UCART22 - (BALLI-01)

June 11, 2026: Cellectis (NASDAQ: CLLS; Euronext Growth: ALCLS) announced it will present final Phase 1 data from BALLI-01 (lasme-cel, CD22-directed allogeneic CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and preliminary data from NATHALI-01 (eti-cel, dual CD20/CD22 allogeneic CAR-T) in relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) at the EHA 2026 Annual Congress (June 13).

Lasme-cel / BALLI-01 (r/r B-ALL): In the target Phase 2 population (n=7), ORR was 100% (7/7) with CR/CRi 57% (4/7); 75% of CR/CRi patients achieved MRD-negative status. All patients proceeded to HSCT. Safety: ≥Grade 3 CRS 4%, ≥Grade 3 ICANS 4%, and ≥Grade 3 IEC-HS 2%; all resolved. The pivotal Phase 2 BALLI-01 trial is open; first interim analysis expected Q4 2026. Oral presentation scheduled June 13 (Abstract 4689).

Eti-cel / NATHALI-01 (r/r B-NHL): As of Feb 2026 cutoff, 14 patients treated across three dose levels; in the optimal dose cohort, ORR 88% and CR 63%. Higher alemtuzumab exposure correlated with improved inflammatory milieu, greater eti-cel expansion, and higher response rates; responders showed sustained low-level IL-2 vs non-responders. Weight-based alemtuzumab dosing and subcutaneous low-dose IL-2 are being investigated. Full Phase 1 data expected Q4 2026. Poster scheduled June 13 (Poster 4758).