Full Press Release Details
Ovid Therapeutics Reports First Quarter 2017 Financial Results and Recent
Completed Initial Public Offering Raising $75 Million in Gross Proceeds
Initiated Phase 2 STARS Clinical Trial of OV101 in Adults with Angelman Syndrome
Entered into Innovative Global Collaboration with Takeda Focused on the Clinical Development
and Commercialization of TAK-935/OV935 in Rare Pediatric Epilepsies
NEW YORK June 13, 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 first quarter ended March 31, 2017 and provided an overview of the company s recent progress.
Ovid has a clear strategy and business plan to build a neurology company focused on rare disorders of the brain. Earlier this year we initiated two
clinical trials for OV101, a Phase 2 ( STARS ) trial in adults with Angelman syndrome and a Phase 1 trial in adolescents with either Angelman syndrome or Fragile X syndrome, said Jeremy Levin, DPhil, MB BChir, chairman and chief
executive officer of Ovid Therapeutics. In addition, we entered into a collaboration with Takeda Pharmaceutical Company Limited to develop and commercialize TAK-935/OV935 for rare epileptic encephalopathies. Building on the momentum in the
company we successfully closed our initial public offering in May. We look forward to continued progress throughout 2017 and beyond.
Highlights and Upcoming Milestones
First Quarter 2017 Financial Results
The Company reported net losses of $34.2 million, or basic and
diluted net loss per share attributable to common stockholders of $3.48, for the first quarter of 2017, as compared to a loss of $3.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.37, for the
same period in 2016.
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
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 THIP (OV101). The issued patents expire in 2035, without regulatory extensions.
TAK-935, which is being studied in rare
pediatric 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.i 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.ii Recent literature indicates CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA
channel,iii implying its potential role in CNS diseases such as epilepsy. To Ovid s knowledge, TAK-935 is the only molecule with this mechanism of action in clinical development.
TAK-935 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 TAK-935 in the brain.iv In addition, TAK-935 s effect on CH24H enzyme activity in the brain has been assessed by following measurable reductions in the plasma concentration of 24HC.
TAK-935 has completed four Phase 1 clinical
studiesv,vi,vii,viii which have
assessed tolerability and target engagement at doses which are believed to be therapeutically relevant. TAK-935 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 BoldMedicineTM 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. Ovid expects to initiate a Phase 1b/2a trial of OV935 to treat rare
epileptic encephalopathies in 2017.
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, the reporting of clinical data
regarding Ovid s product candidates, and the potential use of TAK-935/OV935 to treat epileptic encephalopathies. 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 registration statement on Form S-1, as amended, 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 (unaudited)
| March 31, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 44,225,807 | $ | 51,939,661 | ||||
| Prepaid and other current assets | 389,360 | 221,507 | ||||||
| Due from related parties | 7,369 | |||||||
| Deferred transaction costs | 1,926,017 | 242,673 | ||||||
| Total current assets | 46,541,184 | 52,411,210 | ||||||
| Security deposit | 415,260 | 407,785 | ||||||
| Property, plant and equipment, net | 46,586 | 43,591 | ||||||
| Other assets | 200,281 | 165,301 | ||||||
| Total assets | $ | 47,203,311 | $ | 53,027,887 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,579,789 | $ | 857,169 | ||||
| Accrued expenses | 3,287,974 | 2,876,243 | ||||||
| Total current liabilities | 4,867,763 | 3,733,412 | ||||||
| Stockholders Equity: | ||||||||
| Common stock, $0.001 par value; 62,000,000 and 58,000,000 shares authorized at March 31, 2017 and December 31, 2016, respectively, 9,838,590 shares issued and outstanding at March 31, 2017 and December 31, 2016 | 9,839 | 9,839 | ||||||
| Preferred Series A 5,121,453 shares authorized at March 31, 2017 and December 31, 2016, 2,382,069 issued and outstanding at March 31, 2017 and December 31, 2016 (liquidation preference $5,060,000) | 2,382 | 2,382 | ||||||
| Preferred Series B 12,038,506 shares authorized, 5,599,282 issued and outstanding at March 31, 2017 and December 31, 2016 (liquidation preference $74,999,883) | 5,599 | 5,599 | ||||||
| Preferred Series B-1 3,831,923 and zero shares authorized at March 31, 2017 and December 31, 2016, respectively, 1,781,996 and zero issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 1,782 | |||||||
| Additional paid-in-capital | 112,464,370 | 85,186,269 | ||||||
| Accumulated deficit | (70,148,424 | ) | (35,909,614 | ) | ||||
| Total stockholders equity | 42,335,548 | 49,294,475 | ||||||
| Total liabilities and stockholders equity | $ | 47,203,311 | $ | 53,027,887 |
OVID THERAPEUTICS INC.
Condensed Statements of Operations and Comprehensive Loss (unaudited)
| Three Months Ended March 31, | Three Months Ended March 31, | |||||||
| 2017 | 2016 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 31,284,429 | $ | 1,126,602 | ||||
| Selling, general and administrative | 2,977,864 | 2,587,894 | ||||||
| Total operating expenses | 34,262,293 | 3,714,496 | ||||||
| Interest income (expense), net | 23,483 | 32,330 | ||||||
| Loss before income tax | (34,238,810 | ) | (3,682,166 | ) | ||||
| Income taxes | ||||||||
| Net loss and comprehensive loss | $ | (34,238,810 | ) | $ | (3,682,166 | ) | ||
| Net loss attributable to common stockholders | $ | (34,238,810 | ) | $ | (3,682,166 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (3.48 | ) | $ | (0.37 | ) | ||
| Weighted-average common shares outstanding basic and diluted | 9,838,590 | 9,838,590 |
Steve Klass, 212-213-0006
Pure Communications, Inc.
Katie Engleman, 910-509-3977