UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

o	REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES<br><br>EXCHANGE ACT OF 1934

x	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF<br><br>1934

For the fiscal year ended December 31, 2025

o	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT<br><br>OF 1934

For the transition period from _ to _

o	SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE<br><br>ACT OF 1934

Date of event requiring this shell company report: _____________________

Commission file number

001-42128

Telix Pharmaceuticals Limited

(Exact name of Registrant as specified in its charter)

N/A

(Translation of Registrant's name into English)

Australia

(Jurisdiction of incorporation or organization)

55 Flemington Road

North Melbourne, Victoria

3051

, Australia

(Address of principal executive offices)

Christian Behrenbruch

55 Flemington Road

North Melbourne, Victoria

3051

, Australia

Tel: +

61 3

9093 3855

(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
American depositary shares, each<br><br>representing one ordinary share, no<br><br>par value Ordinary shares, no par<br><br>value*	TLX	The Nasdaq Global Select Market

•Listed not for trading, but only in connection with the listing of the American Depositary Shares, pursuant to the

requirements of the Securities & Exchange Commission

Securities registered or to be registered pursuant to Section 12(g) of the Act: None.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of

the period covered by the annual report: The number of ordinary shares outstanding as of December 31, 2025 was

338,777,049.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes x No o

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 15(d) of the Securities Exchange Act of 1934. Yes o 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 o

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 such files): Yes x No o

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 the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth

company” in Rule 12b-2 of the Exchange Act.

Large accelerated<br><br>filer	x	Accelerated filer	o	Non-accelerated filer	o	Emerging growth<br><br>company	o

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. ☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting

Standards Board to its Accounting Standards Codification after April 5, 2012.

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 control 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. x

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. o

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). o

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

this filing:

U.S. GAAP o

International Financial Reporting Standards as issued by the International Accounting Standards Board x

Other o

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 o

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 o No x

ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	4
ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE	4
ITEM 3.	KEY INFORMATION	4
ITEM 4.	INFORMATION ON THE COMPANY	82
ITEM 4A.	UNRESOLVED STAFF COMMENTS	157
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	157
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	171
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	210
ITEM 8.	FINANCIAL INFORMATION	213
ITEM 9.	THE OFFER AND LISTING	214
ITEM 10.	ADDITIONAL INFORMATION	215
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	222
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	224
ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	227
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF<br><br>PROCEEDS	227
ITEM 15.	CONTROLS AND PROCEDURES	227
ITEM 16.	RESERVED	228
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	228
ITEM 16B.	CODE OF ETHICS	228
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	228
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	229
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED<br><br>PURCHASERS	229
ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	229
ITEM 16G.	CORPORATE GOVERNANCE	229
ITEM 16H.	MINE SAFETY DISCLOSURE	230
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	230
---	---	---
ITEM 16J.	INSIDER TRADING POLICIES	230
ITEM 16K.	CYBERSECURITY	230
ITEM 17.	FINANCIAL STATEMENTS	231
ITEM 18.	FINANCIAL STATEMENTS	231
ITEM 19.	EXHIBITS	231

INTRODUCTION

Telix Pharmaceuticals Limited was incorporated under the laws of Australia in January 2017. Our ordinary shares have

been listed on the Australian Securities Exchange ("ASX") since November 2017, and since November 2024, have been

listed on the Nasdaq Global Select Market in the form of American depositary shares ("ADSs"), with each ADS

representing one of our ordinary shares. JP Morgan Chase Bank, N.A., acts as depositary for the ADSs. Throughout this

annual report, all references to “ADRs” mean the American depositary receipts that evidence the ADSs.

As of January 1, 2025, our reporting currency is the United States Dollar ("US$"). All amounts presented in this Annual

Report on Form 20-F ("Annual Report") are presented in US$ unless otherwise indicated. Prior to January 1, 2025, our

presentation currency was the Australian Dollar. The change in presentation currency has been applied retrospectively to

all comparative periods presented See Note 2.3.1 to our audited consolidated financial statements included elsewhere in

this Annual Report.

The consolidated financial statements and related notes included elsewhere in this Annual Report have been prepared in

accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board,

(“IFRS Accounting Standards”), which differ in certain significant respects from generally accepted accounting principles

in the United States ("U.S. GAAP").

We also maintain a website at www.telixpharma.com. The information contained on our website or available through our

website is not incorporated by reference into and should not be considered a part of this Annual Report, and any

references to our website throughout this Annual Report are inactive textual references only.

Unless otherwise stated or the context indicates otherwise, all references herein to “Telix,” “Telix Pharmaceuticals,” "the

Company,” "the Group," “our company,” “we,” “us,” “our” and similar references refer to Telix Pharmaceuticals Limited

and its consolidated subsidiaries, taken as a whole.

Australian Disclosure Requirements

Our ordinary shares are primarily quoted on the ASX in addition to our listing of our ADSs on the Nasdaq Global Select

Market. As part of our ASX listing, we are required to comply with various disclosure requirements as set out under the

Australian Corporations Act 2001 (Cth) and the ASX Listing Rules. Information furnished under the sub-heading

“Australian Disclosure Requirements” is intended to comply with ASX listing and Australian Corporations Act 2001 (Cth)

disclosure requirements and is not intended to fulfill information required by this Annual Report.

INDUSTRY AND MARKET DATA

This Annual Report contains estimates and information concerning our industry and our business, including estimated

market size and projected growth rates of the markets for our product candidates. Unless otherwise expressly stated,

we obtained this industry, business, market, medical and other information from reports, research surveys, studies and

similar data prepared by third parties, industry, medical and general publications, government data and similar sources.

This information involves a number of assumptions and is based on limited available information. Although we are

responsible for all of the disclosure contained in this Annual Report and we believe the third-party market position,

market opportunity and market size data included in this Annual Report are reliable, we have not independently verified

the accuracy or completeness of this third-party data. In addition, projections, assumptions and estimates of our future

performance and the future performance of the industry in which we operate are necessarily subject to a high degree of

uncertainty and risk due to a variety of factors, including those described in “Item 3. Key Information — D. Risk Factors.”

These and other factors could cause results to differ materially from those expressed in these publications and reports.

TRADEMARKS AND SERVICE MARKS

Telix Pharmaceuticals, the Telix logo and other trademarks or service marks of Telix appearing in this Annual Report are

the property of Telix or its subsidiaries. Solely for convenience, the trademarks, service marks and trade names referred

to in this Annual Report are listed without the ® and ™ symbols, but such references should not be construed as any

indicator that their respective owners will not assert, to the fullest extent under applicable law, their right thereto. All

other trademarks, trade names and service marks appearing in this Annual Report are the property of their respective

owners. Any use or display of any third-party trademarks, trade names or service marks is not intended to imply a

relationship with, endorsement or sponsorship of or by the respective owners.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report contains forward-looking statements about us and our industry that involve substantial risks and

uncertainties. All statements other than statements of historical facts contained in this Annual Report, including

statements regarding our future results of operations, financial condition, business strategy, prospective products,

product approvals, research and development costs, future revenue and plans and objectives of management for future

operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they

contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,”

“plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar

terms or expressions. We have based these forward-looking statements largely on our current expectations and

projections about future events and trends that we believe may affect our financial condition, results of operations,

business strategy and financial needs. These forward-looking statements are subject to a number of known and

unknown risks, uncertainties, other factors and assumptions, including the risks described in “Item 3. Key Information —

D. Risk Factors” and elsewhere in this Annual Report, regarding, among other things:

•the ongoing commercialization of our Commercial Products and our preparation for the commercialization of our

product candidates, if they are approved;

•the timing and review of submissions for regulatory approval of our product candidates, including review of our

resubmissions for Pixclara® (TLX101-Px) and Zircaix® (TLX250-Px), and our ability to obtain and maintain such

regulatory approvals;

•the initiation, timing, progress and results of our ongoing and planned clinical trials, including the timing of dosing of

patients, enrollment and completion of these trials, including multi-national trials, and the anticipated results from

these trials;

•our sales, marketing and distribution capabilities and strategies, including for the commercialization and

manufacturing of our Commercial Products and any future products;

•our ability to obtain and maintain an adequate supply at reasonable costs of raw materials we may incorporate into

our products and product candidates;

•our ability to address the fulfillment and logistical challenges posed by the time-limited stabilization of our products

and product candidates;

•our commercialization, marketing and manufacturing capabilities and strategy, including the timing and costs of

expanding our manufacturing capabilities;

•the rate and degree of market acceptance and clinical utility of our products and product candidates, if they are

approved;

•the pricing and reimbursement of our products and product candidates, if and after they have been approved;

•estimates of our expenses, future revenues and capital requirements;

•our financial performance;

•developments relating to our competitors and industry;

•the success of our collaborations and partnerships with third parties;

•our ability to maintain, expand, protect and enforce our regulatory exclusivity and intellectual property ("IP")

portfolio;

•our expectations regarding our ability to obtain and maintain regulatory exclusivity and intellectual property

protection for our products and product candidates;

•our ability to successfully integrate the businesses that we have acquired or may acquire in the future;

•our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

•changes to law, policy and regulation in the U.S., Australia and other jurisdictions;

•disruptions caused by the current U.S. presidential administration or as a result of legislative or judicial action or lack

thereof, including at the FDA and other government agencies;

•our ability to remain compliant with the respective listing rules and standards of the ASX, the Singapore Exchange

Securities Trading Limited ("SGX"), and the Nasdaq Global Select Market ("Nasdaq");

•our ability to attract and retain key scientific or management personnel;

•the success of competing therapies that are or may become available;

•the volatility of currency exchange rates;

•the impact of and changes in governmental regulations or the enforcement thereof, tax laws and rates, accounting

guidance and similar matters in regions in which we operate or will operate in the future;

•any changes in laws, rules or regulations, including the imposition of tariffs or other trade restrictions, affecting our

ability to manufacture, test, develop, or commercialize our Commercial Products and product candidates;

•changes to staffing, process, or policy at government agencies, including, but not limited to, the FDA; and

•changes in U.S. and international trade policies, including the imposition of tariffs on raw materials and finished

products; and

•other risks and uncertainties, including those listed under “Item 3. Key Information — D. Risk Factors.”

These risks are not exhaustive. Other sections of this Annual Report may include additional factors that could harm our

business and financial performance. New risk factors may emerge from time to time and it is not possible for our

management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which

any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by,

any forward-looking statements.

You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking

statements contained in this Annual Report primarily on our current expectations and projections about future events and

trends that we believe may affect our business, financial condition and operating results. We undertake no obligation to

update any forward-looking statements made in this Annual Report to reflect events or circumstances after the date of

this Annual Report or to reflect new information or the occurrence of unanticipated events, except as required by law.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you

should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the

potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.

These statements are based on information available to us as of the date of this Annual Report. While we believe that

information provides a reasonable basis for these statements, that information may be limited or incomplete. Our

statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant

information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these

statements.

You should read this Annual Report and the documents that we reference and have filed as exhibits to the Annual Report

with the understanding that our actual future results, performance and achievements may be different from what we

expect. We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all

of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained

in the Private Securities Litigation Reform Act of 1995.

PART I

ITEM 1.IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

A.Directors and Senior Management

Not applicable.

B.Advisers

Not applicable.

C.Auditors

Not applicable.

ITEM 2.OFFER STATISTICS AND EXPECTED TIMETABLE

A.Offer Statistics

Not applicable.

B.Method and Expected Timetable

Not applicable.

ITEM 3.KEY INFORMATION

A.Reserved

B.Capitalization and Indebtedness

Not applicable.

C.Reasons for the Offer and Use of Proceeds

Not applicable.

D.Risk Factors

Investing in our securities involves a high degree of risk. You should consider and read carefully all of the risks and

uncertainties described below, as well as other information included in this Annual Report, including our consolidated

financial statements and related notes included elsewhere in this Annual Report, before making an investment decision. If

any of the following risks actually occur, it could harm our business, prospects, results of operations and financial

condition. In such event, the trading price of our ordinary shares and the ADSs could decline, and you might lose all or

part of your investment.

Risk Factors Summary

•We have a history of significant net losses, our operating expenses may increase in the future, and we may not be

able to maintain profitability in future periods.

•We may need to raise capital to achieve our business objectives if we are unable to fund our operations with our

cash flows from the sale of our products. If we are unable to raise capital when needed or on acceptable terms, we

would be forced to delay, reduce or eliminate our research and development programs and/or commercialization

efforts.

•We may not be able to effectively integrate the businesses that we have acquired and/or may acquire in the future.

•Our business is substantially dependent on the commercial success of our Commercial Products and our product

candidates, if approved. If we are unable to successfully commercialize our Commercial Products as currently

approved or to successfully commercialize our product candidates, if approved, our business, financial condition

and results of operations will be materially harmed.

•Clinical development is a lengthy and expensive process, with uncertain timelines and outcomes. If clinical trials of

our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not

otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately

be unable to complete, the development and commercialization of such product candidates, if approved.

•The results of previous clinical trials may not be predictive of future trial results, and preliminary, interim or top-line

data may be subject to change or qualification based on the complete analyses of data and, therefore, may not be

predictive of the final results of a trial.

•We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling subjects in our

clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

•Due to their radioactive nature, our Commercial Products and our product candidates have time-limited stability,

and as a result, we may encounter difficulties with fulfillment and logistics.

•We face substantial competition, which may result in others discovering, developing, or commercializing products

before or more successfully than we do.

•The commercial success of our Commercial Products and our product candidates, if approved, will depend upon

public perception of radiopharmaceuticals and the degree of their market acceptance by physicians, patients,

healthcare payors and others in the medical community.

•We may be unable to generate and/or obtain a sufficient supply of radioisotopes to support clinical development or

manufacturing at commercial scale.

•Even if we are able to effectively commercialize our Commercial Products or any product candidates for which we

obtain approval, the products may not receive coverage or may become subject to unfavorable pricing regulations,

third-party reimbursement practices or healthcare reform initiatives, all of which would harm our business.

•We depend on collaborations with third parties for certain aspects of the development, marketing and/or

commercialization of our Commercial Products and our product candidates. If those collaborations are not

successful, or if we are not able to maintain our existing collaborations or establish additional collaborations, we

may have to alter our development and commercialization plans and may not be able to capitalize on the market

potential of our Commercial Products or our product candidates, if approved.

•If we are unable to obtain and/or maintain commercially valuable regulatory exclusivity and intellectual property, or

to protect our patents, trademarks, know-how and trade secrets, our ability to successfully commercialize our

Commercial Products and product candidates, if approved, would be adversely impacted.

•We may experience sustainability risks, including: physical climate-related risks such as extreme weather events

that could disrupt internal operations, suppliers, and logistics, and increase operational costs; resource and energy

risks such as increasing energy prices, regulatory actions and increased resource efficiency standards that may

increase operating expenses and capital expenditure for facility upgrades; and, non-compliance with increased

social and governance regulations that could lead to fines, reputational damage, and increased compliance costs.

•An active and liquid market for our securities may not continue to be developed or sustained, which could harm the

market price of the ADSs.

•As a foreign private issuer, we are permitted to follow certain home country corporate governance practices in lieu

of certain Nasdaq requirements applicable to domestic issuers.

•We have identified a material weakness in our internal control over financial reporting. If we are unable to remediate

this material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain

an effective system of internal controls, we may not be able to accurately or timely report our financial condition or

results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ADSs.

Risks Related to Our Financial Position and Capital Requirements

We have a history of significant net losses, our operating expenses may increase in the future, and we may not be

able to maintain profitability in future periods.

Until 2023, we incurred significant operating losses. Our loss after tax was $7.1 million for the year ended December 31,

2025

. Our net operating cash flow was $17.3 million (outflow) for the year ended December 31, 2025. As of

December 31, 2025, we had an accumulated deficit of $154.5 million. Although we launched Illuccix in April 2022 and

Gozellix in June 2025 and have recognized profits in recent periods, we cannot be certain that we will sustain profitability

or positive cash flows from operations in future periods.

We have invested most of our resources in developing our technology and product candidates, building our intellectual

property portfolio, developing our supply chain, conducting business planning, raising capital and providing general and

administrative support for these operations. We continue to incur significant research and development ("R&D"), and

other expenses related to ongoing operations and may incur losses in the future.

Investment in biotechnology product development, as well as medical device development, is highly speculative because

it entails substantial upfront capital expenditures and significant risk that any potential product candidate will be unable

to demonstrate effectiveness or an acceptable safety profile, gain regulatory approval, gain competitive pricing or

reimbursement and become commercially viable.

Illuccix has been approved by the FDA, the Australian Therapeutic Goods Administration ("TGA"), by Health Canada, by

the Brazilian Health Regulatory Agency ("ANVISA"), by the United Kingdom Medicines and Healthcare Products

Regulatory Agency ("MHRA") and by health regulators in 19 European Economic Area member states. Gozellix was

approved by the FDA in March 2025. Throughout this Annual Report, “Commercial Products” is used to refer to Illuccix

and Gozellix collectively.

We have historically financed our operations principally through product sales, private and institutional placements of our

ordinary shares, proceeds from our initial public offering of ordinary shares on the ASX, proceeds from our issuance of

convertible bonds, loan agreements with financial institutions and cash generated from our business development

activities. Substantially all of our operating losses in previous periods have resulted from costs incurred in connection

with our research and development programs, the pursuit of regulatory approvals within and outside of the

U.S.,

and the

commercialization of our Commercial Products. We expect to continue to incur significant expenses as we continue to

commercialize our Commercial Products in the jurisdictions in which we have received marketing authorization, and other

jurisdictions, if approved, and engage in activities to prepare for the potential approval and commercialization of our

product candidates. The profits or losses we incur may fluctuate significantly from quarter to quarter and year to year.

While we began to generate revenue from the sales of Illuccix in April 2022 and from Gozellix in June 2025, there can be

no assurance as to the amount or timing of future product or license and other revenues, and we may not be able to

maintain profitability in future periods. Our ability to remain profitable depends significantly on our success in many

areas, including:

•effectively commercializing Illuccix, Gozellix or any future products either on our own or with a collaborator,

including by maintaining a full commercial organization required to market, sell and distribute our products, and

achieving an adequate level of market acceptance;

•the impact of current or future competing products on product sales of Illuccix, Gozellix or any future products;

•obtaining sufficient pricing, coverage and reimbursement, under U.S. federal healthcare programs, such as

Medicare and Medicaid, and from private payors, for Illuccix, Gozellix and any future products from private and

government payors and the impact of any pricing changes;

•initiating and successfully completing clinical trials required to file for, obtain and maintain regulatory approval for

our product candidates;

•obtaining and maintaining regulatory approvals, and the timing of such approvals;

•manufacturing at commercial scale;

•establishing and managing any collaborations for the development, marketing and/or commercialization of our

products and product candidates, if approved, including the level of success of any such collaborators’ efforts and

the timing and amount of any milestone or royalty payments we may receive; and

•obtaining, maintaining and protecting our intellectual property rights.

We anticipate that our operating expenses will continue to be significant and increase as we continue to:

•commercialize Illuccix and Gozellix in the U.S., and Illuccix in Australia, New Zealand, Brazil, Canada, Europe and

other jurisdictions following regulatory approval, including maintaining our commercial infrastructure;

•obtain and/or maintain regulatory approval for Illuccix, Gozellix and our product candidates, including completing

any required post-marketing requirements to the satisfaction of the FDA or other regulatory agencies;

•expand our research and development programs, identify additional product candidates and initiate and conduct

clinical trials, including clinical trials required by the FDA or other regulatory agencies in addition to those that have

been or are currently expected to be conducted;

•maintain, expand and protect our intellectual property portfolio;

•manufacture Illuccix, Gozellix and our product candidates;

•add clinical, scientific, operational, financial and management information systems and personnel, including

personnel to support our product development and potential future radiopharmaceutical commercialization efforts;

•operate as a publicly listed company in the U.S. and Australia; and

•acquire or in-license other products, product candidates or technologies.

Because of the numerous risks and uncertainties associated with pharmaceutical product development and

commercialization, we are unable to accurately predict the timing or amount of our revenue and expenses or if we will be

able to maintain profitability. We cannot be certain that our revenue from sales of Illuccix and Gozellix, in the currently

approved indications, will be sufficient for us to remain profitable in future periods. We may not generate revenues that

are significant or large enough to sustain or increase profitability on an annual basis. Our failure to remain profitable

would decrease the value of our company and could impair our ability to raise capital, maintain our research and

development and commercialization efforts, expand our business and/or continue our operations. This could result in a

material adverse effect on the value of our company and could cause our shareholders and ADS holders to lose all or part

of their investment.

We may need to raise additional capital to achieve our business objectives if we are unable to fund our operations

with our cash flows from the sale of our products. If we are unable to raise capital when needed or on acceptable

terms, we would be forced to delay, reduce or eliminate our research and development programs and/or

commercialization efforts.

Discovering, developing and commercializing products involve time-consuming, expensive and uncertain processes that

take years to complete. We have used substantial funds to develop Illuccix and Gozellix and expect our operating

expenses to continue to increase as we continue to commercialize Illuccix, Gozellix or any future approved products,

conduct further research and development of our product candidates, seek approval and prepare for commercialization

of TLX250-Px and TLX101-Px and continue to conduct clinical trials for our other product candidates.

Furthermore, we will continue to incur additional costs associated with operating as a public company, hiring additional

personnel and expanding our geographical reach. Although currently Illuccix is commercially available in multiple

jurisdictions worldwide and Gozellix is commercially available in the U.S., we cannot be certain that our revenue from

product sales of Illuccix and Gozellix will be sufficient for us to remain profitable on an annual basis. Accordingly, we may

need to continue to rely on additional financing to achieve our business objectives.

As of December 31, 2025, we had $141.9 million in cash and cash equivalents. The amount and timing of our future

capital requirements will depend on many factors, including, but not limited to:

•the scope, progress, results, timing and costs of our current and planned development efforts and regulatory review

of our product candidates;

•the amount and timing of revenues from sales of Illuccix, Gozellix or any product candidate for which we receive

regulatory approval;

•the cost of, and our ability to expand and maintain, the commercial infrastructure required to support the

commercialization of Illuccix, Gozellix and any other product for which we receive regulatory approval, including

medical affairs, manufacturing, marketing and distribution functions;

•our ability to establish and maintain collaboration, partnership, licensing, marketing, distribution or other

arrangements on favorable terms and the level and timing of success of these arrangements;

•the extent to which we acquire or in-license other products, product candidates and technologies; and

•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our

intellectual property rights and defending intellectual property-related claims.

In addition, the terms of any financing may adversely affect the holdings or the rights of our shareholders and ADS

holders. If we raise funds by issuing equity securities, dilution to our existing shareholders and ADS holders will result,

and this may also have an impact on the market price of our ordinary shares and ADSs. In addition, as a condition to

providing additional funding to us, future investors may demand, and may be granted, rights superior to those of existing

shareholders. Moreover, any debt financing, if available, may involve restrictive covenants that could limit our flexibility in

conducting future business activities and, in the event of insolvency, would be paid before holders of equity securities

received any distribution of corporate assets. Our ability to satisfy and meet any future debt service obligations will

depend upon our future performance, which will be subject to financial, business and other factors affecting our

operations, many of which are beyond our control.

Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due

to favorable market conditions or strategic considerations. Any future fundraising efforts could divert our management’s

attention away from their day-to-day activities. Further, adequate additional financing may not be available to us on

acceptable terms, or at all. In addition, raising funds in the current economic environment may present additional

challenges. For example, any sustained disruption in the capital markets from adverse macroeconomic conditions, such

as the disruption and uncertainty caused by rising inflation, increasing interest rates and slower economic growth or

recession, could negatively impact our ability to raise capital and we cannot predict the extent or duration of such

macro-economic disruptions. If adequate funds are not available to us on a timely basis or on attractive terms, we may

be required to delay, reduce or eliminate our research and development programs or any current or future

commercialization efforts for one or more of our products or product candidates, any of which could have a material

adverse effect on our business, operating results and prospects.

Our operating results may fluctuate significantly or may fall below the expectations of investors or securities

analysts, each of which may cause the trading price of our ordinary shares and the ADSs to fluctuate or decline.

We expect our operating results to be subject to fluctuations. Our profit or loss and other operating results will be

affected by numerous factors, including:

•timing and variations in the level of expense related to the current or future development of our programs;

•timing and status of enrollment for our clinical trials;

•results of clinical trials, or the addition or termination of clinical trials or funding support by us or potential future

partners;

•timing of any milestone payments or other payment obligations to be paid by us pursuant to existing supply

agreements, licenses or collaborations;

•timing of any milestone payments or other payments to be received by us pursuant to our license agreement;

•our execution of any collaboration, licensing or similar arrangements, and the timing of payments we may make or

receive under potential future arrangements or the termination or modification of any such potential future

arrangements;

•any intellectual property infringement, misappropriation or violation lawsuit or opposition, or other post-grant

proceeding or cancellation proceeding in which we may become involved;

•additions and departures of key personnel;

•strategic decisions, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in

business strategy;

•if any product candidate we may develop receives regulatory approval, the timing and terms of such approval and

market acceptance and demand for such product candidate;

•the timing and cost to establish a sales, marketing and distribution infrastructure to commercialize any products or

product candidates for which we may obtain regulatory approval and intend to commercialize on our own or jointly

with current or future collaborators;

•regulatory developments affecting our Commercial Products or any other of our product candidates or those of our

competitors, including disruptions at FDA or other government agencies; and

•changes in general market and economic conditions, including as a result tariffs, trade restrictions, conflicts or other

geopolitical risks that may arise.

If our operating results fall below the expectations of investors or securities analysts, the price of our ordinary shares and

ADSs could decline substantially. Furthermore, any fluctuations in our operating results may, in turn, cause the price of

our ordinary shares and ADSs to fluctuate substantially. We believe that comparisons of our financial results are not

necessarily meaningful and should not be relied upon as an indication of our future performance.

Our Loan Agreements with BNP Paribas and IMBC Group contain various covenants and other provisions, which, if

violated, could result in the acceleration of payments due under such agreement, as well as affect the buildout of our

Brussels South manufacturing facility.

In March 2022, one of our subsidiaries, Telix Pharmaceuticals (Belgium) SPRL (now "Telix Pharmaceuticals (Belgium)

SRL"), entered into Loan Agreements ("the Loan Agreements") with BNP Paribas and IMBC Group. The borrowings under

these Loan Agreements were used to fund in part the construction of our Brussels South manufacturing facility. Pursuant

to the Loan Agreements, Telix Pharmaceuticals (Belgium) SRL is required to comply with various covenants relating to

the conduct of its business. The Loan Agreements also include customary events of default upon the occurrence of

enumerated events, including non-payment of required repayments, failure to perform certain covenants and the

occurrence of insolvency proceedings, specified judgments, specified cross-defaults or specified revocations. Upon the

occurrence of an event of default and in the event of a change of control, BNP Paribas and IMBC Group may accelerate

payments due under the Loan Agreements or terminate the Loan Agreements, which would have an adverse impact on

our business.

Future issuances of equity or convertible debt securities may cause dilution to our shareholders and ADS holders,

restrict our operations or require us to relinquish rights to our product candidates.

We expect to finance our cash needs through a combination of revenues from product sales, equity offerings, debt

financings, collaborations, strategic alliances and/or licensing arrangements. To the extent that we raise additional

capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders and ADS

holders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely

affect the rights of ordinary shareholders and ADS holders. Debt financing, if available, may involve agreements that

include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making

capital expenditures or declaring dividends.

If we raise funds through further collaborations, strategic alliances or licensing arrangements with third parties, we may

have to relinquish valuable rights to our future revenue streams, research programs or product candidates or to grant

licenses on terms that may not be favorable to us. If we are unable to raise funds through equity or debt financings when

needed, we may be required to delay, limit, reduce or terminate our research and product development or current or

future commercialization efforts or grant rights to develop and market product candidates that we would otherwise

prefer to develop and market ourselves.

Our indebtedness could limit cash flow available for our operations, expose us to risks that could adversely affect our

business, financial condition and results of operations and impair our ability to satisfy our obligations under our

indebtedness.

On July 30, 2024, we issued $426.1 million (A$650.0 million) principal amount of 2.375% unsecured convertible bonds

due 2029 ("the Convertible Bonds") on the SGX. Additionally, as of December 31, 2025, we had $10.3 million of other

indebtedness. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have

significant negative consequences for our security holders and our business, results of operations and financial condition

by, among other things:

•increasing our vulnerability to adverse economic and industry conditions;

•limiting our ability to obtain additional financing;

•requiring the dedication of a portion of our cash flow from operations to service our indebtedness, which would

reduce the amount of cash available for other purposes;

•limiting our flexibility to plan for, or react to, changes in our business;

•diluting the interests of our existing shareholders as a result of issuing ordinary shares upon conversion of the

Convertible Bonds; and

•placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better

access to capital.

Our ability to pay the principal of or interest on the Convertible Bonds or to make cash payments in connection with any

conversion of the Convertible Bonds depends on our future performance, which is subject, in part, to economic, financial,

competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future

sufficient to service the Convertible Bonds or other future indebtedness and make necessary capital expenditures.

If we are unable to redeem the Convertible Bonds for cash when required, or repay the Convertible Bonds when due

at maturity, we may need to seek alternative financing arrangements, which could impose restrictions on our

operations and business.

On July 30, 2024, we completed our issuance of the Convertible Bonds to institutional and professional investors on the

SGX outside of the U.S. The Convertible Bonds mature on July 30, 2029, unless redeemed, repurchased, or converted in

accordance with their terms.

Subject to the satisfaction of conditions in the trust deed, we have the right at our option to redeem all of the bonds on

or after August 13, 2027 if (i) the closing price of our ordinary shares on the ASX exceeds 130% of the then-applicable

conversion price for at least 20 trading days, whether consecutive or not, during any consecutive 30 trading day period

or (ii) conversion rights have been exercised in respect of 85% or more in principal amount of the Convertible Bonds.

We may be required to redeem the Convertible Bonds prior to the maturity date in certain circumstances. Upon the

occurrence of an event constituting a change of control or the delisting of our ordinary shares on the ASX, each

bondholder will have the right under the trust deed governing the Convertible Bonds to require us to redeem all or some

of such bondholder’s Convertible Bonds at their principal amount, together with accrued but unpaid interest. We are also

required under the trust deed to redeem the Convertible Bonds on July 30, 2027 at the option of each holder at their

principal amount, together with accrued but unpaid interest.

We may not be able to redeem all or any of such Convertible Bonds or pay all or any amounts due upon conversions

thereof if we do not have sufficient funds to do so. Non-payment of any principal or interest payable with respect to the

Convertible Bonds would constitute an event of default under the trust deed governing the Convertible Bonds. Upon the

occurrence of an event of default, the full principal amount, together with accrued but unpaid interest, of the Convertible

Bonds then outstanding will become due and payable. A default under the trust deed could also lead to a default under

agreements governing any of our indebtedness outstanding at the time. If we are unable to redeem the Convertible

Bonds at maturity or upon the occurrence of certain events specified by the trust deed governing the Convertible Bonds,

we may need to seek alternative financing arrangements, which could impose restrictions on our operations and

business. We cannot assure you that such alternative financing will be available to us on acceptable terms, if at all.

Servicing the Convertible Bonds will require a significant amount of cash, and we may not have sufficient cash flow

from our business to make payments on the Convertible Bonds.

Our ability to make scheduled payments of the principal of, to pay interest on or to refinance the Convertible Bonds

depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our

control. Our business may not generate sufficient cash flow from operations in the future to service the Convertible

Bonds. If we are unable to generate sufficient cash flow, we may be required to adopt one or more alternatives, such as

selling assets, restructuring debt or obtaining additional share capital on terms that may be unfavorable to us or highly

dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at the

time we seek to refinance such indebtedness. We may not be able to engage in any of these activities or engage in these

activities on desirable terms, which could result in a default on our debt obligations.

We have engaged and plan to engage in various acquisitions and strategic partnerships in the future. If we engage in

acquisitions or strategic partnerships, this may increase our capital requirements, dilute our shareholders and ADS

holders, cause us to incur debt or assume contingent liabilities and subject us to other risks.

We have engaged and plan to continue to engage in various acquisitions and strategic partnerships in the future,

including licensing or acquiring complementary products, intellectual property rights, technologies or businesses. Any

acquisition or strategic partnership may entail numerous risks, including:

•increased operating expenses and cash requirements;

•the assumption of indebtedness or contingent liabilities;

•the issuance of our equity securities which would result in dilution to our shareholders and ADS holders;

•assimilation of operations, intellectual property, products and product candidates of an acquired company,

including difficulties associated with integrating new personnel;

•the diversion of our management’s attention from our existing product programs and initiatives in pursuing such an

acquisition or strategic partnership;

•retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business

relationships;

•risks and uncertainties associated with the other party to such a transaction, including the prospects of that party

and their existing products or product candidates and regulatory approvals; and

•our inability to generate revenue from acquired intellectual property, technology and/or products sufficient to meet

our objectives or even to offset the associated transaction and maintenance costs.

RLS may have liabilities that are not known to us and the indemnities in the purchase agreement may not offer

adequate protection.

As part of the acquisition, we have agreed to assume certain liabilities of RLS. In addition, there may be liabilities that we

failed or were unable to discover in the course of performing due diligence investigations, including with respect to

decommissioning and decontamination ("D&D"), requirements with respect to the closing of facilities that use and

produce radioactive materials. Also, we may not have correctly assessed the significance of certain liabilities and assets

identified in the course of our due diligence. Any such liabilities, individually or in the aggregate, could have a material

adverse effect on our business, financial condition and results of operations. As we integrate RLS into our operations, we

may learn additional information about the entity, such as unknown or contingent liabilities and issues relating to

compliance with applicable laws, that could potentially have an adverse effect on our business, financial condition and

results of operations.

We may not be able to effectively integrate the businesses that we have acquired and/or may acquire in the future.

Our ability to realize the anticipated benefits of acquisitions we have completed and/or may complete in the future,

including the completed acquisitions of RLS (USA) Inc. ("RLS"), QSAM Biosciences, Inc. ("QSAM"), ARTMS Inc. ("ARTMS"),

IsoTherapeutics Group, LLC, ("IsoTherapeutics"), and certain assets of ImaginAb, Inc., ("ImaginAb") will depend on our

ability to integrate those businesses with our own. The combination of multiple independent businesses is a complex,

costly and time-consuming process and there can be no assurance that we will be able to successfully integrate

businesses into our business, or if such integration is successfully accomplished, that such integration will not be costlier

or take longer than presently contemplated. If we cannot successfully integrate and manage the businesses within a

reasonable time, such difficulties or delays could result in the loss of key employees from the acquired businesses, the

disruption of the acquired businesses, inefficiencies, or inconsistencies in standards, controls, information technology

systems, procedures and policies, and we may not be able to realize the potential and anticipated benefits of such

acquisitions, which could have a material adverse effect on our business, financial position, and results of operations. We

face numerous risks relating to the integrated of acquired businesses, including:

•the inability to integrate effectively the operations, products, technologies and personnel of the acquired companies

(some of which are in diverse geographic regions) and achieve expected synergies;

•the potential disruption of existing business and diversion of management’s attention from day-to-day operations;

•the inability to maintain uniform standards, controls, procedures and policies;

•the need or obligation to divest portions of the acquired companies to satisfy regulatory requirements;

•the potential failure to identify material problems and liabilities during due diligence review of acquisition targets;

•the potential failure to obtain sufficient indemnification rights to fully offset possible liabilities associated with

acquired businesses; and

•the challenges associated with operating in new product segments and/or geographic regions.

The failure to maintain our licenses and realize their benefits may harm our business.

We have acquired and in-licensed certain of our technologies from third parties. We may in the future acquire, in-license

or invest in additional technology that we believe would be beneficial to our business. We are subject to a number of

risks associated with our acquisition, in-license or investment in technology, including the following:

•diversion of financial and managerial resources from existing operations;

•successfully negotiating a proposed acquisition, in-license or investment in a timely manner and at a price or on

terms and conditions favorable to us;

•successfully combining and integrating a potential acquisition into our existing business to fully realize the benefits

of such acquisition;

•the impact of regulatory reviews on a proposed acquisition, in-license or investment; and

•the outcome of any legal proceedings that may be instituted with respect to the proposed acquisition, in-license or

investment.

If we fail to properly evaluate potential acquisitions, in-licenses, investments or other transactions associated with the

creation of new R&D programs or the maintenance of existing ones, we might not achieve the anticipated benefits of any

such transaction, we might incur costs in excess of what we anticipate, and management resources and attention might

be diverted from other necessary or valuable activities.

Risks Related to Commercialization and Product Development

Our business is substantially dependent on the commercial success of our Commercial Products and our product

candidates, if approved. If we are unable to successfully commercialize our Commercial Products as currently

approved or to successfully obtain regulatory approvals to commercialize our other product candidates, our

business, financial condition and results of operations will be materially harmed.

Our business and our ability to generate product revenue from the sales of diagnostic imaging agents and therapies that

treat cancer and other diseases depend on continued commercialization of our Commercial Products in the jurisdictions

in which they have received marketing authorization. We are also developing our Commercial Products for additional

indications. We are currently pursuing marketing authorizations for our Commercial Products, either directly or in

collaboration with regional commercial partners, in a number of additional jurisdictions. We believe that obtaining these

additional regulatory approvals and successfully developing our Commercial Products for additional potential indication

will be important to reach the full potential utilization of our Commercial Products and failure to do so could have a

material adverse effect on our business.

Our long-term prospects also depend on our ability to obtain regulatory approval for additional imaging and therapeutic

product candidates. Regulatory approvals are subject to changing standards from time to time and the timing to obtain

the required regulatory approvals is subject to many factors, some of which may be outside our control. For example,

regulatory agencies may face resource constraints, causing delays in the review process, and there is no guarantee that

the regulators are bound by any product development or regulatory advice offered earlier in the review process. In May

2024, we completed our submission of a biologics license application ("BLA"), to the FDA for TLX250-Px for the

characterization of renal masses as clear cell renal cell carcinoma ("ccRCC"). In July 2024, the FDA declined to review

the BLA and issued a Refuse to File ("RTF"), determination.

A RTF

determination is a response from the FDA following its

preliminary review, communicating the FDA’s determination that the application does not include all pertinent information

and data. The denial of acceptance for filing was based on a filing concern related to demonstrating adequate sterility

assurance during dispensing of TLX250-Px in the radiopharmacy production environment. In December 2024 we

resubmitted our BLA to the FDA for TLX250-Px, and the FDA accepted our application in February 2025. In August 2025,

the FDA issued a Complete Response Letter ("CRL"), citing deficiencies relating to the Chemistry, Manufacturing, and

Controls ("CMC") package. The FDA requested additional data to establish comparability between the drug product used

in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally,

the FDA documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain

partners that required remediation prior to resubmission. In December 2025 we participated in a Type A meeting with the

FDA to align on plans to address CMC deficiencies cited, and in January 2026 we participated in an additional Type A

meeting to align on plans to address comparability between the clinical drug product and that intended for commercial

use. Following these meetings, Telix believes it has alignment with the Agency on key resubmission aspects. While we

believe that the planned remediation of the BLA for TLX250-Px will meet FDA requirements, there can be no assurance

that, once re-submitted, the FDA will accept our BLA for review, or approve TLX250-Px.

In August 2024, we submitted a NDA for TLX101-Px for the characterization of progressive or recurrent glioma from

treatment related changes in both adult and pediatric patients. In October 2024, the FDA accepted the New Drug

Application ("NDA"), and granted priority review and assigned a Prescription Drug User Fee Act ("PDUFA"), goal date of

April 26, 2025. In April 2025, the FDA issued a CRL, stating that additional confirmatory clinical evidence was required to

progress the application. Following engagement with the FDA, including a successful Type A meeting, in September 2025

we reached agreement with the FDA regarding our NDA and are finalizing our resubmission package. There can be no

assurance that the FDA will accept our resubmitted NDA for review, or approve TLX101-Px.

In February 2026, we submitted a Marketing Authorization Application ("MAA") for TLX101-Px in Europe, with France

acting as the Reference Member State ("RMS"). The French National Agency for Medicines and Health Products Safety

("ANSM") in its capacity as RMS is responsible for coordinating and leading the scientific evaluation of the dossier, in

collaboration with the Concerned Member States, nominated by Telix and representing the major European markets for

Telix’s brain cancer imaging product. There can be no assurance that the MAA will be validated, or that marketing

authorizations for TLX101‑Px will ultimately be granted.

Any adverse action by the FDA with respect to the BLA or NDAs, could delay our planned commercial development

timelines or could prevent us from commercializing these product candidates. If the FDA determines that our

submissions and the data supporting the submissions are not sufficient to support approval in these indications, we may

be required to conduct an additional clinical trial or trials, which would increase our costs and delay the program. Any

such delay or other adverse impact could have a material adverse effect on our business.

We have not submitted any applications for regulatory approval or obtained regulatory approval for any of our

therapeutic product candidates. Our most advanced therapeutic candidate, TLX591-Tx (lutetium (Lu177) rosopatamab

tetraxetan), is a lutetium-labeled radio antibody-drug conjugate ("rADC"), which we are evaluating in a two-part Phase 3

clinical trial in patients with advanced prostate cancer, called ProstACT Global. We dosed the first patient in this clinical

trial in November 2023 in Australia. We received authorization to conduct Part 1 of the trial in the U.S. in April 2024 and

completed target enrollment of 30 patients in August 2025. We dosed the first patient in ProstACT Global Part 2

(randomized treatment expansion) in Australia in December 2025. We cannot be certain that TLX591-Tx, or any of our

clinical trials of our other therapeutic product candidates, will generate safety and efficacy data sufficient for regulatory

approval in any jurisdiction.

The commercial success of our Commercial Products and our product candidates, if approved, is dependent on many

factors, some of which are beyond our control, including clinical development, the regulatory submission and approval

process, market access or reimbursement frameworks, potential threats to our intellectual property rights and the

manufacturing, marketing and sales efforts. If we are unable to continue to commercialize our Commercial Products or to

develop, receive regulatory approval for and successfully commercialize our product candidates, or experience delays as

a result of any of these factors or otherwise, our business and results of operations could be substantially harmed.

Clinical development is a lengthy and expensive process, with uncertain timelines and outcomes. If clinical trials of

our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not

otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately

be unable to complete, the development and commercialization of such product candidates, if approved.

Our long-term success depends in large part on our ability to continue to successfully develop additional product

candidates in imaging and therapeutic indications. Clinical testing is expensive, time consuming, difficult to design and

implement, and is inherently uncertain as to outcome. Clinical failure can occur at any stage of the clinical development

process and, therefore, the outcome of preclinical studies and early-stage clinical trials may not be predictive of the

success of later stage clinical trials. Furthermore, the failure of any product candidates to demonstrate safety and

efficacy in any clinical trial could negatively impact the perception of our company or our products and/or cause the FDA

or other regulatory authorities to require additional testing before any of our product candidates are approved.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our

ability to receive regulatory approval of our product candidates, including, but not limited to, the following:

•delays or failure to reach agreement with regulatory authorities on a trial design or the receipt of feedback requiring

us to modify the design of our clinical trials, perform additional or unanticipated clinical trials to obtain approval or

alter our regulatory strategy;

•clinical trials of our product candidates may produce negative or inconclusive results or other patient safety

concerns, including undesirable adverse events or other unexpected characteristics, and we may decide, or

regulatory authorities may require us, to conduct additional clinical trials, suspend ongoing clinical trials or abandon

product development programs, including as a result of a finding that the participants are being exposed to

unacceptable health risks;

•enrollment in our clinical trials may be slower than we anticipate or we may not be able to enroll the number of

patients that we expect, including as a result of competition with other ongoing clinical trials for the same

indications as our product candidates or because the patient population may be limited for orphan indications;

•regulators may revise the requirements for approving our product candidates, even after providing a positive

opinion on or otherwise reviewing and providing comments on a clinical trial protocol, or such requirements may not

be as we anticipate;

•delays or failure in obtaining the necessary authorization from regulatory authorities or institutional review boards to

permit us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or the

suspension or termination of a clinical trial once commenced;

•delays or failure to reach agreement on acceptable terms with prospective clinical trial sites or contract research

organizations ("CROs");

•delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our

product candidates for use in clinical trials or the inability to do any of the foregoing;

•the number of patients required for clinical trials of our product candidates may be larger than we anticipate or

participants may drop out of these clinical trials at a higher rate than we anticipate;

•our third-party contractors, including manufacturers or CROs, may fail to comply with regulatory requirements,

perform effectively, or meet their contractual obligations to us in a timely manner, or at all;

•we or our investigators might be found to be non-compliant with regulatory requirements;

•the cost of clinical trials of our product candidates may be greater than we anticipate;

•the supply or quality of our product candidates or other materials necessary to conduct clinical trials may be

insufficient or inadequate;

•regulators or institutional review boards/ethics committees may not authorize us or our investigators to commence

a clinical trial or conduct a clinical trial at a prospective trial site;

•imposition of a temporary or permanent clinical hold by regulatory authorities for a number of reasons, including

after review of an IND or amendment or equivalent foreign application or amendment, as a result of a new safety

finding that presents unreasonable risk to clinical trial participants, or a negative finding from an inspection of our

clinical trial operations or study sites;

•developments on trials conducted by competitors for related technology that raises FDA or foreign regulatory

authority concerns about risk to patients of the technology broadly, or if the FDA or a foreign regulatory authority

finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

•occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential

benefits, or occurrence of adverse events in trial of the same class of agents conducted by other companies;

•any partners or collaborators that help us conduct clinical trials may face any of the above issues, and may conduct

clinical trials in ways they view as advantageous to them but that are suboptimal for us; and

•negative impacts resulting from infectious disease epidemics or pandemics, including impacts to healthcare

systems and our trial sites’ ability to conduct trials.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we

currently contemplate or are unable to successfully complete clinical trials of our product candidates or other testing, on

a timely basis or at all, and/or if the results of these trials or tests are not positive or are only modestly positive or if there

are safety concerns, we may:

•be delayed in obtaining, or not obtain at all, regulatory approval for the indication or product candidate;

•obtain regulatory approval in some countries and not in others;

•obtain approval for indications or patient populations that are not as broad as intended or desired;

•obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including

boxed warnings;

•be subject to additional post-marketing testing requirements; or

•have the product removed from the market after obtaining regulatory approval.

Further, we do not know whether clinical trials will begin as planned, will need to be restructured or will be completed on

schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive

right to commercialize our products, allow our competitors to bring products to market before we do or impair our ability

to successfully commercialize our products, which would harm our business and results of operations. In addition, many

of the factors that cause, or lead to, clinical trial delays may ultimately lead to the denial of regulatory approval of our

product candidates.

If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of

necessary regulatory approval could be delayed or prevented.

We may not be able to initiate or continue our ongoing or planned clinical trials for our product candidates if we are

unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or

other applicable foreign regulator. In addition, some of our competitors may have planned or ongoing clinical trials or

expanded access programs for approved and/or investigational products that would treat the same patients as our

therapeutic product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in

our competitors’ clinical trials or expanded access programs. Patient enrollment is also affected by other factors,

including:

•severity of the disease under investigation;

•our ability to recruit clinical trial investigators of appropriate competencies and experience;

•the incidence and prevalence of our target indications;

•clinicians’ and patients’ awareness of, and perceptions as to the potential advantages and risks of our product

candidates in relation to other available therapies, including any new products that may be approved for the

indications we are investigating;

•invasive procedures required to enroll patients and to obtain evidence of the product candidate’s performance

during the clinical trial;

•availability and efficacy of approved medications for the disease under investigation;

•eligibility criteria defined in the protocol for the trial in question;

•the ability of our companion diagnostics to identify patients;

•the size of the patient population required for analysis of the trial’s primary endpoints;

•efforts to facilitate timely enrollment in clinical trials;

•whether we are subject to a partial or full clinical hold on any of our clinical trials;

•reluctance of physicians to encourage patient participation in clinical trials;

•the ability to monitor patients adequately during and after treatment;

•our ability to obtain and maintain patient consents; and

•proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll and retain a sufficient number of patients for our clinical trials would result in significant delays or

may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in

increased development costs, which would cause the value of our company to decline and limit our ability to obtain

additional financing.

Serious adverse events related to our Commercial Products or our product candidates may delay or prevent their

regulatory approval, cause us to suspend or discontinue clinical trials or abandon further development, limit the

commercial value of approved indications or result in significant negative financial consequences following any

regulatory approval.

If our Commercial Products or any of our product candidates are associated with undesirable adverse events or have

characteristics that are unexpected in clinical trials or following approval and/or commercialization, we may need to

abandon or limit their development or limit marketing to certain uses or subpopulations in which the undesirable adverse

events or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Adverse events in our clinical trials to date have been generally predictable and typically manageable, with frequency

and severity for adverse events applicable to imaging less than for therapy product candidates. The most common

adverse events for Illuccix in clinical trials were nausea, diarrhea, and dizziness. The most common adverse events

arising in the Phase 3 ZIRCON clinical trial of 300 patients dosed with TLX250-Px were mild and non-serious, including

nausea, procedural pain and headache. The most common severe adverse events were post-procedural hemorrhage (six

events), urinary retention (three events), hypertension (three events), pyelonephritis (two events), anemia (two events),

and syncope (two events). For TLX101-Px there have been two events reported to date in an ongoing clinical trial, which

are injection site reaction and nausea, both mild and non-serious.

With respect to our therapeutic product candidates, our most clinically advanced therapeutic, TLX591-Tx, has been

evaluated in 242 patients across eight Phase 1 and 2 trials, including the Phase 1 ProstACT SELECT trial. In Cohort 2 of

ProstACT SELECT (25 participants), treatment emergent adverse events ("TEAE") rates were: Grade 3 thrombocytopenia

(16%, 4/25), grade 3 neutropenia (28%, 7/25), grade 4 thrombocytopenia (20%, 5/25) and grade 4 neutropenia (4%,

1/25). Six patients received intervention in the form of platelet or red blood cell transfusion(s), or both. Early-stage trial

results should be interpreted with caution and efficacy outcomes should be evaluated for statistical and clinical

significance in a larger Phase 3 randomized controlled trial. TLX591-Tx is presently being investigated in Telix's Phase 3

ProstACT Global trial.

The occurrence of adverse events in either our clinical trials or following regulatory approval could result in a more

restrictive label for any product candidates approved for marketing or could result in the delay or denial of approval to

market any product candidates by the FDA or comparable foreign regulatory authorities, which could prevent us from

generating sufficient revenue from product sales or maintaining profitability. Treatment-related adverse effects could

also affect patient recruitment or the ability of enrolled patients to complete the trial, result in potential product liability

claims or cause patients and/or healthcare providers to elect alternative courses of treatment. In addition, these adverse

events may not be appropriately recognized or managed by the treating medical staff. Inadequate training or education

of healthcare professionals to recognize or manage the potential adverse events following treatment with our

Commercial Products or our product candidates, if approved, could result in increased treatment-emergent adverse

events and cause patients to discontinue treatment. Any of these occurrences may harm our business, financial

condition and prospects significantly.

Results of our trials could reveal an unacceptably high severity and prevalence of adverse events. In such an event, our

trials could be suspended or terminated by us or the FDA or comparable foreign regulatory authorities could order us to

cease further development of or deny approval of our product candidates for any or all targeted indications.

Adverse events in the results of trials conducted by our competitors could also cause the FDA or comparable foreign

regulatory authorities to raise concerns regarding our trials and product candidates, and/or impose additional safety and

tolerance procedures on us, which may be costly. Many compounds that initially showed promise in early-stage trials for

treating cancer or other diseases have later been found to cause adverse events that prevented further development of

the compound. If such an event occurs after any of our product candidates are approved and/or commercialized, a

number of potentially significant negative consequences may result, including:

•regulatory authorities may withdraw the approval of such product;

•regulatory authorities may require additional warnings on the label, such as a “black box” warning, precaution or a

contraindication, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications

containing warnings or other safety information about the product, or impose distribution or use restrictions;

•patients and/or healthcare providers may elect to utilize other treatment options that have or are perceived to have

more tolerable adverse events;

•regulatory authorities may require one or more post-marketing studies;

•we may be required to implement a Risk Evaluation and Mitigation Strategy ("REMS"), or create a medication guide

outlining the risks of such adverse events for distribution to patients;

•additional restrictions may be imposed on the marketing or promotion of the particular product or the manufacturing

processes for the product or any component thereof;

•we could be sued and held liable for harm caused to patients;

•the product could become less competitive; and

•our reputation may suffer.

Further, we and our clinical trial investigators currently determine if serious adverse events are product-related in

accordance with scientific practice and current knowledge. The FDA or foreign regulatory authorities may disagree with

our or our clinical trial investigators’ interpretation of data from clinical trials and the conclusion by us or our clinical trial

investigators that a serious adverse event was not product-related. The FDA or foreign regulatory authorities may

require more information related to the safety profile of our Commercial Products or our product candidates, including

additional preclinical or clinical data to support approval, which may cause us to incur additional expenses, delay or

prevent the approval of one of our product candidates, and/or delay or cause us to change our commercialization plans,

or we may decide to abandon the development of the product candidate altogether.

Any of these events could prevent the affected product candidate, if approved, from achieving or maintaining market

acceptance, or could substantially increase costs and expenses of development or commercialization, which could delay

or prevent us from generating sufficient revenue from the sale of our Commercial Products or any other approved

product and harm our business and results of operations.

The results of previous clinical trials may not be predictive of future trial results, and preliminary, interim or top-line

data may be subject to change or qualification based on the complete analyses of data and, therefore, may not be

predictive of the final results of a trial.

Clinical failure can occur at any stage of the clinical development process and, therefore, the outcome of preclinical

studies and early-stage clinical trials may not be predictive of the success of later stage clinical trials. For example,

preliminary, interim or top-line data may be based on unaudited data provided by our clinical trial investigators.

Finalization and cleaning of this data may change the conclusions drawn from this unaudited data provided by our clinical

trial investigators indicating less promising results than we currently anticipate. Further, there can be significant

variability in safety and/or efficacy results between different trials of the same product candidate due to numerous

factors, including changes in trial protocols, differences in size and type of the patient populations, adherence to the

dosing regimen and other trial protocols and the dropout rate among clinical trial participants. We do not know whether

any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety data sufficient to obtain

regulatory approval to market our product candidates, if approved. Moreover, preclinical and clinical data are often

susceptible to varying interpretations and analyses, and many companies have suffered significant setbacks in late-

stage clinical trials after achieving positive results in earlier development, and we could face similar setbacks.

We may publicly disclose preliminary, interim or top-line data from our clinical trials. Disclosures are based on a

preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change as

further patient data become available and following a more comprehensive review of the data related to the particular

study or trial. For any study that we report preliminary, interim or top-line data, we make assumptions, estimations,

calculations and conclusions as part of our analyses of data. We may not have received or had the opportunity to fully

and carefully evaluate all data, or our conclusions may differ from those of the FDA or other regulatory authorities.

Consequently, the preliminary, interim or top-line data results that we report may differ from future results of the same

studies, or different conclusions or considerations may qualify such results, once additional data have been received and

fully evaluated or based on differing views from regulatory agencies. Preliminary, interim or top-line data also remain

subject to audit and verification procedures that may result in the final data being materially different from the

preliminary data we previously published. As a result, these early data points should be viewed with caution until the final

data are available. Adverse differences between previous preliminary or interim data and future interim or final data could

significantly harm our business.

In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically selected

from a more extensive amount of available information. Furthermore, we may report interim analyses of only certain

endpoints rather than all endpoints. Investors may not agree with what we determine is the material or otherwise

appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be

deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular

product, product candidate or our business.

If the preliminary, interim or top-line data that we report differ from final results, or if others, including regulatory

authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product

candidates, if approved, may be harmed, which could harm our business, operating results, prospects, or financial

condition.

Our approach to the discovery and development of therapeutic product candidates represents a novel approach to

radiation therapy, which creates significant and potentially unpredictable challenges for us.

Our success depends on the successful development of our therapeutic product candidates, which are designed to treat

solid tumors using a novel approach to radiation therapy. There are currently few approved radiopharmaceutical

therapeutic products. In addition, there has been limited historical clinical trial experience, generally, for the development

of radiopharmaceutical therapeutics. As a result, the design and conduct of clinical trials for these drugs is uncertain and

subject to increased risk.

While the use of external beam radiation as a therapy for cancers has existed for decades, the use of systemic delivery

of targeted radiopharmaceuticals in general is relatively new, including for both beta- and alpha-emitting therapies. It is

difficult to accurately predict the challenges we may incur for our therapeutic product candidates as they proceed

through clinical trials. In addition, assessments of the long-term safety of targeted beta- and alpha-emitting isotope

therapies have been limited, and there may be long-term effects from treatment with our therapeutic product candidates

that we cannot predict at this time.

Any difficulties or delays in the commencement or completion, or termination or suspension, of our ongoing or

planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely

affect our commercial prospects.

Before obtaining marketing approval from regulatory authorities for our product candidates, we must conduct extensive

clinical trials to demonstrate the safety and efficacy of the product candidates in humans. Before we can initiate clinical

trials for any future product candidates, we must submit the results of preclinical studies to the FDA or comparable

foreign regulatory authorities along with other information, including information about product candidate chemistry,

manufacturing and controls and our proposed clinical trial protocol, as part of an IND or similar regulatory filing required

for authorization to proceed with clinical development. The FDA or comparable foreign regulatory authorities may require

us to conduct additional preclinical studies for any product candidate before it allows us to initiate clinical trials under any

IND or similar regulatory filing, which may lead to delays and increase the costs of our preclinical development programs.

Moreover, even if we commence clinical trials, issues may arise that could cause regulatory authorities to suspend or

terminate such clinical trials. Any such delays in the commencement or completion of our ongoing or planned clinical

trials for our product candidates could significantly affect our product development timelines and product development

costs.

We do not know whether our planned and ongoing trials will begin on time or be completed on schedule, if at all. The

commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays

related to:

•obtaining regulatory authorizations to commence a trial or reaching a consensus with regulatory authorities on trial

design;

•the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical

studies;

•any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to

extensive negotiation and may vary significantly among different CROs and trial sites;

•obtaining approval from one or more institutional review boards ("IRBs");

•IRBs or ethics committees refusing to approve, suspending or terminating the trial at an investigational site,

precluding enrollment of additional subjects, or withdrawing their approval of the trial;

•changes to the clinical trial protocol;

•delays in identifying, recruiting and training suitable clinical investigators;

•clinical sites deviating from the trial protocol or dropping out of a trial;

•manufacturing sufficient quantities of our product candidates for use in clinical trials;

•subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-

up, including subjects failing to remain in our trials due to movement restrictions, health reasons or otherwise

resulting from ongoing or future public health or geopolitical concerns;

•subjects choosing alternative treatments for the indications for which we are developing our therapeutic product

candidates, or participating in competing clinical trials;

•lack of adequate funding to continue the clinical trial or incurring greater costs than we anticipate;

•subjects experiencing severe or serious unexpected treatment-emergent adverse events;

•occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

•selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the

resulting data;

•failure of a facility manufacturing our product candidates or any of their components to produce clinical trial

materials in accordance with current good manufacturing practice requirements("cGMP"), regulations (and similar

foreign requirements) or other applicable requirements;

•a facility manufacturing our product candidates or any of their components being ordered by the FDA or

comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of cGMP

regulations (and similar foreign requirements) or other applicable requirements, or infections or cross-

contaminations of product candidates in the manufacturing process;

•any transfer of manufacturing processes to alternate facilities or any other changes to our manufacturing process

that may be necessary or desired;

•third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not

performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical

practice ("GCP"), requirements or other regulatory requirements;

•third-party contractors not performing data collection or analysis in a timely or accurate manner; or

•third-party clinical investigators or becoming debarred or suspended or otherwise penalized by the FDA or other

government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a

substitute contractor, and we may not be able to use some or all of the data produced by such clinical investigators

or contractors in support of our marketing applications.

We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such

trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign

regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors,

including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols,

inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in

the imposition of a clinical hold, unforeseen safety issues or adverse events, failure to demonstrate a benefit from using a

drug or diagnostic, changes in governmental regulations or administrative actions or lack of adequate funding to continue

the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend

clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols

to IRBs or ethics committees for reexamination, which may impact the costs, timing or successful completion of a clinical

trial.

If we experience delays in the completion of, or termination of, any 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, if approved, will be delayed. Any delays in completing our clinical trials will increase our

costs, slow down our product candidate development and approval process and jeopardize our ability to commence

product sales and generate revenues if the product candidate is approved. Such delays could also shorten any period

during which we may have the exclusive right to commercialize our product candidates, if approved, and our competitors

may be able to bring products to market before we do, and the commercial viability of our product candidates could be

significantly reduced. In addition, many of the factors that cause, or lead to, the termination or suspension of, or a delay

in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a

product candidate. Any of these occurrences may harm our business, financial condition and prospects significantly.

We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling subjects in our

clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Patient enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part,

on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up

periods. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to identify

and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory

authorities outside the U.S. Subject enrollment is affected by many factors including the size and nature of the patient

population, the severity of the disease under investigation, the availability and efficacy of approved drugs and

diagnostics for the disease under investigation, the proximity of patients to clinical sites, the eligibility and exclusion

criteria for the trial, the design of the clinical trial, the risk that enrolled patients will not complete a clinical trial, our ability

to recruit clinical trial investigators with the appropriate competencies and experience, patient referral practices of

physicians, the ability to monitor patients adequately during and after treatment, competing clinical trials and clinicians’

and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to

other available therapies, including any new products that may be approved for the indications we are investigating as

well as any product candidates under development.

We will be required to identify and enroll a sufficient number of subjects for each of our clinical trials. The potential

patient populations for our clinical trials may be narrow, and we may experience difficulties in identifying and enrolling a

sufficient number of patients in our clinical trials. We may not be able to initiate or continue clinical trials if we are unable

to locate a sufficient number of eligible subjects to participate in the clinical trials required by the FDA or comparable

foreign regulatory authorities.

Other pharmaceutical or biotechnology companies targeting the same diseases and intended uses as our product

candidates are recruiting for their clinical trials from these patient populations, which may make it more difficult to fully

enroll our clinical trials. Our inability to enroll a sufficient number of subjects for any of our future clinical trials would

result in significant delays or may require us to abandon one or more clinical trials altogether. In addition, the process of

finding eligible subjects may prove costly.

Moreover, we rely on CROs and clinical trial sites to ensure proper and timely conduct of our clinical trials and, while we

intend to enter into agreements governing their services, we will have limited influence over their actual performance. We

cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will

not experience delays in enrollment, which would result in the delay of completion of such trials beyond our expected

timelines.

Due to their radioactive nature, our Commercial Products and our product candidates have time-limited stability, and

as a result, we may encounter difficulties with fulfillment and logistics.

The radioactive components of our Commercial Products and our product candidates have short shelf lives due to their

half lives, which refers to the time it takes for the radioactivity to decrease by 50%. Post addition of the radioactive

isotope, radioactivity decay reduces the shelf life of our Commercial Products and our product candidates, which

requires us to manufacture and deliver our Commercial Products and our product candidates for use in clinical trials to

patients in a timely manner.

Our products and product candidates are commonly manufactured as a cold-kit, namely our Commercial Products,

enabling longer shelf storage of between 12-24 months prior to radiolabeling for specific patient administration on an as-

needed basis. As such, our Commercial Products and our product candidates must be radiolabeled on an as-needed

basis, and shipped almost immediately thereafter. Because of this, specific radiolabeled patient doses of our Commercial

Products or our product candidates cannot be “stock-piled” and stored for even a small number of days ahead of

shipment, we or any third-party pharmacy network or hospital must be able to radiolabel them on an as-needed rolling

basis. Any delay, even if seemingly insignificant, could result in an immediate and substantial impact on our ability to

deliver our Commercial Products or product candidates to patients. Any significant delays in delivering our Commercial

Products or our product candidates to patients could damage our reputation and result in deviations from our clinical trial

protocols, which in turn could affect our ability to advance the clinical development of our current and future product

candidates on a timely basis, or at all. In addition, we currently substantially rely on our third-party radiopharmacy

partners for the production of our Commercial Products for commercial supply in the U.S. We cannot be sure that these

manufacturers will be able to meet our demand for our Commercial Products on a timely basis.

With respect to our product candidates, as we continue to scale our operations and enroll larger clinical trials, and

prepare for potential commercialization, if marketing authorization is obtained, we will need to scale our shipping abilities.

Labor disputes, government restrictions, work stoppages, pandemics, derailments, damage or loss events, adverse

weather conditions, other events beyond our control could interrupt or delay transportation, which could result in the loss

or damage of our Commercial Products or any product candidates with similar stabilization restrictions. We have

insurance which covers material loss or damage to Illuccix and/or Gozellix while in partner control or during transit,

subject to customary insurance limitations and restrictions. Our insurance may not cover all instances worldwide.

If we or our manufacturers are unable to meet the challenges posed by the time-limitations inherent in the composition of

our Commercial Products or any of our product candidates, it would adversely affect our business, financial condition,

results of operations and prospects.

We may not be successful in our efforts to identify or discover additional product candidates or our decisions to

prioritize the development of certain product candidates over others may later prove wrong.

Part of our strategy involves identifying and developing product candidates to build a pipeline of product candidates. Our

diagnostic and therapeutic discovery or development efforts may not be successful in identifying compounds that are

useful in diagnosing or treating cancer or other diseases. Our research programs may initially show promise in identifying

potential product candidates, yet fail to yield product candidates for clinical development for a number of reasons,

including:

•the research methodology used may not be successful in identifying potential product candidates;

•potential product candidates may, on further study, be shown to have harmful adverse events or other

characteristics that indicate that they are unlikely to be products that will receive regulatory approval and/or

achieve market acceptance; or

•potential product candidates may not be effective in treating their targeted diseases or yield clinically significant

outcomes.

We are currently advancing multiple imaging and therapeutic product candidates in clinical development, which may

create a strain on our limited human and financial resources. As a result, we may not be able to provide sufficient

resources to any single product candidate to permit the successful development and commercialization of such product

candidate, if approved, which could result in material harm to our business. Further, we have limited financial and

managerial resources, and we can only focus our research programs on developing product candidates for certain

indications.

As a result, we may forego or delay pursuit of opportunities with other product candidates or the same product

candidate for other indications that later prove to have greater commercial potential. Our resource allocation decisions

may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on

current and future research and development programs and product candidates for specific indications may not yield any

commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular

product candidate, we may relinquish valuable rights to that product candidate 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 product candidate.

Our strategy involves pairing our diagnostic imaging product or product candidates with a complementary

therapeutic product candidate, and we may not be successful in developing both the diagnostic and therapeutic

product candidates that are designed to be paired, which could impact the successful development of both.

In connection with certain targets for which we are developing drug or biological candidates for treatment use, we are

developing diagnostic imaging agents to help inform whether a particular patient’s disease condition is appropriate for

treatment with our drug or biological candidate. For example, we are using Illuccix as the paired diagnostic to our

therapeutic product candidate, TLX591-Tx (in addition to Illuccix being previously studied and used in the VISION trial as

a diagnostic for Novartis’ Pluvicto radioligand therapy) and we are developing TLX300-Px as the paired diagnostic to

evaluate the potential utility of TLX300-Tx, and similarly we are developing paired diagnostics for our other therapeutic

product candidate development programs. We may not be successful in developing an appropriate diagnostic imaging

agent or its development may cause a delay or result in expenditure of more funds than we currently anticipate. In

addition, the development of a diagnostic imaging agent will be subject to FDA review and approval, which may be

delayed or not obtained, or require additional development and testing than currently planned. If the FDA considers the

diagnostic imaging agent to be required for the use of the therapeutic product candidate, the FDA may require the

approval of the diagnostic imaging agent before it can approve the therapeutic product candidate. Equivalent foreign

regulatory review and approval would also be required before the product could be supplied for use in patient treatment.

