[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, detailing net losses, accumulated deficit, and future funding needs Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (2025 vs 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) | | Accumulated deficit | $(278,436) | $(237,664) | $(40,772) | Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands, except per share amounts) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $7,953 | $11,662 | $16,243 | $22,787 | | General and administrative expenses | $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 | $(21,126) | $(16,943) | $(40,784) | $(32,463) | | Net loss per share, basic | $(0.52) | $(0.43) | $(1.01) | $(0.83) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 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 | | Net decrease in cash, cash equivalents and restricted cash | $(24,616) | $(24,316) | | Cash, cash equivalents and restricted cash, end of period | $87,784 | $117,774 | - The Company is a **clinical-stage biopharmaceutical company** focused on developing **novel immunotherapeutic drug candidates** for treating **autoimmune and inflammatory diseases (I&I)**, utilizing proprietary viral vector platform technologies (ChAdOx and MVA) and the **SNAP-TI platform**[20](index=20&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - As of June 30, 2025, the Company had **$87.8 million in cash, cash equivalents, and restricted cash**, and an **accumulated deficit of $278.4 million**; management expects current funds to be **sufficient for at least the next twelve months** but anticipates incurring losses and will seek additional funding[24](index=24&type=chunk)[135](index=135&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Nature of Business and Basis of Presentation](index=8&type=section&id=1.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) [3. Segment information](index=10&type=section&id=3.%20Segment%20information) [4. Foreign Currency Translation in General and Administrative Expenses](index=11&type=section&id=4.%20Foreign%20Currency%20Translation%20in%20General%20and%20Administrative%20Expenses) [5. Net Loss Per Share](index=12&type=section&id=5.%20Net%20Loss%20Per%20Share) [6. Property and Equipment, Net](index=12&type=section&id=6.%20Property%20and%20Equipment,%20Net) [7. Intangible Assets, Net](index=12&type=section&id=7.%20Intangible%20Assets,%20Net) [8. Prepaid Expenses and Other Current Assets](index=12&type=section&id=8.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) [9. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=9.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) [10. Grant Income](index=13&type=section&id=10.%20Grant%20Income) [11. Ordinary Shares](index=14&type=section&id=11.%20Ordinary%20Shares) [12. Deferred Shares](index=15&type=section&id=12.%20Deferred%20Shares) [13. Fair Value](index=15&type=section&id=13.%20Fair%20Value) [14. Share-Based Compensation](index=15&type=section&id=14.%20Share-Based%20Compensation) [15. Commitments and Contingencies](index=16&type=section&id=15.%20Commitments%20and%20Contingencies) [16. Related Party Transactions](index=18&type=section&id=16.%20Related%20Party%20Transactions) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results, emphasizing pipeline prioritization, net losses, and future financing needs - Barinthus Bio is a **clinical-stage biopharmaceutical company** focused on developing **novel immunotherapeutic drug candidates** for **autoimmune and inflammatory diseases (I&I)**, leveraging its **proprietary SNAP-TI platform**[87](index=87&type=chunk)[88](index=88&type=chunk) - The lead candidate, **VTP-1000 for celiac disease**, is currently 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[88](index=88&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - The company incurred **net losses of $21.2 million** and **$40.8 million** for the three and six months ended June 30, 2025, respectively, and does not expect **positive cash flows** from operations in the foreseeable future[91](index=91&type=chunk)[117](index=117&type=chunk)[126](index=126&type=chunk) - **Research and development expenses decreased by $3.7 million** (3 months) and **$6.5 million** (6 months) primarily due to a strategic decision to **deprioritize infectious disease and oncology programs** and a **reduction in headcount**[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - **General and administrative expenses increased significantly by $8.2 million** (3 months) and **$14.8 million** (6 months), mainly due to **unrealized foreign exchange losses** on USD balances in GBP-denominated entities and **increased professional fees**, partially offset by reduced personnel-related expenses[121](index=121&type=chunk)[130](index=130&type=chunk) - The company expects its existing cash, cash equivalents, and restricted cash to fund operating expenses and capital expenditure requirements **into the start of 2027**, but will **require substantial additional