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Ovid TherapeuticsDDocument history
Earnings documents stored for OVID.
Investor releaseQuarter not tagged2026-08-13Ovid Therapeutics Reports Business Updates and Second Quarter 2026 Financial Results
GlobeNewswire
Ovid Therapeutics Reports Business Updates and Second Quarter 2026 Financial Results
First-ever oral direct KCC2 activator, OV4071, advancing in an ongoing Phase 1 study Initiated Phase 2 proof-of-concept and photosensitivity studies for OV329, a next-generation GABA-AT inhibitor A newly-formed portfolio company with funds advised by Perceptive Advisors acquired global rights to soticlestat; Ovid secured equity in the company and the potential to receive regulatory and sales milestone payments and royalties upon success Strengthened executive leadership team with appointment of Kevin Norrett as Chief Business Officer and Eliseo Salinas, MD, as Executive R&D Advisor Cash, cash equivalents and marketable securities were $169.8 million as of June 30, 2026; expected financial runway into 2029 NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to pioneering better, gentler medicines for brain disorders with significant unmet need, today provided business updates including financial results for the second quarter ended June 30, 2026. “Ovid is focused on the execution of multiple near-term clinical, proof-of-concept studies across our differentiated pipeline,” said Meg Alexander, President and Chief Executive Officer. “Our team is well positioned to realize the potential of KCC2 direct activation and GABA aminotransferase inhibition for many intractable disorders of the brain. Additionally, through the recent transaction with Perceptive Advisors and Takeda, Ovid has the potential to realize value from our interests in soticlestat, which may provide future capital to Ovid and most importantly, advance a meaningful therapy to epilepsy patients who can benefit.” PIPELINE AND BUSINESS UPDATES KCC2 direct activator portfolio: OV4071 advancing in Phase 1 study: Ovid continues to progress OV4071 through an ongoing Phase 1 study in healthy volunteers. The Phase 1 study is intended to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of this first-ever oral direct potassium-chloride cotransporter 2 (KCC2) activator. Data from the study are expected to support initiation of a Phase 2 proof-of-concept study in acute schizophrenia in 2027 and provide insights into future development across additional high-value central nervous system (CNS) indications. A growing body of pharmacodynamic and translational data demonstrates OV4071’s ability to restore excitatory/inhib…Read full documentShow less
First-ever oral direct KCC2 activator, OV4071, advancing in an ongoing Phase 1 study Initiated Phase 2 proof-of-concept and photosensitivity studies for OV329, a next-generation GABA-AT inhibitor A newly-formed portfolio company with funds advised by Perceptive Advisors acquired global rights to soticlestat; Ovid secured equity in the company and the potential to receive regulatory and sales milestone payments and royalties upon success Strengthened executive leadership team with appointment of Kevin Norrett as Chief Business Officer and Eliseo Salinas, MD, as Executive R&D Advisor Cash, cash equivalents and marketable securities were $169.8 million as of June 30, 2026; expected financial runway into 2029 NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to pioneering better, gentler medicines for brain disorders with significant unmet need, today provided business updates including financial results for the second quarter ended June 30, 2026. “Ovid is focused on the execution of multiple near-term clinical, proof-of-concept studies across our differentiated pipeline,” said Meg Alexander, President and Chief Executive Officer. “Our team is well positioned to realize the potential of KCC2 direct activation and GABA aminotransferase inhibition for many intractable disorders of the brain. Additionally, through the recent transaction with Perceptive Advisors and Takeda, Ovid has the potential to realize value from our interests in soticlestat, which may provide future capital to Ovid and most importantly, advance a meaningful therapy to epilepsy patients who can benefit.” PIPELINE AND BUSINESS UPDATES KCC2 direct activator portfolio: OV4071 advancing in Phase 1 study: Ovid continues to progress OV4071 through an ongoing Phase 1 study in healthy volunteers. The Phase 1 study is intended to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of this first-ever oral direct potassium-chloride cotransporter 2 (KCC2) activator. Data from the study are expected to support initiation of a Phase 2 proof-of-concept study in acute schizophrenia in 2027 and provide insights into future development across additional high-value central nervous system (CNS) indications. A growing body of pharmacodynamic and translational data demonstrates OV4071’s ability to restore excitatory/inhibitory (E/I) balance across more than 40 disease models, including psychosis, cognition and behavioral dysfunction with results meeting or exceeding marketed traditional antipsychotics. In preclinical studies, OV4071 also demonstrated favorable properties and no evidence of sedation. OV4071 is supported by a translational biomarker strategy designed to help guide and de-risk clinical development. Ketamine challenge study: Building on the encouraging Phase 1 results thus far and as a part of the clinical development plan, Ovid intends to initiate a ketamine challenge study of OV4071 in the second half of 2026 to further characterize potential pharmacodynamic effects and proof-of-mechanism using electrophysiology and biomarkers. The study is designed to reproduce biological and neurotransmitter surges of glutamate and dopamine in a healthy volunteer to assess key biomarkers relevant to schizophrenia and other potential indications. KCC2 portfolio expansion; advancing next-generation compounds to support broad CNS therapeutic potential: Ovid has a discovery engine focused on identifying novel KCC2 direct activator molecules that are amenable for oral and injectable administration and moving them into IND-enabling studies. OV329 next-generation GABA-AT inhibitor: Phase 2 initiated with proof-of-concept studies underway, supporting continued development across multiple seizure disorders Ovid continues to advance OV329, its next-generation 4-aminobutyrate aminotransferase (GABA-AT) inhibitor, through proof-of-concept studies designed to establish the program's clinical potential across multiple seizure disorders. OV329 acts as a GABA-AT inhibitor and this represents a mechanism of action that has been previously validated in multiple seizure disorders. Building upon robust cortical inhibition that was established in human healthy volunteers, the Company is expanding development into multiple indications, including treatment-resistant focal onset seizures (FOS), tuberous sclerosis complex (TSC)-associated seizures and infantile spasms (IS). Initiated Phase 2 randomized, placebo-controlled study evaluating efficacy, safety and tolerability in treatment-resistant FOS: Ovid has received regulatory clearance across multiple regions and has initiated the dose-confirmatory study to evaluate seizure reduction efficacy, safety and tolerability of OV329 in people living with treatment-resistant FOS. This global study is designed with registrational-level rigor to potentially support multiple future seizure indications for OV329. The study is anticipated to be completed in the second half of 2027. Exploratory proof-of-mechanism photosensitivity study: Ovid has received regulatory clearances and has initiated a photo stimulation study to evaluate the anti-convulsant effect of multiple potential doses of OV329. The Company intends to test three doses of OV329, including 5, 7 and 9 milligrams, and anticipates results near year end 2026. Proof-of-concept studies in developmental epileptic encephalopathies (DEEs), TSC and IS: Ovid is in the process of initiating development programs for OV329 to assess proof of safety and anti-convulsant effect in TSC-associated seizures and IS using a weight-based pediatric formulation, which is independent from the adult fixed-dose tablets being tested in FOS. The Company expects to initiate a proof-of-concept safety and signal-finding study in the fourth quarter of 2026 to evaluate OV329 in patients with TSC-associated seizures. This study will help inform the dosing strategy for a subsequent study in IS, which is anticipated to commence in 2027. GABA-AT inhibition has previously been established as an effective mechanism of action in these DEEs, and OV329 is designed to be a GABA-AT inhibitor with a favorable safety, tolerability and efficacy profile. BUSINESS STRATEGY AND CORPORATE UPDATES Recent Events Strengthened leadership team: In July 2026, Ovid strengthened its executive leadership team to support the Company’s next phase of development. Kevin Norrett, MS, MBA, was appointed Chief Business Officer to lead business and corporate development and strategic partnerships. Charles Carter, MS, MBA, was promoted to Chief Financial Officer, succeeding Jeffrey Rona, who will remain an advisor to the Company through the end of 2027. Eliseo Salinas, MD, MSc, joined as Executive R&D Advisor, providing strategic and operational guidance for the Company’s research and development programs, and Victoria Fort was promoted to Chief Strategy Officer, leading enterprise strategy, investor relations and operational growth initiatives. Appointed additional board director: In June 2026, Ovid appointed Anna Greka, MD, PhD, a globally recognized physician-scientist, academic leader and biotech entrepreneur, to its Board of Directors. Dr. Greka chairs Ovid’s Science and Technology Committee and serves as a member of the Compensation Committee. Potential monetization of soticlestat interests: Ovid and Takeda assigned global intellectual property rights in soticlestat to a new privately held company (“NewCo”) launched by Perceptive Advisors to develop and commercialize the program for all potential indications, including developmental and epileptic encephalopathies, such as Dravet syndrome. Ovid has always believed in soticlestat’s potential to meaningfully improve the treatment paradigm for people with rare epilepsies, and NewCo was launched to carry this program forward with the focus and resources needed to reach these patients who are currently underserved by existing therapies. As part of the transaction, Ovid is eligible to receive up to $294.5 million in potential clinical, regulatory and commercial milestone payments, a portion of which is payable to Ligand under Ovid’s previously disclosed, royalty monetization agreement, as amended; and may receive low- to mid-single digit royalties on net sales of soticlestat if commercialized. Soticlestat has received Orphan Drug and Rare Pediatric Disease designation from the U.S. Food and Drug Administration. In April 2026, the Series A warrants issued by the Company in connection with its October 2025 private placement expired. The aggregate number of common shares underlying the Series A warrants was 38,481,325, and investors elected to exercise the warrants into 33,597,860 shares of the Company’s common stock for $1.40 per share and 4,883,465 pre-funded warrants for $1.399 per share, resulting in proceeds to the Company of approximately $53.9 million. Second Quarter 2026 Financial Results Cash, cash equivalents and marketable securities as of June 30, 2026 totaled $169.8 million. Research and development expenses were $10.0 million for the second quarter ended June 30, 2026, compared to $6.5 million for the same period in 2025. The increase is primarily related to elevated preclinical and clinical study activities on the OV329 and OV4071 programs. General and administrative expenses were $6.5 million for the second quarter ended June 30, 2026, as compared to $4.9 million for the same period in 2025. The increase between the periods was comprised of accounting and audit, legal, business development and other professional fees, offset by a decrease in payroll and related expenses resulting from lower headcount between the periods as well as recognition of approximately $0.4 million of severance and talent acquisition costs in the quarter ended June 30, 2025. Total operating expenses were $16.4 million for the second quarter ended June 30, 2026, as compared to $11.3 million for the same period in 2025. Ovid reported a net loss of $15.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.08, for the three months ended June 30, 2026, as compared to a net loss of $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.06, for the same period in 2025. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to pioneering better, gentler medicines for the brain. The Company discovers and develops differentiated, small molecule medicines for neurological and neuropsychiatric disorders with significant unmet need. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant FOS and DEEs, including TSC and IS; and OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation, statements regarding the expected timing of initiation, completion and results and data of Ovid’s ongoing and planned clinical studies; the reproducibility and durability of any favorable results initially seen to date in clinical trials; the potential use and development of OV4071, other compounds from Ovid’s library of direct activators of KCC2 and OV329; the potential opportunity for soticlestat, including the potential to receive milestone payments and royalties upon success; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; the potential opportunity and ability to achieve full therapeutic potential of OV4071, other compounds from Ovid’s library of direct activators of KCC2 and OV329; Ovid’s clinical pipeline strategy and plans for future clinical studies; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, and the risk that Ovid may not be able to realize the intended benefits of its business strategy. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Investor Relations & [email protected]
Investor releaseQuarter not tagged2026-08-06Outlook Therapeutics, Inc. (OTLK) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
Zacks
Outlook Therapeutics, Inc. (OTLK) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
The market expects Outlook Therapeutics, Inc. (OTLK) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +79.6%. Revenues are expected to be $1.2 million, down 20% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 12.5% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positi…Read full documentShow less
The market expects Outlook Therapeutics, Inc. (OTLK) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +79.6%. Revenues are expected to be $1.2 million, down 20% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 12.5% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Outlook Therapeutics, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +42.31%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Outlook Therapeutics, Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Outlook Therapeutics, Inc. would post a loss of$0.12 per share when it actually produced a loss of -$0.16, delivering a surprise of -33.33%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Outlook Therapeutics, Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Ovid Therapeutics (OVID), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $0.1 for the quarter ended June 2026. This estimate points to a year-over-year change of -66.7%. Revenues for the quarter are expected to be $0.15 million, down 97.6% from the year-ago quarter. The consensus EPS estimate for Ovid Therapeutics has remained unchanged over the last 30 days. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -6.94%. When combined with a Zacks Rank of #2 (Buy), this Earnings ESP makes it difficult to conclusively predict that Ovid Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Outlook Therapeutics, Inc. (OTLK) : Free Stock Analysis Report Ovid Therapeutics (OVID) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05Earnings Preview: Ovid Therapeutics (OVID) Q2 Earnings Expected to Decline
Zacks
Earnings Preview: Ovid Therapeutics (OVID) Q2 Earnings Expected to Decline
Ovid Therapeutics (OVID) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of -66.7%. Revenues are expected to be $0.15 million, down 97.6% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is…Read full documentShow less
Ovid Therapeutics (OVID) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of -66.7%. Revenues are expected to be $0.15 million, down 97.6% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Ovid Therapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -6.94%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination makes it difficult to conclusively predict that Ovid Therapeutics will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Ovid Therapeutics would post a loss of$0.12 per share when it actually produced a loss of -$0.12, delivering no surprise. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Ovid Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, ANI Pharmaceuticals (ANIP), is soon expected to post earnings of $2.01 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +11.7%. Revenues for the quarter are expected to be $262.73 million, up 24.3% from the year-ago quarter. The consensus EPS estimate for ANI has been revised 0.3% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +1.33%. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that ANI will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ovid Therapeutics (OVID) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-12Ovid Therapeutics Reports Business Updates and First Quarter 2026 Financial Results
GlobeNewswire
Ovid Therapeutics Reports Business Updates and First Quarter 2026 Financial Results
