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- **Clinical Milestones**: OCU400 Phase 3 nearing completion, with BLA submission in 2026. OCU410ST 50% enrolled in Phase 2/3, targeting 51 subjects. OCU410 shows 23% lesion reduction in Phase 1,优于现有疗法.
- **Partnerships & Funding**: $7.5M deal with Kwangdong for South Korea rights; $20M financing extends runway to Q2 2026. European MAA submission aligned with U.S. timeline.
- **Manufacturing Readiness**: Process validation on track; U.S. manufacturing site to support 2027 launch.
- **Market Potential**: OCU400 addresses 300,000 RP patients in U.S./Europe; OCU410 targets 2-3 million GA patients globally.

**【CEO Summary Section】**
- **OCU400 Phase 3 Progress**: Enrollment nearing completion for the liMeLiGhT trial, with BLA submission planned for 2026. OCU400 targets 98% of RP patients, addressing multiple genetic mutations with a single therapy. Phase 3 is the largest orphan gene therapy trial, with 150 subjects (100 treated, 50 control). 12-month data release expected Q4 2026.
- **OCU410ST Update**: Phase 2/3 GARDian3 trial 50% enrolled, targeting 51 subjects (34 treated, 17 control). CHMP accepted U.S. trial data for MAA submission, aligning timelines with OCU400. 12-month Phase 1 data showed 48.2% lesion growth reduction and visual acuity gains.
- **OCU410 for GA**: 12-month Phase 1 data shows 23% lesion growth reduction, outperforming existing therapies. Phase 2/3 planned for 2026, targeting 2-3 million GA patients globally.
- **Partnerships**: $7.5M deal with Kwangdong Pharmaceutical for OCU400 in South Korea, with $1.5M per $15M sales milestone and 25% royalty. European MAA submission aligned with U.S. timeline.
- **Manufacturing**: Process validation runs on track; U.S. manufacturing site in Malvern, PA, to support 2027 commercial launch.

**【CFO Financial Commentary】**
- **Cash Position**: $32.9M as of Q3 2025, down from $58.8M in Q4 2024. Recent $20M financing extends runway to Q2 2026; $30M warrant exercise could extend to 2027.
- **Operating Expenses**: Q3 2025 total $19.4M (R&D: $11.2M, G&A: $8.2M), up 34% YoY. Focus on clinical trial costs and commercial preparation.

**【Q&A Highlights】**
- **BLA Timeline**: Rolling submission for OCU400 BLA to begin H1 2026, with full submission late 2026. Manufacturing material ready for commercial use.
- **Trial Design**: OCU400 Phase 3 includes untreated control group for direct comparison; 97% statistical power. OCU410ST interim data mid-2026 will include lesion growth and visual acuity metrics.
- **Commercial Strategy**: U.S. commercialization ramp-up with regional partnerships; South Korea deal preserves global rights. European MAA submission aligned with U.S. timeline.
- **Manufacturing Capacity**: Ex-U.S. partner provides sufficient capacity; U.S. site to be FDA-approved by 2027.
- **LCA Program**: Not prioritized due to small market size; potential Phase 4 evaluation post-RP launch.

Ocugen, Inc. (OCGN) Q3 2025 Earnings Call Transcript

Revenue

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OCGN

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