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NEW YORK, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company developing medicines designed to conquer epilepsies and meaningfully improve the lives of people affected by brain disorders, today reported financial results and corporate highlights for the third quarter ended September 30, 2022.
“During the third quarter, we successfully fulfilled several corporate objectives while we reduced quarter-over-quarter expenses," said Jeremy Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid. “We look forward to advancing OV329, our potent GABA-aminotransferase inhibitor, into human studies before year-end and are continuing to optimize our unique library of KCC2 activators to potentially treat a range of epilepsies. In addition, we entered into a strategic collaboration with Gensaic to harness its novel, non-viral platform for our genetic epilepsy programs. We believe the phage platform potentially averts the immune response and manufacturing costs associated with prior genetic platforms, such as adeno-associated viruses. Collectively, these efforts continue to progress our strategy of building a company with a leading epilepsy franchise poised for near- and long-term success."
2022 Corporate Highlights & Anticipated Milestones
Pipeline Updates
Corporate Updates
Third Quarter 2022 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 and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies. Ovid is developing 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 potential Phase 1 study in healthy volunteers for OV329; the potential use of OV329 to treat rare and treatment-resistant forms of epilepsy and seizures; the clinical and regulatory development of OV329, including the anticipated timing of clinical trials of OV329; the likelihood that data for OV329 will support future development and therapeutic potential; the potential development of OV350 and other KCC2 compounds in the Company's library; the suitability of the Company’s library of novel, direct KCC2 transporter activators for a range of formulations and administrations that would make it possible to pursue both chronic and acute epilepsies; the timing for filing of the Company’s IND applications; the potential benefits of Gensaic's proprietary phage-derived platform; the timing for the completion of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Lennox-Gastaut and Dravet syndromes; and the duration of the Company’s cash runway and the expectation that it will support the advancement of the Company’s pipeline. You can identify forward-looking statements because they contain words such as "anticipates," "believes," "expected," "intends," "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, 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 and risks to Ovid’s or any of its partners’ abilities to meet anticipated deadlines and milestones presented by the ongoing COVID-19 pandemic. 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 August 9, 2022, 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 September 30, 2022 | For The Three Months Ended September 30, 2021 | For The Nine Months Ended September 30, 2022 | For The Nine Months Ended September 30, 2021 | ||||||||||||
| Revenue: | |||||||||||||||
| License and other revenue | $ | 11,102 | $ | — | $ | 1,456,468 | $ | 12,382,779 | |||||||
| License revenue - related party | — | — | — | 196,000,000 | |||||||||||
| Total revenue | 11,102 | — | 1,456,468 | 208,382,779 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 5,183,253 | 4,917,393 | 19,062,192 | 28,849,969 | |||||||||||
| General and administrative | 7,631,705 | 6,764,341 | 25,769,525 | 28,970,053 | |||||||||||
| Total operating expenses | 12,814,958 | 11,681,734 | 44,831,717 | 57,820,022 | |||||||||||
| (Loss) income from operations | (12,803,856 | ) | (11,681,734 | ) | (43,375,249 | ) | 150,562,757 | ||||||||
| Other income (expense), net | 836,085 | 2,657 | 711,009 | (49,593 | ) | ||||||||||
| (Loss) income before provision for income taxes | (11,967,771 | ) | (11,679,077 | ) | (42,664,240 | ) | 150,513,164 | ||||||||
| (Benefit) provision for income taxes | — | (294,829 | ) | — | 1,678,532 | ||||||||||
| Net (loss) income | $ | (11,967,771 | ) | $ | (11,384,248 | ) | $ | (42,664,240 | ) | $ | 148,834,632 | ||||
| Net (loss) income per share, basic | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.61 | ) | $ | 2.15 | ||||
| Net (loss) income per share, diluted | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.61 | ) | $ | 2.14 | ||||
| Weighted-average common shares outstanding, basic | 70,430,554 | 67,929,894 | 70,408,657 | 67,282,495 | |||||||||||
| Weighted-average common shares outstanding, diluted | 70,430,554 | 67,929,894 | 70,408,657 | 67,848,033 | |||||||||||
Select Condensed Balance Sheet Data
Unaudited
| September 30, 2022 | December 31, 2021 | |||||
| Cash, cash equivalents and marketable securities | $ | 137,857,661 | $ | 187,797,532 | ||
| Working capital1 | 133,765,840 | 175,680,808 | ||||
| Total assets | 165,031,865 | 194,544,757 | ||||
| Total stockholder's equity | 142,050,733 | 179,746,436 | ||||
| 1Working capital defined as current assets less current liabilities | ||||||
Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
917-943-6681
malexander@ovidrx.com
OR
Investors:
Argot Partners
Maeve Conneighton
212-596-7231
ovid@argotpartners.com
1Petroff OA, Rothman DL, Behar KL, Collins TL, Mattson RH. Human brain GABA levels rise rapidly after initiation of vigabatrin therapy. Neurology. 1996 Dec;47(6):1567-71. doi: 10.1212/wnl.47.6.1567. PMID: 8960747.
2 Petroff OA, Rothman DL, Behar KL, Mattson RH. Human brain GABA levels rise after initiation of vigabatrin therapy but fail to rise further with increasing dose. Neurology. 1996 May;46(5):1459-63. doi: 10.1212/wnl.46.5.1459. PMID: 8628502.
3Prescot AP, Miller SR, Ingenito G, Huber RS, Kondo DG, Renshaw PF. In Vivo Detection of CPP-115 Target Engagement in Human Brain. Neuropsychopharmacology. 2018 Feb;43(3):646-654. doi: 10.1038/npp.2017.156. Epub 2017 Jul 25. PMID: 28741622; PMCID: PMC5770752.