Full Press Release Details
Ovid Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update
NEW YORK, November 12, 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 third quarter ended September 30, 2020 and provided a corporate update.
"We are very pleased with the progress made on our pipeline this quarter, which was highlighted by encouraging results from both the ELEKTRA and the ARCADE Phase 2 trials of OV935," said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. "We look forward to advancing OV935 into a Phase 3 program for Dravet syndrome and Lennox-Gastaut syndrome next year after our end-of-phase 2 meeting with FDA. We are continuing to explore further clinical development opportunities in CDKL5 deficiency disorder, and Dup15q syndrome. Additionally, we remain on track to report topline data for the pivotal Phase 3 NEPTUNE trial of OV101 in Angelman syndrome this quarter. Pending a successful NEPTUNE readout, OV101 has the potential to become the first-ever treatment approved for Angelman syndrome, a disorder affecting some 500,000 patients worldwide."
Pipeline Updates and Recent Highlights
OV101 (gaboxadol) for Angelman Syndrome
OV101 for Fragile X Syndrome
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
Third 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 in development. 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 (DEEs). 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: clinical and regulatory development of our programs, potential benefits of OV101, OV935 and our other research programs and the anticipated reporting schedule of clinical data and the potential benefits. 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 September 30, | For the Three Months Ended September 30, | For the Nine Months Ended September 30, | For the Nine Months Ended September 30, | |||||
| 2020 | 2019 | 2020 | 2019 | |||||
| Revenue: | ||||||||
| License revenue | $ 6,914,034 | $ - | $ 6,914,034 | $ - | ||||
| Operating expenses: | ||||||||
| Research and development | $ 15,875,295 | $ 11,597,633 | $ 46,533,610 | $ 30,052,432 | ||||
| General and administrative | 7,442,401 | 5,168,103 | 20,220,160 | 14,089,106 | ||||
| Total operating expenses | 23,317,696 | 16,765,736 | 66,753,770 | 44,141,538 | ||||
| Loss from operations | (16,403,662) | (16,765,736) | (59,839,736) | (44,141,538) | ||||
| Other (expense) income, net | (21,127) | 131,164 | 833,661 | 649,504 | ||||
| Net loss | $ (16,424,789) | $ (16,634,572) | $ (59,006,075) | $ (43,492,034) | ||||
| Net loss attributable to common stockholders | $ (16,424,789) | $ (16,634,572) | $ (59,006,075) | $ (43,492,034) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ (0.28) | $ (0.43) | $ (1.04) | $ (1.21) | ||||
| Weighted-average common shares outstanding basic and diluted | 59,406,215 | 38,504,825 | 56,586,640 | 35,872,441 |
Selected Condensed Balance Sheet Data
| September 30, | December 31, | |||
| 2020 | 2019 | |||
| Cash, cash equivalents and short-term investments | $ 86,866,275 | $ 76,739,113 | ||
| Working capital 1 | 72,387,568 | 69,279,584 | ||
| Total Assets | 91,599,016 | 80,843,731 | ||
| Total stockholder's equity | 63,643,038 | 70,023,561 |
1Working capital defined as current assets less current liabilities
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