Immunocore Holdings plc 10-Q for FY2025 Q3
Immunocore Holdings plc (IMCR)
10-Q
2025-11-06
For: 2025-09-30
View Original
Added on
April 07, 2026
About this 10-Q
Immunocore Holdings plc filed this 10-Q on November 6, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $103.69M
- up 29.2% from $80.25M a year earlier
- Net loss
- $177K
- compared with net income of $8.74M a year earlier
- Diluted EPS
- $0.00
- compared with $0.17 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended September 30, 2025
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from ____________ to ____________
Commission File Number: 001-39992
| (Exact name of registrant as specified in its charter) | ||
| Not Applicable | |||||
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
| (Address of principal executive offices) | (Zip Code) | ||||
| (Registrant’s telephone number, including area code) | ||
| (Former name, former address and former fiscal year, if changed since last report) | ||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
The | ||||||||
The | ||||||||
*Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC
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. x Yes o No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). x Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Accelerated filer o | ||||||||
Non-accelerated filer o | Smaller reporting company | |||||||
Emerging growth company | ||||||||
If an emerging growth company, 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. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
Indicate the number of shares outstanding of each of the issuer’s classes of shares, as of the latest practicable date.
As of October 31, 2025, the registrant had 50,530,419 ordinary shares (including ordinary shares in the form of American Depositary Shares) outstanding, par value £0.002, consisting of (i) 49,796,022 voting ordinary shares and 734,397 non-voting ordinary shares.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the "Quarterly Report"), contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Quarterly Report are based upon information available to us as of the date of this Quarterly Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include, but are not limited to, statements about:
•the therapeutic potential and expected clinical benefits of KIMMTRAK;
•the planned geographic expansion and expansion of patient reach for KIMMTRAK;
•the safety, efficacy and clinical progress of our various ongoing clinical programs and any planned clinical programs, including those for tebentafusp, brenetafusp, IMC-P115C, IMC-T119C, IMC-R117C, IMC-M113V, IMC-I109V, IMC-S118AI, and IMC-U120AI;
•our ability to continue to generate revenues, which is dependent upon maintaining significant market acceptance among physicians, patients and healthcare payors;
•our ability to maintain regulatory approval of KIMMTRAK for metastatic uveal melanoma ("mUM") in the United States, European Union and other territories, as well as our ability to obtain and maintain regulatory approval in additional indications, jurisdictions, and the timing thereof;
•our expectations regarding the continued commercialization and marketing of KIMMTRAK for mUM, including expanding into and the related timing of reaching patients in additional indications and territories;
•our ability to build a sustainable pipeline of new product candidates, including but not limited to future generations of KIMMTRAK and additional product candidates identified and developed using our ImmTAX platform;
•our ability to continue successfully executing our sales and marketing strategy of KIMMTRAK in the United States, Europe and elsewhere, including continuing to successfully recruit and retain sales and marketing personnel and to successfully build the market for our medicines;
•the rate and degree of market acceptance of our product candidates among physicians, patients, patient advocacy groups, third-party payors and the medical community and our ability and our distribution and marketing partners’ ability to obtain coverage and adequate reimbursement and pricing for our medicines from government and third-party payors and risks relating to the success of our patient assistance programs;
•the initiation, timing, progress and results of our ongoing and planned clinical trials, including the expansion arms of such trials, for tebentafusp in advanced melanoma and adjuvant uveal (or ocular) melanoma, brenetafusp, IMC-P115C, IMC-T119C, IMC-R117C, IMC-M113V, IMC-I109V, IMC-S118AI, and IMC-U120AI, and our research and development programs, including delays or disruptions in clinical trials, non-clinical experiments and investigational new drug application-enabling studies;
•our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations, our future expenses, including the impact thereon of changes in interest rates and inflation, fluctuating exchange rates and other macroeconomic factors, and our future revenues and our need for and ability to obtain additional financing;
•our expectations regarding timing of regulatory filings for, or our ability to obtain regulatory approval of, our product candidates;
•our ability to obtain accelerated approval for current and future product candidates from the U.S. Food and Drug Administration ("FDA"), the European Commission, or other comparable regulatory authorities in other jurisdictions;
•our expectations regarding business disruptions affecting the initiation, patient enrollment, clinical trial site monitoring, development and operation of our current and proposed clinical trials, including as a result of a public health emergency or other global and macroeconomic factors, such as the war in Ukraine, the conflict in the Middle East, global geopolitical tensions, supply chain disruptions, and changes in interest rates and inflation;
•our business strategies and goals;
•our plans to collaborate, or statements regarding our current collaborations, and our ability to find future partners and collaborators;
•the performance of our third-party suppliers and manufacturers;
•our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our products and product candidates and our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others;
•our expectations regarding competition with respect to KIMMTRAK or any of our current or future product candidates, as well as innovations by current and future competitors in our industry;
•our expectations regarding regulatory developments in the United States and other countries, including potential changes in healthcare laws and regulations;
•our financial performance and our ability to effectively manage our anticipated growth;
•our ability to identify, recruit and retain qualified employees, including key commercial or management personnel; and
•whether we are classified as a Passive Foreign Investment Company ("PFIC") for current and future periods.
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and assumptions that could cause our actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report, if any, our Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on February 26, 2025, and in our other SEC filings. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report.
TABLE OF CONTENTS
Page | ||||||||
Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 | ||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2025 and 2024 | ||||||||
Condensed Consolidated Statements of Shareholders’ Equity for the three and nine months ended September 30, 2025 and 2024 | ||||||||
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 | ||||||||
1
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Immunocore Holdings plc
Condensed Consolidated Balance Sheets
(Unaudited) (In thousands, except share and per share data)
| September 30, 2025 | December 31, 2024 | ||||||||||
| Assets | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
Marketable securities | |||||||||||
| Accounts receivable, net | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Inventory, net | |||||||||||
| Total current assets | |||||||||||
| Property and equipment, net | |||||||||||
| Operating lease right of use assets, net | |||||||||||
| Deferred tax assets, net | |||||||||||
| Other non-current assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and shareholders’ equity | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued expenses and other current liabilities | |||||||||||
| Deferred revenue, current | |||||||||||
| Operating lease liabilities, current | |||||||||||
| Total current liabilities | |||||||||||
| Accrued expenses, non-current | |||||||||||
| Deferred revenue, non-current | |||||||||||
| Operating lease liabilities, non-current | |||||||||||
Interest-bearing loans and borrowings | |||||||||||
| Total liabilities | |||||||||||
Commitments and contingencies (Note 10) | |||||||||||
| Shareholders’ equity | |||||||||||
Ordinary shares (voting and non-voting), £ | |||||||||||
Deferred shares, £ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Accumulated other comprehensive loss | ( | ( | |||||||||
| Total shareholders' equity | |||||||||||
| Total liabilities and shareholders' equity | $ | $ | |||||||||
The accompanying notes form an integral part of these condensed consolidated financial statements.
2
Immunocore Holdings plc
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited) (In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Revenue from sale of therapies, net | $ | $ | $ | $ | |||||||||||||||||||
| Collaboration revenue | |||||||||||||||||||||||
| Total revenue | |||||||||||||||||||||||
| Cost and operating expenses: | |||||||||||||||||||||||
| Cost of revenue from sale of therapies | ( | ( | ( | ( | |||||||||||||||||||
| Research and development expense | ( | ( | ( | ( | |||||||||||||||||||
| Selling, general and administrative expense | ( | ( | ( | ( | |||||||||||||||||||
| Loss from operations | ( | ( | ( | ( | |||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
| Interest income | |||||||||||||||||||||||
| Interest expense | ( | ( | ( | ( | |||||||||||||||||||
Foreign currency gain | |||||||||||||||||||||||
Other income, net | |||||||||||||||||||||||
Net income (loss) before income taxes | ( | ( | |||||||||||||||||||||
Income tax (expense) benefit | ( | ( | |||||||||||||||||||||
Net (loss) income | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Other comprehensive (loss) income: | |||||||||||||||||||||||
| Exchange differences on translation of foreign operations | ( | ||||||||||||||||||||||
Total comprehensive (loss) income | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Basic net (loss) income per share | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Basic weighted-average number of shares outstanding | |||||||||||||||||||||||
Diluted net (loss) income per share | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Diluted weighted-average number of shares outstanding | |||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated financial statements.
3
Immunocore Holdings plc
Condensed Consolidated Statements of Shareholders’ Equity
(Unaudited) (In thousands, except share data)
| Ordinary Shares | Deferred Shares | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
As of December 31, 2024 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
Net income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of March 31, 2025 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of June 30, 2025 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of September 30, 2025 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated financial statements.
