(1)	These stock options are fully vested.
(2)	Of these options, 25% of the options vest 12 months after the grant date, and the remaining options will vest<br> in 12 equal quarterly tranches over a subsequent three-year period.
---	---

Agreements with Senior Management

Stephen Stamp. On September 9, 2019, we entered into a service agreement, or the Service Agreement, with Mr. Stamp. The Service Agreement provides for a base salary, incentive compensation benefits, and, in certain circumstances, severance benefits. The Service Agreement may be terminated, subject to certain exceptions, upon six months’ prior notice.

The Service Agreement provides for an initial base salary of £160,000. Mr. Stamp’s base salary is subject to increase each April 1 by the percentage increase, if any, in the “All Items Index of Retail Prices” published by the United Kingdom Office for National Statistics over the previous year. The base salary of Mr. Stamp is reviewed annually to consider any increase in salary. Mr. Stamp’s base salary was increased to £230,000 effective as of April 1, 2022. Mr. Stamp’s base salary was increased to £260,000 effective as of January 1, 2026.

The Service Agreements also include a bonus target for Mr. Stamp of 33% of his annual base salary, which bonus is payable upon attainment of objectives as determined in the subjective judgment of the Board of Directors or a committee thereof, taking into account various factors without any preassigned weighting. Mr. Stamp’s bonus target was increased to 50% of his annual base salary with effect from January 1, 2026. In addition to base salary and bonus, the Service Agreement provides for additional benefits, such as a 10% pension contribution, life insurance, medical insurance, vacation benefits and any other additional benefits as determined by the Board of Directors from time to time. In August 2021, we agreed to commute his Company pension contribution of 10% to salary.

Pursuant to the terms of the Service Agreement, Mr. Stamp has also agreed that, for a period of six months following his termination, he will not directly or indirectly compete with the Company. The Service Agreement includes provisions related to the non-disclosure of information and assignment of inventions. Among other things, these provisions prohibit Mr. Stamp from disclosing any of our proprietary and confidential information received during the course of employment and obligates him to assign to the Company any inventions conceived or developed during the course of his employment. The Service Agreement also includes customary confidentiality, non-solicitation, non-poaching and non-disparagement provisions.

The Service Agreement also provides Mr. Stamp with certain payments and/or benefits upon certain terminations of employment. If he is terminated due to his inability to perform his duties due to illness or other incapacity for a continuous period of three months, or an aggregate period exceeding 100 working days in any period of 12-months, we may, notwithstanding any other provision of the Service Agreement, terminate Mr. Stamp’s employment upon six months’ written notice. During that period, Mr. Stamp will not be entitled to receive his salary or any bonus payment, but will be entitled to any benefits owed under the Service Agreement. Further, notwithstanding any notice requirements for termination set forth in the Service Agreements, we may, at any time and in our absolute discretion, terminate the Service Agreement and provide Mr. Stamp with a payment in lieu of any required notice. The payment will comprise of his base salary, but will not include any bonus or other benefits, and shall be subject to any tax or insurance deductions. Notwithstanding the foregoing, we may terminate the Service Agreement without notice or payment in lieu thereof if Mr. Stamp:

·	is guilty of serious misconduct or any other misconduct which affects, or is likely to affect, prejudicially<br> our interests;
·	fails or neglects to efficiently and diligently discharge his duties or commits any serious or repeated breach<br> or non-observance of any of the provisions of the Service Agreement or any share dealing code we have adopted;
---	---
·	has an interim receiving order made against him, becomes bankrupt or makes any composition or enters into<br> any deed of arrangement with his creditors;
---	---
·	is charged with an arrestable criminal offense (other than a road traffic offense in the United Kingdom or<br> elsewhere for which a fine or non-custodial penalty is imposed);
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| --- | | · | is disqualified from holding office in any company by reason of an order of a court of competent jurisdiction; | | --- | --- | | · | becomes of unsound mind or becomes a patient under any statute relating to mental health; | | --- | --- | | · | is convicted of an offense under the United Kingdom’s Criminal Justice Act 1993 in relation to insider dealings or under any other present or future statutory enactment or regulations relating to insider dealings; | | --- | --- | | · | is in breach of the Model Code on directors’ dealings in listed securities, including securities trading on AIM, published by the London Stock Exchange (the Model Code has subsequently been replaced by provisions under the MAR, however the employment agreements have not been updated to reflect this); or | | --- | --- | | · | commits any other act warranting summary termination at common law including, but not limited to, any act justifying dismissal without notice in the terms of our generally applicable disciplinary rules. | | --- | --- |

Policies and Procedures Related to the Grantof Certain Equity Awards

We do not purposefully time our grants to coincide or be near in time to the release of material non-public information, or MNPI. However, from time to time, we may grant options close in time to the release of MNPI to the extent those options are being granted upon the hiring of new executive officers and in connection with grants being made as part of our director compensation policy, including upon appointment of a new director.

C. Board Practices

Board of Directors

Our Board of Directors is currently comprised of six directors, two of whom are executive directors and four of whom are non-executive directors, reflecting a blend of different experience and backgrounds. The roles of Chairman of the Board of Directors (which is a non-executive position) and Chief Executive Officer have been split and there is a clear division of responsibility between the two positions. With a view towards maintaining the independence of the Board of Directors, no remuneration is paid to either the Chairman or non-executive directors in the form of shares.

Effective as of September 28, 2018, all AIM quoted companies were required to formally apply a recognized corporate governance code. While we are no longer traded on AIM, we have chosen to adopt the principles of the Quoted Companies Alliance Corporate Governance Code for Small and Mid-Sized Quoted Companies, or the QCA Code. The QCA Code identifies ten principles to be followed in order for companies to deliver growth in long term shareholder value, encompassing and efficient, effective and dynamic management framework, accompanied by good communication, to promote confidence and trust.

The Board of Directors is responsible for interalia, approving interim and annual financial statements, formulating and monitoring our strategy, approving financial plans and reviewing performance, as well as complying with legal, regulatory and corporate governance matters. There is a schedule of matters reserved for the Board of Directors.

The Board of Directors meets regularly to consider strategy, performance and the framework of internal controls. To enable the Board of Directors to discharge its duties, all directors receive appropriate and timely information. Briefing papers are distributed to all directors in advance of board meetings.

Board Committees

We have established audit, nomination, and remuneration committees of the Board of Directors with formally delegated duties and responsibilities. From time to time, separate committees may be set up by the Board of Directors to consider specific issues when the need arises.

Audit Committee

The Audit Committee consists of three members: Dr. Turton (Chairman), Dr. Parker and Ms. Merchant. The Board of Directors has determined that Dr. Turton, Dr. Parker and Ms. Merchant are independent under Rule 10A-3 of the Exchange Act and that Dr. Turton qualifies as an “audit committee financial expert” as defined under in Item 16A of Form 20-F.

The Audit Committee of the Board of Directors assists the Board of Directors in discharging its responsibilities with regard to financial reporting, external and internal audits and controls, including reviewing and monitoring the integrity of the Company’s annual and interim financial statements, advising on the appointment of external auditors, reviewing and monitoring the extent of the non-audit work undertaken by external auditors, overseeing our relationship with our external auditors, reviewing the effectiveness of the external audit process and reviewing the effectiveness of our internal control review function. The ultimate responsibility for reviewing and approving the annual report and accounts and the half-yearly reports remains with the Board of Directors.

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In addition, the Audit Committee is responsible, within agreed terms of reference, for ensuring compliance with the rules and regulations promulgated by the SEC and the rules of NASDAQ, and disclosure of information.

The Audit Committee meets not less than twice a year and otherwise as required.

Nomination Committee

The Nomination Committee consists of three members: Dr. Parker (Chairman), Dr. de Vries and Dr. Turton. The Nomination Committee assists the Board of Directors in discharging its responsibilities relating to the composition and make-up of the Board of Directors and any committees of the Board of Directors. It is responsible for periodically reviewing the Board of Director’s structure and identifying potential candidates to be appointed as directors or committee members as the need may arise. The Nomination Committee is responsible for evaluating the balance of skills, knowledge and experience and the size, structure and composition of the Board of Directors and committees of the Board of Directors, retirements and appointments of additional and replacement directors and committee members and will make appropriate recommendations to the Board of Directors on such matters.

The Nomination Committee meets not less than once a year and otherwise as required.

Remuneration Committee

The Remuneration Committee consists of three members: Dr. de Vries (Chairman), Dr. Turton and Ms. Merchant. The Board of Directors has determined that Dr. de Vries, Dr. Turton and Ms. Merchant are independent.

The Remuneration Committee of the Board of Directors is responsible, within agreed terms of reference, for establishing a formal and transparent procedure for developing policy on executive remuneration and setting the remuneration packages of individual directors. This includes agreeing with the Board of Directors on the framework for remuneration of the executive directors, the company secretary and such other members of our executive management as it is designated to consider. It is also responsible for determining the total individual remuneration packages of each director including, where appropriate, bonuses, incentive payments and share options. No director may be involved in any decision as to his/her own remuneration. The Remuneration Committee ensures compliance with the QCA Code in relation to remuneration wherever possible.

The Remuneration Committee meets not less than twice a year and otherwise as required.

Service Contracts

Except as described herein, we do not have service contracts with any member of our Board of Directors or our senior management.

D.	Employees

Employees

The number of our employees by geographic location and function as of the end of the period for the fiscal years ended December 31, 2025, 2024 and 2023 were as follows:

	As of December 31,
	2025		2024		2023
Business functional area:
Research and development		7		8		16
General and administration		4		5		5
Total		11		13		21
	As of December 31,
---	---	---	---	---	---	---
	2025		2024		2023
Geography:
United Kingdom		7		11		19
Germany		1		1		1
Republic of Ireland		1		1		1
United States of America		2		-		-
Total		11		13		21

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To our knowledge, none of our employees are currently represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.

E.	Share Ownership

Information with respect to share ownership of members of our Board of Directors and our senior management is included in “Item 7. Major Shareholders andRelated Party Transactions—A. Major Shareholders.”

Equity Benefit Plans

Biodexa Pharmaceuticals PLC Enterprise ManagementIncentive and Unapproved Share Option Scheme

The Board of Directors has established the Biodexa Pharmaceuticals PLC Enterprise Management Incentive and Unapproved Share Option Scheme, or Plan, to allow us to grant options to acquire Ordinary Shares (in the form of Depositary Shares) to our employees and directors or any of our subsidiaries, or Plan Participants, for the purpose of attracting, rewarding and retaining such persons. The Plan was originally adopted in December 2014 and amended on April 11, 2024 (with a U.S. sub-plan addendum approved on October 30, 2024) to govern the grant of tax-advantaged enterprise management incentive stock options, or EMI Options, and unapproved stock options, or Unapproved Options, by the Company.

Administration. The overall responsibility for the operation and administration of the Plan is vested in the Board of Directors.

Eligibility. Unapproved Options may be granted to any person who is an employee or director of the Company or any of its subsidiaries. However, in order to be eligible to be granted EMI Options pursuant to the Plan, a person must be an employee or director of the Company or any of our subsidiaries whose “committed time” amounts to at least 25 hours a week or, if less, 75% of his or her “working time,” as each of those terms are defined in Schedule 5 to the Income Tax (Earnings and Pensions) Act 2003 of the United Kingdom, or Schedule 5. The Board of Directors may exercise its discretion in selecting the Plan Participants to whom stock options will be granted under the Plan.

Grant of Options. Options may be granted from time to time by the Board of Directors, other than when grants are not permitted under the applicable law or there are other restrictions with regards to the Ordinary Shares. No payment will be made for the grant of a stock option.

Form of Options. The stock options may be stock options to subscribe for new Ordinary Shares (in the form of Depositary Shares). EMI Options granted under the Plan may be granted with an exercise price greater than or equal to the market value of the Ordinary Share at the date of grant, but not in any event at a price less than the nominal value of such Ordinary Shares subject to such EMI Options. Unapproved Options granted under the Plan may be granted on the same basis.

A Plan Participant will have no stockholder rights until such time as he or she is able to exercise the stock option and acquire Ordinary Shares (in the form of Depositary Shares).

Plan Limits. The Board of Directors may from time to time specify the maximum number of Ordinary Shares in respect of which options may be granted pursuant to the Plan.

There are limits on the grants of EMI Options. EMI Options shall be granted under, and comply with, Schedule 5. This confers tax benefits on EMI Options up to a certain threshold. That threshold is currently such that if an employee holds unexercised EMI Options with a value at grant of £250,000, he or she may not have any further EMI Options granted. In the event that this threshold is exceeded, or we cease to satisfy the qualifying conditions, Unapproved Options may still be granted under the terms of the Plan. At grant, the total value of Ordinary Shares subject to unexercised EMI Options at any time may currently not exceed £3.0 million, increasing to £6.0 million for EMI Options granted on or after April 6, 2026. All EMI Options must be exercised within 10 years from the grant date, or as set forth in the applicable option agreement, following which they will lapse.

Vesting of Options. In the normal course, stock options will become eligible for vesting subject to the satisfaction of any time and/or other financial performance targets. Unvested options may vest in full upon a takeover event at the Board of Directors’ discretion.

If a Plan Participant leaves the employment, or ceases to be a member of the Board of Directors, of the Company or its subsidiaries for any reason, his or her unvested stock option will generally lapse.

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Performance Targets. Stock options granted under the Plan may be subject to appropriate performance targets determined by the Board of Directors, with stock options vesting in part on the attainment of each performance target.

Rights Attaching to OrdinaryShares. Ordinary Shares issued in connection with the exercise of stock options will rank equally with all other Ordinary Shares then in issue (save as regards any rights attaching to Ordinary Shares by reference to a record date prior to entry of the shares on the register of stockholders).

Adjustments. If there is any adjustment of our issued share capital, the Ordinary Shares (in the form of Depositary Shares) subject to a stock option will be subject to appropriate adjustment. The Board of Directors may adjust stock options in such manner as it determines to be appropriate.

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ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTYTRANSACTIONS.

A.	Major Shareholders

The following table sets forth information, to our knowledge, as of March 12, 2026, regarding the beneficial ownership of Ordinary Shares, including:

·	each person that is known by us to be a beneficial owner of 5% or more of Ordinary Shares (based on information<br> in our share register and/or information provided by such persons);
·	each member of our Board of Directors;
---	---
·	each member of our senior management; and
---	---
·	all members of our Board of Directors and our senior management, taken as a group.
---	---

Beneficial ownership of shares is determined under rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power. Except as noted by footnote, and subject to community property laws where applicable, we believe, based upon the information provided to us, that the persons and entities named in the table below have sole voting and investment power with respect to all Ordinary Shares shown as beneficially owned by them. The percentage of beneficial ownership is based upon 324,156,808,922 Ordinary Shares outstanding as of March 12, 2026. Ordinary Shares subject to options or warrants currently exercisable or exercisable within 60 days of March 12, 2026 are deemed to be outstanding and beneficially owned by the person holding the options for the purposes of computing the percentage of beneficial ownership of that person and any group of which that person is a member, but are not deemed outstanding for the purpose of computing the percentage of beneficial ownership for any other person. Unless otherwise indicated, the address for each holder listed below is Biodexa Pharmaceuticals PLC, Caspian Point, 1 Caspian Way, Cardiff, CF10 4DQ, United Kingdom. All holders of Ordinary Shares, including those shareholders listed below, have the same voting rights with respect to such shares.

Name of Beneficial Owner
Major Shareholders
Armistice Capital, LLC (1)	35,977,408,301	9.99	%
Sabby Management, LLC (2)	35,977,408,301	9.99	%
Directors and Senior Management:
Ann Merchant (3)	16,200,000	*
Stephen Parker (4)	32,400,000	*
Fiona (Powell) Sharp (5)	16,126,475	*
Stephen Stamp (6)	48,372,625	*
Simon Turton (7)	16,202,765	*
Sijmen de Vries (8)	16,200,000	*
Directors and senior management as a group (6 persons) (9)

__________________

*	Less than one percent of the outstanding Ordinary Shares.
**	Excludes certain securities subject to a beneficial ownership blocker. See notes (1) and (2) below.
---	---
(1)	Based upon our information and belief. Includes 35,977,408,301 Ordinary Shares (in the form of Depositary<br> Shares) issuable upon currently exercisable warrants. The warrants are subject to a beneficial ownership limitation of 9.99%, which does<br> not permit the holder to exercise that portion of the warrants that would result in the holder and its affiliates owning, after exercise,<br> a number of our Ordinary Shares in excess of the beneficial ownership limitation. The remaining 317,810,391,699 Ordinary Shares (in the<br> form of Depositary Shares) issuable upon exercise of the warrants are excluded pursuant to the beneficial ownership limitation. The securities<br> are directly held by the Armistice Capital Master Fund, LP, and may be deemed to be beneficially owned by: (i) Armistice Capital, LLC,<br> or Armistice Capital, as the investment manager of Armistice Capital Master Fund, LP; and (ii) Steven Boyd, as the Managing Member<br> of Armistice Capital, LLC. The address of Armistice Capital Master Fund, LP is 510 Madison Ave, 7th Floor, New York, NY 10022.
---	---
(2)	Based upon our information and belief. Includes 35,977,408,301 Ordinary Shares (in the form of Depositary<br> Shares) issuable upon currently exercisable warrants. The warrants are subject to a beneficial ownership limitation of 9.99%, which does<br> not permit the holder to exercise that portion of the warrants that would result in the holder and its affiliates owning, after exercise,<br> a number of our Ordinary Shares in excess of the beneficial ownership limitation. The remaining 317,810,391,699 Ordinary Shares (in the<br> form of Depositary Shares) issuable upon exercise of the warrants are excluded pursuant to the beneficial ownership limitation. The securities<br> are directly held by Sabby Volatility Warrant Master Fund Ltd., or SVWMF, and may be deemed to be beneficially owned by (i) Sabby Management,<br> LLC, as the investment manager of SVWMF, and (ii) Hal Mintz, as manager of Sabby Management, LLC. The address of Sabby Management, LLC<br> is 1011 Links Drive, Miami Beach, FL 33109.
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| --- | | (3) | Shares owned by Ms. Merchant are Ordinary Shares subject to outstanding stock options which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (4) | Shares owned by Dr. Parker are Ordinary Shares subject to outstanding stock options which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (5) | Shares owned by Ms. Sharp are Ordinary Shares subject to outstanding stock options which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (6) | Shares owned by Mr. Stamp are Ordinary Shares subject to outstanding stock options which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (7) | Shares owned by Dr. Turton include 16,200,000 Ordinary Shares subject to outstanding stock options which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (8) | Shares owned by Dr. de Vries are Ordinary Shares subject to outstanding stock options which are exercisable at March 1, 2026 or will become exercisable within 60 days after such date. | | --- | --- | | (9) | Shares owned by all directors and senior management as a group include 145,499,100 Ordinary Shares subject to outstanding stock options, which are exercisable at March 12, 2026 or will become exercisable within 60 days after such date. | | --- | --- |

As of March 12, 2026, approximately 0.00015% of our outstanding Ordinary Shares was held by registered shareholders with addresses in the United Kingdom, and we had 183 holders of record in the United Kingdom (in each case, excluding shares held by the custodian under our depositary agreement with JPMorgan Chase Bank, N.A.). As of March 12, 2026, JPMorgan Chase Bank, N.A., as depositary for the Depositary Shares, held 323,863,352,427 Ordinary Shares, representing 99.9% of the issued share capital held at that date. As of March 12, 2026, we had two holders of record with an address in the United States. The number of holders of record or registered holders in the United States or United Kingdom is not representative of the number of beneficial holders or of the residence of beneficial holders.

Based on our share register, we believe that we are not directly or indirectly controlled by another corporation or government, or by any other natural or legal persons. There are no arrangements that may result in a change of control. Our major shareholders do not have different voting rights than other holders of our Ordinary Shares.

To our knowledge, other than due to the expiration of unexercised warrants held by our shareholders or as otherwise disclosed elsewhere in this this annual report, there has been no significant change in the percentage ownership of our Ordinary Shares held by the principal shareholders listed above in the last three years.

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| --- | | B. | Related Party Transactions | | --- | --- |

Deed of Indemnity

We have entered into a Deed of Indemnity for the benefit of our Board of Directors and Company Secretary. For more information, see “Management—Compensationof Non-Executive Directors—Deed of Indemnity.”

Agreements with Directors and Senior Management

We have previously entered into agreements with directors and certain of our senior management related to their service on our Board of Directors or employment with the Company. For more information, see “Management.”

C.	Interests of Experts and Counsel

Not Applicable

ITEM 8. FINANCIAL INFORMATION.

A.	Consolidated Statements and Other Financial Information

See “Item 18. Financial Statements.”

Legal Proceedings

For more information, see “Information on the Group—B. Business Overview—Legal Proceedings.”

Dividend Policy

We have never declared or paid any cash dividends on our shares, and have no present intention of declaring or paying any dividends in the foreseeable future. We may, by ordinary resolution, declare a dividend to be paid to the share owners according to their respective rights and interests in profits, and may fix the time for payment of such dividend. No dividend may be declared in excess of the amount recommended by the directors. The directors may from time to time declare and pay to our share owners such interim dividends as appear to the directors to be justified by our profits available for distribution. There are no fixed dates on which entitlement to dividends arises on our Ordinary Shares.

The share owners may pass, on the recommendation of the directors, an ordinary resolution to direct that all or any part of a dividend to be paid by distributing specific assets, in particular paid up shares or debentures of any other body corporate. The Articles of Association also permit, with the prior authority of an ordinary resolution of shareholders, a scrip dividend scheme under which share owners may be given the opportunity to elect to receive fully paid Ordinary Shares instead of cash, or a combination of shares and cash, with respect to future dividends.

By the way of the exercise of a lien, if a share owner owes any money to the Company relating in any way to shares, the Board of Directors may deduct any of this money from any dividend on any shares held by the share owner, or from other money payable by the Company in respect of the shares. Money deducted in this way may be used to pay the amount owed to the Company.

Unclaimed dividends and other money payable in respect of a share can be invested or otherwise used by directors for the benefit of the Company until they are claimed. A dividend or other money remaining unclaimed 12 years after it first became due for payment will be forfeited and shall revert to the Company.

All of the shares represented by the Depositary Shares have the same dividend rights as all of our other outstanding shares.

B.	Significant Changes

Other than the information set forth in this annual report, there have been no significant changes since December 31, 2025.

ITEM 9. THE OFFER AND LISTING.

A.	Offer and Listing Details.

Our Depositary Shares are listed on the NASDAQ Capital Market under the symbol “BDRX.” There is currently no market for our Ordinary Shares.

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| --- | | B. | Plan of Distribution | | --- | --- |

Not applicable.

C.	Markets

Our Depositary Shares are listed on the NASDAQ Capital Market under the symbol “BDRX.” The Depositary Shares trade exclusively on NASDAQ. There is currently no market for our Ordinary Shares.

D.	Seller Shareholders

Not applicable.

E.	Dilution

Not applicable.

F.	Expenses of the Issue

Not applicable.

ITEM 10. ADDITIONAL INFORMATION.

A.	Share Capital

Not applicable.

B.	Memorandum and Articles of Association

We incorporate by reference into this annual report the description of our articles of association contained in Exhibit 2.1 to this annual report.

C.	Material Contracts

Except as otherwise disclosed in this annual report, we are not currently, and have not been in the last two years, party to any material contract, other than contracts entered into in the ordinary course of business.

D.	Exchange Controls

Other than certain economic sanctions which may in place from time to time, there are currently no United Kingdom laws, decrees or regulations restricting the import or export of capital or affecting the remittance of dividends or other payment to holders of Ordinary Shares who are non-residents of the United Kingdom. Similarly, other than certain economic sanctions which may be in force from time to time, there are no limitations relating only to non-residents of the United Kingdom under English law or our articles of association on the right to be a holder of, and to vote in respect of, the Ordinary Shares.

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| --- | | E. | Taxation | | --- | --- |

Certain United Kingdom Taxation Considerations

The following is a general summary of certain United Kingdom tax considerations relating to the ownership and disposal of our Ordinary Shares or Depositary Shares and does not address all possible tax consequences relating to an investment in our Ordinary Shares or Depositary Shares. It is based on United Kingdom tax law and generally published His Majesty’s Revenue & Customs, or HMRC, practice as of the date of this prospectus, both of which are subject to change, possibly with retrospective effect.

Save as provided otherwise, this summary applies only to a person who is the absolute beneficial owner of our Ordinary Shares or Depositary Shares and who is at all relevant times resident (and, in the case of an individual, long-term resident) in the United Kingdom for tax purposes and who is not and has not been resident for tax purposes in any other jurisdiction, or a U.K. Holder. A person who is not a U.K. Holder or who is resident or otherwise subject to tax in a jurisdiction outside the United Kingdom, is recommended to seek the advice of professional advisors in relation to their taxation obligations.

This summary is for general information only and is not intended to be, nor should it be considered to be, legal or tax advice to any particular investor. It does not address all of the tax considerations that may be relevant to specific investors in light of their particular circumstances or to investors subject to special treatment under United Kingdom tax law. In particular this summary:

only applies to an absolute beneficial owner of Ordinary Shares or Depositary Shares and any dividend paid in respect of that Ordinary Share where the dividend is regarded for United Kingdom tax purposes as that person’s own income (and not the income of some other person); and

(a) only addresses the principal United Kingdom tax consequences for an investor who holds Ordinary Shares or Depositary Shares as a capital asset, (b) does not address the tax consequences that may be relevant to certain special classes of investor such as a dealer, broker or trader in shares or securities and any other person who holds Ordinary Shares or Depositary Shares otherwise than as an investment, (c) does not address the tax consequences for a holder that is a financial institution, insurance company, collective investment scheme, pension scheme, charity or tax-exempt organization, or a person for whom income or capital returns in relation to their Ordinary Shares or Depositary Shares may be treated as carried interest, (d) assumes that a holder is not an officer or employee of the company (nor of any related company) and has not (and is not deemed to have) acquired the Ordinary Shares or Depositary Shares by reason of an office or employment, and (e) assumes that a holder does not control or hold (and is not deemed to control or hold), either alone or together with one or more associated or connected persons, directly or indirectly (including through the holding of Depositary Shares), an interest of 10% or more in the issued share capital (or in any class thereof), voting power, rights to profits or capital of the company, and is not otherwise connected with the company.

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This summary further assumes that a holder of Depositary Shares is the beneficial owner of the underlying Ordinary Shares for United Kingdom direct tax purposes.

POTENTIAL INVESTORS INTHE ORDINARY SHARES OR DEPOSITARY SHARES SHOULD SATISFY THEMSELVES PRIOR TO INVESTING AS TO THE OVERALL TAX CONSEQUENCES, INCLUDING, SPECIFICALLY,THE CONSEQUENCES UNDER UNITED KINGDOM TAX LAW AND HMRC PRACTICE OF THE ACQUISITION, OWNERSHIP AND DISPOSAL OF THE ORDINARY SHARES OR DEPOSITARYSHARES, IN THEIR OWN PARTICULAR CIRCUMSTANCES BY CONSULTING THEIR OWN TAX ADVISERS.

Taxation of Dividends

Withholding Tax. The Company is not required to withhold United Kingdom tax when paying a dividend.

An individual holder of Ordinary Shares or Depositary Shares who is not a U.K. Holder will not generally be chargeable to United Kingdom income tax on a dividend paid by the Company, unless such holder carries on (whether solely or in partnership) a trade, profession or vocation in the United Kingdom through a branch, agency or permanent establishment in the United Kingdom to which the Ordinary Shares or Depositary Shares are attributable. In these circumstances, such holder may, depending on his or her individual circumstances, be chargeable to United Kingdom income tax on a dividend received from the Company.

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A dividend received by an individual U.K. Holder will be subject to United Kingdom income tax. The rate of United Kingdom income tax that is chargeable on dividends received in the United Kingdom tax year 2025/2026 by an individual U.K. Holder who is (i) an additional rate taxpayer is 39.35%, (ii) a higher rate taxpayer is 33.75%, and (iii) a basic rate taxpayer is 8.75%. For the United Kingdom tax year 2026/2027, the applicable rate remains 39.35% for an additional rate taxpayer, but has increased to 35.75% for a higher rate taxpayer and to 10.75% for a basic rate taxpayer. An individual U.K. Holder may be entitled to a tax-free dividend allowance (in addition to their personal allowance), currently of £500 for the tax year 2025/2026 and remaining at this level for the tax year 2026/2027, being the amount of dividend income that the relevant individual can receive before United Kingdom income tax is payable. Dividends within the dividend allowance will still count towards the relevant individual's basic, higher or additional rate bands, however. An individual’s dividend income is treated as the top slice of their total income that is chargeable to United Kingdom income tax. Dividends which are covered by an individual’s personal income tax allowance do not count towards and are ignored for the dividend allowance.

*Corporation Tax.*A U.K. Holder within the charge to United Kingdom corporation tax may be entitled to exemption from United Kingdom corporation tax in respect of dividend payments in respect of an Ordinary Share. If the conditions for the exemption are not satisfied or such U.K. Holder elects for an otherwise exempt dividend to be taxable, United Kingdom corporation tax will be chargeable on the dividend. The main rate of corporation tax of 25% applies to companies with profits in excess of £250,000, with a lower rate of corporation tax of 19% applying to certain companies with profits of up to £50,000, and a marginal scaled rate between 19% and 25% applying to certain companies with profits between £50,000 and £250,000. The availability of these lower and marginal rates may be affected by the number of associated companies a company has and the thresholds may be proportionately reduced in respect of accounting periods of less than 12 months. If potential investors are in any doubt as to their position, they should consult their own professional advisers.

A corporate holder of Ordinary Shares or Depositary Shares that is not a U.K. Holder will not generally be subject to United Kingdom corporation tax on a dividend received from the company, unless it carries on (whether solely or in partnership) a trade in the United Kingdom through a permanent establishment to which the Ordinary Shares or Depositary Shares are attributable. In these circumstances, such holder may, depending on its particular circumstances and if the exemption from United Kingdom corporation tax discussed above does not apply, be chargeable to United Kingdom corporation tax on dividends received from the Company.

Taxation of Chargeable Gains

U.K. Holders. A disposal or deemed disposal of Ordinary Shares or Depositary Shares by an individual U.K. Holder may, depending on his or her individual circumstances, give rise to a chargeable gain or to an allowable loss for the purpose of United Kingdom capital gains tax. The principal factors that will determine the capital gains tax position on a disposal of Ordinary Shares or Depositary Shares are the extent to which the holder realizes any other capital gains in the tax year in which the disposal is made, the extent to which the holder has incurred capital losses in that or any earlier tax year and the level at which the annual exempt amount for United Kingdom capital gains tax (the “annual exempt amount”) is set by the United Kingdom government for that tax year. The current annual exempt amount is £3,000. If, after all allowable deductions, an individual U.K. Holder’s total taxable income for the relevant tax year exceeds the basic rate income tax band, any taxable capital gain accruing on a disposal of an Ordinary Share or a Depositary Shares is taxed at the rate of 24%. Where a U.K. Holder’s total taxable income is within or less than the basic rate income tax band, any taxable capital gain accruing on a disposal of our Ordinary Shares or Depositary Shares may be taxed at the rate of 18% or the rate of 24% or at a combination of both rates.

An individual U.K. Holder who ceases to be resident in the United Kingdom (or who fails to be regarded as resident in a territory outside the United Kingdom for the purposes of double taxation relief) for a period of five calendar years or less and who disposes of Ordinary Shares or Depositary Shares during that period of temporary non-United Kingdom residence may be liable to United Kingdom capital gains tax on a chargeable gain accruing on such disposal on his or her return to the United Kingdom (or upon ceasing to be regarded as resident outside the United Kingdom for the purposes of double taxation relief) (subject to available exemptions or reliefs).

A disposal (or deemed disposal) of Ordinary Shares or Depositary Shares by a corporate U.K. Holder may give rise to a chargeable gain or an allowable loss for such holder for the purpose of United Kingdom corporation tax.

Any gain or loss in respect of currency fluctuations over the period of holding Ordinary Shares or Depositary Shares is also brought into account on a disposal.

Non-U.K. Holders. An individual holder who is not a U.K. Holder will not generally be liable to United Kingdom capital gains tax on capital gains realized on the disposal of Ordinary Shares or Depositary Shares unless such holder carries on (whether solely or in partnership) a trade, profession or vocation in the United Kingdom through a branch, agency or permanent establishment in the United Kingdom to which the Ordinary Shares or Depositary Shares are attributable (assuming that the Company is not treated as deriving 75% or more of its gross asset value from interests in or rights over United Kingdom real estate). In these circumstances, such holder may, depending on his or her individual circumstances, be chargeable to United Kingdom capital gains tax on chargeable gains arising from a disposal of his or her Ordinary Shares or Depositary Shares.

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A corporate holder of Ordinary Shares or Depositary Shares that is not a U.K. Holder will not generally be liable for United Kingdom corporation tax on chargeable gains realized on the disposal of Ordinary Shares or Depositary Shares unless it carries (whether solely or in partnership) on a trade in the United Kingdom through a permanent establishment to which the Ordinary Shares or Depositary Shares are attributable (assuming that the Company is not treated as deriving 75% or more of its gross asset value from interests in United Kingdom real estate). In these circumstances, a disposal (or deemed disposal) of Ordinary Shares or Depositary Shares by such holder may give rise to a chargeable gain or an allowable loss for the purposes of United Kingdom corporation tax.

Inheritance Tax

If for the purposes of the Double Taxation Relief (Taxes on Estates of Deceased Persons and on Gifts) Treaty United States of America Order 1979 (SI 1979/1454) between the United States and the United Kingdom an individual holder is at the time of their death or a transfer made during their lifetime, domiciled in the United States (and not treated as domiciled in the United Kingdom (including, from April 6, 2025 onwards, as a result of being a long-term United Kingdom resident)) and is not a national of the United Kingdom, any Ordinary Shares or Depositary Shares beneficially owned by that holder should not generally be subject to United Kingdom inheritance tax, provided that any applicable United States federal gift or estate tax liability is paid, except where (i) the Ordinary Shares or Depositary Shares are part of the business property of a United Kingdom permanent establishment or pertains to a United Kingdom fixed base used for the performance of independent personal services; or (ii) the Ordinary Shares or Depositary Shares are comprised in a settlement unless, at the time the settlement was made, the settlor was domiciled in the United States and not a national of the United Kingdom (in which case no charge to United Kingdom inheritance tax should generally apply).

Stamp Duty and Stamp Duty Reserve Tax

The United Kingdom stamp duty treatment, or stamp duty, and United Kingdom stamp duty reserve tax, or SDRT, treatment of the issue and transfer of, and the agreement to transfer, an Ordinary Share outside a depositary receipt system or a clearance service is discussed in the paragraphs under “General” below. The stamp duty and SDRT treatment of such transactions in relation to such systems is discussed in the paragraphs under “DepositaryReceipt Systems and Clearance Services” below.

General

An agreement to transfer an Ordinary Share will normally give rise to a charge to SDRT at the rate of 0.5% of the amount or value of the consideration payable for the transfer. SDRT is, in general, payable by the purchaser.

Subject to an exemption for certain low value transactions properly certified as being for consideration of less than £1,000, an instrument transferring an Ordinary Share would be subject to stamp duty at the rate of 0.5% of the consideration given for the transfer (rounded up to the next £5). The purchaser is liable to HMRC for the payment of the stamp duty (if any). Under current HMRC guidance, no stamp duty should be payable on a written instrument transferring a Depositary Share or on a written agreement to transfer a Depositary Share, on the basis that the Depositary Share is not regarded as either “stock” or a “marketable security” for United Kingdom stamp duty purposes.

If a duly stamped transfer completing an agreement to transfer is produced within six years of the date on which the agreement is made (or, if the agreement is conditional, the date on which the agreement becomes unconditional) any SDRT already paid is generally repayable, normally with interest, and any SDRT charge yet to be paid is canceled to avoid a double charge as the stamp duty has been paid.

No SDRT or stamp duty is chargeable in respect of shares that are admitted to trading on a “recognized growth market” and not listed on any “recognized stock exchange,” or the AIM Exemption. Following the cancellation of admission of the Ordinary Shares on AIM, the AIM Exemption no longer applies.

Depositary Receipt Systems and ClearanceServices

Legislative changes with effect from January 1, 2024 have made clear that an issue of Ordinary Shares to a clearance service (such as, in our understanding, DTC) or a depositary receipt system will not attract a 1.5% stamp duty or SDRT charge. Similarly, transfers or agreements to transfer shares to (or to a nominee for) a clearance service or depositary receipt system should not attract a 1.5% stamp duty or SDRT charge provided the conditions to be treated as an exempt capital raising instrument or exempt listing instrument or as applicable an exempt capital-raising transfer or exempt listing transfer. If these conditions are not met in relation to such a transfer, a 1.5% charge may arise. Broadly speaking, these legislative changes put on a statutory footing, following the United Kingdom's exit from European Union, the position that previously applied in practice in light of case law of the Court of Justice of the European Union and United Kingdom tax tribunals and HMRC published practice.

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It is our understanding that DTC has not to date made an election under section 97A(1) of the Finance Act 1986 to elect for SDRT to be chargeable in respect of transfers within DTC. On that basis, paperless transfers within DTC should not attract a charge to SDRT.

Any liability for stamp duty or SDRT in respect of a transfer into a clearance service or depositary receipt system, or in respect of a transfer within such a service, which does arise, will strictly be accountable to HMRC by the clearance service or depositary receipt system operator or their nominee, as the case may be, but will, in practice, be payable by the participants in the clearance service or depositary receipt system.

Certain United States Taxation Considerations

The following discussion describes the material United States federal income tax considerations to U.S. Holders (as defined below) under present law of the purchase, ownership and disposition of the Depositary Shares. This discussion is based on the United States Internal Revenue Code of 1986, as amended, or the Code, for purposes of this discussion, in effect as of the date of this annual report and on United States Treasury Regulations in effect or, in some cases, proposed, as of the date of this annual report, as well as judicial and administrative interpretations thereof available on or before such date. All of the foregoing authorities are subject to change, which change could apply retroactively and could affect the tax consequences described below.

This discussion applies only to U.S. Holders that hold the Depositary Shares as capital assets for United States federal income tax purposes. It does not purport to be a comprehensive description of all tax considerations that may be relevant to a decision to purchase the Depositary Shares by any particular investor. In particular, this discussion does not address tax considerations applicable to a U.S. Holder that may be subject to special tax rules, including, without limitation, a dealer in securities or currencies, a trader in securities that elects to use a mark-to-market method of accounting for securities holdings, banks, thrifts, or other financial institutions, an insurance company, a tax-exempt organization, a person that holds the Depositary Shares as part of a hedge, straddle or conversion transaction for tax purposes, a person whose functional currency for tax purposes is not the United States dollar, certain former citizens or residents of the United States or a person that owns directly, indirectly or constructively shares representing 10% or more of our shares by vote or value. Moreover, this description does not address the United States federal estate, gift, or alternative minimum tax consequences, or any state, local or non-U.S. tax consequences, of the acquisition, ownership and disposition of the Depositary Shares. In addition, the discussion does not address tax consequences to an entity or arrangement treated as a partnership or other pass-through entity for U.S. federal income tax purposes that holds the Depositary Shares, or a partner in or owner of such partnership or other pass-through entity. The United States federal income tax treatment of each partner of such partnership or owner of such pass-through entity generally will depend upon the status of the partner or owner and the activities of the partnership or other pass-through entity. Prospective purchasers that are partners in a partnership or owners of a pass-through entity holding the Depositary Shares are urged to consult their own tax advisers.

The discussion below of the United States federal income tax consequences to “U.S. Holders” will apply to an investor that is a beneficial owner of Depositary Shares and that is, for United States federal income tax purposes:

·	an individual who is a citizen or resident of the United States;
·	a corporation (or other entity taxable as a corporation for United States federal income tax purposes) that<br> is created or organized in the United States or under the laws of the United States or any state thereof or the District of Columbia;
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·	an estate the income of which is subject to United States federal income taxation regardless of its source;<br> or
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·	any trust if (a) a court within the United States is able to exercise primary supervision over the administration<br> of the trust and one or more United States persons have the authority to control all substantial decisions of the trust, or (b) such trust<br> has a valid election in effect under applicable United States Treasury regulations to be treated as a United States person.
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For U.S. federal income tax purposes, a beneficial owner of Depositary Shares generally will be treated as the owner of the underlying Ordinary Shares represented by such Depositary Shares. Accordingly, deposits or withdrawals of the underlying Ordinary Shares for Depositary Shares generally will not be subject to United States federal income tax. The discussion below assumes that the representations contained in the deposit agreement are true and that the obligations in the deposit agreement and any related agreement will be complied with in accordance with their terms. The United States Treasury has expressed concerns that parties to whom Depositary Shares are released before shares are delivered to the depositary or intermediaries in the chain of ownership between the U.S. Holder of a Depositary Share and the issuer of the security underlying the Depositary Share may be taking actions that are inconsistent with the claiming of foreign tax credits by U.S. Holders of Depositary Shares. These actions would also be inconsistent with the claiming of the reduced rate of tax, described below, applicable to dividends received by certain noncorporate U.S. Holders. As a result, the creditability of non-U.S. withholding taxes (if any), and the availability of the reduced tax rate for dividends received by certain non-corporate U.S. Holders, each described below, could be affected by actions taken by such parties or intermediaries. Accordingly, U.S. persons considering an investment in Depositary Shares that, as described below, are generally taxed in the same manner as a U.S. Holder of Depositary Shares, should consult their own tax advisors as to the particular tax consequences applicable to them relating to the purchase, ownership and disposition of Depositary Shares, including the applicability of United States federal, state and local tax laws and non-United States tax laws.

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You are urged to consultyour tax advisors about the application of the United States federal income tax rules to your particular circumstances as well as thestate, local, non-United States and other tax consequences of the purchase, ownership and disposition of the Depositary Shares.

Passive Foreign Investment Company Considerations

A foreign corporation is a PFIC if either (1) 75% or more of its gross income for the taxable year is passive income or (2) the average percentage of assets held by such corporation during the taxable year that produce passive income or that are held for the production of passive income is at least 50%. For purposes of applying the tests in the preceding sentence, the foreign corporation is deemed to own its proportionate share of the assets, and to receive directly its proportionate share of the income, of any other corporation of which the foreign corporation owns, directly or indirectly, at least 25% by value of the stock.

Based upon estimates with respect to its income, assets, and operations, it is expected that we will not be a PFIC for the current taxable year. However, because the determination of PFIC status must be made on an annual basis after the end of the taxable year and will depend on the composition of the income and assets, as well as the nature of the activities, of our activities and those of our subsidiaries from time to time, there can be no assurance that we will not be considered a PFIC for the current taxable year or any subsequent taxable year.

If we were to be classified as a PFIC for any taxable year in which a U.S. Holder held the Depositary Shares, various adverse United States tax consequences could result to such U.S. Holders, including taxation of gain on a sale or other disposition of the Depositary Shares at ordinary income rates and imposition of an interest charge on gain or on distributions with respect to the Depositary Shares. Unless a U.S. Holder of PFIC shares elects to be taxed annually on a mark-to-market basis or makes a “qualified electing fund,” or QEF, election (in either case, if eligible) and certain other requirements are met, gain realized on the sale or other disposition of PFIC shares would generally not be treated as capital gain. Instead, the U.S. Holder would be treated as if the U.S. Holder had realized such gain ratably over such holder’s holding period for such securities. The amounts allocated to the taxable year of sale or other disposition and to any year before the foreign corporation became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject to tax at the highest rate in effect for such year, together with an interest charge in respect of the tax attributable to each such year. Similar rules apply to the extent any distribution in respect of PFIC shares exceeds 125% of the average annual distribution on such PFIC securities received by the U.S. Holder during the preceding three years or such holder’s holding period, whichever is shorter. With certain exceptions, a foreign corporation is treated as a PFIC with respect to a U.S. Holder (including a U.S. Holder of warrants, as applicable) if the corporation was a PFIC with respect to such holder at any time during the holder’s holding period of the foreign corporation’s stock or warrants. Dividends paid to with respect to shares of a PFIC are not eligible for the special tax rates applicable to qualified dividend income of certain non-corporate holders. Instead, such dividend income is taxable at rates applicable to ordinary income.

If we were to be treated as a PFIC, the tax consequences described above could be avoided by a “mark-to-market” election with respect to the Depositary Shares. A U.S. Holder making a “mark-to-market” election (assuming the requirements for such an election are satisfied) generally would (i) be required to include as ordinary income the excess of the fair market value of the Depositary Shares on the last day of the U.S. Holder’s taxable year over the U.S. Holder’s adjusted tax basis in such Depositary Shares and (ii) be allowed a deduction in an amount equal to the lesser of (A) the excess, if any, of the U.S. Holder’s adjusted tax basis in the Depositary Shares over the fair market value of such Depositary Shares on the last day of the U.S. Holder’s taxable year or (B) the excess, if any, of the amount included in income because of the election for prior taxable years over the amount allowed as a deduction because of the election for prior taxable years. In addition, upon a sale or other taxable disposition of Depositary Shares, a U.S. Holder would recognize ordinary income or loss (which loss could not be in excess of the amount included in income because of the election for prior taxable years over the amount allowed as a deduction because of the election for prior taxable years). If we were to be treated as a PFIC, different rules would apply to a U.S. Holder making a QEF election with respect to Depositary Shares. However, we do not intend to prepare or provide the information necessary for U.S. Holders to make a QEF election.

If we are a PFIC for any taxable year during which a U.S. Holder holds the Depositary Shares, each such U.S. Holder generally will be required to file an annual information return on IRS Form 8621 containing such information as the United States Treasury Department may require. The failure to file IRS Form 8621 could result in the imposition of penalties and the extension of the statute of limitations with respect to United States federal income tax.

The United States federal income tax rules relating to PFICs are complex. U.S. Holders are urged to consult their tax advisors with respect to the purchase, ownership and disposition of the Depositary Shares, the availability of the mark-to-market election and whether making the election would be advisable in their particular circumstances, and the IRS information reporting obligations with respect to the purchase, ownership and disposition of the Depositary Shares.

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Taxation of the Depositary Shares

Dividends and Other Distributionson the Depositary Shares. Subject to the discussion above under the heading “—Passive Foreign Investment Company Considerations”, generally the gross amount of distributions made by us, if any, to a U.S. Holder with respect to the Depositary Shares, before reduction for any non-U.S. taxes withheld therefrom, will be includable in gross income as a dividend to the extent that such distribution is paid out of our current or accumulated earnings and profits (as determined under United States federal income tax principles). To the extent, if any, that the amount of any cash distribution exceeds our current and accumulated earnings and profits, it will be treated first as a tax-free return of such U.S. Holder’s tax basis in its Depositary Shares, and to the extent the amount of the distribution exceeds such U.S. Holder’s tax basis, the excess will be taxed as capital gain. We do not intend to calculate our earnings and profits under United States federal income tax principles. Therefore, a U.S. Holder should expect that a distribution will generally be treated as a dividend even if that distribution would otherwise be treated as a non-taxable return of capital or as capital gain under the rules described above. A dividend in respect of the Depositary Shares will not be eligible for the dividends-received deduction allowed to corporations in respect of dividends received from other United States corporations. Non-corporate U.S. Holders may qualify for the lower rates of taxation with respect to dividends on Depositary Shares applicable to long term capital gains (i.e., gains from the sale of capital assets held for more than one year), provided that certain conditions are met, including certain holding period requirements and the absence of certain risk reduction transactions. However, such reduced rate shall not apply if we are a PFIC for the taxable year in which we pay a dividend, or were a PFIC in the preceding taxable year. As indicated in the section titled “DividendPolicy” herein, we intend to retain any earnings for use in our business and do not currently intend to pay dividends on our Ordinary Shares.

Subject to the paragraph below, dividends generally will constitute income from sources outside the United States, which may be relevant in calculating a U.S. Holder’s foreign tax credit limitation. For this purpose, dividends that we distribute generally should constitute “passive category income,” or, in the case of certain U.S. Holders, “general category income.” Dividend payments may be made without withholding or deduction for or on account of United Kingdom tax.

Notwithstanding the paragraph above, if 50% or more of the Depositary Shares are treated as held by United States persons, we will be treated as a “U.S.-owned foreign corporation.” In that case, dividends may be treated for United States foreign tax credit purposes as income from sources outside the United States to the extent paid out of our non-United States source earnings and profits, and as income from sources within the United States to the extent paid out of our United States source earnings and profits. There can be no assurance that we will not be treated as a United States-owned foreign corporation. If the dividends are taxed at the lower tax rates generally applicable to long-term capital gains (as discussed above), the amount of the dividend taken into account for purposes of calculating the United States foreign tax credit limitation will generally be limited to the gross amount of the dividend, multiplied by the preferential rate divided by the highest rate of tax normally applicable to dividends. The rules relating to the determination of the foreign tax credit are complex, and U.S. Holders are urged to consult their tax advisors to determine whether and to what extent such U.S. Holder will be entitled to a foreign tax credit.

Taxation of Dispositionsof Depositary Shares. Subject to the discussion above under “—Passive Foreign Investment Company Considerations”, a U.S. Holder will recognize taxable gain or loss on any sale, exchange or other taxable disposition of a Depositary Share equal to the difference between the amount realized (the amount of cash (in U.S. dollars) plus the fair market value of any property received) for the Depositary Share and such U.S. Holder’s tax basis (in U.S. dollars) in the Depositary Share. The gain or loss will generally be capital gain or loss. Such capital gain or loss generally will be long-term capital gain taxable at a reduced rate for non-corporate U.S. Holders or long-term capital loss if, on the date of sale, exchange or other disposition, the Depositary Shares were held by the U.S. Holder for more than one year. The deductibility of capital losses is subject to limitations. Any such gain or loss generally will be treated as United States source income or loss for United States foreign tax credit purposes.

Disposition of Foreign Currency

U.S. Holders are urged to consult their tax advisors regarding the tax consequences of receiving, converting or disposing of any non-U.S. currency received as dividends on our Depositary Shares or on the sale or retirement of a Depositary Share.

Tax on Net Investment Income

An additional 3.8% Medicare tax may be imposed on some or all of such U.S. Holder’s “net investment income.” Net investment income generally includes income from the Depositary Shares unless such income is derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). You should consult your tax advisors regarding the effect this Medicare tax may have, if any, on your acquisition, ownership or disposition of the Depositary Shares.

Information Reporting and Backup Withholding

Distributions with respect to Depositary Shares and proceeds from the sale, exchange or disposition of Depositary Shares may be subject to information reporting to the IRS, and possible U.S. backup withholding. Backup withholding will not apply, however, to a U.S. Holder who furnishes a correct taxpayer identification number and makes any other required certification or who is otherwise exempt from backup withholding. U.S. Holders who are required to establish their exempt status generally must provide such certification on U.S. Internal Revenue Service Form W-9. U.S. Holders are urged to consult their tax advisors regarding the application of the United States information reporting and backup withholding rules.

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Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. Holder’s United States federal income tax liability, and a U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS and furnishing any required information.

Foreign Financial Asset Information Reporting

U.S. Holders who are either individuals or certain domestic entities may be required to submit certain information to the IRS with respect to such holder’s beneficial ownership of the Depositary Shares, if such Depositary Shares are not held on such holder’s behalf by a financial institution, as our ordinary shares are considered “specified foreign financial assets.” This law also imposes penalties and potential other adverse tax consequences if a U.S. Holder is required to submit such information to the IRS and fails to do so. U.S. Holders are urged to consult their tax advisors regarding the potential information reporting obligations that may be imposed with respect to the ownership and disposition of the Depositary Shares.

THE DISCUSSION ABOVE ISA GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PARTICULAR INVESTOR. EACH PROSPECTIVE INVESTOR INOUR SECURITIES IS URGED TO CONSULT ITS OWN TAX ADVISER ABOUT THE TAX CONSEQUENCES TO IT OF OWNING AND DISPOSING OF OUR SECURITIES IN LIGHTOF SUCH PROSPECTIVE INVESTOR’S OWN CIRCUMSTANCES.

F.	Dividends and Payment Agents

Not applicable.

G.	Statements by Experts

Not applicable.

H.	Documents on Display

We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains an Internet website that contains reports and other information about issuers, like us, that file electronically with the SEC. The address of that website is www.sec.gov.

We also make available on our website, free of charge, our annual report and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Our website address is www.biodexapharma.com. The information contained on our website is not incorporated by reference in this annual report.

I.	Subsidiary Information

Not applicable.

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURESABOUT MARKET RISK.

We are exposed to a variety of financial risks, including, but not limited to, market risk (including foreign exchange and interest rate risks), credit risks, and liquidity risks. Our overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on its financial performance.

