Efficacy of Icovamenib - In Severe Insulin-Deficient Diabetes (SIDD) patients (Arm B), 12 weeks of icovamenib treatment resulted in a mean HbA1c reduction of 1.5% at Week 52 (p=0.01)[46, 55, 65] - Patients on GLP-1 based therapy who were not achieving target HbA1c levels experienced a clinically meaningful HbA1c reduction of 1.3% at Week 52 (p=0.05) after 12 weeks of icovamenib treatment[56, 66] - Higher icovamenib exposure, measured by PK Mean AUC, was associated with greater HbA1c reduction across all dosing arms[43, 44] - The company believes data suggest that a readily achievable exposure level could provide ≥1.5% HbA1c reductions in T2D patients[47, 56] Safety and Tolerability - Icovamenib was generally well-tolerated, with no adverse-event related discontinuations and no related serious adverse events reported[29, 66, 70] - The percentage of patients with at least one Treatment Emergent Adverse Event (TEAE) in the combined icovamenib arms was 27% (55 out of 201 patients), comparable to the placebo arm at 27% (18 out of 66 patients)[59] - No deaths were reported in any of the treatment arms[59] Trial Design and Patient Characteristics - The COVALENT-111 study was a Phase 2 randomized, double-blind, placebo-controlled study in participants with Type 2 Diabetes (T2D)[10] - The study included 216 planned participants, with a 3:1 randomization ratio of icovamenib to placebo[11] - The Per Protocol Population on 1 or More Antihyperglycemic Agents at Baseline included 163 patients, with 114 in the combined icovamenib arms and 49 in the placebo arm[15, 17, 18] Next Steps - The company plans to optimize icovamenib exposure and define dosing criteria with a Food Effect Study (COVALENT-121)[71] - The company plans to investigate icovamenib in severe insulin deficient diabetes patients in a Phase IIb Type 2 Diabetes Study (COVALENT-211)[71] - The company plans to investigate icovamenib in combination with a GLP-1 based therapy in a Phase II Type 2 Diabetes Study (COVALENT-212)[71]

Biomea Fusion (NASDAQ:BMEA) shares rose after reporting positive results from its mid-stage study testing icovamenib in individuals with type 2 diabetes over a 52-week period. The stock closed up 24% on Monday. The study found that icovamenib provided lasting treatment ...

Core Insights - Biomea Fusion, Inc. announced positive 52-week results from its Phase II COVALENT-111 study for icovamenib in type 2 diabetes patients, indicating durable efficacy and safety [1][2][5] Study Design and Results - COVALENT-111 is a double-blind, randomized, placebo-controlled trial involving adult patients with type 2 diabetes diagnosed within the last 7 years, with specific HbA1c and BMI criteria [3][4] - The study evaluated three dosing regimens of icovamenib, with a total of 267 patients receiving at least one dose, focusing on a modified intent-to-treat population of 163 patients [4] - Positive results were observed across multiple subgroups, with severe insulin-deficient patients showing a durable HbA1c reduction of 1.2% (p=0.01) sustained through Week 52 [5][8] - Patients on GLP-1-based therapy who did not achieve glycemic targets also showed a 1.3% reduction in HbA1c (p=0.05) after 8 or 12 weeks of treatment [6][8] Safety Profile - Icovamenib maintained a favorable safety profile throughout the 52-week observation period, with no treatment-related serious adverse events reported [7][8] Future Plans - The company plans to initiate Phase II trials in severe insulin-deficient diabetes patients and those not achieving glycemic targets with GLP-1 therapy in the fourth quarter of 2025 [8][15] Mechanism of Action - Icovamenib is a selective covalent inhibitor of menin, which is believed to enable the proliferation and preservation of healthy insulin-producing beta cells, addressing the underlying dysfunction in diabetes [12][13] Market Context - Diabetes is a significant health issue, with over 38 million people in the U.S. affected, highlighting the need for effective treatments [14]

SAN CARLOS, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that on September 24, 2025, the compensation committee of Biomea’s board of directors granted one new employee non-qualified stock options to purchase 48,000 shares of the Company’s common stock. The shares underlying each employee’s stock options will vest 1/16 on a quarterly basis over four years, subject to such empl ...

