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Barinthus Bio and Clywedog Merger Outlook Positive
"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."
Barinthus Biotherapeutics Updates on VTP-1000 Phase 1 Trial Progress
Barinthus Biotherapeutics announced an update on its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. In the single ascending dose, SAD, portion of the trial, VTP-1000 was well tolerated with no treatment-related serious adverse events, SAEs, and a dose-dependent pharmacological effect observed. The multiple ascending dose, MAD, portion of the trial, which includes a gluten challenge, is ongoing with data expected in the second half of 2026. The SAD portion of the Phase 1 AVALON trial enrolled 18 patients in three placebo-controlled cohorts of ascending doses. VTP-1000 was well tolerated at all dose levels with no treatment-related SAEs. Pharmacological data collected showed a dose-dependent effect.
Barinthus Biotherapeutics announces Q3 earnings per share of 36 cents, compared to a loss of 21 cents in the same period last year.
"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."
Barinthus Bio and Clywedog Finalize Merger Agreement
Barinthus Biotherapeutics and Clywedog Therapeutics entered into a definitive merger agreement to combine in an all-stock transaction. The newly combined company will advance a novel 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, 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 supported by existing cash and additional investments by OrbiMed and Torrey Pines Investment, both existing shareholders in Clywedog, and new investors. The combined company's diversified pipeline will comprise three assets with broad potential for treating metabolic and autoimmune diseases, with an initial focus on three on-going programs in Type 1 diabetes, Type 2 diabetes and celiac disease. The combined company will be led by Bill Enright, CEO, Dr. Leon Hooftman, CMO, and Nick Fullenkamp, VP Corporate Development from Barinthus Bio, as well as Dr. Iain Dukes and Dr. Nikolay Savchuk, currently serving as Clywedog's CEO and COO, respectively. The combined company's Board of Directors will be led by Executive Chairman, Dr. Iain Dukes and will consist of designees of each of Clywedog and Barinthus Bio. Under the terms of the agreement, which was unanimously approved by the Boards of Directors of each of the companies, and subject to adjustment as provided therein, shareholders of Barinthus Bio will receive one share of common stock in the new combined company for each American Depositary Share or ordinary share owned, and each stockholder of Clywedog will receive 4.358932 shares of common stock in the new combined company for each common or preferred share owned. Prior to the closing of the transaction, the combined company may commence a partial tender offer to acquire shares of the combined company then issued and outstanding and held by Barinthus Bio shareholders for an aggregate offer price of up to $27M. Upon completion of the transaction, the shareholders of Barinthus Bio are expected to own approximately 34%, and the stockholders of Clywedog are expected to own approximately 66% of the combined company on a fully diluted basis, based on the respective valuations of Barinthus Bio and Clywedog as of the execution of the merger agreement. Upon the closing of the transaction, the combined company will be renamed "Clywedog Therapeutics, Inc." and is expected to trade on the Nasdaq Global Market under the new ticker symbol "CLYD." As a result of the transaction, Barinthus Bio ADSs will no longer trade on NASDAQ. The transaction, which is subject to approval by both companies' stockholders as well as to customary closing conditions and regulatory approvals, is expected to close in the first half of 2026. The combined company will be supported by existing cash as well as additional investments by OrbiMed and Torrey Pines Investment, both existing shareholders in Clywedog, and new investors.
Barinthus Biotherapeutics sees cash runway into 2027
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.
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