On March 24, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the full year ended December 31, 2025, and provided a business update.
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"The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical experiments to now generating durable, clinical data in patients with type 2 diabetes with our lead asset, icovamenib," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "We reported persistent 52-week clinical activity with icovamenib following a short 12-week treatment course. Following these initial findings, we initiated two Phase II studies in type 2 diabetes from which we expect to have primary end point data before year end. We also advanced our own next-generation oral GLP-1 receptor agonist, BMF-650, into a Phase I study which we expect will read out in the second quarter. We are excited about the current momentum as we believe Biomea is well positioned to execute on key value-creating milestones with multiple data readouts from our four clinical studies, while predicting a cash runway into the first quarter of 2027."
Recent Corporate Highlights:
Icovamenib
Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes
The Company presented 52-week follow-up data from the Phase II COVALENT-111 study in patients with type 2 diabetes not achieving glycemic targets despite standard of care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course.
In patients with severe insulin-deficient type 2 diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.01) that was maintained through Week 52 following 12 weeks of dosing.
In a subgroup of patients receiving GLP-1 RA-based therapy who had not achieved glycemic targets at study entry, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.05) that was maintained through Week 52 following 12 weeks of dosing.
In both populations, icovamenib treatment was associated with increased C-peptide levels measured off treatment, supporting the proposed mechanism of action of restoration of beta cell function.
Icovamenib was generally well tolerated across all dosing arms, with no treatment-related serious adverse events or treatment discontinuations observed during the 52-week observation period.
The Company completed the COVALENT-121 food-effect study which demonstrated that icovamenib achieved optimal pharmacokinetic exposure and a safety profile consistent with prior clinical experience when administered within 30 minutes after a meal. These findings informed our dosing strategy for ongoing Phase II studies.
The Company also completed the 52-week follow-up from the Phase II COVALENT-112 study in patients with type 1 diabetes. Patients who completed at least 80% of their planned dosing will be reviewed for their 52-week follow-up data per the study protocol. This read-out is expected in the second quarter of 2026.
Two Phase II clinical studies evaluating icovamenib in type 2 diabetes have been initiated:
COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled study in patients with insulin-deficient type 2 diabetes not achieving glycemic targets despite standard of care therapy.
COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled study in patients with type 2 diabetes not achieving glycemic targets while on a GLP-1 RA-based therapy.
Both studies are designed with a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026.
BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity
In preclinical studies, BMF-650 demonstrated robust, dose-dependent weight reduction of up to approximately 15% in obese non-human primates and was generally well tolerated.
GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing.
Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the second quarter of 2026.
Year End 2025 Financial Results
Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2025, the Company had cash, cash equivalents and restricted cash of $56.2 million, compared to $58.6 million as of December 31, 2024.
Net Loss: The Company reported a net loss attributable to common stockholders of $61.8 million for the year ended December 31, 2025, which included $9.5 million of stock-based compensation, compared to a net loss of $138.4 million for the same period in 2024, which included $19.1 million of stock-based compensation.
Research and Development (R&D) Expenses: R&D expenses were $62.0 million for the year ended December 31, 2025 compared to $118.1 million for the same period in 2024. The decrease of $56.1 million was primarily due the decrease of $42.7 million in external costs primarily driven by a decrease of $28.5 million related to clinical activities due to our strategic realignment to focus on our core assets and ceasing internal development of our oncology programs, a decrease of $4.4 million in manufacturing costs, a decrease of $4.0 million related to consultants, advisors and other professional services to support our clinical studies, discovery research and overall research and development program, and a decrease of $5.8 million related to preclinical and exploratory programs. Personnel-related expenses, including stock-based compensation, decreased by $11.3 million due to a decrease in headcount. Facilities and other allocated expenses decreased by $2.1 million due to a decrease in rent and facilities-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $19.3 million for the year ended December 31, 2025 compared to $26.0 million for the same period in 2024. The decrease of $6.7 million was primarily driven by a decrease of $5.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. Consulting and professional expenses decreased by $0.7 million due to legal, accounting, consulting and other services. Facilities and other allocated expenses decreased by $0.1 million due to a decrease in rent and facilities-related costs.
(Press release, Biomea Fusion, MAR 24, 2026, View Source [SID1234663869])