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ocugen . Ocugen Provides Business Update and Second Quarter 2021 Financial Results August 6 , 2021 Conference Call and Webcast Today at 8:30 a.m. ET • Rolling regulatory submission to Health Canada completed and review process initiated ; U.S. FDA talks continue • Multiple milestones achieved across regulatory and supply chain to support potential commercialization of pipeline assets • The Company experienced organizational growth to reflect new business requirements in clinical development , manufacturing , and commercialization MALVERN , Pa . , Aug. 06 , 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 second quarter 2021 financial results along with a general business update . " The second quarter has proven how dynamic the life sciences sector is during this time of global crisis , and we are undeterred in our efforts to contribute to the public health agenda . Our regulatory submission to Health Canada and our ongoing discussions with the U.S. Food and Drug Administration continue to provide us direction in potentially obtaining regulatory approvals for COVAXINTM in North America . We are also continuing our forward momentum to take on blindness diseases and are on track to initiate our first gene therapy clinical trial for OCU400 in the latter part of 2021. Overall , I'm very pleased with our growth and efforts to date , " said Dr. Shankar Musunuri , Chairman , Chief Executive Officer , and Co - Founder of Ocugen . Business Highlights FORWARD MOMENTUM FOR COVAXIN TM AND OPHTHALMIC PIPELINE • The Company's partner , Bharat Biotech of India , completed and posted its Phase 3 clinical trial results for COVAXIN ™ demonstrating 77.8 % efficacy against overall COVID - 19 disease , 93.4 % efficacy against severe COVID - 19 disease , 63.6 % efficacy against asymptomatic COVID - 19 disease , and 65.2 % efficacy against the Delta variant , B.1.617.2 . Adverse events in the COVAXINTM and control arms of the Phase 3 clinical trial were observed in 12.4 % of subjects , with less than 0.5 % of subjects experiencing serious adverse side effects . This data was submitted to a peer - reviewed journal for future potential publication . • In June , an amendment to the agreement with Bharat Biotech was finalized which expanded the Company's rights to develop , manufacture , and commercialize COVAXINTM into Canada ( in addition to the United States ) . Soon after in July , the Company announced the completion of its regulatory submission to Health Canada for COVAXIN ™ M , which was accepted under the Minister of Health's Interim Order Respecting the Importation , Sale and Advertising of Drugs for Use in Relation to COVID - 19 and transitioned to a New Drug Submission for COVID - 19 . The submission was conducted through the Company's new affiliate , Vaccigen , Ltd. , and the review process has begun in Canada . • Discussions with the U.S. Food and Drug Administration are ongoing , and the Company is still proceeding with a strategy focused on the agency's requested Biologics License Application pathway and determining what data requirements and U.S. - based clinical trials will be required to support such submission . • Technology transfer activities are ongoing between Bharat Biotech and Jubilant HollisterStier , which the Company has selected to be its contract manufacturing partner with respect to COVAXIN ™ M . • The Company's development activities targeting retinal diseases based on its breakthrough modifier gene therapy platform continue to progress . Its first candidate therapy , OCU400 , is anticipated to move into two parallel Phase 1 / 2a clinical trials in the United States later this year . The Company is currently also evaluating options to commence OCU400 clinical trials in Europe in 2022 . COMPANY POSITIONING FOR FUTURE GROWTH • New management team member , Mike Shine , joined the Company in early June as Senior Vice President , Commercial , bringing nearly 35 years of industry experience . Mr. Shine will lead commercial efforts for the Company's portfolio including COVAXIN TM's launch in Canada and the United States , if authorized or approved . • Employee count has grown as the Company establishes enhanced capabilities in Research and Development , Clinical Development , Commercial , Supply Chain , and Communications . • The Company entered the Russell 2000 and 3000 Indices in June , which reflects the organization's performance , growth ,