financing** thereafter[93](index=93&type=chunk)[151](index=151&type=chunk) [Overview](index=19&type=section&id=Overview) [Recent Developments](index=21&type=section&id=Recent%20Developments) [Components of Our Operating Results](index=21&type=section&id=Components%20of%20Our%20Operating%20Results) [Critical Accounting Policies and Use of Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) [Emerging Growth Company Status](index=32&type=section&id=Emerging%20Growth%20Company%20Status) [Recent Accounting Pronouncements](index=32&type=section&id=Recent%20Accounting%20Pronouncements) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) Discusses market risks, primarily foreign currency fluctuations (USD/GBP), and notes insignificant interest rate risk - The company is exposed to **foreign currency exchange rate fluctuations**, especially between the **United States dollar** (reporting currency) and the **pound sterling** (functional currency for UK subsidiaries), impacting **operating costs and payables**[160](index=160&type=chunk)[162](index=162&type=chunk) - A hypothetical **10% weakening of the United States dollar** relative to the pound sterling would **materially change current and projected expenses** denominated in pound sterling[162](index=162&type=chunk) - **Interest rate sensitivity 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) [Foreign Currency and Currency Translation](index=32&type=section&id=Foreign%20Currency%20and%20Currency%20Translation) [Interest Rate Sensitivity](index=32&type=section&id=Interest%20Rate%20Sensitivity) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures effective as of June 30, 2025, with no material changes in internal control - The principal executive officer and principal financial officer concluded that the company's **disclosure controls and procedures were effective** as of June 30, 2025[164](index=164&type=chunk)[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) [Evaluation of Disclosure Controls and Procedures](index=33&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) No material adverse legal claims as of June 30, 2025, though legal proceedings could incur costs and divert resources - As of June 30, 2025, the company does not believe it is party to any claim or litigation that would individually or in aggregate have **no 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) Updates risk factors: U.S. government funding, fiscal/tax policy, healthcare reforms, and U.K. Takeover Code - **Inadequate funding or disruptions** to U.S. government agencies like the FDA and SEC, including potential government shutdowns, could **delay product development, regulatory approvals, and access to capital**[172](index=172&type=chunk)[173](index=173&type=chunk)[175](index=175&type=chunk) - **Changes in U.S. fiscal and tax policies**, such as the One Big Beautiful Bill Act (OBBBA), could **adversely affect the company's financial condition**, particularly regarding the **capitalization and amortization of R&D expenses** performed outside the U.S. after December 31, 2021[176](index=176&type=chunk)[185](index=185&type=chunk) - **Healthcare legislative or regulatory reforms**, including executive orders aimed at **lowering drug prices** and state-level cost containment efforts, may lead to more rigorous coverage criteria and **downward pressure on product prices**, potentially **hindering revenue generation and profitability**[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) - The **U.K. City Code on Takeovers and Mergers currently does not apply** to the company, meaning shareholders are not entitled to its protections, but this will **change from February 3, 2027**, if the company's securities are quoted on a UK regulated market[181](index=181&type=chunk)[183](index=183&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 reallocated for R&D and general 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, approximately $102.8 million**, are now allocated to **advancing immune tolerance research and development programs** and **general corporate purposes**, a **change from the original plan due to pipeline prioritization**[193](index=193&type=chunk)[194](index=194&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers - **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) Lists Form 10-Q exhibits, including Articles of Association, officer certifications, and Inline XBRL - Key exhibits include the **Articles of Association**, **certifications of the Principal Executive Officer and Principal Financial Officer**, and various **Inline XBRL documents**[199](index=199&type=chunk) [SIGNATURES](index=41&type=section&id=SIGNATURES)

