Ovid Therapeutics Reports Third Quarter 2019 Financial Results and Recent Progress
November 08 2019 - 8:00AM
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 third quarter ended September 30, 2019 and provided
an overview of the company’s recent progress.
“2020 is poised to be a transformational year for Ovid. We
expect multiple clinical trial data readouts across our pipeline
including topline results from our pivotal Phase 3 NEPTUNE trial in
Angelman syndrome,” said Jeremy Levin, DPhil, MB, BChir, Chairman
and Chief Executive Officer of Ovid Therapeutics. “All of our
development programs demonstrate strong momentum. This is
highlighted most recently by the initial positive results from our
ENDYMION study in rare epilepsies, robust enrollment trends in our
randomized ELEKTRA study, as well as the commencement of patient
enrollment in the pivotal Phase 3 NEPTUNE trial. We completed a
public equity offering in October and now have the resources
necessary to take us through these anticipated clinical data
inflection points. We are excited by the upcoming events in our
pipeline and believe they hold great promise for creating value for
both patients and shareholders.”
Recent Progress and Upcoming Milestones
OV101 (gaboxadol) for Angelman Syndrome
- Commenced patient enrollment in the pivotal Phase 3 NEPTUNE
trial.○ Topline results from the trial are expected in
mid-2020.
OV101 (gaboxadol) for Fragile X Syndrome
- Results from the Phase 2 ROCKET trial are expected in early
2020.
OV935 (soticlestat) for Rare Developmental and Epileptic
Encephalopathies (DEE)
- Reported positive initial data from the open-label extension
ENDYMION trial from patients who previously completed Ovid’s
12-week Phase 1b/2a clinical trial of soticlestat in adults with
DEE.○ Overall, safety and tolerability observations with
soticlestat in the ENDYMION study were consistent with the
completed Phase 1b/2a clinical trial.○ Longer-term data from
ENDYMION out to 48 weeks suggest increased seizure reduction with
prolonged treatment of soticlestat in this difficult-to-treat,
adult patient population with various types of DEE.○ Median
seizure frequency reductions were 84% following 25-36 weeks (n=6)
and 90% following 37-48 weeks (n=4) of treatment.○ Longest
seizure-free durations experienced by two different patients were
264 consecutive days and 150 consecutive days, respectively.
- Initial data from the open-label Phase 2 ARCADE trial in
individuals with Dup15q syndrome or CDKL5 Deficiency is expected in
the first quarter of 2020.
- Data from the global, randomized Phase 2 ELEKTRA trial in
children with Dravet syndrome or Lennox-Gastaut syndrome is
expected in the second half of 2020.
- To date, all patients who have completed the Phase 2 ARCADE and
ELEKTRA trials continue to roll over into the ENDYMION open-label
extension study.
Corporate
- Strengthened financial position with the completion of a public
equity offering in October 2019, resulting in net proceeds of
approximately $33.7 million.
- Announced the promotions of Amit Rakhit, M.D., MBA to President
and Timothy Daly to Executive Vice President, Finance as the
company prepares for its next stage of growth.
Third Quarter 2019 Financial Results
- As of September 30, 2019, cash and cash equivalents totaled
$37.9 million. In addition, Ovid completed a public equity offering
in October 2019 resulting in net proceeds of approximately $33.7
million, including the exercise of the green shoe option, and after
deducting the underwriting discounts and commissions and estimated
offering expenses.
- Research and development expenses were $11.6 million for the
third quarter ended September 30, 2019, as compared to $8.5 million
for the same period in 2018. The increase of $3.1 million was
primarily due to an increase in clinical activities related to the
Company’s ongoing development programs.
- General and administrative expenses were $5.2 million for the
third quarter ended September 30, 2019, as compared to $4.6 million
for the same period in 2018. The increase of $0.6 million was
primarily due to a decrease in payroll and payroll-related expenses
of $0.4 million offset by an increase in professional fees and
general office expenses of $1.0 million.
- The Company reported a net loss of $16.6 million, or basic and
diluted net loss per share attributable to common stockholders of
$0.43, for the third quarter of 2019, as compared to a net loss of
$13.0 million, or net loss per share attributable to common
stockholders of $0.53, for the same period in 2018.
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 StatementsThis press release
includes certain disclosures that contain “forward-looking
statements,” including, without limitation, statements regarding
advancing 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 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) |
|
|
|
For the ThreeMonths
EndedSeptember 30,2019 |
|
|
For the ThreeMonths
EndedSeptember 30,2018 |
|
|
For the NineMonths
EndedSeptember 30,2019 |
|
|
For the NineMonths
EndedSeptember 30,2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,597,633 |
|
|
$ |
8,544,547 |
|
|
$ |
30,052,432 |
|
|
$ |
25,168,446 |
|
General and administrative |
|
|
5,168,103 |
|
|
|
4,631,228 |
|
|
|
14,089,106 |
|
|
|
14,636,941 |
|
Total operating expenses |
|
|
16,765,736 |
|
|
|
13,175,775 |
|
|
|
44,141,538 |
|
|
|
39,805,387 |
|
Loss from operations |
|
|
(16,765,736 |
) |
|
|
(13,175,775 |
) |
|
|
(44,141,538 |
) |
|
|
(39,805,387 |
) |
Interest income |
|
|
131,164 |
|
|
|
213,992 |
|
|
|
649,504 |
|
|
|
725,709 |
|
Net loss |
|
$ |
(16,634,572 |
) |
|
$ |
(12,961,783 |
) |
|
$ |
(43,492,034 |
) |
|
$ |
(39,079,678 |
) |
Net loss attributable to
common stockholders |
|
$ |
(16,634,572 |
) |
|
$ |
(12,961,783 |
) |
|
$ |
(43,492,034 |
) |
|
$ |
(39,079,678 |
) |
Net loss per share
attributable to common stockholders, basicand diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.59 |
) |
Weighted-average common shares
outstanding basic and diluted |
|
|
38,504,825 |
|
|
|
24,634,380 |
|
|
|
35,872,441 |
|
|
|
24,623,225 |
|
Selected Condensed Balance Sheet Data |
(Unaudited) |
|
|
|
September 30,2019 |
|
|
December 31,2018 |
|
Cash, cash equivalents and short-term investments |
|
$ |
37,907,904 |
|
|
$ |
41,500,652 |
|
Working capital¹ |
|
$ |
28,789,479 |
|
|
$ |
35,423,690 |
|
Total assets |
|
$ |
40,694,177 |
|
|
$ |
47,649,602 |
|
Total stockholders'
equity |
|
$ |
30,046,599 |
|
|
$ |
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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