Ocugen Provides Business Update and First Quarter 2022 Financial Results
May 06 2022 - 6:33AM
Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene therapies, biologicals, and vaccines,
today reported first quarter 2022 financial results along with a
general business update.
“We’ve made significant progress this quarter
across multiple areas and we remain confident in the long-term
opportunities and growth that we believe our pipeline will unlock,”
said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and
Co-Founder of Ocugen. “I am very proud of our dedicated team for
moving our breakthrough gene therapy into the clinic and for their
commitment to advancing COVAXIN™ to fight against COVID-19.”
Business Updates
- OCU400 Clinical Trial — The Company
achieved a key milestone in its Phase 1/2 clinical trial for OCU400
of “first patient, first dose” in late March 2022. The Data and
Safety Monitoring Board for the clinical trial reviewed safety data
based on dosing to date and recommended that the study proceed with
enrolling the remaining study subjects in the current cohort at the
target dose level. A second patient was dosed in May 2022.
- COVAXIN™ Rights Expanded to include
Mexico — In April 2022, the Company expanded its rights to develop,
manufacture, and commercialize COVAXIN™ to include Mexico, where
the vaccine is already authorized for emergency use in adults and
is currently under review by local regulators for emergency
pediatric use. The company is now working on commercializing the
vaccine in Mexico. The Company’s exclusive territory for COVAXIN™
now encompasses the entire North American region.
- COVAXIN™ in the United States — The
Company is actively engaged in discussions with the U.S. Food and
Drug Administration (the “FDA”) to address its questions and resume
the Company’s Phase 2/3 immuno-bridging and broadening clinical
trial for COVAXIN™, OCU-002. In addition, the Company intends to
continue working with the FDA to finalize the additional studies
required for a Biologics License Application (“BLA”).
- COVAXIN™ in Canada — Discussions
with Health Canada regarding COVAXIN™ are ongoing. The Company is
in discussions with Canadian officials regarding financial support
for the potential acquisition of a manufacturing facility in
Belleville, Ontario, Canada that would be transformed to become a
manufacturing and research and development hub to support both the
Company’s current and future product candidate pipeline.
- Organizational Growth — Nearly 20
employees joined Ocugen in the first quarter to fill key roles that
support operational needs, including clinical trials and regulatory
milestones. The number of employees now totals 79.
- Addition to the Board of Directors —
In March 2022, Marna C. Whittington, Ph.D., former Chief Executive
Officer of Allianz Global Investors Capital, joined the Company’s
Board of Directors. Dr. Whittington is a renowned financial sector
leader and her experience and expertise will be exceedingly
important to the Company’s growth strategy.
First Quarter 2022 Financial Results
- The Company’s
cash, cash equivalents, and restricted cash totaled $129.9 million
as of March 31, 2022, compared to $95.1 million as of
December 31, 2021. The Company had 215.6 million shares of
common stock outstanding as of March 31, 2022.
- Research and
development expenses for the three months ended March 31, 2022 were
$7.9 million compared to $2.9 million for the three months ended
March 31, 2021. General and administrative expenses for the three
months ended March 31, 2022 were $10.1 million compared to $4.2
million for the three months ended March 31, 2021. Ocugen reported
a $0.09 net loss per share for the three months ended March 31,
2022 compared to a $0.04 net loss per share for the three months
ended March 31, 2021.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and
webcast for 8:30 a.m. eastern time today to discuss the financial
results and recent business updates. Ocugen’s senior management
team will host the call, which will be open to all listeners. There
will also be a question-and-answer session following the prepared
remarks.
The call can be accessed by dialing (844)
873-7330 (U.S.) or (602) 563-8473 (international) and providing the
conference ID 6995784. To access a live audio webcast of the call
on the “Investors” section of the Ocugen website, please click
here. A replay of the webcast will be archived on Ocugen’s website
for approximately 45 days following the call.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene therapies, biologicals and vaccines that
improve health and offer hope for people and global communities. We
are making an impact through courageous innovation, taking science
in new directions in service of patients. Our breakthrough modifier
gene therapy platform has the potential to treat multiple diseases
with one drug and we are advancing research in other therapeutic
areas to offer new options for people with unmet medical needs.
Discover more at www.ocugen.com and follow us on Twitter and
LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995, which are subject to risks and uncertainties.
