Ocugen Provides Business Update and First Quarter 2021 Financial Results
May 07 2021 - 7:30AM
Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biopharmaceutical company
focused on discovering, developing, and commercializing gene
therapies to cure blindness diseases and developing a vaccine to
save lives from COVID-19, today reported first quarter 2021
financial results along with a general business update.
“We continue our dedication to help save lives from COVID-19 by
bringing COVAXIN to the U.S. market while simultaneously driving
our ophthalmology gene therapy pipeline toward the clinic. We
shared compelling second interim analysis results of Bharat
Biotech’s Phase 3 clinical trial in India as well as positive data
from in-vitro studies regarding COVAXIN’s ability to neutralize
emerging variants. We continue to make progress toward Emergency
Use Authorization for COVAXIN while also considering clinical
development in special populations, such as children, as well as
booster doses. We are delighted to have raised additional capital
to fund our ongoing and future operations and to allow us to
recruit key talent during this important stage of our growth,” said
Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and
Co-Founder of Ocugen.
Business Highlights
- COVAXIN Demonstrates Positive
Efficacy and Variant Neutralization Results — In April 2021, Ocugen
announced that its co-development partner, Bharat Biotech
International Limited (“Bharat Biotech”), shared positive results
from the second interim analysis of its Phase 3 clinical trial of
COVAXIN showing 78% overall efficacy against COVID-19 disease, 100%
efficacy against severe COVID-19 disease (including
hospitalization), and 70% efficacy against asymptomatic COVID-19
infection, indicating the potential to significantly reduce virus
transmission. COVAXIN has additionally demonstrated a remarkable
safety profile with several million doses administered to date in
India. Moreover, in-vitro studies conducted by the Indian Council
of Medical Research-National Institute of Virology have provided
data suggesting effectiveness in neutralizing the double mutant
India variant, the U.K. variant, and the Brazil variant. Based on
broad immunogenicity, Ocugen believes that COVAXIN has the
potential to be effective against other emerging variants. COVAXIN
is based on proven technology and Ocugen plans to consider clinical
development in special populations, such as children, as well as
booster doses.
- Continued Progress Toward U.S.
Emergency Use Authorization (“EUA”) — Ocugen is currently in
discussions with the U.S. Food and Drug Administration (“FDA”)
regarding the development of COVAXIN and has submitted key
information and data to date as a Master File for FDA review prior
to a planned EUA application once additional data is received from
Bharat Biotech from the ongoing Phase 3 clinical trial. Ocugen is
additionally in discussions with the Biomedical Advanced Research
and Development Authority, commonly known as BARDA, regarding the
U.S. government’s support of COVAXIN.
- Capital Raised — In April 2021,
Ocugen sold an aggregate of 10.0 million shares of its common
stock priced at a premium to market at $10.00 per share in a
registered direct offering. The registered direct offering
generated net proceeds of $93.4 million, after deducting
placement agent’s fees and other offering expenses payable by
Ocugen, further strengthening Ocugen’s balance sheet and further
extending its cash runway.
- Attracted and Hired Significant Key
Talent — Ocugen has increased its headcount to 26 full-time
employees as of as of the date of this press release, including the
addition of John Paul Gabriel as the Senior Vice President of
Manufacturing and Supply Chain. Mr. Gabriel is an established
biopharma and vaccines operations leader, who will be instrumental
in the technology transfer from Bharat Biotech for the
manufacturing of COVAXIN for the U.S. market. Ocugen will continue
to expand its headcount this year as necessary for the development
and commercialization of COVAXIN and the advancement of the
ophthalmology pipeline into the clinic.
- Continued Advancement of
Ophthalmology Pipeline — Ocugen’s ophthalmology pipeline continues
to advance toward the initiation of four Phase 1/2 clinical trials
by the end of 2022 including OCU400, Ocugen’s lead gene therapy
candidate, entering the clinic in the second half of this year.
Ocugen has continued to make progress in preclinical development
including sharing promising preclinical results for OCU200 at the
Wet Age-Related Macular Degeneration Conference in April 2021.
First Quarter 2021 Financial Results
- Ocugen’s cash, cash equivalents, and
restricted cash totaled $44.9 million as of March 31,
2021, compared to $24.2 million as of December 31, 2020.
Ocugen had 188.2 million shares of common stock outstanding as
of March 31, 2021.
- Research and development expenses
for the three months ended March 31, 2021 were $2.9 million
compared to $1.7 million for the three months ended March 31,
2020. General and administrative expenses for the three months
ended March 31, 2021 were $4.2 million compared to
$2.3 million for the three months ended March 31, 2020. Ocugen
reported a $0.04 net loss per share for the three months ended
March 31, 2021 compared to a $0.07 net loss per share for the three
months ended March 31, 2020.
