Biomea Fusion (BMEA) Corporate presentation summary

Transformative therapies and pipeline overview

• Developing oral small molecules for diabetes and obesity, aiming to restore beta cell function and reduce body weight with patient-friendly options.

• Lead assets include icovamenib (menin inhibitor for diabetes) and BMF-650 (oral GLP-1 receptor agonist for obesity).

• Retains full worldwide rights to all programs, with multiple clinical trials ongoing or planned through 2026.

• Key upcoming milestones: Phase IIb for icovamenib in insulin-deficient T2D and Phase II for T2D not controlled on GLP-1 therapies, both starting 1Q 2026.

Icovamenib: Mechanism, clinical data, and differentiation

• Icovamenib is a first-in-class, oral, non-chronic menin inhibitor targeting the root cause of diabetes by regenerating beta cells.

• Demonstrated durable HbA1c reductions (up to 1.2–1.3%) in severe insulin-deficient and GLP-1-resistant T2D patients, sustained 9 months post-treatment.

• Increased insulin secretion (C-peptide index) and improved beta cell function observed.

• Favorable safety profile: no treatment-related serious adverse events, low rates of mild TEAEs.

• Mechanism validated by preclinical and clinical data, with enhanced GLP-1 receptor expression and synergy with GLP-1 therapies.

Market opportunity and clinical positioning

• Addresses high unmet need: 80 million diagnosed T2D patients in US/EU, with 15–25% severely insulin-deficient.

• Estimated $20B US/EU revenue potential at 10% market penetration.

• Short-course oral therapy offers a disease-modifying approach, potentially improving adherence and long-term outcomes.

• Outperformed or matched chronic standards of care in HbA1c reduction, with lasting effects post-treatment.