Item 1. Financial Statements
Item 1. Financial Statements.
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Condensed Consolidated Financial Statements (Unaudited) Page
Condensed Consolidated Balance Sheets
F - 1
Condensed Consolidated Statements of Operations and Comprehensive Loss
F - 2
Condensed Consolidated Statements of Changes in Stockholders’ Equity
F - 3
Condensed Consolidated Statements of Cash Flows
F - 4
Notes to Condensed Consolidated Financial Statements
F - 5
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BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
As of
September 30,
2025 As of
December 31,
2024
ASSETS
Cash and cash equivalents $ 74,272 $ 110,662
Restricted cash 1,402 1,738
Research and development incentives receivable 4,633 7,139
Prepaid expenses and other current assets 6,336 6,203
Assets held for sale 138 —
Total current assets 86,781 125,742
Property and equipment, net 4,519 7,373
Intangible assets, net 14,909 21,947
Right of use assets, net 2,063 4,384
Other assets 929 881
Total assets $ 109,201 $ 160,327
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 698 $ 2,474
Accrued expenses and other current liabilities 6,681 9,525
Deferred income 1,402 1,738
Operating lease liability - current 2,017 1,920
Total current liabilities 10,798 15,657
Non-current liabilities:
Operating lease liability - non-current 9,553 10,087
Contingent consideration 2,508 2,650
Other non-current liabilities 1,461 1,360
Deferred tax liability, net 320 438
Total liabilities $ 24,640 $ 30,192
Commitments and contingencies (Note 15)
Stockholders’ equity:
Ordinary shares, £ 0.000025 nominal value; 40,827,263 shares authorized, issued and outstanding (December 31, 2024: authorized, issued and outstanding: 40,234,663 )
1 1
Deferred A shares, £ 1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2024: authorized, issued and outstanding: 63,443 )
86 86
Additional paid-in capital 393,248 393,474
Accumulated deficit ( 293,002 ) ( 237,664 )
Accumulated other comprehensive loss – foreign currency translation adjustments ( 15,868 ) ( 25,868 )
Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 84,465 130,029
Noncontrolling interest 96 106
Total stockholders’ equity $ 84,561 $ 130,135
Total liabilities and stockholders’ equity $ 109,201 $ 160,327
The accompanying notes are an integral part of these condensed consolidated financial statements.
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BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
Three months ended Nine months ended
September 30, 2025 September 30, 2024 September 30, 2025 September 30, 2024
License revenue 1
$ — $ 14,969 $ — $ 14,969
Total revenue — 14,969 — 14,969
Operating expenses
Research and development $ 5,390 $ 11,139 $ 21,633 $ 33,926
General and administrative 5,165 13,420 33,188 26,615
Impairment of long-lived assets 4,667 — 4,667 —
Total operating expenses 15,222 24,559 59,488 60,541
Other operating income 156 210 498 992
Loss from operations ( 15,066 ) ( 9,380 ) ( 58,990 ) ( 44,580 )
Other income/(expense):
Interest income 472 631 1,551 2,041
Interest expense ( 13 ) ( 17 ) ( 38 ) ( 41 )
Research and development incentives 240 608 1,884 1,895
Other income ( 275 ) 26 120 46
Total other income, net 424 1,248 3,517 3,941
Loss before income tax ( 14,642 ) ( 8,132 ) ( 55,473 ) ( 40,639 )
Tax benefit 71 3 118 47
Net loss ( 14,571 ) ( 8,129 ) ( 55,355 ) ( 40,592 )
Net loss attributable to noncontrolling interest 5 15 17 58
Net loss attributable to Barinthus Biotherapeutics plc shareholders ( 14,566 ) ( 8,114 ) ( 55,338 ) ( 40,534 )
Weighted-average ordinary shares outstanding, basic 40,661,118 39,419,447 40,424,735 39,079,259
Weighted-average ordinary shares outstanding, diluted 40,661,118 39,419,447 40,424,735 39,079,259
Net loss per share attributable to ordinary shareholders, basic $ ( 0.36 ) $ ( 0.21 ) $ ( 1.37 ) $ ( 1.04 )
Net loss per share attributable to ordinary shareholders, diluted $ ( 0.36 ) $ ( 0.21 ) $ ( 1.37 ) $ ( 1.04 )
Net loss $ ( 14,571 ) $ ( 8,129 ) $ ( 55,355 ) $ ( 40,592 )
Other comprehensive gain/(loss) – foreign currency translation adjustments ( 2,934 ) 9,191 10,007 7,778
Comprehensive loss ( 17,505 ) 1,062 ( 45,348 ) ( 32,814 )
Comprehensive loss/(gain) attributable to noncontrolling interest 8 5 10 44
Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 17,497 ) $ 1,067 $ ( 45,338 ) $ ( 32,770 )
1 Includes license revenue from related parties for the three and nine months ended September 30, 2025 of nil (three and nine months ended September 30, 2024: $ 15.0 million).
The accompanying notes are an integral part of these condensed consolidated financial statements.
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BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
(UNAUDITED)
Three and Nine months ended September 30, 2025
Ordinary Shares Deferred A Shares
Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Noncontrolling Interest Total Stockholders' Equity
Balance, January 1, 2025 40,234,663 $ 1 63,443 $ 86 $ 393,474 $ ( 237,664 ) $ ( 25,868 ) $ 130,029 $ 106 $ 130,135
Share based compensation — — — — 468 — — 468 — 468
Issue of ordinary shares, net of issuance costs 104,732 0 1 — — 2 — — 2 — 2
Foreign currency translation adjustments — — — — — — 4,643 4,643 3 4,646
Net loss — — — — — ( 19,648 ) — ( 19,648 ) ( 10 ) ( 19,658 )
Balance, March 31, 2025 40,339,395 $ 1 63,443 $ 86 $ 393,944 $ ( 257,312 ) $ ( 21,225 ) $ 115,494 $ 99 $ 115,593
Share based compensation — — — — ( 281 ) — — ( 281 ) — ( 281 )
Issue of ordinary shares, net of issuance costs 9,270 0 1 — — 0 1 — — 0 1 — 0 1
Foreign currency translation adjustments — — — — — — 8,288 8,288 7 8,295
Net loss — — — — — ( 21,124 ) — ( 21,124 ) ( 2 ) ( 21,126 )
Balance, June 30, 2025 40,348,665 $ 1 63,443 $ 86 $ 393,663 $ ( 278,436 ) $ ( 12,937 ) $ 102,377 $ 104 $ 102,481
Share based compensation — — — — ( 415 ) — — ( 415 ) — ( 415 )
Issue of ordinary shares, net of issuance costs 478,598 0 1 — — 0 1 —
— 0 1 — —
Foreign currency translation adjustments — — — — — — ( 2,931 ) ( 2,931 ) ( 3 ) ( 2,934 )
Net loss — — — — — ( 14,566 ) — ( 14,566 ) ( 5 ) ( 14,571 )
Balance, September 30, 2025 40,827,263 $ 1 63,443 $ 86 $ 393,248 $ ( 293,002 ) $ ( 15,868 ) $ 84,465 $ 96 $ 84,561
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these condensed consolidated financial statements
BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
(UNAUDITED)
Three and Nine months ended September 30, 2024
Ordinary Shares Deferred A Shares
Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Noncontrolling Interest Total Stockholders' Equity
Balance, January 1, 2024 38,643,540 $ 1 63,443 $ 86 $ 386,602 $ ( 176,590 ) $ ( 23,315 ) $ 186,784 $ 211 $ 186,995
Share based compensation — — — — 1,615 — — 1,615 — 1,615
Issue of ordinary shares, net of issuance costs 309,416 0 1 — — 503 — — 503 — 503
Foreign currency translation adjustments — — — — — — ( 1,580 ) ( 1,580 ) 3 ( 1,577 )
Net loss — — — — — ( 15,489 ) — ( 15,489 ) ( 31 ) ( 15,520 )
Balance, March 31, 2024 38,952,956 $ 1 63,443 $ 86 $ 388,720 $ ( 192,079 ) $ ( 24,895 ) $ 171,833 $ 183 $ 172,016
Share based compensation — — — — 1,195 — — 1,195 — 1,195
Issue of ordinary shares, net of issuance costs 231,382 0 1 — — 358 — — 358 — 358
Foreign currency translation adjustments — — — — — — 163 163 1 164
Net loss — — — — — ( 16,931 ) — ( 16,931 ) ( 12 ) ( 16,943 )
Balance, June 30, 2024 39,184,338 $ 1 63,443 $ 86 $ 390,273 $ ( 209,010 ) $ ( 24,732 ) $ 156,618 $ 172 $ 156,790
Share based compensation — — — — 1,144 — — 1,144 — 1,144
Issue of ordinary shares, net of issuance costs 358,180 0 1 — — 465 — — 465 — 465
Foreign currency translation adjustments — — — — — — 9,181 9,181 10 9,191
Net loss — — — — — ( 8,114 ) — ( 8,114 ) ( 15 ) ( 8,129 )
Balance, September 30, 2024 39,542,518 $ 1 63,443 $ 86 $ 391,882 $ ( 217,124 ) $ ( 15,551 ) $ 159,294 $ 167 $ 159,461
1 Indicates amount less than one thousand
The accompanying notes are an integral part of these condensed consolidated financial statements
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BARINTHUS BIOTHERAPEUTICS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Nine months ended
September 30, 2025 September 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ ( 55,355 ) $ ( 40,592 )
Adjustments to reconcile net loss to net cash used in operating activities:
Share based compensation ( 228 ) 3,954
Impairment of long-lived assets 4,667 —
Depreciation and amortization 4,936 4,372
Non-cash lease expenses 3,108 1,086
Unrealized foreign exchange loss 3,683 2,022
Change in contingent consideration ( 322 ) ( 306 )
Non-cash interest expense 38 36
Deferred tax benefit ( 118 ) ( 47 )
Profit on sale of property and equipment ( 349 ) —
Changes in operating assets and liabilities:
Contract asset (including related parties) — ( 14,969 )
Prepaid expenses and other current assets 426 2,083
Research and development incentives receivable 2,946 ( 233 )
Accounts payable ( 1,854 ) 1,358
Accrued expenses and other current liabilities ( 3,340 ) ( 1,528 )
Deferred income ( 498 ) 2,044
Operating lease liabilities ( 1,477 ) ( 1,306 )
Net cash used in operating activities $ ( 43,737 ) $ ( 42,026 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of property and equipment 451 —
Purchases of property and equipment ( 37 ) ( 614 )
Net cash provided by/(used) in investing activities $ 414 $ ( 614 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issue of ordinary shares, net of issuance costs — 1,326
Issue of shares from the exercise of stock options 2 0 1
Net cash provided by financing activities $ 2 $ 1,326
Effect of exchange rates on cash, cash equivalents and restricted cash 6,595 5,326
Net decrease in cash, cash equivalents and restricted cash ( 36,726 ) ( 35,988 )
Cash, cash equivalents and restricted cash, beginning of the period 112,400 142,090
Cash, cash equivalents and restricted cash, end of the period $ 75,674 $ 106,102
Supplemental cash flow disclosures:
Non-cash investing and financing activities:
Proceeds from sale of property and equipment included in other current assets $ 219 $ —
1 Indicates amounts less than one thousand
The accompanying notes are an integral part of these condensed consolidated financial statements.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Nature of Business and Basis of Presentation
Barinthus Biotherapeutics plc is a public limited company incorporated pursuant to the laws of England and Wales in March 2021. Barinthus Biotherapeutics plc and its direct and indirect subsidiaries, Barinthus Biotherapeutics (UK) Limited, Barinthus Biotherapeutics North America, Vaccitech Oncology Limited (“VOLT”), Barinthus Biotherapeutics Pty Limited, Barinthus Biotherapeutics Switzerland GmbH, are collectively referred to as the “Company” or “Barinthus Bio.” During the quarterly period ended September 30 2025, the Company incorporated two new subsidiaries, Beacon Topco, Inc. (“Topco”) and Cdog Merger Sub, Inc. (“Merger Sub”), for the purpose of the transactions contemplated by the recently announced merger agreement with Clywedog Therapeutics, Inc. ("Clywedog"). These entities are not material to the Company's consolidated financial position or results of operations.
