Ovid Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update
August 10 2020 - 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 second quarter ended June 30, 2020 and provided a
corporate update.
"Ovid is in an exciting and transformational period. We expect a
number of important late-stage data readouts across our pipeline
this quarter and over the remainder of the year,” said Jeremy
Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of
Ovid Therapeutics. “We have completed enrollment in our pivotal
Phase 3 NEPTUNE trial and expect topline results to be available in
the fourth quarter. We also expect data from our comprehensive
Phase 2 development program with soticlestat in four different rare
developmental and epileptic encephalopathies during the third
quarter. These upcoming data readouts, coupled with our recent
commercial partnership with Angelini Pharma for OV101 in Europe,
the receipt of Rare Pediatric Disease Designation from the FDA for
OV101 in Angelman syndrome, and the expansion of our early-stage
novel pipeline in genetics of rare neurological disease, have the
potential to deliver near-term products and longer-term innovation,
which will drive our strategy. These important building blocks set
the stage for Ovid to command a leading position in rare
neurology."
Pipeline Updates and Recent Highlights
OV101 (gaboxadol) for Angelman Syndrome
- Ovid has completed enrollment in the pivotal Phase 3 NEPTUNE
trial of OV101 in Angelman syndrome. Topline results from the trial
are expected in the fourth quarter of 2020. NEPTUNE, if positive,
will be part of a broad data set intended to support registrational
filings for OV101 in the U.S. and the rest of the world.
- Ovid entered into an exclusive license agreement with Angelini
Pharma to develop, manufacture and commercialize OV101 for the
treatment of Angelman syndrome in Europe. Terms of the agreement
include an upfront payment of $20 million from Angelini with Ovid
eligible to receive up to an additional $212.5 million in payments
upon the achievement of development, manufacturing and sales
milestones for the initial indication (Angelman syndrome), as well
as double-digit royalties, above the teens, on net sales if OV101
is successfully commercialized. Ovid retains all U.S. and
rest-of-world commercial rights to OV101.
- In June 2020, the U.S. Food and Drug Administration (FDA)
granted Rare Pediatric Disease Designation to OV101 for the
treatment of Angelman syndrome. If a new drug application (NDA) for
OV101 in Angelman syndrome is approved, Ovid may be eligible to
receive a priority review voucher from the FDA, which can be
redeemed to obtain priority review for any subsequent marketing
application or may be transferred and/or sold to other
companies.
OV101 for Fragile X Syndrome
- Ovid announced positive topline results from the Phase 2 ROCKET
trial with OV101 in Fragile X syndrome in May 2020, and the Company
plans to meet with regulatory authorities to discuss the future
development path and registration pathway.
OV935 (soticlestat) for Rare Developmental and Epileptic
Encephalopathies (DEE)
- Results from the Phase 2 ARCADE trial in CDKL5 deficiency
disorder (CDD) and Dup15q syndrome are expected in the third
quarter of 2020.
- Results from the randomized Phase 2 ELEKTRA trial in patients
with Dravet syndrome and Lennox-Gastaut syndrome (LGS) are expected
in the third quarter of 2020.
- To date, all patients who have completed the Phase 2 ARCADE and
ELEKTRA trials have rolled over into the ENDYMION open-label
extension study. Ovid plans to report updated data from ENDYMION in
the third quarter of 2020.
Summary of Anticipated Clinical Data Readouts
Product Candidate |
Trial |
Condition or Disease |
Phase of Clinical Trial |
Expected Timing of Data Release |
Soticlestat |
ARCADE |
CDD or Dup15q syndrome |
Phase 2 |
3Q 2020 |
Soticlestat |
ELEKTRA |
Dravet syndrome or LGS |
Phase 2 |
3Q 2020 |
Soticlestat |
ENDYMION |
CDD, Dup15q syndrome, Dravet syndrome, LGS, other DEEs |
Open-label Extension |
3Q 2020 |
OV101 |
NEPTUNE |
Angelman syndrome |
Phase 3 |
4Q 2020 |
Expansion of Early-Stage Pipeline Research
Activities
- Ovid and the University of Connecticut School of Medicine
(UConn) announced a license agreement to accelerate the development
of a next-generation short hairpin RNA (shRNA)-based therapeutic
for Angelman syndrome and potentially other indications. Ovid will
work closely with UConn’s Stormy J. Chamberlain, Ph.D., and gain
exclusive access to identified genetic sequences for a shRNA-based
therapeutic for potential future use alone or in combination with
OV101 in Angelman syndrome.
