Biomea Fusion, Inc. reported a net loss of $138.4 million for the year ended December 31, 2024, compared to a net loss of $117.3 million in 2023. Research and development expenses increased by $15.5 million to $118.1 million in 2024, primarily due to increased clinical activity expenses of $12 million and an increase in personnel-related expenses of $3 million. General and administrative expenses rose by $2.4 million to $26 million. Interest and other income, net, decreased by $3.2 million to $5.6 million.
The company announced a leadership transition in March 2025, appointing Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, replacing Thomas Butler. In January 2025, Biomea Fusion also announced a strategic shift to focus solely on diabetes and obesity treatments, discontinuing its oncology programs. The company's lead product candidate, icovamenib, is currently in Phase II clinical trials for both type 1 and type 2 diabetes. Positive topline data from the COVALENT-111 study (type 2 diabetes) showed statistically significant HbA1c reductions at week 26. The COVALENT-112 study (type 1 diabetes) experienced enrollment delays due to a clinical hold, which was lifted in September 2024.
Biomea Fusion is also developing BMF-650, a next-generation oral GLP-1 receptor agonist for diabetes and obesity, with an IND application planned for the second half of 2025. As of December 31, 2024, the company had 106 full-time employees, 79 of whom were in research and development. The company relies on third-party manufacturers for production and anticipates needing substantial additional capital to fund its operations and continue as a going concern. The company's cash, cash equivalents, and restricted cash totaled $58.6 million as of December 31, 2024.
Biomea Fusion's financial performance is heavily reliant on the success of its clinical trials and subsequent regulatory approvals. The company's future capital requirements are dependent on various factors, including the progress and costs of clinical trials, manufacturing, and commercialization efforts. The company has not generated any revenue to date and anticipates continuing to incur significant losses for the foreseeable future. The company's ability to continue as a going concern is dependent on securing additional funding.
The company's 10-K filing also details various risk factors, including those related to its limited operating history, dependence on key personnel, competition, regulatory approvals, intellectual property protection, and the inherent uncertainties of drug development. The filing includes forward-looking statements regarding future financial performance, clinical trial progress, and regulatory submissions, which are subject to various risks and uncertainties.
About Biomea Fusion, Inc.
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