Ocugen Provides Business Update and Third Quarter 2021 Financial Results
November 09 2021 - 7:30AM
Ocugen, Inc. (Ocugen or the Company) (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
third quarter 2021 financial results along with a general business
update.
“We’ve been relentless in our efforts to launch our innovative
medicines onto regulatory pathways here in the United States. The
submission of COVAXIN for Emergency Use Authorization for
pediatrics is another example of Ocugen contributing to public
health efforts to curb the pandemic, giving parents another option
for protecting their children. Two Investigational New Drug
submissions within a span of two weeks is a phenomenal achievement
resulting from the work of international teams aligned around
serving people with serious diseases. Our capabilities in the areas
of R&D, clinical development, manufacturing, and commercial
continue to expand with our workforce nearly doubling since the
last quarter to deliver for the future. I’m really proud of the
teams for their commitment to meeting our mission,” said Dr.
Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder
of Ocugen.
Business Highlights
FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC
PIPELINE
- The Company filed an Emergency Use
Authorization (EUA) application with the U.S. Food and Drug
Administration (FDA) for the use of the COVID-19 vaccine candidate,
COVAXIN™ (BBV152), for children aged 2 – 18 years. The Company
believes its vaccine candidate has the potential to fulfill an
unmet need in the national arsenal of COVID-19 vaccines. The
inactivated virus platform has been used for decades in vaccines
for pediatric populations.
- The Company also
filed an Investigational New Drug (IND) application with the FDA to
initiate a Phase 3 clinical trial evaluating COVAXIN™ (BBV152) in
support of an upcoming Biologics License Application (BLA)
submission. The observer-blind, immuno-bridging study of the
whole-virion, inactivated SARS-CoV-2 vaccine candidate in healthy
adults, if allowed to proceed, will help demonstrate that the Phase
3 data from the studies conducted by Bharat Biotech International
Limited (Bharat Biotech) in India will be applicable to the U.S.
population. Under the IND, the Company will also initiate a
safety-bridging study, if required.
- The Company
filed an IND application with the FDA for OCU400 for the Phase 1/2
study to assess the safety of OCU400 (NR2E3) in patients with a
mutation in NR2E3 and RHO mutation-associated retinal degeneration.
If allowed to proceed, the Company is planning to initiate this
clinical trial in the United States around the end of 2021.
- In September 2021, the Company entered
into a Development and Commercial Supply Agreement with Bharat
Biotech, pursuant to which Bharat Biotech will supply the Company
with clinical trial materials and commercial supplies of COVAXIN™
finished drug product prior to the completion of the Company’s
technology transfer to Jubilant HollisterStier.
- In September 2021, the Company and
CanSino Biologics, Inc. (“CanSinoBIO”) expanded their current
collaboration on the development of OCU400 to now include OCU410.
With that, CanSinoBIO will be responsible for the chemistry,
manufacturing, and controls (CMC) development and manufacture of
clinical supplies of both products and be responsible for the costs
associated with such activities.
Third Quarter 2021 Financial Results
- Ocugen’s cash, cash equivalents, and
restricted cash totaled $107.5 million as of September 30,
2021, compared to $24.2 million as of December 31, 2020.
Ocugen had 198.9 million shares of common stock outstanding as of
September 30, 2021.
- Research and development expenses
for the three months ended September 30, 2021 were $6.3 million
compared to $1.5 million for the three months ended September 30,
2020. General and administrative expenses for the three months
ended September 30, 2021 were $4.5 million compared to $1.7 million
for the three months ended September 30, 2020. Ocugen reported a
$0.05 net loss per share for the three months ended September 30,
2021 compared to a $0.07 net loss per share for the three months
ended September 30, 2020, which includes the in-process research
and development expense of $7.0 million related to the reduction of
the carrying value of an asset that was previously recorded as held
for sale.
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
8198297. 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. and Canadian markets. 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, including with respect to our belief
that COVAXIN™ has the potential to fulfill an unmet need in the
national arsenal of COVID-19 vaccines, our plans to initiate the
Phase 1/2 study for OCU400, if authorized to proceed, near the end
of 2021, and our belief that the results from the Phase 3 study for
COVAXIN™, if allowed to proceed, will help demonstrate that the
Phase 3 data from the studies conducted by Bharat Biotech Bharat
Biotech in India will be applicable to the U.S. population. 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, including whether the FDA will authorize COVAXIN™ for
administration as a vaccine for pediatric uses against COVID-19
pursuant to the EUA we submitted with the FDA and the timing and
scope of any such authorization, 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 the results of in-vitro
studies will not be duplicated in human clinical trials; 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 data and results
from the preclinical and clinical studies of COVAXIN™, which have
been conducted by Bharat Biotech in India, will be accepted by the
FDA or otherwise sufficient to support our EUA or IND submissions,
as applicable; whether the FDA will accept our IND submissions
without any changes, or if we are required to submit additional
information to the FDA in support of our IND submissions, the
extent and significance of any such changes; the size, scope,
timing, and outcome of any additional trials or studies that we may
be required to conduct to support an EUA or BLA for COVAXIN™; any
additional CMC information that we may be required to submit to the
FDA; whether and when a BLA for COVAXIN™ will be submitted to or
approved by the FDA; whether developments with respect to the
COVID-19 pandemic will affect the regulatory pathway available for
vaccines in the United States, Canada, or other jurisdictions;
market demand for COVAXIN™ in the United States or Canada;
decisions by the FDA or Health Canada impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of COVAXIN™ in the
United States or Canada, 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.