The Company is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the immunology and inflammation (“I&I”) space enabled by the proprietary and highly differentiated platform for promoting immune tolerance, referred to as SNAP-TI. The Company's lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease, and is currently being assessed in a Phase 1 clinical trial. The Company occupies laboratory and office space in Germantown, Maryland, United States.
The Company operates in an environment of rapid technological change and substantial competition from pharmaceutical and biotechnology companies. The Company is subject to risks common to companies in the biopharmaceutical industry that are also in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain required regulatory approval or that any approved products will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant product sales. If the Company does not successfully commercialize any of its products or mitigate any of these other risks, it will be unable to generate revenue or achieve profitability.
Merger Agreement with Clywedog
On September 29, 2025, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among the Company, Topco, Merger Sub and Clywedog. The Merger Agreement provides that, among other things, upon the terms and subject to the conditions set forth therein: (i) Topco will acquire the entire issued and to be issued share capital of the Company pursuant to a scheme of arrangement (subject to any modification, addition or condition which (a) the Company, Topco and Clywedog mutually agree and which (if required) is approved by the High Court of Justice of England and Wales (the “Court”) or (b) is otherwise imposed by the Court and mutually acceptable to the Company, Topco and Clywedog, each acting reasonably and in good faith, in each case in accordance with the Part 26 of the United Kingdom Companies Act 2006 and the Merger Agreement (the “Scheme of Arrangement” and such transaction, the “Scheme Transaction”)), resulting in the Company becoming a direct wholly owned subsidiary of Topco, and (ii) Merger Sub will merge with and into Clywedog, with Clywedog continuing as the surviving corporation and a direct wholly owned subsidiary of Topco in accordance with the Delaware General Corporations Law (the “Merger” and, together with the Scheme Transaction, the “Combinations”, and, together with such other transactions contemplated by the Merger Agreement, the “Contemplated Transactions”). The Scheme Transaction will be consummated prior to the Merger.
At the effective time of the Scheme Transaction (the “Scheme Effective Time”), upon the terms and subject to the conditions set forth in the Merger Agreement, Topco will acquire each outstanding ordinary share of the Company, with a par value £ 0.000025 per ordinary share (each such acquired ordinary share, a “Scheme Share”), which, for the avoidance of doubt, will include ordinary shares held by The Bank of New York Mellon (the “Depositary”) (or to the extent that the Depositary is not itself the registered holder of such shares that underly the Company’s American Depositary Shares (the “ADSs”), each representing one ( 1 ) ordinary share, whichever nominee, custodian or other entity is the registered holder under the terms of the Deposit Agreement, dated as of April 29, 2021, among the Company, the Depositary, and all holders from time to time of the ADSs, as may be amended from time to time), from the holders of Scheme Shares whose names appear in the register of members of the Company at the Scheme Effective Time) in accordance with the provisions of the Scheme of Arrangement, and each Scheme Share will be converted into the right to receive (i) one ( 1 ) share of common
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
stock, $ 0.0001 par value per share, of Topco (the “Topco Common Stock”) subject to and strictly in accordance with the terms of the Scheme of Arrangement plus (ii) cash in lieu of any fractional shares, rounded down to the nearest whole share. Following the Scheme Effective Time, Topco may in its discretion elect to commence a self-tender offer (“Self-Tender Offer”) to purchase up to $ 27.0 million in shares of Topco Common Stock then issued and outstanding, which Self-Tender Offer, if elected, will be consummated prior to the Merger.
At the effective time of the Merger (the “Merger Effective Time”), subject to adjustment in accordance with the terms of the Merger Agreement, each share of common stock, $ 0.0001 par value per share, of Clywedog (the “Clywedog Common Stock”) and each share of Series Seed Preferred Stock, $ 0.0001 par value per share, of Clywedog (the “Clywedog Preferred Stock”, and together with the Clywedog Common Stock, the “Clywedog Capital Stock”), other than Clywedog Capital Stock held as treasury stock or owned by Topco or Merger Sub immediately prior to the Merger Effective Time, will be converted solely into the right to receive (i) 4.358932 of shares of Topco Common Stock rounded down to the nearest whole share plus (ii) cash in lieu of any fractional shares.
The closing of the Contemplated Transactions is subject to the satisfaction or waiver of certain customary conditions, including, among other things: (i) the effectiveness of a registration statement (the “Registration Statement”) to register the shares of Topco Common Stock to be issued in connection with the Combinations; (ii) approvals by the Company’s shareholders of the Scheme Transaction and certain related matters, and sanction by the Court of the Scheme Transaction; (iii) approval by Clywedog’s stockholders of the Merger Agreement, the Merger and Contemplated Transactions; (iv) the approval for listing by the Nasdaq Stock Market of the shares of Topco Common Stock issuable in the Combinations, subject to official notice of issuance; (v) the completion of the Self-Tender Offer to the extent that Topco elects to commence the Self-Tender Offer; (ivi) minimum cash requirements for each party.
The Merger Agreement may be terminated and the transactions contemplated thereby abandoned at any time prior to the closing under certain specified circumstances. Either the Company or Clywedog may terminate the Merger Agreement if, among other things: (i) the closing date will not have occurred by September 30, 2026, subject to up to a 60 day extension if the U.S. Securities and Exchange Commission (the “SEC”) has not declared effective the Registration Statement by July 31, 2026, (ii) a governmental authority of competent jurisdiction has issued a final, non-appealable order prohibiting the Contemplated Transactions, (iii) the required Company shareholder approval or Clywedog shareholder approval is not obtained in accordance with the Merger Agreement, (iv) the Scheme of Arrangement is not sanctioned by the Court, or (v) another party breaches or fails to perform in any material respect any of its covenants or any of the other party’s representations or warranties are inaccurate and such breach, failure to perform or inaccuracy would result in certain of the closing conditions not being satisfied, subject to a cure period.
Basis of presentation
The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the "SEC") for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Certain notes or other information that are normally required by GAAP have been omitted if they substantially duplicate the disclosures contained in the Company’s annual audited consolidated financial statements. Accordingly, the unaudited condensed consolidated financial statements should be read in connection with the Company’s audited consolidated financial statements and related notes as of and for the year ended December 31, 2024. The condensed consolidated balance sheet as of December 31, 2024, was derived from the audited financial statements but does not contain all of the footnote disclosures from the annual financial statements.
As of September 30, 2025, the Company had cash, cash equivalents and restricted cash of $ 75.7 million and an accumulated deficit of $ 293.0 million, and the Company expects to incur losses for the foreseeable future. The Company expects that its cash, cash equivalents and restricted cash will be sufficient to fund current operations for at least the next twelve months from the issuance of these condensed consolidated financial statements. The Company expects to continue to incur costs and expenditures in connection with the process of consummating the Contemplated Transactions. If such
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
activities are not successful, the Company expects to seek additional funding through equity financing, government or private-party grants, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or rights of the Company’s stockholders. If the Company is unable to obtain sufficient capital, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. If the Contemplated Transactions are consummated, any additional funding will be sought by the combined company.
The unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.
Unaudited Condensed Consolidated Financial Information
The accompanying Condensed Consolidated Balance Sheets as of September 30, 2025, and December 31, 2024, the Condensed Consolidated Statements of Operations and Comprehensive Loss, Condensed Consolidated Statements of Changes in Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2025 and 2024 are unaudited. These unaudited condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities Exchange Commission (the “Annual Report”) on March 20, 2025. In the Company's opinion, the unaudited condensed consolidated financial statements include all adjustments of a normal recurring nature necessary for the fair statement of its financial position as of September 30, 2025, its results of operations for the three and nine months ended September 30, 2025, and 2024, and its cash flows for the nine months ended September 30, 2025, and 2024. The results of operations 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, or any other interim periods.