Credit Risk

We are exposed to credit risk from amounts due from collaborative partners and from cash and cash equivalents and deposits with banks and financial institutions. The risk from collaborative partners is deemed to be low. For banks and financial institutions, only independently rated parties with high credit status are accepted. We do not enter into derivatives to manage credit risk. The gross carrying amount of a financial asset is written off (either partially or in full) to the extent that there is no realistic prospect of recovery.

We do not enter into derivatives to manage credit risk.

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Our total exposure to credit risk is equal to the total value of the financial assets held at year end. The consolidated entity recognizes a loss allowance for expected credit losses on financial assets which are either measured at amortized cost or fair value through other comprehensive income. The measurement of the loss allowance depends upon the consolidated entity's assessment at the end of each reporting period as to whether the financial instrument's credit risk has increased significantly since initial recognition, based on reasonable and supportable information that is available, without undue cost or effort to obtain.

Where there has not been a significant increase in exposure to credit risk since initial recognition, a 12-month expected credit loss allowance is estimated. This represents a portion of the asset’s lifetime expected credit losses that is attributable to a default event that is possible within the next 12 months. Where a financial asset has become credit impaired or where it is determined that credit risk has increased significantly, the loss allowance is based on the asset's lifetime expected credit losses. The amount of expected credit loss recognized is measured on the basis of the probability weighted present value of anticipated cash shortfalls over the life of the instrument discounted at the original effective interest rate. For financial assets measured at fair value through other comprehensive income, the loss allowance is recognized within other comprehensive income. In all other cases, the loss allowance is recognized in profit or loss.

Cash in Bank

We are continually reviewing the credit risk associated with holding money on deposit in banks and seek to mitigate this risk by holding deposits with banks with high credit status.

Foreign Exchange Risk

Foreign exchange risk also arises when our individual entities enter into transactions denominated in a currency other than our functional currency. Our transactions outside the United Kingdom to Europe and the United States drive foreign exchange movements where suppliers invoice in currency other than British pounds sterling. We do retain some cash balances in US Dollars from our US Dollar denominated equity raises to reduce the foreign exchange exposure on US$ denominated suppliers related to our NASDAQ listing and US based clinical studies. To the extent other assets and/or consumables are purchased in foreign currencies, the requisite currency is purchased immediately upon invoice.

Interest Rate Risk

We do not hold any derivative instruments, or other financial instruments, that expose us to material interest rate risk.

Liquidity Risk

Liquidity risk arises from our management of working capital. It is the risk that we will encounter difficulty in meeting our financial obligations as they fall due.

It is our aim to settle balances as they become due.

Our future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering our assets. Our failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

As noted herein, we believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, we consider it is appropriate to continue to adopt the going concern basis in preparing the financial information. Our consolidated financial information have therefore been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

We have prepared cash flow forecasts and considered the cash flow requirement for the next three years, including the period 12 months from the date of approval of the financial statements included in this this annual report. Our forecasts show that further financing will be required in the third quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. In January 2025, we entered into a $35.0 million ELOC with the Investor, whereby we may direct such investor from time to time to purchase Depositary Shares (subject to certain limitations) and receive proceeds in accordance with a formula price. However, there is no guarantee that we will be able to use the ELOC or raise from other financing to the extent necessary to finance our operations. As at December 31, 2025, $26.08 million remains undrawn from the ELOC.

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This requirement for additional financing represents a material uncertainty that raises substantial doubt about our ability to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2025 with respect to this uncertainty. Should it become evident in the future that there are no realistic financing options available to us which are actionable before our cash resources run out then we will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities.

For more information, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Critical Accounting Estimates and Judgments—GoingConcern.”

ITEM 12. DESCRIPTION OF SECURITIES OTHERTHAN EQUITY SECURITIES.

A.	Debt Securities

Not applicable.

B.	Warrants and Rights

Not applicable.

C.	Other Securities

Not applicable.

D.	American Depositary Shares

JPMorgan Chase Bank, N.A., or the Depositary, has acted as depositary in relation to our Depositary Shares program since December 18, 2023. The principal executive office of the Depositary is located at 383 Madison Avenue, Floor 11, New York, New York 10179. Each Depositary Share will also represent any other securities, cash or other property which may be held by the Depositary from time to time. The deposited Ordinary Shares, together with any other securities, cash or other property held by the depositary are referred to as the “deposited securities.”

Fees and Expenses

The depositary may charge each person to whom Depositary Shares are issued, including, without limitation, issuances against deposits of Ordinary Shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the Depositary Shares or deposited securities, and each person surrendering Depositary Shares for withdrawal of deposited securities or whose Depositary Shares are cancelled or reduced for any other reason, a fee of up to $5.00 for each 100 Depositary Shares (or any portion thereof) issued, delivered, reduced, cancelled or surrendered, or upon which a share distribution or elective distribution is made or offered, as the case may be. The depositary may sell (by public or private sale) sufficient securities and property received in respect of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.

The following additional fees, charges and expenses shall also be incurred by the American depositary receipt, or ADR, holders, the beneficial owners, by any party depositing or withdrawing Ordinary Shares or by any party surrendering Depositary Shares and/or to whom Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the Depositary Shares or the deposited securities or a distribution of Depositary Shares), whichever is applicable:

a fee of up to U.S.$0.05 per Depositary Share held for any cash distribution made, or for any elective cash/stock dividend offered, pursuant to the Second Amended and Restated Deposit Agreement with the Depositary, or the Deposit Agreement;

an aggregate fee of up to US$0.05 per Depositary Share per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision);

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| --- | | · | an amount for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian, as well as charges and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law, rule or regulation relating to foreign investment) in connection with the servicing of the Ordinary Shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary's or its custodian's compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions); | | --- | --- | | · | a fee of up to $0.05 per Depositary Share held for the direct or indirect distribution of securities (other than Depositary Shares or rights to purchase additional Depositary Shares) or the net cash proceeds from the public or private sale of such securities, regardless of whether any such distribution and/or sale is made by, for, or received from, or (in each case) on behalf of, the depositary, us and/or any third party (which fee may be assessed against ADR holders as of a record date set by the depositary); | | --- | --- | | · | stock transfer or other taxes and other governmental charges; | | --- | --- | | · | a transaction fee per cancellation request (including any cancellation request made through SWIFT, facsimile transmission or any other method of communication) as disclosed on the “Disclosures” page (or successor page) of www.adr.com (as updated by the depositary from time to time, "ADR.com") and any applicable delivery expenses (which are payable by such persons or ADR holders); | | --- | --- | | · | transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and | | --- | --- | | · | fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the Deposit Agreement. | | --- | --- |

To facilitate the administration of various depositary receipt transactions, including disbursement of dividends or other cash distributions and other corporate actions, the depositary may engage the foreign exchange desk within the banking division of JPMorgan Chase Bank, N.A., or the Bank, and/or its affiliates in order to enter into spot foreign exchange transactions to convert foreign currency into U.S. dollars. For certain currencies, foreign exchange transactions are entered into with the Bank or an affiliate, as the case may be, acting in a principal capacity. For other currencies, foreign exchange transactions are routed directly to and managed by an unaffiliated local custodian (or other third party local liquidity provider), and neither the Bank nor any of its affiliates is a party to such foreign exchange transactions.

The foreign exchange rate applied to a foreign exchange transaction will be either (a) a published benchmark rate, or (b) a rate determined by a third party local liquidity provider, in each case plus or minus a spread, as applicable. The depositary will disclose which foreign exchange rate and spread, if any, apply to such currency on the “Disclosures” page (or successor page) of ADR.com. Such applicable foreign exchange rate and spread may (and neither the depositary, the Bank nor any of their affiliates is under any obligation to ensure that such rate does not) differ from rates and spreads at which comparable transactions are entered into with other customers or the range of foreign exchange rates and spreads at which the Bank or any of its affiliates enters into foreign exchange transactions in the relevant currency pair on the date of the foreign exchange transaction. Additionally, the timing of execution of a foreign exchange transaction varies according to local market dynamics, which may include regulatory requirements, market hours and liquidity in the foreign exchange market or other factors. Furthermore, the Bank and its affiliates may manage the associated risks of their position in the market in a manner they deem appropriate without regard to the impact of such activities on the depositary, us, ADR holders or beneficial owners. The spread applieddoes not reflect any gains or losses that may be earned or incurred by the Bank and its affiliates as a result of risk management or otherhedging related activity.

Notwithstanding the foregoing, to the extent we provide U.S. dollars to the depositary, neither the Bank nor any of its affiliates will execute a foreign exchange transaction as set forth herein. In such case, the depositary will distribute the U.S. dollars received from us.

Further details relatingto the applicable foreign exchange rate, the applicable spread and the execution of foreign exchange transactions will be provided bythe depositary on ADR.com. Each holder and beneficial owner by holding or owning an ADR or Depositary Share or an interest therein, andwe, each acknowledge and agree that the terms applicable to foreign exchange transactions disclosed from time to time on ADR.com willapply to any foreign exchange transaction executed pursuant to the Deposit Agreement.

We will pay all other fees, charges and expenses of the depositary and any agent of the depositary (except the custodian) pursuant to agreements from time to time between us and the depositary.

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The right of the depositary to charge and receive payment of fees, charges and expenses survives the termination of the Deposit Agreement, and shall extend for those fees, charges and expenses incurred prior to the effectiveness of any resignation or removal of the depositary.

The fees and charges described above may be amended from time to time by agreement between us and the depositary.

The depositary anticipates reimbursing us for certain expenses incurred by us that are related to the establishment and maintenance of the ADR program upon such terms and conditions as we and the depositary may agree from time to time. The depositary may make available to us a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as we and the depositary may agree from time to time. The depositary may also agree to reduce or waive certain fees that would normally be charged on Depositary Shares issued to or at the direction of, or otherwise held by, us and/or certain holders and beneficial owners and holders and beneficial owners of Ordinary Shares of ours. The depositary collects its fees for issuance and cancellation of Depositary Shares directly from investors depositing Ordinary Shares or surrendering Depositary Shares for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions, or by directly billing investors, or by charging the book-entry system accounts of participants acting for them. The depositary will generally set off the amounts owing from distributions made to holders of Depositary Shares. If, however, no distribution exists and payment owing is not timely received by the depositary, the depositary may refuse to provide any further services to ADR holders that have not paid those fees and expenses owing until such fees and expenses have been paid. At the discretion of the depositary, all fees and charges owing under the Deposit Agreement are due in advance and/or when declared owing by the depositary.

Payment of Taxes

ADR holders and/or beneficial owners must pay any tax or other governmental charge payable by the custodian or the depositary on any Depositary Share or ADR, deposited security or distribution. If any taxes or other governmental charges (including any penalties and/or interest) shall become payable by or on behalf of the custodian or the depositary with respect to any ADR, any deposited securities represented by the Depositary Shares evidenced thereby or any distribution thereon such tax or other governmental charge shall be paid by the ADR holder thereof to the depositary and by holding or owning, or having held or owned, an ADR or any Depositary Shares evidenced thereby, the ADR holder and all beneficial owners thereof, and all prior ADR holders and beneficial owners thereof, jointly and severally, agree to indemnify, defend and save harmless each of the depositary and its agents in respect of such tax or other governmental charge. Notwithstanding the depositary’s right to seek payment from current or former ADR holders and beneficial owners, each ADR holder and beneficial owner, and each prior ADR holder and beneficial owner, by holding or owning, or having held or owned, an ADR or an interest in Depositary Shares acknowledges and agrees that the depositary has no obligation to seek payment of amounts owing from any current or prior beneficial owner. If an ADR holder owes any tax or other governmental charge, the depositary may (i) deduct the amount thereof from any cash distributions, or (ii) sell deposited securities (by public or private sale) and deduct the amount owing from the net proceeds of such sale. In either case, the ADR holder remains liable for any shortfall. If any tax or governmental charge is unpaid, the depositary may also refuse to effect any registration, registration of transfer, split-up or combination of ADRs or withdrawal of deposited securities until such payment is made. If any tax or governmental charge is required to be withheld on any cash distribution, the depositary may deduct the amount required to be withheld from any cash distribution or, in the case of a non-cash distribution, sell the distributed property or securities (by public or private sale) in such amounts and in such manner as the depositary deems necessary and practicable to pay such taxes and distribute any remaining net proceeds or the balance of any such property after deduction of such taxes to the ADR holders entitled thereto. Neither we nor the depositary nor any of our or its respective agents, shall be liable to ADR holders or beneficial owners of the Depositary Shares for failure of any of them to comply with applicable tax laws, rules and/or regulations.

As an ADR holder or beneficial owner, you will be agreeing to indemnify us, the depositary, its custodian and any of our or their respective officers, directors, employees, agents and affiliates against, and hold each of them harmless from, any claims by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced rate of withholding at source or other tax benefit obtained, which obligations shall survive any transfer or surrender of Depositary Shares or the termination of the Deposit Agreement.

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PART II

ITEM 13. DEFAULTS, DIVIDEND ARREARAGES ANDDELINQUENCIES.

Not applicable.

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTSOF SECURITY HOLDERS AND USE OF PROCEEDS.

Not applicable.

ITEM 15. CONTROLS AND PROCEDURES.

A.	Disclosure Controls and Procedures

We have carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) under the supervision and the participation of the Group’s management, which is responsible for the management of the internal controls, and which includes our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively). The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Group’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.

Based upon our evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable level of assurance.

B.	Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is a process designed, under the supervision of the Chief Executive Officer and the Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external reporting purposes in accordance with International Financial Reporting Standards.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Moreover, projections of any evaluation of the effectiveness of internal control to future periods are subject to a risk that controls may become inadequate because of changes in conditions and that the degree of compliance with the policies or procedures may deteriorate.

Our management has assessed the effectiveness of internal control over financial reporting as of December 31, 2025 based on the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) 2013.

Based on this assessment, our management concluded that our internal control over financial reporting was effective as of December 31, 2025.

C.	Attestation Report of the Registered Public Accounting Firm

This annual report does not include an attestation report of our registered public accounting firm we are a non-accelerated filer.

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| --- | | D. | Changes in Internal Control Over Financing Reporting | | --- | --- |

We regularly review our system of internal control over financial reporting to ensure we maintain an effective internal control environment. Other than the changes discussed herein, there were no changes in our internal control over financial reporting that occurred during the fiscal year ended December 31, 2025 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT.

The Audit Committee consists of three members: Simon Turton (Chairman), Stephen Parker and Ann Merchant. The Board of Directors has determined that Dr. Turton and Dr. Parker and Ms. Merchant are independent under Rule 10A-3 of the Exchange Act and the applicable rules of NASDAQ and that Dr. Turton qualifies as an “audit committee financial expert” as defined under in Item 16A of Form 20-F.

ITEM 16B.	CODE OF ETHICS.

We have adopted a Code of Ethics and Business Conduct, or Code of Ethics, which is applicable to all of our employees, officers and directors and is available on our website at http://www.biodexapharma.com/investors/corporate-governance. The Code of Ethics provides that our directors and officers are expected to avoid any action, position or interest that conflicts with the interests of the Group or gives the appearance of a conflict. Our directors and officers have an obligation under the Code of Ethics to advance our interests when the opportunity to do so arises. We expect that any amendment to this code, or any waivers of its requirements, will be disclosed on our website. Information contained on, or that can be accessed through, our website is not incorporated by reference into this document, and you should not consider information on the website to be part of this document.

ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES.

PKF Littlejohn LLP acted as our independent registered public accounting firm for the fiscal years ended December 31, 2025 and 2024. Forvis Mazars LLP (then called Mazars LLP) acted as our independent registered public accounting firm until October 31, 2024, when they resigned. The following table sets forth by category of service the total fees for services provided to us by our independent registered public accounting firms during the fiscal years ended December 31, 2025 and 2024.

	2025
	( in thousands)
Audit Fees (1)		222
Audit-Related Fees(2)		59
Tax Fees(3)		-
All Other Fees(4)		-
Total		281

All values are in British Pounds.

______________

(1)	Audit fees consist of the aggregate fees billed in connection with the audit and United Kingdom statutory<br> audit of our annual consolidated financial statements included in this annual report, interim reviews of our half-yearly financial information<br> and other services related to SEC filings. For the fiscal year ended December 31, 2024, audit fees included £72,000 in respect of<br> fees paid to Forvis Mazars LLP (then called Mazars LLP), with the balance relating to PKF Littlejohn LLP.
(2)	Audit-related fees are fees for services that are traditionally performed by the independent accountants,<br> including consultations concerning financial accounting and reporting, employee benefit plan audits, due diligence on mergers or acquisitions<br> and the issuance of comfort letter.
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(4)	Represents the aggregate fees billed for tax compliance, tax advice and tax consulting services.
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(5)	Represents the aggregate fees billed for all products and services provided that are not included under “audit<br> fees”, “audit related fees” or “tax fees,” including, but not limited to, fees billed for services relating<br> to mergers and acquisitions.
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Audit Committee Pre-Approval Policies and Procedures

The pre-approval of the Audit Committee or member thereof, to whom pre-approval authority has been delegated, is required for the engagement of our independent auditors to render audit or non-audit services. Audit Committee pre-approval of audit and non-audit services will not be required if the engagement for the services is entered into pursuant to pre-approval policies and procedures established by the Audit Committee regarding our engagement of the independent auditor, provided the policies and procedures are detailed as to the particular service, the Audit Committee is informed of each service provided and such policies and procedures do not include delegation of the Audit Committee’s responsibilities under the Exchange Act to management. Audit Committee pre-approval of non-audit services (other than review and attest services) also will not be required if such services fall within available exceptions established by the SEC.

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDSFOR AUDIT COMMITTEES.

Not applicable.

ITEM 16E. PURCHASE OF EQUITY SECURITIESBY THE ISSUER AND AFFILIATED PURCHASERS.

None.

ITEM 16F. CHANGE IN REGISTRANT’SCERTIFYING ACCOUNTANTS.

The information required by this Item 16F was previously reported in our Report on Form 6-K filed with the SEC on November 1, 2024, which is incorporated herein by reference.

ITEM 16G. CORPORATE GOVERNANCE.

Companies with securities listed on NASDAQ are required to comply with United States federal securities laws, including the Sarbanes-Oxley Act of 2002, as well as certain NASDAQ rules and corporate governance requirements. As a foreign private issuer, however, we are entitled to follow our home country practice in lieu of the NASDAQ corporate governance standards, subject to certain exceptions and except to the extent that such exemptions would be contrary to United States federal securities laws. The United Kingdom laws and practices followed by the Company in lieu of NASDAQ rules are described below:

·	We do not follow NASDAQ’s requirement that the Board of Directors be comprised of a majority of Independent<br> Directors, as defined under Rule 5605(a)(2). In accordance with United Kingdom law and practice, we do not require a majority of our Board<br> of Directors to be considered independent.
·	We do not follow NASDAQ’s requirements applicable to independent director oversight of director nominations,<br> which require that director nominees either be selected or recommended by independent directors. In accordance with United Kingdom law<br> and practice, our directors are nominated by the Nominations Committee, which is comprised of all of the directors of the Company.
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·	We do not follow NASDAQ’s requirement that the compensation committee be comprised of Independent Directors,<br> as defined under Rule 5605(a)(2).
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·	We do not require that the compensation committee consider the specific factors affecting consultant independence<br> that are set forth in NASDAQ Rule 5605(d)(3)(D). Our compensation committee may engage independent compensation consultants at its discretion.
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·	We do not follow NASDAQ’s requirements that non-executive directors meet on a regular basis without<br> management present. Our Board of Directors may choose to meet in executive session at their discretion.
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·	We do not follow NASDAQ’s quorum requirements for stockholder meetings. In accordance with United Kingdom<br> law and practice, our Articles of Association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
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·	We do not follow NASDAQ’s requirements to seek shareholder approval for the establishment of, or any<br> material amendments to, certain equity compensation or purchase plans or other equity compensation arrangements. We follow United Kingdom<br> law and practice with respect to any requirement to obtain shareholder approval in connection with equity compensation or purchase plans<br> or other equity compensation arrangements.
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·	We do not follow NASDAQ’s requirement for shareholder approval in connection with certain private placements<br> of our equity securities.. We follow United Kingdom law and practice with respect to any requirement to obtain shareholder approval in<br> connection with any private placement of equity securities.
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ITEM 16H. MINE SAFETY DISCLOSURE.

Not applicable.

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ITEM 16I. DISCLOSURE REGARDING FOREIGNJURISDICTIONS THAT PREVENT INSPECTIONS.

Not applicable.

ITEM 16J. INSIDER TRADING POLICY.

We have adopted a written insider trading policy governing the purchase, sale, and other disposition of our securities by directors, senior management and employees that is reasonably designed to promote compliance with applicable insider trading laws, rules and regulations, and any listing standards applicable to us.

A copy of the insider trading policy is included as an exhibit to this annual report.

ITEM 16K. CYBERSECURITY.

We recognize the importance of maintaining the confidentiality, integrity and availability of our business operations and systems. Our information technology, or IT, systems are largely outsourced to a third party vendor which we rely on for implementation of the security measures of those systems and the data stored in them. Generally, our board of directors oversees our risk management activities, and cybersecurity represents an important element of our overall approach to risk management. We adopt a cross-functional approach that, together with our outsourced IT vendor, aims to preserve the confidentiality, security and availability of the information that we collect and store by identifying, preventing and mitigating cybersecurity threats and effectively responding to cybersecurity incidents when they occur.

Cybersecurity Risk Management and Strategy;Effect of Risk

We face risks related to cybersecurity such as unauthorized access, cybersecurity attacks and other security incidents, including as perpetrated by hackers and unintentional damage or disruption to hardware and software systems, loss of data, and misappropriation of confidential information. To identify and assess material risks from cybersecurity threats, we, together with our outsourced IT vendor, maintain a comprehensive cybersecurity program to ensure our systems are effective and prepared for information security risks, including regular oversight of our programs for security monitoring for internal and external threats to ensure the confidentiality and integrity of our information assets. We consider risks from cybersecurity threats alongside other company risks as part of our overall risk assessment process. Together with our outsourced IT vendor, we employ a range of tools and services, including regular network and endpoint monitoring and audits.

To provide for the availability of critical data and systems, maintain regulatory compliance, manage our material risks from cybersecurity threats, and protect against and respond to cybersecurity incidents, we, together with our outsourced IT vendor, ensure that the following activities and measures are in place:

·	monitor emerging data protection laws and implement changes to our processes that are designed to comply with<br> such laws;
·	through our policies, practices and contracts (as applicable), require employees, as well as third parties<br> that provide services on our behalf, to treat confidential information and data with care;
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·	employ technical safeguards that are designed to protect all information systems from cybersecurity threats,<br> including firewalls, intrusion prevention and detection systems, anti-malware functionality and access controls, which are evaluated and<br> improved through cybersecurity threat intelligence;
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·	provide regular, mandatory training for our employees and contractors regarding cybersecurity threats as a<br> means to equip them with effective tools to address cybersecurity threats, and to communicate our evolving information security policies,<br> standards, processes and practices; and
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·	carry information security risk insurance that provides protection against the potential losses arising from<br> a cybersecurity incident.
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Our incident response plan coordinates the activities we take to prepare for, detect, respond to and recover from cybersecurity incidents, which include processes to triage, assess severity for, escalate, contain, investigate and remediate the incident, as well as to comply with potentially applicable legal obligations and mitigate damage to our business and reputation.

As part of the above processes, we regularly engage with our outsourced IT vendor to review our cybersecurity program to help identify areas for continued focus, improvement and compliance.

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Our processes also address cybersecurity threat risks associated with our use of third-party service providers who have access to data or our systems. In addition, cybersecurity considerations affect the selection and oversight of our third-party service providers. We perform diligence on third parties that have access to our systems, data or facilities that house such systems or data. As a matter of policy, other than our outsourced IT vendor, we do not grant third parties access to our systems, data or facilities that house such systems or data. Our outsourced IT vendor continually monitors cybersecurity threat risks to its systems and infrastructure.

We describe whether and how risks from identified cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, under the heading “ We are subject to cybersecurity risks, including the misappropriation or compromise of our information, our informationtechnology systems, and other cybersecurity incidents that may result in operational or service disruption, harm to our reputation, litigation,fines, penalties and liabilities, and the incurrence of costs in an effort to minimize those risks ,” in Item 3D--Risk Factors ” which disclosures are incorporated by reference herein.

In the last three fiscal years, we have not experienced any material cybersecurity incidents.

Cybersecurity Governance; Management

Cybersecurity is an important part of our risk management processes and an area of focus for our board of directors and management. In general, our board of directors oversees risk management activities designed and implemented by our management. Our board of directors executes its oversight responsibility for risk management both directly and through delegating oversight of certain of these risks to its committees, and our board of directors has authorized our audit committee to oversee risks from cybersecurity threats.

Our cybersecurity risk management and strategy processes, which are discussed in greater detail above, are led by our Chief Executive Officer and supported by our Group Controller and Finance & Administration Manager. These individuals have experience in various roles involving managing information security, developing cybersecurity strategy, implementing effective information and cybersecurity programs, as well as managing outsourced IT vendors. These management team members are in close contact with our outsourced IT vendor who is responsible for day-to-day monitoring of the prevention, mitigation, detection, and remediation of cybersecurity incidents. The delegated management team referenced above, together with our outsourced IT vendor, are responsible for the operation of our incident response plan. As discussed above, these management team members report to the audit committee of our board of directors about cybersecurity threat risks, among other cybersecurity related matters, at least annually and more frequently should a cybersecurity event occur.

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PART III

ITEM 17. FINANCIAL STATEMENTS.

We have elected to provide financial statements pursuant to Item 18 of Form 20-F.

ITEM 18. FINANCIAL STATEMENTS.

The financial statements are filed as part of this annual report beginning on page F-1.

The financial statements of the Company included in this annual report do not constitute statutory financial statements within the meaning of the United Kingdom Companies Act 2006. The Company’s statutory financial statements for the years ended December 31, 2025 and 2024 have been reported on by PKF Littlejohn LLP, independent auditors, and for the year ended December 31, 2023 has been reported on by Forvis Mazars LLP (then called Mazars LLP), independent auditors, under applicable law and the International Standards on Auditing (United Kingdom). The Independent Auditors’ Report of PKF Littlejohn LLP on the statutory financial statements for the years ended December 31, 2025 and 2024 included an emphasis of matter regarding material uncertainty over going concern. The Independent Auditors’ Report of Forvis Mazars LLP (then called Mazars LLP) on the statutory financial statements for the year ended December 31, 2023 included an emphasis of matter regarding material uncertainty over going concern.

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ITEM 19. EXHIBITS.

Exhibit Index

Exhibit Number	Title
3.1	Articles<br> of Association of Biodexa Pharmaceuticals PLC, adopted on June 11, 2025 (incorporated by reference to Exhibit 1.1 to the Company’s<br> Report on Form 6-K, filed with the SEC on June 13, 2025).
2.1*	Description of Securities Registered Under Section 12 of the Exchange<br> Act.
2.2	Specimen<br> certificate representing ordinary shares of Biodexa Pharmaceuticals Plc (incorporated by reference to Exhibit 4.2 to the Company’s<br> Registration Statement on Form F-1 (File No. 333-272693), filed with the SEC on June 16, 2023).
2.3	Form<br> of Second Amended and Restated Deposit Agreement by and among Biodexa Pharmaceuticals PLC, JPMorgan Chase Bank, N.A., as depositary, and<br> all owners and holders from time to time of American Depositary Shares thereunder (incorporated by reference to Exhibit (a) to the Company’s<br> Registration Statement on Form F-6 (File No. 333-275909), filed with the SEC on December 6, 2023).
2.4	Form<br> of JPMorgan Chase Bank, N.A. American Depositary Receipt (included in Exhibit 4.3 as Exhibit A thereto).
2.5	Form<br> of Series L Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Report on Form 6-K, filed with the SEC on December<br> 18, 2025).
2.6	Form<br> of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Report on Form 6-K, filed with the SEC on December<br> 18, 2025).
2.7	Form<br> of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Report on Form 6-K, filed with<br> the SEC on December 18, 2025).
2.8	Form<br> of Placement Agent Warrant (incorporated by reference to Exhibit 4.4 of the Company’s Report on Form 6-K, filed with the SEC on<br> February 9, 2023).
2.9	Form<br> of Series D Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Report on Form 6-K, filed with the SEC on May 24,<br> 2023).
2.10	Form<br> of May 2023 Placement Agent Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Report on Form 6-K, filed with the<br> SEC on May 24, 2023).
2.11	Form<br> of Series E Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Report on Form 6-K, filed with the SEC on December<br> 21, 2023).
2.12	Form<br> of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Report on Form 6-K, filed with the SEC on December<br> 21, 2023).
2.13	Form<br> of December 2023 Underwriter Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Report on Form 6-K, filed with the<br> SEC on December 21, 2023).
2.14	Form<br> of Series G Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Report on Form 6-K, filed with the SEC on May 28,<br> 2024).

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| --- | | 97.1 | Clawback Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC on April 19, 2024). | | --- | --- | | 101.INS | Inline XBRL Instance Document | | 101.SCH | Inline XBRL Taxonomy Extension Schema Documents | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |

_________________

*	Filed herewith.
**	Furnished herewith.
---	---
#	Management contract or compensatory plan or arrangement
---	---
†	Certain portions of this exhibit (indicated by asterisks) have been omitted because they are not material and would likely cause competitive<br> harm to Biodexa Pharmaceuticals PLC if publicly disclosed.
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SIGNATURES

The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.

BIODEXA PHARMACEUTICALS PLC
By:	/s/ Stephen Stamp
Name:	Stephen Stamp
Title:	Chief Executive Officer

Date: March 27, 2026

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BIODEXA PHARMACEUTICALS PLC

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

	Page
Report of Independent Registered Public Accounting Firm (PKF Littlejohn LLP, London, United Kingdom, PCAOB ID 2814)	F-1
Report of Independent Registered Public Accounting Firm (Forvis Mazars LLP (then called Mazars LLP), London, United Kingdom, PCAOB ID 1401)	F-2
Consolidated statements of comprehensive income for the years ended 31 December 2025, 2024 and 2023	F-4
Consolidated statements of financial position at 31 December 2025, 2024 and 2023	F-5
Consolidated statements of cash flows for the years ended 31 December 2025, 2024 and 2023	F-7
Consolidated statements of changes in equity for the years ended 31 December 2025, 2024 and 2023	F-9
Notes forming part of the consolidated financial statements	F-12

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Report of Independent Registered Public AccountingFirm

To the Shareholders and Board of Directorsof Biodexa Pharmaceuticals Plc

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated statement of financial position of Biodexa Pharmaceuticals plc and its subsidiaries (the “Group”) as of December 31, 2025 and 2024, and the related consolidated statement of comprehensive income, changes in equity and cash flows for the years ended December 31, 2025 and 2024, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Group as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years ended December 31, 2025 and 2024, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Going Concern Uncertainty

The accompanying consolidated financial statements have been prepared assuming that the Group will continue as a going concern. As discussed in note 1 to the consolidated financial statements, the Group is pre-revenue and its business model requires significant ongoing expenditure on research and development that include the costs to develop its portfolio, together with working capital requirements. The Group’s future viability is dependent on its ability to secure additional financing during the going concern period. A number of available financing options are currently being evaluated in addition to the existing Equity Line of Credit facility, and there is no guarantee the Group will be able to use the facility to the extent necessary to finance its operations as currently planned. These conditions raise substantial doubt about the Group’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for opinion

These consolidated financial statements are the responsibility of the Group’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Group in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Group is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Group’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical audit matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: 1) relate to accounts or disclosures that are material to the financial statements and 2) involved especially challenging, subjective, or complex judgements. We determined that there were no critical audit matters.

We have served as the Group’s auditor since 31 October 2024.

/s/ PKF Littlejohn LLP

PKF Littlejohn LLP

London, England

Date: March 27, 2026

PCAOB ID No. 2814

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM

The Board of Directors and Shareholders of Biodexa Pharmaceuticals plc (formerly known as Midatech Pharma plc)

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated statements of financial position of Biodexa Pharmaceuticals plc (formerly known as Midatech Pharma plc) and its subsidiaries (the “Group”) as of December 31, 2023 and 2022, and the related consolidated statements of comprehensive income, changes in equity, and cash flows for each of the years in the two-year period ended December 31, 2023, including the related notes (collectively, the “Consolidated Financial Statements”). In our opinion, the Consolidated Financial Statements present fairly, in all material respects, the financial position of the Group as of December 31, 2023 and 2022, and the consolidated results of its operations and its cash flows for each of the year in the two-year period ended December 31, 2023, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Going Concern Uncertainty

The accompanying Consolidated Financial Statements have been prepared assuming that the Group will continue as a going concern. As discussed in note 1 to the Consolidated Financial Statements the Group has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding these matters are also described in note 1. The Consolidated Financial Statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These Consolidated Financial Statements are the responsibility of the Group’s management. Our responsibility is to express an opinion on these Consolidated Financial Statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Group in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the Consolidated Financial Statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the Consolidated Financial Statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the Consolidated Financial Statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the Consolidated Financial Statements. We believe that our audits provide a reasonable basis for our opinion.

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Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the Consolidated Financial Statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the Consolidated Financial Statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the Consolidated Financial Statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

We have identified one critical audit matter, being the going concern basis of preparation. The nature of the critical audit matter, together with our conclusion, is set out above in the going concern uncertainty paragraph*.* Given the circumstances described, the Directors were required to exercise significant judgement in making their assessment as to whether it is appropriate to prepare the Consolidated Financial Statements on a going concern basis and in preparing their related explanatory disclosures. As a result of the requirement for the Directors to exercise significant judgment, much of which is qualitative in nature, together with the pervasive impact of the going concern basis of preparation and the importance of the related explanatory disclosures in providing context for the Consolidated Financial Statements, we have concluded that the going concern basis of preparation is a critical audit matter.

Our evaluation of the Directors’ assessment of the appropriateness of the going concern basis of preparation of these consolidated financial statements included, but was not limited to:

·	Undertaking an initial assessment at the planning stage of the audit to identify events or conditions<br>that may cast significant doubt on the Group’s ability to continue as a going concern;
·	Obtaining an understanding of the relevant controls relating to the Directors’ going concern assessment;
---	---
·	Reviewing the Directors’ formal going concern assessment, including the supporting cash flow projections<br>to 31 December 2026;
---	---
·	Evaluating the key assumptions used and judgements applied by the Directors in forming their conclusions<br>on going concern; and
---	---
·	Reviewing the appropriateness of the disclosures made by the Directors in the Consolidated Financial Statements.
---	---

We have served as the Group’s auditor from 2020 until October 24, 2024.

/s/ Mazars LLP

Mazars LLP

London, England

April 18, 2024

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Consolidated StatementS of Comprehensive Income

For the year ended 31 December


Revenue	3
Other income
Research and development costs		)	)	)
Administrative costs		)	)	)
Loss from operations	4	)	)	)
Finance income	6
Finance expense	6	)	)	)
Loss before tax		)	)	)
Taxation	7
Loss for the year attributable to the owners of the parent		)	)	)
Other comprehensive income:
Items that will or may be reclassified subsequently to profit or loss:
Exchange gains arising on translation of foreign operations
Total other comprehensive income net of tax
Total comprehensive loss attributable to the owners of the parent		)	)	)
Loss per share
Continuing operations
Basic and diluted loss per ordinary share	8	)p	)	)

All values are in British Pounds.

The notes form an integral part of these consolidated financial statements.

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Consolidated statementS of financial position

At 31 December

Company number 09216368	Note		2025 ’000	2024 ’000	2023 ’000
Assets
Non-current assets
Property, plant and equipment		9
Intangible assets		11
Total Non-Current Assets
Current assets
Trade and other receivables		13
Current taxation receivable
Cash and cash equivalents		14
Total Current Assets
Total assets
Liabilities
Non-current liabilities
Deferred consideration		16
Borrowings		17
Total Non-Current Liabilities
Current liabilities
Trade and other payables		15
Deferred consideration		16
Borrowings		17
Provisions		18
Derivative financial liability		19
Total Current liabilities
Total liabilities

All values are in British Pounds.

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CONSOLIDATED STATEMENTS OF FINANCIAL POSITION(continued)

At 31 December


Issued capital and reserves attributable to owners of the parent
Share capital	22
Share premium	23
Merger reserve	23
Warrant reserve	23
Foreign exchange reserve	23
Accumulated deficit	23	)	)	)
Total equity
Total equity and liabilities

All values are in British Pounds.

The notes form an integral part of these consolidated financial statements.

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Consolidated statements of cash flows

For the year ended 31 December


Cash flows from operating activities
Loss for the year		)	)	)
Adjustments for:
Depreciation of property, plant and equipment	9
Depreciation of right of use asset	9
Amortisation of intangible fixed assets	11
Loss on disposal of property, plant and equipment
Impairment of loan	4
Impairment of ELOC upfront fee
Finance income	6	)	)	)
Finance expense	6
Share-based payment charge	4
Taxation	7	)	)	)
Foreign exchange losses/(gains)		)
Cash flows from operating activities before changes in working capital		)	)	)
Decrease/(Increase) in trade and other receivables			)
(Decrease)/Increase in trade and other payables		)		)
(Decrease)/Increase in provisions				)
Cash used in operations		)	)	)
Taxes received
Net cash used in operating activities		)	)	)

All values are in British Pounds.

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Consolidated statements of cash flows(continued)

For the year ended 31 December


Investing activities
Purchases of property, plant and equipment	9	)	)	)
Proceeds from disposal of fixed assets
Purchase of intangible asset/deferred consideration	11	)	)	)
Loan granted	4			)
Interest received
Net cash (used in)/generated from investing activities		)	)	)
Financing activities
Interest paid		)		)
Amounts paid on lease liabilities		)	)	)
(Repayment)/Proceeds from promissory note		)
Share issues including warrants, net of costs	14
Net cash generated from financing activities
Net increase/(decrease) in cash and cash equivalents			)
Cash and cash equivalents at beginning of year
Exchange (losses)/gains on cash and cash equivalents
Cash and cash equivalents at end of year	14

All values are in British Pounds.

The notes form an integral part of these consolidated financial statements.

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Consolidated statements of changes in equity

For the year ended 31 December


At 1 January 2025				)
Loss for the year				)	)
Foreign exchange translation
Total comprehensive loss				)	)
Transactions with owners
Shares issued under ELOC agreement	14,22
Costs associated with ELOC agreement	14,22	)
Shares issued on 15 May 2025	14,22
Costs associated with share issue on 15 May 2025	14,22	)			)
Shares issued 19 December 2025
Costs associated with share issue on 19 December 2025	14/22	)	)		)
Lapse warrants			)
Share-based payment charge
Total contribution by and distributions to <br><br>owners
At 31 December 2025				)

All values are in British Pounds.

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Consolidated statements of changes in equity(cONTINUED)


At 1 January 2024				)
Loss for the year				)	)
Total comprehensive loss				)	)
Transactions with owners
Shares issued on 22 May 2024	14,22
Costs associated with share issue on 22 May 2024	14,22	)			)
Shares issued on 22 July 2024	14,22
Costs associated with share issue on 22 July 2024	14,22	)		)	)
Exercise of warrants during the year	14,22		)
Issue of shares to purchase intangible asset	11
Share-based payment charge
Total contribution by and distributions to <br><br>owners			)
At 31 December 2024				)

All values are in British Pounds.

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Consolidated statements of changes in equity(cONTINUED)


At 1 January 2023			)
Loss for the year			)	)
Total comprehensive loss			)	)
Transactions with owners
Exercise of warrants on 22 March 2022	14,22
Shares issued on 15 February 2023	14,22
Costs associated with share issue on 15 February 2023	14,22	)		)
Shares issued on 26 May 2023	14,22		)
Costs associated with share issue on 26 May 2023	14,22		)	)
Shares issued on 21 December 2023	14,22		)
Costs associated with share issue on 21 December 2023	14,22		)	)
Issue of shares to purchase intangible asset	11
Share-based payment charge
Total contribution by and distributions to <br><br>owners			)
At 31 December 2023			)

All values are in British Pounds.

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Notes forming part of the financial statements

For the years ended 31 December 2025, 2024 and 2023

1	Accounting policies

General information

Biodexa Pharmaceuticals PLC (the ‘Company’) is a company registered and domiciled in England and Wales. The Company was incorporated on 12 September 2014.

The Company is a public limited company, whose ordinary shares were admitted to trading on AIM (‘AIM’), which is a submarket of the London Stock Exchange, on 8 December 2014 until admission of the Company’s ordinary shares to trading on AIM was cancelled 26 April 2023.

In addition, since 4 December 2015 the Company has American Depository Receipts (‘ADRs’) registered with the US Securities and Exchange Commission (‘SEC’) and is listed on the NASDAQ Capital Market.

The financial statements were approved and authorised for issue by the Board of Directors on 27 March 2026.

Basis of preparation

The Group was formed on 31 October 2014 when the Company entered into an agreement to acquire the entire share capital of Biodexa Limited and its wholly owned subsidiaries through the issue equivalent of shares in the Company which took place on 13 November 2014.

These financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB).

The principal accounting policies adopted in the preparation of the financial statements are set out below. The policies have been consistently applied to all the periods presented.

The consolidated financial statements have been prepared on a historical cost basis, except for the following item (refer to individual accounting policies for details):

Certain financial instruments – fair value through profit or loss.

Adoption of new and revised standards

New standards, interpretations and amendments effective from 1 January 2025

The Group reviewed the new standards, interpretations and amendments effective from 1 January 2025 and deemed none were applicable to the annual financial statements for the year ended 31 December 2025.

New standards, interpretations and amendmentsnot yet effective

There are a number of standards, amendments to standards, and interpretations which have been issued by the IASB that are effective in future accounting periods that the group has decided not to adopt early.

The Group reviewed the new standards, interpretations and amendments effective from 1 January 2026 and 1 January 2027 and deemed none have a material impact on the group.

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Basis for consolidation

The Group financial statements consolidate those of the parent company and all of its subsidiaries. The parent controls a subsidiary if it has power over the investee to significantly direct the activities, exposure, or rights to variable returns from its involvement with the investee, and the ability to use its power over the investee to affect the amount of the investor’s returns. All subsidiaries have a reporting date of 31 December.

All transactions and balances between Group companies are eliminated on consolidation, including unrealised gains and losses on transactions between Group companies. Where unrealised losses on intra-Group asset sales are reversed on consolidation, the underlying asset is also tested for impairment from a Group perspective. Amounts reported in the financial statements of subsidiaries have been adjusted where necessary to ensure consistency with the accounting policies adopted by the Group.

The consolidated financial statements consist of the results of the following entities:

Schedule of entities
Entity	Summary description
Biodexa Pharmaceuticals PLC	Ultimate holding company
Biodexa Australia PTY Limited	Trading company
Biodexa Limited	Trading company
Biodexa Ireland Limited	Trading company
Biodexa Pharmaceuticals (Wales) Limited	Trading company
Biodexa US, Inc	Trading company
Haaland UK Limited	Dormant
PharMida AG	Dormant

Going concern – material uncertainty

We have experienced net losses and significant cash outflows from cash used in operating

activities over the past years as it develops its portfolio. For the year ended 31 December 2025, the Group incurred a consolidated loss for the year of £6.38 million and negative cash flows from operations of £5.59 million. As of 31 December 2025, the Group had an accumulated deficit of £155.81 million.

Our future viability is dependent on our ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. Our failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

We believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, we consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realisation of assets and the satisfaction of liabilities in the normal course of business.

As at 31 December 2025, we had cash and cash equivalents of £8.53

million. We have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required in Q3 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit, or ELOC, as described in the Finance Review, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price There is no guarantee that the Company will be able to use the ELOC or raise from other financing to the extent necessary to finance the Company’s operations. As at 31 December 2025 $26.08 million remains undrawn from the ELOC.

This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities.

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Revenue

Revenue is accounted for in line with principles of IFRS 15 ‘Revenue from contracts with customers.

Supply of Research and Development Services

Revenue from the supply of services is subject to specific agreement. This is recognised over the contract term, proportionate to the progress in overall satisfaction of the performance obligations (the services performed by the Group), measured by cost incurred to date out of total estimate of costs. The primary input of substantially all work performed under these arrangements is labour. There is normally a direct relationship between costs incurred and the proportion of the contract performed to date.

Where the Group supplies services to a client it generally bills an agreed percentage in advance of the commencement of any work and the balance on completion. Invoices to clients are payable under normal commercial terms.

Grant revenue

Where grant income is received, which is not a direct re-imbursement of related costs, revenue is recognised at the point at which the conditions have been met, this has been recognised within grant revenue. Where grants are received as a re-imbursement of directly related costs they are credited to research and development expense in the same period as the expenditure towards which they are intended to contribute.

Accounting for rRapa and CPRIT grant

On 25 April 2024 the Company entered into a License and Collaboration Agreement (LCA) with Rapamycin Holdings, Inc. (d/b/a Emtora Biosciences). The LCA entered into with Emtora meets the definition of a Joint Arrangement under IFRS 11, specifically related to the FAP program.

A jointly controlled escrow account was established on completion of the LCA. FAP program transactions eligible to be allocated against the CPRIT grant and match funding are processed through the escrow account, including the Company’s deposits of matching funds, as set out in the agreement, the receipt of grant funding from CPRIT and the payment of eligible R&D expenses. Although the CPRIT grant and R&D supplier contracts are with Emtora, the joint arrangement nature of the LCA results in Emtora being deemed to be acting as the Company’s agent. Accordingly, the Company recognises 100% of the grant and 100% of the R&D expenditure. The CPRIT grant recognised is on a 1 for 2 match basis for the first $17 million, the final $3 million is recognised on a 1 for 1 basis. In accordance with the Company’s accounting policy, the grant, as it is the re-imbursement of directly related costs, is credited to R&D costs in the same period in the Statements of Comprehensive Income. The escrow account is recognised within prepayments, CPRIT grant received in advance is recognised within deferred revenue and any grant not yet received is recognised in accrued income.

The balances as at 31 December were as follows in relation to the FAP project:

Schedule of FAP project
	31 December 2025 ’000	31 December 2024 ’000
Prepayments*
Accrued revenue
Deferred revenue

All values are in British Pounds.

*	prepayment reflects only the escrow account balance

| F-14 |

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| --- | | 1 | Accounting policies (continued) | | --- | --- |

Business combinations and externally acquired intangible assets

Business combinations are accounted for using the acquisition method at the acquisition date, which is the date at which the Group obtains control over the entity. The cost of an acquisition is measured as the amount of the consideration transferred to the seller, measured at the acquisition date fair value, and the amount of any non-controlling interest in the acquiree. The Group measures goodwill initially at cost at the acquisition date, being:

·	the fair value of the consideration transferred to the seller, plus;
·	the amount of any non-controlling interest in the acquiree, plus;
---	---
·	if the business combination is achieved in stages, the fair value of the existing equity interest in the acquiree re-measured at the<br>acquisition date, less;
---	---
·	the fair value of the net identifiable assets acquired and assumed liabilities.
---	---

Acquisition costs incurred are expensed and included in administrative costs. Any contingent consideration to be transferred by the acquirer is recognised at fair value at the acquisition date. Subsequent changes to the fair value of the contingent consideration, whether it is an asset or liability, will be recognised through the consolidated statement of comprehensive income. If the contingent consideration is classified as equity, it is not re-measured.

An intangible asset, which is an identifiable non-monetary asset without physical substance, is recognised to the extent that it is probable that the expected future economic benefits attributable to the asset will flow to the Group and that its cost can be measured reliably. The asset is deemed to be identifiable when it is separable or when it arises from contractual or other legal rights. Further contingent payments due on the purchase of the intangible asset are only recognised when it is probable that payments are due.

Externally acquired intangible assets other than goodwill are initially recognised at cost and subsequently amortised on a straight-line basis over their useful economic lives where they are in use. Goodwill is stated at cost less any accumulated impairment losses.

The amounts ascribed to intangibles recognised on business combinations are arrived at by using appropriate valuation techniques. In-process research and development (‘IPRD’) programmes acquired in business combinations are recognised as assets even if subsequent expenditure is written off because the criteria specified in the policy for development costs below are not met.

IPRD is subject to annual impairment testing until the completion or abandonment of the related project. No further costs are capitalised in respect of this IPRD unless they meet the criteria for research and development capitalisation as set out below.

As per IFRS 3, once the research and development of each defined project is completed, the carrying value of the acquired IPRD is reclassified as a finite-lived asset and amortised over its useful life.

The significant intangibles recognised by the Group and their useful economic lives are as follows:

Schedule of intangibles assets useful economic lives
Goodwill	– Indefinite life
IPRD	– In process, not yet amortising
IT and website costs	– 4 years

The useful economic life of IPRD will be determined when the in-process research projects are completed.

Internally generated intangible assets (development costs)

Expenditure on the research phase of an internal project is recognised as an expense in the period in which it is incurred. Development costs incurred on specific projects are capitalised when all the following conditions are satisfied:

·	completion of the asset is technically feasible so that it will be available for use or sale;
·	the Group intends to complete the asset and use or sell it;
---	---
·	the Group has the ability to use or sell the asset and the asset will generate probable future economic benefits (over and above cost);
---	---
·	there are adequate technical, financial and other resources to complete the development and to use or sell the asset; and
---	---
·	the expenditure attributable to the asset during its development can be measured reliably.
---	---

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All internal activities related to the research and development of new projects are continuously monitored by the Directors. The Directors consider that the criteria to capitalise development expenditure are not met for a product prior to that product receiving regulatory approval in at least one country.

Development expenditure not satisfying the above criteria, and expenditure on the research phase of internal projects are included in research and development costs recognised in the Consolidated Statement of Comprehensive Income as incurred. No projects have yet reached the point of capitalisation.

1	Accounting policies (continued)

Impairment of non-financial assets

Assets that have an indefinite useful life, for example goodwill, or intangible assets not ready for use, such as IPRD, are not subject to amortisation and are tested annually for impairment. Assets that are subject to amortisation are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. The reversal of any impairment charge is limited to the carrying amount of the asset that would have been determined (net of amortisation or depreciation) had no impairment charge been recognised for the asset in prior periods.

For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). The Group at 31 December 2025 had two cash generating units(2024: two, 2023: one) as disclosed in note 11. Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of impairment at each reporting date.

Patents and trademarks

The costs incurred in establishing patents and trademarks are either expensed in accordance with the corresponding treatment of the development expenditure for the product to which they relate or capitalised if the development expenditure to which they relate has reached the point of capitalisation as an intangible asset.

Foreign currency

Transactions entered into by Group entities in a currency other than the currency of the primary economic environment, in which they operate, are recorded at the rates ruling when the transactions occur. Foreign currency monetary assets and liabilities are translated at the rates ruling at the reporting date. Exchange differences arising on the retranslation of unsettled monetary assets and liabilities are recognised immediately in profit or loss.

The presentational currency of the Group is Pounds Sterling. Foreign subsidiaries use the local currencies of the country where they operate. On consolidation, the results of overseas operations are translated into Pounds Sterling at rates approximating to those ruling when the transactions took place. All assets and liabilities of overseas operations, including goodwill arising on the acquisition of those operations, are translated at the rate ruling at the reporting date. Exchange differences arising on translating the opening net assets at opening rate and the results of overseas operations at actual rate are recognised in other comprehensive income and accumulated in the foreign exchange reserve.

Exchange differences recognised in the profit or loss of Group entities on the translation of long-term monetary items forming part of the Group’s net investment in the overseas operation concerned are reclassified to other comprehensive income and accumulated in the foreign exchange reserve on consolidation.

On disposal of a foreign operation, the cumulative exchange differences recognised in the foreign exchange reserve relating to that operation up to the date of disposal are transferred to the consolidated statement of comprehensive income as part of the gain or loss on disposal.

Financial assets and liabilities

Assets at amortised cost

The Group does not have any financial assets which it would classify as fair value through profit or loss. Therefore, all financial assets are classed as assets at amortised cost as defined below.

These assets are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They arise principally through the provision of goods and services to customers (e.g., trade receivables), but also incorporate other types of contractual monetary asset. They are initially recognised at fair value plus transaction costs that are directly attributable to their acquisition or issue and are subsequently carried at amortised cost using the effective interest rate method, less provision for impairment.

For impairment provisions, the Group applies the IFRS 9 simplified approach to measure expected credit losses using a lifetime expected credit loss provision for trade receivables to measure expected credit losses on a collective basis. Trade receivables are grouped based on a similar credit risk and ageing.

The expected loss rates are based on the Group’s historic credit losses experienced over the three-year period prior to the period end. The historic loss rates are then adjusted for current and forward-looking information on macroeconomic factors.

