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

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]

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]

Group 1 - Ovid Therapeutics reported a quarterly loss of $0.13 per share, better than the Zacks Consensus Estimate of a loss of $0.16, and an improvement from a loss of $0.22 per share a year ago, resulting in an earnings surprise of 18.75% [1] - The company posted revenues of $0.08 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 45.71%, compared to year-ago revenues of $0.14 million [2] - Ovid Therapeutics shares have declined approximately 47.6% since the beginning of the year, contrasting with the S&P 500's decline of 4.5% [3] Group 2 - The earnings outlook for Ovid Therapeutics is mixed, with the current consensus EPS estimate for the coming quarter at -$0.15 on revenues of $0.15 million, and -$0.64 on revenues of $0.55 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which Ovid Therapeutics belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Position - The company has sufficient cash on hand to fund operations into the second half of 2026[52]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $53.1 million[412]. - The company’s primary exposure to market risk is interest rate sensitivity, which is influenced by changes in U.S. interest rates[412]. - An immediate 100 basis point change in interest rates would not materially affect the fair market value of the company's cash equivalents and marketable securities[412]. - The company intends to maintain its portfolio of cash equivalents and marketable securities in institutional market funds, including U.S. Treasury and high-quality short-term corporate bonds[412]. Drug Development and Pipeline - OV329, a next-generation GABA-AT inhibitor, is being developed for adult and pediatric drug-resistant epilepsies and is shown to be 100-fold more potent than vigabatrin (VGB)[56][57]. - OV329 has demonstrated acceptable tolerability in humans with no serious adverse events reported during the Phase 1 study[62]. - The Phase 1 trial of OV329 is ongoing, with topline data expected in Q3 2025, and initial biomarker data suggests encouraging signs of target engagement[70][71]. - The company has in-licensed a portfolio of over 100 KCC2 direct activators from AstraZeneca, with plans to progress four unique programs into human clinical studies[72]. - OV329's preclinical studies indicate it does not accumulate in ocular tissues, unlike VGB, which is associated with ocular toxicity[64][68]. - The drug development strategy includes pursuing rare, resistant conditions as initial indications to demonstrate rapid proof-of-concept[52]. - The company employs biomarker strategies early in development to assess target engagement and pharmacodynamic effects[52]. - OV329's mechanism of action involves increasing GABA concentrations by inhibiting GABA-AT, potentially reducing seizures in patients[58]. - The KCC2 portfolio includes four programs in active development, targeting epilepsy and other neurological conditions, with potential therapeutic properties for anti-psychosis, anxiolytic, and anticonvulsant responses[75]. - OV350 IV initiated first-in-human studies in Q1 2025, with topline results expected in Q4 2025, focusing on safety, tolerability, and exploratory biomarkers[77]. - The company anticipates annual regulatory submissions for human trials from the KCC2 portfolio over the next three to four years, with a pending composition-of-matter application expiring in 2041[76]. - A collaboration with Graviton Bioscience Corporation was established in May 2023, involving a $10 million investment to develop OV888 (GV101), a selective ROCK2 inhibitor for rare neurological conditions[80][84]. - OV888 is currently on pause pending regulatory feedback on a competitive clinical-stage program for cerebral cavernous malformation (CCM), which affects approximately 1 in 250 individuals[82]. - The company has invested $5.1 million in Gensaic, Inc. to develop genetic medicines for neurological indications, retaining commercial rights to any resulting therapies[87]. - An exclusive license agreement with AstraZeneca was signed in December 2021, granting worldwide rights to KCC2 transporter activators for an upfront payment of $5 million and $7.3 million in stock[91]. Regulatory Environment - The FDA's review process for New Drug Applications (NDAs) typically takes about 10 to 12 months from submission, with a preliminary review occurring within the first 60 days[120][121]. - The FDA may require a risk evaluation and mitigation strategy (REMS) plan for drug approval, which could include various risk minimization tools[123]. - The company must comply with substantial regulatory requirements imposed by the FDA and other authorities throughout the drug development process[113][114]. - The FDA may impose post-approval requirements, including Phase 4 clinical trials and surveillance to monitor product safety and effectiveness after commercialization[131]. - Orphan Drug Act allows for orphan designation for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing benefits like PDUFA fee waivers[128]. - Orphan drug exclusivity grants seven years of market exclusivity post-approval, preventing other applications for the same indication unless clinical superiority is demonstrated[129]. Market and Competitive Landscape - The field of epilepsy and psychiatric medicines is highly fragmented, with competitors including UCB, Jazz Pharmaceuticals, and Acadia Pharmaceuticals, among others[100]. - The company faces significant competition in drug development, with competitors having greater financial and technical resources, as well as more experience in obtaining regulatory approvals[101]. - The company may face challenges in obtaining regulatory approval and achieving market acceptance due to the competitive landscape and potential advancements by competitors[103]. - Sales of drug candidates depend on coverage by third-party payors, which are increasingly limiting coverage and reducing reimbursements[136]. - The Affordable Care Act has significantly impacted the pharmaceutical industry, including establishing fees for manufacturers and revising Medicaid rebate calculations[142]. - The Inflation Reduction Act allows HHS to negotiate prices for certain high-expenditure drugs, affecting future revenue potential[145]. Human Capital and Corporate Governance - As of December 31, 2024, the company had 23 full-time employees, primarily in research and development, including professionals with extensive neurology experience[146]. - The company emphasizes employee engagement, talent acquisition, and diversity in managing human capital assets[147]. - The company has implemented hybrid work policies since 2022, enhancing employee work environment[152]. - The Board of Directors consists of five members, with four being independent, providing diverse expertise for company performance and growth[151]. - The company has equity incentive plans aimed at attracting and retaining top talent through equity-based and cash-based compensation awards[150]. - The company emphasizes a diverse and inclusive culture to attract and retain top talent necessary for growth[148]. Intellectual Property - The company has licensed a portfolio of U.S. and international patents related to its drug candidates, including OV101, OV329, and OV888, with expiration dates ranging from 2036 to 2041[106][107][108]. - The company relies on trade secrets and confidentiality agreements to protect its proprietary information, but there is a risk of breaches or independent discovery by competitors[111]. - The company has a library of proprietary genetic sequences targeting various disorders, which is part of its expanding intellectual property portfolio[109]. - The company has filed multiple patent families directed to methods of treatment and formulations, enhancing its competitive position in the market[106][108]. Compliance and Risk Management - Compliance with healthcare regulations is critical, as violations can lead to significant penalties, including exclusion from federal healthcare programs[140]. - Future healthcare reforms may result in lower reimbursements and impact revenue from product sales[141].

