10 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
+Added: September 30,
Cash and cash equivalents $ 74,272 $ 110,662
41 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: Three months ended Six months ended
−Removed: June 30, 2025 June 30, 2024 June 30, 2025 June 30, 2024
+Added: Three months ended Nine months ended
+Added: September 30, 2025 September 30, 2024 September 30, 2025 September 30, 2024
+Added: License revenue 1
+Added: $ — $ 14,969 $ — $ 14,969
+Added: Total revenue — 14,969 — 14,969
Operating expenses
1 unchanged sentence
General and administrative 5,165 13,420 33,188 26,615
+Added: Impairment of long-lived assets 4,667 — 4,667 —
Total operating expenses 15,222 24,559 59,488 60,541
21 unchanged sentences
Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 17,497 ) $ 1,067 $ ( 45,338 ) $ ( 32,770 )
+Added: 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:
+Added: $ 15.0 million).
The accompanying notes are an integral part of these condensed consolidated financial statements.
3 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three and Six months ended June 30, 2025
+Added: Three and Nine months ended September 30, 2025
Ordinary Shares Deferred A Shares
11 unchanged sentences
Balance, June 30, 2025 40,348,665 $ 1 63,443 $ 86 $ 393,663 $ ( 278,436 ) $ ( 12,937 ) $ 102,377 $ 104 $ 102,481
−Removed: Three and Six months ended June 30, 2024
+Added: Share based compensation — — — — ( 415 ) — — ( 415 ) — ( 415 )
+Added: Issue of ordinary shares, net of issuance costs 478,598 0 1 — — 0 1 —
+Added: Foreign currency translation adjustments — — — — — — ( 2,931 ) ( 2,931 ) ( 3 ) ( 2,934 )
+Added: Net loss — — — — — ( 14,566 ) — ( 14,566 ) ( 5 ) ( 14,571 )
+Added: Balance, September 30, 2025 40,827,263 $ 1 63,443 $ 86 $ 393,248 $ ( 293,002 ) $ ( 15,868 ) $ 84,465 $ 96 $ 84,561
+Added: 1 Indicates amount less than one thousand
+Added: The accompanying notes are an integral part of these condensed consolidated financial statements
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
+Added: STOCKHOLDERS’ EQUITY
+Added: (IN THOUSANDS, EXCEPT NUMBER OF SHARES)
+Added: Three and Nine months ended September 30, 2024
Ordinary Shares Deferred A Shares
11 unchanged sentences
Balance, June 30, 2024 39,184,338 $ 1 63,443 $ 86 $ 390,273 $ ( 209,010 ) $ ( 24,732 ) $ 156,618 $ 172 $ 156,790
+Added: Share based compensation — — — — 1,144 — — 1,144 — 1,144
+Added: Issue of ordinary shares, net of issuance costs 358,180 0 1 — — 465 — — 465 — 465
+Added: Foreign currency translation adjustments — — — — — — 9,181 9,181 10 9,191
+Added: Net loss — — — — — ( 8,114 ) — ( 8,114 ) ( 15 ) ( 8,129 )
+Added: 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
3 unchanged sentences
(IN THOUSANDS)
−Removed: Six months ended
−Removed: June 30, 2025 June 30, 2024
+Added: Nine months ended
+Added: September 30, 2025 September 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
2 unchanged sentences
Share based compensation ( 228 ) 3,954
+Added: Impairment of long-lived assets 4,667 —
Depreciation and amortization 4,936 4,372
Non-cash lease expenses 3,108 1,086
−Removed: Unrealized foreign exchange loss/(gain) 4,869 ( 583 )
+Added: Unrealized foreign exchange loss 3,683 2,022
Change in contingent consideration ( 322 ) ( 306 )
3 unchanged sentences
Changes in operating assets and liabilities:
+Added: Contract asset (including related parties) — ( 14,969 )
Prepaid expenses and other current assets 426 2,083
6 unchanged sentences
CASH FLOWS FROM INVESTING ACTIVITIES:
+Added: Proceeds from sale of property and equipment 451 —
Purchases of property and equipment ( 37 ) ( 614 )
−Removed: Net cash used in investing activities $ ( 37 ) $ ( 500 )
+Added: Net cash provided by/(used) in investing activities $ 414 $ ( 614 )
CASH FLOWS FROM FINANCING ACTIVITIES:
15 unchanged sentences
Barinthus Biotherapeutics plc is a public limited company incorporated pursuant to the laws of England and Wales in March 2021.
−Removed: 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, and Barinthus Biotherapeutics Switzerland GmbH, are collectively referred to as the “Company” or “Barinthus Bio.”
−Removed: 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.
−Removed: The Company is also evaluating two product candidates to treat infectious diseases and cancer that harness its proprietary viral vector platform technologies, consisting of ChAdOx and MVA, which are designed to increase disease-specific CD8+T cells.