The Group’s assets at amortised costs comprise trade and other receivables and cash and cash equivalents in the consolidated statement of financial position.

Cash and cash equivalents include cash in hand, deposits held at call with original maturities of three months or less.

| F-16 |

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| --- | | 1 | Accounting policies (continued) | | --- | --- |

Financial liabilities

The Group classifies its financial liabilities into one of two categories, depending on the purpose for which the liability was acquired.

Fair value through profit and loss (‘FVTPL’)

The Group has outstanding warrants in the ordinary share capital of the company. The number of ordinary shares to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the parent company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account.

The financial liability is valued using the either the Monte Carlo model or the Black-Scholes option pricing model. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. Fair value is determined in the manner described in note 19.

Other financial liabilities include the following items:

Borrowings are initially recognised at fair value net of any transaction costs directly attributable to the issue of the instrument. Such interest-bearing liabilities are subsequently measured at amortised cost using the effective interest rate method, which ensures that any interest expense over the period to repayment is at a constant rate on the balance of the liability carried in the consolidated statement of financial position. Interest expense in this context includes initial transaction costs and premium payable on redemption, as well as any interest or coupon payable while the liability is outstanding.

Trade payables and other short-term monetary liabilities are initially recognised at fair value and subsequently carried at amortised cost using the effective interest method.

---

Share capital

Financial instruments issued by the Group are classified as equity only to the extent that they do not meet the definition of a financial liability or financial asset. The Group has three classes of share in existence:

·	ordinary shares of £0.00005 each are classified as equity instruments;
·	‘A’ deferred shares of £1 each are classified as equity instruments;
---	---
·	‘B’ deferred shares of £0.001 each are classified as equity instruments;
---	---
·	‘C’ deferred shares of £0.00005 each are classified as equity instruments;
---	---
·	‘D’ deferred shares of £0.000001 each are classified as equity instruments.
---	---

Retirement benefits: defined contribution schemes

Contributions to defined contribution pension schemes are charged to the consolidated statement of comprehensive income in the year to which they relate.

Provisions

Provisions are recognised when the Group has a present obligation (legal or constructive) as a result of a past event; it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation.

Share-based payments

The Group operates a number of equity-settled, share-based compensation plans, under which the entity receives services from Directors and employees as consideration for equity instruments (options) of the Group. The fair value of the Directors and employee services received in exchange for the grant of the options is recognised as an expense. The total amount to be expensed is determined by reference to the fair value of the options granted:

·	including any market performance conditions (including the share price);
·	excluding the impact of any service and non-market performance vesting conditions (for example, remaining an employee of the entity<br>over a specified time period); and
---	---
·	including the impact of any non-vesting conditions (for example, the requirement for employees to save).
---	---

Non-market performance and service conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognised over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. Where vesting conditions are accelerated on the occurrence of a specified event, such as a change in control or initial public offering, such remaining unvested charge is accelerated to the income statement.

| F-17 |

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| --- | | 1 | Accounting policies (continued) | | --- | --- |

Share-based payments (continued)

In addition, in some circumstances employees may provide services in advance of the grant date and therefore the grant date fair value is estimated for the purposes of recognising the expense during the period between service commencement period and grant date.

At the end of each reporting period, the Group revises its estimates of the number of options that are expected to vest based on the non-market vesting conditions. It recognises the impact of the revision to original estimates, if any, in the income statement, with a corresponding adjustment to equity. When the options are exercised, the Company issues new shares. The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium.

The Group also issues warrants over ADSs to certain professional advisors in connection with equity transactions that fall within the scope of IFRS2 and are accounted for as share based payments. The fair value of the services received in exchange for the grant of the warrant is recognised as an expense of the equity transaction. The total expense is recognised immediately.

Leases

Identifying Leases

The Group accounts for a contract, or a portion of a contract, as a lease when it conveys the right to use an asset for a period of time in exchange for consideration. Leases are those contracts that satisfy the following criteria:

(a) There is an identified asset;

(b) The Group obtains substantially all the economic benefits from use of the asset; and

The Group considers whether the supplier has substantive substitution rights. If the supplier does have those rights, the contract is not identified as giving rise to a lease.

In determining whether the Group obtains substantially all the economic benefits from use of the asset, the Group considers only the economic benefits that arise from the use of the asset, not those incidental to legal ownership or other potential benefits.

In determining whether the Group has the right to direct use of the asset, the Group considers whether it directs how and for what purpose the asset is used throughout the period of use. If there are no significant decisions to be made because they are pre-determined due to the nature of the asset, the Group considers whether it was involved in the design of the asset in a way that predetermines how and for what purpose the asset will be used throughout the period of use. If the contract or portion of a contract does not satisfy these criteria, the Group applies other applicable IFRSs rather than IFRS 16.

All leases are accounted for by recognising a right-of-use asset and a lease liability except for:

·	Leases of low value assets; and
·	Leases with a duration of 12 months or less.
---	---

Lease liabilities are measured at the present value of the contractual payments due to the lessor over the lease term, with the discount rate determined by reference to the group’s incremental borrowing rate on commencement of the lease.

Right of use assets are initially measured at the amount of the lease liability, reduced for any lease incentives received, and increased for lease payments made at or before commencement of the lease. The Group has taken advantage of the practical expedient to ignore the requirement to separate non-lease components and instead account for the entire contract as a single lease.

Subsequent to initial measurement lease liabilities increase as a result of interest charged at a constant rate on the balance outstanding and are reduced for lease payments made. Right-of-use assets are amortised on a straight-line basis over the remaining term of the lease.

When the group revises its estimate of the term of any lease (because, for example, it re-assesses the probability of a lessee extension or termination option being exercised), it adjusts the carrying amount of the lease liability to reflect the payments to make over the revised term, which are discounted using a revised discount rate. An equivalent adjustment is made to the carrying value of the right-of-use asset, with the revised carrying amount being amortised over the remaining (revised) lease term. If the carrying amount of the right-of-use asset is adjusted to zero, any further reduction is recognised in profit or loss.

Nature of leasing activities (in the capacityas lessee)

As at 31 December 2025 the Group had one property lease in place in the UK.

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| --- | | 1 | Accounting policies (continued) | | --- | --- |

Taxation

Tax is recognised in the Comprehensive Statement of Income, except that a charge attributable to an item of income and expense recognised as other comprehensive income or to an item recognised directly in equity is also recognised in other comprehensive income or directly in equity respectively.

The current income tax credit is calculated on the basis of tax rates and laws that have been enacted or substantively enacted by the reporting date in the country where the Company operates. Current tax includes credits for qualifying research and development expenditure under the UK’s Merged R&D Expenditure Credit scheme.

Deferred taxation

Deferred tax assets and liabilities are recognised where the carrying amount of an asset or liability in the consolidated statement of financial position differs from its tax base, except for differences arising on:

·	the initial recognition of goodwill;
·	the initial recognition of an asset or liability in a transaction which is not a business combination and at the time<br><br>of the transaction affects neither accounting or taxable profit or loss; and
---	---
·	investments in subsidiaries and jointly controlled entities where the Group is able to control the timing of the reversal of the difference<br>and it is probable that the difference will not reverse in the foreseeable future.
---	---

Recognition of deferred tax assets is restricted to those instances where it is probable that taxable profit will be available against which the difference can be utilised.

The amount of the asset or liability is determined using tax rates that have been enacted or substantively enacted by the reporting date and are expected to apply when the deferred tax assets or liabilities are recovered or settled.

Property, plant and equipment

Property, plant and equipment is stated at cost, net of accumulated depreciation and accumulated impairment losses.

Depreciation is provided on all items of property, plant and equipment so as to write off their carrying value over their expected useful economic lives. It is provided at the following rates:

Schedule of depreciation rates of property, plant and equipment
Fixtures and fittings	– 20%- 25% per annum straight line
Leasehold improvements	– the shorter of 10% per annum straight line or over the lease term
Computer equipment	– 25% per annum straight line
Laboratory equipment	– 15% – 25% per annum straight line
Right of use asset	– Economic life of contractual relationship

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| --- | | 2 | Critical accounting estimates and judgements | | --- | --- |

The preparation of these consolidated financial statements requires the Group to make estimates, assumptions and judgments that can have a significant impact on the reported amounts of assets and liabilities, revenue and expenses and related disclosure of contingent assets and liabilities, at the respective dates of our financial statements. The Group bases its estimates, assumptions and judgments on historical experience and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Management evaluates estimates, assumptions and judgments on a regular basis and makes changes accordingly and discusses critical accounting estimates with the board of Directors.

The following are considered to be critical accounting estimates:

Impairment of intangible assets not yet ready for use

Intangible assets not yet ready for use are tested for impairment at the cash generating unit level on an annual basis at the year end and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a cash generating unit below its carrying value. Impairment indications include events causing significant changes in any of the underlying assumptions used in valuing intangibles not ready for use. The key assumptions are the probability of success, the discount factor, the timing of future revenue flows, market penetration and peak sales assumptions, and expenditure required to complete development.

The carrying value of intangibles not yet ready for use was £5.6 million (2024:

£5.6 million; 2023: £2.9 million) as at 31 December 2025 (note 11).

Management apply a further 20% sensitivity to the probability of success, this resulted in the following change in the fair value of the asset:

Schedule of fair value of the asset
	% change in fair value
	2025			2024			2023
MTX228 tolimidone acquired IPRD*		40	%		41	%		18	%
MTX230 eRapa acquired IPRD*		20	%		19	%		n/a

Share-based payments

The Group accounts for share-based payment transactions for Directors and employees in accordance with IFRS 2 Share-based Payment, which requires the measurement of the cost of Director and employee services received in exchange for the options on our ordinary shares, based on the fair value of the award on the grant date.

The Directors selected the Black-Scholes-Merton option pricing model as the most appropriate method for determining the estimated fair value of our share-based awards without market conditions.

The resulting cost of an equity incentive award is recognised as an expense over the requisite service period of the award, which is usually the vesting period.

The assumptions used for estimating fair value for share-based payment transactions are disclosed in note 25 to our consolidated financial statements and are estimated as follows:

·	volatility is estimated based on the average annualised volatility of a number of publicly traded peer companies in the biotech sector;
·	the estimated life of the option is estimated to be until the first exercise period, which is typically the month after the option<br>vests; and
---	---
·	the dividend return is estimated by reference to our historical dividend payments. Currently, this is estimated to be zero as no dividend<br>has been paid in the prior periods.
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| --- | | 2 | Critical accounting estimates and judgements (continued) | | --- | --- |

Financial liabilities

Fair value through profit andloss (‘FVTPL’)

The Group has outstanding warrants in the ordinary share capital of the Company. The number of ordinary shares to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the parent company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account.

The financial liability is valued using the either the Monte Carlo model or the Black-Scholes option pricing model. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement.

The assumptions used for estimating fair value for warrants transactions as disclosed in note 19 to our consolidated financial statements and are estimated as follows:

·	volatility is estimated based on the average annualised volatility of a number of publicly traded peer companies in the biotech sector;
·	the dilutive impact of the exercise of the warrants; and
---	---
·	the dividend return is estimated by reference to our historical dividend payments. Currently, this is estimated to be zero as no dividend<br>has been paid in the prior periods.
---	---

The following are considered to be critical accounting judgments:

Income taxes

Deferred tax assets are recognised for unused tax losses to the extent that it is probable that taxable profit will be available against which the losses can be utilised. Judgment is required to determine the amount of deferred tax assets that can be recognised based upon the likely timing and the level of future taxable profits together with future tax planning strategies.

In 2025, there were approximately £82.2 million

of gross unutilised tax losses carried forward (2024: £79.7 million; 2023: £75.5 million). No deferred tax asset has been provided in respect of these losses as there was insufficient evidence to support their recoverability in future periods. The losses do not have an expiry date.

Going Concern – material uncertainty

The director’s considerations and judgement on going concern are set out in note 1.

| F-21 |

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| --- | | 3 | Revenue | | --- | --- |

Revenue from contracts with customers

Geographical analysis of revenue by destination of customer

Schedule of revenue by geographical analysis
	2025 ’000	2024 ’000	2023 ’000
Revenue:
Belgium

All values are in British Pounds.

All revenue came from the sale of services in 2023. It is derived entirely from the Group’s R&D collaboration agreements. It is recognised over the contract term proportionate to the progress in overall satisfaction of the performance obligations.

Schedule of performance obligations
	Contractual Assets				Contractual Liabilities
	2025 ’000		2024 ’000	2023 ’000	2025 ’000		2024 ’000		2023 ’000
At 1 January						)				)
Transfers in the period from contract assets to trade receivables		)
Amounts included in contract liabilities that was recognised as revenue during the period
Amounts included in contract liabilities that was recognised as grant income and netted against the relevant expenses in the period
Excess of revenue recognised over cash
Cash received in advance of performance and not recognised as revenue during the period						)		)
Foreign exchange
At 31 December						)		)

All values are in British Pounds.

The Group’s R&D collaboration agreements are the delivery of services within the next 12 months for which the practical expedient in paragraph 121 (a) of IFRS15 applies.

In 2025, no revenue from customers (2024: no revenue; 2023: 1 customer).

Schedule of commercial segment
	2025<br> £’000	2024<br> £’000	2023 ’000
Customer A	n/a	n/a		%

All values are in British Pounds.

The Group contains one reportable operating segment, Pipeline Research and Development (‘Pipeline R&D’). This segment seeks to develop products using the Group’s nanomedicine and sustained release technology platforms. All the reconciliations required for segmental reporting can be found in the primary statements.

The accounting policies of the reportable segments are consistent with the Group’s accounting policies described in note 1.

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| --- | | 4 | Loss from operations | | --- | --- | | Schedule of loss from operations | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Note | | 2025 ’000 | 2024 ’000 | | 2023 ’000 | | Loss from operations is stated after charging/(crediting): | | | | | | | | Depreciation of property, plant and equipment | | | | | | | | - Research and development costs | | 9 | | | | | | - Administrative costs | | 9 | | | | | | Depreciation of right of use asset | | | | | | | | - Research and development costs | | 9 | | | | | | - Administrative costs | | 9 | | | | | | Amortisation of intangible assets – software | | | | | | | | - Research and development costs | | 11 | | | | | | - Administrative costs | | 11 | | | | | | Impairment of financial asset | | 13 | | | | | | Impairment of commission paid in advance on ELOC | | | | | | | | Provision against future loss on loan agreement | | 18 | | | | | | Fees payable to the Company’s auditor for the audit of the parent Company financial statements | | | | | | | | Fees payable to the Company’s auditor for the audits of the subsidiary financial statements | | | | | | | | Fees payable to the Company’s auditor for: | | | | | | | | - Audit related services | | | | | | | | Fees payable to the Company’s previous auditor for: | | | | | | | | - Audit | | | | | | | | - Audit related services | | | | | | | | Foreign exchange (gain)/loss | | | | | ) | | | Loss on disposal of property, plant and equipment | | | | | | | | Equity settled share-based payment – employee schemes | | | | | | |

All values are in British Pounds.

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| --- | | 5 | Staff costs | | --- | --- |

Staff costs (including Directors) comprise:

Schedule of staff costs
	2025 ’000	2024 ’000	2023 ’000
Wages and salaries
Defined contribution pension cost (note 24)
Social security contributions and similar taxes
Share-based payment charge
Staff costs gross

All values are in British Pounds.

Employee numbers

The average number of staff employed by the Group during the financial year amounted to:

Schedule for average number of employed staff
	2025		2024		2023
Research and development		7		8		16
General and administration		4		5		5
		11		13		21

Key management personnel compensation

Key management personnel are those persons having authority and responsibility for planning, directing and controlling the activities of the Group, including the Directors of the Company, including the Chief Executive Officer and Chief Scientific Officer for 2024 and 2023.

Schedule of Management Personnel Compensation
	2025 ’000	2024 ’000	2023 ’000
Short term employee benefits
Post-employment benefits
Termination benefits
Share-based payment
Management Personnal Compensation

All values are in British Pounds.

During the year no Directors (2024:0; 2023: 0) participated in a defined contribution pension scheme. Pension contributions in the above note include those of the Chief Scientific Officer for 2024 and 2023.

Emoluments disclosed above include the following amounts in respect of the highest paid Director.

Schedule of emoluments disclosed
	2025 ’000	2024 ’000	2023 ’000
Short term employee benefits
Post-employment benefits
Management Personnal Compensation

All values are in British Pounds.

None of the Directors have exercised share options during the year (2024: nil, 2023: nil).

| F-24 |

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| --- | | 6 | Finance income and expense | | --- | --- | | Schedule of finance income | | | | | --- | --- | --- | --- | | | 2025 ’000 | 2024 ’000 | 2023 ’000 | | Finance income | | | | | Interest received on bank deposits | | | | | Other interest receivable | | | | | Gain on equity settled derivative financial liability | | | | | Total finance income | | | |

All values are in British Pounds.

	2025 ’000	2024 ’000	2023 ’000
Finance expense
Interest expense on lease liabilities
Interest expense on deferred consideration
Other loans
Total finance expense

All values are in British Pounds.

The gain on the equity settled derivative financial liability in 2025, 2024 and 2023 arose as a result of the movement in share price (note 19).

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| --- | | 7 | Taxation | | --- | --- | | Schedule of components of income tax expense | | | | | | | --- | --- | --- | --- | --- | --- | | | 2025 ’000 | | 2024 ’000 | 2023 ’000 | | | Current tax credit | | | | | | | Current tax (charged)/credited to the income statement | | ) | | | | | Adjustment in respect of prior year | | | | | ) | | Current tax credit | | | | | | | Deferred tax credit | | | | | | | Reversal of temporary differences | | | | | | | Total tax credit | | | | | |

All values are in British Pounds.

The reasons for the difference between the actual tax credit for the year and the standard rate of corporation tax in the United Kingdom applied to losses for the year are as follows:

Schedule of difference between actual tax charge and the standard rate of corporation tax
	2025 ’000		2024 ’000		2023 ’000
Loss before tax		)		)		)
Expected tax credit based on the standard rate of United Kingdom corporation tax at the domestic rate of 25% (2024: 25%; 2023: 25.52%)		)		)		)
Expenses not deductible for tax purposes
Income not taxable		)		)		)
Adjustment in respect of prior period		)		)
Effect of R&D relief
Deferred tax not recognised
Total tax credited to the income statement		)		)		)

All values are in British Pounds.

The taxation credit arises on the enhanced research and development tax credits accrued for the respective periods.

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| --- | | 8 | Loss per share | | --- | --- | | Schedule of loss per share | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | 2025 ’000 | | 2024 ’000 | | 2023 ’000 | | | Numerator | | | | | | | | Loss used in basic EPS and diluted EPS: | | | | | | | | Continuing operations | | ) | | ) | | ) | | Denominator | | | | | | | | Weighted average number of ordinary shares used in basic EPS: | | | | | | | | Basic and diluted loss per share: | | | | | | | | Continuing operations | | ) | | ) | | ) |

All values are in British Pounds.

At a General Meeting on 1 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. The share sub-division and redesignation did not impact the calculation of the denominator as the number of Issued Ordinary Shares did not change.

During the year the Company issued warrants that were accounted through the Warrant Reserve as detailed in note 22.

The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Pre-Funded warrants as disclosed in note 22. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator.

The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted loss per share is presented on the same basis as basic loss per share.

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| --- | | 9 | Property, plant and equipment | | --- | --- | | Schedule of detailed information about property, plant and equipment | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Fixtures and fittings ’000 | | Leasehold improvements ’000 | Computer equipment ’000 | | Laboratory equipment ’000 | | Right of use asset ’000 | | Total ’000 | | | Cost | | | | | | | | | | | | | At 1 January 2023 | | | | | | | | | | | | | Additions | | | | | | | | | | | | | Transfers | | | | | | | | | ) | | | | Disposal | | | | | ) | | ) | | | | ) | | At 31 December 2023 | | | | | | | | | | | | | Additions | | | | | | | | | | | | | Disposals | | | | | ) | | ) | | | | ) | | At 31 December 2024 | | | | | | | | | | | | | Additions | | | | | | | | | | | | | Disposals | | ) | | | ) | | ) | | | | ) | | At 31 December 2025 | | | | | | | | | | | |

All values are in British Pounds.


Accumulated depreciation
At 1 January 2023
Transfers				)
Charge for the year
Disposal		)	)		)
At 31 December 2023
Charge for the year
Disposal		)	)		)
At 31 December 2024
Charge for the year
Disposal	)	)	)		)
At 31 December 2025
Net book value
At 31 December 2025
At 31 December 2024
At 31 December 2023

All values are in British Pounds.

As at 31 December the right of use

asset consisted of leasehold improvements of net book value £79,000 (2024: £215,000; 2023: £350,000).

On 1 February 2023 laboratory equipment previously disclosed within right of use assets was transferred to laboratory equipment when the final payment on the finance lease was made.

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| --- | | 10 | Leases | | --- | --- | | Schedule of market rental rates | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Lease Liabilities | 2025 ’000 | | 2024 ’000 | | 2023 ’000 | | | At 1 January | | | | | | | | Interest expenses | | | | | | | | Lease payments | | ) | | ) | | ) | | At 31 December | | | | | | |

All values are in British Pounds.

The right of use assets is disclosed in note 9.

In April 2021 the Group signed an agreement to lease new premises in Cardiff, Wales, to house its corporate offices and laboratories. The agreement to lease allowed the Group to carry out the Cat A works and fit out prior to completion of the lease and its occupation in August 2021. The lease agreed was for a 5 year period with no break clause. The lease was recognised as a right of use asset in 2021. The recognition in 2021 of the right of use asset and corresponding lease liability were a non cash investing and financing transaction.

Low value leases expensed in year:

Low value leases expensed in year
	2025 ’000	2024 ’000	2023 ’000
Low value leases expensed
Total

All values are in British Pounds.

Total cash outflow for leases in

2025 was £246,000 (2024: £187,000; 2023: £190,000).

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| --- | | 11 | Intangible assets | | --- | --- | | Schedule of reconciliation of changes in intangible assets and goodwill | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | In-process research and development ’000 | Goodwill ’000 | IT/Website costs ’000 | | Total ’000 | | | Cost | | | | | | | | At 1 January 2023 | | | | | | | | Acquisition | | | | | | | | At 31 December 2023 | | | | | | | | Acquisition | | | | | | | | Disposals | | | | ) | | ) | | At 31 December 2024 | | | | | | | | Acquisition | | | | | | | | Disposals | | | | ) | | ) | | At 31 December 2025 | | | | | | |

All values are in British Pounds.


Accumulated amortisation and impairment
At 1 January 2023
Amortisation charge for the year
Disposal
At 31 December 2023
Amortisation charge for the year
Disposal	)	)
At 31 December 2024
Amortisation charge for the year
Disposal	)	)
At 31 December 2025
Net book value
At 31 December 2025
At 31 December 2024
At 31 December 2023

All values are in British Pounds.

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| --- | | 11 | Intangible assets (continued) | | --- | --- |

The individual intangible asset which is material to the financial statements is as follows:

Schedule of condensed financial statements
	Carrying amount			Remaining amortisation <br> period
	2025 ’000	2024 ’000	2023 ’000	2025<br> (years)	2024<br> (years)	2023<br> (years)
MTX228 tolimidone acquired IPRD*				n/a	n/a	n/a
MTX230 eRapa acquired IPRD*				n/a	n/a	n/a

All values are in British Pounds.

*	asset is not yet in use and has not started amortising

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| --- | | 12 | Subsidiaries | | --- | --- |

The subsidiaries of the Company, all of which are 100% owned as at 31 December 2025, either directly or through subsidiaries where indicated, and have been included in these financial statements in accordance with the details set out in the basis of preparation and basis of consolidation note 1, are as follows:

Schedule of subsidiaries
Name	RegisteredOffice	Nature ofBusiness	Notes
Biodexa Australia PTY Limited	c/o Prime Accounting & Business Advisory, HWT Towel Level 17, 40 City Road, Southbank, VIC, 3006, Australia	Trading company
Biodexa Limited	1 Caspian Point, Caspian Way, Cardiff, <br><br>CF10 4DQ	Trading company
Biodexa Ireland Limited	First Floor, Riverside Two, 43-49 Sir John Rogerson's Quay, Dublin 2, Ireland, C02 KV60	Trading company
Biodexa Pharmaceuticals (Wales) Limited	1 Caspian Point, Caspian Way, Cardiff, <br><br>CF10 4DQ	Trading company
Biodexa US, Inc	16601 Blanco Rd, Suite 120, San Antonio, Texas, 78232	Trading company
Haaland UK Limited	1 Caspian Point, Caspian Way, Cardiff, CF10 4DQ	Dormant
PharMida AG	c/o Kellerhals, Hirschgässlein 11, 4051 Basel, Switzerland	Dormant	(a) (b)

Notes:

(a)	Wholly owned subsidiary of Biodexa Limited.
(b)	PharMida AG became dormant in January 2016. Proceedings to wind<br>up the company commenced in 2025.
---	---

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| --- | | 13 | Trade and other receivables | | --- | --- | | Schedule of trade and other receivables | | | | | --- | --- | --- | --- | | | 2025 ’000 | 2024 ’000 | 2023 ’000 | | Trade receivables | | | | | Prepayments | | | | | Other receivables | | | | | Total trade and other receivables | | | | | Less: non-current portion | | | | | Current portion | | | |

All values are in British Pounds.

The Group has applied the practical expedient permitted by IFRS 15 to not disclose the transaction price allocated to performance obligations unsatisfied (or partially unsatisfied) as of the end of the reporting period as contracts typically have an original expected duration of a year or less.

Book values approximate to fair value at 31 December 2025, 2024 and 2023.

Expected Credit Loss

Given the short-term nature of the Group’s trade receivables and accrued income, which are mainly due from large national or multinational companies, the Group's assessment of expected credit losses includes provisions for specific clients and receivables where the contractual cash flow is deemed at risk. Considerations include the current economic environment along with historical and forward-looking information. No assumptions or estimating techniques are applied in considering these. Additional provisions are made based on the assessment of recoverability of aged receivables over one year where sufficient evidence of recoverability is not evident.

2025 and 2023 Trade and other receivables did not contain any impaired asset. Trade and other receivables contained one impaired asset in 2024; this was recovered in 2025.

The maximum exposure to credit risk at the consolidated statement of financial position date is the fair value of each class of receivable.

The Company recognises a default on a financial asset when the counter party announces they have limited resources to satisfy the debt.

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| --- | | 14 | Cash and cash equivalents and cash flow supporting notes | | --- | --- |

Cash and cash equivalents for purposes of the consolidated statement of cash flows comprises:

Schedule of cash and cash equivalents
	2025 ’000	2024 ’000	2023 ’000
Cash at bank available on demand

All values are in British Pounds.

During 2025, 2024 and 2023, cash inflows arose from equity financing transactions, included within financing activities on the face of the cash flow statement. As part of the equity transactions entered in December 2025, July and May 2024 and December and May 2023 warrants to the value of £5.0 million ( 2024: £3.1 million; 2023: £4.6 million) were issued as disclosed in note 19.

Schedule of cash inflows from an equity financing transaction
	2025 ’000		2024 ’000		2023 ’000
Gross proceeds
Transaction costs		)_		)		)

All values are in British Pounds.

The following changes in loans and borrowings arose as a result of financing activities during the year:

Schedule of changes in bank loan liabilities
	Non-current liabilities ’000		Current liabilities ’000		Total ’000
At 1 January 2025
Cash flows				)		)
Non-cashflows:
Foreign exchange				)		)
Loans and borrowings classified as non-current 31 December 2024 becoming current in 2025		)
Transfer to share premium on exercise of warrants				)		)
Warrants issued
Gain recognised in finance income within the consolidated statement of comprehensive income				)		)
Interest accruing in period
At 31 December 2025

All values are in British Pounds.

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| --- | | 14 | Cash and cash equivalents and cash flow supporting notes(continued) | | --- | --- | | | Non-current liabilities ’000 | | Current liabilities ’000 | | Total ’000 | | | --- | --- | --- | --- | --- | --- | --- | | At 1 January 2024 | | | | | | | | Cash flows | | | | ) | | | | Non-cashflows: | | | | | | | | Foreign exchange | | | | ) | | ) | | Loans and borrowings classified as non-current 31 December 2023 becoming current in 2024 | | ) | | | | | | Deferred consideration on acquisition | | | | | | | | Promissory note issued | | | | | | | | Warrants issued | | | | | | | | Exercise of warrants – transfer to share premium | | | | ) | | ) | | Gain recognised in finance income within the consolidated statement of comprehensive income | | | | ) | | ) | | Interest accruing in period | | | | | | | | At 31 December 2024 | | | | | | |

All values are in British Pounds.


At 1 January 2023
Cash flows		)	)
Non-cashflows:
Loans and borrowings classified as non-current 31 December 2022 becoming current in 2023	)
Warrants issued
Gain recognised in finance income within the consolidated statement of comprehensive income		)	)
Interest accruing in period
At 31 December 2023

All values are in British Pounds.

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| --- | | 15 | Trade and other payables | | --- | --- | | Schedule of trade and other payables | | | | | --- | --- | --- | --- | | Current | 2025 ’000 | 2024 ’000 | 2023 ’000 | | Trade payables | | | | | Other payables | | | | | Accruals | | | | | Total financial liabilities, excluding loans and borrowings, classified as financial liabilities measured at amortised cost | | | | | Tax and social security | | | | | Deferred revenue | | | | | Total trade and other payables | | | |

All values are in British Pounds.

Book values approximate to fair value at 31 December 2025, 2024 and 2023.

All current trade and other payables are payable within 3 months of the period end date shown above.

16	Deferred consideration
Schedule of deferred consideration
---	---	---	---	---	---
	2025 ’000		2024 ’000		2023 ’000
Current
Opening provision at 1 January
On acquisition of licence
Payments		)		)
Interest expense
Foreign exchange		)		)

Less: non-current portion
Current portion

All values are in British Pounds.

On 25 April 2024 the Company entered into a LCA

with Emtora, relating to the license of eRapa. Under the LCA the Company is obligated to make quarterly payments to Emtora of $0.25 million less 75% of any research sales by Emtora until the handover trigger event occurs. The obligation meets the definition of a financial liability in accordance with IAS32 and is measured at fair value in accordance with IFRS9.

This financial liability is measured on Level 3, the fair value is derived using a discounted cash flow approach. The discount rate applied to the obligation was 11.64% (2024: 11.64%).

A 1% increase or decrease in the discount rate would decrease or increase the liability by approximately £0.13 million (2024: £0.03 million) and £0.01 million (2024: £0.03 million), respectively. An increase in the liability would result in a loss in the revaluation of financial instruments, while a decrease would result in a gain.

There were no transfers between Level 1 and 2 in the period.

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| --- | | 17 | Borrowings | | --- | --- | | Schedule of borrowings | | | | | --- | --- | --- | --- | | | 2025 ’000 | 2024 ’000 | 2023 ’000 | | Current | | | | | Promissory note | | | | | Lease liabilities | | | | | Total | | | | | Non-current | | | | | Lease liabilities | | | | | Total | | | |

All values are in British Pounds.

Book values approximate to fair value at 31 December 2025, 2024 and 2023.

Promissory note

In December 2024 the Company issued a Promissory Note to C/M Capital Master Fund, LP in the aggregate principal amount of $600,000 at a 10% original issue discount. The Note is an unsecured obligation of the Company and bears interest at an annual rate of 5%, which may be increased under certain circumstances, and has a maturity date of one year from the Issuance Date. The Note includes a monthly repayment schedule, with the entire principal amount of the Note, plus accrued and unpaid interest, due and payable by the Company on the date that is twelve months from the Issuance Date.

The Company received $540,000 pursuant to the Promissory Note on 24 December 2024. The note was repaid in full during 2025.

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| --- | | 18 | Provisions | | --- | --- | | Schedule of provisions | | | | | | --- | --- | --- | --- | --- | | | 2025 ’000 | 2024 ’000 | 2023 ’000 | | | Opening provision at 1 January | | | | | | Utilisation of provision | | | | ) | | Provision recognised in the year | | | | | | At 31 December | | | | | | Less: non-current portion | | | | | | Current portion | | | | |

All values are in British Pounds.

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| --- | | 19 | Derivative financial liability – current | | --- | --- | | Schedule of derivative financial liability | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | 2025 ’000 | | 2024 ’000 | | 2023 ’000 | | | Equity settled derivative financial liability | | | | | | | | At 1 January | | | | | | | | Warrants issued | | | | | | | | Transfer to share premium on exercise of warrants | | ) | | ) | | | | Gain recognised in finance (income)/expense within the consolidated statement of comprehensive income | | ) | | ) | | ) | | At 31 December | | | | | | |

All values are in British Pounds.

Equity settled derivative financial liability is a liability that is not to be settled for cash.

The Company issues warrants in the ADSs of the Company as part of registered direct offerings and private placements in the US. The number of ADSs to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the Company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account (‘FVTPL’). The financial liability is valued using the Black-Scholes model in 2024 and 2023. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. A key input in the valuation of the instrument is the Company share price.

Details of the warrants are as follows:

December 2025 warrants

In December 2025 the Company issued 6,097,562 Series L ADS warrants

as part of the Registered Offering in the US.

July 2024 warrants

In July 2024 the Company issued 21,315 Series J ADS Warrants and 21,315

Series K warrants as part of the Registered Direct Offering and Concurrent Private Placement in the US. The Series K warrants expired on 22 July 2025.

May 2024 warrants

In May 2024 the Company issued 9,434 Series G ADS Warrants and 14,780

Series H warrants as part of the Warrant Inducement in the US. The Series H warrants expired on 22 May 2025.

December 2023 warrants

In December 2023 the Company issued 11,998 Series E ADS Warrants and

11,998 Series F ADS Warrants as part of the Registered Offering in the US. The Series F warrants expired on 23 December 2024.

May 2023 warrants

In June 2023 the Company issued 1,098 Series D ADS Warrants as part

of a registered direct offering and private placement in the US after securing shareholder approval.

May 2020 warrants

In May 2020 the Company issued 2 ADS warrants as part of a registered direct offering in the US. The warrants expired on 20 November 2025.

October 2019 warrants

In October 2019 the Company issued 1 ADS warrants as part of a registered direct offering in the US. The warrants expired on 23 June 2025.

*	Number and original price of warrants have been adjusted to reflect<br>the share consolidation and ratio change of ADS’s to ordinary shares that occurred on 24 March 2023 and the ratio change of ADS’s<br>to ordinary shares on 5 July 2023, 4 October 2024 and 31 July 2025.

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19	Derivative financial<br>liability – current (continued)

DARA warrants and share options

The Group also assumed fully vested warrants and share options on the acquisition of DARA Biosciences, Inc. (which took place in 2015). The number of ordinary shares to be issued when exercised is fixed, however the exercise prices are denominated in US Dollars. The warrants are classified equity settled derivative financial liabilities and accounted for in the same way as those detailed above. The financial liability is valued using the Black-Scholes option pricing model. All warrants and options have lapsed as at 31 December 2025.

The following table details the outstanding warrants over ADSs and ordinary shares as at 31 December and also the movement in the year:

Schedule of warrants outstanding
	At 31 <br> December <br> 2022		Lapsed			Granted		At 31 <br> December <br> 2023		Lapsed			Granted		Exercised			At 31 <br> December <br> 2024		Lapsed			Granted		Exercised			At 31 <br> December <br> 2025
ADSs
December 2025 grant		–		–			–		–		–			–		–			–		–			6,097,562		–			6,097,562
July 2024 grant		–		–			–		–		–			42,630		–			42,630		(8,594	)		–		(17,018	)		17,018
May 2024 grant		–		–			–		–		–			24,214		–			24,214		(6,695	)		–		(8,085	)		9,434
December 2023 grant		–		–			23,996		23,996		(1,602	)				(17,129	)		5,265		(4,753	)		–		–			512
May 2023 grant		–		–			1,098		1,098		–			–		–			1,098					–		–			1,098
May 2020 grant		2		–			–		2		–			–		–			2		(2	)		–		–			–
October 2019 grant		1		–			–		1		–			–		–			1		(1	)		–		–			–
Ordinary shares																								–		–			–
Dara warrants		–		–			–		–		–			–		–			–					–		–			–
Dara options		138		(10	)		–		128		(29	)		–		–			99		(99	)		–		–			–
*	Number and original price of warrants have been adjusted to reflect<br>the share consolidation and ratio change of ADS’s to ordinary shares that occurred on 24 March 2023 and the ratio change of ADS’s<br>to ordinary shares on 5 July 2023, 4 October 2024 and 31 July 2025.
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20	Financial instruments<br>– risk management

The Group is exposed through its operations to the following financial risks:

·	Credit risk
·	Foreign exchange risk
---	---
·	Liquidity risk
---	---

This note describes the Group’s policies and processes for managing those risks. The policy for managing these risks is reviewed and agreed with the Board, however it has delegated the authority for designing and operating processes that ensure the effective management of the risks to the Group’s management.

Principal financial instruments

The principal financial instruments used by the Group, from which financial instrument risk arises, are as follows:

·	Trade and other receivables
·	Cash and cash equivalents
---	---
·	Trade and other payables
---	---
·	Accruals
---	---
·	Deferred considerations
---	---
·	Loans and borrowings
---	---
·	Derivative financial liability
---	---

A summary of the financial instruments held by category is provided below:

Financial assets – amortised cost

Schedule of consolidated derivative financial instruments
	2025 ’000	2024 ’000	2023 ’000
Cash and cash equivalents
Trade receivables
Other receivables
Total financial assets

All values are in British Pounds.

Financial liabilities – amortised cost

	2025 ’000	2024 ’000	2023 ’000
Trade payables
Other payables
Accruals
Deferred consideration
Borrowings
Total financial liabilities – amortised cost

All values are in British Pounds.

Financial liabilities – fair value through profit and loss – current

	2025 ’000	2024 ’000	2023 ’000
Equity settled derivative financial liability

All values are in British Pounds.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- |

Fair value hierarchy

The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique:

·	Level 1: quoted (unadjusted) prices in active markets for identical assets and liabilities;
·	Level 2: other techniques for which all inputs which have a significant effect on the recorded fair value are observable, either directly<br>or indirectly; and
---	---
·	Level 3: techniques which use inputs that have a significant effect on the recorded fair value that are not based on observable market<br>data.
---	---

The fair value of the Group’s derivative financial liability is measured on a recurring basis. The following table gives information about how the fair value of this financial liability is determined, additional disclosure is given in note 19:

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20	Financial instruments<br>– risk management (continued)
Schedule of consolidated financial assets and liabilities at fair value
---	---	---	---	---
Financial <br> liabilities	Fair value as at 31/12/2025	Valuation <br> technique(s)<br> and key input(s)	Significant unobservable input(s)	Relationship of <br> unobservable inputs to <br> fair value
Equity settled financial derivative liability – Series L warrants	2,914,000	Black-Scholes Model	Volatility rate of 110.0% determined using historical volatility of comparable companies.	The higher the volatility the higher the fair value.
			Expected life between a range of 0.1 and 4.97 years determined using the remaining life of the warrant.	The shorter the expected life the lower the fair value.
			Risk-free rate of 3.73% determined using the expected life assumptions.	The higher the risk-free rate <br> the higher the fair value.
Equity settled financial derivative liability – Series J warrants	1,000	Black-Scholes Model	Volatility rate of 115.0% determined using historical volatility of comparable companies.	The higher the volatility the higher the fair value.
			Expected life between a range of 0.1 and 3.56 years determined using the remaining life of the warrant.	The shorter the expected life the lower the fair value.
			Risk-free rate of 3.60% determined using the expected life assumptions.	The higher the risk-free rate <br> the higher the fair value.
Equity settled financial derivative liability – Series G warrants	–	Black-Scholes Model	Volatility rate of 115.0% determined using historical volatility of comparable companies.	The higher the volatility the higher the fair value.
			Expected life between a range of 0.1 and 3.39 years determined using the remaining life of the warrant.	The shorter the expected life the lower the fair value.
			Risk-free rate of 3.59% determined using the expected life assumptions.	The higher the risk-free rate <br> the higher the fair value.
Equity settled financial derivative liability – Series E warrants	–	Black-Scholes Model	Volatility rate of 115.0% determined using historical volatility of comparable companies.	The higher the volatility the higher the fair value.
			Expected life between a range of 0.1 and 2.98 years determined using the remaining life of the warrant.	The shorter the expected life the lower the fair value.
			Risk-free rate of 3.55% determined using the expected life assumptions.	The higher the risk-free rate <br> the higher the fair value.
Equity settled financial derivative liability – Series D warrants	–	Black-Scholes Model	Volatility rate of 120.0% determined using historical volatility of comparable companies.	The higher the volatility the higher the fair value.
			Expected life between a range of 0.1 and 2.47 years determined using the remaining life of the share options.	The shorter the expected life the lower the fair value.
			Risk-free rate of 3.51% determined using the expected life assumptions.	The higher the risk-free rate <br> the higher the fair value.
Total	2,915,000

All values are in British Pounds.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- | | Financial liabilities | Fair value as at 31/12/2024 | Fair value hierarchy | Valuation technique(s) and key input(s) | Significant unobservable input(s) | Relationship of unobservable inputs to fair value | | --- | --- | --- | --- | --- | --- | | Equity settled financial derivative liability – Series K warrants | £ – | Level 3 | Black-Scholes Model | Volatility rate of 75.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | | Expected life between a range of 0.1 and 0.51 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | | Risk-free rate of 4.24% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series J warrants | £231,000 | Level 3 | Black-Scholes Model | Volatility rate of 100.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | | Expected life between a range of 0.1 and 4.56 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | | Risk-free rate of 4.36% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series H warrants | £– | Level 3 | Black-Scholes Model | Volatility rate of 75.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | | Expected life between a range of 0.1 and 0.39 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | | Risk-free rate of 4.29% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series G warrants | £102,000 | Level 3 | Black-Scholes Model | Volatility rate of 105.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | | Expected life between a range of 0.1 and 4.39 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | | Risk-free rate of 4.35% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. |

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| --- | | Equity settled financial derivative liability – Series E warrants | 47,000 | Black-Scholes Model | Volatility rate of 105.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | --- | --- | --- | --- | --- | | | | | Expected life between a range of 0.1 and 3.98 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.32% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series D warrants | 2,000 | Black-Scholes Model | Volatility rate of 110.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 3.47 years determined using the remaining life of the share options. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.30% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – May 2020 warrants | – | Black-Scholes Model | Volatility rate of 100.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 0.89 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.18% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – October 2019 warrants | – | Black-Scholes Model | Volatility rate of 80.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 0.48 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.24% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Total | 383,000 | | | |

All values are in British Pounds.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- | | Financial liabilities | Fair value as at 31/12/2023 | Valuation technique(s) and key input(s) | Significant unobservable input(s) | Relationship of unobservable inputs to fair value | | --- | --- | --- | --- | --- | | Equity settled financial derivative liability – Series E warrants | 2,592,000 | Black-Scholes Model | Volatility rate of 90.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 0.98 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.79% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series F warrants | 1,444,000 | Black-Scholes Model | Volatility rate of 95.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 4.98 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 3.84% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – Series D warrants | 124,000 | Black-Scholes Model | Volatility rate of 95.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 4.40 years determined using the remaining life of the share options. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 3.93% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – May 2020 warrants | – | Black-Scholes Model | Volatility rate of 100.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 1.88 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.23% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Equity settled financial derivative liability – October 2019 warrants | – | Black-Scholes Model | Volatility rate of 100.0% determined using historical volatility of comparable companies. | The higher the volatility the higher the fair value. | | | | | Expected life between a range of 0.1 and 1.50 years determined using the remaining life of the warrant. | The shorter the expected life the lower the fair value. | | | | | Risk-free rate of 4.51% determined using the expected life assumptions. | The higher the risk-free rate the higher the fair value. | | Total | 4,160,000 | | | |

All values are in British Pounds.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- |

Changing the unobservable risk-free rate input to the valuation model by 10% higher while all other variables were held constant, would not impact the carrying amount of warrants (2024: nil; 2023: nil).

There were no transfers between Level 1 and 2 in the period.

The financial liability measured at fair value at 31 December 2025 on Level 3 fair value measurement represents consideration relating to warrants issued in December 2025, July 2024, May 2024, December 2023 and May 2023 as part of Registered Direct offerings and private placement.

Credit risk

The Group is exposed to credit risk from amounts due from collaborative partners and from cash and cash equivalents and deposits with banks and financial institutions. The risk from collaborative partners is deemed to be low. For banks and financial institutions, only independently rated parties with high credit status are accepted. The Group does not enter into derivatives to manage credit risk. The gross carrying amount of a financial asset is written off (either partially or in full) to the extent that there is no realistic prospect of recovery.

The total exposure to credit risk of the Group is equal to the total value of the financial assets held at each year end as noted above.

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20	Financial instruments<br>– risk management (continued)

Foreign exchange risk

The group operates internationally although its operations are based in the United Kingdom. The group incorporated subsidiaries in the United Sate of America and the Republic of Ireland during the year, there were minimal transactions in these entities during 2025.

The group assets and liabilities are predominately denominated in Pounds Sterling and US Dollar. The Group retains cash balances in US Dollars as a hedge against these liabilities. The assets and liabilities associated with the Joint Arrangement with Emtora, as disclosed in note 1, are held in US dollars as the majority of operations under the arrangement are undertaken in the US.

The group is exposed to foreign exchange risk arising from exposure to various currencies primarily the US Dollar and Euro.

The table below shows analysis of the Pounds Sterling equivalent of year-end cash and cash equivalent balances by currency:

Schedule of foreign exchange risk
	2025 ’000	2024 ’000	2023 ’000
Cash and cash equivalents:
Pounds Sterling
US Dollar
Other
Total

All values are in British Pounds.

Foreign exchange risk also arises when individual Group entities enter into transactions denominated in a currency other than their functional currency, the Group’s transactions outside the UK to the US and Europe drive foreign exchange movements where suppliers invoice in currency other than sterling. The Group does retain some cash balances in US Dollars from its US Dollar denominated equity raises to reduce the foreign exchange exposure on US$ denominated suppliers related to its NASDAQ listing and US based clinical trial. All other assets and/or consumables that are purchased in foreign currencies, such currency is purchased immediately upon invoice. These transactions are not hedged because the cost of doing so is disproportionate to the risk.

Foreign currency sensitivity analysis

The most significant currencies in which the Group transacts, other than Pounds Sterling, are the US Dollar and the Euro. The Group also trades in other currencies in small amounts as necessary.

The following table details the Group’s sensitivity to a 10% change in year-end exchange rates, which the Group feels is the maximum likely change in rate based upon recent currency movements, in the key foreign currency exchange rates against Pounds Sterling:

Schedule of foreign currency exchange rates
Year ended 31 December 2025	US Dollar ’000	Euro ’000	Other ’000
Loss before tax
Total equity

All values are in British Pounds.

Year ended 31 December 2024	US Dollar ’000	Euro ’000	Other ’000
Loss before tax				)
Total equity				)

All values are in British Pounds.

Year ended 31 December 2023	US Dollar ’000	Euro ’000	Other ’000
Loss before tax
Total equity

All values are in British Pounds.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- |

Liquidity risk

Liquidity risk arises from the Group’s management of working capital. It is the risk that the Group will encounter difficulty in meeting its financial obligations as they fall due. It is the Group’s aim to settle balances as they become due.

During 2025 the Company utilised its Equity Line of Credit (“ELOC”)

to raise gross proceeds of $8.92 million before expenses. In May 2025, the Company completed a Warrant Inducement which raised £47,000. In December 2025, the Company completed a Registered Offering in the US which raised $10 million before expenses.

In December 2024 the Company issued a Promissory Note as detailed in

Note 17 for the principle amount of $600,000. The Company received $540,000 on 24 December 2024 as the note was issued at a 10% discount. The Promissory Note was repaid in full during 2025.

In May 2024, the Company completed a Warrant Inducement which raised

£4.8 million before expenses. In July 2024, the Company completed a Registered Direct Offering in the US which raised £3.9 million before expenses. During the year warrants previously issued were exercised resulting in the Company receiving £0.4 million.

In February 2023, the Company completed a Private Placement in the

US which raised £5.0 million before expenses. In May 2023, the Company completed a Registered Direct Offering in the US which raised £2.7 million before expenses. In December 2023, the Company completed a Registered Offering in the US which raised £4.4 million before expenses.

The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required before Q4 2025 assuming, inter alia, that certain development programs and other operating activities continue as currently planned.

Pursuant to its $35 million Equity Line of Credit, or ELOC, as described above, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price for up to 36 months from the Commencement Date. There is no guarantee that the Company will be able to use the ELOC or raise from other financing to the extent necessary to finance the Company’s operations. As at 31 December 2025 $26.08 million remains undrawn from the ELOC.

In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful.

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| --- | | 20 | Financial instruments – risk management (continued) | | --- | --- |

The following table sets out the contractual maturities (representing undiscounted contractual cash-flows) of financial liabilities:

Schedule of contractual maturities of financial liabilities
2025	Up to 3 months ’000	Between 3 and 12 months ’000	Between 1 and 2 years ’000	Between 2 and 5 years ’000	Over 5 years ’000
Trade and other payables
Deferred considerations
Promissory note
Lease liabilities
Total

All values are in British Pounds.

2024	Up to 3 months ’000	Between 3 and 12 months ’000	Between 1 and 2 years ’000	Between 2 and 5 years ’000	Over 5 years ’000
Trade and other payables
Deferred considerations
Promissory note
Lease liabilities
Total

All values are in British Pounds.

2023	Up to 3 months ’000	Between 3 and 12 months ’000	Between 1 and 2 years ’000	Between 2 and 5 years ’000	Over 5 years ’000
Trade and other payables
Lease liabilities
Total

All values are in British Pounds.

More details with regard to the line items above are included in the respective notes:

·	Trade and other payables<br> – note 15
·	Deferred consideration<br> – note 16
---	---
·	Borrowings – note 17
---	---

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20	Financial instruments<br>– risk management (continued)

Capital risk management

The Group monitors capital which comprises all components of equity (i.e. share capital, share premium, foreign exchange reserve and accumulated deficit).

The Group’s objectives when maintaining capital are:

·	to safeguard the entity’s ability to continue as a going concern; and
·	to have sufficient resource to take development projects forward towards commercialisation.
---	---

The Group continues to incur substantial operating expenses. Until the Group generates positive net cash inflows from the commercialisation of its products it remains dependent upon additional funding through the injection of equity capital and government funding. The Group may not be able to generate positive net cash inflows in the future or to attract such additional required funding at all, or on suitable terms. In such circumstances the development programmes may be delayed or cancelled, and business operations cut back.

The Group seeks to reduce this risk by keeping a tight control on expenditure, avoiding long term supplier contracts (other than clinical trials), prioritising development spend on products closest to potential revenue generation, obtaining government grants (where applicable), maintaining a focussed portfolio of products under development and keeping shareholders informed of progress.

There have been no changes to the Group’s processes for managing capital risk since the previous year.

21	Deferred tax

Deferred tax is calculated in full on temporary differences under the liability method using tax rates applicable in the tax jurisdictions where the tax asset or liability would arise.

The movement on the deferred tax account in 2025 is £nil (2024: £nil, 2023: £nil) as the net credit arising on the amortisation of intangible assets and other timing differences has been matched by a reduction in the deferred tax asset recognised on the losses offsetting the liability remaining.

Unused tax losses carried forward, subject to agreement with local tax authorities, were as follows:

Schedule of unused tax losses carried forward
	Gross losses ’000	Potential deferred tax asset ’000
31 December 2025
31 December 2024
31 December 2023

All values are in British Pounds.

The potential deferred tax asset of £20.5 million (2024: £19.9

million, 2023: £18.9 million) has not been provided in these accounts due to uncertainty as to whether the asset would be recovered. The losses have arisen as a result of accumulated trading losses.

Deferred tax asset balances disclosed as at 31 December 2025 have been calculated at 25%. The main rate of corporation tax increased to 25% from 1 April 2023.

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| --- | | 22 | Share capital | | --- | --- | | Schedule of detailed information about share capital | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Authorised, allotted and fully paid – classified as equity | | 2025 | 2024 Number | | 2024 | 2023 Number | | 2023 | | At 31 December | | | | | | | | | | Ordinary shares of 0.000001 each | 225,817,808,922 | | | 6,685,918,922 | | | 1,189,577,722 | | | ‘A’ Deferred shares of 1 each | 1,000,001 | | | 1,000,001 | | | 1,000,001 | | | ‘B’ Deferred shares of 0.001 each | 4,063,321,418 | | | 4,063,321,418 | | | 4,063,321,418 | | | ‘C’ Deferred shares of 0.00005 each | 126,547,389,518 | | | 126,547,389,518 | | | – | | | ‘D’ Deferred shares of 0.000001 each | 2,482,747,137,178 | | | – | | | – | | | Total | | | | | | | | |

All values are in British Pounds.