Core Insights - Biomea Fusion, Inc. presented preclinical data on its investigational menin inhibitor icovamenib in combination with semaglutide, showing enhanced body weight loss and glycemic control in a Type 2 Diabetes (T2D) animal model [1][2][3] Preclinical Findings - In a Zucker diabetic fatty (ZDF) rat model, the combination therapy of icovamenib and low-dose semaglutide resulted in significant improvements compared to semaglutide alone, including a 60% mean reduction in fasting blood glucose after two weeks and a 50% lower mean glucose AUC during an oral glucose tolerance test [5][7] - The combination therapy led to a greater mean body weight loss of -12.5% compared to -3.4% for semaglutide alone, with the weight loss driven entirely by fat mass reduction while preserving lean mass [7] Clinical Development Plans - Biomea plans to advance clinical evaluation of icovamenib in combination with GLP-1 therapies, with a Phase II study expected to begin in the second half of 2025 [5][8] - The company has received FDA clearance for the Investigational New Drug Application (IND) for its next-generation oral GLP-1 receptor agonist, BMF-650, with a Phase I clinical trial in obesity set to initiate soon [6][8] Mechanism of Action - Icovamenib is designed to inhibit menin, which is believed to support beta cell regeneration, potentially reversing the progression of T2D by enhancing insulin-producing beta cell function [9][11] Market Context - Diabetes is a significant health issue in the U.S., with over 37 million people affected and a substantial economic burden on the healthcare system, indicating a strong need for effective treatments [10]

Core Insights - Biomea Fusion reported a net loss of $20.7 million for Q2 2025, a significant reduction from $37.3 million in Q2 2024, and beat consensus estimates with a loss of $0.51 per share compared to an expected loss of $0.53 per share [1][2] - The company recorded no revenue, aligning with expectations for a pre-commercial-stage firm, while demonstrating progress in financial efficiency through major cost reductions in research and administrative expenses [1][5] Financial Performance - Net loss decreased by 44.5% year-over-year from $37.3 million in Q2 2024 to $20.7 million in Q2 2025 [2][5] - Research and development expenses were reduced to $16.6 million from $31.8 million in the same period last year, a decrease of 47.8% [2][5] - General and administrative expenses also fell to $4.7 million from $7.1 million, a decrease of 33.8% [2][5] - Total cash as of June 30, 2025, was $56.6 million, with an additional $42.8 million raised through an equity offering during the quarter [5][11] Business Model and Strategic Focus - Biomea Fusion is focused on developing covalent small molecules for metabolic diseases, particularly type 2 diabetes and obesity, with icovamenib as its lead candidate [3][4] - The company aims to address the root causes of diabetes rather than just glucose levels, positioning icovamenib as a potential disease-modifying agent [3] Clinical Developments - The COVALENT-111 Phase II study of icovamenib showed promising results, including reduced hemoglobin A1c levels and improved beta cell function [6][8] - Preclinical studies indicated that icovamenib combined with semaglutide resulted in greater reductions in blood sugar and body weight compared to semaglutide alone [6][7] - Upcoming clinical catalysts include 52-week data from the COVALENT-111 study and additional Phase II studies in difficult-to-treat diabetes populations [8][12] Future Outlook - The company did not provide specific financial guidance but indicated that available cash is expected to fund operations into the second half of 2026 [11] - Future operating expenses are projected to be about 40% lower than in Q2 2025, reflecting planned cost reductions [11][12] - Key developments to monitor include long-term data from ongoing trials and regulatory steps for BMF-650 in obesity [12]

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 June 30, 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 ...

