Cellectis Announces 2026 Strategy and Catalysts

Rhea-AI Summary

Cellectis (NASDAQ:CLLS) outlined its 2026 strategy focused on advancing allogeneic CAR-T candidates and delivering multiple clinical catalysts. Key near-term milestones include a pivotal Phase 2 BALLI-01 interim analysis for lasme-cel (n=40) expected in Q4 2026, presentation of the full Phase 1 NATHALI-01 dataset for eti-cel in r/r NHL in Q4 2026, and a Q1 2026 IL-2 enrollment cohort for NATHALI-01. Phase 1 highlights for lasme-cel: ORR 68% (Process 2), 83% at RP2D, 100% in the target Phase 2 population, 56% CR/CRi with ~80% MRD-negativity, and 14.8 months median OS in MRD-neg CR/CRi. The company expects cash to fund operations into H2 2027 and continues collaborations with AstraZeneca, Servier/Allogene and Iovance.

Positive

• Pivotal BALLI-01 interim analysis for lasme-cel scheduled in Q4 2026 (n=40)
• lasme-cel Phase 1 efficacy: 68% ORR (Process 2) and 83% ORR at RP2D
• Target Phase 2 subgroup showed 100% ORR (n=9)
• 56% CR/CRi with ~80% MRD-negative among CR/CRi in target population
• 14.8 months median OS in patients achieving MRD-negative CR/CRi
• Cash runway expected to fund operations into H2 2027

Negative

• Pivotal Phase 2 results remain pending, with key interim readout not due until Q4 2026
• Full Phase 1 NATHALI-01 dataset is preliminary and will not be available until Q4 2026
• Clinical progress and commercial outcomes rely on external partnerships (AstraZeneca, Servier/Allogene, Iovance)

Key Figures

Lasme-cel ORR 68% Overall response rate with lasme-cel Process 2 (n=22) in Phase 1 BALLI-01

Lasme-cel ORR at RP2D 83% Overall response rate at recommended Phase 2 dose (n=12) in BALLI-01

Target population ORR 100% Overall response rate in target Phase 2 BALLI-01 population (n=9)

Median OS 14.8 months Median overall survival in patients achieving MRD-negative CR/CRi on lasme-cel

Eti-cel ORR 88% Overall response rate at current dose level in Phase 1 NATHALI-01 (r/r NHL)

Eti-cel CR rate 63% Complete response rate at current dose level in Phase 1 NATHALI-01

Servier milestones $340 million Potential development and sales milestones under Servier agreement plus royalties

Cash runway Into H2 2027 Company’s stated cash, cash equivalents and deposits funding horizon

Market Reality Check

$4.41 Last Close

Volume Volume 63,310 is 0.56x the 20-day average 112,935, indicating subdued trading interest pre-announcement. low

Technical Shares at $4.48 are trading above the 200-day MA of $2.74, reflecting a pre-existing uptrend into this strategy update.

Peers on Argus

CLLS gained 3.41% while close peers were mixed: ENGN +0.35%, GLUE +8.35%, KRRO +8.54%, FDMT -5.19%, ABEO -0.39%. Scanner data shows no coordinated sector momentum, suggesting a stock-specific reaction to Cellectis’s 2026 catalysts.

Common Catalyst Both Cellectis and peer KRRO highlighted participation in the 44th Annual J.P. Morgan Healthcare Conference, pointing to a broader conference-driven news flow in biotech rather than a unified price move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 05	Share capital update	Neutral	-5.4%	Routine disclosure of total shares and voting rights as of Dec 31, 2025.
Dec 15	Arbitration outcome	Neutral	+2.4%	Arbitral decision with partial license termination and dismissal of other claims.
Dec 08	Clinical data update	Positive	-2.5%	ASH 2025 Phase 1 NATHALI-01 eti-cel data with high ORR and CR rates.
Dec 03	Share capital update	Neutral	+3.6%	Monthly report on total shares and voting rights as of Nov 30, 2025.
Nov 19	Research publication	Positive	+7.1%	Nature Communications article on non-viral CssDNA TALEN gene editing efficiency.

Pattern Detected

Recent news has often produced aligned moves, but positive clinical updates have shown at least one notable divergence between news tone and price reaction.

Recent Company History

Over the last few months, Cellectis has mixed routine disclosures with clinically focused milestones. Monthly share-capital updates on Nov 30 and Dec 31, 2025 produced modest but directionally opposite moves despite neutral content. A Nature Communications article on Nov 19, 2025 detailing non-viral gene editing efficiency coincided with a strong positive reaction. The ASH 2025 eti‑cel update in r/r NHL showed high response rates but was followed by a small decline, indicating some skepticism toward early clinical data. Today’s 2026 strategy and catalysts build directly on these BALLI‑01 and NATHALI‑01 developments.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-02

Cellectis has an effective Form F-3 shelf registration dated 2025-07-02, expiring on 2028-07-02, with 0 recorded usages so far. This provides a pre-cleared mechanism to raise capital via registered offerings if management elects to do so, but no specific amounts or usage details are disclosed in the provided context.

Market Pulse Summary

This announcement lays out Cellectis’s 2026 strategy, centered on pivotal Phase 2 BALLI‑01 interim data in Q4 2026, full Phase 1 NATHALI‑01 results, and expansion of its AstraZeneca collaboration for up to 10 cell and gene therapies. The company highlights strong lasme‑cel and eti‑cel efficacy metrics and a cash runway into H2 2027. Investors may track upcoming BALLI‑01 and NATHALI‑01 readouts, Servier milestone progress of up to $340 million, and any use of the existing Form F‑3 registration.

