Lyell Immunopharma (LYEL) Q3 2026 earnings summary

Executive summary

• Ronde-cel 3L+ data showed 91% ORR and 77% CR among 44 patients; 2L data showed 95% ORR and 76% CR among 37 patients, with pivotal trials underway.

• In 3L+, estimated continued CR rates were 92% at six months and 75% at 12 months; median duration of CR and median PFS were not reached. No Grade 3+ CRS occurred; Grade 3 ICANS was reported in 9%.

• Q3 net loss was $45.5M; 9M net loss was $114.4M, partly reflecting a $17.6M SPA put/call fair-value gain.

• LYL273 dosing continued after its LyFE technology transfer; an $80.0M private placement was agreed on November 3, 2026, subject to customary closing conditions.

Financial highlights

• Q3 revenue was $3K vs. $15K year over year; 9M revenue was $9K vs. $30K. No product-sale revenue has been generated.

• Q3 GAAP operating loss was $48.3M vs. $37.3M and net loss was $45.5M vs. $38.8M; 9M operating loss was $139.9M vs. $141.8M and net loss was $114.4M vs. $133.7M.

• Q3 R&D expense rose to $40.9M from $28.2M; 9M R&D rose to $117.0M from $106.5M, primarily on higher clinical activity and outside services.

• Q3 G&A expense fell to $9.3M from $10.7M; 9M G&A fell to $28.4M from $34.5M, largely reflecting lower personnel and professional-service costs.

• Q3 non-GAAP net loss was $41.3M vs. $29.1M; non-GAAP R&D was $38.8M vs. $26.2M and G&A was $6.9M vs. $7.5M.

Outlook and guidance

• PiNACLE enrollment was expected to complete by year-end; pivotal data are expected mid-2027, followed by a planned BLA submission in 2H 2027.

• PiNACLE-H2H progress update was expected in 2H 2026; the randomized 2L trial continues enrollment and compares ronde-cel with investigator’s choice of two approved CAR T therapies.

• Additional LYL273 clinical data and an FDA End-of-Phase 1 meeting are expected in 2027; work continues on recommended Phase 2 dose selection and safety management.

• Current operating plan cash was expected to cover working capital and capital expenditures for at least 12 months; with private-placement proceeds, operations are expected to be funded into 2028.

• R&D and G&A expenses are expected to increase as trials, manufacturing capabilities and operating support expand.