Ovid Therapeutics Reports First Quarter 2019 Financial Results
Remains on track for all previously stated milestones expected throughout 2019
The STARS study selected as one of three abstracts featured at the 2019
“We continue to execute on all fronts,” said
OV101 for Angelman Syndrome
May 7th, at the 71st annual meeting of the American Academy of Neurology(AAN) in Philadelphia, Ovid will present data from OV101 in adolescents and adults with Angelman syndrome (STARS study), as part of the Emerging Science program.
- In addition, the STARS study abstract was selected by the Chair of the AAN Science Committee as one of three data presentations featured at the
Top Science Press Conference, held on May 5th.
- The open-label extension ELARA study for people with Angelman syndrome who previously completed a clinical trial with OV101 continues to enroll patients.
- The pivotal Phase 3 NEPTUNE trial in Angelman syndrome is expected to initiate with the first patient enrolling in 2H19.
OV101 for Fragile X Syndrome
- Also at the 71st annual meeting of the
American Academy of Neurology, Ovid presented research on frameworks to assess outcomes in patients with Fragile X syndrome.
- The Phase 2 ROCKET trial continues to enroll patients and results are expected in 2H19.
- Ovid continues to enroll the open-label extension ENDYMION trial for people with DEE who previously completed a clinical trial with OV935.
- The open-label Phase 2 ARCADE trial in people with Dup15q syndrome or CDKL5 Deficiency Disorder continues to enroll and Ovid anticipates completion of enrollment in 2H19.
- The global, Phase 2 ELEKTRA trial in people with Dravet syndrome or Lennox-Gastaut syndrome continues to enroll.
- The Company strengthened its management team with the appointment of pharmaceutical veteran,
Thomas Perone, previously at Celgene, as Senior Vice President, General Counsel and Corporate Secretary.
- To align expertise with the company’s advancing clinical stage pipeline, Ovid made additional changes to its senior management, including the promotion of
Amit Rakhit, M.D., MBA to the role of Head of R&D, on top of his current position as CMO.
- In February, Ovid raised net proceeds of approximately
$30.5 millionin a public offering to further strengthen its balance sheet and to fund ongoing and anticipated development programs.
- As of
March 31, 2019, cash, cash equivalents, and short-term investments totaled $59.6 million.
- Research and development expenses were
$9.3 millionfor the first quarter ended March 31, 2019, as compared to $8.5 millionfor the same period in 2018. The increase of $0.8 millionwas primarily due to an increase in clinical activities related to the Company’s ongoing development programs.
- General and administrative expenses were
$4.7 millionfor the first quarter ended March 31, 2019, as compared to $5.0 millionin 2018. The decrease of $0.3 millionwas primarily due to an increase in payroll and payroll-related expenses of $0.4 millionoffset by a decrease in professional fees and general office expenses of $0.6 million.
- The Company reported a net loss of
$13.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.46, for the first quarter of 2019, as compared to a net loss of $13.2 million, or net loss per share attributable to common stockholders of $0.54, for the same period in 2018.
For more information on Ovid, please visit http://www.ovidrx.com/.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding advancing Ovid’s product candidates, progress, timing, scope and results of clinical trials for Ovid’s product candidates, and the reporting of clinical data regarding Ovid’s product candidates. You can identify forward-looking statements because they contain words such as “will,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the
Condensed Consolidated Statements of Operations
|Research and development||$||9,337,304||$||8,474,557|
|General and administrative||4,716,231||4,955,307|
|Total operating expenses||14,053,535||13,429,864|
|Loss from operations||(14,053,535||)||(13,429,864||)|
|Net loss attributable to common stockholders||$||(13,800,195||)||$||(13,182,758||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.46||)||$||(0.54||)|
|Weighted-average common shares outstanding basic and diluted||30,329,640||24,609,050|
|Selected Condensed Balance Sheet Data
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||59,640,781||$||41,500,652|
|Total stockholders' equity||$||57,245,801||$||38,805,145|
1Working capital defined as current assets less current liabilities
Investor Relations & Public Relations
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Investor Relations & Public Relations
Source: Ovid Therapeutics Inc.