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Dec 31, 2023
Ovid Therapeutics Q4 2023 Earnings Report
Reported business updates and financial results.
Key Takeaways
Ovid Therapeutics reported its Q4 and full-year 2023 financial results, highlighting the progress of its pipeline programs, including OV888, OV329, and OV350, and the anticipated milestones for soticlestat by Takeda. The company's cash runway is expected to extend into the first half of 2026.
Two pivotal Phase 3 clinical trials studying soticlestat for LGS and DS completed enrollment; Takeda anticipates topline data readout by or before September 2024.
OV888 (GV101) is progressing on-track in a Phase 1, double-blind, multiple-ascending dose trial; a higher dose cohort has been added and no serious adverse events have been observed.
Feedback from a pre-IND session with the FDA supports potential initiation of a Phase 2 study of OV888 (GV101) in the second half of 2024.
Phase 1 study with OV329 continues to progress; data expected in the second half of 2024.
Forward Guidance
Ovid anticipates its cash runway will support operations and clinical development programs into the first half of 2026. Ovid also anticipates several events for its current pipeline programs and clinical results for soticlestat from Takeda in 2024.
Positive Outlook
- OV888 (GV101) is progressing on-track in a Phase 1, double-blind, multiple-ascending dose trial
- Feedback from a pre-IND session with the FDA supports potential initiation of a Phase 2 study of OV888 (GV101) in the second half of 2024
- Phase 1 study with OV329 continues to progress; data expected in the second half of 2024
- An IV formulation of OV329 for potential treatment of acute seizures is on track for an anticipated IND application or an equivalent regulatory application by late 2024
- The initial program from the portfolio, which is an IV formulation of OV350, is anticipated to submit an IND by year-end 2024.
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