Lineage Cell Therapeutics Q2 FY26 earnings call LCTX

Lineage is focusing on its 'Lineage 3.0' strategy, which involves leveraging the AlloSCOPE manufacturing platform to create a new, internally-owned pipeline of cell therapy assets. The platform aims to enable commercial-scale production at costs of hundreds of dollars per dose, significantly lower than autologous products, and has demonstrated FDA-cleared GMP banking and production capabilities. This strategy prioritizes programs where AlloSCOPE offers a competitive advantage, can generate meaningful signals in small, single-arm trials, and provides superior overall economics, allowing for rapid asset generation with consistent annual investment.

The COR1 program, a wholly-owned preclinical asset for Fuchs or other corneal endothelial dystrophies, is rapidly advancing. Lineage successfully employed its AlloSCOPE 5D technology for precursor expansion and differentiation within 9 months of starting wet lab work in Q3 2025. The program is now moving into preclinical testing, with initial in vivo data expected by year-end 2026. COR1 addresses a critical supply issue for CEnCs, as cadaver-sourced cells are limited and have variable quality and shelf life, offering a scalable and consistent solution.

The ILT1 program for Type 1 Diabetes is primarily focused on solving the significant manufacturing scale-up challenge for islet cell transplants, which can require up to 1 billion cells per patient. Lineage is applying a modified AlloSCOPE 5D platform to generate large-scale production of predifferentiated pluripotent cells, aiming to solve this hurdle before extensive preclinical and clinical studies. The company has demonstrated a fully suspension-based process at a multi-liter scale and is working towards showing differentiation into islet precursors, believing this manufacturing-first approach will de-risk future development.

ReSonance, an auditory neuronal cell transplant for hearing loss, is being developed under a partnership with William Demant Invest (Demant), which funds up to $12 million for preclinical development towards an IND/CTA filing. The program rapidly advanced into preclinical testing within approximately one year. Lineage has successfully completed three engineering runs and its first GMP run, which is currently undergoing release testing. A novel deafening model is also being established to conduct functional animal testing, aligning with the Lineage 3.0 strategy of seeking meaningful signals in small patient populations.

Lineage is re-evaluating the development path for its OPC1 program, potentially prioritizing chronic spinal cord injury (SCI) patients over subacute. This shift is driven by chronic patients having a more stable neurological baseline, allowing them to serve as their own internal controls, and being significantly more prevalent (10x) and easier to enroll. Recent data from other groups suggests chronic patients with preserved tissue bridges are more likely to recover from cell therapy combined with rehabilitation. The ongoing DOSED study, assessing a novel delivery device, has performed as expected with no unexpected adverse events, and additional patients are expected to enroll this year.

The lead OpRegen program, partnered with Roche and Genentech, continues to show positive signs of partner commitment. Phase I/IIa data demonstrated improved retinal anatomy, halting/reversal of atrophic progression, and improved vision in dry AMD patients. Roche is actively optimizing surgical delivery methods to enhance clinical outcomes and adoption. Recent activities include registration in the EMA IRIS database, expansion of the GAlette study from 6 to 17 sites, and significant promotional efforts at the ARVO conference, all indicating strong support within the Roche organization.