MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) on Friday reported first quarter 2022 financial results along with a general business update.
“We’ve made significant progress this quarter across multiple areas and we remain confident in the long-term opportunities and growth that we believe our pipeline will unlock,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “I am very proud of our dedicated team for moving our breakthrough gene therapy into the clinic and for their commitment to advancing COVAXIN™ to fight against COVID-19.”
- OCU400 Clinical Trial — The Company achieved a key milestone in its Phase 1/2 clinical trial for OCU400 of “first patient, first dose” in late March 2022. The Data and Safety Monitoring Board for the clinical trial reviewed safety data based on dosing to date and recommended that the study proceed with enrolling the remaining study subjects in the current cohort at the target dose level. A second patient was dosed in May 2022.
- COVAXIN™ Rights Expanded to include Mexico — In April 2022, the Company expanded its rights to develop, manufacture, and commercialize COVAXIN™ to include Mexico, where the vaccine is already authorized for emergency use in adults and is currently under review by local regulators for emergency pediatric use. The company is now working on commercializing the vaccine in Mexico. The Company’s exclusive territory for COVAXIN™ now encompasses the entire North American region.
- COVAXIN™ in the United States — The Company is actively engaged in discussions with the U.S. Food and Drug Administration (the “FDA”) to address its questions and resume the Company’s Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN™, OCU-002. In addition, the Company intends to continue working with the FDA to finalize the additional studies required for a Biologics License Application (“BLA”).
- COVAXIN™ in Canada — Discussions with Health Canada regarding COVAXIN™ are ongoing. The Company is in discussions with Canadian officials regarding financial support for the potential acquisition of a manufacturing facility in Belleville, Ontario, Canada that would be transformed to become a manufacturing and research and development hub to support both the Company’s current and future product candidate pipeline.
- Organizational Growth — Nearly 20 employees joined Ocugen in the first quarter to fill key roles that support operational needs, including clinical trials and regulatory milestones. The number of employees now totals 79.
- Addition to the Board of Directors — In March 2022, Marna C. Whittington, Ph.D., former Chief Executive Officer of Allianz Global Investors Capital, joined the Company’s Board of Directors. Dr. Whittington is a renowned financial sector leader and her experience and expertise will be exceedingly important to the Company’s growth strategy.
First Quarter 2022 Financial Results
- The Company’s cash, cash equivalents, and restricted cash totaled $129.9 million as of March 31, 2022, compared to $95.1 million as of December 31, 2021. The Company had 215.6 million shares of common stock outstanding as of March 31, 2022.
- Research and development expenses for the three months ended March 31, 2022 were $7.9 million compared to $2.9 million for the three months ended March 31, 2021. General and administrative expenses for the three months ended March 31, 2022 were $10.1 million compared to $4.2 million for the three months ended March 31, 2021. Ocugen reported a $0.09 net loss per share for the three months ended March 31, 2022 compared to a $0.04 net loss per share for the three months ended March 31, 2021.
Ocugen, Inc. is a biotechnology company based in Malvern, Pennsylvania. Discover more at www.ocugen.com.
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