Full Press Release Details
Ovid Therapeutics Reports Second Quarter 2019 Financial Results and Highlights Recent Progress
Phase 3 NEPTUNE Trial of OV101 in Angelman Syndrome on Track to Enroll the First Patients in the Third Quarter of 2019
Regulatory Authorities in the U.S. and Germany agree that NEPTUNE, if positive, could support the filings of an NDA and MAA for OV101
Interim Data from Open-Label ENDYMION Trial with OV935 for Individuals with DEE Expected in the Third Quarter of 2019
NEW YORK - August 7, 2019 - 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, 2019 and provided an overview of the company's recent progress.
"Our Phase 3 NEPTUNE clinical trial, if positive, has the potential to make OV101 the first drug approved specifically for patients with Angelman syndrome," said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. "We expect to enroll the first patients in NEPTUNE during the coming weeks. In addition, we expect interim data from our open-label ENDYMION trial with OV935 (soticlestat) for individuals with rare developmental and epileptic encephalopathies to be available later this quarter. This is an exciting and productive time at Ovid as we continue to execute on our programs and corporate objectives."
Recent Progress and Upcoming Milestones
OV101 (gaboxadol) for Angelman Syndrome
OV101 (gaboxadol) for Fragile X Syndrome
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
Second Quarter 2019 Financial Results
About Ovid Therapeutics
Ovid Therapeutics (NASDAQ: OVID) 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 http://www.ovidrx.com/.
Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding advancing Ovid's product candidates, progress, timing, scope and results of clinical trials for Ovid's product candidates, and the reporting of clinical data regarding Ovid's product candidates. You can identify forward-looking statements because they contain words such as "will," "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 are set forth in Ovid's filings with the Securities and Exchange Commission under the caption "Risk Factors". 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
| Three Months Ended June 30, | Three Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, | |||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 9,117,495 | $ | 8,116,385 | $ | 18,454,804 | $ | 16,590,942 | ||||||||
| General and administrative | 4,204,771 | 5,093,311 | 8,920,999 | 10,048,615 | ||||||||||||
| Total operating expenses | 13,322,266 | 13,209,696 | 27,375,803 | 26,639,557 | ||||||||||||
| Loss from operations | (13,322,266 | ) | (13,209,696 | ) | (27,375,803 | ) | (26,639,557 | ) | ||||||||
| Interest income | 264,999 | 274,556 | 518,341 | 521,662 | ||||||||||||
| Net loss | $ | (13,057,267 | ) | $ | (12,935,140 | ) | $ | (26,857,462 | ) | $ | (26,117,895 | ) | ||||
| Net loss attributable to common stockholders | $ | (13,057,267 | ) | $ | (12,935,140 | ) | $ | (26,857,462 | ) | $ | (26,117,895 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.34 | ) | $ | (0.53 | ) | $ | (0.78 | ) | $ | (1.06 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 38,693,018 | 24,625,966 | 34,534,432 | 24,617,555 |
| Selected Condensed Balance Sheet Data (Unaudited) | ||
| June 30, | December 31, | |
| 2019 | 2018 | |
| Cash, cash equivalents and short-term investments | $ 47,361,966 | $ 41,500,652 |
| Working capital 1 | $ 44,423,321 | $ 35,423,690 |
| Total assets | $ 54,908,278 | $ 47,649,602 |
| Total stockholders' equity | $ 45,437,899 | $ 38,805,145 |
1Working capital defined as current assets less current liabilities
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