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Biomea Fusion, Inc. (BMEA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-15 07:35
Company Overview - Biomea Fusion is currently developing two significant assets focused on diabetes and obesity [3] Product Development - The first asset, Icovamenib, is an oral small molecule specifically targeted at diabetes [4] - The company has reported data from the Covalent 111 study, highlighting significant activity in two patient populations [4]
Biomea Fusion (NasdaqGS:BMEA) FY Earnings Call Presentation
2026-01-15 01:15
1 Legal Disclaimer & Forward-looking Statements 2026 J.P. Morgan Healthcare Conference Mick Hitchcock, CEO Biomea Fusion January 14, 2026 Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the "Company") and involve known and unknown risks, uncertainties, and other factors that may cause the actual results, levels of activity, performance ...
Biomea Fusion (NasdaqGS:BMEA) Earnings Call Presentation
2025-10-07 12:30
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 (BMEA) Earnings Call Presentation
2025-07-04 10:33
Icovamenib Program - Icovamenib, a menin inhibitor, demonstrates significant and durable HbA1c reductions, up to approximately 1.5%, sustained well beyond the end of treatment[5] - In a Phase 2a study (COVALENT-111), a 12-week oral dosing of Icovamenib led to a placebo-adjusted HbA1c reduction of 1.5% (p=0.02) at Week 26 in patients with severe insulin-deficient diabetes[71] - At Week 26, patients with Severe Insulin-Deficient Diabetes (SIDD) showed a 53% mean increase in C-peptide levels after Icovamenib treatment[60] - Icovamenib has a $6 billion+ estimated U S revenue potential based on 10% penetration at $10,000 per year in the target T2D patients[7, 15] BMF-650 Program - BMF-650, an oral GLP-1 RA, is built on a similar scaffold as orforglipron, aiming for best-in-class status with an optimized exposure profile[7] - Preclinical studies of BMF-650 showed approximately 2 to 3-fold greater oral bioavailability compared to orforglipron[100] - In obese cynomolgus monkeys, BMF-650 demonstrated meaningful appetite suppression over a 6-day treatment period[110, 112] - In a weight loss study in obese cynomolgus monkeys, BMF-650 at 30 mg/kg resulted in a 15.2% average weight reduction from baseline over 28 days[126, 133] Financials and Milestones - For the three months ended March 31, 2025, Biomea Fusion reported a net loss of $29.262 million, or $0.80 per share[139] - As of March 31, 2025, Biomea Fusion had $36.2 million in cash, cash equivalents, and restricted cash[139]