Biomea Fusion(BMEA) - 2025 Q2 - Quarterly Results

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 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] - 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] - 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] - Completed a $42.8 million equity financing to advance high-priority diabetes and obesity programs[3] Second Quarter 2025 Corporate Highlights 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][6] - 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] - Raised approximately $42.8 million in gross proceeds through a public offering, extending projected cash runway into the second half of 2026[5] - Reduced workforce and quarterly expenses to support core programs, anticipating future quarterly operational expenses to be approximately 40% lower[5][8] 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) 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] - 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] 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] BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity) 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] - BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations[10] - 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] BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia ("AML")) 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] - The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500[10] 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 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] - 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] - Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025[12] BMF-650 Milestones 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] - Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance[12] 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 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