SAN CARLOS, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it will participate in the upcoming investor conferences: Piper Sandler 37th Annual Healthcare Conference: Biomea will participate in a fireside chat at 8:00 AM (EST) and in one-on-one meetings on December 2, 2025 in New York, NY.8th Annual Evercore Healthcare Conference: Biomea will participate in a Fires ...

Summary of Biomea Fusion Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS:BMEA) - **Industry**: Biotechnology, focusing on metabolic diseases, specifically diabetes and obesity [14][15] Core Points and Arguments Metabolic Disease Focus - Biomea is positioned in the metabolic space, targeting diabetes and obesity, which are identified as significant health challenges [14][15] - The company aims to address the root causes of diabetes by focusing on insulin deficiency rather than just symptom management [19][20] Product Development - **Icovamenib**: A menin inhibitor designed to regenerate beta cells in the pancreas, targeting insulin-deficient patients [21][22] - The drug aims to provide a more effective treatment for diabetes by addressing the underlying issue of insufficient insulin production [20][21] - **Next-Generation GLP-1 Receptor Agonist**: Biomea is developing an oral GLP-1 receptor agonist based on the orforglipron scaffold, which aims to improve patient compliance and efficacy [23][41] Clinical Trials and Data - The company is preparing for Phase 2 trials, focusing on insulin-deficient patients and those failing GLP-1 therapy [40][41] - Initial data from trials show promising results, with a significant reduction in HbA1c levels and weight loss in patients [27][50] - The company plans to release data in Q1 of the following year, with expectations of enrolling patients quickly [31][41] Safety and Efficacy - Biomea emphasizes a favorable safety profile for icovamenib, with minimal side effects compared to placebo [26][27] - The company has a safety database covering over 400 patients, which is considered sufficient for regulatory discussions with the FDA [44][45] Future Directions - Biomea is exploring additional applications for icovamenib in obesity and Type 1 diabetes, indicating a broader potential for the drug beyond its initial indications [51][57] - The company is focused on refining dosing instructions to minimize variability in trial results [30][36] Important but Overlooked Content - The discussion highlights the innovative approach of icovamenib in directly targeting menin, contrasting with other menin inhibitors that focus on preventing protein interactions, which may lead to side effects [25][26] - The potential for icovamenib to enhance the effects of existing GLP-1 therapies, leading to greater weight loss and improved metabolic outcomes, is a significant point of interest [50][51] - Biomea's strategic focus on a defined patient population (insulin-deficient and GLP-1 failing patients) is crucial for its clinical development and regulatory strategy [39][40]

Core Insights - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity [3] - The company will participate in the Jefferies London Healthcare Conference on November 17, 2025, including a fireside chat and one-on-one meetings [1] - Biomea's key products include icovamenib, a selective menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist for obesity [3] Company Overview - Biomea Fusion aims to address cardiometabolic disorders, which affect nearly half of Americans and one-fifth of the global population [3] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [3]

Core Insights - Biomea Fusion, Inc. presented two late-breaking posters at ObesityWeek® 2025, showcasing preclinical data for its investigational drugs BMF-650 and icovamenib [1][2] Group 1: BMF-650 - BMF-650 is an oral small-molecule GLP-1 receptor agonist currently in Phase I study, with 28-day weight loss data expected in the first half of 2026 [5] - In preclinical studies, BMF-650 demonstrated potent weight loss effects, achieving a 12-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing [8] - The drug showed strong oral bioavailability of 33% in rats and 54% in monkeys, exceeding that of orforglipron under matched conditions [8] Group 2: Icovamenib - Icovamenib, a covalent menin inhibitor, was tested in combination with low-dose semaglutide in ZDF rats, showing superior weight loss and glycemic control compared to semaglutide alone [7] - The combination treatment resulted in a 60% lower fasting blood glucose compared to semaglutide alone and a greater improvement in insulin sensitivity, with a 75% lower HOMA-IR [9] - Clinical evaluation of icovamenib is set to begin in T2D patients currently on GLP-1 based treatment, with the first patient expected to be dosed in the first quarter of 2026 [10] Group 3: Company Overview - Biomea Fusion focuses on developing oral small molecule therapies for diabetes and obesity, targeting metabolic disorders affecting a significant portion of the global population [13] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [13]

