Lineage Cell Therapeutics (LCTX) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Industry context and cell therapy landscape

• Cell therapy is a key pillar in cancer treatment and is expanding into non-oncology areas, especially neurology, with breakthroughs in diseases like Parkinson's and type 1 diabetes highlighting curative potential.

• The field is shifting focus from crowded oncology markets to broader applications in other diseases.

• Lineage's platform supports over 200 cell types, with commercial scalability and validated technology, addressing multi-billion dollar markets.

Pipeline and technology approach

• The pipeline includes five allogeneic, off-the-shelf assets, reducing cost and complexity compared to autologous therapies.

• Core technology uses pluripotent stem cells for scalable, consistent manufacturing and differentiation into specific cell types without gene editing.

• Emphasis on process control, purity, potency, and scalability as essential for commercial success.

• Proprietary cell engineering enables preclinical programs for hearing loss, photoreceptor loss, and neurology indications.

Lead program: OpRegen for dry AMD

• OpRegen, an RPE cell transplant for dry AMD, is partnered with Genentech/Roche, with $50M upfront, $620M in milestones, and double-digit royalties.

• Clinical trials showed durable anatomical and functional improvements in vision, with sustained visual acuity gains at 12 and 24 months and strong correlation between cell delivery and outcomes.

• Genentech is optimizing surgical delivery methods, and a new services agreement (May 2024) funds clinical, technical, and manufacturing activities.

• The ongoing GAlette Phase 2a study aims to enroll up to 60 patients, focusing on safety and retinal structure improvement.

• OpRegen has Fast Track and RMAT designations, no cases of rejection, and potential expansion to other retinal diseases.