Ovid Therapeutics Reports Second Quarter 2019 Financial Results and Highlights Recent Progress
August 07 2019 - 4:05PM
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 second quarter ended June 30, 2019 and provided an
overview of the company’s recent progress.
“Our Phase 3 NEPTUNE clinical trial, if positive, has the
potential to make OV101 the first drug approved specifically for
patients with Angelman syndrome,” said Jeremy Levin, DPhil, MB,
BChir, Chairman and Chief Executive Officer of Ovid Therapeutics.
“We expect to enroll the first patients in NEPTUNE during the
coming weeks. In addition, we expect interim data from our
open-label ENDYMION trial with OV935 (soticlestat) for individuals
with rare developmental and epileptic encephalopathies to be
available later this quarter. This is an exciting and productive
time at Ovid as we continue to execute on our programs and
corporate objectives.”
Recent Progress and Upcoming Milestones
OV101 (gaboxadol) for Angelman Syndrome
- Based on Ovid’s interactions with regulatory authorities in the
U.S. and Germany regarding a Phase 3 program and registration path,
Ovid, the U.S. Food and Drug Administration (FDA) and Germany’s
Federal Institute for Drugs and Medical Devices (BfArM) agree on
the study design of the Phase 3 NEPTUNE trial, including the use of
the Angelman syndrome-specific Clinical Global Impressions of
Improvement (CGI-I-AS) as the primary efficacy outcome measure.
Both the FDA and BfArM agreed that NEPTUNE, if positive, could
support the filings of a New Drug Application (NDA) and Marketing
Authorization Application (MAA), respectively.
- Ovid has initiated the pivotal Phase 3 NEPTUNE trial and plans
to enroll the first Angelman syndrome patients in the third quarter
of 2019. Topline results from the trial are expected in
mid-2020.
- In July 2019, Ovid announced that the European Commission (EC)
granted orphan drug designation (ODD) to OV101 for the treatment of
Angelman syndrome based on the results of the Phase 2 STARS
trial.
OV101 (gaboxadol) for Fragile X Syndrome
- The Phase 2 ROCKET trial continues to enroll patients and
results are expected around year-end 2019 or early 2020.
OV935 (soticlestat) for Rare Developmental and Epileptic
Encephalopathies (DEE)
- Interim data from the open-label extension ENDYMION trial for
individuals with DEE who previously completed a clinical trial with
OV935 are expected in the third quarter of 2019.
- The open-label Phase 2 ARCADE trial in individuals with Dup15q
syndrome or CDKL5 Deficiency Disorder continues to enroll patients
with data expected in the first quarter of 2020.
- The global Phase 2 ELEKTRA trial in children with Dravet
syndrome or Lennox-Gastaut syndrome continues to enroll
patients.
Second Quarter 2019 Financial Results
- As of June 30, 2019, cash and cash equivalents totaled $47.4
million.
- Research and development expenses were $9.1 million for the
second quarter ended June 30, 2019, as compared to $8.1 million for
the same period in 2018. The increase of $1.0 million was primarily
due to an increase in clinical activities related to the Company’s
ongoing development programs.
- General and administrative expenses were $4.2 million for the
second quarter ended June 30, 2019, as compared to $5.1 million for
the same period in 2018. The decrease of $0.9 million was primarily
due to a decrease in payroll and payroll-related expenses of $1.5
million offset by an increase in professional fees and general
office expenses of $0.6 million.
- The Company reported a net loss of $13.1 million, or basic and
diluted net loss per share attributable to common stockholders of
$0.34, for the second quarter of 2019, as compared to a net loss of
$12.9 million, or net loss per share attributable to common
stockholders of $0.53, for the same period in 2018.
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 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 Ovid’s product candidates, progress, timing, scope and
results of clinical trials for Ovid’s product candidates, and the
reporting 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 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 June 30, |
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
9,117,495 |
|
|
$ |
8,116,385 |
|
|
$ |
18,454,804 |
|
|
$ |
16,590,942 |
|
General and administrative |
|
4,204,771 |
|
|
|
5,093,311 |
|
|
|
8,920,999 |
|
|
|
10,048,615 |
|
Total operating expenses |
|
13,322,266 |
|
|
|
13,209,696 |
|
|
|
27,375,803 |
|
|
|
26,639,557 |
|
Loss from operations |
|
(13,322,266 |
) |
|
|
(13,209,696 |
) |
|
|
(27,375,803 |
) |
|
|
(26,639,557 |
) |
Interest income |
|
264,999 |
|
|
|
274,556 |
|
|
|
518,341 |
|
|
|
521,662 |
|
Net loss |
$ |
(13,057,267 |
) |
|
$ |
(12,935,140 |
) |
|
$ |
(26,857,462 |
) |
|
$ |
(26,117,895 |
) |
Net loss attributable to
common stockholders |
$ |
(13,057,267 |
) |
|
$ |
(12,935,140 |
) |
|
$ |
(26,857,462 |
) |
|
$ |
(26,117,895 |
) |
Net loss per share attributable to common stockholders, basic
and diluted |
$ |
(0.34 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.06 |
) |
Weighted-average common shares outstanding basic and
diluted |
|
38,693,018 |
|
|
|
24,625,966 |
|
|
|
34,534,432 |
|
|
|
24,617,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Balance Sheet
Data
(Unaudited)
|
June 30, |
December 31, |
|
2019 |
2018 |
|
|
|
Cash, cash equivalents and short-term investments |
$ |
47,361,966 |
$ |
41,500,652 |
Working capital1 |
$ |
44,423,321 |
$ |
35,423,690 |
Total assets |
$ |
54,908,278 |
$ |
47,649,602 |
Total stockholders' equity |
$ |
45,437,899 |
$ |
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
Engleman1ABkatie@1abmedia.com (919) 333-7722
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