Company Overview and Q2 2025 Highlights Biomea Fusion, a clinical-stage diabetes and obesity company, reported Q2 2025 results, highlighting clinical data and a **$42.8 million** financing [Introduction and CEO Commentary](index=1&type=section&id=1.1.%20Introduction%20and%20CEO%20Commentary) The Interim CEO highlighted positive clinical and preclinical data for icovamenib and BMF-650, and a **$42.8 million** equity financing to advance programs - Biomea Fusion is a clinical-stage diabetes and obesity company[2](index=2&type=chunk) - Icovamenib demonstrated potential as a novel, potentially first-in-class investigational agent for type 2 diabetes and obesity, with preclinical data showing superior glycemic control and weight reduction in combination with low-dose semaglutide, while fully preserving lean mass[3](index=3&type=chunk) - BMF-650 showed encouraging results in obese cynomolgus monkeys, achieving up to **15% weight reduction** and robust dose-dependent appetite suppression, reinforcing its potential as an oral GLP-1 RA[3](index=3&type=chunk) - Completed a **$42.8 million** equity financing to advance high-priority diabetes and obesity programs[3](index=3&type=chunk) [Second Quarter 2025 Corporate Highlights](index=1&type=section&id=1.2.%20Second%20Quarter%202025%20Corporate%20Highlights) Q2 2025 highlights included icovamenib presentations, robust BMF-650 preclinical results, a **$42.8 million** public offering, and workforce reduction to optimize expenses - Three presentations at ADA 2025 highlighted icovamenib's therapeutic potential, demonstrating durable HbA1c reduction and improved beta-cell function in T2D patients, and promoting healthy myotube morphology[5](index=5&type=chunk)[6](index=6&type=chunk) - BMF-650 demonstrated robust, dose-dependent weight loss and appetite suppression in obese non-human primates; planned Investigational New Drug (IND) submission remains on track for the second half of 2025[5](index=5&type=chunk) - Raised approximately **$42.8 million** in gross proceeds through a public offering, extending projected cash runway into the second half of 2026[5](index=5&type=chunk) - Reduced workforce and quarterly expenses to support core programs, anticipating future quarterly operational expenses to be approximately **40% lower**[5](index=5&type=chunk)[8](index=8&type=chunk) Clinical Development Program Updates Updates on clinical development programs for icovamenib, BMF-650, and BMF-500 detail their progress and key findings [Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)](index=1&type=section&id=2.1.%20Icovamenib%20%28Oral%20Small%20Molecule%20Menin%20Inhibitor%20for%20T2D%20and%20T1D%29) Icovamenib showed significant therapeutic potential in T2D patients with durable HbA1c reduction and enhanced beta-cell function, and superior metabolic benefits in preclinical models - In T2D patients, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months post-dosing, particularly in severe insulin deficient patients enrolled in its Phase II trial[6](index=6&type=chunk) - In a ZDF rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone, including[10](index=10&type=chunk) Fasting Blood Glucose, Glucose OGTT AUC, HbA1c Decline, HOMA-IR (Insulin Resistance), C-peptide to Glucose Ratio, Body Weight Reduction | Metric | Icovamenib + Low-dose Semaglutide vs. Low-dose Semaglutide Alone | | :-------------------------------- | :---------------------------------------------------------------- | | Fasting Blood Glucose | **60% lower** | | Glucose OGTT AUC | **50% lower** | | HbA1c Decline | **>1% by Day 28** and **>2% by Day 39** | | HOMA-IR (Insulin Resistance) | **75% lower** | | C-peptide to Glucose Ratio | **2-fold increase** | | Body Weight Reduction | **10% greater**, primarily due to fat mass reduction with complete lean mass preservation | - Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures[10](index=10&type=chunk) [BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)](index=2&type=section&id=2.2.%20BMF-650%20%28Next-generation%20Oral%20Small%20Molecule%20GLP-1%20RA%20for%20Obesity%29) BMF-650 demonstrated rapid, dose-dependent reductions in food intake and significant weight loss in obese cynomolgus monkeys, achieving average weight reductions of **15%** at the higher dose - In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of **15%** at the higher dose of 30 mg/kg/day[10](index=10&type=chunk) - BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations[10](index=10&type=chunk) - These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development, supporting BMF-650's potential as a best-in-class oral small-molecule GLP-1 RA[10](index=10&type=chunk) [BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia ("AML"))](index=2&type=section&id=2.3.%20BMF-500%20%28Oral%20Small%20Molecule%20FLT3%20Inhibitor%20in%20Acute%20Myeloid%20Leukemia%20%28%22AML%22%29%29) Updated Phase I data for BMF-500 in relapsed/refractory FLT3-mutant AML patients showed sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit; the company is now exploring strategic partnerships - Presented updated Phase I data at EHA 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib[10](index=10&type=chunk) - The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500[10](index=10&type=chunk) Key Anticipated 2025 Milestones Biomea Fusion anticipates key milestones for icovamenib and BMF-650 in 2025, including clinical data releases and IND submission [Icovamenib Milestones](index=2&type=section&id=3.1.%20Icovamenib%20Milestones) Biomea Fusion anticipates 52-week data from the Phase II COVALENT-111 study, initiation of a new Phase II study for T2D, and preliminary data from the Phase II COVALENT-112 study in T1D in the second half of 2025 - 52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025[12](index=12&type=chunk) - Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025[12](index=12&type=chunk) - Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025[12](index=12&type=chunk) [BMF-650 Milestones](index=3&type=section&id=3.2.%20BMF-650%20Milestones) Key milestones for BMF-650 in 2025 include the planned submission of the Investigational New Drug (IND) application and the anticipated initiation of a Phase I study in obese, otherwise healthy volunteers - Submission of the IND application for BMF-650 is planned for the second half of 2025[12](index=12&type=chunk) - Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance[12](index=12&type=chunk) Second Quarter 2025 Financial Results Biomea Fusion reported a reduced net loss for Q2 and H1 2025, driven by decreased R&D and G&A expenses, with **$56.6 million** cash expected to fund operations into H2 2026 [Financial Summary](index=3&type=section&id=4.1.%20Financial%20Summary) Biomea Fusion reported a reduced net loss for Q2 and H1 2025, primarily due to significant decreases in R&D and G&A expenses, with **$56.6 million** in cash expected to fund operations into H2 2026 Cash, Cash Equivalents, and Restricted Cash | As of | Amount (in millions) | | :---- | :------------------- | | June 30, 2025 | **$56.6** | | Expected Runway | Into H2 2026 | Net Loss Attributable to Common Stockholders (in millions) | Period | 2025 | 2024 | Change (YoY) | | :----- | :--- | :--- | :----------- | | Q2 Ended June 30 | **$(20.7)** | $(37.3) | **$(16.6) decrease** | | H1 Ended June 30 | **$(50.0)** | $(76.3) | **$(26.3) decrease** | Research and Development (R&D) Expenses (in millions) | Period | 2025 | 2024 | Decrease (YoY) | Primary Drivers | | :----- | :--- | :--- | :------------- | :-------------- | | Q2 Ended June 30 | **$16.6** | $31.8 | **$15.3** | Clinical activities (**$9.1M**), preclinical/explor

