Cellectis (NASDAQ: CLLS) maps 2026 CAR-T catalysts and cash runway

Rhea-AI Filing Summary

Cellectis set out its 2026 strategy, centered on advancing its allogeneic CAR-T pipeline, key partnerships, and extending its cash runway. The company is executing a pivotal Phase 2 BALLI-01 trial of lasme-cel in relapsed/refractory B-ALL, targeting a first interim analysis for 40 patients in Q4 2026, after Phase 1 data showed a 68% overall response rate with Process 2, rising to 83% at the recommended Phase 2 dose and 100% in the target Phase 2 population, with strong MRD-negative complete remissions and a favorable safety profile.

For eti-cel in relapsed/refractory NHL, preliminary Phase 1 data from NATHALI-01 showed an 88% response rate and 63% complete remissions, with an IL-2 combination cohort starting enrollment in Q1 2026 and full Phase 1 data expected in Q4 2026. Cellectis highlighted progress under its AstraZeneca collaboration (up to 10 products), potential milestones and royalties from Servier/Allogene including up to $340 million tied to a CD19 program, and upcoming Iovance IOV-4001 data. The company believes its cash, cash equivalents, and fixed-term deposits will fund operations into H2 2027.

Positive

• Compelling early efficacy and safety for lasme-cel in B-ALL, including 83% overall response at the recommended Phase 2 dose and 100% responses in the target Phase 2 population, with MRD-negative complete remissions and described favorable tolerability.
• Strong preliminary results for eti-cel in NHL, with an 88% overall response rate and 63% complete responses, plus defined 2026 milestones for IL-2 combination data and a full Phase 1 dataset.
• Diversified partnership portfolio and non-dilutive potential, including an AstraZeneca collaboration on up to 10 products and eligibility for up to $340 million in milestones plus low double-digit royalties under the Servier CD19 agreement.
• Stated cash runway into H2 2027, providing multi-year funding visibility to advance pivotal and early-stage programs and support partnered development work.

Negative

• None.

Insights

Biotech pipelines and partnerships analyst

Cellectis outlines late-stage CAR-T milestones, partner programs and cash runway into H2 2027.

Cellectis emphasizes its transition toward late-stage development, led by lasme-cel in the pivotal Phase 2 BALLI-01 trial for relapsed/refractory B-ALL. Prior Phase 1 results showed a 68% overall response rate with lasme-cel Process 2, 83% at the recommended Phase 2 dose, and 100% responses in the target Phase 2 population, plus a median overall survival of 14.8 months in patients achieving MRD-negative complete responses. Safety was described as generally favorable, with one resolved grade 2 IEC-HS case.

Eti-cel in the NATHALI-01 NHL study adds a second key asset, with preliminary Phase 1 data showing an 88% overall response rate and 63% complete responses at the current dose level. The plan to launch an IL-2 support cohort in Q1 2026 and report the full Phase 1 dataset, including IL-2, in Q4 2026 provides clear clinical catalysts. These timelines, together with the Phase 2 BALLI-01 interim analysis expected in Q4 2026, frame a data-rich year that could influence future regulatory and partnering discussions depending on outcomes.

On the business side, the AstraZeneca collaboration to develop up to 10 cell and gene therapies, Servier/Allogene programs (including cema-cel with up to $340 million in potential milestones and low double-digit royalties), and Iovance’s IOV-4001 program broaden Cellectis’ exposure to partnered pipelines. Management states that cash, cash equivalents, and fixed-term deposits are expected to fund operations into H2 2027, which, if borne out, supports the planned clinical and partnership activities over the next several years. Overall, the disclosed data and run-rate outlook represent a meaningfully constructive update for a clinical-stage platform company.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

Date of Report: January 8, 2026

Commission File Number: 001-36891

Cellectis S.A.
(Exact Name of registrant as specified in its charter)

8, rue de la Croix Jarry
75013 Paris, France
+33 1 81 69 16 00
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

EXHIBIT INDEX

Exhibit		Title
99.1		Press Release dated January 8, 2026

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Cellectis S.A.
		(Registrant)
Date: January 8, 2026		/s/ André Choulika
		André Choulika
		Chief Executive Officer

EXHIBIT 99.1

Cellectis Announces 2026 Strategy and Catalysts

NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) -- 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 outlined its strategic priorities and key catalysts expected for 2026.

“2025 was a transformational year for Cellectis, as we transitioned to a late-stage development allogeneic CAR-T company with the initiation of a pivotal Phase 2 trial for lasme-cel.” said André Choulika, Ph.D., Chief Executive Officer of Cellectis. “As we enter 2026, we remain fully committed to executing our pivotal Phase 2 BALLI-01 trial for lasme-cel in ALL, with interim data expected in Q4, presenting the full Phase 1 data of the NATHALI-01 trial for eti-cel in NHL, and leveraging the momentum of our strategic partnership with AstraZeneca.”

Allogeneic CAR-T Pipeline

Lasme-cel in r/r B-ALL (BALLI-01)

Following the initiation of the pivotal Phase 2 BALLI-01 clinical trial in October 2025, Cellectis expects to complete the first interim analysis in Q4 2026. This upcoming milestone (n=40) builds upon the encouraging Phase 1 clinical data presented at the Cellectis’ R&D Day, which highlighted:

• Strong Efficacy: 68% overall response rate (ORR) with lasme-cel Process 2 (n=22), 83% at the recommended Phase 2 dose (RP2D) (n=12) and 100% in the target Phase 2 population (n=9). 56% complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate with ~80% of these patients achieving minimal residual disease (MRD)-negative status in the target Phase 2 population. 60% MRD-negative CR/CRi rate achieved in patients who relapsed following a prior CD22 targeted therapy.
• Strong Survival Benefit: 14.8 months median overall survival (OS) in patients who achieved MRD-negative CR/CRi.
• Favorable Safety Profile: lasme-cel was generally well tolerated, with a single case of grade 2 immune effector cell–associated hemophagocytic syndrome (IEC-HS), which resolved.
  
