Shares of Ovid Therapeutics (OVID) plunged 76% on Monday after it announced that treatment with soticlestat, its Takeda (TAK) -partnered investigational epilepsy drug, failed to meet the primary endpoint of two pivotal late-stage studies. Image Source: Zacks Investment Research Ovid's partner Takeda evaluated soticlestat for treating two rare and severe forms of epilepsy, namely Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), in the late-stage SKYLINE and SKYWAY studies, respectively. While the SKYL ...

Takeda Pharmaceutical Company Limited announced the results of its trial of soticlestat as a treatment for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). The bad news is that the treatment narrowly missed its primary endpoints in both of these cases. Dr. Jeremy Levin, chairman and CEO of Ovid Therapeutics, said the following about the news. Heavy trading is pulling down OVID stock on Monday. That has more than 13 million shares changing hands as of this writing. This is well above the company's dai ...

"After selling our rights back to Takeda three years ago, we have built an exciting and differentiated pipeline, which we believe will generate multiple value-creating opportunities in the near-term. Our R&D and financial strategy is independent of soticlestat's outcome. We will advance our pipeline thoughtfully and continue to apply the fiscal discipline to achieve our goals," remarked Dr. Levin. Takeda's Skyline study in Dravet syndrome narrowly missed its primary endpoint of reduction in convulsive seizu ...

Ovid Therapeutics (OVID) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 26.09%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.22, delivering a surprise of -29.41%. Over the last four quarters, the company has sur ...

Financial Performance - Total revenue for the three months ended March 31, 2024, was $148,000, an increase of 124% compared to $66,000 for the same period in 2023[142] - The net loss for the three months ended March 31, 2024, was $11.7 million, a decrease of 12.5% compared to a net loss of $13.4 million for the same period in 2023[142] - The company recorded other income of $5.7 million for the three months ended March 31, 2024, compared to $1.5 million for the same period in 2023[142] - General and administrative expenses decreased to $7.2 million for the three months ended March 31, 2024, down from $8.3 million in 2023, reflecting a reduction in force and strategic cost-reduction initiatives[145] - The company recorded net losses of approximately $11.7 million for the three months ended March 31, 2024, compared to $13.4 million for the same period in 2023, with an accumulated deficit of $289.6 million[148] - Net cash used in operating activities was $16.7 million for the three months ended March 31, 2024, compared to $12.1 million in 2023, reflecting a net loss offset by non-cash charges[155] - The company anticipates continued losses and negative operating cash flows for at least the next several years, with no products approved for commercial sale to date[148] Research and Development - Research and development expenses increased to $10.4 million for the three months ended March 31, 2024, from $6.6 million in the same period in 2023, reflecting a 57% increase[142] - Total research and development expenses for the three months ended March 31, 2024, were $10.4 million, an increase of $3.8 million from $6.6 million in the same period of 2023, primarily due to accelerated clinical development expenses[144] - The company expects to submit an investigational new drug (IND) application for its third program in the second half of 2024[122] - The company plans to develop an intravenous formulation of OV329, with an IND application expected in the second half of 2024[130] - The Phase 1 study for OV888 is anticipated to be completed in the first half of 2024, with plans to initiate a signal-finding trial in the second half of 2024[128] Cash and Investments - As of March 31, 2024, the company had total cash, cash equivalents, and marketable securities of $90.3 million, sufficient to fund projected operating expenses for at least the next 12 months[147] - Net cash provided by investing activities was $20.2 million for the three months ended March 31, 2024, down from $30.2 million in 2023, primarily due to the maturity of marketable securities[156] Capital and Debt - The company has raised net proceeds of $275.4 million from the sale of its capital stock as of March 31, 2024[124] - The company has no long-term debt and no material non-cancelable purchase commitments as of March 31, 2024, and has agreed to make milestone payments up to $279.3 million under various license agreements[150] - The company filed a shelf registration statement allowing the sale of up to $250.0 million of common stock, including $75.0 million available under an at-the-market offering program[153] Milestones and Agreements - The company is eligible to receive up to $660 million in regulatory and commercial milestones and tiered royalties up to 20% under the RLT Agreement with Takeda[127]

Ovid pipeline programs are advancing on track. Multiple data and regulatory milestones are expected before year-end. These include: • Takeda has completed two Phase 3 trials studying soticlestat as a treatment for Lennox-Gastaut syndrome and Dravet syndrome; topline data are anticipated in Takeda's H1 2024 fiscal year • A Phase 1, double-blind, multiple-ascending dose trial evaluating OV888 (GV101) is complete; topline safety data are expected in H1 2024 • Ovid expects to initiate a Phase 2 clinical program ...

Wall Street expects a year-over-year decline in earnings on higher revenues when Ovid Therapeutics (OVID) reports results for the quarter ended March 2024. 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 earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the st ...

Corporate Governance and Stockholder Rights - The company is governed by Delaware law, which requires at least 66 2/3% stockholder approval to amend or repeal certain provisions of its charter or bylaws[338] - Delaware law prohibits business combinations with any holder of 15% or more of the company's capital stock unless the holder has held the stock for three years or the board approves the transaction[340] - The company has provisions that limit stockholder actions, including prohibiting written consent and requiring actions to be taken at stockholder meetings[339] - The company has established advance notice requirements for stockholder proposals and director nominations[338] - The company's board can issue preferred stock without stockholder approval, which could be used to implement a "poison pill" strategy[338] Financial Reporting and Internal Controls - The company determined it requalifies as a smaller reporting company and non-accelerated filer for 2023, no longer requiring an attestation report on internal control over financial reporting[318] - The company's internal control over financial reporting may require significant expense and management effort to comply with Section 404 of the Sarbanes-Oxley Act[319] - The company has elected to adopt scaled-back disclosure obligations for smaller reporting companies, including reduced executive compensation disclosures[401] Capital Structure and Financing - The company has $250.0 million available under its Current S-3 Registration Statement, including $75.0 million for an at-the-market (ATM) offering program[326] - The company relies on external financing, including equity and debt, to fund operations, which may result in stockholder dilution[325] - The company does not anticipate paying cash dividends on its capital stock in the foreseeable future, retaining earnings for business growth[332] Stock Ownership and Equity - As of December 31, 2023, the company had outstanding options to purchase 15,124,546 shares of common stock at a weighted average exercise price of $3.87 per share[327] - Executive officers, directors, and principal stockholders collectively own approximately 52.4% of the company's outstanding common stock as of December 31, 2023[328] - Takeda, a major stockholder, is subject to standstill provisions, transfer restrictions, and voting obligations under the RLT Agreement[329][335] - Sales of a substantial number of shares in the public market could significantly reduce the market price of the company's common stock[341] Risk Factors and Litigation - The company may face securities litigation due to stock price volatility, which could result in substantial costs and divert management attention[336] - Provisions in the company's charter documents and Delaware law may discourage or delay mergers, acquisitions, or changes in control[334][337] Cash and Marketable Securities - The company has cash, cash equivalents, and marketable securities totaling $105.8 million as of December 31, 2023[401] - A 100 basis point change in interest rates would not materially affect the fair market value of the company's cash equivalents and marketable securities due to their short-term maturities and low-risk profile[401] - The company plans to maintain its portfolio in institutional market funds, including U.S. Treasury and Treasury-backed repurchase agreements, treasury notes, and high-quality short-term corporate bonds to minimize future risk[401]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________ FORM 10-Q _______________________________________________________ (Mark One) Delaware 46-5270895 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification Number) 441 Ninth Avenue, 14th Floor New York, New York 10001 (Address of principal executive offices) (Zip Code) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECU ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________ FORM 10-Q _______________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to _____ ...