BRNS

Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) progressing towards closing which will result in a differentiated company focusing on metabolic and autoimmune pipeline assets with multiple important clinical development milestones in the 18 months after closing Multiple ascending dose part of the Phase 1 AVALON trial of VTP-1000 in celiac disease patients is progressing; data expected in the second half of 2026 GERMANTOWN, Md., April 30, 2026 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), today announced its financial results for the quarter ended March 31, 2026, and provided an overview of the Company’s corporate developments. Barinthus Bio is an immunology and inflammation (“I&I”) company focused on developing therapies that promote immune tolerance with curative potential. "As we complete the first quarter of 2026, our focus remains on advancing the proposed combination with Clywedog, which we believe represents a transformative opportunity for Barinthus Bio by creating a compelling and differentiated pipeline focused on autoimmune and metabolic diseases,” said Bill Enright, Chief Executive Officer of Barinthus Bio. "Throughout the first quarter, we continued to advance the activities necessary to complete the transaction, while also preparing for a seamless integration following closing. At the same time, our major focus is to progress the ongoing clinical development of our core asset, VTP-1000, in celiac disease. With encouraging single ascending dose data in hand from the Phase I AVALON trial and multiple ascending dose data expected in the second half of 2026, we see a clear opportunity for VTP-1000 to deliver near-term clinical milestones and to contribute to long-term shareholder value for the combined company.” Recent Corporate Developments Doug Swirsky, seasoned biotechnology executive with public company CFO experience, has been appointed to serve as the Chief Financial Officer effective May 1, 2026. Upcoming Milestones Celiac Disease (VTP-1000): Data from the multiple ascending dose portion of the Phase 1 AVALON clinical trial, which includes a gluten challenge following three doses of test medication, is expected in the second half of 2026. Corporate: Barinthus Bio expects to complete the merger with Clywedog mid-2026. Upon the closing of the transaction, the combined com...

Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) to create a differentiated company focusing on clinical metabolic and autoimmune pipeline assets and to build on the Company’s base of high caliber institutional investors, expected to complete in the second quarter of 2026 Multiple ascending dose part of the Phase 1 AVALON trial of VTP-1000 in celiac disease patients is progressing; data expected in the second half of 2026 GERMANTOWN, Md., March 13, 2026 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), today announced its financial results for the year ended December 31, 2025, and provided an overview of the Company’s corporate developments. Barinthus Bio is an immunology and inflammation (“I&I”) company focused on developing therapies that promote immune tolerance with curative potential. “As we move into 2026, we are excited by the proposed combination of Barinthus Bio and Clywedog, which positions us for multiple near-term catalysts emerging from our differentiated and complimentary clinical portfolio.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We finished 2025 reporting encouraging results from the single ascending dose portion of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and expect multiple ascending dose data in the second half of 2026. These upcoming results will help us confirm whether VTP-1000 has the potential to be disease-modifying by restoring balance to the immune system.” Corporate Milestones In January 2025, Barinthus Bio announced a strategic business refocus and restructuring to prioritize immunology and inflammation indications, including antigen-specific immune tolerance and the development of VTP-1000 in celiac disease. Infectious disease and oncology assets, collectively referred to as "Barinthus legacy assets," which include VTP-300 in chronic hepatitis B ("CHB") and VTP-850 in prostate cancer, were deprioritized for direction operations, and will only be progressed with a partner. In May 2025, Barinthus Bio presented data from two Phase 2 clinical trials of VTP-300 in CHB at the European Association for the Study of the Liver (“EASL”) Congress 2025 showing VTP-300 induced meaningful and sustained reductions in hepatitis B surface antigen levels. In September 2025, Barinthus Bio announced it had entered into a definitive merg...

Single ascending dose data readout for VTP-1000 expected before the end of 2025 Enrollment advancing in multiple ascending dose part of the AVALON trial; data expected in the second half of 2026 Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) to strengthen and diversify the pipeline and broaden the Company’s base of high caliber institutional investors. GERMANTOWN, Md., Nov. 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 September 30, 2025, and provided an overview of the Company’s corporate developments. "The proposed combination of Barinthus Bio and Clywedog represents an important step toward building a stronger, more resilient company, with several expected near-term catalysts.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “By combining our complementary pipelines and deep expertise in metabolic and autoimmune diseases, we are diversifying risk across multiple assets and creating a differentiated portfolio. This combination will position us to advance disease-modifying therapies for Type 1 and Type 2 diabetes, celiac disease, and other serious conditions.” Recent Corporate Developments Clinical Developments and Upcoming Milestones Phase 1 AVALON trial of VTP-1000 in patients with celiac disease Part A: Single ascending dose (“SAD”): SAD is ongoing with no treatment related serious adverse events (“SAEs”) reported. Data expected to be announced before the end of 2025. Part B: Multiple ascending dose (“MAD”): Enrollment in the MAD portion of the trial is ongoing, with data expected in the second half of 2026. Corporate Updates On September 30, 2025, Barinthus Bio announced it had entered into a definitive merger agreement to combine in an all-stock transaction with Clywedog, a private company advancing breakthrough medicines in diabetes. The newly combined company will advance a differentiated portfolio of clinical-stage candidates targeting metabolic and autoimmune diseases, with four clinical data milestones expected within 18 months of the closing of the transaction. Upon the closing of the transaction, the combined company will be renamed “Clywedog Therapeutics Hold...

