Ovid Therapeutics Reports Second Quarter 2017 Financial Results and Corporate Progress
“Ovid continues to build a robust pipeline of promising medicines. We have made important progress over the last quarter in all our programs,” said
Recent Highlights and Upcoming Milestones
OV101 for Neurodevelopmental Disorders
- Ovid continues to enroll patients in the Phase 2 STARS clinical trial of OV101 in adults with Angelman syndrome. The company expects topline data from the STARS trial to be available in 2018.
- The company also continues to enroll patients in a Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK) and tolerability of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome aged 13 to 17 years. The company expects topline data to be available in the second half of 2017.
- Ovid also is planning to initiate clinical development in a younger pediatric population pending completion of the adolescent PK trial and juvenile animal toxicity studies.
OV935 for Epileptic Encephalopathies
- Ovid and Takeda initiated a Phase 1b/2a clinical trial with OV935 to treat rare developmental and/or epileptic encephalopathies. The primary endpoint of the study is to characterize the safety and tolerability of OV935. Secondary endpoints include assessment of standard safety laboratory values and evaluation of pharmacokinetics (PK).
- Strengthened the company’s board of directors with the appointment of
Barbara G. Duncan, who will serve as chairperson of the Audit Committee.
- Completed an initial public offering (IPO) of 5,000,000 shares of common stock, raising gross proceeds of $75 million, prior to deducting the underwriting discount and estimated expenses of the offering.
Second Quarter 2017 Financial Results
- As of
June 30, 2017, cash and cash equivalents totaled $106.1 million.
- Research and development expenses were
$6.1 millionfor the second quarter of 2017, as compared to $1.8 millionfor the same period in 2016. The increase was primarily due to higher clinical expenses related to the clinical studies of OV101, costs related to the Takeda collaboration for OV935, preclinical development expenses, and an increase in payroll and payroll-related expenses due to increased headcount as the company expanded its operations.
- General and administrative expenses were
$4.2 millionfor second quarter of 2017, as compared to $3.6 millionfor the same period in 2016. The increase was primarily due to the increase in payroll and payroll-related expenses due to increased headcount as the company expanded its operations.
- The company reported net losses of
$10.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.57, for the second quarter of 2017, as compared to a loss of $5.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.55, for the same period in 2016.
OV101 (gaboxadol) is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first investigational drug to specifically target the disruption of tonic inhibition that is thought to be the underlying cause of certain neurodevelopmental disorders. OV101 has been demonstrated in laboratory studies and animal models to selectively activate the δ-subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and thereby impact neuronal activity through tonic inhibition.
Ovid is developing OV101 for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and relieve several of the symptoms of these disorders. In preclinical studies, it was observed that OV101 improved symptoms of Angelman syndrome and Fragile X syndrome.
OV935, which is being studied in rare epilepsies, is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24-S-hydroxycholesterol (24HC) which then exits the brain into the blood plasma circulation. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity. Recent literature indicates CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel, implying its potential role in central nervous system diseases such as epilepsy. To Ovid’s knowledge, OV935 is the only molecule with this mechanism of action in clinical development.
OV935 has been tested in preclinical models to provide data to support the advancement of the drug into human clinical studies in patients suffering from rare epilepsy syndromes. A novel proprietary PET ligand, developed by
OV935 has completed four Phase 1 clinical studies which have assessed tolerability and target engagement at doses which are believed to be therapeutically relevant. OV935 is being co-developed by
For more information on Ovid, please visit http://www.ovidrx.com/.
This press release includes certain disclosures which contain “forward-looking statements,” including, without limitation, statements regarding 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
|OVID THERAPEUTICS INC.|
|Condensed Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$||106,115,648||$||51,939,661|
|Prepaid and other current assets||1,195,669||221,507|
|Due from related parties||-||7,369|
|Deferred transaction costs||-||242,673|
|Total current assets||107,311,317||52,411,210|
|Property, plant and equipment, net||49,798||43,591|
|Liabilities and Stockholders' Equity|
|Total current liabilities||7,065,027||3,733,412|
|Common stock, $0.001 par value; 125,000,000 and 58,000,000 shares authorized at|
|June 30, 2017 and December 31, 2016, respectively, 24,601,936 and 9,838,590 shares|
|issued and outstanding at June 30, 2017 and December 31, 2016, respectively||24,602||9,839|
|Preferred Series A - zero and 5,121,453 shares authorized at June 30, 2017 and December 31, 2016, respectively|
|zero and 2,382,069 issued and outstanding at June 30, 2017 and December 31, 2016, respectively||-||2,382|
|Preferred Series B - zero and 12,038,506 shares authorized at June 30, 2017 and December 31, 2016, respectively|
|zero and 5,599,282 issued and outstanding at June 30, 2017 and December 31, 2016, respectively||-||5,599|
|Total stockholders' equity||100,942,111||49,294,475|
|Total liabilities and stockholders' equity||$||108,007,138||$||53,027,887|
|OVID THERAPEUTICS INC.|
|Condensed Statements of Operations and Comprehensive Loss|
|For the Three
|For the Three
|For the Six
|For the Six
|Research and development||$||6,074,927||$||1,770,202||$||37,359,355||$||2,896,804|
|General and administrative||4,213,173||3,646,731||7,191,039||6,234,624|
|Total operating expenses||10,288,100||5,416,933||44,550,394||9,131,428|
|Loss from operations||(10,288,100||)||(5,416,933||)||(44,550,394||)||(9,131,428||)|
|Net loss and comprehensive loss||$||(10,248,379||)||$||(5,385,626||)||$||(44,487,189||)||$||(9,067,792||)|
|Net loss attributable to common stockholders||$||(10,248,379||)||$||(5,385,626||)||$||(44,487,189||)||$||(9,067,792||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.57||)||$||(0.55||)||$||(3.18||)||$||(0.92||)|
|Weighted-average common shares outstanding basic and diluted||18,112,554||9,838,590||13,998,428||9,838,590|
Contacts Investors: Burns
McClellan Steve Klass, 212-213-0006 Sklass@burnsmc.com Media: Pure Communications, Inc. Katie Engleman, 910-509-3977 firstname.lastname@example.org