Lineage Cell Therapeutics, Inc. · AMEX:LCTX
Lineage Cell Therapeutics — Retinal Innovation Summit 2026
22 slides from Lineage Cell Therapeutics's conference presentation, 2026
Slide 1: RPE Cell Therapy in Geographic Atrophy Secondary to AMD: 3-Year Results from the Phase 1/2a Study
Retinal Pigment Epithelium Cell Therapy in Geographic Atrophy Secondary to Age-related Macular Degeneration: 3-Year Results from the Phase 1/2a Study Eyal Banin, MD, PhD, on behalf of OpRegen® Phase 1/2a Study Investigators Center for Retinal and Macular Degenerations, Department of Ophthalmology Ha
Slide 2: Disclosures
Disclosures • Grants or Contracts (Past 36 months): – CellCure Neurosciences: Sponsored the translational research and the clinical trial – Lineage Cell Therapeutics: Research Grant (2019-2022) held jointly with B. Reubinoff • Royalties or Licenses (Past 36 months): – Lineage Cell Therapeutics & Gen
Slide 3: OpRegen Cell Therapy – A Suspension of Allogeneic RPE Cells
OpRegen Cell Therapy – A Suspension of Allogeneic RPE Cells With the Potential to Counteract RPE Cell Dysfunction & Loss in GA Retina treated with Retina OpRegen OpRegen with GA Subretinal Delivery Cell Therapy cGMP, current Good Manufacturing Practice; hESC, human embryonic stem cell. NIH registry
Slide 4: Phase I/IIa Study Design (NCT02286089; Active)
Phase I/IIa Study Design (NCT02286089; Active) An Open-Label, Single-Arm, Multi-Center, Dose-Escalation Trial Key Enrollment Criteria Single OpRegen Administration Patients with bilateral GA secondary Subretinal Delivery to AMD Cohort 1 (n=3) 50,000 cells Transvitreal (n=5) Cohorts 1-3 (n=12): ● Leg
Slide 5: Baseline Characteristics and Safety Summary
Baseline Characteristics and Safety Summarya • The most frequent ocular AEs reported in all Cohorts 1-3 (n=12) Cohort 4 (n=12) patients on study were conjunctival Baseline Characteristic Legally Blind Impaired Vision hemorrhage/hyperemia (71%) and ERM (67%)d Age, years, mean 78.1 75.7 (SD, min–max)
Slide 6: Subgroup Analysis in Cohort 4: Outcomes With and Without Delivery to Central GA
Subgroup Analysis in Cohort 4: Functional and Anatomic Outcomes in Eyes With and Without Delivery of OpRegen Cell Therapy to Central GA Extensive bleb coverage (n=5) Limited bleb coverage (n=7) Extensive bleb coverage of GA (including fovea) Minimal to no bleb coverage of GA Baseline Intraop video B
Slide 7: SD-OCT May be More Suitable than FAF for Defining Area of GA
SD-OCT May be More Suitable than FAF for Defining an Instructions Home Area of GA in the Setting of RPE Cell Therapy CFP FAF SD-OCT • The allogeneic hESC-derived Baseline RPE cells in OpRegen are young and have low lipofuscin content • Therefore, OpRegen RPE cells are not expected to be readily dete
Slide 8: Resolution of cRORA Near Borders of Baseline GA
Resolution of cRORA Near Borders of Baseline GA In Cases With Extensive OpRegen Bleb Coverage of Area of GA Baseline Month 12 • Features of cRORA no longer present • Resolution of retinal subsidence, with greater continuity of outer retinal layers • Greater hyperreflectivity at the level of RPE/BM •
Slide 9: Resolution of cRORA/iRORA Near Borders of Baseline GA
Resolution of cRORA/iRORA Near Borders of Baseline GA In Cases With Extensive OpRegen Bleb Coverage of Area of GA Baseline Month 12 Baseline Month 12 Case #14 9
Slide 10: Resolution of iRORA After OpRegen Treatment
Resolution of iRORA After OpRegen Treatment In Cases With Extensive OpRegen Bleb Coverage of Area of GA Baseline • Focal disruption of the RPE layer, choroidal hypertransmission, and outer retinal subsidence at baseline are no longer present at Month 12 Month 12 • Registration of scans is confirmed
Slide 11: SD-OCT Imaging Suggests OpRegen Presence in Areas of Former GA
SD-OCT Imaging Suggests OpRegen Presence in Areas of Former GA Greater Hyperreflectivity Visible at RPE/BM & Weaker Choroidal Hypertransmission Baseline Month 1 Month 3 Month 12 Reappearance of ONL and ELM Greater hyperreflectivity visible at RPE/BM Weaker choroidal hypertransmission Case #21 BM, Br