Failure to successfully develop and obtain regulatory approval for a diagnostic imaging agent may delay FDA or foreign

regulatory approval of a drug or biological candidate intended for therapeutic use and delay or adversely affect

commercialization of that drug or biological candidate, if approved, or require us to engineer or identify alternative

solutions to select patients who are most likely to benefit from our drug or biological candidates.

We face substantial competition, which may result in others discovering, developing or commercializing products

before or more successfully than we do.

The discovery, development and commercialization of new diagnostics and therapies is highly competitive, particularly in

the cancer field. We face competition with respect to our Commercial Products and will face competition with respect to

any product candidates that we are developing and may seek to commercialize in the future, from major pharmaceutical

companies, specialty pharmaceutical companies, biotechnology companies, academic institutions and governmental

agencies as well as public and private research institutions worldwide, many of which have significantly greater financial

resources and expertise in research and development, manufacturing, preclinical studies, conducting clinical trials,

obtaining regulatory approvals and marketing approved products than we do.

There are a number of major pharmaceutical, specialty pharmaceutical and biotechnology companies that currently

market and sell diagnostics and therapies and/or are pursuing the development of diagnostics and therapies for the

treatment of cancer and the other disease indications for which we are developing our products and product candidates.

With respect to Illuccix and Gozellix, our main competitors in the U.S. include companies with approved PSMA-PET

diagnostics, including Novartis AG, Lantheus Holdings, Inc. and The Bracco Group (through its Blue Earth Diagnostics

affiliate). Certain academic institutions, like University of California, Los Angeles and University of California, San

Francisco, also hold a license for a commercial PSMA-PET diagnostic. Our main competitors also include companies

developing PSMA imaging agents, including Curium Holding France S.A.S., Clarity Pharmaceuticals Limited, ABX

advanced biochemical compounds GmbH, Isotopia Molecular Imaging Ltd., Itel Group, ITM Isotope Technologies Munich

SE, Five Eleven Pharma Inc., FutureChem Co. Ltd., Radiomedix, Inc., CellBion Co., Ltd., Norroy Biosciences Co. Ltd., HTA,

and Jiangsu Hengrui Pharmaceuticals Company Ltd. Our competitors will also include companies developing other

modalities to localize prostate cancer.

In the kidney and brain cancer imaging fields, there are no approved agents for molecular imaging for ccRCC or glioma.

Our main future competitors in these fields are companies developing agents, including ITM Isotope Technologies

Munich SE, Philogen S.p.A., Precision Molecular, Inc., Norroy Biosciences Co. Ltd., PeptiDream Inc., Five Eleven Pharma

Inc., Novartis AG, The Bracco Group (through its Blue Earth Diagnostics Ltd. Subsidiary), RadioPharm Theranostics

Limited, Curasight A/S, Molecular Targeting Technologies, Inc. ("MTTI"), and BoomRay Pharmaceuticals Co., Ltd.

With respect to our therapeutic product candidates, we consider our most direct competitors to be companies

developing targeted radiopharmaceuticals for the treatment of cancer. There are several companies with approved beta-

based radiopharmaceuticals, including Novartis AG, Sirtex Medical Limited, Boston Scientific Corporation, Acrotech

Biopharma LLC, and Q BioMed Inc. and other companies developing beta-based radiopharmaceuticals, including

Lantheus Holdings, Inc., Eli Lilly and Company Ltd, ITM Isotope Technologies Munich SE, Debiopharm SA, Curium Holding

France S.A.S, Clarity Pharmaceuticals Limited, The Bracco Group (through its Blue Earth Therapeutics Ltd. subsidiary),

and Y-mAbs Therapeutics, Inc. The beta emitting isotopes used by these companies include Iodine-131, Lutetium-177,

Strontium-89, Copper-67, and Yttrium-90. A recently approved beta particle-based radiopharmaceutical is Pluvicto,

which was developed by Novartis AG and approved by the FDA in 2022 for the treatment of patients with metastatic

prostate cancer.

There are also several companies developing targeted alpha-based radiopharmaceuticals for the treatment of cancer,

including Bayer AG, Novartis AG, Johnson & Johnson, Abdera Therapeutics Inc., Actinium Pharmaceuticals, Inc., Aktis

Oncology, Inc., Convergent Therapeutics, Inc., AstraZeneca PLC, ITM Isotope Technologies Munich SE, Perspective

Therapeutics, Inc., Eli Lilly & Company Ltd, RadioMedix, Inc., Bristol Myers Squibb Company, and Y-mAbs Therapeutics,

Inc. These companies are targeting a wide range of solid and hematologic malignancies using various alpha-emitting

isotopes, including Radium-223, Lead-212, and Actinium-225. The first and only approved alpha particle-based therapy

is Xofigo (Radium-223), which was developed by Bayer AG and approved in 2013 for the treatment of prostate cancer

with symptomatic bone metastases.

With respect to TLX591-Tx (lutetium (Lu177) rosopatamab tetraxetan), our main competitors include Novartis AG, with

Pluvicto as the only currently approved PSMA-targeted therapy. Our main competitors also include companies

developing PSMA-targeted therapies, including AstraZeneca PLC, Convergent Therapeutics, Inc., Eli Lilly & Company

Ltd., Lantheus Holdings, Inc., Curium Holding SAS, ArtBio, Inc., The Bracco Group (through its Blue Earth Therapeutics

Ltd. Subsidiary), Clarity Pharmaceuticals Ltd., Bayer AG, Orano Med SAS, Isotopia Molecular Imaging Ltd., ITM Isotope

Technologies Munich SE, Johnson & Johnson, AdvanCell Isotopes Pty Ltd., Alpha-9 Theranostics Inc., Cancer Targeted

Technology LLC, FutureChem Co Ltd., Beijing Sinotau Intl. Pharmaceutical Technology Co., Ltd., Norroy Biosciences Co.

Ltd., RadioPharm Theranostics Limited, Precision Molecular, Inc., CellBion Co., Ltd., StarPharma Holdings Limited, Amgen

Inc., Crescendo Biologics Limited, Poseida Therapeutics, Inc., Regeneron Pharmaceuticals Inc., BioXcel Therapeutics,

Inc., Lava Therapeutics NV, Janux Therapeutics, Inc., Vir Therapeutics, Inc., Bivision Pharmaceuticals, Inc., GlyTherix Ltd,

Jiangsu Hengrui Pharmaceuticals Co., Ltd., and Full-Life Technologies Limited. Our competitors also include companies

developing other modalities to treat patients in metastatic castration-resistant prostate cancer ("mCRPC").

For TLX400-Tx (177Lu-DOTAGA.Glu.(FAPi)2), our main competitors are companies developing FAP-targeting

radiotherapeutics or diagnostics, including Novartis AG, Eli Lilly and Company Ltd, 3BP Pharmaceuticals GmbH, Ratio

Therapeutics Inc., Akiram Therapeutics, BoomRay Pharmaceuticals Co., Ltd., Philogen SPA, Precirix NV, Ratio

Therapeutics Inc., Spago Nanomedical AB, Yantai LNC, ITM Isotope Technologies Munich SE, Lantheus Holdings, Inc,

Perspective Therapeutics, Inc., Precision Molecular Inc., Sofie Biosciences, Inc., and GE Healthcare.

For TLX300-Tx (-olaratumab), our main competitors include companies with licensed soft-tissue sarcoma treatments

including Novartis AG, Adaptimmune Therapeutics plc, Agilent Technologies Inc., Boehringer Ingelheim GmbH, Esai Co.,

Ltd., , Mark, PharmaMar SA, Johnson & Johnson, Taiho Pharmaceuticals as well as other companies commercializing

chemotherapy regimens approved in soft-tissue sarcoma. Our competitors also include companies developing therapies

in the field of sarcoma including Ratio Therapeutics Inc., PTC Therapeutics, Polaris Pharmaceuticals, BioAtla. Eli Lilly and

Company Ltd, Advenchen Laboratories LLC, Intensity Therapeutics Inc, Sun Pharmaceutical Industries Ltd, Exelixis Inc,

Y-mAbs Therapeutics Inc, QBiotics Group Limited, Apollomics Inc, Pyxis Oncology, AADi Bioscience Inc, Moleculin

Biotech Inc, Cornerstone Pharmaceuticals Inc, Shasqi Inc, Noxopharm Limited, NANO MRNA Co Ltd, Avacta Group plc,

Iovance Biotherapeutics Inc, Foghorn Therapeutics Inc., OncoTherapy Science Inc. and Syena.

For TLX250-Tx (177Lu-DOTA-girentuximab), our main competitors include ITM Isotope Technologies Munich SE, Precision

Molecular, Inc., Norroy Biosciences Co. Ltd., PeptiDream Inc, Bristol Myers Squibb Company and Bayer AG. Our

competitors will also include companies developing other modalities to image renal cell carcinoma and carbonic

anhydrase IX.

For TLX101-Tx (iodofalan 131I), our main competitors include ITM Isotope Technologies Munich SE, Molecular Targeting

Technologies, Inc. ("MTTI"), Novartis AG, Radiopharm Theranostics Limited, Plus Therapeutics, Inc., Ariceum

Therapeutics GmbH, Boston Scientific Corporation, and Cellectar Biosciences, Inc. Our competitors will also include

companies developing other modalities to treat brain cancer.

For TLX090-Tx (153Sm-DOTMP), our main competitors include commercially available compounds that relieve pain from

osteoblastic bone metastases, including Novartis AG, Bayer AG, Pfizer Inc., Purdue Pharma L.P., Roxane Laboratories,

Inc., Johnson & Johnson, Mallinckrodt Inc., Endo Pharmaceuticals Holdings Inc., Mylan Laboratories Inc., Noven

Pharmaceuticals, Inc., Aveva Group PLC, Sandoz Group AG, Ranbaxy Laboratories Ltd., Amneal Pharmaceuticals LLC,

Hoffmann-La Roche AG, Apotex Inc, Orchid Healthcare LTD, Grünenthal GmbH, as well as other companies

commercializing or developing other palliative agents for osteoblastic bone metastases.

We are currently focused on developing and commercializing our Commercial Products and our product candidates for

the diagnosis and treatment of cancer and there are a variety of commercially available imaging and therapeutic

products marketed for cancer. In many cases, cancer imaging products and therapeutics are administered in combination

to enhance efficacy. Some of these products are branded and subject to patent protection, and others are available on a

generic basis or prepared under the practice of pharmacy or pharmacy compounding exemptions in certain jurisdictions.

Many of these products are well-established and are widely accepted by physicians, patients and third-party payors.

Insurers and other third-party payors may also encourage the use of generic diagnostics and therapeutics. Our

Commercial Products are, and any candidate for which we obtain marketing authorization will likely be, priced at a

significant premium over competitive generic products, also known as “home-brew” or “compounded” non-cGMP

products, which may make it difficult for us to achieve our business strategy of using our products in combination with

existing products or replacing existing products with our products, particularly if clinical differentiation or innovation

contribution is more limited compared to currently available products.

Further, our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize

products that are or are perceived to be more effective, safer, more tolerable, more convenient and/or less costly than

any of our currently approved products or product candidates which receive marketing authorization or that would

render our products obsolete or non-competitive. Our competitors may also obtain regulatory approval from the FDA or

other regulatory authorities for their product candidates more rapidly than we may obtain approval for ours, which could

result in our competitors establishing a stronger market position before we are able to enter the market or preventing us

from entering into a particular indication at all.

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 and management personnel, engaging clinical

trial sites and enrolling patients in clinical trials, as well as in acquiring technologies complementary to, or that may be

necessary for, our programs.

If we are not able to compete effectively against current or potential competitors, our business may be materially harmed

and our financial condition and results of operations will be adversely affected.

We may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the

medical community necessary for commercial success, of our Commercial Products and any product candidates for

which we obtain regulatory approval, including Illuccix and Gozellix, in which case we may not generate significant

revenues or remain profitable.

We may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical

community necessary for commercial success of our Commercial Products and any product candidates for which we

obtain regulatory approval. Oncologists may be reluctant to switch their patients from existing therapies even when new

and potentially more effective or convenient treatments enter the market. Further, patients often acclimate to the

therapy that they are currently taking and do not want to switch unless their oncologists recommend switching products

or they are required to switch therapies due to lack of coverage and reimbursement for existing therapies.

Efforts to drive adoption within the medical community and third-party payors based on the benefits of our products and

product candidates require significant resources and may not be successful. The success of our Commercial Products

and our current or future product candidates, if approved, whether alone or in collaboration with third parties, including

achieving and maintaining an adequate level of market adoption, depends on several factors, including:

•our ability to successfully launch and achieve broad adoption of our Commercial Products or any other product for

which we obtain approval, or any future indications for which our Commercial Products may be approved;

•the competitive landscape for our Commercial Products and our product candidates, including the timing of new

competing products entering the market and the level and speed at which these products achieve market

acceptance;

•actual or perceived advantages or disadvantages of our Commercial Products or any product candidates for which

we obtain approval as compared to alternative treatments, including their respective safety, tolerability and efficacy

profiles, the potential convenience and ease of administration, access or cost effectiveness;

•the effectiveness of our sales, marketing, manufacturing and distribution strategies and operations;

•the consistency of any new data we collect and analyses we conduct with prior results; whether they support a

favorable safety, efficacy and effectiveness profile of our Commercial Products; and any potential impact on our

FDA or any foreign regulatory approvals and/or labeling for our Commercial Products;

•our ability to comply with the FDA’s and comparable foreign regulatory authorities’ post-marketing requirements

and commitments, including through successfully conducting, on a timely basis, additional studies that confirm

clinical efficacy, effectiveness and safety of our Commercial Products (or any product candidates for which we

obtain approval and are required to conduct such studies) and acceptance of the same by the FDA or similar foreign

regulatory authorities;

•acceptance of current indications of our Commercial Products and future indications of our Commercial Products

and other product candidates, if approved, by patients, the medical community and third-party payors;

•obtaining and maintaining coverage, adequate pricing and reimbursement by third-party payors, including

government payors, for our Commercial Products and our product candidates, if approved;

•the willingness of patients to pay out-of-pocket in the absence of third-party coverage or as co-pay amounts under

third-party coverage;

•our ability to enforce intellectual property rights in and to our products to prohibit a third-party from marketing a

competing product and our ability to avoid third-party post-grant patent proceeding or intellectual property

infringement claims;

•current and future restrictions or limitations on our approved or future indications and patient populations or other

adverse regulatory actions;

•the performance of our manufacturers, license partners, distributors, providers and other business partners, over

which we have limited control;

•any significant mis-estimations of the size of the market and market potential for any of our Commercial Products or

our product candidates;

•establishing and maintaining commercial manufacturing capabilities or making arrangements with third-party

manufacturers;

•the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies,

based, in part, on their perception of our clinical trial data and/or the actual or perceived safety, tolerability and

effectiveness profile;

•maintaining an acceptable safety and tolerability profile of our Commercial Products or any of our product

candidates for which we obtain approval, including the prevalence and severity of any adverse events;

•the ability to offer our Commercial Products or any product candidates for which we obtain approval for sale at

competitive prices;

•adverse publicity about our Commercial Products or favorable publicity about competitive products; and

•our ability to maintain compliance with existing and new health care laws and regulations, including government

pricing, price reporting and other disclosure requirements related to such laws and regulations, and the potential

impact of such laws and regulations on physician prescribing practices and payor coverage.

If we do not achieve one or more of these factors in a timely manner, or at all, we could experience significant delays or

an inability to successfully commercialize our Commercial Products or our product candidates, if approved, which would

materially harm our business.

If we are unable to maintain or expand our sales, marketing and distribution capabilities, we may not be successful in

commercializing our Commercial Products or any of our product candidates, if approved.

We have built a commercial infrastructure in Australia, New Zealand, the U.S., Brazil, Canada and Europe for our

Commercial Products. Prior to building this infrastructure, we did not previously have any experience in the sales,

marketing or distribution of pharmaceutical products. If any of our product candidates are approved, we may need to

evolve our sales, marketing and distribution capabilities and we may not be able to do so successfully or on a timely

basis. In the future, we may choose to expand our sales, marketing and distribution infrastructure to market or co-

promote one or more of our product candidates, if and when they are approved, or enter into collaborations with respect

to the sale, marketing and distribution of our product candidates. We are working with existing and may in the future

work with additional partners to develop the commercial infrastructure to support the sale of our Commercial Products in

other jurisdictions.

There are risks involved with establishing and maintaining our own sales, marketing and distribution capabilities. For

example, recruiting and training a sales force is expensive and time-consuming and could delay any commercial launch

of a product candidate or negatively impact ongoing commercialization efforts for our approved products.

Further, we may underestimate the size of the sales force required for a successful product launch and we may need to

expand our sales force earlier and at a higher cost than we anticipated. If the commercial launch of any of our product

candidates is delayed or does not occur for any reason, including if we do not receive regulatory approval in the

timeframe we expect, we may have prematurely or unnecessarily incurred commercialization expenses. This may be

costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to successfully commercialize our Commercial Products or any of our product

candidates, if approved, on our own include:

•our inability to recruit, train and retain adequate numbers of effective sales, market access, market analytics,

operations and marketing personnel;

•the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to

prescribe current or future products;

•the lack of complementary products, which may put us at a competitive disadvantage relative to companies with

more extensive product lines;

•unforeseen costs and expenses associated with creating an independent sales, marketing and distribution

organization;

•our inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies;

•our ability to supply, manufacture and deliver sufficient inventory of our products for commercial sale on a timely

basis; and

•existing or new competitors taking share from our Commercial Products or any other product candidate for which

we obtain approval in the future, or preventing our Commercial Products or any such product from gaining share in

its approved indications.

The commercial success of our Commercial Products and our product candidates, if approved, will depend upon

public perception of radiopharmaceuticals and the degree of their market acceptance by physicians, key opinion

leaders, patients, healthcare payors and others in the medical community.

Adverse events in clinical trials of our product candidates, or in clinical trials or other studies conducted by others

involving similar products, which may include the same radioisotopes as our Commercial Products and/or our product

candidates, and the resulting negative publicity, as well as any other adverse events in the field of radiopharmaceuticals

that may occur in the future, could result in a decrease in demand for our Commercial Products or any future product

candidates that we may develop and for which we obtain regulatory approval. If public perception is influenced by claims

that radiopharmaceuticals or specific therapies within radiopharmaceuticals are unsafe, our Commercial Products or any

product candidates for which we obtain regulatory approval may not be accepted by the general public or the medical

community.

In particular, the commercial success of our Commercial Products and our product candidates, if approved, will depend

upon, among other things, these products gaining and maintaining acceptance by physicians, key opinion leaders,

patients, third-party payors, and other members of the medical community as efficacious and cost-effective alternatives

to competing products and treatments. If our Commercial Products or any of our product candidates, once approved, do

not achieve and maintain an adequate level of acceptance, we may not generate material sales of that product or be able

to successfully commercialize it. The degree of market acceptance of our Commercial Products or our product

candidates, if approved, will depend on a number of factors, including:

•our ability to provide acceptable evidence of safety and efficacy;

•the prevalence and severity of any adverse events in general, and differentiation relative to other treatments;

•limitations or warnings contained in the labeling approved by the FDA;

•the size of the target patient population;

•advertising concerning our products or competing products and treatments;

•availability, relative cost and relative efficacy of alternative and competing treatments;

•the ability to offer our products for sale at competitive prices;

•the relative convenience and ease of administration of our Commercial Products and product candidates, if

approved, which may require coordination amongst multiple physicians across disciplines for administration;

•the willingness of the target patient population to try new products and of physicians to prescribe these products;

•strength of marketing and distribution support;

•publicity for our Commercial Products and competing products and treatments;

•the existence of distribution and/or use restrictions, such as through a REMS;

•the availability of third-party payor coverage and adequate reimbursement;

•the timing of any marketing approval in relation to other product approvals;

•support from patient advocacy groups;

•any restrictions on the use of our products together with other medications; and

•the sufficiency of coverage or reimbursement by third parties.

Manufacturing of radiopharmaceuticals is complex and we may encounter difficulties in production. If we encounter

such difficulties, our ability to provide supply of our Commercial Products or any of our product candidates for

preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.

Manufacturing of radiopharmaceuticals is complex, highly regulated and must comply with cGMPs and similar foreign

requirements. While we have manufacturing capabilities of our own, we also rely on third parties, such as contract

manufacturing organizations ("CMOs"), for the manufacture of our Commercial Products and our product candidates. If

we are unable to obtain or maintain arrangements with CMOs, or to do so on commercially reasonable terms, we may not

be able to commercialize our Commercial Products or develop our product candidates successfully. Our third-party

manufacturing providers may not be able to provide adequate resources or capacity to meet our needs on a timely basis

or at all, and may incorporate their own proprietary processes into our product candidate manufacturing processes. We

have limited control and oversight of a third-party’s proprietary process, and a third-party may elect to modify its

process without our consent or knowledge. These modifications could negatively impact our manufacturing, including

product loss or failure that requires additional manufacturing runs or a change in manufacturer, either of which could

significantly increase the cost of and significantly delay the manufacture of our Commercial Products or any of our

product candidates.

Additionally, as we expect the market for our Commercial Products and PSMA-PET imaging to expand and our product

candidates to progress through preclinical studies and clinical trials towards potential approval and commercialization, it

is possible that various aspects of manufacturing will be altered in an effort to optimize processes and results. Such

changes may require new submissions to and approval from regulators, which may further delay the timeframes under

which modified manufacturing processes can be used for our Commercial Products or any of our product candidates,

and additional bridging studies or trials may be required. Any such delay could harm our business, financial condition,

results of operations and prospects.

We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic

unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure

compliance with cGMPs or similar foreign requirements. Despite our efforts to audit and verify regulatory compliance, we

or one or more of our third-party manufacturing vendors may be found on regulatory inspection by the FDA or other

comparable foreign regulatory authorities to be noncompliant with cGMPs or similar foreign regulations. This may result

in shutdown of our facility or that of the third-party vendor or invalidation of product lots or processes, which could

adversely affect our business, financial condition, results of operations and prospects. In some cases, a product recall

may be warranted or required, which would materially affect our ability to supply and market our products and could be

costly and result in reputational damage.

We may be unable to generate and/or obtain a sufficient supply of radioisotopes to support clinical development or

manufacturing at commercial scale.

As a radiopharmaceutical company, our Commercial Products and our product candidates are prepared for patient

administration using radioisotopes. Gallium-68 (68Ga) is a necessary component isotope for radiopharmacies to radiolabel

our Commercial Products for patient administration and is sourced by a radiopharmacy directly. Other important isotopes

applicable to our current pipeline of diagnostic and therapeutic product candidates include zirconium-89 (89Zr),

lutetium-177 (

177

Lu), yttrium-90 (90Y), fluorine-18 (18F), iodine-131 (

131

I), technetium-99m or (99mTc), actinium-225 (

225

Ac),

astatine-211 (

211

At), and Samarium-153 (

153

Sm). We procure these isotopes from suppliers based predominantly in

Canada or Europe. Global isotope supply chains, including obtaining precursor or raw materials necessary to produce

many of the synthetic radioisotopes used in nuclear medicine, are commonly sourced from countries such as Russia,

Brazil, South Africa and Türkiye that may, from time-to-time, be subject to instability, unrest, protests, intergovernmental

conflicts and various international trade or monetary sanctions. Where isotopes or raw materials are procured under

various medical or humanitarian exemptions, including countries that may, from time-to-time, be subject to instability,

unrest, protests, intergovernmental conflicts and various international trade or monetary sanctions, those exemptions

may be repealed or altered in a way that is detrimental to our ability to operate our business.

We aim to maintain multiple supply agreements with isotope suppliers and stockpiles to ensure adequate quantities to

meet our current pipeline development needs. However, there is a limited supply of some radioisotopes due to the

limited supply of starting radioactive raw materials to create the radioisotope or the complexity required to manufacture

isotopes to the required quality and purity standards for effective radiolabeling. We aim to maintain supply relationships

with all major current suppliers and for certain isotopes there are no or limited alternatives to our current suppliers.

While we are making investments to secure additional access to and capabilities for manufacturing isotopes, we may

encounter supply shortages which could affect our business operations and results of operations. There can be no

assurance that our suppliers will renew existing contracts on acceptable terms, or even at all. Additionally, failure to

acquire enough medical-grade isotopes for specific product candidates would make it impossible to effectively complete

clinical trials, especially as we scale up for later-stage clinical trials, and to commercialize any product candidates that

we may develop, which would materially harm our business.

Isotope suppliers may also have limited production capacity to meet future commercial demand, and there is no

guarantee that production will start in the time frame we expect. Even where a contract exists, we may have limited

recourse if a supplier is unable to meet its obligations. Suppliers may also be unable to meet their obligations for any

number of reasons. For example, the U.S. Department of Energy has reserved its ability to cancel private orders when the

supply is instead needed for national defense, environmental safety, or in the event of any other sort of lack of supply

capacity or for a number of other reasons that are outside of our control.

Radioisotopes or radioactive raw materials may only be available from a limited number of countries, including Russia,

Brazil, Türkiye or South Africa. Our isotope suppliers obtain the radioactive materials from source material countries in

accordance with applicable laws and export regulations, usually under medical exemption, and then use the raw

materials to manufacture the radioisotopes for onward clinical sale and commercial sale to third parties, including

governments, hospitals and pharmaceutical companies. We and our suppliers are exposed to a number of environmental

and geopolitical risks beyond radioactive raw material availability, including restrictions on trade of certain items with

Russia, and other unforeseen geopolitical factors that limit our ability to access our supply of raw material. The ongoing

war in Ukraine and subsequent economic sanctions imposed on Russia, including by the U.S., may impact our ability to

procure supply of necessary isotopes and may impact our product development timelines. For example, while our current

suppliers are not currently designated on any export or sanctions-related restricted party lists maintained by the U.S.

government, there is no guarantee our suppliers (or their third-party suppliers of raw materials) will not be designated on

such lists in the future. In addition, our dependence on international radioisotope suppliers is increased in the near term

because the U.S. Department of Energy restricts usage for certain isotopes for clinical development outside the U.S., and

therefore, we must rely on our suppliers for our international operations. To date, the ongoing war in Ukraine has not

materially impacted the development of any of our product candidates, nor has it materially impacted the price at which

we are able to purchase isotopes. Although we do not expect to encounter additional delays from our suppliers based on

the ongoing war in the Ukraine, we may experience delays in the future, and any such delay could have an adverse

material impact on our development plans and business. We expect to continue to monitor and adapt our development

plans as necessary in response to environmental and geopolitical risks. Any difficulty that our suppliers have in procuring

raw materials may also magnify the impact of other risks described in this Annual Report.

Our ability to conduct clinical trials to advance our product candidates is dependent on our ability to either self-generate

and/or obtain these radioisotopes and other isotopes we may choose to utilize in the future. While we intend to scale-up

our manufacturing facilities to achieve vertical integration and the ability to self-manufacture our final diagnostics and

therapeutics products, we are dependent on third-party manufacturers and suppliers for many of our isotopes, and our

suppliers will be dependent on third parties to supply the raw radioactive materials. These parties may not perform their

contracted services or may breach or terminate their agreements with us. Our suppliers are subject to regulations and

standards that are overseen by regulatory and government agencies, and we have no control over our suppliers’

compliance with these standards. Failure to comply with regulations and standards may result in their inability to supply

an isotope that could result in delays in our clinical trials or commercialization, which could have a negative impact on our

business.

Even if we are able to effectively commercialize our Commercial Products or any product candidates for which we

obtain approval, the products may not receive coverage or may become subject to unfavorable pricing regulations,

third-party reimbursement practices or healthcare reform initiatives, all of which would harm our business.

The legislation and regulations that govern regulatory approvals, pricing, coverage and reimbursement for new imaging

and therapy products vary widely from country to country. As a result, we might obtain regulatory approval for a product

in a particular country, but then be subject to pricing or reimbursement regulations that delay the commercial launch of

the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from product

sales in that country. In the U.S. and most other major markets internationally, approval and reimbursement decisions are

not linked directly, but there is increasing scrutiny from the Congress, government or regulatory authorities, payors,

patient organizations of the pricing or reimbursement of pharmaceutical products. Adverse pricing or reimbursement

limitations may also hinder our ability to recoup our investment in one or more product candidates, even if our product

candidates obtain regulatory approval.

Our ability to successfully commercialize our Commercial Products and any other products that we may develop or

acquire will depend, in part, on the extent to which satisfactory pricing, coverage and reimbursement for these products

is available from government payors, private health insurers and other organizations. Government authorities and third-

party payors, such as private health insurers and health maintenance organizations, decide which medications they will

pay for and establish reimbursement levels. Obtaining and maintaining adequate coverage and reimbursement for our

Commercial Products and any of our product candidates, if approved, may be difficult. Moreover, the process for

determining whether a third-party payor will provide coverage for a product may be separate from the process for

setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.

Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide

coverage and reimbursement for our products. Even with payor coverage, patients may be unwilling or unable to pay the

copay required and may choose not to take or use our products.

A primary trend in the healthcare industry in the U.S. and elsewhere is cost containment. Government authorities and

third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular

medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined

discounts from list prices and are challenging the prices charged for medical products.

Third-party payors may also seek, with respect to an approved product, additional clinical evidence that goes beyond

the data required to obtain regulatory approval. They may require such evidence to demonstrate clinical benefits and

value in specific patient populations or they may call for costly pharmaceutical studies to justify coverage and

reimbursement or the level of reimbursement relative to other therapies before covering our products. Accordingly, we

cannot be sure that reimbursement will be or will continue to be available for our Commercial Products and any product

that we commercialize in the future and, if reimbursement is available, we cannot be sure as to the level of

reimbursement and whether it will be adequate. Coverage and reimbursement may impact the demand for or the price of

our Commercial Products or any product candidate for which we obtain regulatory approval. If reimbursement is not

available or is available only at limited levels, we may not be able to successfully commercialize our Commercial Products

or any other approved products.

There may be significant delays in obtaining reimbursement for newly approved products, and coverage may be more

limited than the indications for which the product is approved by the FDA or comparable foreign regulatory authorities.

Moreover, eligibility for reimbursement does not imply that our Commercial Products or any product candidate for which

we obtain approval will be paid for in all cases or at a rate that covers our costs, including research, development,

manufacture, sale and distribution. Interim reimbursement levels for new products, if applicable, may also not be

sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of

the product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost

products and may be incorporated into existing payments for other services. Net prices for products may be reduced by

mandatory discounts or rebates required by government healthcare programs or private payors and by any future

relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than

in the U.S. Third-party payors in the U.S. often rely upon Medicare coverage policy and payment limitations in setting

their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both

government-funded and private payors for any approved products that we develop could have a material adverse effect

on our operating results, our ability to raise capital needed to commercialize our products and our overall financial

condition.

Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit

commercialization of our Commercial Products or any other products or product candidates that we may develop or

acquire.

We face an inherent risk of product liability exposure related to our commercialization of our Commercial Products and

the testing of our product candidates in human clinical trials as the administration of our products to humans may expose

us to liability claims, whether or not our products are actually at fault for causing any harm or injury. As our Commercial

Products are used over longer periods of time by a wider group of patients taking numerous other medicines or by

patients with additional underlying conditions, the likelihood of adverse product reactions or unintended adverse events,

including death, may increase. For example, we may be sued if any of our Commercial Products or product candidates

we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing,

marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in

design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims

could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against claims

that our products or product candidates caused injuries, we will incur substantial liabilities or may be required to limit

commercialization of our Commercial Products and product candidates, if approved. Regardless of merit or eventual

outcome, liability claims may result in:

•decreased demand for our Commercial Products and any other products that we may develop or acquire;

•injury to our reputation and significant negative media attention;

•loss of critical partners and/or partnership agreements;

•withdrawal of clinical trial participants;

•initiation of investigations by regulators;

•product recalls, withdrawals or labeling, marketing or promotional restrictions;

•significant costs to defend the related litigation;

•substantial monetary awards to trial participants or patients;

•loss of revenue;

•reduced resources of our management to pursue our business strategy; and

•the inability to successfully commercialize our Commercial Products and any other products that we may develop or

acquire.

We currently hold clinical trial liability insurance of up to US$20 million per occurrence in the aggregate and general

product liability insurance coverage in the amount of US$20 million in the aggregate, but that coverage may not be

adequate to cover any and all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be

able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

We may be subject to securities class action litigation or other shareholder litigation, which could result in

substantial costs and divert management's attention and resources.

Companies that have experienced volatility in the market price of their securities have frequently been subject to

securities class action litigation or other shareholder derivative actions. We may become the target of this type of

litigation in the future, particularly if we experience significant stock price volatility or declines, announce material

restatements of financial results, fail to meet earnings expectations, or disclose material weaknesses in our internal

controls, such as we have disclosed in our management report on internal control over financial reporting. Additionally,

public companies are increasingly subject to litigation related to corporate governance matters, executive compensation,

environmental, social and governance ("ESG") disclosures, and other matters that may give rise to shareholder claims or

derivative actions.

Securities litigation and shareholder derivative actions, regardless of their outcome or merit, can result in substantial

costs, including significant legal fees and expenses, damages, and settlement amounts. Such litigation may also divert

management's attention and resources away from business operations, which could adversely affect our ability to

execute on our strategic initiatives. The defense or settlement of any such litigation could have a material adverse effect

on our business, financial condition, results of operations, and cash flows.

Furthermore, any adverse judgment or settlement in connection with shareholder litigation could result in negative

publicity and reputational harm, which may further impact our stock price and ability to attract and retain key personnel.

The outcome of complex legal proceedings is inherently unpredictable and subject to significant uncertainties, and we

may not be able to accurately estimate potential liabilities associated with any pending or threatened litigation.

Our directors' and officers' liability insurance may not cover all potential claims or may not be adequate to indemnify us

for all liability that may be imposed. Any future claims could also make it more difficult and expensive to obtain adequate

insurance coverage

Risks Related to Regulatory Matters

Even if we complete the necessary preclinical studies and clinical trials for our product candidates, the regulatory

approval process is expensive, time-consuming and uncertain and we or they may not receive approvals for the

commercialization of some or all of our product candidates in a timely manner, or at all.

Our long-term success and ability to sustain and grow revenue depends on our ability to continue to successfully

develop our product candidates and obtain regulatory approval to market our products both in and outside of the U.S. In

order to market and sell our products in the European Union and many other jurisdictions, we must obtain separate

marketing approvals and comply with numerous and varying regulatory requirements. The FDA and comparable foreign

regulatory authorities, whose laws and regulations may differ from country to country, impose substantial requirements

on the development of product candidates to become eligible for marketing approval, have substantial discretion in the

process, and may refuse to accept any application or may decide that the data are insufficient for approval and require

additional preclinical studies, clinical trials or other studies and testing. The time required to obtain approval outside of

the U.S. may differ substantially from that required to obtain FDA approval. For example, in many countries outside of the

U.S., it is required that the drug also be approved for reimbursement before the drug can be sold in that country.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval

by one regulatory authority outside of the U.S. does not ensure approval by regulatory authorities in other countries or

jurisdictions or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a

negative effect on the regulatory process in other countries.

In addition, the FDA and foreign regulatory authorities retain broad discretion in evaluating the results of our clinical trials

and in determining whether the results demonstrate that any product candidate is safe and effective. If we are required

to conduct additional clinical trials of our Commercial Products prior to approval of any additional investigational

indications we are developing them for, or of any product candidates prior to approval, we may need substantial

additional funds, and there is no assurance that the results of any such additional clinical trials will be sufficient for

approval.

The process of obtaining marketing approvals, both in the U.S. and abroad, is lengthy, expensive and uncertain. It may

take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the

type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of

extensive preclinical and clinical data and supporting information, including manufacturing information, to regulatory

authorities for each indication to establish the product candidate’s safety and efficacy.

In addition, changes in or the enactment of additional statutes, promulgation of regulations or issuance of guidance

during preclinical or clinical development, or comparable changes in the regulatory review process for each submitted

product application, may cause delays in the approval or rejection of an application. For example, in December 2022,

with the passage of Food and Drug Omnibus Reform Act ("FDORA"), Congress required sponsors to develop and submit

a Diversity Action Plan ("DAP"), for each Phase 3 clinical trial or any other “pivotal study” of a new drug or biological

product. These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical

trials of FDA regulated products. In June 2024, as mandated by FDORA, the FDA issued draft guidance outlining the

general requirements for DAPs. Unlike most guidance documents issued by the FDA, the DAP guidance when finalized

will have the force of law because FDORA specifically dictates that the form and manner for submission of DAPs are

specified in FDA guidance. On January 27, 2025, in response to an Executive Order issued by President Trump on

January 21, 2025, on Diversity, Equity and Inclusion programs, the FDA removed this draft guidance from its website.

This action raises questions about the applicability of statutory obligations to submit DAPs and the agency’s current

thinking on best practices for clinical development.

Further, on January 31, 2022, the new Clinical Trials Regulation (EU) No 536/2014 became applicable in the European

Union and replaced the prior Clinical Trials Directive 2001/20/EC. The new regulation aims at simplifying and streamlining

the authorization, conduct and transparency of clinical trials in the European Union. Under the new coordinated

procedure for the approval of clinical trials, the sponsor of a clinical trial to be conducted in more than one EU Member

State will only be required to submit a single application for approval. The submission will be made through the Clinical

Trials Information System, a new clinical trials portal overseen by the European Medicines Agency ("EMA"), and available

to clinical trial sponsors, competent authorities of the EU Member States and the public. We have not previously secured

authorization to conduct clinical studies in the European Union pursuant to this new regulation and, accordingly, there is

a risk that we may be delayed in commencing such studies.

The FDA or other regulatory authorities may determine that (i) our product candidates are not safe and effective, are only

moderately effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude

our obtaining marketing approval or prevent or limit commercial use; (ii) the dose used in a clinical trial has not been

optimized and require us to conduct additional dose optimization studies; or (iii) the comparator arm in a trial is no longer

the appropriate comparator due to the evolution of the competitive landscape or subsequent data of the comparator

product, even if the FDA or other regulatory authority had previously approved the trial design, and we may be required

to amend the trial or we may not receive approval of the indication.

Moreover, principal investigators for our future clinical trials may serve as scientific advisors or consultants to us and

receive compensation in connection with such services. Under certain circumstances, we may be required to report

some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or a comparable foreign

regulatory authority may conclude that a financial relationship between us and a principal investigator has created a

conflict of interest or otherwise affected interpretation of the study. The FDA or a comparable foreign regulatory

authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of

the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing

applications by the FDA or a comparable foreign regulatory authority, as the case may be, and may ultimately lead to the

denial of marketing approval of one or more of our product candidates.

Further, under the Pediatric Research Equity Act ("PREA"), an NDA, BLA or supplement to an NDA or BLA for certain

drugs and biological products must contain data to assess the safety and effectiveness of the drug or biological product

in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for

which the product is safe and effective, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be

granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in

adults before pediatric trials are complete or that additional safety or effectiveness data needs to be collected before the

pediatric trials begin. The applicable legislation in the European Union also requires sponsors to either conduct clinical

trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of

the EMA, or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any of our product

candidates for which we are seeking regulatory approval in the U.S. or the European Union, we cannot guarantee that we

will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner,

or at all, which could result in associated reputational harm and subject us to enforcement action.

In addition, we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme

Court in 2024. In Loper Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural

Resources Defense Council, Inc., which for 40 years required federal courts to defer to permissible agency

interpretations of statutes that are silent or ambiguous on a particular topic. The U.S. Supreme Court stripped federal

agencies of this presumptive deference and held that courts must exercise their independent judgment when deciding

whether an agency such as the FDA acted within its statutory authority under the Administrative Procedure Act ("APA").

Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the court held that actions to

challenge a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather

than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to

challenge longstanding agency regulations. Another decision, Securities and Exchange Commission v. Jarkesy,

overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings. These decisions could

introduce additional uncertainty into the regulatory process and may result in additional legal challenges to actions taken

by federal regulatory agencies, including the FDA and Centers for Medicare & Medicaid Services ("CMS"), that we rely

on. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased

regulatory uncertainty and delays and other impacts, any of which could adversely impact our business and operations.

Finally, with the change in presidential administrations in 2025, there is substantial uncertainty as to how, reductions in

force, changes in leadership, and modifications or revisions to the requirements and policies of the FDA and other

regulatory agencies with jurisdiction over our product candidates will impact our business and operations. The

uncertainty could present new challenges or potential opportunities as we navigate the clinical development and

approval process for our product candidates.

The approval of our product candidates for commercial sale could also be delayed, limited or denied or we may be

required to conduct additional studies for a number of reasons, including, but not limited to, the following:

•regulatory authorities may determine that our product candidates do not demonstrate safety and effectiveness in

accordance with regulatory agency standards based on a number of considerations, including adverse events that

are reported during clinical trials;

•regulatory authorities could analyze and/or interpret data from clinical trials and preclinical testing in different ways

than we interpret them and determine that our data is insufficient for approval;

•regulatory authorities may require more information, including additional preclinical or clinical data or the conduct of

new trials, to support approval;

•regulatory authorities could determine that our manufacturing processes are not properly designed, are not

conducted in accordance with federal or other laws or otherwise not properly managed, and we may be unable to

obtain regulatory approval for a commercially viable manufacturing process for our product candidates in a timely

manner, or at all;

•the supply or quality of our product candidates for our clinical trials may be insufficient, inadequate or delayed;

•the size of the patient population required to establish the efficacy of our product candidates to the satisfaction of

regulatory agencies may be larger than we or they anticipated;

•our failure or the failure of clinical sites, and the records kept at the respective locations, including records

containing clinical trial data, to be in compliance with the FDA’s GCP, requirements or comparable regulations

outside of the

U.S.

•regulatory authorities may change their approval policies or adopt new regulations;

•regulatory authorities may not be able to undertake reviews of our marketing applications, conduct applicable

inspections or proceed through their approval processes in a timely manner;

•the results of our earlier clinical trials may not be representative of our future, larger trials;

•regulatory authorities may not agree with our regulatory approval strategies or components of our or their

regulatory filings, such as the design or implementation of the relevant clinical trials; or

•a product may not be approved for the indications that we request or may be limited or subject to restrictions or

post-approval commitments that render the approved drug not commercially viable.

Accordingly, we may not be able to submit applications for marketing approvals/authorizations and may not receive

necessary approvals to commercialize our products in any market. Any failure, delay or setback in obtaining regulatory

approval for our product candidates could materially adversely affect our ability to generate revenue from a particular

product candidate, which could result in significant harm to our financial position and adversely impact the price of our

ordinary shares and ADSs.

Failure to obtain marketing approval in foreign jurisdictions would prevent our medicines from being marketed in

such jurisdictions and any of our medicines that are approved for marketing in such jurisdiction will be subject to risk

associated with foreign operations.

In order to market and sell our medicines in the European Union and many other foreign jurisdictions, we or our

collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing. The time required to obtain approval

may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the U.S.

generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the U.S.,

a product must be approved for reimbursement before the product can be approved for sale in that country. We or our

collaborators may not obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all. Moreover,

approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval

by one regulatory authority outside the U.S. does not ensure approval by regulatory authorities in other countries or

jurisdictions or by the FDA.

Additionally, we could face heightened risks with respect to obtaining marketing authorization in the United Kingdom as a

result of the withdrawal of the United Kingdom from the European Union, commonly referred to as Brexit. The United

Kingdom is no longer part of the European Single Market and EU Customs Union. As of January 1, 2025, the Medicines

and Healthcare Products Regulatory Agency ("MHRA"), is responsible for approving all medicinal products destined for

the United Kingdom market (i.e., Great Britain and Northern Ireland). At the same time, a new international recognition

procedure ("IRP"), will apply, which intends to facilitate approval of pharmaceutical products in the United Kingdom. The

IRP is open to applicants that have already received an authorization for the same product from one of the MHRA’s

specified Reference Regulators ("RRs"). The RRs notably include EMA and regulators in the EU/European Economic Area

("EEA") member states for approvals in the EU centralized procedure and mutual recognition procedure as well as the

FDA (for product approvals granted in the U.S.). However, the concrete functioning of the IRP is currently unclear. Any

delay in obtaining, or an inability to obtain, any marketing approvals may force us or our collaborators to restrict or delay

efforts to seek regulatory approval in the United Kingdom for our product candidates, which could significantly and

materially harm our business.

In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted. For

instance, the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the

Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European

Commission’s proposal for revision of several legislative instruments related to medicinal products was published on April

26, 2023.

In December 2025, the Council of the European Union and the European Parliament reached provisional

agreement on a comprehensive overhaul of the EU legislative framework for pharmaceuticals. There are a number of

significant changes, including a potential reduction in regulatory data protection, a streamlining of the regulatory

approval process potentially allowing products to reach the market in a shorter period of time, and introduction of

shortage prevention plans. The agreement still requires formal approval and adoption. If adopted, there will be a

transitional period (between 18-36 months) for implementation. The revisions may have a significant impact on the

pharmaceutical industry in general and our business in the long term.

We expect that we will be subject to additional risks in commercializing any of our product candidates that receive

marketing approval outside the U.S., including tariffs, trade barriers and regulatory requirements; economic weakness,

including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment,

immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in

increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

and workforce uncertainty in countries where labor unrest is more common than in the U.S. In addition, we have limited

experience commercializing products outside of the U.S. and such efforts may depend on our ability to find a suitable

collaborator.

We intend to conduct certain of our clinical trials globally. However, the FDA and other foreign equivalents may not

accept data from such trials, in which case our development plans will be delayed, which could materially harm our

business.

We have conducted and intend to continue conducting certain of our clinical trials globally. The acceptance by the FDA

or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to

certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as

the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of

foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were

performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be

considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be

necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.

In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not

accept the data as support for an application for marketing approval unless the study is well-designed and well-

conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an

onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In

addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are

conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from

trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any comparable foreign regulatory

authority does not accept such data, it would result in the need for additional trials, which could be costly and time-

consuming, and which may result in current or future product candidates that we may develop not receiving approval for

commercialization in the applicable jurisdiction.

Conducting clinical trials outside the U.S. also exposes us to additional risks, including risks associated with:

•additional foreign regulatory requirements;

•foreign exchange fluctuations;

•compliance with foreign manufacturing, customs, shipment and storage requirements;

•cultural differences in medical practice and clinical research;

•diminished protection of intellectual property in some countries; and

•interruptions or delays in our trials resulting from geopolitical events, such as tariffs, other trade restrictions, armed

conflict, or political instability.

Products utilizing our technology may need to be approved or cleared by the FDA and similar regulatory agencies or

certified by notified bodies worldwide as medical devices. We may not receive, or may be delayed in receiving, the

necessary approval, clearance or certification for our future medical device products, which would adversely affect

business, financial condition, results of operations and prospects.

We are developing artificial intelligence ("

AI")

and surgical assistance offerings that may be subject to regulation as

medical devices in the U.S. and other jurisdictions. We have not yet utilized our AI platform in the development of our

Commercial Products or product candidates. To date, we have not had any discussion with the FDA or other regulatory

authorities or notified bodies regarding the regulatory pathways required to market these technologies. The FDA or

similar regulatory agencies may subject these offerings to medical device requirements, including premarket review,

lengthier or more rigorous processes than we expected that may include the performance of one or more clinical trials.

Efforts to achieve requisite governmental clearances and approvals could be costly and time consuming, and we may not

be able to obtain any such required clearances or approvals in accordance with our anticipated timeline or in a cost-

efficient manner. Any delay or failure to obtain necessary regulatory clearances, approvals or certifications could have a

material negative impact on our ability to generate revenues.

The FDA categorizes medical devices into one of three classes - Class I, II, or III - based on the risks presented by the

device and the regulatory controls necessary to provide a reasonable assurance of the device’s safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be

assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable

portions of the Quality System Regulation ("QSR") facility registration and product listing, reporting of adverse medical

events or certain malfunctions, and truthful and non-misleading labeling, advertising, and promotional materials. Class II

devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the

safety and effectiveness of the device. Special controls are established by the FDA for a specific device type and often

include specific labeling provisions, performance metrics, and other types of controls that mitigate risks of the device.

Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable

devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that

of a legally marketed device, are placed in Class III, requiring approval of a premarket approval application ("PMA").

In the U.S., before we can market a new medical device, or a new use of, new claim for or significant modification to an

existing product, we must first receive either clearance under Section 510(k) of the Federal Food Drug and Cosmetic Act

("FDCA") marketing authorization under the de novo classification pathway, or approval of a

PMA,

from the FDA, unless

an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a

proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has

been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-

amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-

classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same

intended use as the predicate device, and either have the same technological characteristics as the predicate device or

have different technological characteristics and not raise different questions of safety or effectiveness than the

predicate device. FDA then determines whether the device is as safe and effective as the predicate device by reviewing

the scientific methods used to evaluate differences in technological characteristics and performance data. Clinical data

are sometimes required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must

determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including,

but not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data. The PMA process is typically

required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable

devices.

If no legally marketed predicate can be identified for a new device to enable use of the 510(k) pathway, the device is

automatically classified as Class III, which generally requires PMA approval. This results in some low to moderate risk

devices being classified unnecessarily as Class III. To address this, FDA regulations include a pathway to market for low

to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device,

called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure and

pathway. This procedure allows a manufacturer whose novel device is automatically classified into Class III to request

down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate

risk, rather than requiring the submission and approval of a PMA. The FDA can also reclassify a product from Class III to

Class I or II. If the data and information provided to the FDA in support of a de novo request demonstrate that general

controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and

the probable benefits of the device outweigh the probable risks, then the FDA will grant the de novo request authorizing

marketing of the product subject to the specified controls. After a device receives de novo classification, any

modification that could significantly affect its safety or efficacy, or that would constitute a major change or modification

in its intended use, will require a new 510(k) clearance or, depending on the modification, another de novo request or

even PMA approval.

Modifications to products that are approved through a PMA application generally require FDA approval. Similarly, certain

modifications made to products cleared through a 510(k) may require a new 510(k) clearance. Both the PMA approval

and the 510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually

takes from three to 12 months, but can last longer. The process of obtaining a PMA is generally much more costly and

uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time

the application is submitted to the FDA. In addition, a PMA generally requires the performance of one or more clinical

trials. Despite the time, effort and cost, a device may not be approved or cleared by the FDA. Any delay or failure to

obtain necessary regulatory clearances or approvals could harm our business. Furthermore, even if we are granted

regulatory clearances or approvals, they may include significant limitations on the indicated uses for the device or other

restrictions or requirements, which may limit the market for the device.

The FDA, comparable foreign regulatory authorities or notified bodies can delay, limit or deny clearance, approval or

certification of a medical device for many reasons, including:

•our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory authority or notified body

that our product candidates are safe or effective for their intended uses or are substantially equivalent to a

predicate device;

•the disagreement of the FDA or the applicable foreign regulatory authority with the design or implementation of

our clinical studies or the interpretation of data from pre-clinical studies or clinical studies;

•serious and unexpected adverse events experienced by participants in our clinical studies;

•the data from our pre-clinical studies and clinical studies may be insufficient to support clearance, approval or

certification where required;

•our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;

•the manufacturing process or facilities we use may not meet applicable requirements; and

•the potential for approval policies or regulations of the FDA or applicable foreign regulatory authorities to change

significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.

Subject to the transitional provisions and in order to sell our products in EU member states, our products must also

comply with the general safety and performance requirements of the EU Medical Devices Regulation, which repeals and

replaces the Medical Devices Directive. Compliance with these requirements is a prerequisite to be able to affix the

European Conformity ("CE") mark to our products, without which they cannot be sold or marketed in the European Union.

All medical devices placed on the market in the European Union must meet the general safety and performance

requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device

must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended

purpose. Medical devices must be safe and effective and must not compromise the clinical condition or safety of

patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be

associated with their use constitute acceptable risks when weighed against the benefits to the patient and are

compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of

the art. Even if regulatory clearance, approval or certification is obtained, such products will remain subject to extensive

regulatory requirements. If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and

foreign regulatory authorities, or previously unknown problems with any approved commercial products, manufacturers

or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions. In

addition, the cost of compliance with new laws or regulations governing our technology or future products could

adversely affect our business, financial condition, results of operations and prospects. New laws or regulations may

impose restrictions or obligations on us that could force us to redesign our technology or other future products or

services, and may impose restrictions that are not possible or practicable to comply with, which could cause our

business to fail.

Our Commercial Products and any of our product candidates for which we obtain marketing approval in the future are

subject to post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal

from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if

we experience unanticipated problems with our products following approval.

Once marketing approval has been granted, an approved product and its manufacturer and marketer are subject to

ongoing review and extensive regulation. Our Commercial Products and any of our product candidates for which we

obtain marketing clearance or approval in the future, as well as the manufacturing processes, post-approval studies and

measures, labeling, advertising and promotional activities for such products, among other things, will be subject to

continual requirements of and review by the FDA and other U.S. and foreign regulatory authorities. These requirements

include submissions of safety and other post-marketing information and reports, registration and listing requirements,

requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and

documents, and related compliance requirements such as price reporting, transparency reporting and requirements

regarding the distribution of samples to physicians and recordkeeping. Even if marketing authorization is granted, it may

be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval,

including in the case of drug or biological products, the requirement to implement a REMS, which could include

requirements for a restricted distribution system.

The FDA and comparable foreign regulatory authorities may also impose requirements for costly post-marketing studies

or clinical trials and surveillance to monitor the safety or efficacy of a drug or biological product. There are similar

potential requirements for medical devices. In addition, manufacturers of approved products and those manufacturers’

facilities are required to comply with extensive requirements by the FDA and comparable foreign regulatory authorities,

including ensuring that quality control and manufacturing procedures conform to cGMP regulations, which include

requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and

documentation and reporting requirements. We and our contract manufacturers could be subject to periodic

unannounced inspections by the FDA or foreign regulatory authorities to monitor and ensure compliance with cGMPs

(and similar foreign requirements) or other regulations.

If the FDA or another regulatory authority discovers previously unknown problems with a product, such as adverse

events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or

disagrees with the promotion, marketing or labeling of a product, such regulatory authorities may impose restrictions on

that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable

regulatory requirements, a regulatory authority or enforcement authority may, among other things:

•refuse to approve pending applications or supplements to approved applications;

•require us to change the way a product is distributed, conduct additional clinical trials, change the labeling of a

product or require us to conduct additional post-marketing studies or surveillance;

•restrict our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;

•require additional warnings on the product label, such as a “black box” warning, precaution or a contraindication;

•impose restrictions on the products, manufacturers or manufacturing process;

•require warning or untitled letters;

•seek injunctions or civil or criminal penalties;

•suspend or withdraw regulatory approvals;

•seize or detain products or implement import bans;

•impose voluntary or mandatory product recalls and publicity requirements;

•totally or partially suspend production; and

•impose restrictions on operations, including costly new manufacturing requirements.

Any government investigation of alleged violations of law could require us to expend significant time and resources in

response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may

adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied

or if regulatory approval is withdrawn, our business will be seriously harmed.

In connection with our Commercial Products and assuming we receive marketing approval for one or more of our product

candidates, we and our contract manufacturers will continue to expend time, money and effort in all areas of regulatory

compliance, including manufacturing, production, product surveillance and quality control. If we are not able to comply

with post-approval regulatory requirements, our ability to market any future products could be limited, which could

adversely affect our ability to sustain profitability. Further, the cost of compliance with post-approval regulations may

have a negative effect on our operating results and financial condition.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of

products inconsistent with approved labeling. If we are found or alleged to have improperly promoted a product, we

may become subject to significant liability.

The FDA and other U.S. or foreign agencies, including the U.S. Department of Justice ("DOJ") closely regulate and

monitor the post-approval marketing and promotion of drugs and biological products to ensure that they are

manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the

approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use,

and if we communicate about any of our product candidates for which we, or they, receive marketing approval in a way

that regulators assert goes beyond their approved indications, we, or they, may be subject to warnings or enforcement

action for off-label marketing. Alleged violations of the FDCA or other statutes, including the False Claims Act ("FCA")

relating to the promotion and advertising of prescription drugs may lead to investigations or allegations of violations of

federal and state health care fraud and abuse laws and state consumer protection laws.

In September 2021, the FDA published a Final Rule which describes the types of evidence that the agency will consider in

determining the intended use of a drug or biologic.

Notwithstanding the regulatory restrictions on off-label promotion, the FDA and other regulatory authorities allow

companies to engage in truthful, non-misleading, and non-promotional scientific communications concerning their

products in certain circumstances. For example, in January 2025, the FDA published final guidance outlining the agency’s

non-binding policies governing the distribution of scientific information on unapproved uses to healthcare providers. This

final guidance calls for such communications to be truthful, non-misleading, factual, and unbiased and include all

information necessary for healthcare providers to interpret the strengths and weaknesses and validity and utility of the

information about the unapproved use. In addition, under some relatively recent guidance from the FDA and the Pre-

Approval Information Exchange Act ("PIE Act") signed into law as part of the Consolidated Appropriations Act of 2023,

companies may also promote information that is consistent with the prescribing information and proactively speak to

formulary committee members of payors regarding data for an unapproved drug or unapproved uses of an approved

drug. We may engage in these discussions and communicate with healthcare providers, payors and other constituencies

in compliance with all applicable laws, regulatory guidance and industry best practices. We will need to carefully navigate

the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with

restrictions governing promotion of our Commercial Products.

In recent years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries

and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in

connection with the promotion of products for unapproved uses and other sales practices, including the Department of

Justice and various U.S. Attorneys’ Offices, the Office of Inspector General of the Department of Health and Human

Services, the FDA, the Federal Trade Commission ("FTC") and various state Attorneys General offices. These

investigations have alleged violations of various federal and state laws and regulations, including claims asserting

antitrust violations, violations of the FDCA, the False Claims Act, the Prescription Drug Marketing Act and anti-kickback

laws and other alleged violations in connection with the promotion of products for unapproved uses, pricing and

Medicare and/or Medicaid reimbursement. Many of these investigations originate as “qui tam” actions under the False

Claims Act. Under the False Claims Act, any individual can bring a claim on behalf of the government alleging that a

person or entity has presented a false claim or caused a false claim to be submitted to the government for payment. The

person bringing a qui tam suit is entitled to a share of any recovery or settlement. Qui tam suits, also commonly referred

to as “whistleblower suits,” are often brought by current or former employees. In a qui tam suit, the government must

decide whether to intervene and prosecute the case. If it declines, the individual may pursue the case alone.

If the FDA or any other governmental agency initiates an enforcement action against us or if we are the subject of a qui

tam suit and it is determined that we violated prohibitions relating to the promotion of products for unapproved uses, we

could be subject to substantial civil or criminal fines or damage awards and other sanctions such as consent decrees and

corporate integrity agreements pursuant to which our activities would be subject to ongoing scrutiny and monitoring to

ensure compliance with applicable laws and regulations. Any such fines, awards or other sanctions would have an

adverse effect on our revenue, business, financial prospects and reputation.

Similar to the U.S., pharmaceutical companies in the European Union, the United Kingdom, and Australia are generally

prohibited from promoting drugs for any use that is not consistent with the product’s authorized uses. Doing so may

result in regulatory enforcement action. While off‑label prescribing by clinicians is permitted as part of medical practice,

the active promotion of off‑label uses by manufacturers is not.

In the European Union, promotion must be consistent with the approved marketing authorization. Promotion that

suggests or encourages use of a medicine for an unapproved indication, in an unapproved patient population, or using an

unapproved dose, route or regimen is treated as unlawful off‑label promotion. EU law distinguishes between the freedom

of healthcare professionals to prescribe off‑label based on clinical judgment and the strict limits on companies’

promotional activities, which may not extend beyond the authorized product information. Limited scientific exchange -

such as publication of data in peer‑reviewed journals or responses to unsolicited requests from healthcare professionals

may be acceptable, but only where it is clearly non‑promotional, balanced, and not designed to increase prescribing.

In the United Kingdom, post‑Brexit rules continue to mirror this approach. Advertising of medicines is regulated by the

Human Medicines Regulations, enforced by the MHRA, and supplemented by the self‑regulatory Association of the

British Pharmaceutical Industry ("ABPI") Code. Both require that promotional materials align with the product’s current

labeling. Communications that directly or indirectly promote an unapproved indication or off‑label use breach these rules.

The MHRA and the Prescription Medicines Code of Practice Authority ("PMCPA"), which administers the ABPI Code,

routinely treat off‑label promotion as a serious violation. As in the European Union, manufacturers may provide scientific,

non‑promotional information—particularly in response to unsolicited, specific questions from healthcare professionals—

but must avoid any appearance of encouraging off‑label prescribing.

In Australia, the TGA, together with industry codes (such as the Medicines Australia Code of Conduct), prohibit

advertising of unapproved medicines and unapproved indications. Any communication that constitutes “advertising” and

promotes an off‑label use is not permitted, even if directed only to healthcare professionals. Promotional materials, detail

aids, and speaker programs must therefore be confined to the indications, populations and regimens approved in the

Australian Register of Therapeutic Goods ("ARTG") entry and associated product information. As in the European Union

and United Kingdom, companies may engage in limited scientific exchange, but this must be clearly separated from

promotional activities and must not function as de facto marketing for off‑label uses.

We may seek certain designations for our product candidates in the

U.S.

, including breakthrough therapy, fast track

and priority review designations, and PRIME designation in the European Union, but we might not receive such

designations, and even if we do, such designations may not lead to a faster development or regulatory review or

approval process.

We may seek certain designations for one or more of our product candidates that could expedite review and approval by

the FDA. A breakthrough therapy-designated product candidate is defined as a product candidate that is intended, alone

or in combination with one or more other products, 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. For product candidates that have been designated as breakthrough therapies, interaction and

communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical

development while minimizing the number of patients placed in ineffective control regimens. Breakthrough therapy

designation may not lead to a faster development or regulatory review or approval process, and does not increase the

likelihood that any product candidate that receives a breakthrough therapy designation will receive marketing approval.

The FDA may also issue fast track designation to a product candidate if it is intended, alone or in combination with one or

more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the

potential to address unmet medical needs for such a disease or condition. For fast track-designated product candidates,

sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a fast track product

candidate’s application 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.

We may also seek priority review for one or more of our product candidates. If the FDA determines that a product

candidate has the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious

disease or condition, and if approved would provide a significant improvement in the safety or effectiveness of the

treatment, prevention, or diagnosis of such disease or condition, the FDA may designate the product candidate for

priority review upon submission of a marketing application seeking approval of that product. A priority review designation

means that the goal for the FDA to review an application is six months, rather than the standard review period of ten

months.

These designations are within the discretion of the FDA. Accordingly, even if we believe that one of our product

candidates meets the criteria for these designations, the FDA may disagree and reject our request for designation.

Further, even if we receive a designation, the receipt of such designation for a product candidate may not result in a

faster development or regulatory review or approval process compared to product candidates considered for approval

under conventional FDA procedures, and the designation does not assure ultimate approval by the FDA. In addition, even

if one or more of our product candidates qualifies for these designations, the FDA may later decide that the product

candidates no longer meet the conditions for qualification and rescind the designation or decide that the time period for

FDA review or approval will not be shortened.

In the European Union, we may seek PRIME designation for some of our product candidates in the future. PRIME is a

voluntary program aimed at enhancing the EMA’s role to reinforce scientific and regulatory support in order to optimize

development and enable accelerated assessment of new medicines that are of major public health interest with the

potential to address unmet medical needs. The program focuses on medicines that target conditions for which there

exists no satisfactory method of treatment in the European Union or even if such a method exists, it may offer a major

therapeutic advantage over existing treatments. PRIME is limited to medicines under development and not authorized in

the European Union and the sponsor intends to apply for an initial MAA through the centralized procedure. To be

accepted for PRIME, a product candidate must meet the eligibility criteria with respect to its major public health interest

and therapeutic innovation based on information that is capable of substantiating the claims. The benefits of a PRIME

designation include the appointment of a CHMP rapporteur to provide continued support and help to build knowledge

ahead of a MAA, early dialogue and scientific advice at key development milestones, and the potential to qualify

products for accelerated review, meaning reduction in the review time for an opinion on approvability to be issued earlier

in the application process. PRIME enables a sponsor to request parallel EMA scientific advice and health technology

assessment advice to facilitate timely market access. Even if we or our collaborators receive PRIME designation for any

of our product candidates, the designation may not result in a materially faster development process, review or approval

compared to conventional EMA procedures. Further, obtaining PRIME designation does not assure or increase the

likelihood of the EMA’s grant of a marketing authorization.

We may submit an application for a Commissioner’s National Priority Voucher ("CNPV") from the FDA but there can be

no assurance that we will receive a voucher and, if a voucher is received, we may not be able to comply with the

requirements of the program. It is also possible that a competitor may receive a voucher which could harm our

competitive position in the marketplace.

In June 2025, the FDA announced the CNPV pilot program which was designed to accelerate the development and

review of certain drugs and biologics that are aligned with U.S. national health priorities, such as addressing a U.S. public

health crisis, developing more innovative cures for the American people, addressing a large unmet medical need,

onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply

chain resiliency, and increasing affordability. The FDA has stated that voucher recipients will receive a decision with

respect to an application on an accelerated basis, as well as enhanced communication with review staff throughout the

review process. The FDA expects the CNPV program to accelerate the application review timeline from 10-12 months to

1-2 months by convening a multidisciplinary team of physicians and scientists for a team-based review, interacting

frequently with the sponsor of the application to clarify questions, and completing review of the application concurrently.

The FDA retains full discretion to extend the review window if the data or application components submitted are

insufficient or incomplete, if the results of the pivotal trial(s) are ambiguous, or if the review is particularly complex. The

FDA has indicated that the CNPV program does not change the FDA’s rigorous safety and efficacy standards for review

and approval. In late 2025, FDA began issuing approvals for drugs with CNPVs within the 1-2 month review timeframe.

The CNPV program is new, limited in scope, and subject to evolving guidance, and available FDA resources. The FDA

retains broad discretion to modify the criteria, processes, or benefits of the program and may rescind participation or

alter timelines or the intended benefits at any time. Adding to the uncertainty, concerns have been raised regarding the

legality of the CNPV program.

We may seek approval of our product candidates from the FDA or comparable foreign regulatory authorities through

the use of accelerated development pathways. If we are not able to use such pathways, we may be required to

conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining,

and delay or prevent the receipt of, necessary marketing approvals. Moreover, even if we receive accelerated

approval from the FDA or comparable foreign regulatory authorities, if our confirmatory trials do not verify clinical

benefit, or if we do not comply with rigorous post-marketing requirements, the FDA or comparable foreign regulatory

authorities may seek to withdraw accelerated approval.