2. Summary of Significant Accounting Policies
The accounting policies of the Company are set forth in Note 2 to the consolidated financial statements contained in the Annual Report, except as discussed below related to newly adopted accounting pronouncements.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of income and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions.
During the current quarter, the Company updated certain estimates related to the carrying value of long-lived assets as a result of the announced Contemplate Transactions with Clywedog. The adjustment reflects updated assumptions regarding expected future cash flows and market participant perspectives. Additional information regarding this change in estimate and its impact on the financial statements is included in Note 7.
As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any other specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the unaudited condensed consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Recently issued accounting pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company can adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
The Company has reviewed all recently issued standards and have determined that such standards do not or are not expected to have a material impact on its condensed consolidated financial statements or do not otherwise apply to its current operations.
In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity. This ASU amends the guidance for identifying the accounting acquirer in transactions involving variable interest entities (“VIEs”) where the transaction is achieved primarily through the exchange of equity interests, aligning it more closely with the guidance for voting interest entities. The amendments are effective for fiscal years beginning after December 15, 2026, including interim periods within those fiscal years, with early adoption permitted. The Company elected to early adopt ASU 2025-03 as of July 1, 2025. The adoption did not have a material impact on the our consolidated financial statements. The Company will apply the amended guidance prospectively to applicable transactions.
In January 2025, the FASB issued ASU 2025-01, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, in which the Board's intent in the basis of conclusion of Update 2024-03 is clear that all public business entities should initially adopt the disclosure requirements in the first annual reporting period beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact of adopting this standard to determine its impact on its disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), which requires disaggregation of specific expense categories in the notes to the financial statements and a qualitative description of the remaining expense amounts not separately disaggregated. This standard is effective for annual reporting periods beginning after December 15, 2026, and requires prospective application with the option to apply it retrospectively. The Company is currently evaluating the impact of adopting this standard to determine its impact on its disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). This standard is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of adopting this standard to determine its impact on its disclosures.
3. Segment information
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 Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The CODM approves key operating and strategic decisions, including key decisions in clinical development and clinical operating activities, entering into significant contracts and approves the Company's consolidated operating budget. The Company views its operations and manages its business as one operating segment, the research and development of immunotherapies and vaccines. The CODM uses loss before income tax to monitor budget versus actual results and decide how to use the Company's resources. As the Company operates in one operating segment, all required financial segment information can be found in these condensed consolidated financial statements. The following table is a summary of the Company's significant segment expenses:
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Three months ended September 30, 2025 Three months ended September 30, 2024 Change
Direct research and development expenses:
VTP-1000 Celiac $ 1,420 $ 1,751 $ ( 331 )
VTP-300 HBV 1,632 2,748 ( 1,116 )
Other clinical programs 1
— 1,308 ( 1,308 )
Other pre-clinical programs 437 707 ( 270 )
Total direct research and development expenses 3,489 6,514 ( 3,025 )
Indirect research and development expenses:
Personnel-related (including share-based compensation) 2
1,667 3,871 ( 2,204 )
Facility related 166 214 ( 48 )
Other indirect costs 68 540 ( 472 )
Total indirect research and development expenses 1,901 4,625 ( 2,724 )
Total research and development expenses $ 5,390 $ 11,139 $ ( 5,749 )
Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
Direct research and development expenses:
VTP-1000 Celiac $ 4,184 $ 4,496 $ ( 312 )
VTP-300 HBV 4,819 7,695 ( 2,876 )
Other clinical programs 1
1,384 4,201 ( 2,817 )
Other pre-clinical programs 1,305 2,398 ( 1,093 )
Total direct research and development expenses 11,692 18,790 ( 7,098 )
Indirect research and development expenses:
Personnel-related (including share-based compensation) 2
8,061 12,968 ( 4,907 )
Facility related 850 947 ( 97 )
Other indirect costs 1,030 1,221 ( 191 )
Total indirect research and development expenses 9,941 15,136 ( 5,195 )
Total research and development expenses $ 21,633 $ 33,926 $ ( 12,293 )
1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”)). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
2 This includes $ 0.1 million and $ 0.2 million for the three and nine months ended September 30, 2025, respectively (three and nine months ended September 30, 2024:$ 0.6 million and $ 0.6 million, respectively) of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The Company operates in two geographic regions: the U.S. and the U.K. The following table summarizes the Company’s assets held for sale and long-lived assets, which include the Company’s intangible assets, property and equipment, net, and right-of-use assets, by geography:
September 30, 2025 December 31, 2024
United States
$ 21,490 $ 28,907
United Kingdom
138 4,797
$ 21,628 $ 33,704
4. Foreign Currency Translation in General and Administrative Expenses
The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three and nine months ended September 30, 2025 was a gain of $ 3.0 million and loss of $ 9.4 million, respectively (three and nine months ended September 30, 2024: $ 7.7 million loss and $ 6.6 million loss, respectively).
5. Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2025, and 2024 (in thousands, except number of shares):
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Numerator:
Net loss $ ( 14,571 ) $ ( 8,129 ) $ ( 55,355 ) $ ( 40,592 )
Net loss attributable to noncontrolling interest 5 15 17 58
Net loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 14,566 ) $ ( 8,114 ) $ ( 55,338 ) $ ( 40,534 )
Denominator:
Weighted-average ordinary shares outstanding, basic 40,661,118 39,419,447 40,424,735 39,079,259
Weighted-average ordinary shares outstanding, diluted 40,661,118 39,419,447 40,424,735 39,079,259
Net loss per share attributable to ordinary shareholders, basic $ ( 0.36 ) $ ( 0.21 ) $ ( 1.37 ) $ ( 1.04 )
Net loss per share attributable to ordinary shareholders, diluted $ ( 0.36 ) $ ( 0.21 ) $ ( 1.37 ) $ ( 1.04 )
Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share, as the inclusion of all potential ordinary share equivalents outstanding would have been anti-dilutive. As of September 30, 2025, 6,231,609 potential ordinary shares issuable for stock options were excluded from the computation of diluted weighted-average shares outstanding because including these shares would have had an anti-dilutive effect (September 30, 2024: 7,340,000 ).
6. Property and Equipment, Net
Depreciation expense for the three and nine months ended September 30, 2025 was $ 0.1 million and $ 2.6 million, respectively (three and nine months ended September 30, 2024: $ 0.7 million and $ 2.0 million, respectively).
During the three and nine months ended September 30, 2025, the Company recorded a gain of $ 0.05 million and $ 0.3 million, respectively, from the sale of U.K. laboratory equipment (three and nine months ended September 30, 2024: nil ). The recorded associated proceeds from the equipment sale for the three and nine months ended September 30, 2025 was $ 0.2 million and $ 0.7 million, respectively (three and nine months ended September 30, 2024: nil ).
As of September 30, 2025, the Company had $ 0.1 million (December 31, 2024: nil ) of U.K. laboratory equipment as held for sale in the condensed consolidated balance sheet. The Company measures assets held for sale at the lower of the carrying amount or fair value less cost to sell. The sale of U.K. laboratory equipment is expected to be completed in 2025.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
7. Intangible Assets, Net
The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of both September 30, 2025 and December 31, 2024, and accumulated amortization was $ 16.7 million and $ 9.7 million as of September 30, 2025 and December 31, 2024, respectively. For the three and nine months ended September 30, 2025 impairment of long-lived assets expense was $ 4.7 million (three and nine months ended September 30, 2024: nil ). The amortization expense for the three and nine months ended September 30, 2025 was $ 0.8 million and $ 2.4 million, respectively (three and nine months ended September 30, 2024: $ 0.8 million and $ 2.4 million, respectively). The estimated annual amortization expense is $ 2.5 million for the years 2025 through 2031.
During the quarter ended September 30, 2025, the Company announced it had entered into a definitive merger agreement to combine in an all-stock transaction with Clywedog. The indicative offer price was below fair value of the Company's net assets expected at completion and below prior valuations utilized in our most recent impairment assessments, thereby constituting an impairment triggering event. As a result, the Company recorded a total impairment charge for acquired development technology intangible assets of $ 4.7 million during the quarter. The determination of the fair value of the Company's net assets expected at completion, is a non-recurring fair value measurement. Additional triggers for impairment may be identified prior to completion of the Contemplated Transactions, as the purchase price accounting is finalized.
8. Prepaid Expenses and Other Current Assets (in thousands):
September 30,
2025 December 31,
2024
Prepayments $ 5,412 $ 5,771
Value Added Tax receivable 189 —
Accrued income 72 88
Other 663 344
Total $ 6,336 $ 6,203
9. Accrued Expenses and Other Current Liabilities (in thousands):
September 30,
2025 December 31,
2024
Accrued manufacturing and clinical expenses $ 2,079 $ 3,326
Value Added Tax payable — 2,416
Accrued bonus 308 1,774
Accrued payroll and employee benefits 621 656
Accrued professional fees 2,473 737
Accrued other 1
1,200 616
Total $ 6,681 $ 9,525
1 Included in Accrued other as of September 30, 2025 is a provision of $ 0.7 million for severance costs for the reduction in workforce.
10. Grant Income
Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
On December 20, 2023, Barinthus Biotherapeutics (UK) Limited, the Chancellors, Masters and Scholars of the University of Oxford (“Oxford,” together with Barinthus Biotherapeutics (UK) Limited, the “Partners”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) entered into a Funding Agreement (the “Funding Agreement”) pursuant to which CEPI will provide funding of up to $ 34.8 million to the Company to advance the development of VTP-500, the
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Company’s vaccine candidate against Middle East Respiratory Syndrome (“MERS,” and such development activities, the “Project”). In December 2023, VTP-500 received PRIME (PRIority MEdicines) designation by the European Medicines Agency. There have been no changes to the terms or conditions of the grant since the previous reporting period.
