3 unchanged sentences
Condensed Consolidated Balance Sheets
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Income
+Added: Condensed Consolidated Statements of Operations and Comprehensive Loss
Condensed Consolidated Statements of Changes in Stockholders’ Equity
4 unchanged sentences
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: September 30,
−Removed: Cash, cash equivalents and restricted cash $ 106,102 $ 142,090
−Removed: Contract asset - related parties 14,969 —
+Added: Cash and cash equivalents $ 99,118 $ 110,662
+Added: Restricted cash 1,461 1,738
Research and development incentives receivable 2,997 7,139
1 unchanged sentence
Total current assets 109,882 125,742
−Removed: Goodwill 12,209 12,209
Property and equipment, net 6,201 7,373
33 unchanged sentences
BARINTHUS BIOTHERAPEUTICS PLC
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
+Added: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
−Removed: Three months ended Nine months ended
−Removed: September 30, 2024 September 30, 2023 September 30, 2024 September 30, 2023
−Removed: License revenue 1
−Removed: $ 14,969 $ — $ 14,969 $ 802
−Removed: Total revenue 14,969 — 14,969 802
+Added: Three months ended
+Added: March 31, 2025 March 31, 2024
Operating expenses
8 unchanged sentences
Research and development incentives 302 594
−Removed: Other income/(expense) 26 ( 2 ) 46 308
+Added: Other income 75 —
Total other income, net 920 1,357
10 unchanged sentences
Other comprehensive gain/(loss) – foreign currency translation adjustments 4,646 ( 1,577 )
−Removed: Comprehensive income/(loss) 1,062 ( 21,930 ) ( 32,814 ) ( 53,793 )
+Added: Comprehensive loss ( 15,012 ) ( 17,097 )
Comprehensive loss attributable to noncontrolling interest 7 28
−Removed: Comprehensive income/(loss) attributable to Barinthus Biotherapeutics plc shareholders $ 1,067 $ ( 21,882 ) $ ( 32,770 ) $ ( 53,693 )
−Removed: 1 Includes license revenue from related parties for the three and nine months ended September 30, 2024 of $ 15.0 million (three and nine months ended September 30, 2023:
−Removed: nil and $ 0.8 million, respectively).
+Added: Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ ( 15,005 ) $ ( 17,069 )
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 Nine months ended September 30, 2024
+Added: Three months ended March 31, 2025
Ordinary Shares Deferred A Shares
−Removed: Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive (Loss)/Income Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
+Added: Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Noncontrolling Interest Total Stockholders' Equity
Balance, January 1, 2025 40,234,663 $ 1 63,443 $ 86 $ 393,474 $ ( 237,664 ) $ ( 25,868 ) $ 130,029 $ 106 $ 130,135
4 unchanged sentences
Balance, March 31, 2025 40,339,395 $ 1 63,443 $ 86 $ 393,944 $ ( 257,312 ) $ ( 21,225 ) $ 115,494 $ 99 $ 115,593
−Removed: Share based compensation — — — — 1,195 — — 1,195 — 1,195
−Removed: Issue of ordinary shares, net of issuance costs 231,382 0 1 — — 358 — — 358 — 358
−Removed: Foreign currency translation adjustments — — — — — — 163 163 1 164
−Removed: Net loss — — — — — ( 16,931 ) — ( 16,931 ) ( 12 ) ( 16,943 )
−Removed: Balance, June 30, 2024 39,184,338 $ 1 63,443 $ 86 390,273 $ ( 209,010 ) $ ( 24,732 ) $ 156,618 $ 172 $ 156,790
−Removed: Share based compensation — — — — 1,144 — — 1,144 — 1,144
−Removed: Issue of ordinary shares, net of issuance costs 358,180 0 1 — — 465 — — 465 — 465
−Removed: Foreign currency translation adjustments — — — — — — 9,181 9,181 10 9,191
−Removed: Net loss — — — — — ( 8,114 ) — ( 8,114 ) ( 15 ) ( 8,129 )
−Removed: Balance, September 30, 2024 39,542,518 $ 1 63,443 $ 86 $ 391,882 $ ( 217,124 ) $ ( 15,551 ) $ 159,294 $ 167 $ 159,461
−Removed: Indicates amount less than one thousand
−Removed: The accompanying notes are an integral part of these condensed consolidated financial statements
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
−Removed: STOCKHOLDERS’ EQUITY
−Removed: (IN THOUSANDS, EXCEPT NUMBER OF SHARES)
−Removed: Three and Nine months ended September 30, 2023
−Removed: Ordinary Shares Deferred A Shares Deferred B Shares Deferred C Shares
−Removed: Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive (Loss)/Income Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Non-Controlling Interest Total Stockholders' Equity
+Added: Three months ended March 31, 2024
+Added: Ordinary Shares Deferred A Shares
+Added: Shares Amount Shares Amount Additional Paid-in-Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total stockholders’ equity attributable to Barinthus Biotherapeutics plc stockholders Noncontrolling Interest Total Stockholders' Equity
Balance, January 1, 2024 38,643,540 $ 1 63,443 $ 86 $ 386,602 $ ( 176,590 ) $ ( 23,315 ) $ 186,784 $ 211 $ 186,995
2 unchanged sentences
Foreign currency translation adjustments — — — — — — ( 1,580 ) ( 1,580 ) 3 ( 1,577 )
−Removed: Cancellation of deferred shares — — — — ( 570,987 ) ( 8 ) ( 27,828,231 ) ( 0 ) 1 8 — — — — —
Net loss — — — — — ( 15,489 ) — ( 15,489 ) ( 31 ) ( 15,520 )
Balance, March 31, 2024 38,952,956 $ 1 63,443 $ 86 $ 388,720 $ ( 192,079 ) $ ( 24,895 ) $ 171,833 $ 183 $ 172,016
−Removed: Share based compensation — — — — — — — — 1,990 — — 1,990 — 1,990
−Removed: Issue of ordinary shares, net of issuance costs 167,034 0 1 — — — — — — 123 — — 123 — 123
−Removed: Foreign currency translation adjustments — — — — — — — — — — 5,597 5,597 7 5,604
−Removed: Net loss — — — — — — — — — ( 23,802 ) — ( 23,802 ) ( 22 ) ( 23,824 )
−Removed: Balance, June 30, 2023 38,524,059 $ 1 63,443 $ 86 — $ — — $ — $ 385,636 $ ( 145,225 ) $ ( 23,289 ) $ 217,209 $ 253 $ 217,462
−Removed: Share based compensation — — — — — — — — 57 — — 57 — 57
−Removed: Issue of ordinary shares, net of issuance costs 22,535 0 1 — — — — — — 14 — — 14 — 14
−Removed: Foreign currency translation adjustments — — — — — — — — — — ( 7,810 ) ( 7,810 ) ( 10 ) ( 7,820 )
−Removed: Net loss — — — — — — — — — ( 14,072 ) — ( 14,072 ) ( 38 ) ( 14,110 )
−Removed: Balance, September 30, 2023 38,546,594 $ 1 63,443 $ 86 — $ — — $ — $ 385,707 $ ( 159,297 ) $ ( 31,099 ) $ 195,398 $ 205 $ 195,603
1 Indicates amount less than one thousand
3 unchanged sentences
(IN THOUSANDS)
−Removed: Nine months ended
−Removed: September 30, 2024 September 30, 2023
+Added: Three months ended
+Added: March 31, 2025 March 31, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
4 unchanged sentences
Non-cash lease expenses 813 359
−Removed: Unrealized foreign exchange loss 2,022 879
+Added: Unrealized foreign exchange loss/(gain) 1,587 ( 1,026 )
Change in contingent consideration 1 60
2 unchanged sentences
Changes in operating assets and liabilities:
−Removed: Contract asset (including related parties) ( 14,969 ) 5,800
Prepaid expenses and other current assets 48 1,875
4 unchanged sentences
Operating lease liabilities ( 478 ) ( 346 )
−Removed: Other assets — ( 73 )
Net cash used in operating activities $ ( 14,902 ) $ ( 11,822 )
5 unchanged sentences
Issue of shares from the exercise of stock options 2 0 1
−Removed: Payment of contingent consideration — ( 163 )
Net cash provided by financing activities $ 2 $ 503
5 unchanged sentences
Non-cash investing and financing activities:
−Removed: Asset retirement obligation $ — $ 287
−Removed: Changes to right-of-use asset resulting from lease reassessment event $ — $ 88
+Added: Purchases of property and equipment included in accounts payable and accrued liabilities $ — $ 95
1 Indicates amounts less than one thousand
4 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 Australia Pty Limited, Vaccitech Oncology Limited (“VOLT”), Barinthus Biotherapeutics North America, Inc., Barinthus Biotherapeutics Switzerland GmbH and Barinthus Biotherapeutics S.R.L., are collectively referred to as the “Company” or “Barinthus Bio.” The Company is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity.
+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, and Barinthus Biotherapeutics Switzerland GmbH, are collectively referred to as the “Company” or “Barinthus Bio.” On January 16, 2025, the liquidation process of Barinthus Biotherapeutics S.R.L.
+Added: was completed and the company was cancelled from the Italian Business Register.
+Added: The Company is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating auto-immune and inflammatory diseases within the immunology and inflammation (“I&I”) space.
+Added: 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.
The Company is headquartered in Harwell, Oxfordshire, United Kingdom.
The Company operates in an environment of rapid technological change and substantial competition from pharmaceutical and biotechnology companies.
−Removed: The Company is subject to risks common to companies in the biopharmaceutical industry in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its immunotherapeutic product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology.
+Added: The Company is subject to risks common to companies in the biopharmaceutical industry that are also in a similar stage of its life cycle including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of any of its products that are approved, and protection of proprietary technology.
There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain required regulatory approval or that any approved products will be commercially viable.
9 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 September 30, 2024, the Company had cash, cash equivalents and restricted cash of $ 106.1 million and an accumulated deficit of $ 217.1 million, and the Company expects to incur losses for the foreseeable future.
−Removed: 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 the financial statements.
+Added: As of March 31, 2025, the Company had cash, cash equivalents and restricted cash of $ 100.6 million and an accumulated deficit of $ 257.3 million, and the Company expects to incur losses for the foreseeable future.
