Lyell Immunopharma (LYEL) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Company overview and strategic focus

• Developing next-generation cell therapies for hematologic malignancies and solid tumors, with two lead clinical programs targeting large markets.

• Ronde-cel, a dual-targeted CD19/CD20 CAR T-cell therapy, aims to become standard of care in large B-cell lymphoma.

• Novel CAR T-cell program for metastatic colorectal cancer is advancing in clinical trials, showing promising activity.

• Owns a state-of-the-art manufacturing facility capable of producing up to 1,200 doses annually, supporting commercial launch.

Clinical data and competitive differentiation

• Ronde-cel pivotal trials show 93% overall response, 76% complete response, and 18 months median progression-free survival in third or later line large B-cell lymphoma.

• No grade 3 or higher cytokine release syndrome and less than 5% ICANS rate, supporting outpatient administration.

• CD62L enrichment during manufacturing enhances T-cell persistence and safety profile.

• Head-to-head trial design allows comparator choice, increasing real-world relevance and investigator support.

Competitive landscape and market positioning

• Johnson & Johnson exited the CD19/CD20 CAR T race, and Kite Gilead changed manufacturing, leaving Lyell in the lead.

• Main competitors in third line are Breyanzi and Yescarta, with Ronde-cel showing superior efficacy and safety.

• In vivo CAR T approaches are promising but remain early; Ronde-cel's durability and safety set a high bar.

• Being first to market in third line is seen as a major advantage due to limited headroom for further efficacy or safety improvements.