+Added: 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.
+Added: (“Topco”) and Cdog Merger Sub, Inc.
+Added: (“Merger Sub”), for the purpose of the transactions contemplated by the recently announced merger agreement with Clywedog Therapeutics, Inc.
+Added: ("Clywedog").
+Added: These entities are not material to the Company's consolidated financial position or results of operations.
+Added: 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.
+Added: 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.
4 unchanged sentences
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.
+Added: Merger Agreement with Clywedog
+Added: 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.
+Added: The Merger Agreement provides that, among other things, upon the terms and subject to the conditions set forth therein:
+Added: (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”).
+Added: The Scheme Transaction will be consummated prior to the Merger.
+Added: 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
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The closing of the Contemplated Transactions is subject to the satisfaction or waiver of certain customary conditions, including, among other things:
+Added: (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;
+Added: (ii) approvals by the Company’s shareholders of the Scheme Transaction and certain related matters, and sanction by the Court of the Scheme Transaction;
+Added: (iii) approval by Clywedog’s stockholders of the Merger Agreement, the Merger and Contemplated Transactions;
+Added: (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;
+Added: (v) the completion of the Self-Tender Offer to the extent that Topco elects to commence the Self-Tender Offer;
+Added: (ivi) minimum cash requirements for each party.
+Added: The Merger Agreement may be terminated and the transactions contemplated thereby abandoned at any time prior to the closing under certain specified circumstances.
+Added: Either the Company or Clywedog may terminate the Merger Agreement if, among other things:
+Added: (i) the closing date will not have occurred by September 30, 2026, subject to up to a 60 day extension if the U.S.
+Added: 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
−Removed: 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 Securities and Exchange Commission for interim financial statements.
+Added: 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.
+Added: 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.
4 unchanged sentences
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.
−Removed: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of $ 87.8 million and an accumulated deficit of $ 278.4 million, and the Company expects to incur losses for the foreseeable future.
+Added: 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.
−Removed: 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.
+Added: The Company expects to continue to incur costs and expenditures in connection with the process of consummating the Contemplated Transactions.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
2 unchanged sentences
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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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
−Removed: The accompanying Condensed Consolidated Balance Sheets as of June 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 six months ended June 30, 2025 and 2024 are unaudited.
+Added: 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.
−Removed: 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 June 30, 2025, its results of operations for the three and six months ended June 30, 2025, and 2024, and its cash flows for the six months ended June 30, 2025, and 2024.
−Removed: The results of operations for the three and six months ended June 30, 2025, are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or any other interim periods.
+Added: 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.
+Added: 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.
Summary of Significant Accounting Policies
5 unchanged sentences
The Company’s actual results may differ from these estimates under different assumptions or conditions.
+Added: 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.
+Added: The adjustment reflects updated assumptions regarding expected future cash flows and market participant perspectives.
+Added: 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.
1 unchanged sentence
Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Recently issued accounting pronouncements
2 unchanged sentences
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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805):
+Added: Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity.
+Added: 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.
+Added: The amendments are effective for fiscal years beginning after December 15, 2026, including interim periods within those fiscal years, with early adoption permitted.
+Added: The Company elected to early adopt ASU 2025-03 as of July 1, 2025.
+Added: The adoption did not have a material impact on the our consolidated financial statements.
+Added: 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.
−Removed: We are currently evaluating the impact of adopting this standard to determine its impact on our disclosures.
+Added: 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.
−Removed: We are currently evaluating the impact of adopting this standard to determine its impact on our disclosures.
+Added: 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):
1 unchanged sentence
This standard is effective for fiscal years beginning after December 15, 2024.
−Removed: We are currently evaluating the impact of adopting this standard to determine its impact on our disclosures.
+Added: The Company is currently evaluating the impact of adopting this standard to determine its impact on its disclosures.
Segment information
5 unchanged sentences
The following table is a summary of the Company's significant segment expenses:
−Removed: Three months ended June 30, 2025 Three months ended June 30, 2024 Change
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Three months ended September 30, 2025 Three months ended September 30, 2024 Change
Direct research and development expenses:
12 unchanged sentences
Total research and development expenses $ 5,390 $ 11,139 $ ( 5,749 )
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Six months ended June 30, 2025 Six months ended June 30, 2024 Change
+Added: Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
Direct research and development expenses:
15 unchanged sentences
Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
−Removed: 2 This includes $ 0.1 million and $ 0.1 million for the three and six months ended June 30, 2025, respectively (three and six months ended June 30, 2024:$ 0.2 million and $ 0.3 million, respectively) of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
+Added: 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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The Company operates in two geographic regions:
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:
−Removed: June 30, 2025 December 31, 2024
+Added: September 30, 2025 December 31, 2024
United States
3 unchanged sentences
Foreign Currency Translation in General and Administrative Expenses
−Removed: The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three and six months ended June 30, 2025 was a loss of $ 8.0 million and loss of $ 12.4 million, respectively (three and six months ended June 30, 2024:
−Removed: $ 0.1 million loss and $ 1.1 million gain, respectively).
