Core Insights - Biomea Fusion announced positive topline results from the COVALENT-111 study, demonstrating significant efficacy of icovamenib in reducing HbA1c levels in patients with type 2 diabetes [1][3][6] - Icovamenib showed a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 for beta-cell deficient patients, indicating its potential as a novel treatment option [1][3][6] - The study reported no serious adverse events or discontinuations due to adverse events, highlighting the favorable safety profile of icovamenib [4][6] Study Design and Results - COVALENT-111 is a double-blinded, randomized, 3:1 placebo-controlled trial involving 225 adult patients with type 2 diabetes, assessing the efficacy and safety of icovamenib [2][3] - The study included three dosing arms, with the most effective being Arm B, which showed a mean HbA1c reduction of 0.5% [2][3] - Patients with severe insulin deficiency (SIDD) demonstrated the best response, achieving a mean HbA1c reduction of 1.47% in Arm B [3][4] Safety and Tolerability - Icovamenib was well-tolerated throughout the study, with no serious adverse events or drug-to-drug interactions reported [4][6] - The favorable safety profile supports the continued development of icovamenib as a treatment for type 2 diabetes [4][6] Future Plans - Biomea Fusion plans to present detailed results at a medical conference in 2025 and engage with the FDA to discuss the data [5][6] - The company aims to further explore icovamenib's potential as a first-in-class menin inhibitor therapy for type 2 diabetes [6][7] Mechanism of Action - Icovamenib is a potent, selective covalent inhibitor of menin, designed to regenerate insulin-producing beta cells, potentially offering a disease-modifying therapy for diabetes [10][11] - The mechanism of action involves enabling the proliferation and preservation of healthy, functional insulin-producing beta cells [10][11] Industry Context - Diabetes is a significant health issue, with over 37 million people in the U.S. affected, highlighting the need for innovative treatment options [12][13] - The economic burden of diabetes care is substantial, with a significant portion of healthcare costs allocated to managing the disease [13]

Core Insights - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules for treating diabetes, obesity, and genetically defined cancers [2][3] - The company will present topline results from its Phase II trial, COVALENT-111, for icovamenib in patients with type 2 diabetes on December 17, 2024 [1] Company Overview - Biomea Fusion specializes in the discovery and development of covalent small molecules, which form permanent bonds to target proteins, offering advantages such as greater target selectivity and lower drug exposure [2] - The company utilizes its proprietary FUSION™ System to design and develop next-generation covalent-binding small-molecule medicines aimed at maximizing clinical benefits for patients [3] Event Details - A conference call and webcast will be held on December 17, 2024, at 8:00 am EST to discuss the trial results, with a replay available on the company's website [1][2]

In preclinical experiments, icovamenib enhanced beta cell function and responsiveness of human islets to GLP-1-based therapies. These effects were associated with an increase in the expression levels of both the GLP-1 receptor (GLP-1R) as well as intracellular insulin.Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of GLP-1 based therapies. REDWOOD CITY, C ...