Dosed first participant with OV4071, the first-ever oral potassium-chloride cotransporter 2 (KCC2) direct activator, in May 2026 in a Phase 1 study with healthy volunteers OV329 showed favorable safety, tolerability, pharmacokinetics (PK), and drug exposure at higher doses, supporting the planned advancement of Phase 2 and proof-of-concept studies Announced development expansion of OV329 into additional pediatric indications of tuberous sclerosis complex (TSC) seizures and infantile spasms (IS), conditions for which GABA-aminotransferase (GABA-AT) inhibition is a validated mechanism Strengthened balance sheet, raising $60.0 million of gross proceeds in March 2026 PIPE financing with participation from leading healthcare investors Received $53.9 million in gross proceeds upon full exercise of Series A warrants in connection with October 2025 PIPE financing Cash, cash equivalents and marketable securities were $165.6 million as of March 31, 2026, which does not include $27.3 million in proceeds received in April 2026 from exercise of Series A warrants NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to pioneering better, gentler medicines for brain disorders with significant unmet need, today provided business updates including financial results for the first quarter ended March 31, 2026. “Our first quarter reflected focused execution and continued progress across our pipeline of potentially transformative small molecule medicines for intractable brain conditions,” stated Meg Alexander, President and Chief Executive Officer. “Our development programs remain on track, our clinical organization has expanded, and we expect to be well capitalized into 2029, positioning us for multiple anticipated proof-of-concept and proof-of-signal readouts. We are especially pleased to have initiated Phase 1 dosing this month for our oral KCC2 direct activator, OV4071, alongside the expansion of OV329’s development programs, as we advance therapies targeting mechanisms central to excitatory/inhibitory balance in the brain.” PIPELINE AND BUSINESS UPDATES OV329: Higher dose cohorts demonstrate favorable safety, tolerability, PK and exposure profile, supporting advancement into patient studies In March 2026, Ovid reported a favorable safety and tolerability profile from a 7 mg dose cohort of OV329, a next-genera…Read full documentShow less
Dosed first participant with OV4071, the first-ever oral potassium-chloride cotransporter 2 (KCC2) direct activator, in May 2026 in a Phase 1 study with healthy volunteers OV329 showed favorable safety, tolerability, pharmacokinetics (PK), and drug exposure at higher doses, supporting the planned advancement of Phase 2 and proof-of-concept studies Announced development expansion of OV329 into additional pediatric indications of tuberous sclerosis complex (TSC) seizures and infantile spasms (IS), conditions for which GABA-aminotransferase (GABA-AT) inhibition is a validated mechanism Strengthened balance sheet, raising $60.0 million of gross proceeds in March 2026 PIPE financing with participation from leading healthcare investors Received $53.9 million in gross proceeds upon full exercise of Series A warrants in connection with October 2025 PIPE financing Cash, cash equivalents and marketable securities were $165.6 million as of March 31, 2026, which does not include $27.3 million in proceeds received in April 2026 from exercise of Series A warrants NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to pioneering better, gentler medicines for brain disorders with significant unmet need, today provided business updates including financial results for the first quarter ended March 31, 2026. “Our first quarter reflected focused execution and continued progress across our pipeline of potentially transformative small molecule medicines for intractable brain conditions,” stated Meg Alexander, President and Chief Executive Officer. “Our development programs remain on track, our clinical organization has expanded, and we expect to be well capitalized into 2029, positioning us for multiple anticipated proof-of-concept and proof-of-signal readouts. We are especially pleased to have initiated Phase 1 dosing this month for our oral KCC2 direct activator, OV4071, alongside the expansion of OV329’s development programs, as we advance therapies targeting mechanisms central to excitatory/inhibitory balance in the brain.” PIPELINE AND BUSINESS UPDATES OV329: Higher dose cohorts demonstrate favorable safety, tolerability, PK and exposure profile, supporting advancement into patient studies In March 2026, Ovid reported a favorable safety and tolerability profile from a 7 mg dose cohort of OV329, a next-generation GABA-AT inhibitor being developed for drug-resistant epilepsies. The Company also tested a higher dose cohort at 9 mg in April 2026 to further characterize the safety and tolerability profile above the intended clinical dose. Across all doses tested, including at the higher 9 mg dose, OV329 demonstrated a favorable safety and tolerability profile in clinical studies, with no treatment-related serious adverse events observed. These 7 mg dose results build upon previously reported positive biomarker results, which provided linear and predictable pharmacokinetics, and delivered the desired drug exposure in human plasma to maximize the Company’s pharmacology strategy for optimal enzyme inhibition. The targeted exposure levels have been associated with cortical inhibition in humans and anti-convulsant activity in pharmacodynamic models. OV329 Phase 2 development: Advancing dose-confirmatory and proof-of-concept studies in treatment-resistant epilepsies Ovid believes the drug exposure, PK, safety, and tolerability profile observed with the 3 mg, 5 mg, 7 mg and 9 mg doses of OV329 are supportive of continued clinical development and provide dose optionality for planned Phase 2 proof-of-concept and dose confirmatory studies. Ovid plans to initiate an open-label photo paroxysmal response (PPR) study to evaluate the anti-seizure potential of OV329. PPR studies are a well-recognized methodology for characterizing anti-convulsant activity potential by evaluating the electroencephalography (EEG) PPR response as a predictor of anti-seizure effect in a photo-sensitive seizure population. In parallel, the Company plans to launch a Phase 2 randomized, placebo-controlled trial designed to determine seizure reduction efficacy, safety and tolerability in people living with treatment-resistant focal onset seizures (FOS). Ovid anticipates initiating the Phase 2 study in the second quarter of 2026. OV329: Adding complementary development programs in TSC and IS Ovid announced plans to add two new development programs for OV329 to assess its efficacy in TSC-associated seizures and IS using a pediatric formulation. GABA-AT inhibition is a validated anti-convulsant mechanism of action in these conditions; however, it is underutilized commercially today due to compound-specific safety concerns associated with the first-generation GABA-AT inhibitor, vigabatrin. With OV329, the Company intends to develop a next-generation GABA-AT inhibitor that is safe, efficacious, and well tolerated and which thereby, might be used as an earlier line therapy and for increased duration of treatment relative to vigabatrin. There is tremendous unmet medical need in these severe pediatric epilepsies and there have been few-to-no new medicines approved in these conditions in the last twenty years. Ovid plans to initiate a proof-of-concept safety and signal-finding study in Q4 2026 to evaluate OV329 in patients with TSC-associated seizures. Additionally, the Company plans to launch a safety and signal finding study to evaluate patients with IS in 2027. KCC2 direct activator portfolio: Humans dosed with OV4071 in Q2 2026; advancing additional unique KCC2 development candidates from discovery engine Ovid recently dosed the first participant in its Phase 1 study evaluating OV4071 in healthy volunteers. Additionally, in April 2026, the Company highlighted its KCC2 portfolio at a dedicated R&D event. The R&D event featured experimental, translational and clinical experts in schizophrenia and psychosis and reviewed extensive pharmacodynamic data, translational and clinical strategies. The Company is developing multiple, unique molecules with differentiated therapeutic profiles and formulations for potential conditions including a range of psychoses, neurodegenerative and neurodevelopmental disorders and epilepsies. Key programs include: OV4071 (Oral KCC2 activator); Initiated a Phase 1 study and dosed healthy volunteers: OV4071, Ovid’s lead oral direct activator intended for chronic conditions, is advancing in an ongoing Phase 1 study in healthy volunteers. As part of the clinical development plan, Ovid intends to conduct a ketamine challenge study in the second half of 2026 to further characterize potential pharmacodynamic effects and proof-of-mechanism using electrophysiology and biomarkers. Ovid plans to study OV4071 initially in Parkinson’s disease psychosis and Lewy body dementia psychosis, as well as schizophrenia. At the American Psychiatric Association (APA) Annual Meeting, taking place May 16-20, 2026, in San Francisco, Ovid will present a poster showcasing preclinical work that supports KCC2 direct activation as a potential new approach for psychosis and reflects continued progress in the development of Ovid’s KCC2 direct activator portfolio. KCC2 portfolio expansion; Advancing next-generation compounds to support broad CNS therapeutic potential: Ovid has a discovery engine focused on identifying novel KCC2 direct activator molecules that are amenable for oral and injectable administration and moving them into IND-enabling studies. The Company believes KCC2 direct activation may have expansive therapeutic potential and is building a sustainable pipeline designed to unlock the full therapeutic potential of this novel mechanism across multiple indications. BUSINESS STRATEGY AND UPDATES Recent Events On April 17, 2026, the Series A warrants issued by the Company in connection with its October 2025 private placement expired. The aggregate number of common shares underlying the Series A warrants was 38,481,325, and investors elected to exercise the warrants into 33,597,860 shares of the Company’s common stock for $1.40 per share and 4,883,464 pre-funded warrants for $1.399 per share, resulting in proceeds to the Company of approximately $53.9 million of which $26.6 million was received in March, and $27.3 million was received in April. Separately, in March 2026, the Company raised $60.0 million in gross proceeds in a private placement financing, with participation from leading healthcare investors. The Company plans to use the net proceeds of $56.2 million to support expansion of OV329 into TSC and IS. The proceeds from the exercise of the Series A Warrants, together with the proceeds from the private placement financing, are expected to extend the Company’s financial runway into 2029. First Quarter 2026 Financial Results Cash, cash equivalents and marketable securities as of March 31, 2026 totaled $165.6 million; which excludes $27.3 million in proceeds received in April 2026 upon exercise of the Series A warrants. Research and development expenses were $11.2 million for the first quarter ended March 31, 2026, compared to $6.7 million for the same period in 2025. The increase is primarily related to elevated preclinical and clinical study activities on the OV329 and OV4071 programs. General and administrative expenses were $6.7 million for the first quarter ended March 31, 2026, as compared to $6.0 million for the same period in 2025. The increase between the periods was comprised of accounting and audit, legal, business development and other professional fees, offset by a decrease in payroll and related expenses resulting from lower headcount between the periods as well as recognition of approximately $0.6 million of severance and talent acquisition costs in the quarter ended March 31, 2025. Total operating expenses were $17.8 million for the first quarter ended March 31, 2026, as compared to $12.6 million for the same period in 2025. Ovid reported a net loss of $17.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.12, for the three months ended March 31, 2026, as compared to a net loss of $10.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.14, for the same period in 2025. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to pioneering better, gentler medicines for the brain. The Company discovers and develops differentiated, small molecule medicines for neurological and neuropsychiatric disorders with significant unmet need. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant focal onset seizures (FOS) and developmental and epileptic encephalopathies (DEEs), including tuberous sclerosis complex (TSC) and infantile spasms (IS); and OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation, statements regarding the reproducibility and durability of any favorable results initially seen to date in clinical trials; the expected timing of initiation, completion, and results and data of Ovid’s ongoing and planned clinical studies, the potential use and development of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; the potential opportunity and ability to achieve full therapeutic potential of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; Ovid’s clinical pipeline strategy and plans for future clinical studies; the intended use of the proceeds from Series A warrant exercises and the March 2026 private placement, including for the development of OV329 in additional indications including TSC and IS; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, and the risk that Ovid may not be able to realize the intended benefits of its business strategy. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Investor Relations & Media Victoria Fort [email protected] 202.361.0445
Investor releaseQuarter not tagged2026-03-19Ovid Therapeutics Q4 Earnings Call Highlights
MarketBeat
Ovid Therapeutics Q4 Earnings Call Highlights
Financing and runway: Ovid ended 2025 with $90.4 million in cash and announced a $60 million PIPE led by Point72, which management says funds the company into the second half of 2028; full exercise of Series A warrants (triggered by Australia clearance) could add >$53 million and extend runway well into 2029. OV329 safety and development strategy: The 7 mg dose showed no serious adverse events and all subjects in the 5 mg and 7 mg cohorts hit target exposure, with Ovid capping dosing due to a ~60%–65% CNS inhibition ceiling; the company plans a randomized, placebo-controlled Phase II in focal-onset seizures in Q2 2026 and is expanding into pediatric programs for infantile spasms and TSC using an older-to-younger open-label sequencing. OV4071 regulatory progress: OV4071, described as the first oral KCC2 direct activator to receive regulatory clearance (Australia), is slated to start a Phase I in Q2 2026 followed by a ketamine-challenge study later in 2026 to characterize on-mechanism activity. Interested in Ovid Therapeutics? Here are five stocks we like better. Ovid Therapeutics (NASDAQ:OVID) outlined new pipeline and financing updates alongside its fourth-quarter and full-year 2025 results, highlighting regulatory clearance in Australia for its KCC2 direct activator OV4071, new safety and tolerability data for its seizure candidate OV329, and a $60 million PIPE financing led by Point72. Management said the company ended 2025 with $90.4 million in cash, cash equivalents, and marketable securities. Ovid also announced a $60 million PIPE financing (gross proceeds before fees and expenses) led by Point72, with participation from existing shareholders including Janus, RA, Bellevue, Affinity, Coastland, Eventide, Adage, and ADAR1, according to CEO Meg Alexander. → Dollar Tree Planted the Seeds for Triple-Digit Gains in Q4 Chief Business and Financial Officer Jeffrey Rona said the company expects the net proceeds from the PIPE to extend its cash runway into the second half of 2028. He added that if Ovid’s Series A warrants are fully exercised, the pro forma runway would extend well into 2029. Alexander noted that Australia’s clearance for OV4071 triggered a 30-day period for the Series A warrants, and if exercised could generate additional proceeds of more than $53 million. → Why Credo and Astera Soared After Oracle and Broadcom's Earnings Ovid’s main clinical upd…Read full documentShow less
