Lyell Third-Quarter Net Loss Widens to $45.5 Million

The Tip Desk · November 4, 2026 · 4 min read

Third-quarter 2026 revenue was $3,000 and net loss widened to $45.5 million. September 30 cash, cash equivalents and marketable securities of $194.0 million, together with net proceeds from the $80.0 million November private placement, are expected to fund operations into 2028.

Lyell Immunopharma (LYEL) reported revenue of $3,000 for the third quarter ended September 30, 2026, and a net loss of $45.5 million, compared with $38.8 million a year earlier.

Lyell, a late-stage clinical company developing next-generation CAR T-cell therapies, completed the planned technology transfer of LYL273 to its LyFE Manufacturing Center in Bothell, Washington, in September 2026 after FDA review of an improved manufacturing process and updated analytical methods.

The company said LyFE is implementing the improved process and analytical methods to enhance manufacturing performance and increase capacity. The Phase 1/2 trial of LYL273 in relapsed/refractory metastatic colorectal cancer continues to enroll patients, including dosing with product manufactured using the new process, with the goal of determining the recommended Phase 2 dose and optimizing the safety management plan. Additional clinical data from the 3L+ mCRC cohort and an End-of-Phase 1 meeting with the FDA are expected in 2027, later than the second-half-2026 timing given after the prior quarter.

The solid-tumor program had been a secondary thread through 2026. In the second quarter, Lyell had reported that a gastrointestinal prophylaxis regimen and a standardized safety plan had reduced Grade 2 or higher diarrhea or colitis from 55% to 10%, and had amended the U.S. Phase 1 trial to a Phase 1/2 design to allow a seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment. Fast Track designation for mCRC remains in place.

Ronde-cel, the dual-targeting CD19/CD20 CAR T-cell candidate for relapsed/refractory large B-cell lymphoma, remained the nearer-term commercial path. Lyell announced updated PiNACLE pivotal-trial data in more than 80 patients from the 3L+ setting and from the Phase 1/2 second-line cohort in abstracts accepted for ASH 2026, December 12–15. Among 44 efficacy-evaluable patients in 3L+ PiNACLE, the overall response rate was 91% and the complete response rate was 77%. Median duration of complete response and median progression-free survival were not reached; the estimated continued complete response rate was 92% at six months and 75% at 12 months. No Grade 3 or higher CRS was observed, and Grade 3 or higher ICANS was reported in 9% of patients.

Pivotal PiNACLE data disclosure is on track for mid-2027, with a Biologics License Application expected to follow in the second half of 2027, matching the timeline given after the second quarter. Enrollment in PiNACLE is expected to complete by year-end. PiNACLE-H2H, the Phase 3 randomized trial versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in second-line LBCL, continues to enroll. President and Chief Executive Officer Lynn Seely said the company is now focusing on preparation for commercialization.

Research and development expenses were $40.9 million for the three months ended September 30, 2026, compared with $28.2 million a year earlier. The company said the $12.7 million increase was primarily a $12.2 million rise in research activities, collaborations and outside services from increased clinical-trial activity. Non-GAAP R&D was $38.8 million versus $26.2 million. General and administrative expenses were $9.3 million, compared with $10.7 million a year earlier, which the company said was primarily due to lower professional-services expenses.

Net loss was $45.5 million for the third quarter, compared with $38.8 million a year earlier. The company attributed the $6.7 million increase primarily to the R&D rise, partly offset by a $4.0 million prior-year loss on the securities purchase agreement put/call that did not recur. Non-GAAP net loss increased $12.2 million to $41.3 million from $29.1 million, which the company said was driven by increased clinical-trial activity and lower interest income. Revenue was $3,000.

Cash, cash equivalents and marketable securities were $194.0 million as of September 30, 2026, down from $228.0 million as of June 30. In November 2026, Lyell announced an $80.0 million private placement with participation from existing and new investors. The company said those proceeds, together with the September 30 cash balance, are expected to fund operations into 2028, extending the prior runway of into the third quarter of 2027 and covering the anticipated second-half-2027 BLA submission for ronde-cel as well as updated LYL273 data.