Financial Performance - For the three and nine months ended September 30, 2025, the company incurred a net loss of $14.6 million and $55.4 million, respectively, with an accumulated deficit of $293.0 million as of September 30, 2025[110]. - The company has incurred net losses since 2023 and expects to continue incurring losses as it advances its product candidates through clinical development and seeks regulatory approval[110]. - For the three months ended September 30, 2025, the company reported no license revenue compared to $14.97 million in the same period of 2024, reflecting a decrease of $14.97 million[141]. - For the nine months ended September 30, 2025, the company reported no license revenue compared to $15.0 million in the same period of 2024, reflecting a decrease of $15.0 million[152]. - The company incurred a net loss of $55.4 million for the nine months ended September 30, 2025, compared to a net loss of $40.6 million in 2024, an increase in loss of $14.8 million[169]. - Cash used in operating activities was $43.7 million for the nine months ended September 30, 2025, compared to $42.0 million in 2024, indicating an increase of $1.7 million[169]. - Interest income decreased to $1.6 million for the nine months ended September 30, 2025, down from $2.0 million in 2024, a decline of $0.4 million[160]. - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash of $75.7 million[162]. - The company has incurred losses in each year since its inception in 2016, except for 2022 when it was profitable[175]. Merger and Acquisition - A merger agreement was entered into on September 29, 2025, with Topco and Clywedog, which will result in the company becoming a wholly owned subsidiary of Topco[116]. - Upon the merger's effective time, each outstanding ordinary share will be converted into one share of Topco Common Stock plus cash for fractional shares, with a potential self-tender offer of up to $27 million in Topco Common Stock[117]. - The newly combined company will focus on clinical-stage candidates targeting metabolic and autoimmune diseases, with four clinical data milestones expected within 18 months post-merger[120]. - The company entered into a definitive merger agreement with Clywedog, which triggered an impairment assessment due to the indicative offer price being below the fair value of net assets[139]. - The company entered into a merger agreement with Clywedog on September 29, 2025, which includes various covenants and agreements regarding business operations until the merger closes[167]. Research and Development - The company is currently conducting a Phase 1 clinical trial for its lead candidate VTP-1000, aimed at restoring immune non-responsiveness to gluten in celiac disease patients, with data expected before the end of 2025[115]. - The company is evaluating a product candidate, VTP-300, for chronic hepatitis B, which is currently in Phase 2 trials, and is seeking a partner for further development[108]. - Research and development expenses are expected to increase as the company progresses its programs, with significant resources allocated to clinical trials and manufacturing processes[124]. - Research and development expenses decreased to $5.39 million in Q3 2025 from $11.14 million in Q3 2024, a decline of $5.75 million[143]. - Research and development expenses decreased to $21.6 million for the nine months ended September 30, 2025, down from $33.9 million in 2024, representing a reduction of $12.3 million[153]. - Research and development incentives decreased to $0.24 million in Q3 2025 from $0.61 million in Q3 2024, a decline of $0.37 million[150]. - The company expects minimal future activity on the VTP-500 program following a strategic decision to prioritize pipeline assets in the I&I space[148]. Operating Expenses - Total operating expenses for the quarter were $15.22 million, down from $24.56 million in 2024, a reduction of $9.34 million[141]. - Total operating expenses for the nine months ended September 30, 2025, were $59.5 million, a slight decrease of $1.1 million from $60.5 million in 2024[151]. - General and administrative expenses were $5.17 million in Q3 2025, down from $13.42 million in Q3 2024, a decrease of $8.25 million[146]. - General and administrative expenses increased to $33.2 million for the nine months ended September 30, 2025, up from $26.6 million in 2024, reflecting an increase of $6.6 million[156]. - The company recorded an impairment charge of $4.67 million for long-lived assets in Q3 2025, compared to no impairment in Q3 2024[147]. - The company reported an impairment of long-lived assets of $4.7 million for the nine months ended September 30, 2025, compared to no impairment in 2024[158]. Future Outlook and Financing - The company expects to finance future cash needs through public or private equity offerings, debt financings, collaborations, or licensing arrangements, as it does not anticipate positive cash flows from operations in the near future[112]. - The company anticipates that its existing cash and financial resources will fund operating expenses and capital requirements into the start of 2027[181]. - Future capital requirements will depend on various factors, including the success of product candidates and the ability to generate revenue[180]. - The company may require substantial additional financing in the future to meet unanticipated factors and operational needs[182]. - The company may face restrictions on claiming R&D tax credits if it no longer meets eligibility criteria, with unsurrendered UK losses able to be carried forward indefinitely[134]. Currency and International Operations - The company is subject to foreign currency exchange rate fluctuations, particularly with the euro, pound sterling, Swiss franc, and Australian dollar[190]. - The company has significant operating costs in the United Kingdom, exposing it to changes in the exchange ratio of the U.S. dollar and the pound sterling[192]. - A hypothetical 10% weakening of the U.S. dollar relative to the pound sterling would have materially affected current and projected expenses denominated in pound sterling[192]. - The company has no operations or suppliers based in conflict-affected regions, minimizing the impact of international conflicts on its business[121].

Barinthus Bio Reports Third Quarter 2025 Financial Results and Updates on Corporate Developments GERMANTOWN, Maryland, November 7, 2025 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS) ("Barinthus Bio," or the "Company"), an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the quarter ended September 30, 2025, and provided an overview of the Company's corporate developme ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements, management's analysis, and market risk disclosures - The company is a clinical-stage biopharmaceutical company focused on developing immunotherapeutic drug candidates for autoimmune and inflammatory diseases, utilizing proprietary viral vector platform technologies[20](index=20&type=chunk) - The company expects to incur losses for the foreseeable future and anticipates needing additional funding through equity financing, grants, debt, or collaborations to support operations beyond the next twelve months[24](index=24&type=chunk) Key Financial Highlights (Unaudited, In Thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :----------------------------------- | :------------ | :---------------- | :-------------------------- | | Cash and cash equivalents | $86,259 | $110,662 | -$24,403 | | Total current assets | $100,414 | $125,742 | -$25,328 | | Total assets | $129,561 | $160,327 | -$30,766 | | Total current liabilities | $12,725 | $15,657 | -$2,932 | | Total liabilities | $27,080 | $30,192 | -$3,112 | | Total stockholders' equity | $102,481 | $130,135 | -$27,654 | | Metric (Six months ended) | June 30, 2025 | June 30, 2024 | Change (YoY) | | :----------------------------------- | :------------ | :------------ | :----------- | | Net loss | $(40,784) | $(32,463) | $(8,321) | | Net cash used in operating activities | $(33,011) | $(23,828) | $(9,183) | [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited consolidated financial statements, reporting a **$40.8 million net loss** and **$87.8 million cash** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's financial position, including assets, liabilities, and stockholders' equity as of specific dates Condensed Consolidated Balance Sheets (In Thousands) | ASSETS | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $86,259 | $110,662 | | Restricted cash | $1,525 | $1,738 | | Research and development incentives receivable | $4,536 | $7,139 | | Prepaid expenses and other current assets | $7,681 | $6,203 | | Assets held for sale | $413 | — | | Total current assets | $100,414 | $125,742 | | Property and equipment, net | $4,514 | $7,373 | | Intangible assets, net | $20,366 | $21,947 | | Right of use assets, net | $3,323 | $4,384 | | Other assets | $944 | $881 | | Total assets | $129,561 | $160,327 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable | $1,800 | $2,474 | | Accrued expenses and other current liabilities | $7,364 | $9,525 | | Deferred income | $1,525 | $1,738 | | Operating lease liability - current | $2,036 | $1,920 | | Total current liabilities | $12,725 | $15,657 | | Operating lease liability - non-current | $9,952 | $10,087 | | Contingent consideration | $2,544 | $2,650 | | Other non-current liabilities | $1,468 | $1,360 | | Deferred tax liability, net | $391 | $438 | | Total liabilities | $27,080 | $30,192 | | Total stockholders' equity | $102,481 | $130,135 | | Total liabilities and stockholders' equity | $129,561 | $160,327 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's revenues, expenses, and net loss for the reported periods Condensed Consolidated Statements of Operations and Comprehensive Loss (In Thousands, except per share amounts) | Operating expenses (Three months ended June 30) | 2025 | 2024 | | :---------------------------------------------- | :------ | :------ | | Research and development | $7,953 | $11,662 | | General and administrative | $15,384 | $7,201 | | Total operating expenses | $23,337 | $18,863 | | Other operating income | $13 | $577 | | Loss from operations | $(23,324) | $(18,286) | | Net loss | $(21,126) | $(16,943) | | Net loss per share, basic | $(0.52) | $(0.43) | | Operating expenses (Six months ended June 30) | 2025 | 2024 | | :---------------------------------------------- | :------ | :------ | | Research and development | $16,243 | $22,787 | | General and administrative | $28,023 | $13,195 | | Total operating expenses | $44,266 | $35,982 | | Other operating income | $342 | $782 | | Loss from operations | $(43,924) | $(35,200) | | Net loss | $(40,784) | $(32,463) | | Net loss per share, basic | $(1.01) | $(0.83) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section presents the changes in the company's equity accounts over the specified periods Changes in Stockholders' Equity (In Thousands) | Metric (Six months ended June 30, 2025) | Amount | | :-------------------------------------- | :----- | | Balance, January 1, 2025 | $130,135 | | Share based compensation | $468 | | Issue of ordinary shares, net of costs | $2 | | Foreign currency translation adjustments | $4,646 | | Net loss | $(19,658) | | Balance, March 31, 2025 | $115,593 | | Share based compensation | $(281) | | Issue of ordinary shares, net of costs | $0 | | Foreign currency translation adjustments | $8,295 | | Net loss | $(21,126) | | Balance, June 30, 2025 | $102,481 | | Metric (Six months ended June 30, 2024) | Amount | | :-------------------------------------- | :----- | | Balance, January 1, 2024 | $186,995 | | Share based compensation | $1,615 | | Issue of ordinary shares, net of costs | $503 | | Foreign currency translation adjustments | $(1,577) | | Net loss | $(15,520) | | Balance, March 31, 2024 | $172,016 | | Share based compensation | $1,195 | | Issue of ordinary shares, net of costs | $358 | | Foreign currency translation adjustments | $164 | | Net loss | $(16,943) | | Balance, June 30, 2024 | $156,790 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (In Thousands) | Cash Flow Activity (Six months ended June 30) | 2025 | 2024 | | :-------------------------------------------- | :-------- | :-------- | | Net cash used in operating activities | $(33,011) | $(23,828) | | Net cash used in investing activities | $(37) | $(500) | | Net cash provided by financing activities | $2 | $861 | | Effect of exchange rates on cash | $8,430 | $(849) | | Net decrease in cash, cash equivalents and restricted cash | $(24,616) | $(24,316) | | Cash, cash equivalents and restricted cash, beginning of period | $112,400 | $142,090 | | Cash, cash equivalents and restricted cash, end of period | $87,784 | $117,774 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Nature of Business and Basis of Presentation](index=8&type=section&id=1.