In November 2019, we reported positive results from the ongoing SciStar study of OPC1, where the overall safety profile of OPC1 has remained excellent with robust motor recovery in upper extremities maintained through Year 2 patient follow-ups available to date. In July 2020, we reported that following the transfer of OPC1 manufacturing to our cGMP manufacturing facility in Israel, key process improvements have been developed and implemented. Lineage also strengthened its patent position in order to protect the OPC1 processes, product and composition, and methods of use. In December 2020, Lineage reported it has developed an enhanced differentiation process, leading to major improvements in production and quality of its OPC1 cell therapy drug product.
In February 2021, we announced that we had entered into an exclusive option and license agreement with Neurgain Technologies, Inc., a medical device company that is commercializing technology developed by neurosurgeons at the University of California San Diego. Under the terms of the agreement, the Company 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 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.