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Cellectis SA

Cellectis SA Q1 FY2024 earnings call

May 30, 2024 · fiscal period ended 2024-03

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Summary

Generated 2024-05-30

Management highlights

• Strategic collaboration with AstraZeneca: Initial $105M investment, additional $140M investment, AstraZeneca now owns ~44% of share capital. • Clinical trials: BALLI-01 trial with UCART22-P2 showed higher response rate at dose Level 2; NatHaLi-01 trial with UCART20x22 had 100% response at starting dose; AMELI-01 trial enrolling patients. • Financials: Cash and cash equivalents as of March 31, 2024, were $143M, expected to fund operations into 2026; consolidated net income improved from $30.1M loss in Q1 2023 to $5.6M income in Q1 2024. • Management: Arthur Stril appointed as interim CFO.

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Segment performance

As of March 31, 2024, cash, cash equivalents, restricted cash, and fixed-term deposits classified as current financial assets amounted to $143 million. The consolidated net income attributable to shareholders of Cellectis was $5.6 million for the three months ended March 31, 2024, compared to a $30.1 million loss in the same period in 2023. The company believes its cash and cash equivalents will be sufficient to fund operations into 2026.

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Guidance

• The company believes its cash and cash equivalents will be sufficient to fund operations into 2026. • Expect data disclosures for BALLI-01 and NatHaLi-01 clinical trials by the end of 2024, including completion of escalation phases for these studies.

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Risks

• Uncertainties in clinical trial results and regulatory approvals for ongoing trials. • Market competition in the cell and gene therapy space could impact product adoption.

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Q&A highlights

Q: Wondering if there is any strategic change regarding the strategy from a Cellectis perspective? And also how much AstraZeneca can have access to your manufacturing capability both in New Jersey and in Paris. And lastly, very quickly regarding the upcoming data by the year-end '24, I assume you will very likely be at ASH. Can you give us the status of the enrollment for both BALLI-01 and NatHaLi-01? And what kind of data sets should we expect to see?

A: This is Arthur. The strategy on wholly owned assets hasn't changed; pushing 22, 20x22, and 123. AstraZeneca can leverage manufacturing capabilities. Mark provides update: continued enrollment, expect data disclosures by end of 2024 for both studies.

Q: On UCART20x22, can you add some color how many sites are active right now? And will you be able to identify RP2D by year-end? And if you are enrolling three patients per dose level, so should we expect around 10- to 12-patient data by year-end?

A: Mark says sites open in U.S. and EU; hope to complete escalation by end of 2024, which would declare RP2D.

Q: Can you provide any further granularity on the cadence of readouts across the program this year? And what your expectations are for the respective data sets?

A: Mark says for 22 and 20x22, expect completion of escalation and data discussion by end of 2024; 123 study continues enrolling.

Q: Provide some color as to where things sit as it relates to the collaborative work you're doing with the large pharma here and when we might expect to hear the first program announced. And then I was also hoping you could talk a little bit about how you're thinking about potential plans in autoimmune indications. And then finally, if I may, I wanted to ask about what the expectations are for the year-end updates from BALLI-01 and NatHaLi-01 as it relates to durability? How are you thinking about the bar for success in those studies with the allogeneic platform here?

A: Arthur says work with AstraZeneca is in full gear, preselecting targets; Mark says bar for durability includes 3-month CR for 22 and 6-month for 20x22.

Q: In terms of the partner programs, could you just give a brief overview on what we should be on the lookout, let's say, throughout this year?

A: André mentions Allogene's programs like ALPHA3 trial, TRAVERSE trial updates.

Q: On the dose expansion strategy. Do you see a scenario that the dose expansion studies could convert to registrational studies? And if so, what would be the timeline look like? And then the second, I wanted to know what do you think the target population would be for a registrational trial? Is that going to be something like a relapsed/refractory following the CD19 treatment?

A: Mark says expansion could be pivotal, but timeline needs regulatory discussions; target population includes relapsed/refractory following CD19 treatment.

Q: 20x22. So as we've talked before, it seems like this program has great potential in EU market because like less competition there. So can you elaborate to talk about that?

A: Mark says less autologous CAR T cell therapy availability in EU, sites open in France and Spain, planning to open more countries.

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May 30, 2024

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