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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.09 | 2.79% | 3.32 | 3.36 | 3.50 | 3.4258 | 3.18 | 3.26 | 155,063 | 22:21:39 |
“We are entering a transformational period for Ovid,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “2020 is a year where the team at Ovid looks to deliver on the hard work of the last several years. In anticipation of these important clinical readouts, during the fourth quarter of 2019 we raised approximately $56.0 million, providing us with sufficient capital to achieve all of these clinical data points. If we are successful, we have the potential to change the practice of medicine in one area and drive exciting new changes in a second.”
Amit Rakhit, M.D. MBA, President and Chief Medical Officer, said, “We have made significant clinical progress across the pipeline during 2019, which leads us to an eventful 2020 with multiple clinical data readouts expected this year. This includes initial data from the ongoing open-label Phase 2 ARCADE study in CDKL5 deficiency disorder and Dup15q syndrome by the end of the first quarter of 2020. In addition, early in the second quarter of 2020, we will have data from our signal-finding Phase 2 ROCKET trial in Fragile X syndrome along with SKYROCKET, our non-interventional trial in Fragile X syndrome. Also, we completed enrollment significantly ahead of schedule in our placebo-controlled Phase 2 ELEKTRA trial in children with Dravet syndrome and Lennox-Gastaut syndrome, and as a result, we now expect data to be available in the third quarter of 2020. We are also pleased to report that all patients who have completed the ELEKTRA and ARCADE trials have rolled over into our ENDYMION open-label extension study.”
Dr. Rakhit continued, “We are also very excited to see the results of our pivotal Phase 3 NEPTUNE trial in Angelman syndrome. Patient interest in our trial has been strong, and we are on track for clinical data mid-year. There are currently no approved therapies for Angelman syndrome. Achieving a clinically significant improvement in the NEPTUNE trial will indicate that OV101 has the potential to provide these patients and their families with a much-needed treatment, one for which the community has been waiting since the condition was first described over 50 years ago. If successful, this may serve as a basis for an oral once-a-day treatment option for people with Angelman syndrome.”
OV101 (gaboxadol) for Angelman Syndrome and Fragile X Syndrome
OV935/TAK935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
Summary of Anticipated Clinical Data Readouts
Product Candidate | Trial | Condition or Disease | Phase of Clinical Trial | Expected Timing of Data Release |
Soticlestat | ARCADE (Initial Data) | CDD or Dup15q syndrome | Phase 2 | End of 1Q 2020 |
Soticlestat | ENDYMION – ARCADE Cohort | CDD or Dup15q syndrome | Open-label Extension | End of 1Q 2020 (concurrent with ARCADE) |
Gaboxadol | ROCKET | Fragile X | Phase 2 | Early 2Q 2020 |
Gaboxadol | SKYROCKET | Fragile X | Non-treatment, observational | Early 2Q 2020 |
Gaboxadol | NEPTUNE | Angelman syndrome | Phase 3 | Mid-2020 |
Soticlestat | ELEKTRA | Dravet syndrome or LGS | Phase 2 | 3Q of 2020 |
Soticlestat | ENDYMION – All Patients | CDD, Dup15q syndrome, Dravet syndrome, LGS, other DEEs | Open-label Extension | 3Q of 2020 (concurrent with ELEKTRA) |
Soticlestat | ARCADE (Full Data) | CDD or Dup15q syndrome | Phase 2 | Early 2021 |
Fourth Quarter 2019 Corporate Update
Fourth Quarter and Year Ended December 31, 2019 Financial Results
About OV101 (gaboxadol)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, a central physiological process of the brain that is thought to be the underlying cause of certain neurodevelopmental disorders. Gaboxadol 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 modulation of tonic inhibition.
Ovid is developing gaboxadol for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and thereby address several core symptoms of these disorders. In both these syndromes, the underlying pathophysiology includes disruption of tonic inhibition modulated through the δ-subunit of GABAA receptors. In preclinical studies, it was observed that gaboxadol improved symptoms of Angelman syndrome and Fragile X syndrome. This compound has also previously been tested in more than 4,000 patients (more than 1,000 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles. Ovid is conducting a pivotal Phase 3 clinical trial in Angelman syndrome (NEPTUNE) as well as a Phase 2 signal-finding clinical trial in Fragile X syndrome (ROCKET).
