Core Insights - Ovid Therapeutics Inc. announced a CEO succession plan with Meg Alexander set to become CEO on January 1, 2026, while Dr. Jeremy M. Levin transitions to Executive Chairman [1][2][3] - The company reported third-quarter financial results and provided updates on its clinical pipeline, highlighting progress in its drug development programs [1][4][11] Leadership Transition - Meg Alexander has been with Ovid since 2021 and has played a key role in developing the company's pipeline and overseeing operations [2] - Dr. Levin expressed confidence in Alexander's leadership and emphasized the importance of continuity during the transition [3] Pipeline and Clinical Updates - Ovid's OV329, a next-generation GABA-aminotransferase inhibitor, is advancing to Phase 2 patient studies following positive Phase 1 results, demonstrating strong inhibitory activity [4][5][8] - The KCC2 direct activator portfolio is progressing, with OV350 expected to report first-in-human data in Q4 2025 and OV4071 anticipated to enter clinical trials in Q2 2026 [5][9][10] Financial Performance - For Q3 2025, Ovid reported total revenue of $132,000, a decrease from $173,000 in Q3 2024 [15] - Research and development expenses were $5.9 million, down from $7.9 million in the same period last year, while general and administrative expenses increased to $6.8 million from $5.5 million [15] - The net loss for Q3 2025 was $12.2 million, compared to a net loss of $14.0 million in Q3 2024, with a basic and diluted net loss per share of $0.17 [15][19] Funding and Financial Strategy - Ovid completed a private placement of up to $175 million, with an initial closing of approximately $81 million, expected to extend its cash runway into the second half of 2028 [5][11] - As of September 30, 2025, Ovid had $25.6 million in cash, cash equivalents, and marketable securities [15][21]

Summary of Ovid Therapeutics Conference Call Company Overview - **Company**: Ovid Therapeutics (NasdaqGS:OVID) - **Focus**: Development of neurotherapeutics targeting conditions driven by neural hyperexcitability, particularly in epilepsy Key Points and Arguments Pipeline and Product Development - Ovid is advancing a pipeline that includes: - **OV329**: A next-generation GABA aminotransferase (GABA AT) inhibitor for treatment-resistant epilepsies and focal onset seizures - **KCC2 Direct Activators**: Including OV350 (IV) and OV4071 (oral), targeting potassium chloride cotransporter 2 - **Phase 1 Results**: OV329 has completed Phase 1 safety and biomarker studies, with plans to initiate Phase 2a in Q2 2026 and report top-line data in mid-2027 [8][10][42] Market Need and Competitive Landscape - There is a significant unmet need in epilepsy treatment, with only two novel mechanisms approved in the last 30 years despite 30 anti-seizure medications being available [10][11] - Approximately 40% of epilepsy patients are treatment-resistant, representing a market opportunity exceeding $1 billion [44] Safety and Efficacy of OV329 - **Safety Profile**: OV329 demonstrated a favorable safety profile with no serious adverse events and only mild, transient side effects [24][41] - **Efficacy Metrics**: Positive biomarker data indicates OV329 effectively inhibits GABA AT, with a potential for superior efficacy compared to existing treatments like vigabatrin [14][20][41] - **Dosing**: Expected dosing for OV329 is significantly lower than vigabatrin, with estimates of 5-7 mg compared to 2-3 grams for vigabatrin [20][21] Mechanism of Action - OV329 provides both phasic and tonic inhibition of GABA, which may lead to better tolerability and efficacy compared to previous GABAergic medications [15][16][64] - The drug's design aims to avoid the ocular safety issues associated with vigabatrin, which has been linked to vision loss [19][21] Phase 2a Trial Design - The upcoming Phase 2a trial will evaluate a 7 mg dose of OV329 against placebo over eight weeks, focusing on treatment-resistant focal onset seizures [43][44] - The trial will measure various efficacy outcomes, including seizure frequency and responder rates [43] Future Development Plans - Ovid plans to continue developing its KCC2 portfolio, with expected readouts for OV350 by the end of 2025 and initiation of Phase 1 studies for OV4071 in 2026 [45][46] - The company has sufficient resources to fund its development programs through 2028 [45] Additional Important Information - The call emphasized the importance of differentiating OV329 from existing treatments through its unique mechanism and safety profile [54][64] - The company is committed to building a robust safety database to support the development of OV329 and mitigate monitoring requirements for patients [27][41] - The anticipated market dynamics and reimbursement landscape are favorable for OV329, despite the competitive nature of the epilepsy treatment market [44]

Core Viewpoint - Ovid Therapeutics Inc. has announced a private investment in public equity (PIPE) financing expected to generate gross proceeds of up to $175 million, with an initial closing of approximately $81 million to support its operating plan and clinical pipeline through 2028 [1][6]. Financing Details - The PIPE financing is anticipated to close around October 6, 2025, pending customary closing conditions [1]. - New investors participating in the PIPE include Janus Henderson Investors, RA Capital Management, and others, alongside existing investors [2]. - The company is selling 57,722 shares of Series B non-voting convertible preferred stock, Series A warrants for 38,481,325 shares of common stock, and Series B warrants for 28,861,000 shares of common stock [3]. Securities Structure - Each share of Series B Preferred Stock is convertible into 1,000 shares of common stock, subject to stockholder approval and ownership limitations [4]. - Series A and Series B Warrants have an exercise price of $1.40 per share and will be exercisable following stockholder approval [5]. Use of Proceeds - The net proceeds from the PIPE financing will be used for research and development, general corporate expenses, and working capital needs, with expectations to fund operations into 2028 [6]. Company Overview - Ovid Therapeutics is focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline that includes OV329 for treatment-resistant seizures and other compounds targeting CNS disorders [10].

