Biomea Fusion (BMEA -1.86%), a biotechnology firm focused on developing covalent inhibitors for metabolic diseases, released its second quarter 2025 results on August 5, 2025. Net loss attributable to common stockholders was $20.7 million for the three months ended June 30, 2025, down from $37.3 million in the same period of 2024, beating consensus estimates of a $0.53 loss per share for Q2 2025 with an actual reported loss of $0.51 per share. No revenue was recorded, meeting expectations for a pre-commerci ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-2520134 (State or other jurisdiction ...

Exhibit 99.1 Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights SAN CARLOS, Calif., August 5, 2025 (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 second quarter ended June 30, 2025, and provided a business update. "In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role a ...

Core Insights - Biomea Fusion, Inc. reported its financial results for Q2 2025, highlighting advancements in its diabetes and obesity treatment programs, particularly icovamenib and BMF-650 [1][2] Financial Performance - The company reported a net loss of $20.7 million for Q2 2025, a decrease from a net loss of $37.3 million in Q2 2024 [10] - Research and Development (R&D) expenses were $16.6 million for Q2 2025, down from $31.8 million in the same period last year, reflecting a decrease in clinical activities and operational costs [11][13] - General and Administrative (G&A) expenses were $4.7 million for Q2 2025, compared to $7.1 million in Q2 2024, primarily due to reduced personnel-related expenses [14] - As of June 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $56.6 million, expected to fund operations into the second half of 2026 [9] Clinical Developments - Icovamenib demonstrated significant improvements in glycemic control and weight loss in combination with low-dose semaglutide, with a 60% reduction in fasting blood glucose and over 2% decline in HbA1c by Day 39 in rodent models [4][5] - BMF-650 showed promising results in a 28-day study with obese cynomolgus monkeys, achieving up to 15% weight reduction and robust appetite suppression [2][11] - The company plans to submit an Investigational New Drug (IND) application for BMF-650 in the second half of 2025 [12] Strategic Initiatives - Biomea raised approximately $42.8 million through a public offering, enhancing its financial position to support ongoing diabetes and obesity programs [7] - The company has reduced its workforce and operational expenses, anticipating future quarterly operational expenses to be approximately 40% lower than the most recent quarter [8]

SAN CARLOS, Calif., July 24, 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 appointment of Julianne Averill to its Board of Directors (the "Board"), effective July 22, 2025. Ms. Averill has also been appointed to serve as a member of the Audit Committee. She succeeds Bihua Chen, who has stepped down from the Board after more than four years of dedicated service. "Julianne i ...

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]

SAN CARLOS, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Biomea or Biomea Fusion) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the presentation of new preclinical and clinical data for icovamenib, the company's investigational oral menin inhibitor, at the 85th Scientific Sessions of the American Diabetes Association (ADA) June 20–23, 2025 in Chicago. Biomea presented three abstracts: one oral presentation and two posters, all highlighting icovame ...

Core Insights - Biomea Fusion, Inc. announced promising preclinical findings for BMF-650, an investigational oral GLP-1 receptor agonist, showing significant weight loss in obese non-human primates [1][3] Study Design and Key Preclinical Findings - The study involved 15 obese cynomolgus monkeys, with groups receiving either a vehicle or BMF-650 at doses of 10 mg/kg and 30 mg/kg for 28 days [7] - Results indicated a dose-dependent reduction in food intake, with average daily intake dropping to 35g/day (10 mg/kg) and 16g/day (30 mg/kg) compared to 109g/day for the control group [7] - Weight loss was significant, with reductions of 12% for the 10 mg/kg group and 15% for the 30 mg/kg group from baseline by Day 28 [7] - BMF-650 was well tolerated, showing no elevations in aminotransferase levels [7] BMF-650 Preclinical Highlights - BMF-650 demonstrated a favorable pharmacokinetic profile, with enhanced oral bioavailability and less variability compared to other oral GLP-1 RAs [9] - The compound showed robust glycemic control and appetite suppression, leading to pronounced weight reduction in preclinical models [9][10] - The company aims to submit an Investigational New Drug (IND) application in the second half of 2025, with a Phase I trial in obese volunteers expected to start in late 2025 [6][10] About Obesity - Obesity is a chronic disease affecting over 40% of adults in the U.S. and over 650 million adults globally, leading to serious health complications [11] - The condition is associated with metabolic disorders, cardiovascular diseases, and increased risks of chronic diseases [11] About GLP-1 Receptor Agonists - GLP-1 receptor agonists are medications that mimic the effects of the GLP-1 hormone, improving glycemic control and promoting weight loss in individuals with type 2 diabetes and obesity [12] About Biomea Fusion - Biomea Fusion focuses on developing oral small molecules for diabetes and obesity, including BMF-650, aimed at significantly improving patient outcomes [13]

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].

Core Viewpoint - Biomea Fusion, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, with a potential additional 15% of shares available for underwriters [1][2]. Group 1: Offering Details - The offering includes common stock, pre-funded warrants, and warrants to purchase common stock, all to be sold by Biomea [1]. - The expected closing date for the offering is around June 20, 2025, pending customary closing conditions [2]. - Jefferies is the sole book running manager for this public offering [2]. Group 2: Regulatory Information - The securities are being offered under an effective shelf registration statement on Form S-3, filed with the SEC on October 14, 2022, and declared effective on October 24, 2022 [3]. - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and will be available through Jefferies and the SEC's website [3]. Group 3: Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral small molecules, icovamenib and BMF-650, aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [5].