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- **OpRegen Momentum**: 15 clinical sites opened, Genentech device acquisition, and independent competitor validation highlight potential for dry AMD treatment.
- **Pipeline Expansion**: $12M WDI collaboration for hearing loss, T1D islet cell therapy go/no-go Q1 2026, and CIRM grant ($7M potential) for spinal cord injury.
- **Financial Strength**: $40.5M cash runway to Q2 2027, with $37M warrant capital contingent on OpRegen trial announcement.
- **Strategic Flexibility**: Balance partnerships (e.g., WDI) with internal development, guided by manufacturing innovation and cost efficiency.

**【CEO Summary Section】**
- **OpRegen Progress**: Expanded clinical sites for GAlette study (15 total), with Genentech opening 8 new sites in 6 months. Positive signals include device acquisition for subretinal delivery and RMAT designation. Phase I/IIa data shows durable visual acuity improvements and safety. Competitor validation from multinational pharma reinforces potential.
- **Strategic Goals**: 
  1. **Partnerships**: $12M WDI collaboration for ReSonance hearing loss program, preserving future pharma deal rights.
  2. **Pipeline Expansion**: Early-stage work on multiple cell types; proprietary tracker identifies Type 1 Diabetes (T1D) islet cell therapy as top opportunity.
  3. **Manufacturing Innovation**: Scale-up efforts for T1D islet cells aim to overcome production limitations (1 billion cells/patient).
  4. **CIRM Grant**: $7M potential funding for OPC1 spinal cord injury study, with decision expected by Dec 11.
  5. **Milestone Revenue**: Progress on Roche/Genentech milestones, though specifics confidential.
- **Islet Cell Initiative**: Early-stage work suggests potential 1,000x production scale improvement. Go/no-go decision Q1 2026; could accelerate partnerships if successful.

**【CFO Financial Commentary】**
- **Cash Position**: $40.5M as of Q3, supporting operations into Q2 2027 (1 quarter longer than prior guidance). Includes $3.7M Q3 revenue (down 3% YoY) and $37M potential warrant capital if OpRegen enters controlled trial.
- **Expenses**: Operating expenses $7.5M (flat YoY). R&D $3.3M (+3%), G&A $4.2M (-5%). Net loss $29.8M driven by $26.6M warrant liability remeasurement.
- **Funding Sources**: WDI collaboration, CIRM grant, and Roche milestones. No OpRegen milestone revenue included in current cash runway.

**【Q&A Highlights】**
- **Islet Cell Program**: Go/no-go decision Q1 2026 hinges on feasibility of proprietary differentiation methods. Success could enable partnerships or internal advancement.
- **CIRM Grant**: $7M would offset 50% of OPC1 study costs. Reimbursement timeline delays cash impact but validates program value.
- **OpRegen Data**: Genentech likely to present GAlette findings at 2026 ophthalmology conferences. Device performance data shared with FDA for potential OPC1 formulation update.
- **Partnership Strategy**: Prioritize partners with disease expertise (e.g., WDI for hearing loss). Retain optionality to develop internally or partner based on capital efficiency.
- **OPC1 Dose Study**: First patient dosed July 30; no safety issues. FDA engagement on new cell formulation integration. Enrollment pace constrained by device learning curve and CIRM funding uncertainty.

Lineage Cell Therapeutics, Inc. (LCTX) Q3 2025 Earnings Call Transcript

Revenue

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LCTX

LCTX fundamentals

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