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BRNS

Barinthus BiotherapeuticsD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-06
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Investor releaseQuarter not tagged2026-08-06

Barinthus Bio Reports Second Quarter 2026 Financial Results and Updates on Corporate Developments

GlobeNewswire
Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) progressing towards closing Completed enrollment of 42 planned subjects in the Phase 1 AVALON trial evaluating VTP-1000 in patients with celiac disease; topline data from multiple ascending dose ("MAD") expected in the fourth quarter of 2026 GERMANTOWN, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), today announced its financial results for the quarter ended June 30, 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. “During the second quarter, our primary focus remained advancing the proposed combination with Clywedog and progressing the clinical development of VTP-1000, our lead asset for celiac disease,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We are pleased to announce the completion of enrollment in the multiple ascending dose portion of the Phase 1 AVALON trial and remain on track to report topline data in the fourth quarter of 2026. We believe VTP-1000 has the potential to address a significant unmet need in celiac disease and to be an important driver of long-term value for shareholders of the combined company.” Recent Corporate Developments During the third quarter of 2026, Barinthus Bio completed enrollment in all cohorts in the MAD portion of the Phase 1 AVALON clinical trial. On June 30, 2026, Barinthus Bio received a notice (the “Extension Notice”) from the Nasdaq Stock Market (“Nasdaq”) informing the Company that Nasdaq had granted the Company an additional 180 calendar days, or until December 28, 2026, to regain compliance with the Bid Price Requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). In connection with the Extension Notice, the listing of the Company’s American Depositary Shares (the “ADSs”) was transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective as of July 2, 2026. The Extension Notice has no other immediate effect on the listing of the ADSs. Upcoming Milestones Celiac Disease (VTP-1000): Data from the MAD portion of the Phase 1 AVALON clinical trial, which includes a gluten challenge following three doses of test medication, is…Read full document

Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) progressing towards closing Completed enrollment of 42 planned subjects in the Phase 1 AVALON trial evaluating VTP-1000 in patients with celiac disease; topline data from multiple ascending dose ("MAD") expected in the fourth quarter of 2026 GERMANTOWN, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), today announced its financial results for the quarter ended June 30, 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. “During the second quarter, our primary focus remained advancing the proposed combination with Clywedog and progressing the clinical development of VTP-1000, our lead asset for celiac disease,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We are pleased to announce the completion of enrollment in the multiple ascending dose portion of the Phase 1 AVALON trial and remain on track to report topline data in the fourth quarter of 2026. We believe VTP-1000 has the potential to address a significant unmet need in celiac disease and to be an important driver of long-term value for shareholders of the combined company.” Recent Corporate Developments During the third quarter of 2026, Barinthus Bio completed enrollment in all cohorts in the MAD portion of the Phase 1 AVALON clinical trial. On June 30, 2026, Barinthus Bio received a notice (the “Extension Notice”) from the Nasdaq Stock Market (“Nasdaq”) informing the Company that Nasdaq had granted the Company an additional 180 calendar days, or until December 28, 2026, to regain compliance with the Bid Price Requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). In connection with the Extension Notice, the listing of the Company’s American Depositary Shares (the “ADSs”) was transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective as of July 2, 2026. The Extension Notice has no other immediate effect on the listing of the ADSs. Upcoming Milestones Celiac Disease (VTP-1000): Data from the MAD portion of the Phase 1 AVALON clinical trial, which includes a gluten challenge following three doses of test medication, is expected in the fourth quarter of 2026. An abstract outlining Phase 1 Single Ascending Dose data for VTP-1000 has been selected for poster presentation at the American College of Gastroenterology ("ACG") Annual Scientific Meeting, to be held October 9–14, 2026 in Nashville, Tennessee. The poster will be presented by Dr. Adam Bledsoe, from the Division of Gastroenterology and Hepatology at Mayo Clinic. Corporate: Barinthus Bio expects to complete the merger with Clywedog in the second half of 2026 which will result in a differentiated biopharmaceutical company focusing on metabolic and autoimmune diseases with three potentially disease-modifying clinical stage therapies. At closing, the combined company will be renamed “Clywedog Therapeutics Holdings, Inc.” and is expected to trade on the NASDAQ under the new ticker symbol “CLYD.” The combined company's estimated cash runway is expected to extend through 2027, supported by existing cash and additional investments by OrbiMed and Torrey Pines Investments, LLC, both existing shareholders in Clywedog, and new investors. Second Quarter 2026 Financial Highlights Cash: As at June 30, 2026, cash, cash equivalents and restricted cash were $59.6 million, compared to $67.2 million as of March 31, 2026. The $7.6 million decrease was a result of the net cash used in operating activities of which $8.1 million was used for the development of the Company's pipeline and general corporate expenses, and a $0.5 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency. Based on standalone research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of the financial statements. Research and Development Expenses: Research and development expenses were $3.9 million in the second quarter of 2026 compared to $3.6 million for the first quarter of 2026. The increase was primarily attributable to an increase in VTP-1000 Celiac program cost in second quarter of 2026 offset by reduced activity in the Barinthus legacy asset clinical programs and the reduction in workforce. The quarter-on-quarter research and development expenses are outlined in the following table, with the expense primarily attributable to the continued progression of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and the reduced activity on legacy assets in infectious disease and oncology. It is anticipated that research and development expenses related to the Barinthus legacy assets in infectious disease and oncology will continue to decrease going forward as the clinical trials complete, and that research and development expenses related to the autoimmune program will continue at current levels or increase, as the clinical development continues. 1 In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology. The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented: VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs. General and Administrative Expenses: General and administrative expenses were $7.1 million in the second quarter of 2026, compared to $2.5 million for the first quarter of 2026. The increase of $4.6 million related primarily to an increase in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities and an increase in professional fees. Net Loss: For the second quarter of 2026, the Company generated a net loss attributable to its shareholders of $10.6 million or $(0.26) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $5.5 million, or $(0.14) per share on both basic and fully diluted bases for the first quarter of 2026. About Barinthus BioBarinthus Biotherapeutics (Nasdaq: BRNS) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the immunology and inflammation ("I&I") space. Helping patients and their families is the guiding principle at the heart of Barinthus Bio. We aim to achieve this by developing truly transformational and highly disease-specific immunotherapies. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in autoimmunity including: VTP-1000, which utilizes the Company's SNAP-Tolerance Immunotherapy (SNAP-TI) platform which is designed to treat people with celiac disease. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, positions the Company to navigate towards delivering treatments that improve the lives of people with autoimmunity. For more information, visit www.barinthusbio.com. Forward Looking StatementsThis press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding future expectations, plans and prospects, including product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, and the anticipated presentation of clinical data for our programs, the Company’s cash runway and cash burn, the Company’s ability to develop and advance current and future product candidates and programs, the Company’s ability to establish and maintain collaborations or strategic relationships, the Company’s ability to regain and maintain compliance with the continued listing requirements of Nasdaq, the proposed transaction with Clywedog, the expected timing of the closing of the proposed transaction, the ability of the parties to complete the proposed transaction considering the various closing conditions, the expected benefits of the proposed transaction, the competitive ability and position of the combined company after completion of the proposed transaction, the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results, including without limitation the expected cash runway of the combined company, and the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction. Any forward-looking statements in this press release 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, the Company’s ability to execute on strategy, regulatory developments, the risk that the Company may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, the Company’s ability to fund its operations and access capital, the Company’s cash runway, including the risk that the estimate of the cash runway may be incorrect, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect our business and the price of our securities, the risk that that the proposed transaction may involve unexpected costs, liabilities or delays, or divert management’s attention from our ongoing business operations, the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected, risks relating to the value of the combined company securities to be issued in the proposed transaction, the risk that the Company may be unable to regain compliance with the continued listing requirements of Nasdaq, the risks associated with global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, the disruptions in U.S. federal government operations, tariffs imposed by the U.S. and other countries, and the other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent annual report on Form 10-K and subsequent filings the Company may make with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Additional Information and Where to Find ItIn connection with the proposed transaction, the combined company has filed with the SEC and mailed or otherwise provided to Barinthus Bio's investors and security holders a registration statement on Form S-4 that contains a joint proxy statement/prospectus (the “Registration Statement”). BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY AND ANY OTHER DOCUMENTS FILED OR THAT WILL BE FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com. No Offer or SolicitationThis press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in the SolicitationClywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Registration Statement. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in the Registration Statement, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction is included in the Registration Statement. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com. Company contact:[email protected]

Investor releaseQuarter not tagged2026-04-30

Barinthus Bio Reports First Quarter 2026 Financial Results and Updates on Corporate Developments

GlobeNewswire
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…Read full document

