Cellectis S.A. (NASDAQ: CLLS) anticipates filing a Biologics License Application for lasme-cel with the FDA in 2028, advancing its gene-edited CAR-T therapy toward commercialization. The company projects peak gross sales of $700M annually by 2035 across the U.S., U.K., and four major European markets, treating approximately 1,100 B-cell acute lymphoblastic leukemia patients yearly.
The clinical-stage biotech held $225M in cash and equivalents at the end of Q3 2025, down from $264M at year-end 2024. Management stated this runway extends into the second half of 2027. The cash position includes $168.2M in fixed-term deposits, with $137.6M maturing in October 2026.
Cellectis reported $62.6M in revenues for the nine months ended September 30, up from $28.8M in the same 2024 period. The increase stems primarily from collaboration activities with AstraZeneca. Third-quarter revenues alone totaled $35.2M, compared to $16.2M a year earlier.
The company narrowed its net loss to $41.3M for the nine-month period, versus $42.7M in 2024. Diluted loss per share improved to $0.41 from $0.49. Third-quarter results showed net income of $0.6M, reversing a $23.1M loss from Q3 2024.
Operating expenses held relatively flat. R&D spending declined slightly to $69.1M from $69.7M, while selling, general and administrative costs rose to $15M from $14.2M. The company attributed increased personnel costs to stock-based compensation.
Cellectis projects lasme-cel could generate up to $1.3B in peak sales if approved for expanded indications, including second-line treatment and first-line consolidation in minimal residual disease-positive patients. The allogeneic approach positions the therapy for higher margins compared to autologous CAR-T products.
The BLA filing timeline positions Cellectis for potential commercialization in 2029 or 2030, depending on FDA review duration. Manufacturing capacity exists at company facilities in Paris and Raleigh, North Carolina.
Average shares outstanding increased to 100.3M from 87.4M, reflecting equity financing activities. The company maintains partnerships with AstraZeneca and other pharmaceutical firms for its gene-editing platform.