Biomea Fusion Showcases Preclinical Advances for BMF-650 and Icovamenib with Low Dose Semaglutide at ObesityWeek® 2025

• The Company’s investigational small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), BMF-650, demonstrated potent weight loss and good tolerability in obese cynomolgus monkeys
• A Phase I study of BMF-650 in healthy obese patients is currently enrolling with data expected first half of 2026
• In a rodent model of type 2 diabetes (“T2D”), icovamenib in combination with low dose semaglutide promoted enhanced glycemic control and body weight reduction with preservation of lean mass, outperforming the group given low dose semaglutide alone
  

SAN CARLOS, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the presentation of two late breaking posters at ObesityWeek® 2025 in Atlanta, Georgia.

The presentations highlighted preclinical data for BMF-650, Biomea’s investigational next-generation oral small molecule GLP-1 RA, and combination data for icovamenib, the Company’s potential best-in-class covalent menin inhibitor product candidate, with semaglutide, an injectable GLP-1 based therapy.

Presentation Summaries:

Late Breaking Poster 085
Title: Preclinical Efficacy of BMF-650, an Oral Small-Molecule GLP-1 Receptor Agonist
Study Design: BMF-650 potency, GLP-1 receptor agonism, selectivity, and mechanism of action were evaluated in a series of in vitro studies. Absorption, distribution, metabolism, and excretion (“ADME”) and pharmacokinetics were assessed in both in vitro and in vivo models. In male cynomolgus monkeys, glucose stimulated insulin secretion (“GSIS”) and glycemic control were measured following intravenous glucose administration. BMF-650-induced appetite suppression and weight loss were evaluated in a 28-day study in obese cynomolgus monkeys (n=15, five per group) receiving once-daily oral doses of 10 mg/kg, 30 mg/kg, or vehicle.

Key Findings:

• Potent and biased GLP-1 receptor agonism
• Strong incretin response with robust insulin release in intravenous glucose tolerance test studies
• Oral bioavailability of 33% in rats and 54% in monkeys, exceeding that of orforglipron under matched conditions
• Dose-dependent improvements in glycemia
• 12-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing
• Sustained decreases in daily food intake that paralleled weight loss outcomes
• Generally well tolerated without safety concerns outside of the observed class effects
• No aminotransferase elevations during the weight-loss study

BMF-650 is currently in a Phase I study in healthy obese patients with 28-day weight loss data expected in the first half of 2026.

Late Breaking Poster 136
Title: Icovamenib and Semaglutide Combination Enhances Weight Loss While Preserving Lean Mass in ZDF Rats
Study Design: Zucker diabetic fatty (ZDF) rats were treated with icovamenib (200 mg/kg, oral, once daily) or vehicle for 4 weeks, with low-dose semaglutide (0.02 mg/kg, subcutaneous, once daily) administered during Weeks 3 and 4. Effects on appetite, body weight and composition, and glycemic control were compared between combination treatment and low dose semaglutide alone.

Key Findings:
Combination treatment was superior to low dose semaglutide

• 60% lower fasting blood glucose vs semaglutide alone
• 50% lower glucose area under the curve during oral glucose tolerance test
• >1% HbA1c reduction by Day 28 and >2% by Day 39
• Greater improvement in insulin sensitivity; 75% lower HOMA-IR
• Significant enhancement of beta-cell function (C-peptide to glucose ratio)
• ~10% greater total body weight reduction, driven by fat loss with lean mass preservation
  

In the fourth quarter of 2025, Biomea plans to begin clinical evaluation of icovamenib added to the treatment of T2D patients who are currently on GLP-1 based treatment and not achieving glycemic targets. The first patient is expected to be dosed in the first quarter of 2026.

About Icovamenib
Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The proposed mechanism of action for icovamenib in diabetes is selective and partial inhibition of menin, a regulator of beta cell quantity and function, thereby enabling the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the first potential non-chronic therapy for T2D, icovamenib could become an important addition to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies.

About BMF-650
BMF-650 is an investigational, next-generation oral small-molecule GLP-1 RA being developed by Biomea Fusion for the treatment of obesity. Related to the broader orforglipron chemotype, BMF-650 is designed to combine enhanced oral bioavailability and durable receptor activation to deliver robust metabolic benefits. Biomea’s development strategy for BMF-650 focuses on achieving consistent daily target coverage from oral dosing to support a potential best-in-class profile among oral small-molecule GLP-1 therapies.

About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook. 

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib, and BMF-650, the potential of icovamenib as a treatment for T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans, the initiation, progress and availability and timing of data from our clinical trials; the mechanism of action of our product candidates and development programs and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:  
Meichiel Jennifer Weiss  
Sr. Director, Investor Relations and Corporate Development
IR@biomeafusion.com  

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