Lyell Immunopharma (LYEL) investor relations material

Strategic focus and clinical pipeline

• Focused on next-generation CAR T-cell therapies for hematologic malignancies and solid tumors, with two clinical programs: ronde-cel (CD19/CD20 CAR T) and LYL273 (GCC-targeted CAR T for metastatic colorectal cancer).

• Ronde-cel is in two pivotal trials for large B-cell lymphoma, including the single-arm PiNACLE study and a head-to-head trial against approved CD19 CARs.

• LYL273 targets a high unmet need in metastatic colorectal cancer, with promising early efficacy and ongoing dose optimization.

• Owns a manufacturing facility, enabling control over production and process improvements, including enhanced cryopreservation.

• Cash position of $228 million expected to fund operations through Q3 2027, covering key data milestones.

Ronde-cel clinical results and development

• Achieved a 76% complete response rate and 18-month median progression-free survival in third-line or later large B-cell lymphoma, outperforming existing CD19 CARs.

• Safety profile shows no Grade 3 or higher CRS and neurotoxicity incidence below 10%.

• PiNACLE pivotal trial aims for fast approval, with data updates in the second half of 2024 and BLA submission expected mid-2025.

• No upper age limit in trials, successfully treating patients over 75, expanding potential patient population.

• Head-to-head PiNACLE-H2H trial designed to demonstrate superiority over current CD19 CARs, with real-world comparator arms and cost mitigation strategies.

LYL273 program and market opportunity

• LYL273 addresses a large and growing market, with 150,000 new colorectal cancer cases and 50,000 deaths annually in the U.S.

• Early data from China and U.S. sites show 40–50% overall response rates, significantly higher than current therapies.

• GI toxicity managed by a new prophylactic regimen, reducing severe diarrhea and colitis from 55% to 10%.

• Manufacturing process transferred in-house, with improvements in cell viability and process automation.

• Phase I/II trial expanded, with a key data update expected in 2027 and regulatory pathway discussions ongoing.