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Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results

NEW YORK, March 08, 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 fourth quarter and year ended December 31, 2023.

“Ovid is progressing well and we are excited. This year we anticipate five clinical and regulatory milestones from our pipeline of novel compounds. Our ROCK2 collaboration with Graviton Bioscience is producing results faster than expected. We look forward to initiating a Phase 2 study of OV888 (GV101) in cerebral cavernous malformations (CCM) in the second half of this year. By year end 2024, we expect to deliver biomarker data from our oral OV329 program and investigational new drug submissions for intravenous formulations of both OV329 and OV350,” said Dr. Jeremy Levin, D. Phil, MB Chir, Chairman and CEO of Ovid.

“Importantly, the first potential rare epilepsy medicine that Ovid helped shape, soticlestat, is expected to have two pivotal Phase 3 study topline readouts by Takeda. If the trials are successful, we believe a new and important medicine will be available to LGS and DS patients in 2025. If approved and successfully commercialized, Ovid will be eligible to receive regulatory and sales milestone payments as well as royalties on all future sales of soticlestat,” Dr. Levin added.

Pipeline Updates

Ovid anticipates five clinical and regulatory milestones this year from its own pipeline. In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.

General Corporate & Business Updates

Fourth Quarter and Annual 2023 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 certain 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), 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 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 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 and compounds from Ovid’s library of direct activators of KCC2; the potential opportunity for soticlestat; the timing and data readout of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Dravet syndrome and Lennox-Gastaut syndrome; 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,” “expected,” “intends,” “may,” “potentially,” “seek,” 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 3, 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
December 31,
2023
  For the Three
Months Ended
December 31,
2022
  For the Year
Ended
December 31,
2023
  For the Year
Ended
December 31,
2022
Revenue:              
License and other revenue $ 141,562     $ 46,280     $ 391,695     $ 1,502,748  
Total revenue   141,562       46,280       391,695       1,502,748  
Operating expenses:              
Research and development   10,641,957       5,545,269       28,587,884       24,618,399  
General and administrative   7,687,951       6,673,710       31,085,274       32,432,510  
Total operating expenses   18,329,908       12,218,979       59,673,158       57,050,909  
Loss from operations   (18,188,346 )     (12,172,699 )     (59,281,464 )     (55,548,161 )
Other income (expense), net   2,866,312       668,124       6,942,505       1,379,132  
Loss before provision for income taxes   (15,322,035 )     (11,504,575 )     (52,338,959 )     (54,169,029 )
Provision for income taxes                      
Net loss $ (15,322,035 )   $ (11,504,575 )   $ (52,338,959 )   $ (54,169,029 )
Net loss per share, basic $ (0.22 )   $ (0.16 )   $ (0.74 )   $ (0.77 )
Net loss per share, diluted $ (0.22 )   $ (0.16 )   $ (0.74 )   $ (0.77 )
Weighted-average common shares outstanding, basic   70,687,307       70,472,598       70,580,604       70,424,819  
Weighted-average common shares outstanding, diluted   70,687,307       70,472,598       70,580,604       70,424,819  
                               
Select Condensed Balance Sheet Data
Unaudited
       
  December 31, 2023   December 31, 2022
Cash, cash equivalents and marketable securities $ 105,833,375   $ 129,001,411
Working capital(1)   98,123,417     124,389,166
Total assets   144,026,783     155,265,814
Total stockholder’s equity   87,796,887     132,272,564
(1)Working capital defined as current assets less current liabilities
 

Contacts

Investors & Media:
Garret Bonney
IR@ovidrx.com
617-735-6093


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