Ovid Therapeutics Reports Second Quarter 2017 Financial Results and Corporate Progress
August 10 2017 - 4:05PM
Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company
committed to developing medicines for patients with rare
neurological disorders, today announced financial results for the
second quarter ended June 30, 2017 and provided an overview of the
company’s recent business progress.
“Ovid continues to build a robust pipeline of promising
medicines. We have made important progress over the last quarter in
all our programs,” said Jeremy Levin, DPhil, MB BChir, chairman and
chief executive officer of Ovid Therapeutics. “In collaboration
with Takeda, we have rapidly advanced TAK935/OV935 into a Phase
1b/2a clinical trial in rare epilepsies. We have set the stage for
a broader development strategy, including a pediatric program and
biomarker strategy. The initiation of this trial, along with the
two clinical trials for OV101 in neurodevelopmental disorders we
commenced earlier this year, demonstrates our execution and
underscores our commitment to deliver impactful medicines for those
living with devastating rare neurological disorders.”
Recent Highlights and Upcoming Milestones
OV101 for Neurodevelopmental Disorders
- Ovid continues to enroll patients in the Phase 2 STARS clinical
trial of OV101 in adults with Angelman syndrome. The company
expects topline data from the STARS trial to be available in
2018.
- The company also continues to enroll patients in a Phase 1
clinical trial to evaluate the safety, pharmacokinetics (PK) and
tolerability of OV101 in adolescents diagnosed with Angelman
syndrome or Fragile X syndrome aged 13 to 17 years. The company
expects topline data to be available in the second half of 2017.
- Ovid also is planning to initiate clinical development in a
younger pediatric population pending completion of the adolescent
PK trial and juvenile animal toxicity studies.
OV935 for Epileptic Encephalopathies
- Ovid and Takeda initiated a Phase 1b/2a clinical trial with
OV935 to treat rare developmental and/or epileptic
encephalopathies. The primary endpoint of the study is to
characterize the safety and tolerability of OV935. Secondary
endpoints include assessment of standard safety laboratory values
and evaluation of pharmacokinetics (PK).
Corporate
- Strengthened the company’s board of directors with the
appointment of Barbara G. Duncan, who will serve as chairperson of
the Audit Committee.
- Completed an initial public offering (IPO) of 5,000,000 shares
of common stock, raising gross proceeds of $75 million, prior
to deducting the underwriting discount and estimated expenses of
the offering.
Second Quarter 2017 Financial Results
- As of June 30, 2017, cash and cash equivalents totaled $106.1
million.
- Research and development expenses were $6.1 million for the
second quarter of 2017, as compared to $1.8 million for the same
period in 2016. The increase was primarily due to higher clinical
expenses related to the clinical studies of OV101, costs related to
the Takeda collaboration for OV935, preclinical development
expenses, and an increase in payroll and payroll-related expenses
due to increased headcount as the company expanded its
operations.
- General and administrative expenses were $4.2 million for
second quarter of 2017, as compared to $3.6 million for the same
period in 2016. The increase was primarily due to the increase in
payroll and payroll-related expenses due to increased headcount as
the company expanded its operations.
- The company reported net losses of $10.2 million, or basic and
diluted net loss per share attributable to common stockholders
of $0.57, for the second quarter of 2017, as compared to a
loss of $5.4 million, or basic and diluted net loss per share
attributable to common stockholders of $0.55, for the same
period in 2016.
About OV101OV101 (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 that is thought to be the underlying
cause of certain neurodevelopmental disorders. OV101 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 tonic inhibition.
Ovid is developing OV101 for the treatment of Angelman syndrome
and Fragile X syndrome to potentially restore tonic inhibition and
relieve several of the symptoms of these disorders. In preclinical
studies, it was observed that OV101 improved symptoms of Angelman
syndrome and Fragile X syndrome.
In September 2016, the FDA granted orphan drug designation for
OV101 for the treatment of Angelman syndrome. The United States
Patent and Trademark Office has granted Ovid two patents directed
to methods of treating Angelman syndrome using OV101. The issued
patents expire in 2035, without regulatory extensions.
About OV935 OV935, which is being studied in
rare epilepsies, is a potent, highly-selective, first-in-class
inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). CH24H
is predominantly expressed in the brain, where it plays a central
role in cholesterol homeostasis. CH24H converts cholesterol to
24-S-hydroxycholesterol (24HC) which then exits the brain into the
blood plasma circulation. 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 CH24H is involved in over-activation of the glutamatergic
pathway through modulation of the NMDA channel, implying its
potential role in central nervous system diseases such as epilepsy.
To Ovid’s knowledge, OV935 is the only molecule with this mechanism
of action in clinical development.
OV935 has been tested in preclinical models to provide data to
support the advancement of the drug into human clinical studies in
patients suffering from rare epilepsy syndromes. A novel
proprietary PET ligand, developed by Takeda and Molecular
Neuroimaging, LLC (MNI), has been used to determine target
occupancy of OV935 in the brain. In addition, OV935’s effect
on CH24H enzyme activity in the brain has been assessed by
following measurable reductions in the plasma concentration
of 24HC.
OV935 has completed four Phase 1 clinical studies which have
assessed tolerability and target engagement at doses which are
believed to be therapeutically relevant. OV935 is being
co-developed by Ovid and Takeda Pharmaceutical Company Limited.