The FDA has granted Orphan Drug and Fast Track designations for gaboxadol for both the treatment of Angelman syndrome and Fragile X syndrome. The European Commission (EC) has granted orphan drug designation to gaboxadol for the treatment of Angelman syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using gaboxadol. The issued patents expire in 2035 without regulatory extensions.
About OV935/TAK935 (soticlestat)Soticlestat is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it converts cholesterol into 24S-hydroxycholesterol (24HC) to adjust the homeostatic balance of brain cholesterol. 24HC is a positive allosteric modulator of the NMDA receptor and modulates glutamatergic signaling associated with epilepsy. 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 that CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel and that increased expression of CH24H can disrupt the reuptake of glutamate by astrocytes, resulting in epileptogenesis and neurotoxicity. Inhibition of CH24H by soticlestat reduces the neuronal levels of 24HC and may improve excitatory/inhibitory balance of NMDA channel activity. To Ovid’s knowledge, soticlestat is the only molecule with this mechanism of action in clinical development as an anti-epileptic drug (AED).
Ovid and Takeda are conducting a comprehensive Phase 2 clinical development program with soticlestat in people with Developmental and Epileptic Encephalopathies (DEE), a heterogeneous group of rare highly-refractory epilepsy syndromes that encompasses Dravet syndrome, Lennox-Gastaut syndrome and others. The FDA has granted orphan drug designation to soticlestat for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome.
About Ovid TherapeuticsOvid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company’s most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharmaceutical Company Limited for the potential 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: advancing and commercializing Ovid’s product candidates, progress, timing, scope and the potential therapeutic benefits based on results of clinical trials for Ovid’s product candidates; and the anticipated reporting schedule 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 include uncertainties in the development and regulatory approval processes, and the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks 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 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 Consolidated Statements of Operations (Unaudited)
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 12,105,209 | $ | 8,621,585 | $ | 42,157,641 | $ | 33,790,031 | |||||||
General and administrative | 5,162,720 | 4,504,711 | 19,251,826 | 19,141,652 | |||||||||||
Total operating expenses | 17,267,929 | 13,126,296 | 61,409,467 | 52,931,683 | |||||||||||
Loss from operations | (17,267,929 | ) | (13,126,296 | ) | (61,409,467 | ) | (52,931,683 | ) | |||||||
Interest income | 298,720 | 226,364 | 948,224 | 952,073 | |||||||||||
Net loss and comprehensive loss | $ | (16,969,209 | ) | $ | (12,899,932 | ) | $ | (60,461,243 | ) | $ | (51,979,610 | ) | |||
Net loss attributable to common stockholders | $ | (16,969,209 | ) | $ | (12,899,932 | ) | $ | (60,461,243 | ) | $ | (51,979,610 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.35 | ) | $ | (0.52 | ) | $ | (1.54 | ) | $ | (2.11 | ) | |||
Weighted-average common shares outstanding basic and diluted | 49,142,504 | 24,635,038 | 39,217,223 | 24,631,011 |
Selected Condensed Balance Sheet Data (Unaudited)
December 31, | December 31, | |||
2019 | 2018 | |||
Cash, cash equivalents and short-term investments | $ | 76,739,113 | $ | 41,500,652 |
Working capital1 | $ | 69,279,584 | $ | 35,423,690 |
Total assets | $ | 80,843,731 | $ | 47,649,602 |
Total stockholders' equity | $ | 70,023,561 | $ | 38,805,145 |
1Working capital defined as current assets less current liabilities
Contacts
Investors and Media:Ovid Therapeutics Inc.Investor Relations & Public Relationsirpr@ovidrx.com
Or
Investors: Steve KlassBurns McClellan, Inc.sklass@burnsmc.com (212) 213-0006
Media: Katie Engleman 1AB katie@1abmedia.com (919) 333-7722
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