Lyell Immunopharma (LYEL) Company Report

Lyell Immunopharma reported a net loss of $38.8 million for the third quarter ended September 30, 2025, compared to a net loss of $44.6 million for the same period in 2024.
As of September 30, 2025, the company held approximately $320 million in cash, cash equivalents, and marketable securities, which is expected to support advancing its pipeline into 2027 through key clinical milestones.
Lyell acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer, which demonstrated a 67% overall response rate at the highest dose level in a Phase 1 clinical trial.
The U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in the second-line (2L) setting.
The company announced the initiation of PiNACLE \u2013 H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial for aggressive LBCL in the 2L setting, with enrollment anticipated by early 2026.

Nov 12, 2025, 9:12 PM

Lyell Immunopharma Reports Q3 2025 Financial Results and Pipeline Progress

LYEL

Earnings

Guidance Update

New Projects/Investments

Lyell Immunopharma reported approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is projected to support pipeline advancement into 2027.
The company received RMAT designation from the U.S. FDA for ronde-cel for relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting and initiated PiNACLE - H2H, a Phase 3 head-to-head clinical trial for ronde-cel in 2L LBCL, with enrollment expected to begin by early 2026.
Lyell acquired exclusive global rights to LYL273, a novel CAR T-cell product candidate that achieved a 67% overall response rate and 83% disease control rate at the highest dose level in a Phase 1 trial for refractory metastatic colorectal cancer.
For the third quarter ended September 30, 2025, the GAAP net loss was $(38,846) thousand.

Nov 12, 2025, 9:05 PM

Lyell Immunopharma Acquires Global Rights to LYL273 for Metastatic Colorectal Cancer

LYEL

M&A

New Projects/Investments

Guidance Update

Lyell Immunopharma, Inc. acquired exclusive global rights to LYL273, a novel CAR T-cell product candidate for metastatic colorectal cancer, from Innovative Cellular Therapeutics, effective November 6, 2025.
The acquisition included an upfront payment of $40 million in cash and 1.9 million shares of Lyell common stock to ICT Holdings, with potential contingent payments up to $820 million in milestones and tiered royalties.
In a U.S. Phase 1 clinical trial, LYL273 achieved a 67% overall response rate and an 83% disease control rate at the highest dose level in patients with refractory metastatic colorectal cancer.
Lyell anticipates its cash will be sufficient to fund operations into 2027 and updated its 2025 net cash use guidance to between $155 million and $160 million, excluding the upfront payment.

Nov 10, 2025, 12:32 PM

Lyell Immunopharma Acquires Global Rights to LYL273 and Updates Financial Guidance

LYEL

M&A

New Projects/Investments

Guidance Update

Lyell Immunopharma has acquired exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) to LYL273, a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics.
In a U.S. Phase 1 clinical trial, LYL273 demonstrated a 67% overall response rate and an 83% disease control rate at the highest dose level in patients with refractory mCRC, based on data as of October 28, 2025.
The transaction includes an upfront payment of $40 million and 1.9 million shares of Lyell common stock to ICT, with potential for additional cash and equity milestones totaling up to $820 million and tiered royalties on future net sales.
Lyell updated its financial outlook, now expecting net cash use in 2025 to be between $155 million and $160 million (excluding the $40 million upfront payment), which is below its previous guidance of $175 million to $185 million, and anticipates its cash will fund operations into 2027.

Nov 10, 2025, 12:30 PM

Lyell Immunopharma to present new clinical and translational data for ronde-cel at 67th ASH Annual Meeting

LYEL

New Projects/Investments

Lyell Immunopharma (LYEL) announced it will present new clinical and translational data for its dual-targeting CD19/CD20 CAR T-cell candidate, rondecabtagene autoleucel (ronde-cel), for aggressive large B-cell lymphoma (LBCL) at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition on December 7, 2025.
As of June 27, 2025, the Phase 1/2 trial data for ronde-cel in LBCL showed high overall response rates and complete response rates with an encouraging safety profile.
Ronde-cel has been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations by the FDA for relapsed and/or refractory diffuse LBCL in the third- or later-line setting.
Lyell is currently enrolling patients in the PiNACLE single-arm registration trial and is initiating a randomized controlled trial of ronde-cel in LBCL.

Nov 3, 2025, 2:00 PM

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