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NEW YORK, May 05, 2023 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare epilepsies and seizure-related disorders, today reported business updates and financial results for the first quarter ended March 31, 2023.
“Our recent transaction with Graviton adds a clinical stage program with a novel mechanism of action to our pipeline of potential first-in-class or potential best-in-class medicines for rare epilepsies and seizure-related disorders. We are excited to explore the therapeutic opportunity of applying ROCK2 inhibition for people suffering with serious neurological conditions, beginning with brainstem cavernous malformations, a grave condition that has no approved medicine today,” said Jeremy Levin, D.Phil, MB BChir, Ovid's Chairman and CEO.
“Importantly, all elements of our pipeline are progressing. We are encouraged by long-term and post hoc analyses on soticlestat, recently presented by Takeda, and look forward to seeing results from the Phase 3 pivotal trials. Additionally, we have assembled a unique set of programs, anchored by four potential best-in-class or only-in-class mechanisms of action, including: selective ROCK2 inhibition, GABA-aminotransferase inhibition, direct KCC2 activation and cholesterol 24-hydroxylase inhibition that was since out-licensed to Takeda. The mechanisms in this pipeline strategically position Ovid to be a leader in rare seizure-related disorders. Collectively, we believe these programs will deliver multiple clinical milestones that can generate value for patients and shareholders,” added Dr. Levin.
First Quarter Business Update
The Company intends to make disciplined strategic investments in its scientific and leadership team to steward the business and its programs.
Pipeline Update
First Quarter 2023 Financial Results
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science. Ovid’s pipeline of small molecule candidates seek to meaningfully improve the lives of people and families affected by rare epilepsies and seizure-related disorders. Ovid seeks to develop: GV101, a potent and highly selective ROCK2 inhibitor for the potential treatment of lesions associated with cerebral cavernous malformations; OV329, a GABA-aminotransferase inhibitor, for treatment-resistant seizures, and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies. In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes. For more information about these and other Ovid research programs, please visit www.ovidrx.com.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation: statements regarding the Phase 1 study in healthy volunteers for OV329; the potential use of OV329, GV101 and OV350; the clinical and regulatory development of our programs, including the anticipated timing of clinical data; the likelihood that data for OV329, GV101 and OV350 will support future development and therapeutic potential; the potential development of GV101 and the library of ROCK2 inhibitors and OV350 and other KCC2 compounds in Ovid’s library; the suitability of Ovid’s library of novel, direct KCC2 transporter activators and the library of ROCK2 inhibitors for a range of formulations and administrations; the timing for filing of Ovid’s IND applications; the potential development and therapeutic opportunity of GV101 and other Rho/Rho associated coiled-coil containing protein kinase 2 inhibitors; and the potential safety, selectivity and potency of GV101 and other ROCK2 inhibitors; the timing for the completion of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Dravet syndrome and Lennox-Gastaut syndrome; and the duration of Ovid’s expectations regarding its cash runway and the expectation that it will support the advancement of Ovid’s pipeline. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expected,” “intends,” "may," “plan,” “potentially,” “seek,” “strive” 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, 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 technology or 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. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 13, 2023, and in 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.
| Condensed Consolidated Statements of Operations Unaudited | |||||
| For the Three Months Ended March 31, 2023 | For the Three Months Ended March 31, 2022 | ||||
| Revenue: | |||||
| License and other revenue | $ | 66,160 | $ | 1,445,366 | |
| License revenue - related party | — | — | |||
| Total revenue | 66,160 | 1,445,366 | |||
| Operating expenses: | |||||
| Research and development | 6,614,717 | 7,832,269 | |||
| General and administrative | 8,343,748 | 9,880,203 | |||
| Total operating expenses | 14,958,465 | 17,712,472 | |||
| Loss from operations | (14,892,304) | (16,267,106) | |||
| Other income (expense), net | 1,536,095 | 159,050 | |||
| Loss before provision for income taxes | (13,356,209) | (16,108,056) | |||
| Provision for income taxes | — | — | |||
| Net loss | $ | (13,356,209) | $ | (16,108,056) | |
| Net loss per share, basic | $ | (0.19) | $ | (0.23) | |
| Net loss per share, diluted | $ | (0.19) | $ | (0.23) | |
| Weighted-average common shares outstanding, basic | 70,490,704 | 70,345,828 | |||
| Weighted-average common shares outstanding, diluted | 70,490,704 | 70,345,828 | |||
| Select Condensed Balance Sheet Data Unaudited | |||||
| March 31, 2023 | December 31, 2022 | ||||
| Cash, cash equivalents and marketable securities | $ | 117,720,021 | $ | 129,001,411 | |
| Working capital(1) | 112,798,366 | 124,389,166 | |||
| Total assets | 143,367,004 | 155,265,814 | |||
| Total stockholder's equity | 120,947,682 | 132,272,564 | |||
| (1)Working capital defined as current assets less current liabilities | |||||
Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
Chief Corporate Affairs Officer
917-943-6681
malexander@ovidrx.com
OR
Investors:
Argot Partners
Maeve Conneighton
212-596-7231
ovid@argotpartners.com