CLLS
CellectisDDocument history
Earnings documents stored for CLLS.
Investor releaseQuarter not tagged2026-08-06Cellectis Reports Financial Results for the Second Quarter 2026
GlobeNewswire
Cellectis Reports Financial Results for the Second Quarter 2026
Lasme-cel: Pivotal Phase 2 in r/r B-ALL (BALLI-01) FDA RMAT designation received for lasme-cel Full Phase 1 clinical data from the BALLI-01 trial presented at EHA 2026 Pivotal Phase 2 first interim analysis expected in Q4 2026 Eti-cel: Phase 1 in r/r NHL (NATHALI-01) Translational data from the NATHALI-01 trial highlighting key drivers of response presented at EHA 2026 Full Phase 1 dataset expected in Q4 2026 Cash, cash equivalents and fixed-term deposits of $169 million as of June 30, 20261 provide runway into Q4 2027. NEW YORK, Aug. 06, 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 provided financial results for the second quarter 2026 ending June 30, 2026. "The lasme-cel and eti-cel clinical results presented at EHA 2026 are promising for patients with relapsed or refractory B-cell malignancies. We are also pleased to have received RMAT designation from the FDA for lasme-cel, which recognizes its potential to address an unmet medical need in B-ALL. We remain focused on advancing new options for people whose disease has returned or stopped responding to available therapies," said André Choulika, Ph.D., Co-Founder and Chief Executive Officer at Cellectis. ___________________________________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $2.3 million as of June 30, 2026 classified as current and non-current financial assets and fixed-term deposits of $131.1 million as of June 30, 2026, classified as current financial assets. Allogeneic CAR-T Pipeline Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) – BALLI-01 The Pivotal Phase 2 BALLI-01 trial is ongoing. In June 2026, Cellectis received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for lasme-cel for treatment of r/r CD22 positive B-ALL. This designation was granted based on the BALLI-01 clinical data, demonstrating promising efficacy and a manageable safety profile. It reflects the FDA's recognition of the potential of lasme-cel to address the unmet medical need faced by patients with r/r B-ALL. In June 2026, Cellectis presented full Phase 1 data from the BALLI-01 trial at an oral presentation at the European Hematology Association (EHA) 2026 Annual…Read full documentShow less
Lasme-cel: Pivotal Phase 2 in r/r B-ALL (BALLI-01) FDA RMAT designation received for lasme-cel Full Phase 1 clinical data from the BALLI-01 trial presented at EHA 2026 Pivotal Phase 2 first interim analysis expected in Q4 2026 Eti-cel: Phase 1 in r/r NHL (NATHALI-01) Translational data from the NATHALI-01 trial highlighting key drivers of response presented at EHA 2026 Full Phase 1 dataset expected in Q4 2026 Cash, cash equivalents and fixed-term deposits of $169 million as of June 30, 20261 provide runway into Q4 2027. NEW YORK, Aug. 06, 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 provided financial results for the second quarter 2026 ending June 30, 2026. "The lasme-cel and eti-cel clinical results presented at EHA 2026 are promising for patients with relapsed or refractory B-cell malignancies. We are also pleased to have received RMAT designation from the FDA for lasme-cel, which recognizes its potential to address an unmet medical need in B-ALL. We remain focused on advancing new options for people whose disease has returned or stopped responding to available therapies," said André Choulika, Ph.D., Co-Founder and Chief Executive Officer at Cellectis. ___________________________________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $2.3 million as of June 30, 2026 classified as current and non-current financial assets and fixed-term deposits of $131.1 million as of June 30, 2026, classified as current financial assets. Allogeneic CAR-T Pipeline Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) – BALLI-01 The Pivotal Phase 2 BALLI-01 trial is ongoing. In June 2026, Cellectis received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for lasme-cel for treatment of r/r CD22 positive B-ALL. This designation was granted based on the BALLI-01 clinical data, demonstrating promising efficacy and a manageable safety profile. It reflects the FDA's recognition of the potential of lasme-cel to address the unmet medical need faced by patients with r/r B-ALL. In June 2026, Cellectis presented full Phase 1 data from the BALLI-01 trial at an oral presentation at the European Hematology Association (EHA) 2026 Annual Congress. 45 patients were treated in third line and beyond (3L+), including 15 at the recommended Phase 2 dose (RP2D), and 7 in the target Phase 2 population. Heavily pretreated population: A median of 5 prior lines of therapy in the target Phase 2 population (range 2–11); 82% had received prior blinatumomab, 56% a CD22-directed antibody drug conjugate (ADC), 53% CD19 CAR-T, and 47% a prior hematopoietic stem cell transplantation (HSCT). Efficacy Data (target Phase 2 population) 100% overall response rate (ORR) (7/7) 57% complete remission/complete remission with incomplete count recovery (CR/CRi) (4/7), of whom 75% were minimal residual disease (MRD)-negative All responding patients proceeded to HSCT Safety Data The therapy demonstrated a manageable safety profile, with grade ≥ 3 cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS), each occurring in 4% of patients. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in 2% of patients. All events resolved. In June 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the initiation of the Phase 2 study of BALLI-01 in the UK. In July 2026, enrollments in the Phase 2 BALLI-01 study in France, Italy and Spain have been authorized. The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026. Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01 The Phase 1 NATHALI-01 trial is ongoing. In June 2026, Cellectis presented translational data highlighting the key drivers of response at a poster presentation at the EHA 2026 annual congress. As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels. Heavily pretreated population: median of 3 prior lines of therapy; 93% had received prior CD19-directed CAR-T therapy. Efficacy Data (optimal dose cohort, n=8) 88% ORR 63% complete response (CR) rate Higher alemtuzumab exposure was associated with a lower inflammatory homeostatic milieu prior to eti-cel infusion, enhanced eti-cel expansion, and higher response rates. Responders demonstrated sustained low-level interleukin-2 (IL-2) secretion versus non-responders. These findings support a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Subcutaneous low-dose IL-2 is also being evaluated to further enhance eti-cel expansion and response. Cellectis expects to present the full Phase 1 dataset in Q4 2026. Partnerships AstraZeneca - Joint Research and Collaboration Agreement Activities are continuing 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 (through its sublicensee Allogene) – Anti-CD19 CAR-T In July 2026, Allogene announced that the FDA has granted RMAT and Fast Track designations to cema-cel for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease (MRD). 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 sublicensed by Servier to Allogene in certain territories. Allogene – Anti-CD70 CAR-T In July 2026, Allogene announced the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology. Allogene announced that ALLO-316 achieved a 31% confirmed response rate with the recommended Phase 2 regimen in patients with Stage IV RCC with high CD70 expression, and that the safety profile was manageable with proactive diagnostic and management strategies effective in mitigating IEC-HS.2 Allogene’s investigational allogeneic CAR-T oncology products utilize Cellectis technologies. The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program. ___________________________________ 2 IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis. Corporate Updates Annual Shareholders’ Meeting On June 25, 2026, Cellectis held a Shareholders General Meeting at the Biopark auditorium in Paris, France. At the meeting, during which approximately 56% of voting rights were exercised, resolutions 1 through 29 were adopted, while resolution 30 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/ Financial Results Cash, cash equivalent and fixed-term deposits: As of June 30, 2026, Cellectis had $169 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into Q4 2027. This compares to $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2025. The $42 million change was primarily driven by payments to suppliers of $26.9 million, payroll-related payments (salaries, bonuses and social charges) totaling $28.5 million, lease liability payments of $5.4 million, repayments of $2.7 million under the “PGE” loan and capital expenditures of $0.5 million, partially offset by $16.8 million of cash received from customers and $4.9 million of interest received from our financial and cash-equivalent investments. We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina). Revenues and Other Income: Consolidated revenues and other income were $14.5 million for the six-month period ended June 30, 2026, compared to $30.2 million for the six-month period ended June 30, 2025. The $15.8 million decrease between the six-month periods ended June 30, 2025 and 2026 was primarily attributable to a $16.4 million decrease in revenues mainly driven by the level of activities performed under the Research Plans of the AstraZeneca Joint Research Collaboration Agreement in the first half of 2026. It was partially offset by a $0.6 million increase, which was mainly attributable to a higher research tax credit resulting from increased eligible R&D expenses, as well as favorable foreign exchange effects. R&D Expenses: Consolidated R&D expenses were $52.2 million for the six-month period ended June 30, 2026, compared to $45.0 million for the six-month period ended June 30, 2025. The $7.2 million increase was primarily driven by (i) a $4.5 million increase in personnel expenses reflecting changes in our R&D headcount and higher stock-based compensation expense associated with awards granted in 2026, whose grant-date fair value increased due to a higher underlying share price, and (ii) a $3.7 million increase in purchases and external expenses, primarily attributable to higher clinical development costs related to our BALLI-01 and NATHALI-01 studies, partially offset by (iii) a $1.0 million decrease in depreciation and amortization expenses. SG&A Expenses: Consolidated SG&A expenses were $11.3 million for the six-month period ended June 30, 2026, compared to $9.8 million for the six-month period ended June 30, 2025. The $1.5 million increase was primarily attributable to a $1.2 million increase in personnel expenses, mainly reflecting higher stock-based compensation expense associated with awards granted in 2026, whose grant-date fair value increased due to a higher underlying share price. Purchases and external expenses increased slightly by $0.2 million, from $4.4 million in 2025 to $4.7 million in 2026. Net financial gain (loss): The consolidated net financial gain for the six-month period ended June 30, 2026 was $9.2 million, compared to a $18.1 million net financial loss for the six-month period ended June 30, 2025. The $27.3 million difference reflects a $5.0 million increase in financial income and a $22.3 million decrease in financial expenses. The $5.0 million increase in financial income was primarily attributable