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ocugen . TM Ocugen Provides Business Update and Third Quarter 2021 Financial Results November 9 , 2021 Conference Call and Webcast Today at 8:30 a.m. ET • Emergency Use Authorization application filed with the U.S. FDA for the COVID - 19 vaccine candidate , COVAXIN ™ ( BBV152 ) , for children aged 2 - 18 years • Investigational New Drug application filed with the U.S. FDA for COVAXIN TM ( BBV152 ) • Investigational New Drug application filed with the U.S. FDA for breakthrough modifier gene therapy candidate , OCU400 • Collaboration with CanSinoBIO expanded to include OCU410 for chemistry , manufacturing , and controls development and manufacturing MALVERN , Pa . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- 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 ™ M 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 , COVAXINTM ( 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 COVAXINTM ( 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 ™ M 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