In January 2025, the Company announced its strategic focus on developing a pipeline in I&I, and the deprioritization of its programs in infectious disease and oncology. The Company intends to exit the Funding Agreement as part of aligning resources in accordance with the Company's strategy.
During the nine months period ended September 30, 2025, nil (September 30, 2024: $ 3.0 million) proceeds have been received. For the three and nine months ended September 30, 2025 $ 0.1 million and $ 0.4 million, respectively (three and nine months ended September 30, 2024: $ 0.2 million and $ 1.0 million, respectively) income has been recognized in relation to this contract. This is presented as other operating income in the condensed consolidated statements of operations and comprehensive loss.
The Funding Agreement cash payments are restricted as to the use and management of the funds. The remaining unused amounts of the Funding Agreement cash payments of $ 1.4 million as of September 30, 2025 (December 31, 2024: $ 1.7 million) are reflected in restricted cash in the condensed consolidated balance sheets until expenditures contemplated in the Funding Agreement are incurred.
Deferred income
Deferred income relates to payments received from CEPI in advance of the eligible research and development expenses being incurred and are disclosed as deferred income separately in the condensed consolidated balance sheets. Deferred income is released to the condensed consolidated statements of operations and comprehensive loss in the period in which such research and development activities are actually performed in a manner that satisfies the conditions of the Funding Agreement.
Changes in deferred income during the three and nine months ended September 30, 2025 and 2024, are as follows (in thousands):
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Beginning balance $ 1,525 $ 839 $ 1,738 $ —
Cash payments received — 1,360 — 2,989
Other operating income recognized related to the Funding Agreement ( 84 ) ( 210 ) ( 426 ) ( 992 )
Foreign exchange translation ( 38 ) 55 91 47
Ending balance $ 1,402 $ 2,044 $ 1,402 $ 2,044
11. Ordinary Shares
All ordinary shares rank pari passu as a single class. The following is a summary of the rights and privileges of the holders of ordinary shares as of September 30, 2025:
Liquidation preference: in the event of the liquidation, dissolution or winding up of the Company, the assets of the Company available for distribution to holders of the ordinary shares shall be distributed amongst all holders of the ordinary shares in proportion to the number of shares held irrespective of the amount paid or credited as paid on any share.
Dividends: The Company may, subject to the provisions of the Companies Act 2006 and its Articles, by ordinary resolution from time to time declare dividends to be paid to shareholders not exceeding the amount recommended by the Company’s board of directors. Subject to the provisions of the Companies Act 2006, insofar as, in the board of directors’ opinions, the Company’s profits justify such payments, the board of directors (the "Board") may pay interim dividends on the Company’s ordinary shares.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Voting Rights: Each holder of ordinary shares has the right to receive notice of, and to vote at, the Company’s general meetings. Each holder of ordinary shares who is present (in person or by proxy) at a general meeting on a show of hands has one vote and, on a poll, every such holder who is present (in person or by proxy) has one vote in respect of each share of which they are the holder.
Preemption rights: Pursuant to section 561 of the Companies Act 2006, shareholders are granted preemptive rights when new shares are issued for cash. However, it is possible under the Articles, for shareholders at a general meeting representing at least 75 % of the Company's ordinary shares present (in person or by proxy) and eligible to vote at that general meeting, to disapply these preemptive rights by passing a special resolution. Such a disapplication of preemption rights may be for a maximum period of up to five years from the date on which the shareholder resolution was passed. In either case, this disapplication would need to be renewed by the Company's shareholders upon its expiration ( i.e. , at least every five years ) to remain effective.
On April 21, 2021, the Company's shareholders approved the disapplication of preemptive rights for a period of five years from the date of approval by way of a special resolution of shareholders. This included the disapplication of preemption rights in relation to the allotment of the Company's ordinary shares in connection with the initial public offering ("IPO"). This disapplication will need to be renewed upon expiration ( i.e. , at least every five years ) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
On November 6, 2023, the Company held a general meeting where its shareholders approved resolutions granting the Board or any duly authorized committee of the Board the authority to allot shares in the Company or grant rights to subscribe for or to convert any security into shares in the Company free from pre-emption rights. Pursuant to such approval, the Board was authorized to allot shares up to an aggregate nominal amount of £ 1,928 free from statutory pre-emption rights. The granting of this authority and the corresponding disapplication of preemptive rights was in addition to all subsisting authorities. This disapplication will need to be renewed upon expiration ( i.e. , at least every five years ) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
12. Deferred Shares
All deferred shares rank pari passu as a single class. The deferred shares do not have rights to dividends or to any other right of participation in the profits of the Company. On a return of assets on liquidation, the deferred shares shall confer on the holders thereof an entitlement to receive out of the assets of the Company available for distribution amongst the shareholders (subject to the rights of any new class of shares with preferred rights) the amount credited as paid up on the deferred shares held by them respectively after (but only after) payment shall have been made to the holders of the ordinary shares of the amounts paid up or credited as paid up on such shares and the sum of £ 1.0 million in respect of each ordinary share held by them respectively. The deferred shares shall confer on the holders thereof no further right to participate in the assets of the Company. The Company’s deferred A shares with a nominal value of £ 1.00 each remain in issue for the purposes of satisfying the minimum share capital requirements for a public limited company as prescribed by the Companies Act 2006.
13 . Fair Value
The Company’s financial instruments consist of cash, cash equivalents and restricted cash, accounts payable, certain accrued expenses, and contingent consideration. The carrying amounts of cash, cash equivalents and restricted cash, accounts payable and accrued expenses approximated their respective fair value due to the short-term nature and maturity of these instruments.
As of September 30, 2025, the Company had a contingent consideration liability of $ 2.5 million related to the acquisition of Avidea. Avidea’s stockholders may be entitled to receive an aggregate of up to $ 40.0 million in additional payments, payable in a combination of cash and American Depositary Shares, upon the achievement of certain milestones. To date, the Company has made settlement payments of $ 0.5 million. The fair value of the contingent consideration is a Level 3 valuation and determined using the cost approach. The significant unobservable inputs used in the fair value measurement of the contingent consideration are the probability of success of achievement of the milestones and the expected date of the milestone achievement. Significant judgment is employed in determining the appropriateness of certain of these inputs. Significant increases (decreases) in the probability of success of achievement of the milestones would have resulted in a significantly higher (lower) fair value measurement. Significant extension (reduction) in the expected date of the milestone achievement would have resulted in a significantly lower (higher) fair value measurement.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following table summarizes changes to the Company's financial instruments carried at fair value and classified within Level 3 of the fair value hierarchy (in thousands):
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Beginning balance $ 2,544 $ 1,888 $ 2,650 $ 1,823
Change in fair value recognized in net loss 17 ( 378 ) ( 322 ) ( 300 )
Foreign exchange translation recognized in other comprehensive loss ( 53 ) 100 180 87
Ending balance $ 2,508 $ 1,610 $ 2,508 $ 1,610
14. Share-Based Compensation
During the nine month period ended September 30, 2025, in accordance with the terms of the Annual Increase of the Barinthus Biotherapeutics plc Award Plan 2021 (the “Plan”), the total number of ordinary shares available for issuance under the Plan increased by 4 % of the Company’s issued and outstanding ordinary shares as of January 1, 2025.
For the nine months ended September 30, 2025, the Company granted 1,470,812 options to employees and directors with a weighted average grant date fair value of $ 0.85 per share and a weighted average exercise price of $ 1.00 per share (September 30, 2024: granted 1,953,422 options, weighted average grant date fair value of $ 2.71 per share and a weighted average exercise price of $ 3.41 per share). For the nine months ended September 30, 2025, 1,931,878 options (September 30, 2024: 658,512 ) were forfeited.
The fair value of each stock option issued to employees was estimated at the date of grant using the Black-Scholes model with the following weighted-average assumptions:
Nine months ended September 30,
2025 2024
Expected volatility 114.1 % 108.7 %
Expected term (years) 6.0 6.0
Risk-free interest rate 4.4 % 4.0 %
Expected dividend yield — % — %
As of September 30, 2025, 6,231,609 options with a weighted average exercise price of $ 6.21 per share were outstanding (September 30, 2024: 7,340,000 options with a weighted average exercise price of $ 6.03 per share were outstanding). As of September 30, 2025, there was $ 1.0 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.7 years.
Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Research and development $ ( 308 ) $ 394 $ ( 241 ) $ 1,611
General and administrative ( 107 ) 750 13 2,343
Total $ ( 415 ) $ 1,144 $ ( 228 ) $ 3,954
15. Commitments and Contingencies
In-License Agreements
The Company is party to a number of licensing agreements, most of which are with related parties. These agreements serve to provide the Company with the right to develop and exploit the counterparties’ intellectual property for certain medical
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
indications. As part of execution of these arrangements, the Company paid certain upfront fees, which have been expensed as incurred because the developing technology has not yet reached technical feasibility, the lack of alternative use, and the lack of proof of potential value. The agreements cover a variety of fields, including influenza, cancer, human papillomavirus infection, (“HPV”), hepatitis B virus (“HBV”) and MERS. The Company’s obligations for future payments under these arrangements are dependent on its ability to develop promising drug candidates, the potential market for these candidates and potential competing products, and the payment mechanisms in place in countries where the Company retains the right to sell. Each agreement provides for specific milestone payments, typically triggered by achievement of certain testing phases in human candidates, and future royalties ranging from 1 % to 5 % for direct sales of a covered product to 3 % to 7 % of net payments received for allowable sublicenses of technology developed by the Company. The obligation to make these payments is contingent upon the Company’s ability to develop candidates for submission for phased testing and approvals, and for the development of markets for the products developed by the Company. The Company has not made or accrued any material payments under these license agreements during the nine month periods ended September 30, 2025 and 2024.
