Biomea Fusion (BMEA) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Strategic approach to diabetes and obesity

• Focus on addressing the root cause of diabetes by restoring beta cell function, rather than only lowering blood sugar levels.

• Targeting severe insulin-deficient diabetes (SIDD) patients before insulin dependency to reduce healthcare burden.

• Collaboration with regulators and payers to define patient segments using standard inclusion/exclusion criteria.

• Ongoing phase II studies in both type 1 and type 2 diabetes, with protocols aligned to regulatory expectations.

• Obesity program BMF-650 aims to improve safety, titration, and efficacy over current oral GLP-1 receptor agonists.

Clinical trial progress and data highlights

• Icova­menib demonstrated significant A1C reduction in GLP-1 non-responders and increased C-peptide in type 1 diabetes patients.

• Type 1 diabetes trial showed a 52% increase in C-peptide after 12 weeks, including patients up to three years post-diagnosis.

• Phase II studies for icovamenib and BMF-650 are enrolling, with data readouts expected by year-end or early next year.

• Confirmatory phase II and future phase III studies planned, with leading U.S. diabetes centers involved.

• Animal models suggest potential for icovamenib to enhance weight loss when combined with GLP-1 agents.

Differentiation and future plans

• BMF-650 designed to extend half-life and improve bioavailability, aiming for better tolerability and maintenance of weight loss.

• Plans to assess combination with immunosuppression in type 1 diabetes to enhance beta cell protection.

• Upcoming milestones include phase I data for BMF-650, phase II readouts for icovamenib, and first patient in for type 1 diabetes study.

• Engagement with top diabetes investigators and centers to drive clinical development.

• Ongoing discussions with FDA to define phase III pathways and registration strategies.