+Added: The Company expects that its cash, cash equivalents and restricted cash will be sufficient to fund current operations for at least the next twelve months from the issuance of these condensed consolidated financial statements.
The Company expects to 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.
3 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: 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.
BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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 September 30, 2024, and December 31, 2023, the Condensed Consolidated Statements of Operations and Comprehensive Income, 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, 2024 and 2023 are unaudited.
+Added: The accompanying Condensed Consolidated Balance Sheets as of March 31, 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 months ended March 31, 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 our opinion, the unaudited condensed consolidated financial statements include all adjustments of a normal recurring nature necessary for the fair presentation of our financial position as of September 30, 2024, our results of operations for the three and nine months ended September 30, 2024, and 2023, and our cash flows for the nine months ended September 30, 2024, and 2023.
−Removed: The results of operations for the three and nine months ended September 30, 2024, are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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 presentation of its financial position as of March 31, 2025, its results of operations for the three months ended March 31, 2025, and 2024, and its cash flows for the three months ended March 31, 2025, and 2024.
+Added: The results of operations for the three months ended March 31, 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
1 unchanged sentence
Use of Estimates
−Removed: The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period.
+Added: The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of income and expenses during the reporting period.
The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances.
4 unchanged sentences
Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
+Added: Recently issued accounting pronouncements
+Added: From time to time, new accounting pronouncements are issued by Financial Accounting Standards Board ("FASB") or other standard setting bodies that the Company adopts as of the specified effective date.
+Added: The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company can adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
+Added: 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.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
+Added: This standard is effective for annual reporting periods beginning after December 15, 2026, and requires prospective application with the option to apply it retrospectively.
+Added: We are currently evaluating the impact of adopting this standard to determine its impact on its disclosures.
Segment information
2 unchanged sentences
The Company views its operations and manages its business as one operating segment, the research and development of immunotherapies and vaccines.
−Removed: The chief operating decision maker uses loss before income tax to monitor budget versus actual results and decide how to use the Company's resources.
+Added: The CODM uses loss before income tax to monitor budget versus actual results and decide how to use the Company's resources.
As the Company operates in one operating segment, all required financial segment information can be found in these condensed consolidated financial statements.
+Added: The following table is a summary of the Company's significant segment expenses:
+Added: Three months ended March 31, 2025 Three months ended March 31, 2024 Change
+Added: Direct research and development expenses by program:
+Added: VTP-1000 Celiac $ 982 $ 1,374 $ ( 392 )
+Added: VTP-300 HBV 1,350 1,913 ( 563 )
+Added: Other clinical programs 1
+Added: 741 1,767 ( 1,026 )
+Added: Other pre-clinical programs 419 784 ( 365 )
+Added: Total direct research and development expenses 3,492 5,838 ( 2,346 )
+Added: Indirect research and development expenses:
+Added: Personnel-related (including share-based compensation) 2
+Added: 3,944 4,335 ( 391 )
+Added: Facility related 335 390 ( 55 )
+Added: Other indirect costs 519 562 ( 43 )
+Added: Total indirect research and development expenses 4,798 5,287 ( 489 )
+Added: Total research and development expenses $ 8,290 $ 11,125 $ ( 2,835 )
+Added: 1 This includes expenses relating to the infectious disease and oncology programs;
+Added: 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”).
+Added: Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
+Added: 2 This includes $ 0.07 million and $ 0.14 million for the three months ended March 31, 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: The Company operates in two geographic regions:
+Added: The following table summarizes the Company’s long-lived assets, which include the Company’s intangible assets, property and equipment, net and right-of-use assets by geography:
+Added: March 31, 2025 December 31, 2024
+Added: United States
+Added: $ 27,877 $ 28,907
+Added: United Kingdom
+Added: $ 31,212 $ 33,704
BARINTHUS BIOTHERAPEUTICS PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Recently issued accounting pronouncements
−Removed: From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date.
−Removed: The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition period related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company can adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
−Removed: We have reviewed all recently issued standards and have determined that such standards will not have a material impact on our condensed consolidated financial statements or do not otherwise apply to our current operations.
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 nine months ended September 30, 2024, was a loss of $ 7.7 million and loss of $ 6.6 million, respectively (three and nine months ended September 30, 2023:
−Removed: $ 6.6 million gain and $ 1.1 million loss, respectively).
+Added: The aggregate, net foreign exchange gain or loss recognized in general and administrative expenses for the three months ended March 31, 2025 was a loss of $ 4.4 million (three months ended March 31, 2024:
+Added: $ 1.2 million gain).
Net Loss Per Share
−Removed: The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2024, and 2023 (in thousands, except number of shares):
−Removed: Three months ended September 30, Nine months ended September 30,
−Removed: 2024 2023 2024 2023
+Added: The following table sets forth the computation of basic and diluted net loss per share for the three months ended March 31, 2025, and 2024 (in thousands, except number of shares):
+Added: Three months ended March 31,
Net loss $ ( 19,658 ) $ ( 15,520 )
6 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 September 30, 2024, 7,340,000 potential ordinary shares issuable for stock options were excluded from the computation of diluted weighted-average shares outstanding because including them would have had an anti-dilutive effect (September 30, 2023:
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of March 31, 2025, 8,133,504 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 (March 31, 2024:
Property and Equipment, Net
−Removed: During the nine months ended September 30, 2024, the Company’s additions to property and equipment, net were $ 0.6 million which primarily related to an increase in lab equipment in the Company's U.K.
−Removed: office (nine months ended September 30, 2023:
−Removed: $ 5.9 million, primarily related to an increase in leasehold improvements for the Company’s U.S.
+Added: During the three months ended March 31, 2025, the Company’s additions to property and equipment, net were $ 0.01 million which related to an increase in lab equipment (three months ended March 31, 2024:
+Added: $ 0.4 million, primarily related to an increase in leasehold improvements from the Company’s U.S.
office in Germantown, Maryland).
−Removed: Depreciation expense for the three and nine months ended September 30, 2024 was $ 0.7 million and $ 2.0 million, respectively (September 30, 2023:
−Removed: three and nine months $ 0.7 million and $ 1.6 million, respectively).
+Added: Depreciation expense for the three months ended March 31, 2025 was $ 1.2 million (three months ended March 31, 2024:
+Added: $ 0.6 million).
Intangible Assets, Net
−Removed: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of September 30, 2024 and December 31, 2023, respectively, and accumulated amortization was $ 8.9 million and $ 6.5 million as of September 30, 2024 and December 31, 2023, respectively.
−Removed: The amortization expense for the three and nine months ended September 30, 2024 was $ 0.8 million and $ 2.4 million, respectively (three and nine months ended September 30, 2023:
−Removed: $ 0.8 million and $ 2.4 million, respectively).
−Removed: The estimated annual amortization expense is $ 3.2 million for the years 2024 through to 2031.
−Removed: In June 2024, the Company announced plans to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Given this change in Company focus, management identified circumstances that could indicate that the carrying amount of the Company's intangible assets may not be recoverable.
−Removed: Therefore, the Company performed both a qualitative and quantitative assessment in July 2024 and determined that the carrying amount of the Company's intangible assets are recoverable.
−Removed: As of September 30, 2024, the Company did not identify any additional circumstances that may indicate the carrying amount of the Company's intangible assets are not recoverable.
+Added: The gross amount of amortizable intangible assets, consisting of acquired developed technology, was $ 31.6 million as of March 31, 2025 and December 31, 2024, respectively, and accumulated amortization was $ 10.5 million and $ 9.7 million as of March 31, 2025 and December 31, 2024, respectively.
+Added: The amortization expense for the three months ended March 31, 2025 was $ 0.8 million (three months ended March 31, 2024:
+Added: $ 0.8 million).
+Added: The estimated annual amortization expense is $ 3.2 million for the years 2025 through 2031.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Prepaid Expenses and Other Current Assets (in thousands):
−Removed: September 30,
2025 December 31,
−Removed: Prepayments and accrued income $ 7,064 $ 5,402
+Added: Prepayments $ 5,011 $ 5,771
Value Added Tax receivable 531 —
+Added: Accrued income 329 88
Other 435 344
1 unchanged sentence
Accrued Expenses and Other Current Liabilities (in thousands):
−Removed: September 30,
2025 December 31,
Accrued manufacturing and clinical expenses $ 2,556 $ 3,326
+Added: Value Added Tax payable — 2,416
Accrued bonus 910 1,774
3 unchanged sentences
Total $ 7,198 $ 9,525
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 1 Included in Accrued other as of March 31, 2025 is a provision of $ 1.4 million for severance costs for the reduction in workforce following the Company's announcement in January 2025 to prioritize its pipeline.
Coalition for Epidemic Preparedness Innovations (“CEPI”) Funding Agreement
7 unchanged sentences
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 Period.
−Removed: During the nine months period ended September 30, 2024, $ 3.0 million proceeds have been received and $ 1.0 million income has been recognized in relation to this contract.
−Removed: This is presented as other operating income in the condensed consolidated statements of operations and comprehensive income.
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
+Added: The Company intends to exit the Funding Agreement as part of aligning resources in accordance with the Company's strategy.
+Added: During the three months period ended March 31, 2025, nil (March 31, 2024:
+Added: $ 1.6 million) proceeds have been received and $ 0.3 million (March 31, 2024:
+Added: $ 0.2 million) income has been recognized in relation to this contract.
+Added: This is presented as other operating income in the condensed consolidated statements of operations and comprehensive loss.
The Funding Agreement cash payments are restricted as to the use and management of the funds.
−Removed: The remaining unused amounts of the Funding Agreement cash payments of $ 2.0 million as of September 30, 2024, are reflected in Cash, cash equivalents and restricted cash in the condensed consolidated balance sheets until expenditures contemplated in the Funding Agreement are incurred.
+Added: The remaining unused amounts of the Funding Agreement cash payments of $ 1.5 million as of March 31, 2025 (December 31, 2024:
+Added: $ 1.7 million) are reflected in Restricted cash in the condensed consolidated balance sheets until expenditures contemplated in the Funding Agreement are incurred.
Deferred income
−Removed: Payments received from CEPI in advance of the eligible research and development expenses being incurred are disclosed as deferred income separately in the condensed consolidated balance sheets.
