Friday, November 10, 2023
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Pipeline Is Set For 2024. Ocugen reported 3Q23 loss of $14.2 million or $(0.06) per share, compared with our estimated loss of $18.2 million or $(0.07) per share. Cash balance at the end of the quarter was $53.5 million. During 3Q23, data was presented for OCU400, INDs were approved for OCU410 and OCU410ST, and OCU500 was selected by the NIAID-NIH (National Allergy and Infectious Disease Institute of the National Institutes of Health) to begin clinical testing. NeoCart is also expected to begin a Phase 3 trial in 2H24. We see these pipeline events as important milestones for the company.
OCU400 is on schedule to finalize the Phase 3 trial design. The Phase 1/2 trial has completed dosing of the RP patients and three LCA patients. The treatment protocols for the Phase 3 trial are expected to be finalized by year-end. Following FDA acceptance, the Phase 3 trial is expected to begin in early 2024 as expected. The final LCA patient data could allow FDA approval to include LCA patients in 2H24.
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