Bullish indicating open at $55-$60, IPO prices at $37
MALVERN, Pa. - Ocugen, Inc. (NASDAQ:OCGN), a clinical-stage biopharmaceutical company with a market capitalization of $292 million, announced Friday it has dosed the first patient in its Phase 2/3 GARDian3 clinical trial for OCU410ST, a modifier gene therapy candidate for Stargardt disease. The company maintains a healthy liquidity position with a current ratio of 2.6, though InvestingPro data shows it’s currently burning through cash with an EBITDA of -$54.34 million in the last twelve months.
The trial will evaluate OCU410ST, which uses an AAV delivery platform for the retinal delivery of the RORA gene, in 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection in the eye with poorer visual acuity, while 17 will serve as untreated controls.
The primary objective is to evaluate reduction in atrophic lesion size, with secondary endpoints including improvements in best corrected visual acuity and low luminance visual acuity compared to controls.
According to the company’s press release, the Phase 2/3 trial builds on Phase 1 results that showed 48% slower lesion growth at 12-month follow-up in treated eyes compared to untreated eyes, and a statistically significant improvement in visual acuity.
"Treating the first patient with this novel gene therapy in the GARDian3 trial is a proud and hopeful moment for our team and for families affected by Stargardt disease," said Victor H. Gonzalez, MD, Principal Investigator and retinal surgeon at Valley Retina Institute.
Stargardt disease, the most common form of inherited macular degeneration, affects approximately 100,000 people in the U.S. and Europe, and 1 million worldwide, according to the company. The condition typically develops during childhood or adolescence and causes progressive vision loss due to degeneration of photoreceptor cells in the macula.
Ocugen plans to submit a Biologics License Application for OCU410ST in 2027, marking its second late-stage clinical program.
In other recent news, Ocugen, Inc. has received a 180-day extension from the Nasdaq Stock Market to meet the minimum closing bid price requirement of $1.00 per share for continued listing. This extension allows the company until December 29, 2025, to comply with Nasdaq Listing Rule 5550(a)(2). In a significant development, Ocugen announced a merger agreement between its subsidiary OrthoCellix and Carisma Therapeutics Inc., aiming to create a Nasdaq-listed company focused on regenerative cell therapy for orthopedic diseases. The merger will leverage OrthoCellix’s NeoCart technology, which is set to enter a Phase 3 clinical trial.
Additionally, Ocugen has received clearance from the U.S. FDA to commence a Phase 2/3 trial for its Stargardt disease therapy, OCU410ST, which has shown promising early results. The company also announced a licensing agreement with a leading Korean pharmaceutical firm for its gene therapy OCU400, targeting retinitis pigmentosa. This agreement includes upfront fees and development milestones totaling $11 million, with Ocugen retaining manufacturing responsibilities. These recent developments reflect Ocugen’s strategic efforts to expand its gene therapy treatments and enhance shareholder value through regional partnerships and clinical advancements.
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