−Removed: Deferred income is released to the condensed consolidated statements of operations and comprehensive income 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 nine months ended September 30, 2024 and 2023, are as follows (in thousands):
−Removed: Three months ended September 30, Nine months ended September 30,
−Removed: 2024 2023 2024 2023
+Added: Deferred income relates to payments received from CEPI in advance of the eligible research and development expenses being incurred and are disclosed as deferred income separately in the condensed consolidated balance sheets.
+Added: 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.
+Added: Changes in deferred income during the three months ended March 31, 2025 and 2024, are as follows (in thousands):
+Added: Three months ended March 31,
Beginning balance $ 1,738 $ —
3 unchanged sentences
Ending balance $ 1,461 $ 1,434
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Ordinary Shares
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 September 30, 2024:
+Added: The following is a summary of the rights and privileges of the holders of ordinary shares as of March 31, 2025:
Liquidation preference:
in the event of the liquidation, dissolution or winding up of the Company, the assets of the Company available for distribution to holders of the ordinary shares shall be distributed amongst all holders of the ordinary shares in proportion to the number of shares held irrespective of the amount paid or credited as paid on any share.
−Removed: The Company may, subject to the provisions of the Companies Act 2006 and our 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.
+Added: The Company may, subject to the provisions of the Companies Act 2006 and its Articles, by ordinary resolution from time to time declare dividends to be paid to shareholders not exceeding the amount recommended by the Company’s board of directors.
Subject to the provisions of the Companies Act 2006, insofar as, in the board of directors’ opinions, the Company’s profits justify such payments, the board of directors may pay interim dividends on the Company’s ordinary shares.
4 unchanged sentences
Pursuant to section 561 of the Companies Act 2006, shareholders are granted preemptive rights when new shares are issued for cash.
−Removed: However, it is possible for our Articles, or shareholders at a general meeting representing at least 75 % of our ordinary shares present (in person or by proxy) and eligible to vote at that general meeting, to disapply these preemptive rights by passing a special resolution.
−Removed: Such a disapplication of preemption rights may be for a maximum period of up to five years from the date on which the shareholder resolution was passed.
−Removed: In either case, this disapplication would need to be renewed by our shareholders upon its expiration ( i.e.
+Added: However, it is possible under the Articles, for shareholders at a general meeting representing at least 75 % of the Company's ordinary shares present (in person or by proxy) and eligible to vote at that general meeting, to disapply these preemptive rights by passing a special resolution.
+Added: Such a disapplication of preemption
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: rights may be for a maximum period of up to five years from the date on which the shareholder resolution was passed.
+Added: In either case, this disapplication would need to be renewed by the Company's shareholders upon its expiration ( i.e.
, at least every five years ) to remain effective.
−Removed: On April 21, 2021, our 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 our shareholders.
−Removed: This included the disapplication of preemption rights in relation to the allotment of our ordinary shares in connection with the IPO.
+Added: 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.
+Added: This included the disapplication of preemption rights in relation to the allotment of the Company's ordinary shares in connection with the 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: On November 6, 2023, we held a general meeting where our shareholders approved resolutions granting our 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, our 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 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.
+Added: 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.
The granting of this authority and the corresponding disapplication of preemptive rights was in addition to all subsisting authorities.
6 unchanged sentences
The deferred shares shall confer on the holders thereof no further right to participate in the assets of the Company.
−Removed: On March 29, 2023, all deferred B shares (nominal value of £ 0.01 each) and deferred C shares (nominal value of £ 0.00000736245954692556 each) previously in issue were transferred back to the Company and subsequently canceled.
−Removed: These deferred shares had previously been issued to certain pre-IPO shareholders in connection with the implementation of certain stages of the Company’s pre-IPO share capital reorganization.
−Removed: The Company received shareholder approval on
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: April 21, 2021 (pursuant to the shareholder resolutions passed on that date) in order to effect the transfer back and cancellation of the deferred shares for nil consideration in accordance with sections 659 and 662 of the Companies Act 2006.
The Company’s deferred A shares with a nominal value of £ 1.00 each remain in issue for the purposes of satisfying the minimum share capital requirements for a public limited company as prescribed by the Companies Act 2006.
−Removed: The Company’s financial instruments consist of cash, cash equivalents and restricted cash, accounts receivable, accounts payable, certain accrued expenses, and contingent consideration.
−Removed: The carrying amounts of cash, cash equivalents and restricted cash, accounts receivable, accounts payable and accrued expenses approximated their respective fair value due to the short-term nature and maturity of these instruments.
−Removed: As of September 30, 2024, the Company had a contingent consideration liability of $ 1.6 million related to the acquisition of Avidea Technologies, Inc.
−Removed: The fair value of the contingent consideration is a Level 3 valuation with the significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement.
+Added: The Company’s financial instruments consist of cash, cash equivalents and restricted cash, accounts payable, certain accrued expenses, and contingent consideration.
+Added: 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.
+Added: As of March 31, 2025, the Company had a contingent consideration liability of $ 2.7 million related to the acquisition of Avidea Technologies, Inc.
+Added: Avidea’s stockholders may be entitled to receive an aggregate of up to $ 40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.
+Added: To date, the Company has made settlement payments of $ 0.5 million.
+Added: The fair value of the contingent consideration is a Level 3 valuation and determined using the cost approach.
+Added: The significant unobservable inputs used in the fair value measurement of the contingent consideration are the probability of success of achievement of the milestones and the expected date of the milestone achievement.
Significant judgment is employed in determining the appropriateness of certain of these inputs.
−Removed: The following table summarizes changes to our financial instruments carried at fair value and classified within Level 3 of the fair value hierarchy (in thousands):
−Removed: Three months ended September 30, Nine months ended September 30,
−Removed: 2024 2023 2024 2023
+Added: Significant increases (decreases) in the probability of success of achievement of the milestones would have resulted in a significantly higher (lower) fair value measurement.
+Added: 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
+Added: 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):
+Added: Three months ended March 31,
Beginning balance $ 2,650 $ 1,823
Change in fair value recognized in net loss ( 79 ) 60
−Removed: Foreign exchange translation recognized in other comprehensive income 100 ( 76 ) 87 14
+Added: Foreign exchange translation recognized in other comprehensive loss 81 ( 16 )
Ending balance $ 2,652 $ 1,867
−Removed: The Company has identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s American Depositary Shares, whereby the market capitalization continues to be below the value of the net assets of the Company, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Therefore, the Company performed both an interim qualitative and quantitative assessment in July 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: The Company also performed an interim qualitative assessment as of September 30, 2024 and did not identify any additional circumstances that may indicate it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on these assessments, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount as of September 30, 2024 and hence no impairment loss has been recognized.
Share-Based Compensation
−Removed: During the nine month period ended September 30, 2024, 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, 2023.
−Removed: For the nine months ended September 30, 2024, the Company granted 1,953,422 options to employees and directors with a weighted average grant date fair value of $ 2.71 per share and a weighted average exercise price of $ 3.41 per share (September 30, 2023:
+Added: During the three month period ended March 31, 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 three months ended March 31, 2025, the Company granted 1,349,768 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 (March 31, 2024:
granted 1,627,958 options, weighted average grant date fair value of $ 2.90 per share and a weighted average exercise price of $ 3.67 per share).
−Removed: For the nine months ended September 30, 2024, 658,512 options (September 30, 2023:
+Added: For the three months ended March 31, 2025, 396,807 options (March 31, 2024:
70,946 ) were forfeited.
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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: Nine months ended September 30,
+Added: Three months ended March 31,
Expected volatility 114.1 % 108.8 %
2 unchanged sentences
Expected dividend yield — % — %
−Removed: As of September 30, 2024, 7,340,000 options with a weighted average exercise price of $ 6.03 per share were outstanding (September 30, 2023:
+Added: As of March 31, 2025, 8,133,504 options with a weighted average exercise price of $ 5.17 per share were outstanding (March 31, 2024:
7,645,076 options with a weighted average exercise price of $ 6.20 per share were outstanding).
−Removed: As of September 30, 2024, there was $ 4.0 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.7 years.
−Removed: Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive income as follows (in thousands):
−Removed: Three months ended September 30, Nine months ended September 30,
−Removed: 2024 2023 2024 2023
+Added: As of March 31, 2025, there was $ 2.9 million unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.1 years.
+Added: Share based compensation expense is classified in the unaudited condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
+Added: Three months ended March 31,
Research and development $ 68 $ 712
1 unchanged sentence
Total $ 468 $ 1,615
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Commitments and Contingencies
7 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 nine month periods ended September 30, 2024 and 2023.
+Added: The Company has not made or accrued any material payments under these license agreements during the three month periods ended March 31, 2025 and 2024.
The Company leases certain laboratory and office space under operating leases, which are described below.
2 unchanged sentences
The property is the Company’s corporate headquarters.
−Removed: As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: basis over a similar term at an amount equal to the lease payments in a similar economic environment.
+Added: As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date, being the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment.
The Company has provided the lessor with a refundable security deposit of $ 0.7 million which is included in Other assets.
+Added: It is more likely than not that the Company will cease the operating activities undertaken in the laboratory and office space in Harwell, Oxfordshire in 2025.
+Added: In 2024, an impairment charge to write down the U.K.
+Added: operating lease right-of-use asset to the estimated recoverable amount has been recorded and the estimated useful life of the asset reduced.
Germantown, Maryland
6 unchanged sentences
The Company’s right-of-use asset and lease liability are as follows (in thousands):
−Removed: September 30,
2025 December 31,
2 unchanged sentences
Lease liability, non-current $ 9,959 $ 10,087
−Removed: Nine months ended September 30,
+Added: BARINTHUS BIOTHERAPEUTICS PLC
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Three months ended March 31,
Other information
2 unchanged sentences
Weighted average discount rate 7.5 % 7.5 %
−Removed: Three months ended September 30, Nine months ended September 30,
−Removed: 2024 2023 2024 2023
−Removed: Short-term lease costs $ — $ — $ — $ 189
+Added: Three months ended March 31,
Operating leases $ 813 $ 359
Total lease cost $ 813 $ 359
−Removed: Future annual minimum lease payments under operating leases as of September 30, 2024, were as follows (in thousands):
+Added: Future annual minimum lease payments under operating leases as of March 31, 2025, were as follows (in thousands):
Remainder of 2025 $ 1,469
3 unchanged sentences
Total lease liability $ 11,919
−Removed: BARINTHUS BIOTHERAPEUTICS PLC
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Other contingencies
−Removed: As of the date of this Quarterly Report on Form 10-Q, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business.
