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Jun 30, 2024
Biomea Fusion Q2 2024 Earnings Report
Reported second quarter 2024 financial results and corporate highlights.
Key Takeaways
Biomea Fusion reported a net loss of $37.3 million for the second quarter of 2024. The company is focused on resolving the clinical hold for BMF-219 in diabetes and advancing its BMF-500 program. Topline readouts for COVALENT-111 and COVALENT-112 are expected in Q4 2024.
COVALENT-111 Phase 2b topline readout is on track for Q4 2024.
COVALENT-112 Phase 2a topline readout is on track for Q4 2024.
A third program in obesity is expected to be announced in Q3 2024.
The company is working with the FDA to resolve the clinical hold for BMF-219 in diabetes.
Biomea Fusion
Biomea Fusion
Forward Guidance
Biomea Fusion anticipates several milestones including topline data readouts for COVALENT-111 and COVALENT-112 in Q4 2024 and the announcement of a third program in obesity in Q3 2024. However, the clinical hold on BMF-219 trials poses a challenge.
Positive Outlook
- Topline Week 26 data readout of Phase 2b with approximately 195 patients of COVALENT-111 expected for Q4 2024.
- Topline data readout of Phase 2a of COVALENT-112 with approximately 20 patients expected for Q4 2024.
- Announcement of a third development candidate, a potent, selective, GLP-1 receptor agonist, expected in Q3 2024.
- Complete dose escalation portion of COVALENT-101 expected by year end 2024.
- Complete dose escalation portion of COVALENT-102 expected by year end 2024.
Challenges Ahead
- A full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of BMF-219 in type 2 and type 1 diabetes.
- FDA noted deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of COVALENT-111.
- Two cohorts, CLL and DLBCL of COVALENT-101 have been discontinued due to insufficient enrollment.
- The company's top priority is working with FDA to resolve the clinical hold for BMF-219 in diabetes.
- There is a risk that Biomea may encounter delays in preclinical or clinical development.