Full Press Release Details
Ovid Therapeutics Reports Fourth Quarter and Full Year 2017 Financial
Results and Corporate Progress
Enrollment Completed in Phase 2 STARS Clinical Trial in Adults and Adolescents with Angelman Syndrome; Topline Data Expected Third
Enrollment Ongoing in Phase 1b/2a Clinical Trial of
TAK-935/OV935 in Adults with Rare Developmental and Epileptic Encephalopathies (dEE); Topline Data Expected Second Half 2018
Plan to Initiate Phase 2 Clinical Trial with OV101 for the Treatment of Adolescents and Young Adults with Fragile X syndrome in 2018
Ovid to Host Conference Call and Webcast Today at 5:00 p.m. EDT
NEW YORK March 29, 2018 Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing
medicines that transform the lives of people with rare neurological disorders, today reported financial results for the fourth quarter and full year ended December 31, 2017 and provided an overview of the company s recent business
2017 was a year of consistent and dynamic execution at Ovid Therapeutics, said Jeremy Levin, DPhil, MB BChir, chairman and chief
executive officer of Ovid Therapeutics. We delivered on a major corporate alliance with Takeda, secured multiple new patents, received additional regulatory designations for several of our programs, and meaningfully advanced our clinical
programs. In 2018, we expect to continue this positive momentum. We anticipate topline results later this year from both the OV101 Phase 2 STARS trial in Angelman syndrome and Phase 1b/2a clinical trial of
TAK-935/OV935 in developmental and epileptic encephalopathies. As we look ahead, we intend to expand the clinical development of both OV101 and TAK-935/OV935 into
additional indications and age groups.
Recent Highlights and Upcoming Milestones
OV101 for Neurodevelopmental Disorders
TAK-935/OV935 for Developmental and Epileptic Encephalopathies
Fourth Quarter and Full Year 2017 Financial Results
Conference Call and Webcast Information
Therapeutics will host a live conference call and webcast today, March 29, 2018 at 5:00 p.m. Eastern Time to review the company s financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the company s website at investors.ovidrx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 866-830-1640
(U.S.) or 210-874-7820 (International) to listen to the live conference call. The conference ID number for the live call is 3387007. A replay of the webcast will be
available for on the company s website for two weeks following the live conference call.
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, a central physiological process of the brain 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. Gaboxadol has previously been tested in over 4,000 patients (approximately 950 patient-years of exposure)
and was observed to have favorable safety and bioavailability profiles.
The FDA has granted orphan drug and Fast Track designations for OV101 for both
the treatment of Angelman syndrome and Fragile X syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101. The issued patents expire in 2035 without
regulatory extensions.
TAK-935/OV935, which is being studied in developmental and epileptic encephalopathies, 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 24S-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 24HC 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 and Takeda s knowledge, TAK-935/OV935 is the only molecule with this mechanism of action in clinical development.
TAK-935/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 enzyme occupancy of TAK-935/OV935 in the brain. In addition, the effect of TAK-935/OV935 on CH24H enzyme activity in the brain has been assessed by following measurable reductions in the plasma
concentration of 24HC.
TAK-935/OV935 has completed four Phase 1 clinical studies, which have assessed
tolerability and target engagement at doses believed to be therapeutically relevant. The FDA has granted orphan drug designation for TAK-935/OV935 for the treatment of both Dravet syndrome and Lennox-Gastaut
syndrome. TAK-935/OV935 is being co-developed by Ovid and Takeda Pharmaceutical Company Limited.
OVID THERAPEUTICS INC.
Condensed Statements of Operations and Comprehensive Loss
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,713,269 | $ | 3,990,834 | $ | 49,972,102 | $ | 9,585,649 | ||||||||
| General and administrative | 4,334,794 | 3,597,983 | 15,035,461 | 12,949,525 | ||||||||||||
| Total operating expenses | 11,048,063 | 7,588,817 | 65,007,563 | 22,535,174 | ||||||||||||
| Loss from operations | (11,048,063 | ) | (7,588,817 | ) | (65,007,563 | ) | (22,535,174 | ) | ||||||||
| Interest income | 87,799 | 27,500 | 201,509 | 120,822 | ||||||||||||
| Net loss and comprehensive loss | $ | (10,960,264 | ) | $ | (7,561,317 | ) | $ | (64,806,054 | ) | $ | (22,414,352 | ) | ||||
| Net loss attributable to common stockholders | $ | (10,960,264 | ) | $ | (7,561,317 | ) | $ | (64,806,054 | ) | $ | (22,414,352 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.45 | ) | $ | (0.77 | ) | $ | (3.35 | ) | $ | (2.28 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 24,604,303 | 9,838,590 | 19,344,355 | 9,838,590 |
OVID THERAPEUTICS INC.
Selected Condensed Balance Sheet Data
| December 31, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Cash and cash equivalents | $ | 87,125,600 | $ | 51,939,661 | ||||
| Working capital 1 | $ | 82,566,948 | $ | 48,677,798 | ||||
| Total assets | $ | 89,457,603 | $ | 53,027,887 | ||||
| Total stockholders equity | $ | 83,436,503 | $ | 49,294,475 |
1Working capital defined as current assets less current liabilities
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 initiated the Phase 2 STARS trial of OV101 in people with Angelman syndrome in 2017 and completed 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 epileptic encephalopathies and in 2017 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 that contain forward-looking statements, including, without limitation, statements regarding the
development of new therapies for previously unidentified disorders, the expansion of clinical development programs into additional indications and age groups, the number of patients to be enrolled, the initiation, progress, timing, scope and results
of clinical trials for Ovid s product candidates, the timing of reporting of clinical data regarding Ovid s product candidates, the presentation of scientific date at scientific meetings, and the company s preclinical and clinical
development plans. 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 September 30, 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.
Steve Klass, 212-213-0006
Katie Engleman, 910-509-3977