SAN CARLOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that it will present poster presentations at ObesityWeek® 2025, taking place November 4-7, 2025 in Atlanta, Georgia. The presentations will highlight preclinical data for BMF-650, Biomea’s next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), and combination data for icovamenib, the company’s fir ...

SAN CARLOS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”). BMF-650 is an orally administered, next-generation small molecule GLP-1 RA being developed by Biomea ...

PresentationYigal NochomovitzCitigroup Inc., Research Division All right. Hi, everyone. I'm Yigal Nochomovitz, biotech analyst at Citi here in Tribeca in Downtown Manhattan. So we do this virtual C-suite fireside chat periodically. We've had many over the summer. We have many on the schedule. You can check your e-mail if you want the full lineup. Today, we have the pleasure of having the senior leadership from Biomea here with me. And I have Ramses Erdtmann, who is the Chief Operating Officer and President; ...

Summary of Biomea C-Suite Fireside Chat Company Overview - **Company**: Biomea - **Founded**: 2017 - **Public Listing**: 2021 - **Location**: California - **Employee Count**: Approximately 40 - **Focus Areas**: Diabetes and obesity [3][4] Key Objectives and Pipeline - **Diabetes Program**: - Targeting the root cause of diabetes by addressing depleted beta cells in the pancreas. - Developed a drug that inhibits the protein menin, allowing beta cells to grow again. - Clinical studies have shown a significant reduction in glucose toxicity, with HbA1c levels decreasing by 1.5% to 1.8% compared to placebo after 12 weeks of dosing [6][7][23]. - Phase 2 study planned for insulin-deficient patients, who represent about 20% of all diabetic patients in the U.S. [7][10]. - **Obesity Program**: - Targeting the growing obesity market, with 36% of the U.S. population classified as obese. - Developing a non-injectable oral agent based on the GLP-1 receptor agonist pathway, aiming to reduce side effects like nausea that are common with current injectable therapies [8][9]. - Anticipated market size for obesity treatments to reach $100 billion by 2030 [7]. Clinical Data and Future Studies - **Recent Clinical Data**: - The company has shown that their drug can rebuild the pool of beta cells, leading to sustained HbA1c reduction even after stopping the drug [22][24]. - The FDA's approval hurdle is set at a 0.5% reduction in HbA1c, which Biomea believes they can exceed [23][24]. - **Upcoming Studies**: - Two phase 2 studies planned: one for insulin-deficient patients and another for patients on GLP-1 therapies who are not achieving target HbA1c levels [27][28]. - Expected to start early next year, with primary readouts in 26 weeks and secondary readouts at 52 weeks [34][38]. Market Dynamics and Competitive Landscape - **Diabetes Market**: - Approximately 38 million people in the U.S. have diabetes, with a significant portion being insulin deficient [26]. - Current therapies often lead to insulin dependency, which Biomea aims to avoid with their non-chronic treatment approach [17][34]. - **Obesity Market**: - The company is positioning itself to address the unmet needs in obesity treatment, particularly with a focus on patient-friendly oral medications [8][9][62]. Additional Insights - **Combination Therapies**: - There is potential for combining Biomea's drugs with existing GLP-1 therapies to enhance efficacy and reduce side effects [49][84]. - Preclinical studies have shown promising results when combining their menin inhibitor with GLP-1 agents [85]. - **Type 1 Diabetes Research**: - Interest in exploring the effects of their drug in type 1 diabetes patients, particularly in regrowing beta cells [63][94]. - Plans to initiate studies in type 1 diabetes, focusing on chronic dosing and potential immune suppression strategies [64][94]. Conclusion Biomea is strategically positioned in the diabetes and obesity markets with innovative therapies targeting the underlying causes of these conditions. The company is preparing for significant clinical trials that could reshape treatment paradigms, particularly for insulin-deficient diabetes patients and those struggling with obesity. The focus on non-chronic therapies and combination treatments may provide a competitive edge in a rapidly evolving pharmaceutical landscape.