Core Insights - Ovid Therapeutics Inc. announced positive topline results from its Phase 1 study of OV329, a next-generation GABA-aminotransferase inhibitor aimed at treating drug-resistant epilepsies, demonstrating a favorable safety and tolerability profile [1][2][6] Trial Design - The Phase 1 trial involved 68 healthy volunteers, with 51 receiving active treatment and 17 receiving placebo, testing doses from 1 mg to 5 mg [3] - Safety, tolerability, pharmacokinetic, and pharmacodynamic activities were assessed, including rigorous ophthalmic evaluations and extensive exploratory biomarker analyses [3][4] Biomarker and Efficacy Results - OV329 showed significant GABAergic inhibition, with a 53% increase in inhibition at the 5 mg dose as measured on the abductor pollicis brevis muscle [8] - The study confirmed OV329's ability to penetrate the brain and engage its target, achieving biological modulation consistent with elevated GABA levels [4][8] - After 7 days of dosing at 5 mg, mean GABA levels increased by 7.13% in the medial parietal lobe compared to 0.24% in placebo [8] Safety and Tolerability - The safety profile of OV329 was favorable, with all treatment-related adverse events reported as mild and transient, and no evidence of ophthalmic or retinal changes observed [6][9] - Extensive ophthalmic tests showed no adverse effects, contrasting with existing treatments like vigabatrin, which can accumulate in the retina [6] Future Development Plans - Ovid plans to advance OV329 into a Phase 2a study for drug-resistant focal onset seizures, expected to start in Q2 2026 [10] - The company is also progressing its KCC2 direct activator portfolio, with several regulatory and clinical milestones anticipated in the next 12 months [10][11]

Core Insights - Ovid Therapeutics Inc. reported business updates and financial results for Q2 2025, highlighting advancements in its drug pipeline and financial performance [1][19]. Pipeline and Business Updates - The company is advancing its pipeline with key readouts expected soon, including Phase 1 data for OV329, a potential treatment for conditions driven by excess neuronal excitation [2][3]. - OV329 is designed to be a safer GABA-aminotransferase inhibitor, aiming to replace vigabatrin, which has serious safety concerns [4][5]. - The Phase 1 study for OV329 is on track for topline results in late Q3 2025, with plans for a Phase 2a trial in adults with treatment-resistant focal onset seizures [9][16]. - Ovid is also progressing its KCC2 direct activator programs, with OV350's safety data expected in Q4 2025 and OV4071's first-in-human studies anticipated in early 2026 [10][11][12]. Financial Performance - As of June 30, 2025, Ovid had cash, cash equivalents, and marketable securities totaling $38.3 million, expected to support operations into early H2 2026 [7][22]. - Revenue from royalty agreements increased to $6.3 million in Q2 2025, compared to $169,000 in the same period of 2024 [22]. - Research and development expenses decreased to $6.5 million in Q2 2025 from $12.6 million in Q2 2024, reflecting organizational restructuring [22]. - The company reported a net loss of $4.7 million for Q2 2025, compared to a net income of $8.5 million in Q2 2024 [22]. Strategic Developments - Ovid entered a $7.0 million agreement with Immedica Pharma AB to monetize ganaxolone royalties, strengthening its balance sheet and extending its operational runway [14][15]. - The company plans to explore strategic options to accelerate development and offset costs, including partnerships and monetizing intellectual property [17][18].

Company Overview - Ovid Therapeutics Inc. is a biopharmaceutical company based in New York, focused on developing small molecule medicines for brain conditions with significant unmet needs [2] - The company is advancing a pipeline of novel, targeted small molecule candidates that address neuronal hyperexcitability associated with various neurological and neuropsychiatric disorders [2] Product Pipeline - Ovid is developing OV329, a next-generation GABA-aminotransferase inhibitor, aimed at treating treatment-resistant seizures and other undisclosed indications [2] - The company is also working on OV350, OV4071, and additional compounds that activate the KCC2 transporter for multiple central nervous system disorders [2] Upcoming Events - Company management will participate in the BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025 [1]

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].

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]

Core Insights - Ovid Therapeutics Inc. reported strong progress in its clinical pipeline, with a focus on developing small molecule medicines for brain conditions, particularly treatment-resistant seizures and other neurological disorders [2][3][16] Clinical Pipeline - The lead program, OV329, is a next-generation GABA aminotransferase inhibitor aimed at treating drug-resistant epilepsies, with topline results expected in Q3 2025 [4][8] - OV350, the first direct activator of the potassium chloride cotransporter 2 (KCC2), has been initiated in a Phase 1 trial, with safety and tolerability results anticipated by year-end 2025 [9][10] - The company is also developing OV4071, an oral KCC2 direct activator, expected to enter clinical development by the end of 2026 [11][12] Financial Performance - As of March 31, 2025, Ovid had cash, cash equivalents, and marketable securities totaling $43.0 million, which is projected to support operations into the second half of 2026 [6][15] - Revenues from royalty agreements for Q1 2025 were $130,000, a decrease from $148,000 in Q1 2024 [15][19] - Research and development expenses decreased to $6.7 million in Q1 2025 from $10.4 million in the same period in 2024, reflecting organizational restructuring [15][18] Business Strategy - Ovid plans to explore partnerships and co-development opportunities to accelerate development and offset costs, while maintaining fiscal discipline to achieve key clinical milestones [14][12] - Anticipated milestones include results for OV329's pharmacodynamic biomarker and safety data in Q3 2025, and the initiation of a Phase 2a study for OV329 in Q1 2026 [13][12]

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]