Completed Initial Public Offering Raising $75
Million in Gross Proceeds
Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company
committed to developing medicines for patients with rare
neurological disorders, today announced financial results for the
first quarter ended March 31, 2017 and provided an overview of the
company’s recent progress.
“Ovid has a clear strategy and business plan to build a
neurology company focused on rare disorders of the brain. Earlier
this year we initiated two clinical trials for OV101, a Phase 2
(“STARS”) trial in adults with Angelman syndrome and a Phase 1
trial in adolescents with either Angelman syndrome or Fragile X
syndrome,” said Jeremy Levin, DPhil, MB BChir, chairman and chief
executive officer of Ovid Therapeutics. “In addition, we entered
into a collaboration with Takeda Pharmaceutical Company Limited to
develop and commercialize TAK-935/OV935 for rare epileptic
encephalopathies. Building on the momentum in the company we
successfully closed our initial public offering in May. We look
forward to continued progress throughout 2017 and beyond.”
Recent Highlights and Upcoming Milestones
- Successfully completed the company’s initial public offering
(IPO), raising $75.0 million in gross proceeds.
- Initiated the Phase 2 STARS clinical trial of OV101 in adults
with Angelman syndrome, a rare genetic disorder with no
FDA-approved therapies.
- The trial is expected to enroll approximately 75 adults aged 18
to 49 years in the United States and Israel with a confirmed
diagnosis of Angelman syndrome.
- The primary endpoint of the trial is to assess the safety and
tolerability of OV101. Exploratory endpoints include evaluating
measures of gross and fine motor skills, maladaptive behavior,
sleep, clinical global impression and health-related quality of
life questionnaires.
- The company expects topline data from the STARS trial to be
available in 2018.
- Initiated a Phase 1 clinical trial to evaluate OV101 in
adolescents diagnosed with Angelman syndrome or Fragile X syndrome
aged 13 to 17 years.
- The Phase 1 single dose, single-arm, open-label clinical trial
will measure pharmacokinetics (PK), safety and tolerability of
OV101.
- 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 a pediatric PK
trial and juvenile animal toxicity studies.
- Launched a biomarker strategy to identify molecular markers of
treatment responders in neurodevelopmental disorders.
- Ovid entered into a services agreement with NeuroPointDX. The
relationship will focus on identifying novel biomarkers of Angelman
syndrome by analyzing metabolomic profile data generated in the
STARS trial.
- Expanded the pipeline by entering into a global collaboration
with Takeda Pharmaceutical Company Limited focused on the clinical
development and commercialization of TAK-935/OV935, a potent and
highly selective CH24H inhibitor, in rare epileptic
encephalopathies.
- The companies share in the development and commercialization
costs on a 50/50 basis and, if successful, the companies will share
in the profits on a 50/50 basis.
- Ovid will lead clinical development activities and
commercialization of OV935 in the United States, Europe, Canada and
Israel.
- The companies plan to initiate a Phase 1b/2a trial in 2017 in
patients with rare epileptic encephalopathies, including Dravet
syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis
Complex.
- Presented preclinical data for OV935 at an oral presentation at
the Antiepileptic Drug and Device (AEDD) Trials XIV Conference in
May 2017.
- Strengthened the company’s Scientific Advisory Board with the
appointment of Jacqueline A. French, M.D., a world-renowned expert
in the treatment of epilepsy.
First Quarter 2017 Financial Results
- As of March 31, 2017, cash and cash equivalents totaled $44.2
million. On May 10, 2017, the company completed its IPO of
5,000,000 shares of common stock at a public offering price of
$15.00 per share, raising gross proceeds of $75 million, prior to
deducting the underwriting discount and estimated expenses of the
offering.
- Research and development expenses were $31.3 million for the
first quarter of 2017, as compared to $1.1 million for the same
period in 2016. The increase was primarily due to the issuance of
stock to Takeda as an upfront payment upon signing the
collaboration agreement for OV935. Of the $27.5 million in
collaboration agreement expenses, $25.9 million related to the
issuance of common stock to Takeda and $1.6 million in Takeda
alliance costs. Additional higher expenses relating to the STARS
Phase 2 trial for OV101 accounted for the rest of the increase in
2017.
- General and administrative expenses were $3.0 million for first
quarter of 2017, as compared to $2.6 million for the same period in
2016. The increase was primarily due to the increase in payroll and
payroll-related expenses as a result of increased headcount as we
expand our operations.
The Company reported net losses of $34.2 million, or basic and
diluted net loss per share attributable to common stockholders
of $3.48, for the first quarter of 2017, as compared to a loss
of $3.7 million, or basic and diluted net loss per share
attributable to common stockholders of $0.37, 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 THIP (OV101). The
issued patents expire in 2035, without regulatory extensions.
About TAK-935TAK-935, which is being studied in
rare pediatric 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.i 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.ii Recent literature indicates CH24H is involved in
over-activation of the glutamatergic pathway through modulation of
the NMDA channel,iii implying its potential role in CNS
diseases such as epilepsy. To Ovid’s knowledge, TAK-935 is the only
molecule with this mechanism of action in clinical development.
TAK-935 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 TAK-935 in the brain.iv In addition, TAK-935’s
effect on CH24H enzyme activity in the brain has been assessed by
following measurable reductions in the plasma concentration
of 24HC.
TAK-935 has completed four Phase 1 clinical
studiesv,vi,vii,viii which have assessed tolerability and
target engagement at doses which are believed to be therapeutically
relevant. TAK-935 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 BoldMedicineTM 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. Ovid expects to initiate a Phase 1b/2a
trial of OV935 to treat rare epileptic encephalopathies in
2017.
