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Cellectis SA

Cellectis SA Q3 FY2023 earnings call

November 7, 2023 · fiscal period ended 2023-09

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Summary

Generated 2023-11-07

Management highlights

• Strategic collaboration with AstraZeneca: Initial $105M payment, including $80M equity investment and $25M upfront, with potential additional $140M. Collaboration focuses on developing novel cell and gene therapies across multiple therapeutic areas, with Cellectis retaining ownership of clinical stage assets. • Preclinical data releases: Disruptive preclinical data on gene editing of stem cell gene therapy for immunological disease and multi-armored allogenic CAR-T cell targeting MUC1 for triple negative breast cancer. • Clinical trial updates: BALLI-01 trial of UCART22 shows improved response rates with in-house manufacturing; NATHALI-01 trial of UCART20x22 has 100% responses at initial dose; AMELI-01 trial of UCART123 continues enrolling patients.

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Segment performance

No detailed breakdown of product segment financial performance in absolute terms and revenue contribution % provided in the transcript.

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Guidance

• Cash position: Cash, cash equivalents, restricted cash was $72M as of Sep 30, 2023, with AstraZeneca agreement adding $105M. Company believes cash runway extends into 2026 with additional $140M potential investment and EUR15M borrowing. • Financials: Net loss for 2023 nine months was $58M, with decrease in R&D and SG&A expenses partially offset by financial gains from de-consolidation and other items.

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Risks

• Forward statements are subject to risks and uncertainties that may cause actual results to differ from forecasts. Risks are described in recent SEC filings, including Form 20F and subsequent filings.

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Q&A highlights

Q: On UCART20x22, do you plan to increase enrollment sites and how many dose levels to study before finalizing RP2D?

A: Mark Frattini states they anticipate escalation, with data from subsequent escalation determining RP2D.

Q: Timeline for UCART123 clinical data and next step for UCART22 potential to advance to pivotal study?

A: Mark Frattini says UCART123 clinical data anticipated next year; UCART22 has dose escalated to 2.5 million cells per kilo and data will guide next steps.

Q: Timeline for AstraZeneca to select lead targets and potential additional $140M equity investment?

A: Arthur Stril says AstraZeneca will choose up to 10 candidates from 25; Mark Frattini notes additional $140M investment is subject to shareholder approval and regulatory clearances.

Q: Durability of responses in BALLI-01 and NATHALI-01 and status of UCART123 commercial product?

A: Mark Frattini says durability remains to be seen with 3-6 month follow-up in view; UCART123 still using CDMO-made product currently.

Q: Details on grade by AE in UCART22 abstract and impact on study?

A: Mark Frattini explains grade 5 events were related to bacterial infection long after assessment, not affecting further study direction.

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Key numbers

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Transcript

November 7, 2023

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