Ocugen may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should” or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Such forward-looking statements include, but are not
limited to, statements about Ocugen’s progress in advancing the
review of COVAXIN™ and its other product candidates with the FDA,
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by
such statements, including, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, ability to timely enroll clinical
trial participants, commencement and/or completion dates for
clinical trials, regulatory submission dates, regulatory approval
dates and/or launch dates; the risk that Health Canada does not
accept its New Drug Submission (“NDS”) for COVAXIN™ or that Ocugen
may not be able to adequately resolve the deficiencies noted by
Health Canada with respect to its NDS, for which Ocugen has
provided responses that are currently under review by Health
Canada; the risk that Ocugen may not be able to successfully
commercialize COVAXIN™ in Mexico for adults over the age of 18
pursuant to Ocugen’s agreement with Bharat Biotech and the risk
that Ocugen does not obtain emergency pediatric use for COVAXIN™ in
Mexico for children between two and 18 years of age on a timely
basis, if at all; the risk that the FDA does not lift the clinical
hold on Ocugen’s Phase 2/3 immuno-bridging and broadening clinical
trial for COVAXIN™ on a timely basis, if at all; risks associated
with preliminary and interim data, including the possibility of
unfavorable new clinical trial data and further analyses of
existing clinical trial data; the risk that the results of in-vitro
studies will not be duplicated in human clinical trials; the risk
that clinical trial data is subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether and when data from Bharat Biotech's clinical
trials will be published in scientific journal publications and, if
so, when and with what modifications; whether the data and results
from the preclinical and clinical studies of COVAXIN™, which have
been conducted by Bharat Biotech in India, will be accepted by
regulatory authorities or otherwise sufficient to support Ocugen’s
submissions for regulatory approvals or authorizations in the
United States, Canada or Mexico; the size, scope, timing and
outcome of any additional clinical trials or studies that Ocugen
may be required to conduct to support regulatory approvals or
authorizations; any additional chemistry, manufacturing, and
controls information that Ocugen may be required to submit to
regulatory authorities ; whether and when a BLA for COVAXIN™ will
be submitted to or approved by the FDA; the risk that Ocugen may
not be able to successfully negotiate and execute definitive
transaction agreements for the acquisition of the manufacturing
site on acceptable terms, if at all, and the ultimate terms and
timing for closing of the transactions contemplated thereby; the
risk that Ocugen will not be able to successfully close the
acquisition of the manufacturing site; risks associated with the
planned development and refurbishing of the manufacturing site,
including that the expected costs for such development may be
greater than currently contemplated or that the planned development
may take longer than expected or fail to be completed on a timely
basis, if at all; and the risk that Ocugen will not be able to
scale production for such manufacturing site to adequately support
manufacturing of its product candidates or the other products that
may in the future be manufactured at such manufacturing site;
whether developments with respect to the COVID-19 pandemic will
affect the regulatory pathway available for vaccines in the United
States, Canada, Mexico or other jurisdictions; market demand for
COVAXIN™ in the United States, Canada or Mexico; decisions by the
regulatory authorities impacting labeling, manufacturing processes,
safety and/or other matters that could affect the availability or
commercial potential of COVAXIN™ in the United States, Canada or
Mexico, including development of products or therapies by other
companies. These and other risks and uncertainties are more fully
described in Ocugen’s periodic filings with the Securities and
Exchange Commission (“SEC”), including the risk factors described
in the section entitled “Risk Factors” in the quarterly and annual
reports that Ocugen files with the SEC. Any forward-looking
statements that Ocugen makes in this press release speak only as of
the date of this press release. Except as required by law, Ocugen
assumes no obligation to update forward-looking statements
contained in this press release whether as a result of new
information, future events, or otherwise, after the date of this
press release.
Ocugen Contact:
Ken InchaustiHead, Investor Relations &
Communications+1 484 237 3398ken.inchausti@ocugen.com
Please submit investor-related inquiries to:
IR@ocugen.com
(tables to follow)
OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
|
March 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
129,771 |
|
|
$ |
94,958 |
|
Prepaid expenses and other current assets |
|
8,256 |
|
|
|
7,688 |
|
Total current assets |
|
138,027 |
|
|
|
102,646 |
|
Property and equipment, net |
|
1,921 |
|
|
|
1,164 |
|
Restricted cash |
|
151 |
|
|
|
151 |
|
Other assets |
|
1,628 |
|
|
|
1,800 |
|
Total assets |
$ |
141,727 |
|
|
$ |
105,761 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
3,896 |
|
|
$ |
2,312 |
|
Accrued expenses |
|
3,537 |
|
|
|
4,325 |
|
Operating lease obligations |
|
254 |
|
|
|
363 |
|
Total current liabilities |
|
7,687 |
|
|
|
7,000 |
|
Non-current liabilities |
|
|
|
Operating lease obligations, less current portion |
|
1,180 |
|
|
|
1,231 |
|
Long term debt, net |
|
1,731 |
|
|
|
1,712 |
|
Total
liabilities |
|
10,598 |
|
|
|
9,943 |
|
Stockholders' equity |
|
|
|
Convertible preferred stock |
|
1 |
|
|
|
1 |
|
Common stock |
|
2,158 |
|
|
|
1,995 |
|
Treasury stock |
|
(48 |
) |
|
|
(48 |
) |
Additional paid-in capital |
|
278,704 |
|
|
|
225,537 |
|
Accumulated deficit |
|
(149,686 |
) |
|
|
(131,667 |
) |
Total
stockholders' equity |
|
131,129 |
|
|
|
95,818 |
|
Total liabilities and stockholders' equity |
$ |
141,727 |
|
|
$ |
105,761 |
|
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except share and per share
amounts)
(Unaudited)
|
Three months ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
Research and development |
$ |
7,915 |
|
|
$ |
2,872 |
|
General and administrative |
|
10,119 |
|
|
|
4,185 |
|
Total operating expenses |
|
18,034 |
|
|
|
7,057 |
|
Loss from operations |
|
(18,034 |
) |
|
|
(7,057 |
) |
Other income (expense),
net |
|
15 |
|
|
|
(20 |
) |
Net loss and comprehensive
loss |
$ |
(18,019 |
) |
|
$ |
(7,077 |
) |
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
|
205,693,498 |
|
|
|
186,298,122 |
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.04 |
) |
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