Cellectis (NASDAQ:CLLS), a clinical-stage biotechnology company using its proprietary TALEN® gene-editing platform to develop next-generation immunotherapies, announced its financial and operational results for the fiscal year ended December 31, 2025.
The company demonstrated significant clinical de-risking of its "off-the-shelf" CAR-T portfolio, led by standout data from the lasme-cel (UCART22) program.
In the target Phase 2 population for relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), lasme-cel achieved a 100% Overall Response Rate (ORR), positioning the candidate as a potential best-in-class allogeneic therapy.
The company's second lead asset, eti-cel (UCART123), also showed robust activity in patients with relapsed/refractory Acute Myeloid Leukemia (AML).
At the current dose level, eti-cel demonstrated an 88% ORR and a 63% Complete Response (CR) rate.
These results are particularly notable given the high unmet need in the AML space, where traditional treatments often fall short.
Management confirmed that the pivotal interim readout for lasme-cel is on track for the fourth quarter of 2026, a catalyst that could pave the way for a Biologics License Application (BLA) filing.
Financially, Cellectis bolstered its balance sheet through strategic collaborations and disciplined spending.
Consolidated revenue for 2025 reached $79.6 million, largely driven by milestone payments from partners like AstraZeneca and Sanofi.
While the company reported a consolidated net loss of $67.6 million, its liquidity position remains exceptionally strong.
Cellectis ended the year with $211 million in cash and equivalents, providing a clear financial runway into the second half of 2027.