4
Immunocore Holdings plc
Condensed Consolidated Statements of Shareholders’ Equity
(Unaudited) (In thousands, except share data)
| Ordinary Shares | Deferred Shares | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
As of December 31, 2023 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of March 31, 2024 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of June 30, 2024 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
Net income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of share options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
As of September 30, 2024 | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated financial statements.
5
Immunocore Holdings plc
Condensed Consolidated Statements of Cash Flows
(Unaudited) (In thousands)
| Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | |||||||||||||
| Cash flows from operating activities | ||||||||||||||
Net loss | $ | ( | $ | ( | ||||||||||
| Adjustments for: | ||||||||||||||
| Share-based compensation expense | ||||||||||||||
| Depreciation | ||||||||||||||
Unrealized foreign exchange gains, net | ( | ( | ||||||||||||
Unrealized gains on marketable securities | ( | ( | ||||||||||||
| Non-cash lease expense | ||||||||||||||
| Other | ||||||||||||||
| Changes in assets and liabilities: | ||||||||||||||
Increase in accounts receivable | ( | ( | ||||||||||||
Increase in prepayments and other current assets | ( | ( | ||||||||||||
(Decrease) increase in accounts payable | ( | |||||||||||||
Increase in accrued expenses | ||||||||||||||
Decrease in deferred revenue | ( | ( | ||||||||||||
Increase (decrease) in operating lease liabilities | ( | |||||||||||||
Increase in other operating assets | ( | ( | ||||||||||||
Increase in other operating liabilities | ||||||||||||||
Net cash provided by operating activities | ||||||||||||||
| Cash flows from investing activities | ||||||||||||||
Purchase of marketable securities | ( | ( | ||||||||||||
Proceeds from sale of marketable securities | ||||||||||||||
Purchase of property and equipment | ( | ( | ||||||||||||
Net cash used in investing activities | ( | ( | ||||||||||||
| Cash flows from financing activities | ||||||||||||||
Proceeds from exercise of share options | ||||||||||||||
Proceeds from issue of convertible senior notes | ||||||||||||||
Payments for debt issuance costs | ( | |||||||||||||
| Net cash provided by financing activities | ||||||||||||||
Increase in cash and cash equivalents | ||||||||||||||
| Net foreign exchange difference on cash held | ||||||||||||||
| Cash and cash equivalents at beginning of period | ||||||||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||||||||
Supplemental disclosure of cash flow and noncash information | ||||||||||||||
Cash paid for interest | $ | ( | $ | ( | ||||||||||
Cash paid for income taxes, net of refunds | $ | ( | $ | ( | ||||||||||
Purchases of property and equipment in accounts payable | $ | $ | ||||||||||||
The accompanying notes form an integral part of these condensed consolidated financial statements.
6
Immunocore Holdings plc
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Description of business
Immunocore Holdings plc (collectively with its subsidiaries, the “Company”) is a public limited company incorporated in England and Wales and has the following wholly owned subsidiaries: Immunocore Limited, Immunocore LLC, Immunocore Commercial LLC, Immunocore Ireland Limited, Immunocore GmbH, and Immunocore Nominees Limited with operations based primarily in the United Kingdom and United States. The Company is pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, the Company’s pipeline includes clinical and preclinical programs in oncology, infectious diseases, and autoimmune diseases.
In January and April 2022, the Company received approval from the U.S. Food and Drug Administration ("FDA") and European Commission ("EC"), respectively, for its lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma. The Company has subsequently received approvals in further territories, and the Company continues to launch and seek approvals in additional territories. KIMMTRAK is now approved in 39 countries and the Company has commercially launched the product in 28 countries, including the United States, Germany and France, among other territories.
2. Summary of significant accounting policies
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") for interim financial reporting and pursuant to the requirements for reporting on Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information required for the full annual financial statements and should be read in conjunction with the annual consolidated financial statements of the Company for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 26, 2025 (the "Annual Report").
The accompanying condensed consolidated financial statements contain all normal recurring adjustments necessary to present a fair statement of the financial position, results of operations, and cash flows for the interim periods reported. In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period.
Use of estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as income and expenses in the financial period.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond the Company’s control. Actual results could differ from those estimates. Estimates are primarily made in relation to revenue recognition, operating lease incremental borrowing rates, share-based compensation expense, clinical accruals, and deferred tax asset valuation allowances.
7
Fair value measurements
Where financial and non-financial assets and liabilities are measured at fair value, the Company uses appropriate valuation techniques for which sufficient data are available, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
As of September 30, 2025 and December 31, 2024, the Company held $363.1 million and $338.1 million, respectively, of money market funds required to be measured at fair value on a recurring basis within cash and cash equivalents. In addition, as of September 30, 2025 and December 31, 2024, the Company held $393.9 million and $364.6 million of marketable securities, respectively, including unrealized gains of $15.2 million and $14.6 million, respectively. The fair value of these cash equivalents and marketable securities is based on quoted prices from active markets (Level 1 inputs). Other financial instruments, although not recorded at fair value on a recurring basis, include cash, accounts receivable, accounts payable and debt obligations.
The fair value of borrowings under the convertible senior notes (the “Notes”, disclosed in Note 5. “Interest-bearing loans and borrowings”) were based on Level 2 inputs, which include observable inputs estimated using discounted cash flows and market-based expectations for interest rates, credit risk, and the contractual terms of debt instruments. After initial recognition, borrowings are measured at amortized cost using the effective interest method.
Significant accounting policies
With the exception of the below policy, the significant accounting policies used in the preparation of these condensed consolidated financial statements as of and for the three and nine months ended September 30, 2025 are consistent with those disclosed in Note 2. "Summary of Significant Accounting Policies" in the audited consolidated financial statements for the year ended December 31, 2024, included in the Company’s Annual Report.
Share-based compensation
The Company operates equity-settled, share-based compensation plans whereby employees and directors are granted restricted share units ("RSUs") or options to purchase shares in the Company. The fair value of grants is expensed over the vesting period, which is the period in which the services are received. The majority of the Company’s awards have graded vesting schedules, and the expense for these awards is recognized over the requisite service period for each separate vesting portion as if the grant, in substance, represented multiple awards. The grant date fair value of RSUs is based on the market value of the Company's shares on the date of grant. The grant date fair value of options is calculated using the Black-Scholes valuation model.
Estimation of the fair value of options requires judgment, including assumptions about the expected term of share-based options and expected volatility, which are used to determine the fair value of the Company’s options granted. The expected term is based on the Company’s assessment of the period within which participants are expected to exercise options, which requires consideration of employee groups, expected employee service, and other internal factors, and the degree to which these are expected to shorten the term of options in comparison to contractual expiry dates. Estimated expected volatility is based on the Company’s share price volatility since its initial public offering. The expected volatility reflects the assumption that the historical volatility over a period similar to the life of the awards is indicative of future trends, which may not necessarily be the actual outcome.
The Company assumes no dividend payments for the purposes of estimating fair value and uses a zero-coupon U.S. Treasury yield curve applicable for the period of the expected term to form an estimate of the risk-free rate.
Forfeitures expected to occur for options and RSUs are estimated by considering both market and company-specific data and the available internal information at the end of each reporting period.
Recently issued and recently adopted accounting pronouncements
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company is currently assessing the impact of this guidance on its disclosures.
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In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). This ASU requires disclosure in the notes to the financial statements, at each interim and annual reporting period, of specified information about certain costs and expenses including purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption. Also required is a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated. This ASU is effective for all public entities for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027, and early adoption is permitted. This ASU should be applied either prospectively to financial statements issued after the effective date of this update or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating these new disclosure requirements and the impact of adoption on its financial statements.
3. Revenue
During the three and nine months ended September 30, 2025, the Company recognized $103.7 million and $295.5 million, respectively (2024: $80.2 million and $225.9 million, respectively) of net revenue from sale of therapies relating to the sale of KIMMTRAK primarily in the United States and Europe after estimated deductions for rebates, chargebacks and returns, which are recognized in Accrued expenses and other current liabilities and Accrued expenses, non-current, as set out in the Company’s accounting policies included in the Annual Report.
Revenue from sale of therapies, net is presented by country / region based on the location of the end customer below (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| International | |||||||||||||||||||||||
Revenue from sale of therapies, net | $ | $ | $ | $ | |||||||||||||||||||
Revenue from sale of therapies, net for the three and nine months ended September 30, 2025 included $6.2 million and $18.8 million, respectively (2024: $2.8 million and $10.1 million, respectively), of partnered revenue pursuant to the Company's separate agreements with Medison Pharma Ltd. ("Medison") and Er-Kim Pharmaceuticals Bulgaria EOOD. Revenue from these agreements is allocated between the Company's European and International markets.
