Cellectis (ALCLS) Q2 2025 earnings summary

Executive summary

• UCART22 (lasme-cel) is advancing to pivotal Phase II trials for relapsed/refractory B-ALL in H2 2025, following regulatory alignment with FDA and EMA and completion of Phase I; full Phase I data to be presented at R&D Day in October 2025.

• NATHALI-01 (UCART20x22/eti-cel) in relapsed/refractory NHL continues Phase I enrollment, with data expected late 2025 and late-stage strategy to be outlined by year-end.

• Three cell and gene therapy programs are progressing under the AstraZeneca partnership, targeting hematological malignancies, solid tumors, and a genetic disorder.

• Arbitration with Servier over CD19 product rights and compensation is ongoing, with a decision expected by December 15, 2025.

• Board changes include the appointment of André Muller and updates to the Audit Committee.

Financial highlights

• Cash, cash equivalents, and fixed-term deposits totaled $230 million as of June 30, 2025, down from $264 million at year-end 2024.

• Revenues for H1 2025 were $27.4 million, up from $12.6 million in H1 2024, mainly due to AstraZeneca collaboration milestones.

• Net loss attributable to shareholders was $41.9 million ($0.42/share) for H1 2025, compared to $19.6 million ($0.24/share) in H1 2024, mainly due to adverse financial results and FX losses.

• Operating loss for H1 2025 was $23.8 million, improved from $38.1 million in H1 2024.

• Sufficient liquidity to fund operations into H2 2027, including pivotal studies for both UCART22 and UCART20x22.

Outlook and guidance

• Pivotal Phase II trial for UCART22 to initiate in H2 2025, with expanded trial sites in the US, Europe, and UK.

• Full Phase I dataset for UCART22 and late-stage development strategy to be disclosed at R&D Day on October 16, 2025.

• NATHALI-01 Phase I data to be presented at ASH and late-stage development plans to be shared by year-end; Phase II preparation expected in 2026.

• Cash runway assumptions include all pivotal study costs and are prudent regarding milestone/non-dilutive funding.

• Focus remains on advancing clinical pipeline and manufacturing capabilities in Paris and Raleigh.