At a General Meeting on 11 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless.

On 31 July 2025 the Company effected a ratio change in the number of Ordinary Shares represented by ADSs from 10,000 Ordinary Shares per ADS to 100,000 Ordinary Shares per ADS.

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| --- | | 22 | Share capital (continued) | | --- | --- |

During the year the Company issued the following warrants over ADSs, and these were recognised in the warrant reserve until exercise:

Schedule of warrant reserve recognize
	Pre-Funded <br> Warrants
As at 1 January 2025		1,773
Issued:
December 2025 Registered Offering		2,891,781
Exercised		(1,419,391	)
Lapsed		(33	)
As at 31 December 2025		1,474,130

Numbers of warrants and related exercise prices are after the impact of the ADS ratio changes on 31 July 2025.

In accordance with the Articles of Association for the Company adopted on 11 June 2025, the share capital of the Company consists of an unlimited number of ordinary shares of nominal value £0.000001 each. Ordinary and deferred shares were recorded as equity.

Rights attaching to the shares following the incorporation of Biodexa Pharmaceuticals plc

Shares classified as equity

The holders of ordinary shares in the capital of the Company have the following rights:

(a) to receive notice of, to attend and to vote at all general meetings of the Company, in which case shareholders shall have one vote for each share of which he is the holder; and,

(b) to receive such dividend as is declared by the Board on each share held.

The holders of both classes of deferred shares in the capital of the Company:

(a) shall not be entitled to receive notice of or to attend or speak at any general meeting of the Company or to vote on any resolution to be proposed at any general meeting of the Company; and

(b) shall not be entitled to receive any dividend or other distribution of out of the profits of the Company.

In the event of a distribution of assets, the deferred shareholders shall receive the nominal amount paid up on such share after the holder of each ordinary share shall have received (in cash or specie) the amount paid up or credited as paid up on such ordinary share together with an additional payment of £100 per share. The Company has the authority to purchase the deferred shares and may require the holder of the deferred shares to sell them for a price not exceeding 1p for all the deferred shares.

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22	Share capital (continued)
Schedule of ordinary and deferred shares
---	---	---	---	---	---	---	---	---	---	---	---	---
		Ordinary Shares<br> Number		‘A’ Deferred <br> Shares<br> Number		‘B’ Deferred <br> Shares<br> Number		‘C’ Deferred <br> Shares<br> Number		‘D’ Deferred <br> Share Number		Nominal value
At 1 January 2023			5,417,137		1,000,001
15 February 2023	Private Placement*		98,387,275		–		–		–		–
26 May 2023	Registered Direct Offering*		276,697,310		–		–		–		–
14 June 2023	Share sub-division and <br>re-designation				–		4,063,321,418		–		–
21 December 2023	Shares issued on purchase <br>Intangible asset (see note 11)		323,684,800		–		–		–		–
21 December 2023	Registered Offering		485,391,200		–		–		–		–
At 31 December 2023			1,189,577,722		1,000,001		4,063,321,418
25 April 2024	Shares issued on purchase <br>Intangible asset (see note 11)		151,265,200		–		–		–		–
22 May 2024	Warrant inducement		1,614,435,600		–		–		–		–
22 July 2024	Registered Direct Offering		2,129,516,800		–		–		–		–
February - October 2024	Exercise pre-funded warrants		1,502,426,000		–		–		–		–
February - May 2024	Exercise Series E & Series F warrants		98,697,600		–		–		–		–
22 November 2024	Share sub-division and <br>re-designation				–		–		126,547,389,518		–
At 31 December 2024			6,685,918,922		1,000,001		4,063,321,418		126,547,389,518
15 May 2025	Warrant inducement		2,004,330,000
11 June 2025	Share sub-division and <br>re-designation										2,482,747,137,178
	Shares issued under ELOC		59,488,460,000
19 December 2025	Registered Offering		157,639,100,000
At 31 December 2025			225,817,808,922		1,000,001		4,063,321,418		126,547,389,518		2,482,747,137,178

All values are in British Pounds.

*	Number of shares issued includes exercise of pre-funded warrants and Series A, Series B and Series C warrants that were exercisable on an ‘alternative cashless basis’.

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| --- | | 23 | Reserves | | --- | --- |

The following describes the nature and purpose of each reserve within equity:

Schedule of reserves
Reserve	Description and purpose
Share capital	Nominal value of subscribed share capital
Share premium	Amount subscribed for share capital in excess of nominal value.
Merger reserve	Represents the difference between the fair value and nominal value of shares issued on the acquisition of subsidiary companies where the Company has elected to take advantage of merger accounting.
Foreign exchange reserve	Gains/losses arising on retranslating the net assets of overseas operations into sterling
Warrant reserve	Represents the following:<br><br><br> <br>· the fair value of warrants denominated in £ at the date of grant. The number and price are fixed at the date of grant. The warrants expired in November 2025.<br><br> <br>· the fair value of pre-funded warrants granted. The pre-funded warrants do not have an expiry date.<br><br> <br>· The fair value of Series C warrants denominated in US$ at the date of grant but allow for the warrants to be exercised on an alternative cashless basis effectively allowing the holders to exercise for nil consideration.
Accumulated deficit	All other net gains and losses and transactions with owners (e.g., dividends) not recognised elsewhere.
24	Retirement<br>benefits
---	---

The Group operates a defined contribution pension scheme for the benefit

of its employees. The assets of the scheme are administered by trustees in funds independent from those of the Group. The annual charge for the year was £69,000 (2024: £67,000)

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25	Share-based payments

Share Options

The Group has issued options over ordinary shares under the 2014 Biodexa Pharmaceuticals PLC Enterprise Management Incentive Scheme and unapproved share options awarded to non-UK staff and Directors. In addition, certain share options originally issued over shares in Biodexa Limited under the Biodexa Limited 2008 unapproved share option scheme or Biodexa Limited 2013 approved Enterprise Incentive scheme were reissued in 2015 over shares in Biodexa Pharmaceuticals PLC under the 2014 Biodexa Pharmaceuticals PLC Enterprise Management Incentive Scheme, all remaining re-issued share options lapsed during 2024. Exercise of an option is subject to continued employment.

At a General Meeting on 11 June 2024, shareholders approved a share sub-division and re-designation of the Company’s Ordinary Shares. As a result, the par value of the Ordinary Shares was changed from £0.00005 per share to £0.000001 per share.

Details of all share options granted under the Schemes are set out below:

Details of all share options granted under the schemes are set out below
Date of grant	At 1 January <br> 2025		Granted in 2025		Lapsed in 2025		Forfeited in <br> 2025			At <br> 31 December <br> 2025		Exercise <br> Price
19 December 2016		13		–		–		–			13	£	484.00
15 December 2017		38		–		–		–			38	£	184.00
24 April 2019		237		–		–		–			237	£	29.20
2 October 2019		1,500		–		–		–			1,500	£	21.00
17 April 2020		5,000		–		–		–			5,000	£	4.80
17 June 2020		26,450		–		–		–			26,450	£	4.04
15 July 2021		40,850		–		–		(600	)		40,250	£	5.55
1 September 2021		6,000		–		–		–			6,000	£	5.10
7 February 2022		12,500		–		–		–			12,500	£	3.05
23 January 2024		144,000,000		–		–		–			144,000,000	£	0.004
10 February 2024		98,808,800		–		–		(15,752,000	)		83,056,800	£	0.003
10 July 2024		85,922,000		–		–		–			85,922,000	£	0.003
		328,823,388		–		–		(15,752,600	)		313,070,788
Options exercisable at 31 December 2025		137,022,409
---	---	---
Weighted average exercise price of outstanding options at 31 December 2025	£	0.005
Weighted average exercise price of options exercised in 2025		–
Weighted average exercise price of options lapsed in 2025		–
Weighted average exercise price of options forfeited in 2025	£	0.003
Weighted average exercise price of options granted in 2025		–
Weighted average remaining contractual life of outstanding options at 31 December 2025		8.2 years

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| --- | | 25 | Share-based payments (continued) | | --- | --- | | Date of grant | At 1 January 2024 | | Granted in 2024 | | Lapsed in 2024 | | | Forfeited in 2024 | | | At 31 December 2024 | | Exercise Price | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 30 June 2014 | | 25 | | – | | (25 | ) | | – | | | – | £ | 30.00 | | 19 December 2016 | | 13 | | – | | – | | | – | | | 13 | £ | 484.00 | | 15 December 2017 | | 40 | | – | | – | | | (2 | ) | | 38 | £ | 184.00 | | 24 April 2019 | | 312 | | – | | – | | | (75 | ) | | 237 | £ | 29.20 | | 2 October 2019 | | 1,500 | | – | | – | | | – | | | 1,500 | £ | 21.00 | | 17 April 2020 | | 5,000 | | – | | – | | | – | | | 5,000 | £ | 4.80 | | 17 June 2020 | | 27,350 | | – | | | | | (900 | ) | | 26,450 | £ | 4.04 | | 15 July 2021 | | 58,850 | | – | | – | | | (18,000 | ) | | 40,850 | £ | 5.55 | | 1 September 2021 | | 6,000 | | | | | | | – | | | 6,000 | £ | 5.10 | | 7 February 2022 | | 12,500 | | – | | – | | | – | | | 12,500 | £ | 3.05 | | 23 January 2024 | | – | | 144,000,000 | | – | | | – | | | 144,000,000 | £ | 0.004 | | 10 February 2024 | | – | | 130,313,200 | | – | | | (31,504,400 | ) | | 98,808,800 | £ | 0.003 | | 10 July 2024 | | – | | 85,922,000 | | – | | | – | | | 85,922,000 | £ | 0.003 | | | | 111,590 | | 360,235,200 | | (25 | ) | | (31,523,377 | | | 328,823,388 | | | | Options exercisable at 31 December 2024 | | 82,874 | | --- | --- | --- | | Weighted average exercise price of outstanding options at 31 December 2024 | £ | 0.005 | | Weighted average exercise price of options exercised in 2024 | | – | | Weighted average exercise price of options lapsed in 2024 | £ | 30.00 | | Weighted average exercise price of options forfeited in 2024 | £ | 0.006 | | Weighted average exercise price of options granted in 2024 | £ | 0.003 | | Weighted average remaining contractual life of outstanding options at 31 December 2024 | | 9.2 years |

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| --- | | 25 | Share-based payments (continued) | | --- | --- | | Date of grant | At 1 January 2023 | | Granted in 2023 | | Lapsed in 2023 | | | Forfeited in 2023 | | | At 31 December 2023 | | Exercise Price | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 30 June 2014 | | 25 | | – | | – | | | – | | | 25 | £ | 30.00 | | 19 December 2016 | | 13 | | – | | – | | | – | | | 13 | £ | 484.00 | | 15 December 2017 | | 40 | | – | | – | | | – | | | 40 | £ | 184.00 | | 24 April 2019 | | 312 | | – | | – | | | – | | | 312 | £ | 29.20 | | 2 October 2019 | | 1,500 | | – | | – | | | – | | | 1,500 | £ | 21.00 | | 17 April 2020 | | 5,000 | | – | | – | | | – | | | 5,000 | £ | 4.80 | | 17 June 2020 | | 33,600 | | – | | (6,250 | ) | | – | | | 27,350 | £ | 4.04 | | 15 July 2021 | | 64,350 | | – | | – | | | (5,500 | ) | | 58,850 | £ | 5.55 | | 2 August 2021 | | 2,500 | | – | | – | | | (2,500 | ) | | – | £ | 5.30 | | 1 September 2021 | | 6,000 | | – | | – | | | – | | | 6,000 | £ | 5.10 | | 7 February 2022 | | 18,750 | | – | | – | | | (6,250 | ) | | 12,500 | £ | 3.05 | | 12 August 2022 | | 12,500 | | – | | – | | | (12,500 | ) | | – | £ | 2.10 | | | | 144,590 | | – | | (6,250 | ) | | (26,750 | ) | | 111,590 | | | | Options exercisable at 31 December 2023 | | 75,720 | | --- | --- | --- | | Weighted average exercise price of outstanding options at 31 December 2023 | £ | 5.241 | | Weighted average exercise price of options exercised in 2023 | | – | | Weighted average exercise price of options lapsed in 2023 | £ | 4.04 | | Weighted average exercise price of options forfeited in 2023 | £ | 3.33 | | Weighted average exercise price of options granted in 2023 | | – | | Weighted average remaining contractual life of outstanding options at 31 December 2023 | | 7.3 years |

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| --- | | 25 | Share-based payments (continued) | | --- | --- |

The following information is relevant in the determination of the fair value of options granted during the year 2024 under the equity share based remuneration schemes operated by the Group.

Schedule of fair value of options granted
	January 2024			February 2024			July 2024
Number of options		144,000,000			130,313,200			85,922,000
Option pricing models used		Black-Scholes			Black-Scholes			Black-Scholes
Share price	$	1.90		$	1.310		£	0.00139
Exercise price of options issued in year	$	1.90		$	1.310		£	0.00259
Contractual life		10 years			10 years			10 years
Expected life		4 years			4 years			4 years
Volatility		100.0	%**		100.0	%**		110.0	%**
Expected dividend yield		0	%		0	%		0	%
Risk free rate		4.110	%		4.195	%		4.025	%

The share price used in the determination of the fair value of the options granted in 2024 was the share price on the date of grant.

**	Volatility was calculated with reference to the historic share price volatility of comparable companies measured over a four-year period.

Share Incentive Plan

In April 2017 the Group set up the Biodexa Pharmaceuticals Share Incentive Plan (MPSIP). Under the BPSIP, Group employees and Directors can acquire ordinary shares in the Company via a salary sacrifice arrangement. Biodexa grants matching shares for every share bought. In order to retain these shares, scheme participants must remain employed by the Group for three years from the date of acquisition. All shares purchased by the BPSIP are held by an Employee Benefit Trust that is not under the control of Biodexa. Shares must be left in the plan for 5 years to qualify for full income tax and NIC relief.

On 24 April 2023 the Company terminated the Trust and requested the Trustees distribute the assets of the Trust to the relevant Group employees.

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| --- | | 25 | Share-based payments (continued) | | --- | --- |

Warrants issued in lieu of fees

The Company issues warrants over ADSs to certain its brokers in lieu of broker fees connected to the equity transactions in the year. The warrants are accounted for as share based payments.

Schedule of warrants are accounted for as share based payments
Date of grant	At 1 January <br> 2025		Granted in 2025		Lapsed in 2025		Forfeited in <br> 2025		At <br> 31 December <br> 2025		Exercise <br> Price per ADS
24 March 2023		5		–		–		–		5	$	58,000.00
14 June 2023		44		–		–		–		44	$	3,750.00
21 December 2023		480		–		–		–		480	$	625.00
24 May 2024		644		–		–		–		644	$	625.00
22 July 2024		851		–		–		–		851	$	312.50
19 December 2025		–		152,439		–		–		152,439	$	3.28
		2,024		152,439		–		–		154,463
Warrants exercisable at 31 December 2025		154,463
---	---	---
Weighted average exercise price of outstanding options at 31 December 2025	$	12.458
Weighted average exercise price of options exercised in 2025		–
Weighted average exercise price of options lapsed in 2025		–
Weighted average exercise price of options forfeited in 2025		–
Weighted average exercise price of options granted in 2025	$	3.28
Weighted average remaining contractual life of outstanding options at 31 December 2025		4.9 years

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25	Share-based payments (continued)
Date of grant	At 1 January <br> 2024		Granted in 2024		Lapsed in 2024		Forfeited in <br> 2024		At <br> 31 December <br> 2024		Exercise <br> Price per ADS
---	---	---	---	---	---	---	---	---	---	---	---	---
24 March 2023		5		–		–		–		5	$	58,000.00
14 June 2023		44		–		–		–		44	$	3,750.00
21 December 2023		480		–		–		–		480	$	625.00
24 May 2024		–		644		–		–		644	$	625.00
22 July 2024		–		851		–		–		851	$	312.50
		529		1,495		–		–		2,024
Warrants exercisable at 31 December 2024		2,024
---	---	---
Weighted average exercise price of outstanding options at 31 December 2024	$	703.28
Weighted average exercise price of options exercised in 2024		–
Weighted average exercise price of options lapsed in 2024		–
Weighted average exercise price of options forfeited in 2024		–
Weighted average exercise price of options granted in 2024	$	447.12
Weighted average remaining contractual life of outstanding options at 31 December 2024		2.2 years
Date of grant	At 1 January <br> 2023		Granted in 2023		Lapsed in 2023		Forfeited in <br> 2023		At <br> 31 December <br> 2023		Exercise <br> Price per ADS
---	---	---	---	---	---	---	---	---	---	---	---	---
24 March 2023		–		5		–		–		5	$	58,000.00
14 June 2023		–		44		–		–		44	$	3,750.00
21 December 2023		–		480		–		–		480	$	625.00
		–		529		–		–		529
Warrants exercisable at 31 December 2023		529
---	---	---
Weighted average exercise price of outstanding options at 31 December 2023	$	1,427.22
Weighted average exercise price of options exercised in 2023		–
Weighted average exercise price of options lapsed in 2023		–
Weighted average exercise price of options forfeited in 2023		–
Weighted average exercise price of options granted in 2023	$	1,427.22
Weighted average remaining contractual life of outstanding options at 31 December 2023		2.2 years

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25	Share-based payments (continued)

The following information is relevant in the determination of the fair value of warrants granted during the year 2025.

Schedule of fair value of warrants granted
	December 2025
Number of ADS warrants granted		152,439
Option pricing models used		Black-Scholes
Share price	$	3.640
Exercise price of warrants issued in year	$	3.280
Contractual life		5 years
Expected life		5 years
Volatility		110	%**
Expected dividend yield		0	%
Risk free rate		3.70	%
*	The share price used in the determination of the fair value of the ADS warrants granted in 2025 was the ADS price on the date of grant.
---	---
**	Volatility was calculated with reference to the historic share price volatility of comparable companies measured over a three-year period.

The following information is relevant in the determination of the fair value of warrants granted during the year 2024.

	May 2024			July 2024
Number of ADS warrants granted		644			851
Option pricing models used		Black-Scholes			Black-Scholes
Share price	$	325.00		$	198.50
Exercise price of warrants issued in year	$	625.00		$	312.50
Contractual life		3 years			3 years
Expected life		3 years			3 years
Volatility		115	%**		115	%**
Expected dividend yield		0	%		0	%
Risk free rate		4.71	%		4.29	%
*	The share price used in the determination of the fair value of the ADS warrants granted in 2024 was the ADS price on the date of grant.
---	---
**	Volatility was calculated with reference to the historic share price volatility of comparable companies measured over a three-year period.

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| --- | | 25 | Share-based payments (continued) | | --- | --- |

The following information is relevant in the determination of the fair value of warrants granted during the year 2023.

	March 2023			June 2023			December 2023
Number of ADS warrants granted		5			44			480
Option pricing models used		Black-Scholes			Black-Scholes			Black-Scholes
Share price	$	50,400.00	*	$	2,635.00	*	$	632.50
Exercise price of warrants issued in year	$	58,000.00		$	3,750.00		$	625.00
Contractual life		3 years			3 years			3 years
Expected life		3 years			3 years			3 years
Volatility		75.00	%**		80.00	%**		60	%**
Expected dividend yield		0	%		0	%		0	%
Risk free rate		4.35	%		4.04	%		4.06	%
*	The share price used in the determination of the fair value of the ADS warrants granted in 2023 was the ADS price on the date of grant.
---	---
**	Volatility was calculated with reference to the historic share price volatility of comparable companies measured over a three-year period.

Number and original price of warrants have been adjusted to reflect the ratio change of ADS’s to ordinary shares that occurred on 5 July 2023, 4 October 2024 and 31 July 2025.

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| --- | | 26 | Capital commitments | | --- | --- |

The Group had no capital commitments at 31 December 2025, 31 December 2024 and 31 December 2023.

27	Related party transactions

There were no related party transactions in the current or prior periods other than Directors’ remuneration.

28	Contingent liabilities

The Company entered into an Arrangement

Agreement with Bioasis on 13 December 2022 as amended on 18 December 2022. Under the agreement the Company agreed to acquire the entire issued share capital of Bioasis for consideration of, in aggregate, approximately C$7.4 million (c£4.4 million). The agreement was subject to shareholder approval. On January 23, 2023 at the General Meeting to approve the Arrangement Agreement none of the special resolutions were passed and, accordingly, the acquisition of Bioasis did not proceed. Under the agreement the Company agreed to reimburse Bioasis US$225,000 for expenses relating to the transaction should the Company’s shareholders not approve the transaction. On March 3, 2023 the Company advised Bioasis that it would offset this liability against the $500,000 loan it advanced to them during December 2022 and January 2023.

As at 31 December 2023 the Company

had a contingent liability of $225,000 in relation to this potential liability. As at 31 December 2025 and 31 December 2024 the Company no longer believes it has a contingent liability.

29	Ultimate controlling party

The Directors do not consider that there is an ultimate controlling party.

30	Post Balance Sheet Events

On February 4, 2026, the Company announced that it had entered into a license and collaboration agreement (the “License Agreement”) with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), pursuant to which Otsuka granted the Company an exclusive, worldwide (excluding Japan) license (the “Licensed Territory”) to develop manufacture and commercialize OPB-171755, to be designated MTX240 (“MTX240”), a Phase 1-ready molecular glue therapeutic candidate, for all human therapeutic uses. The Company intends to initially develop MTX240 for the treatment of gastrointestinal stromal tumors.

Pursuant to the License Agreement, the Company will be responsible for all development, manufacturing and commercialization activities for MTX240 in the Licensed Territory, and Otsuka will retain all rights to MTX240 in Japan. As consideration for the license, the Company made an upfront payment to Otsuka, and Otsuka is eligible to receive one-time development and regulatory milestones, as well as tiered royalties in the mid-single digits on the net sales of licensed products. The Company is also obligated to pay Otsuka a percentage of any sublicense income it receives, subject to certain exceptions.

F-64

Exhibit 2.1

DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION12 OF THE EXCHANGE ACT

The following description of the securitiesregistered under Section 12 of the Securities Exchange Act of 1934, as amended of Biodexa Pharmaceutucals PLC (“Biodexa,”“we,” “us,” “our” or the “Company”) is a summary of the rights of our issued share capitaland certain provisions of our articles of association. This summary does not purport to be complete and is qualified in its entirety bythe provisions of our articles of association previously filed with the Securities and Exchange Commission, as well as to the applicableprovisions of the corporate law of the United Kingdom.

Capitalized terms used but not defined hereinshall have the meaning set forth in our Annual Report on Form 20-F for the fiscal year ended December 31, 2025.

General

We are a public limited company organized under the laws of England and Wales under registered number 09216368. Our registered office is 1 Caspian Point, Caspian Way, Cardiff, CF10 4DQ, United Kingdom. The principal legislation under which we operate and our shares are issued is the Companies Act.

Our issued share capital as of March 12, 2026 was 324,156,808,922 Ordinary Shares, with each Ordinary Share having a nominal value of £0.000001 per share. Each issued Ordinary Share is fully paid. We currently have 1,000,001 A deferred shares, 4,063,321,418 B deferred shares, 126,547,389,518 C deferred shares, and 2,482,747,137,178 D deferred shares.

There is no limit to the number of Ordinary Shares that we are authorized to issue, as the concept of authorized capital is no longer applicable under the provisions of the Companies Act. There are no conversion rights, redemption provisions or sinking fund provisions relating to any Ordinary Shares.

We are not permitted under English law to hold our own Ordinary Shares unless they are repurchased by us and held in treasury. We do not currently hold any of our own Ordinary Shares.

History of Share Capital

Since January 1, 2023, our issued share capital has changed as provided below.

On February 15, 2023, we completed the closing of a private placement, or the February Private Placement, pursuant to which we sold to certain institutional investors (1) 3,250,000 Ordinary Shares represented by 32 Depositary Shares at $46,400.00 per Depositary Share, (2) 12,931,020 Ordinary Shares represented by 129 Depositary Shares, issuable upon the exercise of Series A warrants, or Series A Warrants, issued in the February Private Placement at an exercise price of $53,600.00 per warrant, (3) 19,396,400 Ordinary Shares represented by 193 Depositary Shares, issuable upon the exercise of Series B warrants, or Series B Warrants, issued in the February Private Placement at an exercise price of $55,360.00 per warrant, and (4) 62,184,525 Ordinary Shares represented by 621 Depositary Shares, issuable upon the exercise of pre-funded warrants issued in the February Private Placement at an exercise price of $8.00 per warrant, for aggregate gross proceeds of approximately $6.0 million. We also issued unregistered warrants to the placement agent in the offering, or the February Placement Agent Warrants, to purchase a total of 500,000 Ordinary Shares represented by five Depositary Shares to the placement agent at an exercise price of $58,000.00 per warrant, and Series A Warrants to purchase 625,000 Ordinary Shares represented by Depositary Shares at an exercise price of $53,600.00 per warrant to an investor pursuant to a waiver.

On March 27, 2023, following shareholder approval at a general meeting, we effected a one-for-20 reverse stock split of our Ordinary Shares, and our Ordinary Shares began trading on AIM on a split-adjusted basis as of such date. No fractional shares were issued in connection with the reverse stock split.

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Concurrently with the reverse stock split, and in an effort to bring the Depositary Shares price into compliance with NASDAQ’s minimum requirement for 500,000 listed Depositary Shares, on March 27, 2023, we effected a ratio change in the number of our Ordinary Shares represented by the Depositary Shares from 25 Ordinary Shares per Depositary Share to five Ordinary Shares per Depositary Share. No fractional Depositary Shares were issued.

Since the date of issuance, we have issued 95,137,075 Ordinary Shares upon the exercise of pre-funded warrants, Series A Warrants and Series B Warrants issued in the February Private Placement.

On May 26, 2023, we completed the closing of a registered direct offering with institutional investors of (1) 166,017,700 Ordinary Shares represented by 1,660 Depositary Shares, issuable upon the exercise of the Series C warrants, or Series C Warrants, at an exercise price of $4,000.00 per warrant, (2) 110,675,600 Ordinary Shares represented by 1,098 Depositary Shares issuable upon the exercise of the Series D warrants, or Series D Warrants, at an exercise price of $4,000.00 per warrant and, (3) 4,426,800 Ordinary Shares represented by 44 Depositary Shares issuable upon the exercise of warrants issued to the placement agent in the offering at an exercise price of $3,750.00 per warrant, or May 2023 Placement Agent Warrants.

On June 14, 2023, we held our June AGM, and our shareholders passed resolutions, among other procedural items, to approve the allotment of, and disapplication of pre-emption rights in respect of, up to 7.0 billion Ordinary Shares. On June 14, 2023, we also held the separate June GM, and our shareholders passed resolutions to, among other things, (i) re-designate our deferred shares into A Deferred Shares, and (ii) subdivide our Ordinary Shares of £0.02 nominal value each into one Ordinary Share of £0.001 nominal value and 19 B Deferred Shares of £0.001 nominal value each.

On June 20, 2023, we issued the Series C Warrants, Series D Warrants and May 2023 Placement Agent Warrants after receiving required shareholder approval of the allotment of, and disapplication of pre-emption rights with respect to the Ordinary Shares to be issued under the warrants at the June GM.

Since the date of issuance, we have issued 166,017,700 Ordinary Shares upon the exercise of Series C Warrants issued in the May 2023 registered direct offering.

On July 5, 2023, we effected a ratio change to the Depositary Shares, pursuant to which the ratio of Ordinary Shares to Depositary Shares was changed such that one Depositary Share represented 400 Ordinary Shares. Our Ordinary Shares were not affected by this change and no fractional Depositary Shares were issued.

On November 22, 2023, we entered into a series of agreements with (1) Adhera Therapeutics, Inc. and certain of its secured noteholders, or the Secured Noteholders, and (1) Melior. On December 21, 2023, in connection with the closing under the agreements, we issued (A) an aggregate of (i) 899 Depositary Shares to certain of the Secured Noteholders and (ii) 9,098 pre-funded warrants to purchase Depositary Shares to certain of the Secured Noteholders, or the December 2023 Private Placement Pre-Funded Warrants, and (B) 1,417 Depositary Shares to Melior. Between December 21, 2023 and April 1, 2025, we have issued 738,002,400 Ordinary Shares upon the exercise of December 2024 Private Placement Pre-Funded Warrants issued to the Secured Noteholders.

On December 21, 2023, we completed the closing of an underwritten public offering, pursuant to which we issued and sold (i) 4,355 Class A units, or Class A Units, at a public offering price of $500.00 per Class A Unit, with each Class A Unit consisting of (a) one Depositary Share, (b) one Series E Warrant, and (c) one Series F Warrant, and (ii) 7,644 Class B units, or Class B Units, at a public offering price of $269.999 per Class B Unit, with each Class B Unit consisting of (a) one pre-funded warrant, exercisable for one Depositary Share, (b) one Series E Warrant, and (c) one Series F Warrant. The aggregate gross proceeds to the Company were approximately $6.0 million. Additionally, we issued warrants to purchase 480 of our Depositary Shares in connection with the offering to the underwriter, or the December 2023 Underwriter Warrants.

On February 26, 2024, in connection with our Company’s obligations under a license agreement with Melior, we issued 1,417 Depositary Shares to Bukwang.

On April 29, 2024, in connection with the closing of the Emtora License Agreement, we issued 1,512 Depositary Shares to Emtora.

| 2 |

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On May 24, 2024, in connection with the transactions contemplated by certain warrant inducement letters, or Warrant Agreements, we issued an aggregate of 12,417 Depositary Shares to certain holders of our Series E Warrants and Series F Warrants, upon the exercise of 6,290 Series E Warrants and 6,127 Series F Warrants, at an exercise price of $375.00 per share. In addition, we issued to such holders an aggregate of 9,434 Series G warrants, or the Series G Warrants, and 14,780 Series H Warrants. The aggregate gross proceeds to the Company were approximately $6.05 million, before deducting agent fees and expenses. Additionally, we issued warrants to purchase 644 of our Depositary Shares in connection with the offering to the warrant agent and certain of their designees, or Warrant Agent Warrants.

Since the date of issuance, we have issued 2,952,928,400 Ordinary Shares upon the exercise of the pre-funded warrants, Series E Warrants and Series F Warrants issued in the December 2023 underwritten public offering and private placement, including warrants exercised pursuant to the terms of the Warrant Agreements (other than shares held in abeyance).

On July 22, 2024, we sold in a registered direct offering an aggregate of (i) 20,203 Depositary Shares and (ii) 1,114 pre-funded warrants, or July 2024 Pre-Funded Warrants, at a price per Depositary Share of $235.00, and a price per July 2024 Pre-Funded Warrant of $234.975, and in a concurrent private placement, we issued and sold (x) Series J Warrants, exercisable for 21,315 Depositary Shares, and (y) Series K Warrants, to purchase an aggregate of 21,315 Depositary Shares. The warrants are immediately exercisable at an exercise price of $250.00 per Depositary Share, subject to adjustments for certain dilutive equity issuances. The aggregate gross proceeds to the Company were approximately $5.0 million. Additionally, we issued warrants to purchase 851 of our Depositary Shares in connection with the offering to the placement agent and certain of its designees, or the July 2024 Placement Agent Warrants.

On October 4, 2024, we effected a ratio change to the Depositary Shares, pursuant to which the ratio of Ordinary Shares to Depositary Shares was changed such that one Depositary Share represented 10,000 Ordinary Shares. Our Ordinary Shares were not affected by this change and no fractional Depositary Shares were issued.

On November 22, 2024, we held the November GM and our shareholders passed resolutions to, among other things, subdivide our Ordinary Shares of £0.001 nominal value each into one Ordinary Share of £0.00005 nominal value and 19 C Deferred Shares of £0.00005 nominal value each.

On January 17, 2025, we entered into the ELOC with the Investor, pursuant to which we, subject to the restrictions and satisfaction of the conditions in the ELOC, have the right, but not the obligation, to sell to the Investor, and the Investor is obligated to purchase, up to $35.0 million of newly issued Depositary Shares over a 36-month period, unless the ELOC is terminated in accordance with its terms. As of December 1, 2025, we have sold 57,648,000,000 Ordinary Shares under the ELOC, for gross proceeds of approximately $8.9 million, and issued 1,840,460,000 Ordinary Shares to the Investor in satisfaction of a commitment fee.

On May 15, 2025, we entered into the 2025 Warrant Agreements with certain Holders of our outstanding Series E Warrants, Series H Warrants, Series J Warrants, and Series K Warrants issued in prior transactions, pursuant to which the Holders agreed to exercise certain of such warrants in exchange for a reduction in exercise price of each warrant to $3.10 per share. An aggregate of 20,041 warrants were exercised for aggregate gross proceeds of approximately $62,000, before estimate offering expenses.

Since their respective dates of issuance, we have issued 1,529,030,000 Ordinary Shares upon exercises of the Series H Warrants, Series J Warrants and Series K Warrants, including warrants exercised pursuant to the terms of the Warrant Agreements (other than shares held in abeyance).

On June 11, 2025, we held the June 2025 GM and our shareholders passed resolutions to, among other things, subdivide our Ordinary Shares of £0.00005 nominal value each into one Ordinary Share of £0.000001 nominal value and 49 D Deferred Shares of £0.000001 nominal value each.

On July 31, 2025, we effected a ratio change in the number of Ordinary Shares represented by our Depositary Shares from 10,000 Ordinary Shares per Depositary Share to 100,000 Ordinary Shares per Depositary Share. No fractional Depositary Shares were issued.

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On December 19, 2025, we completed the closing of the December 2025 Offering, pursuant to which we issued and sold (i) an aggregate of (x) 157,000 ADS Units, each ADS Unit consisting of (A) one Depositary Share and (B) two Series L Warrants, at a public offering price of $3.28 per ADS Unit, and (y) 2,891,781 Pre-Funded Units, each Pre-Funded Unit consisting of (A) one December 2025 Pre-Funded Warrant and (b) two Series L Warrants (i) 4,355 Class A units, or Class A Units, at a public offering price of $3.2799 per Pre-Funded Unit. The aggregate gross proceeds to us were approximately $10.0 million. Additionally, we sold warrants to purchase 152,439 of our Depositary Shares in connection with the offering to the placement agent in the offering, or the December 2025 Placement Agent Warrants.

Since the date of issuance, we have issued 98,339,000,000 Ordinary Shares upon exercise of the December 2025 Pre-Funded Warrants.

Options

We have established the Biodexa Pharmaceuticals PLC Enterprise Management Incentive and Unapproved Option Scheme to allow us to grant options to purchase Ordinary Shares (in the form of Depositary Shares) to employees and directors of the Company or any of its subsidiaries for the purpose of attracting, rewarding and retaining such persons. The Plan was originally adopted in December 2014 and amended on April 11, 2024 to govern the grant of tax-advantaged enterprise management incentive stock options and unapproved stock options by the Company. As of December 31, 2025, there were options to purchase 313,070,788 Ordinary Shares. The options lapse after ten years from the date of the grant. As of December 31, 2025, the weighted average remaining life of the options was 8.1 years.

Warrants

Series D Warrants and May 2023 Placement Agent Warrants

The following is a brief summary of the Series D Warrants, and placement agent warrants, or the May 2023 Placement Agent Warrants, issued in connection with our May 2023 registered direct offering, and is subject in all respects to the provisions contained in the applicable warrants, which are filed as exhibits to our Report on Form 6-K dated May 24, 2023. Unless otherwise stated, references to warrants in this subsection include the Series D Warrants and the May 2023 Placement Agent Warrants.

Exercisability. The warrants became exercisable on June 14, 2023. The Series D Warrants and May 2023 Placement Agent Warrants expire five years and three years, respectively from the initial exercise date. The holder shall deliver the aggregate exercise price for the Depositary Shares specified in the exercise notice within two trading days following the date of exercise (subject to the `cashless exercise’ arrangements described below).

Cashless Exercise. The Series D Warrants and May 2023 Placement Agent Warrants may be exercised on a cashless basis, if and only if, we have not filed a registration statement registering the Depositary Shares underlying such warrants within six months of the initial exercise date.

Exercise Price. The exercise price of each Series D Warrant is $4,000.00 per Depositary Share and the exercise price of each May 2023 Placement Agent Warrant is $3,750.00 per Depositary Share.

*Beneficial Ownership Limitation.*A holder shall have no right to exercise any portion of a warrant, to the extent that, after giving effect to such exercise, such holder, together with such holder’s affiliates, and any persons acting as a group together with such holder or any such affiliate, would beneficially own in excess of 9.99% (or in the case of the May 2023 Placement Agent Warrants, 4.99%), of the number of Ordinary Shares outstanding immediately after giving effect to the issuance of the Ordinary Shares underlying the Depositary Shares upon such exercise. The holder of the warrant, upon notice to us, may increase or decrease the beneficial ownership limitation to a percentage not to exceed 9.99%, provided that any increase in the beneficial ownership limitation shall not be effective until 61 days following notice to us. Beneficial ownership of the holder and its affiliates will be determined in accordance with Section 13(d) of the Exchange Act, and the rules and regulations promulgated thereunder.

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Stock dividends and stocksplits. If we pay a stock dividend or otherwise make a distribution payable in Depositary Shares or Ordinary Shares, or any other equity or equivalent securities, subdivide or combine outstanding Depositary Shares or Ordinary Shares, or reclassify Depositary Shares, Ordinary Shares or any shares of our capital stock, the exercise price of each warrant will be adjusted by multiplying the then exercise price by a fraction, the numerator of which shall be the number of Depositary Shares (excluding treasury shares, if any) outstanding immediately before such event, and the denominator of which shall be the number of Depositary Shares outstanding immediately after such event.

Rights Offerings; pro ratadistributions. If we issue Ordinary Share equivalents or rights to purchase shares, warrants, securities or other property pro rata to holders of Depositary Shares, a holder of a warrant will be entitled to acquire, subject to the beneficial ownership limitation described above, such securities or property that such holder could have acquired if such holder had held the number of Depositary Shares issuable upon complete exercise of the warrant immediately prior to the date a record is taken for such issuance. If we declare or make any dividend or other distribution of assets or rights to acquire assets to holders of Depositary Shares or Ordinary Shares, a holder of a warrant will be entitled to participate, subject to the beneficial ownership limitation, in such distribution to the same extent that the holder would have participated therein if the holder had held the number of Depositary Shares issuable upon full exercise of the warrant.

*Fundamental Transaction.*If we effect a fundamental transaction, including, among other things, a merger, sale of substantially all of our assets, tender offer, exchange offer and other business combination transactions, then upon any subsequent exercise of a warrant, the holder thereof shall have the right to receive, for each Ordinary Share represented by the Depositary Shares that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of the successor’s or acquiring corporation’s securities, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of Ordinary Shares represented by the Depositary Shares for which the warrant is exercisable immediately prior to such fundamental transaction. In addition, with respect to the Series C Warrants, Series D Warrants and the May 2023 Placement Agent Warrants, in the event of a fundamental transaction that is (i) an all cash or substantially all cash transaction, (ii) a “Rule 13e-3 transaction” as defined in Rule 13e-3 under the Exchange Act, or (iii) with certain limited exceptions, a fundamental transaction involving a person or entity not traded on a national securities exchange or other established trading market, including, but not limited to, the London Stock Exchange, AIM, The New York Stock Exchange, Inc., The NYSE MKT, The NASDAQ Global Select Market, The NASDAQ Global Market, The NASDAQ Capital Market, the OTC QX, the OTC QB or the Over-the-Counter Bulletin Board, then the Company or any successor entity will pay at the holder’s option, exercisable at any time concurrently with or within 30 days after the consummation of the fundamental transaction, an amount of cash equal to the value of the warrant as determined in accordance with the Black Scholes option pricing model.

Transferability. Each warrant and all rights thereunder are transferable, in whole or in part, upon surrender of the warrant, together with a written assignment of the warrant subject to applicable securities laws; provided, however, that the May 2023 Placement Agent Warrants are subject to certain FINRA transfer restrictions. We do not intend to apply for listing of the warrants on any securities exchange or other trading system.

No Rights as ShareholderUntil Exercise. Except as set forth in the warrants, the holders of the warrants do not have any voting rights, dividends or other rights as a holder of our capital stock until they exercise the warrants.

Series E Warrants, December 2023 PrivatePlacement Pre-Funded Warrants and December 2023 Underwriter Warrants

The following is a brief summary of the Series E Warrants, December 2023 Private Placement Pre-Funded Warrants, the December 2023 Underwriter Warrants, issued in connection with the with December 2023 private placements and December 2023 public offering, and is subject in all respects to the provisions contained in the applicable warrants, which are filed as exhibits to our Report on Form 6-K dated December 21, 2023. Unless otherwise stated, references to warrants in this subsection include the Series E Warrants, the December 2023 Private Placement Pre-Funded Warrants, and the December 2023 Underwriter Warrants.

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Exercisability. The warrants became exercisable on December 21, 2023. The Series E Warrants and December 2023 Underwriter Warrants expire five years and three years, respectively from the initial exercise date. The December 2023 Private Placement Pre-Funded Warrants are exercisable at any time and do not expire. The holder shall deliver the aggregate exercise price for the Depositary Shares specified in the exercise notice within two trading days following the date of exercise (subject to the ‘cashless exercise’ arrangements described below).

Cashless Exercise. If, at the time a holder exercises its Series E Warrants, a registration statement registering the issuance of the securities underlying the Series E Warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the Series E Warrants.

At the time a holder exercises its December 2023 Private Placement Pre-Funded Warrants, in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the December 2023 Private Placement Pre-Funded Warrants.

Exercise Price. The exercise price of each Series E Warrant, December 2023 Underwriter Warrant and December 2023 Private Placement Pre-Funded Warrant is $550.00, $625.00 and $0.025 per Depositary Share.

*Beneficial Ownership Limitation.*A holder shall have no right to exercise any portion of a warrant, to the extent that, after giving effect to such exercise, such holder, together with such holder’s affiliates, and any persons acting as a group together with such holder or any such affiliate, would beneficially own in excess of 9.99% (or in the case of the December 2023 Underwriter Warrants, 4.99%), of the number of Ordinary Shares outstanding immediately after giving effect to the issuance of the Ordinary Shares underlying the Depositary Shares upon such exercise. The holder of the warrant, upon notice to us, may increase or decrease the beneficial ownership limitation to a percentage not to exceed 9.99%, provided that any increase in the beneficial ownership limitation shall not be effective until 61 days following notice to us. Beneficial ownership of the holder and its affiliates will be determined in accordance with Section 13(d) of the Exchange Act, and the rules and regulations promulgated thereunder.

*Fundamental Transaction.*If we effect a fundamental transaction, including, among other things, a merger, sale of substantially all of our assets, tender offer, exchange offer and other business combination transactions, then upon any subsequent exercise of a warrant, the holder thereof shall have the right to receive, for each Ordinary Share represented by the Depositary Shares that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of the successor’s or acquiring corporation’s securities, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of Ordinary Shares represented by the Depositary Shares for which the warrant is exercisable immediately prior to such fundamental transaction. In addition, with respect to the Series E Warrants and the December 2023 Underwriter Warrants, in the event of a fundamental transaction that is (i) an all cash or substantially all cash transaction, (ii) a “Rule 13e-3 transaction” as defined in Rule 13e-3 under the Exchange Act, or (iii) with certain limited exceptions, a fundamental transaction involving a person or entity not traded on a national securities exchange or other established trading market, including, but not limited to, the London Stock Exchange, AIM, The New York Stock Exchange, Inc., The NYSE MKT, The NASDAQ Global Select Market, The NASDAQ Global Market, The NASDAQ Capital Market, the OTC QX, the OTC QB or the Over-the-Counter Bulletin Board, then the Company or any successor entity will pay at the holder’s option, exercisable at any time concurrently with or within 30 days after the consummation of the fundamental transaction, an amount of cash equal to the value of the warrant as determined in accordance with the Black Scholes option pricing model.

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Transferability. Each warrant and all rights thereunder are transferable, in whole or in part, upon surrender of the warrant, together with a written assignment of the warrant subject to applicable securities laws; provided, however, that the Underwriter Warrants are subject to certain FINRA transfer restrictions. We do not intend to apply for listing of the warrants on any securities exchange or other trading system.

SeriesG Warrants and Warrant Agent Warrants

The following is a brief summary of the Series G Warrants and Warrant Agent Warrants, issued in connection with the closing of a warrant inducement transaction in May 2024, and is subject in all respects to the provisions contained in the applicable warrants, which are filed as exhibits to our Report on Form 6-K dated May 22, 2024. Unless otherwise stated, references to warrants in this subsection include the Series G Warrants and Warrant Agent Warrants. The Series H Warrants issued in the transaction have expired.

Exercisability. The warrants became exercisable on May 24, 2024. The Series G Warrants and Warrant Agent Warrants expire five years and three years, respectively, from the initial exercise date. The holder shall deliver the aggregate exercise price for the Depositary Shares specified in the exercise notice within two trading days following the date of exercise (subject to the ‘cashless exercise’ arrangements described below).

CashlessExercise. If, at the time a holder exercises its warrants, a registration statement registering the issuance of the securities underlying the warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the warrants.

*ExercisePrice.*The exercise price of each Series G Warrant and Warrant Agent Warrants is $625.00 per Depositary Share.

BeneficialOwnership Limitation. A holder shall have no right to exercise any portion of a warrant, to the extent that, after giving effect to such exercise, such holder, together with such holder’s affiliates, and any persons acting as a group together with such holder or any such affiliate, would beneficially own in excess of 9.99% or 4.99%, at the holders determination, of the number of Ordinary Shares outstanding immediately after giving effect to the issuance of the Ordinary Shares underlying the Depositary Shares upon such exercise. The holder of the warrant, upon notice to us, may increase or decrease the beneficial ownership limitation to a percentage not to exceed 9.99%, provided that any increase in the beneficial ownership limitation shall not be effective until 61 days following notice to us. Beneficial ownership of the holder and its affiliates will be determined in accordance with Section 13(d) of the Exchange Act, and the rules and regulations promulgated thereunder.

Stockdividends and stock splits. If we pay a stock dividend or otherwise make a distribution payable in Depositary Shares or Ordinary Shares, or any other equity or equivalent securities, subdivide or combine outstanding Depositary Shares or Ordinary Shares, or reclassify Depositary Shares, Ordinary Shares or any shares of our capital stock, the exercise price of each warrant will be adjusted by multiplying the then exercise price by a fraction, the numerator of which shall be the number of Depositary Shares (excluding treasury shares, if any) outstanding immediately before such event, and the denominator of which shall be the number of Depositary Shares outstanding immediately after such event.

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RightsOfferings; pro rata distributions. If we issue Ordinary Share equivalents or rights to purchase shares, warrants, securities or other property pro rata to holders of Depositary Shares, a holder of a warrant will be entitled to acquire, subject to the beneficial ownership limitation described above, such securities or property that such holder could have acquired if such holder had held the number of Depositary Shares issuable upon complete exercise of the warrant immediately prior to the date a record is taken for such issuance. If we declare or make any dividend or other distribution of assets or rights to acquire assets to holders of Depositary Shares or Ordinary Shares, a holder of a warrant will be entitled to participate, subject to the beneficial ownership limitation, in such distribution to the same extent that the holder would have participated therein if the holder had held the number of Depositary Shares issuable upon full exercise of the warrant.

FundamentalTransaction. If we effect a fundamental transaction, including, among other things, a merger, sale of substantially all of our assets, tender offer, exchange offer and other business combination transactions, then upon any subsequent exercise of a warrant, the holder thereof shall have the right to receive, for each Ordinary Share represented by the Depositary Shares that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of the successor’s or acquiring corporation’s securities, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of Ordinary Shares represented by the Depositary Shares for which the warrant is exercisable immediately prior to such fundamental transaction. In addition, in the event of a fundamental transaction that is (i) an all cash or substantially all cash transaction, (ii) a “Rule 13e-3 transaction” as defined in Rule 13e-3 under the Exchange Act, or (iii) with certain limited exceptions, a fundamental transaction involving a person or entity not traded on a national securities exchange or other established trading market, including, but not limited to, the London Stock Exchange, AIM, The New York Stock Exchange, Inc., The NYSE MKT, The NASDAQ Global Select Market, The NASDAQ Global Market, The NASDAQ Capital Market, the OTC QX, the OTC QB or the Over-the-Counter Bulletin Board, then the Company or any successor entity will pay at the holder’s option, exercisable at any time concurrently with or within 30 days after the consummation of the fundamental transaction, an amount of cash equal to the value of the warrant as determined in accordance with the Black Scholes option pricing model.

Transferability. Each warrant and all rights thereunder are transferable, in whole or in part, upon surrender of the warrant, together with a written assignment of the warrant subject to applicable securities laws; provided, however, that the Warrant Agent Warrants are subject to certain FINRA transfer restrictions. We do not intend to apply for listing of the warrants on any securities exchange or other trading system.

NoRights as Shareholder Until Exercise. Except as set forth in the warrants, the holders of the warrants do not have any voting rights, dividends or other rights as a holder of our capital stock until they exercise the warrants.

SeriesJ Warrants and July 2024 Placement Agent Warrants

The following is a brief summary of the Series J Warrants and July 2024 Placement Agent Warrants issued in connection with a July 2024 private placement, and is subject in all respects to the provisions contained in the applicable warrants, which are filed as exhibits to our Report on Form 6-K dated July 19, 2024. Unless otherwise stated, references to “warrants” in this subsection include the Series J Warrants and July 2024 Placement Agent Warrants.

Exercisability. The warrants became exercisable on July 22, 2024. The Series J Warrants and July 2024 Placement Agent Warrants expire five years and three years, respectively from the initial exercise date. The holder shall deliver the aggregate exercise price for the Depositary Shares specified in the exercise notice within two trading days following the date of exercise (subject to the ‘cashless exercise’ arrangements described below).

CashlessExercise. If, following the date that is six months from the initial issuance date of the warrant, a registration statement registering the issuance of the securities underlying the warrants under the Securities Act is not then effective, or the prospectus contained therein is not available for the resale of the securities issuable upon exercise of the applicable warrants, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the warrants.

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*ExercisePrice.*The exercise price of each Series J Warrant and July 2024 Placement Agent Warrant is $250.00 per Depositary Share and $312.50 per Depositary Share, respectively.

Stockdividends and stock splits. If we pay a stock dividend or otherwise make a distribution payable in Depositary Shares or Ordinary Shares, or any other equity or equivalent securities, subdivide or combine outstanding Depositary Shares or Ordinary Shares, or reclassify Depositary Shares, Ordinary Shares or any shares of our capital stock, the exercise price of each warrant will be adjusted by multiplying the then exercise price by a fraction, the numerator of which shall be the number of Depositary Shares (excluding treasury shares, if any) outstanding immediately before such event, and the denominator of which shall be the number of Depositary Shares outstanding immediately after such event.

Transferability. Each warrant and all rights thereunder are transferable, in whole or in part, upon surrender of the warrant, together with a written assignment of the warrant subject to applicable securities laws; provided, however, that the July 2024 Placement Agent Warrants are subject to certain FINRA transfer restrictions. We do not intend to apply for listing of the warrants on any securities exchange or other trading system.

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NoRights as Shareholder Until Exercise. Except as set forth in the warrants, the holders of the warrants do not have any voting rights, dividends or other rights as a holder of our capital stock until they exercise the warrants.

SeriesL Warrants, December 2025 Pre-Funded Warrants and December 2025 Placement Agent Warrants

The following is a brief summary of the Series L Warrants, December 2025 Pre-Funded Warrants and December 2025 Placement Agent Warrants issued in connection with the December 2025 Offering, and is subject in all respects to the provisions contained in the applicable warrants, which are filed as exhibits to our Report on Form 6-K dated December 18, 2025. Unless otherwise stated, references to “warrants” in this subsection include the Series L Warrants, December 2025 Pre-Funded Warrants and December 2025 Placement Agent Warrants.

Exercisability. The warrants became exercisable on December 19, 2025. The Series L Warrants and December 2025 Placement Agent Warrants expire five years from the initial exercise date. The December 2025 Pre-Funded Warrants are exercisable at any time and do not expire. The holder shall deliver the aggregate exercise price for the Depositary Shares specified in the exercise notice within two trading days following the date of exercise (subject to the ‘cashless exercise’ arrangements described below).

CashlessExercise. If, following the date that is six months from the initial issuance date of the Series L Warrant and Decemer 2025 Placement Agent Warrant, a registration statement registering the issuance of the securities underlying the warrants under the Securities Act is not then effective, or the prospectus contained therein is not available for the resale of the securities issuable upon exercise of the applicable warrants, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the warrants.

