Ovid Therapeutics Q1 2020 Earnings Report
Key Takeaways
Ovid Therapeutics reported a net loss of $20.0 million for the first quarter of 2020. The company is progressing with its clinical development programs, with anticipated data readouts for Soticlestat and OV101 in the coming quarters. Positive topline results were announced from the Phase 2 ROCKET trial of OV101 for the treatment of Fragile X syndrome.
Announced positive topline results from Phase 2 ROCKET trial of OV101 for Fragile X syndrome.
Reported encouraging initial data from Phase 2 ARCADE study of soticlestat in CDKL5 deficiency disorder and Dup15q syndrome.
Topline data from Phase 2 ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome expected in Q3 2020.
Topline data from pivotal Phase 3 NEPTUNE trial in Angelman syndrome expected in Q4 2020, with increased enrollment to 90 patients.
Ovid Therapeutics
Ovid Therapeutics
Forward Guidance
Ovid Therapeutics anticipates several clinical data readouts in the coming quarters, including Phase 2 ELEKTRA trial results in Q3 2020 and Phase 3 NEPTUNE trial results in Q4 2020. The company continues to advance its pipeline of potential first-in-class medicines for rare neurological disorders.
Positive Outlook
- Phase 2 ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome: Topline data expected in Q3 2020.
- ENDYMION Open Label Extension Trial: Data expected in Q3 2020, concurrent with ELEKTRA results.
- Phase 3 NEPTUNE trial in Angelman syndrome: Topline data expected in Q4 2020.
- Phase 2 ARCADE trial (Full Data) in CDD or Dup15q syndrome: Data expected in early 2021.
- Expansion of NEPTUNE trial to include responder analysis requested by European regulatory authorities.
Challenges Ahead
- COVID-19 pandemic has resulted in mandated closures of clinical trial sites.
- Closures have affected new enrollment in the ongoing Phase 3 NEPTUNE clinical trial in Angelman syndrome.
- Delays in the enrollment of the Phase 3 NEPTUNE trial due to clinical site closures.
- Uncertainties in the development and regulatory approval processes.
- Initial data from clinical trials may not be indicative or guarantees of the final results.