Biomea Fusion (BMEA) investor relations material

Strategic focus and pipeline overview

• Two main assets in development: icovamenib, a selective oral menin inhibitor for diabetes, and BMF-650, an oral GLP-1 receptor agonist for weight loss, with GLP-131 also in Phase 1 for obesity.

• Shifted focus to diabetes and obesity, targeting disease progression and beta-cell failure rather than just symptoms.

• Icovamenib aims to restore beta cell function and insulin production, with preclinical and clinical data supporting increased insulin secretion and beta-cell mass.

• BMF-650 and GLP-131 are designed for improved bioavailability and efficacy, with significant weight loss in preclinical models and favorable liver safety profiles.

Clinical data and efficacy

• Icovamenib showed sustained A1C/HbA1c reduction up to 52 weeks post-treatment, with a 1.5% placebo-adjusted drop and durable effects beyond 12 weeks.

• Increased C-peptide and insulin transcript levels indicate enhanced insulin secretion and beta cell regeneration.

• Significant A1C reduction observed in patients failing GLP-1 therapy, with effects persisting after dosing.

• Higher drug exposure correlates with greater A1C reduction; future dosing will require administration with food for optimal exposure.

Safety and tolerability

• Icovamenib was generally well-tolerated over 52 weeks, with adverse event rates similar to placebo and no treatment-related serious adverse events or discontinuations.

• Most common adverse events included mild diarrhea, headache, and transient liver enzyme elevations, all resolving without treatment interruption.

• BMF-650 and GLP-131 showed no ALT/AST elevations in preclinical and early clinical studies.