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Dec 31, 2020
Ocugen Q4 2020 Earnings Report
Reported full year 2020 financial results and provided a business update.
Key Takeaways
Ocugen reported full year 2020 financial results, highlighting progress towards offering a COVID-19 vaccine and curing blindness diseases, with ongoing efforts to develop an Emergency Use Authorization pathway for COVAXIN™ and plans to initiate clinical trials for OCU400.
COVAXIN™ demonstrated 81% efficacy in Phase 3 interim results.
Working with U.S. regulatory authorities to develop a plan around Emergency Use Authorization in the United States for COVAXIN™
First Gene Therapy Candidate OCU400 On Track to Enter the Clinic in 2H21
European Commission granted Orphan Medicinal Product Designation for OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis.
Ocugen
Ocugen
Forward Guidance
Ocugen is focused on advancing its COVID-19 vaccine candidate, COVAXIN™, and its ophthalmology pipeline, with key milestones including pursuing Emergency Use Authorization in the U.S. for COVAXIN™ and initiating clinical trials for OCU400.
Positive Outlook
- COVAXIN™ demonstrates efficacy of 81% in Phase 3 interim results
- Steady Progress to Develop EUA Pathway in the United States for COVAXIN™ Supported by U.S. Leading Experts in Vaccines
- First Gene Therapy Candidate OCU400 On Track to Enter the Clinic in 2H21
- European Commission (“EC”) Grants Orphan Medicinal Product Designation for OCU400 for Retinitis Pigmentosa (“RP”) and Leber Congenital Amaurosis (“LCA”)
- Ocugen generated net proceeds of $4.8 million under an at-the-market offering and net proceeds of $21.2 million under a registered direct offering.
Challenges Ahead
- The uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints
- The risk that clinical trial data are subject to differing interpretations and assessments
- Whether and when any biologics license and/or EUA applications may be filed in the United States for COVAXIN™
- Decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States, including development of products or therapies by other companies.
- Preliminary estimate of Ocugen’s cash, cash equivalents, and restricted cash as of February 28, 2021.