Cema-Cel Pivotal Trial Interim Data Highlight Strength of Cellectis’ Allogeneic CAR-T Platform

Cellectis (NASDAQ: CLLS) highlighted interim futility analysis data from Allogene’s pivotal ALPHA3 trial of cema-cel in first-line consolidation for large B-cell lymphoma.

Rhea-AI Summary

Cellectis (NASDAQ: CLLS) highlighted interim futility analysis data from Allogene’s pivotal ALPHA3 trial of cema-cel in first-line consolidation for large B-cell lymphoma. The Day 45 MRD cutoff showed 58.3% MRD negativity with cema-cel vs 16.7% with observation, a 41.6% absolute difference.

Allogene reported favorable tolerability (no CRS, ICANS, GvHD, or treatment-related SAEs) and expects accrual complete by end-2027, interim EFS analysis mid-2027 and primary EFS analysis mid-2028. Cellectis may receive up to $340M in milestones plus low double-digit royalties on licensed CD19 products.

Positive

• MRD negativity 58.3% with cema-cel (Day 45)
• Absolute MRD difference 41.6% vs observation
• No CRS/ICANS/GvHD reported at cutoff
• Potential milestone payments up to $340M to Cellectis

Negative

• Study accrual prolonged through end-2027, delaying final readouts
• Primary EFS analysis anticipated only in mid-2028, extending regulatory timeline
• Milestone and royalty upside contingent on Allogene trial success

Argus Apr 14 session

-2.80% close to close Open Argus

Details

News Market Reaction – CLLS

In the Apr 14 session, CLLS declined 2.80%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights promising interim MRD and safety data for cema-cel in the pivotal ALPHA...

Analysis

This announcement highlights promising interim MRD and safety data for cema-cel in the pivotal ALPHA3 trial, reinforcing Cellectis’ allogeneic CAR-T platform and economics under the Servier agreement, including up to $340 million in milestones. Historical filings emphasize ongoing losses but a cash runway into H2 2027. Investors may track future EFS readouts in 2027–2028, progress of other candidates like lasme-cel and eti-cel, and any use of the effective Form F-3 shelf for financing.

Key Figures

MRD negativity (cema-cel): 58.3% (7/12 patients) MRD negativity (observation): 16.7% (2/12 patients) MRD clearance difference: 41.6% absolute difference +5 more

MRD negativity (cema-cel)

58.3% (7/12 patients)

Pivotal ALPHA3 trial interim futility analysis

MRD negativity (observation)

16.7% (2/12 patients)

Comparator arm in ALPHA3 interim analysis

MRD clearance difference

41.6% absolute difference

Cema-cel vs observation arms in ALPHA3

Outpatient management

10/12 patients

Patients managed in outpatient setting post cema-cel infusion

Data cutoff trigger

24th patient at Day 45 MRD

Protocol-defined interim futility analysis trigger

Accrual completion target

End of 2027

Planned completion of ALPHA3 study enrollment

EFS interim / primary

Mid-2027 / mid-2028

Planned Event-Free Survival analyses for ALPHA3

Milestone potential

$340 million

Development and sales milestones under Servier Agreement

Historical Context

5 past events · Latest: Apr 07

5 events

1. Apr 07

   Monthly capital update

   24h Move

   +5.7%

   Routine disclosure of total shares and voting rights for March 2026.

2. Mar 19

   Full-year 2025 earnings

   24h Move

   -4.0%

   Reported higher 2025 revenue, clinical progress, and cash runway into H2 2027.

3. Mar 12

   Earnings call scheduling

   24h Move

   +2.7%

   Announced timing and access details for Q4 and full-year 2025 results.

4. Mar 04

   Monthly capital update

   24h Move

   -2.4%

   Updated total shares and voting rights as of February 28, 2026.

5. Feb 04

   Monthly capital update

   24h Move

   -1.1%

   Reported share count and voting rights as of January 31, 2026.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

minimal residual disease, car-t, allogeneic, autologous, +4 more

8 terms

minimal residual disease medical

"triggered by the protocol-defined data cutoff of the 24th patient completing Day 45 minimal residual disease"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

car-t medical

"highlights the interim futility analysis announced by Allogene Therapeutics... allogeneic CAR-T platform"

CAR-T is a type of cancer therapy that reprograms a patient’s own immune cells to seek and destroy specific cancer cells, like teaching guard dogs a new scent to track intruders. It matters to investors because CAR-T treatments can command high prices, drive strong revenue for successful developers, and carry regulatory and manufacturing risks that can sharply affect a company’s valuation and long-term growth prospects.

allogeneic medical

"Cema-cel, which is derived from the UCART19 product initially developed by Cellectis, is an anti-CD19 allogeneic CAR-T cell therapy."

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

autologous medical

"Unlike autologous CAR-T therapies, which are manufactured from each patient's own T-cells"

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

cytokine release syndrome medical

"no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

graft-versus-host disease medical

"no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD)"

Graft-versus-host disease is a complication that can occur after a transplant using donor immune cells, where those transplanted cells attack the recipient’s organs and skin instead of protecting them; imagine a new security team mistaking the building’s occupants for intruders. It matters to investors because its likelihood, severity, and available treatments shape clinical trial results, drug approval chances, safety labels, patient outcomes, and the commercial potential of therapies aimed at preventing or managing the condition.

event-free survival medical

"it anticipates an interim Event-Free Survival (EFS) analysis in mid-2027 and the primary EFS analysis"

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

biologics license application regulatory

"If positive, Allogene announced that these results could support a Biologics License Application (BLA) submission."