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 highlights. 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
9757658. 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
biopharmaceutical company focused on discovering, developing, and
commercializing gene therapies to cure blindness diseases and
developing a vaccine to save lives from COVID-19. Our breakthrough
modifier gene therapy platform has the potential to treat multiple
retinal diseases with one drug — “one to many,” and our novel
biologic product candidate aims to offer better therapy to patients
with underserved diseases such as wet age-related macular
degeneration, diabetic macular edema, and diabetic retinopathy. We
are co-developing Bharat Biotech’s COVAXIN vaccine candidate for
COVID-19 in the U.S. market. For more information, please visit
www.ocugen.com.
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.
We 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 information about qualitative
assessments of available data, potential benefits, expectations for
clinical trials, and anticipated timing of clinical trial readouts
and regulatory submissions. This information involves risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as 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 clinical trial data are
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 FDA will be satisfied with the design of
and results from preclinical and clinical studies of COVAXIN, which
have been conducted by Bharat Biotech in India; whether and when
any Biologics License and/or EUA applications may be filed in the
United States for COVAXIN; whether and when any such applications
may be approved by the FDA; decisions by the FDA impacting
labeling, manufacturing processes, safety and/or other matters that
could affect the availability or commercial potential of COVAXIN in
the United States, including development of products or therapies
by other companies. These and other risks and uncertainties are
more fully described in our 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 we file with the SEC. Any forward-looking
statements that we make in this press release speak only as of the
date of this press release. Except as required by law, we assume 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.
Corporate Contact:Ocugen, Inc.Sanjay
SubramanianCFO and Head of Corp. Dev.IR@Ocugen.com
Media Contact:LaVoieHealthScienceLisa
DeScenzaldescenza@lavoiehealthscience.com+1 978-395-5970
OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
|
March 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
44,792 |
|
|
|
$ |
24,039 |
|
|
Advance for COVAXIN supply |
4,988 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
1,576 |
|
|
|
1,839 |
|
|
Total current assets |
51,356 |
|
|
|
25,878 |
|
|
Property and equipment, net |
762 |
|
|
|
633 |
|
|
Restricted cash |
151 |
|
|
|
151 |
|
|
Other assets |
1,578 |
|
|
|
714 |
|
|
Total
assets |
$ |
53,847 |
|
|
|
$ |
27,376 |
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,040 |
|
|
|
$ |
395 |
|
|
Accrued expenses and other current liabilities |
2,703 |
|
|
|
2,941 |
|
|
Short-term debt, net |
374 |
|
|
|
234 |
|
|
Operating lease obligation |
164 |
|
|
|
44 |
|
|
Total current liabilities |
4,281 |
|
|
|
3,614 |
|
|
Non-current liabilities |
|
|
|
Operating lease obligation, less current portion |
1,375 |
|
|
|
389 |
|
|
Long term debt, net |
1,702 |
|
|
|
1,823 |
|
|
Total liabilities |
7,358 |
|
|
|
5,826 |
|
|
Stockholders’ equity |
|
|
|
Convertible preferred stock |
1 |
|
|
|
— |
|
|
Common stock |
1,883 |
|
|
|
1,841 |
|
|
Treasury stock |
(48 |
) |
|
|
(48 |
) |
|
Additional paid-in capital |
125,032 |
|
|
|
93,059 |
|
|
Accumulated deficit |
(80,379 |
) |
|
|
(73,302 |
) |
|
Total stockholders’ equity |
46,489 |
|
|
|
21,550 |
|
|
Total liabilities and
stockholders’ equity |
$ |
53,847 |
|
|
|
$ |
27,376 |
|
|
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except share and per share
amounts)
(Unaudited)
|
Three months ended March 31, |
|
2021 |
|
2020 |
Operating expenses |
|
|
|
Research and development |
$ |
2,872 |
|
|
|
$ |
1,652 |
|
|
General and administrative |
4,185 |
|
|
|
2,277 |
|
|
Total operating expenses |
7,057 |
|
|
|
3,929 |
|
|
Loss from operations |
(7,057 |
) |
|
|
(3,929 |
) |
|
Other income (expense) |
|
|
|
Interest expense |
(20 |
) |
|
|
(15 |
) |
|
Total other income
(expense) |
(20 |
) |
|
|
(15 |
) |
|
Net loss |
$ |
(7,077 |
) |
|
|
$ |
(3,944 |
) |
|
Shares used in calculating net
loss per common share — basic and diluted |
186,298,122 |
|
|
|
52,627,228 |
|
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.04 |
) |
|
|
$ |
(0.07 |
) |
|
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