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Lyell Immunopharma (LYEL) investor relations material
Lyell Immunopharma Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Advanced pivotal trials for lead CAR T-cell therapy (ronde-cel) in large B-cell lymphoma, with strong response rates in both 2L and 3L+ settings and manageable safety profile; received RMAT designation from the FDA for both settings.
Acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell candidate for metastatic colorectal cancer, showing a 67% overall response rate and 83% disease control rate at the highest dose in a U.S. Phase 1 trial.
Transitioned manufacturing to the LyFE facility, supporting clinical and early commercial supply.
Raised $50M in equity financing and secured options for an additional $50M, strengthening liquidity.
Cash position of $319.6M–$320M at quarter-end, expected to fund operations into 2027 through key milestones.
Financial highlights
Cash, cash equivalents, and marketable securities totaled $319.6M–$320M as of September 30, 2025, down from $384M at year-end 2024.
Net loss for Q3 2025 was $38.8M (GAAP), improved from $44.6M in Q3 2024; non-GAAP net loss was $29.1M for Q3 2025.
Research and development expenses decreased to $28.2M (GAAP) and $26.2M (Non-GAAP) in Q3 2025 from $39.5M in Q3 2024.
General and administrative expenses were $10.7M (GAAP) and $7.5M (Non-GAAP) in Q3 2025, both lower year-over-year.
Operating cash outflow was $117.8M for the nine months ended September 30, 2025.
Outlook and guidance
Existing cash resources expected to fund operations into 2027 and support advancement of the pipeline through key clinical milestones.
Anticipates additional capital needs for late-stage development and commercialization.
Plans to present updated pivotal trial data at ASH in December 2025 and submit a BLA for ronde-cel in 2027.
First patient enrollment in the PiNACLE-H2H Phase 3 trial expected by early 2026; next LYL273 Phase 1 data update anticipated in H1 2026.
IND submission for a new solid tumor CAR T-cell candidate expected in 2026.
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