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Lyell Immunopharma (LYEL) guidance and outlook
Lyell Immunopharma's 10-Q filed Nov 4, 2026 makes 15 forward-looking statements.
Guidance and outlook
Forward-looking statements, 10-Q filed Nov 4, 2026
- Our investigational CAR T-cell therapies start with the identification of promising cancer targets.
- Our lead product candidate, rondecabtagene autoleucel, or ronde-cel, is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies.
- The data are detailed below under “Our Pipeline Programs—Ronde-Cel: Clinical Data.” Updated data from the PiNACLE clinical trial are expected to be reported during the ASH 2026 presentation, including data in additional patients and longer follow-up.
- To realize the potential of cell therapy for solid tumors, we acquired an exclusive global license for LYL273 (excluding mainland China, Hong Kong, Macau and Taiwan), a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, from Innovative Cellular Therapeutics Holdings Limited and Innovative Cellular Therapeutics (collectively, ICT) in November 2025.
- Our pipeline of next-generation CAR T-cell product candidates targets cancers with large unmet need and is summarized in Table 1 below:
- Our lead program, ronde-cel, is targeting patients with aggressive R/R large B-cell non‑Hodgkin lymphoma (NHL), more commonly referred to as LBCL.
- In November 2025, we acquired an exclusive global license, outside of mainland China, Hong Kong, Macau and Taiwan, from ICT for a next-generation GCC-targeted CAR T-cell product candidate (LYL273) with promising dose‑dependent clinical activity in patients with R/R mCRC in a Phase 1 trial conducted in the U.S.
- In September 2026, we completed the planned technology transfer of LYL273 to LyFE following FDA review of the improved manufacturing process and updated analytical methods intended to enhance manufacturing performance and increase capacity.
- Dosing of additional patients with the new process at LyFE is continuing with the goal of determining the recommended Phase 2 dose and optimized safety management plan to support End-of-Phase 1 discussions with the FDA.
- We are advancing a fully-armed solid tumor CAR T-cell product candidate with an undisclosed target, with the CAR T cells enhanced by multiple technologies, each designed to address different barriers to effective cell therapies, including T‑cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
- We anticipate that our research and development expenses will increase over the foreseeable future as we expand our research and development efforts including completing nonclinical studies, commencing planned clinical trials, conducting and completing current and planned clinical trials, seeking regulatory approvals of our product candidates, identifying new product candidates and incurring costs to acquire and…
- We anticipate that our general and administrative expenses will increase over the foreseeable future to support our continued research and development activities, operations generally, future business development opportunities, consulting fees, as well as the costs of operating as a public company such as costs related to accounting, audit, legal, regulatory and tax-related services associated with maintaining…
Lyell Immunopharma's latest quarter
Lyell Immunopharma, Q3 2026: revenue $3K (-80% year over year), net loss $45.5M, operating cash flow −$34.6M. The chart follows the revenue to costs, profit and cash.
Questions
What does Lyell Immunopharma expect?
Our investigational CAR T-cell therapies start with the identification of promising cancer targets. Our lead product candidate, rondecabtagene autoleucel, or ronde-cel, is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies. The data are detailed below under “Our Pipeline Programs—Ronde-Cel: Clinical Data.” Updated data from the PiNACLE clinical trial are expected to be reported during the ASH 2026 presentation, including data in additional patien
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.