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 company will be renamed “Clywedog Therapeutics Holdings, Inc.” and is expected to trade on the NASDAQ under the new ticker symbol “CLYD.” The combined company's estimated cash runway is expected to extend through 2027, supported by existing cash and additional investments by OrbiMed and TPAV, LLC, both existing shareholders in Clywedog, and new investors. First Quarter 2026 Financial Highlights Cash: As of March 31, 2026, cash, cash equivalents and restricted cash were $67.2 million, compared to $71.9 million as of December 31, 2025. The $4.7 million decrease was a result of the net cash used in operating activities of which $3.4 million was used for the development of the Company's pipeline and general corporate expenses, and a $1.4 million translational loss from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency. Based on standalone research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of the financial statements. Research and Development Expenses: Research and development expenses were $3.6 million for the three months ended March 31, 2026 compared to $8.3 million for the three months ended March 31, 2025. The decrease was primarily attributable to reduced activity in the Barinthus legacy asset clinical programs and the reduction in workforce. The quarter-on-quarter research and development expenses are outlined in the following table, with the expense primarily attributable to the continued progression of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and the reduced activity on legacy assets in infectious disease and oncology. It is anticipated that research and development expenses related to the Barinthus legacy assets in infectious disease and oncology will continue to decrease going forward as the clinical trials complete, and that research and development expenses related to autoimmune program will continue at current levels or increase, as the clinical development continues. 1 In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology. The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented: VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs. General and Administrative Expenses: General and administrative expenses were $2.5 million in the first quarter of 2026, compared to $12.6 million in 2025. The decrease of $10.1 million related primarily to an decrease in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities and an increase in professional fees attributable to strategic activity, partially offset by decreases in personnel-related expenses and other costs following the strategic prioritization in the prior year. Net Loss: For the first quarter of 2026, the Company generated a net loss attributable to its shareholders of $5.5 million, or $(0.14) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $19.6 million, or $(0.49) per share on both basic and fully diluted bases for the first quarter of 2025. About Barinthus Bio Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome autoimmunity and chronic infectious diseases. Helping people and their families living with serious diseases is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in autoimmunity including: VTP-1000, which utilizes the Company's SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, positions the Company to navigate towards delivering treatments that improve the lives of people with autoimmunity. For more information, visit www.barinthusbio.com. Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding future expectations, plans and prospects, including product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the Company’s cash runway and cash burn, the Company’s ability to develop and advance current and future product candidates and programs,the Company’s ability to establish and maintain collaborations or strategic relationships, the proposed transaction with Clywedog, the expected timing of the closing of the proposed transaction, the ability of the parties to complete the proposed transaction considering the various closing conditions, the expected benefits of the proposed transaction, the competitive ability and position of the combined company after completion of the proposed transaction, the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results, including without limitation the expected cash runway of the combined company, and the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction. Any forward-looking statements in this press release 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, the Company’s ability to execute on strategy, regulatory developments, the risk that the Company may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, the Company’s ability to fund its operations and access capital, the Company’s cash runway, including the risk that the estimate of the cash runway may be incorrect, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect our business and the price of our securities, the risk that that the proposed transaction may involve unexpected costs, liabilities or delays, or divert management’s attention from our ongoing business operations, the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected, risks relating to the value of the combined company securities to be issued in the proposed transaction, the risks associated with global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, the disruptions in U.S. federal government operations, tariffs imposed by the U.S. and other countries, and the other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent annual report on Form 10-K and subsequent filings the Company may make with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Additional Information and Where to Find It In connection with the proposed transaction, the combined company has filed with the SEC and mailed or otherwise provided to Barinthus Bio's investors and security holders a registration statement on Form S-4 that contains a joint proxy statement/prospectus (the “Registration Statement”). BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY AND ANY OTHER DOCUMENTS FILED OR THAT WILL BE FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com. No Offer or Solicitation This press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in the Solicitation Clywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Registration Statement. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in the Registration Statement, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction is included in the Registration Statement. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com. Company contact: [email protected]

Investor releaseQuarter not tagged2026-03-13

Barinthus Bio Reports Full Year 2025 Financial Results and Updates on Corporate Developments

GlobeNewswire
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…Read full document

