NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to meaningfully improving the lives of people affected by rare epilepsies and brain conditions, today reported business updates and financial results for the first quarter ended March 31, 2024.
“This is an exhilarating period for Ovid. Our innovative programs are progressing through clinical trials and moving closer to addressing the significant unmet needs of individuals with developmental and epileptic encephalopathies,” stated Jeremy Levin, D.Phil, MB BChir., Chairman and CEO of Ovid Therapeutics. “Takeda has recently completed two critical Phase 3 studies of soticlestat for Dravet syndrome and Lennox-Gastaut syndrome, and we are eagerly anticipating the outcomes as soticlestat could herald a new class of anti-seizure medication. Our license agreement with Takeda provides us with significant potential near- and longer-term financial resources.”
“Furthermore, our collaboration with Graviton Bioscience has proven to be highly fruitful. We are on the brink of receiving the Phase 1 findings for our ROCK2 inhibition program and are planning to launch our Phase 2 study later this year, targeting cerebral cavernous malformations,” Dr. Levin continued.
Pipeline Updates
Ovid pipeline programs are advancing on track. Multiple data and regulatory milestones are expected before year-end. These include:
Oral formulation
Intravenous (IV) formulation
General Corporate & Business Updates
First Quarter 2024 Financial Results
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company that is dedicated to meaningfully improving the lives of people affected by epilepsies and brain conditions. The Company is advancing a pipeline of novel, targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of seizures and other neurological symptoms. Ovid is developing: OV888 (GV101), a potent and highly selective ROCK2 inhibitor, for the potential treatment of lesions associated with cerebral cavernous malformations and other brain disorders; OV329, a GABA-aminotransferase inhibitor, a potential therapy for treatment-resistant seizures; and OV350, a direct activator of the KCC2 transporter, for the potential treatment of epilepsies and other psychiatric conditions. Ovid also 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 DS and LGS. 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 potential use and development of OV888 (GV101), OV329, OV350 and compounds from Ovid’s library of direct activators of KCC2; the potential therapeutic opportunity of OV888 (GV101), OV329, OV350 and compounds from Ovid’s library of direct activators of KCC2; the timing of data readout of topline safety data from Ovid’s Phase 1, double-blind, multiple-ascending dose trial evaluating OV888 (GV101); the timing of initiation of Ovid’s Phase 2 clinical program studying OV888 (GV101) in CCM; the potential opportunity for soticlestat; the timing and data readout of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for DS and LGS; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support the advancement of Ovid’s pipeline and Ovid’s potential future business development opportunities. You can identify forward-looking statements because they contain words such as “anticipates,” “expects,” “hope,” “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, 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 8, 2024, 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 |
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(in thousands, except share and per share data) | For The Three Months Ended March 31, 2024 |
For The Three Months Ended March 31, 2023 |
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Revenue: | |||||||
License and other revenue | $ | 148 | $ | 66 | |||
Total revenue | 148 | 66 | |||||
Operating expenses: | |||||||
Research and development | 10,397 | 6,615 | |||||
General and administrative | 7,168 | 8,344 | |||||
Total operating expenses | 17,565 | 14,958 | |||||
Loss from operations | (17,417 | ) | (14,892 | ) | |||
Other income (expense), net | 5,723 | 1,536 | |||||
Loss before provision for income taxes | (11,694 | ) | (13,356 | ) | |||
Provision for income taxes | — | — | |||||
Net loss | $ | (11,694 | ) | $ | (13,356 | ) | |
Net loss per share, basic | $ | (0.17 | ) | $ | (0.19 | ) | |
Net loss per share, diluted | $ | (0.17 | ) | $ | (0.19 | ) | |
Weighted-average common shares outstanding, basic | 70,716,929 | 70,490,704 | |||||
Weighted-average common shares outstanding, diluted | 70,716,929 | 70,490,704 |
Select Condensed Consolidated Balance Sheet Data Unaudited |
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(in thousands) | March 31, 2024 | December 31, 2023 | |||
Cash, cash equivalents and marketable securities | $ | 90,259 | $ | 105,834 | |
Working capital(1) | 84,267 | 98,123 | |||
Total assets | 131,613 | 144,027 | |||
Total stockholder’s equity | 78,279 | 87,797 | |||
(1)Working capital defined as current assets less current liabilities | |||||
Contacts
Investor Relations
Garret Bonney
IR@ovidrx.com
(617) 735-6093
Media
Raquel Cabo
RCabo@ovidrx.com
(646) 647-6553
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