Lyell Immunopharma (LYEL) Leerink Global Healthcare Conference 2026 summary

Key announcements and financial updates

• Appointment of a new Chief Financial and Business Officer with significant experience in finance and business development.

• Achievement of a clinical milestone, enabling access to a second $50 million tranche from a PIPE financing at $25.61 per share.

• Cash runway is projected into Q2 2027, supporting ongoing pivotal trials.

Ronde-cel CAR T-cell therapy program

• Ronde-cel is a dual-targeted CD19/CD20 CAR T-cell therapy, designed for high potency and durability, with a unique CD62L enrichment manufacturing process.

• Two pivotal clinical trials are ongoing: a single-arm third/later line study and a head-to-head second-line study against approved CD19 CARs.

• Clinical data show a 93% overall response rate and 76% complete response rate in third/later line, with 18 months median progression-free survival.

• Safety profile includes no grade 3 or higher cytokine release syndrome and less than 5% grade 3 ICANS after prophylaxis, supporting outpatient administration.

• Manufacturing is semi-automated, digital, and reliable, with a 95% success rate and a median 16-day vein-to-site time.

Clinical trial design and competitive positioning

• Trials allow for real-world practices, including bridging therapy and no upper age limit, aiming for broad patient eligibility.

• Head-to-head second-line trial compares ronde-cel to YESCARTA or Breyanzi, with event-free survival as the primary endpoint.

• Pivotal data from the third-line PiNACLE study expected mid-next year, with BLA submission planned for the same period.

• Manufacturing process and specifications have been presented to the FDA, with no failures due to CD62L enrichment.