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)
|
September 30, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
107,349 |
|
|
$ |
24,039 |
|
Advance for COVAXIN supply |
4,988 |
|
|
— |
|
Prepaid expenses and other current assets |
1,113 |
|
|
1,839 |
|
Total current assets |
113,450 |
|
|
25,878 |
|
Property and equipment, net |
1,052 |
|
|
633 |
|
Restricted cash |
151 |
|
|
151 |
|
Other assets |
1,659 |
|
|
714 |
|
Total
assets |
$ |
116,312 |
|
|
$ |
27,376 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,095 |
|
|
$ |
395 |
|
Accrued expenses and other current liabilities |
3,962 |
|
|
2,941 |
|
Short-term debt, net |
— |
|
|
234 |
|
Operating lease obligation |
172 |
|
|
44 |
|
Total current liabilities |
6,229 |
|
|
3,614 |
|
Non-current liabilities |
|
|
|
Operating lease obligation, less current portion |
1,280 |
|
|
389 |
|
Long term debt, net |
1,693 |
|
|
1,823 |
|
Total liabilities |
9,202 |
|
|
5,826 |
|
Stockholders’ equity |
|
|
|
Convertible preferred stock |
1 |
|
|
— |
|
Common stock |
1,990 |
|
|
1,841 |
|
Treasury stock |
(48 |
) |
|
(48 |
) |
Additional paid-in capital |
222,253 |
|
|
93,059 |
|
Accumulated deficit |
(117,086 |
) |
|
(73,302 |
) |
Total stockholders’ equity |
107,110 |
|
|
21,550 |
|
Total liabilities and
stockholders’ equity |
$ |
116,312 |
|
|
$ |
27,376 |
|
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except share and per share
amounts)
(Unaudited)
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
— |
|
|
|
$ |
— |
|
|
|
— |
|
|
|
43 |
|
|
Total revenues |
— |
|
|
|
— |
|
|
|
— |
|
|
|
43 |
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
6,281 |
|
|
|
1,478 |
|
|
|
28,006 |
|
|
|
4,760 |
|
|
In-process research and development |
— |
|
|
|
7,000 |
|
|
|
— |
|
|
|
7,000 |
|
|
General and administrative |
4,508 |
|
|
|
1,704 |
|
|
|
15,450 |
|
|
|
5,760 |
|
|
Total operating expenses |
10,789 |
|
|
|
10,182 |
|
|
|
43,456 |
|
|
|
17,520 |
|
|
Loss from operations |
(10,789 |
) |
|
|
(10,182 |
) |
|
|
(43,456 |
) |
|
|
(17,477 |
) |
|
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
5 |
|
|
|
— |
|
|
|
15 |
|
|
|
— |
|
|
Interest expense |
(19 |
) |
|
|
(292 |
) |
|
|
(59 |
) |
|
|
(555 |
) |
|
Other income (expense) |
(4 |
) |
|
|
— |
|
|
|
(336 |
) |
|
|
— |
|
|
Total other income
(expense) |
(18 |
) |
|
|
(292 |
) |
|
|
(380 |
) |
|
|
(555 |
) |
|
Loss before income taxes |
(10,807 |
) |
|
|
(10,474 |
) |
|
|
(43,836 |
) |
|
|
(18,032 |
) |
|
Income tax benefit |
(52 |
) |
|
|
— |
|
|
|
(52 |
) |
|
|
— |
|
|
Net loss and comprehensive loss |
$ |
(10,755 |
) |
|
|
$ |
(10,474 |
) |
|
|
$ |
(43,784 |
) |
|
|
$ |
(18,032 |
) |
|
Deemed dividend related to
Warrant Exchange |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(12,546 |
) |
|
Net loss to common
stockholders |
$ |
(10,755 |
) |
|
|
$ |
(10,474 |
) |
|
|
$ |
(43,784 |
) |
|
|
$ |
(30,578 |
) |
|
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
198,790,980 |
|
|
|
141,591,218 |
|
|
|
193,599,525 |
|
|
|
92,764,157 |
|
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.05 |
) |
|
|
$ |
(0.07 |
) |
|
|
$ |
(0.23 |
) |
|
|
$ |
(0.33 |
) |
|
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