Under the Food, Drug, and Cosmetic Act ("

FDCA")

, and implementing regulations, the FDA may grant accelerated

approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful

therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a

surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers

a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as

irreversible morbidity or mortality. 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. An intermediate clinical endpoint is a clinical endpoint that can be measured

earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible

morbidity or mortality or other clinical benefit measurement of a therapeutic effect that is considered reasonably likely to

predict the clinical benefit. Prior to seeking such accelerated approval, we will continue to seek feedback from the FDA

or comparable foreign regulatory agencies and otherwise evaluate our, or their, ability to seek and receive such

accelerated approval.

There can be no assurance that the FDA or foreign regulatory agencies will agree with our surrogate endpoints or

intermediate clinical endpoints in any of our clinical trials, or that we will decide to pursue or submit any additional NDAs

or BLAs seeking accelerated approval. Similarly, there can be no assurance that, after feedback from the FDA or

comparable foreign regulatory agencies, we will continue to pursue or apply for accelerated approval. Furthermore, for

any submission of an application for accelerated approval, there can be no assurance that such submission will be

accepted for filing or that any expedited development, review or approval will be granted on a timely basis, or at all.

Finally, there can be no assurance that we will satisfy all FDA requirements, including new provisions that govern

accelerated approval. For example, with passage of the FDORA in December 2022, Congress modified certain provisions

governing accelerated approval of drug and biologic products. Specifically, the new legislation (i) authorized FDA to

require a sponsor to have its confirmatory clinical trial underway before accelerated approval is awarded; (ii) requires a

sponsor of a product granted accelerated approval to submit progress reports on its post-approval studies to FDA every

six months until the study is completed; and (iii) authorizes FDA to use expedited procedures to withdraw accelerated

approval of an NDA or a BLA if certain conditions are met, including where a required confirmatory study fails to verify

and describe the predicted clinical benefit or where evidence demonstrates the product is not shown to be safe or

effective under the conditions of use. The FDA may also use such procedures to withdraw an accelerated approval if a

sponsor fails to conduct any required post-approval study of the product with due diligence, including with respect to

“conditions specified by the Secretary.” The new procedures include the provision of due notice and an explanation for a

proposed withdrawal, and opportunities for a meeting with the Commissioner or the Commissioner’s designee and a

written appeal, among other things. We will need to fully comply with these and other requirements in connection with

the development and approval of any product candidate that qualifies for accelerated approval.

In March 2023, the FDA issued draft guidance that outlines its current thinking and approach to accelerated approval.

The FDA indicated that the accelerated approval pathway is commonly used for approval of oncology drugs due to the

serious and life-threatening nature of cancer. Although single-arm trials have been commonly used to support

accelerated approval, a randomized controlled trial is the preferred approach as it provides a more robust efficacy and

safety assessment and allows for direct comparisons to an available therapy. To that end, the FDA outlined

considerations for designing, conducting, and analyzing data for trials intended to support accelerated approvals of

oncology therapeutics. Subsequently, in December 2024 and January 2025, the FDA issued additional draft guidances

relating to accelerated approval. These guidances describe FDA’s latest thinking on what it means to conduct a

confirmatory trial with due diligence and how the agency plans to interpret whether such a study needs to be underway

at the time of approval. While these guidances are currently only in draft form and will ultimately not be legally binding

even when finalized, sponsors typically observe the FDA’s guidance closely to ensure that their investigational products

qualify for accelerated approval.

In the European Union, a “conditional” marketing authorization may be granted in cases where all the required safety and

efficacy data are not yet available. A conditional marketing authorization is subject to conditions to be fulfilled for

generating missing data or ensuring increased safety measures. A conditional marketing authorization is valid for one

year and has to be renewed annually until fulfillment of all relevant conditions. Once the applicable pending studies are

provided, a conditional marketing authorization can become a “standard” marketing authorization. However, if the

conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization will cease to be renewed.

Accordingly, a failure to obtain and maintain accelerated approval or any other form of expedited development, review or

approval for our product candidates, or withdrawal of a product candidate, would result in a longer time period until

commercialization of such product candidate, could increase the cost of development of such product candidate and

could harm our competitive position in the marketplace.

We may not be able to obtain orphan drug designation or exclusivity for any product candidates we may develop, and

even if we do, that exclusivity may not prevent the FDA or foreign regulatory authorities from approving other

competing products.

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug or biologic intended to

treat a rare disease or condition, meaning that the product is intended for a condition or disease with a patient population

of fewer than 200,000 individuals annually in the U.S., or more than 200,000 individuals in the U.S. for which there is no

reasonable expectation that the cost of developing and making available in the U.S. the drug or biologic will be recovered

from sales in the U.S. for that drug or biologic. For example, we have received orphan drug designations from the FDA for

TLX101

-Tx for the treatment of glioma, for TLX101-Px for the imaging of glioma and for TLX66-Tx as a conditioning

treatment prior to hematopoietic stem cell transplant. TLX090-Tx has also been granted orphan drug designation by the

FDA for the treatment of osteosarcoma, and TLX102-Tx has been granted orphan drug designation for the treatment of

multiple myeloma and malignant glioma. In addition, in the European Union, a medicinal product may be designated as

orphan if its sponsor can establish that (i) the product is intended for the diagnosis, prevention or treatment of a life-

threatening or chronically debilitating condition; (ii) either (a) such condition affects no more than 5 in 10,000 persons in

the European Union when the application is made, or (b) the product, without the benefits derived from orphan status,

would not generate sufficient return in the European Union to justify investment; and (iii) there exists no satisfactory

method of diagnosis, prevention or treatment of such condition authorized for marketing in the European Union, or if

such a method exists, the medicinal product will be of significant benefit to those affected by the condition. For example,

TLX101

-Tx and TLX66-Tx have been granted orphan drug designation in Europe. Orphan drug designation may not lead

to a faster development or regulatory review or approval process and does not increase the likelihood that any product

candidate that receives an orphan drug designation will receive marketing approval.

Generally, if a product candidate with an orphan drug designation subsequently receives the first marketing approval for

the disease or condition for which it has such designation, the product is entitled to a period of marketing exclusivity,

which precludes the FDA or foreign regulatory authorities, as applicable, from approving another marketing application

for the same product for the same disease or condition for a prescribed time period. The applicable period is seven years

in the U.S. and ten years in the European Union. The exclusivity period in the European Union can be reduced to six years

if, at the end of the fifth year, a product no longer meets the criteria for Orphan Designation, in particular if the product is

sufficiently profitable so that market exclusivity is no longer justified. Even if we obtain the designation and if, upon

approval, we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from

competition because different products can be approved for the same disease or condition. In addition, even after an

orphan drug or biologic is approved, the FDA and comparable foreign regulatory authorities, such as the European

Commission, can subsequently approve the same product for the same condition if the FDA or such other authorities

conclude that the later product is clinically superior in that it is shown to be safer, more effective or makes a major

contribution to patient care. Orphan drug exclusivity may also be lost if the FDA or comparable foreign regulatory

authorities determines that the request for designation was materially defective or if the manufacturer is unable to assure

sufficient quantity of the product to meet the needs of the patients with the rare disease or condition.

The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. This may be

particularly true in light of a decision from the Court of Appeals for the 11th Circuit in September 2021 finding that, for the

purpose of determining the scope of exclusivity, the term “same disease or condition” means the designated “rare

disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” Thus, the court concluded,

orphan drug exclusivity applies to the entire designated disease or condition rather than the “indication or use.” Although

there have been legislative proposals to overrule this decision, they have not been enacted into law. On January 23,

2023, the FDA announced that, in matters beyond the scope of that court order, the FDA will continue to apply its

existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug was approved. We

do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future or whether

Congress will take legislative action, and it is uncertain how any changes might affect our business. Depending on what

changes the FDA or Congress may make to orphan drug regulations and policies, our business could be adversely

impacted.

If the FDA does not conclude that certain of our product candidates satisfy the requirements for the Section

505(b)(2) regulatory approval pathway, or if the requirements for such product candidates under Section 505(b)(2)

are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost

significantly more and entail significantly greater complications and risks than anticipated, and in either case may not

be successful.

We are developing certain product candidates for which we may seek FDA approval through the Section 505(b)(2)

regulatory pathway. The Drug Price Competition and Patent Term Restoration Act of 1984 ("the Hatch-Waxman Act")

added Section 505(b)(2) to the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the

information required for approval comes from studies that were not conducted by or for the applicant and for which the

applicant has not obtained a right of reference. Section 505(b)(2), if applicable to us under the FDCA, would allow an

NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the safety

and effectiveness of approved compounds, which could expedite the development program for our product candidates

by potentially decreasing the amount of clinical data that we would need to generate in order to obtain FDA approval.

If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway as anticipated, we may need to conduct

additional clinical trials, provide additional data and information, and meet additional standards for regulatory approval.

If this were to occur, the time and financial resources required to obtain FDA approval for these product candidates, and

complications and risks associated with these product candidates, would likely substantially increase. We could need to

obtain additional funding, which could result in significant dilution to the ownership interests of our then existing

shareholders to the extent we issue equity securities or convertible debt. We cannot guarantee that we would be able to

obtain such additional financing on terms acceptable to us, if at all. Moreover, inability to pursue the Section 505(b)(2)

regulatory pathway would likely result in new competitive products reaching the market more quickly than our product

candidates, which would likely materially adversely impact our competitive position and prospects. Even if we are

allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot guarantee that our product candidates will

receive the requisite approvals for commercialization.

In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few

years, certain brand-name pharmaceutical companies and others have objected to the FDA’s interpretation of Section

505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may change its 505(b)(2)

policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section

505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to

special requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced

in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of

our NDAs for up to 30 months or longer depending on the outcome of any litigation. It is not uncommon for a

manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose

additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or

even prevent, the approval of the new product. However, even if the FDA ultimately denies such a petition, the FDA may

substantially delay approval while it considers and responds to the petition. In addition, even if we are able to utilize the

Section 505(b)(2) regulatory pathway, there is no guarantee this would ultimately lead to accelerated product

development or earlier approval.

Moreover, even if our product candidates are approved under Section 505(b)(2), the approval may be subject to

limitations on the indicated uses for which the products may be marketed or to other conditions of approval, or may

contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the products.

Disruptions at the FDA, the SEC and other government agencies, including from inadequate funding, government

shut downs, reductions in force, or other disruptions to these agencies’ operations, 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, if at all, or otherwise prevent those agencies from performing normal business

functions on which the operation of our business may rely, which could negatively impact our business. In addition,

changes in FDA policies or regulations, resulting from the foregoing disruptions or otherwise, could adversely impact

the development of our product candidates and, ultimately, our ability to receive approval for and commercialize

them.

The ability of the FDA and comparable foreign regulatory authorities (or notified bodies) to review and approve or certify

new products can be affected by a variety of factors, including government budget and funding levels, reductions in

force, government shutdowns, 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.

Disruptions at the FDA, other agencies, and authorities (or notified bodies) may also slow the time necessary to meet

with and receive agency feedback, review and/or approve our submissions, conduct inspections, issue regulatory

guidance, or take other actions that facilitate the development, approval and marketing of regulated products, which

would adversely affect our business. Moreover, changes in FDA’s policies or regulations, whether as a result of personnel

and budgetary constraints described above, changes in leadership or otherwise, could adversely impact the

development of our product candidates and, ultimately, our ability to receive marketing authorization. Decisions about

the development of product candidates are often based on interactions with FDA and regulatory guidance provided by

the agency following such interactions. If FDA does not agree with our decisions resulting from such interactions and

guidance or there are subsequent policy changes, review and approval of our product candidates may be delayed or not

occur at all. In addition, government funding of 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.

Disruptions at the FDA, other agencies, and authorities (or notified bodies) may also slow the time necessary for new

product candidates to be reviewed and/or approved (or certified) by necessary government agencies, foreign regulatory

authorities (or notified bodies), which would adversely affect our business. For example, over the last several years the

U.S. government has shut down several times, including most recently in October and November 2025, and certain

regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities.

In addition, disruptions may result from events similar to the COVID-19 pandemic. During the COVID-19 pandemic, a

number of companies announced receipt of complete response letters due to the FDA’s inability to complete required

inspections for their applications. In the event of a similar public health emergency in the future, the FDA may not be able

to continue its current pace and review timelines could be extended. Regulatory authorities outside the U.S. facing similar

circumstances may adopt similar restrictions or other policy measures in response to a similar public health emergency

and may also experience delays in their regulatory activities.

If another prolonged government 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. Further, future

government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to

properly capitalize and continue our operations.

Recently enacted and future legislation may increase the difficulty and cost for us to commercialize our or our

collaborators' product candidates, if approved, and affect the prices we, or they, may obtain.

In the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed

changes regarding the healthcare system that could, among other things, restrict or regulate post-approval activities and

affect our ability to profitably sell or commercialize our Commercial Products or any product candidate for which we, or

our collaborators, obtain marketing approval. We expect that current laws, as well as other healthcare reform measures

that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on

the price that we, or any collaborators, may receive for any approved products. If reimbursement of our products is

unavailable or limited in scope, our business could be materially harmed.

Because our Commercial Products are generally reimbursed under Medicare Part B which covers drugs administered by

healthcare providers in outpatient settings, changes to CMS coverage, packaging or bundling policies and site‑of‑service

payment could directly affect utilization and net pricing. We expect that current laws, as well as other healthcare reform

measures that may be adopted in the future, may result in more rigorous coverage criteria and an additional downward

pressure on the price that we, or any collaborators, may receive for any approved products. If reimbursement of our

products is unavailable or limited in scope, our business could be materially harmed.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education

Affordability Reconciliation Act (collectively "the ACA") was enacted. The ACA established an annual, nondeductible fee

on any entity that manufactures or imports specified branded prescription drugs and biologic agents; extended

manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed

care organizations; expanded eligibility criteria for Medicaid programs; expanded the entities eligible for discounts under

the 340B drug pricing program; increased the statutory minimum rebates a manufacturer must pay under the Medicaid

Drug Rebate Program; established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in,

and conduct comparative clinical effectiveness research, along with funding for such research; and established a Center

for Medicare & Medicaid Innovation at CMS, an agency within the U.S. Department of Health and Human Services

("HHS") to test innovative payment and service delivery models to lower Medicare and Medicaid spending. Since its

enactment, there have been executive, judicial, and Congressional challenges to certain aspects of the ACA.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. In August 2011, the

Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select

Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least US$1.2 trillion for the

years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to

several government programs. These changes included aggregate reductions to Medicare payments to providers, which

went into effect in April 2013 and will remain in effect through 2032. The American Taxpayer Relief Act of 2012, among

other things, reduced Medicare payments to several providers and increased the statute of limitations period for the

government to recover overpayments to providers from three to five years. Further, with the passage of the Inflation

Reduction Act ("IRA") in August 2022, Congress authorized Medicare drug price negotiation for certain high‑expenditure,

single‑source drugs and biologics (beginning with 10 Part D products in 2026 and increasing over time), imposed

Medicare Part B and Part D inflation rebates, and redesigned Part D to cap beneficiary out‑of‑pocket spending at

US$2,000 beginning in 2025.

In May 2025, President Trump issued an executive order implementing the concept of most-favored nation pricing.

Under this order, the Department of Health and Human Services, in coordination with other federal agencies, is directed

to take actions to ensure that the price of prescription drugs paid by federal health insurers, including Medicare and

Medicaid, is in line with the prices paid in comparably developed nations. It is unclear how this policy will impact our

business.

As an alternative to the Affordable Care Act, President Trump recently announced the Great Healthcare Plan. As

presented, the plan is intended to lower drug prices by increasing competition and benchmarking U.S. drug prices to

other countries, reduce insurance premiums by redirecting subsidies from insurers to individuals, increase accountability

and transparency from insurers, and promote consumer choice by giving individuals more direct control over how

healthcare dollars are spent. Legislative and regulatory action will be required to fully implement the plan. It is unclear

how these proposed changes will impact our business and the pharmaceutical industry in general.

These and other executive and legislative efforts may result in additional reductions in Medicare and other healthcare

funding and otherwise affect the prices we may obtain for any of our products or product candidates for which we may

obtain regulatory approval or the frequency with which any such product is prescribed or used. For example, on March

11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory cap on the Medicaid

drug rebate, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer

price.

In the European Union, on December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment ("HTA")

amending Directive 2011/24/EU, was adopted. While the Regulation entered into force in January 2022, it began to apply

from January 2025 onwards and will have a phased implementation depending on the concerned products. The

Regulation intends to boost cooperation among EU member states in assessing health technologies, including new

medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for

joint clinical assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and

procedures across the European Union, working together in four main areas, including joint clinical assessment of the

innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby

developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising

technologies early, and continuing voluntary cooperation in other areas. Individual EU member states will continue to be

responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions

on pricing and reimbursement.

We expect that these healthcare reforms, as well as other healthcare reform measures that may be adopted in the future,

may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria and new

payment methodologies that govern our Commercial Products or any product candidate, if approved, and/or the level of

reimbursement physicians receive for administering our Commercial Products or any other product candidate, if

approved, we might bring to market. Reductions in reimbursement levels may negatively impact the prices we receive or

the frequency with which our products are prescribed or administered. Any reduction in reimbursement from Medicare or

other government programs may result in a similar reduction in payments from private payors. Accordingly, such reforms,

if enacted, could have an adverse effect on anticipated revenue from our Commercial Products or from product

candidates for which we may obtain marketing approval and may affect our overall financial condition and ability to

develop or commercialize product candidates.

The insurance coverage and reimbursement status of newly approved products is uncertain. Our Commercial

Products and product candidates, if approved, may become subject to unfavorable pricing regulations, third-party

coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to

obtain or maintain coverage and adequate reimbursement for our Commercial Products or any product candidates

for which we obtain approval could limit our ability to market those products and decrease our ability to generate

revenue.

The regulations that govern marketing approvals, pricing, coverage, and reimbursement for new drugs and other medical

products vary widely from country to country. In the U.S., healthcare reform legislation may significantly change the

approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some

countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review

period begins after marketing or product licensing approval is granted. In some foreign markets, pricing remains subject

to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval

for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the

product, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of

the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in our Commercial

Products or product candidates, even if any product candidates we may develop obtain marketing approval.

Our ability to successfully commercialize our Commercial Products and product candidates, if approved, also will depend

in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be

available from government health administration authorities, private health insurers, and other organizations. Government

authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which

medications they will pay for and establish reimbursement levels. The availability of coverage and extent of

reimbursement by governmental and private payors is essential for most patients to be able to afford treatments. Sales

of our Commercial Products or product candidates, if approved, that we may identify will depend substantially, both

domestically and abroad, on the extent to which the costs of our Commercial Products and product candidates, if

approved, will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management

organizations, or reimbursed by government health administration authorities, private health coverage insurers and other

third-party payors. If coverage and adequate reimbursement is not available, or is available only to limited levels, we may

not be able to successfully commercialize our Commercial Products or product candidates, if approved. Even if coverage

is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing

sufficient to realize a sufficient return on our investment. A primary trend in the U.S. healthcare industry and elsewhere is

cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage

and the amount of reimbursement for particular medications. In many countries, the prices of medical products are

subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under

such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for

medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing

regulation could restrict the amount that we are able to charge for our products and product candidates. Accordingly, in

markets outside the U.S., the reimbursement for products may be reduced compared with the U.S. and may be

insufficient to generate commercially reasonable revenues and profits.

There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products

and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable

foreign regulatory authorities. In the U.S., the principal decisions about reimbursement for new medicines are typically

made by CMS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare

and private payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for

products exists among third-party payors and coverage and reimbursement levels for products can differ significantly

from payer to payer. As a result, the coverage determination process is often a time consuming and costly process that

may require us to provide scientific and clinical support for the use of our products to each payer separately, with no

assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. It is

difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours,

as there is no body of established practices and precedents for these new products.

Reimbursement agencies in Europe may be more conservative than CMS. For example, a number of cancer drugs have

been approved for reimbursement in the U.S. and have not been approved for reimbursement in certain European

countries. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that

covers our costs, including research, development, manufacture, sale, and distribution. Interim reimbursement levels for

new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based

on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other

services. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and

private payors for our Commercial Products or any approved products we may develop could have a material adverse

effect on our operating results, our ability to raise capital needed to commercialize product candidates, if approved, and

our overall financial condition. Further, the number of uninsured individuals in the U.S. may increase, which may

adversely affect our ability to commercialize our Commercial Products or any product candidates for which we receive

marketing authorization, In the U.S., we have various programs to help patients afford our Commercial Products,

including patient assistance programs and co-pay coupon programs for eligible patients.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or

private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they

may be sold at lower prices than in the U.S. Our inability to promptly obtain coverage and profitable reimbursement rates

from third-party payors for our Commercial Products any product candidates that we develop and for which we obtain

marketing authorization could have a material adverse effect on our operating results, our ability to raise capital needed

to commercialize products and our overall financial condition.

Increasingly, third-party payors are requiring that pharmaceutical companies provide them with predetermined discounts

from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will

be available for any product candidate for which we receive marketing authorization and that we commercialize and, if

reimbursement is available, the level of reimbursement. Reimbursement may impact the demand for, or the price of, any

product or product candidate for which we obtain marketing approval. In order to obtain reimbursement, physicians may

need to show that patients have superior treatment outcomes with our products compared to standard-of-care drugs,

including lower-priced generic versions of standard-of-care drugs. We expect to experience pricing pressures in

connection with the sale of our Commercial Products and our product candidates, if approved, due to the trend toward

managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.

The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other

treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new

products. Additionally, we may develop companion diagnostic tests for use with our therapeutic product candidates. We

may be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and

reimbursement we seek for our product candidates, once approved. Even if we obtain regulatory approval or clearance

for such companion diagnostics, there is significant uncertainty regarding our ability to obtain coverage and adequate

reimbursement for the same reasons applicable to our product candidates. Medicare reimbursement methodologies,

whether under Part A, Part B, or clinical laboratory fee schedule may be amended from time to time, and we cannot

predict what effect any change to these methodologies would have on any product candidate or companion diagnostic

for which we receive approval.

The prices of prescription pharmaceuticals in the

U.S.

and foreign jurisdictions are subject to considerable legislative

and executive actions and could impact the prices we obtain for our products, if and when approved.

The prices of prescription pharmaceuticals have also been the subject of considerable discussion in the U.S.. There have

been several recent U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed

to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and

manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.

In October 2020, HHS and the FDA published a final rule allowing states and other entities to develop a Section 804

Importation Program ("SIP") to import certain prescription drugs from Canada into the U.S. Section 804 of the FDCA

allows importation of prescription drugs from Canada to significantly reduce the cost of these drugs to the American

consumer without imposing additional risk to public health and safety. Importation program proposals must be submitted

to FDA for review and authorization. Several states have passed laws allowing for the importation of drugs from Canada.

Several states have passed legislation establishing workgroups to examine the impact of a state importation program. In

May 2025, FDA announced that it will offer individual states the opportunity to submit draft proposals for pre-review and

obtain initial feedback from FDA prior to formally submitting their program proposal. States will have an opportunity to

meet with FDA with the goal of reducing the burden on the states and to help them develop robust proposals. FDA is also

working to assist states with options to streamline the required cost savings analysis, and to provide input regarding the

information the states may rely on to estimate cost savings for American consumers.

Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from

pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers,

unless the price reduction is required by law. The final rule would also eliminate the current safe harbor for Medicare

drug rebates and create new safe harbors for beneficiary point-of-sale discounts and pharmacy benefit manager service

fees. It was originally set to go into effect on January 1, 2022, but with passage of the IRA, has been delayed by

Congress to January 1, 2032.

On August 16, 2022, the IRA was enacted. The new legislation has implications for Medicare Part D, which is a program

available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of

paying a monthly premium for outpatient prescription drug coverage. Among other things, the IRA requires

manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be

negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that

outpace inflation (which began in 2023); and replaces the Part D coverage gap discount program with a new discounting

program (which began in 2025). The IRA permits the Secretary of the HHS to implement many of these provisions

through guidance, as opposed to regulation, for the initial years.

Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly

single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under

Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in

2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and

beyond. This provision applies to drug products that have been approved for at least nine years and biologics that have

been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare disease

or condition. Further, the legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for

failing to comply with the legislation. The legislation also requires manufacturers to pay rebates for drugs in Medicare

Part D whose price increases exceed inflation. The law also capped Medicare out-of-pocket drug costs at approximately

US$4,000 a year in 2024 and, thereafter beginning in 2025, at US$2,000 a year (indexed for inflation in subsequent

years).

The first cycle of negotiations for the Medicare Drug Price Negotiation Program commenced in the summer of 2023. On

August 15, 2024, the HHS published the negotiated "maximum fair prices" for ten selected Part D drugs that treat a range

of conditions, including diabetes, chronic kidney disease, and rheumatoid arthritis. The prices of these ten drugs became

effective January 1, 2026. On January 17, 2025, CMS announced its selection of 15 additional drugs covered by Part D

for the second cycle of negotiations. The negotiated prices for this second group of drugs will be effective on January 1,

While there had been some questions about the Trump Administration’s position on this program, on September

30, 2025, CMS issued final guidance for the third negotiation cycle. On January 27, 2026, CMS announced its selection

of 15 additional drugs (covered under either Part B or Part D) for the third cycle of negotiations. The negotiated prices for

this third group will be effective on January 1, 2028. CMS also selected one previously negotiated drug for the program’s

first renegotiations.

On June 6, 2023, Merck & Co. filed a lawsuit against the HHS and CMS asserting that, among other things, the IRA’s Drug

Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the

Constitution. Subsequently, a number of other parties, also filed lawsuits in various courts with similar constitutional

claims against the HHS and CMS. As of October 2025, Merck’s action is pending motions for summary judgment, and the

other lawsuits have been largely unsuccessful for plaintiffs. Multiple federal district courts have granted summary

judgment in favor of the HHS, and several of these decisions have been affirmed by federal appellate courts. For

example, in 2025, the U.S. Court of Appeals for the Third Circuit rejected appeals from several manufacturers, including

AstraZeneca and Novartis, upholding the program’s constitutionality. The Second and Sixth Circuits have also affirmed

dismissals of similar challenges. In September 2025, AstraZeneca filed a petition for writ of certiorari, asking the U.S.

Supreme Court to review the Third Circuit’s decision. Accordingly, while the IRA is actively being implemented, the

pending appeal to the Supreme Court creates uncertainty regarding the program’s ultimate legal status. We cannot

predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose

new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any

of which could adversely affect our business, results of operations and financial condition.

In May 2025, President Trump issued an executive order implementing the concept of most-favored nation pricing.

Under this order, the Department of Health and Human Services, in coordination with other federal agencies, is directed

to take actions to ensure that the price of prescription drugs paid by federal health insurers, including Medicare and

Medicaid, is in line with the prices paid in comparably developed nations. It is unclear how this policy will impact our

business.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations

designed to control pharmaceutical and biological 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. This is increasingly true with

respect to products approved pursuant to the accelerated approval pathway. State Medicaid programs and other payers

are developing strategies and implementing significant coverage barriers, or refusing to cover these products outright,

arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for

accelerated approval. In addition, regional healthcare organizations 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 Commercial Products

and our product candidates, if approved, or put pressure on our product pricing. We expect that additional state and

federal 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 reduced demand for our

Commercial Products or our product candidates, if approved, or additional pricing pressures.

Finally, outside of the U.S., in some countries, including those of the European Union, the pricing of prescription

pharmaceuticals is subject to governmental control and access. In these countries, official list price country pricing

negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a

product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial

that compares the cost-effectiveness of our product to other available therapies.

These measures, as well as others adopted in the future, may result in additional downward pressure on the price that

we receive for our Commercial Products or any of our product candidates, if approved. Accordingly, such reforms, if

enacted, could have an adverse effect on anticipated revenue from our Commercial Products or from product candidates

that we may successfully develop and for which we, or they, may obtain marketing approval and may affect our overall

financial condition and ability to develop or commercialize product candidates.

Our relationships with radiopharmacies, healthcare providers, physicians and third-party payors will be 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.

Healthcare professionals, including but not limited to physicians, nurses, medical directors, hospitals, pharmacies,

pharmacy benefit managers, group purchasing organizations, wholesalers, insurers, and all individuals employed by such

entities, which we refer to collectively as HCPs, may influence the recommendation and prescription of our Commercial

Products or any of our product candidates, if approved. Our arrangements with HCPs and others who have the ability to

improperly influence the recommendation and prescription of our Commercial Products or any of our product candidates,

if approved may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may

constrain the business or financial arrangements and relationships through which we market, sell and distribute our

Commercial Products or any of our product candidates, if approved. Restrictions under applicable federal, state and

foreign healthcare laws and regulations include the following:

•the federal healthcare Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward

either the referral of an individual for, or the purchase, order, arranging for or recommendation of, any good or

service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. A

person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to

violate it in order to have committed a violation;

•the FCA imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or

entities for knowingly presenting or causing to be presented, to the federal government, claims for payment or

approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false

statement to avoid, decrease or conceal an obligation to pay money to the federal government, with potential

liability including mandatory treble damages and significant per-claim penalties. In addition, the government may

assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute

constitutes a false or fraudulent claim for purposes of the FCA;

•the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which, in addition to privacy

protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any

healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-

Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to

violate it in order to have committed a violation;

•the federal transparency requirements under the federal Physician Payment Sunshine Act, which requires

manufacturers of drugs, devices, biologics and medical supplies to report to the HHS, information related to

payments and other transfers of value to physicians (as defined by statute), other healthcare providers and

teaching hospitals and ownership and investment interests held by physicians and their immediate family members

and applicable group purchasing organizations;

•analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may

apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-

governmental third-party payors, including private insurers, and certain state laws that 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 physicians and other healthcare providers or marketing expenditures; and

•international, federal or state laws, regulations, or rules that oversee the compounding, administration or

distribution of radiopharmaceutical products by licensed pharmacists.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is

possible that some of our business activities could be subject to challenge under one or more of such laws. If our

operations are found to be in violation of any of the laws described above or any other government regulations that apply

to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation

in government healthcare programs, such as Medicare and Medicaid, imprisonment and the curtailment or restructuring

of our operations, any of which could adversely affect our business, financial condition, results of operations and

prospects.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and

regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business

practices, including certain advisory agreements we have entered into with physicians who are paid, in part, in the form

of shares or share options, may not comply with current or future statutes, regulations or case law involving applicable

fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these

laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and

administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and

Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities

with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to

criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Liabilities

they incur pursuant to these laws could result in significant costs or an interruption in operations, which could have a

material adverse effect on our business, financial condition, results of operations and prospects.

Our reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental drug

pricing programs are complex and may involve subjective decisions. Any failure to comply with those obligations

could subject us to penalties and sanctions.

As a condition of reimbursement by various federal and state health insurance programs, we are required to calculate

and report certain pricing information to federal and state agencies. The regulations governing the calculations, price

reporting and payment obligations are complex and subject to interpretation by various government and regulatory

agencies, as well as the courts. Reasonable assumptions have been made where there is lack of regulations or clear

guidance and such assumptions involve subjective decisions and estimates. We are required to report any revisions to

our calculation, price reporting and payment obligations previously reported or paid. Such revisions could affect our

liability to federal and state payors and also adversely impact our reported financial results of operations in the period of

such restatement. Further, a number of states have either implemented or are considering implementation of drug price

transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies.

Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and

factors considered in taking such increases, wholesale acquisition cost information disclosure to prescribers, purchasers,

and state agencies, and new product notice and reporting. Such legislation could limit the price or payment for certain

drugs, and a number of states are authorized to impose civil monetary penalties or pursue other enforcement

mechanisms against manufacturers for the untimely, inaccurate, or incomplete reporting of drug pricing information or for

otherwise failing to comply with drug price transparency requirements. If we are found to have violated state law

requirements, we may become subject to significant penalties or other enforcement mechanisms, which could have a

material adverse effect on our business.

Uncertainty exists as new laws, regulations, judicial decisions, or new interpretations of existing laws, or regulations

related to our calculations, price reporting or payments obligations increases the chances of a legal challenge,

restatement or investigation. If we become subject to investigations, restatements, or other inquiries concerning our

compliance with price reporting laws and regulations, we could be required to pay or be subject to additional

reimbursements, penalties, sanctions or fines, which could have a material adverse effect on our business, financial

condition and results of operations. In addition, it is possible that future healthcare reform measures could be adopted,

which could result in increased pressure on pricing and reimbursement of our Commercial Products and any of our

product candidates, if approved, and thus have an adverse impact on our financial position or business operations.

Further, state Medicaid programs may be slow to invoice pharmaceutical companies for calculated rebates resulting in a

lag between the time a sale is recorded and the time the rebate is paid. This results in us having to carry a liability on our

consolidated balance sheets for the estimate of rebate claims expected for Medicaid patients. If actual claims are higher

than current estimates, our financial position and results of operations could be adversely affected.

In addition to retroactive rebates and the potential for 340B Program refunds, if we are found to have knowingly

submitted any false price information related to the Medicaid Drug Rebate Program to CMS, we may be liable for civil

monetary penalties. Such failure could also be grounds for CMS to terminate our Medicaid drug rebate agreement,

pursuant to which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement,

federal payments may not be available under government programs, including Medicaid or Medicare Part B, for our

covered outpatient drugs.

Additionally, if we overcharge the government in connection with the Federal Supply Schedule pricing program or Tricare

Retail Pharmacy Program, whether due to a misstated Federal Ceiling Price or otherwise, we are required to refund the

difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in

allegations against us under the FCA and other laws and regulations. Unexpected refunds to the government, and

responding to a government investigation or enforcement action, would be expensive and time-consuming, and could

have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Our collaborators are also subject to similar requirements outside of the U.S. and thus the attendant risks and

uncertainties. If our collaborators suffer material and adverse effects from such risks and uncertainties, our rights and

benefits for our licensed products could be negatively impacted, which could have a material and adverse impact on our

revenues.

We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations

related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and

failure to comply with such requirements could subject us to significant fines and penalties, which may have a

material adverse effect on our business, financial condition or results of operations.

We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and

use of personal information, which among other things, impose certain requirements relating to the privacy, security and

transmission of personal information, including comprehensive regulatory systems in the U.S., European Union, United

Kingdom, Australia, and other countries in which we may conduct business. The legislative and regulatory landscape for

privacy and data protection continues to evolve in jurisdictions worldwide, and there has been an increasing focus on

privacy and data protection issues with the potential to affect our business. Failure to comply with any of these laws and

regulations could result in enforcement action against us, including fines, imprisonment of company officials and public

censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could

have a material adverse effect on our business, financial condition, results of operations or prospects.

There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal

information. In particular, regulations promulgated pursuant to HIPAA, establish privacy and security standards that limit

the use and disclosure of protected health information and require the implementation of administrative, physical and

technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity

and availability of electronic protected health information. Determining whether protected health information has been

handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be

subject to changing interpretation.

If we fail to comply with applicable privacy laws, including applicable HIPAA privacy and security standards, we could

face civil and criminal penalties. HHS enforcement activity can result in financial liability and reputational harm, and

responses to such enforcement activity can consume significant internal resources. HHS's Office for Civil Rights ("OCR")

has been especially active in investigating and enforcing actual or alleged non-compliance with the HIPAA rules. In

addition, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response

to violations that threaten the privacy of state residents. Some new state laws, such as the state of Washington's My

Health My Data Act, include a private right of action. We cannot be sure how these regulations will be interpreted,

enforced or applied to our operations. In addition to the risks associated with enforcement activities and potential

contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may

be costly and require ongoing modifications to our policies, procedures and systems.

In addition to potential enforcement by the HHS, we could also be potentially subject to privacy enforcement from the

FTC. The FTC has been particularly focused on the unpermitted processing of health and genetic data through its recent

enforcement actions and is expanding the types of privacy violations that it interprets to be “unfair” under Section 5 of

the FTC Act, as well as the types of activities it views to trigger the Health Breach Notification Rule (which the FTC also

has the authority to enforce). The agency is also in the process of developing rules related to commercial surveillance

and data security. We will need to account for the FTC’s evolving rules and guidance for proper privacy and data security

practices in order to mitigate risk for a potential enforcement action, which may be costly. Finally, both the FTC and

HHS’s enforcement priorities (as well as those of other federal regulators) may be impacted by the change in

administration and new leadership. These shifts in enforcement priorities may also impact our business.

There are also increased restrictions at the federal level relating to transferring sensitive data outside of the U.S. to

certain foreign countries. The Protecting Americans’ Data from Foreign Adversaries Act of 2024. This law creates certain

restrictions for entities that disclose sensitive data (including potential health data) to countries such as China. Failure to

comply with these rules can lead to a potential FTC enforcement action. Additionally, the Department of Justice recently

finalized a rule which creates similar restrictions related to the transfer of sensitive U.S. data to countries such as China.

These data transfer restrictions (and others that may pass in the future) may create operational challenges and legal

risks for our business.

States are also active in creating specific rules relating to the processing of personal information. In 2018, California

passed into law the California Consumer Privacy Act ("CCPA"), which took effect on January 1, 2020 and imposed many

requirements on businesses that process the personal information of California residents. Many of the CCPA’s

requirements are similar to those found in the European Union's General Data Protection Regulation ("GDPR"), which is

further described below, including requiring businesses to provide notice to data subjects regarding the information

collected about them and how such information is used and shared, including use in marketing, and providing data

subjects the right to request access to such personal information and, in certain cases, request the erasure of such

personal information. The CCPA also affords California residents the right to opt-out of “sales” of "sharing" of their

personal information under certain circumstances. The CCPA contains significant penalties for companies that violate its

requirements.

In November 2020, California voters passed a ballot initiative for the California Privacy Rights Act ("CPRA"), which went

into effect on January 1, 2023 and significantly expanded the CCPA to incorporate additional GDPR-like provisions

including requiring that the use, retention and sharing of personal information of California residents be reasonably

necessary and proportionate to the purposes of collection or processing, granting additional protections for sensitive

personal information, and requiring greater disclosures related to notice to residents regarding retention of information.

The CPRA also created a new enforcement agency – the California Privacy Protection Agency or CPPA – the sole

responsibility of which is to enforce the CPRA and other California privacy laws, which will further increase compliance

risk. The CCPA also has rulemaking authority under the CCRA with recent regulations finalized for, among other things,

cybersecurity audits, risk assessment, and use of automated decision-making technologies. The provisions in the CPRA

may apply to some of our business activities. In addition to California, at least 19 other states have passed

comprehensive privacy laws. These laws may impact our business activities if and to the extent applicable to our

business, including our identification of research subjects, relationships with business partners, and ultimately the

marketing and distribution of our Commercial Products and our product candidates, if approved.

Plaintiffs’ lawyers are also increasingly using privacy-related statutes at both the state and federal level to bring lawsuits

against companies for their data-related practices. In particular, there have been a significant number of cases filed

against companies for their use of pixels and other tracking technologies, chatbots, and session replay technologies.

These cases often allege violations of the California Invasion of Privacy Act and other state laws regulating wiretapping,

as well as the federal Video Privacy Protection Act and Electronic Communications Protection Act. The rise in these types

of lawsuits creates potential risk for our business. Additionally, privacy breach class actions under various U.S. state laws

remain highly active which could result in potential litigation exposure in the event that we experience a privacy breach.

Similar to the laws in the U.S., there are significant privacy and data security laws that apply in Europe, the United

Kingdom, and other countries. The collection, use, disclosure, transfer, or other processing of personal data, including

personal health data, regarding individuals who are located in the EEA, and the processing of personal data that takes

place in the EEA, is regulated by the GDPR, which went into effect in May 2018 and which imposes obligations on

companies that operate in our industry with respect to the processing of personal data and the cross-border transfer of

such data. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a

record of their data processing and policies. If our or our partners’ or service providers’ privacy or data security measures

fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement

notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 4% of the

total worldwide annual turnover of the group of companies of the preceding financial year, whichever is higher, as well as

compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and

goodwill.

Certain privacy and data protection laws, including the GDPR, restrict the cross-border transfer of personal data from the

original jurisdiction to countries that have not been found to offer "adequate protection" for personal data. Privacy

advocates have successfully challenged prior compliance mechanisms, such as the EU-U.S. Privacy Shield, prompting

ongoing concerns about the ability of companies to transfer personal data from the European Union to other countries.

In October 2022, President Biden signed an executive order to implement the EU-U.S. Data Privacy Framework, which

serves as a replacement to the EU-U.S. Privacy Shield. An adequacy decision, adopted by the European Commission on

July 10, 2023 permits U.S. companies who self-certify to the EU-U.S. Data Privacy Framework to rely on it as a valid data

transfer mechanism for data transfers from the European Union to the U.S. To date, the EU-U.S. Data Privacy Framework

has withstood challenges from privacy advocates, including in a September 2025 decision by the European General

Court upholding the validity of the European Commission's 2023 adequacy decision in Latombe v. Commission. However,

if any subsequent challenges are successful, they may not only impact the EU-U.S. Data Privacy Framework, but also

further limit the viability of the standard contractual clauses and other data transfer mechanisms. The uncertainty around

this issue has the potential to impact our business. Following the withdrawal of the United Kingdom from the European

Union, the United Kingdom Data Protection Act 2018 ("UK Data Protection Act") applies to the processing of personal

data that takes place in the United Kingdom and includes parallel obligations to those set forth by GDPR. In relation to

data transfers, both the United Kingdom and the European Union have determined, through separate “adequacy”

decisions, that data transfers between the two jurisdictions are in compliance with the UK Data Protection Act and the

GDPR, respectively. The United Kingdom and the U.S. have also agreed to a U.S.-UK “Data Bridge”, which functions

similarly to the EU-U.S. Data Privacy Framework and provides an additional legal mechanism for companies to transfer

data from the United Kingdom to the U.S.

Switzerland has also approved an adequacy decision in relation to the Swiss-U.S. Data Privacy Framework (which

functions similarly to the EU-U.S. Data Privacy Framework and the U.S.-UK Data Bridge in relation to data transfers from

Switzerland to the U.S.). Any changes or updates to these developments have the potential to impact our business.

Beyond GDPR, there are privacy and data security laws in a growing number of countries around the world. While many

loosely follow GDPR as a model, other laws contain different or conflicting provisions. These laws will impact our ability to

conduct our business activities, including both our clinical trials and the sale and distribution of Commercial Products,

through increased compliance costs, costs associated with contracting and potential enforcement actions.

In Australia, we are subject to the Privacy Act 1988 (Cth) and the Australian Privacy Principles ("APPs"), which regulate

the collection, use, disclosure, storage and security of personal information, including health information, which is treated

as sensitive information subject to heightened protections. The Privacy Legislation Amendment (Enforcement and Other

Measures) Act 2022 significantly increased maximum penalties for serious or repeated interferences with privacy to the

greater of A$50 million, three times the value of any benefit obtained from the breach, or 30% of adjusted turnover in the

relevant period. We are also subject to the Notifiable Data Breaches scheme, which requires entities to notify affected

individuals and the Office of the Australian Information Commissioner ("OAIC"), of eligible data breaches that are likely to

result in serious harm. The Australian government has signaled further reforms to privacy legislation, including proposals

to strengthen individual rights, expand the definition of personal information, and introduce a statutory tort for serious

invasions of privacy. If enacted, such reforms could impose additional compliance obligations and increase our exposure

to regulatory enforcement and private claims. Failure to comply with Australian privacy requirements could result in

significant penalties, reputational harm, regulatory investigations and remedial orders, any of which could have a material

adverse effect on our business, financial condition or results of operations.

While we continue to address the implications of the recent changes to data privacy regulations, data privacy remains an

evolving landscape at both the domestic and international level, with new regulations coming into effect and continued

legal challenges, and our efforts to comply with the evolving data protection rules may be unsuccessful. It is possible

that these laws may be interpreted and applied in a manner that is inconsistent with our practices. We must devote

significant resources to understanding and complying with this changing landscape. Failure to comply with laws

regarding data protection would expose us to risk of enforcement actions taken by data protection authorities in the EEA

and Australia and elsewhere and carries with it the potential for significant penalties if we are found to be non-compliant.

Similarly, failure to comply with federal and state laws in the U.S. regarding privacy and security of personal information

could expose us to penalties under such laws. Any such failure to comply with data protection and privacy laws could

result in government-imposed fines or orders requiring that we change our practices, claims for damages or other

liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which

could adversely affect our business. Even if we are not determined to have violated these laws, government

investigations into these issues typically require the expenditure of significant resources and generate negative publicity,

which could harm our business, financial condition, results of operations or prospects.

If we fail to comply with environmental, health and safety laws and regulations, including those governing

radiopharmaceutical products and radioactive materials, we could become subject to fines or penalties or incur costs

that could have a material adverse effect on our business.

We are subject to numerous environmental, health and safety laws and radiation safety regulations, including those

governing laboratory procedures and the handling, use, storage, treatment, transportation and disposal of hazardous

materials and wastes. Our operations involve the use, storage, treatment, and transportation of hazardous and flammable

materials, including chemicals and biological and radioactive materials. While most of the activities are conducted by

third-party partners on our behalf or by pharmacists or healthcare professionals consistent with their own professional

obligations on their own behalf, our operations also produce hazardous waste products and allow the decay of

radioactive material (where legally allowed) on site prior to disposal as non-radioactive waste. We generally contract with

third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from

these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held

liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs

associated with civil or criminal fines and penalties.

Transportation of radioactive, biological, and/or hazardous materials is highly regulated by each governmental

jurisdiction we operate in. Additionally, the physical transportation of these materials puts us at risk of vehicular

accidents which could result in the loss of control of these materials and potential environmental and human health risks

and related regulatory actions against us.

Our use of facilities that use and produce radioactive materials subjects us to compliance with D&D requirements when

we close those facilities, exposing us to potentially significant costs. Our product candidates are manufactured using

radioactive components. When a cyclotron reaches the end of its useful life at one of our facilities or if we need to

abandon such facility for any other reason, we are obligated under the laws and regulatory rules of the various

jurisdictions in which we operate to decommission and decontaminate such facility or cyclotron. Estimating the amount

and timing of such future D&D costs includes, among other factors, country-specific requirements and projections as to

when a facility will retire or the useful life of a cyclotron. If we do not conduct D&D properly at any of our sites, we may

suffer significant additional costs to remediate any D&D deficiencies, fines, regulatory or criminal charges or other

sanction or legal action, any of which could have a material adverse effect upon our business, financial condition and

results of operations. Although we have estimated our future D&D costs and recorded a liability for such costs, there can

be no assurances that we will not incur material D&D costs beyond such estimates or our provisions.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries

to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage

against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be

asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety

laws and regulations. These current or future laws and regulations may impair our research, development or

commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties

or other sanctions.

The use of hazardous materials, including radioactive and biological materials, in our research and development

efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or

misuse of these materials.

Our research, development and manufacturing activities involve the controlled use of hazardous materials, including

chemicals, radioactive and biological materials, such as radioisotopes. We and our third-party manufacturers are subject

to federal, state, local and foreign environmental laws and regulations governing, among other matters, the handling,

storage, use, transportation and disposal of these materials and some waste products.

Our use of chemicals in the manufacturing process for our Commercial Product and product candidates is also subject to

chemicals approvals, registrations and regulations around the world, including a regulation in the European Union known

as Registration, Evaluation, Authorization and Restriction of Chemicals, and similar laws and regulations in certain other

jurisdictions in which we operate. In addition, we are required to obtain and maintain a hazardous materials license,

pursuant to which we are required to perform annual self-audits, and that may result in random inspections by regulators.

If such audit or inspection were to result in adverse findings, it may impact our ability to maintain our license, which

would in turn adversely affect our ability to conduct our business.

Additionally, we cannot completely eliminate the risk of contamination or injury from these materials, and we could be

held liable for any damages that result, which could exceed our financial resources. We currently maintain insurance

coverage for injuries resulting from the hazardous materials we use; however, future claims may exceed the amount of

our coverage. Also, we do not have insurance coverage for pollution cleanup and removal. Currently the costs of

complying with such federal, state, local and foreign environmental regulations are not significant, and consist primarily

of waste disposal expenses. However, they could become expensive, and current or future environmental laws or

regulations may impair our research, development, production and commercialization efforts.

Although we intend to validate that any third-party manufacturers’ procedures for using, handling, storing and disposing

of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or

injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability

or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In

the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our

resources. Comparable restrictions and related risks regarding the use of potentially hazardous substances are also

applicable outside the U.S. Compliance with applicable environmental laws and regulations is expensive, and current or

future environmental regulations may impair our research, development and production efforts, which could harm our

business, financial condition, results of operations and prospects.

Laws and regulations governing international operations may preclude us from developing, manufacturing and

selling certain products outside of the

U.S.

and require us to develop and implement costly compliance programs.

We are subject to numerous laws and regulations in each jurisdiction outside of the U.S. in which we operate. The

creation, implementation and maintenance of international business practices compliance programs is costly and such

programs are difficult to enforce, particularly where reliance on third parties is required.

The U.S. Foreign Corrupt Practices Act ("FCPA") prohibits any U.S. individual or business from paying, offering,

authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or

candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or

business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to

comply with certain accounting provisions requiring us to maintain books and records that accurately and fairly reflect all

transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of

internal accounting controls. The FCPA is enforced by the DOJ and the SEC.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem.

In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries,

hospitals, clinics, universities and similar institutions are operated by the government, and doctors and other healthcare

professionals are considered foreign officials. Certain payments to healthcare professionals in connection with clinical

trials, regulatory approvals, sales and marketing, and other work have been deemed to be improper payments to

government officials and have led to FCPA enforcement actions. Because the FCPA applies to indirect payments, the use

of third parties and other collaborators can increase potential FCPA risk, as we could be held liable for the acts of third

parties that do not comply with the FCPA’s requirements.

The failure to comply with laws governing international business practices may result in substantial penalties, including

suspension or debarment from government contracting. Violation of the FCPA can result in significant civil and criminal

penalties. Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. government

until the pending claims are resolved. Conviction of a violation of the FCPA can result in long-term disqualification as a

government contractor. The termination of a government contract or relationship as a result of our failure to satisfy any

of our obligations under laws governing international business practices would have a negative impact on our operations

and harm our reputation and ability to procure government contracts. The SEC also may suspend or bar issuers from

trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

Like the FCPA, the Australian Criminal Code, the U.K. Bribery Act and other anti-corruption laws throughout the world

similarly prohibit offers and payments made to obtain improper business advantages, including offers or payments to

healthcare professionals and other government and non-government officials. These other anti-corruption laws also can

result in substantial financial penalties and other collateral consequences.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the U.S., or the sharing

with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and

technical data relating to those products. Our expansion outside of the U.S., has required, and will continue to require, us

to dedicate additional resources to comply with these laws, and these laws may preclude us from developing,

manufacturing, or selling certain drugs and product candidates, if approved, outside of the U.S., which could limit our

growth potential and increase our development costs.

Changes in U.S. and international trade policies may adversely impact our business and operating results.

The U.S. government has made statements and taken certain actions that have led to significant changes to U.S. and

international trade policies, including imposing several rounds of tariffs and export control restrictions affecting products

manufactured in certain foreign jurisdictions. Although trade policies continue to evolve, there is ongoing uncertainty as

to whether there will be further changes. It is unknown whether and to what extent new tariffs, export controls, or other

new laws or regulations will be adopted, or the effect that any such actions would have on us or our industry.

Further, some of our manufacturers and suppliers are located outside the United States, including in China. We are

exposed to the possibility of product supply disruption and increased costs and expenses in the event of changes to the

laws, rules, regulations and policies of the governments of countries in which we or our suppliers operate. Certain foreign

biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements or

legislation by the U.S. government, which could restrict or even prohibit our ability to work with such entities, thereby

potentially disrupting their supply of material to us. Such disruptions could have adverse effects on the development of

our product candidates and our business operations.

For example, the pharmaceutical industry generally, and in some instances our Company or our collaborators or other

third parties on which we rely, depend on China-based suppliers or service providers for certain raw materials, products

and services, or other activities. Our ability or the ability of our collaborators or such other third parties to continue to

engage these China-based suppliers or service providers for certain preclinical research programs and clinical

development programs could be restricted due to geopolitical developments between the U.S. and China, including as a

result of the escalation of tariffs or other trade restrictions or the recently enacted BIOSECURE Act. In any such

circumstances, we may not be able to engage a backup or alternative supplier or service provider in a timely manner or

at all. This, in turn, could materially and adversely affect our or our collaborators' ability to manufacture or supply

marketed products and product candidates or advance our or our collaborators' preclinical research or clinical

development programs, which could materially and adversely affect our business and future prospects.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may

increase the cost of manufacturing our Commercial Products and product candidates and platform materials, affect the

demand for our Commercial Products and product candidates, if approved, the competitive position of our Commercial

Products and product candidates, if approved, and import or export of raw materials and finished Commercial Products

and product candidates used in our and our collaborators’ preclinical studies and clinical trials, particularly with respect

to any materials that we import from China. If any new tariffs, export controls, legislation and/or regulations are

implemented, or if existing trade agreements are renegotiated or, in particular, if either the U.S. or Chinese government

takes retaliatory trade actions due to the recent trade tension, such changes could have an adverse effect on our

business, financial condition and results of operations.

With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may

claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-

based terms for testing in support of their abbreviated new drug applications ("ANDAs"), 505(b)(2) NDAs and

biosimilar product applications.

In December 2019, President Trump signed legislation intended to facilitate the development of generic and biosimilar

products. The bill, previously known as the CREATES Act, authorizes sponsors of ANDAs, 505(b)(2) NDAs, or biosimilar

product applications to file lawsuits against companies holding NDAs or BLAs that decline to provide sufficient quantities

of an approved reference drug or biological product on commercially reasonable, market-based terms. Drug or biological

products on FDA’s drug shortage list are exempt from these new provisions unless the product has been on the list for

more than six continuous months or the FDA determines that the supply of the product will help alleviate or prevent a

shortage.

To bring an action under the statute, the developer of a product candidate that seeks to develop the product and seek

approval under an ANDA, 505(b)(2) NDA, or biosimilar product application must take certain steps to request the

reference product from the reference product manufacturer, which, in the case of products covered by a REMS with

elements to assure safe use, include obtaining authorization from the FDA for the acquisition of the reference product. If

the reference product manufacturer does not provide the reference product and the ANDA, 505(b)(2) NDA, or biosimilar

product sponsor does bring an action for failure to provide a reference product, there are certain affirmative defenses

available to the reference product manufacturer, which must be shown by a preponderance of evidence, including that

the NDA or BLA holder sells the reference product through agents, distributors, or wholesalers and has placed no

restrictions, explicit or implicit, on selling the reference product to ANDA, 505(b)(2) or biosimilar sponsors. If the sponsor

prevails in litigation, it is entitled to a court order directing the reference product manufacturer to provide, without delay,

sufficient quantities of the applicable product on commercially reasonable, market-based terms, plus reasonable

attorney fees and costs.

Additionally, the new statutory provisions authorize a federal court to award the product developer an amount “sufficient

to deter” the reference product manufacturer from refusing to provide sufficient product quantities on commercially

reasonable, market-based terms, up to a certain maximum amount based on revenue earned while in noncompliance, if

the court finds, by a preponderance of the evidence, that the reference product manufacturer did not have a legitimate

business justification to delay providing the product or failed to comply with the court’s order. For the purposes of the

statute, the term “commercially reasonable, market-based terms” is defined as (i) the nondiscriminatory price at or below

the most recent wholesale acquisition cost for the product, (ii) a delivery schedule that meets the statutorily defined

timetable, and (iii) no additional conditions on the sale.

Although we intend to comply fully with the terms of these statutory provisions, we are still exposed to potential litigation

and damages by competitors who may claim that we are not providing sufficient quantities of our Commercial Products

on commercially reasonable, market-based terms for testing in support of ANDAs, 505(b)(2) NDA applications or

biosimilar product applications. Such litigation would subject us to additional litigation costs, damages and reputational

harm, which could lead to lower revenues. The CREATES Act may facilitate future competition with our Commercial

Products and any of our product candidates, if approved, which could impact our ability to maximize product revenue.

We are required to comply with governmental economic and trade sanctions and export and import controls that

could impair our or our collaborators’ ability to compete in international markets due to licensing requirements and

subject us or them to liability if we or they are not in compliance with applicable laws.

Our Commercial Products and product candidates are subject to international, national and state export control and

import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, and we are

required to comply with these laws as well as various economic and trade sanctions, including those administered by the

U.S. Treasury Department’s Office of Foreign Assets Controls. These laws and regulations restrict our ability to transact

or deal with certain countries, regions, governments, persons and entities. Our activities, including our procurement of

materials and exports of our Commercial Products and product candidates, must be in compliance with these laws and

regulations. While we have policies and procedures designed to ensure that we maintain compliance with these laws and

regulations, there is a risk that our employees, agents, or business partners may take actions in violation of our policies

and applicable law, for which we may be ultimately held responsible.

If we fail to comply with these laws and regulations, we and certain of our employees could be subject to substantial civil

or criminal penalties, including the possible loss of export or import privileges; fines, which may be imposed on us or our

collaborators and the respective responsible employees or managers; and, in extreme cases, the incarceration of

responsible employees or managers. Investigations of alleged violations can be expensive and disruptive, and such

violation (or allegation of a violation) could materially adversely affect our reputation, business, financial condition and

results of operations.

In addition, changes in our Commercial Products or changes in applicable export or import laws and regulations may

create delays in the introduction, provision, or sale of our Commercial Products in international markets, prevent

customers from using our Commercial Products or, in some cases, prevent the export or import of our Commercial

Products to certain countries, governments or persons altogether. Any limitation on our ability to export, provide, or sell

our Commercial Products could adversely affect our business, financial condition and results of operations.

Risks Related to Our Dependence on Third Parties

We depend on collaborations with third parties for certain aspects of the development, marketing and/or

commercialization of Commercial Products and our product candidates, if approved. If those collaborations are not

successful, or if we are not able to maintain our existing collaborations or establish additional collaborations, we may

have to alter our development and commercialization plans and may not be able to capitalize on the market potential

of Commercial Products or our product candidates, if approved.

Our product development programs and the commercialization of our Commercial Products and product candidates, if

approved, require local expertise and substantial additional cash to fund expenses. We expect to maintain our existing

collaborations and collaborate with additional pharmaceutical and biotechnology companies for certain aspects of the

development, marketing and/or commercialization of our Commercial Products and product candidates. For example, we

expect to rely on additional partners to develop and commercialize our Commercial Products outside of the U.S.,

including our ongoing partnership with Grand Pharmaceutical Group Limited ("Grand Pharma") for our imaging and

therapeutic product candidates in Greater China. In addition, we intend to utilize collaborators to aid in the further

development, potential marketing and/or commercialization of our product candidates. We also have a license agreement

with Eli Lilly and Company Ltd ("Lilly") for the exclusive worldwide rights to develop and commercialize radiolabeled

forms of olaratumab together with our linker and our other proprietary licensed technology, for the diagnosis and

treatment of human cancers.

Potential collaborators include large and mid-size pharmaceutical companies, regional and national pharmaceutical

companies and biotechnology companies and we face significant competition in seeking appropriate collaborators,

including as a result of a significant number of recent business combinations among large pharmaceutical companies that

have reduced the number of potential collaborators. Whether we reach a definitive agreement for a collaboration will

depend, among other things, upon the assessment of the potential collaborator’s expertise, its current and expected

resources and competing priorities, the terms and conditions of the proposed collaboration and the proposed

collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the

likelihood of approval by the FDA or foreign regulatory authorities, the potential market for the product or product

candidate, the costs and complexities of manufacturing and delivering such product or product candidate, if approved, to

patients, the potential of competing products, the existence of uncertainty with respect to our ownership of intellectual

property, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and

industry and market conditions generally. A potential collaborator may also consider alternative product candidates or

technologies for similar indications that may be available to collaborate on and whether such a collaboration could be

more attractive than the one with us.

Collaborations are complex and time-consuming to negotiate, document and manage. We may not be able to negotiate

collaborations on a timely basis, on acceptable terms, or at all, or we may be restricted under then-existing collaboration

agreements from entering into future agreements on certain terms with potential collaborators. If we are unable to

maintain our current collaboration agreements or enter into new collaboration agreements, we may have to curtail,

reduce or delay the development or commercialization programs for our Commercial Products or product candidates, if

approved, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we elect to increase our expenditures to fund and undertake development or commercialization activities on our own,

we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms,

or at all. If we do not have sufficient funds or expertise to undertake the necessary development and commercialization

activities, we may not be able to further develop our Commercial Products or product candidates or bring them to market

and generate product revenue, if approved.

Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully

perform the functions assigned to them in these arrangements, and our collaboration agreements may not lead to the

development or commercialization of future products or our product candidates, if approved, in the most efficient

manner, or at all, and may result in lower product revenues or profitability to us than if we were to market and sell our

Commercial Products or our product candidates, if approved, ourselves. In connection with any such arrangements with

third parties, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to

the development, marketing and/or commercialization of our Commercial Products or product candidates. Further, if our

collaborations do not result in the successful development and commercialization of our future products or product

candidates, if approved, or if any one of our collaborators terminates its agreement with us, we may not receive any

future milestone or royalty payments under the collaboration. If we do not receive the funding we expect under these

agreements, the development and commercialization of future products or product candidates, if approved, could be

delayed and we may need additional resources to develop product candidates.

Collaborations involving our Commercial Products and product candidates pose the following risks to us:

•collaborators have significant discretion in determining the efforts and resources that they will apply to these

collaborations;

•collaborators may not perform their obligations as expected or in compliance with applicable local and national laws

and regulatory requirements;

•collaborators may de-emphasize or may not pursue development, marketing and/or commercialization of our

Commercial Products or product candidates or may elect not to continue or renew development, marketing or

commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus, including as

a result of a sale or disposition of a business unit or development function, or available funding or external factors

such as an acquisition that diverts resources or creates competing priorities;

•collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or

abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product

candidate for clinical testing;

•collaborators could independently develop, or develop with third parties, products that compete directly or

indirectly with our Commercial Products or product candidates if the collaborators believe that competitive

products are more likely to be successfully developed or can be commercialized under terms that are more

economically attractive than ours;

•a collaborator with marketing and distribution rights to one or more products or product candidates may not commit

sufficient resources to the marketing and distribution of our Commercial Products or product candidates;

•disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the

preferred course of development or commercialization, might cause delays or termination of the research,

development or commercialization of products or product candidates, might lead to additional responsibilities for us

with respect to our Commercial Products or product candidates, or might result in litigation or arbitration, any of

which would be time-consuming and expensive;

•collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary

information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or

proprietary information or expose us to potential litigation;

•collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and

potential liability;

•we may lose certain valuable rights under circumstances identified in any collaboration arrangement that we enter

into, such as if we undergo a change of control;

•collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further

development, marketing and/or commercialization of the applicable products or product candidates or to enter into

new collaboration agreements;

•collaborators may learn about our discoveries and use this knowledge to compete with us in the future;

•collaboration agreements may not lead to development or commercialization of product candidates in the most

efficient manner or at all; and

•the number and type of our collaborations could adversely affect our attractiveness to other collaborators or

acquirers.

If any of these events occurs, the market potential of our Commercial Products and product candidates, if approved,

could be reduced, and our business could be materially harmed.

If we are unable to establish and maintain our agreements with third parties to distribute our Commercial Products to

patients, our results of operations and business could be adversely affected.

We rely substantially on third parties to commercially distribute our Commercial Products to patients. For example, we

have contracted with a distribution network of specialty pharmacies, which sell our Commercial Products directly to

patients, and specialty distributors, which sell our Commercial Products to healthcare entities who then resell to patients.

While we have entered into agreements with each of these pharmacies and distributors to distribute our Commercial

Products in the U.S., they may not perform as agreed or they may terminate their agreements with us. We may also need

to enter into agreements with additional pharmacies or distributors, and there is no guarantee that we will be able to do

so on a timely basis, at commercially reasonable terms, or at all. If we are unable to maintain and, if needed, expand, our

network of specialty pharmacies and specialty distributors, we would be exposed to substantial distribution risk. In

addition, and particularly as we expand into less-mature markets or into countries where corruption may be more

prevalent, we will need to conduct robust due diligence with third-party collaboration partners to best ensure that our

Commercial Products and our other product candidates, if approved, are able to be manufactured, compounded, or

distributed on a timely basis that complies will all applicable laws, regulations, and rules, including but not limited to,

those that deal with anti-corruption, anti-kickback, marketing authorization and distribution of pharmaceutical products,

the environment, and the safe use of the products with patients.

The use of specialty pharmacies and specialty distributors involves certain risks, including, but not limited to, risks that

these organizations will:

•not provide us accurate or timely information regarding their inventories, the number of patients who are using our

Commercial Products or serious adverse reactions, events and/or product complaints regarding our Commercial

Products;

•not effectively sell or support our Commercial Products or communicate publicly concerning our Commercial

Products in a manner that is contrary to FDA rules and regulations;

•reduce their efforts or discontinue to sell or support, or otherwise not effectively sell or support, our Commercial

Products;

•not devote the resources necessary to sell our Commercial Products in the volumes and within the time frames that

we expect;

•be unable to satisfy financial obligations to us or others;

•not be able to obtain or maintain all necessary licenses; or

•cease operations.

Any such risks may apply to future products and product candidates we develop, and for which we receive marketing

authorization, such events may result in decreased product sales, which would harm our results of operations and

business.

We rely on third parties as we conduct our clinical trials and some aspects of our research and preclinical studies,

and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such

trials, research or testing.

We rely on third parties, such as strategic partners, CROs, clinical data management organizations, medical institutions

and clinical investigators, as we conduct our clinical trials. For example, in China, during 2025 we completed enrollment

for a Phase 3 study of TLX591-Px (marketed as Illuccix in the U.S.) in collaboration with our strategic partner for the

Greater China region, Grand Pharma, and we aim for this study to support future marketing authorization applications for

Illuccix in China. A new drug application was submitted in December 2025 and accepted for review in January 2026 by

the Chinese National Medical Products Administration ("NMPA") Center for Drug Evaluation ("CDE"). We also currently

rely and expect to continue to rely on third parties to conduct some aspects of our research and preclinical studies. Any

of these third parties may terminate their engagements with us at any time in accordance with agreements or applicable

laws. If we need to enter into alternative arrangements, our product development activities may be delayed.

Our reliance on these third parties for research and development activities reduces our control over these activities but

does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our clinical trials

is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires

us to comply with GCP standards when conducting, recording and reporting the results of clinical trials to ensure that

data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants

are protected. The EMA and TGA also require us to comply with comparable standards. Regulatory authorities ensure

compliance with these requirements through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of the third parties that we rely on in connection with our clinical trials fail to comply with applicable

requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or other

comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our

marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory

authority will determine that any of our clinical trials comply with such requirements. We also are required to register

ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, such as

ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal

sanctions.

Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If

these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical

trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be

delayed in obtaining, regulatory approvals for our product candidates and will not be able to, or may be delayed in our

efforts to, successfully commercialize our Commercial Products or our product candidates, if approved. In such an event,

our financial results and the commercial prospects for our Commercial Products or product candidates, if approved,

could be harmed, our costs could increase and our ability to generate revenues could be delayed, impaired or foreclosed.

We also expect to rely on other third parties to store and distribute product supplies for our clinical trials. Any

performance failure on the part of such third parties could delay clinical development or regulatory approval of our

product candidates or commercialization of our Commercial Products, producing additional losses and depriving us of

potential product revenue.

