Announcement • 1h

Ovid Therapeutics Reports Pipeline and Business Updates

Ovid Therapeutics Inc. announced that OV4071 advancing in Phase 1 study: Ovid continues to progress OV4071 through an ongoing Phase 1 study in healthy volunteers. The Phase 1 study is intended to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of this first-ever oral direct potassium-chloride cotransporter 2 (KCC2) activator. Data from the study are expected to support initiation of a Phase 2 proof-of-concept study in acute schizophrenia in 2027 and provide insights into future development across additional high-value central nervous system (CNS) indications. A growing body of pharmacodynamic and translational data demonstrates OV4071’s ability to restore excitatory/inhibitory (E/I) balance across more than 40 disease models, including psychosis, cognition and behavioral dysfunction with results meeting or exceeding marketed traditional antipsychotics. In preclinical studies, OV4071 also demonstrated favorable properties and no evidence of sedation. OV4071 is supported by a translational biomarker strategy designed to help guide and de-risk clinical development. Ketamine challenge study: Building on the encouraging Phase 1 results thus far and as a part of the clinical development plan, Ovid intends to initiate a ketamine challenge study of OV4071 in the second half of 2026 to further characterize potential pharmacodynamic effects and proof-of-mechanism using electrophysiology and biomarkers. The study is designed to reproduce biological and neurotransmitter surges of glutamate and dopamine in a healthy volunteer to assess key biomarkers relevant to schizophrenia and other potential indications. KCC2 portfolio expansion; advancing next-generation compounds to support broad CNS therapeutic potential: Ovid has a discovery engine focused on identifying novel KCC2 direct activator molecules that are amenable for oral and injectable administration and moving them into IND-enabling studies. OV329 next-generation GABA-AT inhibitor: Phase 2 initiated with proof-of-concept studies underway, supporting continued development across multiple seizure disorders. Ovid continues to advance OV329, its next-generation 4-aminobutyrate aminotransferase (GABA-AT) inhibitor, through proof-of-concept studies designed to establish the program's clinical potential across multiple seizure disorders. OV329 acts as a GABA-AT inhibitor and this represents a mechanism of action that has been previously validated in multiple seizure disorders. Building upon robust cortical inhibition that was established in human healthy volunteers, the Company is expanding development into multiple indications, including treatment-resistant focal onset seizures (FOS), tuberous sclerosis complex (TSC)-associated seizures and infantile spasms (IS). Initiated Phase 2 randomized, placebo-controlled study evaluating efficacy, safety and tolerability in treatment-resistant FOS:Ovid has received regulatory clearance across multiple regions and has initiated the dose-confirmatory study to evaluate seizure reduction efficacy, safety and tolerability of OV329 in people living with treatment-resistant FOS. This global study is designed with registrational-level rigor to potentially support multiple future seizure indications for OV329. The study is anticipated to be completed in the second half of 2027; Exploratory proof-of-mechanism photosensitivity study:Ovid has received regulatory clearances and has initiated a photo stimulation study to evaluate the anti-convulsant effect of multiple potential doses of OV329. The Company intends to test three doses of OV329, including 5, 7 and 9 milligrams, and anticipates results near year end 2026; Proof-of-concept studies in developmental epileptic encephalopathies (DEEs), TSC and IS:Ovid is in the process of initiating development programs for OV329 to assess proof of safety and anti-convulsant effect in TSC-associated seizures and IS using a weight-based pediatric formulation, which is independent from the adult fixed-dose tablets being tested in FOS. The Company expects to initiate a proof-of-concept safety and signal-finding study in the fourth quarter of 2026 to evaluate OV329 in patients with TSC-associated seizures. This study will help inform the dosing strategy for a subsequent study in IS, which is anticipated to commence in 2027. GABA-AT inhibition has previously been established as an effective mechanism of action in these DEEs, and OV329 is designed to be a GABA-AT inhibitor with a favorable safety, tolerability and efficacy profile.

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