Cellectis (ALCLS) Q3 2024 earnings summary

Executive summary

• Initiated three new programs with AstraZeneca: allogeneic CAR-T for hematological malignancies, allogeneic CAR-T for solid tumors, and in vivo gene therapy for genetic disorders.

• Focused clinical development on BALLI-01 (UCART22 for B-cell ALL) and NATHALI-01 (UCART20x22 for non-Hodgkin's lymphoma), deprioritizing UCART123 in AML to optimize resource allocation.

• Ongoing enrollment in Phase 1 trials for UCART22 and UCART20x22, with phase I dataset for BALLI-01 expected in 2025 and late-stage strategy to be presented in 2025.

• Appointment of Dr. Adrian Kilcoyne as Chief Medical Officer to advance cell therapy programs.

• Regulatory planning for phase II studies is ongoing, with endpoints and study design under discussion with authorities.

Financial highlights

• Cash, cash equivalents, restricted cash, and current financial assets totaled $264 million as of September 30, 2024, up from $156 million at year-end 2023, with runway projected into 2027.

• $47 million triggered under AstraZeneca agreement: $25 million upfront, $22 million in milestones, plus research cost reimbursement.

• Revenues and other income for the nine months ended September 30, 2024, were $34.1 million, up from $7.2 million year-over-year, mainly due to AstraZeneca and Servier milestones.

• Net loss attributable to shareholders was $42.7 million ($0.49/share) for the nine months ended September 30, 2024, compared to $59.3 million ($1.09/share) year-over-year.

• R&D expenses increased to $69.7 million from $62.7 million year-over-year; SG&A expenses rose to $14.2 million from $12.1 million.

Outlook and guidance

• Cash runway extended to fund operations into 2027, supported by milestone payments and prudent cash management.

• Continued focus on advancing UCART22 and UCART20x22 clinical programs and manufacturing capabilities.

• Phase 1 data and late-stage development strategy for UCART22 and UCART20x22 to be presented in 2025.

• Updates on AstraZeneca collaboration programs expected in 2025.