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Ocugen Posts Wider FY25 Loss, Advances Gene Therapy And Vaccine Pipeline

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Ocugen, Inc. (OCGN) has reported fourth-quarter and full-year 2025 financial results and provided a broad business update, outlining continued progress across its modifier gene therapy platform, ophthalmology biologics programs, and inhaled vaccine candidates.

The company said 2025 was a transformative year marked by clinical progress, licensing activity and financing intended to support upcoming regulatory milestones.
For the fourth quarter Ocugen reported a net loss of $0.06 per share, compared with a net loss of $0.05 per share from the fourth quarter of 2024.

For the full year, the company reported a net loss of $0.23 per share for 2025, widening from a net loss of $0.20 per share in 2024.

Cash and restricted cash totaled $18.9 million at year-end 2025.

Ocugen said proceeds from its January 2026 financing are expected to fund operations into the fourth quarter of 2026, with potential extension into the second quarter of 2027 if warrants are exercised.

The company's pipeline includes OCU400, OCU410ST, OCU410, OCU200, OCU500 and NeoCart, spanning gene therapies, biologics and regenerative medicine programs.

OCU400, the company's lead modifier gene therapy candidate for retinitis pigmentosa, has completed enrolment in the Phase 3 liMeliGhT clinical trial. As a one-year study topline Phase 3 data are expected in the first quarter of 2027, advancing OCU400 towards potential approval in 2027. Long-term Phase 1/2 data have shown durable safety and tolerability with sustained clinically meaningful improvements.

OCU410ST, in development for Stargardt disease, is progressing ahead of schedule in the Phase 2/3 GARDian3 confirmatory trial, with enrolment expected to complete in the first quarter of 2026. Interim data are expected in the third quarter of 2026, followed by topline results in the second quarter of 2027 in advance of a planned BLA submission.

OCU410, a gene therapy candidate for geographic atrophy secondary to dry age-related macular degeneration, recently reported positive preliminary 12-month data from the Phase 2 ArMaDa trial, including reductions in lesion growth and slower photoreceptor degeneration. Full Phase 2 data are expected in March 2026.

OCU200, a biologic candidate for diabetic macular edema, diabetic retinopathy and wet AMD, continues in its Phase 1 dose-escalation study with no treatment-related adverse events reported to date. Enrolment is expected to complete in the first quarter of 2026.

OCU500, an inhaled COVID-19 vaccine candidate, is expected to enter a Phase 1 clinical trial in the second quarter of 2026 under the National Institute of Allergy and Infectious Diseases. Ocugen also advanced its regenerative medicine program by creating OrthoCellix, a wholly owned subsidiary intended to independently finance and develop the NeoCart cartilage repair platform.

As of December 31, 2025, Ocugen had 312.4 million outstanding shares of common stock.
OCGN has traded between $0.51 and $2.00 over the past year. The stock closed yesterday's trading at $1.96, up 5.38%. During overnight trading the stock fell to $1.94, down 1.02%.

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