to (i) a $7.0 million increase in non-cash gains recognized from fair value measurements, mainly reflecting an $8.7 million gain on the fair value measurement of the Tranche A, B and C warrants issued to the European Investment Bank ("EIB") in the six months ended June 30, 2026, compared with a $1.2 million gain in the same period in 2025, partially offset by (ii) a $1.7 million decrease in interest income earned on cash, cash equivalents and financial assets, and (iii) a $0.4 million decrease in foreign exchange gains. The $22.3 million decrease in financial expenses was primarily attributable to a $22.8 million decrease in foreign exchange losses mainly resulting from the appreciation of the US dollar against the euro. Net Loss Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $39.6 million (or a $0.39 net loss per share) for the six-month period ended June 30, 2026, compared to a $41.9 million net loss (or a $0.42 net loss per share) for the six-month period ended June 30, 2025. The $2.3 million decrease in net loss was mainly due to (i) a $27.3 million improvement in net financial result, from a net financial loss of $18.1 million as of June 30, 2025 to a net financial gain of $9.2 million as of June 30, 2026, partly offset by (ii) a $24.9 million increase in operating loss. Adjusted Net Loss Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $35.6 million (or a $0.35 net loss per share) for the six-month period ended June 30, 2026, compared to a net loss of $39.6 million (or a $0.40 net loss per share) for the six-month period ended June 30, 2025. The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”). Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. Note Regarding Use of Non-IFRS Financial Measures Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS® Accounting Standards. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS Accounting Standards.Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our financial statements prepared in accordance with IFRS Accounting Standards, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial performance as reported under IFRS Accounting Standards. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our statements of consolidated operations prepared in accordance with IFRS Accounting Standards, including Net income (loss) attributable to shareholders of Cellectis. 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 “expected,” “foresee,” “may,” “potential,” “promising,” “will” or the negative of these and/or 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 our licensed partners. Forward-looking statements include statements about the potential of the pivotal Phase 2 BALLI-01 trial to be registrational phases, the advancement, timing and progress of clinical trials, the timing of our presentation of data, the potential safety and efficacy of our product candidates, the potential benefits of RMAT designation, the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, and the outcomes of our collaboration agreements, including with AstraZeneca, Servier, and Allogene. These forward-looking statements are made in light of information currently available to us and are subject to significant risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Actual results, performance or events may differ materially from those projected in any forward-looking statement. Many important factors may adversely affect such forward-looking statements and cause actual results to differ from those in any forward-looking statement, including, without limitation, inconclusive clinical trial results or clinical trials failing to achieve one or more endpoints; early data not being repeated in ongoing or future clinical trials; promising preclinical data not yielding positive clinical results; failures to secure required regulatory approvals; regulatory developments in the United States and European Union and its member countries, and other countries; disruptions from failures by third-parties on whom we rely in connection with our clinical trials; delays or negative determinations by regulatory authorities; changes or increases in oversight and regulation; increased competition, including within the hemato-oncology field, which may affect our assessment of the relative strategic priority of our various research and development programs; manufacturing delays or problems; inability to achieve enrollment targets; disagreements with our collaboration partners or failures of collaboration partners to pursue product candidates; legal challenges, including product liability claims or intellectual property disputes or disputes with respect to a licensing agreement; any failure to achieve potential benefits or our licensing agreements with licensees or to enter into future arrangements; the ability and willingness of licensees to actively pursue development activities under our collaboration agreements; commercialization factors, including regulatory approval and pricing determinations; disruptions to access to raw materials or starting material; delays or disruptions at our in-house manufacturing facilities; proliferation and continuous evolution of new technologies; capital resource constraints; the rate and degree of market acceptance of, and demand for, our product candidates; dislocations in the capital markets; and our ability to attract and retain key scientific and management personnel. Particular caution should be exercised when interpreting results from Phase 1 studies and results and interim data relating to a small number of patients – such results should not be viewed as predictive of 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 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, Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93,[email protected] Investor Relations contact: Arthur Stril, Chief Financial Officer & Chief Business Officer, [email protected] Attachment PRESS RELEASE_Q2_earnings_EN
