Lineage Enters Into Exclusive Agreement with Neurgain Technologies to Evaluate Novel Delivery System for OPC1 to Treat Spinal Cord Injury

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has entered into an exclusive option and license agreement with Neurgain Technologies, Inc. (“Neurgain”), a medical device company that is commercializing technology developed by neurosurgeons at the University of California San Diego (“UC San Diego”). Under the terms of the agreement, Lineage and Neurgain will collaborate on the clinical testing of Neurgain’s novel Parenchymal Delivery Injection (“PDI”) system, which is designed to allow for the administration of cells to the spinal cord without stopping the patient’s respiration. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. Lineage also will be hosting an OPC1 Investor and Analyst Day on February 22, 2021 to provide details on recent OPC1 milestones and plans for 2021.

Lineage will evaluate the Neurgain PDI system’s ability to safely and effectively deliver OPC1, Lineage’s allogeneic oligodendrocyte progenitor cell (OPC) transplant, to the spinal cord in both preclinical and clinical studies beginning this year. If results from the PDI system are positive, then Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the PDI system into a later-stage clinical trial and if approved, commercial use of OPC1 for the treatment of patients with a cervical spinal cord injury. There currently are no U.S. Food and Drug Administration (“FDA”) approved treatments for spinal cord injury.

Brian M. Culley, Lineage CEO stated, “Several months ago, we announced we had significantly improved the process for manufacturing OPC1, leading to large increases in purity and scale. More recently, we successfully developed a new 'thaw-and-inject' formulation, eliminating the commercially undesirable steps of handling and preparing cells one day prior to their use. Today, we are announcing another valuable improvement to the OPC1 program: access to a novel and convenient delivery system, which reduces a significant technical hurdle of conducting a larger-scale clinical trial. The Neurgain PDI offers an easier, potentially safer, and commercially more attractive option to treat SCI patients and is preferable to the complicated gantry utilized in an earlier study. It also will allow us to incorporate our new 'thaw-and-inject' formulation of OPC1, thereby enabling faster patient enrollment via access to a larger number of clinical trial sites. Most importantly, the PDI can eliminate the need for a patient’s respirator to be turned off during the procedure, facilitating a measured and targeted transplantation of cells to the affected area.”