[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, focusing on VTP-1000 for celiac disease and pipeline partnerships [Introduction and Strategic Focus](index=1&type=section&id=Introduction%20and%20Strategic%20Focus) Barinthus Bio, an I&I company, announced Q2 2025 financial results, highlighting its strategic focus on advancing VTP-1000 for celiac disease and seeking partnerships - 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) Q2 2025 highlights include decreased cash, unchanged cash runway into 2027, and VTP-1000 AVALON trial progress 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 updated on VTP-1000 and VTP-850 clinical programs, actively seeking partnerships for pipeline assets [Clinical Developments and Upcoming Milestones](index=1&type=section&id=Clinical%20Developments%20and%20Upcoming%20Milestones) Barinthus Bio updated on VTP-1000 (celiac disease) and VTP-850 (prostate cancer) trials, detailing progress, safety, and data [VTP-1000 (Celiac Disease)](index=1&type=section&id=VTP-1000%20Celiac%20Disease) VTP-1000 Phase 1 AVALON trial is advancing, with SAD cohorts completed without SAEs, final SAD ongoing, and MAD initiated - 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**, including 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) VTP-850 Phase 1 prostate cancer trial is complete, showing no SAEs and encouraging immunogenicity for 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 actively seeks partners for VTP-300, VTP-850, 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 financials show decreased cash, unchanged cash runway into 2027, mixed operating expenses, and increased net loss [Cash Position and Runway](index=1&type=section&id=Cash%20Position%20and%20Runway) Cash, cash equivalents, and restricted cash decreased to **$87.8 million** by June 30, 2025, but resources 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 mixed trends: R&D decreased due to reduced preclinical activity, while G&A increased from unrealized foreign exchange losses [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) R&D expenses decreased slightly to **$8.0 million** in Q2 2025 due to reduced preclinical activity, with future autoimmune R&D expected to increase Research and Development Expenses (QoQ, in Thousands) | 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) G&A expenses increased to **$15.4 million** in Q2 2025, primarily due to increased unrealized foreign exchange losses 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 of **$21.1 million**, or **$(0.52)** per share, for Q2 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 immunotherapeutic candidates for autoimmune and inflammatory diseases [Company Profile and Platform](index=3&type=section&id=Company%20Profile%20and%20Platform) Barinthus Biotherapeutics is a clinical-stage biopharmaceutical company developing immunotherapeutic candidates for autoimmune and inflammatory diseases using its SNAP-TI platform - 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 future expectations, plans, and prospects, emphasizing inherent risks and uncertainties that could materially alter actual results [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 and plans, emphasizing numerous risks and uncertainties that could cause actual results to differ materially - 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) Q2 2025 consolidated financial statements reflect decreased assets and equity, an increased accumulated deficit, and a higher net loss [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheet shows decreased total assets and stockholders' equity from December 2024 to June 2025, driven by reduced cash and 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 three and six months ended June 30, 2025, 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 [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)

Core Insights - Barinthus Biotherapeutics plc reported its financial results for Q2 2025, focusing on advancements in its immunotherapy programs, particularly VTP-1000 for celiac disease [1][5][12]. Clinical Developments - The company is advancing its VTP-1000 immunotherapy, currently in the Phase 1 AVALON trial, with the last cohort of the single ascending dose (SAD) portion being screened and the multiple ascending dose (MAD) portion initiated [2][6][7]. - The SAD data readout is expected early in Q4 2025, while MAD data is anticipated in mid-2026 [6][7]. - The Phase 1 trial of VTP-850 for prostate cancer is complete, showing encouraging signs of immunogenicity [7]. Financial Highlights - As of June 30, 2025, the company had cash and cash equivalents of $87.8 million, down from $100.6 million as of March 31, 2025, primarily due to operating activities [8]. - Research and development expenses for Q2 2025 were $8.0 million, a slight decrease from $8.3 million in Q1 2025, attributed to reduced preclinical activity and workforce [8][9]. - General and administrative expenses increased to $15.4 million in Q2 2025 from $12.6 million in Q1 2025, mainly due to unrealized foreign exchange losses [13]. Net Loss - The net loss for Q2 2025 was $21.1 million, or $(0.52) per share, compared to a net loss of $19.7 million, or $(0.49) per share in Q1 2025 [13][19]. Corporate Updates - Barinthus Bio is actively seeking partners for its VTP-300 program in chronic hepatitis B and other viral vector-based assets [4].

