Wednesday, March 01, 2023
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results Were Within Expectations. Ocugen reported 4Q22 and FY2022 Net Loss of $21.9 million or $(0.10) per share, and $81.4 million or $(0.38) per share for FY2022. Cash on hand as of December 31 was $90.9 million or $0.41 per share, which management projects will fund operations through 1Q24. On its quarterly conference call, management discussed recent milestones and development programs in gene therapy, cellular therapy, and vaccines.
Ophthalmology Programs Are Advancing. Ocugen filed an IND for OCU200 to begin Phase 1 clinical trial in diabetic macular edema (DME), meeting the expected timeframe. Trial enrollment is expected to begin in 2Q23. A second IND filing is expected during 2Q23 for OCU410 in dry AMD and OCU410ST in Stargardt disease. The Phase 1/2 dose testing OCU400 in retinitis pigmentosa (RP) escalation phase previously completed enrollment for the RP cohort, with enrollment continuing in the Leber congenital amaurosis (LCA) patient cohort. Phase 3 is expected to start by year-end 2023.
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