Slide 12: Outer Retinal Structure Analyzed Using EyeNotate OCT Segmentation Algorithm
Outer Retinal Structure Analyzed Using EyeNotate OCT Segmentation Algorithm in Cohort 4 Patients ELM (external limiting membrane): Graded as present or absent (orange line). RPE-C (retinal pigment epithelium complex): The thickness between the hyper-reflective bands representing inner border of RPE
Slide 13: Quantitation of RPE-C and ELM Area Shows Improvement Between Baseline and Month 12
Quantitation of RPE-C and ELM Area Shows Cases of Improvement Between Baseline and Month 12 SD-OCT segmentationa Quantification RPE-C map ELM mapb Baseline Baseline 6.0 mm2 9.1 mm2 Month 12 Month 12 0.8 mm2 8.5 mm2 ELM, external limiting membrane; RPE-C, retinal pigment epithelium complex. aSegmenta
Slide 14: Cohort 4 Shows Sustained Retinal Structural Support Through Month 36
Study Eyes of Cohort 4 Patients (Less Advanced GA) Show Sustained Evidence of Retinal Structural Support by Quantitative OCT Analysis Through Month 36 RPE Complex (RPE-C) External Limiting Membrane (ELM) Cohort 4 (n=12) Cohort 4 (n=12) n=12 +1.1 n=9 n=9 +0.4 n=12 n=9 -0.1 n=9 -0.9 -1.3 -1.4 n=12 n=9
Slide 15: Beneficial Supportive Effect Most Evident with Extensive Coverage of GA
The Beneficial Supportive Effect is Most Evident Among Eyes with Extensive Coverage of GA by the Surgical Bleb RPE Complex (RPE-C) External Limiting Membrane (ELM) Extensive Bleb Coverage (n=5) Limited Bleb Coverage (n=7) Extensive Bleb Coverage (n=5) Limited Bleb Coverage (n=7) n=4 n=4 n=5 n=5 +2.6
Slide 16: Structural Support Accompanied by Sustained BCVA Gains Through Month 36
The Structural Support in Cohort 4 Patients is Accompanied by Sustained BCVA Gains Through Month 36, with Greater Gains Among Eyes with Extensive Coverage of GA Cohort 4 (n=12) Extensive Bleb Coverage (n=5) Limited Bleb Coverage (n=7) n=5 +12.8 n=5 n=12 n=5 +9.0 +7.6 +7.4 n=10 n=10 n=7 +6.2 +5.5 +3.
Slide 17: Structural Support Accompanied by Sustained BCVA Gains Through Month 36
The Structural Support in Cohort 4 Patients is Accompanied by Sustained BCVA Gains Through Month 36, with Greater Gains Among Eyes with Extensive Coverage of GA Cohort 4 (n=12) Extensive Bleb Coverage (n=5) Limited Bleb Coverage (n=7) n=5 +12.8 n=5 n=12 n=5 +9.0 +7.6 +7.4 n=10 n=10 n=7 +6.2 +5.5 +3.
Slide 18: Structural Support Accompanied by Sustained BCVA Gains Through Month 36
The Structural Support in Cohort 4 Patients is Accompanied by Sustained BCVA Gains Through Month 36, with Greater Gains Among Eyes with Extensive Coverage of GA Cohort 4 (n=12) Extensive Bleb Coverage (n=5) Limited Bleb Coverage (n=7) n=5 +12.8 n=5 n=12 n=5 +9.0 +7.6 +7.4 n=10 n=10 n=7 +6.2 +5.5 +3.
Slide 19: GAlette: Phase 2a Study to Optimize Subretinal Delivery of OpRegen in GA
GAlette: A Phase 2a Multicenter, Open-Label, Single-Arm Study to Optimize the Subretinal Delivery of OpRegen Cell Therapy In GA (NCT05626114; Recruiting)1 Key Enrollment Criteria Up to ~60 patients 3-10 patients per cohort Up to 200,000 cells ● Age ≥50 years ● Diagnosis of GA secondary to AMD Cohort
Slide 20: Conclusions
Conclusions • Imaging evidence of structural benefit and greater gains in visual acuity were seen in study eyes in Cohort 4 patients (less advanced GA) at Month 12, continuing through Month 36 – Differences as compared with fellow eyes increased over time, suggesting possible modification of the cou
Slide 21: Thank You to All Participating Ph1/2a Investigators, Sites, and Patients
Thank You to All Participating Ph1/2a Investigators, Sites, and Patients Investigators Trial Conduct • Eyal Banin, Hadassah-Hebrew University Medical Center, Jerusalem, Israel • Central Reading Center: Merit CRO (EyeKor), Madison, WI, USA • Adiel Barak, Sourasky Medical Center, Tel Aviv, Israel • Du
Slide 22: Thank You!
http://ak4.picdn.net/shutterstock/videos/620677/preview/stock-footage-underwter-with-ray-of-light.jpg THANK YOU!
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