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Cellectis S.A.

Cellectis S.A. Q4 FY2024 earnings call

March 14, 2025 · fiscal period ended 2024-12

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Summary

Generated 2025-03-14

Management highlights

Arthur Stril started the call, introducing the conference. Andre Choulika then highlighted key points for 2024: business development with AstraZeneca including start of R&D for three programs, AstraZeneca's $140 million equity investment, and drawing down EIB credit facility with cash runway to mid-2027. Clinical progress was also noted with Dr. Adrian Kilcoyne joining as CMO, UCART22 getting Orphan Drug Designations, and progress in NATHALI-01 study. Adrian Kilcoyne provided details on BALLI-01 and NATHALI-01 studies. Arthur Stril then discussed financial aspects like AstraZeneca's investment, collaboration payments, and cash position focusing on R&D and manufacturing

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Guidance

Cellectis expects to present Phase 1 data set and late stage development strategy for UCART22 in the third quarter of 2025. For the NATHALI-01 study, Phase 1 data set and late state development strategy are expected in late 2025. Cash runway allows funding operations into mid-2027 and they look forward to providing Phase 1 data sets for wholly-owned clinical product candidates in acute lymphoblastic leukemia and non-Hodgkin lymphoma later in the year

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Q&A highlights

Q: About upcoming data for UCART22, could give more color on patient number, data points, and forum?

A: Adrian Kilcoyne stated plan to have full Phase 1 dose escalation data set in the third quarter with possible additional data at ASH. Arthur Stril mentioned likely an ad hoc event for data release.

Q: Thoughts on internal bar for success for UCART22 third quarter readout?

A: Andre Choulika was confident in the data seen so far, considering the heavily pretreated patients and will have ongoing interactions with FDA and EMA.

Q: Near term milestones for AstraZeneca programs, and thoughts on novelness of targets?

A: Andre Choulika said progress is good, targets are carefully selected and potential to disclose data this year. On Servier arbitration, no comment.

Q: Discuss late stage development strategies for UCART22 and how data might inform decision?

A: Andre Choulika said they are planning interactions with FDA and EMA and believe there's a registration path.

Q: Regarding late safety program and partnership details with allogeneic on cema-cel?

A: Andre Choulika said trials reflect unique nature of allogeneic cell therapy. Arthur Stril discussed Allogene's strategy with cema-cel and ALLO-316.

Q: Do near-term mid-2025 readout trigger milestone payments for allo collaboration?

A: Arthur Stril said $410 million milestones are spread out and cash runway mid-2027 is conservative.

Q: Breakdown of R&D spend and terms with AstraZeneca collaboration?

A: Arthur Stril said research activities with AstraZeneca are fully reimbursed and net cash burn in 2024 was $60 million.

Q: Comment on Servier litigation potential outcomes and read-throughs from CARGO's discontinuation to UCART20x22?

A: Arthur Stril couldn't comment on Servier litigation. Adrian Kilcoyne said CARGO's setback shows unmet need for non-CD19 CAR T and their program isn't seeing same toxicity.

Q: Enrollment progress on UCART22 and UCART20x22, and recommended Phase 2 dose?

A: Andre Choulika said planned up to 40 patients in UCART22 Phase 1 and numbers are dependent on regulatory agreement

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Transcript

March 14, 2025

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