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Dec 31, 2022
Biomea Fusion Q4 2022 Earnings Report
Reported fourth quarter and full year 2022 financial results and business highlights.
Key Takeaways
Biomea Fusion reported a net loss attributable to common stockholders of $25.3 million for the three months ended December 31, 2022. As of December 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $113.4 million.
Expanded clinical development footprint of BMF-219 to eight liquid and solid tumor indications and type 2 diabetes across three ongoing clinical trials
Advanced BMF-219 to the clinic for type 2 diabetes; completed the Phase I healthy volunteer portion of the study in Canada, initiated dosing of type 2 diabetic patients in the Phase II portion in the U.S. and Canada and reported initial clinical data from the first two cohorts of diabetic patients
Continued to advance the second product candidate, BMF-500, toward the clinic with IND filing on track for the first half of 2023
Cash position of $113.4 million at the end of the fourth quarter of 2022
Biomea Fusion
Biomea Fusion
Forward Guidance
In 2023, Biomea Fusion will significantly advance all three programs and plan to deliver on multiple data readouts, beginning with initial data reported this quarter from the COVALENT-111 study in patients with type 2 diabetes.
Positive Outlook
- On track to present initial clinical data of AML/ALL patients dosed in the COVALENT-101 study in the first half of 2023
- On track to file IND for BMF-500 in the first half of 2023 to initiate COVALENT-103 study in patients with acute leukemias
- Further clinical updates at higher treatment doses expected including follow up on the initial dosing cohorts reported in the first quarter of 2023
- On track to announce a third development candidate from the FUSIONTM platform in the first half of 2023
- Dosed first patient in January 2023 in COVALENT-102, a study of BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation.