Full Press Release Details
Ovid Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update
NEW YORK, August 10, 2020 -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.
"Ovid is in an exciting and transformational period. We expect a number of important late-stage data readouts across our pipeline this quarter and over the remainder of the year," said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. "We have completed enrollment in our pivotal Phase 3 NEPTUNE trial and expect topline results to be available in the fourth quarter. We also expect data from our comprehensive Phase 2 development program with soticlestat in four different rare developmental and epileptic encephalopathies during the third quarter. These upcoming data readouts, coupled with our recent commercial partnership with Angelini Pharma for OV101 in Europe, the receipt of Rare Pediatric Disease Designation from the FDA for OV101 in Angelman syndrome, and the expansion of our early-stage novel pipeline in genetics of rare neurological disease, have the potential to deliver near-term products and longer-term innovation, which will drive our
strategy. These important building blocks set the stage for Ovid to command a leading position in rare neurology."
Pipeline Updates and Recent Highlights
OV101 (gaboxadol) for Angelman Syndrome
OV101 for Fragile X Syndrome
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
Summary of Anticipated Clinical Data Readouts
| Product Candidate | Trial | Condition or Disease | Phase of Clinical Trial | Expected Timing of Data Release |
| Soticlestat | ARCADE | CDD or Dup15q syndrome | Phase 2 | 3Q 2020 |
| Soticlestat | ELEKTRA | Dravet syndrome or LGS | Phase 2 | 3Q 2020 |
| Soticlestat | ENDYMION | CDD, Dup15q syndrome, Dravet syndrome, LGS, other DEEs | Open-label Extension | 3Q 2020 |
| OV101 | NEPTUNE | Angelman syndrome | Phase 3 | 4Q 2020 |
Expansion of Early-Stage Pipeline Research Activities
Pipeline Teach-In Webinar Series
Second Quarter 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. Ovid has a broad pipeline of potential first-in-class medicines. The Company's most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharmaceutical Company Limited for the potential treatment of rare developmental and epileptic encephalopathies (DEE). 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: development and commercialization of our programs, development of combination therapies, potential benefits of OV101, OV935 and our other research programs, anticipated reporting schedule of clinical data and the potential benefits and value of certain licenses and collaborations and the potential benefits of the Rare Pediatric Disease Designation. 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, and 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. 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
| For the Three Months Ended June 30, | For the Three Months Ended June 30, | For the Six Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 16,032,945 | $ | 9,117,495 | $ | 30,658,313 | $ | 18,454,804 | ||||||||
| General and administrative | 7,108,742 | 4,204,771 | 12,777,759 | 8,920,999 | ||||||||||||
| Total operating expenses | 23,141,687 | 13,322,266 | 43,436,072 | 27,375,803 | ||||||||||||
| Loss from operations | (23,141,687 | ) | (13,322,266 | ) | (43,436,072 | ) | (27,375,803 | ) | ||||||||
| Interest income | 590,491 | 264,999 | 854,786 | 518,341 | ||||||||||||
| Net loss | $ | (22,551,196 | ) | $ | (13,057,267 | ) | $ | (42,581,286 | ) | $ | (26,857,462 | ) | ||||
| Net loss attributable to common stockholders | $ | (22,551,196 | ) | $ | (13,057,267 | ) | $ | (42,581,286 | ) | $ | (26,857,462 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.41 | ) | $ | (0.34 | ) | $ | (0.77 | ) | $ | (0.78 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 55,607,110 | 38,693,018 | 55,161,360 | 34,534,432 |
Selected Condensed Balance Sheet Data
| June 30, | December 31, | |
| 2020 | 2019 | |
| Cash, cash equivalents and short-term investments | $ 41,253,898 | $ 76,739,113 |
| Working capital 1 | $ 29,524,782 | $ 69,279,584 |
| Total assets | $ 45,355,298 | $ 80,843,731 |
| Total stockholders' equity | $ 30,482,914 | $ 70,023,561 |
1Working capital defined as current assets less current liabilities
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