Ovid Therapeutics Announces Q1 2024 Financial Results and Business Updates

Ovid Therapeutics Inc., a biopharmaceutical company dedicated to the advancement of treatments for rare epilepsies and brain disorders, reported significant advancements and financial outcomes for the first quarter ending March 31, 2024. The company's CEO, Jeremy Levin, highlighted the progress of their innovative clinical programs aimed at addressing the urgent needs of individuals suffering from developmental and epileptic encephalopathies.

One of the noteworthy updates is the completion of Takeda's Phase 3 studies on soticlestat, a potential new class of anti-seizure medication for treating Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). The results of these trials are expected in Takeda's fiscal first half of 2024. Ovid, having co-developed soticlestat through Phase 2, retains a substantial financial interest in the drug, including potential milestone payments and royalties from Takeda.

In collaboration with Graviton Bioscience, Ovid has completed a Phase 1 multiple-ascending dose (MAD) study of OV888 (GV101), a highly selective ROCK2 inhibitor aimed at treating cerebral cavernous malformations (CCM) and other rare neurological conditions. Topline safety data from this study are expected in the first half of 2024, and a Phase 2 program is planned for the second half of the year.

Ovid is also advancing development programs for OV329, a next-generation GABA-aminotransferase inhibitor designed to treat chronic and acute seizures. The oral formulation of OV329 is currently undergoing a Phase 1 safety study, with data anticipated by late 2024. Meanwhile, the intravenous (IV) formulation is on track for an investigational new drug (IND) application by the end of 2024.

Furthermore, Ovid is developing OV350 along with a portfolio of potassium chloride co-transporter 2 (KCC2) direct activators. OV350, expected to enter an IND phase by the end of 2024, represents the first program from this novel portfolio aimed at treating multiple diseases, including psychiatric and anticonvulsant conditions.

Financially, Ovid reported cash, cash equivalents, and marketable securities totaling $90.3 million as of March 31, 2024. This capital is projected to sustain operations into the first half of 2026. The company’s revenue for the first quarter was $148,000, a considerable increase from $66,000 in the same period of 2023, primarily driven by royalty and licensing agreements. Research and development expenses also saw a rise, amounting to $10.4 million, up from $6.6 million in the previous year, reflecting the expansion of Ovid’s clinical pipeline. General and administrative expenses decreased to $7.2 million from $8.3 million in the first quarter of 2023 due to reductions in full-time staff. Consequently, Ovid’s total operating expenses were $17.6 million, up from $15.0 million in the previous year. The net loss for the first quarter stood at $11.7 million, slightly improved from the $13.4 million loss reported in the same period of 2023.

Ovid Therapeutics continues to focus on the development of novel, targeted small molecules that could potentially be first-in-class or best-in-class neurotherapeutics. The mechanisms of action in their pipeline address key biological targets implicated in conditions such as neuronal hyperexcitability, vascular, and inflammatory disorders in the brain. This broad therapeutic potential may enable future development and partnering opportunities across a range of neurological conditions, including seizures, psychiatric conditions, and neurovascular diseases.

Moving forward, Ovid aims to advance its business development efforts by seeking collaborations to further develop opportunities for its KCC2 portfolio in non-core indications and exploring commercial partnerships for some of its programs outside the United States.