In addition, as discussed above, the third parties upon whom we rely to conduct our clinical trials could be negatively

impacted as a result of disruptions caused by, for example, pandemics or epidemics including difficulties in initiating

clinical sites or enrolling participants, travel or quarantine policies, and other factors, including ongoing and future

environmental or geopolitical concerns. If these third parties are so affected, our business prospects and results of

operations could be severely adversely impacted.

We rely on third parties to conduct investigator-sponsored clinical trials of our product candidates. Any failure by a

third-party to meet its obligations with respect to the clinical development of our product candidates may delay or

impair our ability to obtain regulatory approval for our product candidates.

We partly rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to our

product candidates. We do not control the design or conduct of the investigator-sponsored trials, and it is possible that

the FDA or foreign regulatory authorities will not view these investigator-sponsored trials as providing adequate support

for future clinical trials, whether controlled by us or third parties, for any one or more reasons, including elements of the

design, execution of the trials, safety concerns or other trial results.

Such arrangements will provide us certain information rights with respect to the investigator-sponsored trials, such as

access to and the ability to use and reference the data resulting from the investigator-sponsored trials, including for our

own regulatory submissions and marketing authorization applications. However, we do not have control over the timing

for patient recruitment and reporting of the data from investigator-sponsored trials, nor do we own the data from the

investigator-sponsored trials. If we are unable to confirm or replicate the results from investigator-sponsored trials or if

negative results are obtained, we would likely be further delayed or prevented from advancing clinical development of

our product candidates. Further, if investigators or institutions breach their obligations with respect to the clinical

development of our product candidates, or if the data proves to be inadequate compared to the first-hand knowledge we

might have gained had the investigator-sponsored trials been sponsored and conducted by us, then our ability to rely on

the data from the investigator-sponsored trials in our clinical development plans may be adversely affected.

Additionally, the FDA or foreign regulatory authorities may disagree with the sufficiency of our right to reference the

preclinical, manufacturing or clinical data generated by these investigator-sponsored trials, our right for exclusive

commercial use of the data or our interpretation of preclinical, manufacturing or clinical data from these investigator-

sponsored trials. If so, the FDA or foreign regulatory authorities may require us to obtain and submit additional preclinical,

manufacturing, or clinical data before we may initiate our planned trials and/or may not accept such additional data as

adequate to initiate our planned trials.

We are currently dependent on third parties for the manufacture, distribution and patient dose preparation of our

Commercial Products and product candidates and any difficulties, disruptions, delays or unexpected costs, or the

need to find alternative sources, could adversely affect our results of operations, profitability and future business

prospects.

While we have acquired some laboratory capability with Optimal Tracers in Sacramento, IsoTherapeutics in Angleton, and

the facility purchased from ImaginAb, Inc. in Los Angeles, completed Stage 1 of the buildout of our European

manufacturing site in Brussels South, which is operational for selected research and development activities and is good

manufacturing practice ("GMP") accredited for production of Illuccix, progressed the buildout of our TMS North

Melbourne facility for early-stage clinical research and radiopharmaceutical production, and established our first

cyclotron facility in the APAC region in Yokohama, Japan, we currently rely, and expect to continue to rely, on third-party

contract manufacturers to manufacture our Commercial Products and product candidates for our commercial and clinical

use.

Facilities used by our third-party manufacturers may be inspected by the FDA or applicable foreign regulatory authorities

after we submit a marketing application and before potential approval of the product candidate and are also subject to

ongoing periodic unannounced inspections by the FDA or applicable foreign regulatory authorities for compliance with

cGMPs (or similar foreign requirements) and other regulatory requirements following approval. Similar regulations apply

to manufacturers of our Commercial Products and our product candidates for use or sale in foreign countries. We do not

control the manufacturing processes of, and are completely dependent on, our third-party manufacturers for compliance

with the applicable regulatory requirements for the manufacture of our products and product candidates. Third-party

manufacturers may not be able to comply with cGMPs or similar regulatory requirements outside of the U.S.. If our

manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory

requirements of the FDA and any applicable foreign regulatory authority, they will not be able to secure and/or maintain

regulatory approval for their manufacturing facilities. If these facilities are not approved for commercial manufacture or

are not able to maintain approval, we may need to find alternative manufacturing facilities, which could significantly

impact our ability to develop, obtain regulatory approval for or market our Commercial Products or product candidates as

alternative qualified manufacturing facilities may not be available on a timely or cost-efficient basis, or at all. Failure by

any of our manufacturers to comply with applicable cGMPs (and similar foreign requirements) or other regulatory

requirements could result in sanctions being imposed on us or the contract manufacturer, including fines, injunctions,

civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply and

criminal prosecutions, any of which could significantly and adversely affect supplies of our Commercial Products or

product candidates and have a material adverse impact on our business, financial condition and results of operations.

We currently have long-term supply agreements with our third-party contract manufacturers to manufacture the clinical

and commercial supplies of our Commercial Products and for our product candidates. Our ability to have our Commercial

Products and product candidates manufactured in sufficient quantities and at acceptable costs to meet our commercial

demand and clinical development needs is dependent on the uninterrupted and efficient operation of our third-party

contract manufacturers’ facilities. Reliance on third-party manufacturers entails risks, including:

•reliance on the third-party for regulatory compliance and quality assurance;

•the possible breach, termination or nonrenewal of a manufacturing agreement by the third-party, including at a time

that is costly or inconvenient to us;

•the possible failure of the third-party to manufacture our Commercial Products or our product candidates according

to our schedule, or at all, including if the third-party manufacturer gives greater priority to the supply of other

products over our Commercial Products or our product candidates, or otherwise does not satisfactorily perform

according to the terms of the manufacturing agreement;

•equipment malfunctions, power outages or other general disruptions experienced by our third-party manufacturers

or distributors to their respective operations and other general problems with a multi-step manufacturing or

distribution process;

•the possible disruptions to supply chain and logistics processes that are required to store, transport, and deliver our

Commercial Products to customers that require timely delivery given the need to inject a dose of our Commercial

Products within a specific window of radioactivity; and

•the possible misappropriation or disclosure by the third-party or others of our proprietary information, including our

trade secrets and know-how.

We currently rely on a single source supplier for our active pharmaceutical ingredient for our Commercial Products and

our related product manufacturing requirements, although additional sources and back-up suppliers are being validated

and implemented. Any performance failure on the part of our existing or future manufacturers could delay clinical

development, regulatory approval or commercialization of our product candidates, if approved. If our suppliers or

contract manufacturers are so affected, our supply chain could be disrupted, our product shipments could be delayed,

our costs could be increased and our business could be adversely affected. If our current contract manufacturers cannot

perform as agreed, we may be required to replace those manufacturers. Although we believe that there are several

potential alternative manufacturers who could manufacture our Commercial Products or our product candidates, we

could incur added costs and delays in identifying and qualifying any such replacement. Consequently, we may not be

able to reach agreement with third-party manufacturers on satisfactory terms, which could negatively impact revenues

from sales of our Commercial Products or delay commercialization of any product candidates that are subsequently

approved.

If, because of the factors discussed above, we are unable to have our Commercial Products or our product candidates

manufactured on a timely or sufficient basis, we may not be able to meet clinical development needs or commercial

demand for our Commercial Products or our product candidates or we may not be able to manufacture our Commercial

Products or our product candidates in a cost-effective manner. As a result, we may lose sales, fail to generate projected

revenues or suffer development or regulatory setbacks, any of which could have an adverse impact on our profitability

and future business prospects.

We are currently party to and may seek to enter into additional collaborations, licenses and other similar

arrangements and may not be successful in maintaining existing arrangements or entering into new ones, and even if

we are, we may not realize the benefits of such relationships.

We are currently parties to license and collaboration agreements with a number of pharmaceutical companies and

universities and expect to enter into additional agreements as part of our business strategy. The success of our current

and any future collaboration arrangements will depend heavily on the efforts and activities of our collaborators.

Collaborations are subject to numerous risks, which may include risks that:

•we may not be able to enter into critical strategic collaborations or enter into them on favorable terms;

•collaborators may have significant discretion in determining the efforts and resources that they will apply to

collaborations, and they may not perform their obligations as agreed, expected, or in compliance with applicable

legal requirements;

•collaborators may not pursue development and commercialization of our product candidates or may elect not to

continue or renew development or commercialization programs based on clinical trial results, changes in their

strategic focus due to their acquisition of competitive products or their internal development of competitive

products, availability of funding or other external factors, such as a business combination that diverts resources or

creates competing priorities;

•collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial,

abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product

candidate for clinical testing;

•collaborators could independently develop, or develop with third parties, products that compete directly or

indirectly with our Commercial Products or product candidates if the collaborators believe that competitive

products are more likely to be successfully developed or can be commercialized under terms that are more

economically attractive than our Commercial Products or product candidates;

•a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit

sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

•we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

•collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual

property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or

invalidate our intellectual property or proprietary information or expose us to potential liability;

•disputes may arise between us and a collaborator that cause the delay or termination of the research, development

or commercialization of our current or future product candidates or that results in costly litigation or arbitration that

diverts management attention and resources;

•collaborations may be terminated, which may result in a need for additional capital to pursue further development or

commercialization of the applicable current or future product candidates;

•collaborators may own or co-own intellectual property covering products that result from our collaboration with

them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual

property;

•disputes may arise with respect to the ownership of any intellectual property developed pursuant to our

collaborations; and

•a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws

resulting in civil or criminal proceedings.

Additionally, we may seek to enter into additional collaborations, joint ventures, licenses and other similar arrangements

for the development or commercialization of our product candidates, if approved, due to capital costs required to

develop or commercialize the product candidate, if approved, or manufacturing constraints. We may not be successful in

our efforts to establish such collaborations for our product candidates because our R&D pipeline may be insufficient, our

product candidates may be deemed to be at too early of a stage of development for collaborative effort or third parties

may not view our product candidates as having the requisite potential to demonstrate safety and efficacy or significant

commercial opportunity. In addition, we face significant competition in seeking appropriate strategic partners, and the

negotiation process can be time consuming and complex. Further, any future collaboration agreements may restrict us

from entering into additional agreements with potential collaborators. We cannot be certain that, following a strategic

transaction or license, we will achieve an economic benefit that justifies such transaction.

Risks Related to Our Intellectual Property

If we are unable to obtain and/or maintain commercially valuable regulatory exclusivity and intellectual property or to

protect our patents, trademarks, know-how and trade secrets, our ability to successfully commercialize our

Commercial Products and product candidates, if approved, would be adversely impacted.

We rely on effective exclusivity and IP protection and our success will depend in part on our ability to obtain and/or

maintain commercially valuable regulatory exclusivity and patent claims and to protect our patents, trademarks, know-

how and trade secrets. We and our collaboration partners face numerous risks and uncertainties with respect to our

licensed patents and those that may subsequently be licensed or issued to us, including that:

•lodged regulatory filings may not result in intended market or data exclusivity;

•governments may change data and market exclusivity provisions;

•know-how and trade secrets may be published, derived independently by third parties, or otherwise publicly

disclosed, resulting in a loss of protections;

•patent or trademark applications may not result in issued patents or registered trademarks or may take longer than

expected to be issued or registered;

•the claims of any patents or trademarks that are issued or registered may not provide meaningful protection;

•patent term extensions may not be granted or, if granted, may be subject to revision;

•we and our research partners may not be able to develop additional proprietary technologies that are patentable or

otherwise protectable under regulatory exclusivity principles;

•patents issued to us, or our industry partners, may not provide a competitive advantage;

•other companies may challenge our issued patents or trademarks;

•other companies may independently develop similar or alternative technologies to ours or duplicate or design

around our technology;

•other companies may hold patents or trademarks that are relevant to our technology or activities and enforce their

rights against us; and

•if patents are not issued, then the value of our underlying IP rights may be significantly diminished.

Additionally, any information contained in our licensed patents could become part of the public domain, so that it will not

be protected as confidential information or trade secrets. As legal regulations and standards relating to the validity and

scope of regulatory exclusivity and IP continue to evolve around the world, the degree of future protection for our

proprietary rights is uncertain. We may also be subject to arbitrary compulsory licenses or governmental acts reducing IP

protection outside our reasonable control. We may incur significant costs in asserting any patent or trademark IP rights

and in defending legal action against us relating to rights. Such disputes could delay our product development or

commercialization activities. Parties making claims against us may be able to obtain injunctive or other equitable relief

that could prevent us from further developing discoveries or commercializing products or require the payment of

damages or royalties.

In addition, in the event a successful claim of infringement is made against us, we may be required to pay damages and

obtain one or more licenses from the prevailing third-party. If we are not able to obtain these licenses at a reasonable

cost, if it all, we may encounter delays and lose substantial resources while seeking to develop or commercialize

alternative products.

There is a risk that third parties may have IP that is relevant to our proposed activities which could prevent us from

conducting these activities or may require us to license in the third-party’s IP, find alternatives to the third-party IP, or

seek to challenge the third-party IP, either at an administrative stage or through the courts. We may need to acquire or

license IP from third parties to develop and commercialize our own pipeline of IP and products. There is no guarantee

such acquisitions or licenses can be obtained or, if obtained, that they will be on reasonable commercial terms.

Additionally, although we enter into non-disclosure and confidentiality agreements with parties who have access to

patentable aspects of our research and development output, such as our employees, corporate collaborators, outside

scientific collaborators, contract research organizations, contract manufacturers, consultants, advisors and other third

parties, there can also be no assurance that any of these parties will not breach confidentiality, or infringe or

misappropriate our IP, which could cause material loss to us.

If we are unable to obtain and maintain patent protection for our products or product candidates and other

discoveries, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop

and commercialize products and other discoveries similar or identical to ours, and our ability to successfully

commercialize our products or product candidates and other discoveries may be adversely affected.

Our success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other countries

with respect to our proprietary products and product candidates and other discoveries. We seek to protect our

proprietary position by filing patent applications in the U.S. and abroad related to our products and product candidates

and other discoveries that are important to our business. For a description of our patent portfolio, see “Item 4.

Information on the Company — B. Business Overview.” We intend to continue to apply for patents with claims covering

our key products, product candidates or other discoveries when and where we deem it appropriate to do so.

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 our research and development output before it is too late to obtain patent protection. As

such, our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. and

we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling

or importing products made using our inventions in and into the U.S. or other jurisdictions. The legal systems of certain

countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual

property protection, particularly those relating to pharmaceuticals or biologics, which could make it difficult for us to stop

the infringement of our patents or marketing of competing products in violation of our proprietary rights generally, which

could result in substantial costs and divert our efforts and attention from other aspects of our business.

In addition, geo-political actions in the U.S. and in foreign countries could increase the uncertainties and costs

surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the

maintenance, enforcement or defense of our issued patents or those of any current or future licensors. For example, due

to the Russia-Ukraine conflict, the U.S. and other foreign governments have implemented various economic sanctions

and trade and activity restrictions involving Russia and Belarus. It is possible that additional sanctions and restrictions will

be imposed by the U. S. or other jurisdictions as the Russia-Ukraine conflict continues, and such actions may include

limiting or preventing filing, prosecution, and/or maintenance of patent applications in Russia. Government actions may

also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents

or patent applications, resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it

could have a material adverse effect on our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal

and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope,

validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent

applications may not result in patents being issued that protect our product candidates or other discoveries, or which

effectively prevent others from commercializing competitive products and discoveries. Changes in either the patent laws

or interpretation of the patent laws in the U.S. and other countries may diminish the value of our patents or narrow the

scope of our patent protection. The patent positions of companies in the development and commercialization of

pharmaceuticals are particularly uncertain.

The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent

protection available in certain circumstances or weakening the rights of patent owners in certain situations. Depending

on future actions by the U.S. Congress, the U.S. courts, the U.S. Patent and Trademark Office ("USPTO") and the relevant

law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways

that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain

in the future.

Composition of matter patents for biological and pharmaceutical products and product candidates often provide a strong

form of intellectual property protection for those types of products, as such patents provide protection without regard to

any method of use. We cannot be certain that the claims in our pending patent applications covering compositions of

matter of our product candidates will be considered patentable by the USPTO or by patent offices in foreign countries, or

that the claims in any of our issued patents will be considered valid and enforceable by courts in the U.S. or foreign

countries. Method of use patents protect the use of a product for the specified method. This type of patent does not

prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside

the scope of the patented method. Moreover, even if competitors do not actively promote their product for our targeted

indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or

contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to

prevent or prosecute.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in

the U.S. and other jurisdictions are typically 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 patents or pending patent

applications, or that we were the first to file for patent protection of such inventions.

Assuming the other requirements for patentability are met, prior to March 2013, in the U.S., the first to invent the claimed

invention was entitled to the patent, while outside of the U.S., the first to file a patent application is entitled to the patent.

In March 2013, the U.S. transitioned to a first-inventor-to-file system in which, assuming the other requirements for

patentability are met, the first inventor to file a patent application is entitled to the patent.

We may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in opposition,

derivation, revocation, reexamination, or post-grant or 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, allow third parties to commercialize our discoveries or

products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize

products without infringing third-party patent rights. In addition, 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. Any failure to obtain or maintain patent protection with respect to our

product candidates could have a material adverse effect on our business, financial condition, results of operations and

prospects.

Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful

protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our

competitors may be able to circumvent our patents by developing similar or alternative discoveries or products in a non-

infringing manner.

The issuance of a patent is not conclusive of its inventorship, its scope, validity or its enforceability, and our patents may

be challenged in the courts or patent offices in the U.S. and abroad. Such challenges may result in patent claims being

narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing

similar or identical discoveries and products, or limit the duration of the patent protection of our products, product

candidates and discoveries. 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. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from

commercializing products similar or identical to ours.

Our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial

advantage from the intellectual property that we own or license. Many companies have encountered significant problems

in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries,

particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual

property protection, particularly those relating to biotechnology or pharmaceutical products, which could make it difficult

for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights

generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our

efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted

narrowly, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate

and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to

enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage

from the intellectual property that we develop or license.

Europe’s Unified Patent Court may in particular present uncertainties for our ability to protect and enforce our patent

rights against competitors in Europe. On June 1, 2023, the EU unitary patent system was launched, providing a single

pan-European Unitary Patent and a new European Unified Patent Court ("UPC"), for litigation involving European patents.

Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by

default automatically fall under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to

centrally revoke our European patents that have not been opted out of the UPC, and allow for the possibility of a

competitor to obtain pan-European injunctions. It will be several years before we will understand the scope of patent

rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU unitary

patent system, we will have the right to opt our patents out of the UPC over the first seven years of the court’s existence,

but doing so may preclude us from realizing the benefits of the new unified court.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a

third-party patent, which might adversely affect our ability to develop and market our product candidates.

We cannot be certain that we are aware of all third-party patents and pending applications in the U.S. and abroad that

are relevant to or necessary for the commercialization of our product candidates in any jurisdiction. We may not be able

to conduct complete and thorough searches, we may not be able to identify all relevant third-party patents, and we may

not be able to fully predict the scope of the patent claims or the expiration of relevant third-party patent applications that

may issue as patents. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in

a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending

application may be incorrect, which may negatively impact our ability to market our product candidates. We may

incorrectly determine that our product candidates are not covered by a third-party patent or may incorrectly predict

whether a third-party’s pending application will issue with claims of relevant scope. Our determination of the expiration

date of any patent in the U.S. or abroad that we consider relevant may be incorrect, which may negatively impact our

ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant patents may

negatively impact our ability to develop and market our product candidates.

In addition, the agreements under which we license intellectual property or technology to or from third parties are

complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any

contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the

relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the

relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of

operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our

ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to

successfully develop and commercialize the affected product candidates. Our business also would suffer if any current

or future licensors fail to abide by the terms of the license, if the licensors fail to enforce licensed patents against

infringing third parties, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable

to enter into necessary licenses on acceptable terms. Moreover, our licensors may own or control intellectual property

that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are

infringing or otherwise violating the licensor’s rights.

Our rights to develop and commercialize our products and product candidates are subject in part to the terms and

conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of

our products and product candidates may be dependent on our licensors.

We currently are reliant upon licenses of certain intellectual property rights and proprietary technologies from third

parties that are important or necessary to the development of our proprietary technologies, including technologies

related to Illuccix and our product candidates. These licenses, and other licenses we may enter into in the future, may

not provide adequate rights to use such intellectual property and proprietary technologies in all relevant fields of use or

in all territories in which we may wish to develop or commercialize technology and product candidates in the future.

Licenses to additional third-party proprietary technology or intellectual property rights that may be required for our

development programs may not be available in the future or may not be available on commercially reasonable terms. In

that event, we may be required to expend significant time and resources to redesign our proprietary technology or

product candidates or to develop or license replacement technology, which may not be feasible on a technical or

commercial basis. If we are unable to do so, we may not be able to develop and commercialize technology and product

candidates in fields of use and territories for which we are not granted rights pursuant to such licenses, which could

harm our competitive position, business, financial condition, results of operations and prospects significantly.

The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established

companies may pursue strategies to license or acquire third-party intellectual property rights we may consider attractive

or necessary. These established companies may have a competitive advantage over us due to their size, capital

resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to

be a competitor may be unwilling to assign or license rights to us.

Moreover, some of our owned and in-licensed patents or patent applications or future patents are or may be co-owned

with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such

patents or patent applications, such co-owners may be able to license their rights to other third parties, including our

competitors, and our competitors could market competing products and technology. In addition, we may need the

cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such

cooperation may not be provided to us. Furthermore, our owned and in-licensed patents may be subject to a reservation

of rights by one or more third parties. Any of the foregoing could have a material adverse effect on our competitive

position, business, financial conditions, results of operations and prospects.

In some circumstances, we may not have the right to control the preparation, filing and prosecution of patent

applications, or to maintain and enforce the patents, covering technology that we license from third parties. In addition,

some of our agreements with our licensors require us to obtain consent from the licensor before we can enforce patent

rights, and our licensor may withhold such consent or may not provide it on a timely basis. Therefore, we cannot be

certain that our licensors or collaborators will prosecute, maintain, enforce and defend such intellectual property rights in

a manner consistent with the best interests of our business, including by taking reasonable measures to protect the

confidentiality of know-how and trade secrets, or by paying all applicable prosecution and maintenance fees related to

intellectual property registrations for any of our products or product candidates and proprietary technologies. We also

cannot be certain that our licensors have drafted or prosecuted the patents and patent applications licensed to us in

compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any

patents that may issue from such applications. This could cause us to lose rights in any applicable intellectual property

that we in-license, and as a result our ability to develop and commercialize products or product candidates may be

adversely affected and we may be unable to prevent competitors from making, using and selling competing products.

In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we

may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In

addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales

of future products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on

the technology and intellectual property we use in product candidates that we successfully develop and commercialize,

if any. Therefore, even if we successfully develop and commercialize product candidates, we may be unable to maintain

profitability. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining

such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors,

including by agreeing to terms that could enable third parties (potentially including our competitors) to receive licenses

to a portion of the intellectual property rights that are subject to our existing licenses. Any of these events could have a

material adverse effect on competitive position, business, financial conditions, results of operations, and prospects.

Our technology licensed from third parties may be subject to retained rights.

Any license we may enter into could provide for the retention by the licensor of certain rights under their agreements

with us, including the right to use the underlying technology for non-commercial academic and research use, to publish

general scientific findings from research related to the technology, and to make customary scientific and scholarly

disclosures of information relating to the technology. It is difficult to monitor whether any future licensors will limit their

use of the technology to these uses, and we may incur substantial expenses to enforce our rights to our licensed

technology in the event of misuse.

In addition, the U.S. federal government retains certain rights in inventions produced with its financial assistance under

the Patent and Trademark Law Amendments Act ("the Bayh-Dole Act"). The federal government retains a “nonexclusive,

nontransferable, irrevocable, paid-up license” for its own benefit. The Bayh-Dole Act also provides federal agencies with

“march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or

successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible

applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. The Bayh-Dole

Act also imposes other obligations, including the requirement that products covered by the government funded patents

be manufactured in the U.S.. We sometimes collaborate with academic institutions to accelerate our preclinical research

or development. In the future, we may own or license technology which is critical to our business that is developed in

whole or in part with federal funds subject to the Bayh-Dole Act. If the federal government exercises its rights under the

Bayh-Dole Act, our ability to enforce or otherwise exploit patents covering such technology may be adversely affected.

If we fail to comply with our obligations in the agreements under which we license intellectual property rights from

third parties or these agreements are terminated or we otherwise experience disruptions to our business

relationships with our licensors, we could lose intellectual property rights that are important to our business.

We are party to various agreements that we depend on to develop Illuccix, Gozellix and our product candidates and

various proprietary technologies, and our rights to use currently licensed intellectual property, or intellectual property to

be licensed in the future, are or will be subject to the continuation of and our compliance with the terms of these

agreements. For example, under certain of our license agreements we are required to use commercially reasonable

efforts to develop and commercialize product candidates covered by the licensed intellectual property rights, maintain

the licensed intellectual property rights, and achieve certain development milestones, each of which could result in

termination in the event we fail to comply.

In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license

agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop

and commercialize products and technology covered by these license agreements.

Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:

•the scope of rights granted under the license agreement and other interpretation-related issues;

•our financial or other obligations under the licensing agreement;

•the extent to which our product candidates, technology and processes infringe on intellectual property of the

licensor that is not subject to the licensing agreement;

•the sublicensing of patent and other rights under our collaboration agreements;

•our rights to transfer or assign the license;

•our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

•the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual

property by our licensors and us and our partners; and

•the priority of invention of patented technology.

In addition, certain provisions in our and our license agreements may be susceptible to multiple interpretations. The

resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of

our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other

obligations under the agreement, either of which could have a material adverse effect on our business, financial

condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed

prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may

be unable to successfully develop and commercialize the affected products or product candidates, which could have a

material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

We are generally also subject to all of the same risks with respect to protection of intellectual property that we may

license as we are for intellectual property that we own, which are described herein. If we or any of our current or future

licensors fail to adequately protect this intellectual property, our ability to commercialize product candidates could suffer.

Issued patents covering our products and product candidates could be found invalid or unenforceable if challenged

in courts or patent offices.

If we or one of our licensing partners initiated legal proceedings against a third-party to enforce a patent covering one or

more of our products or product candidates, the defendant could counterclaim that the asserted patent covering the

relevant product or product candidate is invalid and/or unenforceable. In patent litigation in the U.S., defendant

counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an

alleged failure to meet any of several statutory requirements, including subject matter eligibility, novelty, obviousness,

written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone

connected with prosecution of the patent withheld material information from the USPTO, or made a misleading

statement, during prosecution with the intent to deceive the USPTO. Third parties may also raise similar claims before

administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-

examination inter partes review, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition

proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no

longer cover our products or product candidates. The outcome following legal assertions of invalidity and

unenforceability is unpredictable. In any patent infringement proceeding, there is a risk that a court will decide that a

patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party

from using the invention at issue. With respect to the validity question, for example, we cannot be certain that there is no

invalidating prior art, of which we and the patent examiner were unaware during prosecution. There is also a risk that,

even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not

have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not

cover the invention, or decide that the other party’s use of our patented technology falls under the safe harbor to patent

infringement under 35 U.S.C. §271(e)(1). If a defendant were to prevail on a legal assertion of invalidity and/or

unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products or product

candidates. Such a loss of patent protection would have a material adverse impact on our business. Any of these

occurrences could adversely affect our competitive business position, business prospects and financial condition.

Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid

or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the

marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which

could be expensive, time-consuming and unsuccessful.

Competitors or commercial supply companies or others may infringe our patents and other intellectual property rights. To

counter infringement, we may be required to file infringement actions, which can be expensive and time-consuming. In

an infringement proceeding, a defendant may assert and a court may agree with a defendant that a patent or other

intellectual property right of ours is invalid or unenforceable (or both), or the factfinder may refuse to stop the other party

from using the allegedly infringed intellectual property at issue.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and

instead award only monetary damages, which may or may not be an adequate remedy. An adverse result in any litigation

could put one or more of our patents or registered trademarks at risk of being invalidated or interpreted narrowly and

could limit our ability to assert our patents or trademark rights against those parties or other competitors and may curtail

or preclude our ability to exclude third parties from making and selling similar or competitive products. 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 proceedings alleging that we are infringing their intellectual property rights, the

outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability and the ability of any current and future collaborators to develop,

manufacture, market and sell our Commercial Products and our product candidates, if approved, and 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 or product

candidates and technology, including post-grant proceeding or interference proceedings (patents) or opposition or

cancellation proceedings (trademarks) before the USPTO. Third parties may assert infringement claims against us based

on existing patents or patents that may be granted in the future. No litigation asserting such infringement claims is

currently pending against us, and we have not been found by a court of competent jurisdiction to have infringed a third-

party’s intellectual property rights.

There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and

we may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property

rights with respect to our product candidates and Commercial Products. Our product candidates and other proprietary

technologies that we may develop may infringe existing or future patents owned by third parties. Third parties may

assert infringement claims against us based on existing or future intellectual property rights. We may not be aware of

patents that have already been issued and that a third-party, for example, a competitor in the fields in which we are

developing our product candidates, might assert are infringed by our current or future product candidates, including

claims to compositions, formulations, methods of manufacture or methods of use or treatment that cover our product

candidates. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always

uniform. If we were sued for patent infringement, we would need to demonstrate that our product candidates,

Commercial Products or methods either do not infringe the patent claims of the relevant patent or that the patent claims

are invalid or unenforceable, and we may not be able to do this. If such patent claims were to survive an invalidity

challenge, and if they were asserted against us, we could incur substantial costs in the resulting litigation, including

possible payment of treble damages for willful infringement and an injunction requiring us to cease sale of our products.

If we are found to infringe or think there is a risk we may be found to infringe, a third-party’s intellectual property rights,

we could be required or choose to obtain a license from such third-party to continue developing, marketing and selling

our products, product candidates and technology. However, we may not be able to obtain any required license on

commercially reasonable terms, or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby

giving our competitors access to the same intellectual property licensed to us. We could be forced, including by court

order, to cease commercializing the infringing intellectual property or product or to cease using the infringing technology.

In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from

commercializing our products or product candidates or force us to cease some of our business operations, and could

divert the time and attention of our technical personnel and management, cause development delays, and/or require us

to develop non-infringing technology, which may not be possible on a cost-effective basis, any of which could materially

harm our business. In the event of a successful claim of infringement against us, we may have to pay substantial

monetary damages, including treble damages and attorneys’ fees for willful infringement, pay royalties and other fees,

redesign our infringing drug or obtain one or more licenses from third parties, which may be impossible or require

substantial time and monetary expenditure. Claims that we have misappropriated the confidential information or trade

secrets of third parties could have a similar negative impact on our business.

Intellectual property disputes could delay or prevent our compassionate use or magisterial preparation access

programs and commercialization, expose us to injunctions, damages (including potential royalty back payments) and

additional costs, and require additional public disclosures that could adversely affect our business and the market

price of our ordinary shares and ADSs.

Intellectual property disputes including patent invalidity actions against 3rd party patents and patent infringement

actions against competitor products are a routine business activity. In February 2026, Telix filed an invalidity action

against an Australian patent owned by the Purdue Research Foundation. Patent disputes are costly, uncertain, and time-

consuming. Patent disputes can result in injunctions, damages (including enhanced damages in some jurisdictions), or

compulsory licensing that disrupt development or commercialization and divert significant management attention and

resources. These risks are heightened where a counterparty seeks injunctive or other equitable relief that could limit or

halt lawful compassionate use or magisterial preparation or commercial supply while a dispute is pending or permanent.

These matters often take years to finalise. Litigation and claims can be expensive and disruptive regardless of their merit,

and we may not prevail. Even if we prevail, such proceedings often involve extensive discovery, may require disclosure

of confidential information, and entail substantial legal expenses and management attention.

Unfavorable outcomes in validity or infringement patent disputes can limit our ability to exclude competitors or operate

without a license, and required licenses may be unavailable on reasonable terms or delayed. Adverse rulings can also

result in damages, ongoing royalty obligations that diminish program economics, or could result in our being enjoined

from importing, making, using, offering to sell, or selling technologies critical to development of our product candidates

and/or commercialization of our Commercial Products.

Public announcements or interim developments may also negatively affect investor perception and the market price of

our ordinary shares and ADSs. Significant developments may necessitate public communications and additional

disclosure in our public filings or offering documents, increasing legal, accounting, and compliance costs and contributing

to volatility in the trading price of our ADSs. Public announcements or interim developments may also negatively affect

investor perception and the market price of our ordinary shares and ADSs. Significant developments may necessitate

public communications and additional disclosure in our public filings or offering documents, increasing legal, accounting,

and compliance costs and contributing to volatility in the trading price of our ADSs.

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their

former employers.

Some of our employees may have been previously employed at universities or other biotechnology or pharmaceutical

companies, including our competitors or potential competitors. 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. Although we have no knowledge of any such claims being alleged to date, if such

claims were to arise, litigation may be necessary to defend against any 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.

Moreover, any such litigation or the threat thereof may adversely affect our reputation, our ability to form strategic

alliances or sublicense our rights to collaborators, engage with scientific advisors or hire employees or consultants, each

of which would have an adverse effect on our business, results of operations and financial condition. Even if we are

successful in defending against such claims, litigation could result in substantial costs and be a distraction to

management.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their

normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to

incur significant expenses and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or

developments and if securities analysts or investors perceive these results to be negative, it could have a material

adverse effect on the price of our ordinary shares and ADSs. Such litigation or proceedings could substantially increase

our operating losses and reduce the resources available for development activities or any future sales, marketing or

distribution activities.

Further, we may not have sufficient financial or other resources to adequately conduct such litigation or proceedings,

which typically last for years before they are concluded. Because of the expense and uncertainty of litigation, we may

conclude that even if a third-party is infringing our issued patent or trademark rights, any patents that may be issued as

a result of our pending or future patent applications, pending or future trademark applications or other intellectual

property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best

interest of our company or our shareholders, or it may be otherwise impractical or undesirable to enforce our intellectual

property rights against some third parties. Some of our competitors may be able to sustain the costs of such litigation or

proceedings more effectively than we can because of their greater financial resources and more mature and developed

intellectual property portfolios. In such cases, we may decide that the more prudent course of action is to simply monitor

the situation or initiate or seek some other non-litigious action or solution. In addition, the uncertainties associated with

the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability

to compete in the marketplace and could compromise our ability to raise the funds necessary to continue our clinical

trials, continue our internal research programs, in-license needed technology or other product candidates, or enter into

development partnerships that would help us bring our product candidates to market. Even if we ultimately prevail in

such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific

personnel could outweigh any benefit we receive as a result of the proceedings.

Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee

payment and other requirements imposed by governmental patent agencies, and our patent protection could be

reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or

applications will be due to the USPTO and various foreign patent offices at various points over the lifetime of the patents

and/or applications. We have systems in place to remind us to pay these fees, and we rely on our outside counsel to pay

these fees when due. Additionally, the USPTO and various foreign patent offices require compliance with a number of

procedural, documentary, fee payment and other similar provisions during the patent application process. We employ

reputable law firms and other professionals to help us comply with such provisions, and in many cases, an inadvertent

lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to the particular

jurisdiction. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or

patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were

to occur, it could have a material adverse effect on our business.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate

amount of time.

Patent rights are of limited duration. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent

is generally 20 years after its first effective filing date. 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 product candidates are commercialized. Even if patents covering our product candidates are obtained, once

the patent life has expired for a product, we may be open to competition from biosimilar or generic products. As a result,

our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates

similar or identical to ours. Upon issuance in the U.S., a patent’s life can be increased based on certain delays caused by

the USPTO, but this increase can be reduced or eliminated based on certain delays caused by the patent applicant

during patent prosecution. A patent term extension based on regulatory delay may be available in the U.S.. However,

only a single patent can be extended for each marketing approval, and any patent can be extended only once, for a

single product. Moreover, the scope of protection during the period of the patent term extension does not extend to the

full scope of the claim, but instead only to the scope of the product as approved. Laws governing analogous patent term

extensions in foreign jurisdictions vary widely, as do laws governing the ability to obtain multiple patents from a single

patent family.

Additionally, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory

review process, apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to

satisfy applicable requirements. If we are unable to obtain patent term extension or restoration, or the term of any such

extension is less than we request, the period during which we will have the right to exclusively market our product will be

shortened and our competitors may obtain approval of competing products following our patent expiration and may take

advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to launch

their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially.

If our product candidates or any of our future product candidates obtain regulatory approval, additional competitors

could enter the market with generic or similar versions of such products, which may result in a material decline in

sales of our competing products.

Under the Hatch-Waxman Act, a company may submit an ANDA, seeking approval of a generic version of an approved

innovator product. Under the Hatch-Waxman Act, a company may also submit an NDA under section 505(b)(2) of the

FDCA that references the FDA’s prior approval of the innovator product or preclinical studies and/or clinical trials that

were not conducted by, or for, the sponsor and for which the sponsor has not obtained a right of reference. A 505(b)(2)

NDA product may be for a new or improved version of the original innovator product. The Hatch-Waxman Act also

provides for certain periods of regulatory exclusivity, which preclude FDA approval (or in some circumstances, FDA filing

and review) of an ANDA or 505(b)(2) NDA.

In certain circumstances, third parties may submit an ANDA or NDA under Section 505(b)(2) as early as the so-called

“NCE-1” date that is one year before the expiry of the five-year period of New Chemical Entity exclusivity or more

generally four years after NDA approval. The third parties may rely on certain safety and efficacy data of the innovator’s

product, may not need to conduct clinical trials and can market a competing version of a product after the expiration or

loss of patent exclusivity or the expiration or loss of regulatory exclusivity and often charge significantly lower prices.

Upon the expiration or loss of patent protection or the expiration or loss of regulatory exclusivity for a product, the major

portion of revenues for that product may be dramatically reduced in a very short period of time. If we are not successful

in defending our patents and regulatory exclusivities, we will not derive the expected benefit from them.

In addition to the benefits of regulatory exclusivity, an innovator NDA holder may have patents claiming the active

ingredient, product formulation or an approved use of the drug, which would be listed with the product in the FDA

publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the Orange Book. If there are

patents listed in the Orange Book for the applicable, approved innovator product, a generic or 505(b)(2) sponsor that

seeks to market its product before expiration of the patents must include in their applications what is known as a

“Paragraph IV” certification, challenging the validity or enforceability, or claiming non-infringement, of the listed patent or

patents. Notice of the certification must be given to the patent owner and NDA holder and if, within 45 days of receiving

notice, either the patent owner or NDA holder sues for patent infringement, approval of the ANDA or 505(b)(2) NDA is

stayed for up to 30 months.

Accordingly, if any of our product candidates that are regulated as drugs are approved, competitors could file ANDAs for

generic versions of these products or 505(b)(2) NDAs that reference our products. If there are patents listed for such

drug products in the Orange Book, those ANDAs and 505(b)(2) NDAs would be required to include a certification as to

each listed patent indicating whether the ANDA sponsor does or does not intend to challenge the patent. We cannot

predict which, if any, patents in our current portfolio or patents we may obtain in the future will be eligible for listing in

the Orange Book, how any generic competitor would address such patents, whether we would sue on any such patents

or the outcome of any such suit.

If we do not successfully extend the term of patents covering our product candidates under the Hatch-Waxman Act

and similar foreign legislation, our business may be materially harmed.

Depending upon the timing, duration and conditions of FDA marketing approval, if any, of our products or product

candidates, one or more of our U.S. patents may be eligible for patent term extension under the Hatch-Waxman Act. The

Hatch-Waxman Act permits a patent term extension of up to five years for one patent covering an approved product as

compensation for effective patent term lost during product development and the FDA regulatory review process.

However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration

of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be

less than we request. The total patent term, including the extension period, may not exceed 14 years following FDA

approval. Accordingly, the length of the extension, or the ability to even obtain an extension, depends on many factors.

In the U.S., only a single patent can be extended for each qualifying FDA approval, and any patent can be extended only

once and only for a single product. Laws governing analogous patent term extensions in foreign jurisdictions vary widely,

as do laws governing the ability to obtain multiple patents from a single patent family.

If we are unable to obtain a patent term extension for a product or product candidate or the term of any such extension

is less than we request, the period during which we can enforce our patent rights for that product or product candidate,

if any, in that jurisdiction will be shortened and our competitors may obtain approval to market competing products

sooner. As a result, our revenue could be materially reduced.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be

harmed.

In addition to seeking patents for our products, product candidates and other discoveries, we also rely on trade secrets,

including unpatented know-how, technology and other proprietary information, to maintain our competitive position.

Elements of our product candidates, including processes for their preparation and manufacture, involve proprietary

know-how, information, or technology that is not covered by patents, and thus for these aspects we may consider trade

secrets and know-how to be our primary intellectual property. Any disclosure, either intentional or unintentional, by our

employees, the employees of third parties with whom we share our facilities or third-party consultants and vendors that

we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as

through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or

surpass our technological achievements, thus eroding our competitive position in our market. Because we expect to rely

on third parties in the development and manufacture of our product candidates, we must, at times, share trade secrets

with them. Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a

competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Trade secrets and know-how can be difficult to protect. 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, outside

scientific collaborators, CROs, 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. We also may not have entered into

such agreements with each party that may have or has had access to our trade secrets or proprietary technology and

processes. To the extent that we are unable to timely enter into confidentiality and invention or patent assignment

agreements with our employees and consultants, our ability to protect our business through trade secrets and patents

may be harmed. 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 courts inside and outside of the U.S. are 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 them from using that technology or information to

compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our

competitive position would be harmed. To the extent inventions are made by a third-party under an agreement that does

not grant us an assignment of their rights in inventions, we may choose or be required to obtain a license.

Not all of our trademarks are registered. Failure to secure those registrations could adversely affect our business.

In total, as of December 31, 2025, we own 26 registered U.S. trademarks, 14 pending U.S. trademark applications, 179

foreign trademarks registered in jurisdictions such as Australia, Europe, China, Brazil and Japan, and 93 pending foreign

trademark applications applied for in jurisdictions such as Australia, Europe, China, Brazil and Japan.

For a description of our registered and pending trademarks, see “Item 4. Information on the Company — B. Business

Overview.”

If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third

parties than we otherwise would, which could adversely affect our business. During trademark registration proceedings

in the U.S. and foreign jurisdictions, our trademark applications may receive rejections or may face post-registration

rejections. We are given an opportunity to respond to those rejections, but we may not be able to overcome such

rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an

opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or

cancellation proceedings may be filed against our trademarks, and our trademark applications or registrations may not

survive such proceedings.

In addition, any proprietary name we propose to use with our key product candidates in the U.S. must be approved by

the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically

conducts a review of proposed drug names, including an evaluation of potential for confusion with other drug names. If

the FDA (or an equivalent administrative body in a foreign jurisdiction) objects to any of our proposed proprietary drug

names for any of our product candidates, if approved, we may be required to expend significant additional resources in

an effort to identify a suitable proprietary drug name that would qualify under applicable trademark laws, not infringe the

existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a

trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the

owner of a senior trademark. At times, competitors or other third parties may adopt trade names or trademarks similar to

ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there

could be potential trade name or trademark infringement claims brought by owners of other registered trademarks,

common law trademarks (in territories where such claims are permitted under local laws) or trademarks that incorporate

variations of our registered or unregistered trademarks or trade names. If we assert trademark infringement claims, a

court may determine that the trademarks we have asserted are invalid or unenforceable, or that the party against whom

we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately

be forced to cease use of such trademarks, and may be forced to expend resources to identify, protect, and promote a

new trademark to allow for commercialization of certain products.

We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual

property.

We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or

other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application

can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views

regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign

nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties

involved in developing our product candidates or as a result of questions regarding co-ownership of potential joint

inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership.

Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property.

If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual

property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could

have a material adverse effect on our competitive position, business, financial conditions, results of operations, and

prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a

distraction to management and other employees.

Our licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the U.S.

government, such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third

parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our

competitors, and our competitors could market competing products and technology. This could have a material adverse

effect on our competitive position, business, financial conditions, results of operations, and prospects.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or

development of intellectual property to execute agreements assigning such intellectual property to us, we may be

unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property

that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment

agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they

may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have

a material adverse effect on our business, financial condition, results of operations, and prospects.

Our proprietary rights may not adequately protect our technologies and product candidates, and do not necessarily

address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property

rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage.

The following examples are illustrative:

•others may be able to make products that are the same as or similar to our product candidates but that are not

covered by the claims of the patents that we own or have exclusively licensed;

•others, including inventors or developers of our or our owned or in-licensed patented technologies who may

become involved with competitors, may independently develop similar technologies that function as alternatives or

replacements for any of our technologies without infringing our intellectual property rights;

•we or our licensors or our other collaboration partners might not have been the first to conceive and reduce to

practice the inventions covered by the patents or patent applications that we own or license or will own or license;

•we or our licensors or our other collaboration partners might not have been the first to file patent applications

covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or

will have obtained a license;

•we or our licensors may fail to meet obligations to the U.S. government with respect to in-licensed patents and

patent applications funded by U.S. government grants, leading to the loss of patent rights;

•it is possible that our pending patent applications will not result in issued patents;

•it is possible that there are prior public disclosures that could invalidate our or our licensors’ patents;

•issued patents that we own or exclusively license may not provide us with any competitive advantage, or may be

held invalid or unenforceable, as a result of legal challenges by our competitors;

•our competitors might conduct R&D activities in countries where we do not have patent rights, or in countries where

R&D safe harbor laws exist, and then use the information learned from such activities to develop competitive

products for sale in our major commercial markets;

•ownership, validity or enforceability of our or our licensors’ patents or patent applications may be challenged by

third parties; and

•the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect

on our business.

Risks Related to Employee Matters and Managing Growth

Our future success depends on our ability to retain key members of our management team and to attract, retain and

motivate qualified personnel.

We are highly dependent on the management, technical and scientific expertise of principal members of our

management and scientific teams, including Christian Behrenbruch, our Managing Director and Group Chief Executive

Officer. Although we have entered into formal employment agreements with our executive officers, these agreements do

not prevent them from terminating their employment with us at any time by providing notice within the notice period

specified in such agreements, subject to certain exceptions. We do not maintain “key person” insurance for any of our

executives or other employees. The loss of the services of any of our key employees could impede the achievement of

our research, development, commercialization and other business objectives.

Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel is critical to our

success. We may not be able to attract and retain these personnel on acceptable terms given the competition among

numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the

hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants

and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and

commercialization strategies. Our consultants and advisors may be employed by employers other than us and may have

commitments under consulting or advisory contracts with other entities that may limit their availability to us.

We expect to continue to expand our development and regulatory capabilities, and as a result, we may encounter

difficulties in managing our growth, which could disrupt our operations.

We have experienced rapid growth since our inception in 2017. We expect continued growth in the number of our

employees and the scope of our operations, particularly to continue our clinical operations, preclinical and IND-enabling

studies or studies approved by comparable foreign authorities and to establish regulatory, quality, and manufacturing

supply chain logistics and facility operations.

To manage our anticipated future growth, we will continue to seek to implement and improve our managerial, operational,

and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. Due to our

limited financial resources and the complexity in managing a company with such anticipated growth, we may not be able

to effectively manage the expansion of our operations or recruit and train additional qualified personnel. In addition, we

are completing the commissioning of a European manufacturing facility in Brussels South and have limited experience in

managing the manufacturing processes necessary for delivering potent therapeutic radioisotopes. The expansion of our

operations may lead to significant costs and may divert our management and business development resources. Any

inability to manage growth could delay the execution of our business plans or disrupt our operations.

In addition, future growth imposes significant added responsibilities on members of management, including: identifying,

recruiting, integrating, maintaining, and motivating new employees; managing our internal development efforts

effectively, including the clinical and FDA, or comparable foreign regulatory authority, and review process for our

Commercial Products and any product candidates, while complying with our contractual obligations to third parties; and

improving our operational, financial and management controls, reporting systems, and procedures. We currently rely, and

for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors, and

consultants to provide certain services, including strategic, financial, business development, and research and

development services, as well as certain aspects of regulatory approval and manufacturing. There can be no assurance

that the services of independent organizations, advisors, and consultants will continue to be available to us on a timely

basis when needed or on reasonable terms, or that we can find qualified replacements. In addition, if we are unable to

effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants, CROs,

or CMOs is compromised for any reason, our preclinical or clinical trials may be extended, delayed, or terminated, and we

may not be able to obtain and/or maintain regulatory approval of our Commercial Products or any of our product

candidates or otherwise advance our business. We cannot assure you that we will be able to manage our existing

consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If we are not able to effectively expand our organization by hiring new qualified employees and expanding our groups of

consultants and contractors, we may experience delays or may not be able to successfully implement the tasks

necessary to further develop and commercialize our Commercial Products and any product candidates we develop and,

accordingly, we may not achieve our research, development, and commercialization goals.

Our business and operations may be materially adversely affected in the event of information technology system

failures or security breaches, and the costs and consequences of implementing data protection measures could be

significant.

Despite the implementation of security measures, our internal computer systems, and those of our CROs and other third

parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, fire,

terrorism, war and telecommunication and electrical failures. Such systems are also vulnerable to service interruptions or

to security breaches from inadvertent or intentional actions by our employees, third-party vendors and/or business

partners, or from cyber incidents initiated by malicious third parties. Cyber incidents are increasing in their frequency,

sophistication and intensity, and have become increasingly difficult to detect, respond to and recover from. Cyber

incidents could include the deployment of harmful malware, ransomware, denial-of-service attacks, unauthorized access

to or deletion of files, social engineering and other means to affect service reliability and threaten the confidentiality,

integrity and availability of information. Cyber incidents also could include phishing attempts or e-mail fraud to cause

payments or information to be transmitted to an unintended recipient. We could be subject to risks caused by

misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the

information systems and networks of our company, including personal data of our employees, patients and clinical trial

participants. In addition, we face other kinds of risks related to our commercial and personal data, including lost or stolen

devices or other systems (including paper records) that collect and store our personal and commercial information,

including clinical trial data.

If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our

development and commercialization programs and our business operations, whether due to a loss of our trade secrets or

other proprietary information or other similar disruptions. For example, the loss of clinical trial data from completed,

ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our

costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or

damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur

liability, our reputation or competitive position could be damaged, and the further development and commercialization of

our products or product candidates could be delayed or halted. In addition, we may in certain instances be required to

provide notification to individuals or others in connection with the loss of their personal or commercial information.

If a material breach of our security or that of our vendors occurs, our financial or other confidential information could be

compromised and could adversely affect our business or result in legal proceedings. In addition, the cost and operational

consequences of implementing further data protection measures could be significant. The development and

maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as

technologies change and efforts to overcome security measures become more sophisticated. Moreover, the possibility of

these events occurring cannot be eliminated entirely.

Our employees, independent contractors, consultants, clinical trial investigators, collaborators and vendors may

engage in misconduct or other improper activities, including non-compliance with regulatory standards and/or

requirements and insider trading, which could cause significant liability for us and harm our reputation.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, consultants,

collaborators and vendors. Misconduct by these partners could include intentional, reckless and/or negligent conduct or

unauthorized activities that violate FDA regulations or similar regulations of comparable foreign regulatory authorities;

provide inaccurate information to the FDA or comparable foreign regulatory authorities; fail to comply with manufacturing

standards, federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations

established and enforced by comparable foreign regulatory authorities; fail to comply with state drug pricing

transparency filing requirements; fail to report financial information or data accurately; or fail to disclose unauthorized

activities to us. Employee 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. This could include violations of

HIPAA, other U.S. federal and state laws, and requirements of foreign jurisdictions, including GDPR. We are also exposed

to risks in connection with any insider trading violations by employees or others affiliated with us. It is not always

possible to identify and deter employee or third-party misconduct, and the precautions we take to detect and prevent

these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from

significant penalties, governmental investigations or other actions or lawsuits stemming from a failure to be in

compliance with such laws, standards, regulations, guidance or codes of conduct. 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.

Legal claims and proceedings could adversely impact our business.

We have been in the past the subject of employment-related claims, and may in the future be a party to employment-

related litigation, and any future litigation related to such actions could materially adversely affect us. We consider our

historical experiences with such claims and proceedings to be in the normal course of our business or typical for our

industry; however, it is difficult to assess the outcome of these matters, and we may not prevail in any future

proceedings or litigation. Regardless of their merit, any threatened or actual claims or proceedings can require significant

time and expense to investigate and defend. Since litigation is inherently uncertain, there is no guarantee that we will be

successful in defending ourselves against such claims or proceedings, or that our assessment of the materiality of these

matters, including any reserves taken in connection therewith, will be consistent with the ultimate outcome of such

matters.

Risks Related to Sustainability

We may experience sustainability risks, including: physical climate-related risks such as extreme weather events

that could disrupt internal operations, suppliers, and logistics, and increase operational costs; resource and energy

risks such as increasing energy prices, regulatory actions and increased resource efficiency standards that may

increase operating expenses and capital expenditure for facility upgrades; and, non-compliance with increased

social and governance regulations that could lead to fines, reputational damage, and increased compliance costs.

The Group identifies and manages sustainability risks through a structured process aligned with global reporting

standards and investor expectations. In 2025, the Group completed a Double Materiality Assessment ("DMA"), which

evaluates both impact materiality (how operations affect the environment and society) and financial materiality (how

these impacts influence enterprise value). This assessment informs strategic priorities, and we have identified the

following risk areas:

•Physical Climate Risk: Extreme weather events such as floods, storms, and heatwaves may disrupt suppliers and

logistics, increase operational costs, and threaten facility safety.

•Resource and Energy Risk: Rising energy prices and regulatory actions on resource efficiency standards may

increase operating expenses and capital requirements for facility upgrades and sustainable alternatives.

•Social and Governance Risks: Non-compliance with health and safety, end-user data privacy, and anti-corruption

regulations may result in fines, reputational damage, and increased compliance costs.

These risks and others are described in greater detail in the following risk factors and in our Sustainability report.

Physical Climate Risks

Increasing frequency and severity of climate-related events could disrupt our manufacturing, key suppliers, logistics

and workforce and adversely affect our business and we may not be sufficiently resilient to physical climate risks,

requiring significant investment and potentially constraining our site selection.

Our global operations are exposed to acute and chronic physical risks associated with climate change, including more

frequent and severe storms, floods, heatwaves, wildfires, and other extreme weather events. These events can damage

or impair our manufacturing facilities, laboratories, warehouses, clinical trial sites, data centers and office locations, and

can disrupt utilities and critical infrastructure on which we depend. They may also interrupt our logistics and distribution

networks, including air, sea and land transport routes, and compromise the ability of our employees and contractors to

safely travel to and from company and third‑party sites. Any such disruption could delay the manufacture, testing,

release and delivery of our Commercial Products and regulatory trial materials, increase operating and capital costs

surrounding repairs, hardening, redundancy and insurance, and result in product shortages, lost revenue and damage to

our relationships with customers, healthcare providers and partners. If these climate‑related events increase in frequency

or severity or occur in regions that are strategically important to us, our business, financial condition and results of

operations could be materially and adversely affected.

Certain of our existing facilities and those of our critical suppliers and contract manufacturers are located in regions that

are exposed to increased physical climate risks. Enhancing the resilience of these sites through elevation, hardening,

redundancy in utilities, flood protection, enhanced cooling or other measures may require significant capital expenditures

and extended project timelines. In addition, as we consider new manufacturing, research or distribution sites, physical

climate risk is increasingly a factor in site selection. Suitable locations that offer both operational advantages and

acceptable climate risk profiles may be limited, more expensive, or subject to competing demand from other companies.

If we are unable to adequately assess and mitigate climate‑related physical risks at our existing and future sites, we

could experience higher operating and transportation costs, more frequent disruptions, and constraints on our ability to

expand capacity in a timely and cost‑effective manner.

Water scarcity and wastewater management regulations may adversely affect our manufacturing operations, quality

controls and expansion plans.

Many of our Commercial Products and active pharmaceutical ingredients (“APIs”) are manufactured using water‑intensive

processes which require access to reliable sources of water of appropriate quality, as well as adequate wastewater

treatment and discharge infrastructure. In some regions where we operate or may expand, climate change is contributing

to water scarcity, drought, flooding, or changes in water quality and regulatory requirements. Governments in the

countries where we manufacture our products may impose stricter limits on industrial water use, require additional

investments in water treatment, or restrict new permits and expansions in water‑stressed areas. In some regions, tighter

regulation of industrial water use, wastewater discharge, waste management, and renewable energy procurement is

affecting the feasibility and cost of pharmaceutical operations. We may face requirements to invest in additional on‑site

water or waste infrastructure, secure long‑term renewable energy contracts, or demonstrate compliance with local

climate and environmental standards as a condition to permitting or operating. If we are unable to identify targets or sites

that meet our operational needs and ESG expectations, or if environmental and resource constraints materially increase

the cost or complexity to secure sufficient, reliable and compliant water and wastewater capacity on acceptable terms,

we may be forced to reduce production volumes, reconfigure or relocate manufacturing operations, or materially alter

strategic plans or expansions. We may also incur higher costs to treat, recycle or transport water and wastewater, or to

install alternative water technologies. Any of these developments could adversely affect our manufacturing reliability,

product quality, cost structure and growth strategy.

Climate-related disruptions to transportation and cold-chain logistics could impair the distribution and integrity of

our products.

Many of our products, drug substances and intermediates, including temperature‑sensitive biologics and, where

applicable, radiopharmaceuticals and other hazardous materials, must be stored and transported under strict

temperature‑controlled conditions and delivered within defined time windows. Climate‑related impacts and extreme

weather events, including, but not limited to heatwaves, arctic storms, tropical storms, flooding, and potential resulting

infrastructure failure, can disrupt air and ground transportation, reduce availability of cargo capacity, and increase the

risk of temperature excursions or delays during shipping. We substantially rely on third‑party logistics providers, specialty

couriers, and in some cases just‑in‑time manufacturing and delivery models. Any failure in transport infrastructure or

cold‑chain logistics due to physical climate events, power outages, or related issues could result in spoilage, loss, or

delays of finished products or clinical supplies. This could lead to product shortages, recalls, regulatory non‑compliance,

contractual penalties, or damage to our reputation, any of which could materially and adversely affect our business.

Resource and Energy Risks

Our operations depend on reliable access to energy and increasing energy costs, supply disruptions and

decarbonization pressures could adversely affect our business.

Our manufacturing, research, information technology systems, and office operations require significant and growing

amounts of energy to operate. Climate change and the global transition to a lower‑carbon economy are contributing to

energy price volatility, changes in energy mix, and, in some regions, constraints on grid reliability and capacity. We also

anticipate higher energy demand for temperature control in our facilities and across our distribution network as global

average temperatures rise. We are implementing measures to reduce greenhouse gas emissions, which may include

entering into virtual power purchase agreements and power purchase agreements, investing in on‑site renewable energy

installations, and improving energy usage efficiency. These initiatives require capital and may not be available on

acceptable terms in all jurisdictions, particularly where competition for renewable energy is increasing. If we experience

sustained energy price increases, energy supply interruptions, or are unable to execute our energy strategy effectively,

our capital expenditures and operating costs could increase and our ability to meet sustainability commitments could be

impaired, causing our business and results of operations to be adversely affected.

Limited availability or regulatory constraints on critical raw materials, including biologics and other specialized

inputs, could increase our costs and disrupt production.

We rely on a wide range of raw materials, packaging materials and specialized inputs sourced from third parties

worldwide. These include, but are not limited to, materials derived from biological sources (such as components used in

certain quality control tests), as well as materials that are manufactured using fossil fuel‑based feedstocks or complex

chemical processes. Environmental degradation, biodiversity loss, such as declines in certain species used in

pharmaceutical testing or production, regulatory restrictions, and changes in conservation or harvesting policies may

reduce the availability or increase the cost of some of these inputs. If key materials become scarce, become subject to

new environmental or animal‑welfare regulations, or are concentrated among a small number of suppliers able to meet

evolving ESG standards, we may incur higher procurement costs, need to invest in reformulation or alternative

technologies, or experience delays or interruptions in manufacturing. Any significant interruption in the supply of critical

biologics or raw materials could adversely affect our ability to manufacture and deliver products on a timely basis and

could negatively impact our financial performance.

Transitioning our operations and supply chain to a lower‑carbon model may require substantial investment and may

not proceed as planned.

Regulators, investors, customers and other stakeholders increasingly expect pharmaceutical companies to reduce

greenhouse gas emissions, including Scope 3 emissions across their supply and value chains. Meeting these

expectations may require us to modify processes, invest in new equipment or technologies, change product designs or

packaging, restructure logistics networks, and shift to lower‑carbon energy and materials. For certain specialized

technologies, such as energy‑intensive manufacturing steps or generation of medical isotopes where applicable,

economical low‑carbon alternatives may not yet be available or scalable. If we are unable to implement our

decarbonization initiatives on commercially reasonable terms, or if regulation accelerates faster than technology and

markets evolve, we may face higher compliance costs, potential carbon pricing or taxes, and constraints on operations or

expansion in certain markets. Failure to meet our stated climate or energy targets could also adversely affect our

reputation and our relationships with investors, customers and partners.

We generate hazardous and, at times, radioactive and biologically active waste where evolving environmental, health

and safety requirements may increase our costs and liabilities.

Our manufacturing, research and development, and where relevant, radiopharmaceutical operations, generate

hazardous, chemical, biological and, in some cases, radioactive waste that must be collected, handled, stored,

transported, treated and disposed of in compliance with complex and evolving environmental, health and safety laws and

regulations. Regulators may impose more stringent requirements over time, including with respect to waste minimization,

tracking, treatment technology, emissions limits and long‑term disposal obligations. As the scale and complexity of our

operations expand, the volume of such waste we generate is likely to increase. We may need to invest in additional

on‑site infrastructure, contract with specialized third‑party waste management providers, or adapt to changes in

available disposal capacity or technology. Any failure of our ability to properly manage hazardous or radioactive materials

and waste could result in regulatory enforcement, cleanup obligations, operational restrictions, civil or criminal penalties,

or claims for personal injury, property damage, or environmental harm. Such events could materially and adversely affect

our business, financial condition, results of operations and reputation.

Social and Governance Risks

Failure to meet evolving environmental, social and governance disclosure expectations and regulatory requirements

could adversely affect our access to capital, valuation and reputation.

Evolving expectations and regulatory requirements relating to ESG matters, including climate-related issues, could

adversely affect our business, financial condition and prospects. Regulators and standard-setting bodies in the European

Union and other jurisdictions in which we operate are implementing or may implement new requirements regarding

climate-related and broader ESG disclosures, including with respect to greenhouse gas emissions, climate risk

governance and supply chain transparency. Investors, lenders, customers and other stakeholders are also increasingly

relying on ESG ratings, benchmarks and voluntary disclosures in making investment, procurement and business

decisions. Collecting, verifying and reporting ESG data across our global operations and value chain is exceptionally

complex and resource-intensive while being subject to evolving standards and methodologies. Failure to adequately

integrate ESG considerations, including climate resilience, resource use, human rights and compliance with

environmental and safety regulations, into our governance structures, risk management processes, strategic planning,

capital allocation and expansions could lead to suboptimal decisions, stranded assets, unanticipated compliance and

remediation costs, and underperforming acquisitions. If our ESG-related disclosures or actions are perceived as

incomplete, inaccurate, inconsistent or not aligned with emerging regulatory, customer or investor expectations, we

could face regulatory scrutiny, investigations, sanctions, fines, litigation, reduced access to capital or less favorable

financing terms, and damage to our reputation, and our ability to attract and retain certain investors could be adversely

affected.

ESG practices, especially regarding diversity, equity and inclusion (“DEI”), have been increasingly subject to political

controversy in the United States in recent years. Our policies and practices regarding DEI and other ESG-related matters,

including those that may be required by non-U.S. law, may expose us to legal, reputational and other risks, including anti-

ESG and anti-DEI-related orders, investigations, legislation, litigation, media coverage and scrutiny, boycotts and

negative publicity from investors and other stakeholders. We cannot predict what regulatory or other changes may occur

in the future as a result of this controversy, and we may not be able to meet any conflicting expectations of some or all of

our investors, customers, employees and other third parties (including governmental entities and officials and non-

governmental organizations) regarding various aspects of our business, including with respect to DEI and other ESG

matters.

Failure to manage ESG risks across our operations, workforce and global value chain could result in legal, operational

and reputational harms.

Inadequate management of ESG risks across our operations, workforce and global value chain, including labor, human

rights, modern slavery and climate-related health and safety risks, could adversely affect our operations, reputation and

competitive position. We operate in, and source products and services from, multiple countries, including regions with

higher risks relating to labor practices, human rights and modern slavery. We substantially rely on third-party suppliers,

contract manufacturers, distributors, logistics providers and other partners, some of which in turn rely on their own

complex supply chains, and we may not have complete visibility into or control over their practices. Stakeholders and

regulators are increasingly scrutinizing companies’ efforts to prevent forced labor, child labor, unsafe working conditions

and other human rights abuses in their operations and supply chains. Our employees and contractors work in

manufacturing plants, laboratories, offices, distribution centers and in the field, and climate change can exacerbate

occupational health and safety risks, including heat stress, vector-borne diseases, air quality issues and extreme weather

events. Inadequate planning for emergency response, workplace adaptation, remote work capabilities or business

continuity in the face of climate-related events could lead to increased absenteeism, reduced productivity, higher

healthcare and insurance costs, and difficulties recruiting and retaining talent, particularly in climate-stressed regions.

Public and private healthcare systems, hospital groups, group purchasing organizations and other customers are

increasingly considering suppliers’ environmental and social performance, including carbon footprint, waste and water

management, supply chain practices and human rights, when making procurement and reimbursement decisions, and

some tenders and contracts include ESG criteria or require detailed ESG disclosures.

If we or our partners fail to meet applicable modern slavery, human rights, labor or climate-related health and safety

standards, or if we are unable to demonstrate ESG performance, climate risk management and supply chain transparency

that meet the expectations of key stakeholders, we could face regulatory investigations, fines, litigation, supply

disruptions, product boycotts, loss of customers, reduced pricing power, exclusion from preferred supplier lists and

restrictions on access to certain markets, and our reputation and demand for our products could be adversely affected.

Risks Related to an Investment in the ADSs

An active and liquid market for our securities may not continue to be developed or sustained, which could harm the

market price of the ADSs.

While our ordinary shares have been listed on the ASX since 2017, prior to the November 2024 listing of the ADSs on

Nasdaq, there was no public market on a U.S. national securities exchange for our ordinary shares or ADSs. Given the

limited trading history, an active trading market for the ADSs may not continue to be developed or sustained. In the

absence of an active trading market for the ADSs, investors may not be able to sell their ADSs.

Future sales of ordinary shares or ADSs by existing holders could depress the market price of the ordinary shares or

ADSs.

Sales of a substantial number of shares or ADSs in the public market, or the perception that such sales could occur,

could adversely affect the market price of our ordinary shares or ADSs. As of December 31, 2025, we had 338,777,049

outstanding ordinary shares, and approximately 31,744,502 in ordinary shares underlying outstanding share options and

other equity securities convertible into or exercisable for ordinary shares. In addition, as of December 31, 2025, there

were approximately 26,230,831 ordinary shares underlying outstanding Convertible Bonds, which may be converted at

the option of the holders, subject to the conditions in the trust deed, at any time on or after September 9, 2024, at an

initial conversion price of A$24.78 per ordinary share, subject to adjustment.