Company Overview - Barinthus Bio is developing immunotherapies for autoimmunity and inflammatory diseases, focusing on restoring immune tolerance using the SNAP-TI platform[5] - The company has a strong financial position with $100.6 million in cash as of March 31, 2025, and an estimated cash runway into 2027[5, 92] - Barinthus Bio has 40.4 million outstanding ordinary shares and no debt or outstanding warrants[5] SNAP-TI Platform & VTP-1000 - The SNAP-TI platform is designed for antigen-specific immune tolerance, aiming to reduce inflammation and restore immune non-responsiveness to healthy tissue[5] - VTP-1000, the lead candidate for Celiac disease, is in an ongoing Phase 1 clinical trial with data readout expected in Q3 2025[5, 24, 92] - Approximately 1% of people worldwide have Celiac disease, equating to about 80 million people[27] - Around 60% of Celiac patients, or about 48 million people, cannot adhere to a strict Gluten-Free Diet[27] - Roughly 20% of Celiac patients are Non-Responsive, meaning about 16 million people's symptoms continue despite avoiding gluten[27] Viral Vector Platform Programs - VTP-300, a viral vector-based program for Chronic Hepatitis B, is pursuing partnership opportunities for advancement[56] - Approximately 254 million people are chronically infected with HBV, and there are 1.2 million new HBV infections per year[60] - In the HBV003 Phase 2b trial, 31.8% in Group 1 and 34.8% in Group 2 achieved >1 log HBsAg decline at Day 169, while only 4.2% in Group 3 achieved the same[77] - In the IM-PROVE II trial, 25% (2/8) of participants with starting baseline HBsAg levels less than 1000 IU/mL who received IDR+VTP-300+LDN reached Functional Cure[89]

Summary of Barinthus Biotherapeutics plc (BRNS) Conference Call Company Overview - Barinthus Biotherapeutics plc focuses on next-generation immunotherapies targeting autoimmune and inflammatory diseases, utilizing a platform called SnapTI [4][5] Key Developments - The lead candidate, VTP 1000, is currently in phase one clinical trials for celiac disease, with expected data readout by the end of Q3 or early Q4 2025 [6][48] - The company has approximately $100 million in cash, providing a runway into 2027 with no debt or outstanding warrants [6][48] SnapTI Platform - SnapTI is a self-assembling nanoparticle platform designed to restore immune system balance by co-delivering multiple disease-associated antigens with an immunomodulator [5][11] - The platform allows for patient-friendly administration via intramuscular (IM) or subcutaneous (SubQ) routes, enhancing tolerability and broadening antigen coverage [12][13] Celiac Disease Focus - Celiac disease affects about 1% of the global population, with current treatment limited to a strict gluten-free diet [16] - VTP 1000 aims to rebalance the immune system by reducing T effector cells and stimulating T regulatory cells, addressing the underlying immune imbalance in celiac disease [18] Clinical Trials - The phase one trial is a double-blind, placebo-controlled study involving 18 patients in a single ascending dose (SAD) design, with safety and biomarker changes being key focuses [29][30] - A multiple ascending dose (MAD) portion has received FDA approval, involving 24 patients and a gluten challenge to assess efficacy [30] Viral-Based Platform - The company is winding down its viral-based platform, which includes VTP 300 for chronic hepatitis B and VTP 850 for prostate cancer, seeking partners to advance these programs [35][36] - Chronic hepatitis B presents a significant market opportunity, with over 250 million people affected globally and current treatments yielding low cure rates [37][38] Encouraging Data - VTP 300 is designed to stimulate both exhausted T cells and new T cells to combat hepatitis B, with a focus on achieving a functional cure defined as surface antigen loss after stopping nucleoside treatments [39][40] - Recent studies showed promising results, with 20-25% functional cure rates, significantly higher than current standard care [46][47] Financial Outlook - The company has no immediate plans for fundraising, relying on existing cash reserves and upcoming clinical data to guide future financial strategies [50]

Financial Performance - For the three months ended March 31, 2025, the company incurred a net loss of $19.7 million, with an accumulated deficit of $257.3 million[87]. - The company reported a net loss of $19.7 million for the three months ended March 31, 2025, compared to a net loss of $15.5 million in the same period of 2024, reflecting an increase in loss of $4.1 million[115]. - The company has incurred net losses in each reporting period since 2023 and does not expect positive cash flows from operations in the foreseeable future[87]. - For the three months ended March 31, 2025, total operating expenses increased to $20.9 million from $17.1 million in the same period of 2024, representing a change of $3.8 million[115]. - General and administrative expenses rose significantly to $12.6 million in Q1 2025, compared to $6.0 million in Q1 2024, an increase of $6.6 million[120]. - The company anticipates continued