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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NEW YORK, April 13, 2026 (GLOBE NEWSWIRE) -- Cellectis (or 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 highlights the interim futility analysis announced by Allogene Therapeutics, Inc. (“Allogene”) from Allogene’s sponsored pivotal ALPHA3 trial evaluating cema-cel in first-line consolidation for large B-cell lymphoma (LBCL). Cema-cel is a product candidate licensed to Servier under the License, Development and Commercialization Agreement signed by and between les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) and Cellectis (the “Servier Agreement”) and sublicenced by Servier to Allogene in certain territories.

Allogene announced the futility analysis, which was triggered by the protocol-defined data cutoff of the 24^th patient completing Day 45 minimal residual disease (“MRD”) assessment, showed that 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity compared to 16.7% (2/12) in the observation arm, representing a 41.6% absolute difference in MRD clearance between the arms. Allogene reported that based on specific benchmark literature, a difference of 25-30% in the MRD clearance could translate into meaningful clinical benefit at study completion. Allogene further announced that the cema-cel treatment was generally well-tolerated as of the cutoff, with most patients (10/12) managed in the outpatient setting post-infusion, no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or treatment-related Serious Adverse Events, and no hospitalizations for treatment-related Adverse Events. For more details on the data announced by Allogene, please refer to Allogene’s press release click here.

"Seeing cema-cel advance in a pivotal trial is a great moment. Cema-cel derives from the first allogeneic CAR-T ever made, UCART19, as Cellectis has pioneered the concept of allogeneic “off-the-shelf" cell therapy, a concept many considered impossible. The data disclosed by Allogene is a testament to that vision, as we believe our allogeneic platform will replace autologous CAR-T therapies and expand their use in more indications. We warmly congratulate Servier and Allogene on this milestone and look forward to the continued development of cema-cel," said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. 

Cema-cel, which is derived from the UCART19 product initially developed by Cellectis, is an anti-CD19 allogeneic CAR-T cell therapy. Unlike autologous CAR-T therapies, which are manufactured from each patient's own T-cells, cema-cel is derived from healthy donor T-cells. We believe that allogeneic treatment have the potential to overcome many of the challenges of autologous cell therapies including speed, accessibility, and product consistency, while offering a path to make cell therapies mainstream pharmaceutical products.

Allogene announced that study accrual is anticipated to be complete by the end of 2027 and that it anticipates an interim Event-Free Survival (EFS) analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, Allogene announced that these results could support a Biologics License Application (BLA) submission. Under the Servier Agreement, Cellectis is eligible to receive payments up to $340 million in development and sales milestones, as well as low double-digit royalties on net sales of licensed CD19 products, including cema-cel developed in LBCL.

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 “anticipate,” “believe,” “could,” “eligible,” “encouraging,” “potential,” “signal,” “up to,” or “will” or the negative of these and similar expressions. These forward-looking statements 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 Allogene Therapeutics, Inc. Forward-looking statements include statements about the potential of the pivotal Phase 2 ALPHA3 trial to be a registrational phase, the advancement, timing and progress of ALPHA3 trial, the timing of presentation of data and submission of regulatory filings of ALPHA3 (including without limitation, the date of BLA submission), the potential benefit of allogeneic CAR-T product candidates (including the potential clinical benefits, safety, tolerability, durability, and efficacy of cema-cel), and the financial outcomes of the Servier Agreement. These forward-looking statements are made in light of information disclosed by Allogene and are subject to significant risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Among these are significant risks that the pivotal ALPHA3 trial interim data may not be validated by data from later stage of clinical trials. Particular caution should be exercised when interpreting results from pivotal ALPHA3 interim data and results relating to a small number of patients – such results should not be viewed as predictive of future results in ALPHA3 or in other clinical studies related to allogeneic products, including our sponsored BALLI-01 and NATHALI-01 clinical trials. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F as amended and in our annual financial report (including the management report) for the year ended December 31, 2025 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, which are available on the SEC’s website at www.sec.gov, 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

Attachments

• PRESS RELEASE_Allo-CLLS
  

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the Day 45 MRD results for cema-cel in the ALPHA3 trial (CLLS)?

Cema-cel achieved 58.3% MRD negativity at Day 45 versus 16.7% in observation. According to Allogene, that represents a 41.6% absolute MRD clearance difference which Allogene said may translate to meaningful clinical benefit at study completion.

Did Allogene report any severe safety events for cema-cel in the ALPHA3 interim analysis?

No treatment-related CRS, ICANS, GvHD, or serious adverse events were reported as of the cutoff. According to Allogene, most patients (10/12) were managed outpatient post-infusion with no hospitalizations for treatment-related adverse events.

What is the expected ALPHA3 trial timeline for interim and primary EFS analyses?

Allogene expects interim Event-Free Survival (EFS) analysis in mid-2027 and primary EFS analysis in mid-2028. According to Allogene, study accrual is anticipated to complete by the end of 2027, pacing regulatory milestones and potential filings.

How could Cellectis (CLLS) financially benefit from cema-cel development in LBCL?

Cellectis is eligible for up to $340 million in development and sales milestones plus low double-digit royalties. According to Cellectis, those payments apply under the Servier license for CD19 products, including cema-cel developed in LBCL.

Does the ALPHA3 interim MRD result guarantee regulatory approval for cema-cel (CLLS)?

No, interim MRD results do not guarantee approval; the primary EFS analysis is required for confirmatory evidence. According to Allogene, positive EFS results could support a Biologics License Application, but timing and outcome remain uncertain until final analyses.