Ordinary shares underlying these securities may become eligible for sale in the public market in the future, subject to

certain legal and contractual limitations. Sales of a large number of the ordinary shares in the public market could

depress the market price of the ordinary shares or the ADSs. If these additional ordinary shares are sold, or if it is

perceived that they will be sold, in the public market, the trading price of the ordinary shares and ADSs could decline

substantially, which could impair our ability to raise additional capital through the issuance of ordinary shares, ADSs or

other securities in the future.

Our shareholders may experience dilution if we issue ordinary shares or ADSs in future financings, and, as a result,

the price of the ordinary shares or ADSs may decline.

We may from time-to-time issue additional ordinary shares or ADSs and such issuance may occur at a discount from the

trading price of the ordinary shares or ADSs. Additionally, we have in the past issued debt securities convertible into

equity, and we may do so again in the future. For example, in July 2024, we issued the Convertible Bonds, which may be

converted into ordinary shares. As a result, holders of the ADSs could experience immediate dilution upon the issuance

of any of our ordinary shares, including as a result of the conversion of some or all of the Convertible Bonds. As

opportunities present themselves, we may enter into financing or similar arrangements in the future, including the

issuance of debt securities, preference shares or shares. If we issue ordinary shares or other equity or equity-linked

securities, holders of ADSs would experience additional dilution and, as a result, the trading price of the ordinary shares

or ADSs may decline.

The rights of holders of ADSs to participate in any future preferential subscription rights offering or to elect to

receive dividends in ordinary shares may be limited, which may cause dilution to their holdings.

The deposit agreement provides that the depositary will not make rights available to holders of ADSs unless the

distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act or

exempted from registration under the U.S. Securities Act of 1933, as amended ("Securities Act"). If we offer holders of

our ordinary shares the option to receive dividends in either cash or shares, under the deposit agreement the depositary

may require satisfactory assurances from us that extending the offer to holders of ADSs does not require registration of

any securities under the Securities Act before making the option available to holders of ADSs. 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. Accordingly, ADS holders may be unable to participate in our rights offerings or to elect to receive

dividends in shares and may experience dilution in their holdings. In addition, if the depositary is unable to sell rights that

are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in

which case holders of ADSs will receive no value for these rights.

Our principal shareholders and management own a significant percentage of our ordinary shares and may be able to

exert significant influence over matters subject to shareholder approval.

As of December 31, 2025, our executive officers, directors, holders of 5% or more of our outstanding equity interests and

their respective affiliates beneficially owned approximately

7.71%

of our outstanding ordinary shares. These shareholders

may be able to determine all matters requiring shareholder approval and they may have interests that differ from other

shareholders and may be adverse to the interests of other shareholders. For example, these shareholders may be able to

propose elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets,

or other major corporate transaction, and may be able to exert significant influence over matters subject to shareholder

approval. Please see "Item 7. Major Shareholders and Related Party Transactions - A. Major Shareholders" for more

information on the beneficial ownership of our executive officers, directors and holders of 5% or more of our outstanding

equity interests.

ADS holders may not be entitled to a trial by jury with respect to claims arising under the deposit agreement, which

could result in less favorable outcomes to the plaintiffs in any such action.

The deposit agreement governing our ADSs provides that, to the fullest extent permitted by applicable law, ADS holders,

including holders who acquire ADSs in the secondary market, irrevocably waive the right to a trial by jury for any claim

they may have against us or the depositary arising out of or relating to the deposit agreement, the shares or the ADSs,

including claims under U.S. federal securities laws.

If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver

was enforceable based on the facts and circumstances of that case in accordance with the applicable state and federal

law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising

under the federal securities laws has not been finally adjudicated by the U.S. Supreme Court. If this jury trial waiver

provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement

with a trial by jury. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable,

including under the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the

City of New York, which has non-exclusive jurisdiction over matters arising under the deposit agreement. In determining

whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of

the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any

right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable

that potential owners or holders of ADSs consult legal counsel regarding the jury waiver provision before acquiring any

ADS(s) and thereby becoming subject to the terms of the deposit agreement.

If any owner or holder of our ADSs, including purchasers of ADSs in secondary market transactions, brings a claim

against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including

claims under U.S. federal securities laws, such owner or holder may incur increased costs of bringing a claim and may not

be entitled to a trial by jury with respect to such claims, which may have the effect of limiting and discouraging lawsuits

against us or the depositary. If a lawsuit is brought against us or the depositary under the deposit agreement, it may be

heard only by a judge of the applicable trial court, which would be conducted according to different civil procedures and

may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the

plaintiffs in any such action. The deposit agreement governing our ADSs provides that any legal suit, action or

proceeding against or involving us brought by the depositary or any holder or beneficial owner of ADSs, arising out of or

based upon the deposit agreement, the ADSs, the ADRs or the transactions contemplated therein or thereby, may be

instituted only in any state or federal court in New York, New York. This forum provision may increase costs to owners or

holders of ADRs and limit their ability to bring a claim in a judicial forum that they find favorable for disputes with the

depositary or us, or the depositary’s or our respective directors, officers or employees, which may discourage such

lawsuits against the depositary, us and the depositary’s and our respective directors, officers or employees. However, it

is possible that a court could find this choice of forum provision to be inapplicable or unenforceable. The enforceability of

similar choice of forum provisions has been challenged in legal proceedings. Any legal suit, action or proceeding against

or involving the depositary brought by us, arising out of or based upon the deposit agreement, the ADSs, the ADRs or the

transactions contemplated therein or thereby, may only be instituted in a state or federal court in New York, New York.

No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial

owner of ADSs or by us or the depositary of compliance with any provision of U.S. federal securities laws and the rules

and regulations promulgated thereunder.

Limitations in the deposit agreement may not be effective to waive claims against the Company based on compliance

with the federal securities laws.

Although the deposit agreement provides a waiver of trial by jury as described above, we have been advised that no

condition, stipulation or provision of the deposit agreement or ADSs can serve as a waiver by any owner or holder of

ADSs or by us or the depositary of compliance with any substantive provision of the U.S. federal securities laws and the

rules and regulations promulgated thereunder.

The market price and trading volume of the ADSs may be volatile and may be affected by economic conditions

beyond our control.

The market price of the ADSs may be highly volatile and subject to wide fluctuations. The stock market in general, and

the market for biopharmaceutical companies in particular, has experienced extreme volatility that has often been

unrelated to the operating performance of particular companies. In addition, the trading volume of the ADSs may

fluctuate and cause significant price variations to occur. If the market price of the ADSs declines significantly, you may

be unable to resell the ADSs at or above the purchase price, if at all. We cannot assure you that the market price of the

ADSs will not fluctuate or significantly decline in the future.

Some specific factors that could negatively affect the price of the ADSs or result in fluctuations in their price and trading

volume include:

•adverse results or delays in our preclinical studies or clinical trials;

•reports of adverse events or other negative results in clinical trials of third parties’ product candidates that target

our products’ or product candidates’ target indications;

•an inability for us to obtain additional funding on reasonable terms or at all;

•any delay in submitting an IND, BLA or NDA (or similar foreign application) for our product candidates and any

adverse development or perceived adverse development with respect to the FDA’s (or comparable foreign

regulatory authority’s) review of that IND, BLA or NDA (or similar foreign application);

•failure to develop successfully and commercialize our products and product candidates;

•announcements we make regarding our current products and product candidates, acquisition of potential new

products/product candidates and companies and/or in-licensing;

•failure to maintain our existing license arrangements or enter into new licensing and collaboration agreements;

•failure by us or our licensors to prosecute, maintain or enforce our intellectual property rights;

•changes in laws or regulations applicable to current and future products;

•inability to obtain adequate clinical or commercial supply for our product candidates or the inability to do so at

acceptable prices;

•adverse regulatory decisions, including failure to reach agreement with applicable regulatory authorities on the

design or scope of our planned clinical trials;

•failure to obtain and maintain regulatory exclusivity for our products and product candidates;

•regulatory approval or commercialization of new products or other methods of treating our target disease

indications by our competitors;

•failure to meet or exceed financial projections we may provide to the public or to the investment community;

•publication of research reports or comments by securities or industry analysts;

•the perception of the pharmaceutical and biotechnology industries, and especially the radiopharmaceutical industry,

by the public, legislatures, regulators and the investment community;

•announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our

strategic collaboration partners or our competitors;

•disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to

obtain patent protection for our technologies;

•additions to or departures of our key scientific or management personnel;

•significant lawsuits, including patent or shareholder litigation, against us;

•changes in the market valuations of similar companies;

•fluctuations of exchange rates between the U.S. dollar and the Australian dollar;

•changes in trading volume of ADSs on Nasdaq and of our ordinary shares on the ASX;

•sales or perceived potential sales of the ADSs or ordinary shares by us, our directors, executive officers or our

shareholders in the future;

•announcement or expectations of additional financing efforts; and

•conditions in the U.S. or Australian financial markets or changes in general economic conditions.

ADS holders are not our shareholders and do not have shareholder rights.

JPMorgan Chase Bank, N.A., as depositary, issues, registers and delivers the ADSs. After purchasing an ADS, holders

hold ADSs with underlying ordinary shares in an Australian publicly listed company. ADS holders are not treated as our

shareholders and do not have shareholder rights. The depositary is the holder of our ordinary shares underlying the

ADSs. Holders of ADSs have ADS holder rights, which are solely contractual in nature. A deposit agreement among us,

the depositary, ADS holders, and the beneficial owners of ADSs, sets out ADS holder rights as well as the rights and

obligations of the depositary. New York law governs the deposit agreement and the ADSs. We and the depositary may

amend or terminate the deposit agreement without the ADS holders’ consent in a manner that could prejudice ADS

holders. For a description of ADS holder rights, see “Item 12. Description of Securities Other than Equity Securities — D.

American Depositary Shares.” Our shareholders have shareholder rights. Australian law and our Constitution govern

shareholder rights. For a description of our shareholders’ rights, see “Item 10. Additional Information — B. Memorandum

and Articles of Association.”

ADS holders do not have the same voting rights as our shareholders. Shareholders are entitled to receive our notices of

general meetings and to attend and vote at our general meetings of shareholders. At a general meeting, every

shareholder present and entitled to vote has one vote on a show of hands. Every shareholder present (in person or by

proxy, attorney or representative) and entitled to vote has one vote per fully paid ordinary share on a poll. This is subject

to any other rights or restrictions that may be attached to any shares. ADS holders may exercise voting rights with

respect to the ordinary shares represented by the ADSs only in accordance with the provisions of the deposit agreement.

ADS holders may instruct the depositary to vote the ordinary shares underlying their ADSs. Otherwise, ADS holders are

not entitled to exercise their right to vote unless they surrender their ADSs and withdraw the ordinary shares underlying

their ADSs prior to both the ordinary share and ADS record dates for such meeting.

However, ADS holders may not have sufficient advance notice about the meeting to surrender their ADSs and withdraw

the shares. If we ask for ADS holders’ instructions, the depositary will notify registered holders of ADSs of the upcoming

vote and arrange to deliver our voting materials and form of notice to them. If we ask the depositary to solicit voting

instructions, the depositary will try, as far as practical, subject to Australian law and the provisions of the depositary

agreement, to vote the shares as ADS holders instruct. The depositary will not vote or attempt to exercise the right to

vote other than in accordance with the instructions of ADS holders. We cannot assure ADS holders that they will receive

the voting materials in time to ensure that they can instruct the depositary to vote their shares. In addition, there may be

other circumstances in which ADS holders may not be able to exercise voting rights.

ADS holders do not have the same rights to receive dividends or other distributions as our shareholders. Subject to any

special rights or restrictions attached to any shares, the directors may determine that a dividend will be payable on our

ordinary shares and fix the amount, the time for payment and the method for payment (although we have never declared

or paid any cash dividends on our ordinary shares and we do not anticipate paying any cash dividends in the foreseeable

future). Dividends may be paid on our ordinary shares of one class but not another and at different rates for different

classes. Dividends and other distributions payable to our shareholders with respect to our ordinary shares generally will

be payable directly to them. Any dividends or distributions payable with respect to ordinary shares represented by ADSs

will be paid to the depositary, which has agreed to pay to ADS holders the cash dividends or other distributions it or the

custodian receives on shares or other deposited securities, after deducting its fees and expenses. Before the depositary

makes a distribution to you in respect of your ADSs, any withholding taxes that must be paid will be deducted.

Additionally, if the exchange rate fluctuates during a time when the ADS depositary cannot convert the foreign currency,

you may lose some or all of the value of the distribution.

ADS holders will receive these distributions in proportion to the number of ordinary shares their ADSs represent. In

addition, there may be certain circumstances in which the depositary may not pay to ADS holders amounts distributed by

us as a dividend or distribution.

There are circumstances where it may be unlawful or impractical to make dividends or other distributions to the

holders of the ADSs.

The deposit agreement requires the depositary to convert foreign currency distributions it receives on deposited

ordinary shares into U.S. dollars and distribute the net U.S. dollars to ADS holders if it can do so on a reasonable basis

and transfer the money to the U.S. If it cannot make that conversion and transfer, the deposit agreement allows the

depositary to distribute the foreign currency only to those ADS holders to whom it is possible to do so. If a dividend or

other distribution is payable by us in Australian dollars, the depositary will hold the foreign currency it cannot convert for

the account of ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any

interest. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, ADS

holders may lose some of the value of the dividend or other distribution. The depositary is not responsible if it decides

that it is unlawful or impractical to make a dividend or other distribution available to any ADS holders. This means that

ADS holders may not receive the dividends or other distributions we make on our ordinary shares or any value for them if

it is illegal or impractical for us to make them available to them.

There may be limited ability to bring an action against us or against our directors and executive officers, or to enforce

a judgment against us or them, because we are incorporated in Australia and certain of our directors and executive

officers reside outside of the

U.S

We are incorporated under the laws of Australia. Certain of our directors and executive officers are residents of countries

other than the U.S. and a portion of our and their assets are located outside of the U.S. As a result, it may not be possible

or practicable for owners or holders of ADSs to effect service of process within the U.S. upon such persons or to enforce

against us or them judgments obtained in U.S. courts predicated upon the civil liability provisions of the federal securities

laws of the U.S. Even if a plaintiff is successful in bringing such an action, there is doubt as to whether Australian courts

would enforce certain civil liabilities under U.S. securities laws in original actions or judgments of U.S. courts based upon

these civil liability provisions. In addition, awards of punitive damages in actions brought in the U.S. or elsewhere may be

unenforceable in Australia or elsewhere outside the U.S. An award for monetary damages under U.S. securities laws

would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered and is intended

to punish the defendant. The enforceability of any judgment in Australia will depend on the particular facts of the case as

well as the laws and treaties in effect at the time. As a result, our holders of our ADSs may have more difficulty in

protecting their interests through actions against us, our management or our directors than would shareholders of a

corporation incorporated in a jurisdiction in the U.S. In addition, as a company incorporated in Australia, the provisions of

the Corporations Act 2001, regulate the circumstances in which shareholder derivative actions may be commenced,

which may be different to the circumstances for companies incorporated in the U.S.

The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of the ADSs.

Our ordinary shares are listed on the ASX and our ADSs are listed on Nasdaq. We cannot predict the effect of our dual

listing on the value of our ordinary shares and the ADSs. However, the dual listing of our ordinary shares and the ADSs

may dilute the liquidity of these securities in one or both markets and may adversely affect the development of an active

trading market for the ADSs in the U.S. The price of the ADSs could also be adversely affected by trading in our ordinary

shares on the ASX.

We are subject to risks associated with currency fluctuations, and changes in foreign currency exchange rates could

impact our results of operations.

Our ordinary shares are quoted in Australian dollars on the ASX and the ADSs are quoted in U.S. dollars. In the past year,

the Australian dollar has fluctuated against the U.S. dollar. As such, any significant change in the value of the Australian

dollar may have a negative effect on the value of the ADSs in U.S. dollars. In addition, if the Australian dollar weakens

against the U.S. dollar, then, if we decide to convert our Australian dollars into U.S. dollars for any business purpose,

appreciation of the U.S. dollar against the Australian dollar would have a negative effect on the U.S. dollar amount

available to us. While we engage in limited hedging transactions to manage our foreign exchange risk, these activities

may not be effective in limiting or eliminating foreign exchange losses. Consequently, appreciation or depreciation in the

value of the Australian dollar relative to the U.S. dollar would affect our financial results reported in U.S. dollar terms

without giving effect to any underlying change in our business or results of operations. As a result of such foreign

currency fluctuations, it could be more difficult to detect underlying trends in our business and results of operations.

As a foreign private issuer, we are permitted to follow, and we do follow, certain home country corporate governance

practices in lieu of certain Nasdaq requirements applicable to domestic issuers.

As a foreign private issuer listed on Nasdaq, we are permitted to follow, and we do follow, certain home country

corporate governance practices in lieu of certain Nasdaq practices. In particular, we follow home country law instead of

Nasdaq practice, and expect to continue to follow home country law instead of Nasdaq practice, regarding the following:

•We rely on an exemption from the requirement that our independent directors meet regularly in executive sessions.

The ASX Listing Rules and the Australian Corporations Act 2001 (Cth) do not require the independent directors of an

Australian company to have such executive sessions and, accordingly, we rely on this exemption.

•We rely on an exemption from the requirement that the responsibility for the appointment of the independent

registered public accounting firm be made by the audit committee. While our Audit and Risk Committee is directly

responsible for remuneration and oversight of the independent registered public accounting firm, the ultimate

responsibility for the appointment of the independent registered public accounting firm rests with our shareholders

in accordance with Australian law and our Constitution. In accordance with Rule 10A-3 of the U.S. Securities

Exchange Act of 1934, as amended ("Exchange Act") our Audit and Risk Committee is responsible for the annual

auditor engagement and if there is any proposed change to the independent registered public accounting firm, the

committee will make a recommendation to our board of directors, which would then be considered by our

shareholders at an annual meeting of shareholders.

•We rely on an exemption from the quorum requirements applicable to meetings of shareholders under Nasdaq rules.

Our Constitution provides that two shareholders present and entitled to vote on a resolution at the meeting shall

constitute a quorum for a general meeting. Nasdaq requires that an issuer provide for a quorum as specified in its

bylaws for any meeting of the holders of ordinary shares, which quorum may not be less than 33 1/3% of the

outstanding shares of an issuer’s voting ordinary shares. Accordingly, because applicable Australian law and rules

governing quorums at shareholder meetings differ from Nasdaq’s quorum requirements, we rely on this exemption.

•We rely on an exemption from the requirement prescribed by Nasdaq that issuers obtain shareholder approval prior

to the issuance of securities in connection with certain acquisitions, changes of controls or private placements of

securities, or the establishment or amendment of certain stock option, purchase or other compensation plans.

Applicable Australian law and rules differ from Nasdaq requirements, with the ASX Listing Rules providing generally

for the ability to seek prior shareholder approval in numerous circumstances, including (i) issuance of equity

securities exceeding 15% of our issued share capital in any 12 month period (but, in determining the available issue

limit, securities issued under an exception to the rule or with shareholder approval are not counted), (ii) issuance of

equity securities to related parties, certain substantial shareholders and their respective associates (as defined in

the ASX Listing Rules) and (iii) directors or their associates acquiring securities under an employee incentive plan.

Due to differences between Australian law and rules and the Nasdaq shareholder approval requirements, we rely on

this exemption.

As long as we remain subject to the rules of the ASX, we will be unable to access equity capital without shareholder

approval if such equity capital sales would result in an equity issuance above regulatory thresholds and,

consequently, we could be unable to obtain financing sufficient to sustain our business if we are unsuccessful in

soliciting requisite shareholder approvals.

Our ability to access equity capital is subject to ASX Listing Rules 7.1 and 7.4, which provides that a company must not,

without shareholder approval, issue or agree to issue any equity securities, or other securities with rights to conversion

to equity, if such issue of securities, when aggregated with securities issued by the company during the previous 12-

month period, would be an amount that would exceed 15% of the number of ordinary shares on issue at the

commencement of the 12-month period, subject to certain adjustments and permitted exceptions.

Our equity issuances are subject to limitations under ASX Listing Rule 7.1 as long as we continue to be listed on the ASX

and this constraint may prevent us from raising the sufficient equity capital needed to conduct our operations as planned

without shareholder approval.

As a foreign private issuer, we are permitted to file less information with the SEC than a company that files as a

domestic issuer.

As a foreign private issuer, we are exempt from certain rules under the Exchange Act that imposes disclosure

requirements as well as procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition,

our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery

provisions of Section 16 of the Exchange Act; although, absent an exemption from the SEC, and effective March 18,

2026, our officers and directors will be subject to the insider reporting obligations under Section 16(a) of the Exchange

Act, including the requirements to file Forms 3, 4 and 5, pursuant to the Holding Foreign Insiders Accountable Act

enacted on December 18, 2025. Moreover, we are not required to file periodic reports and financial statements with the

SEC as frequently or as promptly as a company that files as a domestic issuer whose securities are registered under the

Exchange Act. Under Australian law, we prepare financial statements on an annual and semi-annual basis, and we are not

required to prepare or file quarterly financial information.

For as long as we are a “foreign private issuer,” we intend to file our annual financial statements on Form 20-F and

furnish our semi-annual financial statements on Form 6-K to the SEC as long as we are subject to the reporting

requirements of Section 13(g) or 15(d) of the Exchange Act. However, the information we file or furnish is not the same

as the information that is required in periodic reports for U.S. domestic issuers. Accordingly, there may be less

information publicly available concerning us than there is for a company that files as a U.S. issuer.

We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s

domestic reporting regime and cause us to incur additional legal, accounting and other expenses.

While we currently qualify as a foreign private issuer, we will be required to determine our status as a foreign private

issuer on an annual basis at the end of our second fiscal quarter. In order to maintain our current status as a foreign

private issuer, either (i) a majority of our ordinary shares must be either directly or indirectly owned of record by non-

residents of the U.S. or (ii) (a) a majority of our executive officers or directors must not be U.S. citizens or residents, (b)

more than 50 percent of our assets cannot be located in the U.S. and (c) our business must be administered principally

outside the U.S. If we lost this status, 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 rules and Nasdaq listing standards. Further, we would be required to comply with U.S. GAAP, as

opposed to IFRS Accounting Standards, in the preparation and issuance of our financial statements for historical and

current periods. If we are required to comply with the reporting requirements applicable to a U.S. domestic issuer, the

regulatory and compliance costs to us may be higher than the cost we 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.

If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with

applicable regulations could be impaired.

The Sarbanes-Oxley Act ("Sarbanes-Oxley") requires our management to evaluate the effectiveness of our internal

control over financial reporting and disclose its conclusions, which includes identifying any material weaknesses in our

internal control over financial reporting. Beginning with this annual report that we are filing with the SEC, our

management is required to provide an annual report on internal control over financial reporting, and in the future, we

expect that our independent registered public accounting firm will be required to issue an annual report that addresses

the effectiveness of our internal control over financial reporting.

In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over

financial reporting, we will need to expend significant resources and provide significant management oversight.

Implementing any appropriate changes to our internal controls may require specific compliance training of our directors

and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of

time to complete and divert management’s attention from other business concerns. These changes may not, however, be

effective in maintaining the adequacy of our internal control and preventing fraud.

If we are unable to conclude that we have effective internal control over financial reporting or, at the appropriate time, if

required, our independent auditors are unwilling or unable to provide us with an unqualified report on the effectiveness of

our internal control over financial reporting as required by Sarbanes-Oxley, investors may lose confidence in our

operating results, the price of the ADSs could decline and we may be subject to litigation or regulatory enforcement

actions. In addition, if we are unable to meet the requirements of Sarbanes-Oxley, we may not be able to remain listed on

Nasdaq.

We have identified a material weakness in our internal control over financial reporting. If we are unable to remediate

this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain an

effective system of internal controls, we may not be able to accurately or timely report our financial condition or

results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ADSs.

We have identified a material weakness in our internal control over financial reporting as of December 31, 2025 as

disclosed in Item 15. Disclosure Controls and Procedures of this Annual Report on Form 20-F. A material weakness is a

deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable

possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on

a timely basis. As a result of the material weakness, management has concluded that our internal control over financial

reporting was not effective as of December 31, 2025. As a consequence of the material weakness, we have also

determined that our disclosure controls and procedures were not effective.

The material weakness related to segregation of duties, which have not been sufficiently established across the key

business and financial processes to maintain appropriate segregation of duties over certain manual and information

technology (“IT”) business controls. Segregation of duties is an internal control principle that helps prevent errors and

fraud by dividing tasks and responsibilities among different individuals. In our current control environment, due to the

size of our finance team, this segregation has not been adequately maintained. A consequence of the lack of segregation

of duties is a heightened risk of fraud or material misstatement where no appropriate mitigating controls are in place.

We have developed and begun to implement a remediation plan designed to improve our internal control over financial

reporting to remediate this material weakness. The remediation plan includes, and we have undertaken, redesigning roles

and access rights to enforce segregation of duties, implementing system-based workflow approvals, and enhancing

documentation of review controls.

As previously disclosed in Item 15 of the Annual Report on Form 20-F for the year ended December 31, 2024, we

identified a material weakness related to a lack of appropriately designed, implemented and documented procedures and

controls at both the entity-level and process-level to allow us to achieve complete, accurate and timely financial

reporting. We remediated this material weakness as of December 31, 2025, see “Item 15. Disclosure Controls and

Procedures.”

We cannot provide assurance that the measures we have taken to date, and measures we plan to implement, will be

sufficient to remediate the control deficiencies that led to the identified material weakness in our internal control over

financial reporting or that they will prevent or avoid potential future material weaknesses. If we are unable to successfully

remediate our existing or any future material weakness in our internal control over financial reporting, or identify any

additional material weaknesses in the future, or otherwise fail to maintain an effective system of internal controls, the

accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with

securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing

requirements, investors may lose confidence in our financial reporting, and the market price of our ADSs may decline as a

result.

We have incurred and will continue to incur significant increased costs as a result of operating as a company whose

ADSs are publicly traded in the

U.S.

, and our management has devoted and will continue to be required to devote

substantial time to new compliance initiatives and corporate governance practices.

As a company whose ADSs are publicly traded in the U.S., we have incurred and will continue to incur significant legal,

accounting, insurance and other expenses that we did not previously incur. In addition, the Sarbanes-Oxley Act, Dodd-

Frank Wall Street Reform and Consumer Protection Act and related rules implemented by the SEC, have imposed various

requirements on public companies including requiring establishment and maintenance of effective disclosure and internal

controls. Our management and other personnel will need to devote a substantial amount of time to these compliance

initiatives, and we will need to add additional personnel and build our internal compliance infrastructure. Moreover, these

rules and regulations will increase our legal and financial compliance costs and will make some activities more time-

consuming and costly. These laws and regulations could also make it more difficult and expensive for us to attract and

retain qualified persons to serve on our board of directors, our board committees or as our executive officers.

Furthermore, if we are unable to satisfy our obligations as a public company in the U.S., we could be subject to delisting

of the ADSs, fines, sanctions and other regulatory action and potentially civil litigation.

We do not anticipate paying dividends in the foreseeable future.

We do not anticipate paying dividends in the foreseeable future. We currently intend to retain future earnings, if any, to

finance the development of our business. Dividends, if any, on our outstanding ordinary shares will be declared by and

subject to the discretion of our board of directors on the basis of our earnings, financial requirements and other relevant

factors, and subject to Australian law. As a result, a return on an investment in our ADS will only occur if the ADS price

appreciates. We cannot provide assurances that the ADSs will appreciate in value or even maintain the price at which

they are purchased. Investors may not realize a return on their investment in the ADSs and may even lose their entire

investment in the ADSs.

If securities or industry analysts do not publish research reports about our business, or if they issue an adverse

opinion about our business, the market price and trading volume of our ordinary shares or ADSs could decline.

The trading market for our ordinary shares and ADSs is influenced, in part, by the research and reports that securities or

industry analysts publish about us or our business. Securities and industry analysts may discontinue research on us, to

the extent such coverage currently exists, or in other cases, may never publish research on us. If no or too few securities

or industry analysts cover our Company, the trading price for our ordinary shares and the ADSs would likely be

negatively affected. If one or more of the analysts who cover us downgrade the ADSs or publish inaccurate or

unfavorable research about our business, the market price of the ordinary shares and ADSs would likely decline. If one or

more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for the ordinary shares

and ADSs could decrease, which might cause our ordinary share and ADS prices and trading volumes to decline.

You may be subject to limitations on transfers of the ADSs.

The ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any

time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the

depositary may refuse to deliver, transfer or register transfers of ADSs 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 of any government or governmental body, or under any provision of the deposit agreement, or for any other

reason.

Our Constitution and Australian laws and regulations applicable to us may adversely affect our ability to take actions

that could be beneficial to our shareholders and ADS holders.

As an Australian company listed on the ASX, we are subject to different corporate requirements than a corporation

organized under the laws of the U.S. Our Constitution, as well as the Australian Corporations Act 2001 (Cth) and ASX

Listing Rules, set forth various rights and obligations that are applicable to us as an Australian company listed on the

ASX. These requirements may operate differently than those of many U.S. companies. You should carefully review the

summary of these matters set forth under the section entitled “Item 10. Additional Information — B. Memorandum and

Articles of Association,” as well as our Constitution, which is included as an exhibit to this Annual Report, prior to

investing in the ADSs.

Australian takeover and foreign investment laws may discourage takeover offers being made for us or may

discourage the acquisition of a significant position in our ordinary shares or ADSs.

We are incorporated in Australia and are subject to the takeover and foreign investment laws of Australia. Among other

things, we are subject to the Australian Corporations Act 2001 (Cth) and Foreign Acquisitions and Takeovers Act.

Subject to a range of exceptions (including a takeover bid, scheme of arrangement or with shareholder approval), the

takeover provisions in the Australian Corporations Act 2001 (Cth) prohibit the acquisition of a direct or indirect interest in

our issued voting shares if the acquisition of that interest will lead to a person’s voting power in us increasing from 20%

or below to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover and

foreign investment laws may discourage takeover offers being made for us or may discourage or prevent the acquisition

of a significant position in our ordinary shares. This may have the ancillary effect of entrenching our board of directors

and may limit the ability of our shareholders and ADS holders to obtain a premium from a control transaction.

We currently report our financial results under IFRS Accounting Standards, which differs in certain significant

respect from U.S. GAAP.

Currently we report our financial statements under IFRS Accounting Standards. There have been and there may in the

future be certain significant differences between IFRS Accounting Standards and U.S. GAAP, and those difference may

be material. As a result, our financial information and reported earnings for historical or future periods could be

significantly different if they were prepared in accordance with U.S. GAAP. In addition, we do not intend to provide a

reconciliation between IFRS Accounting Standards and U.S. GAAP unless it is required under applicable law. As a result,

you may not be able to meaningfully compare our financial statements under IFRS Accounting Standards with those

companies that prepare financial statements under U.S. GAAP.

There can be no assurance that we will not be a passive foreign investment company for any taxable year, which

could result in adverse U.S. federal income tax consequences to U.S. investors.

In general, a corporation organized outside the U.S. will be classified for U.S. federal tax purposes as a passive foreign

investment company ("PFIC"), for any taxable year in which either (i) 75% or more of its gross income consists of

“passive income,” or (ii) 50% or more of the value of its assets (generally determined on an average quarterly basis)

consists of assets that produce, or are held for the production of, passive income. For purposes of the above

calculations, a foreign corporation that owns (or is treated as owning) at least 25% by value of the shares of another

corporation is treated as if it held its proportionate share of the assets of that other corporation and received directly its

proportionate share of the income derived by that other corporation. “Passive income” generally includes dividends,

interest, rents, royalties and certain gains. Cash is a passive asset for these purposes.

Based on the expected nature and amount of our estimated gross income, the anticipated nature and estimated average

value of our gross assets, the anticipated cash needs of our group’s operations and the nature and extent of the active

businesses conducted by our “25% or greater” owned subsidiaries, we do not expect that we will be classified as a PFIC

in the current taxable year or for the foreseeable future. However, our PFIC status for any taxable year can be

determined only after the end of such year and will depend on the composition of our income and assets and the value of

our assets from time to time (which may be determined, in part, by reference to the market price of our ADSs or ordinary

shares, which could be volatile). Furthermore, the composition of our income and assets for the current and future

taxable years will be affected by how, and how quickly, we spend the cash we have on hand.

Accordingly, there can be no assurance that we will not be a PFIC for our current or any future taxable year. If we were a

PFIC for any taxable year during which a U.S. investor is treated as owning our ADSs or ordinary shares, the U.S. investor

generally would be subject to adverse U.S. federal income tax consequences, possibly including increased tax liability on

disposition gains and “excess distributions,” and additional reporting requirements. See “Item 10. Additional Information

— E. Taxation.”

Future changes to tax laws could materially adversely affect our company and reduce net returns to our

shareholders.

Our tax treatment is subject to the enactment of, or changes in, tax laws, regulations and treaties, or the interpretation

thereof, tax policy initiatives and reforms under consideration and the practices of tax authorities in jurisdictions in which

we operate, including those related to the Organization for Economic Co-Operation and Development’s Base Erosion and

Profit Shifting Project, the imposition of a minimum global effective rate for multinational businesses (Pillar Two) and

other initiatives. Such changes may include (but are not limited to) the taxation of operating income, investment income,

dividends received or (in the specific context of withholding tax) dividends paid. We are unable to predict what tax

reforms may be proposed or enacted in the future or what effect such changes would have on our business, but such

changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our financial

position and overall or effective tax rates in the future in countries where we have operations, reduce post-tax returns to

our shareholders, and increase the complexity, burden and cost of tax compliance.

Tax authorities may disagree with our positions and conclusions regarding certain tax positions, or may apply

existing rules in an unforeseen manner, resulting in unanticipated costs, taxes or non-realization of expected

benefits.

We are subject to taxation in multiple jurisdictions. A tax authority may disagree with tax positions that we have taken,

which could result in increased tax liabilities. For example, although we believe we are compliant with applicable transfer

pricing requirements in various countries, a tax authority could challenge our allocation of income and the amounts paid

between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies. In the event a

tax authority assesses a deficiency, contesting such an assessment may be lengthy and costly and if we were

unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, where

applicable.

General Risk Factors

Unstable market and economic conditions may have serious adverse consequences on our business, financial

condition, results of operations and prospects and the trading price of our ordinary shares and the ADS.

Global credit and financial markets have experienced extreme disruptions over the past several years. Such disruptions

have resulted, and could in the future result, in diminished liquidity and credit availability, declines in consumer

confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. Our

general business strategy may be compromised by economic downturns, a volatile business environment and

unpredictable and unstable market conditions, such as pandemics or epidemics of infectious diseases, ongoing or future

wars or other geopolitical conflicts, imposition of tariffs or other trade restrictions, rising inflation, increasing interest

rates and slower economic growth or recession. If the equity and credit markets deteriorate, it may make any necessary

equity or debt financing more difficult to secure, more costly or more dilutive. Failure to secure any necessary financing

in a timely manner and on favorable terms could harm our growth strategy and financial performance and could require

us to delay or abandon plans with respect to our business, including clinical development plans. In addition, there is a risk

that one or more of our current service providers, manufacturers or other third parties with which we conduct business

may not survive difficult economic times, including ongoing or future wars or other geopolitical conflicts, and the

uncertainty associated with current worldwide economic conditions, which could directly affect our ability to attain our

operating goals on schedule and on budget.

Artificial intelligence-based platforms may present new risks and challenges to our business.

AI technologies may exacerbate existing risks, including risks associated with data privacy, cybersecurity, intellectual

property ("

IP")

, healthcare fraud and abuse, drug development and manufacturing, and risks to patients or human

subjects in clinical trials. AI also introduces new risks, due to the autonomous nature of the technology, which, in some

cases, may be deployed to perform tasks, inform decisions, automate decisions, and make predictions. AI may amplify

biased and discriminatory decision making, perform unreliably and malfunction, generate insights which are difficult to

interpret and explain, and cause direct harm to individuals or groups.

Regulators are proposing, adopting, and implementing new AI laws and regulations, including with respect to the

development of drugs and devices. We may be required to change our business practices and policies as a result of such

laws and regulations and may incur substantial compliance-related costs.

Regulators are also using existing laws and regulations to take enforcement actions related to the deployment of AI in

ways that result in non-compliance with current laws and regulations. If we fail to comply with AI laws and regulations,

we may be subject to sanctions, fines, and reputational damage, orders to stop certain processing of personal data,

orders to delete certain data or destroy AI algorithms derived from data collects, legal action on behalf of impacted

individuals or other enforcement or other actions. If we fail to take steps to protect our confidential data, trade secrets, IP

and personal data, we may be subject to legal, regulatory, financial, and reputational risks. AI technologies present

significant opportunities and risks to our business. Harnessing AI’s transformative potential may enable us to speed up

the discovery and development of new drugs and devices, optimize our manufacturing processes, and drive efficiencies.

Our failure to use AI technologies in a way that maintains trust, quality and control in our business activities and to

capitalize on opportunities presented by AI may also place us at a competitive disadvantage. Failure to address AI risks

will reduce our ability to deliver strategic objectives. Also, investments in AI may not realize the benefits that were

anticipated.

Business disruptions could seriously harm our future revenue and financial condition and increase our costs and

expenses.

Our operations and the operations of our suppliers, CROs, CMOs and clinical sites could be subject to earthquakes,

power shortages, telecommunications or infrastructure failures, cybersecurity incidents, physical security breaches,

water shortages, floods, hurricanes, typhoons, blizzards and other extreme weather conditions, fires, public health

pandemics or epidemics and other natural or manmade disasters or business interruptions, for which we are

predominantly self-insured. We rely on third-party manufacturers or suppliers to produce our Commercial Products and

our product candidates and on CROs and clinical sites to conduct our clinical trials, and do not have a redundant source

of supply for all components of our product candidates. Our ability to obtain sufficient supplies for our Commercial

Products and our product candidates could be disrupted if the operations of these suppliers were affected by a man-

made or natural disaster or other business interruption, and our ability to commence, conduct or complete our clinical

trials in a timely manner could be similarly adversely affected by any of the foregoing. The occurrence of any of these

business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

Global climate change, as well as increasing laws, regulation and litigation in the area of climate change, may have an

adverse effect on our results of operations, financial condition or liquidity.

There is widespread consensus in the scientific community that there is a long-term upward trend in global air and sea

temperatures that, along with shifting demographic trends in catastrophe exposed regions, has increased the severity

and frequency of severe weather events and other natural catastrophes, and is likely to further increase the average

economic value of expected losses in the future. Rising sea levels are also expected to increase the risk of coastal

flooding in many geographical areas. Extreme weather events can disrupt business continuity by negatively impacting

our infrastructure, systems and processes including, but not limited to, manufacturing and supply arrangements in

geographical locations exposed to severe weather events. In addition, global climate change could impair our ability to

predict the costs associated with future weather events. We cannot predict with certainty the frequency or severity of

hurricanes, tropical cyclones, wildfires or other natural catastrophes, and our risk assessments may not accurately reflect

shifting environmental and climate related risks. Unanticipated factors could lead to additional insured losses that exceed

our current estimates, resulting in disruptions to or adverse impacts on our business, the market or our third-party

collaborators.

ITEM 4.INFORMATION ON THE COMPANY

A.History and Development of the Company

Our legal name is Telix Pharmaceuticals Limited. Our company was incorporated under the laws of Australia in January

In November 2017, we completed an initial public offering of our ordinary shares and the listing of our ordinary

shares on the ASX. Since November 13, 2024, we have been dual listed with our ADSs listed on the Nasdaq Global Select

Market, with each ADS representing one of our ordinary shares. JP Morgan Chase Bank, N.A., acts as depositary for the

ADSs.

Our corporate headquarters and registered offices are located at 55 Flemington Road, North Melbourne, Victoria, 3051,

Australia. Our reception telephone number is +61 3 9093 3855. Our agent for service of process in the U.S. is Telix

Pharmaceuticals (US) Inc., located at 11700 Exit 5 Pkwy, Suite 200, Fishers, Indiana 46037. Our website address is

www.telixpharma.com. All information we file with the SEC is available through the SEC’s Electronic Data Gathering,

Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov.

The majority of our workforce is in the U.S., based out of our U.S. headquarters in Indianapolis, Indiana or our Dallas,

Texas office, our R&D and manufacturing facilities in Angleton, Texas and Los Angeles and Sacramento, California,

working remotely, or in one of our network of RLS Radiopharmacies that we acquired in January 2025. We also have R&D

and manufacturing facilities in Australia (North Melbourne, in completion phase), Belgium (Brussels South), Canada

(Vancouver) and Japan (Yokohama) and offices in Australia (Melbourne, Sydney and Brisbane), Belgium (Brussels and

Liège), Switzerland (Geneva), and Japan (Kyoto).

See “— B. Business Overview” (below) for a discussion of significant events and developments relating to our business

and “Item 5. Operating and Financial Review and Prospects — B. Liquidity and Capital Resources” for a discussion of our

capital expenditures.

B.Business Overview

Introduction

We are a global, commercial-stage biopharmaceutical company, focused on the development and commercialization of

therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. We are committed to the

principles of precision oncology. By this we mean developing both therapeutic and diagnostic modalities for the benefit

of patients, an innovative precision medicine concept generally referred to as ‘theranostics’.

As an established leader and innovator in this field, Telix is differentiated by our deep expertise in radiopharmaceutical

drug development and commercialization, our innovative pipeline that spans the cancer care continuum, and our ability

to deliver patient outcomes globally. In order to achieve our mission and deliver on our strategy, Telix has structured the

business into five operating segments: Therapeutics (Tx), Precision Medicine (Px), International, MedTech and Telix

Manufacturing Solutions (TMS). We report financial results by the three reportable segments: Tx, Px (including

International and MedTech) and TMS. A brief overview is provided below.

•Therapeutics are at the core of the Telix portfolio, as we work to improve and extend patient life. We are currently

focused on developing targeted radionuclide therapies for urologic and neurologic oncology, and other solid

tumors.

•Precision Medicine is the commercial arm of Telix, focused on bringing diagnostic imaging solutions to market and

expanding into new geographies and indications. Precision medicine plays a fundamental role in managing patients

and delivering personalized therapeutic solutions. MedTech is advancing surgical solutions and digital products

that power Telix’s precision medicines and therapeutics. International is focused on “rest of world” (ex-U.S.)

commercial operations for the Europe, Middle East and Africa ("EMEA"), Asia Pacific ("APAC") and Latin America

regions.

•Telix Manufacturing Solutions is our global network of facilities designed to deliver patient doses worldwide. We

are investing in building manufacturing capacity, as well as improving the technology and processes to allow us to

deliver products at scale, including next generation alpha therapies. This investment in world-class infrastructure is

helping Telix to develop new products and secure critical supplies required to commercialize the future of cancer

treatments.

This commitment to end-to-end treatment differentiates Telix and is at the core of our radiopharmaceutical approach.

Australian Disclosure Requirements

Review of operations, likely developments and expected results; Business strategies and prospects for future years

A review of the Group’s operations for the financial year ended December 31, 2025, together with Telix’s business

strategies and prospects for future years, can be found in "Item 5. Operating and financial review and prospects" of this

Annual Report. Certain information regarding developments in operations in future years and expected results is

excluded, to the extent permitted by law, on the basis that such information relates to the impending developments or

matters in the course of negotiation and disclosure would likely result in unreasonable material prejudice to the Group.

Telix discloses its financial performance by operating segments. The Group’s operating segments represent components

of the Group that engage in distinct business activities. This provides the most meaningful insight into the nature and

financial outcomes of Telix’s activities and is consistent with the way in which the MD & CEO monitors and assesses

business performance and resource allocation decisions. Further details on Telix’s segment reporting can be found in

Note 3 of the Financial report.

Principal activities of the Company in the year under review

Telix’s principal activities during the year ended December 31, 2025 were directed to further advancing our standing as a

globally recognized theranostics company through executing on our strategy across four strategic pillars:

•Delivering our late-stage therapeutic pipeline: Development of TLX591-Tx (for prostate cancer), TLX250-Tx

(for kidney and other CAIX-expressing cancers), TLX101-Tx (for glioblastoma) and TLX66-Tx (for hematologic

cancers).

•Building the next generation of radiopharmaceuticals: Development of TLX592-Tx (TAT candidate for prostate

cancer), TLX252-Tx (TAT candidate for kidney and other CAIX-expressing cancers), TLX102-Tx (TAT candidate

for GBM and LMD), TLX300-Tx (TAT candidate for soft tissue sarcoma ("STS") and other PDGFRα expressing

cancers), TLX090-Tx (bone seeking candidate for bone metastases and pain palliation), and TLX400-Tx (FAP-

targeting therapeutic candidate with pan-cancer potential).

•Growing our industry leading precision medicine business: Development and commercialization of Gozellix and

Illuccix (focus on additional markets and indications), and development of TLX250-Px (Zircaix) and TLX101-Px

(Pixclara) and commercialization, if approved.

•Expanding our global infrastructure for product delivery: Grow manufacturing footprint and capabilities across

North America, Europe and the Asia Pacific region.

For more information on these four strategic pillars, refer to the "Our Strategy" section below.

Our Product Portfolio

Overview

Our portfolio includes both therapeutic and diagnostic radiopharmaceutical product candidates designed for use

throughout the continuum of the patient journey, from diagnosis and staging to treatment and ongoing care. We also

intend to use our therapeutic and diagnostic radiopharmaceutical product candidates in combination with one another,

as a theranostic treatment approach. Our clinical programs include several product candidates that are being evaluated

in Phase 1, Phase 2 and Phase 3 clinical trials with multiple expected upcoming data readouts and regulatory filings.

For most of our programs, particularly the prostate, kidney and brain programs, we have generated extensive clinical

data that we believe demonstrate the potential of our product candidates to offer meaningful benefits to patients. We

believe the targets and indications we are pursuing are well validated and are well suited for the delivery of therapeutic

and diagnostic targeted radiation. We believe that our use of imaging to select patients for therapy is also a

differentiated aspect of our commercial strategy. We believe that this precision medicine or theranostic approach may

increase the potential of our therapeutic development programs, as patients can be selected for therapy with greater

confidence that the drug target is sufficiently present to potentially confer therapeutic benefit. This may, in turn, lead to

more streamlined and efficient clinical trials, and enable improved patient outcomes.

A summary of our core development pipeline is illustrated below.

Therapeutic pipeline

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Precision medicine portfolio

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In addition to the development pipeline above, we are also exploring product and indication expansion opportunities with

our commercial and late-stage diagnostic portfolio through our lifecycle management programs. Lifecycle management

and product development includes two substantial prostate cancer indications for PSMA imaging, AlFluor™, a novel PET

radiochemistry solution based on 18F-aluminum fluoride ("AlF"), a staging indication for TLX250-Px, and an expansion into

brain metastases for TLX101-Px.

Prostate Cancer and PSMA

Our prostate cancer programs target PSMA, a well-validated protein target for the delivery of both therapeutic and

diagnostic radiopharmaceuticals that is highly expressed on prostate cancer cells with low expression on healthy cells.

We believe that our approach to PSMA therapy is unique because our lead product candidates, TLX591-Tx and TLX592-

Tx, use a monoclonal antibody carrier to target prostate cancer, whereas commercially available agents use a small

molecule peptide carrier. This approach allows for specific targeting of tumor tissue, differentiated pharmacokinetics and

excretion profiles, and prolonged treatment effect enabled by efficient irradiation of tumors. We are also developing a

small molecule PSMA therapeutic, TLX597-Tx, and a small molecule-based theranostic pair (RHN001-Tx for therapy and

RHN001-Dx for imaging, through our wholly-owned subsidiary Rhine Pharma), which are intended to enable access to

PSMA theranostics in select geographies.

TLX591-Tx

Our lead therapeutic product candidate TLX591-Tx (lutetium (Lu177) rosopatamab tetraxetan) is a lutetium-labelled rADC

that we believe has the potential to deliver improved patient outcomes with an efficient dosing regimen. The targeting

and pharmacology of TLX591-Tx differs significantly from PSMA-targeting small peptide molecules used in commercially

available compounds, and was designed for high internalization, long retention and to be highly selective for tumor-

expressed PSMA. This profile was designed with the goal of enabling a short, patient-friendly dosing regimen that

delivers a meaningful therapeutic index and low occurrence of off-target adverse events that are common with the

currently marketed PSMA-targeted small peptide molecules.

TLX591-Tx has demonstrated positive safety and efficacy signals following treatment of 242 patients across eight Phase

1 and Phase 2 clinical trials, including up to 42.3 months median survival in a single-arm Phase 2 clinical trial in 17

patients with mCRPC when delivered under a fractionated dosing regimen (Tagawa et al. Cancer.

2019).

These studies

were not powered for or designed to demonstrate efficacy and results should be interpreted with caution. Efficacy

outcomes are presently being evaluated for statistical and clinical significance in a larger Phase 3 randomized controlled

trial.

ProstACT Global is a randomized, multinational, multicenter, open-label Phase 3 trial for the treatment of PSMA-positive

mCRPC patients in combination with the standard of care, compared to the standard of care alone. In August 2025, Part 1

of this trial, a dosimetry and safety lead-in portion, completed target enrollment of 30 patients. The results will be

presented to the FDA to obtain their agreement for the commencement of the randomized treatment expansion arm (Part

2), in the U.S. Part 2 already has regulatory approvals to commence in Australia, Canada, China, New Zealand, Singapore,

South Korea, Türkiye and the United Kingdom. We dosed the first patients in Part 2 in Australia in December 2025, and

are actively dosing patients at multiple clinical trial sites outside the U.S.

This is the first Phase 3 trial to evaluate TLX591-Tx in combination with the standard of care (androgen receptor pathway

inhibition or docetaxel) compared to the standard of care alone. The use of TLX591-Tx with current real-world standard

of care is intended to differentiate ProstACT Global from other PSMA-targeted trials and reflects our continued

innovation in prostate cancer care and commitment to patient outcomes.

TLX592-Tx

TLX592

-Tx (

225

Ac-RADmAb), is our next generation prostate cancer therapy candidate for targeted alpha therapy ("TAT")

and is our first clinical program based on our proprietary RADmAb-engineered antibody technology. The engineered

antibody vector is designed for faster elimination from circulation than standard antibodies. Therefore, it is expected to

reduce bone marrow residence time, mitigating the risk of hematologic toxicities while retaining PSMA-mediated tumor

localization and exertion of cytotoxic activity. TLX592-Tx is designed to be cleared by the liver without exocrine uptake.

Prior to commencing therapeutic studies with the alpha emitting isotope 225Ac, we conducted the Phase 1 CUPID trial in

which we evaluated TLX592-Tx radiolabeled with the imaging isotope 64Cu, in patients with advanced prostate cancer.

We used 64Cu as a surrogate for 225Ac, since 64Cu is detectable by PET, whereas 225Ac is not. We investigated patients

with PSMA avid disease based on Illuccix imaging, across three mass dose levels, to assess the safety profile,

pharmacokinetics, biodistribution and dosimetry. Based on data from 11 evaluable patients, we observed accelerated

elimination from blood circulation compared to the original antibody used in TLX591-Tx, with similar on-target and off-

target biodistribution. There were no treatment-related adverse events observed in the trial.

We have received regulatory approval to commence the Phase 1 FIH therapeutic trial, AlphaPRO, in Australia, designed to

evaluate the safety profile of 225Ac-labelled TLX592-Tx.

TLX597-Tx

We are also developing a novel lutetium-labelled, small molecule-based, targeted radionuclide therapy candidate,

designated TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA). This candidate is being developed to enable access to lutetium

therapy patients in select geographies, and is the subject of the ongoing Phase 2 OPTIMAL PSMA investigator-initiated

trial ("IIT"), which is expected to enroll 120 mCRPC patients in Australia.

RHN001-Tx

RHINO is an IIT sponsored by the Nuclear Medicine Research Infrastructure ("NuMeRI") at the University of Pretoria in

South Africa, exploring clinical utility of a theranostic pair derived from RHN001 (PSMA-GCK01), a PSMA-targeting small

molecule. RHN001 was developed through a collaboration between Telix and Heidelberg University Hospital ("UKHD"),

which resulted in pre-clinical validation and FIH evaluation of rhenium-188 (188Re) based radiopharmaceutical therapy and

technetium-99m (99mTc) based SPECT imaging (Cardinale et al. J Nucl Med. 2023).

This theranostic pair, designated RHN001-Tx (for therapy) and RHN001-Dx (for imaging), have the potential to enable

access to radiopharmaceuticals for patients in certain geographies where 177Lu availability may be limited. They can be

produced using compact, easily-transportable generators, potentially under practice of pharmacy as with other

generator-based radiopharmaceuticals, with imaging performed using widely available SPECT scanners.

The RHINO trial is a Phase 1/2a theranostic trial exploring the safety profile and dosimetry of both RHN001-Tx and

RHN001-Dx in patients with advanced prostate cancer. Its primary objective is to identify the recommended Phase 2

dose ("RP2D"), and schedule of administration for RHN001-Tx in men with progressive PSMA-positive prostate cancer

who have had adjuvant androgen deprivation therapy and/or taxane-based chemotherapy. Secondary objectives are to

assess the overall safety profile and the dosimetry of RHN001-Tx and RHN001-Dx in men with prostate cancer and

health-related quality of life.

The first cohort of patients received RHN001-Dx for safety and dosimetric analysis. The second cohort received

RHN001-Tx for safety and dosimetric analysis, while the third cohort (in progress) will receive escalating doses of

RHN001-Tx to identify the RP2D and schedule of administration for RHN001-Tx.

PSMA-PET imaging

Our prostate cancer portfolio also includes Illuccix and Gozellix, our commercially available 68Ga-labelled PSMA-PET

imaging agents. The “cold kit” format enables rapid radiolabeling at room temperature with high radiochemical purity and

production consistency, suited to the commercial and hospital radiopharmacy setting. Illuccix is approved in the U.S.,

Australia, Brazil, Canada, the United Kingdom and in 19 European Economic Area member states. Gozellix was approved

in the U.S. in March 2025 and the U.S. Centers for Medicare & Medicaid Services ("CMS") granted Transitional Pass-

Through ("TPT") payment status in September 2025. This designation enables separate reimbursement for Gozellix

under the Hospital Outpatient Prospective Payment System ("HOPPS"), taking effect from 1 October 2025 for three

years, marking a significant milestone in Telix’s U.S. commercial strategy. Approved indications for patients with prostate

cancer include staging of high-risk patients, identification of suspected recurrence, and selection for PSMA-directed

therapy (Illuccix only). In September we received a Prior Approval Supplement ("PAS") to update the U.S. Prescribing

Information for Illuccix. The Illuccix label now includes patient selection for RLT in the pre-taxane setting. During FY 2025,

our Precision Medicine business generated revenue of $621.9 million, primarily through sales of Illuccix and Gozellix.

We are exploring potential future utilization in additional indications for prostate cancer patients through our lifecycle

management program and growing our global PSMA-PET imaging presence through expansion into new geographies.

In June 2025, we launched a novel PET radiochemistry solution based on 18F-aluminum fluoride ("AlF"), named "AlFluor™".

The AlFluor platform technology enables flexible radiolabeling of PSMA with either AlF or 68Ga. It also has the potential to

be used with ligands targeting neuroendocrine tumors ("NETs") and FAP, as well as other novel imaging agents under

development by Telix and our strategic partners. Developed to combine the imaging benefits of 18F with the convenience

of 68Ga kit-based workflows, the AlFluor platform supports both centralized cyclotron manufacturing and distributed

“shake-and-inject” kit production. This flexibility allows a complementary product with the same targeting agent to be

labeled with either isotope, catering to clinical setting or physician preference. As part of AlFluor’s development, we

signed a strategic agreement with University Hospital Ghent and Ghent University for a novel [18F]AlF-PSMA-11 targeting

agent, which we have designated as TLX593-Px.

Bone Metastases and Pain Palliation

TLX090-Tx

TLX090-Tx (153Sm-DOTMP) is our novel kit-based bone-seeking targeted radiopharmaceutical product candidate that

uses a next generation chelating agent, DOTMP, to deliver a proprietary lower specific activity formulation of

Samarium-153 radioisotope, and is optimized for improved targeting, safety and clinical versatility. Importantly, TLX090-

Tx builds on FDA’s prior approval of the active moiety Samarium-153 (153Sm, used in Quadramet) while overcoming key

limitations of legacy formulations, such as skeletal saturation and calcium-binding risks.

153Sm is a beta-emitting radioisotope with a 46-hour half-life, and the chelating agent DOTMP selectively targets sites of

high bone mineral turnover, a known characteristic of bone metastases, while minimizing off-target migration. We believe

that TLX090-Tx may be administered as a single dose, multiple doses and higher dose regimens for pain management of

bone metastases and osteosarcoma therapy, including in pediatric patients. We believe that TLX090-Tx is highly aligned

with our existing therapeutic focus areas of prostate cancer, glioma and sarcoma.

In October 2025, we dosed the first patient in a Phase 1 clinical trial of TLX090-Tx called SOLACE (Samarium Optimized

for Long-lasting Analgesia in Cancerous End-stage bone pain). This open-label Phase 1 clinical trial is expected to enroll

up to 33 patients with advanced cancer that has metastasized to the bony skeleton and is designed to evaluate the

pharmacokinetics, dosimetry, safety, and pain palliation of TLX090-Tx. Data from SOLACE aims to establish clinical

comparability to legacy 153Sm treatments, which we believe may support a streamlined registration pathway as an

analgesic, paving the way for a much-needed, non-opioid solution for patients living with bone pain in the late stages of

advanced cancer. The novel cold-kit formulation and pharmacy-based distribution of TLX090-Tx may also aid in

overcoming barriers to treatment due to cost and supply chain limitations associated with legacy products.

Kidney Cancer and CAIX

Our target for kidney cancer is carbonic anhydrase IX ("CAIX"), a scientifically validated target in ccRCC, which is the

most prevalent and one of the most aggressive subtypes of kidney cancer. CAIX is a cell surface protein that is highly

expressed in ccRCC, and in many other solid tumors in the hypoxic tumor micro-environment. We believe this association

between hypoxia, disease progression, and therapeutic resistance underscores the relevance of this target. To target

CAIX, we use a monoclonal antibody, girentuximab, which is designed to have a high degree of selectivity and affinity for

the target. A single hepatically cleared agent is used for both imaging and therapy, with differing radioisotopes, to

minimize renal excretion, an advantage for assessing or treating primary disease. We believe the target profile and

properties of girentuximab make the ccRCC phenotype promising as the first therapeutic indication for TLX250-Tx, our

targeted radiation therapeutic product candidate.

TLX250-Tx

Our CAIX-targeting therapeutic candidate is TLX250-Tx (

177

Lu-DOTA-girentuximab), a rADC that we are developing for

the treatment of advanced metastatic kidney cancer.

We have had our ethics application approved in Australia and are presently initiating the LUTEON study, a global Phase

2/3 trial of of TLX250-Tx as a monotherapy in participants with recurrent ccRCC, who have progressive disease on or

after two and no more than three prior lines of therapy. The primary objective in Part 1 is to select the recommended

Phase 3 dose ("RP3D") to be administered in Part 2 from the two dose regimens administered in Part 1. The primary

objective in Part 2 is to compare the median progression free survival ("mPFS") of treatment with TLX250-Tx with that of

the SOC comparator as assessed by blinded independent central review.

TLX250-Tx is currently under investigation in the Phase 1b/2 STARLITE-1 investigator-initiated trial for kidney cancer,

where it is being evaluated in combination with immune checkpoint and tyrosine kinase inhibitors in up to 100 patients.

This single arm, Phase 2 study is evaluating the efficacy of TLX250-Tx in combination with nivolumab and cabozantinib

in patients with previously untreated ccRCC.

We believe the combined diagnostic and therapeutic potential of the girentuximab platform may also extend into other

cancers that significantly express CAIX, including certain Von Hippel Landau ("VHL") induced cancers, ovarian cancer,

triple-negative breast cancer and bladder cancer. We believe that proof-of concept imaging data in patients with triple-

negative breast cancer and bladder cancer supports future development of TLX250-Tx in these indications.

TLX252-Tx

TLX252

-Tx (

225

Ac-DOTA-girentuximab) is a CAIX-targeting rADC alpha therapy candidate being developed as a potential

follow-on to the TLX250-Tx (beta) program.

TLX250-Px is used as an imaging surrogate for TLX252-Tx. The ZIRDOSE Phase 1 study characterized the biodistribution

and dosimetry of TLX250-Px in patients with ccRCC, enabling extrapolation to 225Ac (Merkx et al.

EJNMMI.

2021).

Additionally, investigator-initiated trials demonstrated effective tumor targeting with TLX250-Px in triple-negative breast

cancer (Rousseau et al.

EJNMMI.

2025) and non-muscle-invasive bladder cancer (Rousseau et al. Cancers.

2025),

indicating the potential for CAIX-targeted alpha therapy beyond ccRCC.

These findings, along with preclinical studies demonstrating efficacy for TLX252-Tx, support initiation of an

administered-activity escalation trial of TLX252-Tx for patients with advanced metastatic kidney cancer and other CAIX-

expressing tumors. Regulatory approval has been obtained in Australia for ALPHIX, a Phase 1 FIH study.

TLX250-Px

Our imaging candidate TLX250-Px is a PET diagnostic imaging agent that is under development to characterize

indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. The pivotal Phase 3 ZIRCON trial

evaluating TLX250-Px in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints, including

showing 86% sensitivity and 87% specificity and a 93% positive-predictive value ("PPV"), for ccRCC across three

independent readers (Shuch et al. Lancet Oncol. 2024). We believe this demonstrated the ability of TLX250-Px to reliably

detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence

intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of

interpretation.

We submitted a BLA for TLX250-Px to the FDA for regulatory approval in December 2023 for characterization of masses

as ccRCC. The BLA was granted on a rolling review process. We completed the BLA submission in May 2024, and in July

2024, the FDA declined to review the BLA and issued an RTF determination. The denial of acceptance for filing was

based on a filing concern related to demonstrating adequate sterility assurance during dispensing of TLX250-Px in the

radiopharmacy production environment. In December 2024 we resubmitted our BLA to the FDA for TLX250-Px, and the

FDA accepted our application in February 2025. In August 2025, the FDA issued a Complete Response Letter ("CRL")

citing deficiencies relating to the Chemistry, Manufacturing, and Controls ("CMC") package. The FDA requested

additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the

scaled-up manufacturing process intended for commercial use. Additionally, the FDA documented notices of deficiency

(Form 483) issued to two third-party manufacturing and supply chain partners that required remediation prior to

resubmission. In December 2025 we participated in a Type A meeting with the FDA to align on plans to address CMC

deficiencies cited, and in January 2026 we participated in an additional Type A meeting to align on plans to address

comparability between the clinical drug product and that intended for commercial use. Following these meetings, Telix

believes it has alignment with the Agency on key resubmission aspects, and is working both internally and with third-

party vendors to implement these items for resubmission. While we believe that the planned remediation of the BLA for

TLX250-Px will meet FDA requirements, there can be no assurance that, once resubmitted, the FDA will accept our BLA

for review, or approve TLX250-Px. If approved, TLX250-Px would be the first targeted radiopharmaceutical imaging

agent for kidney cancer to be approved in the U.S.

In October 2025, TLX250-Px was included for the first time in joint guidelines from the Society of Nuclear Medicine and

Molecular Imaging ("SNMMI"), the European Association of Nuclear Medicine ("EANM") and The American College of

Nuclear Medicine ("ACNM") for molecular imaging of renal masses (Rowe et al. J Nucl Med. 2025). This is an important

development for Telix and will help raise awareness of this breakthrough precision diagnostic. Subject to regulatory

approval, endorsement by this expert global multidisciplinary panel will help to drive adoption and implementation into

clinical workflows, supporting clinical utility and enhancing decision-making to improve patient outcomes.

In November 2025, we announced new data from the ZIRCON-X study, which found that almost half of all patients

(48.6%) imaged with TLX250-Px PET/CT would undergo a change in clinical management, when compared with SOC

imaging. ZIRCON-X was a non-interventional, prospective, post-hoc study sponsored by Telix – using imaging data from

Telix’s parent pivotal Phase 3 ZIRCON study – that assessed the impact of TLX250-Px imaging on clinical decision-

making versus SOC contrast-enhanced diagnostic imaging in 294 patients with indeterminate renal masses ("IRMs").

As part of our commitment to provide access to medicine, we are running an expanded access program ("EAP") in the

U.S., named patient programs ("NPPs"), in Europe, and a special access scheme ("SAS") in Australia to allow access to

TLX250-Px outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

We also intend to conduct a label-expanding Phase 3 trial of TLX250-Px for the imaging of patients with metastatic

ccRCC. We believe TLX250-Px is a natural follow-on product to Illuccix as it is targeted at the same clinician users, the

urologist and urologic oncologist, and leverages our existing commercial infrastructure.

In June 2023, we dosed the first patient in the Phase 2 STARBURST trial of TLX250-Px exploring CAIX expression in

patients with a diverse range of solid tumors for potential therapeutic and diagnostic applications. This trial was designed

to identify new therapeutic indications for TLX250-Tx through the use of molecular imaging with TLX250-Px. In May

2025 the decision was taken to conclude the trial in the interests of utilizing clinical resources and patient time more

effectively - directing our focus towards theranostic studies that could offer both diagnostic insight and a novel

treatment option to the patients. We believe the integrated approach will yield greater clinical benefits for patients.

Glioma and LAT1/LAT2

Our targets for glioma are L-type amino acid transporters 1 and 2 ("LAT1" and "LAT2"), validated targets that are highly

expressed in several solid tumors, including malignancies of the central nervous system ("CNS"). We believe that the

LAT1 and LAT2 receptors, which are expressed on both sides of the blood-brain barrier, are suitable targets for the

delivery of radiation to both primary CNS malignancies and metastases from non-CNS cancers such as lung and breast

cancer. As such, we believe there are several potential indications for theranostic radiopharmaceuticals targeting LAT1

and LAT2.

TLX101-Tx

Our therapeutic product candidate, TLX101-Tx (iodofalan 131I), is a systemic therapy directed at the LAT1 receptor for the

treatment of glioblastoma. We are using a small molecule for this therapy due to the need to cross the blood-brain barrier

to reach its target. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma.

Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not

increase the likelihood that TLX101-Tx will receive marketing approval.

We are evaluating TLX101-Tx in the front-line and recurrent disease settings where we have observed preliminary clinical

evidence of anti-tumor effect and disease stabilization. We completed the Phase 1/2 IPAX-1 trial of TLX101-Tx in

combination with external beam radiation therapy in patients with recurrent glioblastoma. IPAX-1 enrolled ten patients,

met its primary endpoint of safety and tolerability of TLX101-Tx and demonstrated preliminary efficacy data that

supports continued development (Pichler et al. Neuro-Oncology Advances. 2024). The Phase 1 IPAX-2 trial is designed to

enroll up to 15 patients to evaluate the safety of treatment of patients with newly diagnosed glioblastoma with TLX101-Tx

in combination with standard of care external beam radiation and chemotherapy. In IPAX-2, the second patient cohort

has completed and the third cohort is fully enrolled. As the primary goal of a Phase 1 study is to demonstrate safety and

tolerability criteria in a small patient population, these studies are not powered for or designed to demonstrate efficacy.