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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:
+Added: $ 7.7 million loss and $ 6.6 million loss, respectively).
Net Loss Per Share
−Removed: The following table sets forth the computation of basic and diluted net loss per share for the three and six months ended June 30, 2025, and 2024 (in thousands, except number of shares):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: 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):
+Added: Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
7 unchanged sentences
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.
−Removed: As of June 30, 2025, 7,625,728 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 (June 30, 2024:
+Added: 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:
Property and Equipment, Net
−Removed: Depreciation expense for the three and six months ended June 30, 2025 was $ 1.2 million and $ 2.5 million, respectively (three and six months ended June 30, 2024:
+Added: 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).
−Removed: During the three and six months ended June 30, 2025, the Company recorded a gain of $ 0.3 million, from the sale of U.K.
−Removed: laboratory equipment (three and six months ended June 30, 2024:
−Removed: nil ) and recorded associated proceeds of $ 0.5 million (three and six months ended June 30, 2024:
−Removed: As of June 30, 2025, the Company had $ 0.4 million (December 31, 2024:
+Added: 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.
+Added: laboratory equipment (three and nine months ended September 30, 2024:
+Added: 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:
+Added: As of September 30, 2025, the Company had $ 0.1 million (December 31, 2024:
nil ) of U.K.
3 unchanged sentences
laboratory equipment is expected to be completed in 2025.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Intangible Assets, Net
−Removed: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of June 30, 2025 and December 31, 2024, respectively, and accumulated amortization was $ 11.2 million and $ 9.7 million as of June 30, 2025 and December 31, 2024, respectively.
−Removed: The amortization expense for the three and six months ended June 30, 2025 was $ 0.8 million and $ 1.6 million, respectively (three and six months ended June 30, 2024:
+Added: 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.
+Added: 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:
+Added: 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.
+Added: 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.
+Added: 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.
+Added: As a result, the Company recorded a total impairment charge for acquired development technology intangible assets of $ 4.7 million during the quarter.
+Added: The determination of the fair value of the Company's net assets expected at completion, is a non-recurring fair value measurement.
+Added: Additional triggers for impairment may be identified prior to completion of the Contemplated Transactions, as the purchase price accounting is finalized.
Prepaid Expenses and Other Current Assets (in thousands):
+Added: September 30,
2025 December 31,
4 unchanged sentences
Total $ 6,336 $ 6,203
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Accrued Expenses and Other Current Liabilities (in thousands):
+Added: September 30,
2025 December 31,
6 unchanged sentences
Total $ 6,681 $ 9,525
−Removed: 1 Included in Accrued other as of June 30, 2025 is a provision of $ 0.4 million for severance costs for the reduction in workforce following the Company's announcement in January 2025 to prioritize its pipeline.
+Added: 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.
Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
−Removed: On December 20, 2023, Barinthus Biotherapeutics (UK) Limited (the “Company”), the Chancellors, Masters and Scholars of the University of Oxford (“Oxford,” together with the Company, 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 Company’s vaccine candidate against Middle East Respiratory Syndrome (“MERS,” and such development activities, the “Project”).
+Added: 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
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
−Removed: Pursuant to the Funding Agreement, the Company has agreed to pay CEPI on a country-by-country basis increasing mid-single digit percentage royalties of net sales and net income with respect to future cash sales of VTP-500, less certain deductions, for a period starting on December 20, 2023 (“Effective Date”) and ending the later of:
−Removed: (i) the expiration of the last valid patent claim included in intellectual property developed under the Project covering VTP-500 in such country, (ii) the expiration of Regulatory Exclusivity (as defined in the Funding Agreement) for VTP-500 in such country, and (iii) the tenth ( 10 th) anniversary of the first commercial sale of VTP-500 (the “Royalty Term”).
−Removed: The Company shall also pay CEPI a mid-double-digit percentage of net revenue earned on VTP-500 until CEPI has received payments from the Company under the Funding Agreement equaling the total amount of funding paid by CEPI to the Company and a low double-digit percentage of such net revenue thereafter.
−Removed: Sales for the benefit of end users in specified low and middle income countries (“LMICs”) and upper and middle income countries (“UMICs”) are excluded from the calculations of net sales and net revenue.
−Removed: Sales of the product for the benefit of end users in LMICs and UMICs are subject to tiered discounted pricing requirements under the Funding Agreement.
−Removed: The Company is further required to pay a low to mid-double-digit percentage of any proceeds earned on any priority review voucher related to VTP-500 during the Royalty Term.
+Added: 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.
−Removed: During the six months period ended June 30, 2025, nil (June 30, 2024:
+Added: During the nine months period ended September 30, 2025, nil (September 30, 2024:
$ 3.0 million) proceeds have been received.