Financing and runway: Ovid ended 2025 with $90.4 million in cash and announced a $60 million PIPE led by Point72, which management says funds the company into the second half of 2028; full exercise of Series A warrants (triggered by Australia clearance) could add >$53 million and extend runway well into 2029. OV329 safety and development strategy: The 7 mg dose showed no serious adverse events and all subjects in the 5 mg and 7 mg cohorts hit target exposure, with Ovid capping dosing due to a ~60%–65% CNS inhibition ceiling; the company plans a randomized, placebo-controlled Phase II in focal-onset seizures in Q2 2026 and is expanding into pediatric programs for infantile spasms and TSC using an older-to-younger open-label sequencing. OV4071 regulatory progress: OV4071, described as the first oral KCC2 direct activator to receive regulatory clearance (Australia), is slated to start a Phase I in Q2 2026 followed by a ketamine-challenge study later in 2026 to characterize on-mechanism activity. Interested in Ovid Therapeutics? Here are five stocks we like better. Ovid Therapeutics (NASDAQ:OVID) outlined new pipeline and financing updates alongside its fourth-quarter and full-year 2025 results, highlighting regulatory clearance in Australia for its KCC2 direct activator OV4071, new safety and tolerability data for its seizure candidate OV329, and a $60 million PIPE financing led by Point72. Management said the company ended 2025 with $90.4 million in cash, cash equivalents, and marketable securities. Ovid also announced a $60 million PIPE financing (gross proceeds before fees and expenses) led by Point72, with participation from existing shareholders including Janus, RA, Bellevue, Affinity, Coastland, Eventide, Adage, and ADAR1, according to CEO Meg Alexander. → Dollar Tree Planted the Seeds for Triple-Digit Gains in Q4 Chief Business and Financial Officer Jeffrey Rona said the company expects the net proceeds from the PIPE to extend its cash runway into the second half of 2028. He added that if Ovid’s Series A warrants are fully exercised, the pro forma runway would extend well into 2029. Alexander noted that Australia’s clearance for OV4071 triggered a 30-day period for the Series A warrants, and if exercised could generate additional proceeds of more than $53 million. → Why Credo and Astera Soared After Oracle and Broadcom's Earnings Ovid’s main clinical update focused on OV329, its next-generation GABA aminotransferase inhibitor, which the company is developing for focal onset seizures and is now expanding into pediatric epilepsies. Alexander reported that Ovid now has safety and tolerability data for the 7 mg dose and said there were no serious adverse events and no adverse events associated with the 7 mg dose. Across the broader single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts, Alexander said there were adverse events in the overall cohort but that they were not associated with treatment (citing examples such as cannula site reactions). She added that adverse events considered potentially associated with OV329 across doses included headache, drowsiness, and metallic taste, described as low frequency, mild, and resolving. → Members of Congress Bought These 5 Stocks—Should You? In response to a question about exposure targets, Alexander said all subjects in the 5 mg and 7 mg cohorts were within the targeted exposure range. She also addressed why Ovid is not pursuing doses above 7 mg, arguing there is a ceiling effect for central nervous system GABA aminotransferase inhibition of roughly 60%–65%, and that higher doses may not provide additional benefit relative to potential tolerability tradeoffs. A recurring theme of the call was differentiating OV329 from vigabatrin (Sabril), a first-generation GABA aminotransferase inhibitor with known ophthalmic safety risks. Alexander emphasized that Ovid is conducting extensive visual testing and structural eye imaging and said the company has seen no ophthalmic safety concerns with OV329 to date. In the Q&A, she said Ovid will continue optic and retinal monitoring in the phase II focal onset seizure study and in pivotal studies thereafter, not because the company expects to see issues, but to build a robust patient dataset for regulators. The stated goal is to demonstrate no structural or visual changes and avoid the type of monitoring and risk mitigation requirements that limited vigabatrin’s use. Discussing the commercial history of vigabatrin, Alexander said the drug was initially expected to be a “multi-blockbuster” due to anticonvulsant efficacy but later faced post-market findings related to retinal partitioning that, in some patients, led to blindness. She said Sabril’s U.S. sales peaked at more than $320 million in 2018 across infantile spasms and tuberous sclerosis complex (TSC) seizures, while noting the company could not provide a sales breakdown by indication because Lundbeck did not disclose it. Ovid said OV329 remains on track for proof-of-concept work in focal onset seizures, with additional studies designed to inform dosing and de-risk later development. Phase II focal onset seizures: Ovid plans to initiate a randomized, placebo-controlled phase II trial in Q2 2026 in adults with treatment-resistant focal onset seizures. Alexander described endpoints consistent with “traditional” seizure trials, including percent reduction in seizures and seizure frequency measures, along with CGI-type endpoints. Photosensitivity study: Later in 2026, Ovid expects to initiate an open-label photoparoxysmal response (PPR) study in adults with photosensitive epilepsy at a specialized site in the Netherlands. Alexander said the goal is to show anticonvulsant effect and provide dose confidence ahead of the full phase II readout. She described key measures as reductions in the number of intermittent photic stimulation frequencies inducing PPR, changes in the threshold frequency, and complete suppression of PPR during and post-dose. Using proceeds from the PIPE, Ovid said it is expanding OV329 into infantile spasms and TSC-associated seizures. Alexander characterized infantile spasms as a medical emergency occurring typically at four to seven or eight months of age, with risks including developmental disabilities, increased mortality, and lifelong epilepsies. She cited current standards of care including Acthar Gel or high-dose steroids first line and vigabatrin second line. For TSC, Alexander said seizures occur in about 80% of patients and described current standards of care including Afinitor and Sabril, with limitations related to safety. She said Ovid believes a safe, well-tolerated GABA aminotransferase inhibitor could be used earlier and for longer in both conditions, and suggested the company sees a potential path to efficient registration through signal-finding and pediatric dose confirmation. On development sequencing, Alexander said Ovid is designing the TSC program as open-label and will enroll older patients first, then step down to younger pediatric patients to establish safety, observe signal, and confirm dose modeling before initiating the infantile spasms study. She said Ovid intends to provide updates as enrollment grows to a sufficient size to support decisions. Ovid also highlighted progress for OV4071, which Alexander called the “first-ever” oral KCC2 direct activator to receive regulatory clearance (in Australia). She said the company is on track to initiate a phase I study in Q2, followed by a ketamine challenge study later in 2026, designed to help characterize on-mechanism GABAergic activity using quantitative EEG and other measures. Alexander said the ketamine challenge approach has been used in other antipsychotic development programs and is intended to demonstrate brain penetration and mechanism-consistent effects, potentially correlating EEG readouts with clinical symptom changes. She also said Ovid plans to discuss additional details, including biomarker strategy and broader portfolio efforts beyond OV4071, at a KCC2-focused event on April 14. In closing remarks, management thanked investors participating in the PIPE and said the company does not plan to host regular quarterly earnings calls going forward, tying this call to the business and pipeline updates released alongside year-end results. Ovid Therapeutics is a clinical-stage biopharmaceutical company focused on the development of therapies for rare neurological disorders. Founded in 2014 and headquartered in New York, the company applies a precision medicine approach to target underlying mechanisms of disease in patients with genetic conditions affecting the central nervous system. Its research platform centers on small-molecule modulators of neurotransmitter pathways to restore neural network function in disorders with high unmet medical need. The company's lead development candidate, OV101 (gaboxadol), is a selective extrasynaptic GABAA receptor agonist being investigated for the treatment of Angelman syndrome and Fragile X syndrome. The article "Ovid Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.
Investor releaseQuarter not tagged2026-03-18Ovid Therapeutics (OVID) Q4 Earnings and Revenues Surpass Estimates
Zacks
Ovid Therapeutics (OVID) Q4 Earnings and Revenues Surpass Estimates
Ovid Therapeutics (OVID) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of a loss of $0.1 per share. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +158.71%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.17, delivering a surprise of -13.33%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Ovid Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.72 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 195.47%. This compares to year-ago revenues of $0.08 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Ovid Therapeutics shares have added about 23.3% since the beginning of the year versus the S&P 500's decline of 1.9%. While Ovid Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Ovid Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the…Read full documentShow less
Ovid Therapeutics (OVID) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of a loss of $0.1 per share. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +158.71%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.17, delivering a surprise of -13.33%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Ovid Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.72 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 195.47%. This compares to year-ago revenues of $0.08 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Ovid Therapeutics shares have added about 23.3% since the beginning of the year versus the S&P 500's decline of 1.9%. While Ovid Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Ovid Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.08 on $0.2 million in revenues for the coming quarter and -$0.42 on $0.47 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 43% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Eton Pharmaceuticals, Inc. (ETON), has yet to report results for the quarter ended December 2025. The results are expected to be released on March 19. This company is expected to post quarterly earnings of $0.12 per share in its upcoming report, which represents a year-over-year change of +700%. The consensus EPS estimate for the quarter has been revised 13% lower over the last 30 days to the current level. Eton Pharmaceuticals, Inc.'s revenues are expected to be $20.42 million, up 75.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ovid Therapeutics (OVID) : Free Stock Analysis Report Eton Pharmaceuticals, Inc. (ETON) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-03-18Ovid Therapeutics Announces New OV329 Data and Indication Expansion, Phase 1 Clearance for OV4071, and Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Ovid Therapeutics Announces New OV329 Data and Indication Expansion, Phase 1 Clearance for OV4071, and Reports Fourth Quarter and Full Year 2025 Financial Results
The 7 mg dose of OV329 demonstrated favorable safety and tolerability profile, reinforcing best-in-category potential for refractory epilepsies; Ovid advancing plans to initiate a Phase 2 trial in focal onset seizures and an open-label, proof-of-concept study Expanding OV329 development to complementary indications in tuberous sclerosis complex seizures and infantile spasms, supported by a $60.0 million private placement OV4071, a first-in-class, oral KCC2 direct activator, received Human Research Ethics Committee approval and acknowledgement of its Clinical Trial Notification from the Australian Therapeutic Goods Administration, triggering a 30-day exercise period for the Company’s outstanding Series A Warrants Company to host KCC2-focused R&D Day on April 14, 2026 $90.4 million in cash, cash equivalents and marketable securities as of December 31, 2025, expected to fund key studies for OV329 and OV4071 and operations into late 2028; exercise of outstanding warrants may further extend runway into 2029 Company to host business update call today at 8:30 am ET NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines for brain disorders with significant unmet need, today provided pipeline progress and business updates, including financial results for the fourth quarter and full year ended December 31, 2025. The Company reported favorable topline safety, tolerability and pharmacokinetics (PK) findings from the 7 mg dose cohort of OV329, its next generation GABA-aminotransferase (GABA-AT) inhibitor. Additionally the Company announced it will add complementary development programs for OV329, expanding into tuberous sclerosis complex (TSC) seizures and infantile spasms (IS) which is funded by a private placement financing expected to result in gross proceeds of $60.0 million, before deducting placement agent fees and offering expenses. The Company will initiate a Phase 1 trial for OV4071, a potential first-in-class, oral, direct activator of potassium-chloride cotransporter 2 (KCC2) following Human Research Ethics Committee (HREC) approval of the Phase 1 study and Clinical Trial Notification (CTN) acknowledgement from the Australian Therapeutic Goods Administration (TGA). “We are achieving important steps forward in our mission to pioneer better, gentler medicines for disorde…Read full documentShow less
The 7 mg dose of OV329 demonstrated favorable safety and tolerability profile, reinforcing best-in-category potential for refractory epilepsies; Ovid advancing plans to initiate a Phase 2 trial in focal onset seizures and an open-label, proof-of-concept study Expanding OV329 development to complementary indications in tuberous sclerosis complex seizures and infantile spasms, supported by a $60.0 million private placement OV4071, a first-in-class, oral KCC2 direct activator, received Human Research Ethics Committee approval and acknowledgement of its Clinical Trial Notification from the Australian Therapeutic Goods Administration, triggering a 30-day exercise period for the Company’s outstanding Series A Warrants Company to host KCC2-focused R&D Day on April 14, 2026 $90.4 million in cash, cash equivalents and marketable securities as of December 31, 2025, expected to fund key studies for OV329 and OV4071 and operations into late 2028; exercise of outstanding warrants may further extend runway into 2029 Company to host business update call today at 8:30 am ET NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines for brain disorders with significant unmet need, today provided pipeline progress and business updates, including financial results for the fourth quarter and full year ended December 31, 2025. The Company reported favorable topline safety, tolerability and pharmacokinetics (PK) findings from the 7 mg dose cohort of OV329, its next generation GABA-aminotransferase (GABA-AT) inhibitor. Additionally the Company announced it will add complementary development programs for OV329, expanding into tuberous sclerosis complex (TSC) seizures and infantile spasms (IS) which is funded by a private placement financing expected to result in gross proceeds of $60.0 million, before deducting placement agent fees and offering expenses. The Company will initiate a Phase 1 trial for OV4071, a potential first-in-class, oral, direct activator of potassium-chloride cotransporter 2 (KCC2) following Human Research Ethics Committee (HREC) approval of the Phase 1 study and Clinical Trial Notification (CTN) acknowledgement from the Australian Therapeutic Goods Administration (TGA). “We are achieving important steps forward in our mission to pioneer better, gentler medicines for disorders of the brain. We believe today’s data continue to support OV329’s potential best-in-category profile and give us further conviction to expand OV329 into two complementary indications, tuberous sclerosis complex seizures and infantile spasms, for which GABA-AT inhibition is a validated mechanism of action. Additionally, we are rapidly advancing OV4071 into the clinic to explore its broad therapeutic potential,” said Meg Alexander, President and Chief Executive Officer. “Together, these developments reflect the strength of our scientific approach to restoring the balance of excitation and inhibition in the brain. Today’s plans will add to our growing cadence of near-term clinical milestones, and position Ovid to deliver meaningful progress for patients and value for stockholders over the months and years ahead.” PIPELINE AND BUSINESS UPDATES OV329: New 7 mg cohort demonstrates favorable safety and tolerability profile; advancing into patient studies Today, Ovid announced new results from a 7 mg dose cohort evaluating the safety and tolerability of OV329, a next-generation GABA-AT inhibitor being developed for drug-resistant epilepsies. Following the cortical inhibition and tolerability demonstrated by OV329 at 3 mg and 5 mg doses, Ovid conducted further characterization of a 7 mg cohort to inform dose selection for planned patient studies. The 7 mg Phase 1 study included both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, each consisting of six participants receiving OV329 and two participants receiving placebo. There were no treatment-related adverse events in the 7 mg cohort, and in a total of 19 unrelated adverse events, all were mild and transient. Across all doses tested, OV329 continues to demonstrate a favorable safety and tolerability profile in clinical studies, with no treatment-related serious adverse events observed. These findings continue to support a potential best-in-category profile. The 7 mg dose data builds upon previously reported, positive biomarker results associated with the 3 mg and 5 mg doses of OV329, which were presented at the 2025 American Epilepsy Society (AES) annual meeting in December 2025. At those doses, OV329 demonstrated strong, statistically significant cortical inhibition activity and increase in GABA as measured across multiple metrics. The cortical inhibition results associated with OV329 matched or exceeded those demonstrated by therapeutic doses of vigabatrin as measured in previous studies using the same methodology. Findings confirm OV329 penetrates the brain, engages the target, and achieves biological modulation as expected of elevated levels of GABA, the major inhibitory neurotransmitter. Extensive ophthalmic assessments, including best corrected visual acuity, fundus photography, indirect dilated ophthalmoscopy, optical coherence tomography and automated threshold visual field perimetry, showed no evidence of ophthalmic or retinal changes associated with OV329. This result builds upon prior clinical and preclinical ophthalmic safety characterization studies which demonstrated OV329 enters and then rapidly clears the brain, plasma and tissue, whereas vigabatrin, a first-generation GABA-AT inhibitor, was shown to preferentially partition and accumulate in the retina. Phase 2 dose confirmatory & open-label proof-of-concept study Ovid believes the drug exposure, PK, safety, and tolerability profile observed with the 5 mg and 7 mg doses of OV329 are supportive of further clinical development and provide dose optionality for planned Phase 2 proof-of-concept and dose confirmatory studies. Ovid plans to initiate an open-label photo paroxysmal response study to evaluate the anti-seizure effect of OV329. In parallel, the Company is advancing plans for a Phase 2 randomized, placebo-controlled trial, which is expected to evaluate two dose levels and determine seizure reduction efficacy in people living with treatment-resistant FOS. Ovid is