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) This note describes the company's core business, its focus on immunotherapeutic drug candidates, and the basis for financial statement preparation - Barinthus Biotherapeutics plc is a clinical-stage biopharmaceutical company focused on developing immunotherapeutic drug candidates for autoimmune and inflammatory diseases (I&I), and also evaluating product candidates for infectious diseases and cancer using proprietary viral vector platform technologies[20](index=20&type=chunk) - The company had **$87.8 million in cash, cash equivalents, and restricted cash** and an **accumulated deficit of $278.4 million** as of June 30, 2025. It expects current cash to fund operations for at least the next twelve months but will seek additional funding[24](index=24&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including GAAP and SEC compliance - The financial statements are prepared in conformity with GAAP and SEC rules for interim statements, with certain information condensed or omitted[22](index=22&type=chunk) - The company qualifies as an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised financial accounting standards[31](index=31&type=chunk) - New accounting pronouncements (ASU 2025-01, ASU 2024-03, ASU 2023-09) are being evaluated for their impact on future disclosures, with effective dates ranging from fiscal years beginning after December 15, 2024, to interim periods after December 15, 2027[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) [3. Segment information](index=10&type=section&id=3.%20Segment%20information) This note details the company's operating segments, primarily focusing on research and development of immunotherapies and vaccines - The company operates as one segment: the research and development of immunotherapies and vaccines, with the CEO using loss before income tax to monitor performance[37](index=37&type=chunk) Research and Development Expenses (In Thousands) | Expense Category (Three months ended June 30) | 2025 | 2024 | Change | | :-------------------------------------------- | :------ | :------ | :------ | | VTP-1000 Celiac | $1,782 | $1,371 | $411 | | VTP-300 HBV | $1,837 | $3,034 | $(1,197) | | Other clinical programs | $642 | $1,125 | $(483) | | Other pre-clinical programs | $449 | $908 | $(459) | | Total direct R&D expenses | $4,710 | $6,438 | $(1,728) | | Personnel-related R&D | $2,450 | $4,763 | $(2,313) | | Total R&D expenses | $7,953 | $11,662 | $(3,709) | | Expense Category (Six months ended June 30) | 2025 | 2024 | Change | | :-------------------------------------------- | :------ | :------ | :------ | | VTP-1000 Celiac | $2,764 | $2,744 | $20 | | VTP-300 HBV | $3,187 | $4,947 | $(1,760) | | Other clinical programs | $1,383 | $2,893 | $(1,510) | | Other pre-clinical programs | $868 | $1,693 | $(825) | | Total direct R&D expenses | $8,202 | $12,277 | $(4,075) | | Personnel-related R&D | $6,394 | $9,097 | $(2,703) | | Total R&D expenses | $16,243 | $22,787 | $(6,544) | - Total research and development expenses decreased by **$3.7 million** (3 months) and **$6.5 million** (6 months) year-over-year, primarily due to reduced spending on infectious disease and oncology programs and a reduction in personnel headcount[37](index=37&type=chunk)[39](index=39&type=chunk) [4. Foreign Currency Translation in General and Administrative Expenses](index=11&type=section&id=4.%20Foreign%20Currency%20Translation%20in%20General%20and%20Administrative%20Expenses) This note explains the impact of foreign currency exchange rate fluctuations on general and administrative expenses - The company recognized a net foreign exchange loss of **$8.0 million** for the three months ended June 30, 2025, compared to a **$0.1 million loss** in the prior year, and a **$12.4 million loss** for the six months ended June 30, 2025, compared to a **$1.1 million gain** in the prior year[40](index=40&type=chunk) [5. Net Loss Per Share](index=12&type=section&id=5.%20Net%20Loss%20Per%20Share) This note provides details on the calculation of basic and diluted net loss per share for the reported periods Net Loss Per Share (In Thousands, except per share amounts) | Metric (Three months ended June 30) | 2025 | 2024 | | :---------------------------------- | :-------- | :-------- | | Net loss attributable to shareholders | $(21,124) | $(16,931) | | Weighted-average ordinary shares outstanding, basic | 40,343,521 | 39,041,111 | | Net loss per share, basic | $(0.52) | $(0.43) | | Metric (Six months ended June 30) | 2025 | 2024 | | :---------------------------------- | :-------- | :-------- | | Net loss attributable to shareholders | $(40,772) | $(32,420) | | Weighted-average ordinary shares outstanding, basic | 40,304,584 | 38,907,296 | | Net loss per share, basic | $(1.01) | $(0.83) | - Basic and diluted net loss per share are the same due to the company being in a loss position, making potential ordinary share equivalents anti-dilutive[42](index=42&type=chunk) [6. Property and Equipment, Net](index=12&type=section&id=6.%20Property%20and%20Equipment,%20Net) This note presents information on the company's property and equipment, including depreciation and asset disposals - Depreciation expense for the three and six months ended June 30, 2025, was **$1.2 million** and **$2.5 million**, respectively, an increase from **$0.7 million** and **$1.3 million** in the prior year periods[43](index=43&type=chunk) - The company recorded a **$0.3 million gain** from the sale of U.K. laboratory equipment during the three and six months ended June 30, 2025, with associated proceeds of **$0.5 million**[44](index=44&type=chunk) - As of June 30, 2025, **$0.4 million** of U.K. laboratory equipment was classified as held for sale[45](index=45&type=chunk) [7. Intangible Assets, Net](index=12&type=section&id=7.%20Intangible%20Assets,%20Net) This note details the company's intangible assets, including gross amounts, accumulated amortization, and amortization expense - Gross amortizable intangible assets remained at **$31.6 million** as of June 30, 2025, and December 31, 2024. Accumulated amortization increased to **$11.2 million** as of June 30, 2025, from **$9.7 million** as of December 31, 2024[46](index=46&type=chunk) - Amortization expense was **$0.8 million** for the three months and **$1.6 million** for the six months ended June 30, 2025, consistent with the prior year. Estimated annual amortization expense is **$3.2 million** through 2031[46](index=46&type=chunk) [8. Prepaid Expenses and Other Current Assets](index=12&type=section&id=8.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note provides a breakdown of various prepaid expenses and other current assets held by the company Prepaid Expenses and Other Current Assets (In Thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Prepayments | $6,350 | $5,771 | | Value Added Tax receivable | $338 | — | | Accrued income | $139 | $88 | | Other | $854 | $344 | | Total | $7,681 | $6,203 | [9. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=9.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the company's accrued expenses and other current liabilities, including manufacturing, payroll, and professional fees Accrued Expenses and Other Current Liabilities (In Thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accrued manufacturing and clinical expenses | $2,302 | $3,326 | | Value Added Tax payable | — | $2,416 | | Accrued bonus | $709 | $1,774 | | Accrued payroll and employee benefits | $950 | $656 | | Accrued professional fees | $2,176 | $737 | | Accrued other | $1,227 | $616 | | Total | $7,364 | $9,525 | - Accrued other liabilities include a **$0.4 million provision** for severance costs due to a workforce reduction announced in January 2025[49](index=49&type=chunk) [10. Grant Income](index=13&type=section&id=10.%20Grant%20Income) This note describes the company's grant funding, particularly from CEPI, and its recognition as other operating income - The company has a Funding Agreement with CEPI for up to **$34.8 million** to develop VTP-500 (MERS vaccine candidate), which received PRIME designation[50](index=50&type=chunk) - In January 2025, the company announced a strategic focus on I&I, deprioritizing infectious disease and oncology programs, and intends to exit the CEPI Funding Agreement[52](index=52&type=chunk) Grant Income and Deferred Income (In Thousands) | Metric (Three months ended June 30) | 2025 | 2024 | | :---------------------------------- | :---- | :---- | | Other operating income recognized | $13 | $577 | | Metric (Six months ended June 30) | 2025 | 2024 | | :---------------------------------- | :---- | :---- | | Proceeds received | — | $1,600 | | Other operating income recognized | $342 | $782 | | Deferred Income (In Thousands) | June 30, 2025 | June 30, 2024 | | :---------------------------------- | :------------ | :------------ | | Ending balance | $1,525 | $839 | [11. Ordinary Shares](index=14&type=section&id=11.%20Ordinary%20Shares) This note outlines the rights and characteristics of the company's ordinary shares, including voting and distribution entitlements - Ordinary shares rank pari passu, with holders entitled to proportional distribution of assets upon liquidation and one vote per share[58](index=58&type=chunk)[60](index=60&type=chunk) - Shareholders approved the disapplication of preemptive rights for five years on April 21, 2021, and further authorized the board to allot shares free from pre-emption rights up to **£1,928 nominal amount** on November 6, 2023[62](index=62&type=chunk)[64](index=64&type=chunk) [12. Deferred Shares](index=15&type=section&id=12.%20Deferred%20Shares) This note describes the characteristics of the company's deferred shares, including their limited rights to dividends and liquidation proceeds - Deferred shares do not have dividend rights or participation in profits. Upon liquidation, holders are entitled to the paid-up amount after ordinary shareholders receive their paid-up amounts plus **£1.0 million per share**[65](index=65&type=chunk) - The company's deferred A shares remain in issue to satisfy minimum share capital requirements for a public limited company[65](index=65&type=chunk) [13. Fair Value](index=15&type=section&id=13.%20Fair%20Value) This note discusses the fair value measurements of the company's financial instruments, including contingent consideration - The company's financial instruments include cash, cash equivalents, restricted cash, accounts payable, certain accrued expenses, and contingent consideration, with carrying amounts approximating fair value for short-term instruments[66](index=66&type=chunk) - As of June 30, 2025, the contingent consideration liability related to the Avidea acquisition was **$2.5 million**, a Level 3 valuation based on the probability and expected date of milestone achievement[67](index=67&type=chunk) Changes in Level 3 Fair Value Financial Instruments (In Thousands) | Metric (Three months ended June 30) | 2025 | 2024 | | :---------------------------------- | :---- | :---- | | Beginning balance | $2,652 | $1,867 | | Change in fair value | $(260) | $18 | | Foreign exchange translation | $152 | $3 | | Ending balance | $2,544 | $1,888 | | Metric (Six months ended June 30) | 2025 | 2024 | | :---------------------------------- | :---- | :---- | | Beginning balance | $2,650 | $1,823 | | Change in fair value | $(339) | $78 | | Foreign exchange translation | $233 | $(13) | | Ending balance | $2,544 | $1,888 | [14. Share-Based Compensation](index=15&type=section&id=14.