−Removed: For the three and six months ended June 30, 2025 $ 0.01 million and $ 0.3 million, respectively (three and six months ended June 30, 2024:
+Added: 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.
1 unchanged sentence
The Funding Agreement cash payments are restricted as to the use and management of the funds.
−Removed: The remaining unused amounts of the Funding Agreement cash payments of $ 1.5 million as of June 30, 2025 (December 31, 2024:
+Added: 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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Deferred income
1 unchanged sentence
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.
−Removed: Changes in deferred income during the three and six months ended June 30, 2025 and 2024, are as follows (in thousands):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Changes in deferred income during the three and nine months ended September 30, 2025 and 2024, are as follows (in thousands):
+Added: Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
6 unchanged sentences
All ordinary shares rank pari passu as a single class.
−Removed: The following is a summary of the rights and privileges of the holders of ordinary shares as of June 30, 2025:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of September 30, 2025:
Liquidation preference:
1 unchanged sentence
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.
−Removed: 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 may pay interim dividends on the Company’s ordinary shares.
+Added: 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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Voting Rights:
8 unchanged sentences
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.
−Removed: This included the disapplication of preemption rights in relation to the allotment of the Company's ordinary shares in connection with the IPO.
+Added: 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).
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: On November 6, 2023, the Company held a general meeting where its shareholders approved resolutions granting the board of directors or any duly authorized committee of the board of directors 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.
−Removed: Pursuant to such approval, the board of directors was authorized to allot shares up to an aggregate nominal amount of £ 1,928 free from statutory pre-emption rights.
+Added: 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.
+Added: 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.
9 unchanged sentences
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.
−Removed: As of June 30, 2025, the Company had a contingent consideration liability of $ 2.5 million related to the acquisition of Avidea Technologies, Inc.
+Added: 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.
5 unchanged sentences
Significant extension (reduction) in the expected date of the milestone achievement would have resulted in a significantly lower (higher) fair value measurement.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
4 unchanged sentences
Share-Based Compensation
−Removed: During the six month period ended June 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.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: For the six months ended June 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 (June 30, 2024:
+Added: 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.
+Added: 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).
−Removed: For the six months ended June 30, 2025, 1,016,357 options (June 30, 2024:
+Added: 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:
−Removed: Six months ended June 30,
+Added: Nine months ended September 30,
Expected volatility 114.1 % 108.7 %
2 unchanged sentences
Expected dividend yield — % — %
−Removed: As of June 30, 2025, 7,625,728 options with a weighted average exercise price of $ 5.30 per share were outstanding (June 30, 2024:
+Added: 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).
−Removed: As of June 30, 2025, there was $ 2.0 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.0 years.
+Added: 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):
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
5 unchanged sentences
The Company is party to a number of licensing agreements, most of which are with related parties.
−Removed: These agreements serve to provide the Company with the right to develop and exploit the counterparties’ intellectual property for certain medical indications.
+Added: These agreements serve to provide the Company with the right to develop and exploit the counterparties’ intellectual property for certain medical
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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.
3 unchanged sentences
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.
−Removed: The Company has not made or accrued any material payments under these license agreements during the six month periods ended June 30, 2025 and 2024.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
The Company leases certain laboratory and office space under operating leases, which are described below.
15 unchanged sentences
The Company’s right-of-use asset and lease liability are as follows (in thousands):
+Added: September 30,
2025 December 31,
2 unchanged sentences
Lease liability, non-current $ 9,553 $ 10,087
−Removed: Six months ended June 30,
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Nine months ended September 30,
Other information
2 unchanged sentences
Weighted average discount rate 7.5 % 7.5 %
−Removed: Three months ended June 30, Six months ended June 30,
+Added: Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
1 unchanged sentence
Total lease cost $ 1,449 $ 369 $ 3,108 $ 1,086
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Future annual minimum lease payments under operating leases as of June 30, 2025, were as follows (in thousands):
+Added: Future annual minimum lease payments under operating leases as of September 30, 2025, were as follows (in thousands):
Remainder of 2025 $ 503
3 unchanged sentences
Total lease liability $ 11,570
+Added: Contemplated Transactions
+Added: On September 29, 2025, the Company entered into a merger agreement to combine with Clywedog, a private company advancing novel breakthrough medicines in diabetes.
+Added: The Contemplated Transactions are expected to close in the first half of 2026, subject to customary closing conditions.
+Added: In connection with this strategic combination, the Company may incur additional or contingent costs, including transaction-related legal and advisory fees, and other expenses.
+Added: 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.
