Lyell Immunopharma (LYEL) investor relations material

Key program updates and clinical progress

• Lead program is a dual-targeting CD19/20 CAR T cell therapy, now named RondaCell, for relapsed/refractory large B-cell lymphoma.

• Pivotal single-arm study underway for third-line approval; phase 3 randomized head-to-head trial launching in second line.

• RondaCell showed 88% overall response and 70% complete response rates in third-line patients.

• Six-month complete response rate reached 71%, surpassing benchmarks set by current CD19 CARs.

• Broader patient inclusion in trials, including older and high-risk populations.

Competitive landscape and differentiation

• Dual-targeting CD19/20 CARs are outperforming single-target CD19 CARs in response rates and durability.

• RondaCell uses a single tandem CAR with full potency for both antigens and a 4-1BB domain, linked to lower neurotoxicity.

• Unique enrichment for naïve central memory T cells, associated with better outcomes and persistence.

• Lower rates of CRS and neurotoxicity compared to competitors; proactive safety measures implemented.

• Confident in leadership position, being first to two pivotal trials and a head-to-head study.

Market strategy and commercialization plans

• Third-line setting seen as both a commercial opportunity and a regulatory bridge to second line.

• Strategic selection of clinical trial sites to facilitate rapid commercial adoption.

• Manufacturing capacity supports up to 1,200 doses per year, enabling independent launch.

• Open to future partnerships, especially for ex-U.S. markets, but no urgency due to current resources.

• Expectation that CD19/20 CARs will disrupt and potentially replace current CD19 therapies.