Ocugen (OCGN) Q4 2025 earnings summary

Executive summary

• Achieved significant progress in modifier gene therapy programs, advancing toward three BLA filings over the next three years and transitioning to a commercial-stage company.

• Completed enrollment in the phase III liMeliGhT trial for OCU400 in retinitis pigmentosa, with top-line data expected in Q1 2027 and commercialization targeted for 2027.

• Advanced OCU410ST for Stargardt disease, with phase II/III GARDian3 trial ahead of schedule; interim data expected Q3 2026 and top-line data anticipated in Q2 2027.

• Reported positive preliminary data for OCU410 in geographic atrophy, with full phase II data expected March 2026 and phase III initiation planned for 2026.

• Strengthened leadership team with key executive appointments in business development, commercial, finance, and operations.

Financial highlights

• Q4 2025 R&D expenses were $10.7M, up from $8.3M in Q4 2024; G&A expenses were $6.1M, slightly down from $6.3M.

• Q4 2025 net loss per share was $0.06, compared to $0.05 in Q4 2024.

• Full-year 2025 R&D expenses were $39.8M (vs. $32.1M in 2024); G&A expenses were $27.6M (vs. $26.7M).

• Full-year 2025 net loss per share was $0.23, compared to $0.20 in 2024.

• Cash and equivalents at year-end 2025 were $18.9M, with runway into Q4 2026 and potential extension to Q2 2027 if warrants are exercised.

Outlook and guidance

• OCU400 phase III top-line data expected Q1 2027; BLA filing planned for Q3 2026 and commercialization in 2027.

• OCU410ST phase II/III interim data expected Q3 2026, topline data Q2 2027; BLA submission to follow.

• OCU410 phase II full data expected March 2026; phase III initiation in 2026.

• OCU200 phase I enrollment to complete in Q1 2026; OCU500 phase I to start in Q2 2026.

• Three BLA filings targeted over the next three years.