−Removed: However, from time to time, we could be subject to various legal proceedings and claims that arise in the ordinary course of our business activities.
−Removed: Regardless of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
+Added: As of the date of this Quarterly Report on Form 10-Q, the Company does not believe it is party to any claim or litigation the outcome of which, if determined adversely to it, would individually or in the aggregate be reasonably expected to have a material adverse effect on the Company's business.
+Added: However, from time to time, the Company could be subject to various legal proceedings and claims that arise in the ordinary course of its business activities.
+Added: 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.
Related Party Transactions
−Removed: During the three and nine months ended September 30, 2024, the Company recognized license revenue of $ 15.0 million (three and nine months ended September 30, 2023:
−Removed: nil and $ 0.8 million, respectively), from Oxford University Innovation Limited.
−Removed: As of September 30, 2024, the Company accrued a contract asset receivable of $ 15.0 million (December 31, 2023:
−Removed: nil ) from Oxford University Innovation Limited.
−Removed: During the three and nine months ended September 30, 2024, the Company incurred expenses of $ 0.2 million and $ 0.7 million, respectively (three and nine months ended September 30, 2023:
−Removed: $ 0.2 million and $ 0.6 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 months ended March 31, 2025, the Company incurred expenses, related to clinical study costs, of $ 0.2 million (three months ended March 31, 2024:
+Added: $ 0.2 million) from Oxford University Innovation Limited, which is a wholly owned subsidiary of the Company’s shareholder, the University of Oxford.
+Added: As of March 31, 2025, the Company owed $ 0.2 million (December 31, 2024:
+Added: nil ) to the Oxford University Innovation Limited.
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 developing novel immunotherapeutic candidates designed to guide T cells to overcome chronic infectious diseases and autoimmunity.
+Added: We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating auto-immune and inflammatory diseases within the immunology and inflammation (“I&I”) space.
Helping patients and their families is the guiding principle at the heart of Barinthus Bio.
−Removed: We stand apart through our focused pipeline, built around proprietary platform technologies;
−Removed: viral vector-based, consisting of ChAdOx and MVA;
−Removed: and synthetic, consisting of SNAP-Tolerance Immunotherapy, or SNAP-TI.
−Removed: These platforms are enabling us to develop antigen-specific immunotherapeutic candidates designed to optimize the disease fighting capabilities of T cells and restore a healthy balance.
−Removed: Our immunotherapeutic candidates are designed to work by increasing disease-specific CD8+ T cell activity in the case of chronic infectious diseases, or by dampening effector CD4+ and CD8+ T cells, and increasing regulatory T cells in autoimmunity.
−Removed: Following our strategic pipeline update in June 2024, we are prioritizing a pipeline of two key product candidates in infectious disease and autoimmunity that harness our proprietary viral vector and synthetic platform technologies.
+Added: We aim to achieve this by developing truly transformational and highly disease-specific immunotherapies.
+Added: We are prioritizing the development of a pipeline for I&I indications enabled by our proprietary and highly differentiated platform for promoting immune tolerance, referred to as SNAP-TI, that are designed to guide patient's T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue.
+Added: Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease, and is currently being assessed in a Phase 1 clinical trial.
+Added: Based on encouraging preclinical data, we believe that the SNAP-TI platform has the potential to impact multiple other I&I indications.
+Added: We are also evaluating two product candidates to treat infectious diseases and cancer that harness our proprietary viral vector platform technologies, consisting of ChAdOx and MVA;
+Added: these technologies are designed to increase disease-specific CD8+ T cells.
These include:
−Removed: VTP-300, a Phase 2 immunotherapeutic candidate designed as a potential component of a functional cure for chronic hepatitis B virus infection utilizing ChAdOx/MVA;
−Removed: and VTP-1000, our first clinical autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease, and marking our entry into the autoimmunity space.
−Removed: We are evaluating VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer through to the end of an ongoing Phase 1 clinical trial.
−Removed: Alongside these proprietary programs, we have partnerships in place to advance three additional prophylactic and therapeutic product candidates including VTP-500 for Middle East Respiratory Syndrome, or MERS, VTP-400 for Zoster and VTP-600 for multiple cancer indications including Non-Small Cell Lung Cancer, or NSCLC, and Squamous Esophageal Cancer, or ESCC.
−Removed: We also co-invented Vaxzevria, a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca.
−Removed: We believe our proven scientific expertise, focused portfolio and experience on product candidate development uniquely positions us to navigate towards delivering treatments for patients with chronic infectious diseases and autoimmune-disorders that have a significant impact on their everyday lives.
−Removed: On August 9, 2022, we filed a Registration Statement on Form S-3, as amended, or 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 American Depositary Shares, or 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.
−Removed: As of September 30, 2024, we have sold 1,875,848 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $4.3 million.
−Removed: We incurred net losses each year since inception through to December 31, 2021.
−Removed: For the year ended December 31, 2022, we generated net income of $5.3 million, primarily as a result of revenues arising from prior AstraZeneca sales of Vaxzevria and our agreement with Oxford University Innovation (OUI).
−Removed: For the year ended December 31, 2023, we generated a net loss of $73.4 million.
−Removed: For the three and nine months ended September 30, 2024, we incurred a net loss of $8.1 million and $40.6 million, respectively.
−Removed: As of September 30, 2024, we had an accumulated deficit of $217.1 million and we do not currently expect positive cash flows from operations in the foreseeable future.
−Removed: We expect to incur net
−Removed: 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 and invest to establish a commercial manufacturing facility, as and when appropriate.
+Added: VTP-300, a Phase 2 immunotherapeutic treatment modality that is a component of a treatment regimen to establish functional cure in patients who are chronically infected by the hepatitis B virus, and VTP-850, a second-generation immunotherapeutic candidate for the prevention of recurrence of prostate cancer.
+Added: VTP-850 is being tested in patients in a Phase 1 clinical trial in prostate cancer after surgical resection.
+Added: We intend to progress the development of these product candidates by completing the ongoing clinical trials and are seeking a partner or collaborator for continuing development.
+Added: Alongside these proprietary programs, we have partnerships in place to advance additional prophylactic and therapeutic product candidates utilizing our viral vector platforms, including VTP-500 for Middle East Respiratory Syndrome, or MERS, VTP-400 for Herpes Zoster infections, and VTP-600 with potential for multiple cancer indications, including Non-Small Cell Lung Cancer (“NSCLC”), and Squamous Esophageal Cancer.
+Added: We also co-invented a COVID-19 vaccine with the University of Oxford, which was exclusively licensed worldwide to AstraZeneca U.K.
+Added: Limited (“AstraZeneca”).
+Added: We believe our core capabilities at the intersection of T cell immunology and immunotherapeutic technology platforms combined with our track record of successfully executing development path activities uniquely position us to navigate towards delivering promising new treatments for patients with auto-immune and inflammatory diseases and building value for shareholders.
+Added: We have incurred net losses in each annual and interim reporting period since 2023.
+Added: For the three months ended March 31, 2025, we incurred a net loss of $19.7 million.
+Added: As of March 31, 2025, we had an accumulated deficit of $257.3 million, and we do not currently expect positive cash flows from operations in the foreseeable future.
+Added: 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.
At this time, we cannot reasonably estimate, or know the nature, timing and estimated costs of all of the efforts that will be necessary to complete the development of any of our product candidates that we develop through our programs.
3 unchanged sentences
• sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
−Removed: • acceptance of investigational new drug applications, or INDs, for our planned clinical trials or future clinical trials;
+Added: • acceptance of investigational new drug applications (“INDs”) for our planned clinical trials or future clinical trials;
• successful and timely enrollment and completion of clinical trials;
13 unchanged sentences
Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans.
−Removed: 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
−Removed: 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 second quarter of 2026.
+Added: 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.
+Added: 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.
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: These are estimated timelines only and our pipeline may be subject to change.
−Removed: VTP-300 (Chronic hepatitis B)
−Removed: In September 2024, enrollment was completed in the HBV003 trial (NCT05343481) of VTP-300 in 121 adult participants with chronic hepatitis B.
−Removed: The Phase 2b trial is designed to obtain critical dosing information for a potential functional cure regimen for chronic hepatitis B, with participants receiving VTP-300 and low-dose (LD) nivolumab.
−Removed: A further data update on both the ongoing HBV003 Phase 2b and IM-PROVE Phase 2a trials in collaboration with Arbutus Biopharma is expected at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024 scheduled from November 15-19, 2024 in San Diego, CA., with a late-breaking oral presentation and late-breaking poster having been accepted on the trials, respectively.
−Removed: VTP-1000 (Celiac Disease)
−Removed: In September 2024, we initiated the first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease.
−Removed: The AVALON trial is a randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge.
−Removed: It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.
−Removed: VTP-850 (Prostate Cancer)
−Removed: In October 2024, we announced that the PCA001 trial (NCT05617040) of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e.
−Removed: , biochemical recurrence) had completed enrollment of 22 participants.
−Removed: The Phase 1 trial is designed to evaluate safety and efficacy, as measured by PSA and T cell response.
−Removed: We expect to have data from this Phase 1 trial in the first half of 2025.
−Removed: Management Team
−Removed: Effective from September 1, 2024, Graham Griffiths, our Chief Business Officer since October 2017, was promoted to Chief Operating Officer.
−Removed: Financial Update
−Removed: In October 2024, we were informed of additional amounts due to the Company from Oxford University Innovation (OUI) in relation to the Company's share of royalties received by OUI as a result of prior commercial sales of Vaxzevria® by AstraZeneca.
−Removed: As a result, $15.0 million revenue has been recognized in the third quarter of 2024.
−Removed: There is no expectation of additional payments or that we will be notified of such payments in a timely manner.
−Removed: We expect that this additional revenue will enable us to fund our research and development plans further into the second quarter of 2026.
−Removed: Impact of Israel and Gaza Conflict, Ukraine Crisis and Iran Conflict
+Added: On May 7, 2025, we announced primary endpoint data from two ongoing clinical trials in people with chronic hepatitis B (“CHB ” ), at the European Association for the Study of the Liver (“EASL ” ) Congress 2025.
