NEW YORK, March 15, 2021 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an overview of the Company’s recent progress.
“This new agreement with Takeda strategically positions Ovid, upon closing, to advance our next generation neuroscience pipeline, while demonstrating the value we helped to create for soticlestat by bringing it to the initiation of two pivotal Phase 3 trials,” said Jeremy M. Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “Importantly, we believe this is a positive outcome for patients, potentially accelerating soticlestat’s clinical development with the potential to make this new treatment commercially available in 2024. We are excited for next steps both for this asset and for our pipeline, as we work to file three INDs over the next three years and in tandem pursue an active business development initiative.”
Corporate Update
Pipeline Update
Fourth Quarter and Year Ended December 31, 2020 Financial Results
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an attractive area for drug development as the understanding of the underlying biology has grown meaningfully over the last few years and today represents a substantial opportunity medically and commercially. Based on recent scientific advances in genetics and the biological pathways of the brain, we aim to identify, discover and acquire novel compounds for the treatment of rare neurological disorders. We have built a deep knowledge of such disorders, how to treat them and how to develop the clinically meaningful endpoints required for development of a compound in these disorders. As a result of this knowledge, Ovid has developed a robust pipeline of first-in-class compounds and programs. We continue to execute on our strategy to build this pipeline by discovering, in-licensing and collaborating with leading biopharmaceutical companies and academic institutions. These pipeline programs include programs targeting rare epilepsies, Angelman syndrome and Fragile X syndrome, as well as early-stage programs into other monogenetic disorders. Ovid’s most advanced pipeline programs include OV935 (soticlestat) in collaboration with Takeda and OV101 a δ-selective GABAA receptor agonist. Ovid’s emerging pipeline programs include OV329, a small molecule GABA aminotransferase inhibitor for seizures associated with Tuberous Sclerosis Complex and Infantile Spasms; OV882, a short hairpin RNA therapy approach for Angelman syndrome; OV815, a genetic therapy approach for KIF1A associated neurological disorder; and other non-disclosed researched targets. For more information on Ovid, 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 benefits, clinical and regulatory development and commercialization of soticlestat and Ovid’s other programs and potential programs, the closing of the Royalty, License and Termination Agreement and the potential value, benefits, and outcome of the collaboration with Takeda. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.” 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 uncertainties in the development and regulatory approval processes, the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available, and the ability to commercialize soticlestat. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the Securities and Exchange Commission under the caption “Risk Factors.” Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid’s business and the global economy. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Condensed Consolidated Statements of Operations
(Unaudited)
For the Three Months Ended December 31, |
For the Three Months Ended December 31, |
For the Year Ended December 31, |
For the Year Ended December 31, |
||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Revenue: | |||||||||||||||
License revenue | $ | 5,703,187 | $ | – | $ | 12,617,221 | $ | – | |||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 16,883,784 | $ | 12,105,209 | $ | 63,417,394 | $ | 42,157,641 | |||||||
General and administrative | 10,410,644 | 5,162,720 | 30,630,804 | 19,251,826 | |||||||||||
Total operating expenses | 27,294,428 | 17,267,929 | 94,048,198 | 61,409,467 | |||||||||||
Loss from operations | (27,294,428 | ) | (17,267,929 | ) | (81,430,977 | ) | (61,409,467 | ) | |||||||
Other (expense) income, net | (438,260 | ) | 298,720 | 395,401 | 948,224 | ||||||||||
Net loss | $ | (22,029,501 | ) | $ | (16,969,209 | ) | $ | (81,035,576 | ) | $ | (60,461,243 | ) | |||
Net loss attributable to common stockholders | $ | (22,029,501 | ) | $ | (16,969,209 | ) | $ | (81,035,576 | ) | $ | (60,461,243 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.34 | ) | $ | (0.35 | ) | $ | (1.39 | ) | $ | (1.54 | ) | |||
Weighted-average common shares outstanding basic and diluted | 64,004,719 | 49,142,504 | 58,451,293 | 39,217,223 |
Selected Condensed Balance Sheet Data
(Unaudited)
December 31 | December 31, | ||||
2020 | 2019 | ||||
Cash, cash equivalents and short-term investments | $ | 72,033,930 | $ | 76,739,113 | |
Working capital1 | 52,780,426 | 69,279,584 | |||
Total Assets | 75,925,518 | 80,843,731 | |||
Total stockholder’s equity | 43,631,656 | 70,023,561 |
1Working capital defined as current assets less current liabilities.
Contacts
Ovid Investors and Media
Ovid Therapeutics Inc.
Investor Relations & Public Relations
irpr@ovidrx.com
Or
Ovid Investors:
Argot Partners
Maeve Conneighton/Dawn Schottlandt
212-600-1902
Ovid@argotpartners.com
Ovid Media
Dan Budwick
1AB
dan@1abmedia.com
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