engaged in regulatory conversations and currently anticipates initiating the Phase 2 study in the second quarter of 2026. OV329: New complementary development programs expanding into TSC seizures and IS Ovid also announced plans to expand development of OV329 in TSC-associated seizures and IS, two rare and severe epileptic disorders characterized by significant unmet medical need. GABA-AT inhibition is a clinically validated mechanism for the treatment of certain severe epilepsies, including TSC seizures and IS. The clinical utility of the first-generation GABA-AT inhibitor has been limited by safety concerns which constrain its broader use. Ovid believes OV329’s differentiated, next-generation profile may overcome these limitations, with the potential to unlock the full therapeutic benefit of GABA-AT inhibition for patients with severe pediatric epileptic disorders. The Company is advancing a pediatric-specific formulation of OV329 amenable for infant and child use. For TSC-associated seizures, Ovid plans to initiate a proof-of-concept safety and signal-finding study in the fourth quarter of 2026 to evaluate OV329 in patients with TSC-associated seizures. In IS, the Company intends to initiate a safety and signal finding study in 2027. These additive development programs are expected to proceed in parallel with the FOS program and may support an accelerated development pathway. KCC2 portfolio: First clinical validation achieved; approval received for oral lead candidate OV4071 to enter the clinic in Australia Ovid is advancing a proprietary portfolio of potential first-in-class direct activators of the potassium-chloride cotransporter 2 (KCC2), a CNS-specific target that is essential for synaptic inhibition and implicated in a broad range of neurological and neuropsychiatric disorders. Direct activation of KCC2 represents a mechanism-based approach to restoring inhibitory tone in the brain by regulating the efflux of chloride from neurons and thereby, enabling GABA to be hyperpolarizing (inhibitory). The Company is developing multiple molecules across the clinic and preclinic that have differentiated therapeutic profiles and formulations for potential conditions including psychoses, epilepsies, and neurodevelopmental and neurodegenerative disorders. The Company will be hosting an R&D Day dedicated to the KCC2 portfolio on April 14, 2026. Key programs include: OV4071 (Oral KCC2 direct activator): OV4071, Ovid’s lead oral direct activator intended for chronic conditions, is proceeding to a Phase 1 clinical study in the second quarter of 2026 following receipt of HREC approval and acknowledgment of Ovid’s CTN from the Australian TGA. OV4071 is initially focused on psychosis associated with Parkinson’s disease and Lewy body dementia, both areas of significant unmet need with limited treatment options and established regulatory pathways. As part of the clinical development plan, Ovid intends to conduct a ketamine challenge study in mid-2026 to further characterize potential pharmacodynamic effects and establish proof-of-mechanism. Ovid believes OV4071 also has therapeutic potential across additional neuropsychiatric disorders characterized by neural circuit dysfunction, including schizophrenia and psychosis associated with Alzheimer’s disease, supporting broader expansion opportunities. OV350 (IV KCC2 direct activator): In December 2025, Ovid reported positive Phase 1 results demonstrating the first-ever clinical validation of direct KCC2 activation in humans. OV350 had no treatment-related serious adverse events reported and its PK behaved as predicted. Exploratory electrophysiology suggested OV350 had GABAergic CNS activity consistent with expected PK and the anticipated mechanism of action. These data support advancement of the Company’s oral KCC2 programs, including OV4071. KCC2 portfolio expansion: Ovid continues to advance additional oral and injectable KCC2 direct activators, including next-generation compounds, supporting a sustainable pipeline designed to unlock the full therapeutic potential of this novel mechanism across multiple indications. BUSINESS STRATEGY AND UPDATES The Company’s public announcement of HREC approval for OV4071 triggers a 30-day period for the exercise of the Company’s Series A Warrants to purchase up to 38,481,325 shares of the Company’s common stock and/or Pre-Funded Warrants to purchase common stock. Accordingly, the Series A Warrants will expire on April 17, 2026, if not exercised. If all Series A Warrants are exercised in full, the Company anticipates receiving up to an additional $53.9 million in gross proceeds, prior to deducting placement agent fees, potentially extending Ovid’s cash runway into 2029. On March 17, 2026, the Company entered into a Securities Purchase Agreement, pursuant to which the Company agreed to issue and sell an aggregate of 19,154,321 shares of its common stock at a purchase price of $2.01 per share and, in lieu of common stock, pre-funded warrants to purchase up to 10,701,710 shares of common stock, at a purchase price of $2.009 for each pre-funded warrant (the Private Placement). The pre-funded warrants will have an exercise price of $0.001 per share and will be immediately exercisable. The Company intends to use the proceeds from the Private Placement, together with its existing cash, cash equivalents and marketable securities to support the expansion of the development of OV329 into additional indications, including TSC and IS, alongside its ongoing development in FOS. Multiple pipeline data and regulatory milestones are anticipated for Ovid’s OV329 epilepsy and KCC2 programs in the next 18 to 24 months. These anticipated milestones include: Phase 2 dose confirmatory study for OV329 in drug-resistant epilepsies (Q2 2026 start); initiation and completion of an open-label, patient proof-of-concept photo paroxysmal response study (Q3 2026 start), the potential initiation and completion of a proof-of-concept trial for the first oral KCC2 direct activator, OV4071 (Q2 2026 start); the initiation and results of a ketamine challenge study for OV4071 (mid-2026 start); and subsequently, the potential initiation and completion of Phase 1b studies for OV4071 in psychosis associated with Parkinson’s disease and Lewy body dementia, schizophrenia and other undisclosed indications. Fourth Quarter and Annual 2025 Financial Results Cash, cash equivalents and marketable securities as of December 31, 2025 totaled $90.4 million. Revenue from royalty agreements was $0.7 million and $7.3 million for the three months and full year ended December 31, 2025, as compared to $0.1 million and $0.6 million for the same periods in 2024. Revenue in 2025 comprised royalties on net sales and recognition of a one-time $7.0 million payment primarily related to future royalties, while 2024 revenue only consisted of royalties on net sales. Research and development expenses were $6.6 million and $25.6 million for the three months and full year ended December 31, 2025, compared to $5.9 million and $36.8 million for the same periods in 2024. The increase between the three months ended December 31, 2025 and the same period last year is primarily related to increased clinical study activity on the OV329 and KCC2 programs. The year-over-year decrease is related to restructuring in 2024 to re-prioritize clinical and preclinical pipeline programs. General and administrative expenses were $6.4 million and $24.1 million for the three months and full year ended December 31, 2025, as compared to $4.9 million and $25.7 million for the same periods in 2024. The increase between the three-month periods was primarily due to non-routine investment advisory professional fees; the decrease year-over-year was driven by the organizational restructuring in mid-2024, offset by non-routing business development expenses and investment advisory professional fees. Total operating expenses were $13.0 million and $49.7 million for the three months and full year ended December 31, 2025, as compared to $10.8 million and $62.5 million for the same periods in 2024. Ovid reported net income of $9.7 million, or basic and diluted net income per share attributable to common stockholders of $0.06, for the three months ended December 31, 2025, as compared to a net loss of $9.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.13, for the same period in 2024. Net income for the three months ended December 31, 2025 was primarily due to a gain recorded on adjustment in fair value of a long-term equity investment of approximately $21.0 million. Ovid reported a net loss of $17.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.23, for the year 2025, as compared to a net loss of $26.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.37, for the same period in 2024. Business Update Call and Webcast Ovid’s management team will host a business update call and live audio webcast at 8:30 am ET today, Wednesday, March 18, 2026. A live audio webcast of the presentation can be accessed through the Events & Presentations section of Ovid’s website. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. A replay of the webcast will be archived on Ovid’s website for 90 days following the event. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain disorders with significant unmet need. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant focal onset seizures (FOS) and developmental and epileptic encephalopathies (DEEs), including tuberous sclerosis complex (TSC) and infantile spasms (IS); and OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation, statements regarding the reproducibility and durability of any favorable results initially seen to date in clinical trials; the potential therapeutic opportunity of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; the expected timing of initiation, completion, and results and data of Ovid’s ongoing and planned clinical studies, including the Phase 1 trial of OV4071; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; the potential use and development of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; Ovid’s clinical pipeline strategy and plans for future clinical studies; the potential exercise of the warrants issued in the October 2025 private placement financing, and the aggregate proceeds payable to Ovid should all holders of Series A Warrants choose to exercise their warrants; the intended use of the proceeds from the Private Placement, including for the development of OV329 in additional indications including TSC and IS; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its business strategy, and the holders of the warrants issued in the October 2025 private placement may choose not to exercise the warrants prior to their expiration and the price targets that would permit Ovid to require certain of the warrants to be exercised may not be achieved. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Investor Relations & Media Victoria Fort [email protected] 202.361.0445
TranscriptFY2025 Q42026-03-18FY2025 Q4 earnings call transcript
Earnings source - 108 paragraphs
FY2025 Q4 earnings call transcript
Good afternoon, everyone. My name is Angela, and I will be your conference operator today. At this time, I would like to welcome you to Ovid Therapeutics Business and Pipeline Update Call. This conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers' prepared remarks, there will be a question-and-answer session. At this time, I would like to turn the call over to Victoria Fort. Please proceed.
Thank you. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing business and pipeline updates and financial results for the three months and full year ended December 31, 2025. A copy of the release can be found in the Investor Relations tab on our corporate website, ovidrx.com. As a reminder, during today's call, we'll be making forward-looking statements. Various remarks we make during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for the purpose of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this call are subject to a number of risks and uncertainties, which could cause our actual results to differ materially from those expressed or implied in such statements.
These factors include, but are not limited to, those discussed in our most recent annual report on Form 10-K and other filings with the Securities and Exchange Commission. Joining me on today's call are Meg Alexander, our President and Chief Executive Officer, and Jeffrey Rona, our Chief Business and Financial Officer. Meg will go over the clinical and business updates we announced this morning, and then Jeff will detail our financial results, followed by a question-and-answer session. Before I hand the call to Meg, I would like to note that we are hosting today's call in conjunction with the updates that we announced this morning in our earnings release. However, we do not plan to host regular quarterly earnings calls moving forward. With that, I'd now like to turn the call over to Meg.
Good morning, everyone, and thank you for joining us. This is a great morning for Ovid, and I'm keen to take you through both pipeline progress and business updates that we'll go into greater detail with this morning. I'd like to start with our pipeline. Our good news is that we've now announced that we've received regulatory clearance for the first-ever oral KCC2 direct activator, which is OV4071. I want to thank our team who worked through the holidays to achieve this a quarter earlier than expected. In addition to that, this morning we announced that we now have safety and tolerability data associated with the 7 mg dose of OV329, our next-generation GABA aminotransferase inhibitor. I'm pleased to share that there were no serious adverse events or adverse events associated with the 7 mg dose.
All of our programs are advancing on track to patient proof-of-concept studies, and this is gonna mean exciting progress and potential readouts throughout the end of this year, throughout 2027. We also have new news in addition to that. We're launching additional studies for 329. We'll walk you through the data that gives us conviction. In addition to the programs that we already have in focal onset seizures, we're launching programs today in infantile spasms and seizures associated with tuberous sclerosis complex. What has helped making this possible is additional capital that we also announced this morning through a PIPE financing that was led by Point72. I wanna thank that fund, as well as our top shareholders who have come in again to support us, including Janus, RA, Bellevue, Affinity, Coastland, Eventide, Adage, and ADAR1.
With this capital, we will launch those programs in a way that does not compromise any of the other development programs that we've already discussed. Importantly, for our shareholders, the clearance of OV4071 also triggers a 30-day period for our Series A warrants. If those warrants are exercised, this will bring additional capital and potential proceeds to Ovid greater than $53 million. With this PIPE that we're announcing this morning and the potential exercise of those warrants, Ovid will have a cash runway well into 2029. We're excited to take you through all of this progress, which we'll do in detail and answer questions. Before we do, I just wanna remind you what we're trying to do and how we're trying to operate to develop gentler, better medicines for the brain.
All of our programs are focused on controlling neural hyperexcitability. As you know, we're pursuing fundamental biological targets to address that neural hyperexcitability. We do that by pursuing differentiated and what we believe are universal mechanisms of action through small molecule programs. Because at the end of the day, we want medicines that are easy for patients to be able to take. I'd like to acquaint you on our updated pipeline. What you'll see is some of the programs that we've already been progressing in the clinic and the new ones that I just mentioned. Starting from the top, our program OV329 for focal onset seizures is progressing on track. As we said we would do this upcoming quarter, Q2 of 2026, we will be initiating a phase II randomized placebo-controlled trial.
Later this year, we'll also be initiating an open-label photosensitivity study that will show us anticonvulsant response relative to the doses that we want to take into later development. I'd like to focus you on the green box that you see in the middle of this slide. These are the new programs that we'll be adding as a result of the PIPE financing that we discussed this morning. Specifically, we'll be taking OV329 into signal finding and safety studies, both for tuberous sclerosis complex seizures and infantile spasms. We'll tell you more about the design of these programs in a moment.
Now, with the first-ever clearance of a KCC2 direct activator, OV4071, this upcoming quarter, Q2, we'll be initiating a phase I study, and we'll be running a ketamine challenge that will help us better characterize what we believe is broad antipsychotic activity associated with OV4071. For today's news, we're going to start with OV329, which let me remind you, we believe is a potential best-in-category anti-seizure medicine, which we think is appropriate as a treatment, not just for focal onset seizures, but also these very specific developmental epileptic encephalopathies that we're discussing. I'm going to start today by telling you about the clinical progress we have with the 7 mg dose.
This gives us even more conviction to open those proof-of-concept studies that I just mentioned in infantile spasms and tuberous sclerosis complex. What we believe of OV329 at this point in time is that it has a potential best-in-category profile. What do we mean by that? At this point, we know with 329 it is delivering inhibition in the brain and GABAergic inhibition both in the synapse and the extrasynaptic. We believe that's leading to an optimal tolerability profile. We know that we differentiate from the safety profile of the first generation GABA aminotransferase inhibitor, which was called vigabatrin, which had some irreversible safety ophthalmic issues. Importantly, this is a mechanism that is validated in focal onset seizures. We believe that we will have competitive efficacy. When it comes to patients, what's important is we want a medicine that's easy to take.