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 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. In December 2025, Barinthus Bio announced that the single ascending dose portion of the Phase 1 AVALON trial (NCT06310291) of VTP-1000 for the treatment of celiac disease had been completed. A total of 18 patients were enrolled in three placebo-controlled cohorts of ascending doses. VTP-1000 was well tolerated at all dose levels with no treatment-related serious adverse events. Pharmacodynamic analyses, including IL-2 response, confirmed T cell recognition of VTP-1000 in celiac patients across cohorts. In February 2026, Barinthus Bio announced it had entered into an amendment to the definitive merger agreement with Clywedog to update the exchange ratio framework to provide additional flexibility in finalizing the transaction terms and to revise certain minimum cash requirements to reflect anticipated transaction timing. All other material terms remain unchanged. 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 in the second quarter of 2026. Upon the closing of the transaction, the combined company will be renamed “Clywedog Therapeutics Holdings, Inc.” and is expected to trade on the NASDAQ under the new ticker symbol “CLYD.” The combined company's estimated cash runway is expected to extend through 2027, supported by existing cash and additional investments by OrbiMed and TPAV, LLC, both existing shareholders in Clywedog, and new investors. 2025 Financial Highlights Cash: As of December 31, 2025, cash, cash equivalents and restricted cash were $71.9 million, compared to $112.4 million as of December 31, 2024. The $40.5 million decrease was a result of the net cash used in operating activities of which $48.0 million was used for the development of the Company's pipeline and general corporate expenses, offset by a $7.0 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency and $0.4 million in proceeds from the sale of equipment in the U.K. following the closure of the site. Based on standalone research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of the financial statements. Research and Development Expenses: Research and development expenses were $25.6 million in 2025 compared to $42.2 million in 2024. The decrease was primarily attributable to reduced activity in the Barinthus legacy asset clinical programs and the reduction in workforce. The year-on-year research and development expenses are outlined in the following table, with the expense primarily attributable to the continued progression of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and the reduced activity on legacy assets in infectious disease and oncology. It is anticipated that research and development expenses related to the Barinthus legacy assets in infectious disease and oncology will continue to decrease going forward as the clinical trials complete, and that research and development expenses related to autoimmune program will continue at current levels or increase, as the clinical development continues. 1 In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology. The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented: VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs. General and Administrative Expenses: General and administrative expenses were $40.8 million in 2025, compared to $29.7 million in 2024. The increase of $11.1 million related primarily to an increase in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities and an increase in professional fees attributable to strategic activity, partially offset by decreases in personnel-related expenses and other costs following the strategic prioritization in the year. Impairment of Intangible Assets: Impairment of intangible assets expense was $4.7 million in 2025, compared to nil in 2024. The anticipated valuation of the company, as implied by the definitive merger agreement with Clywedog entered into in the year, was less than the carrying value of the net assets and therefore resulted in an impairment of the intangible assets in the third quarter of 2025. Net Loss: For the financial year 2025, the Company generated a net loss attributable to its shareholders of $66.5 million, or $(1.64) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $61.1 million, or $(1.55) per share on both basic and fully diluted bases for the financial year 2024. About Barinthus Bio Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome autoimmunity and chronic infectious diseases. Helping people and their families living with serious diseases is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in autoimmunity including: VTP-1000, which utilizes the Company's SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, positions the Company to navigate towards delivering treatments that improve the lives of people with autoimmunity. For more information, visit www.barinthusbio.com. Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding future expectations, plans and prospects, including product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, anticipated regulatory filings and approvals, the Company’s cash runway and cash burn, the Company’s ability to develop and advance current and future product candidates and programs,the Company’s ability to establish and maintain collaborations or strategic relationships, the proposed transaction with Clywedog, the exchange of equity interests contemplated by the merger agreement, the issuance of shares of common stock of the newly formed combined company contemplated by the merger agreement, including the final exchange ratios, the anticipated percentage of the combined company securities to be received by Clywedog and Barinthus Bio shareholders in connection with the proposed transaction, the expected timing of the closing of the proposed transaction, the ability of the parties to complete the proposed transaction considering the various closing conditions, the expected benefits of the proposed transaction, the competitive ability and position of the combined company after completion of the proposed transaction, the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results, including without limitation the expected cash runway of the combined company, and the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction. Any forward-looking statements in this press release 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, the Company’s ability to execute on strategy, regulatory developments, the risk that the Company may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, the Company’s ability to fund its operations and access capital, the Company’s cash runway, including the risk that the estimate of the cash runway may be incorrect, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect our business and the price of our securities, the risk that that the proposed transaction may involve unexpected costs, liabilities or delays, or divert management’s attention from our ongoing business operations, the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected, risks relating to the value of the combined company securities to be issued in the proposed transaction, the risks associated with global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, the disruptions in U.S. federal government operations, tariffs imposed by the U.S. and other countries, and the other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent annual report on Form 10-K and subsequent filings the Company may make with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Additional Information and Where to Find It In connection with the proposed transaction, the combined company plans to file with the SEC and mail or otherwise provide to Barinthus Bio's investors and security holders a registration statement on Form S-4 that will contain a joint proxy statement/prospectus (the “Registration Statement”). BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com. No Offer or Solicitation This press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in the Solicitation Clywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Barinthus Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 13, 2026. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in such Annual Report on Form 10-K, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction will be included in the Registration Statement relating to the proposed transaction when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com. 1 Includes license revenue from related parties for the year ended December 31, 2025 of nil (year ended December 31, 2024: $15.0 million). Company contact: [email protected]

Investor releaseQuarter not tagged2025-11-07

Barinthus Bio Reports Third Quarter 2025 Financial Results and Updates on Corporate Developments

GlobeNewswire
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…Read full document