TLX101-Tx was also the subject of the investigator-led Phase 2 IPAX-Linz trial, in patients with recurrent glioblastoma,

which reported positive preliminary results in April 2025.

In July 2025, we received ethics approval in Australia to commence a Phase 3 trial of TLX101-Tx in patients with

recurrent glioblastoma, and in November 2025 we received health authority approval to commence the trial in Europe.

TLX101-Tx is the first radiopharmaceutical candidate for recurrent glioblastoma to enter Phase 3 development.

TLX102-Tx

TLX102

-Tx (

211

At astato-L-phenylalanine, or

211

At-APA) is a LAT1-targeting small molecule-based alpha therapy candidate

that we are developing as a potential complement to the TLX101-Tx and TLX101-Px programs. TLX102-Tx has

demonstrated pre-clinical proof-of-concept (Watabe et al. Oncotarget. 2020) and we believe that TLX102-Tx has the

potential for favorable efficacy and safety profile in future human clinical trials in patients with glioblastoma,

leptomeningeal disease, and multiple myeloma. Due to comparable target binding and molecular structure, we expect

that data from our existing LAT1 theranostic programs, TLX101-Px and TLX101-Tx, will complement and inform the

clinical and regulatory development strategy for TLX102-Tx. In August 2020,

TLX102

-Tx was granted orphan drug

designation from the FDA in the U.S. for the treatment of multiple myeloma and in November 2025, TLX102-Tx was

granted orphan drug designation from the FDA for the treatment of malignant gliomas. Orphan drug designation may not

lead to a faster development or regulatory review or approval process in multiple myeloma or glioma and does not

increase the likelihood that TLX102-Tx will receive marketing approval in either of these disease areas.

TLX101-Px

Our imaging candidate, TLX101-Px, also known as floretyrosine F18, is a PET diagnostic agent designed to image

cancerous lesions in the brain by targeting the LAT1 and LAT2 receptors. 18F-FET is widely used in many jurisdictions and

is recommended by the joint guidelines from the European Association of Nuclear Medicine ("EANM"), European

Association of Neuro-Oncology ("EANO"), Society of Nuclear Medicine and Molecular Imaging ("SNMMI"), Response

Assessment in Neuro-Oncology ("RANO"), The European Society for Pediatric Oncology and The Response Assessment

in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients (Galldiks et al. Lancet Oncol. 2025).

In June 2025, TLX101-Px was included in updated National Comprehensive Cancer Network® ("NCCN") Clinical Practice

Guidelines in Oncology ("NCCN Guidelines®") for Central Nervous System Cancers (V1.2025) for PET imaging of gliomas:

Delineation of tumor extent, diagnostic biopsy planning, radiotherapy planning for better visualization of tumor margins,

and differentiating tumor progression- and treatment-related changes per RANO/EANO/SNMMI guidelines. In October

2020, TLX101-Px was granted orphan drug designation by the FDA in the U.S. for the imaging of glioma. Orphan drug

designation may not lead to a faster development or regulatory review or approval process and does not increase the

likelihood that TLX101-Px will receive marketing approval.

In August 2024, we submitted a NDA to the FDA for TLX101-Px for the characterization of progressive or recurrent

glioma from treatment related changes in both adult and pediatric patients through the 505(b)(2) NDA regulatory

pathway. In October 2024, the FDA accepted the NDA, granted priority review and assigned a PDUFA goal date of April

26, 2025. In April 2025, the FDA issued a CRL citing the need for additional confirmatory clinical evidence to progress the

application. In September 2025 we reached agreement with the FDA regarding the required resubmission package,

which includes a retrospective analysis to supplement clinical data. We are currently finalizing our resubmission package

and will provide an update upon filing. There is no guarantee that the FDA will approve the NDA by the PDUFA goal date,

if at all. TLX101-Px was granted fast track designation by the FDA for this indication in April 2024. Fast track or orphan

drug designations may not lead to a faster development or regulatory review or approval process, and do not increase

the likelihood that TLX101-Px will receive marketing authorization.

In February 2026, we submitted a MAA for TLX101-Px in a selection of European countries, with France acting as RMS.

The French National Agency for Medicines and Health Products Safety, ANSM, in its capacity as RMS is responsible for

coordinating and leading the scientific evaluation of the dossier, in collaboration with the Concerned Member States.

There can be no assurance that the MAA will be validated, or that marketing authorizations for TLX101‑Px will ultimately

be granted.

As part of our commitment to provide access to medicine, we are running an EAP in the U.S. to allow access to TLX101-

Px outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

We also intend to conduct a label-expanding Phase 3 trial of TLX101-Px for the imaging of patients with brain metastases

from non-brain cancers, including lung and breast cancer.

Other Solid Tumors and Hematologic Oncology

Soft Tissue Sarcoma and PDGFRα: TLX300-Tx and TLX300-Px

Our product candidates TLX300-Tx and TLX300-Px employ antibody-directed targeted radiation for both therapeutic

and patient selection applications against platelet-derived growth factor receptor alpha ("PDGFRα"); activation of

PDGFRα is associated with cancer proliferation, metastasis, invasion, and angiogenesis. Eli Lilly Kinsale Limited provided

us with a license for olaratumab, a naked antibody that was formerly marketed as Lartruvo. We re-purposed olaratumab

as a radiopharmaceutical product candidate.

In April 2025, we dosed the first patient in ZOLAR, a first-in-human Phase 1 proof-of-concept targeting and

biodistribution trial using TLX300-Px. We intend to develop the therapeutic application of TLX300-Tx for the treatment of

advanced soft tissue sarcoma ("STS") and other PDGFRα expressing cancers. We have not yet determined the specific

therapeutic isotope that we will use in therapeutic trials.

TLX300-Px (89Zr-DFOsq-olaratumab, including our proprietary DFO-squaramide chelator) is an imaging candidate that

we are developing for use with TLX300-Tx as a theranostic pair.

Hematologic Oncology and CD66

In hematologic oncology and bone marrow conditioning ("BMC"), we are exploring the potential utility of targeted

radiation to ablate bone marrow as part of a pre-conditioning regimen for bone marrow transplantation, novel stem cell

therapies and gene therapies, each of which requires conditioning prior to treatment. The standard of care involves using

highly toxic chemo-ablation techniques that require long hospitalization times and significant treatment-related morbidity

and mortality risks, which considerably limit patient access to these therapeutic interventions. We believe that a safe,

durable and short internment treatment could be transformative to many facets of cancer and autoimmune disease

treatments that require BMC.

TLX66-Tx

Our antibody-based product candidate TLX66-Tx (90Y-DTPA-besilesomab) is designed to target cluster of differentiation

66 ("CD66"), a well-validated leukocyte and neutrophil target. TLX66-Tx has been evaluated as a therapeutic bone

marrow conditioning agent in approximately 80 patients with results that support continued development, both as a

monotherapy and in combination with low dose chemotherapy conditioning regimes (Orchard et al. Bone Marrow

Transplantation. 2024). In June 2025, the first patient was dosed in a Phase 2 IIT in pediatric high-risk leukemia. We also

plan to evaluate TLX66-Tx in a Phase 2 clinical trial as a BMC agent in patients with acute myeloid leukemia who are not

suitable for conventional BMC regimes.

In March 2022, TLX66-Tx was granted orphan drug designation by the FDA in the U.S. as a conditioning treatment prior

to hematopoietic stem cell transplant ("HSCT"). TLX66-Tx was granted orphan drug designation in Europe in October

Orphan drug designation may not lead to a faster development or regulatory review or approval process and does

not increase the likelihood that TLX66-Tx will receive marketing approval.

We believe that the imaging application of besilesomab could support patient selection for TLX66-Tx by informing

healthcare providers whether sufficient activity will be absorbed by a patient’s bone marrow. TLX66-Px, an imaging

application of besilesomab, has already been commercialized and is an approved product (marketed as Scintimun) for

imaging osteomyelitis (bone infection) in 32 European countries and Mexico. Scintimun was previously manufactured and

distributed by Curium Pharma through an out-license from Telix via the acquisition of TheraPharm in 2020. Following a

strategic review of the asset, we brought sales and marketing in-house during 2025, with plans to significantly augment

commercial distribution and indication expansion. TLX66-Px has not received marketing approval in the U.S.

Pan-Cancer, CAIX and FAP

Our pan-cancer programs target CAIX and fibroblast activation protein ("FAP"), two well-validated targets with pan-

cancer potential. This complementary approach targeting CAIX and fibrosis is a potential “double hit” at the tumor micro-

environment, with potential to provide a synergistic benefit when combined with other systemic treatments such as

immuno-therapies.

We have observed encouraging preliminary clinical data in bladder and breast cancers with our CAIX-targeting TLX250

platform, and in March 2025, we completed a transaction to expand our theranostic pipeline with a portfolio of next

generation FAP-targeting assets. Our FAP development program is exploring potential in a range of solid tumors, as

many cancers are known to express this target either in the tumor micro-environment, like breast cancer, or directly on

malignant lesions, like sarcomas. Our lead therapeutic candidate, TLX400-Tx, has been administered in approximately

150 patients in a compassionate use setting covering multiple tumor types.

Operations and Manufacturing Activities

Our corporate headquarters are located in Melbourne, Australia. The majority of our workforce is in the U.S., based out of

our U.S. headquarters in Indianapolis, Indiana, or our Dallas, Texas office, our R&D facilities in Angleton, Texas and Los

Angeles and Sacramento, California, working remotely, or in one of our network of radiopharmacies that we acquired in

January 2025 as part of our acquisition of RLS. We also have facilities in Australia (Melbourne, Sydney and Brisbane),

Belgium (Brussels and Liège), Switzerland (Geneva), Japan (Kyoto and Yokohama) and Canada (Vancouver). We are

investing significantly to build a world-class vertically integrated supply chain, superior manufacturing and distribution

capabilities, and the ability to deliver radiopharmaceuticals to all major global markets.

We believe the impact of our investment into supply chain, manufacturing, distribution, and commercial capabilities to

date is clearly demonstrated through the successful commercial launch of Illuccix. Leveraging our extensive network of

partners, we have expanded manufacturing capabilities to support the scale-up of commercial sales of Illuccix and, since

2025, Gozellix. Furthermore, our widespread distribution network, encompassing over 225 radiopharmacies across the

U.S., is designed to ensure flexibility and reliability in delivering Illuccix and Gozellix imaging doses to patients.

We continue to invest to strengthen our vertically integrated supply chain and manufacturing model. In 2023 we opened

our TMS facility located in Brussels South, Belgium. At approximately 30,000 square feet, it is one of the largest

radiopharmaceutical production facilities in Europe, with nine GMP lines, clean rooms, a radiopharmacy, and two

cyclotrons. We expect this facility to deliver significant flexibility and reliable supply for our growing commercial

production requirements. It also serves as a vital hub for research and development, specifically in manufacturing scale-

up and production of next generation radiopharmaceuticals, including both alpha-emitters and beta-emitters. In May

2025, TMS Brussels South received notice of GMP accreditation for Illuccix, and delivered first GMP grade commercial

radiopharmaceutical doses in June 2025.

In December

2022

, we acquired Optimal Tracers, a Sacramento-based company that provides radiochemistry process

development services and research tracers for use in clinical trials. The acquisition expanded our translational

radiochemistry capability and established a U.S.-based laboratory (now known as TMS Sacramento) and production

footprint for manufacturing doses of radiopharmaceutical to support clinical trials.

In April 2024, we acquired IsoTherapeutics, which is enabling us to internalize select aspects of our development

programs, with the goal of reducing cost and time to achieve technical milestones.

In April 2024, we acquired ARTMS, further enhancing the vertical integration of our supply chain and manufacturing, with

the goal of facilitating broader patient access to therapeutic and diagnostic radiopharmaceuticals through ARTMS’ high-

yield production techniques. In March 2025, ARTMS' drug master file ("DMF"), for gallium-68 production using its

QUANTM Irradiation System® ("QIS®") cyclotron technology was referenced for the first time with a FDA-approved

product, with Gozellix. This approval enables radiopharmacies and hospitals using QIS and associated targets to produce

multi-Curies of 68Ga for use with Gozellix. We believe that the expanded distribution radius and increased dose

production capacity, compared to existing gallium-based PET tracers, will facilitate broader and more equitable access.

In January 2026, ARTMS' DMF for gallium-68 production using QIS was referenced with Illuccix. In addition, use of

ARTMS’ technology is being expanded internationally including at Telix cyclotron facilities. This includes TMS Brussels

South, where QIS was installed on both cyclotrons during 2025, with zirconium-89 and gallium-68 subsequently

produced.

In January 2025, we acquired RLS (USA) Inc., the only Joint Commission-accredited U.S. radiopharmacy network

distributing PET, SPECT and therapeutic radiopharmaceuticals. The RLS acquisition – including over 30 radiopharmacies

across the U.S. – augments our existing distribution network for last-mile delivery and provides expansionary space to

build out a radiometal production network to meet future demand for radiopharmaceuticals. The process to install

cyclotrons at selected RLS radiopharmacy locations is underway.

In March 2025, we announced the establishment of a joint venture with R2PHARMA, structured as Telix Innovations Brazil

Ltda. (the "JV"), to commercialize and distribute our therapeutic and diagnostic radiopharmaceutical products in Brazil,

The JV further strengthens the partnership established in 2019, with a commitment to jointly bring to market innovative

and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil. The JV is expected to hold an exclusive

license to commercialize and distribute Illuccix, as well as future product candidates, once all required regulatory,

licensing, and governmental authorizations are obtained. Until such authorizations are granted, Illuccix continues to be

distributed in Brazil by one of the JV’s affiliated companies within the R2PHARMA Group.

In June 2025, we established TMS Yokohama in Japan, Telix’s first cyclotron facility in the APAC region. TMS Yokohama

will serve as a hub for commercial and clinical supply, and future research and development. It expands Telix’s global

production network which includes in-house and partner facilities. Originally opened in 2018, the site comprises a

cyclotron and multiple production hot cells and was designed and built by JFE Engineering ("JFE"), as the Contract

Manufacturing Organization ("CMO"), for TLX250-Px in Japan and China, including for the ZIRCON-CP study. We believe

that taking over the lease and operational management of this facility will provide greater control over existing clinical

supply with the possibility to expand production to other Telix investigational and future commercial products in the

region, including Illuccix, and TLX101-Px for Greater Tokyo, and TLX591-Tx for the APAC region, if marketing

authorization of the product candidates is granted. Further, we plan to install ARTMS' QIS cyclotron technology, which

we believe will facilitate standardized, high-efficiency and cost-effective production of zirconium-89 supporting TLX250-

Px production.

During 2025, we progressed the construction of a new facility in Melbourne, Australia, to be known as TMS North

Melbourne, for early-phase clinical research and radiopharmaceutical production, to support APAC translational research

and clinical trials. In September 2025, both TMS North Melbourne and TMS Yokohama were granted radiation licenses

for a broad range of clinically and commercially important medical isotopes.

Our Opportunity

The global radiopharmaceutical industry is undergoing a period of transformative growth with theranostics emerging as a

key pillar in the armamentarium of oncology treatment. We believe that with increasing integration of nuclear medicine

and traditional oncology clinical practice, radiopharmaceuticals will become a core component of the multi-disciplinary

approach to cancer treatment with a proportionate benefit to patients.

Our therapeutic radiopharmaceutical platform harnesses the power of radioactive isotopes combined with multi-platform

targeting agents to deliver targeted radiation directly to the tumor site. These therapeutic product candidates have the

potential to be stand-alone treatments or as complements to existing treatment modalities to address areas of high

unmet medical need. Due to our expertise in the multiple components of radiopharmaceuticals we believe we are able to

create theranostics in an “agnostic” manner, pairing the right delivery mechanism with the right isotope most likely to be

suited for the tumor being treated.

We intend to pair each therapeutic with a diagnostic imaging agent, this underpins the “theranostic” approach whereby

two conjugates are used to target the same cell-surface receptor, one for detection, localization or staging, and the other

for selective destruction of target cancer cells. When used in tandem to plan and execute treatment, and then to assess

response and monitor for progression, we believe this approach allows the delivery of truly personalized therapy to

patients.

Our Strategy

Our strategy is to launch innovative imaging agents in our core disease areas, while financing the development of

therapeutic product candidates, including next generation radiopharmaceuticals. This strategy is underpinned by a

vertically integrated approach to supply and manufacturing, and is supported by a first-class commercial organization

ensuring global patient access to our products and product candidates, if approved.

Our strategy is designed to deliver on our purpose and mission and reflects the evolution of our business into a global,

multi-product commercial-stage company with a deep theranostic pipeline. This approach, we believe, will deliver

benefits to patients and returns to shareholders over the near and long-term.

The four strategic pillars central to achieving our mission are:

Deliver our late-stage therapeutic pipeline

We aim to build both breadth and depth in oncology and to address areas of significant unmet medical need, both for

large oncology indications such as prostate cancer and kidney cancer, as well as rare oncology indications such as

glioma. This is based on a target selection process that is aligned with our expertise in radiation biology.

In August 2025, we completed target enrollment in Part 1 of the Phase 3 ProstACT Global study of TLX591-Tx (lutetium

(Lu177) rosopatamab tetraxetan), our lead rADC candidate for advanced prostate cancer. In December 2025, we dosed

first patients in Part 2 (randomization) in Australia with sites also recruiting in Canada and New Zealand. The study is also

approved to commence in China, Japan (Part 1 only), Singapore, South Korea, Türkiye and the United Kingdom. This

multinational Phase 3 study is to investigate and evaluate the potential benefits and risks associated with TLX591-Tx,

when administered together with

SOC

and compared to SOC alone.

We are also advancing TLX250-Tx and TLX101-Tx into late-stage clinical trials for the treatment of kidney cancer and

glioblastoma, respectively. In 2025, we received regulatory approval in Australia and the European Union to commence

the Phase 3 IPAX-BrIGHT pivotal trial of TLX101-Tx with sites open for enrollment, and received regulatory approval in

Australia to commence LUTEON, a global Phase 2/3 trial of TLX250-Tx. We believe that each of our product candidates

is currently the most advanced systemic radiotherapy in its respective indication.

Build the next generation of radiopharmaceuticals

We have established a track-record in identifying validated clinical product candidates that can be optimized as

radiopharmaceutical therapies to develop them through to commercial products. We are leveraging this capability to

expand our pipeline with next generation radiopharmaceuticals, particularly targeted alpha-emitting therapies, through

business development, as well as internal R&D programs and collaborations. Through our existing clinical programs and

dedicated research facilities in the U.S., Australia and Europe, we are focused on the development of alpha therapy

candidates as a future pipeline expansion opportunity, and on building supply and manufacturing capabilities required to

support an eventual commercial launch.

We are advancing TLX592-Tx, TLX252-Tx and TLX102-Tx, our next generation (alpha) therapy candidates for prostate,

kidney and brain cancer into clinical trials. In 2025, we received regulatory approval to commence Phase 1, first-in-

human studies of TLX592-Tx and TLX252-Tx. During the year, we dosed first patients in a Phase 1, first-in-human

imaging study of TLX300-Px, aiming to demonstrate proof of concept for therapy in soft tissue sarcoma ("STS") and

other platelet derived growth factor receptor alpha ("PDGFRα") positive tumors. In 2025, we dosed first patients in the

Phase 1 SOLACE study of TLX090-Tx, Telix's therapy candidate for pain palliation of osteoblastic bone metastases, and

also acquired a suite of clinically validated theranostic candidates (including TLX400-Tx) targeting fibroblast activation

protein ("FAP"), widely considered to be one of the most promising targets for both cancer imaging and therapy.

In January 2025, we acquired a pipeline of next generation therapeutic candidates, a proprietary novel biologics

technology platform, and a protein engineering and discovery research facility based in Los Angeles, California, from

antibody engineering company ImaginAb, Inc. ("ImaginAb"), to enhance existing innovation capabilities. This provides us

with a pipeline of early-stage drug candidates against high-value targets including delta-like ligand 3 ("DLL3"), and

integrin αvβ6, as well as several other novel targets in discovery stage. We believe these next generation drug

candidates fit synergistically with our therapeutics pipeline, enabling expansion to future therapy areas with unmet

clinical need. The acquired intellectual property utilizes small engineered antibody formats that enable highly specific

cancer targeting, combined with fast tumor uptake and blood clearance. This technology has the potential to be highly

effective for imaging and treating tumors with a broad range of radioisotopes, with alpha emitters of particular interest.

In March 2025, we announced a validated breakthrough generator technology for the production of the alpha-emitting

isotope, lead-212 (212Pb) and successfully completed first production. The new generator technology, being developed

internally by our IsoTherapeutics team, produces 212Pb via a Thorium-228 (228Th) emanation source, and significantly

increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators. The

production footprint has been designed to be deployed throughout Telix’s (and select partner) manufacturing and

distribution networks, including RLS Radiopharmacies.

Grow our industry-leading Precision Medicine business

Leveraging the success of our first commercial product, Illuccix, we intend to broaden our commercial footprint in

precision medicine by:

•Expanding Illuccix and Gozellix into new indications and geographies and the continued successful launch of

Gozellix in 2026.

•Obtaining marketing authorization for TLX250-Px, which will expand our urology portfolio with potential to become

the first-in-class targeted radiopharmaceutical imaging agent for ccRCC.

•Obtaining marketing authorization for TLX101-Px for the imaging of glioma.

Expand our global infrastructure for product delivery

To develop and deliver radiopharmaceuticals, which have a relatively short shelf life due to their unique properties,

supply chain, manufacturing and logistics are vitally important. TMS is a global network of facilities, where our continued

focus and investment in infrastructure and technologies is equipping Telix to deliver patient doses worldwide.

Telix has made a number of strategic acquisitions to grow our manufacturing capability and footprint. Going forward,

TMS will be focused on activities including:

•Preparing selected RLS Radiopharmacies sites for cyclotron installation with ARTMS QIS technology, to increase

efficiency and improve yields when producing radioisotopes, and establish a next generation radiometal production

network.

•Expanding the deployment of the ARTMS QIS technology including at our state-of-the-art TMS facility in Brussels

South, Belgium – one of the largest of its kind in Europe, and TMS Yokohama.

•Increasing GMP production at TMS Brussels South.

•Completing the fit-out at TMS North Melbourne and scaling up of operations at TMS Yokohama.

Our Theranostic Approach

Our approach enables us to design and develop product candidates to deliver targeted radiation to cancer cells,

regardless of where the cancer is in the body, via a systemic radioactive infusion. We aim to use imaging and therapy

together to “see and treat” cancer. We refer to this approach as theranostic, which we believe is a powerful way to tackle

unmet need in cancer and rare diseases.

We believe that our ability to harness the power of targeted radiation throughout the patient journey to enhance patient

outcomes is a key differentiator.

Targeted Radiation Overview

We are developing targeted radiation across the continuum from diagnosis and staging to treatment, both as stand-alone

and combination therapies.

Many existing cancer therapies are non-selective and as a result can act against healthy tissue and vital organs while

treating disease. Existing external beam radiation therapy ("EBRT"), approaches are effective but typically only deliver

localized treatment and cause damage to surrounding tissue. Localized therapeutic approaches rely on the treating

physician making assumptions about the extent of disease and can result in imprecise application of treatment.

Treatments that miss small amounts of cancer cells can lead to a recurrence of the cancer or disease.

Targeted radiation uses a radioactive isotope as a payload that is attached to a targeting agent, such as a small molecule

or antibody, with an affinity for specific biomarkers found on the surface of cancerous or diseased cells. Depending on

the choice of radioisotope payload, these target agents can deliver either imaging or therapy.

The targeted radiation drug or antibody is administered into the bloodstream and circulates throughout the body. Once

administered, the targeted radiation seeks cancerous or diseased cells, including primary tumors and small metastases

(where the cancer has spread), upon which it is designed to bind selectively to its target. Some radioactive isotopes have

physical properties that may be used to image cancer or rare diseases, for diagnosis and staging purposes. Higher dose

radiation with different alpha- and beta-emitting radioisotopes can be used as therapies to kill cancerous or diseased

cells, by damaging their DNA.

The Targeting Agent

The targeting agent guides the radiation payload to the targeted cancer cells. The agent is designed to be cancer-

specific due to selective affinity for tumor targets that are prevalent in tumors but not healthy tissues. The targeting

agents can be either an antibody, engineered antibody fragment, peptide or small molecule, and the choice of targeting

agent can impact the other properties of the drug, including:

•Pharmacokinetics: Peptides and small molecules have a short circulation time (several hours) and therefore require

a higher dose of radiation payload to sufficiently irradiate the tumor in therapeutic contexts, which comes at the

expense of a resulting higher radiation exposure to the kidney. Antibodies have a longer circulation time (several

days), are cleared though the liver and are lost slowly, which can transiently impact the levels of blood cells but

results in higher amounts of radiation payload in tumors to maximize the therapeutic effect. The calculations and

study required to determine the optimal dose of radiation to be delivered for maximum therapeutic effect with an

acceptable safety profile are referred to as "dosimetry".

•Binding and cancer specificity: Antibodies have evolved in the immune system to be highly selective and, as a

well-known class of agents, can be generated to be highly specific to their target. Small molecules and peptides are

not as predictable as a delivery platform, however they can be engineered for high selectivity and affinity; their

metabolism properties and off-target toxicity are unique to each molecule.

•Internalization and residualization in the tumor: Once bound to their biological targets, targeting agents can be

taken up by cancer cells through a process called "internalization". Peptides tend to be returned to the blood or

otherwise degraded relatively quickly after internalization. By contrast, antibodies tend to be retained within cancer

cells and, with their sustained presence in the blood, tend to accumulate or ‘residualize’ their radiation payload over

time which can favor the localization of higher amounts of radiation to the tumor than peptides or small molecules.

The slow excretion of antibodies and their ability to highly effectively residualize radiation in tumors means that

lower doses of radiation are needed to treat patients; thereby improving supply chain capability and cost of goods.

•Route of excretion from the body: Small molecules and peptides are primarily excreted in the urine rapidly passing

through from the blood into the bladder via the kidneys. Antibodies are cleared via the liver, which is a more radio-

tolerant organ.

In general, the properties of small molecules and peptides suit diagnostic targeted radiation agents, as the excess or

unbound radiation drug is rapidly lost from the body, resulting in a good contrast between the tumor and background

tissues and enabling favorable imaging within hours, allowing patients to be dosed and imaged within the same day.

Conversely, the high specificity of antibodies, along with their well validated, predictable characteristics in the body and

long retention in the tumor largely favor therapeutic use.

Radio Antibody-Drug Conjugate (rADC)

We refer to our antibody-based candidates as rADCs. These rADCs are radiopharmaceuticals that use an antibody as

both a homing device and a carrier to deliver a therapeutic radiation payload to a specific target. This property

differentiates them from chemotherapy, which cannot distinguish between healthy cells and tumor cells. rADCs are

designed to combine the targeting properties of monoclonal antibodies, which can discriminate between healthy and

cancerous tissue, with the cancer-killing capabilities of cytotoxic radiation.

We are pioneering a novel technology platform designed to optimize the therapeutic window for rADCs, which we refer

to as RADmAbs. This proprietary technology uses antibody engineering to modulate the pharmacokinetics of ‘full length’

antibodies such that they are designed to clear faster from the blood while maintaining the same high specificity to their

target and tumor localization properties. Since they retain the same overall structure as traditional antibodies, they also

share similar characteristics important for commercial development including a standard manufacturing pathway,

biological stability, immunogenicity and regulator familiarity.

In January 2025, we acquired patents, know-how and other intellectual property from ImaginAb comprising a proprietary

drug discovery platform, a pipeline of early-stage drug candidates against high-value targets, and several other novel

targets in discovery stage. The acquired intellectual property utilizes small engineered antibody formats that enable

highly specific cancer targeting, combined with fast tumor uptake and blood clearance.

We believe that this technology, alongside our other radiolabeling knowhow and technologies, can be applied to any

existing cancer-targeting antibody agent to potentially provide new intellectual property and a life-cycle management

option for prospective partners.

The Radiation Payload

The radioisotope is strongly bound to the target agent molecule either using traditional chemistry or trapping it using a

‘chemical cage’ called a 'linker' or 'chelator'. Different chelators are paired with certain isotopes, such as deferoxamine, a

linker that selectively binds with 89Zr (which we use in TLX250-Px), and the tetraxetan chelator, which binds isotopes like

177

Lu (which we use in TLX591-Tx and TLX250-Tx) and

225

Ac (which we use in TLX592-Tx and TLX252-Tx).

The choice of radioisotope and its decay profile impacts properties of the targeted radiation drug.

•Diagnostic radioisotopes for imaging: Radioisotopes emitting positrons can be detected by a PET camera. Gamma

emissions can be detected by a single photon emission computed tomography (SPECT) camera. These are

commonly referred to as “scanners.”

•Diagnostic radioisotopes for surgery: Both gamma and beta emitting radioisotopes can be used for the

intraoperative detection of tumors, using a handheld or robotic probe. The most commonly used isotope in radio-

guided surgery is 99mTc.

•Radioisotopes for therapy: Radioisotopes with the ability to kill cells for therapeutic effect are classified as either

beta- or alpha-emitters, based on their emission profile. Beta emitters (such as

177

Lu and

131

I) have a longer

penetration and may be more suitable for bulky metastatic disease. Alpha-emitters (such as

211

At,

212

Pb and

225

Ac)

are substantially larger isotopes than beta-emitters and have the potential to deliver very high amounts of energy to

cancer cells in closer proximity to these particles, which can decrease the risk of damage to surrounding healthy

cells and increase the selectivity and potency of the radiation treatment. Alpha and beta therapies may be

complementary, with alpha therapies being more suitable for smaller or disseminated tumors (including micro

metastatic disease) and beta therapies being more suitable for treatment of bulkier tumors.

Our Prostate Cancer and PSMA programs

Overview

Our prostate cancer portfolio programs target PSMA, a protein that is overexpressed on the surface of prostate cancer

cells and is low or absent on most normal healthy cells. PSMA has become a major breakthrough in the staging,

treatment and management of prostate cancer. Imaging with targeted radiation can identify prostate cancer wherever it

is in the body and help guide patient treatment. The PSMA receptor is expressed in over 80% of prostate cancer tumors.

This expression of PSMA provides a specific target to design therapeutic and diagnostic agents for the treatment and

imaging of prostate cancer.

Market and Opportunity for Prostate Cancer Therapy

According to Pharma Intelligence, global incidence of prostate cancer was estimated to be 1,349,000 in 2022 and is

expected to reach approximately 1,455,000 by 2027 and in the U.S., the incidence of prostate cancer was estimated to

be 244,000 in 2022 and is expected to reach approximately 268,000 by 2027. The U.S. market opportunity for PSMA-

PET imaging agents in their approved indications is estimated to represent over US$2.5 billion per year, based on current

approved indications. The U.S. market opportunity for PSMA-targeted therapeutic agents is estimated at almost US$8

billion dollars per year based on Datamonitor patient-based forecasts for mCRPC and mHSPC.

High rates of screening in developed countries mean many men are diagnosed and treated early before their disease has

spread. These men receive local therapy, either prostatectomy or EBRT, and may be cured of their disease. However,

approximately 15% of patients develop advanced forms of the disease that can spread to other parts of the body. This is

known as metastatic prostate cancer.

According to Datamonitor's patient-based forecast, there were approximately 51,000 patients treated for mCRPC in the

U.S. in 2025. Approved treatment options for patients with mCRPC include androgen deprivation therapy, androgen

receptor pathway inhibitors, docetaxel chemotherapy, radium-223 for patients with bone-only metastases, PSMA-

targeted lutetium-therapy for patients having received prior docetaxel, and poly (ADP-ribose) polymerase (PARP)

inhibitors for patients with deleterious germline or mutated somatic homologous recombination repair gene. The global

market for systemic treatments for patients with mCRPC is estimated at approximately US$6.9 billion per year.

Pluvicto (lutetium (

177

Lu) vipivotide tetraxetan), marketed by Novartis, was approved by the FDA for the treatment of

patients with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibition and taxane-

based chemotherapy in March 2022. In March 2025, Pluvicto was approved by the FDA for earlier use prior to

chemotherapy, in PSMA-positive mCRPC. Pluvicto is the only FDA-approved PSMA-targeted therapy for the treatment of

prostate cancer. Novartis disclosed that Pluvicto recorded net sales of US$1,390 million in 2024 and US$1,994 million in

Pluvicto uses a small-molecule approach to target the PSMA receptor and is administered in up to six cycles. In a

pivotal clinical trial, patients treated with Pluvicto showed an overall response rate of 30%, a median progression-free

survival of 8.7 months, and a median overall survival of 15.3 months.

Several other systemic radiotherapies are being investigated in clinical trials in the mCRPC setting and across other

stages of prostate cancer, and potentially could be commercialized in the future. We consider our most direct potential

competitors to be companies developing PSMA-targeted therapies in the mCRPC space, including Novartis, Convergent,

Point Biopharma, Eli Lilly & Company Ltd, Lantheus Holdings, Inc, Curium Holding France S.A.S, ARTBIO, Inc., Blue Earth

Therapeutics Ltd, Clarity Pharmaceuticals, Astra Zeneca PLC/Fusion Pharmaceuticals, Inc., Bayer AG, Orano Med SAS,

Isotopia Molecular Imaging Ltd, ITM Isotope Technologies Munich SE, Janssen Pharmaceuticals, AdvanCell Isotopes Pty

Ltd, Alpha-9 Theranostics, Cancer Targeted Technologies, FutureChem Co Ltd., Sinotau Pharmaceutical Group,

RadioPharm Theranostics, Precision Molecular, StarPharma, Ambrx Biopharm, Inc., Amgen Inc., Crescendo Therapeutics,

Poseida Therapeutics, Janux Therapeutics, Bivision Pharmaceuticals and Full-Life Technologies. Our competitors also

include companies developing other modalities to treat patients with mCRPC. (See “Business—Competition” for

additional information).

Market and Opportunity for Prostate Cancer Imaging

PSMA-PET imaging is used by clinicians to locate prostate cancer lesions and inform clinical decisions for patients.

PSMA-PET imaging is indicated in the U.S. for prostate cancer patients:

•with suspected metastasis who are candidates for initial definitive therapy;

•with suspected recurrence based on elevated serum PSA level; and

•for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of

the therapeutic products.

We estimate that the PSMA-PET imaging market opportunity in the U.S. for these indications represents over 645,000

scans per year, which may be worth more than US$2.5 billion.

Guidelines and clinical research suggest potential future utilization of PSMA-PET imaging for:

•monitoring for progression in non-metastatic and mCRPC patients; and

•monitoring response to PSMA-directed therapy.

We estimate that these areas represent over 250,000 scans per year. We estimate that the combined addressable

market based on current and future guideline driven indications may be more than US$3.5 billion per year. Telix is

exploring 68Ga-PSMA-PET with Illuccix or Gozellix for diagnosis as a new indication, not currently FDA approved or

included in clinical guidelines. Combining 68Ga-PSMA-PET for diagnosis with current and guideline-driven indications, has

potential to bring the total addressable market to more than US$6.7 billion per year.

Our main competitors in the prostate cancer imaging market are companies with approved PSMA-PET diagnostics,

including Novartis, Lantheus Holdings, Inc. ("Lantheus"), Curium Pharma Ltd., Bracco Imaging S.p.A. (through its Blue

Earth Diagnostics affiliate) and Isotopia Molecular Imaging Ltd. Certain academic institutions, such as UCLA and UCSF,

also hold a license for a commercial PSMA-PET diagnostic.

In 2020, UCLA and UCSF obtained FDA approval for 68Ga-PSMA-11, which was the first PSMA-PET imaging agent to be

approved by the FDA. Pylarify (18F-piflufolastat), marketed by Lantheus, and Illuccix were subsequently approved by the

FDA in 2021. Locametz (68Ga-PSMA-11), marketed by Novartis, received FDA approval in 2022 and Posluma (18F-

flotufolastat), marketed by Blue Earth Diagnostics, received FDA approval in 2023. Gozellix was approved by the FDA in

March 2025. In August 2025, Lantheus announced that its NDA for a new formulation of its fluorine-18 based PSMA

imaging agent, had been accepted by the FDA with a PDUFA goal date of March 6, 2026. In May 2025, RadioMedix

submitted an Abbreviated New Drug Application ("ANDA") for 68Ga-PSMA-11. Several other PSMA-PET product

candidates are being evaluated in clinical trials for prostate cancer imaging and may be commercialized in the future.

Companies developing PSMA-PET imaging agents include ABX-CRO, Clarity Pharma Ltd., Curium Pharma Ltd., Isotopia

Molecular Imaging Ltd, Itelpharma, ITM Isotope Technologies Munich SE, Five Eleven Pharma, Fortis Therapeutics,

RadioMedix, HTA Co. Ltd and Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Currently approved PSMA-PET imaging compounds use either a gallium-68 isotope (68Ga), such as Illuccix or Gozellix, or

a fluorine-18 isotope (18F) for PET imaging. Recent scientific publications illustrate evidence of important clinical

differences between 68Ga and 18F based imaging agents, including a lower rate of false positives with 68Ga, which can

potentially provide more accurate interpretation and understanding of the extent of disease (Fendler et al.

EJNMMI.

2023; Kroenke et al. J Nucl Med. 2021). Also, 68Ga-based imaging agents have been shown to help clinicians detect

prostate cancer in patients with low disease burden (Burgard et al. Cancers. 2023). This early detection can lead to a

change in management and better outcomes for patients. Additionally, approved 68Ga-based imaging agents can use a

lower radiation dose than approved 18F-based agents, reducing radiation exposure for nuclear medicine physicians and

patients.

Therapy – TLX591-Tx

TLX591

-Tx (lutetium (Lu177) rosopatamab tetraxetan) is a rADC directed at PSMA. We are evaluating the safety and

efficacy of TLX591-Tx in the ProstACT series of clinical trials. The key evidence from Phase 1 and Phase 2 studies

supporting the development of TLX591-Tx includes:

•Evidence that treatment with TLX591-Tx is well tolerated, including data from the Phase 1 ProstACT SELECT trial,

common grade 3 and 4 hematological events included thrombocytopenia, lymphopenia and neutropenia. All

hematological events were transient and manageable;

•Positive efficacy outcomes demonstrated following treatment of 242 patients across eight Phase 1 and Phase 2

clinical trials, including up to 42.3 months median survival in a single-arm Phase 2 clinical trial in 17 patients with

mCRPC when delivered under a fractionated dosing regimen. Data from Cohort 2 in the ProstACT SELECT trial

reported median rPFS of 8.8 months, an encouraging efficacy signal that should be considered directional in nature

given the small sample size in this Phase 1 clinical study;

•Evidence of low rates of off-target organ exposure observed in ProstACT SELECT; and

•Convenient two-dose regimen administered over 14 days with low radiation exposure.

As an rADC with an antibody targeting agent, we believe that TLX591-Tx may be differentiated from PSMA-targeted

therapies leveraging a small molecule approach as it has the potential for:

•Functional specificity for tumor-expressed PSMA, whereas small-molecule PSMA is taken up by endogenous PSMA;

•Reduced off-target radiation, with reduced potential for undesirable adverse events including dry eye, xerostomia,

and back pain from ganglia irradiation;

•Longer circulation time and tumor retention, while small molecule PSMA is rapidly excreted with approximately 70%

of activity lost after 12 hours; and

•Shorter dosing regimen of two doses, 14 days apart compared to dosing regimens lasting up to 30 weeks with

PSMA-targeted small peptide RLT.

Clinical Data

To date, 242 patients have been treated across eight Phase 1 and 2 trials of TLX591-Tx. We believe these data

cumulatively support the clinical validity of our intended fractionated dosing, which is designed to split a dose over a

longer treatment cycle to decrease toxicity without compromising efficacy. In an open-label, single-arm Phase 2 clinical

trial with six experimental dose cohorts of TLX591-Tx of 33 patients, we reported a 42.3 month median survival in 17

patients with advanced mCRPC treated at the higher dose level when TLX591-Tx was delivered under a fractionated

dosing regimen. Median survival was 19.6 months at the lower dose level and was 27.8 months across those dose

cohorts. At the higher dose level, 23.5% and 35.3% of patients had grade 3 and 4 neutropenia, respectively, and 29.4%

and 58.8% of patients had grade 3 and 4 thrombocytopenia, respectively. The trial met its primary endpoint, which was

to identify the maximum tolerated dose of TLX591-Tx when administered in two doses two weeks apart. The survival

benefits were a secondary endpoint. This trial did not contain a control group and was not powered to measure statistical

significance of the survival benefit, which is a limitation of single-arm trials.

ProstACT SELECT was a Phase 1 trial evaluating the safety and tolerability of TLX591-Tx in combination with standard of

care treatment in patients with mCRPC. The purpose of the ProstACT SELECT trial was to evaluate the ability of 68Ga-

PSMA-PET imaging to select patients for rADC-based PSMA therapy and to confirm the biodistribution of TLX591-Tx

when administered as two doses 14 days apart. The primary objectives of the study were to determine the whole body

distribution and organ radiation dose, and assess the safety and tolerability profile of TLX591-Tx, when administered in

combination with standard of care in second-line mCRPC. The evaluable population comprises a total of 30 patients

enrolled in the trial. In Cohort 1 comprising 5 patients, each patient received a 27 mCi dose followed by a 76 mCi

therapeutic dose for accuracy of biodistribution determination. In Cohort 2, 23 of 25 patients each received two

therapeutic 76 mCi doses. These patients included a heterogeneous patient population of low, medium and high disease

burden, with the majority of patients having undergone two prior lines of therapy.

Data from the ProstACT SELECT trial suggested evidence of high on-target PSMA tumor-binding and radiation delivery

to bone, nodal, and visceral metastases while minimizing uptake and toxicity in kidney and salivary glands. We believe

this biodistribution is significant when compared to small molecule therapeutic and diagnostic PSMA agents, which may

have greater off-target binding and subsequent radioactive dose to those organs.

We also observed evidence of consistent lesion delineation between TLX591-Tx and 68Ga-PSMA-11 imaging, within the

detection sensitivity and resolution limits of SPECT, evidence of uptake and retention in tumor and metastases up to 14

days post injection, the highest absorbed dose being in the liver (clearance organ) with minimal uptake in salivary glands,

and a long retention period that was evidence of internalization.

ProstACT SELECT Cohort 2 data also provides evidence of the potential clinical advantage of the short, simple treatment

regimen of two therapeutic doses administered 14 days apart. Hematologic treatment emergent adverse event ("TEAE")

rates were: Grade 3 thrombocytopenia (16% of patients, or 4/25), grade 3 neutropenia (28%, 7/25), grade 4

thrombocytopenia (20%, 5/25) and grade 4 neutropenia (4%, 1/25). All hematologic events were transient and

manageable. The trial demonstrated a median radiographic progression-free survival of 8.8 months, a secondary

objective, based on an evaluable patient population in Cohort 2 of 16 patients who each received two 76 mCi doses of

TLX591-Tx and did not have important protocol deviations. Based on these data, the trial appears to have achieved its

primary safety and tolerability objectives.

We are currently investigating TLX591-Tx in the Phase 3 ProstACT Global clinical trial in mCRPC patients previously

treated with one prior androgen receptor pathway inhibitor ("ARPI") in the metastatic castration-sensitive prostate

cancer ("mCSPC"), non-metastatic castration-resistant prostate cancer ("nmCRPC"), and first line (1L) mCRPC settings.

The trial is a multi-national, multi-center, prospective, randomized, controlled, open label study designed to investigate

and confirm the benefits and risks associated with TLX591-Tx a high-affinity PSMA-targeted rADC that delivers DNA

breaking radiation directly to PSMA-positive bone, nodal, or visceral metastases in patients with mCRPC. The trial will

enroll patients that have PSMA-positive mCRPC who have experienced disease progression following treatment with an

androgen receptor pathway inhibitor (abiraterone or enzalutamide) that was received in either the metastatic castration-

sensitive prostate cancer or first-line mCRPC treatment setting. The primary endpoint of the randomized portion of the

trial is radiographic progression-free survival and secondary endpoints include overall survival, objective response rate,

time to first symptomatic skeletal events, PFS, PSA decline of more than 50%, quality of life, and safety and tolerability.

In August 2025, this trial completed target enrollment of 30 patients in Part 1, a dosimetry and safety lead-in portion,

replicating the prior study using the product candidate specifications intended for commercial release. We dosed the first

patients in Part 2, the randomized treatment expansion arm, which we expect to enroll up to approximately 490 patients,

in Australia in December 2025. Part 1 data will be submitted to the FDA to obtain agreement to expand Part 2 of the trial

to U.S. sites. A public disclosure of preliminary results from Part 1 of the study will be aligned to engagement with the

FDA.

Therapy - TLX592-Tx (alpha-PSMA)

Through our TLX592 program, we are also exploring how the conjugation of an antibody vector with an alpha-emitting

isotope might deliver a next generation rADC with a different therapeutic profile. We believe that TLX592-Tx may be

suitable for patients with early-stage mCRPC with a low disease burden and for patients with late-stage mCRPC who are

no longer responding to lutetium therapy.

TLX592

-Tx (64Cu/

225

Ac-RADmAb), is our next generation prostate cancer therapy candidate for targeted alpha therapy

and is our first clinical program based on our proprietary RADmAb-engineered antibody technology. The engineered

antibody vector is designed for faster elimination from circulation than standard antibodies. Therefore, it is expected to

reduce bone marrow residence time, mitigating the risk of hematologic toxicities while retaining PSMA-mediated tumor

localization and exertion of cytotoxic activity.

TLX592

-Tx is designed to be cleared by the liver without exocrine uptake.

We have conducted in vivo animal studies using an LNCaP (PSMA positive) tumor model and observed that treatment

with TLX592-Tx resulted in a significant improvement in survival time of nude mice compared to a phosphate buffered

saline treated control group (Fletcher et al. Mol Pharmaceutics. 2025). We studied the toxicological profile in CD1 mice

and did not observe any treatment-related toxicity up to the highest dose level (single administration).

Clinical Data

Prior to commencing therapeutic studies with the alpha emitting isotope 225Ac, we conducted the Phase 1 CUPID trial in

which we evaluated TLX592-Tx radiolabelled with the imaging isotope 64Cu, in patients with advanced prostate cancer.

We used 64Cu to understand the safety profile, pharmacology and dosimetry prior to the use of 225Ac, since 64Cu is

detectable by PET, whereas 225Ac is not. We investigated patients with PSMA avid disease based on Illuccix imaging,

across three mass dose levels, to assess the safety profile, pharmacokinetics, biodistribution and dosimetry. Based on

data from 11 evaluable patients, we observed accelerated elimination from blood circulation compared to the standard

antibody used in TLX591-Tx, with similar on-target and off-target biodistribution. There were no treatment-related

adverse events observed in the trial.

In July 2025, we received regulatory approval in Australia to commence the Phase 1 FIH therapeutic trial, AlphaPRO,

designed to evaluate the safety profile of 225Ac-labelled TLX592-Tx.

Therapy - TLX597-Tx (small molecule-based targeted radionuclide therapy)

TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is our novel small-molecule lutetium-PSMA therapy being developed to

enable access for prostate cancer patients in select geographies.

Clinical Data

Initial data from an Australian IIT showed TLX597-Tx could be effective with reduced salivary gland uptake versus

current standard of care, and a retrospective translational study of 145 patients highlighted positive efficacy outcomes

versus a control group (Luna-Gutiérrez et al. Pharmaceutics. 2023). In the IIT, early dosimetry data from 12 of 120

patients suggests TLX597-Tx delivers approximately one-third of the radiation dose to the salivary glands and one-half

to the kidney, compared to the current approved PSMA-directed lutetium therapy. We believe this could lead to reduced

incidence of acute renal injury and xerostomia (dry mouth), while facilitating dose intensification versus current standard

of care, to improve efficacy.

This candidate is being developed to enable access to lutetium therapy in select geographies, and is the subject of the

ongoing Phase 2 OPTIMAL PSMA IIT, which is expected to enroll 120 mCRPC patients in Australia.

Imaging – Illuccix

Illuccix (also referred to as TLX591-Px in territories where approval has not yet been granted, 68Ga-PSMA-11) is a

preparation for imaging prostate cancer with PET.

The “cold kit” format of Illuccix enables rapid radiolabeling at room temperature with high radiochemical purity and

production consistency, suited to the commercial and hospital radiopharmacy setting. Illuccix is approved in the U.S.,

Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland,

Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden and the United Kingdom. Approved

indications for patients with prostate cancer include staging of high-risk patients, identification of suspected recurrence,

and selection for PSMA-directed therapy. We are also exploring potential future utilization in additional indications for

prostate cancer patients through our lifecycle management program. These include monitoring progression in metastatic

and non-metastatic castration resistant patients, monitoring response to PSMA-directed therapy, and as an adjunct to

MRI for the diagnosis and detection of prostate cancer.

The key evidence supporting the use of Illuccix include:

•Broad availability in the

U.S.

through over 225 radiopharmacies and with flexible scheduling;

•Validated accuracy compared to other PSMA imaging agents, including lower rate of false positives and efficacy in

patients with low disease burden; and

•Potential for expanded clinical utility based on guidelines and clinical research.

In May 2025, our pivotal Phase 3 registration study of TLX591-Px for prostate cancer imaging in Chinese patients

completed target patient enrollment. Illuccix China is a prospective, open-label, single-arm, multicenter study conducted

in collaboration with our strategic partner for the Greater China region, Grand Pharma. The study, which enrolled 140

patients, aims to demonstrate equivalence of TLX591-Px in imaging prostate cancer in Chinese and Western patients, in

order to bridge to the marketing authorization granted to Illuccix by the FDA. In December 2025, Telix and Grand Pharma

announced preliminary data from the Illuccix China study, indicating that the primary endpoint had been met. The data

was used to file a new drug application for TLX591-Px with the Chinese National Medical Products Administration

("NMPA") Center for Drug Evaluation ("CDE"), which was accepted for review in January 2026.

In January 2026, we announced that the first patient had been dosed in our pivotal Phase 3 registration study of TLX591-

Px for prostate cancer PET imaging in Japanese patients. Illuccix Japan is a prospective, open-label, single-arm, intra-

patient, multicenter study designed to evaluate the visualization efficacy and safety profile of 68Ga-PSMA-11 PET/CT

compared with conventional imaging (computed tomography ("CT") and bone scintigraphy) in Japanese patients with

biochemically recurrent ("BCR") prostate cancer following prior radical prostatectomy. The study will enroll up to 105

Japanese men at up to 10 sites and data is intended to support a future marketing authorization application for TLX591-

Px in Japan.

Imaging – Gozellix

Gozellix (68Ga PSMA-11) is Telix's next generation cold kit for the preparation of PSMA-PET imaging for prostate cancer,

and was approved by the FDA in March 2025. Gozellix is designed to have an extended distribution profile compared to

currently approved 68Ga PSMA-PET imaging agents due to the use of 68Ga sourced from newer high activity generators

and cyclotrons.

We believe that Gozellix may further expand the availability and distribution of PSMA-PET imaging due to its longer shelf

life and resulting expanded distribution radius. We believe that Gozellix has the potential to address unmet needs by

extending availability of PSMA-PET imaging to substantially all PET/CT locations in the U.S. Many PET/CT imaging sites

that are not served by approved PSMA-PET imaging agents are located in rural and underserved areas.

Gozellix was granted transitional pass-through payment status by CMS, effective October 2025 for a three-year period.

This status enables CMS to provide separate payments for Gozellix and the PET-CT scan when performed in the hospital

outpatient setting.

We are also exploring potential future utilization in additional indications for prostate cancer patients through our

lifecycle management program. These include monitoring progression in metastatic and non-metastatic castration

resistant patients, monitoring response to PSMA-directed therapy and as an adjunct to MRI for the diagnosis and

detection of prostate cancer.

Imaging – TLX593-Px

In June 2025 we launched a novel PET radiochemistry solution based on 18F-aluminum fluoride ("AlF"), named AlFluor™.

As part of AlFluor’s development, we signed a strategic agreement with University Hospital Ghent and Ghent University

for a novel [18F]AlF-PSMA-11 targeting agent, which we have designated as TLX593-Px. The agreement includes a

comprehensive chemistry, manufacturing and controls ("CMC") package suitable for the preparation of a Drug Master

File ("DMF") and provides exclusive access to TLX593-Px clinical safety and efficacy data, including a Phase 3 trial in 96

prostate cancer patients, where PSMA-11 (gozetotide) was labeled interchangeably with 18F and 68Ga.

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Bone Metastases and Pain Palliation

TLX090-Tx

TLX090

-Tx (

153

Sm-DOTMP) is a novel kit-based bone-seeking targeted radiopharmaceutical product candidate that uses

a next generation chelating agent to deliver a proprietary formulation of Samarium-153 radioisotope. It is a combination

of patented, lower specific activity form of Samarium-153, a beta-emitting radioisotope with a 46-hour half-life, and the

chelating agent DOTMP (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetramethylene-phosphonate), which selectively

targets sites of high bone mineral turnover, a known characteristic of bone metastases, and minimizes off-target

migration.

We believe that TLX090-Tx may be administered as a single dose, multiple doses and higher dose regimens for pain

management of bone metastases and osteosarcoma therapy, including in pediatric patients. We believe that TLX090-Tx

is highly aligned with our existing therapeutic focus areas of prostate cancer, glioma and sarcoma.

Clinical Data

In August 2021, the FDA cleared the IND application to commence Phase 1, open-label, dose escalating study for

TLX090

-Tx (originally CycloSam®) in patients with osteosarcoma and other solid tumors metastatic to bone, with the

primary objective of establishing the maximum tolerated dose ("MTD") and evaluating pharmacokinetics, dosimetry, and

safety. Patients received an imaging dose of 0.5 mCi/kg on Day 1 and then a therapeutic dose on Day 8, with escalation

planned up to 3.0 mCi/kg. A total of five patients were enrolled and treated in the first two cohorts (three patients at 0.5

mCi and two patients at 1 mCi/kg). SPECT/CT scans of these patients showed that TLX090-Tx was highly targeted to

bone and had preferential uptake in bone tumors, with no evidence of soft tissue activity and rapid elimination via the

kidney and bladder. Complete blood count and comprehensive metabolic panel blood testing data indicated no toxicities

or drug-related adverse events, some mild and transient drop in white blood cell counts that recovered by Week 6

without intervention, and there were no clinically significant changes in liver and kidney function. No transfusions or stem

cell recovery procedures were necessary. While pain relief was observed in patients, this was exploratory and not a

primary endpoint. Visual analogue scale pain scores taken at baseline and then weekly after dosing suggest fast-acting,

long-lasting pain relief, improved mobility and improved quality of life. We believe that pain relief is evidence of that

TLX090

-Tx may not have similar risks or the potential adverse events of opiate pain medications, and may offer a viable

alternative for pain palliation in patients with advanced cancer and painful osteoblastic bone metastases.

We believe that TLX090-Tx has the potential to deliver significant improvements to existing bone-seeking agents for the

palliation of painful osteoblastic bone metastases in late-stage metastatic disease. We believe TLX090-Tx may enable

the pain management of prostate cancer bone metastases, where there remains a significant unmet medical need

particularly after progression from other forms of radionuclide and radiation therapy. We also believe that TLX090-Tx

may benefit patients with metastatic lung and breast cancer, where many patients develop painful bone metastases, and

disease management often focuses on quality-of-life palliative care.

TLX090

-Tx has also been granted orphan drug and rare pediatric disease designations by the FDA for the treatment of

osteosarcoma. These designations apply only to the osteosarcoma indication and do not apply to the current pain

palliation indication being pursued in the SOLACE trial. The rare pediatric disease designation may enable TLX090-Tx to

be brought to market more rapidly for osteosarcoma through regulatory incentives, including eligibility for a pediatric rare

disease priority review voucher that may be applied to this or other programs. The orphan drug designation and the rare

pediatric disease designation do not increase the likelihood of marketing approval.

In October 2025, we dosed the first patient in an open-label Phase 1 clinical trial designed to evaluate the

pharmacokinetics, dosimetry, safety, and pain palliation of TLX090-Tx. SOLACE (Samarium Optimized for Long-lasting

Analgesia in Cancerous End-stage bone pain) is expected to enroll up to 33 patients with advanced cancer and painful

osteoblastic bone metastases. Data from SOLACE aims to establish clinical comparability to legacy 153Sm treatments,

which in turn is expected to support a streamlined registration pathway as an analgesic, paving the way for a much-

needed, non-opioid solution for patients living with bone pain in the late stages of advanced cancer.

Our Kidney Cancer and CAIX programs

Overview

CAIX is a protein expressed on the surface of ccRCC and other solid tumors, including bladder or urothelial, breast, brain,

cervix, colon, esophagus, head and neck, lung, ovarian, pancreatic and vulval cancers. CAIX is overexpressed in over

95% of ccRCC tumor cells and has limited expression on healthy tissue.

CAIX is often expressed in hypoxic (oxygen deficient) tumor cells. Hypoxic tumors are also typically more aggressive and

less responsive to current treatments, particularly immunotherapies. A published study has shown that tumor sections

from patients that failed to respond to PD-1 blockade therapy showed significantly higher CAIX expression than those

that responded (n = 19), suggesting that CAIX expression is associated with poor response to immunotherapy.

Furthermore, a published study has demonstrated that in 117 hepatocellular carcinoma patients, positive CAIX expression

correlated with reduced disease-free survival and overall survival.

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We believe the association between hypoxia, disease progression, and therapeutic resistance underscores the relevance

of this target. Whereas normal endogenous expression of CAIX is very low, CAIX has been found to be differentially

expressed on Tregs in the tumor micro-environment in a number of solid tumors. We are developing products for the

detection and treatment of ccRCC and investigating the potential of CAIX as a pan-cancer target in multiple tumor types.

Market and Opportunity for Kidney Cancer Therapy

We estimate that over 25% of ccRCC patients, equivalent to over 16,000 patients per year in the U.S., have metastatic

RCC. Approved treatment options for ccRCC patients include immunotherapy, tyrosine kinase inhibitors, mTOR inhibitors,

and HIF-2α inhibitors. The U.S. market for systemic RCC treatment is estimated to be approximately US$6.7 billion per

year based on Datamonitor’s patient-based forecast, and the global market is estimated at approximately US$9.2 billion.

We are exploring the use of TLX250-Tx for the treatment of ccRCC, either in combination with an immunotherapy or as a

monotherapy, to treat metastatic disease expressing the CAIX receptor. There is a significant need for new therapeutic

options for patients with advanced kidney cancer, given its inherent resistance to conventional chemotherapy. Despite

the transformative impact of immunotherapies on the prognosis of patients with metastatic kidney cancer, a considerable

number fail to respond adequately and eventually progress.

An increasing body of scientific evidence suggests low doses of targeted radiation can potentially overcome immune

resistance. This approach, known as immunological “priming,” has the potential to render tumors more susceptible to

cancer immunotherapy. Several pre-clinical studies have shown an enhanced therapeutic outcome of checkpoint

inhibitors when they are administered after a systemic radiotherapy, including rendering immunologically inert tumors

sensitive to treatment.

There is currently no CAIX-targeted radiopharmaceutical therapy approved to treat ccRCC. Several other systemic

radiotherapies are being investigated to treat ccRCC targeting CAIX, and potentially could be commercialized in the

future.

We consider our most direct competitors to be companies developing CAIX-targeted systemic radiotherapies, including

ITM Isotope Technologies Munich SE/Debiopharm SA, Precision Molecular, Inc., Bristol Myers Squibb Company/RayzeBio,

Inc., AstraZeneca PLC/Fusion Pharmaceuticals Inc. and PeptiDream Inc. Our competitors will also include companies

developing other modalities to treat ccRCC.

Market and Opportunity for Kidney Cancer Imaging

According to the Global Cancer Statistics 2022: GLOBOCAN survey, global incidence of kidney cancer was 434,840 in

In the U.S., the incidence of kidney cancer was 81,800 in 2022 according to the American Cancer Society.

Approximately 80-90% of malignant kidney tumors are ccRCC. It is one of the subtypes with the worst prognosis and

survival often depends on how early it is detected.

Kidney cancer is typically discovered incidentally and diagnosed using a number of modalities including CT scanning, MRI

scanning, ultrasound, and biopsy.

The detection of renal masses is increasing due to widespread use of cross-sectional imaging. Many of these are small

and represent a diagnostic challenge as current imaging techniques, including ultrasound and MRI, cannot reliably

distinguish benign or malignant lesions from renal cell carcinoma, leading to invasive biopsy or partial nephrectomy

(kidney removal) to confirm the diagnosis. These procedures are cumbersome and often lead to complications.

Currently, there are major unmet needs for the improvement in diagnosis of ccRCC from indeterminate renal masses as

well as improving the staging of more advanced ccRCC through more accurate and specific imaging techniques. In the

U.S., we estimate that there are at least 116,000 patients per year with renal masses that could require a biopsy or

nephrectomy. We believe that an additional 50,000 patients with ccRCC could benefit from more accurate staging or

improved identification of recurrence using molecular imaging. This market is estimated to represent approximately

US$1.5 billion per year. We also believe that there may be patients that may benefit from more than one scan and from

active surveillance.

Currently, there is no approved agent for CAIX imaging. We consider our most direct competitors to be companies

developing ccRCC or CAIX-targeted imaging agents, including ITM Isotope Technologies Munich SE/Debiopharm SA,

Philogen S.p.A., Precision Molecular, Inc., PeptiDream Inc., Norroy Bioscience Co. Ltd., and Five Eleven Pharma. Our

competitors will also include companies developing other modalities to image ccRCC and CAIX.

Therapy – TLX250-Tx

TLX250

-Tx (

177

Lu-DOTA-girentuximab) is a rADC therapeutic product candidate for the treatment of kidney cancer.

TLX250

-Tx is currently under investigation for the treatment of patients with ccRCC in an investigator-initiated trial in

combination with checkpoint and tyrosine kinase inhibitors in up to 100 patients (Phase 1b/2 STARLITE-1). In October

2025 we received ethics approval in Australia to commence LUTEON, a global Phase 2/3 trial of TLX250-Tx as a

monotherapy in participants with recurrent ccRCC, who have progressive disease on or after two and no more than three

prior lines of therapy.

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We are using girentuximab to target CAIX as it is designed to have a high degree of selectivity and affinity for the target

and is cleared from the body by the liver. The lack of kidney excretion is an advantage for patients with primary kidney

disease. We believe the target profile and the properties of girentuximab make the ccRCC phenotype promising as the

first therapeutic indication for TLX250-Tx. We believe the therapeutic potential of TLX250-Tx may also extend into other

cancers that significantly express CAIX, including certain VHL-induced cancers, ovarian cancer, triple-negative breast

cancer and bladder cancer. We believe that our preliminary clinical data in triple-negative breast cancer and bladder

cancer supports future development of TLX250-Tx in these indications.

Clinical Data

TLX250

-Tx is being evaluated for the treatment of patients with ccRCC, both as a monotherapy and in combination with

checkpoint inhibitors.

In October 2025 we received ethics approval in Australia to commence LUTEON, a global Phase 2/3 trial of TLX250-Tx

as a monotherapy in advanced metastatic ccRCC. This global, multicenter, open-label trial will be conducted in two parts,

a safety and dosimetry lead-in (Part 1), followed by randomized efficacy assessment (Part 2). The objective of Part 1 is to

determine the recommended Phase 3 dose ("RP3D") for use in Part 2.

STARLITE-1 is a single arm Phase 1/2 IIT of TLX250-Tx in combination with cabozantinib and nivolumab in treatment

naïve patients with advanced ccRCC. The trial, which has a target enrollment of 100 patients, is sponsored by the MD

Anderson Cancer Center and commenced dosing patients in September 2025.

We believe that tumor-targeted radiation stimulates remodeling of the tumor micro-environment and can kill

immunosuppressive cells and stimulate T-cell recruitment to attack tumor cells. This immune re-programming may

increase the therapeutic response to treatment with checkpoint inhibitors.

TLX250-Tx was previously the subject of the exploratory Phase 2 STARLITE-2 IIT in combination with nivolumab, and the

Phase 1b STARSTRUCK trial in combination with peposertib, a DNA-dependent protein kinase ("DNA-PK") inhibitor in

collaboration with Merck KGaA, Darmstadt, Germany. We are now initiating the LUTEON study, a global Phase 2/3 trial of

TLX250-Tx as a monotherapy in treatment‑refractory disease. We believe LUTEON will generate the pivotal data

required to define the optimal therapeutic activity, schedule, and treatment window for TLX250-Tx. These data are

essential to inform any future development including combination regimens. In light of this, we have made the decision to

close STARLITE-2 and STARSTRUCK trials at this time to ensure that any future combination‑therapy development is

aligned with the most robust and clinically validated dosing framework.

Therapy – TLX252-Tx

In our TLX252-Tx (

225

Ac-DOTA-girentuximab) program, we are developing girentuximab radiolabeled with the alpha-

emitting isotope actinium-225 as a potential follow-on for the TLX250-Tx (beta) program by addressing unmet need in

radiation-resistant CAIX-positive disease. TLX252-Tx has demonstrated pre-clinical proof-of-concept in several

published studies (Merkx et al. Pharmaceuticals. 2022), which we believe supports the initiation of an administered-

activity escalation trial of TLX252-Tx for patients with advanced metastatic kidney cancer and other CAIX-expressing

tumors.

We expect that data from our existing CAIX-targeting programs (TLX250-Px diagnostic and TLX250-Tx therapy) will

complement and inform the clinical and regulatory development strategy for TLX252-Tx. In September 2025 we received

ethics approval in Australia to commence ALPHIX, a first-in-human Phase 1 study of TLX252-Tx in patients with

advanced metastatic kidney cancer and other CAIX-expressing tumors. CAIX is a broad indicator of aggressive,

treatment-resistant disease in most solid tumors and we believe that the use of an alpha-emitter like

225

Ac for CAIX-

targeted radiation may help overcome treatment resistance in these aggressive tumors given the unique properties of α-

particles, which make this treatment modality impervious to conventional cellular resistance mechanisms.

Imaging – TLX250-Px

TLX250-Px (89Zr-DFO-girentuximab) is a PET imaging candidate for the characterization of renal masses as ccRCC. We

evaluated TLX250-Px in the Phase 3 ZIRCON trial in 300 patients, of which 284 were evaluable. The trial met all primary

and secondary endpoints, including showing 86% sensitivity and 87% specificity and a mean positive predictive value of

93% for ccRCC across three independent readers. We believe this demonstrated the ability of TLX250-Px to reliably

detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. TLX250-Px was

granted breakthrough therapy designation by the FDA in 2020.

We submitted a BLA for TLX250-Px to the FDA for regulatory approval in December 2023. The BLA was granted on a

rolling review process. We completed the BLA submission in May 2024, and in July 2024, the FDA declined to approve

the BLA and issued an RTF determination. The denial was based on a filing concern related to demonstrating adequate

sterility assurance during dispensing of TLX250-Px in the radiopharmacy production environment. In December 2024 we

resubmitted our BLA to the FDA for TLX250-Px, and the FDA accepted our application in February 2025. In August 2025,

the FDA issued a CRL, citing deficiencies relating to the CMC package. The FDA requested additional data to establish

comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing

process intended for commercial use. Additionally, the FDA documented notices of deficiency (Form 483) issued to two

third-party manufacturing and supply chain partners that required remediation prior to resubmission. In December 2025

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we participated in a Type A meeting with the FDA to align on plans to address CMC deficiencies cited, and in January

2026 we participated in an additional Type A meeting to align on plans to address comparability between the clinical

drug product and that intended for commercial use. Following these meetings, Telix believes it has alignment with the

Agency on all key resubmission aspects, and is working both internally and with third-party vendors to implement these

items for resubmission. While we believe that the planned remediation of the BLA for TLX250-Px will meet FDA

requirements, there can be no assurance that, once resubmitted, the FDA will accept our BLA for review, or approve

TLX250-Px. If approved, TLX250-Px would be the first targeted radiopharmaceutical imaging agent for kidney cancer to

be approved in the U.S.

