Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company
committed to developing medicines that transform the lives of
people with rare neurological disorders, today reported financial
results for the quarter ended March 31, 2018 and provided an
overview of the company’s recent business progress.
“We have an exceptionally talented team at Ovid,
and I could not be more pleased with their continued clinical and
operational execution,” said Jeremy Levin, DPhil, MB, BChir,
chairman and chief executive officer of Ovid. “In the second half
of the year, we expect to generate a rich set of data that will
provide us with important information on the profile and potential
of OV101 as a treatment for Angelman syndrome and TAK-935/OV935 as
a treatment for dEE. These near-term data readouts, coupled with
the expansion of our development programs into adolescents with
Fragile X syndrome and younger patients with dEE, are expected to
contribute to the continued growth and evolution of our
company.”
Recent Progress and Upcoming
Milestones
OV101 for Angelman Syndrome
- In March, Ovid announced completion of enrollment in the
12-week Phase 2 STARS trial evaluating OV101 for the treatment of
adults and adolescents ages 13 to 49 years with a confirmed
diagnosis of Angelman syndrome. AS has a wide range of symptoms and
the burden of this disorder is significant. The primary endpoint of
the ongoing STARS trial is safety and tolerability. The trial has
exploratory secondary endpoints evaluating OV101 for disease
activity in several key symptoms, including behavior, sleep, gross
and fine motor skills, clinical global impression, and overall
healthcare-related quality of life measures.
- The company expects topline data from the Phase 2 STARS
clinical trial to be available in the third quarter of 2018. Data
from this trial will help inform the next stage of development for
OV101 in AS.
- In April, Ovid presented two poster presentations for OV101 in
AS at the American Academy of Neurology (AAN) 70th Annual Meeting.
One poster described the baseline characteristics for the 88
patients randomized in the STARS trial. Twenty-five percent of
patients enrolled are adolescents and 75 percent are adults.
OV101 for Fragile X Syndrome
- In March, Ovid announced plans to initiate in 2018 the Phase 2
ROCKET multi-dose, three-arm clinical trial evaluating OV101 for
the treatment of up to 30 males ages 13 to 22 who are diagnosed
with Fragile X syndrome. The primary endpoint will be safety and
tolerability. Secondary endpoints are expected to include an
evaluation of changes in behavior during 12 weeks of treatment with
OV101.
- In April, Ovid presented three poster presentations for OV101
in Fragile X syndrome at AAN, including posters describing the
economic and clinical burden of this severe disorder.
TAK-935/OV935 for Rare Developmental and
Epileptic Encephalopathies
- Ovid and its collaboration partner, Takeda Pharmaceutical
Company Limited continue to enroll patients in a Phase 1b/2a
clinical trial of TAK-935/OV935 in adults with dEE. The primary
endpoint of this study is safety and tolerability. Secondary
endpoints include evaluation of pharmacokinetic (PK) parameters.
The trial also includes exploratory endpoints evaluating the change
from baseline in seizure frequency and 24-S-hydroxycholesteral
(24HC) levels. Plasma 24HC is being further assessed as a potential
biomarker for TAK-935/OV935, which may inform future clinical trial
designs and help clinicians individualize the use of this
investigational medicine. Topline data from the Phase 1b/2a trial
are expected in the second half of 2018.
- Ovid announced today the plan to initiate in 2018 additional
Phase 2 studies with TAK-935/OV935 in younger patient populations
with dEE and additional rare epilepsies.
- At AAN, Ovid and Takeda presented six poster presentations for
TAK-935/OV935, including study participant baseline characteristics
from the Phase 1b/2a clinical trial in adults with dEE.
Upcoming Preclinical Data Presentations
- Ovid plans to present preclinical data for two of its programs
at the 14th Eilat Conference on New Antiepileptic Drugs and Device
(EILAT XIV) taking place May 13 -16, 2018 in Madrid, Spain. The
oral presentations are expected to include new preclinical data for
TAK-935/OV935 in dEE, and the first presentation of preclinical
data for OV329, a next generation GABA aminotransferase (GABA-AT)
inhibitor with the potential to treat treatment-resistant
epilepsy.
First Quarter 2018 Financial
Results
Research and development expenses were $8.5
million for the first quarter of 2018, as compared to $31.3 million
for the same period in 2017. The first quarter of 2017 included a
non-cash equity charge of $25.9 million related to an upfront
payment for the Takeda collaboration
agreement. General and
administrative expenses were $5.0 million for the first quarter of
2018, as compared to $3.0 million for the same period in 2017. The
increase was primarily due to higher payroll and payroll-related
expenses due to growth in headcount as the company expanded its
operations, and an increase in professional fees associated with
operating as a public
company. Net loss was
$13.2 million, or net loss per share of $0.54, for the first
quarter of 2018, as compared to a net loss of $34.2 million, or net
loss per share of $3.48, for the same period in 2017.