Accounts receivable from contracts with customers
Accounts receivable as of September 30, 2025 and December 31, 2024 were $75.9 million and $63.0 million, respectively. An allowance for lifetime expected credit losses on accounts receivable is measured using historical credit loss experience, conditions at the end of each reporting period, and reasonable and supportable forecasts that affect collectability. Expected credit losses as of September 30, 2025 and December 31, 2024 were immaterial.
Accruals for rebates, chargebacks and returns
Current and non-current accruals for rebates, chargebacks and returns as of September 30, 2025 were as follows (in thousands):
| Rebates | Chargebacks | Returns | Total | ||||||||||||||||||||
| As of December 31, 2024 | $ | $ | $ | $ | |||||||||||||||||||
| Provisions related to sales in the period | |||||||||||||||||||||||
| Adjustments related to sales in prior periods | ( | ( | |||||||||||||||||||||
| Credits and payments made | ( | ( | ( | ( | |||||||||||||||||||
| As of September 30, 2025 | $ | $ | $ | $ | |||||||||||||||||||
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Included in the above are non-current accruals for rebates, chargebacks and returns of $96.1 million and $0 million as of September 30, 2025 and December 31, 2024, respectively, which are not required to be paid in the twelve months from the balance sheet date following additional information received in the nine months ended September 30, 2025. The adjustments related to prior period sales in the period ended September 30, 2025 were due to changes in estimates primarily related to European pricing negotiations.
Deferred revenue
4. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| September 30, 2025 | December 31, 2024 | ||||||||||
Rebates, chargebacks and returns | $ | $ | |||||||||
| Clinical accruals | |||||||||||
| Employee related expenses | |||||||||||
| Contract manufacturing | |||||||||||
| Interest accruals | |||||||||||
| Commercial services | |||||||||||
| Other accruals | |||||||||||
| $ | $ | ||||||||||
See Note 3. “Revenue” for a breakdown of rebates, chargebacks and returns.
Clinical accruals primarily represent unbilled work undertaken by contract research organizations as part of the advancement of the Company's clinical programs.
5. Interest-bearing loans and borrowings
Interest-bearing loans and borrowings consisted of the following as of September 30, 2025 (in thousands):
Fair Value | |||||||||||||||||||||||||||||
Principal Amount | Unamortized Debt Issuance Costs | Net Carrying Amount | Amount | Level | |||||||||||||||||||||||||
Convertible senior notes | $ | $ | ( | $ | $ | Level 2 | |||||||||||||||||||||||
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Interest-bearing loans and borrowings consisted of the following as of December 31, 2024 (in thousands):
Fair Value | |||||||||||||||||||||||||||||
Principal Amount | Unamortized Debt Issuance Costs | Net Carrying Amount | Amount | Level | |||||||||||||||||||||||||
Convertible senior notes | $ | $ | ( | $ | $ | Level 2 | |||||||||||||||||||||||
Interest expense consisted of the following (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Convertible senior notes | |||||||||||||||||||||||
Coupon interest | $ | $ | $ | $ | |||||||||||||||||||
Amortization of debt issuance costs | |||||||||||||||||||||||
Pharmakon loan | |||||||||||||||||||||||
Total interest expense | $ | $ | $ | $ | |||||||||||||||||||
6. Share-based compensation
The following table shows the total share-based compensation expense recorded in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Research and development | $ | $ | $ | $ | |||||||||||||||||||
| Selling, general and administrative | $ | $ | $ | $ | |||||||||||||||||||
Equity Incentive Plan
Under the Company’s Equity Incentive Plan ("EIP"), the Company may grant market value options, share appreciation rights or restricted shares, restricted share units ("RSUs"), performance share units and other share-based awards to the Company’s employees. The Company’s board members and consultants are eligible to receive awards under the Company’s non-employee sub-plan to the EIP. Awards may be granted at such times as the Company may determine, but will generally be granted annually following the end of the financial year. Awards vest at such times and as specified in the award agreement, typically being over a four-year period, although the Company retains the discretion to provide for other vesting schedules. If the participant violates the non-competition, non-solicitation, confidentiality or other similar restrictive covenant provisions of any employment contract, the right of the participant to receive these shares on vesting shall terminate immediately. The Company maintains discretion over the type and terms of equity awards granted. Share options lapse on the tenth anniversary from the date of grant, and they are not subject to performance conditions or entitled to dividends. As of September 30, 2025, the Company has reserved 6,137,907 authorized shares for future issuance under the EIP.
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Share option activity
The number and weighted average exercise prices of share options were as follows:
| Number of Share Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Aggregate Intrinsic Value (in thousands) | ||||||||||||||||||||
| Outstanding as of December 31, 2024 | $ | $ | |||||||||||||||||||||
| Awards granted | |||||||||||||||||||||||
| Awards exercised | ( | ||||||||||||||||||||||
| Awards forfeited | ( | ||||||||||||||||||||||
Awards expired | ( | ||||||||||||||||||||||
| Outstanding as of September 30, 2025 | $ | $ | |||||||||||||||||||||
| Exercisable as of September 30, 2025 | $ | $ | |||||||||||||||||||||
As of September 30, 2025, total unrecognized compensation expense related to share options granted but not vested was $25.3 million, which the Company expects to recognize over a remaining weighted-average period of 1.6 years.
Awards granted in the three and nine months ended September 30, 2025 and 2024 have been valued using the Black-Scholes option pricing model. The assumptions used in the models for share options granted were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Share price at grant date | $ | $ | $ | $ | |||||||||||||||||||
| Exercise price | $ | $ | $ | $ | |||||||||||||||||||
| Expected volatility | |||||||||||||||||||||||
| Expected life | |||||||||||||||||||||||
| Risk free rate | |||||||||||||||||||||||
| Fair value | $ | $ | $ | $ | |||||||||||||||||||
Restricted share unit activity
In February 2025, the Company granted RSU awards that vest over a four-year service period with 25 % on each anniversary of the grant date. An RSU award represents the right to receive one of the Company’s ADSs upon vesting of the RSU. The fair value of each RSU award is based on the closing price of the Company’s American Depositary Shares ("ADSs") on Nasdaq on the date of grant.
The number and weighted average fair value of RSUs were as follows:
| Number of RSUs | Weighted Average Grant Date Fair Value | ||||||||||
Unvested and outstanding as of December 31, 2024 | $ | ||||||||||
| Awards granted | |||||||||||
| Awards vested | |||||||||||
| Awards forfeited | ( | ||||||||||
Unvested and outstanding as of September 30, 2025 | $ | ||||||||||
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7. Basic and diluted net loss per share
Basic and diluted net (loss) income per share is calculated as follows (in thousands, except share and per share amounts):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Net (loss) income | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Basic weighted-average number of shares outstanding | |||||||||||||||||||||||
Adjustment for stock options with dilutive effect | |||||||||||||||||||||||
Diluted weighted-average number of shares outstanding | |||||||||||||||||||||||
Basic net (loss) income per share | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Diluted net (loss) income per share | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
A total of 11,064,752 2,222,171 and 9,650,718 , respectively, shares issuable upon the exercise of options granted under the Company’s option plans excluded from the calculation for diluted earnings per share, because they are considered to be anti-dilutive.
8. Income taxes
Income tax expense is recognized at an amount determined by multiplying the net income (loss) before income taxes for the interim reporting period by the Company’s estimated annual effective tax rate, adjusted for the tax effect of certain items recognized in full in the interim period. As such, the effective tax rate in the condensed consolidated financial statements may differ from the Company’s estimate of the effective tax rate for the Company’s consolidated financial statements for the year ending December 31, 2025.
The Company’s consolidated estimated effective tax rate for the three and nine months ended September 30, 2025 was 155.5 % and (64.9 )%, respectively. During the three and nine months ended September 30, 2025, the Company recorded a tax charge of $0.5 million and $2.1 million, respectively (September 30, 2024: tax benefit of $2.6 million and $0.8 million, respectively). The Company benefits from the U.K. large company Research & Development Expenditure Credit ("RDEC") regime which can generate a cash rebate of up to 15 % of qualifying research and development expenditures incurred after April 1, 2023. Tax credits receivable under the RDEC regime are recorded "above the line" as a reduction from research and development expenses. For the three and nine months ended September 30, 2025, the Company excluded the United Kingdom from the calculation of the annual estimated tax rate as the Company anticipates an ordinary loss in this jurisdiction for which no tax benefit can be recognized.
A net deferred tax asset of $14.3 million has been recognized as of September 30, 2025 (December 31, 2024: $14.8 million) primarily representing research and development credits and share-based compensation for one of the Company’s U.S. subsidiaries, Immunocore LLC, following an annual assessment, or periodically as required, of all available and applicable information, including its forecasts of costs and future profitability and the resulting ability to reverse the recognized deferred tax assets over a short period of time.