About Ovid TherapeuticsOvid Therapeutics
(NASDAQ:OVID) is a New York-based, biopharmaceutical company using
its BoldMedicine™ approach to develop therapies that transform the
lives of patients with rare neurological disorders. Ovid’s drug
candidate, OV101, is currently in development for the treatment of
Angelman syndrome and Fragile X syndrome. Ovid has initiated the
Phase 2 STARS trial of OV101 in adults with Angelman syndrome and a
Phase 1 trial in adolescents with Angelman syndrome or Fragile X
syndrome. Ovid is also developing OV935 in collaboration with
Takeda Pharmaceutical Company Limited for the treatment of rare
epileptic encephalopathies and has initiated a Phase 1b/2a trial of
OV935.
For more information on Ovid, please visit
http://www.ovidrx.com/.
Forward-Looking Statements This press release
includes certain disclosures which contain “forward-looking
statements,” including, without limitation, statements regarding
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, including its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2017, 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.
|
|
OVID THERAPEUTICS INC. |
|
Condensed Balance Sheets |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
106,115,648 |
|
|
$ |
51,939,661 |
|
Prepaid
and other current assets |
|
|
1,195,669 |
|
|
|
221,507 |
|
Due from
related parties |
|
|
- |
|
|
|
7,369 |
|
Deferred
transaction costs |
|
|
- |
|
|
|
242,673 |
|
Total
current assets |
|
|
107,311,317 |
|
|
|
52,411,210 |
|
|
|
|
|
|
|
|
|
|
Security deposit |
|
|
430,275 |
|
|
|
407,785 |
|
Property, plant and
equipment, net |
|
|
49,798 |
|
|
|
43,591 |
|
Other assets |
|
|
215,748 |
|
|
|
165,301 |
|
Total
assets |
|
$ |
108,007,138 |
|
|
$ |
53,027,887 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
3,571,534 |
|
|
$ |
857,169 |
|
Accrued
expenses |
|
|
3,493,493 |
|
|
|
2,876,243 |
|
Total
current liabilities |
|
|
7,065,027 |
|
|
|
3,733,412 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value; 125,000,000 and 58,000,000 shares
authorized at |
|
|
|
|
|
|
|
|
June 30, 2017 and December 31, 2016, respectively, 24,601,936 and
9,838,590 shares |
|
|
|
|
|
|
|
|
issued and outstanding at June 30, 2017 and December 31,
2016, respectively |
|
|
24,602 |
|
|
|
9,839 |
|
Preferred
Series A - zero and 5,121,453 shares authorized at June 30, 2017
and December 31, 2016, respectively |
|
|
|
|
|
|
|
|
zero and 2,382,069 issued and outstanding at June 30, 2017 and
December 31, 2016, respectively |
|
|
- |
|
|
|
2,382 |
|
Preferred
Series B - zero and 12,038,506 shares authorized at June 30, 2017
and December 31, 2016, respectively |
|
|
|
|
|
|
|
|
zero and 5,599,282 issued and outstanding at June 30, 2017 and
December 31, 2016, respectively |
|
|
- |
|
|
|
5,599 |
|
Additional paid-in-capital |
|
|
181,314,312 |
|
|
|
85,186,269 |
|
Accumulated deficit |
|
|
(80,396,803 |
) |
|
|
(35,909,614 |
) |
Total
stockholders' equity |
|
|
100,942,111 |
|
|
|
49,294,475 |
|
Total liabilities and stockholders' equity |
|
$ |
108,007,138 |
|
|
$ |
53,027,887 |
|
|
|
OVID THERAPEUTICS INC. |
|
Condensed Statements of Operations and
Comprehensive Loss |
|
|
|
|
|
For the Three Months Ended
June 30, |
|
|
For the Three Months Ended
June 30, |
|
|
For the Six Months Ended
June 30, |
|
|
For the Six Months Ended
June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
6,074,927 |
|
|
$ |
1,770,202 |
|
|
$ |
37,359,355 |
|
|
$ |
2,896,804 |
|
General
and administrative |
|
|
4,213,173 |
|
|
|
3,646,731 |
|
|
|
7,191,039 |
|
|
|
6,234,624 |
|
Total
operating expenses |
|
|
10,288,100 |
|
|
|
5,416,933 |
|
|
|
44,550,394 |
|
|
|
9,131,428 |
|
Loss from
operations |
|
|
(10,288,100 |
) |
|
|
(5,416,933 |
) |
|
|
(44,550,394 |
) |
|
|
(9,131,428 |
) |
Interest income |
|
|
39,721 |
|
|
|
31,307 |
|
|
|
63,205 |
|
|
|
63,636 |
|
Net loss and
comprehensive loss |
|
$ |
(10,248,379 |
) |
|
$ |
(5,385,626 |
) |
|
$ |
(44,487,189 |
) |
|
$ |
(9,067,792 |
) |
Net loss attributable
to common stockholders |
|
$ |
(10,248,379 |
) |
|
$ |
(5,385,626 |
) |
|
$ |
(44,487,189 |
) |
|
$ |
(9,067,792 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.55 |
) |
|
$ |
(3.18 |
) |
|
$ |
(0.92 |
) |
Weighted-average common
shares outstanding basic and diluted |
|
|
18,112,554 |
|
|
|
9,838,590 |
|
|
|
13,998,428 |
|
|
|
9,838,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts
Investors:
Burns McClellan
Steve Klass, 212-213-0006
Sklass@burnsmc.com
Media:
Pure Communications, Inc.
Katie Engleman, 910-509-3977
katie@purecommunicationsinc.com
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