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$OCGN Ocugen Provides Business Update With Fourth Quarter and Full Year 2021 Financial Results
7:31 AM ET 2/25/22 | GlobeNewswire

Ocugen Provides Business Update With Fourth Quarter and Full Year 2021 Financial Results

Conference Call and Webcast Today at 8:30 a.m. ET
-- U.S. FDA lifts clinical hold on IND application for COVAXIN(TM) (BBV152),
clearing the pathway for Phase 2/3 clinical trial in support of a BLA
submission

-- Engagement with U.S. FDA to advance pediatric EUA for COVAXIN(TM)
included submission of a real-world safety database of more than 36
million vaccinated teens along with neutralization data against Omicron

-- Comprehensive responses regarding COVAXIN(TM) submitted to Health Canada
for the NOD

-- OCU400 Phase 1/2 clinical trial initiated for the treatment of inherited
retinal diseases caused by NR2E3 and RHO disease genotypes

MALVERN, Pa., Feb. 25, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen) (NASDAQ: OCGN), a clinical-stage 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 fourth quarter and full year 2021 financial results along with a general business update.

"The fourth quarter capped a transformational year of growth for Ocugen as we saw major progress across our portfolio. The clinical hold for the COVAXIN(TM) development program was lifted, and we bolstered our pediatric Emergency Use Authorization submission to the U.S. Food and Drug Administration with a safety database of more than 36 million teens vaccinated with COVAXIN(TM). Our lead modifier gene therapy platform candidate, OCU400, received approval to initiate a Phase 1/2 clinical trial on target. I'm very pleased with the perseverance and commitment of the Ocugen team and the achievements they've made thus far. 2022 is poised to be another great year for the company. We're excited about commencing these clinical trials and will give periodic updates in the future," said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Updates
-- COVAXIN(TM) in Phase 2/3 clinical trial for future Biologics License
Application (BLA) submission -- The FDA lifted its clinical hold on the
COVAXIN(TM) IND application on February 18, 2022, and the Company expects
to commence this immuno-bridging and broadening clinical trial as soon as
possible.

-- COVAXIN(TM) pediatric (2-18) Emergency Use Authorization (EUA) status --
At the request of the FDA, Ocugen has shared real-world safety data from
36 million teenagers who had been vaccinated with COVAXIN(TM).
Additionally, data (in-vitro) suggesting robust neutralization against
Delta and Omicron variants were submitted to bolster the Company's
pediatric EUA submission, which is currently under review by the FDA.

-- COVAXIN(TM) review with Health Canada -- Ocugen has submitted
comprehensive responses to a Notice of Deficiency received in December
2021 from Health Canada regarding Ocugen's New Drug Submission (NDS) for
COVAXIN(TM). Ocugen's responses are currently under review by Health
Canada.

-- Gene therapy clinical development progress -- A Phase 1/2 clinical trial
for OCU400 was initiated in January 2022, marking an advancement of
Ocugen's modifier gene therapy program with updates for this multicenter,
open-label, dose ranging study to be provided in the near future.

-- Manufacturing site letter of intent (LOI) with Liminal BioSciences Inc.
(Liminal) -- In January 2022, Ocugen entered into a non-binding LOI with
Liminal, a Canadian public company, for the acquisition of Liminal's
manufacturing site in Belleville, Ontario. This manufacturing site, if
acquired, would enable Ocugen to develop its internal manufacturing
capabilities and expend its research and development capabilities to
support its product candidate pipeline.

-- Public offering of common stock -- In February 2022, Ocugen announced an
underwritten public offering of 16.0 million shares of its common stock
for net proceeds of $50.0 million before estimated offering expenses.
This public offering of common stock strengthens Ocugen's balance sheet
and will be used to support Ocugen's product candidate development as
well as general corporate expenses.

2021 Financial Results
-- Ocugen's cash, cash equivalents, and restricted cash totaled $95.1
million as of December 31, 2021, compared to $24.2 million as of
December 31, 2020. Ocugen had 199.4 million shares of common stock
outstanding as of December 31, 2021.

-- Fourth quarter -- Research and development expenses for the three months
ended December 31, 2021 were $7.1 million compared to $1.6 million for
the three months ended December 31, 2020. General and administrative
expenses for the three months ended December 31, 2021 were $7.5 million
compared to $2.2 million for the three months ended December 31, 2020.
Ocugen reported a $0.07 net loss per share for the three months ended
December 31, 2021 compared to a $0.02 net loss per share for the three
months ended December 31, 2020.

-- Full year -- Research and development expenses for the year ended
December 31, 2021 were $35.1 million compared to $6.4 million for the
year ended December 31, 2020. Research and development expenses for the
year ended December 31, 2021 included a $15.0 million up-front payment to
Bharat Biotech for the right and license to COVAXIN(TM) development,
manufacturing, and commercialization in Canada. General and
administrative expenses for the year ended December 31, 2021 were $22.9
million compared to $8.0 million for the year ended December 31, 2020.
Ocugen reported a $0.30 net loss per share for the year ended December
31, 2021 compared to a $0.31 net loss per share for the year ended
December 31, 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 [phone] (U.S.) or [phone] (international) and providing the conference ID 4071887. 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 clinical-stage 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 International Limited's (Bharat Biotech) COVAXIN(TM) vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.