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
Interim Data from Open-Label ENDYMION Trial with OV935 for Individuals with DEE Expected in the Third Quarter of 2019
“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
OV101 (gaboxadol) for Angelman Syndrome
- Based on Ovid’s interactions with regulatory authorities in the U.S. and
Germanyregarding a Phase 3 program and registration path, Ovid, the U.S. Food and Drug Administration( FDA) and Germany’s Federal Institute for Drugs and Medical Devices(BfArM) agree on the study design of the Phase 3 NEPTUNE trial, including the use of the Angelman syndrome-specific Clinical Global Impressions of Improvement (CGI-I-AS) as the primary efficacy outcome measure. Both the FDAand BfArM agreed that NEPTUNE, if positive, could support the filings of a New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively.
- Ovid has initiated the pivotal Phase 3 NEPTUNE trial and plans to enroll the first Angelman syndrome patients in the third quarter of 2019. Topline results from the trial are expected in mid-2020.
July 2019, Ovid announced that the European Commission(EC) granted orphan drug designation (ODD) to OV101 for the treatment of Angelman syndrome based on the results of the Phase 2 STARS trial.
OV101 (gaboxadol) for Fragile X Syndrome
- The Phase 2 ROCKET trial continues to enroll patients and results are expected around year-end 2019 or early 2020.
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
- Interim data from the open-label extension ENDYMION trial for individuals with DEE who previously completed a clinical trial with OV935 are expected in the third quarter of 2019.
- The open-label Phase 2 ARCADE trial in individuals with Dup15q syndrome or CDKL5 Deficiency Disorder continues to enroll patients with data expected in the first quarter of 2020.
- The global Phase 2 ELEKTRA trial in children with Dravet syndrome or Lennox-Gastaut syndrome continues to enroll patients.
Second Quarter 2019 Financial Results
- As of
June 30, 2019, cash and cash equivalents totaled $47.4 million.
- Research and development expenses were
$9.1 millionfor the second quarter ended June 30, 2019, as compared to $8.1 millionfor the same period in 2018. The increase of $1.0 millionwas primarily due to an increase in clinical activities related to the Company’s ongoing development programs.
- General and administrative expenses were
$4.2 millionfor the second quarter ended June 30, 2019, as compared to $5.1 millionfor the same period in 2018. The decrease of $0.9 millionwas primarily due to a decrease in payroll and payroll-related expenses of $1.5 millionoffset by an increase in professional fees and general office expenses of $0.6 million.
- The Company reported a net loss of
$13.1 million, or basic and diluted net loss per share attributable to common stockholders of $0.34, for the second quarter of 2019, as compared to a net loss of $12.9 million, or net loss per share attributable to common stockholders of $0.53, for the same period in 2018.
For more information on Ovid, please visit http://www.ovidrx.com/.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding advancing Ovid’s product candidates, progress, timing, scope and results of clinical trials for Ovid’s product candidates, and the reporting of clinical data regarding Ovid’s product candidates. You can identify forward-looking statements because they contain words such as “will,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the
Condensed Consolidated Statements of Operations
|Three Months Ended June 30,||Three Months Ended June 30,||Six Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||9,117,495||$||8,116,385||$||18,454,804||$||16,590,942|
|General and administrative||4,204,771||5,093,311||8,920,999||10,048,615|
|Total operating expenses||13,322,266||13,209,696||27,375,803||26,639,557|
|Loss from operations||(13,322,266||)||(13,209,696||)||(27,375,803||)||(26,639,557||)|
|Net loss attributable to common stockholders||$||(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||)||$||(1.06||)|
|Weighted-average common shares outstanding basic and diluted||38,693,018||24,625,966||34,534,432||24,617,555|
Selected Condensed Balance Sheet Data
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||47,361,966||$||41,500,652|
|Total stockholders' equity||$||45,437,899||$||38,805,145|
|1Working capital defined as current assets less current liabilities|
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Source: Ovid Therapeutics Inc.