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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ovid Therapeutics Inc | NASDAQ:OVID | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.02 | -1.71% | 1.15 | 1.09 | 1.20 | 1.19 | 1.1399 | 1.19 | 402,974 | 23:18:02 |
“We have an exceptionally talented team at Ovid, and I could not be more pleased with their continued clinical and operational execution,” said Jeremy Levin, DPhil, MB, BChir, chairman and chief executive officer of Ovid. “In the second half of the year, we expect to generate a rich set of data that will provide us with important information on the profile and potential of OV101 as a treatment for Angelman syndrome and TAK-935/OV935 as a treatment for dEE. These near-term data readouts, coupled with the expansion of our development programs into adolescents with Fragile X syndrome and younger patients with dEE, are expected to contribute to the continued growth and evolution of our company.”
Recent Progress and Upcoming Milestones
OV101 for Angelman Syndrome
OV101 for Fragile X Syndrome
TAK-935/OV935 for Rare Developmental and Epileptic Encephalopathies
Upcoming Preclinical Data Presentations
First Quarter 2018 Financial Results
Research and development expenses were $8.5 million for the first quarter of 2018, as compared to $31.3 million for the same period in 2017. The first quarter of 2017 included a non-cash equity charge of $25.9 million related to an upfront payment for the Takeda collaboration agreement. General and administrative expenses were $5.0 million for the first quarter of 2018, as compared to $3.0 million for the same period in 2017. The increase was primarily due to higher payroll and payroll-related expenses due to growth in headcount as the company expanded its operations, and an increase in professional fees associated with operating as a public company. Net loss was $13.2 million, or net loss per share of $0.54, for the first quarter of 2018, as compared to a net loss of $34.2 million, or net loss per share of $3.48, for the same period in 2017.
As of March 31, 2018, cash, cash equivalents and short-term investments totaled $74.2 million.
About OV101OV101 (gaboxadol) is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first investigational medicine 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 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 AS 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 AS 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 U.S. Food and Drug Administration (FDA) has granted orphan drug and Fast Track designations for OV101 for both the treatment of AS and Fragile X syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating AS and Fragile X syndrome using OV101. The issued patents expire in 2035 without regulatory extensions.
About TAK-935/OV935TAK-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.
About Ovid TherapeuticsOvid Therapeutics (NASDAQ:OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of people with rare neurological disorders. Ovid has a broad pipeline of first-in-class medicines. The company’s lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (dEE).
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 (i) the initiation, progress, timing, scope and results of clinical trials for Ovid’s product candidates, (ii) the company’s preclinical and clinical development plans, (iii) the development of new therapies for previously unidentified disorders, (iv) the number of patients to be enrolled, (v) the timing of reporting of clinical data regarding Ovid’s product candidates, and (vi) the presentation of scientific date at scientific meetings. 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 period ended March 31, 2018, 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.
Condensed Statements of Operations | ||||||||
(Unaudited) | ||||||||
For the ThreeMonths EndedMarch 31, | For the ThreeMonths EndedMarch 31, | |||||||
2018 | 2017 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 8,474,557 | $ | 31,284,429 | ||||
General and administrative | 4,955,307 | 2,977,864 | ||||||
Total operating expenses | 13,429,864 | 34,262,293 | ||||||
Loss from operations | (13,429,864 | ) | (34,262,293 | ) | ||||
Interest income | 247,106 | 23,483 | ||||||
Net loss | $ | (13,182,758 | ) | $ | (34,238,810 | ) | ||
Net loss attributable to common stockholders | $ | (13,182,758 | ) | $ | (34,238,810 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.54 | ) | $ | (3.48 | ) | ||
Weighted-average common shares outstanding basic and diluted | 24,609,050 | 9,838,590 | ||||||
Selected Condensed Balance Sheet Data | ||||
(Unaudited) | ||||
March 31, | December 31, | |||
2018 | 2017 | |||
Cash, cash equivalents and short-term investments | $ | 74,158,546 | $ | 87,125,600 |
Working capital1 | $ | 69,108,976 | $ | 82,566,948 |
Total assets | $ | 78,667,463 | $ | 89,457,603 |
Total stockholders' equity | $ | 72,088,199 | $ | 83,436,503 |
1Working capital defined as current assets less current liabilities
ContactsInvestors:Ovid Therapeutics Inc.Lora PikeSenior Director, Investor Relations & Public Relationslpike@ovidrx.com
Burns McClellan Steve Klass, 212-213-0006 Sklass@burnsmc.com
Media: W2O GroupElliott Fox, 212-257-6724efox@w2ogroup
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