Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights

Core Insights - The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Biomea Fusion's COVALENT-111 and COVALENT-112 trials for Type 2 and Type 1 diabetes, respectively [1][3] - The company is on track to announce topline data for COVALENT-111 and COVALENT-112 in December 2024, with approximately 200 and 20 patients involved [1][4] - Biomea Fusion is advancing its third clinical candidate, BMF-650, a next-generation oral small-molecule GLP-1 receptor agonist, with preclinical data expected to be shared on October 30, 2024 [1][2] Clinical Trials - COVALENT-111 and COVALENT-112 trials have resumed following FDA approval, focusing on icovamenib for Type 2 and Type 1 diabetes [3] - The company has formed a Global Scientific Advisory Board consisting of 22 experts in diabetes therapeutics [3] - Upcoming presentations at the 1st Asian Conference on Innovative Therapies for Diabetes Management will feature ongoing trial designs and case studies [3] Financial Performance - As of September 30, 2024, the company reported cash, cash equivalents, and restricted cash of $88.3 million, down from $177.2 million at the end of 2023 [6][14] - The net loss for Q3 2024 was $32.8 million, compared to a net loss of $28.4 million in Q3 2023 [6][12] - Research and Development (R&D) expenses increased to $27.2 million in Q3 2024 from $25.3 million in Q3 2023, primarily due to clinical activities and personnel-related expenses [6][12] Anticipated Milestones - Topline data readouts for COVALENT-111 and COVALENT-112 are expected in December 2024 [4] - Preclinical data on BMF-650 and the combination of icovamenib with GLP-1 RA-based therapies will be shared on October 30, 2024 [4] - The company aims to deliver a fourth IND candidate in 2025 based on its FUSION™ Platform technology [5]