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, the reporting of
clinical data regarding Ovid’s product candidates, and the
potential use of TAK-935/OV935 to treat epileptic encephalopathies.
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 registration statement on Form
S-1, as amended, 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
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
44,225,807 |
|
|
$ |
51,939,661 |
|
Prepaid
and other current assets |
|
|
389,360 |
|
|
|
221,507 |
|
Due from
related parties |
|
|
- |
|
|
|
7,369 |
|
Deferred
transaction costs |
|
|
1,926,017 |
|
|
|
242,673 |
|
Total
current assets |
|
|
46,541,184 |
|
|
|
52,411,210 |
|
|
|
|
|
|
|
|
|
|
Security deposit |
|
|
415,260 |
|
|
|
407,785 |
|
Property, plant and
equipment, net |
|
|
46,586 |
|
|
|
43,591 |
|
Other assets |
|
|
200,281 |
|
|
|
165,301 |
|
Total
assets |
|
$ |
47,203,311 |
|
|
$ |
53,027,887 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,579,789 |
|
|
$ |
857,169 |
|
Accrued
expenses |
|
|
3,287,974 |
|
|
|
2,876,243 |
|
Total
current liabilities |
|
|
4,867,763 |
|
|
|
3,733,412 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value; 62,000,000 and 58,000,000 shares
authorized at March 31, 2017 and December 31, 2016, respectively,
9,838,590 shares issued and outstanding at March 31, 2017 and
December 31, 2016 |
|
|
9,839 |
|
|
|
9,839 |
|
Preferred
Series A - 5,121,453 shares authorized at March 31, 2017 and
December 31, 2016, 2,382,069 issued and outstanding at March 31,
2017 and December 31, 2016 (liquidation preference $5,060,000) |
|
|
2,382 |
|
|
|
2,382 |
|
Preferred
Series B - 12,038,506 shares authorized, 5,599,282 issued and
outstanding at March 31, 2017 and December 31, 2016 (liquidation
preference $74,999,883) |
|
|
5,599 |
|
|
|
5,599 |
|
Preferred
Series B-1 - 3,831,923 and zero shares authorized at March 31, 2017
and December 31, 2016, respectively, 1,781,996 and zero issued and
outstanding at March 31, 2017 and December 31, 2016,
respectively |
|
|
1,782 |
|
|
|
- |
|
Additional paid-in-capital |
|
|
112,464,370 |
|
|
|
85,186,269 |
|
Accumulated deficit |
|
|
(70,148,424 |
) |
|
|
(35,909,614 |
) |
Total
stockholders' equity |
|
|
42,335,548 |
|
|
|
49,294,475 |
|
Total
liabilities and stockholders' equity |
|
$ |
47,203,311 |
|
|
$ |
53,027,887 |
|
|
|
|
|
|
|
|
|
|
OVID THERAPEUTICS INC. |
Condensed Statements of Operations and
Comprehensive Loss (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
31,284,429 |
|
|
$ |
1,126,602 |
|
Selling,
general and administrative |
|
|
2,977,864 |
|
|
|
2,587,894 |
|
Total
operating expenses |
|
|
34,262,293 |
|
|
|
3,714,496 |
|
Interest income
(expense), net |
|
|
23,483 |
|
|
|
32,330 |
|
Loss before income
tax |
|
|
(34,238,810 |
) |
|
|
(3,682,166 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
Net loss and
comprehensive loss |
|
$ |
(34,238,810 |
) |
|
$ |
(3,682,166 |
) |
Net loss attributable
to common stockholders |
|
$ |
(34,238,810 |
) |
|
$ |
(3,682,166 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(3.48 |
) |
|
$ |
(0.37 |
) |
Weighted-average common
shares outstanding basic and diluted |
|
|
9,838,590 |
|
|
|
9,838,590 |
|
|
|
|
|
|
|
|
|
|
i Russell DW, Halford RW, Ramirez DMO, Shah R, Kotti T.
Cholesterol 24-Hydroxylase: An Enzyme of Cholesterol Turnover in
the Brain. Annu Rev Biochem. 2009; 78: 1017–1040.ii Mehta A,
Prabhakar M, Kumar P, Deshmukh R, Sharma PL. Excitotoxicity: bridge
to various triggers in neurodegenerative disorders. Eur J Pharmacol
2013;698(1-3):6-18.iii Paul SM, Doherty JJ, Robichaud AJ,
Belfort GM, Chow BY, Hammond RS, et al. The major brain cholesterol
metabolite 24(S)-hydroxycholesterol is a potent allosteric
modulator of N-methyl-D-aspartate receptors. J Neurosci
2013;33(44):17290-300.iv https://www.clinicaltrials.gov/ct2/show/NCT02497235?term=TAK-935&rank=1v https://www.clinicaltrials.gov/ct2/show/NCT02497235?term=TAK-935&rank=1vi https://www.clinicaltrials.gov/ct2/show/NCT02906813?term=TAK-935&rank=2vii https://www.clinicaltrials.gov/ct2/show/NCT02201056?term=TAK-935&rank=3viii https://www.clinicaltrials.gov/ct2/show/NCT02539134?term=TAK-935&rank=4
Ovid Contacts:
Investors:
Burns McClellan
Steve Klass, 212-213-0006
Sklass@burnsmc.com
Media:
Pure Communications, Inc.
Katie Engleman, 910-509-3977
katie@purecommunicationsinc.com
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From Mar 2024 to May 2024
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From May 2023 to May 2024