Lyell Immunopharma Reports Business Highlights and Financial Results for the Third Quarter 2026
Key Highlights
- ➤PiNACLE: 91% overall response and 77% complete response among 44 evaluable patients
- ➤PiNACLE pivotal data expected mid-2027, with BLA submission expected second half 2027
- ➤$80.0 million private placement announced in November 2026
- ➤Cash plus financing expected to fund operations into 2028
- ➤Third-quarter net loss widened to $45.5 million from $38.8 million
Expert Statements
Lynn Seely, M.D., President and Chief Executive Officer of Lyell
“The updated ronde-cel data accepted for presentation at ASH further strengthen our conviction in ronde-cel’s potential to meaningfully improve outcomes for patients with large B-cell lymphoma. The high rates of very durable complete responses achieved by ronde-cel in both the second- and third- or later-line settings, including in patients with high-risk primary refractory disease, clearly showcase the next-generation potential of ronde-cel. With two pivotal trials underway, including our single-arm pivotal PiNACLE trial expected to complete enrollment by year end and on track for pivotal data and BLA submission in the second half of 2027, we are now focusing on preparation for commercialization. We are also continuing to advance LYL273 following the successful transfer of manufacturing to LyFE, as we work to determine the recommended Phase 2 dose and optimize the safety management plan ahead of our planned End-of-Phase 1 discussions with the FDA in 2027.”
* Announced updated clinical data in more than 80 patients from the ongoing PiNACLE pivotal trial in patients with 3L+ R/R LBCL and from the Phase 1/2 trial 2L cohort of ronde-cel in abstracts accepted for presentation at ASH 2026. * The overall response rate was 91% and the complete response rate was 77% among 44 efficacy-evaluable patients in the 3L+ PiNACLE trial. The median duration of complete response and median progression-free survival were not reached, with an estimated continued complete response rate of 92% at six months and 75% at 12 months. No Grade ≥ 3 CRS was observed and Grade ≥ 3 ICANS was reported in 9% of patients. * PiNACLE pivotal data disclosure is on track for mid-2027, with BLA submission expected to follow in the second half of 2027. * Completed technology transfer of LYL273 to the LyFE Manufacturing Center™ following FDA review of improved manufacturing process and updated analytical methods; additional clinical data and End-of-Phase 1 meeting with FDA expected in 2027. * Announced private placement financing of $80.0 million with participation from a high-quality syndicate of existing and new investors. * Approximately $194.0 million in cash, cash equivalents and marketable securities as of September 30, 2026, together with net proceeds from the private placement, expected to fund operations into 2028. SOUTH SAN FRANCISCO, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today reported financial results and business highlights for the third quarter ended September 30, 2026.
Get started
Create a free account to read the full story.