Core Viewpoint - Biomea Fusion, Inc. is undergoing a strategic realignment to focus on core programs, particularly in diabetes and obesity, while extending its cash runway for long-term success [2][10]. Strategic Realignment Highlights - The company is prioritizing the development of icovamenib, an oral small molecule menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist [8]. - A workforce reduction of approximately 35% has been implemented to streamline operations and reduce costs [8]. - Biomea is consolidating its workforce at the Biomea Innovation Lab Center in San Carlos, CA, effective May 31, 2025 [8]. Key Anticipated 2025 Milestones - Submission of the Investigational New Drug (IND) application for BMF-650 is planned for the second half of 2025 [5]. - Phase II study of icovamenib in T2D patients currently uncontrolled on GLP-1 therapy is set to initiate in the second half of 2025 [8]. - Preliminary data from the Phase II COVALENT-112 study in type 1 diabetes is expected in the second half of 2025 [8]. Financial Results - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $36.2 million, expected to fund operations into the fourth quarter of 2025 [11]. - The net loss for the first quarter of 2025 was $29.3 million, a decrease from a net loss of $39.1 million in the same period of 2024 [12]. - Research and Development (R&D) expenses were $22.9 million for the first quarter of 2025, down from $33.8 million in the same period of 2024 [13].

Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook. Contact: Meichiel Jennifer Weiss Sr. Director, Investor Relations and Corporate Development IR@biomeafusion.com Biomea is a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and metabolic disease. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offe ...

A downtrend has been apparent in Biomea Fusion, Inc. (BMEA) lately with too much selling pressure. The stock has declined 19.3% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround. However, like every investing tool, RSI has its limitations, and should not be used alone for making an investment decision ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 of ...

"2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "As we move into this next phase, the Board made a strategic decision to align leadership with the company's evolution, and I'm honored to ...

REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights. "2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particul ...

Technically, every stock oscillates between being overbought and oversold irrespective of the quality of their fundamentals. And the beauty of RSI is that it helps you quickly and easily check if a stock's price is reaching a point of reversal. Biomea Fusion, Inc. (BMEA) has been on a downward spiral lately with significant selling pressure. After declining 20.4% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement am ...

Executive Leadership Change - Biomea Fusion, Inc. announced the appointment of Mick Hitchcock as interim CEO, replacing Thomas Butler, effective immediately [2][4] - Hitchcock has been a board member since 2021 and has extensive experience in pharmaceutical research and development [3] Clinical Development Progress - The company is focused on developing a novel therapy for diabetes, with recent positive Phase II data for icovamenib in insulin-deficient patients marking a significant milestone [3] - Biomea is advancing late-stage development efforts and preparing for regulatory engagement [3] Company Mission and Strategy - Biomea aims to cure diabetes through innovative covalent therapies, utilizing its proprietary FUSION™ System to develop next-generation small-molecule medicines [5][6] - The company emphasizes the advantages of covalent small molecules, including greater target selectivity and the potential for deeper, more durable responses [5]

Core Insights - Biomea Fusion, Inc. presented promising preclinical and clinical data on icovamenib at the ATTD 2025 Conference, indicating its potential as a first-in-class, disease-modifying therapy for diabetes by targeting beta-cell restoration and enhancing insulin secretion [1][2][3] Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral covalent small molecules aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [18] - The company utilizes its proprietary FUSION™ System to discover and develop next-generation covalent-binding small-molecule medicines [19] Product Insights - Icovamenib is an investigational covalent menin inhibitor designed to restore pancreatic beta-cell mass and function, which are critical in insulin-deficient diabetes [3][17] - The therapy demonstrated a significant increase in C-peptide production, indicating improved beta-cell function, with effects lasting beyond the treatment period [2][4][14] - A strong correlation was observed between C-peptide increase and HbA1c reduction, supporting icovamenib's proposed mechanism of action [6][14] Clinical Findings - Patients with severe insulin-deficient diabetes showed a 53% mean increase in C-peptide index levels by Week 26 after receiving icovamenib [14] - The treatment resulted in a statistically significant placebo-adjusted mean reduction in HbA1c of 1.47% at Week 26 [6] - Icovamenib enhanced the responsiveness of human islets to GLP-1-based medicines, suggesting potential for combination therapy [6][14] Market Context - Severe insulin-deficient diabetes is an underserved patient population, estimated to affect over 100 million people worldwide [6] - The findings from icovamenib's studies could address a significant unmet need in diabetes treatment, particularly for patients with poor beta-cell function [2][4][10]

Core Points - Biomea Fusion, Inc. granted non-qualified stock options to a new employee for a total of 25,000 shares, vesting quarterly over four years [1][2] - The stock option award is part of Biomea's 2023 Inducement Equity Plan, adopted on November 17, 2023 [2] - Biomea is focused on developing oral covalent small molecules for diabetes, obesity, and metabolic diseases, aiming to improve patient outcomes [3][4] Company Overview - Biomea Fusion is a clinical-stage company dedicated to discovering and developing innovative medicines for diabetes and obesity [3] - The company utilizes its proprietary FUSION™ System to create next-generation covalent-binding small-molecule medicines [4] - Biomea aims to provide significant clinical benefits and potentially cure diseases for the patients it serves [4]