Lucy De Yang's questions to Lineage Cell Therapeutics Inc (LCTX) leadership • Q1 2025
Question
Lucy De Yang of Raymond James asked for management's view on the new CDER director's stance on cell therapy and for specifics on the OPC1 spinal cord injury trial design.
Answer
CEO Brian Culley expressed confidence in the new FDA leadership, welcoming a high, data-driven bar that he believes will favor therapies like OpRegen with significant clinical benefits. He outlined the OPC1 trial as a single-arm study for 6-10 patients, with a staggered enrollment starting with three thoracic injury patients before moving to cervical injury patients.