Eric Schmidt

Jason Butler

Sarah Weber

Tim Lugo

Yigal Nochomovitz

- Ovid Therapeutics Inc. announced **positive topline results** from its Phase 1 healthy volunteer study for **OV329**, a next-generation GABA-aminotransferase inhibitor being developed for drug-resistant epilepsies, on **October 3, 2025**.  **[1636651_0001193125-25-230409_d45212dex991.htm:0]** **[1636651_0001193125-25-230409_d45212d8k.htm:7]** 
- The study demonstrated **statistically significant inhibition of GABA-AT** by OV329, matching or exceeding inhibition by vigabatrin, and showed a **preferable safety and tolerability profile** compared to marketed anti-seizure medicines.  **[1636651_0001193125-25-230409_d45212dex991.htm:0]** 
- Ovid plans to advance OV329 into a **Phase 2a study** in drug-resistant focal onset seizures and is completing a final enabling study to support regulatory filings for its oral KCC2 direct activator, **OV4071**, in early 2026.  **[1636651_0001193125-25-230409_d45212dex991.htm:0]** 
- On **October 2, 2025**, the company entered into a Securities Purchase Agreement to sell **57,722 shares of Series B Convertible Preferred Stock** and warrants to purchase a total of **67,342,325 shares of common stock**.  **[1636651_0001193125-25-230409_d45212dex101.htm:0]** **[1636651_0001193125-25-230409_d45212dex102.htm:0]**

Ovid Therapeutics Announces Positive OV329 Trial Results and New Securities Issuance

- Ovid Therapeutics successfully completed its Phase 1 safety and biomarker strategy for **OV329**, a next-generation GABA aminotransferase inhibitor, demonstrating a **positive safety profile** with clean ophthalmic results and target engagement.  **[1636651_2165671_1]** **[1636651_2165671_3]** 
- The company plans to initiate a **Phase 2a trial for OV329 in Q2 2026**, with **top-line data anticipated in mid-2027** for treatment-resistant epilepsies and focal onset seizures.  **[1636651_2165671_1]** 
- For its KCC2 program, top-line safety, tolerability, and PK data for the intravenous **OV350** are expected in **Q4 2025**.  **[1636651_2165671_1]** **[1636651_2165671_10]**  The first oral KCC2 direct activator, **OV4071**, is slated for Phase 1/1b initiation in **Q2 2026**, with early proof of concept data in psychosis indications by **Q1 2027**.  **[1636651_2165671_1]** **[1636651_2165671_10]** 
- Ovid Therapeutics has **sufficient resources to fund its development programs through 2028**.  **[1636651_2165671_10]** **[1636651_2165671_10]** 
- The target market for OV329 in refractory and polypharmacy epilepsy and focal onset seizures represents approximately **40% of epilepsy patients** and a **>$1 billion commercial opportunity**.  **[1636651_2165671_10]** **[1636651_2165671_10]**

Ovid Therapeutics Announces Positive Phase 1 OV329 Data and Pipeline Milestones

- Ovid Therapeutics announced **positive topline results** from its Phase 1 healthy volunteer study evaluating **OV329**, a next-generation GABA-aminotransferase inhibitor for drug-resistant epilepsies.  **[1636651_eadb256f784c415a9da70827c2e27c8e_1]** 
- The study confirmed **statistically significant inhibition of GABA-AT**, with OV329's inhibition matching or exceeding that demonstrated by therapeutic doses of vigabatrin.  **[1636651_eadb256f784c415a9da70827c2e27c8e_0]** **[1636651_eadb256f784c415a9da70827c2e27c8e_3]** 
- OV329 demonstrated a **favorable safety and tolerability profile**, notably showing no evidence of ophthalmic or retinal changes, which appears preferable relative to marketed anti-seizure medicines.  **[1636651_eadb256f784c415a9da70827c2e27c8e_0]** **[1636651_eadb256f784c415a9da70827c2e27c8e_3]** 
- Ovid plans to advance OV329 into a **Phase 2a study in drug-resistant focal onset seizures, planned to initiate in Q2 2026**.  **[1636651_eadb256f784c415a9da70827c2e27c8e_0]** **[1636651_eadb256f784c415a9da70827c2e27c8e_4]** 
- The company also provided pipeline updates, including anticipated regulatory filing for **OV4071** (oral KCC2 direct activator) in Q1 2026 and topline data for **OV350** (intravenous KCC2 direct activator) in Q4 2025.  **[1636651_eadb256f784c415a9da70827c2e27c8e_4]**

Ovid Therapeutics (OVID)