%20Share-Based%20Compensation) This note provides details on the company's share-based compensation plans, including options granted and related expenses - The total number of ordinary shares available for issuance under the Award Plan 2021 increased by **4% of outstanding shares** as of January 1, 2025[69](index=69&type=chunk) Share-Based Compensation Details | Metric (Six months ended June 30) | 2025 | 2024 | | :-------------------------------- | :------------ | :------------ | | Options granted | 1,470,812 | 1,951,377 | | Weighted average grant date fair value | $0.85 | $2.71 | | Weighted average exercise price | $1.00 | $3.41 | | Options forfeited | 1,016,357 | 229,430 | | Outstanding options (June 30) | 7,625,728 | 7,779,884 | | Unrecognized compensation cost | $2.0 million | N/A | | Weighted average recognition period | 2.0 years | N/A | Share-Based Compensation Expense (In Thousands) | Expense Classification (Three months ended June 30) | 2025 | 2024 | | :-------------------------------------------------- | :---- | :---- | | Research and development | $(1) | $505 | | General and administrative | $(280) | $690 | | Total | $(281) | $1,195 | | Expense Classification (Six months ended June 30) | 2025 | 2024 | | :-------------------------------------------------- | :---- | :---- | | Research and development | $67 | $1,217 | | General and administrative | $120 | $1,593 | | Total | $187 | $2,810 | [15. Commitments and Contingencies](index=16&type=section&id=15.%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, including in-license agreements and operating lease liabilities - The company has in-license agreements for intellectual property, with future payments contingent on drug candidate development and market success, including milestone payments and royalties (**1% to 7%**)[74](index=74&type=chunk) - The company leases laboratory and office space in Harwell, Oxfordshire (expires Sept 2031) and Germantown, Maryland (expires Feb 2034). Research and development activities in Harwell ceased in August 2025, and the building is being marketed for the remainder of the lease[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) Operating Lease Liabilities (In Thousands) | Metric (June 30) | 2025 | 2024 | | :-------------------------------- | :------ | :------ | | Right-of-use asset | $3,323 | $4,384 | | Lease liability, current | $2,036 | $1,920 | | Lease liability, non-current | $9,952 | $10,087 | | Total lease liability | $11,988 | N/A | | Weighted average remaining lease term (years) | 7.45 | 8.71 | | Weighted average discount rate | 7.5% | 7.5% | [16. Related Party Transactions](index=18&type=section&id=16.%20Related%20Party%20Transactions) This note discloses transactions with related parties, such as clinical study costs incurred with a subsidiary of a company shareholder - The company incurred **$0.1 million** (three months) and **$0.3 million** (six months) in clinical study costs from Oxford University Innovation Limited, a subsidiary of a company shareholder[85](index=85&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, and future outlook, highlighting **I&I pipeline focus** and **net losses** - Barinthus Bio is a clinical-stage biopharmaceutical company focused on developing immunotherapeutic drug candidates for autoimmune and inflammatory diseases (I&I), prioritizing its SNAP-TI platform[87](index=87&type=chunk)[88](index=88&type=chunk) - The lead candidate, VTP-1000 for celiac disease, is in a Phase 1 clinical trial, with the first two cohorts dosed and screening for the third ongoing. The multiple ascending dose part of the trial opened in July 2025[96](index=96&type=chunk)[97](index=97&type=chunk) - The company incurred net losses of **$21.2 million** (three months) and **$40.8 million** (six months) ended June 30, 2025, and expects to continue incurring losses for the foreseeable future[91](index=91&type=chunk) - Existing cash, cash equivalents, and restricted cash are expected to fund operating expenses and capital expenditure requirements into the start of 2027, but additional funding will be required thereafter[93](index=93&type=chunk)[151](index=151&type=chunk) [Overview](index=19&type=section&id=Overview) This section provides a high-level summary of the company's strategic focus, pipeline development, and financial performance trends - The company is prioritizing the development of a pipeline for I&I indications using its SNAP-TI platform, with VTP-1000 for celiac disease as its lead candidate[88](index=88&type=chunk) - VTP-300 for Hepatitis B virus is also being evaluated, with plans to complete ongoing clinical trials and seek a partner for further development[89](index=89&type=chunk) - The company has incurred significant net losses and negative cash flows, with an **accumulated deficit of $278.4 million** as of June 30, 2025, and expects this trend to continue[91](index=91&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) This section highlights recent progress in clinical trials, potential impacts of global events, and economic factors affecting the company - VTP-1000 for Celiac disease: The first and second cohorts of the Phase 1 AVALON clinical trial have been dosed without serious adverse events. Screening for the third cohort is ongoing, and the multiple ascending dose part of the trial commenced in July 2025[96](index=96&type=chunk)[97](index=97&type=chunk) - The company believes international conflicts (Gaza, Ukraine, Iran) will have minimal impact on its business due to no operations or suppliers in those regions[98](index=98&type=chunk) - Global economic instability, inflationary pressures, and volatile interest rates could adversely affect future financing capabilities and operating costs[99](index=99&type=chunk) [Components of Our Operating Results](index=21&type=section&id=Components%20of%20Our%20Operating%20Results) This section explains the primary drivers of the company's operating expenses, income, and other financial items - Operating expenses consist primarily of research and development (R&D) and general and administrative (G&A) costs. R&D expenses are expected to increase as product candidates advance through clinical development[100](index=100&type=chunk)[101](index=101&type=chunk) - G&A expenses include personnel, professional fees, rent, depreciation, foreign exchange gains/losses, and changes in contingent consideration fair value, and are expected to increase with operational expansion and public company compliance[102](index=102&type=chunk)[103](index=103&type=chunk) - Other operating income includes grant funding from CEPI for VTP-500 development, recognized systematically over the periods related expenses are incurred[104](index=104&type=chunk) - Other income/(expense) includes interest income from cash deposits and research and development incentives from the UK government's tax relief programs[105](index=105&type=chunk)[106](index=106&type=chunk) [Critical Accounting Policies and Use of Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section discusses the significant accounting policies and the use of management estimates that impact the financial statements - Management makes estimates and assumptions for financial statements, particularly for fair value of contingent consideration and impairment of long-lived assets[111](index=111&type=chunk) - Following a strategic shift to I&I and a sustained decline in ADS price, a qualitative and quantitative assessment in January 2025 determined intangible assets were recoverable, with no further impairment identified as of June 30, 2025[114](index=114&type=chunk)[115](index=115&type=chunk) - Contingent consideration liability from the Avidea acquisition is remeasured at fair value each reporting period, with changes recognized in G&A expenses[116](index=116&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's financial performance, including changes in revenues and expenses Summary of Results of Operations (In Thousands) | Metric (Three months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :-------- | :-------- | :-------- | | Research and development | $7,953 | $11,662 | $(3,709) | | General and administrative | $15,384 | $7,201 | $8,183 | | Total operating expenses | $23,337 | $18,863 | $4,474 | | Other operating income | $13 | $577 | $(564) | | Loss from operations | $(23,324) | $(18,286) | $(5,038) | | Net loss | $(21,126) | $(16,943) | $(4,183) | | Metric (Six months ended June 30) | 2025 | 2024 | Change | | :---------------------------------- | :-------- | :-------- | :-------- | | Research and development | $16,243 | $22,787 | $(6,544) | | General and administrative | $28,023 | $13,195 | $14,828 | | Total operating expenses | $44,266 | $35,982 | $8,284 | | Other operating income | $342 | $782 | $(440) | | Loss from operations | $(43,924) | $(35,200) | $(8,724) | | Net loss | $(40,784) | $(32,463) | $(8,321) | - R&D expenses decreased by **$3.7 million** (3 months) and **$6.5 million** (6 months) due to reduced spending on infectious disease/oncology programs and headcount reductions[119](index=119&type=chunk)[120](index=120&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - G&A expenses increased significantly by **$8.2 million** (3 months) and **$14.8 million** (6 months), primarily driven by foreign exchange losses and increased professional fees, partially offset by reduced personnel-related expenses[121](index=121&type=chunk)[130](index=130&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to generate and manage cash, its funding sources, and future capital requirements - The company has funded operations through equity offerings, grants, research incentives, and payments from Oxford University Innovation, raising approximately **$330.1 million** in gross proceeds through June 30, 2025[135](index=135&type=chunk) - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled **$87.8 million**. The company expects these resources to fund operations into early 2027[135](index=135&type=chunk)[151](index=151&type=chunk) Cash Flow Summary (In Thousands) | Cash Flow Activity (Six months ended June 30) | 2025 | 2024 | | :-------------------------------------------- | :-------- | :-------- | | Net cash used in operating activities | $(33,011) | $(23,828) | | Net cash used in investing activities | $(37) | $(500) | | Net cash provided by financing activities | $2 | $861 | | Effect of exchange rates on cash | $8,430 | $(849) | | Net decrease in cash | $(24,616) | $(24,316) | - Net cash used in operating activities increased to **$33.0 million** (2025) from **$23.8 million** (2024), primarily due to the net loss, adjusted for non-cash items and changes in operating assets/liabilities[140](index=140&type=chunk)[141](index=141&type=chunk) - Future funding requirements are substantial and depend on the progress and costs of R&D, clinical trials, regulatory approvals, manufacturing, and commercialization efforts[148](index=148&type=chunk)[150](index=150&type=chunk) [Emerging Growth Company Status](index=32&type=section&id=Emerging%20Growth%20Company%20Status) This section explains the company's status as an 'emerging growth company' and its implications for financial reporting - The company is an 'emerging growth company' under the JOBS Act, allowing it to delay adoption of certain accounting