BRNS News & Events

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.

"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 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.