net negative cash flows from operations for at least the next few years as it progresses clinical development and seeks regulatory approval[127]. - The company expects to incur significant losses and negative cash flows from operations for the foreseeable future, driven by ongoing research and development efforts[135][136]. Research and Development - The company is currently advancing its lead candidate VTP-1000 for celiac disease in a Phase 1 clinical trial, leveraging its proprietary SNAP-TI platform[83]. - VTP-300, a Phase 2 immunotherapeutic treatment for chronic hepatitis B, showed that 33% of participants achieved HBsAg declines of ≥1 log at Day 169[93]. - The company is seeking partners for the continued development of VTP-300 and VTP-850, which it does not intend to develop beyond ongoing trials[99]. - The company plans to prioritize the development of VTP-1000 in celiac disease and focus future pipeline efforts on immunology and inflammation indications[112]. - Research and development expenses are expected to increase as the company progresses its programs through the next stages of development[99]. Cash and Financing - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $100.6 million[125]. - The company received gross proceeds of approximately $330.1 million from the issuance of ordinary and preferred shares and convertible loan notes through March 31, 2025[125]. - The company anticipates that existing cash and equivalents will fund operations into early 2027, although this estimate is subject to change[142]. - The company may require substantial additional financing in the future to meet operational needs and capital requirements, which could impact its ability to develop and market product candidates independently[143]. - The company anticipates financing future cash needs through public or private equity offerings, debt financings, or collaborations[89]. Operational Metrics - For the three months ended March 31, 2025, net cash used in operating activities was $14.9 million, compared to $11.8 million for the same period in 2024, reflecting an increase of 26.5%[130][131]. - Cash used in investing activities was $0.005 million for the three months ended March 31, 2025, down from $0.3 million in the same period of 2024, indicating a decrease of 98.3%[132]. - Cash provided by financing activities was $0.002 million for the three months ended March 31, 2025, compared to $0.5 million in the same period of 2024, a decline of 99.6%[133]. - The effect of foreign exchange on cash resulted in a gain of $3.1 million for the three months ended March 31, 2025, compared to a loss of $0.5 million in the same period of 2024[134]. Partnerships and Collaborations - The company has partnerships for additional product candidates, including VTP-500 for MERS and VTP-600 for multiple cancer indications[85]. - The fair value of contingent consideration related to the acquisition of Avidea Technologies, Inc. could result in additional payments of up to $40.0 million upon achieving certain milestones[114].

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, indicating an increase in loss of approximately 26.5%[17]. - The net loss per share attributable to ordinary shareholders for Q1 2025 was $(0.49), compared to $(0.40) in Q1 2024, indicating a worsening loss per share[17]. - Comprehensive loss for Q1 2025 was $15,012,000, compared to $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, were $100.6 million, down from $112.4 million as of December 31, 2024, primarily due to $14.9 million used in operating activities[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]. Expenses - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, reflecting a reduction in preclinical activity and workforce[12]. - General and administrative expenses increased to $12.6 million in Q1 2025 from $6.0 million in Q1 2024, largely due to foreign exchange losses[12]. - Research and development expenses for Q1 2025 were $8,290,000, down 25.5% from $11,125,000 in Q1 2024[17]. - General and administrative expenses increased significantly to $12,639,000 in Q1 2025, compared to $5,994,000 in Q1 2024, representing a rise of 110.5%[17]. Clinical Trials and Research - In the HBV003 study, 33% of participants with baseline HBsAg levels ≤200 IU/mL achieved ≥1 log decline in HBsAg 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 aims to seek partners for VTP-300 for chronic hepatitis B after the completion of the ongoing Phase 2b HBV003 clinical trial[7]. - The company reported that 71% of participants in the HBV003 study met criteria for discontinuation of NUC therapy by Day 169[6]. - Barinthus Bio's lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial[14]. Liabilities - 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]. Future Outlook - The company anticipates its available resources will fund operations into 2027 based on current research and development plans[12]. - The weighted-average ordinary shares outstanding increased from 38,773,482 in Q1 2024 to 40,265,216 in Q1 2025, reflecting a growth of about 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].

