Full Press Release Details
Ovid Therapeutics Reports Second Quarter 2017 Financial Results and Corporate Progress
NEW YORK August 10, 2017 Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines for patients with rare
neurological disorders, today announced financial results for the second quarter ended June 30, 2017 and provided an overview of the company s recent business 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
Jeremy Levin, DPhil, MB BChir, chairman and chief executive officer of Ovid Therapeutics. In collaboration with Takeda, we have rapidly advanced TAK935/OV935 into a Phase 1b/2a clinical trial in rare epilepsies. We have set the stage for a
broader development strategy, including a pediatric program and biomarker strategy. The initiation of this trial, along with the two clinical trials for OV101 in neurodevelopmental disorders we commenced earlier this year, demonstrates our execution
and underscores our commitment to deliver impactful medicines for those living with devastating rare neurological disorders.
and Upcoming Milestones
OV101 for Neurodevelopmental Disorders
OV935 for Epileptic Encephalopathies
Second Quarter 2017 Financial Results
OV101 (gaboxadol) is believed to be the only delta ( )-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 -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.
In September 2016, the FDA granted orphan drug designation for OV101 for the treatment of Angelman syndrome. The United States Patent and Trademark Office has
granted Ovid two patents directed to methods of treating Angelman syndrome using OV101. The issued patents expire in 2035, without regulatory extensions.
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 Takeda and Molecular Neuroimaging, LLC (MNI), has been used to determine target occupancy of OV935 in the brain. In addition, OV935 s
effect on CH24H enzyme activity in the brain has been assessed by following measurable reductions in the plasma concentration of 24HC.
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 Ovid and Takeda
Pharmaceutical Company Limited.
About Ovid Therapeutics
Ovid Therapeutics (NASDAQ: OVID) is a New York-based, biopharmaceutical company using its BoldMedicine approach to develop therapies that transform the
lives of patients with rare neurological disorders. Ovid s drug candidate, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid has initiated the Phase 2 STARS trial of OV101 in adults with
Angelman syndrome and a Phase 1 trial in adolescents with Angelman syndrome or Fragile X syndrome. Ovid is also developing OV935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare epileptic encephalopathies and has
initiated a Phase 1b/2a trial of OV935.
For more information on Ovid, please visit http://www.ovidrx.com/.
Forward-Looking Statements
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 Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, 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.
OVID THERAPEUTICS INC.
Condensed Balance Sheets
| June 30, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| 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 | ||||||
| Security deposit | 430,275 | 407,785 | ||||||
| Property, plant and equipment, net | 49,798 | 43,591 | ||||||
| Other assets | 215,748 | 165,301 | ||||||
| Total assets | $ | 108,007,138 | $ | 53,027,887 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,571,534 | $ | 857,169 | ||||
| Accrued expenses | 3,493,493 | 2,876,243 | ||||||
| Total current liabilities | 7,065,027 | 3,733,412 | ||||||
| Stockholders Equity: | ||||||||
| 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 | |||||||
| Additional paid-in-capital | 181,314,312 | 85,186,269 | ||||||
| Accumulated deficit | (80,396,803 | ) | (35,909,614 | ) | ||||
| 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 Months Ended June 30, | For the Three Months Ended June 30, | For the Six Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| 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 | ) | ||||||||
| Interest income | 39,721 | 31,307 | 63,205 | 63,636 | ||||||||||||
| 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 |
Steve Klass, 212-213-0006
Pure Communications, Inc.
Katie Engleman, 910-509-3977