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]

Company Performance - Ovid Therapeutics reported a quarterly loss of $0.20 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.19, and compared to a loss of $0.16 per share a year ago, indicating a negative earnings surprise of -5.26% [1] - The company posted revenues of $0.17 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 15.33%, and showing an increase from $0.11 million in the same quarter last year [2] - Over the last four quarters, Ovid Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Performance - Ovid Therapeutics shares have declined approximately 57.8% since the beginning of the year, contrasting with the S&P 500's gain of 25.8% [3] - The current Zacks Rank for Ovid Therapeutics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $0.16 million, and for the current fiscal year, it is -$0.49 on revenues of $0.56 million [7] - The estimate revisions trend for Ovid Therapeutics is mixed, and changes in earnings expectations may occur following the recent earnings report [6] Industry Context - Ovid Therapeutics operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Core Viewpoint - Ovid Therapeutics has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors [4]. - For the fiscal year ending December 2024, Ovid Therapeutics is expected to earn -$0.55 per share, reflecting a 25.7% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Ovid Therapeutics has increased by 35.8%, indicating a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade of Ovid Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Group 1: Earnings Performance - Ovid Therapeutics reported quarterly earnings of $0.12 per share, exceeding the Zacks Consensus Estimate of a loss of $0.22 per share, and compared to a loss of $0.18 per share a year ago, representing an earnings surprise of 154.55% [1] - The company posted revenues of $0.17 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 20.71%, compared to year-ago revenues of $0.08 million [2] - Over the last four quarters, Ovid Therapeutics has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Group 2: Stock Performance and Outlook - Ovid Therapeutics shares have declined approximately 73.8% since the beginning of the year, while the S&P 500 has gained 12.1% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.22 on $0.15 million in revenues, and -$0.81 on $0.5 million in revenues for the current fiscal year [7] Group 3: Industry Context - 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] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that tracking these revisions can be beneficial for investors [5]

Financial Performance - Total revenue for the three months ended June 30, 2024, was $169,000, an increase of 125% from $75,000 in the same period in 2023[93]. - For the six months ended June 30, 2024, total revenue was $317,000, up from $141,000 in the same period in 2023, representing a 125% increase[99]. - Other income for the three months ended June 30, 2024, was $29.0 million, significantly up from $1.8 million in the same period in 2023, marking an increase of $27.2 million[97]. - Net income for the three months ended June 30, 2024, was $8.5 million, a turnaround from a net loss of $12.4 million in the same period in 2023[102]. Expenses and Losses - The company expects to incur significant expenses and operating losses for at least the next several years due to ongoing clinical trials and research activities[82]. - Research and development expenses are expected to increase as the company advances its drug candidates through preclinical studies and clinical trials[89]. - Research and development expenses rose to $12.6 million for the three months ended June 30, 2024, compared to $6.0 million in 2023, reflecting an increase of $6.6 million[94]. - Research and development expenses for the six months ended June 30, 2024, totaled $23.0 million, compared to $12.6 million in 2023, an increase of $10.4 million[99]. - Total operating expenses for the three months ended June 30, 2024, were $20.7 million, compared to $14.2 million in 2023, an increase of $6.4 million[94]. - General and administrative expenses for the six months ended June 30, 2024, were $15.3 million, down from $16.6 million in 2023, a decrease of $1.3 million[100]. Cash and Funding - As of June 30, 2024, the company had $77.0 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $281.0 million[82]. - As of June 30, 2024, the company had total cash, cash equivalents, and marketable securities of $77.0 million, expected to fund operations for at least the next 12 months[102]. - The company has raised net proceeds of $275.4 million from the sale of its capital stock as of June 30, 2024[82]. - The company has $250.0 million available under its S-3 Registration Statement, including $75.0 million available through an at-the-market offering program[105]. - Net cash used in operating activities was $30.9 million for the six months ended June 30, 2024, compared to $23.8 million for the same period in 2023[108]. - Net cash provided by investing activities was $33.0 million for the six months ended June 30, 2024, down from $50.3 million in 2023, primarily due to the maturity of marketable securities[109]. Organizational Changes - The company reduced its workforce by 17 people, approximately 43% of its previous headcount, to prioritize programs and extend cash runway[85]. - The company announced an organizational restructuring in June 2024, which included workforce reduction to prioritize programs and extend cash runway[102]. - The company estimates approximately $3.7 million in charges related to the organizational restructuring, including severance and benefits[85]. - The company expects to complete the majority of its organizational restructuring and related cash payments by the second quarter of 2025[104]. - The company may incur additional charges or cash expenditures due to unanticipated events related to the organizational restructuring[104]. Product Development - The company is developing a portfolio of direct activators of KCC2 for potential treatment of seizures and other neurological indications, with regulatory filings anticipated in the second half of 2024[83]. - The company announced plans to initiate a signal-finding trial for OV888/GV101 in the second half of 2024 following positive topline data from a Phase 1 study[83]. - The company has not generated any revenue from commercial drug sales and does not expect to until regulatory approval is obtained[87]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[104]. Market Risks - Increased inflation rates may lead to higher operating costs and affect the company's operating budgets[104]. - The company’s primary exposure to market risk is interest rate sensitivity, with an immediate 100 basis point change in interest rates not expected to materially affect the fair market value of its cash equivalents and marketable securities[114]. - The company is classified as a smaller reporting company, allowing it to take advantage of scaled disclosures in SEC filings[111].

Core Insights - Ovid Therapeutics Inc. has appointed Dr. Amanda Banks as Chief Development Officer to enhance clinical strategy and execution [1][2] - The company has streamlined operations by reducing its workforce by 43% and has suspended the OV329 IV program to focus on priority clinical programs [1][3] - As of June 30, 2024, Ovid maintains a strong financial position with $77.0 million in cash and marketable securities, expected to support operations and achieve five clinical and regulatory milestones by late H1 2026 [1][7] Corporate Updates - Ovid is restructuring its organization to preserve capital and optimize its pipeline programs, which includes a 43% reduction in workforce [2][3] - The company has expanded its Scientific Advisory Board with top neurologists and neuroscientists to drive advancements in its pipeline [1][4] - Ovid plans to explore partnerships and co-development opportunities for select programs during its cash runway through late H1 2026 [3] Pipeline Strategy - Ovid is focusing resources on advancing OV888/GV101 and OV329 oral programs while pausing the intravenous OV329 program [4][5] - The OV888/GV101 capsule is advancing to a Phase 2 proof-of-concept study in cerebral cavernous malformations, with favorable Phase 1 results indicating safety and tolerability [5][6] - The company anticipates completing a Phase 1 multiple ascending dose study of OV329 in H2 2024 and plans to present ocular accumulation data at the Epilepsy Foundation Pipeline Conference 2024 [6][5] Financial Performance - For Q2 2024, Ovid reported revenue from royalty agreements of $169,000, an increase from $75,000 in Q2 2023 [7][11] - Research and development expenses rose to $12.6 million in Q2 2024, compared to $6.0 million in the same period in 2023, reflecting advancements in clinical pipeline activities [7][11] - Ovid reported a net income of $8.5 million for Q2 2024, a significant improvement from a net loss of $12.4 million in Q2 2023, largely due to a $29.0 million gain from a fair value adjustment to the royalty monetization liability [8][11]