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ocugen . Ocugen Provides Business Update and First Quarter 2021 Financial Results May 7 , 2021 Conference Call and Webcast Today at 8:30 a.m. ET • COVAXIN demonstrates 100 % efficacy against severe COVID - 19 disease ( including hospitalization ) • Master File submitted for U.S. Food nd Drug Administration review prior to a planned Emergency Use Authorization application for COVAXIN • $ 100.0 million in gross proceeds raised through a registered direct offering of common stock • Key talent acquired representing an instrumental step to position Ocugen for future growth MALVERN , Pa . , May 07 , 2021 ( GLOBE NEWSWIRE ) -- 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 .