NEW YORK, Nov. 10, 2021 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today provided a business update and reported corporate highlights and financial results for the quarter ended September 30, 2021.
Ovid reported its strategic intent to pursue a series of business development opportunities aimed at complementing and enhancing its pipeline of small-molecule and next-generation medicines. The Company seeks to acquire platform technologies for the purpose of delivering precision therapeutics that act on rare genetic targets in the brain. Additionally, Ovid plans to complement its early-stage pipeline with precision-medicine and small-molecule assets that align with its demonstrated clinical development competencies. The Company will prioritize potential medicines that can: deliver clear mechanistic targeting, leverage defined clinical endpoints, and fill significant needs for underserved rare disease communities.
“We have the capital, the expert team and the right strategy in place to unlock value in the rapidly growing field of rare neurology,” said Jeremy M. Levin, D.Phil, MB BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “With the perspectives of renowned biotech leaders who have recently joined our board and advisory team, we believe Ovid has the knowledge and access to pursue differentiated technologies and medicines for the brain. We look forward to providing updates on our business development activities.”
Business Update
Corporate Highlights
Third Quarter 2021 Financial Results
Non-GAAP Financial Measures
This press release presents non-GAAP adjusted operating expenses on a historical and projected basis. For the period presented, non-GAAP adjusted operating expenses exclude from operating expenses, as calculated and presented in accordance with GAAP, non-recurring and non-cash items: OV101 clinical costs, severance expense, and stock-based compensation, respectively. Non-GAAP adjusted operating expenses is a financial measure that has not been prepared in accordance with GAAP. Accordingly, investors should consider non-GAAP adjusted operating expenses in addition to, but not as a substitute for, operating expenses that we calculate and present in accordance with GAAP. Among other things, our management uses non-GAAP adjusted operating expenses to establish budgets and operational goals and to manage our business. Other companies may define or use this measure in different ways. We believe that the presentation of non-GAAP adjusted operating expenses provides investors and management with helpful supplemental information relating to operating performance and trends. A table reconciling non-GAAP adjusted operating expenses to operating expenses for all historical periods presented is included below under the heading “Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses.” A quantitative reconciliation of projected non-GAAP adjusted operating expenses to operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense and non-recurring expenses.
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 neurological disorders. Ovid seeks to couple deep CNS experience with emerging advances in genetics and the pathways of the brain to build a leading, next-generation neuroscience pipeline. Ovid’s current 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 disorders; and other research targets. Additionally, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Two Phase 3 trials for soticlestat in Dravet syndrome and Lennox-Gastaut syndrome are actively enrolling patients. 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 development and acceleration of Ovid’s product candidate pipeline, Ovid’s strategic approach and business development intentions and opportunities and ability to realize the desired benefits thereof, Ovid’s ability to identify acquisition targets, the potential therapeutic benefits of Ovid’s current or future product candidates, the clinical and regulatory development and potential commercialization of soticlestat, OV329 or any of Ovid’s other current or future product candidates, Ovid’s eligibility for potential milestone and royalty payments and Ovid’s non-GAAP operating expense guidance for the fourth quarter of 2021. 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, 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, risks related to Ovid’s ability to identify acquisition targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any strategic transactions or acquisitions and risks to Ovid’s or Takeda’s 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 November 10, 2021, 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
For The Three Months Ended September 30, | For The Three Months Ended September 30, | For The Nine Months Ended September 30, | For The Nine Months Ended September 30, | ||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue: | |||||||||||||||
License and other revenue | $ | – | $ | 6,914,034 | $ | 12,382,779 | $ | 6,914,034 | |||||||
License revenue – related party | – | – | 196,000,000 | – | |||||||||||
Total revenue | – | 6,914,034 | 208,382,779 | 6,914,034 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 4,917,393 | $ | 15,875,295 | $ | 28,849,969 | $ | 46,533,610 | |||||||
General and administrative | 6,764,341 | 7,442,401 | 28,970,053 | 20,220,160 | |||||||||||
Total operating expenses | 11,681,734 | 23,317,696 | 57,820,022 | 66,753,770 | |||||||||||
(Loss) income from operations | (11,681,734 | ) | (16,403,662 | ) | 150,562,757 | (59,839,736 | ) | ||||||||
Other income (expenses), net | 2,657 | (21,127 | ) | (49,593 | ) | 833,661 | |||||||||
(Loss) income before (benefit) provision for income taxes | (11,679,077 | ) | (16,424,789 | ) | 150,513,164 | (59,006,075 | ) | ||||||||
(Benefit) provision for income taxes | (294,829 | ) | – | 1,678,532 | – | ||||||||||
Net (loss) income | $ | (11,384,248 | ) | $ | (16,424,789 | ) | $ | 148,834,632 | $ | (59,006,075 | ) | ||||
Net (loss) income per share, basic | $ | (0.17 | ) | $ | (0.28 | ) | $ | 2.15 | $ | (1.04 | ) | ||||
Net (loss) income per share, diluted | $ | (0.17 | ) | $ | (0.28 | ) | $ | 2.14 | $ | (1.04 | ) | ||||
Weighted-average common shares outstanding, basic | 67,929,894 | 59,406,215 | 67,282,495 | 56,586,640 | |||||||||||
Weighted-average common shares outstanding, diluted | 67,929,894 | 59,406,215 | 67,848,033 | 56,586,640 | |||||||||||
Select Condensed Balance Sheet Data
(unaudited) | |||||||
September 30, | December 31, | ||||||
2021 | 2020 | ||||||
Cash, cash equivalents and short-term investments | $ | 201,779,567 | $ | 72,033,930 | |||
Working capital1 | 194,991,892 | 52,780,426 | |||||
Total assets | 207,086,188 | 75,925,518 | |||||
Total stockholder’s equity | 197,021,761 | 43,631,656 | |||||
1Working capital defined as current assets less current liabilities
Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses
Quarter Ended September 30, | ||||
2021 | ||||
Operating expenses | $ | 11,681,734 | ||
Non-recurring and non-cash items included therein: | ||||
Stock-based compensation | 1,161,911 | |||
Wind-down of OV101 clinical costs | 1,105,283 | |||
Severance expense | 106,746 | |||
Non-GAAP adjusted operating expenses | $ | 9,307,794 | ||
Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
917-943-6681
malexander@ovidrx.com
OR
Investors:
Argot Partners
Dawn Schottlandt
212-600-1902
ovid@argotpartners.com
SCOTTSDALE, Ariz., July 3, 2024 /PRNewswire/ -- Evive Brands, a leader in the health and…
CHICAGO, July 3, 2024 /PRNewswire/ -- The global operating room management market is poised to grow…
WESTFORD, Mass., July 3, 2024 /PRNewswire/ -- According to SkyQuest, the global Exoskeleton Market size was…
Business Activity Index at 49.6%; New Orders Index at 47.3%; Employment Index at 46.1%; Supplier…
Codd to Leverage Extensive Background Serving Global Corporations DALLAS, July 3, 2024 /PRNewswire/ -- Axxess,…
French AI company achieves key EU regulatory compliance for multiple algorithms that identify, detect, and…