Financial and Business Developments
- Cash Position: As of October 2, 2024, Biohaven's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $642 million.
- Troriluzole for SCA: Achieved positive topline results from a pivotal trial, showing troriluzole's efficacy in slowing disease progression in SCA patients. The company plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2024.
- BHV-2100 for Migraine: Initiated a Phase 2 trial for BHV-2100, a TRPM3 antagonist, in the acute treatment of migraine, aiming for FDA registration.
- Public Offering: Completed a public offering, raising approximately $269.9 million after expenses.
Clinical Trials and Pipeline Progress
- Troriluzole: Demonstrated statistically significant improvements in SCA patients, with plans for NDA submission and updates to MAA documents to include broader indications.
- BHV-2100: Phase 2 trial in migraine treatment underway, with expectations for enrollment completion and data readouts.
- Taldefgrobep Alfa: Anticipated Phase 3 topline data in spinal muscular atrophy (SMA) and initiation of a Phase 2 trial in obesity.
- MoDE™ Platform: Advancing studies with BHV-1300 and planning IND submissions for new investigational agents.
Financial Highlights
- R&D Expenses: Increased to $157.6 million for the quarter, reflecting advancing clinical trials and preclinical research.
- G&A Expenses: Rose to $20.6 million, partly due to increased non-cash share-based compensation.
- Net Loss: Reported a net loss of $160.3 million for the quarter, with non-GAAP adjusted net loss at $164.1 million.
Upcoming Milestones
Biohaven is poised for significant milestones in 2024 and 2025, including NDA submissions, Phase 3 data readouts, and advancements in its MoDE™ platform and ADC portfolio. The company remains focused on developing life-changing therapies for a broad range of diseases.