Leases
The Company leases certain laboratory and office space under operating leases, which are described below.
The Harwell Science and Innovation Campus, Oxfordshire
On September 3, 2021, the Company entered into a lease agreement for the lease of approximately 31,000 square feet in Harwell, Oxfordshire which expires in September 2031. As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment. The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
In August 2025, the Company ceased the research and development activities undertaken in the laboratory and is transitioning the remaining clinical and operational workforce to remote roles. The Company is actively marketing the building in Harwell, Oxfordshire, for the remainder of the lease. In 2024, an impairment charge to write down the U.K. operating lease right-of-use asset to the estimated recoverable amount has been recorded and the estimated useful life of the asset reduced.
Germantown, Maryland
On June 14, 2022, the Company entered into a lease agreement for the lease of approximately 19,700 square feet in Germantown, Maryland. The site houses the Company’s state-of-the-art wet laboratory in the United States of America. The lease expires on February 28, 2034, with the Company having a single right to extend for an additional five years on the same terms and conditions other than for the base rent. The Company had a rent-free period up to February 29, 2024, and was entitled to up to $ 3.5 million for leasehold improvements to the premises desired by the Company. The Company has provided the lessor with a refundable security deposit of $ 0.2 million which is included in Other assets.
The Company recorded a right-of-use asset and a lease liability on the effective date of the lease term. The Company’s right-of-use asset and lease liability are as follows (in thousands):
September 30,
2025 December 31,
2024
Right-of-use asset $ 2,063 $ 4,384
Lease liability, current $ 2,017 $ 1,920
Lease liability, non-current $ 9,553 $ 10,087
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Nine months ended September 30,
2025 2024
Other information
Operating cash flows from operating leases $ 1,477 $ 1,306
Weighted average remaining lease term (years) 7.22 8.19
Weighted average discount rate 7.5 % 7.5 %
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Lease Cost
Operating leases 1,449 369 $ 3,108 $ 1,086
Total lease cost $ 1,449 $ 369 $ 3,108 $ 1,086
Future annual minimum lease payments under operating leases as of September 30, 2025, were as follows (in thousands):
Remainder of 2025 $ 503
2026 2,023
2027 2,047
2028 2,073
2029 2,099
Thereafter 6,067
Total minimum lease payments $ 14,812
Less: imputed interest ( 3,242 )
Total lease liability $ 11,570
Contemplated Transactions
On September 29, 2025, the Company entered into a merger agreement to combine with Clywedog, a private company advancing novel breakthrough medicines in diabetes. The Contemplated Transactions are expected to close in the first half of 2026, subject to customary closing conditions. In connection with this strategic combination, the Company may incur additional or contingent costs, including transaction-related legal and advisory fees, and other expenses. The timing and magnitude of these costs remain uncertain, and the Company has not accrued future strategic transaction costs as of the period ended September 30, 2025, as the obligations will arise as the transaction progresses to close. Regardless of the outcome, there are anticipated additional costs and a focus of management resources on the strategic transaction which may or may not complete.
Other contingencies
As of the date of this Quarterly Report on Form 10-Q, the Company does not believe it is party to any claim or litigation the outcome of which, if determined adversely to it, would individually or in the aggregate be reasonably expected to have a material adverse effect on the Company's business. However, from time to time, the Company could be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. Regardless of the outcome, legal proceedings can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors.
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BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
16. Related Party Transactions
During the three and nine months ended September 30, 2025, the Company recognized license revenue of nil (three and nine ended September 30, 2024: $ 15.0 million), from Oxford University Innovation Limited, which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
During the three and nine months ended September 30, 2025, the Company incurred expenses, related to clinical study costs, of $ 0.1 million and $ 0.4 million, respectively (three and nine months ended September 30, 2024: $ 0.2 million and $ 0.7 million, respectively) from Oxford University Innovation Limited.
17. Subsequent Events
In October 2025 the Company granted an aggregate of 886,018 restricted stock units (“RSUs”) to employees under the Plan. The RSUs will vest in full following the closing of the Contemplated Transactions, subject to the employee’s continued employment with the Company through such vesting date, and were granted as part of the Company’s equity incentive program to support employee retention and alignment with shareholder interests. The financial impact of this grant will be reflected in future periods in accordance with applicable accounting standards
In October 2025, the Company received $ 3.6 million in cash related to the research and development (“R&D”) tax credit on qualifying expenditures incurred during the financial year ended December 31, 2024.
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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 appearing elsewhere in this unaudited Quarterly Report on Form 10-Q and our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 20, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties, and assumptions. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report on Form 10-K and in other filings with the SEC.
Overview
We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the I&I space. Helping patients and their families is the guiding principle at the heart of Barinthus Bio. We aim to achieve this by developing truly transformational and highly disease-specific immunotherapies.
We are prioritizing the development of a pipeline for I&I indications enabled by our proprietary and highly differentiated platform for promoting immune tolerance, referred to as SNAP-TI, that are designed to guide patient's T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease, and is currently being assessed in a Phase 1 clinical trial. Based on encouraging preclinical data, we believe that the SNAP-TI platform has the potential to impact multiple other I&I indications.
We are also evaluating a product candidate to treat infectious disease that harnesses our proprietary viral vector platform technologies, consisting of ChAdOx and MVA; these technologies are designed to increase disease-specific CD8+ T cells. VTP-300, a Phase 2 immunotherapeutic treatment modality that is a component of a treatment regimen to establish functional cure in patients who are chronically infected by the hepatitis B virus. We intend to progress the development of this product candidate by completing the ongoing clinical trials and are seeking a partner or collaborator for continuing development.
We believe our core capabilities at the intersection of T cell immunology and immunotherapeutic technology platforms combined with our track record of successfully executing development path activities uniquely position us to navigate towards delivering promising new treatments for patients with autoimmune and inflammatory diseases and building value for shareholders.
We have incurred net losses in each annual and interim reporting period since 2023. For the three and nine months ended September 30, 2025, we incurred a net loss of $14.6 million and $55.4 million, respectively. As of September 30, 2025, we had an accumulated deficit of $293.0 million, and we do not currently expect positive cash flows from operations in the foreseeable future. We expect to incur net operating losses for at least the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for approval, and in some cases proceed to commercialization of our product candidates, as well as continue our research and development efforts, as and when appropriate.
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At this time, we cannot reasonably estimate, or know the nature, timing and estimated costs of all of the efforts that will be necessary to complete the development of any of our product candidates that we develop through our programs. We are also unable to predict when, if ever, material net cash inflows will commence from sales of product candidates we develop, if at all. This is due to the numerous risks and uncertainties associated with developing product candidates to approval and commercialization, including the uncertainty of:
• successful completion of preclinical studies and clinical trials;
• sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
• acceptance of investigational new drug applications (“INDs”) for our planned clinical trials or future clinical trials;
• successful and timely enrollment and completion of clinical trials;
• data from our clinical program supporting approvable and commercially acceptable risk/benefit profiles for our product candidates in the intended populations;
• receipt and maintenance of necessary regulatory and marketing approvals from applicable regulatory authorities, in the light of the commercial environment then existent;
• availability and successful procurement of raw materials required to manufacture our products for clinical trials, scale-up of our manufacturing processes and formulation of our product candidates for later stages of development and commercial production;
• establishing either our own manufacturing capabilities or satisfactory agreements with third-party manufacturers for clinical supply for later stages of development and commercial manufacturing;
• entry into collaborations or partnerships, where appropriate, to further the development of our product candidates;
• obtaining and maintaining intellectual property and trade secret protection or regulatory exclusivity for our product candidates as well as qualifying for, maintaining, enforcing and defending such intellectual property rights and claims;
• successfully launching or assisting with the launch of commercial sales of our product candidates following approval;
• acceptance of each product’s benefits and uses by patients, the medical community and third-party payors following approval;
• the prevalence and severity of any adverse events experienced with our product candidates in development;
• establishing and maintaining a continued acceptable safety profile of the product candidates following approval;
• obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors if necessary or desirable; and
• effectively competing with other therapies.
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 of that product candidate, in either direction. Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans. Unless and until we can generate a substantial amount of revenue from our product candidates, if approved, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing. Based on our current standalone research and development plans, we expect that our existing cash, cash equivalents, restricted cash and other financial resources will enable us to fund our operating expenses and capital expenditure requirements into the start of 2027. These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
If we raise additional funds through collaborations, strategic alliances, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
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Recent Developments
VTP-1000: Celiac Disease
The single ascending dose ( “ SAD ” ) part of the Phase 1 AVALON clinical trial of VTP-1000 in patients with celiac disease is ongoing, with no treatment related serious adverse events reported to date. We anticipate announcing data from the SAD phase of the trial before the end of 2025. The multiple ascending dose part of the Phase I Avalon clinical trial has commenced enrolling patients, and data are expected in the second half of 2026.
Merger Agreement with Clywedog
On September 29, 2025, we entered into the Merger Agreement with Topco, Merger Sub and Clywedog. The Merger Agreement provides that, among other things, upon the terms and subject to the conditions set forth therein (i) Topco will acquire our entire issued and to be issued share capital pursuant to a scheme of arrangement (subject to any modification, addition or condition which (a) we, Topco and Clywedog mutually agree and which (if required) is approved by the Court or (b) is otherwise imposed by the Court and mutually acceptable to us, Topco and Clywedog, each acting reasonably and in good faith, in each case in accordance with the Scheme of Arrangement, resulting in us becoming a direct wholly owned subsidiary of Topco, and (ii) Merger Sub will merge with and into Clywedog, with Clywedog continuing as the surviving corporation and a direct wholly owned subsidiary of Topco in accordance with the Delaware General Corporations Law. The Scheme Transaction will be consummated prior to the Merger.
At the Scheme Effective Time, upon the terms and subject to the conditions set forth in the Merger Agreement, Topco will acquire each of our outstanding ordinary shares, which, for the avoidance of doubt, will include ordinary shares held by the Depositary (or to the extent that the Depositary is not itself the registered holder of such shares that underly the ADSs, each representing one (1) ordinary share, whichever nominee, custodian or other entity is the registered holder under the terms of the Deposit Agreement, dated as of April 29, 2021, among us, the Depositary, and all holders from time to time of the ADSs, as may be amended from time to time), from the holders of Scheme Shares whose names appear in our register of members at the Scheme Effective Time) in accordance with the provisions of the Scheme of Arrangement, and each Scheme Share will be converted into the right to receive (i) one (1) share of Topco Common Stock subject to and strictly in accordance with the terms of the Scheme of Arrangement plus (ii) cash in lieu of any fractional shares, rounded down to the nearest whole share. Following the Scheme Effective Time, Topco may in its discretion elect to commence a Self-Tender Offer to purchase up to $27,000,000 in shares of Topco Common Stock then issued and outstanding, which Self-Tender Offer, if elected, will be consummated prior to the Merger.
At the Merger Effective Time, subject to adjustment in accordance with the terms of the Merger Agreement, each share of Clywedog Common Stock and each share of Clywedog Preferred Stock, other than Clywedog Capital Stock held as treasury stock or owned by Topco or Merger Sub immediately prior to the Merger Effective Time, will be converted solely into the right to receive (i) 4.358932 of shares of Topco Common Stock plus (ii) cash in lieu of any fractional shares, rounded down to the nearest whole share.
If the Scheme Transaction is consummated, our ordinary shares will be delisted from the Nasdaq and deregistered under the Exchange Act. Topco will apply to list the shares of Topco Common Stock to be issued in the Combinations on Nasdaq effective immediately following the Merger Effective Time.
The newly combined company will advance a novel portfolio of clinical-stage candidates targeting metabolic and autoimmune diseases, with four clinical data milestones expected within 18 months of the closing of the Contemplated Transactions . Upon the closing of the Contemplated Transactions , the combined company will be renamed “Clywedog Therapeutics Holdings, Inc.” and is expected to trade on the Nasdaq Stock Market under the new ticker symbol “CLYD.” The Contemplated Transactions are expected to close in the first half of 2026, with the combined company supported by existing cash and additional investments by entities managed by OrbiMed and TPAV, LLC, both existing shareholders in Clywedog, and new investors.
Impact of International Conflicts
In respect of the international conflicts in Gaza, Ukraine and Iran, we have no operations or suppliers based in Israel, Gaza, Ukraine, Belarus, Russia, or Iran, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on our business, operations and financial condition will be minimal.
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Impact of Global Economic Conditions and Inflationary Pressures
Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on our results of operations and financial condition. Inflationary pressures, volatile interest rates, or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets. Additionally, we may incur future increases in operating costs due to additional inflationary increases.
Components of Our Operating Results
Operating Expenses
Our operating expenses since inception have consisted of research and development costs and general and administrative costs.
Research and Development Expenses
Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a next-generation adenoviral vector, acquiring new technology platforms including SNAP-TI, conducting preclinical studies, developing various manufacturing processes, and advancing our clinical programs. Research and development activities account for a large portion of our operating expenses, and product candidates in later stages of development generally have higher development costs than those in earlier stages, due to larger and more complex clinical trials, manufacturing scale-up and an increase in research and development headcount to oversee these activities. We are currently seeking partners to fund or collaborate on certain of our programs, including VTP-300 and VTP-850, which we do not intend to develop beyond the completion of the ongoing trials, as applicable. We expect research and development expenses to increase in the future as we progress our program through the next stage of development. Research and development costs are expensed as incurred. These costs include:
• salaries, benefits, and other related costs, including share-based compensation, for personnel engaged in research and development functions;
• expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations ( “ CROs ” );
• the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as contract manufacturing organizations, consultants and contractors;
• laboratory costs; and
• leased facility costs, equipment depreciation and other expenses, which include direct and allocated expenses.
General and Administrative Expenses
Our general and administrative expenses consist primarily of personnel-related expenses, including share-based compensation, in our executive, finance, business development and other administrative functions. Other general and administrative expenses include consulting fees and professional service fees for auditing, tax and legal services, rent expenses related to our offices, depreciation, foreign exchange gains and losses on our cash balances, other central non-research costs and changes in the fair value of contingent consideration. When determining the fair value of contingent consideration, significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.
Our general and administrative expenses would continue to increase in the future if we expand our operating activities and if we seek to manufacture and/or commercialize any of our current and future product candidates. These costs will increase if our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market ( “ Nasdaq ” ) and the SEC, directors’ and officers’ liability insurance premiums and investor relations activities.
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Other Operating Income
Other operating income includes the CEPI Funding Agreement pursuant to which CEPI will provide funding to us to advance the development of VTP-500, our vaccine candidate against MERS. When there is reasonable assurance that we will comply with the conditions attached to a received grant, and when there is reasonable assurance that the grant will be received, grant income is recognized as other operating income on a gross basis in the condensed consolidated statements of operations and comprehensive loss on a systematic basis over the periods in which the Company recognizes expenses for the related costs for which the grants are intended to compensate. Payments received in advance of incurring reimbursable expenses are recorded as deferred income. Any remaining unused amounts of the cash payments received on the balance sheets will be disclosed as restricted cash in the notes of the condensed consolidated financial statements.
Other Income/(Expense)
Interest Income
Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
Research and development incentives contain payments receivable from the United Kingdom government related to corporation tax relief for qualifying expenditure on research and development projects in the United Kingdom. We account for such relief received as other income. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs, externally provided workers and utilities costs incurred as part of research projects. A large portion of costs relating to research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims.
For 2025, we benefit from the applicable United Kingdom research and development tax credit regime, which is the merged scheme Research & Development expenditure credit ( “ RDEC ” ) and enhanced R&D intensive support ( “ ERIS ” ) that replaces the old RDEC and small and medium-sized enterprise ( “ SME ” ) schemes for accounting periods beginning on or after April 1, 2024. For expenditure under the merged scheme, the rate of Research and Development expenditure credit is 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023. For loss-makers and small profit-makers, a lower rate of notional tax restriction (currently 19%) applies at payment. The amount of the Pay As You Earn ( “ PAYE ” ) cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities. The PAYE cap (where applicable) will limit the amount of payable credit that can be received in the accounting period under consideration. Any excess over the cap will be carried forward and treated as an amount of Research and Development expenditure credit to which the company will be entitled for the next accounting period. Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit. Furthermore, legislation included in Finance Act 2024 restricts the extent to which payments to contractors for R&D and externally provided workers can qualify for R&D relief where R&D activity takes place outside the U.K., which may restrict the ability to include cost incurred on externally provided workers based in the U.S.
For 2024, we benefited from the applicable United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program ( “ SME Program ” ), and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program. Under the SME Program, we were able to surrender some of our trading losses that arise from qualifying research and development activities for a cash rebate of up to 18.6% of such qualifying research and development expenditure, as the SME additional deduction is 86% and the SME credit rate is 10%.
Under both the merged RDEC scheme and the SME program, a company qualifies as an R&D intensive business if R&D expenditure constitutes at least 30% of total expenditure. From the analysis performed, we have not and do not expect to claim under the loss-making R&D intensive scheme criteria primarily due to the proportion of total relevant expenditure occurring outside the United Kingdom.
In future years, we may not be able to continue to claim research and development tax credits under the United Kingdom research and development tax credit regime if we no longer qualify based on the eligibility criteria. Unsurrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of U.K. taxable profits. There was no tax loss restriction applied to the R&D tax credits in the U.K. for the nine months ended September 30, 2025 and 2024.
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Critical Accounting Policies and Use of Estimates
This discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of income and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of intangible assets. Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.
We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements and understanding and evaluating our reported financial results.
Long-lived Assets
We review long-lived assets to be held and used, including property and equipment, intangible assets and operating lease right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable. Evaluation of recoverability is first based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values.
In January 2025, we announced plans to prioritize our pipeline to focus on the development of VTP-1000 in celiac disease, and focus the future pipeline on I&I indications. In addition, we continued to experience a sustained decline in the price of our American Depositary Shares (“ADSs”), whereby the market capitalization continues to be below the value of our net assets. Given this change in our focus and sustained decline in share price, management identified circumstances that could indicate the carrying amount of our intangible assets may not be recoverable. Therefore, we performed both a qualitative and quantitative assessment in January 2025 and determined the carrying amount of our intangible assets are recoverable.
During the quarter ended September 30, 2025, we announced that we have entered into a definitive merger agreement to combine in an all-stock transaction with Clywedog. The indicative offer price was below fair value of the Company's net assets expected at completion and below prior valuations utilized in the Company's most recent impairment assessments, thereby constituting an impairment triggering event. As a result, the Company recorded a total impairment charge for acquired development technology intangible assets of $4.7 million during the quarter. The determination of the fair value of the Company's net assets expected at completion, is a non-recurring fair value measurement. Additional triggers for impairment may be identified prior to completion of the Contemplated Transactions, as the purchase price accounting is finalized.
Contingent Consideration
We recognize a contingent consideration liability related to the acquisition of Avidea. The liability is remeasured to fair value at each reporting date until the contingency is resolved. The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement. Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones. This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss. The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
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Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following table sets forth the significant components of our results of operations (in thousands):
Three months ended September 30, 2025 Three months ended September 30, 2024 Change
License revenue
$ — $ 14,969 (14,969)
Operating expenses:
Research and development
5,390 11,139 (5,749)
General and administrative 5,165 13,420 (8,255)
Impairment of long-lived assets 4,667 — 4,667
Total operating expenses 15,222 24,559 (9,337)
Other operating income 156 210 (54)
Loss from operations (15,066) (9,380) (5,686)
Other income/(expense)
Interest income 472 631 (159)
Interest expense (13) (17) 4
Research and development incentives 240 608 (368)
Other income (275) 26 (301)
Total other income 424 1,248 (824)
Loss before income tax
(14,642) (8,132) (6,510)
Tax benefit 71 3 68
Net loss $ (14,571) $ (8,129) $ (6,442)
Revenue
For the three months ended September 30, 2025, and 2024, our revenue consisted of nil and $15.0 million, respectively, from the OUI License Agreement Amendment with respect to amounts owed to us by OUI for the commercial sales of Vaxzevria. In 2024, AstraZeneca announced it had made the strategic decision to initiate the withdrawal of marketing authorization for Vaxzevria within Europe, citing decline in demand as the reason for the decision. We do not expect to receive any further payments relating to future commercial sales of Vaxzevria and, if such payments are due, that we will be notified of such payments in a timely manner.
