Data From All Four Patient Show Improvements Lineage Cell reported new data from the fourth cohort in its Phase 1/2a clinical trial for OpRegen. The data is from the fourth patient in the cohort that received the highest quantity of OpRegen cells. The results showed restoration of cellular structure and functional improvement at 12 months. We believe this demonstrates tissue restoration and efficacy of the product.Trial Was Designed To Show OpRegen Safety and Durability The OpRegen Phase 1/2a treated three cohorts of 12 patients to establish safety, then a fourth cohort of 12 patients to determine efficacy. In this fourth cohort, four of the patients had the majority of their lesions covered with OpRegn cells. The new data shows all four of these patients had cellular engraftment and visual acuity improvements.Treated Eyes Showed Benefits While Untreated Eyes Had Declines. Patients had one eye treated with OpRegen and their untreated fellow eye as a control. Assessment of best corrected visual acuity (BCVA) showed that 7 out of 12 (58%) of the treated eyes were at baseline or better at 15 months. Some patients have been assessed as long as 3 years after treatment. In the fellow eyes, 8 out of 12 (67%) were below baseline.Improvements Were Seen In Cellular Structure and In Visual Function. The outer layer of the retina showed new retinal pigmented epithelium (RPE) cell layers by Optical Coherence Tomography (OCT), indicating anatomical restoration of the areas of lost cells. All four patients had improvements in their visual acuity that were also statistically significant at 9, 12, and 15 months.Conclusion: We believe this new data confirms that the OpRegen cellular therapy can engraft and restore areas of the retina lost to dry AMD. The company plans to begin discussions with the FDA to determine the regulatory path and clinical trial requirements for approval. These discussions are expected for early 2022, with the next clinical trial starting in late 2022. We are reiterating our Outperform rating and $8 price target. Read More >>