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 Holdings, Inc.” and is expected to trade on the NASDAQ under the new ticker symbol “CLYD.” The transaction is expected to close in the first half of 2026, with the combined company's estimated cash runway to extend through 2027 supported by existing cash and additional investments by OrbiMed and TPAV, LLC, both existing shareholders in Clywedog, and new investors. 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. Third Quarter 2025 Financial Highlights Cash: As of September 30, 2025, cash, cash equivalents and restricted cash were $75.7 million, compared to $87.8 million as of June 30, 2025. The $12.1 million decrease was a result of the net cash used in operating activities of which $10.7 million was used for the development of the Company's pipeline and general corporate expenses, and a $1.8 million translational loss from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency, offset by $0.5 million in proceeds received from the sale of U.K. laboratory equipment. Based on standalone research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027. Research and Development Expenses: Research and development expenses were $5.4 million in the third quarter of 2025 compared to $8.0 million for the second quarter of 2025. The decrease was attributable to reduced activity in the infectious disease and oncology clinical programs, a reduction in workforce and the impact of closing the U.K. laboratory in the third quarter of 2025, resulting in a reduction in facility and other indirect costs being allocated to research and development. The quarter-on-quarter research and development expenses per program are outlined in the following table, with the expense primarily attributable to completion and follow up for two Phase 2 clinical trials of VTP-300, and the continued progression of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease. It is anticipated that research and development expenses related to the legacy programs in infectious disease and oncology will continue to decrease going forward as the ongoing clinical trials complete, and that research and development expenses related to autoimmune programs will continue at current levels or increase, as the clinical development continues. 1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”)). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative. 2 This includes $0.1 million for the three months ended September 30, 2025 and June 30,2025, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI. General and Administrative Expenses: General and administrative expenses were $5.2 million for the third quarter of 2025, compared to $15.4 million for the second quarter of 2025. The decrease of $10.2 million related primarily to a reduction in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities. Impairment of Long-Lived Assets Expense: Impairment of long-lived assets expense was $4.7 million for the third quarter of 2025, compared to nil for the second quarter of 2025. The anticipated valuation of the company, as implied by the definitive merger agreement with Clywedog entered into in the period, is less than the carrying value of the net assets and therefore resulted in an impairment of intangible assets. Net Loss: For the third quarter of 2025, the Company generated a net loss attributable to its shareholders of $14.6 million, or $(0.36) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $21.1 million, or $(0.52) per share on both basic and fully diluted bases for the second quarter of 2025. About Barinthus Bio Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome autoimmunity and chronic infectious diseases. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in autoimmunity including: VTP-1000, utilizing the Company's SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the Company to navigate towards delivering treatments that improve the lives of people with autoimmunity. For more information, visit www.barinthusbio.com. Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding future expectations, plans and prospects, including product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, anticipated regulatory filings and approvals, the Company’s cash runway and cash burn, the Company’s ability to develop and advance current and future product candidates and programs, the Company’s ability to establish and maintain collaborations or strategic relationships, the proposed transaction with Clywedog, the exchange of equity interests contemplated by the merger agreement, the issuance of shares of common stock of the newly formed combined company contemplated by the merger agreement, including the final exchange ratios, the anticipated percentage of the combined company securities to be received by Clywedog and Barinthus Bio shareholders in connection with the proposed transaction, the expected timing of the closing of the proposed transaction, the ability of the parties to complete the proposed transaction considering the various closing conditions, the expected benefits of the proposed transaction, the competitive ability and position of the combined company after completion of the proposed transaction, the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results, including without limitation the expected cash runway of the combined company, and the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction. Any forward-looking statements in this press release 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, the Company’s ability to execute on strategy, regulatory developments, the risk that the Company may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, the Company’s ability to fund its operations and access capital, the Company’s cash runway, including the risk that the estimate of the cash runway may be incorrect, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect our business and the price of our securities, the risk that that the proposed transaction may involve unexpected costs, liabilities or delays, or divert management’s attention from our ongoing business operations, the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected, risks relating to the value of the combined company securities to be issued in the proposed transaction, the risks associated with global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, the continuing U.S. federal government shutdown, tariffs imposed by the U.S. and other countries, and the other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent annual report on Form 10-K and subsequent filings the Company may make with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Additional Information and Where to Find It In connection with the proposed transaction, the combined company plans to file with the SEC and mail or otherwise provide to Barinthus Bio's investors and security holders a registration statement on Form S-4 that will contain a joint proxy statement/prospectus (the “Registration Statement”). BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com. No Offer or Solicitation This press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in the Solicitation Clywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Barinthus Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 20, 2025, and Barinthus Bio's definitive proxy statement on Schedule 14A for its 2025 annual meeting of stockholders, which was filed with the SEC on April 25, 2025. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in such Annual Report on Form 10-K, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction will be included in the Registration Statement relating to the proposed transaction when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com. 1 Includes license revenue from related parties for the three and nine months ended September 30, 2025 of nil (three and nine months ended September 30, 2024: $15.0 million). Media contacts: Alexis Feinberg Vice President ICR Healthcare [email protected] Jonathan Edwards Associate Partner ICR Healthcare [email protected] Company contact: [email protected]

Investor releaseQuarter not tagged2025-08-07

Barinthus Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments

GlobeNewswire
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…Read full document

