BioCardia (BCDA) A.G.P.'s Annual Virtual Healthcare Conference summary

Strategic overview and merger plans

• Barinthus Biotherapeutics is transitioning from vaccines to autoimmune therapies, leveraging its SNAP-TI nanoparticle platform for targeted antigen delivery.

• The company is in the process of merging with Clywedog Therapeutics, aiming to add diabetes-focused assets CLY-101 (menin inhibitor) and CLY-201 (TYK2 inhibitor) to its portfolio, with the merger expected to close by mid-2024.

• The merger process involves shareholder voting and UK court procedures, with no major hurdles anticipated.

• Post-merger, the focus will be on advancing three main assets, with additional asset acquisition on hold until integration is complete.

Pipeline progress and clinical milestones

• Lead program VTP-1000 for celiac disease is in a phase I trial (AVALON), with single ascending dose data showing dose-dependent responses and multiple ascending dose data expected in the second half of 2024.

• VTP-1000 uses the SNAP-TI platform, incorporating rapamycin to modulate immune response and reduce reactogenicity.

• CLY-101 is in a phase I-B trial in Australia for diabetes, focusing on safety, A1C, C-peptide, and weight loss, with data expected in Q3 2024.

• CLY-201, a TYK2 inhibitor, targets type 1 diabetes by inhibiting pathways involved in beta islet cell destruction, with phase I-B/II-A trials planned and data anticipated in 2027.

• The company has sufficient cash to fund operations and reach key milestones through 2027, supported by commitments from major investors.

Market opportunity and future outlook

• VTP-1000 addresses a growing celiac disease market, affecting 1% of the global population and expanding at 7.5% annually.

• The celiac disease field is largely open, with few competitors and significant unmet need beyond gluten-free diets.

• Both diabetes assets offer differentiated mechanisms, with potential for combination therapy in the future.

• The company is positioned to deliver multiple clinical readouts and advance its autoimmune and metabolic disease pipeline over the next three years.