Icovamenib Program - Icovamenib, a menin inhibitor, demonstrates significant and durable HbA1c reductions, up to approximately 1.5%, sustained well beyond the end of treatment[5] - In a Phase 2a study (COVALENT-111), a 12-week oral dosing of Icovamenib led to a placebo-adjusted HbA1c reduction of 1.5% (p=0.02) at Week 26 in patients with severe insulin-deficient diabetes[71] - At Week 26, patients with Severe Insulin-Deficient Diabetes (SIDD) showed a 53% mean increase in C-peptide levels after Icovamenib treatment[60] - Icovamenib has a $6 billion+ estimated U S revenue potential based on 10% penetration at $10,000 per year in the target T2D patients[7, 15] BMF-650 Program - BMF-650, an oral GLP-1 RA, is built on a similar scaffold as orforglipron, aiming for best-in-class status with an optimized exposure profile[7] - Preclinical studies of BMF-650 showed approximately 2 to 3-fold greater oral bioavailability compared to orforglipron[100] - In obese cynomolgus monkeys, BMF-650 demonstrated meaningful appetite suppression over a 6-day treatment period[110, 112] - In a weight loss study in obese cynomolgus monkeys, BMF-650 at 30 mg/kg resulted in a 15.2% average weight reduction from baseline over 28 days[126, 133] Financials and Milestones - For the three months ended March 31, 2025, Biomea Fusion reported a net loss of $29.262 million, or $0.80 per share[139] - As of March 31, 2025, Biomea Fusion had $36.2 million in cash, cash equivalents, and restricted cash[139]

Core Viewpoint - Biomea Fusion, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $40 million before expenses, with the offering expected to close on June 20, 2025 [1][2]. Group 1: Offering Details - The offering consists of 19,450,000 shares of common stock and accompanying warrants, along with pre-funded warrants for an additional 550,000 shares [1]. - The combined offering price for each share of common stock and accompanying warrant is set at $2.00, while the pre-funded warrant and accompanying warrant are priced at $1.9999 [1]. - Underwriters have a 30-day option to purchase up to an additional 3,000,000 shares and/or warrants at the public offering price [1]. Group 2: Financial Proceeds - The gross proceeds from the offering are expected to be approximately $40 million, excluding any additional shares or warrants purchased by underwriters [2]. - The offering is subject to customary closing conditions and is anticipated to close on June 20, 2025 [2]. Group 3: Management and Regulatory Information - Jefferies is acting as the sole book-running manager for the offering [3]. - The securities are being offered under an effective shelf registration statement previously filed with the SEC [3].

REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500 in adults with acute leukemia (AL) were selected for a poster presentation at the European Hematology Association (EHA) 2025 Congress, taking place June 12–15 in Milan, Italy. The presentation will highlight emerging safety, pharmacokinetics/pharmacodynamics ...

Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapyBiomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“B ...