BMF-650 (GLP-131)

August 5, 2026: Biomea Fusion (NASDAQ: BMEA) provided a business update highlighting ongoing diabetes and obesity catalysts. For icovamenib, Phase II COVALENT-211 in insulin-deficient type 2 diabetes is near enrollment completion, with 26-week primary endpoint data expected in Q1 2027; Phase II COVALENT-212 in T2D patients inadequately controlled on GLP-1 receptor agonist-based therapy is also enrolling, with 26-week data expected in Q2 2027.

The company also reported 52-week follow-up from Phase II COVALENT-112 in type 1 diabetes presented at the ADA Scientific Sessions: in patients diagnosed within 0-3 years, mean C-peptide AUC increased 52% from baseline at Week 12 with icovamenib 200 mg (n=3), and remained largely preserved through Week 52 after 12 weeks of dosing (~7% decline from baseline). C-peptide preservation was also observed in patients diagnosed 3-15 years earlier (n=9). Icobamenib was generally well tolerated through Week 52. A Phase II trial in recently diagnosed T1D patients is planned for 2H 2026.

In obesity, Biomea initiated a University of Leicester collaboration to study icovamenib plus semaglutide in a Phase II trial, with enrollment expected in Q3 2026 and a Week 24 primary endpoint. Separately, Phase I GLP-131 of BMF-650 is ongoing, expanded to test rapid one-step titration; initial 28-day weight reduction data are expected in Q3 2026. Cash runway is projected into Q2 2027.