The final cohort of the single ascending dose (SAD) part of the Phase 1 AVALON trial initiated, with the SAD data readout expected early in the fourth quarter of 2025; The multiple ascending dose (MAD) part of the AVALON trial initiated; Available resources and cash runway guidance into 2027 remains unchanged. 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 immunotherapy designed to prevent or reduce symptoms following gluten exposure in patients with celiac disease,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We are currently screening patients for the last cohort of the SAD portion of the Phase 1 AVALON trial, and as planned, we initiated the MAD portion of the trial, which includes a gluten challenge, enabling us to assess the potential efficacy of VTP-1000 at this early stage. We look forward to reporting topline data from the SAD portion of the trial early in the fourth quarter of 2025.” Recent Corporate Developments Clinical Developments and Upcoming Milestones Phase 1 AVALON trial of VTP-1000 in patients with celiac disease Part A: SAD: The first two cohorts have been dosed with no treatment related serious adverse events (“SAEs”) reported. The third and final cohort in the SAD part of the trial is ongoing. SAD data is expected early in the fourth quarter of 2025. Part B: MAD: MAD portion of the trial was initiated in July 2025. MAD data is expected in mid-2026. Phase 1 trial of VTP-850 in patients with prostate cancer The trial is now complete, with no treatment related SAEs reported. Data shows encouraging signs of immunogenicity and will be used to facilitate partnering discussions. Corporate Updates 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. Second Quarter 2025 Financial Highlights Cash: As of June 30, 2025, cash, cash equivalents and restrict...

Highly differentiated immunotherapy for celiac disease (VTP-1000) in the clinic, with Phase 1 single ascending dose readout from AVALON expected in the third quarter of 2025; Initiation of VTP-1000 multiple ascending dose expected in the second half of 2025; Encouraging results from HBV003 and IM-PROVE II presented at EASL, supporting ongoing partnering efforts; Available resources expected to provide a cash runway into 2027. OXFORD, United Kingdom and GERMANTOWN, Md., May 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 March 31, 2025 and provided an overview of the Company’s corporate developments. “2025 has started with a strategic focus on immunological and inflammatory diseases, which includes directing our resources to our highly differentiated lead asset,VTP-1000, using the SNAP-TI platform, being tested in patients with celiac disease. Looking ahead, we remain on track to announce Phase 1 single ascending dose data for the celiac program using VTP-1000 in the third quarter of 2025, and will be initiating the multiple ascending dose part of the Phase 1 clinical trial in the second half of 2025, where we are incorporating a gluten challenge as part of our initial clinical evaluation of efficacy,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “Today, we announced multiple data milestones from our viral vector pipeline, including encouraging primary endpoint analyses from the two Phase 2 trials in chronic hepatitis B ("CHB") which we believe strengthen VTP-300’s market positioning as a component of a potential functional cure for CHB.” First Quarter 2025 and Recent Corporate Developments Clinical Developments Data from two Phase 2 clinical trials of VTP-300 will be showcased in poster presentations at the European Association for the Study of the Liver (“EASL”) Congress 2025, taking place May 7-10, 2025, in Amsterdam, the Netherlands. The presentations include the six-month primary analysis of the Phase 2b clinical trial (HBV003), as well as end-of-study data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving...

Strategic transformation ongoing, positioning the Company as a focused leader in immunology and inflammatory diseases Highly differentiated, potentially curative immunotherapy for celiac disease (VTP-1000) in the clinic, with first data expected in third quarter of 2025 Proprietary SNAP-TI platform promoting antigen-specific immune tolerance is anticipated to drive multiple future pipeline and partnership opportunities Strategic prioritization of resources expected to provide a cash runway into 2027 OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 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 year ended December 31, 2024 and provided an overview of the Company’s business updates. “We’ve entered 2025 with a refreshed strategic focus on immunological and inflammatory diseases. Following our restructuring, we are strongly positioned to advance our highly differentiated lead asset,VTP-1000, (and the underlying SNAP-TI platform) in patients with celiac disease. Through design innovations enabling greater targeting of disease antigens, intramuscular administration and potentially improved tolerability, VTP-1000 has promise to be a leading therapy for the approximate 80 million people worldwide with celiac disease. We look forward to reporting single-ascending dose Phase 1 data for this program in the third quarter of this year.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “VTP-1000 is based on our innovative SNAP-TI platform, which is differentiated based on its capacity to promote antigen-specific immune tolerance that specifically guides a patient's T cells to suppress unwanted inflammation and restore the natural state of immune non-responsiveness to healthy tissue without affecting immunity against cancer or infections. Given this mild and potentially curative approach to restoring balance to the immune system, we believe SNAP-TI is poised to drive multiple future pipeline and partnership opportunities for the company particularly for autoimmune diseases where broadly immunosuppressive drugs are not optimal." “Turning to our development candidates designated for partnering, we reported highly encouraging...