+Added: 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
2 unchanged sentences
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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Related Party Transactions
−Removed: During the three and six months ended June 30, 2025, the Company incurred expenses, related to clinical study costs, of $ 0.1 million and $ 0.3 million, respectively (three and six months ended June 30, 2024:
−Removed: $ 0.3 million and $ 0.5 million, respectively) from Oxford University Innovation Limited, which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: During the three and nine months ended September 30, 2025, the Company recognized license revenue of nil (three and nine ended September 30, 2024:
+Added: $ 15.0 million), from Oxford University Innovation Limited, which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: 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:
+Added: $ 0.2 million and $ 0.7 million, respectively) from Oxford University Innovation Limited.
+Added: Subsequent Events
+Added: In October 2025 the Company granted an aggregate of 886,018 restricted stock units (“RSUs”) to employees under the Plan.
+Added: 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.
+Added: The financial impact of this grant will be reflected in future periods in accordance with applicable accounting standards
+Added: 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.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.
2 unchanged sentences
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.
−Removed: We are 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.
+Added: 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.
9 unchanged sentences
We have incurred net losses in each annual and interim reporting period since 2023.
−Removed: For the three and six months ended June 30, 2025, we incurred a net loss of $21.2 million and $40.8 million, respectively.
−Removed: As of June 30, 2025, we had an accumulated deficit of $278.4 million, and we do not currently expect positive cash flows from operations in the foreseeable future.
+Added: For the three and nine months ended September 30, 2025, we incurred a net loss of $14.6 million and $55.4 million, respectively.
+Added: 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.
21 unchanged sentences
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.
−Removed: Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements to the start of 2027.
+Added: 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.
2 unchanged sentences
Recent Developments
−Removed: The first and second cohorts of the single ascending dose part of the Phase 1 AVALON clinical trial have been dosed, with no treatment related serious adverse events reported to date.
−Removed: Screening for enrollment into the third and final cohort in this part of the trial is ongoing, and is anticipated to be complete in the third quarter of 2025.
−Removed: We anticipate having safety, tolerability and biomarker data available from this phase of the trial early in the fourth quarter of 2025.
−Removed: In June 2025, the FDA approved an amendment of the protocol to open the multiple ascending dose cohort of the respective dose following successful completion of the corresponding single ascending dose cohort;
−Removed: consequently we opened the multiple ascending dose part of the Phase 1 AVALON clinical trial in July 2025.
+Added: Celiac Disease
+Added: 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.
+Added: We anticipate announcing data from the SAD phase of the trial before the end of 2025.
+Added: 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.
+Added: Merger Agreement with Clywedog
+Added: On September 29, 2025, we entered into the Merger Agreement with Topco, Merger Sub and Clywedog.
+Added: 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.
+Added: The Scheme Transaction will be consummated prior to the Merger.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: If the Scheme Transaction is consummated, our ordinary shares will be delisted from the Nasdaq and deregistered under the Exchange Act.
+Added: 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.
+Added: 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 .
+Added: 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
24 unchanged sentences
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.
−Removed: 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 Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.
+Added: 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.
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.
−Removed: 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 we recognize expenses for the related costs for which the grants are intended to compensate.
+Added: 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.
15 unchanged sentences
Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit.
−Removed: 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 ( “ EPWs ” ) based in the U.S.
−Removed: 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 ( “ RDEC Program ” ).
+Added: 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.
+Added: 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%.
7 unchanged sentences
There was no tax loss restriction applied to the R&D tax credits in the U.K.
−Removed: for the six months ended June 30, 2025 and 2024.
+Added: for the nine months ended September 30, 2025 and 2024.
Critical Accounting Policies and Use of Estimates
−Removed: 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 accounting principles generally accepted in the United States ( “ GAAP ” ).
+Added: 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.
11 unchanged sentences
Therefore, we performed both a qualitative and quantitative assessment in January 2025 and determined the carrying amount of our intangible assets are recoverable.
−Removed: As of June 30, 2025, we did not identify any additional circumstances that may indicate the carrying amount of our long-lived assets, including intangible assets, are not recoverable and hence no impairment has been recorded.
+Added: 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.
+Added: 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.
+Added: As a result, the Company recorded a total impairment charge for acquired development technology intangible assets of $4.7 million during the quarter.
+Added: The determination of the fair value of the Company's net assets expected at completion, is a non-recurring fair value measurement.
+Added: Additional triggers for impairment may be identified prior to completion of the Contemplated Transactions, as the purchase price accounting is finalized.
Contingent Consideration
−Removed: We recognize a contingent consideration liability related to the acquisition of Avidea Technologies, Inc.
−Removed: ( “ Avidea ” ).
+Added: 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.
5 unchanged sentences
Results of Operations
−Removed: Comparison of the Three Months Ended June 30, 2025 and 2024
+Added: 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):
−Removed: Three months ended June 30, 2025 Three months ended June 30, 2024 Change
+Added: Three months ended September 30, 2025 Three months ended September 30, 2024 Change
+Added: License revenue
+Added: $ — $ 14,969 (14,969)
Operating expenses:
2 unchanged sentences
General and administrative 5,165 13,420 (8,255)
+Added: Impairment of long-lived assets 4,667 — 4,667
Total operating expenses 15,222 24,559 (9,337)
11 unchanged sentences
Net loss $ (14,571) $ (8,129) $ (6,442)
+Added: 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.
