NEW YORK, July 23, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, announced today that the Company's management will participate in the BTIG Virtual Biotechnology Conference being held on July 29-30, 2025. Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet ...

Core Viewpoint - Ovid Therapeutics has entered into a definitive agreement with Immedica Pharma for the sale of future royalties related to ganaxolone sales outside of China, providing Ovid with a non-dilutive capital infusion of $7 million to support its ongoing operations [1][2]. Group 1: Transaction Details - Immedica will pay $7 million in cash to acquire 100% of the royalty rights held by Ovid, enhancing Immedica's focus on ganaxolone by gaining control of additional intellectual property rights [1]. - The transaction includes royalties associated with a previous agreement Ovid had with Marinus Pharmaceuticals regarding ganaxolone for CDKL5 deficiency disorder [4]. - Ovid recorded approximately $566,000 in ganaxolone royalty revenues in 2024, indicating the current revenue scale from this asset [2]. Group 2: Company Backgrounds - Ovid Therapeutics is a biopharmaceutical company focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline of novel candidates targeting neurological disorders [7]. - Immedica is a pharmaceutical company dedicated to the commercialization of medicines for rare diseases, with a global distribution network serving patients in over 50 countries [6].

OV329 Program & Clinical Development - OV329 is a next-generation GABA-aminotransferase inhibitor being developed for neuronal hyperexcitability and seizures[27] - Phase 1 topline results for OV329, including biomarker data, are expected in Q3 2025[20, 16] - A Phase 2a trial in patients with focal-onset seizures is planned to start in Q1 2026, with topline results expected in Q1 2027[20] - Phase 1 trial includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, with a total of 64 participants (48 receiving active treatment)[90] Biomarker Strategy - The OV329 Phase 1 trial incorporates a comprehensive biomarker strategy using magnetic resonance spectroscopy (MRS), transcranial magnetic stimulation (TMS), and electroencephalogram (EEG) to assess target engagement and pharmacodynamic effects[43, 45] - MRS will measure GABA concentrations in the medial parietal lobe to validate target engagement[45] - TMS will assess cortical excitability and brain circuit function, with metrics like cortical silent period (CSP) and paired-pulse long-interval intracortical inhibition (LICI)[45] - EEG will measure brain waves linked to inhibitory (GABAergic) activity, focusing on high and low frequencies[45] - Targeted directional changes in TMS biomarkers are anticipated, with increases in CSP and LICI, consistent with the effects of therapeutic vigabatrin[74] Market Opportunity - The company estimates a >$1 billion market opportunity for OV329 in drug-resistant epilepsy (DRE), targeting 65,000 adults with focal onset seizures and a price of $16,000 per year[38] - There is a substantial opportunity within the developmental epileptic encephalopathies (DEE) segment, with a potential market of ~20,000 patients and an average price of $60,000 per year, representing a >$1 billion market[116] Safety & Tolerability - In the Phase 1 trial, no treatment-related adverse events (AEs) or serious adverse events (SAEs) were observed in 30 treated participants, with headache being the most common AE[95, 94] - Comprehensive ocular safety metrics in Phase 1 showed no vision or ocular findings associated with OV329 treatment[96] - Preclinical studies show OV329 does not accumulate in the retina, unlike vigabatrin, suggesting a differentiated safety profile[107, 109]

Summary of Ovid Therapeutics (OVID) Update / Briefing June 12, 2025 Company Overview - **Company**: Ovid Therapeutics (OVID) - **Focus**: Development of epilepsy treatments, specifically targeting uncontrolled neuronal hyperexcitability through innovative drug mechanisms Key Industry Insights - **Industry Context**: The epilepsy drug development landscape is characterized by a lack of novel mechanisms, with only two new mechanisms introduced in the last fifteen years despite the existence of over 30 anti-seizure medications [17][18] - **Market Opportunity**: Approximately 30-40% of individuals with drug-resistant epilepsy continue to experience seizures, indicating a significant unmet need for effective treatments [18][25] Core Program: OV329 - **Drug Profile**: OV329 is a next-generation GABA aminotransferase inhibitor designed to enhance GABA levels in the brain, aiming for improved safety and efficacy compared to existing treatments [19][21] - **Mechanism of Action**: OV329 works by inhibiting the enzyme that breaks down GABA, thereby increasing its availability in synaptic regions, which is crucial for controlling seizures [22][24] - **Clinical Development**: A Phase 1 readout is expected by the end of Q3 2025, with a Phase 2a study planned for early 2027 [60][66] Biomarker Strategy - **Biomarker Utilization**: The company employs a comprehensive biomarker strategy using MR spectroscopy, transcranial magnetic stimulation (TMS), and electroencephalography (EEG) to assess drug efficacy and safety [28][30][32] - **Expected Outcomes**: The biomarkers are anticipated to demonstrate target engagement, pharmacodynamic effects, and safety profiles, providing confidence in the drug's potential [63][64][66] Safety and Efficacy - **Safety Profile**: Initial Phase 1 results indicate no serious adverse events, with mild headaches being the most common side effect. Comprehensive ophthalmologic assessments show no visual changes, suggesting a favorable safety profile [65][66] - **Efficacy Expectations**: The drug is expected to show significant increases in GABA concentration and improvements in inhibitory measures, which are critical for its anti-seizure effects [63][64] Competitive Landscape - **Differentiation Strategy**: Ovid aims to differentiate OV329 through its unique mechanism of action and improved safety profile, addressing the needs of patients who are often on polypharmacy regimens [77] Additional Insights - **Patient-Centric Approach**: The company emphasizes its commitment to developing effective treatments for patients with drug-resistant epilepsy, highlighting the personal stories of affected families to underscore the urgency of their mission [70][72] - **Future Directions**: Ovid plans to leverage the data from ongoing studies to inform future clinical trials and regulatory submissions, aiming to establish OV329 as a leading treatment option in the epilepsy market [74][75] This summary encapsulates the critical points discussed during the Ovid Therapeutics update, focusing on the company's strategic direction, the innovative approach of OV329, and the broader implications for the epilepsy treatment landscape.