We anticipate in focal onset seizures, once daily dosing, very low dosing, and no titration. Let's dive into some of the data that supports this program, because we know in focal onset seizures, while there are many medicines, there is still tremendous unmet need, with 40% of the community still uncontrolled with the existing mechanisms of action. Starting with the safety data that we have in hand, our 7 mg dose in adults and healthy volunteers has demonstrated a very strong safety and tolerability profile. As many of you may recall, we ran the 7 mg dose to expand dose optionality for our later-stage clinical trials. What the 7 mg dose has now demonstrated is that we have no treatment-related serious adverse events. Additionally, across the entire SAD and MAD cohort, there were no adverse events associated with OV329.
It's important to note there were adverse events in the whole cohort, but those were not associated with treatment. Some of the most common adverse events were things like cannula site reactions. Of course, there was also no ophthalmic safety concerns. Let's take a deeper dive into this. Over the course of 329's characterization in healthy volunteers, what you're seeing in front of you is the adverse events that were reported that could be associated with OV329. These included, across various doses, headache, drowsiness, and metallic taste. All of these were very low in frequency. They were mild, and they resolved.
Importantly, relative to differentiation from the first generation GABA aminotransferase inhibitor, we have extremely rigorous batteries of visual testing as well as structural photography of the eye to ensure and to prove that we do not have the same retinal accumulation and dysregulation that was seen with the first generation drug. I can confidently say we have seen nothing associated with OV329. Of course, we will continue to run this battery of very rigorous testing throughout the entirety of OV329's development because as we move towards registration, we want to be able to take to regulators a very deep armamentarium of patient ophthalmic safety data, because we want to avert the monitoring and the REMS that was seen with the first generation drug. All this is good news, but what makes us really excited as drug developers is what I'm about to show you next.
We have a lot of data that we leverage to inform our dose strategy with OV329. From a pharmacology strategy perspective, to achieve the inhibition that we seek and ultimately the anticonvulsant activity that we want to achieve for patients, our strategy has been to inhibit the GABA aminotransferase enzyme between about 50%-60%. In order for us to achieve that, there is a drug exposure level in the plasma that we have modeled, again, across multiple streams of evidence that are reinforcing to each other. You see that range in the middle bottom of this page here. It's roughly 60 ng per hour per ml to 120. Now I'd like to point you to the right-hand side of this slide.
What you'll see is the actual human data, and this is mean drug exposure in the plasma associated with each dose of OV329 that we've tested. Importantly, if you look where the green box is, you'll see that both our 5- and 7 mg doses deliver drug exposure in the plasma that should be consistent with the inhibition and potentially the anticonvulsant activity that we seek to achieve. Also importantly, we have linear PK as expected and consistent clearance. In addition to this, many of you may recall last fall, we read out the most expansive biomarker program that's ever been done for a seizure medicine at this stage.
What that showed us across multiple biomarkers is that OV329 is not just getting into the brain, but it's delivering cortical inhibition in a way that was highly significant and in a way that either matched or surpassed the levels of inhibition that were seen with therapeutic doses of the first generation GABA-AT inhibitor, giving us incredible conviction. What comes next? We have great confidence now that we have two doses that are within the exposure range that we predict to be therapeutic and that are extremely well-tolerated. They have shown cortical inhibition as measured by multiple biomarkers. At this point, we believe these are two strong doses to be able to take into phase II programs that in addition to being safe, well-tolerated, and delivering inhibition, we believe will also help optimize our responder rate.
I'd like to tell you more about our upcoming trial designs. As I mentioned, we are now launching 2 studies to demonstrate proof of concept in anticonvulsant activity for three two nine. Later this year, we will start an open label photoparoxysmal study. For those of you who are unfamiliar with this design, what it does is essentially allows us to demonstrate potential anticonvulsant activity in a population of patients who have a photosensitive form of epilepsy. We hope to have this data late this year. Why this is helpful is while we enroll a true gold standard randomized placebo-controlled phase II program, which will start next quarter.
This gives us, in the interim, anticonvulsant potential demonstration, again, giving us increased conviction and a potential de-risking event about the doses that we want to take into later development. For our phase II randomized placebo-controlled study, again, we intend to take two doses into that study, and this will be a traditional epilepsy study over 8 weeks to be able to demonstrate the key and traditional primary endpoints associated with seizure trials. This is very good news, and I want to thank our team for delivering this result. Now I'd like to turn to the new news, which is the pediatric programs that we're adding. You've heard us talk about the adult capsule formulation of OV329, but we've long been thinking about expanding based on the data that we have in hand.
We have the opportunity to develop a pediatric and protected weight-based formulation to be able to serve the needs of these children and adults who remain very underserved. I'd like to take a moment to speak about that, starting with infantile spasms. Many of you may not have heard about infantile spasms because frankly, there's been extremely little drug development in this area for the span of the last 20 years, and it's needed. When these babies have an infantile spasm, which occurs between four to seven or eight months of life, it is an emergency. They have associated developmental disabilities, increased mortality, and the risk of lifelong epilepsies as a result of this. Despite the deep severity of this condition, there has been very little innovation.
Today, the current standard of care is Acthar Gel or other high-dose steroids as a first line, and vigabatrin, that first-generation GABAT inhibitor, as a second line. Similarly, in Tuberous Sclerosis Complex, this is a genetic condition in which essentially children are born and form benign tumors or hamartomas across multiple different organs. But in this case, the one that we're most focused on is the brain. People who live with TSC have high probability of having seizures. In fact, 80% of the community experiences them. Similar to infantile spasms, the standard of care is very limited for these patients. Despite that high frequency of seizures, the primary standard of care is Afinitor as well as Sabril, and those have limitations with how they can be used based on their safety.
In contrast to that, we think OV329 has tremendous potential and may even be disease-modifying. Why do I say that? If you look at the profile on the left, which we'll talk through more, but then you look at the column on the right, in infantile spasms, we believe that there is an opportunity for 329 to be used first line with Acthar Gel and to be used longer to mitigate some of those developmental and epilepsy outcomes that we commonly see. We believe this because if you have a safe and well-tolerated and effective GABA aminotransferase inhibitor, clinicians will be comfortable using it earlier and for longer. Similarly, in Tuberous Sclerosis Complex, we believe that a safe and well-tolerated GABAT inhibitor could be used first line for seizure reduction.
Over time, because some of these babies are diagnosed very early, we may be able to build a path to possible prevention of seizures associated with TSC. We think this is hugely important. What gives us conviction beyond the data that we have in 329 from our own trials is that this is a mechanism that we know works. If you look on the left-hand column, the efficacy associated with GABA aminotransferase inhibition in these indications is proven. In fact, it's been pretty profound. We've seen freedom from spasms, freedom from treatment failure in infantile spasms, and we see a high responder rate to those who respond in TSC, including a high degree of seizure freedom. Because of everything that you see on the right-hand side of the slide, Sabril is not used much today.
We think that the opportunity that exists is much bigger. When you look at this, what we're showing you here is how the drugs that are used as a standard of care are prescribed for these indications. There's a lot of information on these slides, but I'm going to mostly acquaint you to the right-hand side of the slide. What we see when you look at Sabril is it really underreflects what we think is the, not just the unmet need, but the market opportunity in these conditions. Sabril, as many of you may know, which is the brand name of vigabatrin, was introduced decades ago. It was initially priced for a larger population epilepsy.
If you look across the middle row of these tables, you'll see that it's very limited in its treatment duration because the clinicians, and oftentimes the caregivers and parents, are concerned about using this for prolonged use because of its safety. Nevertheless, Sabril in the U.S. alone had peak sales of $320 million. We think, again, the opportunity of a safe version of this mechanism could be significantly bigger. This just gives you a sense of what's giving us belief. If you look at the opportunity and the sales that were associated with Sabril, again here just in the U.S., we already have established a better therapeutic index with OV329 than what we saw with Sabril.
If you assume that we're able to also realize ex-US sales, earlier in-line use, and this treatment duration, we believe that the opportunity for OV329, in addition to the opportunity that we are already pursuing in focal onset seizures, is very significant. We hope that this enhanced penetration duration will lead to very significant commercial opportunity. I want to quickly point to, we're not going to spend a lot of time on this today, but we also have preclinical data that gives us confidence that these are the right indications to go to. In infantile spasms and focal onset seizure models, which is the distinctive seizure commonly seen in Tuberous Sclerosis Complex. We have demonstrated that OV329 is highly efficacious.
For those of you who have been following us, you know that we believe that we have a much safer version of a GABA aminotransferase inhibitor than what was seen idiosyncratically with the first generation compound. We have shown that in animals, OV329 does not accumulate in the retina and cause the retinal dysregulation that was the hallmark safety issue associated with vigabatrin. We've looked at this now across multiple species. What this means in terms of the future of OV329, we think is quite bright. If you look at the past registration for OV329, we are continuing on with what we promised to all of you we would do with focal onset seizures with those studies that I mentioned. Importantly, we're opening what we think is not just an opportunity for orphan status, but a very efficient path to registration.
The signal finding studies that we have in tuberous sclerosis complex will allow us to establish signal, safety, and step down and establish our pediatric dosing to inform both a signal finding study in tuberous sclerosis complex, but then also confirm the pediatric dosing that we will take into infantile spasms. We believe there's an opportunity in both of these indications for a combined pivotal phase II, III study, thereby enabling that efficiency to registration. As we wrap up the 329 section, we feel this is a strong win for our patients, for our shareholders, and our company. This is a completely additive clinical expansion program in de-risked indications. It allows us to do what we were doing before and create more value. What that means for our shareholders is you should anticipate more milestones and catalysts, both in the interim and in the long term.
We have the potential to develop these differentiated formulations to be able to protect and separate the IP and to consider the various commercial needs of both of these communities. At the end of the day, we believe this is going to enhance the value both for the program and for the company. This is great news. Again, I wanna thank Point72 and our shareholders for supporting us in this. I wanna take just a couple minutes at the end to tell you about the good news with KCC2, which we've been talking about for a long time, and the oral KCC2 direct activator is now here. Let us tell you what we're on track to do. We have clearance in Australia. That's important, as I mentioned, because it does trigger those Series A warrants.
After Australia, we will be immediately following in the U.S. and then the European Union. We are on track to initiate our phase I study this next quarter in Q2. That will be followed by a ketamine study later this year to show proof of mechanism, and we're on track to start proof of concept patient studies late this year or early next year. I want everyone to know this is not the only KCC2 direct activator. We have an engine of discovery and further candidates coming beyond it, and we'll be telling you more about that at a KCC2 day that we'll be holding about a month from today on April 14th. We hope you'll join us again for that. We'll tell you more about that molecule at the KCC2 day.
Just to give you the highlights of what you should expect to see, we believe that OV4071 has broad syndromic psychosis applications. Just to point to that, we have forthcoming data that gives us conviction not only for the indications that we've talked to you about before, such as psychosis associated with Parkinson's disease and Lewy body dementia, but additionally in schizophrenia and Alzheimer's psychosis, agitation, and well beyond. I'd like to tell you just a little bit about OV4071 knowing that there's more to come. We are very excited about the attributes of this molecule. As many of you know, we read out our tool program last year. We got a lot of great information about that program. This molecule is much better. We have a 20-fold potency. It's highly active at low doses in a range of different animal PD models.
We have very strong brain to plasma penetration and no sedation's been observed with OV4071. What I get really excited about with our team is that the pharmacodynamic data and armamentarium that is now mounting for OV4071 is robust. Across seizure models, psychosis models, pain models, genetic models of things like schizophrenia and Rett, we are seeing consistently GABAergic activity across all of these models associated with OV4071. What makes us also have conviction as we look at this data is that we are running OV4071 in comparison to marketed agents, both old ones and some of the new ones that have been recently approved. We're seeing it perform very well across these battery of animal biological models. This is giving us conviction to advance into that phase I study, as I mentioned.
You'll hear us talk about in April more about the KCC2 portfolio. If our thesis for KCC2 is right in terms of the opportunity of drugging this target, OV4071 will not be the only KCC2 direct activator. It's a very good program, but we have additional discovery engines going on beneath this with further next generation chemistry, so that we will be the company that pioneers and unlocks the opportunity associated with KCC2. Why this matters, again, for those of you who have been following OV329 and maybe not as focused on KCC2, this is a target that is extremely important to the brain. It's fundamental, and it's a fulcrum to neural excitation and inhibition in that balance. These are highly precise small molecules that we're developing.
The therapeutic potential is broad, as you heard me say, and we believe that these will be well-tolerated, and we know we have direct activators. We're very excited to unlock this opportunity. What this means to our shareholders and our stakeholders is a really busy couple of years ahead. Just to give you a sense of what this means from a runway and a milestones perspective, my colleague, Jeffrey Rona, and I will take you through this. Just starting with the milestones, there's a lot going on this page, but what you should pay attention to is the green arrows. Those are data readouts or major milestones. As we promised you we would do, today we're reading out the 7 mg data for OV329 in focal onset seizures. We will be initiating that gold standard phase II study.
We will also be initiating the photosensitivity open label study. We're on track to read those out. We will be opening the programs that we said we would do today in Tuberous Sclerosis Complex and in infantile spasms. You'll see that's going to start with a signal finding and safety study and a dose confirmatory study with Tuberous Sclerosis Complex in an open label format. How we'll be doing that, we'll be starting with older TSC patients and stepping down into younger pediatrics. That allows us to establish safety and signal as we go. It will inform and de-risk our infantile spasms signal finding study. It also allows us to share our progress with you as we enroll enough patients. That will help, of course, inform the pivotal phase II, III studies that I mentioned for each of these indications thereafter.
Finally, we are ready to roll with KCC2. This is what we've been waiting for. We will be starting that phase I study. As soon as we have enough of our PK and Cmax characterized from that phase I study, we will be initiating the ketamine challenge study. We'll be doing that here in the United States. That will help us correlate electrophysiology along with potential clinical signs and symptoms. That will be important because it will help us not just support the initiation of a proof of concept study in Parkinson's disease psychosis, but it helps us inform some of those other indications that you heard me talking about, including schizophrenia, which we have increasing conviction behind.
I just want to turn this over to my colleague and Chief Business and Financial Officer, Jeffrey Rona, who's going to take us through the cash runway and what that means relative to the achievement of these milestones.