standards[157](index=157&type=chunk) - This status will continue until the earliest of the fifth anniversary of its IPO, achieving **$1.235 billion** in annual gross revenue, becoming a 'large accelerated filer' (market value > **$700 million**), or issuing over **$1.0 billion** in non-convertible debt[158](index=158&type=chunk) [Recent Accounting Pronouncements](index=32&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding new accounting standards and their potential impact on the company's financial statements - A description of recently issued accounting pronouncements that may potentially impact the company's financial position and results of operations is disclosed in Note 2 to the condensed consolidated financial statements[159](index=159&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company faces market risks primarily from **foreign currency fluctuations** (USD vs. GBP) and minimal **interest rate risk** - The company is exposed to foreign currency exchange rate fluctuations, mainly between the United States dollar (reporting currency) and the pound sterling (functional currency for UK subsidiaries)[160](index=160&type=chunk) - A hypothetical **10% weakening** of the United States dollar relative to the pound sterling would materially impact current and projected expenses denominated in pound sterling[162](index=162&type=chunk) - Interest rate risk is not significant as the company has no substantial interest-bearing liabilities, and a **10% change** in interest rates would not materially impact financial statements[163](index=163&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were **effective** as of June 30, 2025, with **no material changes** in internal control over financial reporting - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[166](index=166&type=chunk) - No material changes in internal control over financial reporting occurred during the three and six months ended June 30, 2025[167](index=167&type=chunk) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other miscellaneous information relevant to the company [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) No material legal claims, but proceedings could negatively impact operations due to costs and resource diversion - As of June 30, 2025, the company does not believe it is party to any claim or litigation that would individually or in the aggregate have a material adverse effect on its business[170](index=170&type=chunk) - Legal proceedings, regardless of outcome, can adversely impact the company due to defense and settlement costs and diversion of management resources[170](index=170&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include **inadequate government funding**, **U.S. policy changes**, and **U.K. Takeover Code non-applicability** - Inadequate funding for U.S. government agencies (FDA, SEC) or disruptions like government shutdowns could delay product development and regulatory approvals, negatively impacting the business[172](index=172&type=chunk)[173](index=173&type=chunk)[175](index=175&type=chunk) - Changes in U.S. fiscal, tax, and other federal policies, including tariffs and healthcare reforms, could adversely affect the company's business and results of operations[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk)[180](index=180&type=chunk) - Shareholder protections under the U.K. City Code on Takeovers and Mergers currently do not apply to the company, but this may change from February 3, 2027, if its securities are quoted on a UK regulated market[181](index=181&type=chunk)[183](index=183&type=chunk) - Changes in U.S. tax law, such as the OBBBA, could adversely affect financial condition and results of operations, particularly regarding the capitalization and amortization of R&D expenses[185](index=185&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales; **$102.8 million IPO proceeds** redirected to immune tolerance R&D and corporate purposes - No unregistered sales of equity securities occurred during the three and six months ended June 30, 2025[191](index=191&type=chunk) - Net proceeds from the May 2021 IPO were approximately **$102.8 million**[193](index=193&type=chunk) - The planned use of IPO net proceeds has changed due to pipeline prioritization, now focusing on advancing immune tolerance R&D programs and general corporate purposes[194](index=194&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there are no defaults upon senior securities to report - Not Applicable[196](index=196&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - Not Applicable[197](index=197&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025 - None of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025[198](index=198&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Articles of Association, certifications from the Principal Executive and Financial Officers, and Inline XBRL documents List of Exhibits | Exhibit Number | Description | | :------------- | :---------- | | 3.1 | Articles of Association of the Registrant | | 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | | 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | | 32.1** | Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 | | 101.INS* | Inline XBRL Instance Document | | 101.SCH* | Inline XBRL Taxonomy Extension Schema Document | | 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | 104* | Cover Page Interactive Data File | [SIGNATURES](index=41&type=section&id=SIGNATURES) This section contains the official signatures of the company's authorized officers, attesting to the report's accuracy - The report was signed on August 7, 2025, by William Enright, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of Barinthus Biotherapeutics PLC[204](index=204&type=chunk)

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) Barinthus Bio, an I&I company, reported Q2 2025 results, emphasizing its strategic focus on VTP-1000 for celiac disease and pipeline partnerships, alongside key financial and clinical progress [Introduction and Strategic Focus](index=1&type=section&id=Introduction%20and%20Strategic%20Focus) Barinthus Bio, an immunology and inflammation (I&I) company, announced its Q2 2025 financial results, highlighting its strategic focus on advancing VTP-1000 for celiac disease and seeking partnerships for other pipeline assets - **Barinthus Bio** is an **immunology and inflammation (I&I) company** focused on developing therapies that promote **immune tolerance** with **curative potential**[1](index=1&type=chunk) - The company remains **laser-focused on advancing VTP-1000**, an immunotherapy designed to prevent or reduce symptoms following **gluten exposure** in **celiac disease patients**[2](index=2&type=chunk) [Key Q2 2025 Highlights](index=1&type=section&id=Key%20Q2%202025%20Highlights) Key highlights for Q2 2025 include a decrease in cash reserves, but the company's cash runway guidance into 2027 remains unchanged. Significant progress was made in the VTP-1000 AVALON trial, with SAD data expected early Q4 2025 and the MAD portion initiated Cash Position Overview | Metric | As of June 30, 2025 | As of March 31, 2025 | Change | | :-------------------------------- | :------------------ | :------------------- | :----- | | Cash, cash equivalents and restricted cash | $87.8 million | $100.6 million | $(12.8) million | - The **$12.8 million decrease** in cash was a result of **$18.1 million net cash used** in operating activities, partially offset by a **$5.3 million translational gain** from currency conversion[5](index=5&type=chunk) - The company expects its available resources to fund operating expenses and capital expenditure requirements **into 2027**, with this guidance remaining unchanged[5](index=5&type=chunk)[6](index=6&type=chunk) - The final cohort of the single ascending dose (SAD) part of the **Phase 1 AVALON trial** for **VTP-1000** was initiated, with data readout expected **early in the fourth quarter of 2025**[6](index=6&type=chunk) - The multiple ascending dose (MAD) part of the AVALON trial was initiated[6](index=6&type=chunk) [Recent Corporate Developments](index=1&type=section&id=Recent%20Corporate%20Developments) Barinthus Bio provided updates on VTP-1000 and VTP-850 clinical trials, reporting safety and immunogenicity, while actively seeking partnerships for its pipeline assets [Clinical Developments and Upcoming Milestones](index=1&type=section&id=Clinical%20Developments%20and%20Upcoming%20Milestones) Barinthus Bio provided updates on its lead clinical programs, VTP-1000 for celiac disease and VTP-850 for prostate cancer, detailing trial progress, safety, and upcoming data readouts [VTP-1000 (Celiac Disease)](index=1&type=section&id=VTP-1000%20Celiac%20Disease) The Phase 1 AVALON trial for VTP-1000 is advancing, with the first two SAD cohorts completed without serious adverse events, the third and final SAD cohort ongoing, and the MAD portion initiated in July 2025 - In the SAD part of the **Phase 1 AVALON trial**, the first two cohorts have been dosed with **no treatment-related serious adverse events (SAEs) reported**[7](index=7&type=chunk) - The third and final cohort in the SAD part of the trial is ongoing, with SAD data expected **early in the fourth quarter of 2025**[7](index=7&type=chunk) - The MAD portion of the AVALON trial was initiated in July 2025, with MAD data expected in **mid-2026**. This part includes a gluten challenge to assess potential efficacy[2](index=2&type=chunk)[7](index=7&type=chunk) [VTP-850 (Prostate Cancer)](index=1&type=section&id=VTP-850%20Prostate%20Cancer) The Phase 1 trial for VTP-850 in prostate cancer has been completed, reporting no treatment-related SAEs and showing encouraging signs of immunogenicity, which will be used to facilitate partnering discussions - The **Phase 1 trial of VTP-850 in patients with prostate cancer is now complete**, with **no treatment-related SAEs reported**[7](index=7&type=chunk) - Data from the **VTP-850** trial shows **encouraging signs of immunogenicity** and will be used to facilitate partnering discussions[7](index=7&type=chunk) [Corporate Updates](index=1&type=section&id=Corporate%20Updates) Barinthus Bio is actively pursuing partnerships to advance its VTP-300 program in chronic hepatitis B, VTP-850 in prostate cancer, and other viral vector-based assets - **Barinthus Bio** continues to actively seek partners to advance its **VTP-300** program in chronic hepatitis B, its **VTP-850** program in prostate cancer, and other viral vector-based assets[4](index=4&type=chunk) [Second Quarter 2025 Financial Highlights](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Barinthus Bio's Q2 2025 financial results show a decrease in cash reserves, mixed operating expense trends, and an increased net loss, with a cash runway projected into 2027 [Cash Position and Runway](index=1&type=section&id=Cash%20Position%20and%20Runway) As of June 30, 2025, Barinthus Bio's cash, cash equivalents, and restricted cash decreased to $87.8 million from $100.6 million as of March 31, 2025, primarily due to operating activities. Despite this, the company projects its current resources will fund operations into 2027 Cash, Cash Equivalents and Restricted Cash | Metric | As of June 30, 2025 | As of March 31, 2025 | Change | | :-------------------------------- | :------------------ | :------------------- | :----- | | Cash, cash equivalents and restricted cash | $87.8 million | $100.6 million | $(12.8) million | - The decrease in cash was a result of **$18.1 million net cash used** in operating activities for pipeline development and general corporate expenses, partially offset by a **$5.3 million translational gain**[5](index=5&type=chunk) - Based on current plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements **into 2027**[5](index=5&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses showed a mixed trend, with a slight decrease in R&D expenses due to reduced preclinical activity