VACCITECH(VACC) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights 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 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] - 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] Key Q2 2025 Highlights 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] - The company expects its available resources to fund operating expenses and capital expenditure requirements into 2027, with this guidance remaining unchanged[5][6] - 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] - The multiple ascending dose (MAD) part of the AVALON trial was initiated[6] Recent Corporate Developments 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 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) 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] - 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] - 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][7] VTP-850 (Prostate Cancer) 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] - Data from the VTP-850 trial shows encouraging signs of immunogenicity and will be used to facilitate partnering discussions[7] Corporate Updates 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] Second Quarter 2025 Financial Highlights 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 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] - Based on current plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027[5] Operating Expenses 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 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] - 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] - 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] General and Administrative Expenses 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] Net Loss and EPS 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 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 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] - 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] - 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] Forward Looking Statements 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 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] - 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] - 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] - 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] Consolidated Financial Statements 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 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 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 This section provides essential contact information for investor relations and media inquiries regarding Barinthus Bio Contact Information This section provides contact details for investor relations and media inquiries - Investor Relations contact: Kevin Gardner, Managing Director, LifeSci Advisors[14] - Media contacts: Alexis Feinberg and Jonathan Edwards, ICR Healthcare[14] - Company contact email: ir@barinthusbio.com[14]