Lyell Immunopharma (LYEL) TD Cowen 46th Annual Health Care Conference summary

Strategic positioning and pipeline overview

• Positioned for significant value creation in the next 12–18 months with multiple catalysts in large oncology markets.

• Lead program Rondo-cel targets relapsed/refractory large B-cell lymphoma, a $3B+ market, and metastatic colorectal cancer, both with high unmet need.

• Two pivotal trials underway for Rondo-cel: Pinnacle (third/later line, data mid-2027, BLA submission 2027) and Pinnacle-H2H (second line, head-to-head, progress update in second half of year).

• LYL273, a GCC-targeted CAR T-cell for metastatic colorectal cancer, shows high response rates and manageable safety in phase 1; pivotal trial initiation planned for first half of 2027.

• Scalable, wholly-owned manufacturing supports commercial launch readiness.

Rondo-cel program details and clinical data

• Rondo-cel is a dual-targeting CD19/CD20 CAR T-cell with CD62L enrichment for naive/central memory T-cells, aiming for improved durability and safety.

• Phase 1/2 data in third/later line lymphoma: 93% overall response, 76% complete response, 18 months median progression-free survival.

• Safety profile favorable: no grade 3+ cytokine release syndrome, 4% grade 3+ ICANS with dexamethasone prophylaxis.

• Manufacturing process is automated, with a 16-day median vein-to-site time and capacity for 1,200 doses/year.

• Fast-to-market strategy with single-arm pivotal trial in third/later line and head-to-head superiority trial in second line.

LYL273 colorectal cancer program and clinical results

• LYL273 targets GCC, expressed in >95% of colorectal cancers; enhanced with CD19 CARs expressing cytokines for improved expansion and efficacy.

• Phase 1 US trial: 67% overall response at dose level 2, 8 months median progression-free survival, manageable safety profile.

• Supported by China data: 40% objective response, 25 months median overall survival in 15 patients.

• Notable patient cases include complete and near-complete responses, with aggressive management of toxicities implemented.

• Updated phase 1 data expected in both halves of the year; pivotal trial initiation planned for first half of 2027.