+Added: The presentations included preliminary results from the Phase 2b clinical trial (HBV003), as well as results from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving ongoing standard of care nucleos(t)ide analogue (“NUC ” ) therapy.
+Added: VTP-300 and Low-dose Nivolumab
+Added: The HBV003 study is evaluating the safety, immunogenicity and disease modifying activity of three different dosing regimens of VTP-300 in combination with low-dose nivolumab (“LDN”), an anti-PD-1 monoclonal antibody.
+Added: The preliminary analysis showed that in CHB participants with hepatitis B surface antigen (“HBsAg”) levels of <200 IU/mL, meaningful reductions in HBsAg (>1 log decline) occurred soon after dosing on Day 29 in all treatment groups and were maintained to Day 169.
+Added: In the two best treatment arms HBsAg declines of ≥1 log at Day 169 were observed in 33% (15/45) of participants with HBsAg ≤200 IU/mL at baseline, and 22% (10/45) of participants achieved HBsAg loss at any timepoint.
+Added: 71% of participants (48 of 68) met the criteria for discontinuation of NUC therapy.
+Added: NUC discontinuation was optional;
+Added: two participants achieved functional cure and one seroconverted to HBsAg positivity.
+Added: Treatment with VTP-300 in combination with LDN was generally well-tolerated, with no related serious adverse events reported.
+Added: The primary analysis confirms observations from previous interim data, which indicated that stronger responses occurred in participants treated with the combination of VTP-300 and LDN (Groups 1 and 2).
+Added: IM-PROVE II data:
+Added: imdusiran and VTP-300
+Added: Our collaboration partners, Arbutus Biopharma (ABUS), presented data from the IM-PROVE II phase 2a clinical trial, including end of study data from Groups A and B and data though week 84 for Group C, showing that 25% (2/8) of participants with starting baseline HBsAg levels less than 1000 IU/mL that received the combination of imdusiran (“IDR”), VTP-300 and LDN reached functional cure, 3 of 13 participants (23%) receiving IDR+VTP-300+LDN had undetectable HBsAg levels at week 48, and all (3/3) of participants with HBsAg loss seroconverted.
+Added: Treatment with IDR and VTP-300 was generally well-tolerated, with no serious adverse events or treatment discontinuations reported.
+Added: Impact of Israel and Gaza Conflict and Ukraine Crisis and Iran Conflict
In respect of the international conflict in Israel and Gaza, situation in Ukraine and Iran conflict, we have no operations or suppliers based in Israel or Gaza, or in Ukraine, Belarus, Russia or Iran, and as a result, as of the date of this Quarterly Report on Form 10-Q, we believe the impact on our business, operations and financial condition will be minimal.
1 unchanged sentence
Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on our results of operations and financial condition.
−Removed: These inflationary pressures and volatile interest rates in the United States, the United Kingdom and elsewhere have given rise to increasing concerns that the U.S., U.K.
−Removed: and other economies are now in, or may enter, economic recession.
−Removed: Sustained inflationary pressures, volatile interest rates, an economic recession or continued or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets.
+Added: Inflationary pressures, volatile interest rates, or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets.
Additionally, we may incur future increases in operating costs due to additional inflationary increases.
Components of Our Operating Results
−Removed: To date, we have not generated any revenue from direct product sales and do not expect to do so in the near future, if at all.
−Removed: Most of our revenue to date has been derived from the OUI License Agreement Amendment with OUI relating to Vaxzevria.
−Removed: In April 2020, we entered into the OUI License Agreement Amendment with OUI in respect of our rights to use the ChAdOx1 technology in COVID-19 vaccines to facilitate the license of those rights by OUI to AstraZeneca.
−Removed: Under this agreement, we are entitled to receive from OUI a share of payments, including royalties and milestones, received by OUI from AstraZeneca in respect of this vaccine.
−Removed: In March 2022, we were notified by OUI of the commencement of revenue relating to prior commercial sales of Vaxzevria.
−Removed: Our revenue for the three and nine months ended September 30, 2024 was $15.0 million (three and nine months ended September 30, 2023:
−Removed: nil and $0.8 million, respectively), representing the amounts we have been notified of as due by OUI to date and an estimate of future receipts, constrained to the extent that it is probable that a significant reversal of revenue would not occur.
−Removed: In May 2024, AstraZeneca announced its planned withdrawal of Vaxzevria as demand had declined, and therefore we do not expect to receive any future revenue relating to future commercial sales of Vaxzevria.
Operating Expenses
1 unchanged sentence
Research and Development Expenses
−Removed: Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a new next-generation adenoviral vector, acquiring new technology platforms including SNAP, conducting preclinical studies, developing various manufacturing processes, initiating the clinical trials for VTP-200,
−Removed: VTP-300, VTP-600, VTP-850 and VTP-1000 and readying VTP-500 for clinical trials.
−Removed: Research and development activities account for a large portion of our operating expenses, and we expect research and development expenses to increase in the future.
+Added: Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a next-generation adenoviral vector, acquiring new technology platforms including SNAP-TI, conducting preclinical studies, developing various manufacturing processes, advancing our clinical programs.
+Added: Research and development activities account for a large portion of our operating expenses, and product candidates in later stages of development generally have higher development costs than those in earlier stages, due to larger and more complex clinical trials, manufacturing scale-up and an increase in research and development headcount to oversee these activities.
+Added: We are currently seeking partners to fund or collaborate on certain of our programs, including VTP-300 and VTP-850, which we do not intend to develop beyond the completion of the ongoing trials, as applicable.
+Added: We expect research and development expenses to increase in the future as we progress our program through the next stage of development.
Research and development costs are expensed as incurred.
1 unchanged sentence
• salaries, benefits, and other related costs, including share-based compensation, for personnel engaged in research and development functions;
−Removed: • expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations, or CROs;
+Added: • expenses incurred in connection with the development of our programs including preclinical studies and clinical trials of our product candidates, under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations ( “ CROs ” );
• the cost of manufacturing drug products for use in preclinical development and clinical trials, including agreements with third parties, such as contract manufacturing organizations, consultants and contractors;
5 unchanged sentences
When determining the fair value of contingent consideration, significant judgment is used to determine the probability of success of achievement of the technology and clinical milestones and the date of the expected milestone.
−Removed: We expect our general and administrative expenses to continue to increase in the future as we expand our operating activities in both the United Kingdom and United States and potentially prepare for manufacturing and/or commercialization 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 and the Securities and Exchange Commission, directors’ and officers’ liability insurance premiums and investor relations activities.
+Added: 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.
+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 Securities and Exchange Commission, 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 income 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 we recognize 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.
3 unchanged sentences
Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held by Barinthus Biotherapeutics (UK) Limited.
−Removed: Interest Expense
−Removed: Interest expense results primarily from the asset retirement obligation discounted over the length of the relevant lease.
Research and Development Incentives
−Removed: Research and development incentives contain payments receivable from the United Kingdom government related to corporation tax relief on research and development projects in the United Kingdom.
+Added: Research and development incentives contain payments receivable from the United Kingdom government related to corporation tax relief for qualifying expenditure on research and development projects in the United Kingdom.
We account for such relief received as other income.
−Removed: We benefit from the United Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program, or 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, or RDEC Program.
−Removed: Until March 2023 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 33.4% of such qualifying research and development expenditure.
−Removed: Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects.
−Removed: Certain subcontracted qualifying research and development expenditures were eligible for a cash rebate of up to 21.7%.
+Added: Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs, externally provided workers and utilities costs incurred as part of research projects.
A large portion of costs relating to research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims.
−Removed: From April 2023, under the SME Program, the enhanced rate of deduction has decreased from 230% to 186%, the SME credit rate has been reduced from 14.5% to 10% (except for R&D intensive SMEs, which will benefit from a credit rate of 14.5%), and our SME cash rebate has been reduced from an effective rate of 33.4% to 18.6% (or 27.0% for R&D intensive SMEs) and from 21.7% to 12.1% for subcontractors.
−Removed: We are regularly assessing if we can claim under the loss-making R&D Intensive Scheme for SMEs, which would provide benefits consistent with those claimed under the previous SME Program.
−Removed: From the analysis performed, we do not currently expect to claim under the loss-making R&D Intensive Scheme for SMEs primarily due to the proportion of total relevant expenditure occurring outside the United Kingdom.
−Removed: We may not be able to continue to claim research and development tax credits under the SME program in the future because we may no longer qualify as a small or medium-sized company.
−Removed: In addition, the EU State Aid cap limits the total aid claimable in respect of a given project to €7.5 million which may impact our ability to claim R&D tax credits in future.
−Removed: Further, the U.K.
−Removed: Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of £20,000 with effect from April 2021 by reference to, broadly, three times the total Pay As You Earn, or PAYE, and National Insurance Contributions, or NICs, liability, subject to an exception which prevents the cap from applying.
−Removed: That exception requires us to create, take steps to create or manage intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed.
−Removed: If such an exception does not apply, this could restrict the amount of payable credit that we claim.
−Removed: The merged scheme Research & Development expenditure credit (RDEC) and enhanced R&D intensive support (ERIS) replace the old RDEC and small and medium-sized enterprise (SME) schemes for accounting periods beginning on or after April 1, 2024.
−Removed: For expenditure under the merged scheme, the rate of Research and Development expenditure credit will be 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023.
+Added: For 2025 we benefit from the applicable United Kingdom research and development tax credit regime, which is the merged scheme Research & Development expenditure credit ( “ RDEC ” ) and enhanced R&D intensive support ( “ ERIS ” ) that replaces the old RDEC and small and medium-sized enterprise ( “ SME ” ) schemes for accounting periods beginning on or after April 1, 2024.
+Added: For expenditure under the merged scheme, the rate of Research and Development expenditure credit is 20%, which is the same as the rate under the old RDEC scheme for expenditure incurred on or after April 1, 2023.
For loss-makers and small profit-makers, a lower rate of notional tax restriction (currently 19%) applies at payment.
−Removed: For all other companies, the restriction will continue to apply at the Corporation Tax main rate (currently 25%).
−Removed: The amount of the PAYE cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities.
+Added: The amount of the Pay As You Earn ( “ PAYE ” ) cap for claims under both the merged scheme and ERIS is £20,000 plus 300% of the company’s relevant PAYE and National Insurance contributions liabilities.
The PAYE cap (where applicable) will limit the amount of payable credit that can be received in the accounting period under consideration.