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Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024 (in thousands):
Three months ended September 30, 2025 Three months ended September 30, 2024 Change
Direct research and development expenses:
VTP-1000 Celiac $ 1,420 $ 1,751 $ (331)
VTP-300 HBV 1,632 2,748 (1,116)
Other clinical programs 1
— 1,308 (1,308)
Other pre-clinical programs 437 707 (270)
Total direct research and development expenses 3,489 6,514 (3,025)
Indirect research and development expenses:
Personnel-related (including share-based compensation) 2
1,667 3,871 (2,204)
Facility related 166 214 (48)
Other indirect costs 68 540 (472)
Total indirect research and development expenses 1,901 4,625 (2,724)
Total research and development expenses $ 5,390 $ 11,139 $ (5,749)
1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”)).
2 This includes $0.1 million and $0.6 million for the three months ended September 30, 2025 and 2024, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
Our research and development expenses for the three months ended September 30, 2025 and 2024 were $5.4 million and $11.1 million, respectively.
Direct expenses for the three months ended September 30, 2025 and 2024 were $3.5 million and $6.5 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing. Of the $3.0 million decrease, $2.7 million pertains to a net decrease in spend across the infectious disease and oncology programs following the strategic decision to prioritize pipeline assets within the I&I space. Additionally, there was a $0.3 million decrease in spend on VTP-1000, as one-off trial initiation costs incurred in the third quarter of 2024 did not reoccur in the third quarter of 2025.
Indirect research and development expenses for the three months ended September 30, 2025 and 2024 were $1.9 million and $4.6 million, respectively. The decrease of $2.7 million relates primarily to the reduction in headcount and the associated personnel-related expense (including share-based compensation), combined with the closure of the U.K. laboratory which occurred in the third quarter of 2025 resulting in a reduction in the allocation of facility and other indirect costs to research and development.
General and Administrative Expenses
General and administrative expenses for the three months ended September 30, 2025 and 2024 were $5.2 million and $13.4 million, respectively. The decrease of $8.2 million relates primarily to a gain of $3.0 million on foreign exchange for the three months ended September 30, 2025, compared to a loss of $7.7 million for the three months ended September 30, 2024, primarily relating to an increase in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities. There has been an increase of $2.4 million in professional fees attributable to increased strategic activity, and an increase of $0.8 million in depreciation charges due to the decreased estimated useful lives of the U.K. right of use asset, leasehold improvements and laboratory equipment, offset by a decrease of $1.0 million in personnel-related expenses relating to the reduction in headcount.
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Impairment of long-lived assets expense
For the three months ended September 30, 2025 and 2024, impairment of long-lived assets expense was $4.7 million and nil, respectively. This increase relates to the impairment assessment performed during the third quarter of 2025, following an impairment triggering event identified in relation to the Company entering a definitive merger agreement to combine in an all-stock merger transaction with Clywedog. See Note 7 for further details.
Other Operating Income
For the three months ended September 30, 2025 and 2024, other operating income was $0.2 million and $0.2 million, respectively, primarily resulting from qualifying activity on the development of VTP-500 for the prevention of MERS and associated utilization of the funding provided by CEPI under the Funding Agreement. Minimal future activity is expected following the strategic decision to prioritize pipeline assets in the I&I space.
Interest Income
For the three months ended September 30, 2025 and 2024, interest income was $0.5 million and $0.6 million, respectively, with the decrease resulting from both the reduction in interest rates and the reduction in cash amounts on short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
For the three months ended September 30, 2025 and 2024, research and development incentives were $0.2 million and $0.6 million, respectively. Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom. The decrease of $0.4 million is primarily due to a decrease in qualifying research and development activities.
Comparison of the Nine Months Ended September 30, 2025 and 2024
The following table sets forth the significant components of our results of operations (in thousands):
Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
License revenue
$ — $ 14,969 (14,969)
Operating expenses:
Research and development
21,633 33,926 (12,293)
General and administrative 33,188 26,615 6,573
Impairment of long-lived assets 4,667 — 4,667
Total operating expenses 59,488 60,541 (1,053)
Other operating income 498 992 (494)
Loss from operations (58,990) (44,580) (14,410)
Other income/(expense)
Interest income 1,551 2,041 (490)
Interest expense (38) (41) 3
Research and development incentives 1,884 1,895 (11)
Other income 120 46 74
Total other income 3,517 3,941 (424)
Loss before income tax
(55,473) (40,639) (14,834)
Tax benefit 118 47 71
Net loss $ (55,355) $ (40,592) $ (14,763)
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Revenue
For the nine months ended September 30, 2025 and 2024, our revenue consisted of nil and $15.0 million, respectively, from the OUI License Agreement Amendment with respect to amounts owed to us by OUI for the commercial sales of Vaxzevria. In 2024, AstraZeneca announced it had made the strategic decision to initiate the withdrawal of marketing authorization for Vaxzevria within Europe, citing decline in demand as the reason for the decision. We do not expect to receive any further payments relating to future commercial sales of Vaxzevria and, if such payments are due, that we will be notified of such payments in a timely manner.
Research and Development Expenses
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
Direct research and development expenses by program:
VTP-1000 Celiac $ 4,184 $ 4,496 $ (312)
VTP-300 HBV 4,819 7,695 (2,876)
Other clinical programs 1
1,384 4,201 (2,817)
Other pre-clinical programs 1,305 2,398 (1,093)
Total direct research and development expenses 11,692 18,790 (7,098)
Indirect research and development expenses:
Personnel-related (including share-based compensation) 2
8,061 12,968 (4,907)
Facility related 850 947 (97)
Other indirect costs 1,030 1,221 (191)
Total indirect research and development expenses 9,941 15,136 (5,195)
Total research and development expenses $ 21,633 $ 33,926 $ (12,293)
1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”)). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
2 This includes $0.2 million and $0.6 million for the nine months ended September 30, 2025 and 2024, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
Our research and development expenses for the nine months ended September 30, 2025 and 2024 were $21.6 million and $33.9 million, respectively.
Direct expenses for the nine months ended September 30, 2025 and 2024 were $11.7 million and $18.8 million, respectively, and consisted of outside services, consultants, laboratory materials, clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing. Of the $7.1 million decrease, $6.8 million pertains to a net decrease in spend across the infectious disease and oncology programs following the strategic decision to prioritize pipeline assets within the I&I space. Additionally, there was a $0.3 million decrease in spend on VTP-1000, as one-off trial initiation costs incurred in the third quarter of 2024 did not reoccur in the third quarter of 2025.
Indirect research and development expenses for the nine months ended September 30, 2025 and 2024 were $9.9 million and $15.1 million, respectively. The decrease of $5.2 million primarily relates to the reduction in headcount and the associated personnel-related expense (including share-based compensation).
General and Administrative Expenses
General and administrative expenses for the nine months ended September 30, 2025 and 2024 were $33.2 million and $26.6 million, respectively. The increase of $6.6 million relates to an increase of $4.5 million in professional fees attributable to increased strategic activity, a increase of $2.7 million foreign exchange loss, primarily relating to an increase in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities , and an increase of $2.1 million in depreciation charges due to the decreased estimated useful lives of
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the U.K. right of use asset, leasehold improvements and laboratory equipment, offset by a decrease of $2.1 million in personnel-related expenses relating to the reduction in headcount and the associated personnel-related expense (including share-based compensation).
For the nine months ended September 30, 2025 and 2024, impairment of long-lived assets expense was $4.7 million and nil, respectively. This increase relates to the impairment assessment performed during the third quarter of 2025, following an impairment triggering event identified in relation to the Company entering a definitive merger agreement to combine in an all-stock transaction with Clywedog. See Note 7 for further details.
Other Operating Income
For the nine months ended September 30, 2025 and 2024, other operating income was $0.5 million and $1.0 million, respectively, primarily resulting from a reduction in qualifying activity for the development of VTP-500 for the prevention of MERS, and associated utilization of the funding provided by CEPI under the Funding Agreement. Minimal future activity is expected following the strategic decision to prioritize pipeline assets in the I&I space.
Interest Income
For the nine months ended September 30, 2025 and 2024, interest income was $1.6 million and $2.0 million, respectively, with the decrease resulting from both the reduction in interest rates and the reduction in cash amounts on short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
For the nine months ended September 30, 2025 and 2024, research and development incentives were $1.9 million and $1.9 million, respectively. Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, the issuance of convertible loan notes, and most recently from upfront, royalty and milestone payments from Oxford University Innovation ( “ OUI ” ) in connection with the OUI License Agreement Amendment for Vaxzevria. Through September 30, 2025, we have received gross proceeds of approximately $330.1 million from the issuance of our ordinary and preferred shares and convertible loan notes. As of September 30, 2025, we had cash, cash equivalents and restricted cash of $75.7 million. Key financing and corporate milestones include the following:
• Between July 2020 and November 2020, we raised gross proceeds of $41.2 million from the issuance of convertible loan notes;
• In March 2021, we raised gross proceeds of $125.2 million from the issuance of our Series B shares;
• In May 2021, we raised gross proceeds of $110.5 million from the initial public offering of our ordinary shares on Nasdaq;
• Between April 2022 and November 2024, we received $59.5 million of cash from OUI for the commercial sales of Vaxzevria;
• Between December 2022 and December 2024, we raised net proceeds of $5.1 million from the issuance of 2,558,586 shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC ("Jefferies").