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 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 development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027. Research and Development Expenses: Research and development expenses were $8.0 million in the second quarter of 2025 compared to $8.3 million for the first quarter of 2025, with the decrease attributable to a reduction in preclinical activity and a reduction in workforce. The quarter-on-quarter research and development expenses per program are outlined in the following table, with the expense primarily attributable to completion and presentation of preliminary results data from the two phase 2 clinical trials of VTP-300 that were presented at the European Association for the Study of the Liver (“EASL”) Congress 2025 in May, and the continued progression of the phase 1 AVALON clinical trial of VTP-1000 in celiac disease. It is anticipated that research and development expenses related to the legacy programs in infectious disease and oncology will reduce going forward as the ongoing clinical trials complete, and that research and development expenses related to autoimmune programs will continue or increase, as the clinical development continues. 1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative. 2 This includes $0.1 million and $0.2 million for the six months ended June 30, 2025 and 2024, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI. General and Administrative Expenses: General and administrative expenses were $15.4 million for the second quarter of 2025, compared to $12.6 million for first quarter of 2025. 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. Net Loss: For the second quarter of 2025, the Company generated a net loss attributable to its shareholders of $21.1 million, or $(0.52) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $19.7 million, or $(0.49) per share on both basic and fully diluted bases for the first quarter of 2025. About Barinthus Bio Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases. Our guiding principle at the heart of Barinthus Bio is to help patients and their families by developing truly transformational and highly disease-specific immunotherapies that are potentially curative. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to a specific location to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our 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. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com. Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway and cash burn, our ability to develop and advance our current and future product candidates and programs, and our ability to establish and maintain collaborations or strategic relationships. Any forward-looking statements in this press release are based on our 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, tariffs imposed by the U.S. and other countries and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. IR contact: Kevin Gardner Managing Director LifeSci Advisors +1 617-283-2856 [email protected] Media contacts: Alexis Feinberg Vice President ICR Healthcare [email protected] Jonathan Edwards Associate Partner ICR Healthcare [email protected] Company contact: [email protected]

Investor releaseQuarter not tagged2025-05-07

Barinthus Bio Reports First Quarter 2025 Financial Results and Updates on Corporate Developments

GlobeNewswire
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 CH…Read full document

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 ongoing standard of care nucleos(t)ide analogue (“NUC”) therapy. HBV003 data: VTP-300 and Low-dose NivolumabThe HBV003 study is evaluating the safety, immunogenicity and disease modifying activity of three different dosing regimens of VTP-300 in combination with low-dose nivolumab (“LDN”), an anti-PD-1 monoclonal antibody. The primary analysis showed; In CHB participants with hepatitis B surface antigen (“HBsAg”) levels of <200 IU/mL, meaningful reductions in HBsAg (>1 log decline) occurred soon after dosing on Day 29 in all treatment groups and were maintained to Day 169. In the two best treatment arms HBsAg declines of ≥1 log at Day 169 were observed in 33% (15/45) of participants with HBsAg ≤200 IU/mL at baseline, and 22% (10/45) of participants achieved HBsAg loss at any timepoint. 71% (48/68) of participants met the criteria for discontinuation of NUC therapy at day 169; and although NUC discontinuation was optional; two participants who did discontinue NUCs achieved functional cure and one seroconverted to HBsAb positivity. Treatment with VTP-300 in combination with LDN was generally well-tolerated, with no serious adverse events reported. The primary analysis confirms observations from previous interim data, which indicated that stronger responses occurred in participants treated with the combination of VTP-300 and LDN (Groups 1 and 2). IM-PROVE II data: imdusiran and VTP-300The IM-PROVE II study is evaluating the combination of imdusiran (“IDR”), Arbutus’ RNAi therapeutic, followed by Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, with or without LDN. The end of study data showed: 25% (2/8) of participants with starting baseline HBsAg levels less than 1000 IU/mL receiving the combination of IDR, VTP-300 and LDN achieved functional cure. 3 of 13 participants (23%) receiving IDR+VTP-300+LDN had undetectable HBsAg levels at week 48; all (3/3) of participants