At the time a holder exercises its December 2025 Pre-Funded Warrants, in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of Depositary Shares determined according to a formula set forth in the December 2025 Pre-Funded Warrants.

*ExercisePrice.*The exercise price of each Series L Warrant and December 2025 Placement Agent Warrant is $3.28 per Depositary Share. The exercise price of each December 2025 Pre-Funded Warrant is $0.0001 per Depositary Share.

Stockdividends and stock splits. If we pay a stock dividend or otherwise make a distribution payable in Depositary Shares or Ordinary Shares, or any other equity or equivalent securities, subdivide or combine outstanding Depositary Shares or Ordinary Shares, or reclassify Depositary Shares, Ordinary Shares or any shares of our capital stock, the exercise price of each warrant will be adjusted by multiplying the then exercise price by a fraction, the numerator of which shall be the number of Depositary Shares (excluding treasury shares, if any) outstanding immediately before such event, and the denominator of which shall be the number of Depositary Shares outstanding immediately after such event.

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FundamentalTransaction. If we effect a fundamental transaction, including, among other things, a merger, sale of substantially all of our assets, tender offer, exchange offer and other business combination transactions, then upon any subsequent exercise of a warrant, the holder thereof shall have the right to receive, for each Ordinary Share represented by the Depositary Shares that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of the successor’s or acquiring corporation’s securities, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of Ordinary Shares represented by the Depositary Shares for which the warrant is exercisable immediately prior to such fundamental transaction. In addition, with respect to the Series L Warrants and December 2025 Placement Agent Warrants, in the event of a fundamental transaction that is (i) an all cash or substantially all cash transaction, (ii) a “Rule 13e-3 transaction” as defined in Rule 13e-3 under the Exchange Act, or (iii) with certain limited exceptions, a fundamental transaction involving a person or entity not traded on a national securities exchange or other established trading market, including, but not limited to, the London Stock Exchange, AIM, The New York Stock Exchange, Inc., The NYSE MKT, The NASDAQ Global Select Market, The NASDAQ Global Market, The NASDAQ Capital Market, the OTC QX, the OTC QB or the Over-the-Counter Bulletin Board, then the Company or any successor entity will pay at the holder’s option, exercisable at any time concurrently with or within 30 days after the consummation of the fundamental transaction, an amount of cash equal to the value of the warrant as determined in accordance with the Black Scholes option pricing model.

Transferability. Each warrant and all rights thereunder are transferable, in whole or in part, upon surrender of the warrant, together with a written assignment of the warrant subject to applicable securities laws; provided, however, that the December 2025 Placement Agent Warrants are subject to certain FINRA transfer restrictions. We do not intend to apply for listing of the warrants on any securities exchange or other trading system.

NoRights as Shareholder Until Exercise. Except as set forth in the warrants, the holders of the warrants do not have any voting rights, dividends or other rights as a holder of our capital stock until they exercise the warrants.

Articles of Association

Shares and Rights Attaching to Them

Objects

There are no restrictions on the objects of our Company.

Share Rights

Subject to the Companies Act and any special rights attaching to shares already in issue, our shares may be issued with or have attached to them any preferred, deferred or other special rights or privileges or be subject to such restrictions as we may resolve by ordinary resolution of the shareholders or decision of our board.

Voting Rights

Without prejudice to any rights or restrictions as to voting rights attached to any shares forming part of our share capital from time to time, the voting rights attaching to shares are as follows:

·	on a show of hands every shareholder who is present in person and each duly authorized representative<br>present in person of a shareholder that is a corporation shall have one vote;
·	on a show of hands, each proxy present in person has one vote for and one vote against a resolution if<br>the proxy has been duly appointed by more than one shareholder and the proxy has been instructed by one or more of those shareholders<br>to vote for the resolution and by one or more other of those shareholders to vote against it;
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| --- | | · | on a show of hands, each proxy present in person has one vote for and one vote against a resolution if the proxy has been duly appointed by more than one shareholder entitled to vote on the resolution and either: (1) the proxy has been instructed by one or more of those shareholders to vote for the resolution and has been given any discretion by one or more other of those shareholders to vote and the proxy exercises that discretion to vote against it; or (2) the proxy has been instructed by one or more of those shareholders to vote against the resolution and has been given any discretion by one or more other of those shareholders to vote and the proxy exercises that discretion to vote for it; and | | --- | --- | | · | on a poll every shareholder who is present in person or by proxy shall have one vote for each share of which he is the holder. | | --- | --- |

At any general meeting a resolution put to the vote of the meeting shall be decided on a show of hands unless a poll is demanded. Subject to the provisions of the Companies Act, as described in “Differences in Corporate Law - Voting Rights” in this exhibit, a poll may be demanded by:

·	the chairman of the meeting;
·	at least five shareholders present in person or by proxy and entitled to vote;
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·	any shareholder(s) present in person or by proxy and representing in the aggregate not less than 10% of<br>the total voting rights of all shareholders having the right to vote on the resolution; or
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·	any shareholder(s) present in person or by proxy and holding shares conferring a right to vote on the<br>resolution on which there have been paid up sums in the aggregate equal to not less than 10% of the total sums paid up on all shares conferring<br>that right.
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Restrictions on Voting

No shareholder shall be entitled to vote at any general meeting or at any separate class meeting in respect of any share held by him unless all calls or other sums payable by him in respect of that share have been paid.

The Board of Directors may from time to time make calls upon the shareholders in respect of any money unpaid on their shares and each shareholder shall (subject to at least 14 clear days’ notice specifying the time or times and place of payment) pay at the time or times so specified the amount called on his shares. If a call remains unpaid after it has become due and payable, and the 14 days’ notice provided by the Board of Directors has not been complied with, any share in respect of which such notice was given may be forfeited by a resolution of the Board of Directors.

A shareholder’s right to attend general or class meetings of the Company or to vote in respect of his shares may be suspended by the Board of Directors in accordance with our Articles of Association if he fails to comply with a proper request for the disclosure of interests regarding the shares. See “Other United Kingdom Law Considerations—Disclosure of Interest in Shares” in this exhibit.

Dividends

We may, by ordinary resolution, declare a dividend to be paid to the share owners according to their respective rights and interests in profits, and may fix the time for payment of such dividend. No dividend may be declared in excess of the amount recommended by the Board of Directors. The Board of Directors may from time to time declare and pay to our shareholders such interim dividends as appear to the directors to be justified by our profits available for distribution. There are no fixed dates on which entitlement to dividends arises on our Ordinary Shares.

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The shareholders may pass, on the recommendation of the directors, an ordinary resolution to direct that all or any part of a dividend to be paid by distributing specific assets, in particular paid up shares or debentures of any other body corporate. Our articles of association also permit, with the prior authority of an ordinary resolution of shareholders, a scrip dividend scheme under which shareholders may be given the opportunity to elect to receive fully paid Ordinary Shares instead of cash, or a combination of shares and cash, with respect to future dividends.

By the way of the exercise of a lien, if a shareholder owes us any money relating in any way to shares, the Board of Directors may deduct any of this money from any dividend on any shares held by the shareholder, or from other money payable by us in respect of the shares. Money deducted in this way may be used to pay the amount owed to us.

A shareholder’s right to receive dividends on his shares may, if they represent more than 0.25% of the issued shares of that class, be suspended by the directors if he fails to comply with a proper request for the disclosure of interests regarding the shares.

Change of Control

There is no specific provision in our Articles of Association that would have the effect of delaying, deferring or preventing a change of control. We are, however, subject to the provisions of the City Code on Takeovers and Mergers, or City Code, which contains detailed provisions regulating the timing and manner of any takeover offer for those of the Company’s shares which confer voting rights.

Variation of Rights

Whenever our share capital is divided into different classes of shares, all or any of the rights attached to any class may be varied or abrogated in such manner (if any) as may be provided by those rights or (in the absence of any such provision) either with the consent in writing of the holders of at least 75% of the issued shares of that class or with the authority of a special resolution passed at a separate general meeting of the holders of the shares of that class.

Alteration of Share Capital and Repurchases

Subject to the provisions of the Companies Act, and without prejudice to any relevant special rights attached to any class of shares, we may by ordinary resolution, from time to time:

·	increase our share capital by allotting and issuing new shares in accordance with our articles of association<br>and any relevant shareholder resolution;
·	consolidate all or any of our share capital into shares of a larger nominal amount (i.e., par value) than<br>the existing shares;
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·	subdivide any of our shares into shares of a smaller nominal amount (i.e., par value) than our existing<br>shares; or
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·	redenominate our share capital or any class of share capital.
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Preemptive Rights and New Issuance of Shares

Under the Companies Act, the issuance of equity securities (except shares held under an employees’ share scheme) that are to be paid for wholly in cash must be offered first to the existing holders of equity securities in proportion to the respective nominal amounts (i.e., par values) of their holdings on the same or more favorable terms, unless a special resolution to the contrary has been passed or the articles of association otherwise provide an exclusion from this requirement (which exclusion can be for a maximum of five years after which our shareholders’ approval would be required to renew the exclusion). In this context, “equity securities” means Ordinary Shares (and would exclude shares that, with respect to dividends or capital, carry a right to participate only up to a specified amount in a distribution), and any and all rights to subscribe for or convert securities into such Ordinary Shares. This differs from U.S. law, under which shareholders generally do not have pre-emptive rights unless specifically granted in the certificate of incorporation or otherwise.

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The Board seeks general authority to allot shares on a non-pre-emptive basis at each annual general meeting. Preemptive rights under the Companies Act will not apply in respect of allotment of shares for cash made pursuant to such authority.

Transfer of Shares

Any certificated shareholder may transfer all or any of his shares by an instrument of transfer in the usual common form or in any other manner which is permitted by the Companies Act and approved by the Board of Directors. Any written instrument of transfer shall be signed by or on behalf of the transferor and (in the case of a partly paid share) the transferee.

All transfers of uncertificated shares shall be made in accordance with and subject to the provisions of the Uncertificated Securities Regulations 2001 and the facilities and requirements of its relevant system. The Uncertificated Securities Regulations 2001 permit shares to be issued and held in uncertificated form and transferred by means of a computer-based system.

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The Board of Directors may decline to register any transfer of any share unless it is:

·	a fully paid share;
·	a share on which the Company has no lien;
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·	in respect of only one class of shares;
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·	in favor of a single transferee or not more than four transferees;
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·	duly stamped or duly certificated or otherwise shown the satisfaction of the Board of Directors to be<br>exempt from any required stamp duty; or
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·	delivered for registration at the Company’s registered office or such other place as the Board of<br>Directors may decide, accompanied by the certificate for the shares to which it relates (other than uncertificated shares) and any other<br>evidence the Board of Directors may reasonably require to provide the title to such share of the transferor.
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If the Board of Directors declines to register a transfer it shall, as soon as practicable and in any event within two months after the date on which the transfer is lodged, send to the transferee notice of the refusal.

CREST

CREST is a computerized paperless share transfer and settlement system which allows securities to be transferred by electronic means, without the need for a written instrument of transfer. The Articles of Association are consistent with CREST membership and, among other things, allow for the holding and transfer of shares in uncertificated form.

Shareholder Meetings

Annual General Meetings

In accordance with the Companies Act, we are required in each year to hold an annual general meeting in addition to any other general meetings in that year and to specify the meeting as such in the notice convening it. The annual general meeting shall be convened whenever and wherever the board sees fit, subject to the requirements of the Companies Act.

Notice of General Meetings

Subject to certain conditions, holders of Depositary Shares are entitled to receive notices under the terms of the deposit agreement relating to the Depositary Shares.

Quorum of General Meetings

No business shall be transacted at any general meeting unless a quorum is present, but the absence of a quorum shall not preclude the appointment, choice or election of a chairman which shall not be treated as part of the business of the meeting. At least two shareholders present in person or by proxy and entitled to vote shall be a quorum for all purposes.

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Class Meetings

The provisions in the Articles of Association relating to general meetings apply to every separate general meeting of the holders of a class of shares except that:

·	no member, other than a member of the Board of Directors, shall be entitled to notice of it or attend<br>such meeting unless he is a holder of shares of that class;
·	the quorum for such class meeting shall be two holders in person or by proxy representing not less than<br>one-third in nominal value of the issued shares of the class;
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·	at the class meeting, a holder of shares of the class present in person or by proxy may demand a poll<br>and shall on a poll be entitled to one vote for every shares of the class held by him; and
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·	if at any adjourned meeting of such holders a quorum is not present at the meeting, one holder of shares<br>of the class present in person or by proxy at an adjourned meeting constitutes a quorum.
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Directors

Number of Directors

We may not have less than two directors on our Board of Directors. We have no maximum number of directors, though we may fix a maximum number by ordinary resolution of the shareholders. We may, by ordinary resolution of the shareholders, vary the minimum and any maximum number of directors from time to time.

Appointment of Directors

Subject to the provisions of the Articles of Association, we may, by ordinary resolution of the shareholders, elect any person to be a director, either to fill a casual vacancy or as an addition to the existing board.

Without prejudice to the power to appoint any person to be a director by shareholder resolution, the Board of Directors has the power to appoint any person to be a director, either to fill a casual vacancy or as an addition to the existing Board of Directors. Any director appointed by the Board of Directors will hold office only until the earlier to occur of the close of the next following annual general meeting and someone being appointed in his stead at that meeting. Such a director is eligible for re-election at that meeting but shall not be taken into account in determining the directors or the number of directors who are to retire by rotation at such meeting.

Rotation of Directors

At every annual general meeting, one-third of the directors or, if their number is not a multiple of three, then the number nearest to and not exceeding one-third, shall retire from office and each director must retire from office at least once every three years. If there are fewer than three directors, one director shall make himself or herself available for re-election.

The directors to retire on each occasion shall be those subject to retirement by rotation who have been longest in office since their last election, but as between persons who became or were re-elected directors on the same day those to retire shall (unless they otherwise agree amongst themselves) be determined by lot.

A director who retires at the annual general meeting shall be eligible for re-election.

The shareholders may, at the meeting at which a director retires, fill the vacated office by electing a person and in default the retiring director shall, if willing to continue to act, be deemed to have been re-elected, unless at such meeting it is expressly resolved not to fill such vacated office or unless a resolution for the re-election of such director shall have been put to the meeting and lost or such director has given notice in writing to us that he is unwilling to be re-elected or such director has attained the retirement age applicable to him as director pursuant to the Companies Act.

Director’s Interests

The Board of Directors may authorize, to the fullest extent permitted by law, any matter proposed to them which would otherwise result in a director infringing his duty to avoid a situation in which he has, or can have, a direct or indirect interest that conflicts, or possibly may conflict, with our interests and which may reasonably be regarded as likely to give rise to a conflict of interest. A director shall not, save as otherwise agreed by him, be accountable to us for any benefit which he (or a person connected with him) derives from any matter authorized by the directors and any contract, transaction or arrangement relating thereto shall not be liable to be avoided on the grounds of any such benefit.

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Subject to the requirements under Sections 175, 177 and 182 of the Companies Act (which require a director to avoid a situation in which he has, or can have, a direct or indirect interest that conflicts, or possibly conflicts, with our interests, and to declare any interest that he has, whether directly or indirectly, in a proposed or existing transaction or arrangement with us), and provided that he has disclosed to the Board of Directors the nature and extent of any interest of his in accordance with the Companies Act and the Articles of Association, a director notwithstanding his office:

·	may be a party to, or otherwise interested in, any transaction or arrangement with us or in which we are<br>otherwise interested;
·	may be a director or other officer of, or employed by, or a party to any transaction or arrangement with,<br>or otherwise interested in, any body corporate promoted by us or in which we are otherwise interested; and
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·	shall not, by reason of his office, be accountable to us for any benefit which he derives from any such<br>office or employment or from any such transaction or arrangement or from any interest in any such body corporate and no such transaction<br>or arrangement shall be liable to be avoided on the ground of any such interest or benefit.
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In the case of interests arising where a director is in any way, directly or indirectly, interested in (a) a proposed transaction or arrangement with us or (b) a transaction or arrangement that has been entered into by us and save as otherwise provided by the Articles of Association, such director shall not vote at a meeting of the Board of Directors or of a committee of the Board of Directors on any resolution concerning such matter in which he has a material interest (otherwise than by virtue of his interest in shares, debentures or other securities of, or otherwise in or through, us) unless his interest or duty arises only because the case falls within one or more of the following paragraphs:

·	the resolution relates to the giving to him or a person connected with him of a guarantee, security or<br>indemnity in respect of money lent to, or an obligation incurred by him or such a person at the request of or for the benefit of, us or<br>any of our subsidiaries;
·	the resolution relates to the giving of a guarantee, security or indemnity in respect of a debt or obligation<br>of ours or any of our subsidiaries for which the director or a person connected with him has assumed responsibility in whole or part under<br>a guarantee or indemnity or by the giving of security;
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·	the resolution relates in any way to any other company in which he is interested, directly or indirectly<br>and whether as an officer or shareholder or otherwise howsoever, provided that he and any persons connected with him do not to his knowledge<br>hold an interest in shares representing one per cent or more of any class of the equity share capital of such company or of the voting<br>rights available to shareholder of such company;
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·	the resolution relates in any way to an arrangement for the benefit of our employees or any employees<br>of our subsidiaries which does not award him as such any privilege or benefit not generally awarded to the employees to whom such arrangement<br>relates;
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·	the resolution relates in any way to the purchase or maintenance for the directors of insurance; or
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·	the resolution is in respect of any matter in which the interest of the director cannot reasonably be<br>regarded as conflicting.
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A director shall not be counted in the quorum present at a meeting in relation to a resolution on which he is not entitled to vote.

If a question arises at a meeting of the Board of Directors or of a committee of the Board of Directors as to the right of a director to vote or be counted in the quorum, and such question is not resolved by his voluntarily agreeing to abstain from voting or not to be counted in the quorum, the question may, before the conclusion of the meeting, be referred to the chairman of the meeting and his ruling in relation to any director other than himself shall be final and conclusive except in a case where the nature or extent of the interest of the director concerned has not been fairly disclosed.

An interest of a person connected with a director shall be treated as an interest of the director and Section 252 of the Companies Act shall determine whether a person is connected with a director.

Directors’ Fees and Remuneration

Each of the directors shall be paid a fee at such rate as may from time to time be determined by the Board of Directors (or for the avoidance of doubt any duly authorized committee of the Board of Directors) provided that the aggregate of all such fees so paid to directors shall not exceed £600,000 per annum, or such larger amount as may from time to time be determined by ordinary resolution of shareholders.

Each director may be paid his reasonable traveling, hotel and other expenses of attending and returning from meetings of the Board of Directors or committees thereof of or general meetings or separate meetings of the holders class of shares or of debentures and shall be paid all expenses properly and reasonably incurred by him in the conduct of the Company’s business or in the discharge of his duties as a director. Any director who, by request, goes or resides abroad for any purposes required by us or who performs services which in the opinion of the Board of Directors go beyond the ordinary duties of a director may be paid such extra remuneration as the Board of Directors may determine.

An executive director shall receive such remuneration as the Board of Directors may determine, and either in addition to or in lieu of his remuneration as a director as detailed above.

Age Limitations and Share Ownership

We do not have any age limitations for our directors, nor do we have mandatory retirement as a result of reaching a certain age. Our directors are not required to hold any shares in the Company.

Borrowing Power

Our directors may exercise all the powers of the Company to borrow or raise money and mortgage or charge all or any part of our undertaking, property and assets (present and future), and uncalled capital. Subject to the Companies Act, the directors may also create and issue debentures, other loan stock and other securities, whether outright or as collateral security for any debt, liability or obligation of the Company or of any third party. Our directors are required to restrict the borrowings of the Company to ensure that the aggregate principal amount of borrowings at any one time outstanding and all of its subsidiary undertakings (other than intra-Group borrowing) shall not at any time, without the previous sanction of an ordinary resolution of the Company, exceed two times the gross asset value of the Company and our subsidiaries.

Liability of Biodexa and its Directors and Officers

Subject to the provisions on indemnities set out in Companies Act, every director, alternate director or former director (and of any associated company) shall be entitled to be indemnified out of our assets against all costs and liabilities incurred by him or her in relation to any proceedings or any regulatory investigation or action which relate to anything done or omitted or alleged to have been done or omitted by him or her as a director so long as the indemnities do not cover liability for breach of duty to the Company or cover any fine, costs or related expense in connection with any proceedings for default on the part of the director. Lawful indemnities extend to the provision of funds to him or her by the Company to meet expenditure incurred or to be incurred by him in defending himself in any proceedings (whether civil or criminal) or in connection with an application for statutory relief or in an investigation by a regulatory authority which must however be repaid where such proceedings, application, investigation or action are in connection with any alleged negligence, default, breach of duty or breach of trust by him or her in relation to the Company (or any associated company of ours) and he or she is convicted or found in default thereof. Under English law, any provision that purports to exempt a director of a company (to any extent) from any liability that would otherwise attach to him in connection with any negligence, default, breach of duty or breach of trust in relation to the company is void.

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Under a deed poll declared by us on August 5, 2015, or a Deed of Indemnity, our Board of Directors and our Company Secretary are indemnified against costs and liabilities incurred in connection with their office, other than any liability owed by such person to the Company itself (or any of our associated entities) and other than indemnification for liabilities in certain circumstances, which are prohibited by virtue of the Companies Act. The Deed of Indemnity provides that a director may also be lent sums to finance any relevant defense costs, provided that, in the event such proceedings involve criminal or civil matters in which the person is convicted or has a judgment made against him or her, then such loan must be repaid. Our total aggregate liability of Biodexa under the Deed of Indemnity is £5 million.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to a charter provision, by-law, contract, arrangements, statute or otherwise, we acknowledge that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

Other United Kingdom Law Considerations

Mandatory Purchases and Acquisitions

Pursuant to Sections 979 to 991 of the Companies Act, where a takeover offer has been made for us and the offeror has acquired or unconditionally contracted to acquire not less than 90% in value of the shares to which the offer relates and not less than 90% of the voting rights carried by those shares, the offeror may give notice to the holder of any shares to which the offer relates which the offeror has not acquired or unconditionally contracted to acquire that he wishes to acquire, and is entitled to so acquire, those shares on the same terms as the general offer. The offeror would do so by sending a notice to the outstanding minority shareholders telling them that it will compulsorily acquire their shares. Such notice must be sent within three months of the last day on which the offer can be accepted in the prescribed manner. The squeeze-out of the minority shareholders can be completed at the end of six weeks from the date the notice has been given, following which the offeror can execute a transfer of the outstanding shares in its favor and pay the consideration to us, and we would hold the consideration on trust for the outstanding minority shareholders. The consideration offered to the outstanding minority shareholders whose shares are compulsorily acquired under the Companies Act must, in general, be the same as the consideration that was available under the takeover offer.

Sell Out

The Companies Act also gives our minority shareholders a right to be bought out in certain circumstances by an offeror who has made a takeover offer for all of our shares. The holder of shares to which the offer relates, and who has not otherwise accepted the offer, may require the offeror to acquire his shares if, prior to the expiry of the acceptance period for such offer, (i) the offeror has acquired or agreed to acquire not less than 90% in value of the voting shares, and (ii) not less than 90% of the voting rights carried by those shares. The offeror may impose a time limit on the rights of minority shareholders to be bought out that is not less than three months after the end of the acceptance period. If a shareholder exercises his rights to be bought out, the offeror is required to acquire those shares on the terms of this offer or on such other terms as may be agreed.

Disclosure of Interest in Shares

Pursuant to Part 22 of the Companies Act, we are empowered by notice in writing to any person whom we know or have reasonable cause to believe to be interested in our shares, or at any time during the three years immediately preceding the date on which the notice is issued has been so interested, requiring such person within a reasonable time to disclose to us particulars of that person’s interest and (so far as is within his knowledge) particulars of any other interest that subsists or subsisted in those shares. The Articles of Association specify that a response is required from such person within 14 days after service of any such notice.

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Under the Articles of Association, if a person defaults in supplying us with the required particulars in relation to the shares in question, or Default Shares, the directors may by notice direct that:

in respect of the Default Shares, the relevant member shall not be entitled to attend or vote (either in person or by proxy) at any general meeting or of a general meeting of the holders of a class of shares or upon any poll or to exercise any right conferred by the Default Shares; and/or

where the Default Shares represent at least 0.25% of their class, (a) any dividend (or any part of a dividend) payable in respect of the Default Shares shall be retained by us without liability to pay interest, (b) the shareholder may not be entitled to elect to receive shares instead of a dividend, and (c) no transfers by the relevant member of any Default Shares may be registered (unless the member himself is not in default and the transfer does not relate to Default Shares, the transfer is exempt or that the transfer is permitted under the U.K. Uncertificated Securities Regulations 2001).

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Purchase of Own Shares

Under English law, a limited company may only purchase or redeem its own shares out of the distributable profits of the company or the proceeds of a fresh issue of shares made for the purpose of financing the purchase, provided that they are not restricted from doing so by their articles. A limited company may not purchase or redeem its own shares if, as a result of the purchase, there would no longer be any issued shares of the company other than redeemable shares or shares held as treasury shares. Shares must be fully paid in order to be repurchased.

Subject to the above, we may purchase our own shares in the manner prescribed below. We may make a market purchase of our own fully paid shares pursuant to an ordinary resolution of shareholders. The resolution authorizing the purchase must:

·	specify the maximum number of shares authorized to be acquired;
·	determine the maximum and minimum prices that may be paid for the shares; and
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·	specify a date, not being later than five years after the passing of the resolution, on which the authority<br>to purchase is to expire.
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We may purchase our own fully paid shares otherwise than on a recognized investment exchange pursuant to a purchase contract authorized by resolution of shareholders before the purchase takes place. Any authority will not be effective if any shareholder from whom we propose to purchase shares votes on the resolution and the resolution would not have been passed if he had not done so. The resolution authorizing the purchase must specify a date, not being later than five years after the passing of the resolution, on which the authority to purchase is to expire.

Distributions and Dividends

Under the Companies Act, before a company can lawfully make a distribution or dividend, it must ensure that it has sufficient distributable reserves (on a non-consolidated basis). The basic rule is that a company’s profits available for the purpose of making a distribution are its accumulated, realized profits, so far as not previously utilized by distribution or capitalization, less its accumulated, realized losses, so far as not previously written off in a reduction or reorganization of capital duly made. The requirement to have sufficient distributable reserves before a distribution or dividend can be paid applies to us and to each of our subsidiaries that has been incorporated under English law.

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It is not sufficient that we, as a public company, have made a distributable profit for the purpose of making a distribution. An additional capital maintenance requirement is imposed on us to ensure that the net worth of the company is at least equal to the amount of its capital. A public company can only make a distribution:

·	if, at the time that the distribution is made, the amount of its net assets (that is, the total excess<br>of assets over liabilities) is not less than the total of its called up share capital and undistributable reserves; and
·	if, and to the extent that, the distribution itself, at the time that it is made, does not reduce the<br>amount of the net assets to less than that total.
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City Code on Takeovers and Mergers

The Company is a public limited company incorporated in, and with its registered office in, the United Kingdom but its securities are not admitted to trading on a regulated market or multilateral trading facility in the United Kingdom (or a stock exchange in the Channel Islands or the Isle of Man). The City Code shall only apply to the Company if it is considered by the Panel on Takeovers and Mergers, or the Panel, to have its place of central management and control in the United Kingdom (or the Channel Islands or the Isle of Man). This is known as the “residency test”. The way in which the test for central management and control is applied for the purposes of the City Code may be different from the way in which it is applied by the United Kingdom tax authorities, HMRC. Under the City Code, the Panel typically considers where the majority of the directors of the Company are resident, amongst other factors, for the purposes of determining where the Company has its place of central management and control. Three of the five directors of the Company are currently resident in the United Kingdom and the place of central management and control of the Company is intended, for the time being, to remain in the United Kingdom meaning that the Company and its shareholders will have the benefit of the protections that the City Code affords, including, but not limited to, under Rule 9 of the City Code as set out below.

The City Code is issued and administered by the Panel. The City Code provides a framework within which takeovers of companies subject to it are conducted. In particular, the City Code contains certain rules in respect of mandatory offers. Under Rule 9 of the City Code, if a person:

acquires an interest in our shares which, when taken together with shares in which he or persons acting in concert with him are interested, carries 30% or more of the voting rights of our shares; or

who, together with persons acting in concert with him, is interested in shares that in the aggregate carry not less than 30% and not more than 50% of the voting rights in us, acquires additional interests in shares that increase the percentage of shares carrying voting rights in which that person is interested, the acquirer, and depending on the circumstances, its concert parties would be required (except with the consent of the Panel) to make a cash offer for our outstanding shares at a price not less than the highest price paid for any interests in the shares by the acquirer or its concert parties during the previous 12 months.

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Notwithstanding the above, the Company may cease to be subject to the City Code in the future if there are any changes that lead to the Company being deemed to no longer have its place of central management and control in the United Kingdom, Channel Islands or the Isle of Man.

Exchange Controls

There are no governmental laws, decrees, regulations or other legislation in the United Kingdom that may affect the import or export of capital, including the availability of cash and cash equivalents for use by us, or that may affect the remittance of dividends, interest, or other payments by us to non-resident holders of our Ordinary Shares or Depositary Shares, other than withholding tax requirements. There is no limitation imposed by English law or in the Articles of Association on the right of non-residents to hold or vote shares.

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Differences in CorporateLaw

Theapplicable provisions of the Companies Act differ from laws applicable to U.S. corporations and their shareholders. Set forth below isa summary of certain differences between the provisions of the Companies Act applicable to us and the Delaware General CorporationLaw relating to shareholders’ rights and protections. This summary is not intended to be a complete discussion of the respectiverights and it is qualified in its entirety by reference to English law and Delaware law.

	England and Wales	Delaware
Number of Directors	Under the Companies Act, a public limited company must have at least two directors and the number of directors may be fixed by or in the manner provided in a company’s articles of association.	Under Delaware law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner provided in the bylaws.
Removal of Directors	Under the Companies Act, shareholders may remove a director without cause by an ordinary resolution (which is passed by a simple majority of those voting in person or by proxy at a general meeting) irrespective of any provisions of any service contract the director has with the company, provided 28 clear days’ notice of the resolution has been given to the company and its shareholders. On receipt of notice of an intended resolution to remove a director, the company must forthwith send a copy of the notice to the director concerned. Certain other procedural requirements under the Companies Act must also be followed such as allowing the director to make representations against his or her removal either at the meeting or in writing.	Under Delaware law, any director or the entire board of directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors, except (a) unless the certificate of incorporation provides otherwise, in the case of a corporation whose board of directors is classified, shareholders may effect such removal only for cause, or (b) in the case of a corporation having cumulative voting, if less than the entire board of directors is to be removed, no director may be removed without cause if the votes cast against his removal would be sufficient to elect him if then cumulatively voted at an election of the entire board of directors, or, if there are classes of directors, at an election of the class of directors of which he is a part.
Vacancies on Board of Directors	Under English law, the procedure by which directors, other than a company’s initial directors, are appointed is generally set out in a company’s articles of association, provided that where two or more persons are appointed as directors of a public limited company by resolution of the shareholders, resolutions appointing each director must be voted on individually.	Under Delaware law, vacancies and newly created directorships may be filled by a majority of the directors then in office (even though less than a quorum) or by a sole remaining director unless (a) otherwise provided in the certificate of incorporation or by-laws of the corporation or (b) the certificate of incorporation directs that a particular class of stock is to elect such director, in which case a majority of the other directors elected by such class, or a sole remaining director elected by such class, will fill such vacancy.
Annual General Meeting	Under the Companies Act, a public limited company must hold an annual general meeting in each six-month period following the company’s annual accounting reference date.	Under Delaware law, the annual meeting of stockholders shall be held at such place, on such date and at such time as may be designated from time to time by the board of directors or as provided in the certificate of incorporation or by the bylaws.

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| --- | | | England and Wales | Delaware | | --- | --- | --- | | General Meeting | Under the Companies Act, a general meeting of the shareholders of a public limited company may be called by the directors. Shareholders holding at least 5% of the paid-up capital of the company carrying voting rights at general meetings can require the directors to call a general meeting and, if the directors fail to do so within a certain period, may themselves convene a general meeting. | Under Delaware law, special meetings of the stockholders may be called by the board of directors or by such person or persons as may be authorized by the certificate of incorporation or by the bylaws. | | Notice of General Meetings | Under the Companies Act, 21 clear days’ notice must be given for an annual general meeting and any resolutions to be proposed at the meeting. Subject to a company’s articles of association providing for a longer period, at least 14 clear days’ notice is required for any other general meeting. In addition, certain matters, such as the removal of directors or auditors, require special notice, which is 28 clear days’ notice. The shareholders of a company may in all cases consent to a shorter notice period, the proportion of shareholders’ consent required being 100% of those entitled to attend and vote in the case of an annual general meeting and, in the case of any other general meeting, a majority in number of the members having a right to attend and vote at the meeting, being a majority who together hold not less than 95% in nominal value of the shares giving a right to attend and vote at the meeting. | Under Delaware law, unless otherwise provided in the certificate of incorporation or bylaws, written notice of any meeting of the stockholders must be given to each stockholder entitled to vote at the meeting not less than ten nor more than 60 days before the date of the meeting and shall specify the place, date, hour, and purpose or purposes of the meeting. | | Proxy | Under the Companies Act, at any meeting of shareholders, a shareholder may designate another person to attend, speak and vote at the meeting on their behalf by proxy. | Under Delaware law, at any meeting of stockholders, a stockholder may designate another person to act for such stockholder by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. A director of a Delaware corporation may not issue a proxy representing the director’s voting rights as a director. | | Pre-emptive Rights | Under the Companies Act, “equity securities,” being (i) shares in the company other than shares that, with respect to dividends and capital, carry a right to participate only up to a specified amount in a distribution (“ordinary shares”) or (ii) rights to subscribe for, or to convert securities into, ordinary shares, proposed to be allotted for cash must be offered first to the existing equity shareholders in the company in proportion to the respective nominal value of their holdings, unless an exception applies or a special resolution to the contrary has been passed by shareholders in a general meeting or the articles of association provide otherwise in each case in accordance with the provisions of the Companies Act. | Under Delaware law, shareholders have no preemptive rights to subscribe to additional issues of stock or to any security convertible into such stock unless, and except to the extent that, such rights are expressly provided for in the certificate of incorporation. |

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| --- | | | England and Wales | Delaware | | --- | --- | --- | | Authority to Allot | Under the Companies Act, the directors of a company must not allot shares or grant of rights to subscribe for or to convert any security into shares unless an exception applies or an ordinary resolution to the contrary has been passed by shareholders in a general meeting or the articles of association provide otherwise in each case in accordance with the provisions of the Companies Act. | Under Delaware law, if the corporation’s charter or certificate of incorporation so provides, the board of directors has the power to authorize the issuance of stock. It may authorize capital stock to be issued for consideration consisting of cash, any tangible or intangible property or any benefit to the corporation or any combination thereof. It may determine the amount of such consideration by approving a formula. In the absence of actual fraud in the transaction, the judgment of the directors as to the value of such consideration is conclusive. | | Liability of Officers and Directors | Under the Companies Act, any provision, whether contained in a company’s articles of association or any contract or otherwise, that purports to exempt a director of a company, to any extent, from any liability that would otherwise attach to him in connection with any negligence, default, breach of duty or breach of trust in relation to the company is void. Any provision by which a company directly or indirectly provides an indemnity, to any extent, for a director of the company or of an associated company against any liability attaching to him in connection with any negligence, default, breach of duty or breach of trust in relation to the company of which he is a director is also void except as permitted by the Companies Act, which provides exceptions for the company to (a) purchase and maintain insurance against such liability; (b) provide a “qualifying third party indemnity” (being an indemnity against liability incurred by the director to a person other than the company or an associated company or criminal proceedings in which he is not convicted); and (c) provide a “qualifying pension scheme indemnity” (being an indemnity against liability incurred in connection with the company’s activities as trustee of an occupational pension plan). | Under Delaware law, a corporation’s certificate of incorporation may include a provision eliminating or limiting the personal liability of a director to the corporation and its stockholders for damages arising from a breach of fiduciary duty as a director. However, no provision can limit the liability of a director for: · any breach of the director’s duty of loyalty to the corporation or its stockholders; · acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; · intentional or negligent payment of unlawful dividends or stock purchases or redemptions; or · any transaction from which the director derives an improper personal benefit. |

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| --- | | | England and Wales | Delaware | | --- | --- | --- | | Voting Rights | Under English law, unless a poll is demanded by the shareholders of a company or is required by the chairman of the meeting or the company’s articles of association, shareholders shall vote on all resolutions on a show of hands. Under the Companies Act, a poll may be demanded by (a) not fewer than five shareholders having the right to vote on the resolution; (b) any shareholder(s) representing not less than 10% of the total voting rights of all the shareholders having the right to vote on the resolution; or (c) any shareholder(s) holding shares in the company conferring a right to vote on the resolution being shares on which an aggregate sum has been paid up equal to not less than 10% of the total sum paid up on all the shares conferring that right. A company’s articles of association may provide more extensive rights for shareholders to call a poll, and in our case the number in clause (a) above is reduced from five to three. Under English law, an ordinary resolution is passed on a show of hands if it is approved by a simple majority (more than 50%) of the votes cast by shareholders present (in person or by proxy) and entitled to vote. If a poll is demanded, an ordinary resolution is passed if it is approved by holders representing a simple majority of the total voting rights of shareholders present, in person or by proxy, who, being entitled to vote, vote on the resolution. Special resolutions require the affirmative vote of not less than 75% of the votes cast by shareholders present, in person or by proxy, at the meeting. | Delaware law provides that, unless otherwise provided in the certificate of incorporation, each stockholder is entitled to one vote for each share of capital stock held by such stockholder. | | Shareholder Vote on Certain Transactions | The Companies Act provides for schemes of arrangement, which are arrangements or compromises between a company and any class of shareholders or creditors and used in certain types of reconstructions, amalgamations, capital reorganizations or takeovers. These arrangements require: · the approval at a shareholders’ or creditors’ meeting convened by order of the court, of a majority in number of shareholders or creditors representing 75% in value of the capital held by, or debt owed to, the class of shareholders or creditors, or class thereof present and voting, either in person or by proxy; and · the approval of the court. | Generally, under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock, completion of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation’s assets or dissolution requires: · the approval of the board of directors; and · approval by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter. |

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| --- | | | England and Wales | Delaware | | --- | --- | --- | | Standard of Conduct for Directors | Under English law, a director owes various statutory and fiduciary duties to the company, including: · to act in the way he considers, in good faith, would be most likely to promote the success of the company for the benefit of its members as a whole; · to avoid a situation in which he has, or can have, a direct or indirect interest that conflicts, or possibly conflicts, with the interests of the company; · to act in accordance with the company’s constitution and only exercise his powers for the purposes for which they are conferred; · to exercise independent judgment; · to exercise reasonable care, skill and diligence; · not to accept benefits from a third party conferred by reason of his being a director or doing, or not doing, anything as a director; and · to declare any interest that he has, whether directly or indirectly, in a proposed or existing transaction or arrangement with the company. | Delaware law does not contain specific provisions setting forth the standard of conduct of a director. The scope of the fiduciary duties of directors is generally determined by the courts of the State of Delaware. In general, directors have a duty to act without self-interest, on a well-informed basis and in a manner they reasonably believe to be in the best interest of the stockholders. Directors of a Delaware corporation owe fiduciary duties of care and loyalty to the corporation and to its shareholders. The duty of care generally requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself of all material information reasonably available regarding a significant transaction. The duty of loyalty requires that a director act in a manner he reasonably believes to be in the best interests of the corporation. He must not use his corporate position for personal gain or advantage. In general, but subject to certain exceptions, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties. Delaware courts have also imposed a heightened standard of conduct upon directors of a Delaware corporation who take any action designed to defeat a threatened change in control of the corporation. In addition, under Delaware law, when the board of directors of a Delaware corporation approves the sale or break-up of a corporation, the board of directors may, in certain circumstances, have a duty to obtain the highest value reasonably available to the shareholders. |

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| --- | | Stockholder Suits | Under English law, generally, the company, rather than its shareholders, is the proper claimant in an action in respect of a wrong done to the company or where there is an irregularity in the company’s internal management. Notwithstanding this general position, the Companies Act provides that (i) a court may allow a shareholder to bring a derivative claim (that is, an action in respect of and on behalf of the company) in respect of a cause of action arising from a director’s negligence, default, breach of duty or breach of trust and (ii) a shareholder may bring a claim for a court order where the company’s affairs have been or are being conducted in a manner that is unfairly prejudicial to some of its shareholders. | Under Delaware law, a stockholder may initiate a derivative action to enforce a right of a corporation if the corporation fails to enforce the right itself. The complaint must: · state that the plaintiff was a stockholder at the time of the transaction of which the plaintiff complains or that the plaintiffs shares thereafter devolved on the plaintiff by operation of law; and · allege with particularity the efforts made by the plaintiff to obtain the action the plaintiff desires from the directors and the reasons for the plaintiff’s failure to obtain the action; or · state the reasons for not making the effort. Additionally, the plaintiff must remain a stockholder through the duration of the derivative suit. The action will not be dismissed or compromised without the approval of the Delaware Court of Chancery. | | --- | --- | --- |

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DESCRIPTION OF AMERICAN DEPOSITARY SHARES

Our Depositary Shares are deposited pursuant to the Second Amended and Restated Deposit Agreement dated December 18, 2023, among the Company, JPMorgan Chase Bank, N.A., as depositary, ands holders and beneficial owners of American Depositary Receipts, or the Deposit Agreement. The depositary registers and delivers the Depositary Shares. Each Depositary Share represents ownership of 100,000 Ordinary Shares that we will deposit with the custodian, as agent of the depositary, under the Deposit Agreement.

The depositary’s office is located at 383 Madison Avenue, Floor 11, New York, NY 10179.

The Depositary Share-to-share ratio is subject to amendment as provided in the form of American Depositary Receipt, or ADR (which may give rise to fees contemplated by the form of ADR). In the future, each Depositary Share will also represent any securities, cash or other property deposited with the depositary but which they have not distributed directly to you.

A beneficial owner is any person or entity having a beneficial ownership interest in Depositary Shares. A beneficial owner need not be the holder of the ADR evidencing such Depositary Share. If a beneficial owner is not an ADR holder, it must rely on the holder of the ADR(s) evidencing such Depositary Shares in order to assert any rights or receive any benefits under the Deposit Agreement. A beneficial owner shall only be able to exercise any right or receive any benefit under the Deposit Agreement solely through the holder of the ADR(s) evidencing the Depositary Shares owned by such beneficial owner. The arrangements between a beneficial owner and the holder of the corresponding ADRs may affect the beneficial owner’s ability to exercise any rights it may have.

An ADR holder shall be deemed to have all requisite authority to act on behalf of any and all beneficial owners of the Depositary Shares evidenced by the ADRs registered in such ADR holder’s name for all purposes under the Deposit Agreement and ADRs. The depositary’s only notification obligations under the Deposit Agreement and the ADRs is to registered ADR holders. Notice to an ADR holder shall be deemed, for all purposes of the Deposit Agreement and the ADRs, to constitute notice to any and all beneficial owners of the Depositary Shares evidenced by such ADR holder’s ADRs.

Unless certificated ADRs are specifically requested, all Depositary Shares will be issued on the books of our depositary in book-entry form and periodic statements will be mailed to you which reflect your ownership interest in such Depositary Shares. In our description, references to American depositary receipts or ADRs shall include the statements you will receive that reflect your ownership of Depositary Shares.

You may hold Depositary Shares either directly or indirectly through your broker or other financial institution. If you hold Depositary Shares directly, by having a Depositary Share registered in your name on the books of the depositary, you are a ADR holder. This description assumes you hold your Depositary Shares directly. If you hold the Depositary Shares through your broker or financial institution nominee, you must rely on the procedures of such broker or financial institution to assert the rights of an ADR holder described in this section. You should consult with your broker or financial institution to find out what those procedures are.

As an ADR holder or beneficial owner, we will not treat you as a shareholder of ours and you will not have any shareholder rights. The laws of England and Wales govern shareholder rights. Because the depositary or its nominee will be the shareholder of record for the Ordinary Share represented by all outstanding Depositary Shares, shareholder rights rest with such record holder. Your rights are those of an ADR holder or of a beneficial owner. Such rights derive from the terms of the Deposit Agreement to be entered into among us, the depositary and all holders and beneficial owners from time to time of ADRs issued under the Deposit Agreement and, in the case of a beneficial owner, from the arrangements between the beneficial owner and the holder of the corresponding ADRs. The obligations of our Company and the depositary and its agents are also set out in the Deposit Agreement. Because the depositary or its nominee will actually be the registered owner of the Ordinary Shares, you must rely on it to exercise the rights of a shareholder on your behalf.

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The Deposit Agreement, the ADRs and the Depositary Shares are governed by the internal laws of the State of New York without giving effect to the application of the conflict of law principles thereof. Under the Deposit Agreement, as an ADR holder or a beneficial owner of Depositary Shares, you agree that any legal suit, action or proceeding against or involving us or the depositary, arising out of or based upon the Deposit Agreement, the Depositary Shares, the ADRs or the transactions contemplated thereby, may only be instituted in the United States District Court for the Southern District of New York (or, in certain cases, the state courts of New York County, New York), and you irrevocably waive any objection which you may have to the laying of venue of any such proceeding and irrevocably submit to the exclusive jurisdiction of such courts in any such suit, action or proceeding.

The following is a summary of what we believe to be the material terms of the Deposit Agreement. Notwithstanding this, because it is a summary, it may not contain all the information that you may otherwise deem important. For more complete information, you should read the entire form of Deposit Agreement and the form of ADR that contains the terms of your Depositary Shares. You can read a copy of the form of Deposit Agreement, which is filed as an exhibit to our Annual Report on Form 20-F for the year ended December 31, 2024, which is filed with the SEC. You may also obtain a copy of the Deposit Agreement at the SEC’s Public Reference Room, which is currently located at 100 F Street, NE, Washington, DC 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-732-0330. You may also find the Annual Report on Form 20-F and the Deposit Agreement on the SEC’s website at http://www.sec.gov.

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Distributions on DepositedSecurities, Sales

How will I receivedividends and other distributions on the Ordinary Shares underlying my Depositary Shares?

We may make various types of distributions with respect to our securities. The depositary has agreed that, to the extent practicable, it will pay to you the cash dividends or other distributions it or the custodian receives on Ordinary Shares or other deposited securities, after converting any cash received into U.S. dollars (if it determines such conversion may be made on a reasonable basis) and, in all cases, making any necessary deductions provided for in the Deposit Agreement. The depositary may utilize a division, branch or affiliate of JPMorgan Chase Bank, N.A. to direct, manage and/or execute any public and/or private sale of securities and/or property under the Deposit Agreement. Such division, branch and/or affiliate may charge the depositary a fee in connection with such sales, which fee is considered an expense of the depositary chargeable to holders of Depositary Shares. All sales of securities will be handled by the depositary in accordance with its then current policies. You will receive these distributions in proportion to the number of underlying securities that your Depositary Shares represent. In all instances where the Deposit Agreement or an ADR refers to a “sale” (or words of similar import) of securities or property, the depositary may, but shall not be obligated, to effect any such sale unless the securities to be sold are listed and publicly traded on a securities exchange or there is a public market for the property to be sold. To the extent the securities are not so listed and publicly traded or there is no public market for the property so distributed by us: (i) the depositary shall, in the event the Deposit Agreement is terminated and the depositary holds deposited securities that are not listed and publicly traded after the termination date of the Deposit Agreement, act in accordance with the termination provisions of the Deposit Agreement and form of ADR in respect of such securities and property; and (ii) in the event the depositary or its custodian receives a distribution other than cash, our Ordinary Shares and/or rights to acquire our Ordinary Shares, and such distribution consists of securities or property that are not distributed by the depositary the depositary will be deemed to have sold the aggregate number of securities and/or property so received for nominal value and shall have no obligation to distribute such securities or any proceeds from the deemed sale thereof to the ADR holders. Furthermore, in the event the depositary endeavors to make a sale of Ordinary Shares, other securities or property, such securities and/or property may be sold in a block sale or single lot transaction.

Except as stated below, the depositary will deliver such distributions to ADR holders in proportion to their interests in the following manner:

Cash. The depositary will distribute any U.S. dollars available to it resulting from a cash dividend or other cash distribution or the net proceeds of sales of any other distribution or portion thereof (to the extent applicable), on an averaged or other practicable basis, subject to (i) appropriate adjustments for taxes withheld, (ii) such distribution being permissible or practicable with respect to certain registered ADR holders, and (iii) deduction of the depositary’s and/or its agents’ fees and expenses in (1) converting any foreign currency to U.S. dollars to the extent that it determines that such conversion may be made on a reasonable basis, (2) transferring foreign currency or U.S. dollars to the United States by such means as the depositary may determine to the extent that it determines that such transfer may be made on a reasonable basis, (3) obtaining any approval or license of any governmental authority required for such conversion or transfer, which is obtainable at a reasonable cost and within a reasonable time and (4) making any sale by public or private means in any commercially reasonable manner. To the extent that any of the deposited securities is not or shall not be entitled, by reason of its date of issuance, or otherwise, to receive the full amount of such cash dividend, distribution, or net proceeds of sales, the depositary shall make appropriate adjustments in the amounts distributed to the ADR holders issued in respect of such deposited securities. To the extent we or the depositary shall be required to withhold and do withhold from any cash dividend, distribution or net proceeds from sales in respect of any deposited securities an amount on account of taxes, the amount distributed on the Depositary Shares issued in respect of such deposited securities shall be reduced accordingly. To the extent the depositary determines in its discretion that it would not be permitted by applicable law, rule or regulation, or it would not otherwise be practicable, to convert foreign currency into U.S. dollars and distribute such U.S. dollars to some or all of the ADR holders entitled thereto, the depositary may in its discretion distribute some or all of the foreign currency received by the depositary as it deems permissible and practicable to, or retain and hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the ADR holders entitled to receive the same. To the extent the depositary retains and holds any cash, foreign currency, securities or other property as permitted under the Deposit Agreement, any and all fees, charges and expenses related to, or arising from, the holding thereof shall be paid from such cash, foreign currency, securities or other property, or the net proceeds from the sale thereof, thereby reducing the amount so held. If exchange rates fluctuate during a time when the depositary cannot convert a foreign currency, you may lose some or all of the value of the distribution.

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| --- | | · | Shares. In the case of a distribution in Ordinary Shares, the depositary will issue additional ADRs to evidence the number of Depositary Shares representing such Ordinary Shares. Only whole Depositary Shares will be issued. Any Ordinary Shares that would result in fractional Depositary Shares will be sold and the net proceeds of the public or private sales of such will be distributed in the same manner as cash to the ADR holders entitled thereto. | | --- | --- |

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| --- | | · | Rights to receive additional Ordinary Shares. In the case of a distribution of rights to subscribe for additional Ordinary Shares or other rights, if we timely provide evidence satisfactory to the depositary that it may lawfully distribute such rights, the depositary will distribute warrants or other instruments in the discretion of the depositary representing such rights. However, if we do not timely furnish such evidence, the depositary may: | | --- | --- | | (i) | sell such rights if practicable and distribute the net proceeds of the public or private sales of such rights in the same manner as cash to the ADR holders entitled thereto; or | | --- | --- | | (ii) | if it is not practicable to sell such rights by reason of the non-transferability of the rights, limited markets therefor, their short duration or otherwise, do nothing and allow such rights to lapse, in which case ADR holders will receive nothing and the rights may lapse. | | --- | --- |

We have no obligation to file a registration statement under the Securities Act in order to make any rights available to ADR holders.

Other Distributions. In the case of a distribution of securities or property other than those described above, the depositary may either (i) distribute such securities or property in any manner it deems equitable and practicable or (ii) to the extent the depositary deems distribution of such securities or property not to be equitable and practicable, sell such securities or property and distribute any net proceeds of public or private sales in the same way it distributes cash.

