Lyell reports Q3 2026 results, new ronde-cel data headed to ASH

Lyell Immunopharma reported financial results for the third quarter ended September 30, 2026 on November 4, 2026. The company said updated clinical data from the ongoing PiNACLE pivotal trial in patients with third-line or later relapsed/refractory large B-cell lymphoma, along with data from the second-line cohort of the Phase 1/2 trial of ronde-cel, will be presented in two abstracts at the 68th American Society of Hematology Meeting and Exposition, running December 12 to 15, 2026.¹

In the PiNACLE trial, the overall response rate was 91% and the complete response rate was 77% among 44 efficacy-evaluable patients, with median duration of complete response and median progression-free survival not yet reached; the estimated continued complete response rate was 92% at six months and 75% at 12 months, with no Grade 3 or higher cytokine release syndrome and Grade 3 or higher ICANS reported in 9% of patients.¹ The company said pivotal data disclosure from PiNACLE remains on track for mid-2027, with a BLA submission expected to follow in the second half of 2027.¹

Separately, Lyell's Phase 3 trial comparing ronde-cel to investigator's choice of axicabtagene ciloleucel or lisocabtagene maraleucel in second-line relapsed/refractory LBCL, called PiNACLE-H2H, continues to enroll patients, with event-free survival as its primary endpoint.¹

For LYL273, its GCC-targeted CAR T candidate for colorectal cancer, Lyell said it completed technology transfer to the LyFE Manufacturing Center following FDA review of an improved manufacturing process and updated analytical methods, with additional clinical data and an End-of-Phase 1 meeting with FDA expected in 2027.¹

On financing, the company announced a private placement of $80.0 million with participation from existing and new investors.¹ Lyell reported cash, cash equivalents and marketable securities of $194.0 million as of September 30, 2026, down from $247.2 million as of December 31, 2025,¹ and said that balance, together with the private placement proceeds, is expected to be sufficient to meet working capital and capital expenditure needs into 2028.¹