• The combined company, Clywedog Therapeutics, will bring a portfolio that includes three differentiated, clinical stage product candidates which are being studied for the prevention/reversal of Type 1 and Type 2 Diabetes and the treatment of Celiac Disease.
  
  
• Four key value-driving milestones are expected within 18 months, including clinical proof of concept in multiple indications. Estimated cash runway for combined company extends through 2027.
  
  
• Transaction projected to close in the first half of 2026. The combined company will be backed by OrbiMed and Torrey Pines and is expected to trade under the NASDAQ symbol “CLYD.”

Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio”), an immunology and inflammation company focused on developing therapies that promote immune tolerance, and Clywedog Therapeutics, Inc. (“Clywedog”), a private company advancing novel breakthrough medicines in diabetes,  announced that they have 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 LLC, both existing shareholders in Clywedog, and new investors.

“We believe that the combination of Barinthus Bio and Clywedog will create immediate value and long-term upside for all stakeholders by diversifying our pipeline and increasing the number of meaningful clinical milestones. The combined team will bring a deep scientific understanding of metabolic and autoimmune spaces together with strong clinical development experience, positioning us well to execute for patients and shareholders,” said Bill Enright, Chief Executive Officer of Barinthus Bio, who will serve as Chief Executive Officer of the combined company. “I am honored to have the opportunity to lead an exceptional team and am truly excited to advance our highly differentiated pipeline of disease modifying therapies for Type 1 and Type 2 diabetes, and celiac disease."

Dr. Iain Dukes, a venture partner at OrbiMed who will serve as Executive Chairman of Clywedog Therapeutics after the transaction closes, commented, “I am excited to be part of the combined company as we strive to develop potentially disease-modifying therapies for diabetes and autoimmune disorders.”

Combined Company Portfolio

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 (“T1D”), Type 2 diabetes (“T2D”) and celiac disease.

CLY-101 (Balomenib): potential for long-term glucose control for T2D and restoring insulin production for T1D

• Through reversible protein-protein interaction inhibition of menin, CLY101 stimulates the regeneration of pancreatic islets responsible for the secretion of multiple glucose-regulating hormones, including insulin and glucagon, to improve the de novo production of insulin
  
  
• Potential to work synergistically with blockbuster GLP-1 agonists as a result of increased GLP-1 receptor expression and to offer a comprehensive approach to diabetes management through glycemic control and weight management
  
  
• Completed Phase 1 study demonstrated safety and tolerability in healthy volunteers that provided PK/PD data to support the potential use for treatment of T1D and T2D

• Two Phase 2A proof of principle studies planned for treating patients with T2D and T1D (Stage 3)

Upcoming CLY-101 milestones:

• Phase 2A proof of principle study in Type 2 diabetes patients first top-line data readout expected the second half of 2026
  
  
• Phase 2A proof of principle study in Type 1 diabetes (Stage 3) patients first top-line data readout expected the second half of 2026

CLY-201: potential for halting the inflammation which leads to Type 1 diabetes

• A highly-selective TYK2 inhibitor that targets T-cell mediated inflammation, which destroys insulin-secreting pancreatic beta cells, an underlying cause of T1D
  
  
• Phase 1 single and multiple ascending dosing studies (“SAD/MAD”) completed in healthy volunteers with no significant adverse events at exposure levels predicted to show efficacy
  
  
• Phase 2 study planned for Type 1 diabetes (Stage 2) patients to evaluate safety, glycemic control and circulating C-peptide levels

Clywedog’s approach for Type 1 diabetes also provides the potential to pursue a multi-component regimen, synergistically combining its assets to first prevent or slow inflammation and then stimulate beta islet production to promote cell production of insulin.

VTP-1000: a highly differentiated antigen-specific tolerance immunotherapy designed to prevent or reduce symptoms following gluten exposure in patients with celiac disease

• Five out of six patients enrolled in the last cohort of the SAD portion of the Phase 1 AVALON study
  
  
• Initiated the multiple MAD portion of the study, which includes a gluten challenge

Upcoming VTP-1000 milestones:

• Topline data from the SAD portion of the Phase 1 AVALON study expected Q4 2025
  
  
• Topline data from the MAD portion of the Phase 1 AVALON is expected in mid-2026

Management and Organization

The combined company will be led by Bill Enright, Chief Executive Officer, Dr. Leon Hooftman, Chief Medical Officer, and Nick Fullenkamp, Vice President Corporate Development from Barinthus Bio, as well as Dr. Iain Dukes and Dr. Nikolay Savchuk, currently serving as Clywedog’s Chief Executive Officer and Chief Operating Officer, respectively.

The combined company’s Board of Directors will be led by Executive Chairman, Dr. Iain Dukes, MA, D.Phil (current Chief Executive Officer of Clywedog and a venture partner at OrbiMed), and will consist of designees of each of Clywedog and Barinthus Bio.

Transaction Details

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 (“ADS”) 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 $27 million.

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 LLC, both existing shareholders in Clywedog, and new investors.