  

Eti-cel in r/r NHL (NATHALI-01)

Building on the preliminary Phase 1 data presented at the American Society of Hematology (ASH) Annual Meeting in December 2025, Cellectis is focused on maximizing the clinical impact of its dual-target CAR-T candidate:

• Phase 1 interim Results: The NATHALI-01 clinical trial demonstrated an encouraging ORR of 88% and a CR rate of 63% at the current dose level, showcasing the potential of eti-cel in r/r NHL patients who have relapsed following multiple lines of therapy including, for most patients, an autologous CD19 CAR-T.
• Q1 2026: Initiation of patient enrollment in the cohort with low dose interleukin-2 (IL-2) support to evaluate the potential to further enhance the already high response rates and durability of response in patients with r/r NHL.
• Q4 2026: The Company expects to report the full Phase 1 dataset, including results from the IL-2 combination.
  
  

Strategic Partnerships

AstraZeneca

• Activities are progressing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.
  
  

Servier / Allogene

• CD19: Servier’s sublicensee Allogene announced that the H1 2026 interim futility analysis from the pivotal Phase 2 ALPHA3 Trial with cema-cel in first-line consolidation large B-cell lymphoma remains on track. Under the Servier agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales.
  
  
• CD70: Allogene announced that the TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients, and that plans are ongoing to determine the next phase of the program.
  
  

Iovance

• Iovance announced that clinical results for IOV-4001, a PD-1 inactivated tumor-infiltrating lymphocyte (TIL) cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026, and that other potential indications for IOV-4001 are also in development.
  
  

Cash Runway

• Cellectis believes its cash, cash equivalents, and fixed-term deposits will be sufficient to fund its operations into H2 2027.
  
  

J.P. Morgan Healthcare Conference

Cellectis management will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, and will be available for one-on-one investor meetings. To schedule a meeting, please contact Cellectis Investor Relations at investors@cellectis.com

About Cellectis

Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish.

Cellectis’ headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit www.cellectis.com and follow Cellectis on LinkedIn and X.

Cautionary Statement
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “believe,” “expect,” “expected,” “is eligible,” “potential,” “scheduled,” “upcoming,” or “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, include statements regarding the potential of the phase 2 study to be a registrational phase, the advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings (including, without limitation, the date of BLA filing), the operational capabilities of our manufacturing facilities, the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, the potential payments for which Cellectis is eligible under the agreement signed with Servier, and the financial position of Cellectis. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Among these risks are significant risks that the phase 1 or preliminary data of our clinical trials may not be validated by data from later stage of clinical trials and that our product candidates may not receive regulatory approval. Particular caution should be exercised when interpreting the results from phase 1 studies and results relating to a small number of patients, such results should not be viewed as predictive or future results. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2024 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

For further information on Cellectis, please contact:

Media contacts:
Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93

Investor Relations contact:
Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@cellectis.com

Attachment

• PRESS RELEASE_strategy_and_key_catalysts-ENGLISH (https://ml.globenewswire.com/Resource/Download/cf26b30e-e0b2-43da-a2a1-5a3b7066d828)

FAQ

What are Cellectis (CLLS) main clinical priorities for 2026?

Cellectis is focused on executing the pivotal Phase 2 BALLI-01 trial of lasme-cel in relapsed/refractory B-ALL with an interim analysis in Q4 2026, and advancing eti-cel in the NATHALI-01 NHL trial, including starting an IL-2 support cohort in Q1 2026 and reporting the full Phase 1 dataset in Q4 2026.

How strong are the lasme-cel Phase 1 results cited by Cellectis?

Lasme-cel Process 2 showed a 68% overall response rate, increasing to 83% at the recommended Phase 2 dose and 100% in the target Phase 2 population, with a 56% CR/CRi rate and a high proportion of MRD-negative remissions, alongside a generally favorable safety profile.

What preliminary efficacy has eti-cel shown in the NATHALI-01 NHL trial?

In the eti-cel NATHALI-01 trial, Cellectis reports an 88% overall response rate and a 63% complete response rate at the current dose level in heavily pretreated relapsed/refractory NHL patients, many of whom had prior autologous CD19 CAR-T therapy.

What key partnerships does Cellectis highlight in this update?

Cellectis underscores its collaboration with AstraZeneca to develop up to 10 novel cell and gene therapies, its Servier/Allogene agreements including cema-cel (with eligibility for up to $340 million in milestones and low double-digit royalties), and Iovance’s IOV-4001 TIL program in advanced melanoma.

How long does Cellectis expect its current cash resources to last?

Cellectis states that its cash, cash equivalents, and fixed-term deposits are expected to be sufficient to fund operations into H2 2027, based on current operating plans.

What are the main data catalysts Cellectis expects in 2026?

The company expects an interim analysis for 40 patients in the BALLI-01 pivotal Phase 2 trial in Q4 2026, initiation and readouts from the eti-cel IL-2 cohort with full Phase 1 data in Q4 2026, and partner-related updates such as Iovance IOV-4001 clinical results anticipated in the first quarter of 2026.