+Added: 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.
+Added: 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
−Removed: The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024 (in thousands):
−Removed: Three months ended June 30, 2025 Three months ended June 30, 2024 Change
+Added: The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024 (in thousands):
+Added: Three months ended September 30, 2025 Three months ended September 30, 2024 Change
Direct research and development expenses:
14 unchanged sentences
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”)).
−Removed: Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
−Removed: 2 This includes $0.1 million and $0.2 million for the three months ended June 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.
−Removed: Our research and development expenses for the three months ended June 30, 2025 and 2024 were $8.0 million and $11.7 million, respectively.
−Removed: Direct expenses for the three months ended June 30, 2025 and 2024 were $4.7 million and $6.4 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.
−Removed: Of the $1.7 million decrease, $2.1 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 offset by an increase of $0.4 million pertaining to spend on VTP-1000 as the program has progressed into the clinic in the ongoing Phase 1 AVALON clinical trial, having completed the IND enabling studies and manufacturing of drug product during 2024.
−Removed: Indirect research and development expenses for the three months ended June 30, 2025 and 2024 were $3.2 million and $5.2 million, respectively.
−Removed: The decrease of $2.0 million primarily relates to the reduction in headcount in the research and manufacturing teams, following our announcements in June 2024 and January 2025 to prioritize our pipeline and as a result, reduce the size of the workforce and the associated personnel-related expense (including share-based compensation).
+Added: 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.
+Added: Our research and development expenses for the three months ended September 30, 2025 and 2024 were $5.4 million and $11.1 million, respectively.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Indirect research and development expenses for the three months ended September 30, 2025 and 2024 were $1.9 million and $4.6 million, respectively.
+Added: 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.
+Added: 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
−Removed: General and administrative expenses for the three months ended June 30, 2025 and 2024 were $15.4 million and $7.2 million, respectively.
−Removed: The increase of $8.2 million relates primarily to a loss of $8.0 million on foreign exchange for the three months ended June 30, 2025, compared to a loss of $0.1 million for the three months ended June 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 , and an increase of $2.0 million in professional fees attributable to increased strategic activity, offset by a decrease of $1.5 million in personnel-related expenses relating to the reduction in headcount in the general and administrative teams, following our announcements in June 2024 and January 2025 to prioritize our pipeline and as a result, reduce the size of the workforce and the associated personnel-related expense (including share-based compensation).
+Added: General and administrative expenses for the three months ended September 30, 2025 and 2024 were $5.2 million and $13.4 million, respectively.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Impairment of long-lived assets expense
+Added: For the three months ended September 30, 2025 and 2024, impairment of long-lived assets expense was $4.7 million and nil, respectively.
+Added: 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.
+Added: See Note 7 for further details.
Other Operating Income
−Removed: For the three months ended June 30, 2025 and 2024, other operating income was $0.01 million and $0.6 million, respectively, resulting from a reduction in the spend on the development of VTP-500 for the prevention of MERS and associated utilization of the funding provided by CEPI under the Funding Agreement, following the strategic decision to prioritize pipeline assets within the I&I space.
+Added: 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.
+Added: Minimal future activity is expected following the strategic decision to prioritize pipeline assets in the I&I space.
Interest Income
−Removed: For the three months ended June 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.
+Added: 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
−Removed: For the three months ended June 30, 2025 and 2024, research and development incentives were $1.3 million and $0.7 million, respectively.
+Added: 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.
−Removed: The increase of $0.6 million is primarily due to an increase in qualifying research and development activities following completion of the 2024 claim.
−Removed: For the three months ended June 30, 2025 and 2024, other income was $0.3 million and $0.02 million, respectively.
−Removed: This increase primarily relates to a $0.3 million gain on disposal of property plant and equipment recorded in the second quarter of 2025 following the auction of U.K.
−Removed: lab equipment.
−Removed: Comparison of the Six Months Ended June 30, 2025 and 2024
+Added: The decrease of $0.4 million is primarily due to a decrease in qualifying research and development activities.
+Added: 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):
−Removed: Six months ended June 30, 2025 Six months ended June 30, 2024 Change
+Added: Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
+Added: License revenue
+Added: $ — $ 14,969 (14,969)
Operating expenses:
2 unchanged sentences
General and administrative 33,188 26,615 6,573
+Added: Impairment of long-lived assets 4,667 — 4,667
Total operating expenses 59,488 60,541 (1,053)
11 unchanged sentences
Net loss $ (55,355) $ (40,592) $ (14,763)
+Added: 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.
+Added: 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.
