MALVERN, PA — Ocugen, Inc. (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, has 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.
- 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.
First Quarter 2021 Financial Results
- Ocugen’s cash, cash equivalents, and restricted cash totaled $44.9 million as of March 31, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 188.2 million shares of common stock outstanding as of March 31, 2021.
- Research and development expenses for the three months ended March 31, 2021 were $2.9 million compared to $1.7 million for the three months ended March 31, 2020. General and administrative expenses for the three months ended March 31, 2021 were $4.2 million compared to $2.3 million for the three months ended March 31, 2020. Ocugen reported a $0.04 net loss per share for the three months ended March 31, 2021 compared to a $0.07 net loss per share for the three months ended March 31, 2020.
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