GABA - aminotransferase inhibition
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Ovid Therapeutics Announces New OV329 Data and Indication Expansion, Phase 1 Clearance for OV4071, and Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-03-18 10:05
Core Insights - Ovid Therapeutics Inc. reported progress in its pipeline and business updates, highlighting favorable results for OV329, a GABA-AT inhibitor, and plans for additional development programs [1][3][4] Pipeline and Business Updates - OV329 demonstrated a favorable safety and tolerability profile in a 7 mg dose cohort, leading to plans for patient studies [4][5] - The company is expanding OV329's development to include tuberous sclerosis complex (TSC) seizures and infantile spasms (IS), supported by a $60 million private placement [1][6][10] - A Phase 1 trial for OV4071, a first-in-class oral KCC2 direct activator, has been approved and is set to begin [2][14] - Ovid plans to host a KCC2-focused R&D Day on April 14, 2026, to discuss its KCC2 portfolio [6][14] Financial Results - As of December 31, 2025, Ovid reported $90.4 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into late 2028 [6][23] - The company reported a net income of $9.7 million for Q4 2025, compared to a net loss of $9.3 million in Q4 2024, primarily due to a gain from a long-term equity investment [27][30] - Total revenue for 2025 was $7.3 million, an increase from $0.6 million in 2024, driven by royalties and a one-time payment [23][30] Clinical Development Plans - Ovid plans to initiate a Phase 2 trial for OV329 in focal onset seizures and an open-label proof-of-concept study in Q2 2026 [9][20] - The company is also advancing a pediatric-specific formulation of OV329 for use in infants and children [12][11] - A ketamine challenge study for OV4071 is planned for mid-2026 to explore its pharmacodynamic effects [16][20] Business Strategy - The approval of OV4071 triggers a 30-day period for the exercise of Series A Warrants, potentially raising an additional $53.9 million [17][18] - Proceeds from the recent private placement will support the expansion of OV329 into additional indications [19][18]