BioCardia (BCDA) investor relations material

Strategic overview and pipeline updates

• Barinthus Biotherapeutics is transitioning from vaccines to autoimmune therapies, leveraging its SNAP-TI nanoparticle platform for targeted antigen delivery, with VTP-1000 as its lead candidate for celiac disease in phase I trials.

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

• VTP-1000’s phase I single ascending dose portion showed a dose-dependent response; the multiple ascending dose portion is enrolling and expected to report data in the second half of 2024.

• The SNAP-TI platform allows for co-delivery of immunomodulators, such as rapamycin, to modulate T cell responses and reduce reactogenicity.

• The celiac disease market is large and growing, with current treatment limited to gluten-free diets, highlighting significant unmet need.

Clinical development and financial outlook

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

• CLY-201 targets type 1 diabetes by inhibiting pathways that destroy beta islet cells, with a phase I-B/II-A trial planned and data anticipated in 2027.

• The company holds approximately $66 million in cash and, with support from major investors, is funded through key milestones for all three programs into 2027.

• The merger process involves procedural steps with shareholder and court approvals, but no major hurdles are anticipated.

• No additional asset acquisitions are planned until after the merger, with focus on advancing the current pipeline.