Core Insights - Biomea Fusion, Inc. reported its financial results for Q2 2025, highlighting advancements in its diabetes and obesity treatment programs, particularly icovamenib and BMF-650 [1][2] Financial Performance - The company reported a net loss of $20.7 million for Q2 2025, a decrease from a net loss of $37.3 million in Q2 2024 [10] - Research and Development (R&D) expenses were $16.6 million for Q2 2025, down from $31.8 million in the same period last year, reflecting a decrease in clinical activities and operational costs [11][13] - General and Administrative (G&A) expenses were $4.7 million for Q2 2025, compared to $7.1 million in Q2 2024, primarily due to reduced personnel-related expenses [14] - As of June 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $56.6 million, expected to fund operations into the second half of 2026 [9] Clinical Developments - Icovamenib demonstrated significant improvements in glycemic control and weight loss in combination with low-dose semaglutide, with a 60% reduction in fasting blood glucose and over 2% decline in HbA1c by Day 39 in rodent models [4][5] - BMF-650 showed promising results in a 28-day study with obese cynomolgus monkeys, achieving up to 15% weight reduction and robust appetite suppression [2][11] - The company plans to submit an Investigational New Drug (IND) application for BMF-650 in the second half of 2025 [12] Strategic Initiatives - Biomea raised approximately $42.8 million through a public offering, enhancing its financial position to support ongoing diabetes and obesity programs [7] - The company has reduced its workforce and operational expenses, anticipating future quarterly operational expenses to be approximately 40% lower than the most recent quarter [8]

Core Viewpoint - Biomea Fusion, Inc. has appointed Julianne Averill to its Board of Directors, effective July 22, 2025, succeeding Bihua Chen, who has served for over four years [1][2]. Group 1: Appointment Details - Julianne Averill brings extensive financial, operational, and strategic expertise in life sciences and digital health, which will benefit Biomea's mission to transform diabetes and obesity care [2]. - Averill has over two decades of experience in high-growth life sciences and digital health companies, currently serving as Managing Director at Danforth Advisors [2]. - She has been involved in transactions and strategic initiatives exceeding $10 billion in aggregate value [2]. Group 2: Background of Julianne Averill - Averill holds a B.S. in Business Administration and an M.S. in Accountancy from California State University [3]. - She is a licensed CPA in California and holds certifications from the Society of Human Resources and the National Association of Corporate Directors [3]. Group 3: Company Overview - Biomea Fusion is focused on developing oral small molecules, icovamenib and BMF-650, aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [4].