CAR - T Immunotherapy
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Cellectis Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswireยท 2025-11-07 21:30
Core Insights - Cellectis reported promising clinical data for its product candidates lasme-cel (UCART22) and eti-cel (UCART20x22), indicating their potential to improve outcomes in relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and non-Hodgkin lymphoma (r/r NHL) respectively [3][4][11] Financial Results - As of September 30, 2025, Cellectis had $225 million in cash, cash equivalents, and fixed-term deposits, which is projected to fund operations into the second half of 2027 [4][26] - Consolidated revenues and other income for the nine-month period ended September 30, 2025, were $67.4 million, up from $34.1 million in the same period in 2024, primarily driven by activities related to the AstraZeneca collaboration [29] - Consolidated net loss attributable to shareholders for the nine-month period ended September 30, 2025, was $41.3 million, compared to a loss of $42.7 million in the same period in 2024 [34] Clinical Development - The Phase 1 BALLI-01 study of lasme-cel showed an overall response rate (ORR) of 68% with the Cellectis-manufactured product, and 100% in the target Phase 2 population [6][7] - The first interim analysis for the pivotal Phase 2 BALLI-01 trial is expected in Q4 2026, with a Biologics License Application (BLA) anticipated in 2028 [8][9] - For eti-cel, preliminary data indicated an ORR of 86% and a complete response (CR) rate of 57% in the ongoing study [11] Pipeline Highlights - Lasme-cel is positioned as a potentially transformative therapy for r/r B-ALL, with a projected peak gross sales potential of approximately $700 million by 2035, which could increase to $1.3 billion with label expansions [9] - The company plans to present further updates on eti-cel at the ASH 2025 Annual Meeting [10][14] Innovation and Collaboration - Cellectis is advancing its gene editing technology, including the use of circular single-stranded DNA (CssDNA) as a non-viral template for gene therapy, which has shown high gene insertion frequency in hematopoietic stem and progenitor cells [16][22] - A strategic collaboration with AstraZeneca aims to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs [23]