Elective Distributions. In the case of a dividend payable at the election of our shareholders in cash or in additional Ordinary Shares, we will notify the depositary at least 30 days prior to the proposed distribution stating whether or not we wish such elective distribution to be made available to ADR holders. The depositary shall make such elective distribution available to ADR holders only if (i) we shall have timely requested that the elective distribution is available to ADR holders, (ii) the depositary shall have determined that such distribution is reasonably practicable and (iii) the depositary shall have received satisfactory documentation within the terms of the Deposit Agreement including any legal opinions of counsel that the depositary in its reasonable discretion may request. If the above conditions are not satisfied, the depositary shall, to the extent permitted by law, distribute to the ADR holders, on the basis of the same determination as is made in the local market in respect of the Ordinary Shares for which no election is made, either (x) cash or (y) additional Depositary Shares representing such additional Ordinary Shares. If the above conditions are satisfied, the depositary shall establish procedures to enable ADR holders to elect the receipt of the proposed dividend in cash or in additional Depositary Shares. There can be no assurance that ADR holders or beneficial owners of Depositary Shares generally, or any ADR holder or beneficial owner of Depositary Shares in particular, will be given the opportunity to receive elective distributions on the same terms and conditions as the holders of Ordinary Shares.

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If the depositary determines in its sole discretion that any distribution described above is not practicable with respect to any or all ADR holders, the depositary may choose any method of distribution that it deems practicable for such ADR holder, including the distribution of some or all of any cash, foreign currency, securities or other property (or appropriate documents evidencing the right to receive some or all of any such cash, foreign currency, security or other property), and/or it may retain some or all of such items, without paying interest on or investing them, on behalf of the ADR holder as deposited securities, in which case the Depositary Shares will also represent the retained items. To the extent the depositary does not reasonably believe it will be permitted by applicable law, rule or regulation to convert foreign currency into U.S. dollars and distribute such U.S. dollars to some or all of the ADR holders, the depositary may in its discretion distribute the foreign currency received by the depositary to, or hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the ADR holders entitled to receive the same. To the extent the depositary holds such foreign currency, any and all costs and expenses related to, or arising from, the holding of such foreign currency shall be paid from such foreign currency thereby reducing the amount so held.

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Any U.S. dollars will be paid via wire transfer and/or distributed by checks drawn on a bank in the United States for whole dollars and cents. Fractional cents will be withheld without liability and dealt with by the depositary in accordance with its then current practices.

The depositary is notresponsible if it fails to determine that any distribution or action is lawful or reasonably practicable.

There can be no assurancethat the depositary will be able to convert any currency at a specified exchange rate or sell any property, rights, shares or other securitiesat a specified price, nor that any of such transactions can be completed within a specified time period. All purchases and sales of securitieswill be handled by the depositary in accordance with its then current policies, which are currently set forth on the “Disclosures”page (or successor page) of www.adr.com (as updated by the depositary from time to time, “ADR.com”).

Deposit, Withdrawal and Cancellation

How does the depositary issue Depositary Shares?

The depositary will issue Depositary Shares if you or your broker deposit Ordinary Shares or evidence of rights to receive Ordinary Shares with the custodian and pay the fees and expenses owing to the depositary in connection with such issuance.

In connection with the deposit of Ordinary Shares, the depositary or its custodian may require the following in a form satisfactory to it: (i) a written order directing the depositary to issue to, or upon the written order of, the person or persons designated in such order Depositary Shares representing such deposited Shares; (ii) proper endorsements or duly executed instruments of transfer in respect of such deposited Shares; (iii) instruments assigning to the depositary, its custodian or a nominee of either any distribution on or in respect of such deposited shares or indemnity therefor; and (iv) proxies entitling the custodian to vote such deposited shares. The deposited Ordinary Shares and any such additional items are referred to as “deposited securities.” As soon as practicable after the custodian receives deposited securities pursuant to any such deposit or pursuant to a distribution or change affecting deposited securities, the custodian shall present such deposited securities for registration of transfer into the name of the depositary, its custodian or a nominee of either, in each case for the benefit of ADR holders, to the extent such registration is practicable, at the cost and expense of the person making such deposit (or for whose benefit such deposit is made) and shall obtain evidence satisfactory to it of such registration.

The custodian will hold all deposited securities for the account and to the order of the depositary, in each case for the benefit of ADR holders, to the extent not prohibited by law. ADR holders and beneficial owners thus have no direct ownership interest in the Ordinary Shares and only have such rights as are contained in the Deposit Agreement. The custodian will also hold any additional securities, property and cash received on or in substitution for the deposited securities.

Deposited securities are not intended to, and shall not, constitute proprietary assets of the depositary, the custodian or their nominees. Beneficial ownership in deposited securities is intended to be, and shall at all times during the term of the Deposit Agreement continue to be, vested in the beneficial owners of the Depositary Shares representing such deposited securities. Notwithstanding anything else contained herein, in the Deposit Agreement, in the form of ADR and/or in any outstanding Depositary Shares, the depositary, the custodian and their respective nominees are intended to be, and shall at all times during the term of the Deposit Agreement be, the record holder(s) only of the deposited securities represented by the Depositary Shares for the benefit of the ADR holders. The depositary, on its own behalf and on behalf of the custodian and their respective nominees, disclaims any beneficial ownership interest in the deposited securities held on behalf of the ADR holders.

Upon each deposit of Ordinary Shares, receipt of related delivery documentation and compliance with the other provisions of the Deposit Agreement, including the payment of the fees and charges of the depositary and any taxes or other fees or charges owing, the depositary will issue an ADR or ADRs in the name or upon the order of the person entitled thereto evidencing the number of Depositary Shares to which such person is entitled. All of the Depositary Shares issued will, unless specifically requested to the contrary, be part of the depositary’s direct registration system, and a registered holder will receive periodic statements from the depositary which will show the number of Depositary Shares registered in such ADR holder’s name. An ADR holder can request that the Depositary Shares not be held through the depositary’s direct registration system and that a certificated ADR be issued.

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How do ADR holders cancel a Depositary Share and obtain depositedsecurities?

When you turn in your ADR certificate at the depositary’s office, or when you provide proper instructions and documentation in the case of direct registration Depositary Shares, subject to the provisions of or governing our Ordinary Shares (including, without limitation, our governing documents and all applicable laws, rules and regulations), the depositary will, upon payment of certain applicable fees, charges and taxes, deliver the underlying Ordinary Shares to you or upon your written order. Delivery of deposited securities in certificated form will be made at the custodian’s office (or from the custodian to the extent dematerialized). At your risk, expense and request, the depositary may deliver deposited securities (including any certificates therefor) at such other place as you may request.

The depositary may only restrict the withdrawal of deposited securities in connection with:

·	temporary delays caused by closing our transfer books or those of the depositary or the deposit of Ordinary Shares in connection with voting at a shareholders’ meeting, or the payment of dividends;
·	the payment of fees, taxes and similar charges; or
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·	compliance with any U.S. or foreign laws or governmental regulations relating to the ADRs or to the withdrawal<br>of deposited securities.
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This right of withdrawal may not be limited by any other provision of the Deposit Agreement.

Record Dates

The depositary may, after consultation with us if practicable, fix record dates (which, to the extent applicable, shall be as near as practicable to any corresponding record dates set by us) for the determination of the registered ADR holders who will be entitled (or obligated, as the case may be):

·	to receive any distribution on or in respect of deposited securities,
·	to give instructions for the exercise of voting rights,
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·	to pay any fees assessed by, or owing to, the depositary for administration of the ADR program and for any expenses as provided for in the ADR, or
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·	to receive any notice or to act or be obligated in respect of other matters, all subject to the provisions<br>of the Deposit Agreement.
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Voting Rights

How do I vote?

If you are an ADR holder and the depositary asks you to provide it with voting instructions, you may instruct the depositary how to exercise the voting rights for the Ordinary Shares which underlie your Depositary Shares. As soon as practicable after receipt from us of notice of any meeting at which the holders of Ordinary Shares are entitled to vote, or of our solicitation of consents or proxies from holders of Ordinary Shares, the depositary shall fix the Depositary Share record date in accordance with the provisions of the Deposit Agreement, provided that if the depositary receives a written request from us in a timely manner and at least thirty (30) days prior to the date of such vote or meeting, the depositary shall, at our expense, distribute to the registered ADR holders a “voting notice” stating (i) final information particular to such vote and meeting and any solicitation materials, (ii) that each ADR holder on the record date set by the depositary will, subject to any applicable provisions of the laws of England and Wales, be entitled to instruct the depositary as to the exercise of the voting rights, if any, pertaining to the deposited securities represented by the Depositary Shares evidenced by such ADR holder’s ADRs and (iii) the manner in which such instructions may be given, including instructions for giving a discretionary proxy to a person designated by us. Each ADR holder shall be solely responsible for the forwarding of voting notices to the beneficial owners of Depositary Shares registered in such ADR holder’s name. There is no guarantee that ADR holders and beneficial owners generally or any holder or beneficial owner in particular will receive the notice described above with sufficient time to enable such ADR holder or beneficial owner to return any voting instructions to the depositary in a timely manner.

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Following actual receipt by the ADR department responsible for proxies and voting of ADR holders’ instructions (including, without limitation, instructions of any entity or entities acting on behalf of the nominee for The Depositary Trust Company, or DTC), the depositary shall, in the manner and on or before the time established by the depositary for such purpose, endeavor to vote or cause to be voted the deposited securities represented by the Depositary Shares evidenced by such ADR holders’ ADRs in accordance with such instructions insofar as practicable and permitted under the provisions of or governing deposited securities.

ADR holders are strongly encouraged to forward their voting instructions to the depositary as soon as possible. For instructions to be valid, the ADR department of the depositary that is responsible for proxies and voting must receive them in the manner and on or before the time specified, notwithstanding that such instructions may have been physically received by the depositary prior to such time. The depositary will not itself exercise any voting discretion in respect of deposited securities. The depositary and its agents will not be responsible for any failure to carry out any instructions to vote any of the deposited securities, for the manner in which any voting instructions are given, including instructions to give a discretionary proxy to a person designated by us, for the manner in which any vote is cast, including, without limitation, any vote cast by a person to whom the depositary is instructed to grant a discretionary proxy pursuant to the terms of the Deposit Agreement, or for the effect of any such vote. Notwithstanding anything contained in the Deposit Agreement or any ADR, the depositary may, to the extent not prohibited by any law, rule or regulation, or by the rules, regulations or requirements of any stock exchange on which the Depositary Shares are listed, in lieu of distribution of the materials provided to the depositary in connection with any meeting of or solicitation of consents or proxies from holders of deposited securities, distribute to the registered holders of ADRs a notice that provides such ADR holders with or otherwise publicizes to such ADR holders instructions on how to retrieve such materials or receive such materials upon request (i.e., by reference to a website containing the materials for retrieval or a contact for requesting copies of the materials).

There is no guarantee that you will receive voting materials in time to instruct the depositary to vote and it is possible that you, or persons who hold their Depositary Shares through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote.

Reports and Other Communications

Will ADR holders be able to view our reports?

The Deposit Agreement, the provisions of or governing deposited securities, and any written communications from us which are both received by the custodian or its nominee as a holder of deposited securities and made generally available to the holders of deposited securities, are available for inspection by ADR holders at the offices of the depositary in the United States, on the SEC’s internet website or upon request to the depositary (which request may be refused by the depositary at its discretion).

Additionally, if we make any written communications generally available to holders of our Ordinary Shares, and we furnish copies thereof (or English translations or summaries) to the depositary, it will distribute the same to registered ADR holders.

Fees and Expenses

What fees and expenses will I be responsible for paying?

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The following additional fees, charges and expenses shall also be incurred by the ADR holders, the beneficial owners, by any party depositing or withdrawing Ordinary Shares or by any party surrendering Depositary Shares and/or to whom Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the Depositary Shares or the deposited securities or a distribution of Depositary Shares), whichever is applicable:

·	a fee of up to U.S.$0.05 per Depositary Share held for any cash distribution made, or for any elective cash/stock dividend offered, pursuant to the Deposit Agreement;
·	an aggregate fee of up to US$0.05 per Depositary Share per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision);
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·	an amount for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian, as well as charges and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law, rule or regulation relating to foreign investment) in connection with the servicing of the Ordinary Shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions);
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·	a fee of up to $0.05 per Depositary Share held for the direct or indirect distribution of securities (other than Depositary Shares or rights to purchase additional Depositary Shares) or the net cash proceeds from the public or private sale of such securities, regardless of whether any such distribution and/or sale is made by, for, or received from, or (in each case) on behalf of, the depositary, us and/or any third party (which fee may be assessed against ADR holders as of a record date set by the depositary);
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·	stock transfer or other taxes and other governmental charges;
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·	a transaction fee per cancellation request (including any cancellation request made through SWIFT, facsimile transmission or any other method of communication) as disclosed on the “Disclosures” page (or successor page) of www.adr.com (as updated by the depositary from time to time, “ADR.com“) and any applicable delivery expenses (which are payable by such persons or ADR holders);
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·	transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and
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·	fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage<br>and/or execute any public and/or private sale of securities under the Deposit Agreement.
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We will pay all other fees, charges and expenses of the depositary and any agent of the depositary (except the custodian) pursuant to agreements from time to time between us and the depositary.

The fees and charges described above may be amended from time to time by agreement between us and the depositary.

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Payment of Taxes

Reclassifications, Recapitalizations and Mergers

If we take certain actions that affect the deposited securities, including (i) any change in par value, split-up, consolidation, cancellation or other reclassification of deposited securities or (ii) any distributions of Ordinary Shares or other property not made to holders of ADRs or (iii) any recapitalization, reorganization, merger, consolidation, liquidation, receivership, bankruptcy or sale of all or substantially all of our assets, then the depositary may choose to, and shall if reasonably requested by us:

·	amend the form of ADR;
·	distribute additional or amended ADRs;
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·	distribute cash, securities or other property it has received in connection with such actions;
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·	sell by public or private sale any securities or property received and distribute the proceeds as cash; or
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·	none of the above.
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If the depositary does not choose any of the above options, any of the cash, securities or other property it receives will constitute part of the deposited securities and each Depositary Share will then represent a proportionate interest in such property.

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Amendment and Termination

How may the Deposit Agreement be amended?

We may agree with the depositary to amend the Deposit Agreement and the Depositary Shares without your consent for any reason. ADR holders must be given at least thirty (30) days’ notice of any amendment that imposes or increases any fees on a per Depositary Share basis, charges or expenses (other than stock transfer or other taxes and other governmental charges, transfer or registration fees, a transaction fee per cancellation request (including any cancellation request made through SWIFT, facsimile transmission or any other method of communication), applicable delivery expenses or other such fees, charges or expenses), or otherwise prejudices any substantial existing right of ADR holders or beneficial owners. Such notice need not describe in detail the specific amendments effectuated thereby, but must identify to ADR holders and beneficial owners a means to access the text of such amendment. If an ADR holder or beneficial owner continues to hold an ADR or ADRs, or an interest therein, after being so notified, such ADR holder and any beneficial owner are deemed to agree to such amendment and to be bound by the Deposit Agreement as so amended. No amendment, however, will impair your right to surrender your Depositary Shares and receive the underlying securities, except in order to comply with mandatory provisions of applicable law.

Any amendments or supplements that (i) are reasonably necessary (as agreed by us and the depositary) in order for (a) the Depositary Shares to be registered on Form F-6 under the Securities Act or (b) the Depositary Shares or Ordinary Shares to be traded solely in electronic book-entry form and (ii) do not in either such case impose or increase any fees or charges to be borne by ADR holders, shall be deemed not to prejudice any substantial rights of ADR holders or beneficial owners. Notwithstanding the foregoing, if any governmental body or regulatory body should adopt new laws, rules or regulations that would require amendment or supplement of the Deposit Agreement or the form of ADR to ensure compliance therewith, we and the depositary may amend or supplement the Deposit Agreement and the form of ADR (and all outstanding ADRs) at any time in accordance with such changed laws, rules or regulations. Such amendment or supplement to the Deposit Agreement in such circumstances may become effective before a notice of such amendment or supplement is given to ADR holders or within any other period of time as required for compliance.

Notice of any amendment to the Deposit Agreement or form of ADRs shall not need to describe in detail the specific amendments effectuated thereby, and failure to describe the specific amendments in any such notice shall not render such notice invalid, provided, however, that, in each such case, the notice given to the ADR holders identifies a means for ADR holders and beneficial owners to retrieve or receive the text of such amendment (i.e., upon retrieval from the SEC’s, the depositary’s or our website or upon request from the depositary).

How may the Deposit Agreement be terminated?

The depositary may at any time, and shall at our written direction, terminate the Deposit Agreement and the ADRs by mailing notice of such termination to the registered holders of ADRs at least thirty (30) days prior to the date fixed in such notice for such termination; provided, however, if the depositary shall have (i) resigned as depositary under the Deposit Agreement, notice of such termination by the depositary shall not be provided to registered ADR holders unless a successor depositary shall not be operating under the Deposit Agreement within sixty (60) days of the date of such resignation, and (ii) been removed as depositary under the Deposit Agreement, notice of such termination by the depositary shall not be provided to registered holders of ADRs unless a successor depositary shall not be operating under the Deposit Agreement on the 60th day after our notice of removal was first provided to the depositary. Notwithstanding anything to the contrary in the Deposit Agreement, the depositary may terminate the Deposit Agreement (a) without notifying us, but subject to giving thirty (30) days’ notice to the ADR holders, under the following circumstances: (i) in the event of our bankruptcy, liquidation proceedings or insolvency, (ii) if our Depositary Shares are delisted from a “national securities exchange” (that has registered with the Commission under Section 6 of the Securities Exchange Act of 1934, as amended), (iii) if we effect (or will effect) a redemption of all or substantially all of the deposited securities, or a cash or share distribution representing a return of all or substantially all of the value of the deposited securities, (iv) there are no deposited securities with respect to Depositary Shares remaining, including if the deposited securities are cancelled, or the deposit securities have been deemed to have no value, or (v) there occurs a merger, consolidation, sale of assets or other transaction as a result of which securities or other property are delivered in exchange for or in lieu of deposited securities, and (b) immediately without prior notice to the Company, any ADR holder or beneficial owner or any other person if (i) required by any law, rule or regulation relating to sanctions by any governmental authority or body, (ii) the depositary would be subject to liability under or pursuant to any law, rule or regulation, or (iii) required by any governmental authority or body, in each case under (b) as determined by the depositary in its reasonable discretion.

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If our Ordinary Shares are not listed and publicly traded on a stock exchange or in a securities market as of the date so fixed for termination or if, for any reason, the depositary does not sell the deposited securities, then after such date fixed for termination, the depositary shall use its reasonable efforts to ensure that the Depositary Shares cease to be eligible for settlement within DTC and that neither DTC nor any of its nominees shall thereafter be an ADR holder. At such time as the Depositary Shares cease to be DTC eligible and/or neither DTC nor any of its nominees is an ADR holder, to the extent we are not, to the depositary’s knowledge, insolvent or in bankruptcy or liquidation, the depositary shall (A) cancel all outstanding ADRs; (B) request DTC to provide the depositary with information on those holding Depositary Shares through DTC and, upon receipt thereof, revise the ADR register to reflect the information provided by DTC; (C) instruct its custodian to deliver all deposited securities to us, a subsidiary or affiliate of ours (the company representative) or an independent trust company engaged by us (the trustee) to hold those deposited securities in trust for the beneficial owners of the ADRs if we are not permitted to hold any of the deposited securities under applicable law and/or we have directed the depositary to deliver such deposited securities to the company representative or trustee along with a stock transfer form and/or such other instruments of transfer covering such deposited securities as are needed under applicable law, in either case referring to the names set forth on the ADR register and (D) provide us with a copy of the ADR register.

Upon receipt of any instrument of transfer covering such deposited securities and the ADR Register, we have agreed that we will, depending on what is legally required under local law, either deliver to each person reflected on such ADR register appropriate documentation to effect the transfer to such persons of the deposited securities previously represented by the Depositary Shares evidenced by their ADRs, approve the transfer of the deposited securities previously represented by their ADRs to the persons listed on the ADR register (as applicable), procure the relevant updates to the register of members of the Company to reflect the transfer of the deposited securities previously represented by their ADRs to the persons listed on the ADR register (as applicable) and provide the depositary with a certified copy of the updated register of our shareholders.

To the extent the depositary reasonably believes that we are insolvent, or if we are in receivership, have filed for bankruptcy and/or are otherwise in restructuring, administration or liquidation, and in any such case the deposited securities are not listed and publicly traded on a securities exchange after the termination date, or if, for any reason, the depositary believes it is not able to or cannot practicably sell the deposited securities promptly and without undue effort, the deposited securities shall be deemed to have no value (and such holder shall be deemed to have instructed the depositary that the deposited securities have no value). The depositary may (and, by holding an ADR or an interest therein, all holders irrevocably consent and agree that the depositary may) instruct its custodian to deliver all deposited securities to us (acting, as applicable by an administrator, receiver, administrative receiver, liquidator, provisional liquidator, restructuring officer, interim restructuring officer, trustee, controller or other entity overseeing the bankruptcy, insolvency, administration, restructuring or liquidation process) and notify us that the deposited securities are surrendered for no consideration. The Deposit Agreement requires us, subject to applicable law, to promptly accept the surrender of the deposited securities for no consideration and deliver to the depositary a written notice confirming (A) the acceptance of the surrender of the deposited securities for no consideration and (B) the cancellation of such deposited securities. Promptly after notifying us that the deposited securities are surrendered for no consideration and irrespective of whether we haves complied with the immediately preceding sentence, the depositary shall notify ADR holders that their Depositary Shares have been cancelled with no consideration being payable to such ADR holders.

Upon the depositary’s compliance with the provisions of any of the above three paragraphs, the depositary and its agents shall be discharged from all, and cease to have any, obligations under the Deposit Agreement and the ADRs.

If our Ordinary Shares are listed and publicly traded on a securities exchange and the depositary believes that it is able, permissible and practicable to sell the deposited securities without undue effort, then the depositary may endeavor to publicly or privately sell (as long as it may lawfully do so) the deposited securities, which sale may be effected in a block sale/single lot transaction and, after the settlement of such sale(s), to the extent legally permissible and practicable, distribute or hold in an account (which may be a segregated or unsegregated account) the net proceeds of such sale(s), less any amounts owing to the depositary (including, without limitation, cancellation fees), together with any other cash then held by it under the Deposit Agreement, in trust, without liability for interest, for the pro rata benefit of the holders entitled thereto. After making such sale, the depositary shall be discharged from all obligations in respect of the Deposit Agreement and the ADRs, except to account for such net proceeds and other cash.

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Limitations on Obligations and Liability

Limits on our obligations and the obligationsof the depositary; limits on liability to ADR holders, beneficial owners and others

Prior to the issue, registration, registration of transfer, split-up, combination, or cancellation of any ADRs, or the delivery of any distribution in respect thereof, and from time to time in the case of the production of proofs as described below, we or the depositary or its custodian may require:

·	payment with respect thereto of (i) any stock transfer or other tax or other governmental charge, (ii) any stock transfer or registration fees in effect for the registration of transfers of Ordinary Shares or other deposited securities upon any applicable register and (iii) any applicable fees and expenses described in the Deposit Agreement;
·	the production of proof satisfactory to it of (i) the identity of any signatory and genuineness of any signature and (ii) such other information, including without limitation, information as to citizenship, residence, exchange control approval, beneficial or other ownership of, or interest in, any securities, compliance with applicable law, regulations, provisions of or governing deposited securities and terms of the Deposit Agreement and the ADRs, as it may deem necessary or proper; and
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·	compliance with such regulations as the depositary may establish consistent with the Deposit Agreement<br>or as the depositary believes are required, necessary or advisable in order to comply with applicable laws, rules and regulations.
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The issuance of ADRs, the acceptance of deposits of Ordinary Shares, the registration, registration of transfer, split-up or combination of ADRs or the withdrawal of Ordinary Shares, may be suspended, generally or in particular instances, when the ADR register or any register for deposited securities is closed or when any such action is deemed required, necessary or advisable by the depositary for any reason provided that the ability to withdraw Ordinary Shares may only be limited under the following circumstances: (i) temporary delays caused by closing transfer books of the depositary or our transfer books or the deposit of Ordinary Shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes, and similar charges, and (iii) compliance with any laws or governmental regulations relating to ADRs or to the withdrawal of deposited securities. The depositary may close the ADR register (and/or any portion thereof) at any time or from time to time when deemed expedient by it.

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The Deposit Agreement expressly limits the obligations and liability of the depositary, the depositary’s custodian or ourselves and each of our and their respective directors, officers, employees, agents and affiliates, provided, however, that no provision of the Deposit Agreement is intended to constitute a waiver or limitation of any rights that ADR holders or beneficial owners may have under the Securities Act or the Securities Exchange Act of 1934, to the extent applicable. The Deposit Agreement provides that each of us, the depositary and our respective directors, officers, employees, agents and affiliates will:

·	incur or assume no liability (including, without limitation, to ADR holders or beneficial owners) if any<br>present or future law, rule, regulation, fiat, order or decree of the United States, England, Wales or any other country or jurisdiction,<br>or of any governmental or regulatory authority or any securities exchange or market or automated quotation system, the provisions of or<br>governing any Deposited Securities, any present or future provision of the Company’s charter, any act of God, war, terrorism, epidemic,<br>pandemic, nationalization, expropriation, currency restrictions, extraordinary market conditions, work stoppage, strike, civil unrest,<br>revolutions, rebellions, explosions, cyber, ransomware or malware attack, computer failure or circumstance our, the depositary’s<br>or our respective directors’, officers’, employees’, agents’ or affiliates’ direct and immediate control<br>shall prevent or delay, or shall cause any of them to be subject to any civil or criminal penalty in connection with, any act which the<br>Deposit Agreement or the ADRs provide shall be done or performed by any such party (including, without limitation, voting);
·	incur or assume no liability (including, without limitation, to ADR holders or beneficial owners) by reason of any nonperformance or delay, caused as aforesaid, in the performance of any act or things which by the terms of the Deposit Agreement it is provided shall or may be done or performed or any exercise or failure to exercise discretion under the Deposit Agreement or the ADRs including, without limitation, any failure to determine that any distribution or action may be lawful or reasonably practicable;
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·	incur or assume no liability (including, without limitation, to holders or beneficial owners) if it performs its obligations specifically set forth in the Deposit Agreement and ADRs without gross negligence or willful misconduct;
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·	in the case of the depositary and its agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the Depositary Shares or the ADRs;
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·	in the case of us and our agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the Depositary Shares or the ADRs, which in our or our agents’ opinion, as the case may be, may involve us in expense or liability, unless indemnity satisfactory to us or our agent, as the case may be against all expense (including fees and disbursements of counsel) and liability is furnished as often as may be requested;
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·	not be liable (including, without limitation, to ADR holders or beneficial owners) for any action or inaction by it in reliance upon the advice of or information from any legal counsel, any accountant, any person presenting Ordinary Shares for deposit, any registered holder of ADRs, or any other person believed by it to be competent to give such advice or information and/or, in the case of the depositary, from us; or
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·	may rely and shall be protected in acting upon any written notice, request, direction, instruction or<br>document believed by it to be genuine and to have been signed, presented or given by the proper party or parties.
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The depositary shall not be a fiduciary or have any fiduciary duty to ADR holders or beneficial owners.

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The depositary and its agents may fully respond to any and all demands or requests for information maintained by or on its behalf in connection with the Deposit Agreement, any registered holder or holders of ADRs, any ADRs or otherwise related to the Deposit Agreement or ADRs to the extent such information is requested or required by or pursuant to any lawful authority, including without limitation laws, rules, regulations, administrative or judicial process, banking, securities or other regulators. The depositary shall not be liable for the acts or omissions made by, or the insolvency of, any securities depository, clearing agency or settlement system. Furthermore, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, the insolvency of any custodian that is not a branch or affiliate of JP Morgan. Notwithstanding anything to the contrary contained in the Deposit Agreement or any ADRs, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, any act or omission to act on the part of the custodian except to the extent that any registered ADR holder has incurred liability directly as a result of the custodian having (i) committed fraud or willful misconduct in the provision of custodial services to the depositary or (ii) failed to use reasonable care in the provision of custodial services to the depositary as determined in accordance with the standards prevailing in the jurisdiction in which the custodian is located. The depositary and the custodian(s) may use third party delivery services and providers of information regarding matters such as, but not limited to, pricing, proxy voting, corporate actions, class action litigation and other services in connection with the ADRs and the Deposit Agreement, and use local agents to provide services such as, but not limited to, attendance at any meetings of security holders of issuers. Although the depositary and the custodian will use reasonable care (and cause their agents to use reasonable care) in the selection and retention of such third-party providers and local agents, they will not be responsible for any errors or omissions made by them in providing the relevant information or services.

The depositary has no obligation to inform ADR holders or beneficial owners about the requirements of the laws, rules or regulations or any changes therein or thereto of England, Wales, the United States or any other country or jurisdiction or of any governmental or regulatory authority or any securities exchange or market or automated quotation system.

Additionally, none of the depositary, the custodian or us, or any of their or our respective directors, officers, employees, agents or affiliates shall be liable for the failure by any registered holder of ADRs or beneficial owner to obtain the benefits of credits or refunds of non-U.S. tax paid against such ADR holder’s or beneficial owner’s income tax liability. The depositary is under no obligation to provide the ADR holders and beneficial owners, or any of them, with any information about our tax status. None of us, the depositary, the custodian or any of our or their respective directors, officers, employees, agents or affiliates shall incur any liability for any tax or tax consequences that may be incurred by registered ADR holders or beneficial owners on account of their ownership or disposition of ADRs or Depositary Shares.

Neither the depositary nor its agents will be responsible for any failure to carry out any instructions to vote any of the deposited securities, for the manner in which any voting instructions are given, including instructions to give a discretionary proxy to a person designated by us, for the manner in which any vote is cast, including, without limitation, any vote cast by a person to whom the depositary is instructed to grant a discretionary proxy pursuant to the terms of the Deposit Agreement, or for the effect of any such vote. The depositary shall endeavor to effect any sale of securities or other property and any conversion of currency, securities or other property, in each case as is referred to or contemplated in the Deposit Agreement or the form of ADR, in accordance with the depositary’s normal practices and procedures under the circumstances applicable to such sale or conversion, but shall have no liability (in the absence of its own willful default or gross negligence or that of its agents, officers, directors or employees) with respect to the terms of any such sale or conversion, including the price at which such sale or conversion is effected, or if such sale or conversion shall not be practicable, or shall not be believed, deemed or determined to be practicable by the depositary. Specifically, the depositary shall not have any liability for the price received in connection with any public or private sale of securities (including, without limitation, for any sale made at a nominal price), the timing thereof or any delay in action or omission to act nor shall it be responsible for any error or delay in action, omission to act, default or negligence on the part of the party so retained in connection with any such sale or proposed sale. The depositary shall not incur any liability in connection with or arising from any failure, inability or refusal by us or any other party, including any share registrar, transfer agent or other agent appointed by us, the depositary or any other party, to process any transfer, delivery or distribution of cash, shares, other securities or other property, including without limitation upon the termination of the Deposit Agreement, or otherwise to comply with any provisions of the Deposit Agreement that are applicable to it. The depositary may rely upon instructions from us or our counsel in respect of any approval or license required for any currency conversion, transfer or distribution. The depositary shall not incur any liability for the content of any information submitted to it by us or on our behalf for distribution to ADR holders or for any inaccuracy of any translation thereof, for any investment risk associated with acquiring an interest in the deposited securities, for the validity or worth of the deposited securities, for the credit-worthiness of any third party, for allowing any rights to lapse upon the terms of the Deposit Agreement or for the failure or timeliness of any notice from us. The depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the depositary or in connection with any matter arising wholly after the removal or resignation of the depositary.

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We have agreed to indemnify the depositary under certain circumstances and the depositary has agreed to indemnify us under certain circumstances.

Notwithstanding any other provision of the Deposit Agreement or the ADRs to the contrary, neither we nor the depositary, nor any of their respective agents shall be liable to the other for any indirect, special, punitive or consequential damages or lost profits, in each case of any form incurred by any of them or any other person or entity (including, without limitation, holders and beneficial owners), whether or not foreseeable and regardless of the type of action in which such a claim may be brought, collectively Special Damages, except (i) to the extent such Special Damages arise from the gross negligence or willful misconduct of the party from whom indemnification is sought or (ii) to the extent Special Damages arise from or out of a claim brought by a third party (including, without limitation, holders and beneficial owners) against the depositary or its agents acting under the Deposit Agreement, except to the extent such Special Damages arise out of the gross negligence or willful misconduct of the party seeking indemnification hereunder.

In the Deposit Agreement each party thereto (including, for avoidance of doubt, each ADR holder and beneficial owner) irrevocably waives, to the fullest extent permitted by applicable law, any right it may have to a trial by jury in any suit, action or proceeding against the depositary and/or us directly or indirectly arising out of or relating to the Ordinary Shares or other deposited securities, the Depositary Shares or the ADRs, the Deposit Agreement or any transaction contemplated therein, or the breach thereof (whether based on contract, tort, common law or any other theory).

No provision of the Deposit Agreement or the ADRs is intended to constitute a waiver or limitation of any rights which an ADR holder or any beneficial owner may have under the Securities Act or Exchange Act, to the extent applicable.

The depositary and its agents may own and deal in any class of securities of our Company and our affiliates and in Depositary Shares.

Disclosure of Interest in Depositary Shares

To the extent that the provisions of or governing any deposited securities may require disclosure of or impose limits on beneficial or other ownership of, or interest in, deposited securities, other Ordinary Shares and other securities and may provide for blocking transfer, voting or other rights to enforce such disclosure or limits, you as ADR holders or beneficial owners agree to comply with all such disclosure requirements and ownership limitations and to comply with any reasonable instructions we may provide in respect thereof We reserve the right to instruct ADR holders (and through any such ADR holder, the beneficial owners of Depositary Shares evidenced by the ADRs registered in such ADR holder’s name) to deliver their Depositary Shares for cancellation and withdrawal of the deposited securities so as to permit us to deal directly with the ADR holder and/or beneficial owner of Depositary Shares as a holder of shares and, by holding a Depositary Share or an interest therein, ADR holders and beneficial owners of Depositary Shares will be agreeing to comply with such instructions.

Each ADR holder agrees to provide such information as the Company may request in a disclosure notice, or a Disclosure Notice, given pursuant to the Companies Act or the Articles of Association of the Company. Each ADR holder acknowledges that it understands that failure to comply with a Disclosure Notice may result in the imposition of sanctions against the holder of the underlying Ordinary Shares in respect of which the non-complying person is or was, or appears to be or has been, interested as provided in the Companies Act and the Articles of Association which currently may include, subject to the granting of an appropriate order by the court, the withdrawal of the voting rights of such Ordinary Shares and the imposition of restrictions on the rights to receive dividends on and to transfer such Ordinary Shares. In addition, each ADR holder agrees to comply with the provisions of the Disclosure Guidance and Transparency Rules published by the United Kingdom Financial Conduct Authority (as amended from time to time) with regard to the notification to the Company of interests in Ordinary Shares underlying Depositary Shares and certain financial instruments, which currently provide, inter alia, that an ADR holder must notify the Company of the percentage of its voting rights he holds as a shareholder or holds or is deemed to hold through his direct or indirect holding of certain financial instruments (or a combination of such holdings) if the percentage of those voting rights reaches, exceeds or falls below specified thresholds.

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Books of Depositary

The depositary or its agent will maintain a register for the registration, registration of transfer, combination and split-up of ADRs, which register shall include the depositary’s direct registration system. Registered holders of ADRs may inspect such records at the depositary’s office at all reasonable times, but solely for the purpose of communicating with other ADR holders in the interest of the business of our Company or a matter relating to the Deposit Agreement. Such register (and/or any portion thereof) may be closed at any time or from time to time, when deemed expedient by the depositary.

The depositary will maintain facilities for the delivery and receipt of ADRs.

Appointment

In the Deposit Agreement, each registered holder of ADRs and each beneficial owner, upon acceptance of any Depositary Shares or ADRs (or any interest in any of them) issued in accordance with the terms and conditions of the Deposit Agreement will be deemed for all purposes to:

·	be a party to and bound by the terms of the Deposit Agreement and the applicable ADR or ADRs,
·	appoint the depositary its attorney-in-fact, with full power to delegate, to act on its behalf and to take any and all actions contemplated in the Deposit Agreement and the applicable ADR or ADRs, to adopt any and all procedures necessary to comply with applicable laws and to take such action as the depositary in its sole discretion may deem necessary or appropriate to carry out the purposes of the Deposit Agreement and the applicable ADR and ADRs, the taking of such actions to be the conclusive determinant of the necessity and appropriateness thereof; and
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·	acknowledge and agree that (i) nothing in the Deposit Agreement or any ADR shall give rise to a partnership<br>or joint venture among the parties thereto, nor establish a fiduciary or similar relationship among such parties, (ii) the depositary,<br>its divisions, branches and affiliates, and their respective agents, may from time to time be in the possession of non-public information<br>about us, ADR holders, beneficial owners and/or their respective affiliates, (iii) the depositary and its divisions, branches and affiliates<br>may at any time have multiple banking relationships with us, ADR holders, beneficial owners and/or the affiliates of any of them, (iv)<br>the depositary and its divisions, branches and affiliates may, from time to time, be engaged in transactions in which parties adverse<br>to us, ADR holders, or beneficial owners may have interests, (v) nothing contained in the Deposit Agreement or any ADR(s) shall (A) preclude<br>the depositary or any of its divisions, branches or affiliates from engaging in any such transactions or establishing or maintaining any<br>such relationships, or (B) obligate the depositary or any of its divisions, branches or affiliates to disclose any such transactions or<br>relationships or to account for any profit made or payment received in any such transactions or relationships, (vi) the depositary shall<br>not be deemed to have knowledge of any information held by any branch, division or affiliate of the depositary and (vii) notice to an<br>ADR holder shall be deemed, for all purposes of the Deposit Agreement and the ADRs, to constitute notice to any and all beneficial owners<br>of the Depositary Shares evidenced by such ADR holder’s ADRs. For all purposes under the Deposit Agreement and the ADRs, the ADR<br>holders thereof shall be deemed to have all requisite authority to act on behalf of any and all beneficial owners of the Depositary Shares<br>evidenced by such ADRs.
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Consent to Jurisdiction

In the Deposit Agreement, we have submitted to the non-exclusive jurisdiction of the state and federal courts in New York, New York and appointed an agent for service of process on our behalf. Any action based on the Deposit Agreement, the Depositary Shares, the ADRs or the transactions contemplated therein or thereby may also be instituted by the depositary against us in any competent court in England and/or Wales, the United States and/or any other court of competent jurisdiction.

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Under the Deposit Agreement, by holding or owning an ADR or Depositary Share or an interest therein, holders and beneficial owners each irrevocably agree that (i) any legal suit, action or proceeding against or involving holders or beneficial owners brought by us or the depositary, arising out of or based upon the Deposit Agreement, the Depositary Shares, the ADRs or the transactions contemplated therein or thereby, may be instituted in a state or federal court in New York, New York, and by holding or owning an ADR or Depositary Share or an interest therein each irrevocably waives any objection that it may now or hereafter have to the laying of venue of any such proceeding, and irrevocably submits to the non-exclusive jurisdiction of such courts in any such suit, action or proceeding and (ii) any legal suit, action or proceeding against or involving us and/or the depositary brought by holders or beneficial owners, arising out of or based upon the Deposit Agreement, the Depositary Shares, the ADRs or the transactions contemplated therein or thereby, including, without limitation, claims under the Securities Act may be instituted only in the United States District Court for the Southern District of New York (or in the state courts of New York County in New York if either (a) the United States District Court for the Southern District of New York lacks subject matter jurisdiction over a particular dispute or (b) the designation of the United States District Court for the Southern District of New York as the exclusive forum for any particular dispute is, or becomes, invalid, illegal or unenforceable). In the Deposit Agreement each holder and beneficial owner irrevocably waives any objection which it may at any time have to the laying of venue of any such proceeding, and irrevocably submits to the jurisdiction of such courts in any such suit, action or proceeding.

Jury Trial Waiver

In the Deposit Agreement, each party thereto (including, for the avoidance of doubt, each holder and beneficial owner of, and/or holder of interests in, Depositary Shares or ADRs) irrevocably waives, to the fullest extent permitted by applicable law, any right it may have to a trial by jury in any suit, action or proceeding against the depositary and/or us directly or indirectly arising out of, based on or relating in any way to the Ordinary Shares or other deposited securities, the Depositary Shares or the ADRs, the Deposit Agreement or any transaction contemplated therein, or the breach thereof (whether based on contract, tort, common law or any other theory), including any claim under the U.S. federal securities laws.

If we or the depositary were to oppose a jury trial demand based on such waiver, the court would determine whether the waiver was enforceable in the facts and circumstances of that case in accordance with applicable state and federal law, including whether a party knowingly, intelligently and voluntarily waived the right to a jury trial. The waiver to right to a jury trial in the Deposit Agreement is not intended to be deemed a waiver by any holder or beneficial owner of our or the depositary’s compliance with the U.S. federal securities laws and the rules and regulations promulgated thereunder.

Exhibit 4.21

License and Collaboration Agreement

This License and Collaboration Agreement is made and entered into as of February 3, 2026 (the “Effective Date”), between Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), a company incorporated under the laws of Japan with offices at Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8241, Japan, and Biodexa Pharmaceuticals PLC (“Biodexa”), a public limited company incorporated under the laws of England and Wales, with offices at 1 Caspian Point, Caspian Way, Cardiff, CF10 4DQ, United Kingdom. Otsuka and Biodexa are individually referred to as a “Party” and collectively as the “Parties.”

WHEREAS, Otsuka is a healthcare company engaged in the Development, Manufacture and Commercialization of products useful for better health (all capitalized terms as hereinafter defined);

WHEREAS, Otsuka owns the Licensed IP;

WHEREAS, Biodexa is a biopharmaceutical company with capabilities in the Development of pharmaceutical products;

WHEREAS, Biodexa desires to obtain, and Otsuka is willing to grant to Biodexa, an exclusive license of the Licensed IP in the Field and in the Territory for the further Development of the Licensed Compound and Licensed Products and Manufacture and Commercialization of Licensed Products, on the terms set forth herein;

NOW, THEREFORE, in consideration of the foregoing, the mutual agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1. Definitions

For purposes of this Agreement, the following terms shall have the following meanings:

1.1. “Accounting Standards,” with respect to any Person, mean the accounting standards generally used by such person, consistently applied, which standards must be consistent with the requirements of the International Financial Reporting Standards, the generally accepted accounting principles in the U.S. or similar generally-applicable standards as adopted and in effect in the relevant jurisdiction, as applicable.

1.2. “Adverse Event” means any undesirable medical occurrence in a patient or clinical study subject administered the Licensed Compound, a Licensed Product or other product containing the Licensed Compound, which occurrence does not necessarily have a causal relationship with this treatment.

| 1<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.3. “Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such Person at any time during the period for which the determination of affiliation is being made and, for the purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person, means (i) ownership, directly or indirectly of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a corporation, or more than fifty percent (50%) of the equity interests in the case of any other legal entity, or status as a general partner in any partnership; or (ii) any other arrangement whereby a Party controls or has the right to control the management or policies of an entity.

1.4. “Agreement” means this License and Collaboration Agreement, as the same may be amended or supplemented from time to time in accordance with the terms hereof, including the Exhibits hereto.

1.5. “Applicable Law” means all applicable laws, statutes, ordinances, regulations, rules, guidance or orders of any kind whatsoever of any Governmental Authority anywhere in the world.

1.6. “Biodexa Background Patents” means Patents Controlled by Biodexa or its Affiliates as of the Effective Date (other than Licensed Otsuka Patents), and any Patents claiming Inventions other than Biodexa Sole Inventions as to which Biodexa or its Affiliates acquires Control during the Term, in each case, that are necessary or reasonably useful to Exploit the Licensed Compound.

1.7. “Biodexa Indemnitee” shall have the meaning set forth in Section 9.2.

1.8. “Breaching Party” has the meaning set forth in Section 11.3(d).

1.9. “Biodexa Sole Inventions” means Sole Inventions of Biodexa and its Affiliates.

1.10. “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1; provided however, that (a) the first Calendar Quarter of the Term shall begin on the Effective Date and end on December 31, 2025; and (b) the last Calendar Quarter of the Term shall end on the date of expiration or termination of this Agreement.

1.11. “Calendar Year” means a twelve (12)-month period ending on December 31; provided however, that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on the following December 31; and (b) the last Calendar Year of the Term shall end on the date of expiration or termination of this Agreement.

| 2<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.12. “China” means the People’s Republic of China, including Hong Kong and Macau and excluding Taiwan.

1.13. “Claim” has the meaning set forth in Section 9.1.

1.14. “Clinical Trial” means any human clinical study or trial of a product in the Field.

1.15. “Commercialization” means all activities undertaken in support of the promotion, marketing, sale and distribution (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling and delivering) of a product. “Commercialize” means to engage in Commercialization activities.

1.16. “Commercialization Plan” means a plan prepared by Biodexa pursuant to Section 3.4.

1.17. “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party or its Affiliate with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision consistent with the actions a similarly-situated pharmaceutical company would normally use to accomplish a similar objective, activity or decision under similar circumstances (when applying prudent scientific and business judgment to the Development and Commercialization of other products and product candidates that are at a similar stage of Development or Commercialization and have similar market potential, taking into account efficacy, safety, patent and regulatory exclusivity, anticipated or approved labeling, present and future market potential, competitive market conditions, pricing and reimbursement issues, and other relevant factors commonly considered in similar circumstances).

1.18. “Confidential Information” means any technical, scientific, regulatory, commercial, business or other information disclosed by or on behalf of one Party to the other Party in connection with this Agreement, provided that (i) in the case of information provided in tangible form or by electronic media, it is marked with, or accompanied by, the legend “Confidential” (or other similar marking conveying the same intent); (ii) in the case of information disclosed by visual display or orally, it is identified as confidential when revealed and summarized in a writing so marked, referencing the date and type of information disclosed, delivered to the receiving Party within [***] ([***]) days after such disclosure; or (iii) in the case of information disclosed by any means, is otherwise reasonably recognizable as confidential information in view of the nature of the information involved or the circumstances of disclosure. The term “Confidential Information” includes any notes, analyses, compilations, studies, interpretations, memoranda or other documents prepared by the receiving Party to the extent they contain, reflect or are based upon, in whole or in part, any Confidential Information furnished under this Agreement to the receiving Party. Notwithstanding the foregoing, “Confidential Information” does not include information that the receiving Party is able to demonstrate (a) has been generally available to the public at the time of disclosure or has become generally available to the public thereafter through no fault on the part of the receiving Party or its Representatives; (b) has been in the receiving Party’s or its Representatives’ possession at the time of disclosure; (c) has been subsequently disclosed to the receiving Party or its Representatives on a non-confidential basis by a Third Party having the right to lawfully make such disclosure; or (d) has been independently developed by the receiving Party or its Representatives without use, directly or indirectly, of any Confidential Information received from the disclosing Party or its Representatives.

| 3<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.19. “Control,” with respect to any Patent or Know-How, means ownership or possession by a Party, or, where expressly provided, its Affiliates, of the ability (without taking into account any rights granted by one Party to the other Party under this Agreement) to grant access, a license or a sublicense to such item without violating the terms of any agreement or other arrangement with, or necessitating the consent of, any Third Party, at such time that the Party would be first required under this Agreement to grant the other Party such access, license or sublicense; provided that no Party or Affiliate shall be deemed to Control any Patents or Know-How of a Third Party invented or otherwise arising following the Effective Date if access by the other Party requires or triggers a payment obligation unless the other Party agrees to bear such payment obligation.

1.20. “Cure Period” has the meaning set forth in Section 11.3(d).

1.21. “Develop” and “Development” mean all activities involved in bringing a new drug product from discovery to market, including research, development, Clinical Trials and other studies, Manufacturing for purposes of research, Clinical Trials and other studies, preparation of regulatory submissions, and determining chemistry, Manufacturing and controls strategy, formulations, analytical methods, quality control and Labeling.

1.22. “Development Plan” means a plan prepared by Biodexa pursuant to Section 3.3.

1.23. “Dispute” has the meaning set forth in Section 12.1.

1.24. “EMA” means the European Medicines Agency or any successor agency or authority having substantially the same function.

1.25. “Europe” means Albania, Andorra, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Kosovo, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Monaco, Montenegro, Netherlands, North Macedonia (formerly Macedonia), Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom of Great Britain and Northern Ireland, and Vatican City (Holy See).

| 4<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.26. “Exploit” or “Exploitation” means to make, use, sell, offer for sale, import, export and otherwise exploit (and to have performed any of the foregoing) in connection with the Development, Manufacture and Commercialization of a referenced item.

1.27. “FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

1.28. “FFDCA” means the Federal Food, Drug, and Cosmetic Act under United States Code, Title 21, as amended.

1.29. “Field” means all human therapeutic uses.

1.30. “First Commercial Sale” means the first sale of a Licensed Product by Biodexa, its Affiliates or its Sublicensees to a commercial distributor, retailer or prescriber for use, consumption or resale of the Licensed Product in a country in the Territory where Regulatory Approval of the Licensed Product has been obtained by Biodexa, its Affiliate or a Sublicensee.

1.31. “Force Majeure” means any event beyond the reasonable control of the affected Party including embargoes; acts of war; terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; pandemics, quarantine, epidemics, fire, floods, earthquakes or other acts of nature; or acts, omissions or delays in acting by any Governmental Authority, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).

1.32. “Generic Product” means, with respect to a Licensed Product in a particular regulatory jurisdiction, on a Licensed Product-by-Licensed Product and country-by-country basis, any pharmaceutical product (other than a Licensed Product) that (a) is approved by the Regulatory Authority in such country for at least one indication for which such Licensed Product obtained Regulatory Approval from the applicable Regulatory Authority in such jurisdiction through an abbreviated new drug application as described in 21 U.S.C. § 355(j) (or any successor thereto or equivalent outside the United States) and (b) is sold in such jurisdiction by a Third Party that is not a Sublicensee and did not purchase such product in a chain of distribution that included any of Licensee or its Affiliates or Sublicensees.

1.33. “Governmental Authority” means any supranational, national, state, local or other judicial, legislative, executive, or other governmental, government-appointed or quasi-governmental agency or authority.

| 5<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.34. “Indemnitee” shall have the meaning set forth in Section 9.3(a).

1.35. “Indemnifying Party” shall have the meaning set forth in Section 9.3(a).

1.36. “Inventions” means any and all inventions, discoveries and developments, whether or not patentable, made, conceived and/or reduced to practice in the course of performance of activities under this Agreement whether made, conceived and/or reduced to practice solely by, or on behalf of, Otsuka, Biodexa, the Parties jointly, or any Affiliate or Sublicensee of the same.

1.37. “Joint Inventions” shall have the meaning set forth in Section 6.1.

1.38. “Joint Patents” means Patents claiming any (i) Joint Invention, or (ii) Biodexa Sole Invention that is a Related Invention.

1.39. “Know-How” means all data (clinical, preclinical and other), technology, factual knowledge, information and materials that give a Person the ability to Exploit something that it otherwise would not have known how, or had a right, to Exploit with the same accuracy, precision, rights, costs and efficiencies, including all Inventions (whether or not patentable), Invention disclosures, processes, procedures, writings, methods, algorithms and formulae, know-how, trade secrets, scientific and regulatory know-how, technology, software, protocols, information, knowledge, practices, formulas, product specifications, finished goods analytical test methods, stability data, quality control data, contracting and reimbursement strategy and marketing strategy, instructions, skills, techniques, proposals, technical data, designs, drawings, apparatus, ideas, concepts, Development information, results of experiments, test data, including pre-clinical and clinical data, pre-clinical and Clinical Trial results, analytical and quality control data, Manufacturing data and descriptions, market data, devices, assays, chemical formulations, notes of experiments, specifications, compositions of matter, whether in intangible, tangible, written, electronic or other form, and all documentation related to any of the foregoing.

1.40. “Knowledge” means, as applied to a Party, that an officer of such Party, or an officer of an Affiliate of such Party, has actual knowledge of a particular fact or other matter.

1.41. “Labeling” means the healthcare professional information or patient information used in connection with a product, including the package insert, medication guides, summary of product characteristics, patient information leaflets, company core safety information and company core data sheet.

1.42. “[***] Sole Right Designation Exception” shall have the meaning set forth in Section 6.8(b).

| 6<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.43. “Licensed Compound” means the chemical compound known as OPB-171775 and more specifically described on Exhibit A, together with [***].

1.44. “Licensed IP” means the Licensed Otsuka Patents and Licensed Otsuka Know-How.

1.45. “Licensed Otsuka Know-How” means Know-How Controlled by Otsuka during the Term that is specifically related to the Licensed Compound and products containing the Licensed Compound and necessary to Exploit the same in the Field in the Territory.