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9. Segment information
The Company operates in one operating segment: immunotherapies, which is focused on pioneering and delivering transformative immunomodulating medicines in the areas of cancer, infectious diseases and autoimmune diseases. The Company primarily generates revenue from one stream, revenue from the sale of therapies, which consists of sales of KIMMTRAK. Historically, the Company had a second stream, collaboration revenue, which is no longer significant. The Company manages its business activities on a consolidated basis. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM"), the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The measure of the segment profit or loss used is consolidated net income (loss), and the measure of segment assets is reported on the condensed consolidated balance sheet as total assets. The accounting policies of the immunotherapies segment are the same as those described in Note 2. "Summary of significant accounting policies". The following table summarizes the reportable segment's financial information (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Revenue | $ | $ | $ | $ | |||||||||||||||||||
Less: | |||||||||||||||||||||||
Cost of revenue from sale of therapies | ( | ( | ( | ( | |||||||||||||||||||
External research and development (R&D) expenses: | |||||||||||||||||||||||
| PRAME programs | ( | ( | ( | ( | |||||||||||||||||||
| Tebentafusp programs | ( | ( | ( | ( | |||||||||||||||||||
| Infectious disease programs | ( | ( | ( | ( | |||||||||||||||||||
All other external clinical and preclinical costs | ( | ( | ( | ( | |||||||||||||||||||
| Total external R&D expenses | ( | ( | ( | ( | |||||||||||||||||||
| R&D salaries and other employee-related costs | ( | ( | ( | ( | |||||||||||||||||||
Selling, general and administrative (SG&A) salaries and other employee-related costs | ( | ( | ( | ( | |||||||||||||||||||
Other SG&A expenses | ( | ( | ( | ( | |||||||||||||||||||
Other segment (expense) income, net (a) | ( | ( | ( | ||||||||||||||||||||
Segment and consolidated net (loss) income | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
(a) Other segment expenses, net includes other internal R&D expenses, share-based compensation expense, R&D tax credits, interest income, interest expense, foreign currency gain, other income, net and income tax expense (benefit).
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10. Commitments and contingencies
Lease commitments
The maturities of operating lease liabilities as of September 30, 2025 were as follows (in thousands):
Remainder of 2025 | $ | ||||
2026 | |||||
2027 | |||||
2028 | |||||
2029 | |||||
2030 and thereafter | |||||
| Total lease payments | |||||
| Less imputed interest | ( | ||||
| Present value of operating lease liabilities | $ | ||||
Future lease commitments - leases not yet commenced | $ | ||||
Future lease commitments - leases not yet commenced
The Company has entered into a non-cancellable lease agreement for premises that will commence in 2028 and end in 2031, with total future minimum lease payments of $3.0 million. This amount is not included in the present value of operating lease liabilities above as the lease had not commenced as of September 30, 2025.
Lease commencement during the period
During the nine months ended September 30, 2025, the Company commenced a new operating lease and recognized a non‑cash right‑of‑use asset of $1.2 million and a corresponding operating lease liability of $1.4 million. The difference between the right‑of‑use asset and the lease liability primarily reflects a lease incentive, which reduces the initial carrying amount of the related right‑of‑use asset.
Manufacturing commitments
The Company enters into a number of manufacturing commitments for the future purchase of materials and contract manufacturing services. While the majority of such contracts can be cancelled on reasonable notice, due to the significant ongoing expenditure associated with the Company’s programs, including brenetafusp, the Company estimates it has noncancellable commitments in relation to the development and supply of product candidates totaling $20.1 million, the majority of which are estimated to be paid within twelve months from the balance sheet date.
Gates collaboration
Under the terms of the Company’s agreement with the Gates Foundation, the Company is required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by the Company under the agreement, which the Company considers to be within its control, the Gates Foundation has the right to sell, or require the Company to buy back, any of the shareholdings in the Company held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, the Company experiences a change in control at a valuation of more than 150 % of the valuation used for the redemption or the sale of the shares, the Company has agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.
Legal proceedings
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes thereto appearing elsewhere in this Quarterly Report. The accompanying MD&A, including all periods presented, has been prepared under U.S. GAAP. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and notes thereto, and the section titled “Risk Factors” each of which appear in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on February 26, 2025 (the "Annual Report") as well as the section titled “Special Note Regarding Forward-Looking Statements".
Overview
We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging our proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced preclinical programs in autoimmune disease and earlier preclinical programs across three therapeutic areas.
In 2022, we received approval for our lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma ("mUM") from the FDA, the European Commission, and other health authorities. KIMMTRAK is now approved in 39 countries for the treatment of unresectable or mUM. We have commercially launched KIMMTRAK in 28 countries globally including the United States, Germany and France through September 30, 2025, with further commercial launches planned in additional territories where KIMMTRAK is approved.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM. To date, we have treated over 2,000 cancer patients with KIMMTRAK, tebentafusp, and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any TCR therapeutic. Our clinical programs are being conducted with patients with a broad range of cancers including melanoma, ovarian, lung, and colorectal, among others. We believe that these tumor types have large addressable patient populations and significant unmet need. We are progressing three late-stage clinical programs within our ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) portfolio, including KIMMTRAK and PRAME-targeted brenetafusp.
Since our inception, we have focused on organizing and staffing our company, raising capital, performing research and development activities to advance our research, development and technology, and commercialization of KIMMTRAK. While we have successfully generated revenue from KIMMTRAK, which is our first marketed product, our ability to generate higher levels of revenue from other marketed products, which may never be fully developed or commercialized, depends on the successful development and regulatory approval of one or more of our product candidates and our ability to finance operations. We have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners. These funds have been and are being used to fund operations and invest in activities for technology creation, drug discovery and clinical development programs, infrastructure, creation of portfolio of intellectual property and commercial and administrative support.
We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future. We had net losses of $0.2 million and $5.5 million for the three and nine months ended September 30, 2025, respectively, and net income of $8.7 million and net loss of $27.3 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, our accumulated deficit was $801.2 million. We expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the SEC, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company.
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We do not expect to generate revenue from the sale of our other product candidates unless and until we successfully complete clinical development of and obtain regulatory approval for such product candidates. As a result, we may need additional funding to support our continued operations and pursue our clinical development and growth strategy. Until we can generate sufficient revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt financings, government funding arrangements, collaborations and marketing and distribution and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements on favorable terms, or at all, particularly in light of recently worsening macroeconomic conditions, such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets. If we fail to raise capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
Recent Developments
The Independent Data Monitoring Committee ("IDMC") has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, our registrational Phase 3 trial in first-line, advanced cutaneous melanoma. The IDMC made the decision following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial. Patients treated with the dose of 160 mcg will be included in the intent-to-treat analysis for the primary endpoint. Patients who are receiving 40 mcg have the option to dose-escalate to 160 mcg, but will not be included in the intent-to-treat analysis for the primary endpoint. We will now continue with a 1:1 randomization of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
We will present a poster, entitled "IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study" (Poster 1185), at the 2025 American Association for the Study of Liver Diseases’ Meeting on November 7, 2025.
Components of Results of Operations
Revenue
Revenue from sale of therapies, net
Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval. We recognize net revenue from sale of therapies at the point in time that control transfers to a customer, which is typically on delivery to our distributors and healthcare providers. We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory. The amount of revenue recognized reflects the consideration to which we expect to be entitled, net of estimated deductions for rebates, chargebacks and product returns. These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and in certain countries, pricing negotiations. Further information on estimates is provided under the section below headed, “Critical Accounting Estimates”.
Collaboration revenue
Historically, collaboration revenue arose under our collaboration agreements and consisted of non-refundable upfront payments, development milestone payments, as well as reimbursement of certain research and development expenses. We have no continuing performance obligations under our historical collaboration agreements.
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Operating Expenses
Cost of revenue from sale of therapies
Cost of revenue from sale of therapies represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to sale. Cost of revenue from sale of therapies may also include costs related to manufacturing losses and excess or obsolete inventory costs. For example, in June 2025, we initiated a global recall for one batch of KIMMTRAK (tebentafusp) relating to an unexpected result in routine stability testing. As of the date of this Quarterly Report, based on all available data to date, we do not expect there will be a material impact on KIMMTRAK or our financial statements. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.
Research and development expenses
Research and development ("R&D") expenses consist primarily of costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical knowledge and understanding. R&D expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations, and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits. R&D expenses are expensed as incurred, although the timing of expense recognition can vary with contractual and payment terms in order to determine when services are received.
R&D expenses incurred with external organizations to undertake R&D activities on our behalf typically relate to clinical programs and are assigned to the individual programs in tables further below. However, for certain preclinical programs and other research spend incurred externally, such spend is not assigned to individual programs. Internal R&D expenses primarily relate to employee-related costs, facilities, information technology used in R&D activities and laboratory consumables. Due to the cross functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.
