Cellectis (ALCLS) Q3 2025 earnings summary

Executive summary

• Lasme-cel (UCART22) in r/r B-ALL showed an ORR of 68% with Process 2, 83% at RP2D, and 100% in the target Phase 2 population; median OS for MRD-negative CR/CRi was 14.8 months.

• Eti-cel (UCART20x22) in r/r NHL demonstrated an ORR of 86% and a CR rate of 57% at the current dose level.

• Interim analysis for BALLI-01 Phase 2 expected in Q4 2026; full Phase 1 dataset for eti-cel expected in 2026.

• Cash, cash equivalents, and fixed-term deposits totaled $225 million as of September 30, 2025, providing runway into H2 2027.

Financial highlights

• Revenues and other income for the nine months ended September 30, 2025, were $67.4 million, up from $34.1 million year-over-year, mainly due to AstraZeneca collaboration activities.

• R&D expenses were $69.1 million, slightly down from $69.7 million year-over-year.

• SG&A expenses increased to $15.0 million from $14.2 million, mainly due to higher stock-based compensation.

• Net loss attributable to shareholders was $41.3 million (or $0.41 per share) for the nine months, compared to $42.7 million (or $0.49 per share) year-over-year.

• Adjusted net loss was $37.4 million (or $0.37 per share) for the nine months, compared to $40.4 million (or $0.46 per share) year-over-year.

• For Q3 2025, revenues and other income were $37.2 million, with net income of $0.6 million (or $0.01 per share), compared to a net loss of $23.1 million (or $0.23 per share) in Q3 2024.

Outlook and guidance

• First interim analysis for BALLI-01 Phase 2 is expected in Q4 2026; BLA submission anticipated in 2028.

• Full Phase 1 dataset for eti-cel, including low-dose IL-2 cohorts, to be presented in 2026.

• Cash position expected to fund operations into H2 2027.