Core Insights - Barinthus Biotherapeutics plc focuses on developing therapies for immunological and inflammatory diseases, with a strategic emphasis on its lead asset, VTP-1000, for celiac disease [2][3] - The company is on track to announce Phase 1 single ascending dose data for VTP-1000 in Q3 2025 and will initiate the multiple ascending dose part of the trial in the second half of 2025 [2][12] - Recent data from Phase 2 trials of VTP-300 for chronic hepatitis B (CHB) show promising results, supporting its potential as a functional cure [3][4][5] Clinical Developments - Data from two Phase 2 trials of VTP-300 will be presented at the EASL Congress 2025, showcasing significant findings from the HBV003 and IM-PROVE II studies [3][4] - The HBV003 study indicated that 33% of participants with HBsAg levels ≤200 IU/mL achieved ≥1 log decline in HBsAg by Day 169 [6] - The IM-PROVE II study demonstrated that 25% of participants receiving a combination therapy achieved functional cure [11] Financial Highlights - For Q1 2025, the company 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 [18][22] - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, attributed to reduced preclinical activity and workforce [13][22] - As of March 31, 2025, the company had cash and cash equivalents of $100.6 million, expected to fund operations into 2027 [13][20] Corporate Updates - In January 2025, Barinthus Bio announced a strategic refocus on immunology and inflammation, planning to seek partners for VTP-300 after the completion of the ongoing Phase 2b trial [7] - The company aims to leverage its differentiated capabilities in achieving sustained HBsAg loss and functional cure in CHB patients [7] - Upcoming milestones include topline results from the Phase 1 PCA001 trial for prostate cancer (VTP-850) [8]

Financial Performance - For the year ended December 31, 2022, the company generated net income of $5.3 million, primarily from revenues arising from AstraZeneca sales of Vaxzevria and an agreement with OUI[285]. - The company incurred net losses of $61.2 million and $73.4 million for the years ending December 31, 2024 and 2023, respectively[285]. - As of December 31, 2024, the company had an accumulated deficit of $237.7 million[285]. - The company has cumulative carryforward tax losses of approximately $101.7 million as of December 31, 2024, up from $92.7 million as of December 31, 2023[417]. 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 expects to finance future cash needs through public or private equity offerings, debt financings, collaborations, and licensing arrangements[303]. - The company may need to raise additional funding, which could result in dilution to existing shareholders and restrict operations[302]. - The company anticipates substantial increases in expenses as it pursues clinical and preclinical development of product candidates and expands operational capabilities[286]. - The company may need to pursue additional funding through public or private equity offerings, debt financings, or strategic partnerships to support ongoing operations[307]. Product Development and Clinical Trials - The company does not expect to generate significant revenue from current or future product candidates until successful completion of clinical development and marketing authorization[289]. - The company has not yet generated any material revenue from its current product candidates and faces significant translational risks as it advances them through clinical stages[290]. - The company has discontinued further development of the MVA-based influenza vaccine candidate, VTP-100, after it did not meet primary clinical endpoints in two Phase 2b trials[316]. - The company may experience delays in clinical trials or may not be able to complete them on expected timelines, impacting the commercialization of product candidates[320]. - The company may face delays in clinical trials due to various factors, including regulatory holds, unforeseen safety issues, or lack of adequate funding[325][326]. - The company’s product candidates are based on novel approaches, making it difficult to predict development timelines and costs, which could lead to significant delays or unanticipated costs[333]. - The company may need to conduct additional clinical trials if existing therapies used in combination with its product candidates are replaced as the standard of care[340]. - The integrity of clinical trial data may be questioned due to financial relationships between the company and principal investigators, potentially delaying approval processes[327]. Regulatory and Compliance Risks - The marketing authorization process from regulatory authorities like the FDA and EMA is lengthy and unpredictable, potentially delaying market access for product candidates[396]. - Regulatory authorities have substantial discretion