Core Insights - Ovid Therapeutics Inc. is hosting an event on June 12, 2025, to discuss the application of biomarkers in epilepsy and the pharmacodynamic activity of its OV329 program [1][2] - The event will feature Dr. Alexander Rotenberg, a leading expert in neurology, who will discuss the emerging use of biomarkers in anti-seizure medicine development [1][3] Company Overview - Ovid Therapeutics is focused on developing small molecule medicines for brain conditions with significant unmet needs, including treatment-resistant epilepsy [5] - The company is advancing a pipeline that includes OV329, a next-generation GABA-aminotransferase inhibitor designed to provide a novel approach for patients with treatment-resistant seizures [3][5] Clinical Development - OV329 is currently completing a Phase 1 study that evaluates its effects on pharmacodynamic biomarkers, safety, tolerability, and pharmacokinetics [3] - The program is expected to have a topline readout in Q3 2025, indicating progress in its clinical development [2]

Company Overview - Ovid Therapeutics Inc. is a biopharmaceutical company based in New York, focused on developing medicines for brain conditions with significant unmet needs [3] - The company is advancing a pipeline of novel, targeted small molecule candidates aimed at modulating factors involved in neuronal hyperexcitability, which is linked to various neurological and neuropsychiatric disorders [3] Pipeline Development - Ovid is developing several key candidates, including: - OV329, a next-generation GABA-aminotransferase inhibitor, intended for treatment-resistant seizures and other undisclosed indications [3] - OV350, along with a library of compounds that activate the KCC2 transporter, targeting multiple CNS disorders [3] - OV888/GV101, a highly selective ROCK2 inhibitor, aimed at undisclosed neurovascular and neuro-inflammatory conditions [3] Upcoming Events - Meg Alexander, President and Chief Operating Officer of Ovid Therapeutics, will present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 8:45 AM ET [1] - A live webcast of the presentation will be available on the company's website, with an archived replay accessible for approximately 30 days post-event [2]

Core Insights - Ovid Therapeutics is at a pivotal moment with its pipeline advancing into the next stage of clinical development, particularly focusing on OV329 for treatment-resistant epilepsies and KCC2 activators [2][3] - The company has strengthened its leadership team with key appointments to enhance its regulatory and investor strategies [5][6] Business Strategy & Updates - Ovid anticipates its cash runway will support operations and clinical development into the second half of 2026, with several key milestones expected, including results for OV329 biomarker and safety data in Q3 2025 and initiation of a Phase 2a study in Q1 2026 [3][4] - The company is committed to fiscal discipline in managing clinical development programs and exploring partnerships to accelerate development and offset costs [4] Organizational Updates - Key appointments include Stelios Papadopoulos to the Board of Directors and Manal Morsy and Victoria Fort to the management team, aimed at supporting the company's pipeline and business strategies [5][6][7] - The Phase 1 study of OV329 is expected to yield topline results in Q3 2025, focusing on biomarkers that measure clinical effect and safety [5] Pipeline Strategy & Updates - Ovid is developing a differentiated pipeline targeting neurological and psychiatric disorders, including OV329 as a next-generation GABA-AT inhibitor for drug-resistant epilepsies [8][10] - The company is advancing its KCC2 direct activator library, with OV350 already in a first-in-human study and OV4071 expected to enter human trials in Q2 2026 [14] Financial Results - As of December 31, 2024, Ovid reported cash, cash equivalents, and marketable securities totaling $53.1 million, expected to support operations into the second half of 2026 [15][21] - The company reported a net loss of $26.4 million for the year ended December 31, 2024, an improvement from a net loss of $52.3 million in 2023 [16][20]