Biomea Fusion (BMEA) investor relations material

Strategic focus and pipeline overview

• Focus on diabetes and obesity with main assets: icovamenib (for diabetes) and BMF-650 (for weight loss); GLP-131 is also in Phase 1 as a non-peptide oral GLP-1 receptor agonist.

• Icovamenib is a selective oral menin inhibitor targeting beta cell failure, aiming to address the root cause of diabetes rather than just symptoms.

• BMF-650 is an oral GLP-1 receptor agonist designed for improved bioavailability, consistent efficacy, and significant weight loss in preclinical models.

• Preclinical and clinical data showed enhanced GLP-1 receptor expression and insulin transcript levels, supporting improved beta-cell function.

Clinical data and efficacy

• Icovamenib showed sustained A1C (HbA1c) reduction up to 52 weeks post-treatment, with a placebo-adjusted drop of about 1.5 points.

• Increased insulin secretion (C-peptide) and beta cell mass observed in preclinical and clinical studies.

• Significant A1C reduction also seen in patients failing GLP-1 therapy, with effects persisting after treatment.

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

• Preclinical and clinical data support improved beta-cell function and disease modification.

Safety and tolerability

• Icovamenib was generally well-tolerated over 52 weeks, with no treatment-related serious adverse events or discontinuations; mild, transient increases in liver enzymes resolved without intervention.

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

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