+Added: 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
−Removed: The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):
−Removed: Six months ended June 30, 2025 Six months ended June 30, 2024 Change
+Added: The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
+Added: Nine months ended September 30, 2025 Nine months ended September 30, 2024 Change
Direct research and development expenses by program:
15 unchanged sentences
Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
−Removed: 2 This includes $0.1 million and $0.3 million for the six months ended June 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.
−Removed: Our research and development expenses for the six months ended June 30, 2025 and 2024 were $16.2 million and $22.8 million, respectively.
−Removed: Direct expenses for the six months ended June 30, 2025 and 2024 were $8.2 million and $12.3 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.
+Added: 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.
+Added: Our research and development expenses for the nine months ended September 30, 2025 and 2024 were $21.6 million and $33.9 million, respectively.
+Added: 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.
−Removed: Indirect research and development expenses for the six months ended June 30, 2025 and 2024 were $8.0 million and $10.5 million, respectively.
−Removed: The decrease of $2.5 million primarily relates to the reduction in headcount in the research and manufacturing teams, following our announcements in June 2024 and January 2025 to prioritize our pipeline and as a result, reduce the size of the workforce and the associated personnel-related expense (including share-based compensation).
+Added: 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.
+Added: Indirect research and development expenses for the nine months ended September 30, 2025 and 2024 were $9.9 million and $15.1 million, respectively.
+Added: 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
−Removed: General and administrative expenses for the six months ended June 30, 2025 and 2024 were $28.0 million and $13.2 million, respectively.
−Removed: The increase of $14.8 million relates primarily to a loss of $12.4 million on foreign exchange for the six months ended June 30, 2025, compared to a gain of $1.1 million for the six months ended June 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 , and an increase of $2.1 million in professional fees attributable to increased strategic activity, a $1.3 million increase in depreciation charges due to the decreased estimated useful lives of the U.K.
−Removed: right of use asset, leasehold improvements and laboratory equipment, offset by a decrease of $1.1 million in personnel-related expenses relating to the reduction in headcount in the general and administrative teams, following our announcements in June 2024 and January 2025 to prioritize our pipeline and as a result, reduce the size of the workforce and the associated personnel-related expense (including share-based compensation).
+Added: General and administrative expenses for the nine months ended September 30, 2025 and 2024 were $33.2 million and $26.6 million, respectively.
+Added: 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
+Added: 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).
+Added: For the nine months ended September 30, 2025 and 2024, impairment of long-lived assets expense was $4.7 million and nil, respectively.
+Added: 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.
+Added: See Note 7 for further details.
Other Operating Income
−Removed: For the six months ended June 30, 2025 and 2024, other operating income was $0.3 million and $0.8 million, respectively, resulting from a reduction in activity and winding down the development of VTP-500 for the prevention of MERS, and associated utilization of the funding provided by CEPI under the Funding Agreement.
+Added: 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.
+Added: Minimal future activity is expected following the strategic decision to prioritize pipeline assets in the I&I space.
Interest Income
−Removed: For the six months ended June 30, 2025 and 2024, interest income was $1.1 million and $1.4 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.
+Added: 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
−Removed: For the six months ended June 30, 2025 and 2024, research and development incentives were $1.6 million and $1.3 million, respectively.
+Added: 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.
−Removed: The increase of $0.3 million is primarily due to an increase in qualifying research and development activities following completion of the 2024 claim.
−Removed: For the six months ended June 30, 2025 and 2024, other income was $0.4 million and $0.02 million.
−Removed: This increase primarily relates to a $0.3 million gain on disposal of property plant and equipment recorded in the second quarter of 2025 following the auction of U.K.
−Removed: lab equipment.
Liquidity and Capital Resources
1 unchanged sentence
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.
−Removed: Through June 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.
−Removed: As of June 30, 2025, we had cash, cash equivalents and restricted cash of $87.8 million.
+Added: 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.
+Added: 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:
3 unchanged sentences
• Between April 2022 and November 2024, we received $59.5 million of cash from OUI for the commercial sales of Vaxzevria;
−Removed: • 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.
−Removed: On August 9, 2022, we filed a Registration Statement on Form S-3, as amended (the “ Shelf ” ), with the Securities and Exchange Commission 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.
−Removed: The Shelf was declared effective on August 17, 2022.
−Removed: We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
+Added: • 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").
+Added: 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.
+Added: The Shelf was declared effective on August 17, 2022 and expired as of August 17, 2025.
+Added: 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
+Added: million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
+Added: 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.
+Added: 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.
2 unchanged sentences
Operating profits may arise earlier if programs are licensed or sold to third parties before final approval, but this cannot be guaranteed.
+Added: On September 29, 2025, we entered into the Merger Agreement providing for our combination with Clywedog.
+Added: 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.
+Added: 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;
+Added: (iii) incurring additional debt outside the ordinary course of business, (iv) issuing additional securities, or (v) repurchasing ordinary shares or ADSs.
