Table of Contents OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ______________________ Commission File Number: 001-38085 _______________________________________________________ Ovid Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) _______________________________________________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 __________________________ ...

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]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 show a net loss of **$10.2 million**, an improvement from Q1 2024, with total assets decreasing to **$81.7 million** due to reduced cash and marketable securities [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$81.7 million** from **$92.2 million** at year-end 2024, driven by a decline in cash and marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $21,136 | $26,301 | | Marketable securities | $21,860 | $26,774 | | Total current assets | $45,921 | $55,940 | | Total assets | $81,654 | $92,167 | | **Liabilities & Equity** | | | | Total current liabilities | $9,307 | $10,522 | | Total liabilities | $22,377 | $23,941 | | Accumulated deficit | $(314,533) | $(304,299) | | Total stockholders' equity | $59,276 | $68,226 | | Total liabilities and stockholders' equity | $81,654 | $92,167 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the net loss improved to **$10.2 million** from **$11.7 million** in Q1 2024, primarily due to reduced R&D and G&A expenses Statement of Operations Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $130 | $148 | | Research and development | $6,659 | $10,397 | | General and administrative | $6,021 | $7,168 | | Total operating expenses | $12,680 | $17,565 | | Loss from operations | $(12,550) | $(17,417) | | Other income (expense), net | $2,315 | $5,723 | | **Net loss** | **$(10,235)** | **$(11,694)** | | Net loss per common share | $(0.14) | $(0.17) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used **$10.3 million** in cash in Q1 2025, a reduction from Q1 2024, resulting in a **$5.2 million** decrease in total cash and equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,280) | $(16,686) | | Net cash provided by investing activities | $5,102 | $20,188 | | Net cash provided by financing activities | $13 | $228 | | **Net (decrease) increase in cash** | **$(5,165)** | **$3,731** | | Cash, cash equivalents and restricted cash, at end of period | $23,067 | $32,703 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, accounting policies, and significant events, including **$43.0 million** in cash, soticlestat program discontinuation, and a **$1.8 million** fraudulent transfer recovery - Management believes that the Company's existing cash, cash equivalents and marketable securities of **$43.0 million** as of March 31, 2025, will be sufficient to fund its current operating plans for at least the next 12 months[33](index=33&type=chunk)[34](index=34&type=chunk) - In January 2025, Takeda announced the discontinuation of the soticlestat program, eliminating continuing debt or obligations to Ligand Pharmaceuticals related to the prior royalty sale[52](index=52&type=chunk)[115](index=115&type=chunk) - In January 2025, the Company fully recovered **$1.8 million** from a fraudulent transfer that occurred in 2024 and recorded it as a gain in other income[108](index=108&type=chunk) - The company operates as a single segment focused on developing medicines for brain conditions, with the Chairman and CEO as the Chief Operating Decision Maker (CODM)[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, attributing reduced net loss to lower operating expenses from restructuring and program pauses, confirming **$43.0 million** cash sufficiency for 12 months [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Total operating expenses decreased by **$4.9 million** in Q1 2025, driven by **$3.7 million** lower R&D and **$1.1 million** lower G&A expenses due to restructuring and program pauses Change in Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change $ | | :--- | :--- | :--- | :--- | | Research and development | $6,659 | $10,397 | $(3,738) | | General and administrative | $6,021 | $7,168 | $(1,147) | | **Total operating expenses** | **$12,680** | **$17,565** | **$(4,885)** | - The **$3.7 million** decrease in R&D expenses was primarily due to the pause of the OV888 (GV101) program and reduced headcount from the Q2 2024 organizational restructuring[153](index=153&type=chunk) - The decrease in G&A expenses was primarily due to the organizational restructuring executed in Q2 2024, which reduced payroll and other costs[154](index=154&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$43.0 million** in cash and equivalents, deemed sufficient for 12 months, while facing an accumulated deficit and capital raising limitations - As of March 31, 2025, the company had **$43.0 million** in cash, cash equivalents and marketable securities, which is believed to be sufficient to fund operations for at least 12 months[156](index=156&type=chunk) - The company has an at-the-market (ATM) offering program for up to **$75.0 million**, but its ability to sell shares is currently limited to one-third of its public float in any 12-month period because its public float is less than **$75.0 million**[165](index=165&type=chunk)[166](index=166&type=chunk) - Future funding requirements include potential milestone payments up to an aggregate of **$279.3 million** under license agreements with AstraZeneca and Northwestern, which are contingent and not recorded on the balance sheet[160](index=160&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity, though short-term investments mitigate material impact from rate changes - The company's primary market risk is interest rate sensitivity, but due to the short-term maturities of its investments, a **100 basis point** change in interest rates is not expected to have a material effect on their fair market value[177](index=177&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[179](index=179&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[181](index=181&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[183](index=183&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks including the need for additional capital, high drug development failure rates, competition, intellectual property challenges, and Nasdaq listing compliance issues - The company will require additional capital, which may not be available, and failure to obtain it will force delays, limits, or termination of drug development[187](index=187&type=chunk) - All drug candidates are in early clinical or preclinical development, with a high risk of failure, and success depends on successful development, regulatory approval, and commercialization[185](index=185&type=chunk)[207](index=207&type=chunk) - On February 10, 2025, the company received a notice from Nasdaq for non-compliance with the minimum **$1.00** bid price requirement and has until August 11, 2025, to regain compliance[359](index=359&type=chunk) - The company's ability to raise capital via its Form S-3 registration statement is limited to one-third of its public float (currently under **$75.0 million**) in any 12-month period[203](index=203&type=chunk) - A material weakness in internal control over financial reporting related to a fraudulent transfer was identified in Q3 2024 and remediated as of December 31, 2024[353](index=353&type=chunk)[355](index=355&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=71&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025[381](index=381&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and officer certifications

Company Overview - Ovid Therapeutics (OVID) is expected to report a quarterly loss of $0.14 per share, reflecting a year-over-year change of +17.7% [3] - Revenues are anticipated to be $0.07 million, down 53.3% from the same quarter last year [3] Earnings Expectations - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a stable outlook from covering analysts [4] - The Most Accurate Estimate for Ovid is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -1.45%, suggesting a bearish sentiment among analysts [10] Historical Performance - In the last reported quarter, Ovid was expected to post a loss of $0.16 per share but actually reported a loss of $0.13, achieving a surprise of +18.75% [12] - Over the past four quarters, Ovid has beaten consensus EPS estimates three times [13] Comparative Industry Analysis - ImmunityBio (IBRX), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.12 for the same quarter, indicating a year-over-year change of +40% [17] - ImmunityBio's revenues are projected to be $15.69 million, up 39125% from the previous year [17] - The consensus EPS estimate for ImmunityBio has been revised 1.5% lower over the last 30 days, resulting in an Earnings ESP of -2.85% [18]

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]

Ovid Therapeutics (OVID) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.16. This compares to loss of $0.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 18.75%. A quarter ago, it was expected that this company would post a loss of $0.19 per share when it actually produced a loss of $0.20, delivering a surprise of -5.26%.Over the last four quarters, the company has surpas ...