and workforce, while G&A expenses increased primarily due to unrealized foreign exchange losses [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses decreased slightly to $8.0 million in Q2 2025 from $8.3 million in Q1 2025, attributed to reduced preclinical activity and workforce. Significant expenses were directed towards VTP-300 and VTP-1000, with future R&D for autoimmune programs expected to increase Research and Development Expenses (QoQ) | Metric | Three months ended June 30, 2025 ($000) | Three months ended March 31, 2025 ($000) | Change ($000) | | :-------------------------------- | :-------------------------------------- | :------------------------------------- | :------------ | | Total research and development expense | 7,953 | 8,290 | (337) | - The decrease in R&D expenses was attributable to a **reduction in preclinical activity and a reduction in workforce**[8](index=8&type=chunk) - Expenses were primarily attributable to the completion and presentation of preliminary results data from two **Phase 2 clinical trials of VTP-300** and the continued progression of the **Phase 1 AVALON clinical trial of VTP-1000**[8](index=8&type=chunk) - It is anticipated that R&D expenses related to legacy programs in infectious disease and oncology will reduce, while those related to **autoimmune programs will continue or increase**[8](index=8&type=chunk) [General and Administrative Expenses](index=2&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses increased to $15.4 million in Q2 2025 from $12.6 million in Q1 2025, primarily due to an increase in unrealized losses on foreign exchange General and Administrative Expenses (QoQ) | Metric | Three months ended June 30, 2025 | Three months ended March 31, 2025 | Change | | :-------------------------------- | :------------------------------- | :-------------------------------- | :----- | | General and administrative expenses | $15.4 million | $12.6 million | $2.8 million | - The increase of $2.8 million relates primarily to an increase in **unrealized losses on foreign exchange**, driven mainly by translation of **United States dollar balances in pound sterling denominated entities**[9](index=9&type=chunk) [Net Loss and EPS](index=2&type=section&id=Net%20Loss%20and%20EPS) Barinthus Bio reported an increased net loss attributable to shareholders of $21.1 million, or $(0.52) per share, for Q2 2025, compared to a net loss of $19.7 million, or $(0.49) per share, in Q1 2025 Net Loss and EPS (QoQ) | Metric | Three months ended June 30, 2025 | Three months ended March 31, 2025 | Change | | :-------------------------------- | :------------------------------- | :-------------------------------- | :----- | | Net loss attributable to shareholders | $21.1 million | $19.7 million | $(1.4) million | | Net loss per share (basic and diluted) | $(0.52) | $(0.49) | $(0.03) | [About Barinthus Bio](index=3&type=section&id=About%20Barinthus%20Bio) Barinthus Biotherapeutics is a clinical-stage biopharmaceutical company developing immunotherapies for autoimmune and inflammatory diseases using its proprietary SNAP-TI platform, with VTP-1000 as its lead candidate [Company Profile and Platform](index=3&type=section&id=Company%20Profile%20and%20Platform) Barinthus Biotherapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel immunotherapeutic candidates for autoimmune and inflammatory diseases. The company leverages its proprietary SNAP-TI platform to promote immune tolerance, with VTP-1000 for celiac disease as its lead candidate - **Barinthus Biotherapeutics** is a **clinical-stage biopharmaceutical company** focused on developing **novel immunotherapeutic candidates** for treating **autoimmune and inflammatory diseases**[10](index=10&type=chunk) - The company's pipeline for I&I indications is enabled by its **proprietary and highly differentiated platform** for promoting **immune tolerance, SNAP-TI**, designed to **guide T cells to reduce inflammation**[10](index=10&type=chunk) - **VTP-1000**, the lead candidate, is designed to **restore immune non-responsiveness to gluten** in patients with **celiac disease** and is currently in a **Phase 1 clinical trial**[10](index=10&type=chunk) [Forward Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) This section outlines Barinthus Bio's forward-looking statements regarding future plans and financial projections, highlighting inherent risks and uncertainties that could impact actual outcomes [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains forward-looking statements regarding Barinthus Bio's future expectations, plans, and prospects, including product development and financial projections. It emphasizes that these statements are subject to numerous risks, uncertainties, and important factors that could cause actual results to differ materially, and cautions against undue reliance - The press release contains **forward-looking statements** regarding future expectations, plans, and prospects, including product development activities, clinical trials, regulatory filings, cash runway, and collaborations[11](index=11&type=chunk) - These statements are based on management's current expectations and beliefs and are subject to **numerous risks, uncertainties, and important factors** that may cause **actual events or results to differ materially**[11](index=11&type=chunk) - Key risks include the success, cost, and timing of pipeline development and clinical trials, regulatory developments, ability to fund operations, cash runway estimates, and global economic uncertainty[11](index=11&type=chunk) - Readers are **cautioned not to place undue reliance** on any **forward-looking statements**, and the company expressly **disclaims any obligation to publicly update or revise such statements**[11](index=11&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for Q2 2025 reflect changes in assets, liabilities, and equity, alongside an increased net loss for the period [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheet shows a decrease in total assets and total stockholders' equity from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash and cash equivalents and an increased accumulated deficit Consolidated Balance Sheet (Selected Items, in Thousands) | Metric | As of June 30, 2025 | As of December 31, 2024 | Change | | :-------------------------------- | :------------------ | :---------------------- | :------- | | Cash and cash equivalents | $86,259 | $110,662 | $(24,403) | | Total current assets | $100,414 | $125,742 | $(25,328) | | Total assets | $129,561 | $160,327 | $(30,766) | | Total liabilities | $27,080 | $30,192 | $(3,112) | | Accumulated deficit | $(278,436) | $(237,664) | $(40,772) | | Total stockholders' equity | $102,481 | $130,135 | $(27,654) | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The consolidated statements of operations indicate an increased net loss for both the three and six months ended June 30, 2025, compared to the prior year periods, primarily due to higher general and administrative expenses Consolidated Statements of Operations (Selected Items, in Thousands) | Metric | 3 months ended June 30, 2025 | 3 months ended June 30, 2024 | 6 months ended June 30, 2025 | 6 months ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $7,953 | $11,662 | $16,243 | $22,787 | | General and administrative | $15,384 | $7,201 | $28,023 | $13,195 | | Total operating expenses | $23,337 | $18,863 | $44,266 | $35,982 | | Loss from operations | $(23,324) | $(18,286) | $(43,924) | $(35,200) | | Net loss attributable to shareholders | $(21,124) | $(16,931) | $(40,772) | $(32,420) | | Net loss per share (basic & diluted) | $(0.52) | $(0.43) | $(1.01) | $(0.83) | [Investor and Media Contacts](index=6&type=section&id=Investor%20and%20Media%20Contacts) This section provides essential contact information for investor relations and media inquiries regarding Barinthus Bio [Contact Information](index=6&type=section&id=Contact%20Information) This section provides contact details for investor relations and media inquiries - Investor Relations contact: Kevin Gardner, Managing Director, LifeSci Advisors[14](index=14&type=chunk) - Media contacts: Alexis Feinberg and Jonathan Edwards, ICR Healthcare[14](index=14&type=chunk) - Company contact email: ir@barinthusbio.com[14](index=14&type=chunk)

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) Presents Barinthus Biotherapeutics PLC's unaudited condensed consolidated financial statements, management's discussion, market risk, and controls and procedures [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Barinthus Biotherapeutics PLC's unaudited condensed consolidated financial statements, reporting a **$19.7 million net loss** and **$100.6 million in cash** as of March 31, 2025 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (in thousands) | ASSETS (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Cash and cash equivalents | $99,118 | $110,662 | | Restricted cash | $1,461 | $1,738 | | Total current assets | $109,882 | $125,742 | | Total assets | $141,996 | $160,327 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | March 31, 2025 | December 31, 2024 | | Total current liabilities | $11,976 | $15,657 | | Total liabilities | $26,403 | $30,192 | | Total stockholders' equity | $115,593 | $130,135 | - Total assets decreased from **$160.3 million** at December 31, 2024, to **$142.0 million** at March 31, 2025, primarily due to a reduction in cash and cash equivalents[12](index=12&type=chunk) - Total stockholders' equity decreased from **$130.1 million** to **$115.6 million**, largely influenced by the accumulated deficit[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's financial performance, including revenues, expenses, and net loss for the three months ended March 31, 2025, and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) | (in thousands, except per share amounts) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $8,290 | $11,125 | | General and administrative | $12,639 | $5,994 | | Total operating expenses | $20,929 | $17,119 | | Loss from operations | $(20,600) | $(16,914) | | Net loss | $(19,658) | $(15,520) | | Net loss per share, basic | $(0.49) | $(0.40) | - Net loss increased to **$19.7 million** for the three months ended March 31, 2025, from **$15.5 million** in the prior year period, driven by higher general and administrative expenses[13](index=13&type=chunk) - Research and development expenses decreased by **$2.8 million**, while general and administrative expenses increased by **$6.6 million** year-over-year[13](index=13&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Outlines changes in the company's equity, reflecting net loss, share-based compensation, and foreign currency adjustments for the quarter ended March 31, 2025 Condensed Consolidated Statements of Changes in Stockholders' Equity (in thousands, except number of shares) | (in thousands, except number of shares) | Balance, January 1, 2025 | Share based compensation | Issue of ordinary shares | Foreign currency translation adjustments | Net loss | Balance, March 31, 2025 | | :-------------------------------------- | :----------------------- | :----------------------- | :----------------------- | :--------------------------------------- | :------- | :---------------------- | | Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders | $130,029 | $468 | $2 | $4,643 | $(19,648) | $115,494 | | Noncontrolling Interest | $106 | — | — | $3 | $(10) | $99 | | Total Stockholders' Equity | $130,135 | $468 | $2 | $4,646 | $(19,658) | $115,593 | - Total stockholders' equity decreased from **$130.1 million** at January 1, 2025, to **$115.6 million** at March 31, 2025, primarily due to the **$19.7 million net loss**, partially offset by foreign currency translation adjustments[15](index=15&type=chunk) - Share-based compensation contributed **$0.5 million** to equity during the