We expect our R&D expenses to increase in the future as we advance existing and future product candidates into and through clinical studies and pursue further regulatory approval. The process of conducting the necessary clinical studies to obtain regulatory approval is costly and time-consuming. We maintain our headcount at a level required to support our continued research activities and development of our product candidates. Clinical trials generally become larger and more costly to conduct as they advance into later stages. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. As a result, our R&D expenses may vary substantially from period to period based on the timing of our R&D activities.
Research and development tax credits
As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For the periods ending September 30, 2025 and 2024, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.
Under the RDEC program, tax credits for qualifying R&D expenses incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenses. The headline rate under the RDEC program increased from 13% to 20% on April 1, 2023 and can generate cash rebates of up to 15% (increased from 10.5%) on qualifying R&D expenses incurred from this date.
Recent amendments to the U.K. R&D tax credit regime introduced restrictions on the tax relief that can be claimed for expenses incurred on subcontracted R&D activities or externally provided workers, where such subcontracted activities are not carried out in the United Kingdom or such workers are not subject to U.K. payroll taxes, subject to limited exceptions.
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Selling, general and administrative expenses
Selling, general and administrative ("SG&A") expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, for selling, corporate and other administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.
In order to support our continued commercialization and global expansion of KIMMTRAK, R&D activities, and our operations as a public company, we expect that we will continue to incur selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses. Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in employee-related costs and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased employee-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.
Interest income
Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash equivalents.
Interest expense
Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.
Foreign currency (loss) gain
Foreign currency (loss) gain arises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including cash and cash equivalents.
Other income, net
Other income, net consists primarily of unrealized gains (losses) resulting from the change in fair value of our marketable securities and also includes loan and borrowing costs and other items.
Income tax (expense) benefit
We are subject to corporate taxation in the United Kingdom and our wholly-owned subsidiaries are subject to corporate taxation in the United States, Ireland and Switzerland. Due to the nature of our business and on a consolidated basis, we have generated cumulative losses since inception. Our income tax expense represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by deferred tax credits arising on deferred tax assets generated.
Unsurrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $275.7 million as of September 30, 2025. A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom because future profits are not sufficiently certain. A deferred tax asset is, however, recognized in respect of the subsidiary in the United States, relating to unused tax credits on share-based compensation expense and other temporary differences on the basis that we expect to continue generating U.S. taxable income against which deductible temporary differences can unwind.
As we begin to generate significant net revenue from sale of therapies, we may benefit from the U.K.’s “patent box” regime, which allows profits attributable to revenues from patents or patented products to be taxed at a lower rate than other revenue. The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%.
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Comparison of the Three Months Ended September 30, 2025 and 2024
Revenue
The following table summarizes our total revenue (in thousands):
Three Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
Revenue from sale of therapies, net | $ | 103,693 | $ | 80,248 | $ | 23,445 | 29.2 | % | ||||||||||||||||||
Total revenue | $ | 103,693 | $ | 80,248 | $ | 23,445 | 29.2 | % | ||||||||||||||||||
Revenue from sale of therapies, net
Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands):
Three Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
United States | $ | 67,300 | $ | 57,268 | $ | 10,032 | 17.5 | % | ||||||||||||||||||
Europe | 33,526 | 21,098 | 12,428 | 58.9 | % | |||||||||||||||||||||
International | 2,867 | 1,882 | 985 | 52.3 | % | |||||||||||||||||||||
Revenue from sale of therapies, net | $ | 103,693 | $ | 80,248 | $ | 23,445 | 29.2 | % | ||||||||||||||||||
For the three months ended September 30, 2025, we generated net revenue from sale of therapies of $103.7 million due to the sale of KIMMTRAK, of which $67.3 million was in the United States, $33.5 million in Europe and $2.9 million in International. Revenue from sale of therapies, net increased in the three months ended September 30, 2025 compared to the three months ended September 30, 2024, due primarily to increased sales volume in the United States and Europe as well as global country expansion.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Three Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
| External R&D expenses: | ||||||||||||||||||||||||||
| PRAME programs | $ | 21,967 | $ | 18,512 | $ | 3,455 | 18.7 | % | ||||||||||||||||||
| Tebentafusp programs | 11,789 | 8,315 | 3,474 | 41.8 | % | |||||||||||||||||||||
| Infectious disease programs | 1,347 | 1,324 | 23 | 1.7 | % | |||||||||||||||||||||
All other external clinical and preclinical costs | 15,551 | 6,361 | 9,190 | 144.5 | % | |||||||||||||||||||||
| Total external R&D expenses | 50,654 | 34,512 | 16,142 | 46.8 | % | |||||||||||||||||||||
| Internal R&D expenses: | ||||||||||||||||||||||||||
| Salaries and other employee-related costs | 11,932 | 11,272 | 660 | 5.9 | % | |||||||||||||||||||||
| Share-based compensation expense | 2,168 | 1,819 | 349 | 19.2 | % | |||||||||||||||||||||
| All other internal R&D costs | 8,055 | 7,235 | 820 | 11.3 | % | |||||||||||||||||||||
U.K. R&D tax credits | (2,237) | (2,068) | (169) | 8.2 | % | |||||||||||||||||||||
| Total internal R&D expenses | 19,918 | 18,258 | 1,660 | 9.1 | % | |||||||||||||||||||||
| Total R&D expenses | $ | 70,572 | $ | 52,770 | $ | 17,802 | 33.7 | % | ||||||||||||||||||
For the three months ended September 30, 2025, our R&D expenses were $70.6 million, compared to $52.8 million for the three months ended September 30, 2024.
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For the three months ended September 30, 2025, our external R&D expenses increased by $16.1 million due to an increase in all other external clinical and preclinical costs of $9.2 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations. In addition, there was an increase of $3.5 million in expenses incurred for our PRAME programs due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial and an increase of $3.5 million in expenses incurred for our tebentafusp programs as a result of the advanced cutaneous melanoma ("TEBE-AM") and ATOM Phase 3 trials.
For the three months ended September 30, 2025, our internal R&D expenses increased by $1.7 million primarily due to an increase in all other internal R&D costs due to the growth of our clinical and preclinical programs.
We expect our R&D expenses to increase in future periods as we advance our trials and further develop our clinical and preclinical pipeline.
SG&A Expenses
For the three months ended September 30, 2025, our SG&A expenses were $39.8 million, compared to $35.5 for the three months ended September 30, 2024, an increase of $4.2 million. The increase was due to higher costs related to commercial and business support functions to support our growing pipeline and global commercial expansion.
Interest Income and Interest Expense
For the three months ended September 30, 2025, interest income was $4.1 million compared to $6.0 million for the three months ended September 30, 2024. This decrease of $1.9 million was due to lower interest rates earned on our money market funds. For the three months ended September 30, 2025, interest expense was $3.0 million compared to $4.3 million for the three months ended September 30, 2024 and the decrease was related to interest on the Pharmakon loan in 2024, which was repaid in November 2024.
Foreign Currency Gain
For the three months ended September 30, 2025, foreign currency gain was $1.3 million compared to $4.0 million for the three months ended September 30, 2024. This decrease of $2.7 million reflects less favorable exchange rate movements mainly due to the strengthening of the U.S. dollar against the pound sterling and the euro in the three months ended September 30, 2025.
Other Income, Net
For the three months ended September 30, 2025, other income, net was $5.1 million compared to $9.0 million for the three months ended September 30, 2024. This decrease was due to higher unrealized gains resulting from the change in fair value of our marketable securities in the three months ended September 30, 2024 related to more favorable interest rate movement.
Income Tax (Expense) Benefit
For the three months ended September 30, 2025, the income tax expense was $0.5 million compared to an income tax benefit of $2.6 million for the three months ended September 30, 2024. This change was due to a favorable discrete item in the three months ended September 30, 2024 related to U.S. research tax credits claimed on our 2023 U.S. income tax return.
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Comparison of the Nine Months Ended September 30, 2025 and 2024
Revenue
The following table summarizes our total revenue (in thousands):
Nine Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
Revenue from sale of therapies, net | $ | 295,538 | $ | 225,937 | $ | 69,601 | 30.8 | % | ||||||||||||||||||
Collaboration revenue | — | 213 | (213) | (100.0) | % | |||||||||||||||||||||
Total revenue | $ | 295,538 | $ | 226,150 | $ | 69,388 | 30.7 | % | ||||||||||||||||||
Revenue from sale of therapies, net
Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands).