in the approval process, and even promising clinical trial data may not be sufficient for approval, introducing uncertainty into the commercialization process[399]. - The company must comply with Good Clinical Practice (GCP) regulations, and any failure to do so may result in unreliable clinical data and regulatory delays[382]. - The company is subject to varying regulatory requirements in different jurisdictions, which could delay or prevent the introduction of its product candidates[412]. - The company faces ongoing regulatory obligations that may result in significant additional expenses and potential penalties if compliance is not maintained[422]. Market and Competitive Landscape - The commercial success of product candidates will depend on public acceptance of immunotherapies and the absence of adverse events in clinical trials[346]. - The company faces substantial competition from major pharmaceuticals and biotechnology companies, which may have greater financial resources and expertise[355]. - Product candidates based on SNAP-TI will compete against various existing and emerging therapies, including anti-inflammatory compounds and monoclonal antibodies[356]. - The company may not achieve market acceptance for its product candidates, which is critical for generating significant revenue[370]. Intellectual Property and Licensing - The company relies heavily on in-licensed patents and does not own any issued patents for its product candidates, which could harm its competitive position if patent protection is not maintained[455]. - The patent prosecution process is complex and costly, and failure to secure patents could adversely affect the company's ability to commercialize its products[458]. - The company is dependent on third-party licenses for critical technology, and any breach of these agreements could result in the loss of significant rights[462]. - The uncertainty surrounding patent laws and their interpretation may diminish the company's ability to protect its inventions and intellectual property rights[456]. Insurance and Liability - The company is exposed to significant uninsured liabilities due to the high costs of insurance and the potential for contamination or injury claims[378]. - The company may face challenges in maintaining insurance coverage at reasonable costs, which could adversely affect its financial position[377]. Data Protection and Compliance - The GDPR imposes strict obligations on personal data processing, requiring significant resources for compliance and increasing liability risks[441]. - Non-compliance with data protection laws in the EU and U.K. could result in fines up to €20 million or 4% of annual global revenue, whichever is greater[450]. - The CCPA and other U.S. state privacy laws impose new compliance obligations, increasing risks for potential fines and class actions[446]. Future Outlook and Strategic Initiatives - The company may evaluate acquisitions and strategic partnerships in the future, which could increase capital requirements and dilute shareholders[294]. - The company intends to develop certain product candidates in combination with other therapies, exposing it to additional risks if those therapies face regulatory issues[340]. - The company intends to market VTP-300 in Asian markets, particularly for chronic hepatitis B, but faces regulatory challenges and limited development experience in this region[413].

Financial Estimates - The preliminary estimated cash, cash equivalents, and restricted cash for Barinthus Biotherapeutics plc as of December 31, 2024, is expected to be $112 million[5]. Workforce Reduction - The company plans a 65% reduction in workforce, primarily in the UK, with pre-tax costs estimated at $2.5 million related to employee severance and other costs[7]. - The majority of the workforce reduction is anticipated to be completed during the first half of 2025[7]. - The company has announced the termination of employment for two key executives as part of the restructuring[8]. Restructuring Plan - The restructuring plan aims to prioritize immune tolerance research and development programs[7]. - The restructuring costs and potential operating expense reductions are subject to various assumptions, and actual results may vary[7]. Strategic Focus - The company issued a press release on January 10, 2025, outlining its strategic focus in immunology and inflammation[10]. - A corporate presentation was updated for investor meetings, reflecting the company's current strategies and financial updates[11]. Forward-Looking Statements - Forward-looking statements indicate that actual results may differ materially from preliminary estimates due to various risks and uncertainties[13]. - The company cautions against placing undue reliance on forward-looking statements, which are based on current expectations and beliefs[13].