Biomea Fusion (NasdaqGS:BMEA) FY Conference Transcript

Summary of Biomea Fusion FY Conference Call Company Overview - Company: Biomea Fusion (NasdaqGS:BMEA) - Focus: Development of treatments for diabetes and obesity, specifically through two main assets: Covamenib and BMF-650 [2][22] Key Points on Covamenib - Mechanism: Covamenib is a selective and partial menin inhibitor targeting the root cause of diabetes, which is progressive beta cell failure [4][11] - Patient Population: Approximately 35 million people in the U.S. have type 2 diabetes, with 7 million considered insulin deficient [5] - Clinical Study: Covalent 111 study showed significant A1C reduction, with a placebo-adjusted reduction of about 1.5 after 52 weeks [7][19] - Insulin Production: Covamenib increases insulin secretion as measured by C-peptide, indicating enhanced beta cell function [19] - Safety Profile: Adverse event rates were similar between placebo and covamenib groups, with no significant safety issues reported [16][17] Upcoming Studies - Covalent 211: Focused on insulin-deficient patients with HbA1c between 7.5 and 10.5, aiming for a 26-week primary endpoint readout in Q4 2026 [20][28] - Covalent 212: Targets patients on GLP-1 therapy with A1Cs greater than 7.5, also with a 26-week readout expected in Q4 2026 [21][28] Key Points on BMF-650 - Type: Oral GLP-1 receptor agonist designed for better bioavailability and consistent efficacy [22] - Preclinical Data: Demonstrated significant body weight reduction in monkey studies, with a 15% reduction in body weight at the highest dose after 28 days [24] - Clinical Study Design: Phase one study includes single ascending doses and multiple ascending doses, focusing on overweight or obese patients [26][27] Financial Overview - Cash Position: Approximately $70 million at the end of Q3, with a quarterly burn rate of around $12 million, providing a runway into early 2020 [34] Additional Insights - Market Potential: Covamenib offers a potential alternative to chronic insulin therapy, providing a short-term oral treatment option [19] - Weight Loss Expectations: For BMF-650, a 5% weight loss after 28 days is considered a win scenario, with a focus on maintaining weight loss over time [32][33]