Any excess over the cap will be carried forward and treated as an amount of Research and Development expenditure credit to which the company will be entitled for the next accounting period.
−Removed: Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit and the EU State Aid cap will not impact the benefit under the merged scheme.
−Removed: Furthermore, for accounting periods starting on or after April 1, 2024, 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 UK.
−Removed: This may restrict the ability to include cost incurred on EPWs based in the US and Switzerland for future accounting periods.
−Removed: Unsurrendered UK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
−Removed: The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of UK taxable profits.
+Added: Based on prior claims and the split of qualifying spend it is expected that the PAYE cap is unlikely to affect the net benefit.
+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.
+Added: This may restrict the ability to include cost incurred on externally provided workers ( “ EPWs ” ) 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 ( “ RDEC Program ” ).
+Added: 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%, unless the SME qualifies as an R&D intensive business;
+Added: that is R&D expenditure constitutes at least 30% of total expenditure.
+Added: From the analysis performed, we have not and do not expect to claim under the loss-making R&D Intensive Scheme for SMEs primarily due to the proportion of total relevant expenditure occurring outside the United Kingdom.
+Added: In future years, we may not be able to continue to claim research and development tax credits under the United Kingdom research and development tax credit regime if we no longer qualify based on the eligibility criteria.
+Added: Unsurrendered U.K.
+Added: losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
+Added: The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of U.K.
+Added: taxable profits.
+Added: There was no tax loss restriction applied to the R&D tax credits in the U.K.
+Added: for the three months ended March 31, 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, or 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 accounting principles generally accepted in the United States ( “ 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 revenue, income and expenses during the reporting period.
−Removed: On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of goodwill and intangible assets.
+Added: On an ongoing basis, management evaluates its estimates, including those related to fair value of contingent consideration and impairment of intangible assets.
Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances.
1 unchanged sentence
We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements and understanding and evaluating our reported financial results.
−Removed: We assess goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amounts may not be recoverable.
−Removed: We have elected to assess goodwill for impairment by first performing a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis of determining whether it is necessary to perform the quantitative goodwill impairment test.
−Removed: We have one reporting unit.
−Removed: Accordingly, our review of goodwill impairment indicators is performed at the entity-wide level.
−Removed: This requires us to assess and make judgments regarding a variety of factors, including clinical data results, business plans, anticipated future cash flows, economic projections and other market data.
−Removed: Because there are inherent uncertainties involved in these factors, significant differences between these estimates and actual results could result in future impairment charges and could materially impact our future financial results.
−Removed: The goodwill of $12.2 million recognized as of September 30, 2024 relates to the acquisition of Avidea on December 10, 2021.
−Removed: The Company has identified qualitative indicators of impairment due to a sustained decline in the price of the Company’s ADSs, whereby the market capitalization continues to be below the value of the net assets of the Company, and the plans announced in June 2024 to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Therefore, the Company performed both an interim qualitative and quantitative assessment in July 2024 to determine whether it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: The Company also performed an interim qualitative assessment as of September 30, 2024 and did not identify any additional circumstances that may indicate it was more likely than not that the fair value of the reporting unit is less than its carrying amount.
−Removed: Based on these assessments, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount and hence no impairment loss has been recognized related to goodwill for the three and nine months ended September 30, 2024.
Long-lived Assets
−Removed: The Company reviews long-lived assets to be held and used, including property and equipment, intangible assets and operating lease right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.
+Added: We review long-lived assets to be held and used, including property and equipment, intangible assets and operating lease right-of-use assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.
Evaluation of recoverability is first based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition.
In the event such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the assets are written down to their estimated fair values.
−Removed: In June 2024, the Company announced plans to prioritize its pipeline to focus on the development of VTP-300 for chronic Hepatitis B virus infection and VTP-1000 in celiac disease.
−Removed: Given this change in Company focus, management identified circumstances that could indicate that the carrying amount of the Company's intangible assets may not be recoverable.
−Removed: Therefore, the Company performed both a qualitative and quantitative assessment in July 2024 and determined that the carrying amount of the Company's intangible assets are recoverable.
−Removed: As of September 30, 2024, the Company did not identify any additional circumstances that may indicate the carrying amount of the Company's intangible assets are not recoverable, hence no impairment loss related to intangible assets has been recorded during the three and nine months ended September 30, 2024.
+Added: In January 2025, we announced plans to prioritize our pipeline to focus on the development of VTP-1000 in celiac disease, and focus the future pipeline on I&I indications.
+Added: In addition, we continued to experience a sustained decline in the price of our American Depositary Shares ( “ ADSs ” ), whereby the market capitalization continues to be below the value of our net assets.
+Added: Given this change in our focus and sustained decline in share price, management identified circumstances that could indicate the carrying amount of our intangible assets may not be recoverable.
+Added: Therefore, we performed both a qualitative and quantitative assessment in January 2025 and determined the carrying amount of our intangible assets are recoverable.
+Added: As of March 31, 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.
Contingent Consideration
−Removed: We recognize a contingent consideration liability related to the acquisition of Avidea.
+Added: We recognize a contingent consideration liability related to the acquisition of Avidea Technologies, Inc.
+Added: ( “ Avidea ” ).
+Added: The liability is remeasured to fair value at each reporting date until the contingency is resolved.
+Added: The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs being the probability of success of achievement of the milestones and the expected date of the milestone achievement.
Avidea’s stockholders may be entitled to receive an aggregate of up to $40.0 million in additional payments, payable in a combination of cash and ADSs, upon the achievement of certain milestones.
This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved.
−Removed: The fair value of the contingent consideration is a Level 3 valuation determined using significant unobservable inputs, being the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
−Removed: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive income.
+Added: Changes in fair value are recognized in general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.
+Added: The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
Results of Operations
−Removed: Comparison of the Three Months Ended September 30, 2024 and 2023
+Added: Comparison of the Three Months Ended March 31, 2025 and 2024
The following table sets forth the significant components of our results of operations (in thousands):
−Removed: Three months ended September 30, 2024 Three months ended September 30, 2023 Change
−Removed: License revenue
−Removed: $ 14,969 $ — $ 14,969
+Added: Three months ended March 31, 2025 Three months ended March 31, 2024 Change
Operating expenses:
Research and development
−Removed: General and administrative 13,420 961 12,459
−Removed: Total operating expenses 24,559 16,105 8,454
−Removed: Other operating income 210 — 210
−Removed: Loss from operations
8,290 11,125 (2,835)
−Removed: Other income/(expense)
−Removed: Interest income 631 196 435
−Removed: Interest expense (17) (7) (10)
−Removed: Research and development incentives 608 1,205 (597)
−Removed: Other income/(expense)
−Removed: Total other income 1,248 1,392 (144)
−Removed: Loss before income tax
−Removed: (8,132) (14,713) 6,581
−Removed: Tax benefit 3 603 (600)
−Removed: $ (8,129) $ (14,110) $ 5,981
−Removed: For the three months ended September 30, 2024, and 2023, our revenue consisted of $15.0 million and nil, respectively, from the OUI License Agreement Amendment with respect to payments due from OUI in connection with prior commercial sales of Vaxzevria.
−Removed: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
−Removed: Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands):
−Removed: Three Months Ended September 30, 2024 Three Months Ended September 30, 2023 Change
−Removed: Direct research and development expenses by program:
−Removed: VTP-200 HPV $ 246 $ 1,288 $ (1,042)
−Removed: VTP-300 HBV 2,748 4,877 (2,129)
−Removed: VTP-500 MERS 1
−Removed: VTP-600 NSCLC/ESCC 2
−Removed: VTP-850 Prostate cancer 914 1,724 (810)
−Removed: VTP-1000 Celiac 3
−Removed: 1,751 2,507 (756)
−Removed: Other and earlier stage programs 707 1,069 (362)
−Removed: Total direct research and development expenses 6,514 11,620 (5,106)
−Removed: Indirect research and development expenses:
−Removed: Personnel-related (including share-based compensation) 4
−Removed: 3,871 2,711 1,160
−Removed: Facility related 214 368 (154)
−Removed: Other indirect costs 540 445 95
−Removed: Total indirect research and development expenses 4,625 3,524 1,101
−Removed: Total research and development expenses $ 11,139 $ 15,144 $ (4,005)
−Removed: 1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
−Removed: 2 The VTP-600 NSCLC/ESCC Phase 1/2a trial is sponsored by Cancer Research UK.
−Removed: 3 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical.
−Removed: Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we are preparing to initiate the clinical trial for VTP-1000 Celiac.
−Removed: 4 This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
−Removed: Our research and development expenses for the three months ended September 30, 2024 and 2023 were $11.1 million and $15.1 million, respectively.
−Removed: Direct expenses for the three months ended September 30, 2024 and 2023 were $6.5 million and $11.6 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 $5.1 million decrease, $2.1 million pertains to a decrease in VTP-300 HBV clinical trial and manufacturing costs as enrollment for the two ongoing Phase 2 trials is now complete, $0.8 million pertains to the completion of the VTP-1000 clinical trial in the third quarter of 2024, and $1.0 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in the first quarter of 2024.
−Removed: Indirect research and development expenses for the three months ended September 30, 2024 and 2023 were $4.6 million and $3.5 million, respectively.
−Removed: The increase of $1.1 million primarily relates to personnel expenses, including share-based payment charges of $0.4 million, due to an increase in personnel time spent on research and development activities.
−Removed: General and Administrative Expenses
−Removed: General and administrative expenses for the three months ended September 30, 2024 and 2023 were $13.4 million and $1.0 million, respectively.
−Removed: The increase of $12.4 million relates primarily to a net increase of $14.3 million in net loss on foreign exchange, offset by a decrease in personnel expenses, including share-based payment charges of $1.3 million, primarily due to a decrease in personnel costs following the reduction in workforce in Q2 2024 and less personnel time spent on general and administrative activities.
−Removed: Other Operating Income
−Removed: For the three months ended September 30, 2024 and 2023, other operating income was $0.2 million and nil, respectively, resulting from the funding provided by CEPI under the Funding Agreement, dated December 20, 2023, entered into by and among us, the Chancellors, Masters and Scholars of the University of Oxford and the CEPI for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
−Removed: Interest Income
−Removed: For the three months ended September 30, 2024 and 2023, interest income was $0.6 million and $0.2 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
−Removed: Research and Development Incentives
−Removed: For the three months ended September 30, 2024 and 2023 research and development incentives were $0.6 million and $1.2 million, respectively.