As of March 31, 2018, cash, cash equivalents and
short-term investments totaled $74.2 million.
About OV101OV101 (gaboxadol) is
believed to be the only delta (δ)-selective GABAA receptor agonist
in development and the first investigational medicine to
specifically target the disruption of tonic inhibition, a central
physiological process of the brain that is thought to be the
underlying cause of certain neurodevelopmental disorders. OV101 has
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 AS
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 AS and
Fragile X syndrome. Gaboxadol has previously been tested in over
4,000 patients (approximately 950 patient-years of exposure) and
was observed to have favorable safety and bioavailability
profiles.
The U.S. Food and Drug Administration (FDA) has
granted orphan drug and Fast Track designations for OV101 for both
the treatment of AS and Fragile X syndrome. The U.S. Patent and
Trademark Office has granted Ovid patents directed to methods of
treating AS and Fragile X syndrome using OV101. The issued patents
expire in 2035 without regulatory extensions.
About
TAK-935/OV935TAK-935/OV935, which is being studied in
developmental and epileptic encephalopathies, 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
24S-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 24HC 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 and Takeda’s knowledge, TAK-935/OV935 is the only molecule
with this mechanism of action in clinical development.
TAK-935/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 enzyme occupancy of TAK-935/OV935 in the brain. In addition,
the effect of TAK-935/OV935 on CH24H enzyme activity in the brain
has been assessed by following measurable reductions in the plasma
concentration of 24HC.
TAK-935/OV935 has completed four Phase 1
clinical studies, which have assessed tolerability and target
engagement at doses believed to be therapeutically relevant. The
FDA has granted orphan drug designation for TAK-935/OV935 for the
treatment of both Dravet syndrome and Lennox-Gastaut syndrome.
TAK-935/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 medicines that
transform the lives of people with rare neurological disorders.
Ovid has a broad pipeline of first-in-class medicines. The
company’s lead investigational medicine, OV101, is currently in
development for the treatment of Angelman syndrome and Fragile X
syndrome. Ovid is also developing OV935 in collaboration with
Takeda Pharmaceutical Company Limited for the 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 (i) the initiation, progress, timing, scope
and results of clinical trials for Ovid’s product candidates, (ii)
the company’s preclinical and clinical development plans, (iii) the
development of new therapies for previously unidentified disorders,
(iv) the number of patients to be enrolled, (v) the timing of
reporting of clinical data regarding Ovid’s product candidates, and
(vi) the presentation of scientific date at scientific meetings.
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 period ended March 31, 2018, 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 Statements of
Operations |
(Unaudited) |
|
|
|
For the ThreeMonths
EndedMarch 31, |
|
|
For the ThreeMonths
EndedMarch 31, |
|
|
|
2018 |
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
8,474,557 |
|
|
$ |
31,284,429 |
|
General
and administrative |
|
|
4,955,307 |
|
|
|
2,977,864 |
|
Total
operating expenses |
|
|
13,429,864 |
|
|
|
34,262,293 |
|
Loss from
operations |
|
|
(13,429,864 |
) |
|
|
(34,262,293 |
) |
Interest income |
|
|
247,106 |
|
|
|
23,483 |
|
Net loss |
|
$ |
(13,182,758 |
) |
|
$ |
(34,238,810 |
) |
Net loss attributable
to common stockholders |
|
$ |
(13,182,758 |
) |
|
$ |
(34,238,810 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(3.48 |
) |
Weighted-average common
shares outstanding basic and diluted |
|
|
24,609,050 |
|
|
|
9,838,590 |
|
|
|
Selected Condensed Balance Sheet
Data |
(Unaudited) |
|
March 31, |
December 31, |
|
2018 |
2017 |
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
74,158,546 |
$ |
87,125,600 |
Working capital1 |
$ |
69,108,976 |
$ |
82,566,948 |
Total assets |
$ |
78,667,463 |
$ |
89,457,603 |
Total stockholders' equity |
$ |
72,088,199 |
$ |
83,436,503 |
1Working capital defined as current assets less
current liabilities
ContactsInvestors:Ovid
Therapeutics Inc.Lora PikeSenior Director, Investor Relations &
Public Relationslpike@ovidrx.com
Burns McClellan Steve Klass, 212-213-0006
Sklass@burnsmc.com
Media: W2O GroupElliott Fox,
212-257-6724efox@w2ogroup
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