Barinthus(BRNS) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Barinthus Bio, an I&I company, reported Q2 2025 results, focusing on VTP-1000 for celiac disease and pipeline partnerships Introduction and Strategic Focus 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] - 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 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] - 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 updated on VTP-1000 and VTP-850 clinical programs, actively seeking partnerships for pipeline assets Clinical Developments and Upcoming Milestones Barinthus Bio updated on VTP-1000 (celiac disease) and VTP-850 (prostate cancer) trials, detailing progress, safety, and data VTP-1000 (Celiac Disease) 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] - 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, including a gluten challenge to assess potential efficacy[2][7] VTP-850 (Prostate Cancer) 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] - Data from the VTP-850 trial shows encouraging signs of immunogenicity and will be used to facilitate partnering discussions[7] Corporate Updates 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] Second Quarter 2025 Financial Highlights 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 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] - 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 mixed trends: R&D decreased due to reduced preclinical activity, while G&A increased from unrealized foreign exchange losses Research and Development Expenses 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] - 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 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] Net Loss and EPS 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 Barinthus Biotherapeutics is a clinical-stage biopharmaceutical company developing immunotherapeutic candidates for autoimmune and inflammatory diseases Company Profile and Platform 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] - 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 future expectations, plans, and prospects, emphasizing inherent risks and uncertainties that could materially alter actual results Disclaimer and Risk Factors 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] - 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 Q2 2025 consolidated financial statements reflect decreased assets and equity, an increased accumulated deficit, and a higher net loss Consolidated Balance Sheets 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 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 This section provides essential contact information for investor relations and media inquiries 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]