NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to improving the lives of people affected by rare epilepsies and brain conditions, today reported business updates and financial results for the second quarter ended June 30, 2024.
“Following Takeda’s unexpected Phase 3 results for soticlestat, we moved rapidly to focus our resources to preserve capital. This approach included restructuring the organization and initiating ongoing program prioritization efforts to support the achievement of meaningful clinical and regulatory milestones within our financial plan,” explained Dr. Jeremy Levin, D. Phil, MB BChir., Chairman and CEO. “We are thrilled that our current pipeline remains on track to deliver anticipated results. To further our strategic objectives, we welcomed Dr. Amanda Banks as our Chief Development Officer. Her expertise, along with the expanded Scientific Advisory Board, will enhance our ability to capitalize on therapeutic opportunities and prioritize efforts where we can most benefit patients.”
General Corporate & Business Updates
Ovid is streamlining its operations, while seeking to optimize its pipeline programs and strengthen its financial capital to focus on achieving near-term clinical milestones. Key initiatives include:
Pipeline Updates
Ovid is advancing pipeline programs including: OV888/GV101, OV329 and OV350. Updates include:
Second Quarter 2024 Financial Results
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company that is dedicated to improving the lives of people affected by rare epilepsies and brain conditions with seizure symptoms. 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 capsule, a potent and highly selective ROCK2 inhibitor, for the potential treatment of cerebral cavernous malformations and other rare central nervous system diseases; 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. 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 success of Ovid’s Scientific Advisory Board; Ovid’s ability to achieve projected cost savings in connection with the organizational restructuring and related pipeline prioritization efforts; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support the advancement of Ovid’s pipeline; the expected timing of initiation of Ovid’s Phase 2 clinical programs studying OV888/GV101 in CCM; the expected timing of completion of the Phase 1 MAD study of OV329 and expected timing of data presentation; 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 potential opportunity for soticlestat in Dravet syndrome and the outcome of Takeda’s interactions with regulators regarding marketing authorization for soticlestat in Dravet syndrome; Ovid’s potential future business development opportunities; the potential application of Ovid’s pipeline programs and mechanisms of action to broader areas of neurology; 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, impediments to Ovid’s ability to achieve projected cost savings in connection with the organizational restructuring and related pipeline prioritization efforts, 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on May 14, 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 June 30, 2024 |
For The Three Months Ended June 30, 2023 |
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Revenue: | |||||||
License and other revenue | $ | 169 | $ | 75 | |||
Total revenue | 169 | 75 | |||||
Operating expenses: | |||||||
Research and development | 12,582 | 5,999 | |||||
General and administrative | 8,104 | 8,248 | |||||
Total operating expenses | 20,686 | 14,247 | |||||
Loss from operations | (20,517 | ) | (14,172 | ) | |||
Other income (expense), net | 29,038 | 1,764 | |||||
Income (loss) before provision for income taxes | 8,521 | (12,408 | ) | ||||
Provision for income taxes | — | — | |||||
Net income (loss) | $ | 8,521 | $ | (12,408 | ) | ||
Net income (loss) per share, basic | $ | 0.12 | $ | (0.18 | ) | ||
Net income (loss) per share, diluted | $ | 0.12 | $ | (0.18 | ) | ||
Weighted-average common shares outstanding, basic | 70,916,471 | 70,534,181 | |||||
Weighted-average common shares outstanding, diluted | 71,200,798 | 70,534,181 |
Select Condensed Consolidated Balance Sheet Data Unaudited |
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(in thousands) | June 30, 2024 | December 31, 2023 | |||
Cash, cash equivalents and marketable securities | $ | 76,974 | $ | 105,834 | |
Working capital(1) | 66,770 | 98,123 | |||
Total assets | 118,093 | 144,027 | |||
Total stockholder’s equity | 88,903 | 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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