Cellectis S.A. Q2 2025: Key Contradictions on Arbitration, Alemtuzumab Strategy, and Trial Designs

Arbitration outcome expectations and CD19 product recovery, incorporation of alemtuzumab in pivotal trial planning, phase II trial design for Lasme-cel, FDA regulatory support and pivotal trial design, alemtuzumab in treatment regimen are the key contradictions discussed in Cellectis S.A.'s latest 2025Q2 earnings call



Product Development and Clinical Trials:
- Cellectis completed end of Phase I discussions with FDA and EMA, preparing for the initiation of a pivotal Phase II trial for lasme-cel in relapsed or refractory acute lymphoblastic leukemia in the second half of this year.
- The company anticipates presenting data from the NatHaLi-01 study and outlining its late-stage development strategy late in 2025.
- Progress in clinical trials is driven by Cellectis' focus on addressing unmet medical needs in hematological malignancies and its strategic collaborations, such as the AstraZeneca partnership.

AstraZeneca Partnership and R&D Activities:
- Cellectis is advancing research and development activities under three cell and gene therapy programs with AstraZeneca, including allogeneic CAR-T for hematological malignancies and solid tumors, and in vivo gene therapy for a genetic disorder.
- The partnership aims to combine Cellectis' expertise in vector and gene editing technologies with AstraZeneca's capabilities in drug discovery and development.
- Collaboration with AstraZeneca is expected to accelerate the development of novel therapies, enhancing Cellectis' competitiveness in the gene therapy market.

Investor R&D Day and Strategic Initiatives:
- Cellectis announced an Investors R&D Day in New York City on October 16, featuring presentations on the Phase I data set and late-stage development strategy for lasme-cel in acute lymphoblastic leukemia.
- The event is aimed at sharing Cellectis' vision and capabilities with investors and key opinion leaders.
- The strategic initiative is aimed at building investor confidence and awareness around Cellectis' pipeline and positioning in the competitive biotech market.

Cash Position and Financial Outlook:
- Cellectis' cash, cash equivalents, and fixed-term deposits as of June 30, 2025, totaled $230 million, sufficient to fund operations into H2 2027.
- The company reported a decrease of $33.2 million in cash, primarily due to operational expenses and payments to suppliers.
- The strong cash position supports Cellectis' ongoing clinical trials and R&D investments, enhancing its financial stability and resilience amidst market challenges.

Arbitration with Servier:
- Cellectis initiated arbitration with Servier to protect its interests, seeking termination of the agreement and fair compensation for the lack of development of the licensed CD19 products.
- The arbitral decision is expected by December 15, 2025.
- Cellectis is pursuing this action to safeguard its intellectual property and financial interests, underscoring its commitment to its shareholders and stakeholders.