On November 4, 2026 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, reported financial results and business highlights for the third quarter ended September 30, 2026.
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"The updated ronde-cel data accepted for presentation at ASH (Free ASH Whitepaper) further strengthen our conviction in ronde-cel’s potential to meaningfully improve outcomes for patients with large B-cell lymphoma," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "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."
Third Quarter Updates and Recent Business Highlights
Rondecabtagene Autoleucel (ronde-cel): A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of relapsed/refractory large B-cell lymphoma
Ronde-cel is an autologous CAR T-cell product candidate under evaluation in two pivotal trials in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting (PiNACLE) and the second-line (2L) setting (PiNACLE‑H2H). A multi-cohort dose-escalation, dose-expansion Phase 1/2 trial is also ongoing. Ronde-cel targets B cells that express either CD19 or CD20 with a true ‘OR’ logic gate to achieve full potency at either target and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of adults with R/R diffuse LBCL in the 3L+ setting and also RMAT designation for the treatment of LBCL in the 2L setting.
Lyell announced today updated clinical data 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 patients with R/R LBCL in two abstracts accepted for presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (ASH 2026), taking place December 12–15, 2026.
The PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi-cohort trial, is ongoing. Pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in the second half of 2027. The primary endpoint of the trial is overall response rate, including an evaluation of duration of response.
PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting, continues to enroll patients. The trial’s primary endpoint is event-free survival.
LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of relapsed/refractory metastatic colorectal cancer (mCRC) and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.
In September 2026, Lyell completed the planned technology transfer for LYL273 to its LyFE Manufacturing Center (LyFE) in Bothell, Washington, following FDA review of an improved manufacturing process and updated analytical methods. LyFE is implementing the improved manufacturing process and updated analytical methods to enhance manufacturing performance and increase capacity. The Phase 1/2 clinical trial of LYL273 in patients with R/R mCRC continues to enroll patients, including dosing of patients with LYL273 manufactured using the new process at LyFE, with the goal of determining the recommended Phase 2 dose and optimizing the safety management plan.
Additional clinical data from the Phase 1/2 trial of LYL273 in patients with 3L+ R/R mCRC and an End-of-Phase 1 meeting with the FDA are expected in 2027.
Corporate Update
In November 2026, the Company announced a private placement of $80.0 million with participation from a high-quality syndicate of existing and new investors. The proceeds are expected to extend cash runway into 2028, beyond anticipated BLA submission for ronde-cel in the second half of 2027, as well as updated clinical data from the GCC-targeted LYL273 program for patients with mCRC.
Third Quarter 2026 Financial Results
Lyell reported a net loss of $45.5 million for the third quarter ended September 30, 2026, compared to a net loss of $38.8 million for the same period in 2025. The $6.7 million increase in net loss was primarily due to a $12.7 million increase in research and development expenses driven by increased clinical trial activity, partially offset by a $4.0 million prior-year loss on the securities purchase agreement put/call that did not recur. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the securities purchase agreement put/call relating to the Company’s July 2025 private placement transaction and success payment liabilities, increased by $12.2 million to $41.3 million for the third quarter ended September 30, 2026, compared to $29.1 million for the same period in 2025, primarily due to increased clinical trial activity and lower interest income.
GAAP and Non-GAAP Operating Expenses
Research and development (R&D) expenses were $40.9 million for the third quarter ended September 30, 2026, compared to $28.2 million for the same period in 2025. The $12.7 million increase was primarily due to a $12.2 million increase in research activities, collaborations and outside services due to increased clinical trial activity. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2026 were $38.8 million compared to $26.2 million for the same period in 2025.
General and administrative (G&A) expenses were $9.3 million for the third quarter ended September 30, 2026, compared to $10.7 million for the same period in 2025, primarily due to lower professional services expenses. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the third quarter ended September 30, 2026 were $6.9 million compared to $7.5 million for the same period in 2025.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of September 30, 2026 were $194.0 million compared to $247.2 million as of December 31, 2025. Lyell believes that its current cash, cash equivalents and marketable securities balances, together with the net proceeds from the $80.0 million private placement in November 2026, will be sufficient to meet working capital and capital expenditure needs into 2028.
(Press release, Lyell Immunopharma, NOV 4, 2026, View Source [SID1234674199])