1.46. “Licensed Otsuka Patents” means Patents Controlled by Otsuka during the Term in the Territory that are specifically related to the Licensed Compound and necessary to Exploit the same in the Field in the Territory, consisting of: (i) the Patents listed on Exhibit B; (ii) any Patents that issue on applications listed on Exhibit B; (iii) any reissues, reexaminations, renewals, extensions, divisionals, continuations and continuations in part of the Patents listed on Exhibit B; (iv) any foreign counterparts in the Territory directed to the Inventions covered by any of the Patents listed on Exhibit B; (v) any Patent in the Territory claiming an Otsuka Sole Invention that is a Related Invention; (vi) Otsuka’s interest in any Patent in the Territory claiming a Biodexa Sole Invention that is a Related Invention; and (vii) Otsuka’s interest in any Patent in the Territory claiming a Joint Invention that is a Related Invention.

1.47. “Licensed Product” means any pharmaceutical or biological preparation in final form containing a Licensed Compound for any and all uses in the Field that is developed, Manufactured or Commercialized by or under the authority of Biodexa, including any Licensed Product that contains one or more additional therapeutically active ingredients, whether co-formulated or co-packaged (any such Licensed Product which contains one or more such additional therapeutically active ingredients, a “Combination Product”).

1.48. “Losses” shall have the meaning set forth in Section 9.1.

1.49. “Manufacture” or “Manufacturing” means all activities related to the manufacturing of a product, or any ingredient thereof, including manufacturing for Development, Clinical Trials and Commercialization, packaging, in-process and finished product testing, release of the product or any ingredient thereof, quality assurance activities related to manufacturing and release of the product, ongoing stability tests and regulatory activities related to any of the foregoing.

1.50. “Mechanism of Action,” with respect to any orally-administered pharmaceutical compound, means that such compound acts as a molecular glue that (a) induces the ternary complexation of phosphodiesterase 3A (PDE3A) and a schlafen family member 12 (SLFN12), and (b) causes SLFN12 RNase-mediated cell death and activates the SLFN12 RNase-associated GCN2 signaling pathway.

| 7<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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1.51. “Net Sales” means, with respect to any Licensed Product, on a country-by-country basis, the gross amounts invoiced by Biodexa, its Affiliates and Sublicensees (each, a “Selling Party”) for sales of units of such Licensed Product in the Field in the Territory to Third Parties that are not Sublicensees, less the following deductions if actually paid, incurred, accrued or otherwise taken with respect to such sales:

(a) Customary trade, quantity or cash discounts actually allowed and taken for Licensed Products, which discounts are allocated and applied on a basis consistent with the Selling Party’s practices with respect to the Selling Party’s other pharmaceutical products in accordance with its Accounting Standards;

(b) Amounts actually repaid by reason of rejection or return of a Licensed Product;

(c) Rebates and chargebacks allowed, given or accrued (including ones granted on account of price adjustments and billing errors, Governmental Authority and managed care rebates, hospital or other buying group chargebacks, coupons, co-payment support programs, retroactive price reductions, governmental taxes in the nature of a rebate based on usage levels or sales of such Licensed Product), and any other similar allowances described in this (c) granted to non-related parties that effectively reduce the selling price or gross sales of the Licensed Product, including the portion of any management fees paid during the relevant time period to group purchasing organizations, wholesalers and managed care organizations to the extent determined by sales or utilization of such Licensed Product; provided that all such rebates and other allowances are allocated and applied on a basis consistent with the Selling Party’s practices with respect to the Selling Party’s other pharmaceutical products in accordance with its Accounting Standards;

(d) Bad debt;

(e) Sales, turnover, inventory, value-added, import, export, excise (including annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-148) and other comparable laws) and other taxes levied on, absorbed, determined or imposed with respect to the sale of such Licensed Product (excluding income or net profit taxes or franchise taxes of any kind);

(f) Actual shipping, freight and insurance costs in transporting a Licensed Product to Third Parties that are not Sublicensees, but only if separately stated on the applicable invoice and paid by the Third Party; and

(g) Amounts payable as a result of governmental, regulatory or agency-mandated rebate programs, and, as and to the extent deducted by a Sublicensee that is a Selling Party, amounts actually paid or credited to customers for inventory management services.

| 8<br><br>**\[\*\*\*\] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION \(I\) IS NOT MATERIAL AND \(II\) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.** |

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In the case of any sale (other than a sale of a Licensed Product that is excluded by this definition of “Net Sales” below) of a Licensed Product to a Third Party that is not a Sublicensee for which the Selling Party does not provide an invoice to the purchaser, the Selling Party’s revenue from the sale shall be treated as Net Sales to the same extent as if an invoice for such revenue had been provided. In the case of each of clauses (a)-(g), such deductions may be taken only to the extent consistent with the selling Person’s Accounting Standards, and no deduction shall be taken more than once for purposes of calculating the Net Sales for a Licensed Product. If the selling Person makes any adjustments to such deductions after the associated Net Sales have been reported pursuant to this Agreement, then the adjustments must be reported and reconciled with the next report and payment of any royalty due. Without limiting the generality of the foregoing, sales of a Licensed Product at or less than cost of manufacture for charitable, promotional (including samples), pre-clinical, clinical, or regulatory purposes will be excluded from Net Sales, as will sales or transfers of a Licensed Product among the Selling Parties. However, barter transactions disposing of ownership of units of Licensed Products that are not excluded by the immediately preceding sentence shall be considered sales of Licensed Products for purposes of computing Net Sales. Subject to the above deductions, Net Sales shall be deemed to occur on, and only on, the first sale by a Selling Party to a Third Party that is not a Sublicensee. For the avoidance of doubt, in connection with a sale of a Licensed Product, in the event of any cash payment by a Third Party to a Selling Party expressly in return for a permitted deduction pursuant to this definition of “Net Sales” above, such cash payment shall be deemed Net Sales hereunder.

If a Licensed Product is sold as part of a Combination Product, Net Sales will be calculated on a country-by-country basis as the product of (i) Net Sales of the Combination Product calculated as above (i.e., calculated as for a non-Combination Product) and (ii) the fraction (A/(A+B)), where:

“A” is the average selling price in such country during the period to which the Net Sales calculation relates of the Licensed Product with the Licensed Compound as the sole therapeutically active ingredient; and

“B” is the average selling price in such country during the period to which the Net Sales calculation relates of the other therapeutically active ingredients contained in the Combination Product.

If “A” or “B” cannot be determined by reference to non-Combination Product sales as described above, then Net Sales will be calculated as above, but the average selling price in the above equation shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining the same that takes into account, in the applicable country, variation in dosage units and the relative fair market value of each therapeutically active ingredient in the Combination Product.

1.52. “Non-Breaching Party” has the meaning set forth in Section 11.3(d).

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1.53. “Otsuka Indemnitee” shall have the meaning set forth in Section 9.1.

1.54. “Otsuka Product” means any pharmaceutical or biological preparation in final form containing a Licensed Compound that is developed, Manufactured or Commercialized by or under the authority of Otsuka.

1.55. “Patents” means all of the following in any country of the world: (i) patents, including any utility or design patent; (ii) patent applications, including provisionals, substitutions, divisionals, continuations, continuations-in-part and renewals; (iii) patents of addition, restorations, extensions, supplementary protection certificates, registration or confirmation patents, patents resulting from post-grant proceedings, re-issues and re-examinations; (iv) inventor’s certificates; and (v) other rights applied for or issued by a Governmental Authority similar to any of the foregoing.

1.56. “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

1.57. “Phase 1 Clinical Trial” means a Clinical Trial of a product with the endpoint of determining initial tolerance, safety, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens, as more fully described in U.S. federal regulation at 21 C.F.R. § 312.21(a) and its equivalents in other jurisdictions.

1.58. “Product Infringement” has the meaning set forth in Section 6.8(b).

1.59. “Product Trademarks” shall have the meaning set forth in Section 6.12.

1.60. “Regulatory Approval” means all approvals (including supplement, amendment, or pre-and post-approval), licenses, registrations or authorizations of any supranational, national, regional, state or local Regulatory Authority that are necessary for the Commercialization of a product in a country or countries (but excluding approval of any application for pricing or reimbursement for the product by any Governmental Authority).

1.61. “Regulatory Authority” means any Governmental Authority involved in granting approval for the Commercialization of a product in a country, including in the U.S., the FDA and any other applicable Governmental Authority having jurisdiction over the approval of a product.

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1.62. “Regulatory Exclusivity” means, with respect to any country or other jurisdiction in the Territory, (i) any period of regulatory data protection or equivalent that prevents a Third Party during such period from relying on the data submitted in support of an application for Regulatory Approval for a Licensed Product for an application for approval for a generic version of such Licensed Product; or (ii) an additional market protection, other than Patent protection or Patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which Biodexa or its Affiliates or Sublicensees have the exclusive right to market and sell, and any other Third Party is prevented from marketing or selling, a Licensed Product or a generic version of such Licensed Product in such country or other jurisdiction including, for example, orphan exclusivity.

1.63. “Regulatory Materials” means all regulatory applications, submissions, notifications, registrations, authorizations, correspondence, meeting minutes, and amendments and supplements thereto, that in each case are made to, made with, or received from a Regulatory Authority to Develop, Manufacture or Commercialize a product, including Clinical Trial notifications and authorizations, investigational new drug applications, new drug applications, supplemental new drug applications and other items the filing of which is necessary to commence or conduct clinical testing of, or obtain Regulatory Approval for, a pharmaceutical product in any jurisdiction.

1.64. “Related Invention” means an Invention that is specifically related to the Licensed Compound and necessary to Exploit the same in the Field, including any new formulation of the Licensed Compound or new or improved method of Manufacturing or using the Licensed Compound; it being understood and agreed that “Related Invention” shall exclude any composition of matter that does not incorporate the Licensed Compound.

1.65. “Representatives,” with respect to a Person, means that Person’s directors, officers, employees, agents, legal counsel and advisers.

1.66. “Sole Inventions” shall have the meaning set forth in Section 6.1.

1.67. “Sublicensee” has the meaning set forth in Section 2.2.

1.68. “Tax” or “Taxes” shall mean any form of tax, levy, duty or withholding of whatever nature imposed by, or payable to, any Governmental Authority.

1.69. “Territory” means all countries of the world other than Japan. Otsuka retains all rights in Japan.

1.70. “Term” means the period during which this Agreement remains in effect in one or more countries as described in the first sentence of Section 11.1.

1.71. “Third Party” means a Person other than Otsuka and Biodexa and their respective Affiliates.

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1.72. “Trademark” means any word, name, symbol, color or other designation that functions as a source identifier, including any trademark, service mark, trade dress, trade name, logo or domain name, whether or not registered.

1.73. “United States” or “U.S.” means the United States of America, its territories and possessions.

1.74. “Valid Claim” means (i) a claim of an issued and unexpired Patent included within the Licensed Otsuka Patents, to the extent such claim has not been revoked, held invalid or unenforceable by a patent office, court or other Governmental Authority of competent jurisdiction in a final order, from which no further appeal can be taken, and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer; or (ii) a claim of any patent application within the Licensed Otsuka Patents (where such claim was filed in good faith), to the extent such claim has not been canceled, withdrawn, or abandoned or pending for more than [***] from its earliest priority date.

2. Licenses

2.1. Grant of License to Biodexa. As of the Effective Date, and subject to all of the terms of this Agreement, Otsuka hereby grants to Biodexa, and Biodexa hereby accepts, a license under the Licensed IP to Exploit Licensed Products, including by Exploiting the Licensed Compound as part of, or as an intended part of, Licensed Products, for use in the Field in the Territory. Such license is exclusive, except that (i) Otsuka is permitted to Develop and Manufacture the Licensed Compound or Otsuka Products in the Territory for Commercialization outside the Territory (including by conducting Clinical Trials at sites in the Territory) subject to the provisions of Section 3.3 concerning coordination if Otsuka determines to pursue Development of an Otsuka Product; and (ii) Otsuka may not conduct a Clinical Trial in any country in the Territory if either Biodexa or its Sublicensee has an ongoing Clinical Trial in such country in the Territory or has given written notice of commencement of any such Clinical Trial in such country to Otsuka, unless otherwise agreed in writing by Biodexa. Notwithstanding anything else in this Agreement, (a) this Section 2.1 does not authorize Biodexa to Exploit any composition, product or service other than a Licensed Product, and (b) Biodexa does not have the right to use any Trademark of Otsuka or its Affiliates.

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2.2. Sublicensing. Biodexa shall not grant or authorize sublicenses under the license in Section 2.1 except as provided in this Section 2.2. Biodexa may grant and authorize sublicenses under the license in Section 2.1 to (i) its Affiliates; (ii) vendors, contract research organizations and the like to the extent necessary or reasonably useful for Biodexa’s Development or Manufacture of a Licensed Product on Biodexa’s behalf in a manner consistent with Biodexa’s rights under this Agreement; and (iii) any Third Party with the technological and business capability and sufficient financial resources to Exploit a Licensed Product that Biodexa appoints to Develop and Commercialize a Licensed Product in the Field in the Territory (and it is understood and agreed that any Third Party which has at least [***] U.S. dollars (USD $[***]) of revenue from sales of pharmaceutical products in the immediately preceding calendar year shall be deemed to be a Third Party with the technological and business capability and sufficient financial resources to Exploit a Licensed Product). Any such Person receiving a direct or indirect sublicense of rights under Section 2.1 consistent with the provisions of this Section 2.2 is referred to as a “Sublicensee.” Biodexa’s right to grant sublicenses as specified above shall only remain in effect for as long as the license granted in Section 2.1 remains in effect and is not otherwise terminated pursuant to Section 11.3.

(a) Each such sublicense shall be in writing and, as a condition to the grant of such sublicense, the Sublicensee shall agree to be bound by applicable terms of this Agreement (excluding financial terms) to the same extent as if it were Biodexa. Each sublicense must refer to and be subordinate to this Agreement and, except to the extent the Parties otherwise agree in writing, any such sublicense must be consistent with the terms of this Agreement. Any purported sublicense in violation of the terms of this Section 2.2 shall be null and void.

(b) Biodexa shall promptly notify Otsuka in writing of the granting of any sublicense pursuant to Section 2.2(iii) above. On or before the date [***] ([***]) days after execution of any sublicense granted by Biodexa pursuant to Section 2.2(iii) above, or any amendment to any such sublicense, Biodexa shall provide Otsuka with a true and accurate copy of such sublicense or amendment and an English translation of such sublicense or amendment if executed in another language, with no more than reasonable redactions of competitively-sensitive terms that will not prevent Otsuka from reasonably monitoring compliance with the terms of this Agreement.

(c) Biodexa is responsible for the performance of this Agreement and the performance of its Sublicensees hereunder. Any Licensed Products sold or otherwise disposed of by a Sublicensee of Biodexa shall be treated as Licensed Products sold or otherwise disposed of by Biodexa for all purposes of this Agreement (as if “Net Sales” applied to such sale or other disposition), and Biodexa shall pay royalties on such sales or other dispositions as Net Sales in accordance with Section 5.3.

(d) Unless terminated sooner pursuant to Section 11.3, any sublicense granted by Biodexa to an Affiliate pursuant to Section 2.2(i) above shall terminate immediately with respect to that Affiliate without any notice or action on the part of either Party if the relevant entity no longer meets the definition of an Affiliate of Biodexa as set forth in Section 1.3.

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(e) Upon termination of this Agreement pursuant to Section 11.3, Otsuka shall offer any Third Party Sublicensee pursuant to Section 2.2(iii) above that was a party to a sublicense in effect on the effective date of such termination an opportunity to enter into a license agreement directly with Otsuka on substantially the same terms as the sublicense granted by Biodexa; provided that (i) such sublicense is consistent with the requirements of this Section 2.2; (ii) such Sublicensee is not then in breach in any material respect of its sublicense; (iii) such Sublicensee agrees to comply with all the terms of this Agreement to the extent applicable to the rights sublicensed to it by Biodexa; and (iv) such agreement does not impose any obligations upon Otsuka that exceed the obligations of Otsuka under this Agreement.

2.3. License to Otsuka. It is understood that as of the Effective Date, no Biodexa Background Patents exist. To the extent that during the Term there may be Biodexa Background Patents Controlled by Biodexa, Biodexa Sole Inventions that are Related Inventions and which are Controlled by Biodexa, Joint Inventions or Joint Patents, Biodexa hereby grants to Otsuka, and Otsuka hereby accepts, a royalty-free, paid-up, perpetual, irrevocable, exclusive license under Biodexa’s interest in the Biodexa Background Patents, Biodexa’s interest in Joint Patents, and Biodexa’s Know-How that is specifically related to the Licensed Compound and products containing the Licensed Compound to Exploit the Licensed Compound and Otsuka Products in the Field solely for the purpose of Commercialization outside the Territory (which may include Development and Manufacture in the Territory of Otsuka Products for Commercialization outside the Territory); provided that, to the extent any such Biodexa Background Patents which are Controlled (but not owned) are licensed to Biodexa, such sublicense to Otsuka shall be subject to the terms of the applicable license agreement, and the availability to Otsuka of such licensed rights and the obligation of Otsuka to pay for such rights shall be as provided in the definition of “Control” above (and for clarity may not be royalty-free, paid-up, perpetual, irrevocable and exclusive, as applicable). Otsuka may grant and authorize sublicenses under the license in this Section 2.3 in the same manner that Biodexa may sublicense pursuant to Section 2.2.

2.4. Reservation of Rights. Otsuka retains all rights to the Licensed IP not expressly granted to Biodexa by this Agreement. No license or other right is or shall be created or granted hereunder by implication or estoppel. Otsuka specifically reserves the right to Exploit Otsuka Products and otherwise practice the Licensed IP outside the Field or outside the Territory and to authorize Third Parties to do the same. Biodexa shall not, and shall cause its Affiliates and Sublicensees not to, directly or indirectly (i) Commercialize, sell or promote a Licensed Product outside of the Field or outside of the Territory, or (ii) export or distribute a Licensed Product outside of the Territory.

2.5. Acknowledgement. Biodexa acknowledges that (i) subject to the provisions of Section 6.6, Otsuka is not required to obtain or maintain Licensed Otsuka Patents; (ii) Otsuka is not restricted in Exploiting the Licensed Compound outside the Field or Territory; and (iii) subject to the express terms of this Agreement (including Section 7.2), Otsuka does not warrant or indemnify Biodexa or its Affiliates or Sublicensees against the possibility that the Licensed Compound or Licensed Products may infringe or otherwise violate Third Party rights.

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2.6. Competing Product Activities in Japan. During the Term, Biodexa shall not, and shall cause its Affiliates and Sublicensees not to, directly or indirectly, outside of the Territory, file to obtain a Regulatory Approval or Commercialize any product other than a Licensed Product that incorporates a compound with the Mechanism of Action; it being understood and agreed that this Section 2.6 shall not apply to any direct or indirect acquiror of Biodexa or any Sublicensee in a case in which such product that incorporates a compound with the Mechanism of Action has (i) received Regulatory Approval outside of the Territory prior to the acquisition of Biodexa or the Sublicensee; or (ii) been materially Developed for Commercialization outside the Territory without the direct or indirect assistance of Biodexa or the Sublicensee prior to the acquisition of Biodexa or the Sublicensee.

2.7. Legends on Products. Biodexa shall cause all Licensed Products sold or otherwise disposed of by Biodexa, its Affiliates or Sublicensees to be marked with appropriate notice that such Licensed Products are patented. If such Licensed Products are Manufactured or Commercialized in the United States, the form of such notice shall conform to the requirements of 35 U.S.C. § 287(a). Biodexa also shall comply with, and cause its Affiliates and Sublicensees to comply with, any other notice or legend requirement of Applicable Law.

2.8. Insolvency. All rights and licenses granted to Biodexa under this Agreement are licenses of rights to “intellectual property” for all purposes of Section 365(n) of Title 11 of the United States Code and any similar Laws of other jurisdictions.

3. Development and Commercialization

3.1. Biodexa Responsibility. During the Term, Biodexa (either itself or through its Affiliates or Sublicensees) is solely responsible for carrying out at its expense (i) all of its Development activities with respect to the Licensed Compound and Licensed Product in the Territory, including toxicology; pharmacology; non-clinical studies; chemistry, Manufacturing and controls development; and Clinical Trials, including the Manufacturing of Licensed Product for use in Clinical Trials and compliance with Applicable Law in connection therewith; and (ii) all of its Manufacturing and Commercialization of the Licensed Compound and Licensed Products in the Territory, including the marketing, strategy, pricing, promotion, physician targeting, reimbursement, branding, supply, distribution and sale of Licensed Products in the Field and in the Territory, and compliance with Applicable Law in connection therewith. Biodexa shall, and shall cause its Affiliates and Sublicensees to, carry out all Development, Manufacturing and Commercialization activities in accordance with Applicable Law in all material respects.

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3.2. Technology Transfer. Otsuka will provide Biodexa as soon as practicable after the Effective Date (but no later than [***] ([***]) days after the Effective Date) with access to all of the following existing items in Otsuka’s possession or control: (a) Development documents with technical and clinical information specifically related to, and necessary and reasonably useful for, the Development of the Licensed Compound and Licensed Product as identified on Exhibit C; and (b) Manufacturing documents with information specifically related to, and necessary and reasonably useful for, the Manufacturing of the Licensed Compound and Licensed Product as identified on Exhibit D. For purposes of the immediately preceding sentence, it is understood that Otsuka may anonymize any patient data or other personal information contained in such documents (to the extent required by Applicable Law), and the terms of the data-sharing agreement in Exhibit E shall apply to protect any patient data or other personal information contained in such documents in accordance with applicable data protection laws. At Biodexa’s reasonable request, during the [***] period commencing on the Effective Date, Otsuka shall use Commercially Reasonable Efforts to provide Biodexa with technical assistance from and access to Otsuka employees with relevant knowledge related to the Licensed Compound and Licensed Product to enable Biodexa to understand and implement such technical and clinical information; provided that (i) Otsuka shall not be obligated to provide more than [***] ([***]) total hours of such assistance; (ii) such assistance will be charged by Otsuka to Biodexa at an hourly rate of [***] U.S. dollars (USD $[***]) for any assistance in [***]; and (iii) Biodexa shall reimburse Otsuka for reasonable and documented out-of-pocket costs incurred by Otsuka in providing such assistance. Otsuka shall invoice Biodexa for such hourly rates and costs on a monthly basis, and shall provide documentation for such costs. Biodexa shall pay any properly invoiced amounts within [***] ([***]) days after its receipt of Otsuka’s invoice. For clarity, (1) Otsuka retains ownership of all intellectual property rights with respect to information provided pursuant to this Section 3.2; (2) any such information shall be considered Confidential Information of Otsuka; (3) any such information that is Know-How is licensed pursuant to Section 2.1 as Licensed Otsuka Know-How; and (4) any Invention disclosed by Otsuka is an Otsuka Sole Invention owned by Otsuka, and any Patent claiming the same will be licensed pursuant to Section 2.1 to the extent it constitutes a Licensed Otsuka Patent.

3.3. Development Plan. Within [***] after the Effective Date, Biodexa shall deliver to Otsuka a Development Plan setting forth in commercially reasonable detail Biodexa’s strategy and timeline for Developing and Commercializing one or more Licensed Products for one or more indications in the Field in the United States, Europe and China, including at least the subject matter identified in Exhibit F. Biodexa shall consider in good faith any comments concerning such Development Plan that Otsuka may provide. During any portion of the Term during which Development is ongoing, Biodexa shall regularly (and at least annually) review the Development Plan based on changing circumstances and update and amend it as appropriate. Biodexa promptly shall deliver any updated or amended Development Plan to Otsuka. Biodexa shall consider in good faith any comments concerning any updated or amended Development Plan that Otsuka may provide. If, during the Term, Otsuka determines to pursue Development of one or more Otsuka Product outside the Field or Territory (which Development shall be at Otsuka’s own expense), then at the request of either Party, the Parties shall consult and use Commercially Reasonable Efforts to coordinate Clinical Trial design, regulatory strategy and vendor arrangements to achieve reasonably-available efficiencies in the Development and Manufacturing of Licensed Products for the Territory and the relevant Otsuka Products.

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3.4. Commercialization Plan. By no later than the date [***] before the First Commercial Sale of a Licensed Product in the Territory, Biodexa shall deliver to Otsuka a Commercialization Plan setting forth in commercially reasonable detail Biodexa’s strategy and timeline for Commercialization of Licensed Products, including at least the subject matter identified in Exhibit G. Biodexa shall consider in good faith any comments concerning such Commercialization Plan that Otsuka may provide. During the remainder of the Term, Biodexa shall regularly (and at least annually) review the Commercialization Plan based on changing circumstances and update and amend it as appropriate. Biodexa promptly shall deliver any updated or amended Commercialization Plan to Otsuka. Biodexa shall consider in good faith any comments concerning any updated or amended Commercialization Plan that Otsuka may provide.

3.5. Level of Efforts. At Biodexa’s expense, Biodexa shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Licensed Products for one or more indications in the Field in the United States, Europe and China in accordance with the Development Plan and to Manufacture and Commercialize Licensed Products in the Field in the Territory in accordance with the Commercialization Plan. At any time during the Term, upon Otsuka’s request, the Parties will promptly meet to discuss the progress of Biodexa’s Development, Manufacturing and Commercialization activities with respect to Licensed Products. Biodexa will promptly make available executive-level employees to participate in such meetings, and at such meetings, provide Otsuka reasonable visibility into the progress of Biodexa’s Development, Manufacturing and Commercialization activities with respect to Licensed Products.

3.6. Records; Reporting. During the Term, in a manner consistent with prevailing pharmaceutical industry practices and the terms of this Agreement, Biodexa shall prepare and maintain, and cause to be prepared and maintained, complete and accurate written records of the Development, Manufacture and Commercialization of Licensed Products by Biodexa and its Affiliates and Sublicensees. Biodexa shall maintain all such records relating to Clinical Trials, and other material records of Development, until such time as Biodexa delivers them to Otsuka pursuant to Section 11.4(f), or Otsuka agrees in writing that such records may be destroyed. Biodexa shall maintain all other such records for a minimum of [***] years.

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3.7. Reports. Throughout the Term, Biodexa shall provide Otsuka reasonably detailed semiannual reports describing its activities aimed at achieving the Development Plan and Commercialization Plan, including (i) key achievements or milestones and an update on other progress of Biodexa’s Development and Commercialization activities in the reporting period; (ii) goals and plans for Development and Commercialization activities over the next [***] months; and (iii) after First Commercial Sale, the Parties shall meet bi-annually to discuss Biodexa’s then-existing sales forecast for the next [***] months. The first such report shall be due at the end of the [***] full month after the Effective Date, and successive such reports shall be due every [***] months thereafter.

3.8. Additional Reporting. During the Term, in addition to the provisions of Section 3.7, within [***] months after creation or receipt of the final report of any Clinical Trial relating to the Licensed Compound or a Licensed Product, Biodexa shall provide to Otsuka a summary of the data and results of such Clinical Trial which are Controlled by Biodexa. Biodexa hereby grants to Otsuka a non-exclusive, perpetual, irrevocable, royalty-free license (with the right to sublicense) to use and disclose such data for regulatory purposes relating to the Licensed Compound and Otsuka Products, Development and Manufacture of the Licensed Compound and Otsuka Products, and Commercialization outside the Territory or Field of the Licensed Compound and Otsuka Product.

3.9. Nonsolicitation. During the Term, Biodexa shall not, and shall cause its Affiliates and Sublicensees not to, solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of Otsuka or any of its Affiliates who has been or becomes involved in the Development of the Licensed Compound or the discussions leading to this Agreement to terminate his or her relationship with Otsuka or Otsuka’s Affiliate for the purpose of Developing or Commercializing the Licensed Compound.

3.10. Acknowledgement. Biodexa acknowledges that it is aware that during Otsuka’s previous Phase 1 Clinical Trial with respect to the Licensed Compound, certain Adverse Events occurred, which Adverse Events Otsuka hereby represents and warrants to Biodexa have been separately shared with Biodexa. Otsuka represents and warrants that it timely filed with the applicable Regulatory Authorities in accordance with Applicable Laws all such Adverse Events. Except as expressly provided herein (including in the immediately preceding sentence), Otsuka makes no representations or warranties concerning the safety or effectiveness of the Licensed Compound or Licensed Product and has no responsibilities in that regard.

4. Regulatory Matters

4.1. Biodexa Responsibility. During the Term, Biodexa (either itself or through its Affiliates or Sublicensees) is solely responsible for carrying out at its expense all activities necessary to obtain or maintain Regulatory Approval of the Licensed Product in the Field in the Territory, including preparing Regulatory Materials and conducting communications with the relevant Regulatory Authorities related to or needed for the Development, Manufacture or Commercialization of Licensed Products in the Field in the Territory. Without limiting the foregoing, Otsuka will provide Biodexa pursuant to Section 3.2 its investigator’s brochure and development safety update report in the form in which they exist at the time of delivery, and for the remainder of the Term, Biodexa shall be responsible for collecting safety information concerning the Licensed Compound and Licensed Products and updating the investigator’s brochure and development safety update report. During the Term, Biodexa shall own all Regulatory Materials resulting from Biodexa’s activities with respect to Licensed Products in the Field in the Territory under this Agreement. For clarity, Otsuka is responsible for carrying out any activities necessary to obtain or maintain Regulatory Approval for Otsuka Products outside the Field or Territory and shall own any relevant Regulatory Materials.

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4.2. Regulatory Materials. Biodexa shall provide Otsuka with a reasonable opportunity to review and comment on drafts of significant Regulatory Materials for Licensed Products in the Field in the Territory reasonably in advance of when Biodexa or any of its Affiliates or Sublicensees intends to submit such items to the applicable Regulatory Authority. Biodexa shall consider in good faith any comments concerning the same that Otsuka may provide. Biodexa shall provide Otsuka with a copy in electronic form of all significant Regulatory Materials related to Licensed Product in the Field in the Territory, including significant communications received by Biodexa or its Affiliates or Sublicensees from any Regulatory Authority related to Licensed Product.

4.3. Certain Regulatory Communications. During the Term, in addition to Biodexa’s obligations under Section 4.2, Biodexa shall keep Otsuka informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in their respective territories, of the notification of any action by, or notification or other information which it receives from any Regulatory Authority which: (i) raises any material concerns regarding the safety or efficacy of the Licensed Compound or a Licensed Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Licensed Compound or a Licensed Product; (iii) is reasonably likely to lead to a recall or market withdrawal of a Licensed Product; (iv) relates to reports of Adverse Events with respect to the Licensed Compound or a Licensed Product, or other information concerning any dissatisfaction regarding a Licensed Product, that may have a material effect on obtaining or maintaining Regulatory Approval or the continued Commercialization of a Licensed Product; or (v) relates to an inspection or audit of the facility of Biodexa, any Affiliate of Biodexa or any Third Party under contract with Biodexa with regard to a Licensed Product, except for audits or inspections that are of a routine nature or do not relate to the Licensed Compound or a Licensed Product.

4.4. Rights of Reference to Regulatory Materials. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party for the Licensed Compound or Licensed Products (in the case of Biodexa), or Otsuka Products (in the case of Otsuka), solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of Licensed Products (in the case of Biodexa), or Otsuka Products (in the case of Otsuka), in such other Party’s respective territory.

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4.5. Access to Data. Each Party shall have the right to reference and utilize all toxicology, safety and other relevant scientific data developed by or on behalf of the other Party, its Affiliates and Sublicensees with respect to the Licensed Compound, Licensed Products (in the case of Biodexa) and Otsuka Products (in the case of Otsuka). Upon request by a Party, the other Party shall promptly either provide a copy of or otherwise make available all such data without charge.

4.6. [***]

4.7. Compliance with Applicable Law. In performing its activities under this Agreement during the Term, Biodexa shall, and shall cause its Affiliates and Sublicensees to, comply in all material respects with (i) all Applicable Law, including any applicable anti-corruption or anti-bribery laws or regulations, of any Governmental Authority with jurisdiction over the activities performed by Biodexa or its Affiliates or Sublicensees in furtherance of such obligations, and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines and local policies.

4.8. Transparency Reporting. Biodexa and its Affiliates and Sublicensees shall be responsible for tracking and reporting transfers of value pursuant to the requirements of the marketing reporting laws of any Government Authority in the Territory, including Section 6002 of the U.S. Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.”

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4.9. Debarment. During the Term, Biodexa shall promptly inform Otsuka in writing promptly if it or any Person engaged by Biodexa or any of its Affiliates or Sublicensees who is performing any activities under or in connection with this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Biodexa’s Knowledge, is threatened, in any country of the Territory relating to the debarment or conviction of Biodexa, any of its Affiliates or any such Person performing activities.

5. Payments

5.1. Upfront Cash Payment. In partial consideration for Biodexa’s rights in and to the Licensed IP licensed hereunder and its other rights and benefits hereunder, within [***] days after the Effective Date, Biodexa shall pay to Otsuka a one-time upfront fee of [***] U.S. dollars (USD $[***]). Such upfront payment shall be non-refundable and non-creditable against any other payments to be made by Biodexa hereunder.

5.2. Milestones. In partial consideration for Biodexa’s rights in and to the Licensed IP licensed hereunder and its other rights and benefits hereunder, Biodexa shall pay to Otsuka one-time milestone payments as set forth below upon the first achievement of each of the following events:

(a) [***] U.S. dollars (USD $[***]) on completion of the dose escalation stage of a Phase 1 Clinical Trial for the Licensed Product and a decision by Biodexa to commence dosing in the dose expansion stage of a Phase 1 Clinical Trial for the Licensed Product;

(b) [***] U.S. dollars (USD $[***]) on first Regulatory Approval of a Licensed Product by the FDA for Commercialization in the United States;

(c) [***] U.S. dollars (USD $[***]) on first Regulatory Approval of a Licensed Product by the EMA or a national Regulatory Authority in Europe for Commercialization in the European Union or United Kingdom; and

(d) [***] U.S. dollars (USD $[***]) on first Regulatory Approval of a Licensed Product by the Chinese National Medicinal Products Administration for Commercialization in China.

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Biodexa must notify Otsuka in writing concerning the achievement of each milestone event described above. Otsuka will issue an invoice for the payment associated with a milestone event after receipt of such notice, or Otsuka may issue an invoice for the payment associated with a milestone event after otherwise learning of it. Biodexa shall remit the applicable milestone payment to Otsuka within [***] days following its receipt of Otsuka’s invoice. Each milestone payment identified above shall be payable only once, regardless of the number of times that such milestone event is achieved for one or more Licensed Products. For clarity, (i) if more than one of the foregoing milestone events occur simultaneously, Biodexa shall pay to Otsuka the sums set forth above for each such occurring event; and (ii) the total amount payable to Otsuka under this Section 5.2 if all milestone events are achieved is [***] U.S. dollars (USD $[***]). Such payments shall be non-refundable and non-creditable against any other payments to be made by Biodexa hereunder.

5.3. Royalties.

(a) In General. In partial consideration for Biodexa’s rights in and to the Licensed IP licensed hereunder and its other rights and benefits hereunder (and subject to the terms of this Agreement), Biodexa shall pay to Otsuka a running royalty at the following incremental royalty rates, on aggregate Net Sales of Licensed Products in the Territory during each Calendar Year:

(i) For that portion of Calendar Year aggregate Net Sales up to and including [***] (USD $[***]): [***] ([***]%) of Net Sales;

(ii) For that portion of Calendar Year aggregate Net Sales in excess of [***] (USD $[***]) up to and including [***] (USD $[***]): [***] ([***]%) of Net Sales; and

(iii) For that portion of Calendar Year aggregate Net Sales in excess of [***] (USD $[***]): [***] ([***]%) of Net Sales.

(b) Royalty Term. Subject to this Section 5.3 and Section 5.4, royalties under this Section 5.3 shall be payable, on a country-by-country and Licensed Product-by-Licensed Product basis, beginning upon First Commercial Sale and ending upon the latest of (i) the expiration of the last-to-expire Valid Claim of a Licensed Otsuka Patent that Covers the applicable Licensed Product in such country; (ii) the expiration of all Regulatory Exclusivity for such Licensed Product in such country, and (iii) the [***] anniversary of the First Commercial Sale of the applicable Licensed Product in such country (the “Royalty Term”).

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(c) Generic Competition. Subject to Section 5.3(f), on a country-by-country and Licensed Product-by-Licensed Product basis, in the event that one or more Generic Products to a Licensed Product is [***] in any country in the Territory during the Royalty Term for such Licensed Product in such country, and the average quarterly Net Sales of such Licensed Product in such country during any [***] Calendar Quarters decrease by more than [***] ([***]%) of the average quarterly Net Sales of such Licensed Product in such country during the [***] Calendar Quarters immediately preceding the Calendar Quarter in which the first Generic Product is [***] in such country, the royalty rates provided in Section 5.3(a) for such Licensed Product shall be reduced in such country by (i) in the case of Net Sales in the United States, [***] ([***]%) for each subsequent Calendar Quarter in the remainder of such Royalty Term, and (ii) in the case of Net Sales in any other country in the Territory other than the United States, [***] ([***]%) for each subsequent Calendar Quarter in the remainder of such Royalty Term.

(d) Anti-Stack. Subject to Section 5.3(f), on a country-by-country basis, if Biodexa, its Affiliate or any Sublicensee is required by (a) a future order by a court of competent jurisdiction, (b) settlement agreement, (c) license or contract, or (d) other legally binding commitment to make royalty or other payments to a Third Party, in each case in exchange for a license or other right under Patent and other intellectual property rights held by such Third Party and such license or other rights are necessary for the Exploitation of the Licensed Compound in a given country, then Licensee shall be entitled to deduct from royalties due to Otsuka under this Agreement with respect to Net Sales of all Licensed Products in a subsequent Calendar Quarter in each such country, an amount equal to (i) in the case of Net Sales in the United States, [***] ([***]%) of the royalties and other payments actually paid to such Third Party in such Calendar Quarter as consideration for such license under such Patent and other intellectual property rights with respect to such Net Sales in the United States, and (ii) in the case of Net Sales in any country in the Territory other the United States, [***] [***]%) of the royalties and other payments actually paid to such Third Party in such Calendar Quarter as consideration for such license under such Patent and other intellectual property rights with respect to such Net Sales in such countries, up to a maximum amount of (x) in the case of Net Sales in the United States, [***] ([***]%) of the royalties otherwise due to Otsuka in such Calendar Quarter, and (y) in the case of Net Sales in any country in the Territory other than the United States, [***] ([***]%) of the royalties otherwise due to Otsuka in each such affected country in such Calendar Quarter.

(e) Calculation of Royalties. Royalties under this Section 5.3 shall be determined from the books and records of Biodexa and its Affiliates and Sublicensees maintained in accordance with its Accounting Standards.

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(f) Cap on Deductions to Royalties. In no event will the reductions under this Section 5.3 and Section 5.4 together reduce the royalties payable to Otsuka under this Agreement in any country or Calendar Quarter by an amount greater than (i) in the case of Net Sales in the United States, [***] ([***]%) of the royalties due to Otsuka in such Calendar Quarter under Section 5.3(a) (without giving effect to any reductions in this Section 5.3 and Section 5.4), and (ii) in the case of Net Sales in any country in the Territory other than the United States, [***] ([***]%) of the royalties due to Otsuka in such Calendar Quarter under Section 5.3(a) (without giving effect to any reductions in this Section 5.3 and Section 5.4), in each case, in each such affected country in such Calendar Quarter.

5.4. Royalty Reduction for Patent Expiry. Subject to Section 5.3(f), with respect to sales and other dispositions of a Licensed Product on a country-by-country basis in the Territory, the royalty set forth in Section 5.3 shall be reduced by deducting (i) in the case of Net Sales in the United States, [***] ([***]%) of the royalties for such Net Sales, and (ii) in the case of Net Sales in any country in the Territory other than the United States, [***] ([***]%) of the royalties for such Net Sales, in each case as otherwise payable pursuant to Section 5.3 following the expiration of the last to expire Valid Claim in the Licensed Otsuka Patents covering the Licensed Product in the applicable country, such that the Exploitation of the Licensed Product in the applicable country no longer would infringe any Valid Claim in the Licensed Otsuka Patents in the absence of this Agreement. Biodexa acknowledges and shall never dispute that if a royalty remains payable under Section 5.3 after the time specified in the first sentence of this Section 5.4, such royalty is a fair and reasonable royalty for Biodexa’s continued license rights with respect to Licensed Otsuka Know-How.

5.5. Additional Sublicense Royalty. In partial consideration for Biodexa’s rights in and to the Licensed IP licensed hereunder and its other rights and benefits hereunder, and in addition to the royalties under Section 5.3, Biodexa shall pay to Otsuka [***] [***]%) of all payments that a Sublicensee is required to make to Biodexa or its Affiliates, including upfront payments, and any Development, regulatory and sales milestone payments payable by the Sublicensee to Biodexa, but excluding (a) royalties based on Net Sales of Licensed Products and (b) commercially reasonable payments for (i) Development, Manufacturing or similar services actually provided by Biodexa to the Sublicensee and (ii) for bona fide loans to and investments in Biodexa.

5.6. Quarterly Royalty Accounting Reports. In addition to the reports required by Section 3.7, commencing with First Commercial Sale, Biodexa shall provide Otsuka quarterly royalty accounting reports. Such reports shall be provided by no later than the end of the month next following the end of the Calendar Quarter to which they pertain (e.g., a report concerning sales in January-March is to be provided by the end of April). Such reports must provide a true and accurate accounting of the following for the Calendar Quarter involved:

(a) The quantities of Licensed Products billed or invoiced during the Calendar Quarter involved on a country-by-country, Licensed Product-by-Licensed Product (and, to the extent that Biodexa following good faith negotiations is able to obtain monthly information from an applicable Sublicensee, month-by-month basis);

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(b) The computation of the Net Sales of each Licensed Product on a country-by-country and Licensed Product-by-Licensed Product basis, including the deductions made in such computation;

(d) Any additional payments subject to royalties under Section 5.5, and computation of the applicable royalties under Section 5.5; and

(e) The U.S. dollar value of the amount of royalties payable by Biodexa pursuant to Sections 5.3 and 5.5.

If no royalties are due, it shall be so reported. The correctness and completeness of each such report shall be certified in writing by the Chief Financial Officer of Biodexa.

5.7. Currency. All royalties and other payments to be made by Biodexa to Otsuka hereunder shall be paid in U.S. dollars at par. For sales of any Licensed Product made in a currency other than U.S. dollars, and other payments subject to royalties under Section 5.5 that are denominated in a currency other than U.S. dollars, the royalty payable shall first be determined in such other currency and then be converted into its equivalent in U.S. dollars as follows: The rate of exchange to be used in computing the amount of currency equivalent in U.S. dollars shall be calculated on a month-by-month basis, with the rate to be used for each month being the average of (i) the exchange rate published by The Wall Street Journal East Coast Edition for the last day of the relevant month; and (ii) the exchange rate published by The Wall Street Journal East Coast Edition for the last day of the preceding month. If such rate is not so published, then rates published by Citibank of New York or such other bank chosen by Otsuka and reasonably acceptable to Biodexa shall be used instead. For example, in a quarterly royalty accounting report for the first Calendar Quarter, the royalty for net sales and other payments in a particular non-dollar currency is to be calculated separately for January, February and March, and for January, such royalty is to be converted into its equivalent in U.S. dollars at the average of the exchange rate for the preceding December 31 and for the applicable January 31.

5.8. Manner of Payment. Biodexa’s payment of royalties due pursuant to Section 5.3 shall be due at the same time as the reporting covering the period in which the Net Sales were accrued, as provided in Section 5.6 (i.e., the end of the month next following the Calendar Quarter in which the Net Sales were accrued). Biodexa’s payment of royalties due pursuant to Section 5.5 shall be due at the same time as the reporting covering the period in which the relevant additional revenues were accrued (i.e., the end of the month next following the Calendar Quarter in which the additional revenues were accrued). All royalties and other payments payable by Biodexa hereunder shall be paid to Otsuka in U.S. dollars by wire transfer, or by such other method as Otsuka may reasonably request, for value no later than the due date thereof (with twenty-four (24) hours advance notice of each such wire transfer) to such bank account or accounts as Otsuka shall designate in writing within a reasonable period of time prior to such due date.

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5.9. Late Payment. If Otsuka does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to until the date of payment at the annual rate of [***] ([***]%) per month or the maximum rate allowable by Applicable Law, whichever is lower. Any payments received by Otsuka shall be applied first to the satisfaction of any unpaid, accrued interest and then to the satisfaction of any unpaid principal.

5.10. Taxes.

(a) In General. Biodexa shall use Commercially Reasonable Efforts in cooperation with Otsuka to obtain the lowest Tax rate under Applicable Law for Taxes required to be deducted and withheld from a payment made under this Agreement. If Applicable Law requires that Taxes be deducted and withheld from a payment made pursuant to this Agreement, after Biodexa makes a reasonable effort to obtain the lowest Tax rate, Biodexa shall: (i) deduct those Taxes from the payment; (ii) pay the Taxes to the proper taxing authority; and (iii) send to Otsuka within [***] days following that payment evidence of the obligation together with proof of payment and any other documents Otsuka may reasonably require to secure a refund of or credit for the amount of such payment. Except for the foregoing, each Party shall be responsible for any taxes that are levied on it in connection with its obligations under this Agreement.

(b) Tax Residence Certificate. If necessary for Otsuka to claim the benefit of a tax treaty, it shall provide Biodexa appropriate certification that it is a tax resident of a relevant jurisdiction. Upon the receipt thereof, any deduction and withholding of Taxes shall be made at the appropriate treaty tax rate.

(c) Assessment. Either Party may, at its own expense, protest any assessment, proposed assessment, or other claim by any Governmental Authority for any additional amount of Taxes, interest or penalties or seek a refund of such amounts paid if permitted to do so by Applicable Law. The Parties shall cooperate with each other in any protest by providing records and such additional information as may reasonably be necessary for a Party to pursue such protest.

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(d) Sublicensing and Assignment. If Biodexa assigns this Agreement to an Affiliate or Third Party in compliance with Section 14.3, and if such Affiliate or Third Party shall be required by Applicable Law to withhold any additional Taxes from or in respect of any amount payable under this Agreement as a result of such assignment, then any such amount payable under this Agreement shall be increased to take into account the additional Taxes withheld as may be necessary so that, after making all required withholdings, Otsuka receives an amount equal to the sum it would have received as of the Effective Date. If Otsuka assigns this Agreement to an Affiliate or Third Party in compliance with Section 14.3, and if Biodexa or any Affiliate or Third Party shall be required by Applicable Law to withhold any additional Taxes from or in respect of any amount payable under this Agreement as a result of such assignment, then no such amount payable under this Agreement shall be increased to take into account the additional Taxes withheld.

5.11. Books and Records. Biodexa shall keep full, true and accurate books of account containing all particulars and reasonable supporting documentation as may be necessary for the purpose of determining the Net Sales of all Licensed Products and Biodexa’s compliance in other respects with its obligations under this Agreement. The books of account and reasonable supporting documentation shall be kept at Biodexa’s principal place of business and shall be open during normal business hours for inspection no more frequently than once each Calendar Year for [***] years following the end of the Calendar Year to which they pertain (and access shall not be denied thereafter if reasonably available) by any independent Certified Public Accountant, Chartered Accountant or the equivalent retained by Otsuka for the purpose of verifying Biodexa’s payments and compliance in other respects with its obligations under this Agreement. Any amounts shown to be owed to Otsuka but unpaid shall be paid within [***] days after the accountant’s report, plus interest (as set forth in Section 5.9) from the original due date until the time paid. Otsuka shall bear the full expense of such audit unless such records are insufficient for the foregoing purposes or any such inspection discloses an underpayment of royalties of [***] percent ([***]%) or more of the amount of royalties actually due for any quarterly period, in which case, in addition to any other rights and remedies available to Otsuka under this Agreement, including termination, Biodexa shall promptly pay the reasonable cost of such inspection after Biodexa’s receipt of Otsuka’s invoice for such inspection.

6. Intellectual Property Matters

6.1. Inventorship in General. Inventorship of Inventions made by one or more Parties in connection with this Agreement, the Licensed Compound and Licensed Products shall be determined in accordance with U.S. patent laws. Except as provided in Section 6.3, as between the Parties, each Party shall own any Inventions made solely by its own employees and contractors (where such Party has ownership rights with respect to contractor Inventions) in the course of conducting any activities under this Agreement or relating to the Licensed Compound or Licensed Products, together with all intellectual property rights therein (“Sole Inventions”). The Parties shall jointly own any Inventions that are made jointly by employees of each Party, or contractors of a Party (where such Party has ownership rights with respect to contractor Inventions), in the course of performing activities under this Agreement or relating to the Licensed Compound or Licensed Products, together with all intellectual property rights therein (“Joint Inventions”), although for clarity, no joint development activities are contemplated by this Agreement.

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6.2. Certain Otsuka Inventions. During the Term, if employees of Otsuka, or contractors of Otsuka (where Otsuka has ownership rights with respect to contractor Inventions), make a Sole Invention that is a Related Invention, (i) Otsuka shall disclose the same to Biodexa pursuant to Section 6.5; (ii) any Know-How pertaining to such Sole Invention shall be included in the Licensed Otsuka Know-How, with the same to be subject to the license granted in Section 2.1; and (iii) any patent in the Territory claiming such Sole Invention shall be included in the Licensed Otsuka Patents, with the same to be subject to the license granted in Section 2.1.

6.3. Certain Biodexa Inventions. Biodexa shall promptly notify Otsuka if it acquires or becomes aware of any Biodexa Background Patents outside the Territory. During the Term, if employees of Biodexa, or contractors of Biodexa (where Biodexa has ownership rights with respect to contractor Inventions), make a Sole Invention that is a Related Invention, (i) Biodexa shall disclose the same to Otsuka pursuant to Section 6.5; (ii) the Parties shall jointly own all intellectual property rights with respect to such Sole Invention, and to that end, Biodexa hereby assigns to Otsuka an undivided one half interest in and to all Patent and other intellectual property rights with respect to such Sole Invention; (iii) Otsuka’s interest in and to any Know-How pertaining to such Sole Invention shall be included in the Licensed Otsuka Know-How, with the same to be subject to the license granted in Section 2.1; (iv) Otsuka’s interest in and to any Patent in the Territory claiming such Sole Invention shall be included in the Licensed Otsuka Patents, with the same to be subject to the license granted in Section 2.1; (v) Biodexa’s interest in and to any Know-How pertaining to such Sole Invention shall be licensed to Otsuka pursuant to Section 2.3; and (vi) any patent outside the Territory claiming such Sole Invention shall be considered a Joint Patent, with Biodexa’s interest in and to the same included in the license granted in Section 2.3.

6.4. Joint Inventions. If employees or contractors of Otsuka and Biodexa make a Joint Invention that is a Related Invention, (i) Otsuka’s interest in and to any Know-How pertaining to such Joint Invention shall be included in the Licensed Otsuka Know-How, with the same to be subject to the license granted in Section 2.1; (ii) Otsuka’s interest in and to any Patent in the Territory claiming such Joint Invention shall be included in the Licensed Otsuka Patents, with the same to be subject to the license granted in Section 2.1; (iii) Biodexa’s interest in and to any Know-How pertaining to such Joint Invention shall be licensed to Otsuka pursuant to Section 2.3; and (iv) any Patent outside the Territory claiming such Joint Invention shall be considered a Joint Patent, with Biodexa’s interest in and to the same included in the license granted in Section 2.3.

6.5. Disclosure of Inventions. Each Party shall promptly disclose to the other Party any Inventions that such Party believes are or may be patentable and constitute Joint Inventions or Sole Inventions subject to Sections 6.2, 6.3 or 6.4.

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6.6. Prosecution of Patents.