The key attributes supporting development of TLX250-Px include:

•High affinity for CAIX, expressed in up to 95% of ccRCC and many hypoxic solid tumors, low expression in normal

tissue;

•Positive results in Phase 3 ZIRCON trial including key secondary endpoints that demonstrated detection of ccRCC

even in small renal masses (less than 4cm); and

•Breakthrough therapy designation from the FDA granted in 2020.

Breakthrough therapy designation may not lead to a faster development or regulatory review or approval process, and

does not increase the likelihood that TLX250-Px will receive marketing approval.

Clinical Data

In 2022, we completed the pivotal Phase 3 ZIRCON trial evaluating TLX250-Px in 300 patients, and primary results were

published in Lancet Oncology in 2024 (Shuch et al. Lancet Oncol. 2024). The trial met all primary and secondary

endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent

readers. We believe this trial demonstrated the ability of TLX250-Px to reliably detect the clear cell phenotype and

provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three

readers, showing evidence of high accuracy and consistency of interpretation.

The data from the trial demonstrated the ability of TLX250-Px to characterize renal masses as ccRCC, which could

support improved clinical decision making and limiting the need for invasive procedures like biopsies and nephrectomies.

A total of 300 patients were dosed with TLX250-Px in the trial and 284 patients had a central histology reading and

evaluable TLX250-Px PET scan at central review.

The study also met the key secondary endpoint, achieving 85% sensitivity and 89% specificity in detecting ccRCC in

tumors ≤4cm (T1a classification), currently a significant clinical challenge in the diagnosis of ccRCC. In very small renal

lesions (≤2cm, a secondary endpoint), sensitivity was 84% for all three independent readers, with specificity ranging

from 90.0% to 100%.

The table below provides a breakdown of the three independent reader scores, overall score and confidence intervals of

the full analysis set.

	Reader 1	Reader 2	Reader 3	Overall % (95 % CI)
Sensitivity, %	84.13	85.19	87.30	85.50
Lowest bounds, Wilson 95% CI	78.24	79.42	81.80	(79.80; 89.80)
Specificity, %	88.42	88.42	84.21	87.00
Lowest bounds, Wilson 95% CI	80.45	80.45	75.57	(78.80; 92.30)
Positive predictive value, %	93.53	93.60	91.67	93.00 (88.00; 96.00)
Negative predictive value, %	73.68	75.00	76.92	75.00 (66.00; 82.00)
Accuracy, %	85.56	86.27	86.27	86.00 (81.50; 89.60)

The majority of adverse events in the trial were post-surgical complications and not treatment related. A total of 261

treatment-emergent adverse events were reported in 122 of 300 patients (40.7%), of which 146 were mild, 50 were

moderate and 49 were severe. Four of the treatment-emergent adverse events were life-threatening and one was fatal.

13 treatment-emergent adverse events were considered to be treatment related, of which, nine occurred before surgery

and four occurred after surgery. No unexpected safety signals were observed and tolerability data were consistent with

experience of girentuximab in previous therapeutic and imaging studies.

In November 2024, we dosed the first patient in the Phase 3 ZIRCON-CP study of TLX250-Px PET imaging of ccRCC in

Chinese patients. The study, which will enroll up to 82 patients, is being conducted in collaboration with the Company’s

strategic partner for the Greater China region, Grand Pharmaceutical Group Limited ("Grand Pharma"), to demonstrate

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that the diagnostic utility of TLX250-Px is equivalent in Chinese and Western populations. The clinical data from ZIRCON-

CP is intended to support future marketing authorization applications for this breakthrough technology in the region.

In October 2024, we announced that we dosed the first patient in the Phase 2 CA-NINE trial, which is an investigator-

initiated Phase 2 trial evaluating TLX250-Px in patients with ccRCC after surgery. The trial plans to enroll 91 patients with

intermediate-to-high risk ccRCC post-surgery and is designed to identify ccRCC where it has recurred, including

metastatic disease, and may inform future label expansion for TLX250-Px.

There are several other investigator-led trials of TLX250-Px that have recently completed enrollment, including the

Phase 1 ZiP-UP trial in patients with metastatic urothelial carcinoma or bladder cancer, the Phase 2 OPALESCENCE trial

in patients with triple-negative breast cancer, and the Phase 1 PERTINENCE trial in patients with non-muscle invasive

bladder cancer ("NMIBC"). The OPALESCENCE and PERTINENCE trials reported positive preliminary data during 2022 at

the European Association of Nuclear Medicine Annual Congress, with early results suggesting theranostic potential in

these difficult to treat diseases. In May 2025, final positive results from the PERTINENCE trial along with preclinical data

were published in Cancers demonstrating the promising therapeutic role of

211

At-girentuximab in NMIBC. In November

2025, final positive results from the OPALESCENCE trial were published in the European Journal of Nuclear Medicine and

Molecular Imaging, demonstrating the potential for TLX250-Px to detect metastatic triple negative breast cancer

TNBC")

lesions that may be resistant to chemotherapy and therefore have a more aggressive profile resulting from

hypoxia.

In November 2025, we announced results from the ZIRCON-X study which found that almost half of all patients imaged

with TLX250-Px would have undergone a change in clinical management, when compared with baseline

SOC

imaging.

ZIRCON-X was a non-interventional, prospective, post-hoc study sponsored by Telix – using imaging data from Telix’s

parent pivotal Phase 3 ZIRCON study – that assessed the impact of TLX250-Px imaging on clinical decision-making

versus SOC contrast-enhanced diagnostic imaging in 294 patients with indeterminate renal masses ("IRMs"). The study

found that 143 patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-Px, and

over 20% of these patients (31 out of 143) could have potentially avoided invasive biopsy. Of all evaluable patients, more

than one third (110 out of 294, or 37.4%) would have had a major change in clinical management based on defined

categories, with approximately 30% having their treatment escalated or de-escalated. A subset of 18 patients initially

selected for active surveillance would have been escalated to immediate treatment.

Our Brain Cancer Programs and LAT1/LAT2

Overview

According to the Global Cancer Statistics 2022: GLOBOCAN survey, global incidence of brain and nervous system tumors

was 321,731 in 2022. Gliomas make up approximately 30% of all brain and central nervous system tumors and 80% of all

malignant brain tumors. In the U.S., according to the 2025 CBTRUS Statistical Report, the incidence of malignant glioma

was 22,836.

Glioblastoma is the most aggressive sub-type of glioma, representing 14,190 cases per year in the U.S. It has a poor

prognosis, primarily due to there being few effective treatment options. Glioblastoma has a median survival from initial

diagnosis of 12-15 months with a 5-year survival of 7%.

The mainstay of treatment for glioblastoma is surgical resection, followed by combined radiotherapy and chemotherapy.

Despite such treatment, recurrence occurs in almost all patients. Our brain cancer program targets membrane transport

proteins called LAT1 and LAT2, which are important targets in cancer development as they supply tumors with essential

amino acids, promoting cell proliferation, angiogenesis and mediating drug and nutrient delivery across the blood-brain

barrier. LAT1 and LAT2 are highly expressed in the blood-brain barrier and in various types of cancer, including

glioblastoma.

Market and Opportunity for Brain Cancer Treatment

While surgical resection plus radiation therapy are the mainstays of treatment, the vast majority of patients experience

disease recurrence. Thus, there remains an important need for therapies targeted towards glioblastoma in patients in

both the front-line treatment setting, as well as for patients experiencing disease recurrence following surgical

intervention.

There are several systemic radiotherapies being evaluated in clinical trials for the treatment of glioblastoma. We consider

our most direct competitors to be companies developing systemic radiotherapies for brain tumors, including ITM Isotope

Technologies Munich SE, Molecular Targeting Technologies, Inc., EvaThera Theranostics, Novartis, RadioPharm

Theranostics, Plus Therapeutics and Cellectar Biosciences, Inc. Our competitors will also include companies developing

other modalities to treat brain cancer.

Market and Opportunity for Brain Cancer Imaging

We believe there are a number of opportunities to address unmet needs in the market for imaging of glioma. The first is

improving the characterization of recurrence. Although MRI is the current standard of care for imaging of glioma patients,

the accurate identification of recurrence remains an important unmet medical need. The U.S. market opportunity for

imaging in this setting is estimated at 20,000 scans per year. This market is estimated to represent approximately

US$100 million to US$140 million per year.

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The second is improving adjuvant radiation treatment planning in glioblastoma patients, which is also an important unmet

medical need. The U.S. market opportunity imaging in this setting is estimated to be 15,000 scans per year.

The third opportunity is improved identification of recurrence in patients with brain metastases. The incidence of brain

metastases in the U.S. is estimated to be approximately 168,000 cases per year. The U.S. market opportunity for imaging

in this setting is estimated at approximately 100,000 scans per year. This aggregate market is estimated to represent

approximately US$600 million per year.

There are several molecular imaging agents being evaluated in clinical trials for the imaging of glioma and brain

metastases. We consider our most direct competitors to be companies developing imaging agents for brain tumors,

including Novartis, Blue Earth Diagnostics, RadioPharm Theranostics, Curasight, Molecular Targeting Technologies, Inc.,

and EvaThera Theranostics. Our competitors could also include companies developing other modalities to image brain

cancer.

Therapy – TLX101-Tx

TLX101

-Tx (iodofalan 131I) is our lead therapeutic product candidate for the treatment of patients with brain cancer that

targets the LAT1 receptor. TLX101-Tx is a novel approach that is designed to readily pass through the blood-brain

barrier, the normal protective barrier that prevents many potential drug candidates from entering the brain.

We are currently evaluating TLX101-Tx in front line and recurrent glioblastoma in the IPAX series of trials. TLX101-Tx has

been granted orphan drug designation in the U.S. and Europe for the treatment of glioma. Orphan drug designation may

not lead to a faster development or regulatory review or approval process and does not increase the likelihood that

TLX101

-Tx will receive marketing approval.

The key attributes supporting development of TLX101-Tx include:

•IPAX-1 Phase 1 trial, demonstrated evidence of tumor responses in recurrent glioblastoma including some patients

with prolonged disease stabilization, and evidence of rapid clearance of TLX101-Tx from the brain;

•IPAX-2 Phase 1 trial extended TLX101-Tx into the front-line setting, building upon experience in recurrent setting;

•

TLX101

-Tx has been granted orphan drug designation in the U.S. and Europe for the treatment of glioma.

In 2025, we received regulatory approval in Australia and the EU to commence the Phase 3 IPAX-BrIGHT pivotal trial of

TLX101-Tx with sites open for enrollment. IPAX BrIGHT is designed to assess the safety and tolerability of TLX101-Tx in

combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study

is enrolling patients with radiographically confirmed recurrent glioblastoma at first recurrence. The trial consists of two

parts: Part 1, a safety and dosimetry lead-in with a minimum of 18 patients, and Part 2, randomized efficacy assessment,

with enrollment numbers to be determined following Part 1. Patient dosing in IPAX-BrIGHT will mark the first targeted

radionuclide therapy to enter Phase 3 development for recurrent glioblastoma.

Clinical Data

In 2022, we reported the final results from the IPAX-1 Phase 1/2 trial evaluating TLX101-Tx in combination with EBRT in

patients with recurrent glioblastoma. In 2024, results were published in Neuro-Oncology Advances, confirming the trial

met its primary safety and tolerability objective.

We enrolled ten patients in the trial, nine of whom received the full dose of ~2GBq (2000 MBq) of TLX101-Tx, either in

the form of a single administration or one of two triple-fractionated regimens. All dosing regimens were well tolerated.

Dosimetric analysis demonstrated that radiation exposure to key organs was well within acceptable safety limits.

The trial also demonstrated a median overall survival of 23 months from initial diagnosis, or 13 months from the initiation

of treatment in the recurring setting. Of the nine patients who received conventional imaging, four (44%) exhibited stable

disease at day 135 and two (22%) at day 180, determined by longitudinal imaging.

The most frequent treatment emergent adverse events ("TEAEs") were decreased lymphocyte count, fatigue, headache

and hiccups, which occurred in three patients (30%), followed by decreased platelet count, diarrhea, cerebral oedema

(swelling), and insomnia, which occurred in two patients (20%). Except for cerebral oedema (swelling), a common

adverse event following radiation to the brain, adverse events were of low grade, did not show any trends or patterns

and were clinically manageable, with a significant proportion deemed unrelated to therapy.

In 2023, we initiated a Phase 1 trial, IPAX-2, to further evaluate the safety of TLX101-Tx in up to 15 patients as a front-line

therapy for the treatment of glioblastoma in combination with EBRT and temozolomide. In IPAX-2, the second patient

cohort has completed and the third cohort is fully enrolled.

TLX101

-Tx was investigated in the recurrent setting in the investigator-initiated IPAX-Linz Phase 2 trial, which reported

preliminary results in April 2025. Treatment with TLX101-Tx was well tolerated with no serious adverse events reported.

IPAX-Linz demonstrated encouraging preliminary efficacy data, indicating a median overall survival ("OS") of 12.4 months

from the initiation of treatment with TLX101-Tx, or 32.2 months from initial diagnosis. Five of the eight patients enrolled in

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IPAX-Linz had unmethylated MGMT promoter status, which is typically associated with poorer outcomes. These results

are consistent with the positive efficacy outcomes generated in the IPAX-1 study. In comparison, recurrent glioblastoma

patients treated with EBRT alone have a reported median survival of 9.9 months from treatment.

Therapy – TLX102-Tx

In our TLX102-Tx (211At astato-L-phenylalanine) program, we are also exploring how phenylalanine, the same LAT1

targeting small molecule substrate used in TLX101-Tx, radiolabeled with an alpha-emitting isotope might deliver a

different therapeutic profile. Astatine-211 is an alpha-emitting radioisotope with comparable halogen chemistry to

Iodine-131 that can cross the blood-brain barrier. TLX102-Tx has demonstrated pre-clinical proof-of-concept and we

believe that TLX102-Tx has the potential to have a favorable efficacy and safety profile in future human clinical trials in

patients with glioblastoma, leptomeningeal disease, and multiple myeloma. Astatine chemistry has been demonstrated,

scaled up and automated, ready for clinical production. Due to comparable target binding and molecular structure, we

expect that data from our existing LAT1 theranostic programs TLX101-Px and TLX101-Tx will complement and inform the

clinical and regulatory development strategy for TLX102-Tx.

In August 2020, TLX102-Tx was granted orphan drug designation from the FDA in the U.S. for the treatment of multiple

myeloma, and in November 2025, TLX102-Tx was granted orphan drug designation from the FDA for the treatment of

malignant gliomas. Orphan drug designation may not lead to a faster development or regulatory review or approval

process in multiple myeloma or glioblastoma and does not increase the likelihood that TLX102-Tx will receive marketing

approval in either of these disease areas.

In December 2025, the FDA provided positive written feedback on our proposed two-part FIH study design in patients

with leptomeningeal disease ("LMD"), and acknowledged that LMD from solid tumors represents a significant unmet

medical need. The FDA has also provided guidance on a combined protocol for imaging and therapy to enable a true

theranostic evaluation, including potential future label expansion for TLX101-Px.

Imaging – TLX101-Px

TLX101-Px (18F-FET) is a radiolabeled amino acid PET agent for imaging of gliomas that is used in clinical research

settings, including in our IPAX series of trials of TLX101-Tx, as a complementary diagnostic agent. Clinical data suggest

that TLX101-Px can facilitate the identification of recurrence of brain metastases. 18F-FET is widely used in many

jurisdictions and is recommended by the joint guidelines from the European Association of Nuclear Medicine, European

Association of Neuro-Oncology, Society of Nuclear Medicine and Molecular Imaging, The European Society for Pediatric

Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma

patients. 18F-FET is also included in latest NCCN Guidelines® for Central Nervous System Cancers (V1.2025) for PET

imaging of gliomas.

In October 2020, TLX101-Px was granted orphan drug designation from the FDA in the U.S. for the imaging of glioma.

Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not

increase the likelihood that TLX101-Px will receive marketing approval.

We used TLX101-Px to select patients and track disease response in our IPAX-1 Phase 1/2 clinical trial and the recently

completed IPAX-Linz investigator-initiated trial. We are using TLX101-Px in the Phase 1 IPAX-2 trial, which is actively

dosing patients, and for patient selection in our pivotal IPAX BrIGHT trial, as well as assessing metabolic tumor response

according to PET-based response assessment criteria for diffuse gliomas ("

PET RANO 1.0").

In August 2024, we submitted an NDA to the FDA for TLX101-Px for the characterization of progressive or recurrent

glioma in both adult and pediatric patients from treatment related changes through the 505(b)(2) NDA regulatory

pathway. In October 2024, the FDA accepted the NDA, granted priority review and assigned a PDUFA goal date of April

26, 2025. In April 2025, the FDA issued a CRL, stating that additional confirmatory clinical evidence was required to

progress the application. Following engagement with the FDA, including a successful Type A meeting, in September 2025

we reached agreement regarding the required resubmission package, which includes a retrospective analysis to

supplement clinical data. We are currently finalizing our resubmission package and will provide an update upon filing.

There can be no assurance that the FDA will accept our resubmitted NDA for review, or approve TLX101-Px. TLX101-Px

was granted fast track designation by the FDA for this indication in April 2024. Fast track designation may not lead to a

faster development or regulatory review or approval process, and does not increase the likelihood that TLX101-Px will

receive marketing approval.

In February 2026 we submitted a MAA for TLX101-Px in a selection of European countries, with France acting as RMS.

The French National Agency for Medicines and Health Products Safety, ANSM, in its capacity as RMS is responsible for

coordinating and leading the scientific evaluation of the dossier, in collaboration with the Concerned Member States.

There can be no assurance that the MAA will be validated, or that marketing authorizations for TLX101‑Px will ultimately

be granted.

We also intend to conduct a label-expanding Phase 3 trial of TLX101-Px for the imaging of patients with brain metastases

from non-brain cancers, including lung and breast cancer.

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The key attributes supporting development of TLX101-Px include:

•Potential tool for management of progression and treatment monitoring;

•Orphan drug designation, potential to meet major unmet need; and

•Widely used in Europe and recommended in the joint guidelines for imaging of gliomas.

Clinical Data

The ability of 18F-FET PET to characterize gliomas across tumor grades and clinical settings has been evaluated in

multiple prospective and retrospective clinical studies (Dunet et al. J Nucl Med. 2012). Various imaging techniques were

used to compare 18F-FET PET with magnetic resonance imaging ("MRI"), 18F-fluoro-2-deoxy-D-glucose ("FDG-PET"), 18F-

fluorothymidine, and perfusion-weighted MRI (Juhász et al. Mol Imaging. 2014). The findings from these trials indicated

that 18F-FET PET generally demonstrated higher sensitivity and specificity (Galldiks et al.

EJNMMI.

2015; Galldiks et al.

Neuro Oncol. 2015; Albert et al.

EJNMMI.

2016).

18F-FET was the subject of a systematic review and meta-analysis

(Dunet et al. J Nucl Med. 2012) that included multiple studies and patient lesions, concluding that 18F-FET PET may serve

as a complementary modality to standard of care MRI in managing brain malignancies.

As part of our commitment to provide access to medicine, we are running an EAP in the U.S. to allow access to TLX101-

Px outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

We are also exploring applications of TLX101-Px imaging in radiation treatment planning through the 18F-FET in

glioblastoma ("FIG") investigator-initiated trial. This aim is to show that TLX101-Px can help improve radiation treatment

planning in a prospective, multi-center PET/CT trial.

Our Other Solid Tumors and Hematologic Oncology Programs

Soft Tissue Sarcoma and PDGFRα

Soft tissue sarcoma ("STS") is a rare, complex disease that encompasses a diverse group of relatively rare cancers, with

more than 50 histological subtypes. According to the National Cancer Institute, there were an estimated 13,400 new

cases and 5,140 deaths were caused by

STS

in 2023 in the U.S. Standard treatment for STS includes surgery, radiation

therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically

involves chemotherapy with single agents (e.g., doxorubicin) or anthracycline-based combination regimens. However,

the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall

survival of around 12–18 months.

STS is usually diagnosed using imaging tests (CT, MRI and/or FDG-PET) and/or biopsy, depending on the tumor location.

Conventional imaging and biopsy are also used for staging.

There are several programs in clinical development for the treatment of STS, none of which is a targeted systemic

radiotherapy. We consider our most direct competitors to be companies developing systemic radiotherapies in the soft-

tissue sarcoma space, including OncoTherapy Science, RadioPharm Theranostics and Cellectar Biosciences, Inc. Our

competitors will also include companies developing other modalities to treat STS.

Therapy – TLX300-Tx

In April 2022, we entered into a licensing agreement with Lilly that granted us exclusive worldwide rights to develop and

commercialize radiolabeled forms of olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of

cancer. Lilly originally developed olaratumab a non-radiolabeled monoclonal antibody targeting PDGFRα, a protein

expressed in multiple tumor types that is involved in fibrogenesis. Olaratumab has a well-established clinical and

toxicology profile as a non-radiolabeled agent.

Olaratumab was granted accelerated approval in the U.S. and conditional approval in the European Union based on

Phase 2 trial data. Lilly began marketing olaratumab as Lartruvo in 2016.

Sales of Lartruvo peaked at US$304.7 million in 2018. Olaratumab was voluntarily withdrawn from the market by Lilly

following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab in combination with standard

chemotherapy did not improve survival for patients compared to chemotherapy alone. We believe that the therapeutic

limitations of Lartruvo can be overcome through the re-purposing of olaratumab as a radiopharmaceutical.

Our initial development focus for radiolabeled olaratumab is on advanced or metastatic STS and other PDGFRα positive

tumors. Our therapeutic product candidate, TLX300-Tx, employs antibody-directed targeted radiation against PDGFRα.

We believe that the ability of olaratumab to target PDGFRα makes it a promising candidate for use as a targeted

radionuclide therapy.

We completed pre-clinical validation of TLX300-Tx in 2023 and initiated a FIH Phase 1 proof-of-concept targeting and

biodistribution trial, ZOLAR, in April 2025. The aim of the trial is to evaluate the safety, pharmacokinetics, biodistribution

and dosimetry, and establish the optimal dose of TLX300-Px using PET imaging, prior to therapeutic studies, based on a

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theranostic approach. Patient dosimetry and target expression characteristics from

ZOLAR

will inform selection of the

therapeutic radionuclide for TLX300-Tx, in conjunction with currently active non-clinical radiation biology studies.

The key attributes supporting development of TLX300-Tx include:

•Well-established clinical and toxicology profile of olaratumab as a non-radiolabeled agent;

•First-in-human, Phase 1 proof-of-concept and biodistribution trial dosing patients in Australia; and

•Potential application in STS and a range of other cancers (e.g., bone, brain, breast, lung, ovarian and prostate

cancers).

In a preclinical study of a dose of 10 MBq of TLX300-Tx in mice, we observed a significant increase in survival to tumor

endpoint (P=0.0004, Log-Rank test).

Imaging – TLX300-Px

TLX300-Px (89Zr-DFOsq-olaratumab) is an investigational imaging agent that we are developing for use with TLX300-Tx

as a theranostic pair. DFO-squaramide ("DFOsq") is our proprietary chelator technology, designed to optimize the

bioconjugate manufacture, conjugate stability and serum stability for use with this isotope. If approved, TLX300-Px

would be the first imaging agent to specifically detect the presence of PDGFRα in patients with STS or other PDGFRα

positive tumors.

Following the completion of pre-clinical studies, we are conducting a first-in-human Phase 1 proof-of-concept targeting

and biodistribution trial in Australia using TLX300-Px. This dose-finding study is assessing safety, tolerability, dosimetry,

pharmacokinetics and imaging properties of TLX300-Px in participants with STS and other PDGFRα-positive tumors,

prior to therapeutic studies. We have not yet determined the specific isotope(s) that we will use in therapeutic trials.

The pre-clinical studies of radiolabeled-olaratumab have demonstrated that olaratumab can be bioconjugated with

chelators and radiolabeled with imaging and therapeutic radionuclides. In a biodistribution study of TLX300-Px in mice

tumor targeting reached 55% of ID/g at 120 hours post-injection, accompanied by accumulation in main clearance organs

as predicted based on radiolabeled antibody clearance. We believe results of these pre-clinical studies demonstrate the

viability of radiolabeling olaratumab, high uptake of the imaging agent in tumors and subsequent clearance and

demonstrated anti-tumor activity with the therapy agent. Animal or pre-clinical results should be interpreted with caution

as they may not correlate to results in human clinical trials.

Hematologic Oncology and CD66

Hematopoietic stem cell transplantation ("HSCT") is an important lifesaving treatment opportunity for various

hematological malignancies and a variety of non-malignant conditions such as severe aplastic anemia, inherited bone

marrow failure syndromes, sickle cell disease, transfusion-dependent thalassemia, inherited immune deficiency

syndromes, and certain metabolic disorders. Experimentally, HSCT has been used in severe refractory autoimmune

diseases.

Conditions such as acute myeloid leukemia, multiple myeloma and systemic amyloid light chain amyloidosis may also

benefit from more tolerable bone marrow conditioning regimens. The utilization of novel cell and gene therapies may

increase by replacing toxic chemotherapy conditioning approaches with bone marrow conditioning.

Our hematologic oncology program targets distinct members of CD66, a family of receptors expressed on specific types

of immune or blood cells that serve as attractive biomarkers for novel experimental conditioning radiopharmaceuticals.

Market and Opportunity for Bone Marrow Conditioning Treatment

According to the World Wide Network of Bone and Marrow Transplantation, there were approximately 90,000 first HSCT

performed in 2019, of which 47% were allogeneic. According to the U.S. Health Resources and Services Administration,

there were approximately 22,000 HSCT performed in the U.S. in 2020, 41% of which were allogeneic.

Prior to undergoing HSCT for the treatment of hematologic malignancies patients undergo a bone marrow conditioning

treatment. Current standard of care typically requires bone marrow conditioning with multi-drug chemotherapy regimens.

However, these regimens are highly toxic, and patients may not tolerate treatment. This creates an important unmet

medical need for more tolerable bone marrow conditioning regimens.

There are several systemic radiotherapies being evaluated in clinical trials as conditioning agents for HSCT. We consider

our most direct competitors to be companies developing systemic radiotherapies in the hematology space, including

Actinium Pharmaceuticals, Inc., Acrotech Biopharma, Inc., Cellectar Biosciences, Inc. and Jasper Therapeutics, Inc.

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Market and Opportunity for Imaging of Bone Marrow Infection (Osteomyelitis)

The incidence of osteomyelitis is estimated to be as high as 21.8 cases per 100,000 persons per year. The diagnosis of

osteomyelitis is a challenge for diagnostic imaging and timely identification/localization of pathology can be of critical

importance for appropriate management of patients.

Imaging modalities used to diagnose osteomyelitis can include X-ray, bone scintigraphy, CT, and MRI. These are typically

combined with imaging of white blood cells to distinguish infection, sterile inflammation, and other disorders. White blood

cell imaging is typically performed using in vitro separation and labeling of white blood cells, which requires preparation

time and carries the inherent risk of contamination.

Therapy – TLX66-Tx

TLX66

-Tx (90Y-DTPA-besilesomab), is a product candidate for bone marrow conditioning for HSCT conditioning, a broad

clinical indication.

Our HSCT conditioning agent, TLX66-Tx, has been evaluated in acute myeloid leukemia, multiple myeloma and systemic

amyloid light chain amyloidosis through investigator-initiated trials. Clinical data suggest TLX66-Tx could be a well-

tolerated (and therefore highly versatile) bone marrow conditioning agent which could be utilized as a single agent or in

combination with either reduced or high intensity conditioning agents preceding both autologous or allogeneic HSCT.

Orchard et al. (Bone Marrow Transplantation. 2024) reported that “All patients engrafted, treatment-related mortality 1-

year post-transplant was zero. Toxicities were no greater than those anticipated for similar conditioning regimens

without targeted radiation. The ability to substantially intensify conditioning prior to haematopoietic stem cell

transplantation without increasing toxicity warrants further testing to determine efficacy.”

TLX66

-Tx is currently being studied in a Phase 2 IIT in pediatric high-risk leukemia and we plan to evaluate TLX66-Tx in

a Phase 2 clinical trial as a BMC agent in patients with acute myeloid leukemia who are not suitable for conventional BMC

regimes.

TLX66

-Tx was granted orphan drug designation status in the U.S. and Europe. Orphan drug designation may not lead to

a faster development or regulatory review or approval process and does not increase the likelihood that TLX66-Tx will

receive marketing approval.

The key attributes supporting the development of TLX66-Tx include:

•Minimal uptake in non-hematopoietic organs such as liver, kidneys and gut;

•Approximately 80 patients treated in several Phase 1 and 2 investigator-initiated trials of TLX66-Tx in different

hematological diseases requiring autologous or allogeneic stem cell transplantation; and

•Orphan drug designation granted in the

U.S.

and Europe for TLX66-Tx for bone marrow conditioning.

Manufacturing TLX66-Tx and TLX66-Px utilizes a small amount of Triton X-100, which is a non-ionic surfactant, in the

antibody manufacturing process. Triton X-100 is subject to a regulation in the European Union known as Registration,

Evaluation, Authorization and Restriction of Chemicals ("REACH"). We are permitted to manufacture TLX66-Tx for

research and clinical development in the European Union pursuant to a self-certified exemption applicable to research

and development activity. We would need to obtain authorization under REACH in order to use Triton X-100 for the future

commercial manufacturing of TLX66-Tx or re-design the commercial manufacturing process for TLX66-Tx such that

Triton X-100 is not used. We are currently planning to re-design the commercial manufacturing process for TLX66-Tx

and potentially for TLX66-Px. We believe that any improvements to the manufacturing process we may make could also

result in an increase in productivity and a potential reduction in manufacturing costs. If we re-design the manufacturing

process for TLX66-Tx, we may be required to conduct additional clinical trials of TLX66-Tx or meet alternative regulatory

standards.

Clinical Data

TLX66-Tx has been evaluated in over 80 patients in several IITs as a conditioning agent preceding HSCT in patients with

a range of hematological malignancies, including a Phase 1 dose-escalation trial in 55 patients with hematological

malignancies, a Phase 1 trial in nine patients with pediatric relapsed/refractory leukemia, a Phase 1/2a trial in nine

patients with AL-amyloidosis and a Phase 2 randomized controlled trial in 25 patients with multiple myeloma. In these

trials, there have not been significant toxicities and there have not been detectable non-hematological toxicities such as

mucositis/colitis. In the pediatric population, TLX66-Tx has been well tolerated with no serious toxicities.

In a Phase 2 trial using TLX66-Tx and HD-melphalan in 24 patients as a conditioning agent for multiple myeloma

autologous HSCT, the complete response rate in the combination cohort (12 patients) was 50%, compared to 25% in the

HD-melphalan control group (12 patients).

In reported data from 30 patients out of 55 patients treated in a Phase 1 trial of TLX66-Tx, patients were given increasing

doses of TLX66-Tx followed by reduced intensity conditioning and HSCT. The overall survival rate was 73% ten years

after the HSCT procedure with low toxicity for TLX66-Tx. There were no severe non-hematological adverse events

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detected and efficient myeloablation, both in bone marrow and peripheral blood (the anticipated therapeutic effect and

prerequisite for both successful autologous and allogeneic HSCT), was observed.

The Phase 1/2a trial evaluating TLX66-Tx in nine patients with AL amyloidosis evaluated the safety and toxicity of

TLX66

-Tx as a bone marrow conditioning agent prior to HSCT. All nine patients were successfully engrafted following

bone marrow conditioning with TLX66-Tx and autologous HSCT without any chemotherapy. TLX66-Tx was well tolerated

by all patients and had a very low toxicity profile when compared to chemotherapy-based conditioning regimes. There

were no serious adverse events or transplant-related deaths.

TLX66

-Tx is currently being evaluated in a Phase 2 IIT in high-risk pediatric leukemia and we also plan to develop TLX66-

Tx as a bone marrow conditioning agent in high-risk acute myeloid leukemia patients in complete remission with minimal

residual disease in combination with reduced intensity conditioning preceding allogenic HSCT.

Imaging – TLX66-Px

TLX66-Px (99mTc-besilesomab) is our commercial imaging agent for osteomyelitis, approved in 32 European countries

and Mexico (marketed as Scintimun). Scintimun was previously manufactured and distributed by Curium Pharma through

an out-license from Telix via the acquisition of TheraPharm in 2020. Curium Pharma received marketing authorization for

Scintimun in the European Union in 2010 for scintigraphic imaging, in conjunction with other modalities, for determining

the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Following a strategic

review of the asset, we elected to bring sales and marketing in-house in 2025. TLX66-Px has not received marketing

approval in the U.S. We are evaluating the feasibility of filing for a marketing authorization application in the U.S. where

we retain the rights.

The key attributes supporting the use of TLX66-Px include:

•EMA approval for imaging of peripheral osteomyelitis in 2010; and

•Phase 3 trial showed that Scintimun imaging is accurate and well-tolerated in diagnosing infection of the peripheral

skeleton and provides comparable information (Richter et al.

EJNMMI.

2011).

Clinical Data

The approval of Scintimun was based on the results of a multicenter study performed in 22 European centers. This

multinational, Phase 3 clinical study was undertaken to compare anti-granulocyte imaging using Scintimun with 99mTc-

labelled white blood cells in patients with peripheral osteomyelitis. The results of this Phase 3 trial showed that Scintimun

imaging is accurate and well-tolerated in diagnosing infection of the peripheral skeleton and provides comparable

information to 99mTc-labelled white blood cells in patients with chronic osteomyelitis.

MedTech

Our MedTech business is advancing surgical solutions and digital products that power our precision medicines and

therapeutics across the entire patient journey from diagnosis to surgical intervention and therapy. We anticipate applying

this first in urology, for prostate and kidney cancer, and then across the breadth of indications we are pursuing.

Radio-Guided Surgery ("RGS")

Bringing molecular imaging into the operating theater is a key part of our portfolio strategy for urologic oncology.

In November 2023 we acquired the SENSEI radio-guided surgery business from Lightpoint Medical Ltd ("Lightpoint").

SENSEI is a miniature gamma probe device used to detect radiation in patients and guide surgery. The probe is inserted

into a surgical port and can then be controlled by the clinician during the procedure. When used with targeted imaging

agents, SENSEI may enable the intraoperative detection of cancer in real time, supporting greater precision in the

removal of tumors.

The utility of SENSEI has been demonstrated in several studies. These include a prospective multicenter trial assessing

the safety and performance of the SENSEI probe for prostate cancer sentinel lymph node biopsy. The primary objective

was the sentinel lymph node dissection rate with a 100% detection rate achieved by the drop-in probe and no adverse

events linked to the probe. The study concluded that the SENSEI probe meets performance and safety requirements for

sentinel lymph node biopsy in prostate cancer, offering improved maneuverability and sentinel lymph node detection

compared to the conventional rigid laparoscopic gamma probe. Another study covering ten patients concluded that using

the probe is also safe and feasible for sentinel lymph node detection in early-stage cervical cancer. Ongoing studies in

the U.S. (Weiner et al. European Urology Open Science. 2024) and Germany (Falkenbach et al. Current Opinion in

Urology. 2025; Harke et al. Clin Nucl Med. 2024; Bravi et al. Eur Urol Focus. 2025) are using a PSMA-targeted

radiotracer in conjunction with the SENSEI drop-in probe to detect and remove metastatic lymph nodes. One study

reported successful removal in 88% of patients, with 71% achieving complete biochemical response (PSA < 0.2 ng/mL). A

multicenter analysis across 11 sites (259 men) found that PSMA-radio-guided surgery led to lower postoperative PSA

levels, longer time to follow-up (7 vs 24 months), and higher two-year cancer control rates (18% vs 30% BCR-free

survival, 51% vs 73% CR-free survival) compared to standard surgery. These findings suggest PSMA-radio-guided

surgery offers more precise treatment and better short-term outcomes for prostate cancer patients with nodal

recurrence, with longer term oncological benefit still under investigation. SENSEI has a Conformité Européenne ("CE")

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mark for sentinel lymph node biopsy applications in prostate, endometrial and cervical cancers, and is registered with the

FDA as a class I, 510(k) exempt medical device.

In September 2025, we announced a collaboration with IMRA Surgical, an Australian-based company at the forefront of

disruptive technology for surgical training solutions, to accelerate the development of advanced training models and

enhance the integration of cutting-edge radio-guided surgical technologies. IMRA Surgical has established itself as a

leader in the development of synthetic surgical phantoms, medical models made from hydrogel that accurately simulate

the response of actual human tissue. These models are transforming surgical training by enabling trainees to practice

complex procedures in nearly lifelike conditions, without relying on cadavers or animal tissue. The company’s innovative

models are designed to reduce the learning curve for surgeons, ensuring that they gain hands-on experience with

greater precision and efficiency, ultimately leading to fewer mistakes and better patient outcomes. As part of the

collaboration, IMRA Surgical will develop a groundbreaking new hydrogel model designed specifically to support

education and training in the use of Telix’s SENSEI drop-in technology. This hydrogel model will be the first of its kind,

providing practitioners with a realistic, hands-on training experience and facilitating a faster learning curve when

adopting advanced radio-guided technology.

Through the IRiS (Imaging and Robotics in Surgery) Alliance with Mauna Kea Technologies ("Mauna Kea"), a leading

medical device company pioneering the development of real-time intraoperative visualization of cancer tissue during

surgery, we are exploring new hybrid pharmaceutical-device products through the combination of our cancer-targeting

agents with Cellvizio, Mauna Kea’s confocal surgical laser endomicroscopy in vivo cellular imaging platform.

Dosimetry

In April 2024, we entered into an agreement to commercially partner the QDOSE dosimetry software platform with ABX-

CRO and its development partner, Quantinm AB. QDOSE is a 510(k) cleared, CE-marked and Korean-FDA approved

software platform designed to enable reliable estimation of patient-specific dosimetry for both therapeutic and

diagnostic radiopharmaceuticals, supporting the safe and effective integration into clinical practice. We believe that

personalized targeted radionuclide therapy administration based on individual patient dosimetry has the potential to

improve clinical outcomes by optimizing treatment response while reducing effects on normal healthy organs and

optimizing the use of isotope supply chains.

Telix holds the intellectual property rights and leads development of QDOSE. Together with our distributors that serve as

manufacturer and customer support providers, we aim to advance dosimetry and make it more accessible, reliable, and

impactful for healthcare providers.

Artificial Intelligence (AI)

Imaging using targeted radiation relies heavily on digital data processing and input from highly skilled and trained

technicians and radiologists to correctly interpret the data. We believe that AI technology can recognize complex

patterns in large datasets and conduct predictive analysis, with potential to transform imaging analysis and improve the

accuracy of decision making for clinicians.

In 2023, we acquired Dedicaid GmbH and its AI platform capable of rapidly generating indication specific clinical decision

support software ("CDSS") applications from available datasets, for use with PSMA-PET amongst other imaging

modalities. Each CDSS application will be trained to predict outcomes such as the severity of disease, risk to the patient

and/or inform treatment decisions. The platform also houses an automated machine learning engine ("AutoML"). We

believe that this platform is differentiated from commercially-available AI solutions currently used in PSMA-PET imaging,

which are limited to supporting clinicians in the interpretation and reading of images – without a prediction capability. The

platform is designed to reduce the time, cost and level of expertise required to build, test and validate new CDSS

applications, facilitating a streamlined development and regulatory pathway for each new application. We are conducting

final validation of the Dedicaid platform.

The Dedicaid acquisition also included a lead medical device tool that is designed to interpret the risk of prostate cancer

advancement from a PSMA-PET scan image by correlating it to a well-known histopathology indicator (the Gleason

Grade). A second AI asset supporting Illuccix is designed to automate the identification and classification of prostate

cancer lesions from PSMA-PET scans to support greater efficiency and standardization in the imaging workflow.

Our focus for the AI platform is to develop AI-powered solutions that support our product candidates and to enable these

solutions for use by the nuclear medicine community as approved medical devices. We aim to use AI across our

development pipeline by utilizing clinical imaging and outcome data as they become available and to develop and

validate medical device applications supporting approved products.

Research and Development

Telix continues to diversify its drug pipeline through the advancement of a new generation of proprietary targeted

biologics and with the expansion of its protein engineering and discovery research facility in Los Angeles, CA. Efforts

underway are synergistically adding several early‑stage drug candidates against high‑value targets, including DLL3 and

integrin αvβ6, enabling expansion into therapy areas with unmet clinical need. This platform of biologics is based on

small, engineered antibody formats that enable highly specific cancer targeting, combined with rapid tumor uptake and

blood clearance. These features allow for more directed payload delivery, helping to minimize off‑target therapeutic side

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effects. This technology has the potential to be highly effective for imaging and treating tumors with a broad range of

radioisotopes, with diagnostic and therapeutic alpha‑ and beta‑emitters of particular interest.

In addition to developing targeting agents, Telix is committed to utilizing isotopes with the most appropriate physical

characteristics to help deliver the best possible treatments and, ultimately, improved patient outcomes. To support this,

the company is continuously exploring new ways to produce and source these critical components of our drugs. One

emerging alpha‑emitter with significant promise is lead‑212 (212Pb), an isotope to which Telix has steadily increased

access through the design and scale‑up of a thorium‑228 (228Th)–based generator. Telix is preparing to introduce a fully

automated, high‑output generator with a small, single hot‑cell footprint, sufficient 212Pb production capacity for multiple

clinical doses per elution, and the potential to scale based on demand. This production footprint is designed for

deployment throughout Telix’s manufacturing and distribution networks, including the recently acquired RLS

Radiopharmacies network. This development opens new opportunities for the creation of alpha‑emitting

radiopharmaceuticals with a simplified production infrastructure compared with other alpha‑emitting radioisotopes. The

alpha‑emitting profile of 212Pb also offers practical synergies with the engineered antibodies described above.

Telix Manufacturing Solutions (TMS)

We are focused on enhancing our existing global manufacturing and supply chain with a balance of external and in-house

capabilities, securing a robust and innovative manufacturing infrastructure and supply chain to serve our patients.

Manufacturing and supply chain supporting our portfolio broadly cover the following areas: radioisotopes,

radiochemistry, biologics, small molecules, fill/finish, packaging and labeling, and storage and distribution.

Since 2022, we have made significant progress with the buildout of our radioisotope manufacturing facility in Brussels

South. We have been granted an updated radiation license by the Belgian Federal Agency for Nuclear Control, enabling

site activation subject to the regulatory inspections and approvals.

Our approximately 30,000 square foot radioisotope manufacturing facility is one of Europe’s largest radiopharmaceutical

production facilities. The site will enable improved access to radiopharmaceuticals for patients across the EMEA region

and the world as a primary GMP-capable manufacturing site for our clinical and Commercial Products. The site also has

extensive R&D capabilities, with a focus on alpha-emitting isotopes. We believe the proximity of an alpha

radiopharmaceutical laboratory to a production GMP environment is a differentiated capability to our competition. We

expect the site to evolve and develop as a hub for strategic collaborations via R&D facilities and manufacturing line

designated for university and SME partners.

We aim to have a degree of vertical integration in our three operating regions. In line with this goal, in 2022 we acquired

Optimal Tracers, a California-based company that provides radiochemistry process development services and research

tracers for use in clinical trials. The acquisition of Optimal Tracers expanded our translational radiochemistry capability

and establishes a U.S.-based laboratory and production footprint for clinical trial doses, now known as TMS Sacramento.

In April 2024, we acquired IsoTherapeutics Group, LLC ("IsoTherapeutics"), a specialty radiopharmaceutical development

and bioconjugation firm, based in Texas. We expect that the acquisition will further enhance our internal drug

development capabilities.

In April 2024, we also acquired ARTMS Inc. ("ARTMS"), a radioisotope production technology company based in Canada,

and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare

metals required for consumable target production. We expect that the acquisition will further enhance the vertical

integration of our supply chain and manufacturing by providing a greater level of control and security over each of our

diagnostic isotopes.

In January 2025, we acquired RLS (USA) Inc., America’s only Joint Commission-accredited radiopharmacy network

distributing PET, SPECT and therapeutic radiopharmaceuticals. The RLS acquisition augments our existing distribution

network for last-mile delivery and provides expansionary space to build out a radiometal production network to meet

future demand for radiopharmaceuticals.

In June 2025, we established TMS Yokohama, in Yokohama, Japan. Telix’s first cyclotron facility in the Asia Pacific region

represents a significant milestone in our global manufacturing strategy. TMS Yokohama will serve as a hub for

commercial and clinical supply, and future research and development in the region. It expands our global production

network which includes in-house and partner facilities. Originally opened in 2018, the site comprises a cyclotron and

multiple production hot cells and was designed and built by JFE Engineering ("JFE") as the Contract Manufacturing

Organization ("CMO") for TLX250-Px in Japan and China, including for the ZIRCON-CP study.

Assuming operational management of this facility will provide greater control over existing clinical supply with the

possibility to expand production to other Telix investigational and future commercial products in the region, including

Illuccix and Pixclara for Greater Tokyo, and TLX591-Tx for the Asia Pacific region.

During 2025, we progressed the construction of a new facility in Melbourne, Australia, to be known as TMS North

Melbourne, for early-phase clinical research and radiopharmaceutical production, to support APAC translational research

and clinical trials. In September 2025, both TMS North Melbourne and TMS Yokohama were granted radiation licenses

for a broad range of clinically and commercially important medical isotopes.

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Our biologics, small molecule, aseptic fill/finish and commercial secondary packaging manufacturing and supply chain are

accomplished through relationships with external contract manufacturing and development organizations ("CDMOs"). We

have agreements with ABX-CRO, Abzena Holdings (U.S.) LLC., Curia Global, Dalton, DiverChim CDMO, Eurofins,

GenScript ProBio, Goodwin Biotechnology Inc., Grand Rapids Aseptic Manufacturing, Patheon Pharma Services, PCI

Pharma Services, Sharp Packaging, Sharp Sterile Manufacturing, and UPS. We are also pursuing the addition of in-house

capabilities (secondary packaging, antibody conjugation, and fill/finish) where appropriate through vertical integration.

With respect to producing radiolabeled drug product, we aim to continue to deepen our relationship with key

manufacturing networks in the U.S.: PharmaLogic for 18F and 89Zr products, and Cardinal Health for 68Ga and 89Zr and

225

Ac products. We have agreements with Evergreen Theragnostics, AtomVie Global Radiopharma, Eckert & Ziegler SE,

Seibersdorf Laboratories and South Australian Health and Medical Research Institute for the manufacture of our

therapeutic product candidates across multiple regions, and we are working on establishing additional key manufacturers

in APAC and the European Union. Our current capabilities encompass products radiolabelled with

177

Lu,

131

I, and 89Zr, and

we aim to build-up our capabilities with respect to producing products radiolabelled with alpha-emitters such as

225

and

212

Pb.

We are dedicated to enhancing our global supply chain capabilities, particularly for the clinical and commercial supply of

isotopes used in radiolabeling, as well as for supplying generators. We have established a series of strategic supply

agreements with leading industry partners to supply starting material for internal production as well as the final

radioisotope used in radiolabeling. These partnerships include the Australian Nuclear Science and Technology

Organisation, Cardinal Health, Eckert & Ziegler SE, Isotopia, ITM, PanTera, Radnostix, SHINE Technologies, Thor Medical,

and Van Overeem Nuclear, and are pivotal in ensuring a broad and robust supply network for both therapeutic and

diagnostic isotopes. By diversifying our supply chain through these contracts, we aim to create a resilient system that

eliminates dependencies on a single supply chain. This approach is intended to ensure uninterrupted supply and to

enhance our capability to meet growing demand.

Through these strategic agreements, we aim to maximize the available production process methods and diversify the

reactors used for irradiation and production. This not only ensures a steady and diverse supply but also allows us to

adapt quickly to changing market demands and regulatory environments.

We aim to actively pursue the development and supply of future isotopes. Understanding the critical role these materials

play in advancing medical and scientific endeavors, we are dedicated to ensuring a robust and resilient supply chain that

can adapt to the evolving needs of the industry.

Our approach is multi-faceted, focusing on strategic partnerships, technological innovation, and sustainable practices.

We continuously seek to expand our network of suppliers and collaborators, forming alliances with leading entities in the

field. This not only diversifies our supply sources but also fosters innovation through shared expertise and resources.

Moreover, we are investing in cutting-edge technologies and processes that enhance our production capabilities,

ensuring efficiency and reliability. Our commitment to sustainability, particularly in the recycling of materials, further

strengthens our supply chain, reducing environmental impact while maximizing resource utilization.

We recognize that the future of isotope supply lies in our ability to anticipate and respond to market changes and

scientific advancements. Therefore, we are dedicated to ongoing research and development, ensuring that we remain at

the forefront of isotope supply. Our goal is not just to meet current demands but to be a driving force in the development

of new isotopes, paving the way for groundbreaking applications that can transform industries and improve lives.

Our commitment to a robust and resilient supply chain for future isotopes is unwavering. We understand the significance

of our role in this dynamic field and are dedicated to maintaining the highest standards of quality, reliability, and

innovation in all our endeavors.

Through these comprehensive efforts, we are seeking to position ourselves as a leader in the supply of isotopes for

radiolabeling, backed by a supply chain that is as diverse as it is robust, ensuring the highest standards of quality and

reliability for our clients.

Sales and Marketing Operations

Our commercial operations span the Americas, EMEA, and APAC Regions. Illuccix is approved in the U.S., Australia, Brazil,

Canada, the United Kingdom, 19 European Economic Area member states, and permitted to be sold in New Zealand, and

we are commercializing this product in these countries through local sales forces, which currently include over 40

associates, and together with distributor partners. Gozellix is approved in the U.S. We have secured a number of

commercial partnerships covering certain geographies to enable distribution and/or commercialization of our products.

In the U.S., we have established a commercial radiopharmacy network of over 225 commercial radiopharmacies to

distribute Illuccix, including partnerships with Cardinal Health, Inc., PharmaLogic Holdings, Corp., and Jubilant Pharma

Ltd. We also have a distribution agreement with Isologic Innovative Radiopharmaceuticals Ltd for the Canadian market.

In Asia Pacific, we have secured a strategic collaboration with Grand Pharmaceutical Group Limited ("Grand Pharma") in

the Greater China area including Mainland China, Taiwan, Hong Kong and Macau. Grand Pharma has been appointed as

our partner for this territory with exclusive development and commercialization rights to our portfolio.

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In Europe, we have exclusive distribution agreements for the upcoming launch of Illuccix in a number of geographies,

including with Eckert & Ziegler SE in Germany, Xiel Ltd in the United Kingdom, IRE Elit S.A. in France, Radius S.r.l. in Italy,

Biokosmos S.A. in Greece and Cyprus, Sociedade Avanço, Unipessoal, Lda in Portugal, THP Medical Products Vertriebs

GmbH in Austria, Czech Republic and Slovak Republic and WIIK Pharma ApS in Denmark, Finland, Norway and Sweden.

Competition

Our potential competitors include all entities developing and commercializing diagnostics and therapies in the field of

oncology, through nuclear medicine and other modalities. This includes companies, academic institutions, government

agencies, hospitals, other organizations involved in research, manufacturing, and commercialization of diagnostics and

therapies. In addition to the current standard of care for patients, commercial and academic clinical trials are being

pursued by a number of parties in the field of radiopharmaceuticals. Early results from these trials have fueled continued

interest in radiopharmaceuticals, which is being pursued by several biotechnology companies, as well as by large

pharmaceutical companies.

There are several companies with approved beta-based radiopharmaceuticals, including Novartis AG, Bayer AG, Sirtex

Medical, Inc., Boston Scientific Corporation, Acrotech Biopharma LLC and Q BioMed Inc. and other companies developing

beta-based radiopharmaceuticals, including Lantheus Holdings, Inc., Eli Lilly & Company Ltd., ITM Isotope Technologies

Munich SE, Curium Holding France S.A.S, Clarity Pharmaceuticals Limited, The Bracco Group (through its Blue Earth

Therapeutics Ltd. Subsidiary), and Y-mAbs Therapeutics, Inc. The beta emitting isotopes used by these companies

include iodine-131, lutetium-177, strontium-89, copper-67, and yttrium-90.

There are several companies developing targeted alpha-based radiopharmaceuticals for the treatment of cancer,

including Bayer AG, Novartis AG, AstraZeneca PLC/Fusion Pharmaceuticals Inc., Alpha Tau Medical, ARTBIO, Inc., Orano

Med SAS, Johnson & Johnson, Abdera Therapeutics, Inc., Actinium Pharmaceuticals, Inc, Aktis Oncology, Inc.,

Convergent Therapeutics, Inc., ITM Isotope Technologies Munich SE, Perspective Therapeutics, Inc., Eli Lilly & Company

Ltd., RadioMedix, Inc., Bristol Myers Squibb Company and Y-mAbs Therapeutics, Inc. The only approved alpha particle-

based therapy is Bayer’s Xofigo (Radium-223) which was approved in 2013 for the treatment of prostate cancer with

symptomatic bone metastases.

We consider our most direct competitors to be companies developing and commercializing diagnostics and therapies in

our core therapy areas, including prostate cancer, kidney cancer, bladder cancer, brain cancer, sarcoma, and

hematology.

In prostate cancer therapy, Pluvicto (lutetium (

177

Lu) vipivotide tetraxetan), marketed by Novartis AG, was approved by

the FDA for the treatment of patients with PSMA-positive mCRPC who have been treated with androgen receptor

pathway inhibition and taxane-based chemotherapy in March 2022. In March 2025, Pluvicto was approved by the FDA

for earlier use prior to chemotherapy, in PSMA-positive mCRPC. Pluvicto is the only FDA-approved PSMA-targeted

therapy for the treatment of prostate cancer. Several other systemic radiotherapies are being investigated in clinical

trials in the mCRPC setting and across other stages of prostate cancer, and potentially could be commercialized in the

future.

In mCRPC treatment, there are several companies developing PSMA-targeted therapies in the mCRPC space, including

Novartis AG, Convergent Therapeutics, Inc., Eli Lilly & Company Ltd., Lantheus Holdings, Inc, Curium Holding France

S.A.S, ARTBIO, Inc., The Bracco Group (through its Blue Earth Therapeutics Ltd. subsidiary), Clarity Pharmaceuticals Ltd.,

AstraZeneca PLC, Bayer AG, Orano Med SAS, Isotopia Molecular Imaging Ltd, ITM Isotope Technologies Munich SE,

Johnson & Johnson, AdvanCell Isotopes Pty Ltd, Alpha-9 Theranostics, Inc., Cancer Targeted Technology, LLC,

FutureChem Co Ltd., Sinotau Pharmaceutical Group, Norroy Biosciences Co. Ltd., RadioPharm Theranostics Limited,

Precision Molecular, Inc., CellBion Co., Ltd., StarPharma Holding Limited, Amgen Inc., Crescendo Biologics Limited,

Poseida Therapeutics, Inc., Janux Therapeutics, Inc., Vir Therapeutics, Inc., Bivision Pharmaceuticals, Inc., GlyTherix Ltd,

Jiangsu Hengrui Pharmaceuticals Co., Ltd and Full-Life Technologies Limited. Our competitors also include companies

developing other modalities to treat patients with mCRPC.

In prostate cancer imaging, UCLA and UCSF obtained FDA approval for 68Ga-PSMA-11 in 2020, this was the first PSMA-

PET imaging agent to be approved by the FDA. Pylarify (18F-piflufolastat), marketed by Lantheus Holdings, Inc, was

approved by the FDA in 2021. Locametz (68Ga-PSMA-11), marketed by Novartis, received FDA approval in 2022 and

Posluma (18F-flotufolastat), marketed by The Bracco Group (through its Blue Earth Diagnostics Ltd. subsidiary), received

FDA approval in 2023. Several other PSMA-PET product candidates are being evaluated in clinical trials for prostate

cancer imaging and may be commercialized in the future. Companies developing PSMA-PET imaging agents include

Curium Holding France S.A.S., Clarity Pharmaceuticals Limited, ABX advanced biochemical compounds GmbH, Isotopia

Molecular Imaging Ltd, Itel Telecomunicazioni Srl, ITM Isotope Technologies Munich SE, Five Eleven Pharma, Inc.,

RadioMedix, Inc., CellBion Co., Ltd., Norroy Biosciences Co. Ltd., HTA Co. Ltd and Jiangsu Hengrui Pharmaceuticals Co.,

Ltd.

In kidney cancer therapy, there are several companies developing CAIX-targeted systemic radiotherapies, including ITM

Isotope Technologies Munich SE, Precision Molecular, Inc., Norroy Biosciences Co. Ltd., AstraZeneca PLC/Fusion

Pharmaceuticals Inc., PeptiDream Inc., Bayer AG and Bristol Myers Squibb Company. Our competitors also include

companies developing other modalities to treat patients with kidney cancer.

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In kidney cancer imaging, there are several companies developing ccRCC or CAIX-targeted imaging agents, including

ITM Isotope Technologies Munich SE, Philogen S.p.A., ImaginAb, Inc., Precision Molecular, Astellas Pharma, Inc., Norroy

Biosciences Co. Ltd., PeptiDream Inc., and Five Eleven Pharma, Inc.

In bladder cancer therapy, there are several companies developing systemic radiotherapies, including Aktis Oncology,

Inc., Glytherix Ltd., AstraZeneca PLC and NuView Life Sciences, Inc. Our competitors also include companies developing

other modalities to treat patients with bladder cancer.

In glioblastoma therapy, there are several companies developing systemic radiotherapies for brain tumors, including ITM

Isotope Technologies Munich SE, PeptiDream Inc., Molecular Targeting Technologies, Inc., EvaThera Theranostics,

Novartis AG, RadioPharm Theranostics Limited, Plus Therapeutics, Inc., Ariceum Therapeutics GmbH, Boston Scientific

Corporation, and Cellectar Biosciences, Inc. Our competitors also include companies developing other modalities to treat

patients with glioblastoma.

In brain cancer imaging, there are several companies developing imaging agents for primary brain tumors and brain

metastases, including Novartis AG, The Bracco Group (through its Blue Earth Diagnostics Ltd. subsidiary), RadioPharm

Theranostics Limited, Curasight A/S, Molecular Targeting Technologies, Inc., and BoomRay Pharmaceuticals Co., Ltd.

In sarcoma, there are several companies developing systemic radiotherapies in the soft-tissue sarcoma space, including

OncoTherapy Sciences, Inc., RadioPharm Theranostics Limited, Ratio Therapeutics, Inc., Y-mAbs Therapeutics, Inc., and

Cellectar Biosciences, Inc.

In hematology, there are several companies developing systemic radiotherapies in the hematology space, including

Actinium Pharmaceuticals, Inc., Bayer AG, Sensei Biotherapeutics, Inc., ImaginAb, Inc. Acrotech Biopharma Inc., Nordic

Nanovector ASA, Orano Med SAS, Samus Therapeutics, Inc., Cellectar Biosciences, Inc. and Jasper Therapeutics. Inc.

Many of our current or potential competitors, either alone or with their collaboration partners, have significantly greater

financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical

trials, obtaining regulatory approvals and marketing approved products than we do. 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 or early-stage companies may also prove to be significant competitors, particularly

through collaborative arrangements with large and established companies. These competitors also compete with us in

recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient

enrollment in clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

We could see a reduction or elimination in our commercial opportunity if our competitors develop and commercialize

drugs that are safer, more effective, have fewer or less severe adverse events, are more convenient to administer, are

less expensive or with a more favorable label than our product candidates. Our competitors also may obtain FDA or other

regulatory approval for their drugs more rapidly than we may obtain approval for ours, which could result in our

competitors establishing a strong market position before we are able to enter the market. The key competitive factors

affecting the success of all of our product candidates, if approved, are likely to be efficacy, safety, convenience, price,

availability of the relevant isotope, the effectiveness of imaging diagnostics, the level of generic competition and the

availability of reimbursement from government and other third-party payors.

Intellectual Property

Overview

Patent Protection

By their very nature, radiopharmaceuticals must be delivered through a complicated supply chain and go-to-market

model requiring specialized physics, chemistry and biological expertise for successful development and

commercialization protected by know-how and trade secrets. This specialization provides a practical barrier to

competitor entry without the same specialist expertise. Additionally, we aim to build, maintain and continuously improve

our exclusivity and patent position to protect our innovation contribution. We aim to integrate regulatory filing strategy

designed to maximize regulatory market or data exclusivity and through targeted patent protection across the spectrum

of compound, dosing, radiolabeling technology, handling, preparation process and manufacturing inventions.

Older radiopharmaceuticals were historically routinely used in the public domain for many years under practice of

pharmacy or individual named patient prescribing regulatory pathways. This has the benefit of established use and real-

life clinical application and experience for such products when made commercially available, but does potentially create

the result that patent protection is not available or has only limited remaining patent term.

Our original third-party licensed products were in-licensed and were accepted on an “as-is” basis. We have limited

opportunity to determine or influence territory and scope of third-party licensor portfolio and the time to make changes

to scope or territory has long since passed under applicable patent laws. However even for these earlier products, we

have expanded our patent portfolio where possible and seek to obtain related new patents for updates in handling,

dosing and manufacturing to maximize patent exclusivity where feasible, in addition to our supply chain know-how and

trade secrets.

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For our newer programs and next generation radiopharmaceuticals, the patent protection is deeper and wider across the

spectrum of compound, method of treatment, dosing, radiolabeling technology, handling, preparation process and

manufacturing inventions based on our newer proprietary technologies or due to our innovation in the end-to-end

process.

We have in-licensed registered intellectual property associated with our key therapeutic products: TLX591-Tx

, TLX250

, TLX101

-Tx

, TLX102

-Tx

, TLX090

-Tx

, TLX300

-Tx

, TLX66

-Tx, TLX597-Tx, and related imaging product TLX250-Px in

addition to supplementary intellectual property owned by us. Intellectual property for Illuccix, Gozellix, TLX592-Tx,

TLX252

-Tx, TLX400-Tx. RHN001-Tx and RHN001-Dx, and TLX101-Px is wholly owned by us. We have also filed our own

applications for registered patents and trademarks in respect of our key products.

Patents are granted by national and regional intellectual property offices in accordance with the corresponding national

laws. Granted patents provide a right to exclude others from making, using, selling, offering to sell, or importing the

invention as set forth in the claims of the patent. Protection is generally limited to actions in or relating to the countries in

which protection is obtained, and enforcement is generally by litigation.

Patents generally have a maximum term of 20 years after its earliest effective filing date, subject to the payment of

renewal fees in all the relevant countries.

In the field of pharmaceuticals, patent term extensions or supplementary protection certificates may extend the term of a

patent beyond 20 years in certain jurisdictions. Examples of important jurisdictions where these regimes are available are

the U.S., Europe, China, Japan and Australia. Many of the patents and patent applications, if granted, that are in-licensed

or owned by us may be able to be extended under the patent term extension or supplementary protection certificate

regimes (in jurisdictions where these regimes are available) once the key products have been the subject of regulatory

approval as the claims are directed to pharmaceutical products and their uses. The extensions in term are typically up to

five years in duration and are often related to the delay between the grant of the patent and regulatory approval of the

pharmaceutical product.

Requirement for Patentability

The requirements for patentability differ in detail from country to country. However, in general terms the main

requirements are that the invention relate to patentable subject matter; that the invention is novel and has an inventive

step; and that the patent contain an adequate disclosure of performing or making the invention. In order to be novel, the

invention must not have been disclosed in writing or otherwise in public, or offered for sale, before the priority date. The

requirement of inventive step is, in general terms, that the invention must go beyond what the skilled worker in the field

would arrive at as a matter of course when attempting to address the same problem as the invention.

Procedure for Obtaining Patent Protection

Patents are granted on a national basis. International patent protection is based upon a system of well-established and

widely adopted international conventions. The first application for a patent for an invention is called the priority

application, and its filing date is known as the priority date. If patent applications having the same specification are filed

within a year from the priority date in other countries, then (in accordance with the Paris Convention, World Trade

Organization ("WTO") Treaty and bilateral agreements) they retain the effective filing date of the priority application for

the purpose of assessing novelty and inventive step.

There are three different types of patent application of relevance. A provisional application acts as a filing to obtain a

priority date. It does not proceed to grant and is not examined by the patent authorities; rather, a later application must

be filed within a year of its priority date to claim the benefit of that filing. A national filing is a regular patent application in

a particular country or region. It will be examined in most cases by the local or regional patent authorities. Applications

can be filed directly in the country or region, or using another convention called the Patent Cooperation Treaty ("PCT").

The PCT allows for a single application to be filed in a single patent office, designating all the member states, obtain a

preliminary search and opinion, and delay filing into the national and regional intellectual property offices for a period of

30 months from the priority date. The PCT currently has 148 members, including all OECD member countries. At the end

of this period, national filings must be made in the countries of interest.

The patent application is examined in each country (or in some cases regional offices) according to its national laws and

procedures.

Potential Limitations of Patent Protection

Certain limitations are inherent in the patent system. In all relevant countries it is possible to challenge the validity of a

patent even after it has been granted by the intellectual property office. This may be possible by administrative

processes at the relevant patent office, court procedures, or both. However, the laws of some jurisdictions do not

protect intellectual property rights in the same manner and to the same extent as laws in the U.S. Consequently, we may

not be able to prevent third parties from practicing our inventions in all jurisdictions outside the U.S. Competitors may

use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and

further, may export otherwise infringing products to territories where we have patent protection, but enforcement of

such patent protection is not as strong as that in the U.S. These products may compete with our products and any then-

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approved product and our patents or other intellectual property rights may not be effective or sufficient to prevent them

from competing.

A successful challenge to validity will result in the claims of the patent being narrowed in scope, or the patent being

completely revoked. The grant of a patent by a patent office does not mean it is valid. Because of the limited scope of

material searchable by the patent office, compared to the potential to use documents or act before the priority date that

may not have been identified by the patent office to attack validity, there is a risk that presently unknown disclosures or

actions relevant to patentability will be discovered at a later time, with consequent risks to validity. The scope of a

granted patent may be significantly different to a pending application, and so it is not possible to advise with certainty in

relation to infringement of a pending application.

Pending patent applications may never proceed to be granted patents. It is not generally possible to commence a patent

enforcement action based on a pending application; it is necessary to obtain a granted patent. However, damages in

some instances and in some jurisdictions may be backdated for part of the period of pendency. To our knowledge, none

of the patents and patent applications in-licensed or owned by us are presently the subject of a challenge by a third-

party. EP0956506 has previously been challenged in opposition proceedings before the European Patent Office but the

opposition was successfully dismissed.