quarter[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025, and 2024 Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(14,902) | $(11,822) | | Net cash used in investing activities | $(5) | $(308) | | Net cash provided by financing activities | $2 | $503 | | Effect of exchange rates on cash, cash equivalents and restricted cash | $3,084 | $(492) | | Net decrease in cash, cash equivalents and restricted cash | $(11,821) | $(12,119) | | Cash, cash equivalents and restricted cash, end of the period | $100,579 | $129,971 | - Net cash used in operating activities increased to **$14.9 million** for the three months ended March 31, 2025, from **$11.8 million** in the prior year[18](index=18&type=chunk) - The company experienced a net decrease in cash, cash equivalents, and restricted cash of **$11.8 million**, ending the period with **$100.6 million**[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes disclose business, accounting policies, and financial line items, including a strategic shift to I&I programs, deprioritization of other programs, and associated costs - The company completed the liquidation process of Barinthus Biotherapeutics S.R.L. on January 16, 2025[20](index=20&type=chunk) - The company announced a strategic focus on developing a pipeline in I&I and the deprioritization of its infectious disease and oncology programs in January 2025[48](index=48&type=chunk) - A provision of **$1.4 million** for severance costs due to workforce reduction was included in accrued other liabilities as of March 31, 2025[44](index=44&type=chunk) Research and Development Expenses by Program (in thousands) | Research and Development Expenses by Program (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | Change | | :--------------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | VTP-1000 Celiac | $982 | $1,374 | $(392) | | VTP-300 HBV | $1,350 | $1,913 | $(563) | | Other clinical programs | $741 | $1,767 | $(1,026) | | Other pre-clinical programs | $419 | $784 | $(365) | | Total direct research and development expenses | $3,492 | $5,838 | $(2,346) | | Total indirect research and development expenses | $4,798 | $5,287 | $(489) | | Total research and development expenses | $8,290 | $11,125 | $(2,835) | - The company recognized a foreign exchange loss of **$4.4 million** in general and administrative expenses for the three months ended March 31, 2025, compared to a **$1.2 million** gain in the prior year[38](index=38&type=chunk) - As of March 31, 2025, **8.1 million** stock options were outstanding, with an unrecognized compensation cost of **$2.9 million** expected to be recognized over 2.1 years[68](index=68&type=chunk) - The contingent consideration liability related to the Avidea acquisition was **$2.7 million** as of March 31, 2025, with potential additional payments up to **$40.0 million** upon milestone achievement[63](index=63&type=chunk) - The company is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating auto-immune and inflammatory diseases, also evaluating candidates for infectious diseases and cancer[21](index=21&type=chunk) - As of March 31, 2025, the company had **$100.6 million** in cash, cash equivalents, and restricted cash, and an accumulated deficit of **$257.3 million**, expecting to incur losses for the foreseeable future[25](index=25&type=chunk) - The company expects its current cash to fund operations for at least the next twelve months and plans to seek additional funding through equity financing, grants, debt, or collaborations[25](index=25&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, highlighting a strategic shift to I&I programs, a **$19.7 million net loss**, and cash expected to fund operations into early 2027 [Overview](index=18&type=section&id=Overview) Provides a high-level summary of Barinthus Bio's business, strategic focus, and lead product candidates in clinical development - Barinthus Bio is a clinical-stage biopharmaceutical company focused on developing immunotherapeutic drug candidates for auto-immune and inflammatory diseases[82](index=82&type=chunk) - The company's lead candidate, VTP-1000, for celiac disease, is in a Phase 1 clinical trial, utilizing the SNAP-TI platform for immune tolerance[83](index=83&type=chunk) - The company also has product candidates for infectious diseases (VTP-300 for HBV) and cancer (VTP-850 for prostate cancer) using viral vector technologies, for which it is seeking partners[84](index=84&type=chunk) [Recent Developments](index=20&type=section&id=Recent%20Developments) Highlights key recent events, including primary endpoint data from clinical trials for VTP-300 in chronic hepatitis B - Primary endpoint data from two clinical trials for VTP-300 in chronic hepatitis B (HBV003 and IM-PROVE II) were announced on May 7, 2025[92](index=92&type=chunk) - HBV003 study showed meaningful reductions in HBsAg (>1 log decline) in **33%** of participants with HBsAg ≤200 IU/mL at baseline, and **22%** achieved HBsAg loss at any timepoint, with two participants achieving functional cure[93](index=93&type=chunk) - IM-PROVE II data indicated that **25%** of participants with starting baseline HBsAg levels less than 1000 IU/mL, receiving imdusiran, VTP-300, and low-dose nivolumab, reached functional cure[95](index=95&type=chunk) [Components of Our Operating Results](index=21&type=section&id=Components%20of%20Our%20Operating%20Results) Explains the primary components of the company's operating expenses, including R&D, G&A, other operating income, and R&D incentives - Operating expenses consist primarily of research and development costs and general and administrative costs[98](index=98&type=chunk) - Research and development expenses are expected to increase as programs advance through clinical development, but the company is seeking partners for certain programs (VTP-300, VTP-850)[99](index=99&type=chunk) - General and administrative expenses include personnel-related costs, consulting fees, professional services, rent, depreciation, foreign exchange gains/losses, and changes in contingent consideration fair value[100](index=100&type=chunk) - Other operating income primarily stems from the CEPI Funding Agreement for VTP-500 MERS vaccine development[103](index=103&type=chunk) - Research and development incentives are payments receivable from the UK government for corporation tax relief on qualifying R&D expenditure[105](index=105&type=chunk) [Critical Accounting Policies and Use of Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) Discusses key accounting policies and management's significant estimates and judgments, particularly regarding contingent consideration and intangible asset impairment - Management makes estimates and judgments, particularly regarding the fair value of contingent consideration and impairment of intangible assets[109](index=109&type=chunk) - Following a strategic shift in January 2025 and a sustained decline in ADS price, a qualitative and quantitative assessment was performed, determining that intangible assets were recoverable[112](index=112&type=chunk) - The contingent consideration liability for the Avidea acquisition is remeasured to fair value at each reporting date, with changes recognized in general and administrative expenses[114](index=114&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Compares the company's operating results for the three months ended March 31, 2025, and 2024, detailing changes in expenses and net loss Results of Operations (in thousands) | (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | Change | | :----------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $8,290 | $11,125 | $(2,835) | | General and administrative | $12,639 | $5,994 | $6,645 | | Total operating expenses | $20,929 | $17,119 | $3,810 | | Loss from operations | $(20,600) | $(16,914) | $(3,686) | | Net loss | $(19,658) | $(15,520) | $(4,138) | - Research and development expenses decreased by **$2.8 million**, primarily due to a **$2.0 million** net decrease in infectious disease and oncology programs and a **$0.4 million** decrease in VTP-1000 spend as it progressed to clinic[118](index=118&type=chunk) - General and administrative expenses increased by **$6.6 million**, mainly due to a **$4.4 million** foreign exchange loss (vs. **$1.2 million** gain prior year), a **$0.7 million** increase in depreciation, and a **$0.3 million** increase in personnel-related severance costs[120](index=120&type=chunk) - Research and development incentives decreased by **$0.3 million** due to reduced eligible expenses following strategic prioritization of U.S.-based immune tolerance R&D programs[123](index=123&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its financial obligations, detailing cash position, funding history, and future capital requirements - Since inception, the company has funded operations through equity placements, grants, research incentives, convertible loan notes, and payments from the OUI License Agreement Amendment for Vaxzevria[125](index=125&type=chunk) - As of March 31, 2025, cash, cash equivalents, and restricted cash totaled **$100.6 million**[125](index=125&type=chunk) - The company expects existing financial resources to fund operating expenses and capital expenditure requirements into the start of 2027[142](index=142&type=chunk) - Future funding requirements are substantial and depend on the progress and costs of R&D, clinical trials, regulatory approvals, manufacturing, and commercialization efforts[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk) Cash Flow Summary (in thousands) | (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(14,902) | $(11,822) | | Net cash used in investing activities | $(5) | $(308) | | Net cash provided by financing activities | $2 | $503 | | Effect of exchange rates on cash, cash equivalents and restricted cash | $3,084 | $(492) | | Net decrease in cash, cash equivalents and restricted cash | $(11,821) | $(12,119) | - Net cash used in operating activities increased to **$14.9 million** in Q1 2025, primarily due to the net loss and changes in operating assets and liabilities[130](index=130&type=chunk) - Cash provided by financing activities was minimal (**$2 thousand**) in Q1 2025, compared to **$0.5 million** in Q1 2024, mainly from stock exercises[133](index=133&type=chunk) - The company is prioritizing the development of a pipeline for I&I indications, enabled by its proprietary SNAP-TI platform, with VTP-1000 for celiac disease as the lead candidate in Phase 1 clinical trial[83](index=83&type=chunk) - The company is evaluating VTP-300 for chronic hepatitis B and VTP-850 for prostate cancer, seeking partners for their continued development beyond ongoing clinical trials[84](index=84&type=chunk) - The company incurred a net loss of **$19.7 million** for the three months ended March 31, 2025, and expects to incur net operating losses for at least the next several years[87](index=87&type=chunk) - Existing cash, cash equivalents, and restricted cash are expected to fund operating expenses and capital expenditure requirements into the start of 2027[89](index=89&type=chunk)[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) Discusses the company's exposure to market risks, primarily foreign currency exchange rate fluctuations and interest rate sensitivity - The company is subject to foreign currency exchange rate fluctuations, particularly with the pound sterling, as it incurs significant operating costs in the U.K.