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 March 31, 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 ...

Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Exhibit 99.1 • Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapy REDWOOD CITY, Calif., May 5, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a ...

Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapyBiomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“B ...

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]