From GlobeNewswire: 2025-05-13 16:05:00

Lyell Immunopharma, Inc. presented new clinical data on LYL314, a dual-targeting CAR T-cell product for large B-cell lymphoma at a conference. The FDA granted RMAT designation to LYL314 for third-line treatment. The company plans to initiate pivotal trials in 2025 and 2026. They have $330.1 million in cash to support their pipeline through 2027.

LYL314 is a promising CAR T-cell product designed to target CD19/CD20. Clinical data shows a 94% response rate in patients with large B-cell lymphoma. No Grade 3 or greater cytokine release syndrome was reported. The product is now manufactured at the LyFE Manufacturing Center in Washington. Pivotal trials are planned for 2025 and 2026.

Lyell is also advancing a pipeline of CAR T-cell product candidates for solid tumors. They expect to submit an IND for a fully-armed CAR T-cell product in 2026. Preclinical data on engineered T cells for solid tumors will be presented at a gene therapy conference. Their synthetic stimulatory agent, Stim-R, shows promise in lymphocyte manufacturing.

In the first quarter of 2025, Lyell reported a net loss of $52.2 million, compared to $60.7 million in 2024. R&D expenses were $43.4 million, and G&A expenses were $14.0 million. Cash, cash equivalents, and marketable securities totaled $330.1 million as of March 31, 2025. Non-GAAP financial measures are provided for investors and analysts to better understand the company’s performance.



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