Lineage Cell Therapeutics (LCTX) Study update summary

Overview of COR1 program and cell therapy approach

• COR1 is an internally developed, allogeneic, off-the-shelf cell transplant program targeting corneal endothelial disease, leveraging experience from prior cell therapy programs.

• Utilizes the proprietary AlloSCOPE 5D manufacturing platform for scalable, consistent, and cost-effective production of corneal endothelial cells (CEnCs).

• Thaw-and-inject formulation enables immediate use and long-term storage, supporting a superior product profile to cadaver-sourced cells.

• Emphasis on robust, scalable manufacturing and regulatory compliance before clinical trials to minimize risk.

• COR1 development has progressed rapidly, reaching preclinical milestones within nine months of lab initiation and advancing to in-vivo animal testing with initial data expected this year.

Key attributes and manufacturing strategy

• Four critical criteria for COR1: scale, storage, quality, and consistency, all addressed prior to preclinical testing.

• Two-tiered GMP cell banking system and 5D expansion process enable potential production of millions of doses, addressing global donor shortages.

• Proprietary cryopreservation protocol allows for a ready-to-use, thaw-and-inject product, improving accessibility and operational flexibility.

• Advanced analytics and proprietary differentiation ensure high purity, batch consistency, and regulatory compliance.

• Successfully manufactured CEnCs meeting initial thresholds for potency, identity, and scale.

Competitive advantages and commercial potential

• COR1 aims to address the global shortage of donor corneas by providing a scalable, consistent, and cost-effective alternative.

• Manufacturing process is designed for high output and low cost of goods, targeting below four figures per dose.

• Product profile offers advantages over cadaver-derived cells, including reduced variability, lower procedural risk, and broader adoption potential.

• Simpler, minimally invasive outpatient procedure increases accessibility and lowers treatment costs.

• Large addressable market with 2–6 million patients in the US, 16 million in Europe, and over 13 million people waiting for transplants globally.