Biomea Fusion Q3 2024 Financial Results and Corporate Highlights

Biomea Fusion, Inc., a clinical-stage biopharmaceutical company, has provided an update on its third-quarter 2024 financial results and corporate highlights. The company is focused on developing oral covalent small molecules to treat diabetes, obesity, and genetically defined cancers. Notably, the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Biomea's COVALENT-111 and COVALENT-112 trials for Type 2 and Type 1 diabetes, respectively.

Biomea Fusion is progressing with several significant milestones. The topline data for the Phase 2b 26-week dose expansion cohort of COVALENT-111 in Type 2 diabetes is anticipated in December 2024. Similarly, the topline data for the Phase 2a 26-week open label portion of COVALENT-112 in Type 1 diabetes is also expected in December 2024. Additionally, the company is on track to announce its third clinical candidate, BMF-650, for treating diabetes and obesity, which is a next-generation oral small-molecule GLP-1 receptor agonist. Preclinical data combining icovamenib (BMF-219) with GLP-1 RA-based therapy is scheduled to be shared on October 30th.

Biomea Fusion has also formed a Global Scientific Advisory Board composed of 22 world-renowned diabetes experts. This advisory board will provide strategic guidance and expertise as the company advances its diabetes and obesity treatment programs.

In a recent statement, CEO Thomas Butler highlighted the collaborative efforts with the FDA to resolve the clinical hold on their diabetes studies. This resolution has kept the study readouts on track for Type 2 diabetes and allowed the company to continue making significant progress with their third development program, BMF-650. Butler expressed excitement for the upcoming data readouts, particularly the topline Week 26 data of Phase 2b COVALENT-111, which involves around 200 Type 2 diabetes patients. This data will assist in defining the patient population for the Phase 3 trial.

Biomea Fusion has announced its participation in the 1st Asian Conference on Innovative Therapies for Diabetes Management, scheduled in Singapore from November 18-20, 2024. The company will present two trial-in-progress oral presentations and one late breaker oral presentation, showcasing case studies assessing icovamenib in severely insulin-deficient Type 2 diabetes patients.

The World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for Biomea's lead product candidate BMF-219. Additionally, the United States Adopted Name Council has adopted "icovamenib" as the United States Adopted Name (USAN) for BMF-219, further solidifying its identity in the therapeutic market.

Biomea Fusion's anticipated milestones include the completion of the dose escalation portion of the COVALENT-101 trial in acute myeloid leukemia and the COVALENT-102 trial for solid tumors. Similarly, the COVALENT-103 trial for acute leukemias is expected to complete its dose escalation portion. The company also aims to deliver a fourth IND candidate in 2025 based on its proprietary FUSION™ Platform technology.

The company's financial results for the third quarter of 2024 show a net loss attributable to common stockholders of $32.8 million, which included $4.7 million of stock-based compensation. This is compared to a net loss of $28.4 million for the same period in 2023. For the nine months ended September 30, 2024, the net loss was $109.1 million, including $14.6 million of stock-based compensation, compared to a net loss of $82.4 million for the same period in 2023.

Research and development (R&D) expenses for the three months ended September 30, 2024, were $27.2 million, an increase from $25.3 million in the same period in 2023. This increase was primarily due to higher expenses related to clinical activities, personnel-related costs, and external consultants, offset by decreases in preclinical activities and manufacturing costs. For the nine months ended September 30, 2024, R&D expenses were $92.8 million, up from $71.7 million in 2023.

General and administrative (G&A) expenses for the three months ended September 30, 2024, were $6.8 million, compared to $5.8 million in the same period in 2023. The increase was due to higher personnel-related expenses, including stock-based compensation. For the nine months ended September 30, 2024, G&A expenses were $21.2 million, up from $17.1 million in 2023.

As of September 30, 2024, Biomea Fusion had cash, cash equivalents, and restricted cash totaling $88.3 million, compared to $177.2 million as of December 31, 2023.

Biomea Fusion remains focused on utilizing its proprietary FUSION™ System to discover, design, and develop a pipeline of next-generation covalent-binding small-molecule medicines. The company's goal is to maximize clinical benefits for patients and have a significant impact on disease treatment.