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]

Core Viewpoint - Ovid Therapeutics Inc. has appointed Dr. Stelios Papadopoulos to its Board of Directors, which is seen as a strategic move to enhance the company's growth and innovation in developing small-molecule medicines for neurological and psychiatric conditions [1][2]. Company Overview - Ovid Therapeutics is a biopharmaceutical company focused on creating novel medicines for brain conditions with significant unmet needs, advancing a pipeline of targeted small molecule candidates [4]. - The company is developing several key programs, including OV329 for treatment-resistant seizures, OV350 targeting multiple CNS disorders, and OV888/GV101 for neurovascular and neuro-inflammatory conditions [4]. Leadership and Expertise - Dr. Stelios Papadopoulos is recognized as a pioneering force in biotechnology, with over four decades of experience, including roles in investment banking and equity research [2]. - His leadership and strategic vision are expected to be instrumental in propelling Ovid forward, particularly in the context of its advancing pipeline and the potential for transformative medicines [2][3]. Strategic Importance - The appointment of Dr. Papadopoulos comes at a critical time for Ovid, as the company aims to deliver significant advancements in the treatment of neurological and psychiatric diseases [2]. - His involvement is anticipated to enhance Ovid's capabilities in bridging scientific discovery with financial strategy, which is crucial for the company's growth [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, targeting treatment-resistant seizures and other undisclosed indications [3] - OV350, along with a library of compounds that activate the KCC2 transporter, aimed at multiple CNS disorders [3] - OV888/GV101, a highly selective ROCK2 inhibitor, for undisclosed neurovascular and neuro-inflammatory conditions [3] Upcoming Events - Meg Alexander, President and Chief Operating Officer of Ovid Therapeutics, will present at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 3:10 p.m. ET in Boston, Massachusetts [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]

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 - Management will participate in a virtual presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 4:00 p.m. ET [1] - A live webcast of the presentation will be available on the company's website, with an archived replay accessible afterward [2]