(a) By Biodexa. Biodexa shall have the first right to prepare, file, prosecute, extend and maintain the Licensed Otsuka Patents (including Joint Patents) and Biodexa Background Patents in the Territory, at its own expense, provided that it must do so with respect to the Licensed Otsuka Patents in a manner reasonably calculated to obtain and maintain the broadest patent protection for the subject matter disclosed in the Licensed Otsuka Patents that is commercially reasonable, except as provided below in this Section 6.6(a). For clarity, Biodexa’s rights with respect to extension of the Licensed Otsuka Patents and Biodexa Background Patents in the Territory includes the right to apply for patent term extensions in the U.S. pursuant to 35 U.S.C. § 156 and in other jurisdictions in the Territory pursuant to supplementary protection certificates, and in all jurisdictions of the Territory with respect to any other extensions that are now or become available in the future. Biodexa shall provide Otsuka a reasonable opportunity to review and comment on material communications from any Governmental Authority in the Territory regarding any Licensed Otsuka Patents or extensions thereof and drafts of any material filings or responses to be made to such Governmental Authorities sufficiently in advance of submitting such filings or responses as to allow Otsuka a reasonable opportunity to review and comment thereon. Biodexa shall consider Otsuka’s comments regarding such communications and drafts in good faith. Biodexa shall also promptly provide Otsuka copies and confirmation of all filings, including payments of fees, finally made with respect to the Licensed Otsuka Patents and extensions thereof in the Territory. If Biodexa does not wish to continue the prosecution or maintenance of a Licensed Otsuka Patent or extension thereof in any country in the Territory, then Biodexa shall provide Otsuka with written notice of such determination at a time sufficiently far in advance of any applicable filing or payment deadline to allow Otsuka to determine its interest in continuing the prosecution or maintenance of such Licensed Otsuka Patents in such country (which notice shall be given no later than [***] days prior to any final deadline for any pending action or response that may be due with respect to such Licensed Otsuka Patents in such country with the applicable patent authority). If Otsuka provides written notice expressing its interest in assuming responsibility for the prosecution and maintenance of such Licensed Otsuka Patents in such country, (i) Biodexa will provide any assistance reasonably requested by Otsuka associated with the prosecution and maintenance of such Licensed Otsuka Patents or extension thereof in such country; and (ii) Biodexa’s rights under this agreement with respect to such Licensed Otsuka Patents or extension thereof in such country shall terminate and the same shall no longer be considered Licensed Otsuka Patents.

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(b) By Otsuka. Otsuka shall have the first right to prepare, file, prosecute, extend and maintain the Licensed Otsuka Patents, Joint Patents and Biodexa Background Patents outside the Territory, at its own expense, provided that it must do so in a manner reasonably calculated to obtain and maintain the broadest patent protection for the subject matter disclosed in the Joint Patents and Biodexa Background Patents that is commercially reasonable, except as provided below in this Section 6.6(b). For clarity, Otsuka’s rights with respect to extension of the Licensed Otsuka Patents, Joint Patents and Biodexa Background Patents outside the Territory includes the right to apply for patent term extensions in Japan and any other extensions that are now or become available in the future outside the Territory. Otsuka shall provide Biodexa a reasonable opportunity to review and comment on material communications from any Governmental Authority outside the Territory regarding any Joint Patents, Biodexa Background Patents or extensions thereof and drafts of any material filings or responses to be made to such Governmental Authorities sufficiently in advance of submitting such filings or responses as to allow Biodexa a reasonable opportunity to review and comment thereon. Otsuka shall consider Biodexa’s comments regarding such communications and drafts in good faith. Otsuka shall also promptly provide Biodexa copies and confirmation of all filings, including payments of fees, finally made with respect to the Joint Patents, Biodexa Background Patents and extensions thereof outside the Territory. If Otsuka does not wish to continue the prosecution or maintenance of a Joint Patent, Biodexa Background Patent or extension thereof outside the Territory, then Otsuka shall provide Biodexa with written notice of such determination at a time sufficiently far in advance of any applicable filing or payment deadline to allow Biodexa to determine its interest in continuing the prosecution or maintenance of such Joint Patent, Biodexa Background Patent or extension thereof in such country (which notice shall be given no later than [***] days prior to any final deadline for any pending action or response that may be due with respect to such Joint Patent, Biodexa Background Patent or extension thereof with the applicable Governmental Authority). If Biodexa provides written notice expressing its interest in assuming responsibility for the prosecution and maintenance of such Joint Patent, Biodexa Background Patent or extension thereof in such country, Otsuka will provide any assistance reasonably requested by Biodexa associated with the prosecution and maintenance of such Joint Patent, Biodexa Background Patent or extension thereof outside the Territory.

(c) Cooperation in Prosecution. Notwithstanding the foregoing, the Parties shall use reasonable efforts to agree upon a strategy for the filing, prosecution and extension of the Licensed Otsuka Patents, Joint Patents and Biodexa Background Patents. Each Party shall provide the other Party reasonable assistance and cooperation in the Patent prosecution efforts provided above in this Section 6.6, including providing any necessary powers of attorney, executing any other required documents or instruments and providing information and assistance reasonably requested by the prosecuting Party. All communications between the Parties relating to the preparation, filing, prosecution or maintenance of the Licensed Otsuka Patents and Biodexa Background Patents, including copies of any draft or final documents or any communications received from or sent to patent offices or patenting authorities with respect to such Patents, shall be considered Confidential Information and subject to the confidentiality provisions of Article 8.

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6.7. Listing in the Orange Book and the Like. The Party controlling prosecution, extension and maintenance of a Licensed Otsuka Patent, Joint Patent, Biodexa Background Patent or extension thereof in a particular country pursuant to Section 6.6(a) or (b) shall be responsible for listing and maintaining the same in the Orange Book in the U.S., the Patent Register in Canada, and any similar listing in any other country as applicable, including payment of all expenses related to such listing. The other Party shall assist and cooperate in such activities as provided in Section 6.6(c).

6.8. Infringement of Patents and Trade Secrets by Third Parties.

(a) Notification. Each Party shall promptly notify the other Party in writing of any existing, alleged or threatened infringement of a Licensed Otsuka Patent, Joint Patent, Biodexa Background Patent or extension thereof in the Field of which it becomes aware, and of any misappropriation or other violation of any trade secret rights or other legally-enforceable rights to Know-How licensed under this Agreement, and shall provide reasonable information in such Party’s possession or control concerning such infringement, misappropriation or other violation.

(b) Infringement in the Territory. Biodexa shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Third Party engaged in any existing, alleged or threatened infringement of a Licensed Otsuka Patent, Biodexa Background Patent, Joint Patent or extension thereof, including infringement related to any so-called “paragraph IV” certification pursuant to the Hatch-Waxman Act (21 U.S.C. § 355), or any misappropriation or other violation of any trade secret rights or other legally-enforceable rights to Know-How licensed under this Agreement, related to the Exploitation of the Licensed Compound or product containing the Licensed Compound in the Field in the Territory (a “Product Infringement”), subject to the provisions of this Section 6.8(b); provided that, notwithstanding anything to the contrary contained herein, if Biodexa has sublicensed rights hereunder to a Sublicensee that has [***], such Sublicensee (including Biodexa on behalf of such Sublicensee) shall have the sole right to bring any such suit or action unless otherwise agreed between the Parties (the “[***] Sole Right Designation Exception”).

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(i) Biodexa shall notify Otsuka of its election to take any action in accordance with this Section 6.8(b) at least [***] days before any time limit set forth in an Applicable Law, including the time limits set forth under the Hatch-Waxman Act (21 U.S.C. § 355). In the event Biodexa does not so elect, Biodexa shall so notify Otsuka in writing, and, subject to the [***] Sole Right Designation Exception described above, Otsuka shall have the right, but not the obligation, to commence a suit or take action to enforce a Licensed Otsuka Patent, extension thereof or trade secret rights or other legally-enforceable rights to Know-How licensed under this Agreement against such Third Party in the Territory at its own expense. If one Party elects to bring suit or take action against the Product Infringement, then the other Party shall have the right to join any such suit or action except in connection with a [***] Sole Right Designation Exception.

(ii) The Party that has not commenced an enforcement action shall provide to the Party enforcing any rights under this Section 6.8(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including by using Commercially Reasonable Efforts to have its employees testify when requested, making available relevant records, information, specimens and the like, and joining such action as a party plaintiff if required by Applicable Law to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts and shall reasonably consider the other Party’s comments on any such efforts, including determination of litigation strategy and filing of important papers to the court.

(iii) The enforcing Party shall be entitled to keep the entirety of any amounts awarded in connection with such enforcement, and amounts obtained in connection with a settlement of such enforcement, except that when Biodexa is the enforcing Party, any such award shall be treated as Net Sales for purposes of Section 5.3.

(iv) Neither Party shall enter into any settlement of any claim subject to this Section 6.8(b) that affects the other Party’s rights or interests without the other Party’s written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

(c) Infringement Outside the Territory. Otsuka shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Third Party engaged in any existing, alleged or threatened infringement of a Biodexa Background Patent, Joint Patent or extension thereof, or any misappropriation or other violation of any trade secret rights or other legally-enforceable rights to Know-How licensed under this Agreement related to the Exploitation of the Licensed Compound or product containing the Licensed Compound in the Field outside the Territory, subject to the provisions of this Section 6.8(c).

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(i) Otsuka shall notify Biodexa of its election to take any action in accordance with this Section 6.8(c) at least [***] days before any time limit set forth in an Applicable Law. In the event Otsuka does not so elect, Otsuka shall so notify Biodexa in writing, and Biodexa shall have the right, but not the obligation, to commence a suit or take action to enforce a Biodexa Background Patent, Joint Patent, extension thereof or trade secret rights or other legally-enforceable rights to Know-How licensed under this Agreement against such Third Party outside the Territory at its own expense. If one Party elects to bring suit or take action against such infringement, misappropriation or other violation, then the other Party shall have the right to join any such suit or action.

(ii) The Party that has not commenced an enforcement action shall provide to the Party enforcing any rights under this Section 6.8(c) reasonable assistance in such enforcement, at the enforcing Party’s request and expense, including by using Commercially Reasonable Efforts to have its employees testify when requested, making available relevant records, information, specimens and the like, and joining such action as a party plaintiff if required by Applicable Law to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts and shall reasonably consider the other Party’s comments on any such efforts, including determination of litigation strategy and filing of important papers to the court.

(iv) Neither Party shall enter into any settlement of any claim subject to this Section 6.8(c) that affects the other Party’s rights or interests without the other Party written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

6.9. Infringement of Third Party Rights in the Territory.

(a) Notice. If the Licensed Compound or any Licensed Product Manufactured or Commercialized by Biodexa, its Affiliates or Sublicensees becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted, or infringement or other violation of any other intellectual property right, in the Territory, (i) the Party first having notice of the claim or assertion shall promptly notify the other Party; (ii) the Parties shall agree on and enter into a “common interest agreement” wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute; and (iii) thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action.

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(b) Defense. Subject to the provisions of Article 9, Biodexa shall have the first right, but not the obligation, to defend any such Third Party claim as described in Section 6.9(a) above, at Biodexa’s expense. If Biodexa does not assume the defense of such claim within [***] days after it receives notice thereof, then to the extent allowed by Applicable Law, Otsuka shall have the right, but not the obligation, to control the defense of such claim by legal counsel of its choice, at Otsuka’s expense. The non-defending Party shall reasonably cooperate with the Party conducting the defense of the claim or assertion, including if required to conduct such defense, furnishing a power of attorney. If the defending Party recovers monetary damages from any such Third Party asserting such a claim of infringement as a result of counterclaims brought by such defending Party based on any Licensed Otsuka Patent, Biodexa Background Patent, Joint Patent or extension thereof, such recovery shall be allocated in accordance with the provisions of Section 6.8(b)(iii) or 6.8(c)(iii) as applicable.

(c) Settlement. Neither Party shall enter into any settlement of any claim described in this Section 6.9 that affects the other Party’s rights or interests without such other Party’s written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

6.10. Patent Oppositions and Similar Proceedings.

(a) Parties’ Patent Rights. If any Licensed Otsuka Patent, Joint Patent, Biodexa Background Patent or extension thereof becomes the subject of any opposition, interference, reexamination, nullity action, inter partes review, post-grant review, action for a declaratory judgment of non-infringement or other attack upon its ownership, validity or enforceability commenced by a Third Party (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, an action for infringement against a Third Party under Section 6.8(b) or (c), in which case the provisions of Section 6.8(b) or (c), as applicable, shall govern), then the Party responsible for filing, preparing, prosecuting and maintaining such Patent as set forth in Section 6.6, shall control such defense at its own expense. The controlling Party shall permit the non-controlling Party to participate in the proceeding to the extent permissible under Applicable Law, and to be represented by its own legal counsel in such proceeding, at the non-controlling Party’s expense. If either Party decides that it does not wish to defend against such action, then the other Party shall have a backup right to assume defense of such Third-Party action at its own expense.

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(b) Third-Party Patent Rights. If either Party desires to bring an opposition, interference, reexamination, nullity action, inter partes review, post-grant review, action for a declaratory judgment of non-infringement or other attack upon the ownership, validity or enforceability of a Patent owned or controlled by a Third Party having one or more claims that potentially covers the Licensed Compound, a Licensed Product, Otsuka Product or its Exploitation anywhere in the world (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 6.9, in which case the provisions of Section 6.9 shall govern), such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Biodexa shall have the first right, but not the obligation, to bring at its own expense and in its sole control such action in the Territory. If Biodexa does not bring such an action in the Territory, within [***] days after notification thereof pursuant to this Section 6.10(b) (or earlier, if required by the nature of the proceeding), then Otsuka shall have the right, but not the obligation, to bring, at Otsuka’s sole expense, such action. The Party not bringing an action under this Section 6.10(b) shall be entitled to separate representation in such proceeding by legal counsel of its own choice and at its own expense, and shall cooperate fully with the Party bringing such action.

6.11. Reporting. Throughout the Term, Biodexa shall provide Otsuka reasonably detailed semiannual reports describing its activities with respect to preparation, filing, prosecution, extension, maintenance, defense and enforcement of the Licensed Otsuka Patents in the Territory, including (i) the current status of each patent or patent application included in the Licensed Otsuka Patents; and (ii) deadlines for filings and fee payments over the next [***] months. The first such report shall be due at the end of the [***] full month after the Effective Date, and successive such reports shall be due every [***] months thereafter.

6.12. Product Trademarks. Biodexa shall have the sole right to determine the Trademarks to be used with respect to the Exploitation of Licensed Products in the Field in the Territory (“Product Trademarks”). However, Biodexa has no right to, and shall not, use any Trademark of Otsuka or its Affiliates in connection with Licensed Products. Biodexa shall own all right, title, and interest to Product Trademarks, and shall be responsible, at its sole cost and expense, for the registration, prosecution, maintenance and enforcement thereof. If Otsuka ever Commercializes outside the Territory an Otsuka Product, and Biodexa is using in commerce in the Territory a Product Trademark, then upon Otsuka’s request, Biodexa shall grant Otsuka an exclusive license under any rights Biodexa may have to such Product Trademark outside the Territory to use such Product Trademark outside the Territory in connection with such Otsuka Product.

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7. Representations and Warranties.

7.1. Mutual Representations and Warranties. Each of the Parties hereby represents and warrants to the other Party as of the Effective Date that:

(a) It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization.

(b) This Agreement is binding upon such Party and enforceable in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).

(c) The execution, delivery, and performance of this Agreement by such Party have been duly authorized by all necessary corporate action.

(d) The execution, delivery, and performance of this Agreement by such Party do not conflict with any agreement, instrument, or understanding to which it is a party or by which it is bound, nor violate any Applicable Law or any order, judgment, injunction, decree, determination, or award of any court or other Governmental Authority presently in effect applicable to such Party.

(e) Neither such Party nor any of its Affiliates has been debarred by the FDA or is subject to any similar sanction of any other Regulatory Authority anywhere in the world.

7.2. Additional Representations and Warranties of Otsuka. Otsuka represents and warrants as of the Effective Date that:

(a) Otsuka has all rights necessary to grant the license granted in Section 2.1.

(b) The Patents set forth on Exhibit B are all of the Patents specifically related to the Licensed Compound and the Licensed Product Controlled by Otsuka.

(c) No claim, litigation or other proceeding has been brought or, to Otsuka’s Knowledge, threatened against Otsuka or its Affiliates by any Person alleging that (i) any of the Licensed Otsuka Patents is invalid or unenforceable, or (ii) the Licensed Compound infringes any Patent of any Third Party.

(d) To Otsuka’s Knowledge, there is no actual or threatened infringement or misappropriation of the Licensed IP by any Person in the Territory.

7.3. Additional Representations and Warranties of Biodexa. Biodexa represents and warrants as of the Effective Date that:

(a) Biodexa has all rights necessary to grant the license granted in Section 2.3.

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(b) There are no existing Biodexa Background Patents.

7.4. DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, INCLUDING ANY EXPRESS OR IMPLIED WARRANTY OF QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT, INCLUDING AS TO WHETHER BIODEXA, ITS AFFILIATES AND SUBLICENSEES, IN PRACTICING THE LICENSED IP, WILL BE FREE FROM ANY INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY, OR AS TO THE VALIDITY OR ENFORCEABILITY OF ANY PATENTS. EACH PARTY’S REPRESENTATIONS AND WARRANTIES UNDER THIS AGREEMENT ARE SOLELY FOR THE BENEFIT OF THE OTHER PARTY AND MAY BE ASSERTED ONLY BY THE OTHER PARTY AND NOT BY ANY AFFILIATE, SUBLICENSEE OR ANY CUSTOMER OF THE OTHER PARTY, ITS AFFILIATES OR SUBLICENSEES. EACH PARTY, ITS AFFILIATES AND SUBLICENSEES SHALL BE SOLELY RESPONSIBLE FOR ALL REPRESENTATIONS AND WARRANTIES THAT IT, ITS AFFILIATES OR SUBLICENSEES MAKE TO ANY CUSTOMER OF SUCH PARTY, ITS AFFILIATES OR SUBLICENSEES.

8. Confidentiality

8.1. Disclosure. Each Party shall (i) keep in strict confidence the other Party’s Confidential Information and shall not disclose the other Party’s Confidential Information to any Third Party; (ii) use the other Party’s Confidential Information solely for purposes authorized by or related to this Agreement; and (iii) not copy or reproduce any portion of the other Party’s Confidential Information other than to the extent as may be reasonably necessary for purposes authorized by or related to this Agreement. Notwithstanding the foregoing, each Party may disclose the other Party’s Confidential Information to its Representatives, Sublicensees and actual or prospective investors, acquirers, licensees, sublicensees and merger-partners that (a) have a need to know such Confidential Information; and (b) have been advised by such first Party of the confidential nature of such Confidential Information and have agreed to be bound by restrictions on disclosure and use of such Confidential Information comparable to the provisions of this Article 8. In each of the above situations, the receiving Party shall be responsible for any failure by any Person who receives Confidential Information pursuant to this Section 8.1 to treat such Confidential Information as required under this Article 8.

8.2. Terms of this Agreement. The terms of this Agreement shall be treated as Confidential Information of both Parties.

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8.3. Permitted Disclosures in General. Notwithstanding Section 8.1, but subject to the provisions of Sections 8.4, 8.5 and 8.6, each Party may disclose the other Party’s Confidential Information if required to disclose by Applicable Law (including requirements of any securities association, stock exchange or national securities quotation system on which such Party’s securities are listed or traded) or in response to a valid order from a judicial, administrative authority, or any securities association, stock exchange or national securities quotation system on which such Party’s securities are listed or traded, provided that the Party seeking to make such disclosure shall, to the extent reasonably possible, promptly notify the other Party in order to allow the other Party time to seek an appropriate protective order or other remedy; and provided further that any Party disclosing information under this Section 8.3 shall only disclose such information as is required in order to comply with its legal obligation.

8.4. Publicity. Biodexa shall be entitled to make a public announcement of the execution of this Agreement, which shall be issued at a time to be mutually agreed by the Parties. Such public announcement will be substantially similar to the form of press release attached hereto as Exhibit H. Each Party agrees not to issue any other press release or other public statement disclosing other information relating to this Agreement that contains information not previously publicly disclosed in accordance with this Section 8.4 without the prior written consent of the other Party, which shall not be withheld, conditioned or delayed unreasonably.

8.5. Securities Filings. In addition to the provisions of Section 8.3, if either Party proposes to file with the securities regulators of any applicable jurisdiction a disclosure document that describes, refers to or contains the terms of this Agreement, such Party shall notify the other Party of such intention and shall provide the other Party with a copy of relevant portions of the proposed filing a reasonable time prior to the filing thereof. The Party making such filing shall cooperate in good faith with the other Party to obtain confidential treatment of the terms of this Agreement that the other Party requests to be kept confidential or otherwise afforded confidential treatment, and shall only disclose Confidential Information that it is reasonably advised by legal counsel is legally required to be disclosed. No such notice shall be required if the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the either Party in accordance with this Section 8.5 or otherwise approved by the other Party or disclosed in a prior press release by the Parties or other prior public disclosure made by a Party in accordance with the terms of this Article 8.

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8.6. Publications and Promotional Materials. Except to the extent that Otsuka may waive this requirement in writing, Biodexa shall submit to Otsuka for its review any proposed academic, scientific or medical publication or presentation by Biodexa, its Affiliates and its Sublicensees that relates to the Licensed Compound or a Licensed Product or contains Licensed Otsuka Know-How or Know-How pertaining to a Joint Invention that has not been previously publicly disclosed or otherwise approved by Otsuka to be publicly disclosed, for the purposes of determining whether any portion of the proposed publication or presentation should be modified or deleted so as to preserve the value of the same. Biodexa shall consider all comments provided by Otsuka in good faith, including comments regarding the potential adverse impact on Exploitation of products outside the Territory, and subject to the terms of this Article 8, in no event shall Biodexa disclose any Confidential Information of Otsuka without Otsuka’s prior written consent. Written copies of any proposed publication or presentation required to be submitted hereunder shall be submitted to Otsuka no later than [***] days before submission for publication or presentation (the “Review Period”). Otsuka shall provide its comments with respect to such publications and presentations within [***] days after its receipt of such written copy. The Review Period may be extended for an additional [***] days in the event such extension is necessary for the preparation and filing of Patent applications. Each Party shall comply, and shall cause its Affiliates and Sublicensees to comply, with (i) standard academic practice regarding authorship of scientific publications and recognition of contribution of the other Party in any publication governed by this Section 8.6, including International Committee of Medical Journal Editors standards regarding authorship and contributions, and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.

8.7. Ownership. All Confidential Information and all intellectual property rights thereto, shall remain the sole property of the disclosing Party. The disclosure of Confidential Information hereunder shall not be construed to grant to the receiving Party any license or other right under any intellectual property right thereto held by the disclosing party except as specifically set forth in this Agreement.

8.8. End of Term. Subject to Section 11.4(f), if the Term ends, the receiving Party shall, at its cost, use Commercially Reasonable Efforts promptly to (i) deliver to the disclosing Party or destroy all tangible embodiments of the other Party’s Confidential Information; and (ii) delete the other Party’s Confidential Information from any computer or other electronic or magnetic storage in the possession of, or under control of, the receiving Party or its Representatives; provided that the receiving Party may retain (a) any Confidential Information of the other Party that remains subject to a license continuing after termination; and (b) one copy of any Confidential Information for the sole purpose, in the event of a future dispute, of proving what information it did or did not receive hereunder. Such copy shall be kept in a secure manner accessible only to legal counsel of such Party.

8.9. Injunctive Relief. Each Party agrees that monetary damages would not be a sufficient remedy for a breach or threatened breach of this Agreement by either Party or any of its Representatives and that, in the event of any such breach or threatened breach, in addition to all other rights and remedies which may be available to it, the non-breaching Party shall be entitled, without the requirement of posing a bond or other security, to seek an injunction or specific performance of the terms of this Agreement or any other remedy with equivalent effect.

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9. Indemnification.

9.1. Indemnification by Biodexa. Biodexa shall defend, indemnify and hold harmless Otsuka and its Affiliates, and each of their respective Representatives (each, an “Otsuka Indemnitee”) from and against any and all claims, suits, actions, demands, liabilities, expenses and/or loss, including reasonable legal expense and attorneys’ fees (collectively, “Losses”) to which any Otsuka Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (each, a “Claim”) to the extent such Losses arise directly or indirectly out of: (i) the practice by Biodexa or its Affiliate or Sublicensee of any license granted to it under this Agreement; (ii) Development, Manufacture, Commercialization or other use, handling, storage, sale or other disposition of the Licensed Compound or Licensed Product by Biodexa or its Affiliate or Sublicensee, including recalls and Claims relating to personal injury and death; (iii) interactions and communications by Biodexa, its Affiliates and Sublicensees with Governmental Authorities, physicians or other Third Parties relating to the Licensed Compound and Licensed Products; (iv) use or reliance by Biodexa, its Affiliates or Sublicensees on any Know-How or other data or information provided to Biodexa by or for Otsuka; (v) the breach by Biodexa of any warranty, representation, covenant or agreement made by Biodexa in this Agreement; or (vi) the gross negligence or willful misconduct of Biodexa, its Affiliate or its Sublicensee, or any Representative thereof.

9.2. Indemnification by Otsuka. Otsuka shall defend, indemnify and hold harmless Biodexa and its Affiliates, and each of their respective Representatives (each, a “Biodexa Indemnitee”) from and against any and all Losses to which any Biodexa Indemnitee may become subject as a result of any Claim to the extent such Losses arise directly or indirectly out of: (i) the practice by Otsuka or its Affiliate or Sublicensee of any license granted to it under this Agreement; (ii) Development, Manufacture, Commercialization or other use, handling, storage, sale or other disposition of the Licensed Compound or an Otsuka Product by Otsuka or its Affiliate or Sublicensee; (iii) interactions and communications by Otsuka, its Affiliates and Sublicensees with Governmental Authorities, physicians or other Third Parties relating to the Licensed Compound and Otsuka Products; (iv) use or reliance by Otsuka, its Affiliates or Sublicensees on any Know-How or other data or information provided to Otsuka by or for Biodexa; (v) the breach by Otsuka of any warranty, representation, covenant or agreement made by Otsuka in this Agreement; or (vi) the gross negligence or willful misconduct of Otsuka, its Affiliate or its Sublicensee, or any Representative thereof.

9.3. Indemnification Procedures.

(a) Notice. Promptly after an Otsuka Indemnitee or a Biodexa Indemnitee (each, an “Indemnitee”) receives notice of a pending or threatened Claim, such Indemnitee shall give written notice of the Claim to the Party from whom the Indemnitee is entitled to receive indemnification pursuant to Sections 9.1 or 9.2, as applicable (the “Indemnifying Party”). However, an Indemnitee’s delay in providing or failure to provide such notice shall not relieve the Indemnifying Party of its indemnification obligations, except to the extent it can demonstrate prejudice due to the delay or lack of notice.

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(b) Defense. Upon receipt of notice under Section 9.3(a) from the Indemnitee, the Indemnifying Party shall have the duty to either compromise or defend such Claim, at its own expense by legal counsel chosen by it and reasonably satisfactory to the Indemnitee. The Indemnifying Party shall promptly (and in any event not more than [***] days after receipt of the Indemnitee’s original notice) notify the Indemnitee in writing that it acknowledges its obligation to indemnify the Indemnitee with respect to the Claim pursuant to this Article 9 and of its intention either to compromise or defend such Claim. Once the Indemnifying Party gives such notice to the Indemnitee, the Indemnifying Party is not liable to the Indemnitee for the fees of other legal counsel or any other expenses subsequently incurred by the Indemnitee in connection with such defense, other than the Indemnitee’s reasonable expenses of investigation and cooperation. However, the Indemnitee shall have the right to employ separate legal counsel with respect to the Claim at its own expense.

(c) Cooperation. The Indemnitee shall cooperate fully with the Indemnifying Party and its Representatives in the investigation and defense of any Claim. The Indemnifying Party shall keep the Indemnitee informed on a reasonable and timely basis as to the status of such Claim (to the extent the Indemnitee is not participating in the defense of such Claim) and conduct the defense of such Claim in a prudent manner.

(d) Settlement. If an Indemnifying Party assumes the defense of a Claim, no compromise or settlement of such Claim may be effected by the Indemnifying Party without the Indemnitee’s written consent (which consent shall not be unreasonably withheld, conditioned or delayed), unless: (i) there is no finding or admission of any violation of law or any violation of the rights of any Person and no effect on any other claims that may be made against the Indemnitee; (ii) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party; and (iii) the Indemnitee’s rights under this Agreement are not adversely affected. If the Indemnifying Party fails to assume defense of a Claim within a reasonable time, the Indemnitee may settle such Claim on such terms as it deems appropriate with the consent of the Indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed), and the Indemnifying Party shall be obligated to indemnify the Indemnitee for such settlement as provided in this Article 9.

10. Limitation of Liability. EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS SET FORTH IN ARTICLE 9, ANY BREACH OF ARTICLE 2 (LICENSES) OR ARTICLE 8 (CONFIDENTIALITY), OR GROSS NEGLIGENCE OR WILFUL MISCONDUCT, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY (OR THE OTHER PARTY’S AFFILIATES OR SUBLICENSEES) FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY Or PUNITIVE DAMAGES UNDER ANY THEORY, INCLUDING CONTRACT, NEGLIGENCE, OR STRICT LIABILITY, EVEN IF THAT PARTY HAS BEEN PLACED ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

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11. Term and Termination

11.1. Term. This Agreement shall become effective as of the Effective Date and shall continue in full force and effect (unless and until terminated pursuant to Section 11.3) with respect to each country of the Territory on a country-by-country basis until the expiration of the Royalty Term for all Licensed Products in each such country in the Territory. After expiration of the Royalty Term, on a country-by-country basis, the rights and licenses granted by Otsuka to Biodexa under this Agreement to Exploit Licensed Products in the Field in such country in the Territory shall convert to an irrevocable, perpetual, exclusive, royalty-free and fully paid-up (subject to Section 11.2), license, with the right to grant sublicenses (through multiple tiers, but subject to Section 11.2(b)) solely in such country.

11.2. Effects of Expiration in One or More Countries. Upon the effective date of expiration of this Agreement in any country in accordance with Section 11.1:

(a) Biodexa and its Affiliates and Sublicensees must not sell or otherwise distribute Licensed Products from a country of the Territory in which the Royalty Term has expired into a country of the Territory in which the Royalty Term has not expired, or permit any of their authorized distributors to do so, unless Biodexa pays royalties on the sales in the country in which the Royalty Term has not expired in accordance with Article 5.

(b) For so long as the Agreement remains in effect in one or more countries, sublicenses must comply with the requirements of Section 2.2 even insofar as they convey rights in a country in which the Royalty Term has expired.

(c) Biodexa’s obligation to pay royalties under Section 5.3 and provide associated reporting under Section 5.6 shall apply to sales and other Licensed Product dispositions before expiration of the Royalty Term in the relevant country, and Section 5.4 and Sections 5.7 through 5.11 shall apply to such payments.

(d) Biodexa’s obligation to make sublicense-related payments under Section 5.5 shall apply to any sublicense transaction or series of related transactions that includes a country in which the Royalty Term has not expired, even if the Royalty Term has expired in one or more countries that are also included in the sublicense transaction or series of related transactions.

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(e) Subject to Section 11.6, all the provisions of this Agreement specifically identified as applying during the Term, or during a period that extends beyond expiration of the Royalty Term in a particular country, shall continue to apply to the relationship between the Parties, even though the Royalty Term has expired in certain countries.

11.3. Termination. This Agreement may be terminated in any of the following circumstances.

(a) Consensual Termination. The Parties may agree in writing to terminate this Agreement at any time.

(b) Unilateral Termination by Biodexa. Biodexa may terminate this Agreement at any time upon [***] months’ written notice to Otsuka. If Biodexa determines that it, its Affiliates and its Sublicensees do not wish to continue Development or Commercialization of the Licensed Compound and Licensed Products, Biodexa shall provide such notice of termination.

(c) Cessation of Development or Commercialization. This Agreement shall terminate automatically if Biodexa is not, directly or through its Affiliates or Sublicensees, actively engaged in Development or Commercialization activities for a continuous period of longer than [***]; it being understood and agreed that such [***] shall be extended for any then-existing Force Majeure event or any Regulatory Authority directive (including any then-existing clinical hold decision in accordance with Applicable Law) that materially impedes otherwise contemplated Development or Commercialization activities. If Otsuka ever has questions as to whether Biodexa is actively engaged in Development or Commercialization activities, and provides Biodexa written notice inquiring concerning the same, Biodexa shall within [***] days respond in writing with reasonable information concerning the status of its Development and Commercialization activities.

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(d) Default Termination. Either Party (the “Non-Breaching Party”) may terminate this Agreement if the other Party (the “Breaching Party”) has materially breached this Agreement, and such material breach either is not curable or has not been cured within (a) [***] days after the Breaching Party receives written notice of such breach from the Non-Breaching Party, in the case of a breach occurring before First Commercial Sale; or (b) [***] days after the Breaching Party receives written notice of such breach from the Non-Breaching Party, in the case of a breach occurring after First Commercial Sale (in either case, the “Cure Period”); provided that the Cure Period shall be [***] days after the Breaching Party receives written notice of such from the Non-Breaching Party if the breach is a breach of a Party’s obligation to use Commercially Reasonable Efforts hereunder. The written notice describing an alleged material breach shall provide sufficient detail reasonably to put the Breaching Party on notice of such material breach. Any termination of this Agreement pursuant to this Section 11.3(d) shall become effective immediately if such material breach is not curable, or otherwise at the end of the Cure Period, unless the Breaching Party has cured such material breach prior to the expiration of such Cure Period, or unless such allegedly breaching Party disputes such breach. The right of either Party to terminate this Agreement as provided in this Section 11.3(d) shall not be affected in any way by such Party’s waiver of or failure to take action with respect to any previous breach under this Agreement. If the Parties reasonably and in good faith disagree as to whether there has been a material breach, including as to whether such breach was material, (i) the Party that disputes whether there has been a material breach may contest the allegation in accordance with Article 12; (ii) the Cure Period shall run from the date that written notice was first provided to the Breaching Party by the Non-Breaching Party through the resolution of such dispute pursuant to Article 12; and (iii) during the pendency of a dispute pursuant this Section 11.3(d), all of the terms of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement.

(e) Termination for Insolvency. Either Party may terminate this Agreement by written notice to the other Party if the other Party makes a general assignment for the benefit of creditors, files an insolvency petition in bankruptcy, petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets, commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of financially distressed debtors, or becomes a party to any proceeding or action of the type described above, and such proceeding or action remains un-dismissed or un-stayed for a period of more than [***] days.

(f) Termination for Patent Challenge. Otsuka may terminate this Agreement at any time upon written notice to Biodexa, if Biodexa, or any of Biodexa’s Affiliates or Sublicensees, directly, or indirectly through assistance granted to a Third Party, commences any interference or opposition proceeding, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to any Licensed Otsuka Patent or Joint Patent (a “Patent Proceeding”).

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11.4. Effects of Termination. All of the following effects of termination are in addition to the other rights and remedies that may be available to either of the Parties under this Agreement and shall not be construed to limit any such rights or remedies. Upon the effective date of termination (but not expiration) of this Agreement in accordance with Section 11.3:

(a) All rights and licenses granted to Biodexa in this Agreement shall terminate and revert to Otsuka, and Biodexa shall cease any and all Development, Manufacture, and Commercialization activities with respect to the Licensed Compound and Licensed Products, except that Biodexa, at its option, shall be entitled to sell any completed inventory of a Licensed Product that remains unsold as of the date of the termination, so long as the sales are completed within [***] after the date of termination and Biodexa pays to Otsuka royalties applicable to said subsequent sales in accordance with the terms of this Agreement;

(b) Subject to the provisions of Section 2.2(e), all sublicenses under the rights and licenses granted to Biodexa in this Agreement shall also terminate;

(c) All payment obligations under this Agreement shall terminate, other than obligations to pay amounts that have accrued and are unpaid as of the effective date of termination or become payable as a result of post-termination sales permitted by Section 11.4(a);

(d) Biodexa promptly shall assign to Otsuka without charge all of Biodexa’s rights in and to Joint Patents and Biodexa Background Patents owned by Biodexa that may be necessary or reasonably useful for Otsuka to Exploit the Licensed IP and Otsuka Products;

(e) Biodexa promptly shall assign to Otsuka without charge all Regulatory Materials of Biodexa and its Affiliates in respect of the Licensed Compound and Licensed Products; and

(f) At Otsuka’s election with respect to any part of the following, Biodexa promptly shall deliver to Otsuka all physical manifestations of the Licensed IP and all physical manifestations derived from the use thereof, including the entire inventory of Licensed Compound and intermediates in the Manufacture thereof, and Licensed Products remaining after the sell-off period specified in Section 11.4(a) at the cost of Otsuka (and in the case of inventory and intermediates upon reimbursement of Biodexa’s then-existing carrying costs), and records relating to the Development and Commercialization of Licensed Products, including records relating to Clinical Trials, necessary or reasonably useful for the Development or Commercialization of Otsuka Products.

Termination of this Agreement shall not affect the remedies of either Party otherwise available at law or in equity in relation to any rights accrued under this Agreement prior to termination.

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11.5. Remedies. Termination of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration, nor prejudice either Party’s right to obtain performance of any obligation. Each Party shall be free, pursuant to Article 12, to seek, without restriction as to the number of times it may seek, damages, expenses and remedies that may be available to it under Applicable Law or in equity and shall be entitled to offset the amount of any damages and expenses obtained against the other Party in a final determination under Article 12, against any amounts otherwise due to such other Party under this Agreement.

11.6. Survival. The following provisions shall survive any expiration or termination of this Agreement for the period of time specified therein (or, if no such period is specified, indefinitely): Article 1; Sections 2.2(e), 2.3, 2.4, 2.5, 2.6 (for so long as the Royalty Term has not expired or been terminated in any one or more other countries in the Territory), 2.8, 3.6 (for the period set forth therein), 3.10, 4.4, 4.5, 4.6 (for so long as the Royalty Term has not expired or been terminated in any one or more other countries in the Territory), 4.7 (for so long as the Royalty Term has not expired or been terminated in any one or more other countries in the Territory), 4.8, 4.9 (for so long as the Royalty Term has not expired or been terminated in any one or more other countries in the Territory), 5 (solely with respect to countries in the Territory for which the Royalty Term has not expired or been terminated, and obligations to pay amounts that have accrued and are unpaid as of the effective date of expiration or termination), Article 6 (solely with respect to countries in the Territory for which the Royalty Term has not expired or been terminated), Section 7.4, and Articles 8, 9, 10, 11, 12, 13 and 14.

12. Dispute Resolution

12.1. Exclusive Dispute Resolution Mechanism. The Parties agree that the procedures set forth in this Article 12 shall be the exclusive mechanism for resolving any dispute, controversy, or claim between the Parties that may arise from time to time pursuant to this Agreement relating to either Party’s rights or obligations hereunder (each, a “Dispute”) that is not resolved through good faith negotiation between the Parties.

12.2. Resolution by Executive Officers. Except as otherwise provided in this Section 12.2, in the event of any Dispute, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves. In the event that such Dispute is not resolved on an informal basis within [***] days after receipt of written notice of such Dispute by a Party, either Party may, by written notice to the other Party, refer the Dispute to the senior executive officer (or his/her delegate) of the other Party for attempted resolution by good faith negotiation within [***] days after such notice is received. Each Party may, in its sole discretion, seek resolution of any and all Disputes that are not resolved under this Section 12.2 in accordance with Section 12.3.

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12.3. Arbitration. Any unresolved Dispute that was subject to Section 12.2 shall be settled by arbitration administered by the International Centre for Dispute Resolution in accordance with its International Arbitration Rules. The place of arbitration shall be New York, New York. The language of the arbitration shall be English. The arbitrator(s) shall have experience with intellectual property licensing in the pharmaceutical industry. Pre-hearing information exchange shall be limited to the reasonable production of relevant non-privileged documents explicitly referred to by a party for the purpose of supporting relevant facts presented in its case, carried out expeditiously. Except as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both Parties.

12.4. Preliminary Injunctions. Notwithstanding anything in this Article 12 to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any Dispute.

13. Notices. Any notice, request, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be hand delivered or sent by a recognized overnight delivery service, expenses prepaid, or by electronic mail (with receipt confirmed), to the following addresses or to such other addresses as a Party may designate by written notice in accordance with this Article 13:

If to Otsuka:

Director, Global Business Development

Otsuka Pharmaceutical Co., Ltd.

Shinagawa Grand Central Tower

2-16-4 Konan, Minato-ku, Tokyo 108-8241, Japan

Email: [***]

with a copy to:

Director, Legal Affairs Department

Otsuka Pharmaceutical Co., Ltd.

Shinagawa Grand Central Tower

2-16-4 Konan, Minato-ku, Tokyo 108-8241, Japan

Email: [***]

If to Biodexa:

Stephen Stamp, CEO

Biodexa Pharmaceuticals PLC

1 Caspian Point

Caspian Way, Cardiff, CF10 4DQ, United Kingdom

Email: [***]

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With a copy (which shall not constitute notice) to:

Orrick, Herrington & Sutcliffe LLP

2100 Pennsylvania Avenue, N.W.

Washington, D.C. 20037

Attention: David Schulman

Email: [***]

14. Miscellaneous

14.1. Designation of Affiliates. Each Party may discharge any obligations and exercise any rights hereunder through delegation of its obligations or rights to any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

14.2. Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by Force Majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting Force Majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a Force Majeure affecting such Party. If a Force Majeure persists for more than [***] days, then the Parties shall discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such Force Majeure.

14.3. Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other (which consent shall not be unreasonably withheld, conditioned or delayed), except that (i) either Party may assign this Agreement without the other Party’s consent to any Affiliate; and (ii) either Party may assign this Agreement without the other Party’s consent to a successor to all or substantially all of the business of such assigning Party to which this Agreement relates, whether in a merger, sale of stock or units, sale of assets or other transaction; provided that, in the case of any assignment by Biodexa, the assignee has the technological and business capability and sufficient financial resources to Exploit a Licensed Product (and it is understood and agreed that any Third Party which has at least [***] U.S. dollars (USD $[***]) of revenue from sales of pharmaceutical products in the immediately preceding calendar year shall be deemed to be a Third Party with the technological and business capability and sufficient financial resources to Exploit a Licensed Product). Any permitted successor or assignee of rights and/or obligations permitted hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 14.3 shall be null and void.

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14.4. Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any arbitrator or court of competent jurisdiction from which decision no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

14.5. Waiver and Non-Exclusion of Remedies. Any term of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.

14.6. Further Assurances. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof.

14.7. Relationship of the Parties. The Parties are independent contractors, and the relationship between the Parties shall not constitute or be considered a partnership, joint venture or agency, including for Tax purposes. Neither Otsuka nor Biodexa shall have the authority to make any statements, representations or commitments of any kind, or to take any other action, that shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of that Party and not of the other Party and all expenses and obligations incurred by reason of such employment shall be for the account and expense of such Party.

14.8. Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by .pdf or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original handwritten signatures.

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14.9. Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, and the use of any gender shall be applicable to all genders. Whenever this Agreement refers to Applicable Law, it means the same as it may be amended or superseded. Whenever this Agreement refers to a number of days, such number refers to calendar days. The captions of this Agreement are for the convenience of reference only and in no way define, describe, extend, or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The terms “including,” “include,” or “includes” as used herein shall mean “including, but not limited to,” and shall not limit the generality of any description preceding such term. The language of this Agreement shall be deemed to be language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

14.10. Governing Law. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the laws of the State of New York, without giving effect to any choice of law principles that would require the application of the laws of a different state.

14.11. Amendments. No alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized Representative of each Party.

14.12. Order of Precedence. In the event of any inconsistency between the body of this Agreement and the Exhibits to this Agreement or any subsequent agreements ancillary to this Agreement, unless otherwise expressly stated to the contrary in such Exhibit or subsequent ancillary agreement, the terms contained in this Agreement shall control.

14.13. Entire Agreement. This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein.

[Signature page follows]

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IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective Date.

OTSUKA PHARMACEUTICAL CO., LTD.
By:	/s/ Hiroaki Ono
Name:	Hiroaki Ono
Title:	Executive Managing Director & Board Member (Pharmaceutical Business Division)
Date:	February 2, 2026
By:	/s/ Takeshi Watanabe
Name:	Takeshi Watanabe
Title:	Senior Vice President & Operating Officer, Director (Dept. of Business Dev.)
Date:	February 2, 2026
BIODEXA PHARMACEUTICALS PLC
By:	/s/ Stephen Stamp
Name:	Stephen Stamp
Title:	Chief Executive Officer
Date:	February 3, 2026

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Exhibit A

Licensed Compound

[***]

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Exhibit B

Licensed Otsuka Patents

[***]

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Exhibit C

Development Documents*

[***]

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Exhibit D

Manufacturing Documents*

[***]

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Exhibit E

Data Sharing Agreement

[***]

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Exhibit F

Subject Matter to Be Addressed in Development Plan

[***]

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Exhibit G

Subject Matter to be Addressed in Commercialization Plan

[***]

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Exhibit H

Form of Press Release

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Exhibit 8.1

Subsidiaries	Country of Incorporation	Voting Interest
Biodexa Australia PTY Ltd	Australia	100%
Biodexa Ireland Ltd	Republic of Ireland	100%
Biodexa US, Inc.	United States	100%
Biodexa Pharma (Wales) Limited	England and Wales	100%
Biodexa Ltd	England and Wales	100%

Exhibit 12.1

Certification Pursuant to Section 302 ofthe Sarbanes-Oxley Act of 2002

I, Stephen Stamp, certify that:

1.	I have reviewed this annual report on Form 20-F of Biodexa Pharmaceuticals PLC (the “Company”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to<br>state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not<br>misleading with respect to the period covered by this report;
---	---
3.	Based on my knowledge, the financial statements, and other financial information included in this report,<br>fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the<br>periods presented in this report;
---	---
4.	The Company’s other certifying officer(s) and I are responsible for establishing and maintaining<br>disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting<br>(as defined in Exchange Act Rules 13a-15(f) and 15d-15(O)) for the Company and have:
---	---
(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to<br>be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries,<br>is made known to us by others within those entities, particularly during the period in which this report is being prepared;
---	---
(b)	Designed such internal controls over financial reporting, or caused such internal control over financial<br>reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the<br>preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
---	---
(c)	Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in<br>this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by<br>this report based on such evaluation; and
---	---
(d)	Disclosed in this report any change in the Company’s internal control over financial reporting that<br>occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the<br>company’s internal control over financial reporting; and
---	---
5.	The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation<br>of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of<br>directors (or persons performing the equivalent functions):
---	---
(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over<br>financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report<br>financial information; and
---	---
(b)	Any fraud, whether or not material, that involves management or other employees who have a significant<br>role in the Company’s internal control over financial reporting.
---	---
Date: March 27, 2026	/s/ Stephen Stamp
---	---
	Name: Stephen Stamp
	Title: Chief Executive Officer
	(Principal Executive Officer)

Exhibit 12.2

Certification Pursuant to Section 302 ofthe Sarbanes-Oxley Act of 2002

I, Fiona (Powell) Sharp, certify that:

1.	I have reviewed this annual report on Form 20-F of Biodexa Pharmaceuticals PLC (the “Company”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to<br>state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not<br>misleading with respect to the period covered by this report;
---	---
3.	Based on my knowledge, the financial statements, and other financial information included in this report,<br>fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the<br>periods presented in this report;
---	---
4.	The Company’s other certifying officer(s) and I are responsible for establishing and maintaining<br>disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting<br>(as defined in Exchange Act Rules 13a-15(f) and 15d-15(O)) for the Company and have:
---	---
(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to<br>be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries,<br>is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)	Designed such internal controls over financial reporting, or caused such internal control over financial<br>reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the<br>preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
---	---
(c)	Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in<br>this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by<br>this report based on such evaluation; and
---	---
(d)	Disclosed in this report any change in the Company’s internal control over financial reporting that<br>occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the<br>company’s internal control over financial reporting; and
---	---
5.	The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation<br>of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of<br>directors (or persons performing the equivalent functions):
---	---
(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over<br>financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report<br>financial information; and
---	---
(b)	Any fraud, whether or not material, that involves management or other employees who have a significant<br>role in the Company’s internal control over financial reporting.
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Date: March 27, 2026	/s/ Fiona (Powell) Sharp
---	---
	Name: Fiona (Powell) Sharp
	Title: Chief Financial Officer
	(Principal Financial Officer)

Exhibit 13.1

Certification pursuant to 18 U.S.C. Section1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report on Form 20-F of Biodexa Pharmaceuticals PLC (the “Company”) for the year ended December 31, 2025, as filed with the United States Securities and Exchange Commission on the date hereof (the “Report”), the undersigned Stephen Stamp, as Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

1.	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange<br>Act of 1934; and
2.	The information contained in the Report fairly presents, in all material respects, the financial condition<br>and results of operations of the Company.
---	---

Date: March 27, 2026

/s/ Stephen Stamp
Name: Stephen Stamp
Title: Chief Executive Officer
(Principal Executive Officer)

A SIGNED ORIGINAL OF THIS WRITTEN STATEMENT REQUIRED BY SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 HAS BEEN PROVIDED TO BIODEXA PHARMACEUTICALS PLC AND WILL BE RETAINED BY BIODEXA PHARMACEUTICALS PLC AND FURNISHED TO THE SECURITIES AND EXCHANGE COMMISSION OR ITS STAFF UPON REQUEST.

Exhibit 13.2

Certification pursuant to 18 U.S.C. Section1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report on Form 20-F of Biodexa Pharmaceuticals PLC (the “Company”) for the year ended December 31, 2025, as filed with the United States Securities and Exchange Commission on the date hereof (the “Report”), the undersigned Fiona (Powell) Sharp, as Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of her knowledge:

1.	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange<br>Act of 1934; and
2.	The information contained in the Report fairly presents, in all material respects, the financial condition<br>and results of operations of the Company.
---	---

Date: March 27, 2026

/s/ Fiona (Powell) Sharp
Name: Fiona (Powell) Sharp
Title: Chief Financial Officer
(Principal Financial Officer)

Exhibit 15.1

The Directors<br><br> <br>Biodexa Pharmaceuticals plc<br><br> <br>1 Caspian Point<br><br> <br>Caspian Way<br><br> <br>Cardiff<br><br> <br>Wales CF10 4DQ	DDI:<br><br> <br>+44 (0)20 7516 2200<br><br> <br><br><br> <br>Email:<br><br> <br>dthompson@pkf-l.com<br><br> <br><br><br> <br>Date:<br><br> <br>26 March 2026

Consent of Independent Registered Public Accounting Firm – Exhibit 15.1

Dear Sir / Madam

We consent to the inclusion of our audit report dated March 26, 2026 in the Annual Report on Form 20-F on the consolidated financial position of Biodexa Pharmaceuticals plc (the “Group”) and its subsidiaries as of December 31, 2025 and 2024 and the related consolidated statement of comprehensive income, cash flow and changes in equity for the year ended December 31, 2025 and 2024, and the related notes.

Yours faithfully

/s/PKF Littlejohn LLP

PKF Littlejohn LLP

London, United Kingdom

PKF Littlejohn LLP, Chartered Accountants. A list of members’ names is available at the address below. PKF Littlejohn LLP is a limited liability partnership registered in England and Wales No. OC342572. Registered office at 15 Westferry Circus, London E14 4HD. PKF Littlejohn LLP is a member of PKF Global, the network of member firms of PKF International Limited, each of which is a separate and independent legal entity and does not accept any responsibility or liability for the actions or inactions of any individual member or correspondent firm(s).

PKF Littlejohn LLP 15 Westferry Circus Canary Wharf, London E14 4HD T: +44 (0)20 7516 2200 pkf-l.com

Exhibit 15.2

30 Old Bailey<br><br> <br>London<br><br> <br>EC4M 7AU<br><br> <br><br><br> <br>Tel: +44 (0)20 7063 4000<br><br> <br>forvismazars.com/uk

Consent of Independent Registered Public AccountingFirm

RE:

The Board of Directors of Biodexa Pharmaceuticals PLC,

We hereby consent to the incorporation by reference in this Form 20-F (to be filed on or about March 26, 2026) of our audit report dated April 18, 2024 with respect to the consolidated balance sheet as of December 31, 2023 together with the related consolidated statement of comprehensive income, cash flows and changes in shareholders’ equity for each of the period ended December 31, 2023 and the related notes for Biodexa Pharmaceuticals PLC and its subsidiaries, which appears in the Annual Report on Form 20-F of Biodexa Pharmaceuticals PLC for the year ended December 31, 2023, filed on April 19, 2024. Our report contains an explanatory paragraph about the existence of substantial doubt concerning Company’s ability to continue as a going concern.

/S/ Forvis Mazars LLP

London, United Kingdom

March 26, 2026

Forvis Mazars LLP

Forvis Mazars LLP is the UK firm of Forvis Mazars Global, a leading global professional services network. Forvis Mazars LLP is a limited liability partnership registered in England and Wales with registered number OC308299 and with its registered office at 30 Old Bailey, London, EC4M 7AU. Registered to carry on audit work in the UK by the Institute of Chartered Accountants in England and Wales. Details about our audit registration can be viewed at www.auditregister.org.uk under reference number C001139861. VAT number: GB 839 8356 73