Great. Thank you, Meg. I will just briefly highlight our cash position. The full details of our financial results can be found in our fourth quarter and year-end earnings release issued this morning. As of December 31, 2025, Ovid had $90.4 million in cash equivalents, and marketable securities. As Meg mentioned today, we announced the PIPE financing with gross proceeds totaling $60 million before placement agent fees and offering expenses. We are grateful to our shareholders for their support as we continue to unlock the full value of our pipeline and programs. With the net proceeds from this PIPE, we expect that our cash runway will take us into the second half of 2028.
Assuming the full exercise of the Series A warrants triggered by the milestone we met with the clearance of the phase 1 trial protocol for OV4071, along with the gross proceeds from the PIPE financing, we expect that our pro forma cash runway will take us well into 2029. With that, I'll turn the call back to the operator, so we can begin the question-and-answer portion of today's call. Operator?
Thank you. We will now begin Q&A. To join the queue to ask a question, please press star five on your telephone. Again, that's star five on your telephone to ask a question. Please limit to one question before jumping back in the queue. Thank you. We will now pause a moment to assemble the queue. Our first question comes from François Brisebois. Please unmute yourself, and you can ask your question.
Frank, if you're there, we can't hear you.
Looks like he has lowered his hand.
Okay.
Our next question will come from Laura Chico with Wedbush.
Good morning. Thanks very much for taking the question. I was wondering if you could talk a little bit more about 329 and the visual monitoring. Meg, you mentioned you would kind of continue this through phase II, but it sounds like the 7 mg data was quite clean. I guess just trying to better understand specifics on what you'll be implementing during the placebo-controlled study, but also the open-label study. A quick follow-up, if I can squeeze one in. Thanks.
Sure. Yeah. Good morning, Laura. Great questions. Where we will be continuing the optic and the retinal monitoring is in the phase II study and then in the pivotal studies thereafter. The reason why is not because we expect to see anything, because frankly, we don't. What we want to be able to have, as I mentioned, as we move towards registration, is a robust armamentarium of human and importantly, patient safety data that shows that we have not seen any structural changes in the eye, nor have we seen any visual changes. Frankly, this is well more robust than what vigabatrin ever did in their REMS program.
We believe that we have a safe GABA aminotransferase inhibitor, and we want to hit the nail on the head when we take this to regulators and prove it, such that we don't have to have some of the monitoring that has really limited the use of this mechanism in the prior first-generation drug. Laura, if you have a quick second question?
Okay.
We'll try to cover it.
Yeah, just briefly, the PPR study with OV329. I guess I just wanted to make sure, should we assume that a response rate should be similar to what we've seen with published studies on vigabatrin? I know when you did the biomarker assessment, there were some nuances there, but just wanted to make sure I understood on the PPR study expectations there. Thanks.
Yeah. The way that we've designed the PPR study is that we want to be able to demonstrate anticonvulsant effect. We think in focal onset seizures, to do these studies the right way, it takes time to appropriately enroll them and get to an answer and of course, have an N size to be able to show anticonvulsant efficacy. We really like PPR studies, not just because it was used with older drugs, but frankly, our peer set, right? Other companies are using this right now, and it's a good capital efficient and clinically sound way of assessing anticonvulsant activity in a patient population. That's really our intention. It allows us to establish potential anticonvulsant activity at the doses that we want to take into later development. That's the intention for us pursuing this program.
Thanks very much. Congrats.
Thanks, Laura.
Thank you. Our next question will come from Marc Goodman. Marc, please unmute and you can ask your question.
Hi. Good morning, everyone. This is Alyssa on for Mark. Thanks for taking our questions and congrats on all the progress. I was wondering if you could provide additional detail on the planned phase two design for OV329 in FOS starting next quarter, particularly around the key endpoints and what patient populations you'll be targeting. Then separately, could you elaborate on the rationale for the ketamine challenge study for OV4071, and what you're hoping to learn from the EEG and other biomarker data in the context of, the indications that you'll be targeting? Thanks so much.
Thanks, Alyssa. Happy to. Let's start with your first question, which is the phase II design for OV329. To address it is the population that we're looking at is of course, adults with treatment-resistant focal onset seizures. That means by definition, these are seizure patients who've already failed a couple of anti-seizure medicines and continue to experience breakthrough seizures. What is helpful in the space of epilepsy is that we have extremely codified endpoints that have been effective and strengthened, because of the work of the Epilepsy Research Consortium, ourselves and our peers in the space. You know, there's very good methods now for testing seizures, also balancing that relative to placebo rates. Some of the endpoints that are the endpoints to think about here, Alyssa, are, percent reduction in seizures, monthly seizure reduction from baseline. It's also reduction in total seizures.
It's the traditional endpoints, CGI endpoints, for example, the traditional ones that you would expect of a seizure study. We will be doing the same thing here. That's important obviously to establish efficacy. In terms of the ketamine challenge, we get a lot of questions about this. The ketamine challenge has been used before also with other antipsychotic drugs in development. What we're looking to do is, as I mentioned earlier, we'll conduct a broad battery of electrophysiology. One of those things will include quantitative EEG, and we will also look at clinical discomforts and symptoms. We'll talk more about this at the KCC2 Day, and we'll go in a deep dive at it.
At a high level, strategically what we're looking to do is to be able to show that OV4071 is getting into the brain, that it is having an effect, that that effect is consistent with GABAergic activity, which would be on mechanism. There are certain bands and frequency bands that we look for that are also consistent with antipsychotic drugs in certain indications. If we're fortunate, we'll be able to correlate some of that quantitative electrophysiology with actual signs of clinical symptom amelioration relative to placebo subjects who are not exposed to OV4071. This would give us information to show we're getting into the brain, we're having an effect that's on mechanism. There's also some select biomarkers which we'll tell you more about next month, that even help us have a read-through for indication identification and indication sequencing.
We think there's a lot we can extract out of this. I think you can tell from our team we really like trying to use biomarkers to learn as much as we can early versus waiting for later development to ask and answer those questions.
Excellent. Thank you so much. Congrats again.
Thank you. Our next question will come from Myles Minter. Myles, please unmute yourself and ask your question. Myles is with William Blair.
The open label photosensitive epilepsy study. What type of patient going to enroll in that study? I'm just aware that, you know, depending on the stimulus and then the underlying form of epilepsy, like the discharge patterns are quite different amongst those patients. I'm just wondering how much that will actually inform on focal onset versus something like generalized versus something like TSC infantile spasms. That would be really helpful.
Yep. We believe this is a good sign of broad anticonvulsant effect, Miles. We will be doing the study. As you may know, there's not many sites in the world that do these studies. We'll be conducting this at a very specialized site in the Netherlands who focuses on this. We'll be doing it in adults who have diagnosed epilepsy, and we'll be using the. Of course, the challenge is there's not many patients in the world that actually have this form of epilepsy. But we'll be basically selecting patients who have documented photosensitivity on prior EEGs. Those will have to be reproducible. We'll be using screening using intermittent photic stimulation. What you can assume is we're using that population to give us a general read-through, again, for anticonvulsant effect associated with their 5 and 7 mg doses.
We believe that this is a modest and capital efficient way of being able to confirm anticonvulsant activity while, and before we have to wait for the full readout of the phase II program. It, it's not necessarily the same thing, obviously, as a full phase II study. We recognize that. This gives us some de-risking data and again, more information that we're headed down the right trajectory before we continue to spend more capital and also start to consider pivotal programs.
Yeah. A quick one if I may, just on going after both prevalent population with FOS potentially generalized and then moving into TSC and IS on the rare side, how do you think about long-term sort of differential pricing, if that's a consideration? Thanks.
It's absolutely a consideration, Miles. What we have the opportunity to do here with OV329 is, I think, to serve a number of communities that have really deep unmet need with differentiated formulations, where there will be true differences here. For the adult focal onset seizure population, as we've mentioned before, we're pursuing a capsule. For the populations with infantile spasms and tuberous sclerosis complex, these are pediatric populations. We will be developing essentially a liquid or a syrup to be able to serve them. This is going to be weight-based dosing. It'll be very different. There will be other differences I can say between the formulations that allow us to achieve the pharmacology strategy associated with these indications. That will allow us to have differential pricing relative to the communities.
Obviously, we're doing so in a way that we think would be appropriate and responsible, and there's some good analogs for this in the environment with other major developers that we've seen that we can point you to.
Beautiful. Congrats. Thanks again.
Thanks, Myles.
Thank you. Our next question comes from François Brisebois with LifeSci Capital.
Hi. Can you guys hear me?
We can hear you now, François.
Hello? Oh, great. All right. I don't even know how to lower my hand, so not sure what happened. All right, well, congrats on everything. I just was wondering if you can touch a little bit more on vigabatrin and the history here. You touched on peak sales, and maybe as you answer, maybe help us understand how like what kind of market size TSC and then the IS part of that is, and just, you know, when that visual issue came up with vigabatrin, what was the impact on it? Just, like, color around, like how serious is the visual concern here? Thank you.
Thanks, Frank. When Sabril or vigabatrin was first launched by Lundbeck, the field of epilepsy thought this was going to be a multi-blockbuster epilepsy medicine. The reason why is because it works so well as an anticonvulsant. However, it was determined post-market to have this preferential partitioning in the retina that in some patients led to blindness. It took the field, and frankly, it took us several years to demonstrate that this is idiosyncratic to that compound and to show that, of course, it's not on mechanism. There's a lot of evidence that we have that shows that now. What that means in terms of what the opportunity was, the sales of Sabril really understate where we think there's both a lot of unmet need and also a market.
Because Sabril had that post-market safety finding, its use was very limited and constrained in the United States. Nevertheless, between the two indications, primarily infantile spasms, but also tuberous sclerosis complex, its sales peaked a couple of years ago at more than $320 million. You know, a drug that essentially can make children blind, that is only used in six- to nine-month treatment durations for very limited use, peaked at that sales figure.
What we think, and in our conversations, most importantly with the clinicians who treat these children and these babies, is that if we have a safe GABA aminotransferase inhibitor, that the opportunity to use it earlier, to use it longer, can not only change the trajectory of the disease for these kids, but potentially may be a very large opportunity, and they would be much more comfortable using it for longer, hoping to improve those developmental outcomes. You asked one other question, François, that I wanna make sure we address, which was what was the breakout of sales. I'd love to be able to point you to that, but Lundbeck actually never broke out their sales by indication. That $320 million peak figure that I mentioned to you was in 2018. That included both of those two indications in the U.S. alone.
That doesn't reflect Europe or worldwide sales.
Perfect. Thank you very much, and congrats on all the progress.
Thank you.
Thank you. Our next question will come from Madison El-Saadi with B. Riley.
Hey, guys. Thanks for taking our questions. Congrats on the really comprehensive update here. Maybe starting with OV329. Did you say, maybe I missed it, how many patients in the 7 mg arm reached above the 80 nanograms AUC threshold, which is correlated with higher biomarker efficacy? Wondering if there's any rationale to explore dose above 7 mg. Thanks.
Yeah. Superb questions, Madison. Thank you. The answer to your first question about how many were within the exposure range that we wanted to achieve, that's a good and easy answer. All, 100%. With the 5- and 7 mg doses, we have a lot of confidence that we're in the exposure range that we targeted. The second question, also a super question, which is why not go higher? There is a reason. We know through all of our work, which is extensive now, but also looking at 30 years of vigabatrin's pharmacology, that there is a ceiling of how much inhibition of the GABA aminotransferase enzyme can be achieved in the central CNS, and that's around 60%-65%.
When you consider that and you are well within, and in the case of our 7 mg dose, above the drug exposure level in the plasma needed to achieve that, continuing to go higher doesn't necessarily warrant the trade-off relative to what you may start to then take on relative to possible AEs, though we haven't seen any of those, of course. We believe that we are well within the pharmacology strategy of being able to maximize the enzyme inhibition that should correlate with therapeutic activity. Our two doses are delivering drug exposure level that gets us there and of the 7 mg that gets us over it and it gets all the subjects from our 7 mg cohort over it, giving us again a lot of conviction behind these doses.
Understood, Meg. That makes total sense. If I may, lastly, I just noticed you seemed excited to mention the KCC2 program. Looking towards the R&D day next month, will we see any additional pre-clinical data, maybe in AD agitation, please?
I would be in deep trouble with our chief corporate affairs officer if I tell you too much and scoop her for a month from now. What you will see is more pre-clinical data supporting biomarker strategy, supporting indication selection, and supporting the broad profile that we believe that OV4071 holds is, again, a broad syndromic psychosis agent.
Got it. Thanks for doing this.
Thank you. Our final question will come from Jay Olson with Oppenheimer.
Oh, hey, congrats on all the progress, and thank you for taking our question. How are you thinking about longer-term clinical development for three-two-nine in focal onset seizure after demonstrating efficacy in the treatment refractory population? Would you expand three-two-nine into development as a monotherapy in earlier lines of treatment? Eventually, as you look beyond focal onset seizures, do you expect three-two-nine to be studied in status epilepticus with an IV formulation? Thank you.
Thank you for the question, Jay. I think you've heard us and everyone at the team here at Ovid espouse our belief that OV329 and the inhibition of the GABA aminotransferase enzyme is a universal mechanism. We believe that safely elevating your natural levels of GABA in your brain, the braking system, has broad therapeutic utility in both seizures and epilepsies, but even in indications beyond that. I don't want to comment too much further on long-term development planning. We've got plenty to do in the next two years, as you can see. What you can take away from this is that as we build more data behind OV329, much as we're doing today, we will use the evidence to inform where we potentially expand and go next.
We absolutely believe that a safe and well-tolerated GABA aminotransferase inhibitor has a place across a lot of epilepsies, particularly if we continue to demonstrate what we think may be best in category tolerability, not just within the GABA-A mechanism, but potentially relative to the entire field of seizure medicines. Obviously, we need to continue to establish this with patients. If we do, we think this could have a very significant opportunity. As it relates to refractory status epilepticus, we have certainly pre-clinical data that would support taking us into those indications. There is a lot of unmet need there. With that said, from an operational and clinical perspective, those are very complex trials to run. I don't think you should anticipate that we will be doing that in any time in the near future.
Just for the operator, I believe there's one more question from our analyst at TD Cowen, Ritu.
Yes. Our next question will come from Ritu Baral with TD Cowen.
Good morning, guys. Thanks for pulling me back into the queue. I wanted to ask about the first readout from the TSC study. There's a pretty broad bar on your pipeline, Meg, and you mentioned that you were hoping to find early signal findings. Will those first signals out of 329 in TSC be at the 12-week timeframe, which I think is the primary endpoint of the pivotal phase II-III, or will there be some additional dose-finding in there as well?