Key Terms

allogeneic car-t medical

"we transitioned to a late-stage development allogeneic CAR-T company with the initiatio"

Allogeneic CAR‑T is a type of cancer therapy made from immune cells taken from a donor, genetically modified to recognize and kill cancer cells, and then given to unrelated patients like an off‑the‑shelf medicine. Investors care because it promises faster, cheaper manufacturing and wider patient reach than personalized (autologous) CAR‑T, but its commercial value depends on safety, effectiveness, regulatory approval and the ability to scale production reliably.

overall response rate (orr) medical

"Strong Efficacy: 68% overall response rate (ORR) with lasme-cel Process 2 (n=22), 83%"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

complete remission medical

"56% complete remission or complete remission with incomplete hematologic recovery (CR/"

Complete remission means that medical tests and exams show no detectable signs or symptoms of a disease after treatment, though it does not guarantee the disease is permanently gone. Investors care because complete remission rates are a clear, measurable outcome used by regulators and doctors to judge a therapy’s effectiveness; like a fire appearing fully extinguished, it can boost a drug’s perceived value and commercial prospects while still requiring ongoing monitoring.

minimal residual disease (mrd) medical

"with ~80% of these patients achieving minimal residual disease (MRD)-negative status in"

The presence of minimal residual disease (MRD) means a very small number of cancer cells remain in the body after treatment, too few to cause symptoms or show up on routine scans but detectable with sensitive tests. For investors it matters because MRD status is a strong early indicator of whether a patient is likely to relapse and is increasingly used as a trial endpoint and regulatory signal, affecting a therapy’s market prospects and valuation much like finding glowing embers after a fire signals risk of re-ignition.

median overall survival (os) medical

"Strong Survival Benefit: 14.8 months median overall survival (OS) in patients who achi"

Median overall survival (OS) is the midpoint of how long patients live after a diagnosis or start of a treatment — half the patients lived longer and half lived shorter than that time. Investors use it as a headline measure of a therapy’s real-world benefit because longer median OS can drive regulatory approval, physician adoption, pricing and sales; think of it as the median performance metric that helps predict a drug’s commercial potential.

immune effector cell–associated hemophagocytic syndrome (iec-hs) medical

"with a single case of grade 2 immune effector cell–associated hemophagocytic syndrome ("

An immune effector cell–associated hemophagocytic syndrome (IEC-HS) is a severe inflammatory reaction where therapy-activated immune cells go into overdrive and start damaging blood cells and organs, similar to a security system that malfunctions and harms the building it’s meant to protect. Investors care because IEC-HS can stop or delay regulatory approval, lead to costly safety monitoring or lawsuits, reduce patient use of a therapy, and affect clinical trial outcomes and commercial prospects.

interleukin-2 (il-2) medical

"enrollment in the cohort with low dose interleukin-2 (IL-2) support to evaluate the pot"

Interleukin-2 (IL-2) is a naturally occurring protein that acts like a signal or switch to activate and grow certain immune cells; in medicine it is used or mimicked to boost the body’s immune response against infections and cancers. For investors, IL-2 matters because drugs based on it can drive clinical trial outcomes, safety profiles, regulatory decisions and potential market value, much like a key ingredient that determines whether a new recipe succeeds or fails.

tumor-infiltrating lymphocyte (til) medical

"IOV-4001, a PD-1 inactivated tumor-infiltrating lymphocyte (TIL) cell therapy, in prev"

Tumor-infiltrating lymphocytes (TILs) are white blood cells that have moved into a tumor and are recognizing cancer cells as a threat. They matter to investors because therapies that collect a patient’s TILs, grow them in the lab and return them aim to boost the body’s own attack on cancer; successful results can create a new treatment market and trigger regulatory and commercial milestones. Think of TIL therapy as strengthening a local neighborhood watch to remove intruders.

AI-generated analysis. Not financial advice.

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

FAQ

When is Cellectis (CLLS) expected to report the interim analysis for the pivotal BALLI-01 trial of lasme-cel?

Cellectis expects the first interim analysis for BALLI-01 (n=40) in Q4 2026.

What were the key Phase 1 efficacy results for lasme-cel reported by Cellectis?

Phase 1 showed 68% ORR for Process 2, 83% ORR at the RP2D, and 56% CR/CRi with ~80% MRD-negative in the target population.

When will Cellectis report the full Phase 1 NATHALI-01 results for eti-cel (CLLS)?

The company expects to present the full NATHALI-01 Phase 1 dataset, including the IL-2 cohort, in Q4 2026.

How long is Cellectis’ cash runway according to the January 8, 2026 update?

Cellectis believes cash, cash equivalents, and fixed-term deposits will fund operations into H2 2027.

What partnership activity is Cellectis highlighting that could affect CLLS shareholders in 2026?

Cellectis is advancing a Joint Research and Collaboration Agreement with AstraZeneca and remains tied to programs with Servier/Allogene and Iovance, which support development and potential milestones.

Will Cellectis management be available to investors at the J.P. Morgan Healthcare Conference 2026?

Yes. Management will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026 and is available for one-on-one meetings.