[151](index=151&type=chunk)[153](index=153&type=chunk) - A hypothetical **10%** weakening in the United States dollar relative to the pound sterling would materially change current and projected expenses denominated in pound sterling[153](index=153&type=chunk) - The company is not significantly exposed to interest rate risk, as it has no significant interest-bearing liabilities, and a **10%** change in interest rates would not materially impact financial statements[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) The principal executive and financial officers evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2025, concluding they were effective - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[157](index=157&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2025[158](index=158&type=chunk) [PART II - OTHER INFORMATION](index=31&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) Covers legal proceedings, risk factors, equity sales, and other required disclosures for the reporting period [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any legal proceedings or claims expected to have a material adverse effect on its business - As of March 31, 2025, the company does not believe it is party to any claim or litigation that would have a material adverse effect on its business[160](index=160&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Updates previously disclosed risk factors, emphasizing the potential negative impact of inadequate government agency funding and changes in U.S. fiscal and trade policies - Inadequate funding for U.S. government agencies (FDA, SEC) or disruptions to their operations could hinder product development, regulatory approvals, and overall business functions[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - Changes in U.S. fiscal, tax, and other federal policies, including tariffs, could adversely affect the company's business, the U.S. and global economy, and international trade relations[166](index=166&type=chunk)[167](index=167&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no recent unregistered equity sales or purchases, and notes a change in the planned use of IPO proceeds to focus on immune tolerance R&D programs - No unregistered sales of equity securities or purchases of equity securities occurred during the three months ended March 31, 2025[172](index=172&type=chunk)[176](index=176&type=chunk) - The planned use of net proceeds from the May 2021 IPO (**$102.8 million**) has changed due to pipeline prioritization, now focused on immune tolerance R&D programs and general corporate purposes[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended March 31, 2025 - No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended March 31, 2025[180](index=180&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Articles of Association, certifications from the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents Exhibits Filed with Form 10-Q | Exhibit Number | Description | | :------------- | :---------- | | 3.1 | Articles of Association of the Registrant | | 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | | 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | | 32.1** | Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 | | 101.INS* | Inline XBRL Instance Document | | 101.SCH* | Inline XBRL Taxonomy Extension Schema Document | | 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | 104* | Cover Page Interactive Data File | [SIGNATURES](index=35&type=section&id=SIGNATURES) Contains the official signatures for the report, confirming its submission and accuracy [SIGNATURES](index=35&type=section&id=SIGNATURES) The report was duly signed on behalf of Barinthus Biotherapeutics PLC by William Enright, Chief Executive Officer, on May 7, 2025 - The report was signed by William Enright, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) on May 7, 2025[186](index=186&type=chunk)

Financial Performance - For Q1 2025, Barinthus Bio reported a net loss of $19.6 million, or $(0.49) per share, compared to a net loss of $15.5 million, or $(0.40) per share in Q1 2024[12]. - The net loss attributable to Barinthus Biotherapeutics plc shareholders for Q1 2025 was $19,648,000, compared to a net loss of $15,489,000 in Q1 2024, reflecting a 26.5% increase in losses[17]. - Comprehensive loss for Q1 2025 was $15,012,000, compared to a comprehensive loss of $17,097,000 in Q1 2024, showing an improvement of about 12.2%[17]. Cash and Assets - Cash, cash equivalents, and restricted cash as of March 31, 2025, totaled $100.6 million, down from $112.4 million as of December 31, 2024, reflecting a net cash used in operating activities of $14.9 million[12]. - Total current assets decreased from $125,742,000 on December 31, 2024, to $109,882,000 on March 31, 2025, a decline of approximately 12.6%[16]. - Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders decreased from $130,029,000 on December 31, 2024, to $115,494,000 on March 31, 2025, a decline of approximately 11.2%[16]. - Total liabilities decreased from $30,192,000 on December 31, 2024, to $26,403,000 on March 31, 2025, a reduction of about 12.5%[16]. Expenses - General and administrative expenses rose to $12.6 million in Q1 2025 from $6.0 million in Q1 2024, primarily due to foreign exchange losses and increased personnel costs[12]. - General and administrative expenses increased significantly to $12,639,000 in Q1 2025, compared to $5,994,000 in Q1 2024, representing a 110.5% increase[17]. - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, attributed to reduced clinical development activity and workforce[12]. - Research and development expenses for Q1 2025 were $8,290,000, down 25.5% from $11,125,000 in Q1 2024[17]. - Total operating expenses rose to $20,929,000 in Q1 2025, up 22.5% from $17,119,000 in Q1 2024[17]. Clinical Trials and Strategic Focus - In the HBV003 study, 33% of participants with baseline HBsAg ≤200 IU/mL achieved ≥1 log decline in HBsAg by Day 169[6]. - The company reported that 71% of participants in the HBV003 study met criteria for discontinuation of NUC therapy by Day 169[6]. - The company expects to announce Phase 1 single ascending dose data for VTP-1000 in celiac disease in Q3 2025 and initiate multiple ascending dose trials in the second half of 2025[5]. - Barinthus Bio's strategic focus includes prioritizing immunology and inflammation indications, with plans to seek partners for VTP-300 beyond the ongoing Phase 2b trial[7]. - Encouraging results from the Phase 2 trials of VTP-300 were presented at the EASL Congress 2025, supporting ongoing partnering efforts[5]. Shareholder Information - The weighted-average ordinary shares outstanding increased from 38,773,482 in Q1 2024 to 40,265,216 in Q1 2025, indicating a growth of approximately 3.8%[17]. - Other comprehensive gain from foreign currency translation adjustments was $4,646,000 in Q1 2025, contrasting with a loss of $1,577,000 in Q1 2024[17].

Financial Performance - For the year ended December 31, 2022, the company generated net income of $5.3 million, primarily from revenues related to AstraZeneca's sales of Vaxzevria and an agreement with OUI[287]. - The company incurred net losses of $61.2 million and $73.4 million for the years ending December 31, 2024 and 2023, respectively[287]. - As of December 31, 2024, the company had an accumulated deficit of $237.7 million[287]. - The company’s cumulative carryforward tax losses amounted to approximately $101.7 million as of December 31, 2024, up from $92.7 million as of December 31, 2023[419]. Cash and Funding - The company's cash, cash equivalents, and restricted cash were $112.4 million as of December 31, 2024, which is expected to support operations into the start of 2027 without additional financing[301]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially affecting its ability to continue operations[302]. - The company may require substantial additional funding to support ongoing operations and product development, with potential financing sources including public or private equity offerings and debt financings[307]. - The company may need to pursue equity or debt financings to meet capital needs, which could lead to significant dilution for existing stockholders[310]. Research and Development - The company does not expect to generate significant revenue from current or future product candidates until successful completion of clinical development and marketing authorization[290]. - The company has not yet generated any material revenue from its current product candidates[290]. - The company anticipates substantial increases in expenses as it pursues clinical and preclinical development of product candidates and expands operational capabilities[287]. - The company anticipates that research and development expenses will increase significantly as it continues preclinical and clinical development activities[308]. Clinical Trials and Regulatory Risks - The company faces significant translational risk as product candidates advance through clinical stages, with promising preclinical results not guaranteed to replicate in human trials[291]. - The company faces risks related to the successful completion of clinical trials, which are lengthy and expensive, and may not yield predictable outcomes[320]. - The company may experience delays in obtaining regulatory approvals for clinical trials, which could impact the timelines for product development[322]. - The marketing authorization processes from regulatory authorities like the FDA and EMA are lengthy and unpredictable, potentially harming the business if approvals are not obtained[396]. Product Development and Market Risks - The company’s ability to generate product revenues is heavily dependent on the successful development and commercialization of its product candidates, which may take several years[318]. - The company acknowledges that the addressable patient population for its product candidates may be limited, potentially impacting profitability without additional marketing authorizations for first or second-line therapies[346]. - The commercial success of the company's product candidates will depend on public acceptance of immunotherapies and could be adversely affected by negative developments in the field[347]. - The company faces substantial competition from various sources, including major pharmaceuticals and biotechnology companies, which may hinder its ability to successfully market its product candidates[354]. Manufacturing and Supply Chain Risks - The company does not currently own any facility for clinical-scale manufacturing and must rely on third-party manufacturers, exposing it to risks related to quality and supply[387]. - The production process for product candidates is complex, requiring specific know-how from a limited number of contract manufacturing organizations (CMOs), which may lead to competition for scarce manufacturing capacities[391]. - The company may face delays in clinical trials or commercial distribution if any CMO fails to perform its obligations, as alternative supply sources may not be secured on reasonable terms[392]. Intellectual Property Risks - The company relies heavily on in-licensed patents and patent applications, with no issued patents for its product candidates, which could materially harm its competitive position[457]. - The company cannot assure that its product candidates do not infringe existing patents, which could lead to costly litigation[473]. - The competitive landscape for acquiring third-party intellectual property rights is challenging, with more established companies having greater resources[482]. - Litigation to protect intellectual property rights could be expensive and time-consuming, with no guarantee of success[483]. Compliance and Legal Risks - The company must comply with Good Clinical Practice (GCP) regulations, and failure to do so could result in unreliable clinical data and regulatory delays[381]. - The company is subject to the Foreign Corrupt Practices Act and similar laws, which could result in significant penalties if violated[433]. - Non-compliance with data protection laws could result in fines up to €20 million or 4% of annual global revenue, whichever is greater[451]. - The company will face ongoing regulatory obligations and potential penalties if it fails to comply with regulatory requirements for its product candidates[424].

