BMF-219 (icovamenib)

May 11, 2026 — Biomea Fusion, Inc. (Nasdaq: BMEA) reported first-quarter 2026 financial results (quarter ended March 31, 2026) and provided R&D updates for its diabetes and obesity pipeline.

Key program updates: the company completed chronic toxicology studies in two species for icovamenib (menin inhibitor), supporting the ability to move beyond the prior 12-week clinical dosing; with >400 subjects dosed, icovamenib has been generally well tolerated. In the Phase II COVALENT-112 trial in type 1 diabetes, 52-week follow-up topline data showed a 52% increase from baseline in mean C-peptide AUC at Week 12 in recently diagnosed patients (0–3 years; n=5) at 200 mg, with dose response vs 100 mg (n=6), and persistence through Week 52 (~7% decline from baseline in the 200 mg group). Two Phase II type 2 diabetes trials (COVALENT-211 and -212) have begun dosing; 26-week topline data are expected in Q4 2026. The Phase I GLP-131 trial of oral GLP-1 RA candidate BMF-650 is ongoing; initial 28-day weight data are expected in Q2 2026.

Financials: cash/cash equivalents/restricted cash were $45.1M; net loss was $12.4M (vs $29.3M in Q1 2025), with reduced R&D ($9.1M vs $22.9M) and G&A ($3.7M vs $6.8M). Cash runway is projected into Q1 2027.