Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission File Number: 001-40367 BARINTHUS BIOTHERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) Engl ...

• Cash: As of June 30, 2025, cash, cash equivalents and restricted cash was $87.8 million, compared to $100.6 million as of March 31, 2025. The $12.8 million decrease is a result of the net cash used in operating activities of $18.1 million for the development of our pipeline and general corporate expenses, offset by a $5.3 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency. Based on current research and developmen ...

GERMANTOWN, Md., Aug. 07, 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 June 30, 2025, and provided an overview of the Company's corporate developments. "In the second quarter, we remained laser-focused on advancing VTP-1000, our highly differentiated immun ...

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].