Financial Performance - For the year ended December 31, 2024, total revenue was $15.0 million, a significant increase from $0.8 million in 2023, primarily due to royalties from Vaxzevria® sales[15] - The net loss for 2024 was $61.1 million, or $(1.55) per share, an improvement from a net loss of $73.3 million, or $(1.91) per share, in 2023[16] - Total revenue for Barinthus Biotherapeutics in 2024 was $14,969,000, a significant increase from $802,000 in 2023[20] - The net loss for 2024 was $61,183,000, compared to a net loss of $73,447,000 in 2023, reflecting an improvement in financial performance[20] Research and Development - Total research and development expenses decreased to $42.2 million in 2024 from $44.9 million in 2023, mainly due to reduced spending on VTP-200 and VTP-850 programs[15] - Research and development expenses decreased to $42,236,000 in 2024 from $44,874,000 in 2023, indicating a reduction in R&D spending[20] - The company reported 19% undetectable HBsAg levels in participants from two Phase 2 trials of VTP-300, indicating potential for functional cure in chronic hepatitis B[6] - The first data from the Phase 1 AVALON trial for VTP-1000 in celiac disease is expected in the third quarter of 2025[5] - The company completed enrollment of 22 participants in the Phase 1 PCA001 clinical trial for VTP-850 in prostate cancer in October 2024[8] - Barinthus Biotherapeutics anticipates ongoing clinical trials and product development activities, with a focus on regulatory filings and approvals[18] Financial Position - As of December 31, 2024, cash and cash equivalents totaled $112.4 million, down from $142.1 million at the end of 2023, with a net cash used in operating activities of $28.9 million[15] - Cash and cash equivalents decreased to $110,662,000 in 2024 from $142,090,000 in 2023, indicating a decline in liquidity[19] - Total assets decreased to $160,327,000 in 2024 from $214,506,000 in 2023, showing a reduction in overall asset base[19] - The total stockholders' equity attributable to Barinthus Biotherapeutics shareholders decreased to $130,029,000 in 2024 from $186,784,000 in 2023[19] Goodwill and Impairment - Goodwill impairment expense increased to $12.2 million in 2024, reflecting an impairment assessment based on expected asset utilization and market conditions[16] - The company reported a goodwill impairment of $12,209,000 in 2024, which was not present in 2023[20] Future Outlook - The company expects its available resources to fund operating expenses and capital expenditures into 2027[15] - The company has a cash runway that is subject to various risks, including global economic uncertainties and potential delays in clinical trial data[18] - Barinthus Bio's proprietary SNAP-TI platform is anticipated to drive multiple future pipeline and partnership opportunities, particularly in autoimmune diseases[5] - The weighted-average ordinary shares outstanding increased to 39,348,240 in 2024 from 38,386,491 in 2023, indicating a potential dilution of shares[20]

Financial Performance - The company reported a net loss of $73.4 million for the year ended December 31, 2023, and incurred a net loss of $8.1 million and $40.6 million for the three and nine months ended September 30, 2024, respectively[92][93]. - As of September 30, 2024, the company had an accumulated deficit of $217.1 million and does not expect positive cash flows from operations in the foreseeable future[92]. - The net loss for the three months ended September 30, 2024, was $8.13 million, a decrease of $5.98 million from a net loss of $14.11 million in the same period of 2023[129]. - The net loss for the nine months ended September 30, 2024, was $40.6 million, an improvement of $15.6 million compared to a net loss of $56.2 million in 2023[139]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future, primarily due to ongoing research and development efforts[153][161]. Revenue Generation - The company recognized $15.0 million in revenue in Q3 2024 from royalties related to prior sales of the Vaxzevria vaccine, with no expectation of future payments[105][109]. - For the three months ended September 30, 2024, the company reported license revenue of $14.97 million, compared to $0 in the same period of 2023, marking a significant increase[130]. - License revenue for the nine months ended September 30, 2024, was $15.0 million, a significant increase from $0.8 million in the same period of 2023[139]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $24.56 million, an increase of $8.45 million from $16.11 million in the same period of 2023[129]. - General and administrative expenses rose to $13.42 million for the three months ended September 30, 2024, an increase of $12.46 million compared to $961,000 in the same period of 2023[129]. - Total operating expenses for the nine months ended September 30, 2024, were $60.5 million, down from $64.7 million in 2023, reflecting a decrease in research and development costs[139]. Research and Development - The company is advancing two key product candidates: VTP-300 for chronic hepatitis B in Phase 2 and VTP-1000 for celiac disease in Phase 1[87][102]. - Enrollment was completed for the VTP-300 trial with 121 participants, aimed at obtaining dosing information for a potential functional cure for chronic hepatitis B[100]. - The company expects research and development expenses to increase in the future as it prepares for clinical trials and potential commercialization of product candidates[112]. - Total research and development expenses for the nine months ended September 30, 2024, were $33.9 million, a decrease of $4.6 million from $38.5 million in 2023[143]. Cash Flow and Financial Resources - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $106.1 million, with an accumulated deficit of $217.1 million[151][160]. - The company expects to fund its operating expenses and capital requirements into the second quarter of 2026 based on current cash resources[97]. - The company anticipates that existing financial resources will fund operating expenses and capital expenditures into the second quarter of 2026[167]. - For the nine months ended September 30, 2024, net cash used in operating activities was $42.0 million, compared to $31.3 million for the same period in 2023[154][156]. Market and Geopolitical Factors - The company has no operations or suppliers in conflict-affected regions, minimizing the impact of geopolitical issues on its business[106]. - The company incurs significant operating costs in the U.K. and is exposed to a potential 10% weakening of the U.S. dollar against the pound sterling, which could materially affect current and projected expenses denominated in pounds[178]. Other Financial Metrics - Interest income increased to $631,000 for the three months ended September 30, 2024, compared to $196,000 in the same period of 2023, an increase of $435,000[129]. - Interest income for the nine months ended September 30, 2024, was $2.0 million, slightly down from $2.3 million in 2023[148]. - The effect of foreign exchange on cash, cash equivalents, and restricted cash resulted in a gain of $5.3 million for the nine months ended September 30, 2024[159].

Clinical Trials - Enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B was completed with 121 adult participants[3] - Interim data from the HBV003 trial showed 76% of participants met criteria for nucleos(t)ide analogue therapy discontinuation, and 19% reached undetectable levels of HBsAg[4] - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated in September 2024[5] - The PCA001 trial of VTP-850 for prostate cancer completed enrollment with 22 participants, with data expected in the first half of 2025[6] - Upcoming milestones include updated data from VTP-300 at AASLD 2024 and results from VTP-1000 and VTP-850 trials in the first half of 2025[8][9] Financial Performance - Cash position as of September 30, 2024, was $106.1 million, down from $117.8 million as of June 30, 2024[12] - Revenue for Q3 2024 was $15.0 million, compared to nil in Q2 2024, attributed to royalties from prior sales of Vaxzevria®[12] - Total revenue for the three months ended September 30, 2024, was $14.969 million, compared to $0 for the same period in 2023, representing a significant increase[18] - License revenue from related parties for the three months ended September 30, 2024, was $15.0 million, compared to nil for the same period in 2023[18] Expenses - Research and development expenses for Q3 2024 were $11.1 million, a decrease from $11.7 million in Q2 2024[12] - Research and development expenses for the three months ended September 30, 2024, were $11.139 million, down from $15.144 million in the same period of 2023, indicating a 26.5% decrease[18] - General and administrative expenses increased to $13.4 million in Q3 2024, primarily due to a foreign exchange loss of $7.7 million[12] - General and administrative expenses increased to $13.420 million for the three months ended September 30, 2024, compared to $0.961 million in the same period of 2023[18] Net Loss and Income - Net loss for Q3 2024 was $8.1 million, or $(0.21) per share, an improvement from a net loss of $16.9 million, or $(0.43) per share in Q2 2024[12] - The net loss attributable to Barinthus Biotherapeutics plc shareholders for the three months ended September 30, 2024, was $8.114 million, compared to a net loss of $14.072 million for the same period in 2023, showing a 42.5% improvement[18] - The company reported a comprehensive income of $1.062 million for the three months ended September 30, 2024, compared to a comprehensive loss of $21.930 million for the same period in 2023[18] Assets and Liabilities - Total assets decreased to $188.689 million as of September 30, 2024, from $214.506 million as of December 31, 2023, reflecting a decline of 12.1%[17] - Total current liabilities increased to $15.072 million as of September 30, 2024, compared to $12.598 million as of December 31, 2023, marking a 19.6% increase[17] - The accumulated deficit increased to $217.124 million as of September 30, 2024, from $176.590 million as of December 31, 2023[17] - The total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders decreased to $159.294 million as of September 30, 2024, from $186.784 million as of December 31, 2023, a decline of 14.7%[17]