Ocugen Stock Earnings Reports

Key investor takeaways: Ocugen reported meaningful clinical and corporate progress across its three gene therapy programs and provided near-term timelines and financing context. OCU400 (broad, gene‑agnostic retinitis pigmentosa [RP] candidate): Phase 3 enrollment is nearing completion, rolling BLA submission planned to begin in H1 2026 with top‑line Phase 3 data expected in Q4 2026 and anticipated commercialization in 2027. Ocugen emphasizes OCU400’s potential to address the ~98–99% of RP patients not covered by single‑gene therapies. OCU410ST (ABCA4/Stargardt): Phase 2/3 GARDian3 enrollment is ahead of schedule (≈50% enrolled), interim data expected mid‑2026; the EMA CHMP accepted a single U.S. trial for MAA submission in Europe, simplifying development and costs. OCU410 (geographic atrophy/dry AMD): Phase 1/2 results showed lesion growth reduction (12‑month: 23% reduction; 6‑month interim: 27% reduction) and functional benefit; full 12‑month Phase 2 data expected Q1 2026 with Phase 3 initiation planned in 2026. Commercial/operational: Ocugen closed a registered direct financing in August (~$20M gross proceeds) and has a licensing deal with Kwangdong for South Korea (up to $7.5M upfront/development milestones + sales milestones and 25% royalties). Manufacturing process validation is underway; company aims to have U.S. manufacturing ready by 2027 while leveraging ex‑U.S. partners in the near term. Financials and runway: Cash and equivalents were $32.9M as of 9/30/2025 (down from $58.8M at year‑end 2024); with the recent financing management expects runway into Q2 2026 and an additional ~$30M potential if warrants are exercised. Total operating expenses for Q3 2025 were $19.4M (R&D $11.2M; G&A $8.2M). Risks: forward‑looking timelines depend on enrollment, trial readouts, regulatory interactions, manufacturing validation and additional financing; company reiterated the usual SEC‑filed risk factors.