Cellectis Reports Second Quarter 2025 Financial Results & Business Updates

 

• Cellectis to host an Investor R&D Day in New York City on October 16, 2025: Phase 1 dataset and late-stage development strategy for lasme-cel (UCART22) in r/r B-ALL to be presented
• End-of-Phase 1 meetings with FDA & EMA for lasme-cel (UCART22) in r/r B-ALL completed in July 2025; on track to launch pivotal Phase 2 in H2 2025
• Servier arbitration: arbitral decision expected to be rendered on or before December 15, 2025
• eti-cel (UCART20x22): Phase 1 study in r/r NHL ongoing with readout expected in late 2025
• AstraZeneca partnership: R&D activities are continuing to advance for the three programs initiated
• Appointment of Mr. André Muller as Director to Cellectis’ Board of Directors
• Cash, cash equivalents and fixed-term deposits of $230 million as of June 30, 2025[1] provides runway into H2 2027
• Conference call and webcast scheduled for tomorrow, August 5, 2025 at 8:00AM ET / 2:00PM CET

 

New York, NY – August 4, 2025 - Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today provided financial results for the second quarter 2025 ending June 30, 2025 and business updates.

“I am pleased to announce that Cellectis will host an Investor R&D Day in New York City on October 16, 2025. The Company’s leadership team and key opinion leaders will present the Phase 1 dataset and outline the late-stage development strategy for lasme-cel (UCART22) in r/r B-ALL and will share insights on the Company’s vision and differentiated capabilities,” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

“Our teams have remained focused on advancing research and developing solutions for patients with unmet medical needs. In July 2025, we completed the end-of-Phase 1 multidisciplinary meetings with both the FDA and EMA for lasme-cel in r/r B-ALL. We are excited about a pivotal Phase 2 which we expect to initiate in the second half of this year.”

 

Pipeline Highlights

UCART Clinical Programs

BALLI-01 study evaluating lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

• In July 2025, Cellectis completed the multidisciplinary end-of-Phase 1 regulatory interactions with both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Preparations are currently underway in anticipation for an amendment to initiate a pivotal Phase 2 of lasme-cel in r/r B-ALL, which is expected in H2 2025.

 

• Cellectis will present the Phase 1 dataset and late-stage development strategy for lasme-cel in r/r B-ALL at an Investor R&D Day that will take place on October 16, 2025 in New York City.

 

NatHaLi-01 study evaluating eti-cel (UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL)

• Cellectis continues to focus on the enrollment of patients in the NatHaLi-01 study and expects to present a Phase 1 readout for eti-cel in r/r NHL in late 2025.

 

Partnerships

Servier – Anti-CD19 CAR-T

• In May 2025, Allogene Therapeutics, Inc. (“Allogene”), Servier’ sublicensee, announced that, as part of the ALPHA3 clinical trial evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma, the milestone for lymphodepletion regimen selection and futility analysis has been shifted by approximately two quarters and is now expected by Allogene in the first half of 2026.

 

• On August 1, 2025, Allogene announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. According to Allogene, this decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. According to Allogene, this event was deemed unrelated to cema-cel. Allogene further announced that the amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same. The next milestone will be the futility analysis comparing MRD conversion and is expected by Allogene to occur 1H 2026.

Allogene – Anti-CD70 CAR-T

• In June 2025, Allogene presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma during an oral presentation at the 2025 ASCO Annual Meeting. The presentation focused on the Phase 1b expansion cohort from the Phase 1 TRAVERSE study in which patients were treated with a standard regimen of cyclophosphamide and fludarabine following by a single dose of 80 million CAR-T cells.

 

AstraZeneca – Joint Research and Collaboration Agreement

• Research and development activities are continuing to advance for the three cell and gene therapy programs under our Joint Research and Collaboration Agreement with AstraZeneca in November 2023 (the “AZ JRCA”): one allogeneic CAR-T for hematological malignancies, one allogeneic CAR-T for solid tumors, and one in vivo gene therapy for a genetic disorder.

 

Servier arbitration

• With respect to the ongoing arbitration proceeding through the Centre de Médiation et d’Arbitrage de Paris, the arbitral decision is expected to be rendered on or before December 15, 2025.

 

Corporate Updates

Annual Shareholders’ Meeting

• On June 26, 2025, Cellectis held a Shareholders General Meeting at the Biopark auditorium in Paris, France. At the meeting, during which approximately 57% of voting rights were exercised, resolutions 1 through 23 and resolutions 25 and 26 were adopted, while resolution 24 was rejected, consistent with the recommendations of the Board of Directors. The detailed results of the vote and the resolutions are available on Cellectis’ website: https://www.cellectis.com/en/investors/general-meetings/

 

• The Cellectis Shareholders' Meeting appointed Mr. André Muller as a director of the Company's Board of Directors, with immediate effect. In addition, at the close of this meeting, the term of Mr. Axel-Sven Malkomes expired, and the previously announced resignation of Mr. Pierre Bastid became effective. In connection with these changes to the Board of Directors, the Board of Directors appointed André Muller, Donald Bergstrom, and Rainer Boehm as the members of the Company’s Audit Committee.