Nine Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
United States | $ | 187,994 | $ | 162,900 | $ | 25,094 | 15.4 | % | ||||||||||||||||||
Europe | 99,372 | 55,454 | 43,918 | 79.2 | % | |||||||||||||||||||||
International | 8,172 | 7,583 | 589 | 7.8 | % | |||||||||||||||||||||
Revenue from sale of therapies, net | $ | 295,538 | $ | 225,937 | $ | 69,601 | 30.8 | % | ||||||||||||||||||
For the nine months ended September 30, 2025, we generated revenue from sale of therapies, net of $295.5 million, due to the sale of KIMMTRAK, of which $188.0 million was in the United States, $99.4 million in Europe (including the impact of a net decrease in estimated reserves related to prior periods of $6.0 million) and $8.2 million in International. Revenue from sale of therapies, net increased in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, due primarily to increased volume in the United States and Europe as well as global country expansion.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Nine Months Ended September 30, | ||||||||||||||||||||||||||
| 2025 | 2024 | Increase / (decrease) | % Increase / (decrease) | |||||||||||||||||||||||
| External R&D expenses: | ||||||||||||||||||||||||||
| PRAME programs | $ | 59,950 | $ | 67,144 | $ | (7,194) | (10.7) | % | ||||||||||||||||||
| Tebentafusp programs | 30,196 | 18,766 | 11,430 | 60.9 | % | |||||||||||||||||||||
| Infectious disease programs | 4,077 | 5,009 | (932) | (18.6) | % | |||||||||||||||||||||
| All other external clinical and preclinical costs | 42,035 | 17,309 | 24,726 | 142.9 | % | |||||||||||||||||||||
| Total external R&D expenses | 136,258 | 108,228 | 28,030 | 25.9 | % | |||||||||||||||||||||
| Internal R&D expenses: | ||||||||||||||||||||||||||
| Salaries and other employee-related costs | 35,882 | 33,247 | 2,635 | 7.9 | % | |||||||||||||||||||||
| Share-based compensation expense | 6,667 | 5,971 | 696 | 11.7 | % | |||||||||||||||||||||
| All other internal R&D costs | 23,780 | 19,577 | 4,203 | 21.5 | % | |||||||||||||||||||||
U.K. R&D tax credits | (6,539) | (5,722) | (817) | 14.3 | % | |||||||||||||||||||||
| Total internal R&D expenses | 59,790 | 53,073 | 6,717 | 12.7 | % | |||||||||||||||||||||
| Total R&D expenses | $ | 196,048 | $ | 161,301 | $ | 34,747 | 21.5 | % | ||||||||||||||||||
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For the nine months ended September 30, 2025, our R&D expenses were $196.0 million, compared to $161.3 million for the nine months ended September 30, 2024.
For the nine months ended September 30, 2025, our external R&D expenses increased by $28.0 million due to an increase in all other external clinical and preclinical costs of $24.7 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiation. In addition, R&D expenses incurred for our tebentafusp programs increased by $11.4 million as a result of the TEBE-AM and ATOM Phase 3 trials and purchases of drug consumables. There was a decrease of $7.2 million in expenses incurred for our PRAME programs primarily resulting from higher costs in the nine months ended September 30, 2024 due to timing of manufacturing batches and purchases of drug consumables for our clinical trials, partially offset by higher costs in the nine months ended September 30, 2025 due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial.
For the nine months ended September 30, 2025, our internal R&D expenses increased by $6.7 million primarily due to an increase in salaries and other employee-related costs and all other internal R&D costs due to the growth of our clinical and preclinical programs.
SG&A Expenses
For the nine months ended September 30, 2025, our SG&A expenses were $122.8 million, compared to $113.5 million for the nine months ended September 30, 2024, an increase of $9.3 million. The increase was due to costs related to commercial and business support functions to support our growing pipeline and global commercial expansion.
Interest Income and Interest Expense
For the nine months ended September 30, 2025, interest income was $12.6 million compared to $20.4 million for the nine months ended September 30, 2024. This decrease of $7.8 million was due to reduced cash and cash equivalents balances primarily related to purchases of marketable securities of $350.0 million in the second quarter of 2024 and lower interest rates earned on our money market funds in the nine months ended September 30, 2025. For the nine months ended September 30, 2025, interest expense was $9.1 million compared to $11.8 million for the nine months ended September 30, 2024, and the decrease was related to interest on the Pharmakon loan which was repaid in November 2024.
Foreign Currency Gain
For the nine months ended September 30, 2025, foreign currency gain was $3.7 million compared to $1.0 million for the nine months ended September 30, 2024. This increase of $2.7 million reflects favorable exchange rate movements mainly due to the weakening of the U.S. dollar against the pound sterling and the euro in the nine months ended September 30, 2025.
Other Income, Net
For the nine months ended September 30, 2025, other income, net was $15.2 million compared to $13.2 million for the nine months ended September 30, 2024. The increase was primarily related to income on our marketable securities purchased in the second quarter of 2024, including the unrealized gains resulting from the change in fair value, partially offset by lower unrealized gains due to less favorable interest rate movement in the nine months ended September 30, 2025.
Income Tax (Expense) Benefit
For the nine months ended September 30, 2025, the income tax expense was $2.1 million compared to an income tax benefit of $0.8 million for the nine months ended September 30, 2024. This change was due to a favorable discrete item in the nine months ended September 30, 2024 related to U.S. research tax credits claimed on our 2023 U.S. income tax return.
Liquidity and Capital Resources
Sources of Liquidity
Although we have recorded revenue from the sale of therapies, we have continued to incur operating losses and cumulative negative cash flows from our operations since our inception. We have an accumulated deficit of $801.2 million as of September 30, 2025.
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Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, revenue from sale of therapies, debt financings and historical payments from collaboration partners. As of September 30, 2025 and December 31, 2024, we had cash and cash equivalents of $498.4 million and $455.7 million, respectively, and marketable securities of $393.9 million and $364.6 million, respectively.
In September 2022, we entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may issue and sell ADSs, each representing one ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal. The at-the-market facility has been registered under the Securities Act of 1933, as amended, pursuant to our Registration Statement on Form S-3ASR (File No. 333-278120). As of September 30, 2025, no issuances or sales had been made pursuant to the Sales Agreement.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. Part of the proceeds were used to repay in full loans outstanding under our previous loan agreement with Pharmakon.
In the three months ending December 31, 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.
Other than the above mentioned indebtedness and payments, we currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our lease obligations and supplier purchase commitments in the normal course of business.
Cash Flows
As of September 30, 2025, we had cash and cash equivalents of $498.4 million, as compared to $455.7 million as of December 31, 2024 and we also have marketable securities of $393.9 million as of September 30, 2025 as compared to $364.6 million as of December 31, 2024. Our working capital was $852.5 million as of September 30, 2025, compared to $717.7 million as of December 31, 2024.
The following table summarizes the primary sources and uses of cash and cash equivalents for each period presented (in thousands):
| Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | |||||||||||||
Cash and cash equivalents at beginning of period | $ | 455,731 | $ | 442,626 | ||||||||||
| Net cash provided by operating activities | 21,943 | 40,012 | ||||||||||||
| Net cash used in investing activities | (15,460) | (351,589) | ||||||||||||
| Net cash provided by financing activities | 8,087 | 395,392 | ||||||||||||
Net foreign exchange difference on cash held | 28,112 | 11,326 | ||||||||||||
Cash and cash equivalents at end of period | $ | 498,413 | $ | 537,767 | ||||||||||
Net cash provided by our operating activities was $21.9 million for the nine months ended September 30, 2025, compared to $40.0 million for the nine months ended September 30, 2024. This decrease of $18.1 million was primarily driven by a reduction in accrued expenses and other liabilities, reflecting the timing of payments, partially offset by an increase in net revenue from sale of therapies and cash collections.
Net cash used in investing activities was $15.5 million for the nine months ended September 30, 2025, compared to $351.6 million for the nine months ended September 30, 2024. The decrease of $336.1 million is predominantly due to higher purchases of marketable securities in the nine months ended September 30, 2024 compared to the same period in 2025.
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Net cash provided by our financing activities during the nine months ended September 30, 2025 was $8.1 million compared to $395.4 million for the nine months ended September 30, 2024. The decrease of $387.3 million was primarily the result of the net cash proceeds from the Notes of $389.1 million received in the nine months ended September 30, 2024 with no similar proceeds received in the nine months ended September 30, 2025.
Future Capital Requirements
We expect to continue to incur significant operating losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize KIMMTRAK in additional territories, continue our research and development programs and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates.