Financial Performance - The company reported an accumulated deficit of $357.9 million as of September 30, 2024, with net losses of $109.1 million and $82.4 million for the nine months ended September 30, 2024, and 2023, respectively[61]. - The total operating expenses for the nine months ended September 30, 2024, were $114.0 million, an increase of $25.2 million compared to $88.8 million for the same period in 2023[68]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $89.9 million, compared to $73.8 million for the same period in 2023[76][78]. - The net loss for the nine months ended September 30, 2024, was $109.1 million, offset by non-cash adjustments of $18.0 million[77]. - Interest and other income, net for the three months ended September 30, 2024, was $1.3 million, a decrease of $1.4 million compared to $2.7 million for the same period in 2023[68]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for a product candidate[61]. - The company has not generated any revenue to date and does not expect to do so in the near future[63]. Research and Development - Icovamenib demonstrated a placebo-adjusted mean percent change of A1c of -1.4% in the 200 mg cohort after 26 weeks, with 36% of participants achieving a durable glycemic response[49]. - The FDA lifted the clinical hold on the COVALENT-111 and COVALENT-112 trials in September 2024, allowing the company to continue its clinical investigations[52]. - The company expects to announce preclinical data for a third development candidate, BMF-650, in Q4 2024[43]. - The Phase 1/2 clinical trial COVALENT-111 for type 2 diabetes includes approximately 270 participants, with dosing durations up to 12 weeks[47]. - Icovamenib is being investigated in oncology through ongoing Phase 1 trials COVALENT-101 and COVALENT-102, focusing on liquid tumors and KRAS solid tumors, respectively[54]. - The company initiated dosing in the Phase 1 clinical trial COVALENT-101 in January 2022, targeting relapsed/refractory AML and ALL[55]. - BMF-500, a third-generation oral covalent small molecule inhibitor, was nominated in May 2022 and is currently in a Phase 1 study (COVALENT-103) for relapsed or refractory acute leukemia[61]. - The company anticipates completing dose escalation for COVALENT-101 and COVALENT-102 by the end of 2024[60]. - The company expects research and development expenses to increase substantially in the coming years as it seeks to initiate and complete clinical trials[63]. Expenses and Financial Outlook - Research and development expenses for the three months ended September 30, 2024, were $27.2 million, an increase of $1.9 million compared to $25.3 million for the same period in 2023[68]. - General and administrative expenses increased by $1.0 million during the three months ended September 30, 2024, primarily due to personnel-related costs[72]. - The company anticipates significant increases in general and administrative expenses due to staff expansion and compliance costs associated with being a public company[65]. - The company has substantial doubt about its ability to continue as a going concern without obtaining additional financing[73]. - The company anticipates needing to raise substantial additional capital to fund operations and product development, with requirements depending on various factors including clinical trials and regulatory reviews[74]. - The company sold 5,750,000 shares of common stock at a price of $30.00 per share in April 2023, resulting in net proceeds of $161.8 million[73]. - Net cash provided by financing activities was $1.3 million during the nine months ended September 30, 2024, significantly lower than $163.2 million in the same period of 2023[80][81]. Cash Position - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash of $88.3 million and an accumulated deficit of $357.9 million[73]. - As of September 30, 2024, the company held $88.3 million in cash, cash equivalents, and restricted cash[85]. Market Risks - The company is exposed to market risks primarily related to interest rate sensitivities, with no significant foreign currency risk reported[85]. - The company has no material changes in contractual obligations from the previous reporting period[82]. - The company has not reported any off-balance sheet arrangements during the periods presented[82]. - Non-cash adjustments in operating activities included stock-based compensation expense of $14.6 million for the nine months ended September 30, 2024[77]. - The company may seek additional capital through various means, including public or private equity offerings and collaborations[74].

Exhibit 99.1 Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights • U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT112 (Type 1 Diabetes) trials • COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024 • COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024 • On track to announce our third clinical candidate, BMF-650, for the treatment o ...

U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trialsCOVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and obesity – a next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA) - and pre ...

REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that the World Health Organization (WHO) has approved “icovamenib” as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, and that the United States ...

BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells Two trial-in-progress oral presentations to feature Phase II study design of oral covalent menin inhibitor BMF-219 in patients with type 2 diabetes (COVALENT-111) and in patients with type 1 diabetes (COVALENT-112) One late breaker oral presentation to highlight two case studies assessing BMF-219 in persons with poorly controlled severe insulin-deficient (SIDD) type 2 diabetes REDWOOD CITY, Calif ...

Shares of Biomea Fusion (BMEA) gained 9.1% on Thursday after the FDA lifted the clinical hold it had earlier placed on the company's ongoing early to mid-stage studies evaluating its lead candidate, BMF-219, for treating type 2 and type 1 diabetes (T2D and T1D). The update follows a thorough review of the clinical data on the candidate, to date. Biomea's BMF-219 is an investigational novel covalent menin inhibitor that has been developed using the company's proprietary FUSION System. Recent Regulatory Updat ...

REDWOOD CITY, Calif., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Biomea's ongoing Phase I/II clinical trials of the Company's investigational cova ...