Cellectis (ALCLS) R&D Day 2025 summary
Event summary combining transcript, slides, and related documents.
R&D Day 2025 summary
3 Feb, 2026Pipeline overview and program updates
UCART22 (lasme-cel), an allogeneic off-the-shelf CAR-T targeting CD22, is advancing to a pivotal phase II trial for relapsed/refractory B-ALL, with first patient enrollment expected by year-end and a focus on patients aged 12–50 years.
Eti-cel (UCART20x22) for r/r NHL showed an 86% ORR and 57% CR rate in preliminary data, with further updates expected by end of 2025.
Internalized manufacturing enables scalable, high-quality, and cost-controlled production, with capacity expansion planned to meet global demand and support AstraZeneca collaborations.
Additional programs include Epicel (dual CD20/CD22 targeting) and preclinical in vivo gene therapy, with key data readouts expected by 2026.
Clinical trial data and development milestones
Phase I/II data for UCART22/lasme-cel show high response rates in heavily pretreated B-ALL patients, with 100% response and high MRD negativity in the phase II target population; median OS for MRD-negative responders reached 14.8 months.
Safety profile is favorable, with low rates of severe CRS, ICANS, and GvHD, and manageable toxicity.
Most eligible patients proceeded to transplant, supporting the therapy as a bridge to HSCT.
Pivotal phase II is designed as a registrational trial, with BLA submission targeted for 2028.
R&D strategy and innovation priorities
Emphasis on allogeneic, off-the-shelf CAR-T therapies for scalability, standardization, and rapid patient access.
Strategic focus on internal manufacturing, process optimization, and expansion into in vivo gene editing and dual-targeting constructs.
Achieving MRD-negative remission to enable stem cell transplantation and improve survival.
Latest events from Cellectis
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Q4 202520 Mar 2026 - Q1 2025 revenues up to $12M, net loss $18.1M; cash runway into H2 2027, key data readouts ahead.ALCLS
Q1 202520 Mar 2026 - Cash runway extended to 2027 as CAR-T pipeline and partnerships drive clinical progress.ALCLS
Q3 202416 Jan 2026 - AstraZeneca partnership and strong clinical progress set up major 2025 milestones in CAR-T therapies.ALCLS
JMP Hematology and Oncology Summit 202412 Jan 2026 - $140M investment boosts cash to $264M, narrows net loss, and advances CAR-T milestones.ALCLS
Q4 202426 Dec 2025 - 44 million shares registered for resale by a major investor, no proceeds to the company.ALCLS
Registration Filing16 Dec 2025 - Shelf registration allows up to $200M in securities offerings to fund gene-editing and CAR T-cell programs.ALCLS
Registration Filing16 Dec 2025 - Pivotal trials advance with $230M cash runway into H2 2027 despite higher net loss.ALCLS
Q2 202523 Nov 2025 - Strong clinical results and improved financials position the pipeline for future growth.ALCLS
Q3 20258 Nov 2025