Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical
company committed to developing medicines that transform the lives
of people with rare neurological diseases, today reported financial
results for the first quarter ended March 31, 2020 and provided a
corporate update. In addition, Ovid today provided an overview of
the status of its clinical development programs in the context of
the ongoing COVID-19 pandemic.
“2020 remains an important and eventful year for the Company.
The team at Ovid has continued to execute during these challenging
times,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief
Executive Officer of Ovid Therapeutics. “Earlier this morning, we
announced positive topline results from our Phase 2 Rocket trial in
Fragile X syndrome. Additionally, in March, we reported encouraging
initial data with soticlestat in CDKL5 deficiency disorder and
Dup15q syndrome.”
Dr. Levin continued, “Over the past few months, we have been
closely monitoring the evolving impact of COVID-19 to our clinical
studies. We have seen limited impact on our fully enrolled Phase 2
ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome and
remain on track to announce topline data in the third quarter of
2020. However, the COVID-19 pandemic has resulted in mandated
closures of clinical trial sites, and such closures have affected
new enrollment in our ongoing Phase 3 NEPTUNE clinical trial in
Angelman syndrome. Because interest in the study is very high and
clinical sites are reopening, new patients are beginning to be
screened. As such, we expect to report topline data from the
pivotal Phase 3 NEPTUNE trial in the fourth quarter of 2020.”
Amit Rakhit, M.D., MBA, President and Chief Medical Officer,
added, “After ongoing dialogue with European regulatory
authorities, we have decided to increase enrollment in the NEPTUNE
study from 60 to 90 patients. These additional patients will allow
for inclusion of a responder analysis of the primary endpoint
(CGI-I-AS), which has been specifically requested by the European
regulatory authorities. The data from NEPTUNE will support a broad
data package for a regulatory filing of OV101 for the treatment of
Angelman syndrome. Even with this increase in study size, we expect
to release topline data in the fourth quarter of 2020.”
Pipeline and Clinical Development Updates
OV101 (gaboxadol) for Angelman Syndrome
Phase 3 NEPTUNE Trial – Due to mandated closures of clinical
sites in the U.S., Europe, Israel and Australia in response to the
ongoing COVID-19 pandemic, the Company has experienced delays in
the enrollment of the Phase 3 NEPTUNE trial. The interest in
the trial from the Angelman syndrome patient community has been,
and remains, very strong. The trial was nearing completion of
enrollment when the clinical trial sites started to close. Based on
current assessments of clinical trial site re-openings and
continued patient interest, Ovid expects topline results from the
Phase 3 NEPTUNE trial in the fourth quarter of 2020.
In addition, after receiving Scientific Advice from the European
Committee for Medicinal Products for Human Use (CHMP), the Company
has decided to expand the trial sample size from 60 to 90
participants. The expansion of the trial will allow for the
inclusion of a responder analysis of the primary endpoint
(CGI-I-AS), specifically requested by the European regulatory
authorities. Ovid expects that by increasing the trial sample
size, it will enable the Company to provide additional data to
support an EU regulatory filing of OV101 for the treatment of
Angelman syndrome.
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 March 2020, Ovid announced initial
data from its ongoing exploratory Phase 2 open-label ARCADE study
of soticlestat in patients with CDKL5 deficiency disorder (CDD) and
Dup15q syndrome (Dup15q). Data from the first 11 patients
demonstrated that soticlestat was well tolerated and showed a
reduction in seizure frequency compared to baseline levels in a
majority of the individual patients. Full results from the Phase 2
ARCADE trial are expected in early 2021.
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 |
|
3Q 2020 (concurrent with ELEKTRA) |
|
OV101 |
|
NEPTUNE |
|
Angelman syndrome |
|
Phase 3 |
|
4Q 2020 |
|
Soticlestat |
|
ARCADE (Full Data) |
|
CDD or Dup15q syndrome |
|
Phase 2 |
|
Early 2021 |
|
Corporate
- Appointed 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 million for the
first quarter ended March 31, 2020, as compared to $9.3 million for
the same period in 2019. The increase of $5.3 million was primarily
due to an increase in clinical activities related to Ovid’s ongoing
development programs.
- General and administrative expenses were $5.7 million for the
first quarter ended March 31, 2020, as compared to $4.7 million for
the same period in 2019. The increase of $1.0 million was 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.
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 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(Unaudited)
|
|
For the ThreeMonths EndedMarch 31, |
|
|
For the ThreeMonths EndedMarch 31, |
|
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
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 |
) |
Interest income |
|
|
264,296 |
|
|
|
253,340 |
|
Net loss |
|
$ |
(20,030,090 |
) |
|
$ |
(13,800,195 |
) |
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 (Unaudited)
|
March 31, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments |
$ |
58,333,501 |
|
|
$ |
76,739,113 |
|
Working capital1 |
$ |
50,745,633 |
|
|
$ |
69,279,584 |
|
Total assets |
$ |
61,723,224 |
|
|
$ |
80,843,731 |
|
Total stockholders'
equity |
$ |
51,444,800 |
|
|
$ |
70,023,561 |
|
1 Working 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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