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
−Removed: Six months ended June 30, 2025 Six months ended June 30, 2024
+Added: Nine months ended September 30, 2025 Nine months ended September 30, 2024
Net cash used in operating activities $ (43,737) $ (42,026)
−Removed: Net cash used in investing activities (37) (500)
+Added: Net cash provided by/(used) in investing activities 414 (614)
Net cash provided by financing activities 2 1,326
2 unchanged sentences
Cash Used in Operating Activities
−Removed: During the six months ended June 30, 2025, net cash used in operating activities was $33.0 million, primarily resulting from our net loss of $40.8 million adjusted by unrealized foreign exchange loss of $4.9 million, depreciation and amortization of $4.0 million, non-cash lease expenses of $1.7 million, profit on sale of property and equipment of $0.3 million, and changes in our operating assets and liabilities, net, of $2.3 million.
−Removed: The changes in our operating assets and liabilities, net, of $2.3 million primarily related to a $3.6 million increase in accounts payable and accrued expenses, a $0.5 million increase in prepaid expenses and other current assets and a $1.0 million decrease in operating lease liabilities, offset by a $3.1 million decrease in research and development incentive receivables, following receipt of the 2023 research and development tax credit claim.
−Removed: During the six months ended June 30, 2024, net cash used in operating activities was $23.8 million, primarily resulting from our net loss of $32.5 million adjusted by share based compensation of $2.8 million, depreciation and amortization of $2.9 million, non-cash lease expense of $0.7 million, unrealized foreign exchange gain of $0.6 million and changes in our operating assets and liabilities, net of $2.7 million primarily related to a $2.1 million decrease in accounts payable and accrued expenses, other current assets, $0.8 million increase in deferred income, and $0.8 million decrease in operation lease liabilities.
−Removed: Net Cash Used in Investing Activities
−Removed: During the six months ended June 30, 2025 and 2024, cash used in investing activities was $0.04 million and $0.5 million, respectively.
−Removed: For the six months ended June 30, 2024, these amounts resulted primarily from capital expenditures related to lab equipment and leasehold improvements in our facilities in Germantown, Maryland, U.S.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Net Cash Provided By/(Used) in Investing Activities
+Added: 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.
+Added: For the nine months ended September 30, 2025, these amounts primarily related to
+Added: proceeds received upon the sale of U.K.
+Added: laboratory equipment.
+Added: 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
−Removed: During the six months ended June 30, 2025, cash provided by financing activities related only to net proceeds received from the issuance of ordinary shares through stock exercises.
−Removed: During the six months ended June 30, 2024, cash provided by financing activities of $0.9 million primarily related to net proceeds received from the issuance of ordinary shares through the “ at-the-market ” sales agreement.
+Added: 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.
+Added: 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
−Removed: During the six months ended June 30, 2025 and 2024, the effect of foreign exchange on cash, cash equivalents and restricted cash was a gain of $8.4 million and a loss of $0.8 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 .
+Added: 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
1 unchanged sentence
As a result, we have incurred losses in each year since our inception in 2016, except for 2022 when we were profitable.
−Removed: We have negative operating cash flows for the period ended June 30, 2025 and as of June 30, 2025, we had an accumulated deficit of $278.4 million.
+Added: 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.
4 unchanged sentences
• attract, hire and retain additional clinical, regulatory, quality control and other personnel;
−Removed: • 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 Chimpanzee Adenovirus Oxford ( “ ChAdOx ” ) and Modified vaccinia Ankara ( “ MVA ” ) vectors;
+Added: • 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;
4 unchanged sentences
• incur additional legal, accounting and other expenses in operating our business, including the additional costs associated with operating as a public company;
+Added: • 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.
3 unchanged sentences
If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: Accordingly, our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.
+Added: Accordingly, our failure to become and remain profitable would decrease the value of our company and could impair our
+Added: 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.
6 unchanged sentences
Our future capital requirements may depend on many factors, including:
+Added: • 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;
2 unchanged sentences
• 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;
−Removed: • the success of our collaborations with CEPI, Oxford University/OUI, Arbutus, CanSino, Cancer Research UK, and the Ludwig Institute and any future collaboration partners;
+Added: • 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;
6 unchanged sentences
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.
−Removed: Based on our research and development plans, we expect that our existing cash, cash equivalents and restricted cash and other financial resources, will enable us to fund our operating expenses and capital expenditure requirements into the start of 2027.
+Added: 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.
−Removed: We may require substantial additional financing in the future to meet any such unanticipated factors.
−Removed: 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.
+Added: 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.
+Added: If we raise additional funds through collaborations,
+Added: 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.
6 unchanged sentences
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;
−Removed: however, the amount, timing and likelihood of such payments are not known as of June 30, 2025.
+Added: however, the amount, timing and likelihood of such payments are not known as of September 30, 2025.
Emerging Growth Company Status
5 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.