Monday, November 11, 2024
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.
Clinical Trials Continued, Capital Was Raised, and New Data Expected. Ocugen reported a loss for 3Q24 of $13.0 million or $(0.05) per share. The company reported continued enrollment in all of its ongoing clinical trials and has scheduled a Clinical Showcase meeting in New York on Tuesday, November 12, 2024. We expect the meeting presentations to include data updates from the clinical trials. In August, Ocugen completed a stock offering that raised $35 million to end 3Q24 with $38.7 million in cash. After the quarter ended, the company added $30 million in debt funding.
OCU400 in Retinitis Pigmentosa (RP) Is On Schedule. The company confirmed that the Phase 3 liMeliGhT (pronounced “Limelight”) trial continues to enroll patients and is on schedule to complete enrollment in 1H25. An approval by Health Canada will allow patient enrollment at up to 5 Canadian sites. The FDA has approved an expanded access program (EAP) to allow patients to be treated outside of the clinical trials before OCU400 receives market approval.
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