Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights

Core Insights - Biomea Fusion, Inc. reported transformative advancements in 2024, particularly with icovamenib entering late-stage development for diabetes treatment, especially for patients with severe insulin deficiency [2][3] - The company announced a leadership transition with Mick Hitchcock, Ph.D., appointed as Interim CEO, reflecting confidence in the menin inhibitor program and the covalent small molecule platform [2][3] - Biomea is focusing exclusively on metabolic disorders, terminating ongoing oncology trials for icovamenib and reallocating resources to enhance diabetes and obesity programs [3] Financial Results - As of December 31, 2024, the company had cash, cash equivalents, and restricted cash of $58.6 million, a decrease from $177.2 million as of December 31, 2023 [17][29] - The net loss attributable to common stockholders was $29.3 million for Q4 2024, compared to a net loss of $34.9 million for the same period in 2023; for the full year, the net loss was $138.4 million, up from $117.3 million in 2023 [18] - Research and Development (R&D) expenses for Q4 2024 were $25.2 million, down from $30.9 million in Q4 2023; however, R&D expenses for the full year increased to $118.1 million from $102.5 million in 2023 [19] Clinical Development Updates - Icovamenib demonstrated significant reductions in HbA1c levels, achieving a 1.47% reduction in severe insulin deficient patients after 26 weeks of treatment [7] - The company anticipates key milestones in 2025, including an FDA meeting to discuss icovamenib's late-stage development and data readouts from ongoing studies [6][9] - Preclinical studies for BMF-650, an oral small molecule GLP-1 RA, showed promising results, including improved glucose-stimulated insulin secretion and appetite suppression [14] Strategic Initiatives - The formation of a Global Scientific Advisory Board with 22 experts in beta cell science and diabetes therapeutics aims to advance the clinical development of icovamenib [4] - Biomea plans to seek strategic partnerships to further its oncology portfolio while focusing on metabolic disease programs [3][16] - The company is utilizing its proprietary FUSION™ System to develop next-generation covalent-binding small-molecule medicines targeting diabetes and obesity [22][23]