Biomea Fusion, Inc. Stock Price, News & Analysis

Biomea Fusion (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, has appointed Julianne Averill to its Board of Directors, effective July 22, 2025. Averill, who will serve on the Audit Committee, brings over 20 years of experience in life sciences and digital health, currently serving as Managing Director at Danforth Advisors.

The appointment comes as Bihua Chen steps down after more than four years on the board. Averill's expertise includes capital markets, M&A, and operational scale, with involvement in transactions exceeding $10 billion in aggregate value. She holds both B.S. and M.S. degrees from California State University, along with CPA licensure and NACD Directorship Certification.

Biomea Fusion (BMEA) presented promising new data for icovamenib, their oral menin inhibitor, at the ADA Scientific Sessions. In clinical trials, icovamenib demonstrated significant efficacy in type 2 diabetes treatment, achieving a 1.0% placebo-adjusted HbA1c reduction and 55% C-peptide increase in insulin-deficient patients. When combined with low-dose semaglutide in preclinical studies, the treatment showed superior metabolic benefits including enhanced glycemic control, 60% lower fasting blood glucose, and greater body weight reduction while preserving lean mass. The Phase II COVALENT-111 trial revealed sustained benefits even after treatment discontinuation, with particularly strong results in patients using GLP-1 RA therapy. The drug demonstrated good tolerability with no significant adverse events or discontinuations.

Biomea Fusion reported promising preclinical results for BMF-650, their oral GLP-1 receptor agonist candidate for obesity treatment. In a 28-day study with obese cynomolgus monkeys, BMF-650 demonstrated significant weight loss and appetite suppression. The drug, administered orally once daily at 10 mg/kg and 30 mg/kg, achieved average weight reductions of 12% and 15% respectively. Daily food intake decreased dramatically to 35g/day (10 mg/kg) and 16g/day (30 mg/kg) compared to 109g/day in the control group. The drug was generally well-tolerated with no concerning safety signals. Biomea plans to file an IND in H2 2025 and initiate Phase I trials in obese, healthy volunteers by late 2025.

Biomea Fusion (BMEA) has priced its public offering of securities, consisting of 19,450,000 shares of common stock and warrants, plus 550,000 pre-funded warrants with accompanying warrants. The combined offering price is $2.00 per share of common stock with warrant, and $1.9999 for each pre-funded warrant with warrant. The accompanying warrants have an exercise price of $2.50, are immediately exercisable, and expire in 18 months. The offering is expected to generate approximately $40 million in gross proceeds before deductions. Biomea has granted underwriters a 30-day option to purchase up to 3 million additional shares and/or warrants. The offering is expected to close on June 20, 2025, with Jefferies acting as the sole book-running manager.

Biomea Fusion (BMEA), a clinical-stage diabetes and obesity company, has announced a proposed public offering of common stock and warrants. The offering includes shares of common stock, pre-funded warrants, and accompanying warrants to purchase common stock. Biomea will grant underwriters a 30-day option to purchase up to 15% additional shares and pre-funded warrants. Jefferies is serving as the sole book running manager for the offering, which is expected to close around June 20, 2025. The securities will be offered through an effective shelf registration statement on Form S-3 filed with the SEC. The final size, terms, and completion of the offering are subject to market conditions.

Biomea Fusion (NASDAQ: BMEA) presented updated clinical data for BMF-500, their covalent FLT3 inhibitor, in treating relapsed/refractory acute leukemia. The Phase I COVALENT-103 trial included 27 heavily pretreated patients, with 18 having FLT3 mutations. Key findings showed 9 of 11 evaluable FLT3m patients achieved bone marrow blast reduction, with one patient achieving complete remission with incomplete hematologic recovery (CRi) sustained for 6 cycles. The median overall survival was 3.8 months in Arm A and 3.5 months in Arm B, comparing favorably to historical 2.1 months survival. BMF-500 demonstrated good tolerability with no dose-limiting toxicities or QT prolongation. Following dose escalation completion, Biomea plans to conclude internal development and seek strategic partnerships for the program's advancement.

Biomea Fusion (BMEA) announced that preliminary Phase I data for BMF-500, their covalent FLT3 inhibitor, will be presented at the EHA 2025 Congress in Milan. The COVALENT-103 trial shows promising results in relapsed/refractory acute leukemia patients. Key findings include:

• 24 patients enrolled, with 15 having FLT3 mutations
• 81.8% of evaluable patients showed clinical activity
• 77.8% demonstrated decreased bone marrow blasts
• Median overall survival of 3.48 months vs. historical 2.1 months
• Well-tolerated safety profile with no treatment-related discontinuations

Despite these positive results, Biomea plans to conclude internal development of BMF-500 in oncology and is seeking strategic partnerships, as the company shifts focus to metabolic diseases.

Biomea Fusion (BMEA) announced a strategic realignment in Q1 2025, focusing on its core diabetes and obesity programs while implementing cost-reduction measures. The company reported a net loss of $29.3M for Q1 2025, with cash reserves of $36.2M expected to fund operations into Q4 2025. Key initiatives include a 35% workforce reduction and facility consolidation. The company is prioritizing development of icovamenib (oral menin inhibitor for diabetes) and BMF-650 (oral GLP-1 receptor agonist). Important upcoming milestones include 52-week Phase II data for icovamenib, FDA discussions for Phase IIb trials, and IND submission for BMF-650 in H2 2025. The company has ceased internal oncology program development and appointed Mick Hitchcock as Interim CEO.

Biomea Fusion (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, has granted stock options to two new employees as part of their inducement package. The grants, approved on March 23, 2025, by the compensation committee, allow the purchase of a total of 30,000 shares of common stock.

The stock options will vest quarterly over a four-year period, with 1/16 of the shares vesting each quarter, contingent on continued employment. These awards were issued under Biomea's 2023 Inducement Equity Plan, which was adopted by the board on November 17, 2023, and comply with Nasdaq Listing Rule 5635(c)(4) regarding inducement grants for new employees.