Ovid Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update
- Announced earlier today positive topline results from the Phase 2 ROCKET trial of OV101 for the treatment of Fragile X syndrome
- Previously reported encouraging initial results from Phase 2 ARCADE study in CDKL5 deficiency disorder and Dup15q syndrome
- Two late-stage clinical readouts expected during the remainder of 2020: Phase 2 ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome and Pivotal Phase 3 NEPTUNE trial in Angelman syndrome
“2020 remains an important and eventful year for the Company. The team at Ovid has continued to execute during these challenging times,” said
Pipeline and Clinical Development Updates
OV101 (gaboxadol) for Angelman Syndrome
Phase 3 NEPTUNE Trial – Due to mandated closures of clinical sites in the
In addition, after receiving Scientific Advice from the
OV101 for Fragile X syndrome
Phase 2 ROCKET Trial - Earlier today, Ovid announced positive topline results from the Phase 2 ROCKET trial with OV101 in Fragile X syndrome. OV101 met its primary objective and appeared to be well tolerated over 12 weeks of treatment with no serious adverse events reported across all three dose cohorts. OV101 produced statistically significant reductions in behavioral and functional symptoms in individuals with Fragile X syndrome.
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
Phase 2 ARCADE Trial - In
Phase 2 ELEKTRA Trial - Topline results from the fully enrolled randomized Phase 2 ELEKTRA trial in patients with Dravet syndrome and Lennox-Gastaut syndrome (LGS) are expected in the third quarter of 2020.
ENDYMION Open-Label Extension Trial - To date, all patients who have completed the Phase 2 ARCADE and ELEKTRA trials have rolled over into the ENDYMION open-label extension study. Ovid plans to report data from ENDYMION in conjunction with the results of the Phase 2 ELEKTRA trial expected in the third quarter of 2020.
Summary of Anticipated Clinical Data Readouts
|Product Candidate||Trial||Condition or Disease||Phase of Clinical Trial||Expected Timing of Data Release|
|Soticlestat||ELEKTRA||Dravet syndrome or LGS||Phase 2||3Q 2020|
|Soticlestat||ENDYMION – All Patients||CDD, Dup15q syndrome, Dravet syndrome, LGS, other DEEs||Open-label Extension
(concurrent with ELEKTRA)
|OV101||NEPTUNE||Angelman syndrome||Phase 3||4Q 2020|
|Soticlestat||ARCADE (Full Data)||CDD or Dup15q syndrome||Phase 2||Early 2021|
Alexander Kolevzon, M.D., a leader in child and adolescent psychiatry, to the Scientific Advisory Board.
First Quarter 2020 Financial Results
- As of
March 31, 2020, cash, cash equivalents and short-term investments totaled $58.3 million.
- Research and development expenses were
$14.6 millionfor the first quarter ended March 31, 2020, as compared to $9.3 millionfor the same period in 2019. The increase of $5.3 millionwas primarily due to an increase in clinical activities related to Ovid’s ongoing development programs.
- General and administrative expenses were
$5.7 millionfor the first quarter ended March 31, 2020, as compared to $4.7 millionfor the same period in 2019. The increase of $1.0 millionwas primarily due to an increase in legal and professional fees and general office expenses, offset by decreases in payroll and payroll-related expenses.
- The Company reported a net loss of
$20.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.37, for the first quarter of 2020, as compared to a net loss of $13.8 million, or net loss per share attributable to common stockholders of $0.46, for the same period in 2019.
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 development and potential therapeutic benefits of 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,” “appears,” “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”. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid’s business and the global economy. 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
|For the Three
|For the Three
|Research and development||$||14,625,367||$||9,337,304|
|General and administrative||5,669,019||4,716,231|
|Total operating expenses||20,294,386||14,053,535|
|Loss from operations||(20,294,386||)||(14,053,535||)|
|Net loss attributable to common stockholders||$||(20,030,090||)||$||(13,800,195||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.37||)||$||(0.46||)|
|Weighted-average common shares outstanding basic and diluted||54,715,610||30,329,640|
Selected Condensed Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||58,333,501||$||76,739,113|
|Total stockholders' equity||$||51,444,800||$||70,023,561|
1 Working capital defined as current assets less current liabilities
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Source: Ovid Therapeutics Inc.