- Ovid entered into a research collaboration with Columbia
University Irving Medical Center researchers to focus on
development of potential medicines using genetic-based therapies
and create a therapeutic platform for a range of rare neurological
conditions such as KIF1A-associated neurological disorder
(KAND).
Pipeline Teach-In Webinar Series
- In June 2020, Ovid hosted a webinar to review the Company’s
soticlestat development program for rare developmental and
epileptic encephalopathies (DEE).
- Ovid is planning to hold a second educational webinar early in
the fourth quarter of 2020 to review the Company’s OV101
development program for Angelman syndrome and Fragile X
syndrome.
Second Quarter 2020 Financial Results
- As of June 30, 2020, cash and cash equivalents totaled $41.3
million. Additionally, the Company received an upfront net payment
from Angelini Pharma of $19.6 million in July 2020.
- Research and development expenses were $16.0 million for the
second quarter ended June 30, 2020, as compared to $9.1 million for
the same period in 2019. The increase of $6.9 million was primarily
due to an increase in clinical activities related to Ovid’s ongoing
development programs.
- General and administrative expenses were $7.1 million for the
second quarter ended June 30, 2020, as compared to $4.2 million for
the same period in 2019. The increase of $2.9 million was primarily
due to an increase in legal fees, compliance and
pre-commercialization expenses and professional fees, payroll and
payroll-related expenses and general office expenses.
- The Company reported a net loss of $22.6 million, or basic and
diluted net loss per share attributable to common stockholders of
$0.41, for the second quarter of 2020, as compared to a net loss of
$13.1 million, or net loss per share attributable to common
stockholders of $0.34, for the same period in 2019.
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 www.ovidrx.com.
Forward-Looking StatementsThis press release
includes certain disclosures that contain “forward-looking
statements,” including, without limitation, statements regarding:
development and commercialization of our programs, development of
combination therapies, potential benefits of OV101, OV935 and our
other research programs, anticipated reporting schedule of clinical
data and the potential benefits and value of certain licenses and
collaborations and the potential benefits of the Rare Pediatric
Disease Designation. You can identify forward-looking statements
because they contain words such as “will,” “appears,” “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 uncertainties in the
development and regulatory approval processes, and 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”. Such risks may be amplified by the COVID-19 pandemic and
its potential impact on Ovid’s business and the global economy.
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 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, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,032,945 |
|
|
$ |
9,117,495 |
|
|
$ |
30,658,313 |
|
|
$ |
18,454,804 |
|
General and administrative |
|
|
7,108,742 |
|
|
|
4,204,771 |
|
|
|
12,777,759 |
|
|
|
8,920,999 |
|
Total operating expenses |
|
|
23,141,687 |
|
|
|
13,322,266 |
|
|
|
43,436,072 |
|
|
|
27,375,803 |
|
Loss from operations |
|
|
(23,141,687 |
) |
|
|
(13,322,266 |
) |
|
|
(43,436,072 |
) |
|
|
(27,375,803 |
) |
Interest income |
|
|
590,491 |
|
|
|
264,999 |
|
|
|
854,786 |
|
|
|
518,341 |
|
Net loss |
|
$ |
(22,551,196 |
) |
|
$ |
(13,057,267 |
) |
|
$ |
(42,581,286 |
) |
|
$ |
(26,857,462 |
) |
Net loss attributable to
common stockholders |
|
$ |
(22,551,196 |
) |
|
$ |
(13,057,267 |
) |
|
$ |
(42,581,286 |
) |
|
$ |
(26,857,462 |
) |
Net loss per share attributable to common stockholders, basic
and diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.77 |
) |
|
$ |
(0.78 |
) |
Weighted-average common shares outstanding basic and
diluted |
|
|
55,607,110 |
|
|
|
38,693,018 |
|
|
|
55,161,360 |
|
|
|
34,534,432 |
|
Selected Condensed Balance Sheet
Data (Unaudited)
|
June
30, |
December 31, |
|
|
2020 |
|
2019 |
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
41,253,898 |
$ |
76,739,113 |
Working
capital1 |
$ |
29,524,782 |
$ |
69,279,584 |
Total
assets |
$ |
45,355,298 |
$ |
80,843,731 |
Total
stockholders' equity |
$ |
30,482,914 |
$ |
70,023,561 |
|
|
|
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
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