Core Insights - Biomea Fusion, Inc. has made significant advancements in its diabetes and obesity programs, particularly with icovamenib showing durable results in a 52-week Phase II study and BMF-650 entering Phase I clinical trials [1][5][8] - The company raised approximately $68 million through public offerings, extending its cash runway into the first quarter of 2027 [1][6] Icovamenib Developments - Icovamenib, an oral small molecule menin inhibitor, demonstrated a sustained 1.5% mean reduction in HbA1c at Week 52 in patients with severe insulin-deficient diabetes [5] - The drug was well tolerated, with no serious adverse events reported during the 52-week observation period [5] - Preclinical data presented at the EASD Annual Meeting showed enhanced glycemic control and body weight reduction when icovamenib was combined with semaglutide in a T2D animal model [5] BMF-650 Progress - BMF-650, a next-generation oral small molecule GLP-1 receptor agonist, has dosed its first patient in a Phase I study, which will evaluate its weight loss potential in obese volunteers [1][4][8] - Preclinical findings indicated that BMF-650 led to significant reductions in food intake and body weight in obese nonhuman primates [5] Financial Performance - For Q3 2025, Biomea reported a net loss of $16.4 million, a decrease from a net loss of $32.8 million in Q3 2024 [11][12] - Research and development expenses were $14.4 million for Q3 2025, down from $27.2 million in the same period of 2024, reflecting a year-over-year decrease of over 50% in operating expenses [11][12] - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $47 million [11][19] Key Milestones - The initiation of Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D patients is expected in Q4 2025, with the first patient expected to be dosed in Q1 2026 [10] - The ongoing Food Effect Study (COVALENT-121) aims to optimize dosing criteria for icovamenib and is expected to be completed by December 2025 [10]

Core Insights - Biomea Fusion, Inc. will present at ObesityWeek® 2025, showcasing preclinical data for its drug candidates BMF-650 and icovamenib [1][2] Group 1: Presentation Details - Biomea will present two posters on November 4, 2025, focusing on BMF-650's efficacy and the combination of icovamenib with semaglutide [3] - The abstracts from these presentations will be published in the peer-reviewed Obesity journal supplement [3] Group 2: Product Information - Icovamenib is a selective covalent inhibitor of menin, aimed at enhancing the function and quantity of insulin-producing beta cells, representing a potential non-chronic therapy for Type 2 Diabetes (T2D) [4] - BMF-650 is a next-generation oral small-molecule GLP-1 receptor agonist designed for obesity treatment, offering improved oral bioavailability and sustained receptor activation [5] Group 3: Company Overview - Biomea Fusion is focused on developing oral small molecule therapies for diabetes and obesity, addressing metabolic disorders that affect a significant portion of the global population [6]

Core Insights - Biomea Fusion, Inc. will participate in Citi's SMID Biotech C-Suite Fireside Chat Series on October 23, 2025 [1] - A live audio webcast of the discussion will be available on Biomea's website, with a replay accessible after the event [2] Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral small molecule therapies, icovamenib and BMF-650, targeting diabetes and obesity [3] - The company addresses metabolic disorders, which affect nearly half of Americans and one-fifth of the global population [3] - Biomea's mission is to provide transformative treatments aimed at curing diabetes, obesity, and related conditions [3]

Core Points - The conference call is led by Ramses Erdtmann, the President and Chief Operating Officer of Biomea, who introduces the discussion on the 52-week results from the COVALENT-111 study [3]. Group 1: Study Overview - The COVALENT-111 study is a randomized double-blind, placebo-controlled Phase II clinical trial [3]. - The study aims to assess the safety and tolerability profile of icovamenib in patients with type II diabetes, along with exploratory efficacy endpoints [3].

Core Insights - The conference call is led by Ramses Erdtmann, the President and Chief Operating Officer of Biomea, who will present the results from the COVALENT-111 study [3]. Group 1: Study Overview - The COVALENT-111 study is a randomized double-blind, placebo-controlled Phase II clinical trial [3]. - The study aims to assess the safety and tolerability profile of icovamenib in patients with type II diabetes, along with exploratory efficacy endpoints [3].

Core Viewpoint - Biomea Fusion Inc's stock price has significantly declined following the announcement of a public offering, raising concerns about stock dilution and the offering price being below market value [1][3]. Offering Details - The public offering consists of 11.2 million shares of common stock and warrants for an equal number of shares, with certain investors receiving pre-funded warrants for up to 1 million shares [1][2]. - The offering is expected to generate approximately $25 million in gross proceeds, with a closing date set for October 8, subject to customary conditions [2]. Market Reaction - The stock price dropped by 33.9% to $1.76, likely due to fears of dilution from new shares and the offering price of $2.05 per share being lower than the previous market value [3][7]. - The inclusion of warrants with an exercise price of $2.50 and ongoing challenges, such as a clinical hold on trials, contributed to the negative market response [3]. Clinical Study Results - Biomea Fusion recently reported results from its Phase 2 COVALENT-111 study, which evaluated the efficacy of icovamenib in type 2 diabetes patients, showing a durable HbA1c reduction of 1.2% in severe insulin-deficient patients [4]. - Patients receiving 12 weeks of treatment experienced the best results, with a 1.5% reduction in HbA1c [4]. - The drug maintained a favorable safety profile, with no serious adverse events reported [5]. Future Plans - Ongoing studies include the Food Effect Study (COVALENT-121), with data expected by December 2025, and a Phase 2b trial (COVALENT-211) anticipated to start in Q4 2025 [8]. - A Phase 2 trial (COVALENT-212) with GLP-1-based therapy is also expected to begin in Q4 2025, along with a Phase 1 trial (GLP-131) for Biomea's oral GLP-1 RA (BMF-650), with data expected in the first half of 2026 [8].