with HBsAg loss seroconverted. Treatment with IDR and VTP-300 was generally well-tolerated, with no serious adverse events or treatment discontinuations reported. Corporate Updates In January 2025, Barinthus Bio announced a strategic business refocus and restructuring to prioritize immunology and inflammation indications, including antigen-specific immune tolerance. Barinthus Bio will not invest in VTP-300 for chronic hepatitis B beyond the completion of the ongoing Phase 2b HBV003 clinical trial and will seek potential partners to be able to take advantage of its differentiated ability to achieve sustained HBsAg loss and functional cure in patients with low levels of HBsAg. Partners are also being sought for the other assets that are based upon the viral vector platforms. Upcoming Milestones Celiac Disease (VTP-1000): Single ascending dose data from the Phase 1 AVALON clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease expected in the third quarter of 2025. Initiation of the multiple ascending dose portion of the Phase 1 AVALON clinical trial is expected in the second half of 2025. Prostate Cancer (VTP-850): Topline results from the Phase 1 PCA001 clinical trial evaluating safety and efficacy of VTP-850 in men with rising prostate-specific antigen after definitive local therapy for prostate cancer were received and analysis is ongoing. Data will be used to support partnering efforts for VTP-850. First Quarter 2025 Financial Highlights Cash: As of March 31, 2025, cash, cash equivalents and restricted cash was $100.6 million, compared to $112.4 million as of December 31, 2024. The $11.8 million decrease is a result of the net cash used in operating activities of $14.9 million for the development of our pipeline and ongoing clinical trials, offset by a $3.1 million gain on foreign exchange on cash, cash equivalents and restricted cash. Based on current research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027. Research and Development Expenses: Research and development expenses were $8.3 million for the three months ended March 31, 2025 compared to $11.1 million for the three months ended March 31, 2024, with the decrease attributable to the stage of clinical development of the pipeline assets, a reduction in preclinical activity and a reduction in workforce when compared to the prior year. The year-on-year research and development expenses per program are outlined in the following table. It is anticipated that research and development expenses related to the legacy programs in infectious disease and oncology will reduce going forward, as the ongoing clinical trials complete, and that research and development expenses related to autoimmune programs will continue or increase, as the clinical development continues. 1 This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200 HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”). Expenses relating to these programs were previously presented separately, but are now aggregated for the prior period comparative. 2 This includes $0.07 million and $0.14 million for the three months ended March 31, 2025 and 2024, respectively, of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI. General and Administrative Expenses: General and administrative expenses were $12.6 million in the first quarter of 2025, compared to $6.0 million in 2024. The increase of $6.6 million relates primarily to a loss of $4.4 million on foreign exchange in 2025, compared to a gain of $1.2 million in 2024 due to fluctuations between the pound sterling and the US dollar during the year. The remaining increase is attributable to an increase in depreciation of U.K. assets as a result of the expected closure of the U.K. site, and an increase in personnel costs as a result of the workforce reduction. Net Loss: For the first quarter of 2025, the Company generated a net loss attributable to its shareholders of $19.6 million, or $(0.49) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $15.5 million, or $(0.40) per share on both basic and fully diluted bases for the first quarter of 2024. About Barinthus BioBarinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases. Our guiding principle at the heart of Barinthus Bio is to help patients and their families by developing truly transformational and highly disease-specific immunotherapies that are potentially curative. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to a specific location to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our 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. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com. Forward Looking StatementsThis press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway and cash burn, our ability to develop and advance our current and future product candidates and programs, our ability to establish and maintain collaborations or strategic relationships and the terms and timing of the restructuring and related activities. Any forward-looking statements in this press release are based on our 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, tariffs imposed by the U.S. and other countries and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. IR contact:Kevin GardnerManaging DirectorLifeSci Advisors+1 [email protected] Media contacts:Alexis Feinberg Vice President ICR Healthcare [email protected] Jonathan EdwardsAssociate PartnerICR [email protected] Company contact:[email protected]

