Ocugen (OCGN) Q4 2025 earnings summary

Executive summary

• Achieved significant progress in modifier gene therapy programs, including OCU400, OCU410ST, and OCU410, with key clinical milestones and strategic licensing agreements in 2025.

• Completed enrollment for the phase III liMeliGhT trial for OCU400 in retinitis pigmentosa; 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 12-month data for OCU410 in geographic atrophy, showing 46% lesion growth reduction and 50% responder rate; full phase II data expected March 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 restricted cash at year-end 2025 was $18.9M, with a cash runway extending into Q4 2026 and potential extension to Q2 2027 if warrants are exercised.

Outlook and guidance

• Rolling BLA submission for OCU400 to begin in Q3 2026, with potential approval and commercialization in 2027.

• OCU410ST phase II/III interim data expected Q3 2026, top-line data Q2 2027, with BLA submission to follow.

• OCU410 phase III trial initiation planned for 2026, with full phase II data to be reported March 2026.

• Multiple defined inflection points in 2026, including interim pivotal data and key regulatory milestones.

• Cash runway expected through Q4 2026 with recent financings; potential extension to Q2 2027 if warrants exercised.