Yeah, excellent questions. I don't want anyone to walk away from this call thinking that you're not going to hear anything about TSC until the middle of 2028, 'cause you will. You'll hear things sooner than that. We've designed the tuberous sclerosis complex open label study very intentionally as an open label. There's a lot that we hope to get from this that we will sequentially communicate around when we feel like the enrollment and the N size is big enough to have an answer that will give us all the evidence and sufficient evidence that we believe that we can make decisions and base information on.
What I mean by that, Ritu and colleagues, is that because this is an open label study, we've designed this to be able to start with older tuberous sclerosis patients, including adolescents, then going down to younger pediatrics before we initiate that infantile spasm study. Why we're doing this is we want to, of course, establish safety in these pediatric populations. We'd like to be able to establish signal. Importantly, it allows us to confirm the dose modeling. We feel actually very confident based on the modeling that we already have internally with some of our animal models and our human data. We'd like to be able to confirm this with pediatric cohorts as we go. We have the opportunity to communicate about this throughout these open label programs.
In fact, we have a very similar approach with the infantile spasm open-label, as you see here as well. You know, again, this is a matter of as we enroll the study, we believe that this gives us the information we need. It also allows us to communicate with these communities, to give them the confidence that if we're going to move into registrational trials, that we have an agent that may offer a benefit to the children.
Got it. Remind me how many patients were in the 7 mg healthy volunteer arm? Oh, I think I believe it was 11. Are you surprised that it was so clean compared to the prior doses? You know, what, if anything, does that tell you about how you expect both doses to behave from a safety perspective going forward?
You did answer the question for me, but I'll just reinforce what you said. It was 11 in the SAD/MAD cohort that were taking the 7 mg dose of OV329. You know, at this point, we've had, I think, nearing 70 people throughout the phase I study. We've had a goodly number of healthy volunteers be now treated with various ascending doses of OV329. In terms of the tolerability, I'm not surprised. This is on mechanism for we believe some of the differentiators of OV329. Importantly, it would be one thing if we just had this tolerability and safety data and didn't have the biomarker data that we have.
We have the benefit now of not just knowing that OV329 is getting into the brain at these doses, that it's elevating levels of GABA in the medial parietal lobe, that it is driving cortical inhibition that's known to be the mechanism that exceeds or is commensurate with that of what we've seen with therapeutic doses of vigabatrin. We're also seeing exposure increase by dose as we predicted and expected. We feel very good that these are doses that are doing what they need to do in terms of the pharmacology strategy while also having that tolerability. Just, you know, for those who are newer to our story, 329 is designed to not only be safer but well-tolerated. Unlike the first generation drug vigabatrin, OV329 delivers GABA in the synapse and in the extrasynaptic region. These are called forms of phasic and tonic inhibition.
Why does any of that matter? It matters because Sabril only drives or vigabatrin only drove GABA in the synapse. Similar to other drugs, like benzodiazepines, for example. What happens when that occurs is when you flood the synapse with GABA, you hit synaptic GABA-A receptors. That drives a lot of tolerability issues like sedation and other. But because OV329 has this broad therapeutic index that the first generation drug did not have, we're able to deliver this phasic and tonic inhibition, essentially coating the entire neural environment in a more inhibitory milieu. It's less of this surge that you see with other drugs, and it's a more cooling down of the ecosystem around the neurons. We believe that that's leading to a better tolerability profile.
What we're excited to go ask and answer next is will it lead to an even better efficacy profile? That's why we're running the studies that we're running.
Great. If I could squeeze one last one in just about your FOS and your PPR study. As you look at those efficacy endpoints, which I believe are a percentage change of certain EEG thresholds, do you believe that those changes in the PPR model, I mean, as we compare it to. Well, first of all, is there a target that you guys are looking for in those EEG markers? Second, is a PPR response proportional to ultimate seizure response? Basically if you end up with stronger PPR data, is it indicative of potential stronger seizure reduction?
The way that we have looked at designing this PPR study is we feel that it gives us conviction about the doses and conviction of anticonvulsant effect. I think truly to see what the anticonvulsant profile is of OV329 is why we're running the phase II study that we're running, right? A true randomized placebo-controlled trial. But just from an endpoint perspective, what we'll be looking for in photosensitivity study is three key points to be clear. We'll be looking at reductions in the number of IPS frequencies that induce the PPR, the photosensitivity response. We'll be looking for the threshold frequency to induce these photosensitive responses, and we'll be looking also at complete suppression of these photosensitive responses, both during and post-dose. We think, you know, this will give us some helpful information.
It's not the same thing as a pivotal or a phase II study. While we do the full phase 2 study, I think it gives us confidence-building and de-risking data that enables us as we continue to expand the life cycle and the broad opportunity of OV329 to continue to make those investments and to robustly pursue the value creation opportunity associated with this program. This concludes our question.
Great. Thank you.
Thank you.
Sure thing. This concludes our question and answer session. Meg, any closing remarks?
I just wanna thank everyone for your time this morning and for your continued interest in our company. I wanna thank Point72 and our shareholders who supported us in today's news. We're really pleased with this progress across the pipeline and the business, and I wanna just take a moment to thank the patients, the caregivers and parents who are advisors, the doctors and clinicians who are our partners, and I really wanna thank our team here at Ovid. They made it possible. They worked through the holidays in order for us to deliver early on some of these outcomes. Thank you all for your support. Keep watching us, and we're gonna work to deliver.
Thank you for joining. This concludes today's call. You may now disconnect.
Investor releaseQuarter not tagged2026-03-05Niagen Bioscience (NAGE) Tops Q4 Earnings and Revenue Estimates
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Niagen Bioscience (NAGE) Tops Q4 Earnings and Revenue Estimates
Niagen Bioscience (NAGE) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of $0.02 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +100.00%. A quarter ago, it was expected that this natural products company would post earnings of $0.02 per share when it actually produced earnings of $0.05, delivering a surprise of +150%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Niagen Bioscience, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $33.84 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 8.81%. This compares to year-ago revenues of $29.13 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Niagen Bioscience shares have lost about 23.4% since the beginning of the year versus the S&P 500's decline of 0.4%. While Niagen Bioscience has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Niagen Bioscience was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You c…Read full documentShow less
Niagen Bioscience (NAGE) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of $0.02 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +100.00%. A quarter ago, it was expected that this natural products company would post earnings of $0.02 per share when it actually produced earnings of $0.05, delivering a surprise of +150%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Niagen Bioscience, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $33.84 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 8.81%. This compares to year-ago revenues of $29.13 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Niagen Bioscience shares have lost about 23.4% since the beginning of the year versus the S&P 500's decline of 0.4%. While Niagen Bioscience has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Niagen Bioscience was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.05 on $35.1 million in revenues for the coming quarter and $0.29 on $153.4 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Ovid Therapeutics (OVID), has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of +23.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Ovid Therapeutics' revenues are expected to be $0.24 million, up 203.8% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Niagen Bioscience, Inc. (NAGE) : Free Stock Analysis Report Ovid Therapeutics (OVID) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2025-12-18Ovid Therapeutics Reports Phase 1 Results for the First-Ever Direct Activator of Potassium-Chloride Cotransporter 2 (KCC2), OV350 Intravenous (IV)
GlobeNewswire
Ovid Therapeutics Reports Phase 1 Results for the First-Ever Direct Activator of Potassium-Chloride Cotransporter 2 (KCC2), OV350 Intravenous (IV)
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071 There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs) Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2 modulation; aligned with expected drug exposure in the brain Pharmacokinetics for OV350 were as predicted, and will inform dosing strategies for future KCC2 development programs OV4071 (oral) is on track for regulatory submission for a Phase 1/1b clinical trial in Q1 2026 NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines to treat brain disorders and symptoms caused by excess neural excitability, today announced results from its Phase 1 study of OV350, the first-ever KCC2 direct activator known to be dosed in humans. The study met its primary objectives to evaluate safety, tolerability and pharmacokinetics. Results from this intravenous program support the advancement of the Company’s portfolio of oral KCC2 direct activators into the clinic. “OV350 is a valuable tool program that supported human safety for drugging KCC2, an entirely new therapeutic target in the brain, which could be a master switch to curb neural hyperexcitability,” said Meg Alexander, President and Chief Operating Officer of Ovid Therapeutics. “The results from this study give us confidence that this new mechanistic class is amenable for further development and reinforces our decision earlier this year to invest in the development of additional direct activator molecules and formulations for chronic use, including OV4071, the first oral KCC2 direct activator. We expect to submit our regulatory application for a Phase 1/1b study of OV4071 in Q1 2026 and plan to initiate clinical studies in Q2 2026.” Study Design and Key Results OV350 was evaluated in an exploratory randomized, placebo-controlled, single-ascending dose study in 16 healthy participants (six active, two placebo per cohort). Doses of 50 mg and 100 mg were administered by IV infusion over ten minutes, with pharmacokinetic sampling conducted up to 48 hours post-dosing. In addition to laboratory and clinical re…Read full documentShow less
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071 There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs) Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2 modulation; aligned with expected drug exposure in the brain Pharmacokinetics for OV350 were as predicted, and will inform dosing strategies for future KCC2 development programs OV4071 (oral) is on track for regulatory submission for a Phase 1/1b clinical trial in Q1 2026 NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines to treat brain disorders and symptoms caused by excess neural excitability, today announced results from its Phase 1 study of OV350, the first-ever KCC2 direct activator known to be dosed in humans. The study met its primary objectives to evaluate safety, tolerability and pharmacokinetics. Results from this intravenous program support the advancement of the Company’s portfolio of oral KCC2 direct activators into the clinic. “OV350 is a valuable tool program that supported human safety for drugging KCC2, an entirely new therapeutic target in the brain, which could be a master switch to curb neural hyperexcitability,” said Meg Alexander, President and Chief Operating Officer of Ovid Therapeutics. “The results from this study give us confidence that this new mechanistic class is amenable for further development and reinforces our decision earlier this year to invest in the development of additional direct activator molecules and formulations for chronic use, including OV4071, the first oral KCC2 direct activator. We expect to submit our regulatory application for a Phase 1/1b study of OV4071 in Q1 2026 and plan to initiate clinical studies in Q2 2026.” Study Design and Key Results OV350 was evaluated in an exploratory randomized, placebo-controlled, single-ascending dose study in 16 healthy participants (six active, two placebo per cohort). Doses of 50 mg and 100 mg were administered by IV infusion over ten minutes, with pharmacokinetic sampling conducted up to 48 hours post-dosing. In addition to laboratory and clinical results, exploratory quantitative electroencephalography (qEEG) endpoints were collected. Key findings include: At 50 mg and 100 mg doses of OV350, exposure levels achieved expected pharmacologically active concentrations reinforcing the potential for further clinical development of KCC2 direct activators, including OV4071, which performs with twenty-fold greater potency than OV350 in pharmacodynamic models. The most frequent treatment-emergent adverse event (AE) associated with OV350 was headache. Nausea and vomiting occurred in a subset of participants who experienced headache. These AEs coincided with the timing of food intake and are believed to be caused by secondary off-target pharmacology unique to OV350. There were no treatment-emergent SAEs associated with OV350 and stopping criteria were not met in the study. The pharmacokinetics were as predicted for all doses. qEEG findings supportive of central activity and spectral power relevant for the expected pharmacologic impact of KCC2 modulation were observed. These effects were contemporaneous with the expected exposure of OV350 in the brain. Results from the study will be submitted for a future congress. Earlier this year, Ovid prioritized and directed its capital resources to accelerate chronic (oral) formulations of its oral direct activator programs, including OV4071 and OV4041. Accordingly, the Company does not intend to advance OV350 IV further in the clinic. Advancing a First-in-Class Portfolio of Oral KCC2 Direct Activators Ovid believes the results from OV350 support the advancement of Ovid’s portfolio of KCC2 direct activators, which contains multiple unique molecules. Most advanced in the portfolio is development candidate OV4071, an oral direct activator that is twenty-fold more potent than OV350 in pharmacodynamic disease models. Ovid expects to initiate a Phase 1/1b safety and proof-of-concept clinical study in Q2 2026 for the treatment of psychosis associated with Parkinson’s disease and Lewy body dementia. These conditions have high unmet need, validated endpoints, an established regulatory pathway, and traditional atypical antipsychotics are typically contraindicated. Additionally, the Company is planning to characterize the pharmacodynamic effects of OV4071 and relevant mechanisms in additional neuropsychiatric conditions, such as schizophrenia and psychoses or agitation associated with other neurodegenerative conditions including Alzheimer’s disease. Concurrent to the clinical translation of OV4071, Ovid is advancing next-generation KCC2 activators from its proprietary library of compounds. These molecules are designed for oral and injectable formulations. About KCC2 KCC2 is a neuron-specific chloride transporter that maintains inhibitory balance in the brain. The cotransporter plays a central role in regulating neuronal excitability by enabling gamma-aminobutyric acid (GABA) to exert its inhibitory effect. Direct activation of KCC2 represents a differentiated, mechanism-based approach to treating serious neurological and neuropsychiatric conditions in which neuronal hyperexcitability is central to disease and symptom manifestation. Ovid’s KCC2 programs are designed to build a first-in-class franchise targeting restoration of excitatory/inhibitory balance in the brain, which may offer therapeutic benefit across multiple neurological and neuropsychiatric disorders. About OV350 OV350 is a first-in-class, investigational direct activator of KCC2, the neuron-specific chloride transporter that restores inhibitory signaling and helps rebalance hyperexcitable neural circuits. Data from this tool program is informative in establishing safety, tolerability, pharmacokinetics and pharmacodynamic properties of this new mechanism of action for the brain. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; and is developing OV4071 and other candidates within a library of compounds that directly activate the KCC2 transporter for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation: statements regarding the expected timing of initiation, completion, and results and data of Ovid’s ongoing and planned clinical studies; the potential use and development of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; the potential therapeutic opportunity of OV329, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; Ovid’s clinical pipeline strategy and plans for future clinical studies; the expected timing of IND-enabling and formulation efforts for molecules from its KCC2 direct activator library and related regulatory submissions; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its business strategy, or risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions or unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Investor Relations & Media Victoria Fort [email protected] 202.361.0445
