Biomea Fusion Reports Third Quarter 2026 Financial Results and Corporate Highlights
Key Highlights
- ➤COVALENT-211 enrollment completed; primary endpoint data expected in Q1 2027
- ➤COVALENT-212 enrollment ongoing; primary endpoint data expected in Q2 2027
- ➤BMF-650 reduced mean weight 1.5%-3.2% across Cohorts 1-4 versus 0.1% placebo
- ➤Cash runway projected into the second quarter of 2027
- ➤Third-quarter net loss narrowed to $6.2 million from $16.4 million
Expert Statements
Mick Hitchcock, Interim Chief Executive Officer of Biomea Fusion
“The third quarter was marked by meaningful execution across both of our clinical programs. We completed enrollment in our first diabetes Phase II clinical trial, COVALENT-211, and continue to advance enrollment in our Phase II COVALENT-212 clinical trial, bringing us closer to important Phase II data readouts for icovamenib in two distinct diabetes populations that we estimate represent over 30% of treated patients with diabetes in the U.S., We also reported first-in-human results for BMF-650, providing initial clinical support for our design hypothesis, in that BMF-650 achieved meaningful weight reduction while limited GI side effects were observed, all of which were Grade 1 AEs at the highest dose level. Encouragingly, BMF-650 demonstrated weight reduction and a generally favorable tolerability profile with only one-step titration. We also made important progress with the OPAL trial, overseen by the Leicester Diabetes Centre, dosing the first patient evaluating icovamenib in combination with semaglutide. Together, we believe these accomplishments reinforce our confidence in our pipeline and position us for several important Phase II readouts in 2027.”
* Completed enrollment in the Phase II COVALENT-211 clinical trial evaluating icovamenib in patients with insulin-deficient type 2 diabetes (“T2D”); topline data expected in the first quarter of 2027 * Enrollment ongoing in the Phase II COVALENT-212 clinical trial evaluating icovamenib in patients with T2D not achieving glycemic targets on GLP-1 receptor agonist (“GLP-1 RA”)-based therapy; topline data expected in the second quarter of 2027 * Announced Phase I results for BMF-650, an investigational next-generation oral GLP-1 RA, that, demonstrated weight reduction over 28 days and a generally favorable tolerability profile * First patient dosed in the Open Label Adaptive Platform (“OPAL”) trial evaluating icovamenib in combination with semaglutide, in collaboration with the University of Leicester * Cash runway projected into the second quarter of 2027 SAN CARLOS, Calif., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the third quarter ended September 30, 2026, and provided a business update.
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