Biomea Fusion Q2 2024 Financial Results and Highlights

Biomea Fusion, Inc., a clinical-stage biopharmaceutical company dedicated to developing oral covalent small molecules for treating metabolic diseases and genetically defined cancers, has announced its financial results and corporate highlights for the second quarter of 2024. The company remains focused on several key projects, including resolving a clinical hold with the FDA and advancing its pipeline of clinical trials.

During Q2 2024, Biomea’s top priority was addressing the FDA’s clinical hold on its investigational covalent menin inhibitor BMF-219, which is being tested in clinical trials for type 2 and type 1 diabetes under the names COVALENT-111 and COVALENT-112, respectively. The FDA's concerns stemmed from potential drug-induced hepatotoxicity observed in earlier trials. Biomea reported that initial data from the first two patients with type 1 diabetes treated with BMF-219 showed improved beta-cell function and the drug was generally well tolerated.

Key milestones are anticipated in the near future. The topline readout for COVALENT-111's Phase 2b trial, involving approximately 195 patients, is expected in Q4 2024. Similarly, the topline readout for COVALENT-112's Phase 2a trial with about 20 patients is also slated for Q4 2024.

Biomea is also planning to announce its third program focused on obesity, featuring a potent and selective GLP-1 receptor agonist. This announcement is expected in Q3 2024.

In the oncology domain, Biomea continues to progress with several trials:
- COVALENT-101 (BMF-219 for Liquid Tumors): The completion of the dose escalation portion is expected by the end of 2024, although two cohorts (CLL and DLBCL) have been discontinued due to insufficient enrollment.
- COVALENT-102 (BMF-219 for Solid Tumors): Dose escalation is also expected to conclude by year-end 2024.
- COVALENT-103 (BMF-500 for Acute Leukemias): The dose escalation portion is projected to complete by the end of 2024.

Biomea continues to invest in its proprietary FUSION™ System, which aims to enhance the discovery and development of covalent-binding small molecule medicines.

Financially, the company reported having $113.7 million in cash, cash equivalents, and restricted cash as of June 30, 2024, a decrease from $177.2 million at the end of 2023. The net loss for Q2 2024 was $37.3 million, which included $4.8 million in stock-based compensation. This marks an increase compared to the $24.9 million net loss reported for the same quarter in 2023. The six-month net loss for 2024 stood at $76.3 million, inclusive of $9.9 million in stock-based compensation, compared to a $53.9 million loss in the same period of the previous year.

Research and Development (R&D) expenses for Q2 2024 were $31.8 million, up from $21.9 million in Q2 2023. The increase was attributed to higher clinical and pre-clinical development costs for BMF-219 and BMF-500, as well as personnel-related expenses. For the first half of 2024, R&D expenses totaled $65.6 million, a significant rise from $46.3 million in the same timeframe of 2023.

General and Administrative (G&A) expenses also saw an increase, reaching $7.1 million for Q2 2024 compared to $5.7 million in Q2 2023. This was mainly due to higher personnel-related expenses, including stock-based compensation. For the first six months of 2024, G&A expenses were $14.4 million, up from $11.4 million in the same period in 2023, driven by personnel costs and external consultant fees.

Biomea Fusion remains committed to advancing its clinical trials and expanding its pipeline of therapies, with the ultimate goal of improving patient outcomes in metabolic diseases and genetically defined cancers.

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