Lyell Immunopharma (LYEL) 25th Annual Needham Virtual Healthcare Conference summary

Company overview and lead programs

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

• Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell therapy designed to replace current CD19 CAR T therapies, with two pivotal trials underway.

• Manufacturing is fully in-house, supporting commercial launch and providing control over production and scalability.

Ronde-cel differentiation and clinical data

• Ronde-cel targets both CD19 and CD20, addressing antigen loss and improving response rates.

• Enrichment for naive and central memory T cells enhances persistence and safety profile.

• Head-to-head phase III trial compares ronde-cel to investigator's choice of leading CD19 CAR Ts, aiming to demonstrate superior efficacy and safety.

• Data show 93% overall response, 76% complete response, and 18-month median progression-free survival in late-line settings.

• Safety profile includes no grade 3+ CRS and <5% grade 3+ ICANS, supporting outpatient administration.

Clinical trial design and commercial strategy

• Trials allow bridging therapy and have broad inclusion criteria, including no upper age limit.

• Third-line study (PINNACLE) targets a 6,000–7,000 patient market, with accelerated approval strategy.

• Upcoming data updates expected in the second half of this year, with pivotal data and BLA submission planned for mid-next year.

• Commercial advantage expected from being first to market in the CD19/CD20 CAR T-cell space.