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Mar 31, 2022
Ocugen Q1 2022 Earnings Report
Ocugen reported financial results and provided a business update for the first quarter of 2022.
Key Takeaways
Ocugen reported a net loss of $0.09 per share for the first quarter of 2022. The company's cash, cash equivalents, and restricted cash totaled $129.9 million as of March 31, 2022. They also achieved a key milestone in its Phase 1/2 clinical trial for OCU400 of “first patient, first dose” in late March 2022 and expanded its rights to develop, manufacture, and commercialize COVAXIN™ to include Mexico.
OCU400 Phase 1/2 clinical trial is advancing after DSMB Review.
Ocugen's exclusive territory for COVAXIN™ marketing expanded to include all of North America.
The Company achieved a key milestone in its Phase 1/2 clinical trial for OCU400 of “first patient, first dose” in late March 2022.
In April 2022, the Company expanded its rights to develop, manufacture, and commercialize COVAXIN™ to include Mexico.
Ocugen
Ocugen
Forward Guidance
Ocugen 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”).
Positive Outlook
- Advancing OCU400 Phase 1/2 clinical trial
- Expanding COVAXIN™ marketing rights to include all of North America
- Engaging in discussions with the FDA to resume the Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN™
- Continuing to work with the FDA to finalize additional studies required for a BLA
- Ongoing discussions with Health Canada regarding COVAXIN™
Challenges Ahead
- Uncertainties inherent in research and development
- Risk that Health Canada does not accept its New Drug Submission (“NDS”) for COVAXIN™
- Risk that Ocugen may not be able to successfully commercialize COVAXIN™ in Mexico
- Risk that the FDA does not lift the clinical hold on Ocugen’s Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN™ on a timely basis
- Whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada, Mexico or other jurisdictions