Ovid Therapeutics Inc. Q4 FY2025 earnings call

Meg Alexander discussed pipeline progress including regulatory clearance for OV4071 (first-ever oral KCC2 direct activator), safety and tolerability data for OB329 7-milligram dose, launching additive studies for OB329, and new programs in infantile spasms and seizures associated with tuberous growth complex. Jeff Rona highlighted cash position with $90.4 million as of Dec 31, 2025, and pipe financing gross proceeds of $60 million, with cash runway into late 2028 and well into 2029 with warrant exercise.

No regular quarterly earnings calls moving forward. On track to initiate Phase I study for OV4071 next quarter, Phase II randomized placebo-controlled trial for OB329 in Q2, open-label photosensitivity study later this year, start programs in tuberous sclerosis complex and infantile spasms with signal finding and safety studies, and have cash runway well into 2029 with pipe financing and warrant exercise.

Q: Talk more about 329 and visual monitoring, PPR study expectations.

A: Continue ophthalmic and retinal monitoring in Phase II and pivotal studies. PPR study designed to demonstrate anticonvulsant effect.

Q: Phase II design for OB329 in FOS, rationale for ketamine challenge study.

A: Phase II in adults with treatment-resistant focal-onset seizures, endpoints like percent reduction in seizures. Ketamine challenge to show OV4071 gets into brain, has GABAergic effect.

Q: Open label photosensitive epilepsy study enrollment, long-term differential pricing.

A: Enroll adults with documented photosensitivity. Consider differential pricing with different formulations for different populations.

Q: Vagabitrin history, market size, visual concern.

A: Vigabatrin had post-market visual issues, peak sales over 320M in U.S. for related indications.

Q: 329 dose, rationale for not higher dose.

A: 100% of 5 and 7mg doses in exposure range. Ceiling of GABA aminotransferase enzyme inhibition around 60-65%.

Q: KCC2 program, R&D day preclinical data.

A: More preclinical data on biomarker strategy, indication selection at KCC day.

Q: Longer-term clinical development for 329, status epilepticus.

A: Believe broad utility, but complex trials for status epilepticus not near.

Q: First readout from TSC study, PPR study efficacy endpoints.

A: Open label TSC study designed to establish safety, signal, confirm dose modeling. PPR study looks at reductions in IPS frequencies, threshold frequency, complete suppression.