Earnings release
Page 1
LINEAGE CELL THERAPEUTICS Lineage Reports Third Quarter 2021 Financial Results and Highlights Progress From Clinical Cell Therapy Programs November 10 , 2021 • Op Regen® Continues to Demonstrate Functional and Anatomical Improvements in Patients with Dry AMD • Performance Testing Underway to Support New Delivery Device for OPC1 Clinical Trials • Cash , Cash Equivalents , and Marketable Securities of $ 65.1 Million CARLSBAD , Calif .-- ( BUSINESS WIRE ) -- Nov . 10 , 2021-- Lineage Cell Therapeutics . Inc. ( NYSE American and TASE : LCTX ) , a clinical - stage biotechnology company developing allogeneic cell therapies for unmet medical needs , today reported financial and operating results for the third quarter 2021. Lineage will host a conference call today at 4:30 p.m. Eastern Time to discuss its third quarter 2021 financial results and to provide a business update . " Lineage's approach is to produce specific types of human cells and stably transplant those cells as a treatment for serious medical conditions . We believe our approach , in certain settings , can generate clinical outcomes beyond the reach of traditional methods , as evidenced by the restoration of retinal tissue in patients in our dry AMD trial and the restoration of a tissue matrix in patients in our spinal cord injury trial , " stated Brian M. Culley , Lineage CEO . " During the third quarter , we reported positive interim outcomes in patients with dry AMD with geographic atrophy , initiated performance testing of our OPC1 delivery device for spinal cord injury , and we expanded our executive team with the appointment of a new General Counsel . Looking ahead , we are preparing for engagement with FDA for our OpRegen program to discuss aspects of product designation , manufacturing plans , and later - stage clinical development . In parallel , we look forward to the initiation of our OPC1 and novel delivery device clinical safety study early next year . We believe our technology platform has broad potential beyond even the indications we currently are pursuing and while we continue to advance our three clinical - stage programs , we also are evaluating new applications of our technology , either on our own or through strategic alliances . " Some of the milestones achieved in the third quarter include : - Presented OpRegen clinical data at the 54th Annual Scientific Meeting of the American Retina Society from the ongoing Phase 1 / 2a study of OpRegen for the treatment of dry - AMD with GA ; statistically significant evidence of a treatment effect with OpRegen was observed in Cohort 4 better vision patients . - Reported continued positive interim clinical data with OpRegen : 8/12 ( 67 % ) of the Cohort 4 patients ' treated eyes were at or above baseline visual acuity at their last assessment , based on per protocol scheduled visits ranging from 9 months to over 3 years post - transplant , while visual acuity predictably declined in the majority of untreated eyes ; notably , three patients with evidence of retinal restoration and confirmed history of GA growth continued to demonstrate areas of retinal restoration as of their last per protocol assessments , ranging from 9 months to 33 months following treatment . - Announced the appointment of George A. Samuel III as General Counsel and Corporate Secretary . Mr. brings extensive corporate , transactional , intellectual property and commercial expertise which spans nearly 15 years across the life sciences and technology sectors as well as in private practice . - Featured in the B. Riley Securities Fall 2021 " Growth Biotech Best Idea " Virtual Series as well as the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference . Some of the events and milestones anticipated by Lineage include : - OpRegen Program o Additional interim data from the Phase 1 / 2a clinical study to be featured at the 2021 American Academy of Ophthalmology Annual Meeting in a presentation on November 13 , 2021 , as part of the Gene and Cell - Based Therapies Session , by Michael S. Ip , M.D. , Professor , Department of Ophthalmology at the David Geffen School of Medicine at the University of California , Los Angeles . o Multiple interactions with the U.S. Food and Drug Administration ( FDA ) planned to discuss product designation , manufacturing plans , and later - stage clinical development , anticipated to begin in Q4 2021 and continue in Q1 2022 . - OPC1 Program o Complete evaluation of a novel Parenchymal Spinal Delivery ( PSD ) system in non - clinical testing ; anticipated in Q4 2021 . o Complete GMP production of OPC1 via an improved and larger - scale manufacturing process and a new thaw - and - inject formulation ; anticipated in Q1 2022 . o FDA interaction to discuss recent manufacturing improvements made to OPC1 ; anticipated in Q1 2022 . o Initiation of clinical performance and safety testing of the novel PSD device for OPC1 ; anticipated Investigational New Drug ( IND ) amendment submission in Q1 2022 . - VAC Programs