Ocugen Q4 Earnings Call Highlights

• OCU400 Phase III enrollment complete: Ocugen finished enrollment successful the liMeliGhT proceedings (140 patients) and expects top-line information successful Q1 2027, targeting a rolling BLA commencement successful Q3 2026 to enactment imaginable support successful 2027.

• Stargardt and GA programs advancing: GARDian3 is up of docket with Phase II/III top-line information expected Q2 2027 and the EMA confirmed a azygous U.S. proceedings tin enactment a European filing, portion preliminary Phase II ArMaDa GA information showed a 46% simplification successful lesion maturation astatine 12 months and Phase III is planned for 2026.

• Higher walk but funded into precocious 2026: R&D roseate to $39.8M successful 2025 and nett nonaccomplishment widened to $0.23 per share, with currency runway into Q4 2026 (extendable into Q2 2027 if $30M of warrants are exercised).

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Ocugen (NASDAQ:OCGN) executives utilized the company’s fourth-quarter and full-year 2025 net telephone to item late-stage advancement crossed its modifier cistron therapy pipeline, outline upcoming regulatory milestones, and reappraisal a higher year-over-year operating walk alongside an extended currency runway into precocious 2026.

Chairman, CEO, and co-founder Dr. Shankar Musunuri said 2025 was “a transformative year,” pointing to improvement advancement crossed the company’s programs, determination partnering activity, and enactment appointments arsenic Ocugen works toward becoming a commercial-stage company.

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Musunuri said enrollment is present implicit successful the Phase III liMeliGhT proceedings of OCU400 successful retinitis pigmentosa (RP). He described liMeliGhT arsenic a wide RP, gene-agnostic Phase III orphan cistron therapy study, and said astir 300,000 radical successful the U.S. and Europe are surviving with RP caused by mutations successful much than 100 genes.

According to management, OCU400 is designed arsenic a modifier cistron therapy utilizing NR2E3 to code aggregate mutations with a one-time treatment. Musunuri contrasted the attack with the lone approved cistron therapy for RP, which targets RPE65 and accounts for astir 1% to 2% of RP patients, and said Ocugen believes OCU400 could code 98% to 99% of RP patients.

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The institution said liMeliGhT enrolled 140 patients randomized 2:1 into attraction and untreated power groups crossed RHO and gene-agnostic arms. The superior endpoint is 12-month alteration successful ocular relation assessed by the Luminance Dependent Navigation Assessment (LDNA), measured by betterment successful lux level from baseline to 12 months. Management said top-line information are expected successful the archetypal 4th of 2027, which it anticipates volition enactment a biologics licence exertion (BLA) filing and imaginable support successful 2027.