The amounts and timing of our actual expenditure may vary significantly depending on numerous factors. Our expenses will continue to increase if, and as, we:
•pursue further approval and commercialization of KIMMTRAK in additional indications and territories;
•continue to advance the development of our clinical trials and preclinical programs;
•continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;
•change or add additional suppliers;
•add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;
•seek to attract and retain skilled personnel;
•create additional infrastructure to further support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;
•seek marketing approvals and reimbursement for our other product candidates;
•further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval;
•seek to identify and validate additional product candidates;
•acquire or in-license other product candidates and technologies;
•maintain, protect, defend, enforce and expand our intellectual property portfolio; and
•experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the conflict in the Middle East, global geopolitical tension, worsening macroeconomic conditions, including supply chain disruptions, fluctuations in interest rates, rising inflation, tariffs and other trade barriers, or health epidemics or pandemics.
Since our inception, we have raised funds from sales of equity securities, debt financing, revenue from sale of therapies and collaboration agreements. In order to maintain such levels of expenditure and our anticipated expenditure, we may raise further funds by exploring debt or equity financing, or potentially further collaborations, in the future. The amount we are able to raise from these options can vary with market conditions, including the impacts of macroeconomic conditions such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets, and our longer term strategy as a company is dependent on our ability to successfully raise such funding. Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
We held cash and cash equivalents of $498.4 million and marketable securities of $393.9 million as of September 30, 2025. Based on our current operating plans, we expect that our existing cash and cash equivalents and marketable securities balances, along with anticipated revenue from KIMMTRAK, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report. Given our need for additional financing to support the long-term clinical development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential future clinical trials;
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•the time and costs required to perform R&D to identify and characterize new product candidates from our research programs;
•the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;
•the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved;
•our ability to successfully commercialize our other product candidates;
•our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations;
•the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;
•the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;
•the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
•the continued costs of operating as a public company;
•the time and cost necessary to respond to technological, regulatory, political and market developments;
•the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
•the costs, associated with, and terms and timing of, any future potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and
•the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development and commercialization of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. Further, to the extent that we raise additional capital through the sale of ordinary shares or securities convertible or exchangeable into ordinary shares, our shareholders’ ownership interest will be diluted. If we raise additional capital through debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding on favorable terms when needed, we may have to delay, reduce the scope of or terminate one or more of our R&D programs or clinical trials.
Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, financial markets in the United States and worldwide. We are also mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. We sell our products in countries that face economic volatility and weakness. Although we have historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.
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Contractual Obligations
Leases and manufacturing
As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $75.7 million. The majority of such payments represent longer-term commitments as outlined in the notes to our condensed consolidated financial statements. The lease agreements are cancellable assuming certain conditions are met prior to expiry. We expect to continue to incur expenses for such leases for the foreseeable future. As we continue to grow, launch further products or expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would increase our cash outflows. Further obligations or commitments in the near term relate to our capital expenditure requirements for the purpose of improving our leased facilities. If we continue to grow, such commitments may become significant in value.
We have a number of existing manufacturing obligations, some of which relate to the manufacture of KIMMTRAK. We have similar obligations related to our earlier stage programs. These obligations and potential obligations could result in payments of up to $20.1 million, and are expected to increase as we continue to advance our pipeline in 2025 and beyond. While we have already incurred costs for commercial launches of KIMMTRAK in the United States, Europe and other territories, additional manufacturing obligations may arise in future in relation to product sales in these territories. We have also entered into third-party agreements relating to marketing and distribution of KIMMTRAK. The majority of such obligations have standard payment terms, and our level of non-cancellable commitments with such parties is not considered material. To meet demand, we may amend or enter into further agreements with CMOs or other parties which could cause our cash requirements to increase. While receipts from the sale of KIMMTRAK or other future products may fund our ongoing manufacturing and sales efforts, there can be no assurance that we will earn such revenues. In the longer term, if we received regulatory approval for our other product candidates, we would expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
In addition to the above obligations, commitments and potential future cash outflows, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally provide us the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
Financing obligations
Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by us under the agreement, the Gates Foundation has the right to sell, or require us to buy-back, any of the shareholdings of us held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, we experience a change in control at a valuation of more than 150% of the valuation used for the redemption or the sale of the shares, we have agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. See Note 5. “Interest-bearing loans and borrowings” of the notes to our condensed consolidated financial statements in Part I of this Quarterly Report for further information.
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Our Key Collaboration Agreements
Bristol-Myers Squibb ("BMS") Collaboration
In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01, brenetafusp, in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma. Under the terms of the BMS Agreement, we are sponsoring and funding the registrational Phase 3 clinical trial of brenetafusp in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS is providing nivolumab. No monetary consideration is transferred as a result of the BMS Agreement.
Critical Accounting Estimates
Our condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024, respectively, have been prepared in accordance with U.S. GAAP. The preparation of the condensed consolidated financial statements requires us to make judgments, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues and expenses arising during the fiscal period.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.
Those judgments and estimates made, together with our significant accounting policies, are set out in our Annual Report.
Expected rebate and chargeback percentage for revenue deductions
Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. We use the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance.
We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after we have sold vials to specialty distributors. We are also subject to chargebacks from its specialty distributors under the 340B program in the United States, whereby qualifying hospitals are entitled to purchase KIMMTRAK at a lower price. For such sales, our specialty distributors charge back the difference between the wholesale acquisition cost and this lower price. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to specialty distributors and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We form estimates of 340B chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by specialty distributors. For Medicaid and other rebates, we form estimates based on information obtained from claims received and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
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Judgment has historically been required in determining expected rebate percentages for the amount of net revenue from sale of therapies in France. Rebates payable were subject to a high degree of estimation uncertainty. Our estimate of these rebates represented the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which has historically been subject to negotiation, and the initial price of tebentafusp and KIMMTRAK until the Company completed price negotiations in France during the three months ended March 31, 2025. Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to patients in France was also required in the assessment of rebates payable. We applied judgment to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue. For other European markets where the price is open to negotiation, judgments are made in line with expected pricing outcomes.
Our total accrued revenue deductions as of September 30, 2025 were $170.2 million, including amounts of $10.2 million for the critical estimates subject to greater estimation uncertainty and judgments described above. These amounts are included within Accrued expenses and other current liabilities and Accrued expenses, non-current in the Condensed Consolidated Balance Sheet as of September 30, 2025. In the three months ending December 31, 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.
A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have resulted in a $2.0 million reduction or increase in Revenue from sale of therapies, net reported in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the nine months ended September 30, 2025. We believe our expected values of accruals reported in the Condensed Consolidated Balance Sheet are materially appropriate; however, due to the uncertainties and judgments outlined above, it is possible eventual amounts could significantly differ to these estimates. For critical estimates reported as of December 31, 2024, additional information including completing price negotiations in France and Germany in the nine months ended September 30, 2025 resulted in a change in estimate of $6.0 million of net decrease to our total accrued revenue deductions as of September 30, 2025.
Recently Issued and Adopted Accounting Pronouncements
We discuss the effect of recently issued and adopted pronouncements in Note 2. ''Summary of Significant Accounting Policies'' to the condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to interest rate, currency, credit and liquidity risks. Our executive board oversees the management of these risks supported by a financial risk committee that advises on financial risks and the appropriate financial risk governance framework for us. The financial risk committee provides assurance to our executive board that our financial risk activities are governed by appropriate policies and procedures and that financial risks are identified, measured and managed in accordance with our policies and risk objectives. The most significant financial risks to which we are exposed include the risks discussed below.
Interest Rate Risk
Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits and marketable securities. Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of Notes, which mature on February 1, 2030, unless earlier converted, redeemed, or repurchased. The Notes accrue interest payable semiannually at a fixed rate of 2.50% per annum, commencing August 1, 2024. Issuance costs totaling $13.4 million are being amortized as interest expense at an effective rate of 3.06% over the life of the Notes. Given the fixed interest rate, the Company is not subject to interest rate risk with respect to these Notes. However, changes in market interest rates could affect the fair value of the Notes and the price of our ADSs, influencing the decision of noteholders to convert their Notes.
We are currently not subject to interest rate risks related to any other liabilities shown in the Condensed Consolidated Balance Sheets.
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Currency Risk
Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to fluctuations in value of foreign currency cash and cash equivalents balances held by our main operating subsidiary in the United Kingdom, our operating activities in foreign subsidiaries, and outsourced supplier agreements denominated in currencies other than functional currency. We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical.
Our cash and cash equivalents were $498.4 million and $455.7 million as of September 30, 2025 and December 31, 2024, respectively. As of September 30, 2025, 75% of our cash and cash equivalents were held by our U.K. operating subsidiary, of which 48% were denominated in U.S. dollars, 39% were denominated in pounds sterling and 13% were denominated in euros. All of our marketable securities were held by our U.K. parent company and were denominated in U.S. dollars. The remainder of our cash and cash equivalents are held across our other subsidiaries and denominated in a mix of operating currencies. Changes in exchange rates had an impact on U.S. dollar cash and cash equivalents balances held by our main operating subsidiary in the United Kingdom, which resulted in foreign exchange losses in the nine months ended September 30, 2025 and 2024. These losses were more than offset by foreign exchange gains primarily on intercompany loans in the nine months ended September 30, 2025. Further movements in exchange rates or returns to previous exchange rate levels have caused, and may continue to cause, material fluctuations or equivalent losses in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss).
