Skip to content
CLLS

Cellectis S.A.

Cellectis S.A. Q2 FY2025 earnings call

August 5, 2025 · fiscal period ended 2025-06

EPS · actual vs est

/

Revenue · actual vs est

/
Ask about this call

Summary

Generated 2025-08-05

Management highlights

• Announced that Cellectis will host an Investors R&D Day in New York City on October 16, 2025, to present Phase I data set and late-stage development strategy for lasme-cel, UCART22. • Completed end-of-Phase I discussions with US FDA and European Medicines Agency for lasme-cel, UCART22, and anticipates initiating pivotal Phase II trial in H2 2025. • NatHaLi-01 study for eti-cel program, UCART20x22, expects data presentation from Phase I and late-stage development strategy outline late 2025. • Ongoing R&D activities under joint agreement with AstraZeneca on three cell and gene therapy programs. • Initiated arbitration with Servier in 2022, with arbitral decision expected by December 15, 2025. • Appointed André Muller to Board of Directors, and thanked Pierre Bastid and Axel-Sven Malkomes for their service. • Cash, cash equivalents, restricted cash, and fixed-term deposits as of June 30, 2025, total $230 million, sufficient to fund operations into H2 2027.

View in transcript ↓

Guidance

• Hosting Investors R&D Day on October 16, 2025, to share Phase I data and late-stage strategy for lasme-cel. • Anticipates initiating pivotal Phase II trial for lasme-cel in H2 2025. • NatHaLi-01 study expects data presentation late 2025. • Cash runway into H2 2027 includes costs for pivotal studies for lasme-cel and eti-cel.

View in transcript ↓

Risks

• Forward statements are subject to risks and uncertainties that may cause actual results to differ from forecasts, as detailed in recent SEC filings. • Uncertainties in clinical trial progress, arbitration outcomes, and regulatory approvals.

View in transcript ↓

Q&A highlights

Q: Could you contextualize the different scenarios and likely actions regarding the Servier arbitration decision by December 15? And share high-level thoughts on lasme-cel's Phase II trial design path forward.

A: Andre Choulika mentioned it's hard to predict arbitration scenarios but hopes to prevail, and defers the trial design question to Adrian Kilcoyne. Adrian Kilcoyne stated productive interactions with FDA and EMA, clear path forward for Phase II, and details to be shared at R&D Day.

Q: What data points to expect at the R&D Day and thoughts on FDA dynamics affecting pivotal trials?

A: Arthur Stril said R&D Day will present full Phase I data set for lasme-cel and late-stage development strategy including Phase II design. Adrian Kilcoyne noted no significant barriers from regulatory authorities, supportive feedback, and registration path seems clear.

Q: Thoughts on the bar for success in relapsed or refractory for UCART22, durability of response, and Allogene's CD52 lymphodepletion decision?

A: Adrian Kilcoyne said details on endpoints and durability will be shared at R&D Day. Stressed alemtuzumab importance in lymphodepletion, different product positionings, and risk-benefit assessments differ.

Q: Population and patient number for lasme-cel's pivotal trial, and size of eti-cel data set by year-end?

A: Adrian Kilcoyne said population details and patient numbers for pivotal trial will be shared at R&D Day. Eti-cel data set will have smaller patient numbers compared to lasme-cel.

View in transcript ↓

Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS
Revenue

Transcript

August 5, 2025

Full transcript unavailable for redistribution

The structured summary above covers the available call sections. Full transcript text is not included on this page.

Continue exploring

Prior quarters

This page presents the stored structured earnings-call summary and deterministic earnings calendar values. How this is generated. For informational purposes only; not investment advice.