Trademarks

Registered trademarks protect indications which serve to distinguish the goods or services of one competitor from those

of others, and provide the trademark owner with the exclusive right to use or authorize others to use the trademark in

relation to the goods and services for which it is registered. Trademarks are granted generally on a national or territorial

basis. International filings are governed by international treaties to simplify the process of securing trademark protection

at the national or territorial level of parties to the relevant international treaties, in a similar manner to patents. In

particular, international trademark applications made through the World Intellectual Property Organization under the

Madrid Protocol offer a six-month priority period from the application filing date. Generally, the intellectual property

offices in each country or territory conduct searches and examination of trademark applications prior to registration.

Trademark applications are subject to the pace of examination in the relevant national intellectual property office. It is

not unusual for a trademark application to be pending for a period of six months to two years prior to grant, but some

trademark applications may be pending for years. Trademarks may be subject to challenge by third parties in most

jurisdictions before and after registration, with many national or territorial intellectual property offices offering

administrative and/or judicial processes to address challenges to the relevant trademark on various grounds, which often

include likelihood of confusion concerns with senior trademark registrations.

In total, as of December 31, 2025, we own 26 registered U.S. trademarks, 14 pending U.S. trademark applications, 179

foreign trademarks registered in jurisdictions such as Australia, Europe, China, Brazil and Japan, and 93 pending foreign

trademark applications applied for in jurisdictions such as Australia, Europe, China, Brazil and Japan. We currently have

trademark registrations in the U.S. for the Telix Pharmaceuticals name, the Illuccix name and logo, the Gozellix name and

logo, the Pixclara name and logo, the ANMI name, the SENSEI name, the ARTMS name, and the RADMAB name and other

trademarks are pending in the U.S. such as Zircaix. Outside of the U.S., Illuccix is registered in Australia, Brazil, Canada,

China, the European Union, India, Israel, Japan, Malaysia, New Zealand, Norway, Peru, Philippines, South Korea,

Singapore, Switzerland, Taiwan, Türkiye, the United Kingdom and is pending in Thailand. We have also selectively filed

the following names and logos outside of the U.S.: Pixclara, Gozellix, Zircaix, ANMI, ARTMS, and RADMAB.

Data and Market Exclusivity Provisions

Data and market exclusivity provisions relating to the regulatory approval of pharmaceutical products exist in each

relevant jurisdiction. The provisions provide periods during which a competitor is limited in their ability to seek and/or

obtain regulatory approval for a generic or similar product. Data exclusivity relates to the period in which information

relating to the safety and efficacy of a product, provided to a regulatory authority for the purposes of obtaining

regulatory approval, remains confidential, or cannot be relied upon by the regulatory authority or a third-party in order to

obtain regulatory approval of another. Data exclusivity is separate from other forms of exclusivity, such as the monopoly

provided by patents. In some instances, the period of data exclusivity may extend beyond the term of any patent which

protects the same product. Market exclusivity refers to a period where a party wishing to sell a product is prohibited

from doing so, even if regulatory approval has been obtained.

As our key products are radio pharmaceutical products, they will have the benefit of periods of data and market

exclusivity available in each jurisdiction following regulatory approval. These are typically five years or more in duration

(and eight years data exclusivity plus two years market exclusivity for European jurisdictions).

Our Patent Portfolio

Our commercial success depends in part on our ability to obtain and maintain regulatory exclusivity, proprietary or

intellectual property protection for our products and product candidates, our core technologies, and other know-how, to

operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary or

intellectual property rights. Our policy is to seek to protect our proprietary and intellectual property position by, among

other methods, filing patent applications in the U.S. and in foreign jurisdictions related to our proprietary technology and

products and product candidates. We also rely on trade secrets, know-how and continuing technological innovation to

develop and maintain our proprietary and intellectual property position.

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We also in-license patent portfolios relating to our product pipeline and to emerging product candidates as well as

technologies that are adjacent such as radiolabeling technologies, linker technologies, chelator technologies,

bioconjugation techniques, antibody manufacturing and modifications, isotope manufacture, AI techniques and

applications, and medical imaging devices,

In total, as of December 31, 2025, we have in-licensed 40 U.S.-issued patents and 408 foreign-issued patents granted in

jurisdictions such as Australia, Canada, Germany, Italy, Spain, the United Kingdom, France, Türkiye, Russia, Japan, China,

Korea, Singapore, India, Israel, Mexico, and Brazil. As of December 31, 2025, we have also in-licensed 10 pending non-

provisional U.S. patent applications, 66 pending foreign-patent applications applied for in jurisdictions such as in

Australia, Canada, Europe, Russia, Japan, China, India, Mexico, and Brazil, and one pending international application filed

under the PCT. The PCT is an international patent law treaty that provides a unified procedure for filing a single initial

patent application to seek patent protection for an invention simultaneously in each of the member states. Although a

PCT application is not itself examined and cannot issue as a patent, it allows the applicant to seek protection in any of

the member states through national-phase applications.

In total, as of December 31, 2025, we own either solely, or jointly with our commercial partners, 15 U.S.-issued patents

and 118 foreign patents granted in jurisdictions such as Australia, Canada, Germany, Italy, Spain, the United Kingdom,

France, Türkiye, Russia, Japan, China, India, Israel, Mexico, and Brazil. As of December 31, 2025, we also have pending,

either solely or jointly with our commercial partners, 38 non-provisional U.S. patent applications, 182 foreign patent

applications applied for in jurisdictions such as in Australia, Canada, Europe, Japan, China, Korea, Singapore, India, Israel,

Mexico, and Brazil, and 18 pending international applications filed under the PCT.

The intellectual property portfolios for our key products and product candidates as of December 31, 2025 are

summarized below:

Illuccix and Gozellix

Our Illuccix patent portfolio covers the pharmaceutical product and the unique arrangement of components of the kit as

well as methods of making gozetotide. The patent family directed to the pharmaceutical product and the unique

arrangement of components of the kit consists of five U.S.-issued patents; 53 foreign-issued patents granted in

Australia, Canada, Belgium, Finland, Switzerland, Lichtenstein, the Czech Republic, Denmark, Austria, Greece, Hungary,

Ireland, the Netherlands, Norway, Portugal, Sweden, Germany, Italy, Spain, the United Kingdom, France, Türkiye, Russia,

Japan, China, India, Israel, Mexico, South Africa, New Zealand and Brazil, six pending foreign patent applications applied

for in Europe, India and Hong Kong, and four pending U.S. non-provisional applications. The patent family directed to

methods of making gozetotide consists of one pending U.S. non-provisional patent application and ten pending foreign

patent applications in Australia, Brazil, Canada, Mexico, China, Europe, Japan, Korea, Hong Kong and Singapore.

There is one U.S. patent registered under the U.S. Orange Book which is directed to methods of imaging using the

pharmaceutical product prepared with Illuccix.

Any patents that may issue in the U.S. as part of our patent portfolio directed to the pharmaceutical product or the kit will

expire no earlier than 2035, not including any terminal disclaimer, patent term adjustment due to administrative delays by

the U.S. Patent and Trademark Office ("

USPTO")

or patent term extension under the Hatch-Waxman Act. Any patents

that may issue in foreign jurisdictions will likewise expire no earlier than 2035. Any patents that may issue in the U.S.

directed to methods of making gozetotide will expire in 2042, absent any terminal disclaimer, patent term adjustment

due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire in 2042.

The Illuccix patent portfolio also covers Gozellix. In addition, there is one patent family directed solely to the formulation

of Gozellix comprising one pending U.S. non-provisional application and one PCT application which has yet to enter the

National Phase. Any patents that may issue in the U.S. as part of our patent portfolio directed to the pharmaceutical

product or the kit will expire no earlier than 2045, not including any terminal disclaimer, patent term adjustment due to

administrative delays by the

USPTO,

or patent term extension under the Hatch-Waxman Act. Any patents that may issue

in foreign jurisdictions will likewise expire no earlier than 2045.

TLX250-Px (89Zr-DFO-girentuximab) and TLX250-Tx (177Lu-DOTA-girentuximab)

We have in-licensed six patent families from Heidelberg Pharma AG (formerly Wilex AG) directed to the CAIX-targeting

girentuximab antibody and various therapeutic and imaging applications thereof.

The in-licensed patent portfolio includes three U.S.-issued patents, 17 foreign-issued patents granted in Australia,

Canada, Germany, Spain, Italy, France, the United Kingdom, Korea, New Zealand, South Africa, Israel, Russia and Mexico,

and one foreign patent applications applied for in China. Expiry dates vary from 2026 to 2034 across the portfolio, not

including any patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984,

commonly referred to as the Hatch-Waxman Act, or equivalent provisions in foreign jurisdictions.

We have two patent families directed to aspects of the manufacture of TLX250-Px. These patent families include two

pending U.S. non-provisional patent applications and 16 foreign patent applications in Australia, Brazil, Canada, Europe,

Korea, Singapore, China and Japan. Any patents that may issue in the U.S. based on the non-provisional U.S. patent

applications will expire no earlier than 2042, not including any terminal disclaimer, patent term adjustment due to

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administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire no earlier than 2042.

We have one patent family directed to the use of TLX250-Px in imaging CAIX-expressing cancers other than ccRCC. This

patent family consists of one pending U.S. non-provisional patent application and nine foreign patent applications in

Brazil, Singapore, China, Mexico, Australia, Canada, Japan, Korea and Europe. Any patents that may issue in the U.S.

based on the pending PCT application will expire no earlier than 2043, not including any terminal disclaimer, patent term

adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any

patents issued in foreign jurisdictions will likewise expire no earlier than 2043.

We have one patent family directed to the use of TLX250-Tx in therapy of CAIX-expressing cancers other than ccRCC.

This patent family consists of one pending PCT application. Any patents that may issue in the U.S. based on the pending

PCT application will expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to

administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire no earlier than 2043.

We have one patent family directed to combinations of TLX250-Tx with checkpoint inhibitors. This patent family consists

of one pending U.S. non-provisional patent application and 6 foreign patent applications applied for in Australia, Brazil,

Canada, Europe, Mexico and Singapore. Any patents that may issue in the U.S. based on the pending PCT application will

expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by

the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will

likewise expire no earlier than 2043.

We have one patent family directed to the combination of TLX250-Tx with DNA damage repair inhibitors. This patent

family includes one pending U.S. non-provisional patent application and ten foreign patent applications applied for in

Australia, Brazil, Canada, Europe, Israel, Korea, Mexico, Singapore, China and Japan, Any patents that may issue in the

U.S. based on the U.S. non-provisional patent application will expire no earlier than 2042, not including any terminal

disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the

Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2042.

As biological products, TLX250-Px and TLX250-Tx will be entitled to 12 years data exclusivity from the date of product

approval.

TLX252

-Tx (

225

Ac-DOTA-girentuximab)

We have a single patent family patent directed to the composition of matter of TLX252-Tx, its radiolabeled forms and

uses in imaging and therapy. The patent family includes one pending U.S. non-provisional patent application and 16

pending foreign patent applications in Canada, Chile, China, India, Japan, Korea, Mexico, Australia, Europe, Eurasia, India,

New Zealand, Brazil, Hong Kong, Israel and Singapore. Any patents that may issue in the U.S. will expire no earlier than

2040, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent

term extension under the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will likewise expire no

earlier than 2040.

TLX101-Px (18

F-FET)

We have orphan drug and fast track designation for TLX101-Px in the U.S., which we expect to yield up to seven years

regulatory exclusivity following product approval.

TLX101

-Tx (

131

I-IPA) and TLX102-Tx (

211

At-APA)

We have in-licensed a patent portfolio directed to methods of treatment using TLX101-Tx and TLX102-Tx from Dr.

Samuel Samnick, a German nuclear medicine researcher. There are two U.S.-issued patents which will expire no earlier

than 2028 and 2031 respectively, not including any patent term extension under the Hatch-Waxman Act. There are eight

foreign issued patents in Australia, Canada, Germany, the United Kingdom, Spain, France, Japan, and Korea which will

expire no earlier than 2026.

We have in-licensed a patent portfolio directed to a method of manufacturing TLX101-Tx and TLX102-Tx from Osaka

University. There are two U.S.-issued patents, one pending U.S. non-provisional application, seven foreign-issued

patents in Australia, Japan, Switzerland, Lichtenstein, Spain, the United Kingdom, and Türkiye, one foreign issued patent

under the European Unified Patent Convention (which covers Austria, Belgium, Bulgaria, Denmark, Estonia, Finland,

France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia, and Sweden) and

two pending foreign applications in Europe and Hong Kong. Any patents in this portfolio that may issue in the U.S. will

expire no earlier than 2038, not including any terminal disclaimer, patent term adjustment due to administrative delays by

the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will

likewise expire no earlier than 2038.

We have one PCT application directed to combinations of TLX101-Tx and other chemotherapeutic agents. Any patents

that may issue in the U.S. based on this PCT application will expire no earlier than 2045, not including any terminal

disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the

Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2045.

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We have orphan drug designation for TLX101-Tx in the U.S. and Europe and for TLX102-Tx in the U.S. which will grant us

the customary regulatory exclusivity, currently expected to be up to seven years from date of product approval.

TLX591-Tx (lutetium (Lu177) rosopatamab tetraxetan)

We have sub-licensed a Cornell University (and associated entities) patent portfolio from Convergent Therapeutics, Inc

as successor in title of BZL Biologics LLC. The portfolio is directed to TLX591-Tx and combination therapies of TLX591-

Tx with androgen deprivation therapy.

The sub-licensed patent portfolio includes one U.S.-issued patent, one pending U.S. non-provisional patent application,

14 foreign-issued patents in Belgium, Canada, Japan, Germany, France, Spain, the United Kingdom, Luxembourg and the

Netherlands, and a pending foreign application in Europe directed to combinations with androgen deprivation therapy.

Any patents that may issue in the U.S. will expire no earlier than 2028, not including any terminal disclaimer, patent term

adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any

patents that may issue in foreign jurisdictions will likewise expire no earlier than 2028.

As a biological product, TLX591-Tx will be entitled to 12 years data exclusivity from the date of product approval.

TLX592

-Tx (

225

Ac-RADmAb®)

We have a single patent family patent directed to the composition of matter of TLX592-Tx, its radiolabeled forms and

uses in imaging and therapy. The patent family includes one pending U.S. non-provisional patent application, one granted

Japanese patent, and 16 pending foreign patent applications in Canada, Chile, China, India, Japan, Korea, Mexico,

Australia, Europe, Eurasia, India, New Zealand, Brazil, Hong Kong, Israel and Singapore. Any patents that may issue in the

U.S. will expire no earlier than 2040, not including any terminal disclaimer, patent term adjustment due to administrative

delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents that may issue in foreign

jurisdictions will likewise expire no earlier than 2040.

TLX592

-Tx is currently in early development so regulatory pathway to product approval is not yet confirmed or known,

however the customary regulatory exclusivity period is expected to apply.

TLX300-Px (89Zr-olaratumab) and

TLX300

-Tx

We have two patent families directed to radiolabeled forms of olaratumab and their use in imaging and therapy. The

patent family includes two pending U.S. non-provisional patent applications and 16 pending foreign applications filed in

Australia, Brazil, Canada, China, Europe, Japan, Korea, and Mexico. Any patents that may issue in the U.S. will expire no

earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by the

USPTO or patent term extension under the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will

likewise expire no earlier than 2043.

TLX66-Px (99mTc-besilesomab, Scintimun) and TLX66-Tx (90Y-DTPA-besilesomab)

We have one patent family directed to the use of TLX66-Tx in the treatment of multiple myeloma. The patent family

includes one U.S.-issued patent and foreign-issued patents in Canada, Australia, and Europe (validated in Belgium,

Germany, Spain, France, the United Kingdom and Italy). The U.S. patent has a maximum expiry date of 2031, not

including any patent term extension under the Hatch-Waxman Act. The other patents will expire no earlier than 2026.

A second patent family is directed to the use of TLX66-Tx for treating AL-amyloidosis and for specific bone-marrow

conditioning. We have one pending U.S. non-provisional patent application and pending applications in China, Japan and

Canada.

The second family includes a granted patent in Europe which has been validated under the unitary patent system (which

covers seventeen European countries and includes coverage of Belgium, Germany, France, and Italy) and has also been

validated in Switzerland, Spain, and the United Kingdom. There are also foreign-issued patents in Australia and South

Africa.

Any patents in the U.S. that may issue in the second family will expire no earlier than 2038, not including any terminal

disclaimer, patent term adjustment, or patent term extensions under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire no earlier than 2038.

We have one PCT application directed to the use of TLX66-Px (Scintimun) in dosimetry. Any patents that may issue in

the U.S. based on the pending PCT application will expire no earlier than 2045, not including any terminal disclaimer,

patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman

Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2045.

TLX090-Tx (

153

Sm-DOTMP)

We have in-licensed three patent families from IGL Pharma, Inc in connection with our acquisition of QSAM Biosciences,

Inc., which are directed to methods of manufacturing TLX090-Tx, kits comprising TLX090-Tx, and its use in treatment.

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The portfolio includes five U.S.-issued patents, 39 foreign-issued patents in Canada, Germany, France, Great Britain,

Hungary, Ireland, Iceland, Italy, Luxembourg, the Netherlands, Norway, Austria, Belgium, Bulgaria, the Czech Republic,

Denmark, Finland, Poland, Portugal, Slovakia, Slovenia, Sweden, Switzerland, Türkiye and Japan, and three pending

foreign patent applications in Japan and Europe. Any patents issued in the U.S. will expire no earlier than 2035, not

including any terminal disclaimer or patent term adjustment due to administrative delays by the USPTO or patent term

extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than

2035.

TLX400-Tx (177Lu-DOTAGA.Glu.(FAPi)2)

We have one patent family directed to the composition of matter of TLX400-Tx. The family includes one granted German

utility patent, one pending U.S. non-provisional patent application and nine foreign patent applications in Australia, Brazil,

Canada, China, Europe, India, Japan, Korea and Hong Kong. The granted German utility patent will expire no earlier than

Any patents issued or that may issue based on the pending application in the U.S. will expire no earlier than 2042,

not including any terminal disclaimer or patent term adjustment due to administrative delays by the USPTO or patent

term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier

than 2042.

TLX593-Px

We have in-licensed a PCT application from the University of Ghent directed to methods of preparing TLX593-Px and

associated compositions of matter. Any patents issued or that may issue based on the pending PCT application in the

U.S. will expire no earlier than 2045, not including any terminal disclaimer or patent term adjustment due to

administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire no earlier than 2045.

TLX597-Tx

We have in-licensed a patent family directed to the composition of matter of TLX597-Tx from Instituto Nacional de

Investigaciones Nucleares ("ININ") a nuclear medicine research organization. The license covers all territories except

Mexico and South Africa. The patent family includes one U.S. issued patent and foreign issued patents in Eurasia, China,

Hong Kong, the United Kingdom, Switzerland and Spain, and one foreign issued patent under the European Unified

Patent Convention (which covers Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia, and Sweden). There are three foreign patent

applications filed in Brazil, Canada, and Egypt. Any patents issued or that may issue in the U.S. will expire no earlier than

2039, not including any terminal disclaimer or patent term adjustment due to administrative delays by the USPTO or

patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no

earlier than 2039.

We have one unpublished PCT application directed to novel radiolabeled forms of TLX597-Tx. Any patents that may

issue in the U.S. based on the pending PCT application will expire no earlier than 2045, not including any terminal

disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the

Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2045.

RHN001-Tx and RHN001-Dx

We have one patent family directed to RHN001-Tx and RHN001-Dx as a composition of matter. The patent family

includes one U.S non-provisional patent application and patent applications in Europe, Canada, Australia, India, South

Africa, Mexico, China, Eurasia, Brazil and Hong Kong. Any patents that may issue in the U.S. will expire no earlier than

2042, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent

term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier

than 2042.

TLR602-Tx and TLR603-Tx

We have one PCT application directed to TLX602-Tx as a composition of matter. Any patents that may issue in the U.S.

based on the pending PCT application will expire no earlier than 2044, not including any terminal disclaimer or patent

term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any

patents issued in foreign jurisdictions will likewise expire no earlier than 2044.

We have one patent family directed to TLX603-Tx as a composition of matter. The patent family includes one U.S non-

provisional patent application and patent applications in Europe, China, Korea, Mexico, Japan, Singapore, Brazil,

Australia, Canada, and Hong Kong. Any patents that may issue in the U.S. based on the pending PCT application will

expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by

the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will

likewise expire no earlier than 2043.

Lightpoint Medical

In connection with our acquisition of Lightpoint’s radio-guided surgery business, we acquired a patent portfolio relating

to surgical applications of radiopharmaceuticals including the SENSEI probe. The patent portfolio comprises five U.S.-

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issued patents, 25 foreign-issued patents in Australia, China, Belgium, Luxembourg, Switzerland, Germany, Italy, France,

the Netherlands, Spain and the United Kingdom, one granted European patent which has been validated in Great Britain,

Spain and under the European Unified Patent Convention (which covers Austria, Belgium, Bulgaria, Denmark, Estonia,

Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia, and

Sweden), and two pending non-provisional U.S. applications. Any patents issued or that may issue based on the pending

applications in the U.S. will expire no earlier than 2033, not including any terminal disclaimer or patent term adjustment

due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in

foreign jurisdictions will likewise expire no earlier than 2033.

Collaboration and License Agreements

Advanced Nuclear Medicine Ingredients SA

In December 2018, we acquired Advanced Nuclear Medicine Ingredients ("ANMI") including the pre-cursor kit that was

ultimately developed to become Illuccix. We paid A$2.7 million in cash and issued 6,090,805 ordinary shares, based on a

share price of A$0.637 per share, in connection with the closing of the acquisition.

We are obligated to make deferred earn-out payments to former shareholders of ANMI on an annual basis equal to a

percentage in the low teens of net sales of Illuccix in the U.S. and equal to a percentage in the low twenties of net sales

of Illuccix outside the U.S., in each case until April 13, 2027, which is five years following the first commercial sale of

Illuccix in the U.S. We hold an option to buy out the remaining deferred payments by paying €10 million within 90 days of

April 13, 2025. This option was exercised and the final buy out payment was made in July 2025.

Heidelberg License Agreement

On January 16, 2017, we entered into a license agreement, or, as amended, the Heidelberg License, with Wilex AG (now

Heidelberg Pharma AG, "Heidelberg"), pursuant to which Heidelberg granted us an exclusive, royalty-bearing license

under certain patents and know-how to develop, manufacture and commercialize the CAIX-targeting girentuximab

antibody ("girentuximab"), radio-labeled with an isotope in both diagnostic and therapeutic products. We paid Heidelberg

US$250,000 in connection with the execution of the Heidelberg License and initial technology transfer. In addition, from

2018 to 2022, we have paid Heidelberg US$1.25 million for achievement of certain manufacturing and regulatory

milestones for IND approval and enrollment of the last patient in a Phase 3 clinical trial. Under the agreement, we are

obligated to pay milestone payments to Heidelberg of US$2.4 million in the aggregate with payment owed upon FDA

approval for a BLA for a diagnostic product and upon first reimbursements for first indication of a diagnostic product.

Under the Heidelberg License, Heidelberg retained the right to develop and commercialize products that contain

girentuximab that are not radio-labeled. In the event we intend to file a BLA for a therapeutic product that includes

girentuximab, we are obligated to notify Heidelberg and may be required to pay up to US$3.0 million to extinguish any of

Heidelberg’s retained rights that have been granted to a third-party for co-promotion of girentuximab in the U.S. In the

event of commercial launch of a diagnostic product, we are obligated to pay Heidelberg royalties in the low twenties on

net sales of such product by us or a sublicensee during the first ten years of such sales and mid single-digit royalties on

net sales of such product during the second ten years of such sales. In the event of commercial launch of a therapeutic

product, we are obligated to pay Heidelberg low single-digit royalties on net sales of such product during the first ten

years of such sales. Our obligation to pay royalties on net sales of diagnostic products expires 20 years after first

commercial sale of each diagnostic product and our obligation to pay royalties on therapeutic products expires ten years

after first commercial sale of each therapeutic product. We are obligated to use commercially reasonable efforts to

develop products for regulatory approval worldwide subject to certain excepted countries for therapeutic products. The

Heidelberg License expires when we cease selling products subject to the license granted thereunder, subject to

customary termination provisions regarding material breach by or bankruptcy of either party. In addition, we can

terminate the agreement upon 180 days’ written notice for any reason. In the event of termination of the agreement for

Heidelberg’s material breach or bankruptcy, we have the option to purchase intellectual property relating to the products

for nominal consideration.

On March 1, 2024, Heidelberg assigned its rights and obligations under the Heidelberg License to HDP G250, AG & Co.

KG, a wholly owned subsidiary of Heidelberg. In connection with the assignment, the subsidiary agreed to perform all

obligations of Heidelberg under the Heidelberg License. On March 4, 2024, Heidelberg announced that it entered into a

royalty financing agreement with HealthCare Royalty Partners relating to royalty payments that Heidelberg is entitled to

receive from us under the Heidelberg License.

Olaratumab License Agreement

In April 2022, we entered into a license agreement ("the Lilly License") with Eli Lilly Kinsale Limited, pursuant to which

Lilly granted us an exclusive, royalty-bearing license under certain patents and know-how directed to its proprietary

antibody, olaratumab, to develop, manufacture and commercialize radio-labeled forms of olaratumab for the diagnosis

and treatment of human cancers. Under the Lilly License, we are obligated to use commercially reasonable efforts to

develop, obtain regulatory approval for and commercialize radio-labeled forms of olaratumab in several major markets.

As consideration for the Lilly License, we paid Lilly an upfront payment of US$5.0 million and are obligated to pay up to a

total of US$225.0 million upon satisfaction of specified clinical, regulatory and commercial milestones. In the event of

launch of a commercial product, we are also obligated to pay Lilly royalties in the low teens based on net sales of

products, with the royalty term being, on a product-by-product and country-by-country basis, the latest of (i) the 12th

anniversary of the first commercial sale of such product in such country, (ii) the first day on which there is not at least

one of Lilly’s patents covering such product in such country, or (iii) the expiration of the last-to-expire data exclusivity

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period for such product in such country, which we refer to as the Telix Royalty Term. The royalties may also be subject to

reductions during the Telix Royalty Term in the event the product is not covered by a valid claim of a licensed patent or

in the event we are required to obtain a license from a third-party to commercialize the product. In addition to the

foregoing royalties on net sales of products, we are obligated to pay Lilly a percentage of any sublicense revenue

received pursuant to any sublicense or similar agreement. The Lilly License defines sublicense revenue to include

amounts paid for milestones similar to the milestones specified in the Lilly License, but solely to the extent such amounts

are above the amount paid to Lilly under the Lilly License, and further defines sublicense revenue to exclude royalties

calculated on the basis of sales of the product for which royalties are already due under the Lilly License, reimbursement

for patent costs, certain profit sharing payments and any equity or debt investment at fair market value. The Lilly License

further specifies that the royalty owed on such sublicense revenue varies based on the date we enter into such

sublicense or similar agreement, ranging from mid-teens if entered into within one (1) year of the effective date of the

Lilly License down to mid-single digits if entered into following the third (3rd) anniversary of the effective date of the Lilly

License.

Under the Lilly License, we also granted Lilly an option to enter into an exclusive license under certain patents and know-

how to develop, commercialize and otherwise exploit a companion diagnostic for use with olaratumab, or the companion

diagnostic option. To exercise the companion diagnostic option, Lilly is obligated to pay us an option exercise fee of

US$5.0 million and would be obligated to pay up to a total of US$30.0 million upon satisfaction of specified regulatory

milestones. In the event of launch of a companion diagnostic, Lilly would pay us low single digit royalties on net sales of

its products incorporating olaratumab, or Lilly Products, for the labeled use for the treatment of human cancer and mid-

single digit royalties on net sales of companion diagnostics, with the royalty term being, on a product-by-product and

country-by-country basis, the latest of (i) the 12th anniversary of the first commercial sale of such Lilly Product or

companion diagnostic in such country, (ii) the first day on which there is not at least one of our patents covering such

Lilly Product or companion diagnostic in such country, or (iii) the expiration of the last-to-expire data exclusivity period

for such Lilly Product or companion diagnostic in such country, or the Lilly Royalty Term. The royalties may also be

subject to reductions during the Lilly Royalty Term in the event the Lilly Product or companion diagnostic is not covered

by a valid claim of a licensed patent or in the event Lilly is required to obtain a license from a third-party to commercialize

the product.

The Lilly License continues until the expiration of the last-to-expire Telix Royalty Term or, if Lilly exercises the companion

diagnostic option, the Lilly Royalty Term, subject to customary termination provisions regarding material breach by or

bankruptcy of either party. Each party, in its capacity as the licensee, may terminate the agreement with respect to the

licenses granted to it upon 30 days’ written notice to the other party. Lilly may terminate the agreement if a patient has

not been enrolled in a Phase 1 or Phase 2 clinical trial using the companion diagnostic by April 8, 2025. If Lilly exercises

the companion diagnostic option, we may terminate the agreement if no patient has qualified for enrollment into a

registrational study of the Lilly Product for use by patients that have been screened using the companion diagnostic

within two years of the date that Lilly exercised the companion diagnostic option.

Lightpoint Medical Share Sale Agreement

In June 2023, we entered into a share sale agreement to acquire the SENSEI business from Lightpoint. We completed the

acquisition of Lightpoint on November 1, 2023. The acquisition was implemented through the purchase of Lightpoint

Medical Limited’s wholly owned subsidiary, Lightpoint Surgical Limited, as the then owner of Lightpoint’s business, assets

and operation. We paid upfront consideration of US$20.0 million, of which we paid US$19.6 million through the issuance

of 3,298,073 ordinary shares at a price of A$9.3659 per share. We are obligated to pay an additional US$15.0 million via

an earn-out in the form of performance rights, which may be settled in cash or ordinary shares, at our option, upon

achievement of regulatory, commercial and operational milestones relating to the ongoing development and

commercialization of SENSEI. As at 31 December 2025, US$4.5 million of these performance rights have been settled by

the issue of 269,075 ordinary shares.

Strategic License and Commercial Partnership with Grand Pharma

In November 2020, we entered into a strategic partnership with Grand Pharma, pursuant to which we appointed Grand

Pharma as our partner with exclusive development and commercialization rights to our portfolio of imaging and

therapeutic products and product candidates in Mainland China, Taiwan, Hong Kong and Macau ("the Grand Pharma

Territory"). As part of the strategic partnership, we entered into an Imaging Products Commercialization Agreement and a

Therapeutic Products License Agreement with Grand Pharma.

Pursuant to the Imaging Products Commercialization Agreement, we appointed Grand Pharma as our exclusive

commercial partner in the Grand Pharma Territory for Illuccix and TLX250-Px. The Imaging Products Commercialization

Agreement includes minimum annual purchase obligations of Grand Pharma following marketing authorization in

applicable regions in the Grand Pharma Territory in order to maintain exclusivity in the Grand Pharma Territory.

There are currently no approved imaging products in the Grand Pharma Territory under the Imaging Products

Commercialization Agreement.

The Imaging Products Commercialization Agreement has a 15-year term for each product beginning on the date of

marketing authorization in China and the agreement will automatically renew for five-year renewal terms unless either

party gives a written notice of nonrenewal. Either party may terminate the Imaging Products Commercialization

Agreement upon material breach or insolvency by the other party.

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Pursuant to the Therapeutic Products License Agreement, Grand Pharma is responsible, at its own cost, for conducting

any clinical trials of therapeutic products in the Grand Pharma Territory in accordance with the agreed development plan.

Pursuant to the Therapeutic Products License Agreement, we are eligible to receive payments of up to US$69.0 million

upon achievement of regulatory milestones with respect to therapeutic products by Grand Pharma and up to US$156.0

million upon achievement of commercial milestones with respect to therapeutic products by Grand Pharma. We are also

eligible to receive single-digit percentage royalties on net sales of therapeutics products in the Grand Pharma Territory

for ten years after marketing authorization is granted in the Grand Pharma Territory. There are currently no approved

therapeutic products in the Grand Pharma Territory and we have not received any milestone payments from Grand

Pharma under the Therapeutic Products License Agreement.

We received an upfront, non-refundable cash payment of US$25.0 million upon execution of the Therapeutic Products

License Agreement. This upfront payment will be credited against any regulatory or commercial milestone payments

owed to us by Grand Pharma.

The Therapeutic Products License Agreement has a ten-year term ending after the date that marketing authorization is

granted in respect of each product. Either party may terminate the Therapeutic Products License Agreement upon

material breach or insolvency by the other party.

Agreement and Plan of Merger with IsoTherapeutics Group, LLC

On February 27, 2024, we entered into an agreement and plan of merger ("the IsoTherapeutics Agreement") to acquire

IsoTherapeutics Group, LLC ("IsoTherapeutics"), a specialty radiopharmaceutical development and bioconjugation firm,

based in Texas. IsoTherapeutics provides radiochemistry and bioconjugation development and contract manufacturing

services to many companies in the radiopharmaceutical industry. We completed the acquisition of IsoTherapeutics on

April 9, 2024.

The acquisition has enhanced our internal drug development capabilities, enabling us to internalize select aspects of our

development programs, with the goal of reducing cost and time to achieve technical milestones. The acquisition

expanded our U.S. manufacturing footprint with a site that includes a GMP clean room and production infrastructure

suitable for clinical use. The site also has extensive capacity to process a wide variety of therapeutic isotopes used in our

development portfolio. We are realizing cost savings from internalizing radiochemistry-related R&D activities, as

demonstrated by the inter-segment activity during the year.

The purchase price for the acquisition consists of (i) US$8.1 million paid at closing in the form of US$2.1 million in cash

and US$6.0 million in our ordinary shares which we paid in the form of 717,587 of our ordinary shares issued at closing,

(ii) US$5.0 million in performance-related milestone payments, which are payable in cash and are subject to meeting

certain milestone conditions within 12 months of closing, and (iii) a two-year revenue share that is based on actual

revenue earned from existing customers of IsoTherapeutics, which we estimate will require total cash payments of

approximately US$0.6 million. The upfront cash consideration was subject to customary working capital, debt and

transaction expense adjustments. The number of shares issued at closing was determined by converting US$6.0 million

to Australian dollars using the Reserve Bank of Australia exchange rate at closing and dividing that amount by the volume

weighted average price at which our ordinary shares traded on the ASX over the 10-trading day period prior to closing.

The shares issued at closing are subject to voluntary escrow restrictions.

The US$5.0 million in performance-related milestones was paid during the year following satisfaction of the performance

conditions. In addition, the first year of the revenue share has been paid totalling US$0.4 million.

Share Purchase Agreement with ARTMS Inc.

On March 5, 2024, we entered into a share purchase agreement ("the ARTMS Agreement") to acquire ARTMS Inc.

("ARTMS"), a radioisotope production technology company based in Canada, and its advanced cyclotron-based isotope

production platform, manufacturing plant and stockpile of ultra-pure rare metals required for consumable target

production. We completed the acquisition of ARTMS on April 11, 2024. ARTMS is a commercial-stage company that

specializes in the physics, chemistry and materials science of cyclotron-produced radionuclides and its technology is

used by major manufacturing networks to optimize production of a range of medical radioisotopes. We expect that the

acquisition will further enhance the vertical integration of our supply chain and manufacturing by providing a greater level

of control and security over each of our diagnostic isotopes.

ARTMS’ core technology platform is based on the QUANTM Irradiation System ("QIS"), a complete cyclotron-based

isotope production system that is designed to support high efficiency and cost-effective production of commercially

important medical isotopes including zirconium-89, gallium-68, technetium-99m and copper-64. We also expect that its

advanced cyclotron technologies will have immediate application and differentiation in the production of future

commercially important alpha-emitting, therapeutic isotopes, including actinium-225 and astatine-211.

We believe that QIS may be able to produce zirconium-89 that is ready for radiopharmaceutical use with TLX250-Px by

irradiating yttrium-89. ARTMS also holds a stockpile of zinc-68, which is used to produce gallium-68 that could be used

with Illuccix. Following closing of the acquisition, we intend to work with pharmacy networks and partners to enhance the

reliability and routine production of commercially useful cyclotron-produced diagnostic radionuclides such as copper-64

and technetium-99. In particular, ARTMS has a stockpile of nickel-65, an essential raw material for copper-64

production, and which is in limited global supply. As part of the acquisition, we also acquired ARTMS’ production facility

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and clean rooms, located in Burnaby, British Columbia. We plan to continue to operate and expand ARTMS’ R&D and

production capabilities at the Burnaby location to support our in-house and customer needs, subject to applicable laws

and transaction terms.

The purchase price for the acquisition consists of: (i) US$57.5 million upfront consideration, US$15.0 million of which we

paid in cash and the balance of which we paid in the form of 5,674,635 of our ordinary shares issued at closing, (ii)

US$24.5 million million in contingent future earn out payments, payable in cash following achievement of certain

regulatory and commercial milestones, and (iii) cash earnouts representing low teens percentage royalties based on net

sales of ARTMS products and related services and representing low single-digit percentage royalties based on net sales

of Telix products prepared using ARTMS products for up to three years depending on the product location where the

sale occurs. All earn-out royalties which have not otherwise expired will terminate on the 10-year anniversary following

closing of the ARTMS acquisition. The cash upfront consideration was subject to customary working capital, debt and

transaction expense adjustments. The shares issued at closing were subject to voluntary escrow restrictions. As at

31 December 2025, US$2.0 million of the contingent future earn outs have been paid following achievement of the

milestones.

Agreement and Plan of Merger with QSAM Biosciences, Inc.

On February 7, 2024, we entered into an Agreement and Plan of Merger ("the QSAM Agreement") with QSAM

Biosciences, Inc. ("QSAM") and we completed the acquisition of QSAM on May 3, 2024.

QSAM is developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer. Its lead product

candidate is Samarium-153-DOTMP, (

153

Sm-DOTMP), which is a novel kit-based bone-seeking targeted

radiopharmaceutical candidate that uses a next generation chelating agent to deliver a proprietary formulation of

Samarium-153 radioisotope.

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Sm-DOTMP, which we have designated as TLX090-Tx, has two potential applications –

pain management of bone metastases and osteosarcoma therapy, including in pediatric patients. We believe that

TLX090

-Tx is highly aligned with our existing therapeutic focus areas of prostate cancer, glioma and sarcoma.

TLX090

-Tx has shown evidence of safety, efficacy and future commercial utility in pre-clinical studies and early clinical

trials. We believe that it has the potential to deliver significant improvements on prior bone-seeking agents in the

treatment and management of late-stage metastatic disease. TLX090-Tx may enable the pain management of prostate

cancer bone metastases, where there remains a significant unmet patient need particularly after progression from other

forms of radionuclide and radiation therapy. We also believe that TLX090-Tx may benefit patients with metastatic lung

and breast cancer, where many patients develop brain and bone metastases, and disease management often focuses on

quality-of-life palliative care.

TLX090

-Tx has also been granted orphan drug and rare pediatric disease designations by the FDA for the treatment of

osteosarcoma. The rare pediatric disease designation may enable TLX090-Tx to be brought to market more rapidly

through regulatory incentives, including eligibility for a pediatric rare disease priority review voucher that may be applied

to this or other programs. The orphan drug designation and the rare pediatric disease designation do not increase the

likelihood of marketing approval.

The total consideration, calculated based on the announced purchase price, for the acquisition consists of: (i) US$33.1

million upfront consideration, US$27.8 million of which was paid in closing consideration through the issuance of

3,671,120 ordinary shares, and the balance of which was paid in certain cash adjustments or through the issuance of

approximately 409,026 of our ordinary shares in change of control fees, transaction bonuses and holdback shares

reserved for settlement of purchase price adjustments and (ii) up to US$90.0 million in contingent future earn-out

payments, in cash and/or ordinary shares, without interest, upon the achievement of certain regulatory and commercial

milestones, at the times and subject to the terms and conditions of the contingent value rights agreement. The ordinary

shares issued upon closing are subject to voluntary escrow conditions. The ordinary shares issued as part of the upfront

purchase price were issued pursuant to an exemption from registration under the Securities Act, in reliance on Section

4(a)(2) and Regulation D thereunder, as a transaction by an issuer not involving a public offering.

Stock Purchase Agreement with RLS (USA) Inc.

On September 20, 2024, we entered into a stock purchase agreement ("the RLS Agreement") to acquire RLS, which we

closed in January 2025. The purchase price for the acquisition consists of: (i) US$230.0 million upfront consideration,

payable in cash at closing of the acquisition, which amount will be adjusted for transaction expenses, cash and cash

equivalents (net of restricted cash), debt and debt equivalents and working capital, and (ii) milestone payments of up to

US$20.0 million in the aggregate, payable in cash upon the achievement of certain commercial milestones. The purchase

price and related transaction costs incurred prior to closing were funded from existing cash reserves.

RLS is a U.S.-based radiopharmacy company distributing PET, SPECT and therapeutic radiopharmaceuticals. Its network

includes over 30 licensed radiopharmacies located in major metropolitan areas in 18 states across the U.S. The RLS

footprint includes over 100,000 square feet of licensed expansion space that we believe can be utilized to meet rapidly

growing production demand. RLS has approximately 1,500 customers and currently is one of the distributors of Illuccix in

the U.S.

The acquisition significantly expands our North American manufacturing footprint and establishes the basis of a next

generation radiometal production network. By augmenting our existing distribution network with RLS’ capabilities, we aim

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to provide additional supply chain back-up and improve capacity to meet future demand, while broadening access for

patients across the entire U.S. market, including under-served populations. We believe the acquisition of RLS is highly

aligned with our investment strategy to strengthen our vertically integrated supply chain and manufacturing and

distribution capabilities. We expect the acquisition to provide a pathway for deploying ARTMS’ QIS technology by

enabling us to scale up the production of key isotopes and build a stable and consistent supply of PET and SPECT

diagnostic tracers, along with therapeutic radiopharmaceuticals across the U.S.

RLS will continue to service its existing customer base and will operate as part of our Manufacturing Solutions business,

which includes ARTMS, IsoTherapeutics, TMS Brussels South in Belgium, TMS North Melbourne in Australia, TMS

Sacramento and Telix Targeting Technologies ("T3") in California (U.S.), and TMS Yokohama in Japan. We expect that

RLS will become a key node in our network of U.S. manufacturing and distribution partnerships and is geographically

complementary to our manufacturing facility in Belgium.

Asset purchase and in-license agreements for FAP-targeting theranostics

On November 19, 2024, we entered into an asset purchase agreement with Medianezia GmbH, a company based in

Wiesbaden, Germany, and a separate exclusive, worldwide license and commercialization agreement with SCV GmbH, a

company based in Berlin, Germany, which we refer to collectively as the Medianezia/SCV Transaction. The asset

purchase completed on March 12, 2025. The technology to be acquired and licensed in the Medianezia/SCV Transaction

is comprised of FAP-targeting small molecules, patents and patent applications covering such molecules and their uses,

and the related know-how for potential use in diagnostic and therapeutic applications relating to cancer and other

diseases. FAP is a cell surface protein expressed in the tumor micro-environment of epithelial cancers and on the surface

of some specific cancer types, making FAP an attractive pan-cancer marker for therapeutic and diagnostic

radiopharmaceutical applications.

Pursuant to the Medianezia/SCV Transaction, we paid a total of €0.7 million in cash in connection to the signing of the

agreements with a further €6.3 million due at closing and will pay a further €3.0 million 12 months from closing, subject

to any potential indemnity setoff. We are also obligated to pay up to €132.0 million in contingent future earn-out

payments upon achievement of certain clinical development and regulatory milestones related to both the diagnostic and

therapeutic products under both agreements and up to €20.0 million in contingent future earn-out payments upon

achievement of certain commercial milestones related to the diagnostic product under the license agreement, as well as

low- to mid- single-digit royalties on net sales of the diagnostic product and an earlier formulation of the therapeutic

product, if used.

Acquisition of ImaginAb Assets

On January 13, 2025, we entered into an asset purchase agreement with ImaginAb ("the ImaginAb Transaction") to

acquire a significant portion of the intellectual property and technology assets of ImaginAb. The acquisition closed on

January 30, 2025. Upon closing of the ImaginAb Transaction, we acquired patents, know-how and other intellectual

property comprising a proprietary drug discovery platform, a pipeline of early-stage drug candidates against high-value

targets including DLL3 and integrin αvβ6, and several other novel targets in discovery stage. The acquired intellectual

property utilizes small engineered antibody formats that enable highly specific cancer targeting, combined with fast

tumor uptake and blood clearance. We believe this technology has the potential to be highly effective for imaging and

treating tumors with a broad range of radioisotopes, with alpha emitters of particular interest.

At the closing of the ImaginAb Transaction, we also assumed the lease for a state-of-the-art research facility in

Inglewood, California, and hired members of ImaginAb’s talented team of discovery, protein engineering and

radiopharmaceutical development experts. We expect that these assets will provide us with further in-house capabilities

in antibody engineering and preclinical development, as well as a novel biologics platform to create the next generation

of Telix precision medicine and therapeutic products, beyond the current clinical-stage pipeline.

The ImaginAb Transaction was conducted through an asset purchase agreement with a concurrent technology license

agreement, the latter of which provided us additional exclusive and non-exclusive rights to certain patents and know-

how being retained by ImaginAb. The upfront purchase price for the transaction was

$67,116,000

which comprised

$10,000,000

in cash and 29,895,000 in equity through the issue of

2,053,311

fully paid ordinary Telix shares in January

2025 at a share price of

$14.56

per share. A further

$60,000,000

in Milestone Rights, or performance rights, is payable in

cash and/or in ordinary shares, upon achievement of certain clinical milestones. The purchase price also includes a

deferred amount payable of

$3,472,000

(up to a maximum of

$4,000,000

in equity) at the conclusion of a 15-month non-

fundamental indemnity period, which is subject to set-off in the instance we have substantiated claims against ImaginAb.

Upon achievement of specific key development and commercial milestones, Telix will pay up to a total of $185 million, a

portion of which may be paid in cash or equity at Telix’s election. Royalties are also payable on net sales in the low single

digits on a limited number of platform and early-stage products after the first four products have been developed, as

well as single-digit sublicense fees, as applicable.

Upfront equity consideration was subject to voluntary escrow (lock-up/leak-out) restrictions with equal tranches being

released from escrow 60, 90 and 120 days after closing. The ImaginAb Transaction agreements contain comprehensive

fundamental and non-fundamental representations, indemnity protections, and specific non-compete and non-

solicitation restrictions for ImaginAb, among other standard terms for such agreements.

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Government Regulation and Product Approval

Government authorities in the U.S., at the federal, state and local level, and in other countries and jurisdictions, including

the European Union ("EU") extensively regulate, among other things, the research, development, testing, manufacture,

quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,

sales, pricing, reimbursement, post-approval monitoring and reporting, and import and export of pharmaceutical

products. The processes for obtaining regulatory approvals in the U.S. 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. The regulatory requirements applicable to product development,

approval and marketing are subject to change, and regulations and administrative guidance often are revised or

reinterpreted by government agencies in ways that may have a significant impact on our business.

Review and Approval of Drugs and Biologics in the U.S.

In the U.S., the FDA approves and regulates drugs under the FDCA and related regulations. Biological products are

licensed for marketing under the Public Health Service Act ("PHSA") and subject to regulation under the FDCA and

related regulations. Pursuant to Section 3621 of the Consolidated Appropriations Act of 2023, which was signed into law

on December 29, 2022, contrast agents and radioactive pharmaceuticals are regulated as drugs or biologics.

A company, institution, or organization which takes responsibility for the initiation and management of a clinical

development program for such products, and for their regulatory approval, is typically referred to as a sponsor. A

sponsor seeking approval to market and distribute a new drug or biological product in the U.S. must typically secure the

following:

•Completion of preclinical laboratory tests in compliance with the FDA’s good laboratory practice ("GLP") standards

and applicable regulations;

•Design of a clinical protocol and submission to the FDA of an Investigational New Drug Application ("IND"), which

must take effect before human clinical trials may begin;

•Approval by an IRB representing each clinical site before each clinical trial may be initiated;

•Performance of adequate and well-controlled human clinical trials in accordance with GCPs to establish the safety

and efficacy of the proposed drug product for each proposed indication or with respect to biologics, the safety,

purity and potency of the product candidate for each proposed indication;

•Submission to the FDA of an NDA, for a drug candidate product and a BLA for a biological product requesting

marketing for one or more proposed indications;

•Review of the request for approval by an FDA advisory committee, where appropriate or if applicable;

•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 cGMPs to assure the product’s identity, strength,

quality and purity;

•Completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;

•Payment of user fees pursuant to the PDUFA;

•Securing FDA approval of the NDA or BLA; and

•Compliance with any post-approval requirements, including the potential requirement to implement a REMS and the

potential requirement to conduct post-approval studies.

Preclinical Studies

Before a sponsor begins testing a drug or biologic compound with potential diagnostic or therapeutic value in humans,

the product candidate enters the preclinical testing stage. Preclinical studies include laboratory evaluation of the purity

and stability of the manufactured substance or active pharmaceutical ingredient and the formulated product, as well as in

vitro and animal studies to assess the safety and activity of the product candidate for initial testing in humans and to

establish a rationale for therapeutic use. These studies are generally referred to as IND-enabling studies. The conduct of

preclinical studies is subject to federal regulations and requirements, including GLP standards and regulations and the

U.S. Department of Agriculture’s Animal Welfare Act, if applicable. With passage of the FDA’s Modernization Act 2.0 in

December 2022, Congress eliminated provisions in both the FDCA and the PHSA that required animal testing in support

of an NDA or BLA. While animal testing may still be conducted, the FDA was authorized to rely on alternative non-clinical

tests, including cell-based assays, micro-physiological systems, or bio-printed or computer models. Some long-term

preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and long-term toxicity

studies, may continue after the IND is submitted.

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The IND and IRB Processes

An IND is a request for FDA authorization to administer a product candidate to humans. Such authorization must be

secured prior to interstate shipment and administration of any new drug or biologic that is not the subject of an approved

NDA or BLA. In support of a request for an IND, sponsors must submit a protocol for each clinical trial and any

subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, 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. The FDA requires a 30-day

waiting period after the filing of each IND before clinical trials may begin. This waiting period is designed to allow the FDA

to review the IND to determine whether human research subjects and patients will be exposed to unreasonable health

risks. At any time during this 30-day period, or thereafter, the FDA may raise concerns or questions about the conduct of

the trials as outlined in the IND and impose a clinical hold or partial clinical hold. In this case, the IND sponsor and the

FDA must resolve any outstanding concerns before clinical trials can begin or continue, if the clinical hold is initiated after

the study has begun. The FDA’s primary objectives in reviewing an IND are to assure the safety and rights of patients and

to help assure that the quality of the investigation will be adequate to permit an evaluation of the drug’s effectiveness

and safety and of the biological product’s safety, purity and potency.

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 protocol or protocols

under the IND. For example, a specific protocol or part of a protocol is not allowed to proceed, while other protocols or

parts of the protocols may do so. 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. The FDA will base that determination

on information provided by the sponsor correcting the deficiencies previously cited or otherwise demonstrating to the

satisfaction of the FDA that the investigation can proceed.

A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. When a foreign clinical study

is conducted under an IND, all IND requirements must be met unless waived. When a foreign clinical study is not

conducted under an IND, the sponsor must ensure that the study complies with certain regulatory requirements of the

FDA in order to use the study as support for an IND or application for marketing approval in the U.S.

The FDA’s regulations are intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical

studies, as well as the quality and integrity of the resulting data. They further help ensure non-IND foreign studies are

conducted in a manner comparable to that required for IND studies.

In addition to the foregoing IND requirements, 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

continuing review and reapprove the trial at least annually. The IRB must review and approve, among other things, the

trial protocol and informed consent information to be provided to trial subjects. An IRB must operate in compliance with

FDA regulations. 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 product

candidate has been associated with unexpected serious harm to patients.

Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known

as a data monitoring committee. This group provides authorization for whether a trial may move forward at designated

check points based on access only the group maintains to available data from the trial. Suspension or termination of

development during any phase of clinical trials can occur if it is determined the participants or patients are being

exposed to an unacceptable health risk.

Human Clinical Studies in Support of an NDA or BLA

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 trial protocols detailing, among other things, the inclusion and exclusion criteria, the objectives

of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

The clinical investigation of an investigational drug or biological product is generally divided into four phases. Although

the phases are usually conducted sequentially, they may overlap or be combined. The four phases of an investigation are

as follows:

•Phase 1: Studies include the initial introduction of an investigational new drug or biological product into humans.

These studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the

investigational drug or biological product in humans, any adverse events associated with increasing doses, and if

possible, to gain early evidence on effectiveness.

•Phase 2: Includes controlled clinical trials conducted to preliminarily or further evaluate the effectiveness of the

investigational drug or biological product for a particular indication(s) in patients with the disease or condition under

trial, to determine dosage tolerance and optimal dosage, and to identify possible adverse events and safety risks

associated with the drug or biological product. Phase 2 clinical trials are typically well-controlled, closely monitored,

and conducted in a limited patient population.

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•Phase 3: Clinical trials are generally controlled clinical trials conducted in an expanded patient population generally

at geographically dispersed clinical trial sites. They are performed after preliminary evidence suggesting

effectiveness of the drug or biological product has been obtained, and are intended to further evaluate dosage,

clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational drug or

biological product, and to provide an adequate basis for product approval.

•Phase 4: Post-approval studies may be conducted after initial marketing approval. These studies are used to gain

additional experience from the treatment of patients in the intended therapeutic indication.

A clinical trial may combine the elements of more than one phase and the FDA often requires more than one Phase 3 trial

to support marketing approval of a product candidate. A company’s designation of a clinical trial as being of a particular

phase is not necessarily indicative the study will be sufficient to satisfy the FDA requirements of that phase because this

determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA. Generally,

pivotal trials are Phase 3 trials, but they may be Phase 2 trials if the design provides a well-controlled and reliable

assessment of clinical benefit, particularly in an area of unmet medical need.

In March 2022, the FDA released final guidance entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to

Expedite Development of Oncology Drugs and Biologics,” which outlines how developers can utilize an adaptive trial

design commonly referred to as a seamless trial design in early stages of oncology biological product development (i.e.,

the first-in-human clinical trial) to compress the traditional three phases of trials into one continuous trial called an

expansion cohort trial. Information to support the design of individual expansion cohorts are included in IND applications

and assessed by FDA. Expansion cohort trials can potentially bring efficiency to biological product development and

reduce developmental costs and time.

In December 2022, with the passage of FDORA, Congress required sponsors to develop and submit a DAP for each

Phase 3 clinical trial or any other “pivotal study” of a new drug or biological product. These plans are meant to encourage

the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products. Specifically,

action plans must include the sponsor’s goals for enrollment, the underlying rationale for those goals, and an explanation

of how the sponsor intends to meet them. In June 2024, as mandated by FDORA, the FDA issued draft guidance outlining

the general requirements for DAPs. Unlike most guidance documents issued by the FDA, the DAP guidance when

finalized will have the force of law because FDORA specifically dictates the form and manner for submission of DAPs are

specified in FDA guidance. On January 27, 2025, in response to an Executive Order issued by President Trump on

January 21, 2025, on Diversity, Equity and Inclusion programs, the FDA removed this draft guidance from its website.

This action raises questions about the applicability of statutory obligations to submit DAPs and the agency’s current

thinking on best practices for clinical development.

In June 2023, the FDA issued draft guidance with updated recommendations for GCPs aimed at modernizing the design

and conduct of clinical trials. The updates are intended to help pave the way for more efficient clinical trials to facilitate

the development of medical products. The draft guidance is adopted from the International Council for Harmonisation of

Technical Requirements for Pharmaceuticals for Human Use’s ("ICH's"), recently updated E6(R3) draft guideline

developed to enable the incorporation of rapidly developing technological and methodological innovations into the

clinical trial enterprise. In addition, the FDA issued draft guidance outlining recommendations for the implementation of

decentralized clinical trials.

Finally, sponsors of clinical trials are required to register and disclose certain clinical trial information on a public registry

(clinicaltrials.gov) maintained by the U.S. National Institutes of Health ("NIH"). In particular, information related to the

product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is

made public as part of the registration of the clinical trial. The failure to submit clinical trial information to

clinicaltrials.gov, as required, is a prohibited act under the FDCA with violations subject to potential civil monetary

penalties of up to US$10,000 for each day the violation continues. To date, the FDA has issued six notices of non-

compliance, thereby signaling the government’s willingness to begin enforcing these requirements against non-compliant

clinical trial sponsors. These notices of non-compliance did not result in civil monetary penalties.

Concurrent with clinical trials, companies often complete additional animal studies and must also develop additional

information about the chemistry and physical characteristics of the candidate product as well as finalize a process for

manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process

must be capable of consistently producing quality batches of the product candidate and, among other things, must

develop methods for testing the identity, strength, quality, purity, and potency of the final product candidate.

Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate

the product candidate does not undergo unacceptable deterioration over its shelf life.

Clinical Studies Outside the U.S. in Support of FDA Approval

In connection with our clinical development programs, we are conducting trials at sites outside the U.S. When a foreign

clinical trial is conducted under an IND, all IND requirements must be met unless waived. When a foreign clinical trial is

not conducted under an IND, the sponsor must ensure the trial complies with certain regulatory requirements of the FDA

in order to use the trial as support for an IND or application for marketing approval. Specifically, the trials must be

conducted in accordance with GCP, including undergoing review and receiving approval by an independent ethics

committee ("IEC") and seeking and receiving informed consent from subjects. GCP requirements encompass both ethical

and data integrity standards for clinical trials. The FDA’s regulations are intended to help ensure the protection of human

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subjects enrolled in non-IND foreign clinical trials, as well as the quality and integrity of the resulting data. They further

help ensure that non-IND foreign trials are conducted in a manner comparable to that required for IND trials.

The acceptance by the FDA of trial data from clinical trials conducted outside the U.S. in support of U.S. approval may be

subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to

serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis

of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were

performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be

considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be

necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.

In addition, even where the foreign trial data are not intended to serve as the sole basis for approval, the FDA will not

accept the data as support for an application for marketing approval unless the trial is well-designed and well-conducted

in accordance with GCP requirements and the FDA is able to validate the data from the trial through an onsite inspection

if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign

trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted.

Interactions with the FDA During the Clinical Development Program

Following the clearance of an IND and the commencement of clinical trials, the sponsor will continue to have interactions

with the FDA. Progress reports detailing the results of clinical trials must be submitted annually within 60 days of the

anniversary dates that the IND went into effect and more frequently if serious adverse events occur.

These reports must include a development safety update report ("DSUR"). 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 product; and any clinically

important increase in the occurrence 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. The FDA will typically inspect one or more clinical sites to assure compliance with GCP and the

integrity of the clinical data submitted. With passage of FDORA, Congress clarified FDA’s authority to conduct

inspections by expressly permitting inspection of facilities involved in the preparation, conduct, or analysis of clinical and

non-clinical studies submitted to FDA as well as other persons holding study records or involved in the study process.

In addition, sponsors are given opportunities to meet with the FDA at certain points in the clinical development program.

Specifically, sponsors may meet with the FDA prior to the submission of an IND ("Pre-IND meeting"), at the end of Phase

2 clinical trial ("EOP2 meeting") and before an NDA is submitted ("Pre-NDA meeting"). Meetings at other times may also

be requested. There are five types of meetings that occur between sponsors and the FDA.

Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to

address an important safety issue. Type B meetings include pre-IND and pre-NDA meetings as well as end of phase

meetings such as EOP2 meetings. A Type C meeting is any meeting other than a Type A or Type B meeting regarding the

development and review of a product, including for example meetings to facilitate early consultations on the use of a

biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in

the proposed context of use. A type D meeting is focused on a narrow set of issues (should be limited to no more than 2

focused topics) and should not require input from more than 3 disciplines or Divisions. Finally, INTERACT meetings are

intended for novel products and development programs that present unique challenges in the early development of an

investigational product.

The FDA has indicated that its responses, as conveyed in meeting minutes and advice letters, only constitute mere

recommendations and/or advice made to a sponsor and, as such, sponsors are not bound by such recommendations

and/or advice. Nonetheless, from a practical perspective, a sponsor’s failure to follow the FDA’s recommendations for

design of a clinical program may put the program at significant risk of failure.

Manufacturing and Other Regulatory Requirements

Concurrently with clinical trials, sponsors usually complete additional animal safety studies, develop additional

information about the chemistry and physical characteristics of the product candidate, and finalize a process for

manufacturing commercial quantities of the product candidate in accordance with cGMP requirements. The

manufacturing process must be capable of consistently producing quality batches of the product candidate and, among

other criteria, the sponsor must develop methods for testing the identity, strength, quality, and purity of the finished

product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to

demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

Specifically, the FDA’s regulations require that pharmaceutical products be manufactured in specific approved facilities

and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel,

buildings and facilities, equipment, control of components and product containers and closures, production and process

controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports, and returned

or salvaged products. Manufacturers and other entities involved in the manufacture and distribution of approved

pharmaceuticals are required to register their establishments with the FDA and some state agencies, and they are

subject to periodic unannounced inspections by the FDA for compliance with cGMPs and other requirements. The

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PREVENT Pandemics Act, which was enacted in December 2022, clarifies that foreign drug manufacturing

establishments are subject to registration and listing requirements even if a drug undergoes further manufacture,

preparation, propagation, compounding, or processing at a separate establishment outside the U.S. prior to being

imported or offered for import into the U.S.

Pediatric Studies

Under PREA, an application or supplement thereto must contain data that are adequate to assess the safety and

effectiveness of the 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. Sponsors must also

submit an initial Pediatric Study Plan ("PSP") prior to the assessment data. The PSP must contain an outline of the

proposed pediatric study or studies the sponsor plans to conduct, including study objectives and design, any deferral or

waiver requests and other information required by regulation. The sponsor, the FDA, and the FDA’s internal review

committee must then review the information submitted, consult with each other and agree upon a final plan. The FDA or

the sponsor may request an amendment to the plan at any time.

The FDA may, on its own initiative or at the request of the sponsor, 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.

A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for

approval for use in adults before pediatric trials are complete or that additional safety or effectiveness data needs to be

collected before the pediatric trials begin. The FDA is required 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. Unless otherwise required by regulation,

the pediatric data requirements do not apply to products with orphan designation, although the FDA has recently taken

steps to limit what it considers abuse of this statutory exemption.

The Food and Drug Administration Reauthorization Act of 2017 ("FDARA") also established new requirements to govern

certain molecularly targeted cancer indications. Any company that submits an application three years after the date of

enactment of that statute must submit pediatric assessments with the application if the product is intended for the

treatment of an adult cancer and is directed at a molecular target that the FDA determines to be substantially relevant to

the growth or progression of a pediatric cancer. The investigation must be designed to yield clinically meaningful

pediatric study data regarding the dosing, safety and preliminary efficacy to inform pediatric labeling for the product.

Section 505(b)(2) NDAs

NDAs for most new drug products are based on two full clinical studies which must contain substantial evidence of the

safety and efficacy of the proposed new product for the proposed use. These applications are submitted under Section

505(b)(1) of the FDCA. The FDA is, however, authorized to approve an alternative type of NDA under Section 505(b)(2)

of the FDCA. This type of application allows the sponsor to rely, in part, on the FDA’s previous findings of safety and

efficacy for a similar product, or published literature. Specifically, Section 505(b)(2) applies to NDAs for a drug for which

the investigations made to show whether or not the drug is safe for use and effective in use and relied upon by the

sponsor for approval of the application “were not conducted by or for the applicant and for which the applicant has not

obtained a right of reference or use from the person by or for whom the investigations were conducted.”

Section 505(b)(2) thus authorizes the FDA to approve an NDA based on safety and effectiveness data that were not

developed by the applicant. NDAs filed under Section 505(b)(2) may provide an alternate and potentially more

expeditious pathway to FDA approval for new or improved formulations or new uses of previously approved products.

If the 505(b)(2) applicant can establish that reliance on the FDA’s previous approval is scientifically appropriate, the

applicant may eliminate the need to conduct certain preclinical or clinical studies of the new product. The FDA may also

require companies to perform additional studies or measurements to support the change from the approved product. The

FDA may then approve the new drug candidate for all or some of the label indications for which the referenced product

has been approved as well as for any new indication sought by the Section 505(b)(2) applicant.

Fast Track, Breakthrough Therapy and Priority Review Designations

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 include fast track

designation, breakthrough therapy designation and priority review designation. None of these expedited programs

changes the standards for approval but each may help expedite the development or approval process governing product

candidates.

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 products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates

the potential to address unmet medical needs for such a disease or condition. For fast track products, sponsors may

have greater interactions with the FDA and the FDA may initiate review of sections of a fast track product’s application

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

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pay applicable user fees. However, the FDA’s time period goal for reviewing a fast track application does not begin until

the last section of the application 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.

Second, a product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one

or more other products, 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 help the sponsor design the clinical trials in an efficient manner.

Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if

approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case

basis, whether the proposed product 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 product reaction, documented enhancement of

patient compliance that may lead to improvement in serious outcomes, and 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.

Accelerated Approval Pathway

The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful

therapeutic advantage to patients over existing treatments based upon a determination that the product 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 condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than

an effect on irreversible morbidity or mortality ("IMM") and that is reasonably likely to predict an effect on irreversible

morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and

the availability or lack of alternative treatments. Products 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, such as an effect on IMM.

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 product’s clinical benefit. As a result, a product

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

initiate expedited proceedings to withdraw approval of the product. All promotional materials for product candidates

approved under accelerated regulations are subject to prior review by the FDA.

With passage of FDORA in December 2022, Congress modified certain provisions governing accelerated approval of drug

and biologic products. Specifically, the new legislation authorized the FDA to require a sponsor to have its confirmatory

clinical trial underway before accelerated approval is awarded and to submit progress reports on its post-approval

studies to FDA every six months until the study is completed. Moreover, FDORA established expedited procedures

authorizing FDA to withdraw an accelerated approval if certain conditions are met, including where a required

confirmatory study fails to verify and describe the predicted clinical benefit or where evidence demonstrates the product

is not shown to be safe or effective under the conditions of use. The FDA may also use such procedures to withdraw an

accelerated approval if a sponsor fails to conduct any required post-approval study of the product with due diligence,

including with respect to “conditions specified by the Secretary.” The new procedures include the provision of due notice

and an explanation for a proposed withdrawal, and opportunities for a meeting with the Commissioner or the

Commissioner’s designee and a written appeal, among other things.

More recently, in March 2023, the FDA issued draft guidance that outlines its current thinking and approach to

accelerated approval. The agency indicated that the accelerated approval pathway is commonly used for approval of

oncology drugs due to the serious and life-threatening nature of cancer. Although single-arm trials have been commonly

used to support accelerated approval, a randomized controlled trial is the preferred approach as it provides a more

robust efficacy and safety assessment and allows for direct comparisons to an available therapy. To that end, the FDA

outlined considerations for designing, conducting, and analyzing data for trials intended to support accelerated

approvals of oncology therapeutics. Subsequently, in December 2024 and January 2025, the FDA issued additional draft

guidances relating to accelerated approval. These guidances describe FDA’s latest thinking on what it means to conduct

a confirmatory trial with due diligence and how the agency plans to interpret whether such a study needs to be

underway at the time of approval. While these guidances are currently only in draft form and will ultimately not be legally

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binding even when finalized, sponsors typically observe the FDA’s guidance closely to ensure that their investigational

products qualify for accelerated approval.

FDA Commissioner’s National Priority Review Voucher (CNPV) Pilot Program