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Sep 30, 2023
Biomea Fusion Q3 2023 Earnings Report
Reported third quarter 2023 financial results and corporate highlights.
Key Takeaways
Biomea Fusion reported a net loss of $28.4 million for the third quarter of 2023. They had a cash position of $199.5 million at the end of the third quarter. Clinical trials for BMF-219 in type 1 and type 2 diabetes are progressing, and the first patient was dosed with BMF-500 in a Phase I clinical trial.
Demonstrated durable HbA1c lowering in the escalation portion of ongoing Phase II study in type 2 diabetes (COVALENT-111).
Expansion portion of COVALENT-111 cleared and actively enrolling in the U.S. and Canada; expected to enroll approximately 200 adults with type 2 diabetes.
Investigational new drug (IND) application cleared for Phase II clinical trial of BMF-219 in type 1 diabetes (COVALENT-112); enrollment of 150 adults with type 1 diabetes anticipated to begin in Q4 2023.
Dosed first relapsed/refractory AML patient with BMF-500, Biomea’s novel third generation investigational oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3).
Forward Guidance
Biomea Fusion is focused on advancing its clinical trials for BMF-219 and BMF-500, with anticipated milestones including reporting topline data for the escalation portion of COVALENT-111 and dosing the first patient in COVALENT-112.
Positive Outlook
- Report topline data for the escalation portion in Q4 2023 to include multiple BMF-219 dosing cohorts.
- Start enrollment of expansion portion of COVALENT-111 at two dose levels including 100 mg and 200 mg, with a fourth cohort following the completion of the escalation portion.
- Dose the first patient in COVALENT-112.
- Report additional details of the clinical data set of AML/ALL patients dosed in the COVALENT-101 study at an upcoming medical conference.
- Continued site activation and patient enrollment to establish optimal dose levels across all three solid tumor indications (NSCLC, CRC and PDAC with an activating KRAS mutation).
Historical Earnings Impact
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