Cellectis reports Q2 2026 results as lasme-cel gains FDA RMAT status

Cellectis reported financial results for the second quarter of 2026 on August 6, 2026, covering the period ended June 30, 2026.

The company said in June 2026, it received FDA Regenerative Medicine Advanced Therapy designation for lasme-cel for treatment of relapsed or refractory CD22 positive B-cell acute lymphoblastic leukemia, based on BALLI-01 clinical data demonstrating promising efficacy and a manageable safety profile.¹ Full Phase 1 data from BALLI-01 were presented at the EHA 2026 congress, where the target Phase 2 population showed a 100% overall response rate (7/7), with 57% achieving complete remission or complete remission with incomplete count recovery (4/7), of whom 75% were minimal residual disease-negative. All responding patients proceeded to hematopoietic stem cell transplantation.¹ The first interim analysis for the pivotal Phase 2 portion of BALLI-01 is expected in the fourth quarter of 2026.¹

For eti-cel, in the NATHALI-01 trial, the optimal dose cohort of 8 patients showed an 88% overall response rate and a 63% complete response rate.¹ Cellectis expects to present the full Phase 1 dataset in the fourth quarter of 2026.¹

On partner programs, in July 2026, Allogene announced that the FDA granted RMAT and Fast Track designations to cema-cel for the treatment of adult patients with large B-cell lymphoma who, at the completion of first-line therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease.¹

On finances, Cellectis had $169 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits as of June 30, 2026, which the company believes is sufficient to fund operations into the fourth quarter of 2027.¹ Net loss attributable to shareholders was $39.6 million, or $0.39 per share, for the six months ended June 30, 2026, compared to a $41.9 million loss a year earlier.¹