−Removed: Such research and development incentives relate to corporation tax relief on research and development projects incentive programs in the United Kingdom.
−Removed: The decrease of $0.6 million is due to reduced expenses eligible for the research and development corporation tax relief, as well as a decrease in the enhanced rate of deduction and credit rate under the scheme, effective from April 2023.
−Removed: For the three months ended September 30, 2024 and 2023, the tax benefit was $0.003 million and $0.6 million respectively, which primarily relates to movements in deferred tax.
−Removed: Comparison of the Nine months ended September 30, 2024 and 2023
−Removed: The following table sets forth the significant components of our results of operations (in thousands):
−Removed: Nine months ended September 30, 2024 Nine months ended September 30, 2023 Change
−Removed: License Revenue
−Removed: $ 14,969 $ 802 $ 14,167
−Removed: Operating expenses:
−Removed: Research and development 33,926 38,501 (4,575)
General and administrative 12,639 5,994 6,645
2 unchanged sentences
Loss from operations (20,600) (16,914) (3,686)
−Removed: (44,580) (63,926) 19,346
Other income/(expense)
2 unchanged sentences
Research and development incentives 302 594 (292)
−Removed: Other income, net 46 308 (262)
+Added: Other income 75 — 75
Total other income 920 1,357 (437)
2 unchanged sentences
Tax benefit 22 37 (15)
−Removed: $ (40,592) $ (56,157) $ 15,565
−Removed: For the nine months ended September 30, 2024 and 2023, our revenue consisted of $15.0 million and $0.8 million, respectively, from the OUI License Agreement Amendment with respect to payments due from OUI in connection with
−Removed: prior commercial sales of Vaxzevria.
−Removed: There is no guarantee that such payments will be made in the future and, if they do, that we will be notified of such payments in a timely manner.
+Added: Net loss $ (19,658) $ (15,520) $ (4,138)
Research and Development Expenses
−Removed: The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
−Removed: Nine months ended September 30, 2024 Nine months ended September 30, 2023 Change
+Added: The following table summarizes our research and development expenses for the three months ended March 31, 2025 and 2024 (in thousands):
+Added: Three months ended March 31, 2025 Three months ended March 31, 2024 Change
Direct research and development expenses by program:
−Removed: VTP-200 HPV $ 1,882 $ 4,463 $ (2,581)
−Removed: VTP-300 HBV 7,695 10,752 (3,057)
−Removed: VTP-500 MERS 1
−Removed: VTP-600 NSCLC/ESCC 2
−Removed: 296 509 (213)
−Removed: VTP-850 Prostate cancer 1,506 2,181 (675)
VTP-1000 Celiac $ 982 $ 1,374 $ (392)
+Added: VTP-300 HBV 1,350 1,913 (563)
+Added: Other clinical programs 1
741 1,767 (1,026)
−Removed: Other and earlier stage programs 2,398 2,050 348
+Added: Other pre-clinical programs 419 784 (365)
Total direct research and development expenses 3,492 5,838 (2,346)
6 unchanged sentences
Total research and development expenses $ 8,290 $ 11,125 $ (2,835)
−Removed: 1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
−Removed: 2 The VTP-600 NSCLC/ESCC Phase 1/2a trial is sponsored by Cancer Research UK.
−Removed: 3 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical.
−Removed: Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we are preparing to initiate the clinical trial for VTP-1000 Celiac.
−Removed: 4 This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
−Removed: Our research and development expenses for the nine months ended September 30, 2024 and 2023 were $33.9 million and $38.5 million, respectively.
−Removed: Direct expenses for the nine months ended September 30, 2024 and 2023 were $18.8 million and $27.1 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 $8.3 million decrease, $3.1 million pertains to a decrease in VTP-300 HBV clinical trial and manufacturing costs as enrollment for the two ongoing Phase 2 trials is now complete, $2.6 million pertains to the completion of the VTP-1000 clinical trial in the third quarter of 2024, and the deprioritization of VTP-1100 for HPV cancer announced earlier in 2024, and $2.6 million pertains to a reduction in clinical trial and manufacturing development costs for the VTP-200 HPV program following the completion of the Phase 1b/2 APOLLO (HPV001) clinical trial in 2024.
−Removed: Indirect research and development expenses for the nine months ended September 30, 2024 and 2023 were $15.1 million and $11.4 million, respectively.
−Removed: Of the $3.7 million increase, $3.3 million relates primarily to an average increase in headcount on a year-to-date basis, severance costs of $0.7 million across our locations in the United Kingdom and United States following the Company’s announcement in June 2024 to prioritize its pipeline, more personnel time spent on research and development activities a nd higher share-based payment charges due to higher value awards expensed in the period.
+Added: 1 This includes expenses relating to the infectious disease and oncology programs;
+Added: 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”).
+Added: Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative.
+Added: 2 This includes $0.07 million and $0.14 million for the three months ended March 31, 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 March 31, 2025 and 2024 were $8.3 million and $11.1 million, respectively.
+Added: Direct expenses for the three months ended March 31, 2025 and 2024 were $3.5 million and $5.8 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.
+Added: Of the $2.3 million decrease, $2.0 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 immunology and inflammation space, and $0.4 million pertains to a decrease in 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.
+Added: Indirect research and development expenses for the three months ended March 31, 2025 and 2024 were $4.8 million and $5.3 million, respectively.
+Added: The decrease of $0.5 million primarily relates to the reduction in headcount in the research and manufacturing teams, following the Company’s announcements in June 2024 and January 2025 to prioritize its pipeline and as a result, reduce the size of the workforce.
General and Administrative Expenses
−Removed: General and administrative expenses for the nine months ended September 30, 2024 and 2023 were $26.6 million and $26.2 million, respectively.
−Removed: The increase of $0.4 million relates primarily to an increase in net loss on foreign exchange of $5.5 million, offset by a decrease in personnel expenses primarily due to a decrease in personnel cost due to the workforce reduction in Q2 2024 (net of $0.1 million severance cost) and a reduction in share-based payment charges due to the timing of high value awards, a decrease in insurance costs of $1.5 million related to a reduction in insurance premiums, and a decrease of $0.7 million in facility related costs due to the relocation to our new U.S.
−Removed: laboratory in June 2023.
+Added: General and administrative expenses for the three months ended March 31, 2025 and 2024 were $12.6 million and $6.0 million, respectively.
+Added: The increase of $6.6 million relates primarily to a loss of $4.4 million on foreign exchange for the three months ended March 31, 2025, compared to a gain of $1.2 million for the three months ended March 31, 2024, a $0.7 million increase in depreciation charges due to the decreased estimated useful lives of the U.K.
+Added: right of use asset, leasehold improvements and laboratory equipment and a $0.3 million increase in personnel-related expenses mainly relating to severance costs.
Other Operating Income
−Removed: For the nine months ended September 30, 2024 and 2023, other operating income was $1.0 million and nil, respectively, resulting from the funding provided by CEPI under the Funding Agreement, dated December 20, 2023, entered into by and among us, the Chancellors, Masters and Scholars of the University of Oxford and the CEPI for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
+Added: For the three months ended March 31, 2025 and 2024, other operating income was $0.3 million and $0.2 million, respectively, resulting from the funding provided by CEPI under the Funding Agreement, dated December 20, 2023, entered into by and among us, the Chancellors, Masters and Scholars of the University of Oxford and the CEPI for the development of VTP-500 through Phase 2 clinical trials for the prevention of MERS.
Interest Income
−Removed: For the nine months ended September 30, 2024 and 2023, interest income was $2.0 million and $2.3 million, respectively, resulting from the interest earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
+Added: For the three months ended March 31, 2025 and 2024, interest income was $0.6 million and $0.8 million, respectively, resulting from the reduction in interest rates earned on our short-term cash deposits held by Barinthus Biotherapeutics (UK) Limited.
Research and Development Incentives
−Removed: For the nine months ended September 30, 2024 and 2023 research and development incentives were $1.9 million and $2.9 million, respectively.
+Added: For the three months ended March 31, 2025 and 2024, research and development incentives were $0.3 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 decrease of $1.0 million is due to reduced expenses eligible for the research and development corporation tax relief, as well as a decrease in the enhanced rate of deduction and credit rate under the scheme, effective from April 2023.
−Removed: For the nine months ended September 30, 2024 and 2023, the tax benefit was $0.05 million and $2.3 million respectively, which primarily relates to movements in deferred tax.
+Added: The decrease of $0.3 million is due to a reduction in expenses incurred that are eligible for the research and development tax credit regime, following strategic prioritization of our U.S.
+Added: based immune tolerance research and development programs announced in January 2025.
+Added: For the three months ended March 31, 2025 and 2024, the tax benefit was $0.02 million and $0.04 million respectively, which primarily relates to movements in deferred tax.
Liquidity and Capital Resources
Sources of Liquidity
−Removed: 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 OUI in connection with the OUI License Agreement Amendment.
−Removed: Through September 30, 2024, we received gross proceeds of approximately $329.2 million from the issuance of our ordinary and preferred shares and convertible loan notes.
−Removed: As of September 30, 2024, we had cash, cash equivalents and restricted cash of $106.1 million.
−Removed: Recent financing and corporate milestones include the following:
+Added: 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.
+Added: Through March 31, 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 March 31, 2025, we had cash, cash equivalents and restricted cash of $100.6 million.
+Added: Key financing and corporate milestones include the following:
• Between July 2020 and November 2020, we raised gross proceeds of $41.2 million from the issuance of convertible loan notes;
1 unchanged sentence
• In May 2021, we raised gross proceeds of $110.5 million from the initial public offering of our ordinary shares on Nasdaq;
−Removed: • Between April 2022 and June 2023, we received $44.5 million of cash from OUI for the commercial sales of Vaxzevria;
−Removed: • Between December 2022 and September 2024, we raised net proceeds of $4.3 million from the issuance of shares represented by ADSs through “at-the-market” offerings under the sales agreement with Jefferies LLC.
−Removed: On August 9, 2022, we filed 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.
+Added: • Between April 2022 and November 2024, we received $59.5 million of cash from OUI for the commercial sales of Vaxzevria;
+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.
