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Announced Positive Initial Results from the Ongoing ENDYMION trial with OV935 (Soticlestat) in Rare Epilepsies; Sustained and Progressively-Improving Median Seizure Frequency Reduction with Prolonged Treatment in Difficult-to-Treat Patient Population
Strengthened Financial Position with the Completion of a Public Equity Offering Raising Approximately $33.7 Million in Net Proceeds
Expects Four Clinical Data Readouts Across Pipeline in 2020 Including Topline Results from Pivotal Phase 3 NEPTUNE Trial in Angelman Syndrome
NEW YORK, Nov. 08, 2019 (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 reported financial results for the third quarter ended September 30, 2019 and provided an overview of the company’s recent progress.
“2020 is poised to be a transformational year for Ovid. We expect multiple clinical trial data readouts across our pipeline including topline results from our pivotal Phase 3 NEPTUNE trial in Angelman syndrome,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “All of our development programs demonstrate strong momentum. This is highlighted most recently by the initial positive results from our ENDYMION study in rare epilepsies, robust enrollment trends in our randomized ELEKTRA study, as well as the commencement of patient enrollment in the pivotal Phase 3 NEPTUNE trial. We completed a public equity offering in October and now have the resources necessary to take us through these anticipated clinical data inflection points. We are excited by the upcoming events in our pipeline and believe they hold great promise for creating value for both patients and shareholders.”
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)
Third Quarter 2019 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 http://www.ovidrx.com/.
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 the potential therapeutic benefits based on results of clinical trials for Ovid’s product candidates; and the anticipated reporting schedule 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 include 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”. 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|
|For the Three|
|For the Nine|
|For the Nine|
|Research and development||$||11,597,633||$||8,544,547||$||30,052,432||$||25,168,446|
|General and administrative||5,168,103||4,631,228||14,089,106||14,636,941|
|Total operating expenses||16,765,736||13,175,775||44,141,538||39,805,387|
|Loss from operations||(16,765,736||)||(13,175,775||)||(44,141,538||)||(39,805,387||)|
|Net loss attributable to common stockholders||$||(16,634,572||)||$||(12,961,783||)||$||(43,492,034||)||$||(39,079,678||)|
|Net loss per share attributable to common stockholders, basic|
|Weighted-average common shares outstanding basic and diluted||38,504,825||24,634,380||35,872,441||24,623,225|
|Selected Condensed Balance Sheet Data|
|Cash, cash equivalents and short-term investments||$||37,907,904||$||41,500,652|
|Total stockholders' equity||$||30,046,599||$||38,805,145|
|¹Working capital defined as current assets less current liabilities|
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Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) and living microorganisms like virus and bacteria where the virulance of viruses and b...