Financial Performance - Total revenue for the three months ended September 30, 2024, was $173,000, an increase of $64,000 (approximately 58.7%) compared to $109,000 for the same period in 2023[96]. - Total revenue for the nine months ended September 30, 2024, was $490,000, an increase of $240,000 (approximately 96%) compared to $250,000 for the same period in 2023[104]. - Other income for the nine months ended September 30, 2024, was $34.0 million, an increase of $29.9 million compared to $4.1 million in the same period in 2023, primarily due to an adjustment to the royalty monetization liability[107]. - Net loss for the three months ended September 30, 2024, was $14.0 million, an increase of $2.8 million (approximately 24.7%) compared to a net loss of $11.3 million in the same period in 2023[108]. - The net loss for the nine months ended September 30, 2024, was $17.2 million, primarily due to a non-cash fair value adjustment resulting in a $29.0 million gain[115]. Cash and Securities - The company had $62.7 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $295.0 million as of September 30, 2024[83]. - As of September 30, 2024, the company had total cash, cash equivalents, and marketable securities of $62.7 million, expected to fund operations for at least the next 12 months[108]. - Cash, cash equivalents, and marketable securities totaled $62.7 million as of September 30, 2024[121]. - Net cash used in operating activities was $45.9 million for the nine months ended September 30, 2024, compared to $33.9 million for the same period in 2023[115]. - Net cash provided by investing activities was $33.3 million for the nine months ended September 30, 2024, primarily due to the maturity of marketable securities[116]. Research and Development - The company expects to submit an IND application for OV350 in Q4 2024 and initiate clinical trials in Q1 2025[87]. - The company is developing a library of KCC2 direct activators and anticipates multiple clinical development programs in the next 2-3 years[87]. - Research and development expenses are expected to increase significantly as the company advances its drug candidates through clinical trials[91]. - Research and development expenses for the three months ended September 30, 2024, were $7.9 million, up $2.5 million (approximately 47.2%) from $5.3 million in the same period in 2023, primarily due to accelerated preclinical and clinical research[99]. - Research and development expenses for the nine months ended September 30, 2024, were $30.8 million, an increase of $12.9 million (approximately 71.8%) from $17.9 million in the same period in 2023, driven by costs related to multiple clinical programs[104]. Organizational Changes - The company announced an organizational restructuring in June 2024, including workforce reduction to prioritize programs and extend cash runway[109]. - General and administrative expenses decreased to $5.5 million for the three months ended September 30, 2024, down $1.3 million (approximately 18.5%) from $6.8 million in 2023, attributed to organizational restructuring[100]. - General and administrative expenses for the nine months ended September 30, 2024, were $20.8 million, down $2.6 million (approximately 11.1%) from $23.4 million in 2023, due to cost reduction strategies[106]. - The company may incur additional charges related to organizational restructuring expected to be completed by the second quarter of 2025[114]. Market and Economic Conditions - The company is subject to risks including global economic conditions, inflation, and challenges in obtaining regulatory approvals[90]. - Increased inflation rates and interest rate hikes by the U.S. Federal Reserve may adversely affect the company's operating costs and liquidity[114]. Future Financing - The company expects to finance its cash needs through equity offerings, debt financings, and additional funding from collaborations[114]. - The company filed a shelf registration statement allowing the sale of up to $250.0 million of common stock, including $75.0 million available under an at-the-market offering program[112]. Product Development and Sales - The company has not generated revenue from commercial drug sales and does not expect to until regulatory approval is obtained[91]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[114]. - The company paused the initiation of the Phase 2 proof-of-concept study of OV888/GV101 to evaluate insights from competitor trials[88]. - The company sold rights to soticlestat to Takeda, which did not meet primary endpoints in two pivotal Phase 3 trials[89].

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]

Investor Relations: Garret Bonney 617-735-6093 IR@ovidrx.com NEW YORK, July 30, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to meaningfully improving the lives of people affected by certain epilepsies and brain conditions, today announced that management will participate in two upcoming investor conferences in August: Live webcasts of the fireside chat and panel discussion can be accessed through the Events & Presentations section of the Company's we ...

Sustained exposure to OV329 in preclinical models reduced GABA-aminotransferase (GABA-AT) activity, increased steady state GABA levels in the brain, and induced phasic and tonic inhibition OV329 demonstrated anti-convulsant effects in mice, reducing the severity of status epilepticus and preventing the development of benzodiazepine-resistant seizures OV329 was shown to have a higher potency (as measured by IC50) for the GABA-AT target than published studies of vigabatrin, an FDA-approved GABA-AT inhibitor N ...

The Phase 1 study for OV888/GV101 capsule met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse events Secondary endpoint results indicate that the target pharmacokinetic profile was achieved at the targeted clinical dose, supporting once daily dosing OV888/GV101 capsule was shown to be biologically active in participants and elicited dose-dependent pharmacodynamic effects within the planned therapeutic dose range A Phase 2 study for the treatment of cerebral c ...

NEW YORK, June 30, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ovid Therapeutics Inc. ("Ovid" or the "Company") (NASDAQ: OVID). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. [Click here for information about joining the class action] On this news, Ovid's stock price fell $2.50 per share, or 75.99%, to close at $0.79 per share on June 17, 2024. Attorney advertising. Prior results do not guarantee similar ...

CONTACT: Danielle Peyton Pomerantz LLP dpeyton@pomlaw.com 646-581-9980 ext. 7980 NEW YORK, June 22, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ovid Therapeutics Inc. ("Ovid" or the "Company") (NASDAQ: OVID). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Ovid and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practic ...