+Added: 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.
The Shelf was declared effective on August 17, 2022.
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.
−Removed: As of September 30, 2024, we have sold 1,875,848 ordinary shares represented by ADSs under the sales agreement amounting to net proceeds of $4.3 million.
+Added: As of March 31, 2025, we have sold 2,558,586 ordinary shares represented by ADSs under the sales agreement, amounting to net proceeds of $5.1 million.
We do not currently expect positive cash flows from operations in the foreseeable future, if at all.
3 unchanged sentences
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
−Removed: Nine months ended September 30, 2024 Nine months ended September 30, 2023
+Added: Three months ended March 31, 2025 Three months ended March 31, 2024
Net cash used in operating activities $ (14,902) $ (11,822)
4 unchanged sentences
Cash Used in Operating Activities
−Removed: 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 unrealized foreign exchange loss of $2.0 million, depreciation and amortization of $4.4 million, share based compensation of $4.0 million, non-cash lease expenses 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 expenses, a $2.0 million increase in deferred income, a $1.3 million decrease in operating lease liabilities and a $0.2 million decrease in accounts payable and accrued expenses.
−Removed: During the nine months ended September 30, 2023, net cash used in operating activities was $31.3 million, primarily resulting from our net loss of $56.2 million adjusted by share based compensation of $4.3 million, depreciation and amortization of $4.0 million, non-cash lease expense of $0.8 million, foreign exchange loss of $0.9 million, deferred tax benefit of $2.3 million, and changes in our operating assets and liabilities, net of $17.1 million related to a $5.8 million decrease in accounts receivable, a $5.2 million decrease in prepaid expenses and other current assets, and a $5.2 million increase in accrued expenses.
+Added: During the three months ended March 31, 2025, net cash used in operating activities was $14.9 million, primarily resulting from our net loss of $19.7 million adjusted by depreciation and amortization of $2.0 million, unrealized foreign exchange loss of $1.6 million, non-cash lease expenses of $0.8 million, share based compensation of $0.5 million and changes in our operating assets and liabilities, net, of $0.1 million.
+Added: The changes in our operating assets and liabilities, net, of $0.1 million primarily related to a $3.7 million decrease in accounts payable and accrued expenses, a $0.3 million decrease in deferred revenue, and a $0.5 million decrease in operating lease liabilities, offset by a $4.2 million decrease in research and development incentive receivables, following receipt of the 2023 research and development tax credit claim.
+Added: During the three months ended March 31, 2024, net cash used in operating activities was $11.8 million, primarily resulting from our net loss of $15.5 million adjusted by share based compensation of $1.6 million, depreciation and amortization of $1.4 million, non-cash lease expense of $0.4 million, foreign exchange gain of $1.0 million and changes in our operating assets and liabilities, net of $1.3 million primarily related to a $1.9 million decrease in prepaid expenses and other current assets, $1.4 million increase in deferred revenue, $1.3 million decrease in accounts payable and accrued expenses and $0.3 million decrease in operation lease liabilities.
Net Cash Used in Investing Activities
−Removed: During the nine months ended September 30, 2024, and 2023 cash used in investing activities was $0.6 million and $5.6 million, respectively.
−Removed: These amounts are resulted primarily from capital expenditures related to leasehold improvements on our new office and laboratory facilities in Germantown, Maryland, United States, that we relocated to in June 2023.
+Added: During the three months ended March 31, 2025 and 2024, cash used in investing activities was $0.005 million and $0.3 million, respectively.
+Added: These amounts resulted primarily from capital expenditures related to lab equipment and leasehold improvements in our United Kingdom facility.
Net Cash Provided by Financing Activities
−Removed: During the nine months ended September 30, 2024 and 2023, cash provided by financing activities was $1.3 million and $1.8 million, respectively.
+Added: During the three months ended March 31, 2025, cash provided by financing activities was $0.002 million.
+Added: These amounts primarily related to net proceeds received from the issuance of ordinary shares through stock exercises.
+Added: During the three months ended March 31, 2024, cash provided by financing activities was $0.5 million.
These amounts 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 nine months ended September 30, 2024 and 2023, the effect of foreign exchange on cash, cash equivalents and restricted cash was a gain of $5.3 million and a gain of $1.0 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
+Added: During the three months ended March 31, 2025 and 2024, the effect of foreign exchange on cash, cash equivalents and restricted cash was a gain of $3.1 million and a loss of $0.5 million respectively, primarily as a result of fluctuations between the United States dollar and pound sterling exchange rates.
Future Funding Requirements
To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of our product candidates.
−Removed: As a result, we have incurred losses in each year since our inception in 2016, through to December 31, 2021.
−Removed: We were profitable in 2022, however we have negative operating cash flows for the period ended September 30, 2024 and year ended December 31, 2023.
−Removed: As of September 30, 2024, we had an accumulated deficit of $217.1 million.
+Added: As a result, we have incurred losses in each year since our inception in 2016, except for 2022 when we were profitable.
+Added: We have negative operating cash flows for the period ended March 31, 2025 and as of March 31, 2025, we had an accumulated deficit of $257.3 million.
We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future.
−Removed: We anticipate that our expenses will increase substantially as we:
+Added: We anticipate that our expenses will increase substantially if, and as we:
• pursue the clinical and preclinical development of our current product candidates;
1 unchanged sentence
• seek marketing authorizations for product candidates that successfully complete clinical trials, if any;
−Removed: • attract, hire and retain additional clinical, regulatory, quality control and other scientific personnel;
−Removed: • establish our manufacturing capabilities through third parties or by ourselves and scale-up manufacturing to provide adequate supply for clinical trials and commercialization, including any manufacturing finishing and logistics personnel;
−Removed: • expand our operational, financial and management systems and increase personnel appropriately, including personnel to support our manufacturing and commercialization efforts and our operations as a public company;
−Removed: • maintain, expand, enforce, and protect our intellectual property portfolio as appropriate;
−Removed: • establish sales, marketing, medical affairs and distribution teams and infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly;
−Removed: • acquire or in-license other companies, product candidates and technologies;
−Removed: • incur additional legal, accounting and other expenses in operating our business, including office expansion and the additional costs associated with operating as a public company.
−Removed: Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development and other expenditure to develop and market additional product candidates.
−Removed: We may encounter unforeseen expenses, difficulties, complications, delays and other factors that may adversely affect our business.
−Removed: The size of our future net losses will depend on the rate of future growth of our expenses combined with our ability to generate revenue.
−Removed: Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital unless and until eliminated by revenue growth.
−Removed: We may require substantial additional financing in the future to meet any such unanticipated factors and a failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
−Removed: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, development of new technologies in house, and our product candidates derived from these technologies.
+Added: • attract, hire and retain additional clinical, regulatory, quality control and other personnel;
+Added: • conduct preclinical studies and clinical trials for our current and future product candidates based on our proprietary biologic and synthetic platforms, including the Chimpanzee Adenovirus Oxford ( “ ChAdOx ” ) and Modified vaccinia Ankara ( “ MVA ” ), vectors, SNAP-TI, SNAP-CI and our other technologies;
+Added: • 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;
+Added: • establish our manufacturing capabilities through third parties or by ourselves and scale-up manufacturing to provide adequate supply for clinical trials and commercialization;
+Added: • expand, maintain, protect and enforce our intellectual property portfolio;
+Added: • establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or through a selected partner;
+Added: • acquire or in-license other product candidates and technologies for development and commercialization;
+Added: • incur additional legal, accounting and other expenses in operating our business, including the additional costs associated with operating as a public company.
+Added: 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.
+Added: We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
+Added: The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.
+Added: Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital unless and until such losses are eliminated by revenue.
+Added: If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
+Added: 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: A decline in the value of our company also could cause you to lose all or part of your investment.
+Added: Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our viral vector platform (ChAdOx and MVA), acquisition of additional complementary platforms such as SNAP-TI, in-house development of new technologies, and our product candidates derived from these technologies.
Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete.
We believe that we will continue to expend substantial resources for the foreseeable future in connection with the development of our current product candidates and programs as well as any future product candidates we may elect to pursue, as well as the gradual gaining of control over our required manufacturing capabilities and other corporate functions.
−Removed: These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and
−Removed: selling any products approved for sale.
+Added: These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and selling any products approved for sale.
In addition, other unanticipated costs may arise as outlined above.
5 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, Arbutus, CanSino, CRUK and the Ludwig Institute and any future collaboration partners;
−Removed: • our ability to establish and maintain collaborations, strategic licensing or other arrangements and the financial terms of such agreements;
−Removed: • the cost to the company of commercialization activities for our current and future product candidates that we may take on, whether alone or with a collaborator;
−Removed: • the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent and other intellectual property claims, including litigation costs and the outcome of such litigation;
−Removed: • the timing, receipt and amount of sales of, or royalties or other income from, our future products, if any;
−Removed: • the emergence and success or otherwise of competing infectious disease or autoimmune therapies and other market developments.
+Added: • the success of our collaborations with CEPI, Oxford University/OUI, Arbutus, CanSino, CRUK and the Ludwig Institute and any future collaboration partners;
+Added: • our ability to establish, maintain or terminate collaborations, strategic licensing or other arrangements, and the financial terms of such agreements;
+Added: • the costs of future commercialization activities, including product launch, product sales, marketing, manufacturing and distribution, for any of our current and future product candidates for which we receive marketing approval;
+Added: • the timing, receipt and amount of commercial sales, revenues, milestones or royalties or other income from our future products, should any of our product candidates receive marketing approval;
+Added: • the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, enforcing and protecting our intellectual property rights and defending intellectual property-related claims including litigation costs and any damages awarded in such litigation;
+Added: • the emergence and success or otherwise of competing autoimmune or infectious disease therapies and other market developments.
A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development of that product candidate, in either direction.
1 unchanged sentence
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 second quarter of 2026.
+Added: 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.
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.
+Added: We may require substantial additional financing in the future to meet any such unanticipated factors.
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.
−Removed: If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
+Added: If we are unable to raise additional funds when needed, we would be required to delay, limit, reduce or terminate our product development programs, future commercialization efforts, other operational plans or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Lease, Purchase, and Other Obligations
5 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 September 30, 2024.
+Added: however, the amount, timing and likelihood of such payments are not known as of March 31, 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.