SAN CARLOS, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it will participate in Citi’s SMID Biotech C-Suite Fireside Chat Series on Thursday, October 23, 2025, at 8:00 a.m. Pacific Time / 11:00 a.m. Eastern Time. A live audio webcast of the discussion will be available here or by visiting the Investors & Media section of Biomea’s website at https://investors.biomeafusion.com/news-events/events. A ...

PresentationLadies and gentlemen, please stand by. Ladies and gentleman, please remain on line, your conference will begin shortly.I would now like to hand the conference over to your speaker today, Ramses Erdtmann, President and Chief Operating Officer. Please go ahead.Ramses ErdtmannCo-Founder, President, COO & Director Perfect. Okay. All the other speakers that have dialed in, we're going to go live. Maybe you can let Juan Pablo now. Okay. Thank you, operator, and welcome, everyone, to this conference ca ...

PresentationLadies and gentlemen, please stand by. Ladies and gentleman, please remain on line, your conference will begin shortly.I would now like to hand the conference over to your speaker today, Ramses Erdtmann, President and Chief Operating Officer. Please go ahead.Ramses ErdtmannCo-Founder, President, COO & Director Perfect. Okay. All the other speakers that have dialed in, we're going to go live. Maybe you can let Juan Pablo now. Okay. Thank you, operator, and welcome, everyone, to this conference ca ...

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].

Summary of Biomea Fusion Conference Call - October 07, 2025 Company Overview - **Company**: Biomea Fusion (NasdaqGS: BMEA) - **Focus**: Development of acobaminib, a menin inhibitor for type 2 diabetes treatment Key Points from the Conference Call Clinical Study Results - **Study**: COVALENT-111, a phase 2 clinical trial assessing acobaminib's safety and efficacy in type 2 diabetes patients [5][6] - **Duration**: 52-week results presented, with a focus on the drug's effects on severe insulin-deficient patients and those on GLP-1 therapy [9][32] - **Efficacy**: - Severe insulin-deficient patients showed a mean HbA1c reduction of 1.5% compared to placebo, statistically significant with a p-value of 0.01 [16][32] - Patients on GLP-1 therapy who did not achieve target HbA1c levels experienced a 1.3% reduction [32] - **Durability**: HbA1c reductions were sustained for up to 52 weeks post-treatment, indicating potential long-term benefits [32][30] Mechanism of Action - **Menin Inhibition**: Acobaminib selectively inhibits menin, leading to increased beta cell mass and function, and enhanced GLP-1 receptor expression on beta cells [8][26] - **Clinical Implications**: This mechanism may provide a new treatment modality for patients with severe insulin deficiency, who currently have limited options [24][30] Safety Profile - **Safety Observations**: Acobaminib was generally well tolerated with no serious adverse events reported. The side effects included mild nausea and diarrhea [19][29] - **Long-term Monitoring**: Ongoing safety assessments are planned, especially regarding liver enzyme levels at higher doses [29][30] Future Directions - **Next Steps**: - Conducting a food effect study to optimize dosing and improve drug exposure [34] - Planning larger studies targeting severe insulin-deficient patients and those on GLP-1 therapy [33] - **Funding**: Recent public offering strengthens the company's financial position, extending cash runway into the second half of 2027 [34] Market Context - **Diabetes Treatment Landscape**: Current diabetes therapies often require chronic dosing and can have significant side effects. Acobaminib's episodic treatment approach may represent a significant advancement in diabetes care [30][64] - **Potential Impact**: If successful, acobaminib could become a cornerstone therapy for type 2 diabetes, particularly for difficult-to-treat patient populations [31][32] Additional Insights - **Patient Subtypes**: The study identified specific patient subtypes that respond best to acobaminib, including those with severe insulin deficiency and those inadequately controlled on GLP-1 therapies [9][33] - **Regulatory Pathway**: The company is optimistic about the FDA's acceptance of their novel treatment approach, which does not fit traditional chronic treatment guidelines [63][64] This summary encapsulates the critical findings and future directions discussed during the Biomea Fusion conference call, highlighting the potential of acobaminib in transforming diabetes treatment.

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