Lyell Immunopharma, Inc.

What they do

Lyell engineers a patient's own T cells with proprietary CAR constructs and manufacturing protocols to target hematologic malignancies and solid tumors. Its lead candidate, rondecabtagene autoleucel (ronde-cel, LYL314), is a dual-targeting CD19/CD20 CAR T-cell therapy in two pivotal trials in relapsed/refractory large B-cell lymphoma (LBCL). In November 2025 it licensed LYL273 (formerly GCC19CART), a GCC-targeted CAR T-cell candidate for metastatic colorectal cancer, from Innovative Cellular Therapeutics. It wholly owns and operates the LyFE Manufacturing Center, which it expects to have capacity for more than 1,200 CAR T-cell doses per year.

Revenue drivers

• Product sales — None. Lyell states it has not generated any revenue from product sales and does not expect to for the foreseeable future unless a candidate is approved.
• Collaboration and license revenue — Historically the only reported revenue line, from strategic collaboration and license agreements; annual revenue fell from $130,000 in 2023 to $61,000 in 2024 and $36,000 in 2025.
• Rondecabtagene autoleucel (ronde-cel, LYL314) — Lead pre-commercial asset in R/R LBCL; would require FDA approval and a BLA submission, which management expects to follow pivotal data in mid-2027, before generating any sales.
• LYL273 — In-licensed, pre-commercial GCC-targeted CAR T-cell candidate for mCRC and other GCC-expressing cancers; no revenue today and still in Phase 1/2 development.

Recent performance

Annual revenue declined to $36,000 in 2025 from $61,000 in 2024 and $130,000 in 2023, with recent quarters at $2,000-$15,000. Net losses remain large: $343.0M in 2024 and $274.4M in 2025, with operating cash use of $162.4M and $150.0M in those years. At June 30, 2026, total assets were $311.2M, total liabilities $77.3M and shareholder equity $233.8M, including $73.0M of cash and equivalents. The company reported approximately $228.0M in cash, cash equivalents and marketable securities as of June 30, 2026, which it says funds operations into Q3 2027.

Strategy

Lyell is prioritizing ronde-cel in LBCL: the PiNACLE single-arm pivotal trial in 3L+ patients and the first-of-its-kind Phase 3 PiNACLE-H2H randomized trial versus investigator's choice of axi-cel or liso-cel in 2L. It is also advancing LYL273 in mCRC, and amended that U.S. Phase 1 trial to a Phase 1/2 design to enable seamless expansion into a potential pivotal single-arm Phase 2 trial, pending regulatory alignment, including new 2L and radiotherapy-combination cohorts. Research continues on next-generation CAR T candidates for solid tumors using its anti-exhaustion and arming technologies and proprietary manufacturing protocols. The company operates its own LyFE Manufacturing Center to supply clinical trial material and potential commercial launch.

Risks

• No approved product or product revenue — Lyell has never generated product sales and does not expect to for the foreseeable future, so it remains dependent on financing and collaboration/license revenue.
• Substantial and continuing losses — Net losses were $343.0M in 2024 and $274.4M in 2025, and operating cash use was $150.0M in 2025, with management expecting losses to continue.
• Clinical and regulatory uncertainty — Ronde-cel and LYL273 could fail to demonstrate safety or efficacy; pivotal ronde-cel data are expected mid-2027 and any BLA submission would follow, with no guarantee of approval.
• Cash runway and financing need — Management states approximately $228.0M in cash, cash equivalents and marketable securities at June 30, 2026 funds operations only into Q3 2027, meaning additional capital would be needed beyond that point.

Outlook

Management says PiNACLE is on track to report additional ronde-cel data in the second half of 2026, pivotal data in mid-2027 and a BLA submission expected to follow in the second half of 2027. Additional LYL273 data from the U.S. Phase 1 trial in 3L+ R/R mCRC and an End-of-Phase 1 FDA meeting are expected in the second half of 2026, along with a PiNACLE-H2H enrollment progress update. The company expects its roughly $228.0M of cash, cash equivalents and marketable securities at June 30, 2026 to provide runway into Q3 2027.