Investor releaseQuarter not tagged2025-11-12Ovid Therapeutics Announces Planned Leadership Succession and Reports Business Updates and Third Quarter 2025 Financial Results
GlobeNewswire
Ovid Therapeutics Announces Planned Leadership Succession and Reports Business Updates and Third Quarter 2025 Financial Results
Meg Alexander appointed Chief Executive Officer effective January 1, 2026; Dr. Jeremy M. Levin to transition to Executive Chair of the Board of Directors Next-generation GABA-aminotransferase (GABA-AT) inhibitor, OV329, demonstrated strong inhibitory activity and a potential best-in-category safety profile in a Phase 1 study, supporting advancement into planned Phase 2 patient studies OV329 Phase 1 results selected for late-breaking poster presentation at the 2025 American Epilepsy Society (AES) annual meeting Ovid’s first-in-class KCC2 direct activator portfolio is progressing on-track with first-in-human data for OV350 intravenous (IV) expected in Q4 2025 and the first-ever oral KCC2 direct activator, OV4071, anticipated to enter the clinic in Q2 2026 Completed private placement of up to $175 million in gross proceeds, including initial closing of approximately $81 million, expected to extend anticipated cash runway into 2H 2028 NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines for brain disorders with significant unmet need, today announced a Chief Executive Officer (CEO) succession plan under which Meg Alexander will assume the role of CEO and join Ovid’s Board of Directors, effective January 1, 2026. Dr. Jeremy M. Levin, who has served as Ovid’s Chairman and CEO since he co-founded the company, will transition to Executive Chairman of the Board. The Company also reported financial results for the third quarter ended September 30, 2025 and provided key pipeline and business updates. Since joining Ovid in 2021, Ms. Alexander has been instrumental in helping architect the Company’s pipeline and has overseen core operations and strategic initiatives, most recently in her role as President and Chief Operating Officer. During Ms. Alexander’s transition to CEO, Dr. Levin will work closely with Ms. Alexander to maintain continuity. “Ovid is operating from a position of scientific and fiscal strength. The OV329 biomarker results, progress across our KCC2 direct activator programs, and our recent financing reflect disciplined execution,” said Dr. Jeremy M. Levin, D.Phil., MB BChir. “Over the past four years, Meg and I have worked closely with our team to build this foundation. She has led key facets of the business, including development of our pipeline and scientific…Read full documentShow less
Meg Alexander appointed Chief Executive Officer effective January 1, 2026; Dr. Jeremy M. Levin to transition to Executive Chair of the Board of Directors Next-generation GABA-aminotransferase (GABA-AT) inhibitor, OV329, demonstrated strong inhibitory activity and a potential best-in-category safety profile in a Phase 1 study, supporting advancement into planned Phase 2 patient studies OV329 Phase 1 results selected for late-breaking poster presentation at the 2025 American Epilepsy Society (AES) annual meeting Ovid’s first-in-class KCC2 direct activator portfolio is progressing on-track with first-in-human data for OV350 intravenous (IV) expected in Q4 2025 and the first-ever oral KCC2 direct activator, OV4071, anticipated to enter the clinic in Q2 2026 Completed private placement of up to $175 million in gross proceeds, including initial closing of approximately $81 million, expected to extend anticipated cash runway into 2H 2028 NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company developing small molecule medicines for brain disorders with significant unmet need, today announced a Chief Executive Officer (CEO) succession plan under which Meg Alexander will assume the role of CEO and join Ovid’s Board of Directors, effective January 1, 2026. Dr. Jeremy M. Levin, who has served as Ovid’s Chairman and CEO since he co-founded the company, will transition to Executive Chairman of the Board. The Company also reported financial results for the third quarter ended September 30, 2025 and provided key pipeline and business updates. Since joining Ovid in 2021, Ms. Alexander has been instrumental in helping architect the Company’s pipeline and has overseen core operations and strategic initiatives, most recently in her role as President and Chief Operating Officer. During Ms. Alexander’s transition to CEO, Dr. Levin will work closely with Ms. Alexander to maintain continuity. “Ovid is operating from a position of scientific and fiscal strength. The OV329 biomarker results, progress across our KCC2 direct activator programs, and our recent financing reflect disciplined execution,” said Dr. Jeremy M. Levin, D.Phil., MB BChir. “Over the past four years, Meg and I have worked closely with our team to build this foundation. She has led key facets of the business, including development of our pipeline and scientific strategy. I have deep respect for Meg’s judgment, integrity and strong leadership, and the Board and I have full confidence in her. I look forward to supporting a smooth handover while strategically supporting the Company as Executive Chairman.” “The Board’s unanimous decision to appoint Meg reflects her strong record of execution and leadership across Ovid’s operations and strategy,” said Bart Friedman, Lead Independent Director and Chair of the Nomination and Governance Committee of the Board of Directors. “With Jeremy continuing as Executive Chairman, this succession further strengthens Ovid’s leadership and expands the Company’s opportunities with strong continuity.” “Ovid is at an important inflection point. We are within months of bringing OV329 into patient trials with drug-resistant epilepsies, reading out safety of the first-ever KCC2 direct activator, and submitting the first-ever oral KCC2 direct activator for human studies. I’m energized to build upon this momentum, advance potentially transformative medicines for patients and create meaningful value for shareholders,” said Meg Alexander, incoming Chief Executive Officer. “Jeremy’s leadership has been inspiring. I am grateful for his partnership and continued service to the Company. Jeremy co-founded and named Ovid with the vision of making medicines that fundamentally improve patient lives. It is an honor to take on this role and lead this remarkable team.” KEY PIPELINE AND BUSINESS UPDATES OV329: Progressing to Phase 2 patient study following positive Phase 1 results Based upon recent clinical and preclinical results, Ovid believes OV329 may have a highly differentiated profile and mechanism-of-action relative to approved anticonvulsants and is advancing its clinical development. Demonstrated target engagement and strong inhibitory activity: On October 3, 2025, Ovid announced positive topline results from its Phase 1 clinical trial evaluating OV329, a next-generation GABA-AT inhibitor, in healthy volunteers. The study enrolled 68 participants, including 51 who received OV329 and 17 who received placebo across single and multiple ascending dose cohorts. The study used an expansive biomarker strategy to characterize OV329’s potential target engagement and pharmacodynamic activity. OV329 3 mg and 5 mg doses suppressed the GABA-AT enzyme and delivered statistically significant inhibition in the brain as measured across multiple metrics on transcranial magnetic stimulation and magnetic resonance spectroscopy. The degree of OV329’s cortical inhibition matched or exceeded levels of inhibition previously observed for therapeutic doses of the first-generation GABA-AT inhibitor vigabatrin in comparable healthy volunteer studies. Positive clinical safety and tolerability profile: Across all doses tested, OV329 was well tolerated. No treatment-related serious adverse events were observed, and adverse events were generally mild and transient. This supports OV329’s potential to offer a best-in-category safety profile. Ophthalmic safety: Comprehensive ophthalmic evaluations, including best-corrected visual acuity, fundus photography, dilated indirect ophthalmoscopy, automated threshold perimetry, and optical coherence tomography, showed no treatment-related ocular changes. This outcome contrasts with the known visual field defects and retinal changes historically associated with vigabatrin. It also reinforces preclinical studies showing that OV329 does not accumulate in the retina like vigabatrin. Advancing to Phase 2 patient studies: The favorable safety, tolerability, and pharmacodynamic profile observed in the Phase 1 study support plans for continued development of OV329 as a potential next-generation GABA-AT inhibitor for the treatment of drug-resistant focal onset seizures. Ovid is in the process of seeking scientific advice with regulators across multiple regions and plans to initiate a Phase 2a clinical study in Q2 2026. The Company is concurrently assessing the safety and tolerability of a 7 mg dose of OV329 for potential evaluation in patient studies given the favorable tolerability profile observed for the 5 mg dose. The 7 mg cohort data, including safety, tolerability and pharmacokinetics, will be available before the initiation of the Phase 2a trial, helping to confirm dose selection. Phase 1 data selected for presentation at American Epilepsy Society (AES): The OV329 Phase 1 study results will be featured in a late-breaking poster session at the 2025 AES annual meeting, occurring December 5-9, 2025 in Atlanta, Georgia. KCC2 portfolio: Advancing multiple, novel direct activators and accelerating oral candidates toward clinical proof-of-concept Translation and development of Ovid’s first-in-class portfolio of small molecules that directly activate potassium-chloride cotransporter 2 (KCC2) is progressing well. KCC2 is a neuron-specific chloride transporter that maintains inhibitory balance in the brain. The cotransporter plays a central role in regulating neuronal excitability by enabling gamma-aminobutyric acid (GABA) to exert its inhibitory effect. Direct activation of KCC2 represents a differentiated, mechanism-based approach to treating serious neurological and neuropsychiatric conditions in which neuronal hyperexcitability is central to disease and symptom manifestation. OV350 (IV KCC2 direct activator): Ovid is completing a first-in-human clinical study of OV350 in healthy volunteers to assess safety, tolerability and pharmacokinetics. The Company expects to report data in Q4 2025. Results from OV350 are intended to establish foundational safety for this new class of molecules and to inform the continued development of Ovid’s future oral candidates. OV4071 (Oral KCC2 direct activator): IND-enabling studies are completing for OV4071, Ovid’s first oral KCC2 candidate. The Company plans to submit for regulatory clearance in Q1 2026 and begin a Phase 1/1b safety and proof-of-concept clinical study in Q2 2026. OV4071 is believed to have broad therapeutic and anti-psychotic activity. The first indications for which OV4071 is initially being developed are for the treatment of psychosis associated with Parkinson’s disease and Lewy body dementia, both of which represent areas of high unmet need with established regulatory pathways. The Company is exploring a ketamine challenge to further characterize potential proof of mechanism of OV4071 in neuropsychiatric conditions and is exploring additional conditions for development, such as schizophrenia and psychoses associated with other neurodegenerative conditions. Next-generation KCC2 programs: In parallel to the clinical translation of the above mentioned programs, Ovid is advancing next-generation KCC2 activators from its proprietary library of compounds. These molecules are designed for oral and injectable formulations. Collectively, Ovid’s KCC2 programs are designed to build a first-in-class franchise targeting restoration of inhibitory tone in the brain, which may offer therapeutic benefit across multiple neurological and neuropsychiatric disorders. BUSINESS STRATEGY AND UPDATES On October 3, 2025, Ovid announced a private placement totaling up to $175 million in gross proceeds, including an initial closing of approximately $81 million. This capital, combined with the $25.6 million in cash, cash equivalents and marketable securities which Ovid had as of September 30, 2025, is expected to fund the current operating plan and clinical pipeline into 2H 2028. Multiple pipeline and regulatory milestones are anticipated for Ovid in the next 18 - 24 months. These anticipated milestones include potential initiation and completion of a Phase 2a patient study for OV329 in drug-resistant epilepsies (Q2 2026 start); results from the Phase 1 study of OV350 (Q4 2025); the potential initiation and completion of a proof-of-concept trial for the first oral KCC2 direct activator, OV4071 (Q2 2026 start); the potential initiation and completion of a ketamine challenge study for OV4071 (Q3 2026 start); and the initiation and completion of Phase 1b studies for OV4071 in psychoses associated with Parkinson’s disease and Lewy body dementia (projected Q3 2026 start), schizophrenia and other undisclosed indications. Third Quarter 2025 Financial Results Cash, cash equivalents and marketable securities as of September 30, 2025 totaled $25.6 million. Ovid’s capital has subsequently been augmented by the private placement conducted in October 2025, which includes $81 million in additional upfront capital and up to an additional $94 million in proceeds upon exercise of issued warrants. Revenue from royalty agreements were $132,000 for the third quarter ended September 30, 2025, as compared to $173,000 for the same period in 2024. Research and development expenses were $5.9 million for the third quarter ended September 30, 2025, compared to $7.9 million for the same period in 2024. The decrease is related to the organizational restructuring in Q2 2024 to re-prioritize Ovid’s clinical and preclinical pipeline programs. General and administrative expenses were $6.8 million for the third quarter ended September 30, 2025, as compared to $5.5 million for the same period in 2024. The increase was driven by non-routine business development professional fees. Total operating expenses were $12.7 million for the third quarter ended September 30, 2025, as compared to $13.4 million for the same period in 2024. Ovid reported a net loss of $12.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.17, for the third quarter of 2025, as compared to a net loss of $14.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.20, for the same period in 2024. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; and OV350, OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation: statements regarding the reproducibility and durability of any favorable results initially seen to date in clinical trials; the expected timing of initiation, completion, and results and data of Ovid’s ongoing and planned clinical studies; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; the potential use and development of OV329, OV350, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; the potential therapeutic opportunity of OV329, OV350, OV4071 and other compounds from Ovid’s library of direct activators of KCC2; Ovid’s clinical pipeline strategy and plans for future clinical studies; the expected timing of IND-enabling and formulation efforts for molecules from its KCC2 direct activator library and related regulatory submissions; Ovid’s potential future business development opportunities; the planned leadership transition; the potential exercise of the warrants issued in the October 2025 private placement financing; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its business strategy, or risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions or unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions, and the exercise of the warrants issued in the October 2025 private placement is subject to stockholder approval which may not be received, and even if such stockholder approval is received, the warrant holders may choose not to exercise the warrants prior to their expiration and the price targets that would permit Ovid to require certain of the warrants to be exercised may not be achieved. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Investor Relations & Media Victoria Fort [email protected] 202.361.0445
Investor releaseQuarter not tagged2025-11-04Ovid Therapeutics (OVID) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
Zacks
Ovid Therapeutics (OVID) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
Wall Street expects a year-over-year increase in earnings on higher revenues when Ovid Therapeutics (OVID) reports results for the quarter ended September 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.15 per share in its upcoming report, which represents a year-over-year change of +25%. Revenues are expected to be $0.34 million, up 100% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 5.26% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a…Read full documentShow less
Wall Street expects a year-over-year increase in earnings on higher revenues when Ovid Therapeutics (OVID) reports results for the quarter ended September 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.15 per share in its upcoming report, which represents a year-over-year change of +25%. Revenues are expected to be $0.34 million, up 100% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 5.26% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Ovid Therapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -4.50%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Ovid Therapeutics will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Ovid Therapeutics would post a loss of$0.16 per share when it actually produced a loss of -$0.06, delivering a surprise of +62.50%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Ovid Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Avidity Biosciences, Inc. (RNA), is soon expected to post loss of $1.05 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of -61.5%. This quarter's revenue is expected to be $2.5 million, up 6.8% from the year-ago quarter. The consensus EPS estimate for Avidity Biosciences has been revised 3.4% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -9.35%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Avidity Biosciences will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ovid Therapeutics (OVID) : Free Stock Analysis Report Avidity Biosciences, Inc. (RNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