A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies as of September 30, 2025 by $5.9 million and as of December 31, 2024 by $6.5 million. A five percentage point decrease in exchange rates would increase the carrying value of net financial assets and liabilities held in foreign currencies as of September 30, 2025 by $5.9 million and as of December 31, 2024 by $6.5 million.
Credit Risk
We are exposed to credit risk from our operating activities, primarily accounts receivable, and cash and cash equivalents and marketable securities held with banks and financial institutions. Cash and cash equivalents and marketable securities are maintained with high-quality financial institutions in the United Kingdom and United States. We are also potentially subject to concentrations of credit risk in our accounts receivable with respect to amounts owed by a limited number of entities comprising our customer base. Our exposure to credit losses is low, however, owing largely to the credit quality of our distributors and other customers, the significant majority of which are considerably larger than us.
We continually monitor our positions with, and the credit quality of, the financial institutions and corporations which are counterparts to our financial instruments and do not anticipate non-performance. The maximum default risk corresponds to the carrying amount of the financial assets shown in the Condensed Consolidated Balance Sheets. We monitor the risk of a liquidity shortage. The main factors we consider are the maturities of financial assets as well as expected cash flows from equity measures.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
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Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2025. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2025, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become subject to arbitration, litigation or claims arising in the ordinary course of business. We are not currently a party to any arbitration or legal proceeding that, if determined adversely to us, would have a material adverse effect on our business, operating results or financial condition. The results of any future claims or proceedings cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and litigation costs, diversion of management resources, and other factors.
Item 1A. Risk Factors
Our business has significant risks. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risks described in Part I, Item 1A. “Risk Factors” in our Annual Report. These are not the only risks facing our business. Other risks and uncertainties that we are not currently aware of or that we currently consider immaterial also may materially adversely affect our business, financial condition and future results if our assumptions about those risks are incorrect or if circumstances change.
There were no material changes during the period covered in this Quarterly Report to the risk factors previously disclosed in Item 1A. Risk Factors in our Annual Report, except for the risk factor noted below.
As a company based outside of the United States, we are subject to economic, political, regulatory and other risks associated with international operations.
As a company based in the United Kingdom, our business is subject to risks associated with conducting business outside of the United States. Many of our suppliers and clinical trial relationships are located outside the United States. Accordingly, our future results could be harmed by a variety of factors, including:
•economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;
•differing and changing regulatory requirements for product approvals;
•differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions;
•potentially reduced protection for intellectual property and proprietary rights;
•difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations;
•changes in global regulations and customs, tariffs and trade barriers;
•changes in non-U.S. currency exchange rates of the pound sterling, U.S. dollar, euro and currency controls;
•changes in a specific country’s or region’s political or economic environment, including the longer-term implications of Brexit;
•trade protection measures, import or export licensing requirements or other restrictive actions by governments;
•differing reimbursement regimes and price controls in certain non-U.S. markets;
•negative consequences from changes in tax laws;
•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of options or restricted share units granted under our share option schemes or equity incentive plans;
•workforce uncertainty in countries where labor unrest is more common than in the United States;
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•litigation or administrative actions resulting from claims against us by current or former employees or consultants individually or as part of class actions, including claims of wrongful terminations, discrimination, misclassification or other violations of labor law or other alleged conduct;
•difficulties associated with staffing and managing international operations, including differing labor relations;
•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
•business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
For example, in July 2025, the United States and the European Union announced a bilateral agreement on tariffs and trade, which was further detailed in a joint statement on August 21, 2025. Under this framework, the United States committed to an all inclusive ceiling of 15% on most tariffs applied to goods originating from the European Union, including pharmaceuticals. These proposed tariffs are subject to further review and implementation by the U.S. government, but some level of tariff is expected to apply to our supply of drug, which is manufactured in the European Union. As of the date of this Quarterly Report, the effective date of the proposed tariffs is unknown. We are assessing the impact these tariffs would have on our cost of importing clinical and commercial product into the United States, which is expected to increase the cost of revenue from sale of therapies and reduce our margins on the sale of our products. Unlike many industries, our ability to pass increased costs to customers is limited by the structure of pharmaceutical pricing and reimbursement systems. The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or non-U.S. jurisdictions related to compliance with trade regulations. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business. Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects.
Additionally, due to the Russia-Ukraine conflict, the United States, United Kingdom, EU, and other nations announced various sanctions against Russia and Belarus. The military conflict and the retaliatory measures that have been taken, or could be taken in the future, by the United States, United Kingdom, EU, and other countries, as well as the conflict in the Middle East, have created global security concerns and global geopolitical tension that could result in a lasting impact on regional and global economies, any or all of which could disrupt our supply chain, adversely affect our ability to conduct ongoing and future clinical trials of our product candidates, and adversely affect our ability to commercialize our products (subject to regulatory approval) in these regions and have wider implications globally that could impact our business outside of these regions. Ongoing military conflict will likely impact our ability to conduct clinical trials in Ukraine, Russia and potentially in other Eastern European countries, and may prevent us from continuing follow-up for patients previously enrolled or enrolling patients in future trials at sites in these countries, and may also prevent us from commercializing our products (subject to regulatory approval) in this region. In addition, there could be an impact on our international operations because of the conflict in the Middle East, because our distributor outside the US and Western Europe has significant exposure in the region. This could negatively impact the anticipated timing and completion of future clinical trials and/or analyses of future clinical results, and negatively impact our plans to commercialize our product (subject to regulatory approval) in this region, which could harm our business.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds and Issuer Purchases of Equity Securities
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
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Item 5. Other Information
During our last fiscal quarter, our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated the contracts, instructions or written plans for the purchase or sale of our securities as set forth in the table below.
Type of Trading Arrangement | ||||||||||||||||||||
Name and Position | Action | Adoption/ Termination Date | Rule 10b5-1(1) | Non- Rule 10b5-1(2) | Total Ordinary Shares to be Sold(3) | Expiration Date | ||||||||||||||
| X | ||||||||||||||||||||
(1) Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
(2) “Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.
Item 6. Exhibits
Exhibit Number | Incorporation by Reference | |||||||||||||||||||||||||||||||
Description | Schedule / Form | File Number | Exhibit | Filing Date | ||||||||||||||||||||||||||||
10-Q | 001-39992 | 3.1 | August 8, 2024 | |||||||||||||||||||||||||||||
101.INS* | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). | |||||||||||||||||||||||||||||||
101.SCH* | Inline XBRL Taxonomy Extension with Embedded Linkbase Schema Documents. | |||||||||||||||||||||||||||||||
104* | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). | |||||||||||||||||||||||||||||||
* | Filed herewith. | ||||
** | This certification is deemed furnished, not "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act. | ||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| IMMUNOCORE HOLDINGS PLC | ||||||||||||||
Date: | November 6, 2025 | By: | /s/ Bahija Jallal | |||||||||||
Name: | Bahija Jallal, Ph.D. | |||||||||||||
Title: | Chief Executive Officer | |||||||||||||
(On Behalf of the Registrant and as Principal Executive Officer) | ||||||||||||||
Date: | November 6, 2025 | By: | /s/ Travis Coy | |||||||||||
Name: | Travis Coy | |||||||||||||
Title: | Chief Financial Officer | |||||||||||||
(Principal Financial Officer) | ||||||||||||||
35
Exhibit 31.1
Certification by the Principal Executive Officer pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Bahija Jallal, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Immunocore Holdings plc;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 6, 2025
| By: | /s/ Bahija Jallal | |||||||
| Bahija Jallal, Ph.D. | ||||||||
| Chief Executive Officer | ||||||||
| (Principal Executive Officer) | ||||||||
Exhibit 31.2
Certification by the Principal Financial Officer pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Travis Coy, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Immunocore Holdings plc;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 6, 2025
| By: | /s/ Travis Coy | |||||||
| Travis Coy | ||||||||
| Chief Financial Officer | ||||||||
| (Principal Financial Officer) | ||||||||
Exhibit 32.1
Certification by the Principal Executive Officer and Principal Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Bahija Jallal, Chief Executive Officer of Immunocore Holdings plc (the “Company”), and Travis Coy, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
1.The Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2.The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 6, 2025
| /s/ Bahija Jallal | ||||||||
| Chief Executive Officer | ||||||||
| (Principal Executive Officer) | ||||||||
| /s/ Travis Coy | ||||||||
| Chief Financial Officer | ||||||||
| (Principal Financial Officer) | ||||||||
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Immunocore Holdings plc under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.