Investor releaseQuarter not tagged2025-03-20

Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments

GlobeNewswire
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 enc…Read full document

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 results from two Phase 2 trials in our chronic hepatitis B (“CHB”) program demonstrating that VTP-300 contributed to the achievement of undetectable HBsAg levels in eight participants, with two participants meeting functional cure criteria. Further Phase 2 data are anticipated in the second quarter of 2025, which are expected to strengthen VTP-300’s market positioning as a component of a functional cure for CHB.” 2024 Corporate MilestonesClinical developments Celiac Disease (VTP-1000) In April 2024, Barinthus Bio received clearance from the U.S. Food and Drug Administration and Australian regulatory authorities on an Investigational New Drug application to progress VTP-1000 in a first in human clinical trial in celiac disease. In September 2024, Barinthus Bio initiated the first-in-human, Phase 1 AVALON trial for VTP-1000 in celiac disease. The AVALON trial aims to enroll 42 participants with celiac disease and will be conducted in two parts: the first part, a randomized double-blind placebo controlled single ascending dose, followed by the second part, a randomized double-blind placebo-controlled multiple ascending dose and incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients’ exposure to gluten. Chronic Hepatitis B (VTP-300) In June 2024, Barinthus Bio presented interim data from the two Phase 2 trials of VTP-300, which achieved 19% undetectable HBsAg levels across both studies, indicating potential rates of functional cure. The majority of patients who were assessed reached very low levels of HBsAg and eligibility for nucleos(t)ide discontinuation. In October 2024, the Company completed enrollment of the Phase 2b HBV003 clinical trial for VTP-300 in CHB. In November 2024 Barinthus Bio reported positive updated interim data from the Phase 2b HBV003 clinical trial for VTP-300 showing that as of the data cut off, eight participants achieved complete HBsAg loss (defined as HBsAg levels below the lower limit of quantitation [<LLOQ, 0.05 IU/mL]) and two participants met the criteria for functional cure. Uniquely, two of the eight participants with HBsAg loss, including one of those who met functional cure criteria, developed anti-hepatitis B antibodies that they did not have before. The data were presented as an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024. Barinthus Bio announced interim data from the Phase 2a IM-PROVE II clinical trial in collaboration with Arbutus Biopharma Corporation (“Arbutus”). Participants received imdusiran followed by VTP-300 and low-dose nivolumab. Results indicated that Group C participants receiving nivolumab experienced increased rates of HBsAg loss at Week 48 (3/13) compared to Group A and B participants who received imdusiran and VTP-300 or placebo. These data were presented in a poster at AASLD. Prostate Cancer (VTP-850) In October 2024, Barinthus Bio completed enrollment of 22 participants in the Phase 1 PCA001 clinical trial of VTP-850 for prostate cancer. High-Risk Human Papillomavirus (VTP-200) In April 2024, Barinthus Bio announced topline results from the Phase 1b/2 APOLLO dose-ranging trial (also known as HPV001) of VTP-200 in women aged 25-55 with low-grade cervical lesions associated with persistent high-risk human papillomavirus (HPV) infection. Corporate Updates In May 2024, Barinthus Bio appointed physician, Leon Hooftman, M.D., as Chief Medical Officer, effective as of June 3, 2024. In November 2024, Geoffrey Lynn, M.D., Ph.D. was promoted to Chief Scientific Officer following the departure of Nadège Pelletier, Ph.D. In January 2025, Barinthus Bio announced a strategic business refocus and restructuring to prioritize immunology and inflammation indications, including antigen-specific immune tolerance. As part of the restructuring, two executive leadership team members based in the U.K., the Chief Operating Officer, Graham Griffiths, and Chief Financial Officer, Gemma Brown, will leave the Company following a greater strategic focus on U.S. operations. Barinthus Bio will not invest in VTP-300 for chronic hepatitis B beyond the completion of the ongoing Phase 2b HBV003 clinical trial and will seek potential partners able to take advantage of its differentiated ability to achieve sustained HBsAg loss and functional cure in patients with low levels of HBsAg. Upcoming MilestonesCeliac Disease (VTP-1000): Single ascending dose data from the Phase 1 AVALON clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease expected in the third quarter of 2025. Initiation of the multiple ascending dose portion of the Phase 1 AVALON clinical trial is expected in the second half of 2025. Chronic Hepatitis B (VTP-300): Topline results from the Phase 2b HBV003 clinical trial evaluating additional dosing of VTP-300 and low-dose nivolumab timing in people with chronic hepatitis B infection are expected in the second quarter of 2025. Topline results from the Phase 2a IM-PROVE II clinical trial evaluating VTP-300, low-dose nivolumab and Arbutus’ imdusiran in people with chronic hepatitis B infection are expected in the second quarter of 2025. Prostate Cancer (VTP-850): Topline results from the Phase 1 PCA001 clinical trial evaluating safety and efficacy of VTP-850 in men with rising prostate-specific antigen after definitive local therapy for prostate cancer (i.e., biochemical recurrence) are expected in the second quarter of 2025. 2024 Financial Highlights Cash: As of December 31, 2024, cash, cash equivalents and restricted cash was $112.4 million, compared to $142.1 million as of December 31, 2023. The net cash used in operating activities was $28.9 million, primarily resulting from development of our pipeline and ongoing clinical trials, offset by revenue of $15.0 million. Based on current research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into 2027. Revenue: Revenue was $15.0 million in 2024 compared to $0.8 million in 2023 and was comprised of the Company’s share of royalties received by Oxford University Innovation as a result of commercial sales of Vaxzevria® by AstraZeneca. There is no expectation of additional payments. Research and Development Expenses: Research and development expenses were $42.2 million in 2024 compared to $44.9 million in 2023, with the decrease mainly attributable to a reduction in expenses from VTP-200 (HPV) which completed in the first quarter of 2024 and VTP-850 (prostate cancer) which completed enrollment in the third quarter of 2024, partially offset by an increase in spending on earlier stage programs in tolerance indications. The year-on-year R&D expense per program is outlined in the following table. It is anticipated that research and development expenses related to legacy programs in infectious disease and oncology will reduce going forward, as the ongoing trials complete. 1 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical. Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we have initiated the clinical trial for VTP-1000 Celiac. 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK. 3 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI). 4 This includes $0.9 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI. General and Administrative Expenses: General and administrative expenses were $29.7 million in 2024, compared to $39.8 million in 2023. The decrease of $10.1 million relates primarily to a gain of $2.4 million on foreign exchange in 2024, compared to a loss of $7.8 million in 2023 due to fluctuations between the pound sterling and the US dollar during the year. Goodwill Impairment Expense: For the years ended December 31, 2024 and 2023, goodwill impairment expense was $12.2 million and nil, respectively, with the increase pertaining to the impairment assessment performed in the fourth quarter of 2024 based on the expected utilization of Company assets and external market conditions. Net Loss: For the financial year 2024, the Company generated a net loss attributable to its shareholders of $61.1 million, or $(1.55) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $73.3 million, or $(1.91) per share on both basic and fully diluted bases for 2023. About Barinthus BioBarinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases. Our guiding principle at the heart of Barinthus Bio is to help patients and their families by developing truly transformational and highly disease-specific immunotherapies that are potentially curative. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to a specific location to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our 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. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com. Forward Looking StatementsThis press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway, our ability to develop and advance our current and future product candidates and programs, and the terms and timing of the restructuring and related activities. Any forward-looking statements in this press release are based on our 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 from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. 1  All license revenue is from related parties and is generated in the United Kingdom for the years ended December 31, 2024 and 2023. IR contact:Kevin GardnerManaging DirectorLifeSci Advisors+1 [email protected] Media contacts:Alexis Feinberg Vice President ICR Healthcare [email protected] Jonathan EdwardsAssociate PartnerICR [email protected] Company contact:[email protected]

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook