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Ocugen (OCGN) investor relations material
Ocugen Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary5 Nov, 2025
Executive summary
Lead gene therapy programs OCU400 (retinitis pigmentosa) and OCU410ST (Stargardt disease) advanced rapidly, with BLA/MAA filings planned for 2026–2027 and significant clinical trial enrollment progress.
Exclusive licensing agreement for OCU400 in South Korea with Kwang Dong Pharmaceutical includes up to $7.5M in upfront and milestone payments, $1.5M sales milestones per $15M in sales, and 25% royalty on net sales.
Positive regulatory milestones achieved, including EMA's CHMP acceptance of a single U.S.-based trial for MAA submission for OCU410ST, streamlining development.
Termination of planned NeoCart business merger due to insufficient investment commitments.
Focus remains on gene therapy for retinal diseases, with late-stage programs and ongoing regional partnership discussions.
Financial highlights
Cash, cash equivalents, and restricted cash totaled $32.9M as of September 30, 2025, down from $58.8M at December 31, 2024.
Net loss for Q3 2025 was $20.1M, compared to $13.0M in Q3 2024; net loss for the nine months ended September 30, 2025, was $50.1M.
Total operating expenses for Q3 2025 were $19.4M (R&D: $11.2M, G&A: $8.2M), up from $14.4M in Q3 2024.
Revenue from collaborative arrangements was $1.8M for Q3 2025 and $4.6M for the nine months, both up year-over-year.
Cash runway extends through Q2 2026, with potential for $30M more if warrants are exercised.
Outlook and guidance
BLA rolling submission for OCU400 planned for 1H 2026; commercialization ramp-up targeted for 2027.
OCU410 Phase 2 full data expected Q1 2026; Phase 3 initiation anticipated next year.
OCU410ST pivotal trial enrollment ahead of schedule, with interim data expected mid-2026 and BLA submission in H1 2027.
Management expects continued significant expenses for R&D, clinical trials, and commercialization preparation.
Current cash is insufficient to fund operations for the next 12 months without additional capital; actively pursuing further funding.
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Frequently asked questions
Ocugen, Inc., a clinical-stage biopharmaceutical company, focuses on the development of gene therapies to cure blindness diseases. The company's lead product candidate is OCUL-001, an adeno-associated virus vector-based gene therapy for the treatment of wet age-related macular degeneration. The company is also engaged in the discovery, design, development and clinical trial advancement of additional AAV and complementary non-AAV gene therapies for retinal diseases, including EIPAO-203 and EPAC1. The company is headquartered in Malvern, Pennsylvania.
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