On August 9, 2022, we filed a Registration Statement on Form S-3, as amended (the “ Shelf ” ), with the SEC in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million. The Shelf was declared effective on August 17, 2022 and expired as of August 17, 2025. We also simultaneously entered into a sales agreement with Jefferies, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0
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million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf. Between December 2022 and December 2024, whilst the Shelf was effective, the Company raised net proceeds of $5.1 million from the issuance of 2,558,586 shares represented by ADSs through "at-the-market" offerings under the sales agreement with Jefferies. Following the expiration of the Shelf on August 17, 2025, this ATM facility is no longer available as a source of liquidity.
We do not currently expect positive cash flows from operations in the foreseeable future, if at all. In most periods, we have incurred operating losses as a result of ongoing efforts to develop our immunotherapy platforms and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio. We expect to continue to incur net negative cash flows from operations for at least the next few years as we progress clinical development, seek regulatory approval, prepare for and, if approved, proceed to manufacture and commercialization of our most advanced product candidates. Operating profits may arise earlier if programs are licensed or sold to third parties before final approval, but this cannot be guaranteed.
On September 29, 2025, we entered into the Merger Agreement providing for our combination with Clywedog. We have agreed to various covenants and agreements, including, among others, agreements to conduct our business in the ordinary course of business between the execution of the Merger Agreement and the closing of the Combinations. Outside of certain limited exceptions, we may not take certain actions without Clywedog’s consent, including (i) acquiring businesses and disposing of significant assets, (ii) incurring expenditures above specified thresholds; (iii) incurring additional debt outside the ordinary course of business, (iv) issuing additional securities, or (v) repurchasing ordinary shares or ADSs.
Cash Flows
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
Nine months ended September 30, 2025 Nine months ended September 30, 2024
Net cash used in operating activities $ (43,737) $ (42,026)
Net cash provided by/(used) in investing activities 414 (614)
Net cash provided by financing activities 2 1,326
Effect of exchange rates on cash, cash equivalents and restricted cash 6,595 5,326
Net decrease in cash, cash equivalents and restricted cash $ (36,726) $ (35,988)
Cash Used in Operating Activities
During the nine months ended September 30, 2025, net cash used in operating activities was $43.7 million, primarily resulting from our net loss of $55.4 million adjusted by depreciation and amortization of $4.9 million, impairment of long-lived assets of $4.7 million, unrealized foreign exchange loss of $3.7 million, non-cash lease expenses of $3.1 million, contingent consideration adjustments of $0.3 million and profit on sale of property and equipment of $0.3 million. The changes in our operating assets and liabilities, net, of $3.8 million primarily related to a $5.2 million decrease in accounts payable and accrued expenses, a $0.4 million decrease in prepaid expenses and other current assets and a $1.5 million decrease in operating lease liabilities, offset by a $2.9 million decrease in research and development incentive receivables, following receipt of the 2023 research and development tax credit claim.
During the nine months ended September 30, 2024, net cash used in operating activities was $42.0 million, primarily resulting from our net loss of $40.6 million adjusted by depreciation and amortization of $4.4 million, share based compensation of $4.0 million, unrealized foreign exchange loss of $2.0 million, non-cash lease expense of $1.1 million and changes in our operating assets and liabilities, net of $12.6 million primarily related to a $15.0 million increase in contract asset (including related parties), a $2.1 million decrease in prepaid expense, $2.0 million increase in deferred income, $1.3 million decrease in operating lease liabilities and $0.2 million decrease in accounts payable and accrued expenses.
Net Cash Provided By/(Used) in Investing Activities
During the nine months ended September 30, 2025 and 2024, cash provided by/(used) in investing activities was $0.4 million and ($0.6 million), respectively. For the nine months ended September 30, 2025, these amounts primarily related to
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proceeds received upon the sale of U.K. laboratory equipment. For the nine months ended September 30, 2024, these amounts primarily related to capital expenditures related to leasehold improvements on our new office and laboratory facilities in Germantown, Maryland, United States, that the Company relocated its operations in June 2023.
Net Cash Provided by Financing Activities
During the nine months ended September 30, 2025, cash provided by financing activities related only to net proceeds received from the issuance of ordinary shares through stock exercises. During the nine months ended September 30, 2024, cash provided by financing activities of $1.3 million primarily related to net proceeds received from the issuance of ordinary shares through the “ at-the-market ” sales agreement.
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash
During the nine months ended September 30, 2025 and 2024, the effect of foreign exchange on cash, cash equivalents and restricted cash was a gain of $6.6 million and a gain of $5.3 million respectively, primarily as a result of a translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency .
Future Funding Requirements
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of our product candidates. As a result, we have incurred losses in each year since our inception in 2016, except for 2022 when we were profitable. We have negative operating cash flows for the period ended September 30, 2025 and as of September 30, 2025, we had an accumulated deficit of $293.0 million. We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future. We anticipate that our expenses will increase substantially if, and as we:
• pursue the clinical and preclinical development of our current product candidates;
• use our technologies to advance additional product candidates into preclinical and clinical development;
• seek marketing authorizations for product candidates that successfully complete clinical trials, if any;
• attract, hire and retain additional clinical, regulatory, quality control and other personnel;
• conduct preclinical studies and clinical trials for our current and future product candidates based on our proprietary synthetic and biologic platforms, including SNAP-TI, the ChAdOx and MVA vectors;
• expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;
• establish our manufacturing capabilities through third parties or by ourselves and scale-up manufacturing to provide adequate supply for clinical trials and commercialization;
• expand, maintain, protect and enforce our intellectual property portfolio;
• establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or through a selected partner;
• acquire or in-license other product candidates and technologies for development and commercialization;
• incur additional legal, accounting and other expenses in operating our business, including the additional costs associated with operating as a public company; and
• incur additional legal, advisory, accounting, tax and other expenses in operating our business, including the additional costs associated with completing the Contemplated Transactions.
Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development costs and other expenditures to develop and market additional product candidates and we may never generate revenue that is significant or large enough to achieve profitability. We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital unless and until such losses are eliminated by revenue.
If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Accordingly, our failure to become and remain profitable would decrease the value of our company and could impair our
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ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company also could cause you to lose all or part of your investment.
Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, in-house development of new technologies, and our product candidates derived from these technologies. Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete. We believe that we will continue to expend substantial resources for the foreseeable future in connection with the development of our current product candidates and programs as well as any future product candidates we may elect to pursue, as well as the gradual gaining of control over our required manufacturing capabilities and other corporate functions. These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and selling any products approved for sale. In addition, other unanticipated costs may arise as outlined above. Because the outcome of any preclinical study or clinical trial is uncertain and the rate of change of third-party costs is also unpredictable, we cannot reasonably estimate now the actual amounts which will be necessary to complete the development and commercialization of our current or future product candidates successfully.
Our future capital requirements may depend on many factors, including:
• the timing, outcome and terms of the Contemplated Transactions currently in progress as well as associated transaction and advisory costs;
• the scope, progress, results and costs of researching and developing our current and future product candidates and programs, and of conducting preclinical studies and clinical trials;
• the number and development requirements of other product candidates that we may pursue, and of other indications for our current product candidates that we may pursue;
• the stability, scale and yield of future manufacturing processes as we scale-up production and formulation of our product candidates either internally or externally for later stages of development and commercialization;
• the timing of, success achieved and the costs involved in obtaining regulatory and marketing approvals and developing our ability to establish license or sale transactions and/or sales and marketing capabilities, if any, for our current and future product candidates if clinical trials and approval processes are successful;
• the success of our collaborations with CEPI, Oxford University/OUI, Arbutus, CanSino Biologics Inc., Cancer Research UK, and the Ludwig Institute and any future collaboration partners;
• our ability to establish, maintain or terminate collaborations, strategic licensing or other arrangements, and the financial terms of such agreements;
• the costs of future commercialization activities, including product launch, product sales, marketing, manufacturing and distribution, for any of our current and future product candidates for which we receive marketing approval;
• the timing, receipt and amount of commercial sales, revenues, milestones or royalties or other income from our future products, should any of our product candidates receive marketing approval; and
• the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, enforcing and protecting our intellectual property rights and defending intellectual property-related claims including litigation costs and any damages awarded in such litigation; and
• the emergence and success or otherwise of competing autoimmune or infectious disease therapies and other market developments.
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 of that product candidate, in either direction. Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans. Unless and until we can generate a substantial amount of revenue from our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources, or any combination of the foregoing.
Based on our current standalone research and development plans, we expect that our existing cash, cash equivalents, restricted cash and other financial resources will enable us to fund our operating expenses and capital expenditure requirements into the start of 2027. These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
We may require substantial additional financing in the future to meet any such unanticipated factors, including if the Contemplated Transactions are not consummated timely or at all. If we raise additional funds through collaborations,
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strategic alliances, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development programs, future commercialization efforts, other operational plans or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Lease, Purchase, and Other Obligations
We have operating lease obligations related to our property, plant and equipment. The obligations related to both short- and long-term lease arrangements are set forth in Note 15 “Commitment and Contingencies” to our condensed consolidated financial statements.
We enter into contracts in the normal course of business with CROs and other third parties for clinical trials and preclinical research studies and testing. These contracts are generally cancellable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.
We have contingent payment obligations that we may incur upon achievement of clinical, regulatory and commercial milestones, as applicable, or royalty payments that we may be required to make under our licenses; however, the amount, timing and likelihood of such payments are not known as of September 30, 2025.
Emerging Growth Company Status
We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an emerging growth company, we may delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year (a) following the fifth anniversary of the date of the closing of our IPO, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our ADSs held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.