Investor releaseQuarter not tagged2026-07-30Cellectis to Report Second Quarter Financial Results on August 6, 2026
GlobeNewswire
Cellectis to Report Second Quarter Financial Results on August 6, 2026
NEW YORK, July 30, 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 announced that it will report financial results for the second quarter 2026 ending June 30, 2026 on Thursday, August 6, 2026 after the close of the US market. The press release will be available in the Investors section of Cellectis’ website: https://www.cellectis.com/en/investors/press-releases/ Cellectis will not host a conference call to discuss these results. Our investor relations team remains available for questions at [email protected] 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. For further information on Cellectis, please contact: Media contacts:Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, [email protected] 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, [email protected] Attachment Q2 2026 announcement PR_ENGLISH
Investor releaseQuarter not tagged2026-06-25Cellectis Reports Results from Shareholders Meeting Held on June 25, 2026
GlobeNewswire
Cellectis Reports Results from Shareholders Meeting Held on June 25, 2026
NEW YORK, June 25, 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, held today its shareholders general meeting at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. At the meeting, during which approximately 55,84% of voting rights were exercised, resolutions 1 through 29 were adopted, while resolution 30 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/ 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. For further information on Cellectis, please contact: Media contacts:Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, [email protected] 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, [email protected] Attachments Cellectis GM June 25, 2026 - PR voting results.pdf
Investor releaseQuarter not tagged2026-06-11Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress
GlobeNewswire
Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress
NEW YORK, June 11, 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, presents final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress. BALLI-01 clinical trial evaluating lasme-cel in r/r B-ALL - Oral Presentation The BALLI-01 final Phase 1 data will be presented as an oral presentation by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, TX. 45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%). Final Phase 1 data In the target Phase 2 population An overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status. All patients subsequently proceeded to HSCT. Lasme-cel demonstrated a manageable safety profile Cytokine release syndrome (CRS) ≥ grade 3 occurred in 4% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade 3 occurred in 4% of patients. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in 2% of patients. All CRS, ICANS, and IEC-HS resolved. “These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options” said Nitin Jain, M.D., Pr…Read full documentShow less
NEW YORK, June 11, 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, presents final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress. BALLI-01 clinical trial evaluating lasme-cel in r/r B-ALL - Oral Presentation The BALLI-01 final Phase 1 data will be presented as an oral presentation by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, TX. 45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%). Final Phase 1 data In the target Phase 2 population An overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status. All patients subsequently proceeded to HSCT. Lasme-cel demonstrated a manageable safety profile Cytokine release syndrome (CRS) ≥ grade 3 occurred in 4% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade 3 occurred in 4% of patients. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in 2% of patients. All CRS, ICANS, and IEC-HS resolved. “These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options” said Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at UT MD Anderson. “Being able to achieve deep remissions in these patients and allowing them to subsequently receive an HSCT is promising. We look forward to accelerating accrual into the ongoing Pivotal Phase 2 study and bringing this treatment to patients.” The Pivotal Phase 2 BALLI-01 trial is open for recruitment. Eligible patients and treating physicians are encouraged to visit BALLI-01 (NCT04150497) or contact Cellectis at [email protected] for information and participating sites. The first interim analysis is expected in Q4 2026. Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial Date/Time: Saturday, June 13 at 5:15 - 6:30pm, local timeSession Title: Advances in the treatment of lymphoblastic leukemiaSession Room: K1Abstract Number: 4689 Note: presentation slides will be uploaded to Cellectis’ website concurrently with the live presentation. NATHALI-01 clinical trial evaluating eti-cel in r/r B-NHL - Poster Presentation The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL. As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy, 93% of whom had received prior CD19-directed CAR-T therapy, and all of whom presented with stage IV disease at baseline. In the optimal dose cohort, ORR and complete response (CR) were 88% and 63%, respectively. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes: higher alemtuzumab exposure created a favorable lower inflammatory homeostatic milieu prior to eti-cel infusion and was associated with enhanced eti-cel expansion and higher response rates. Additionally, responders maintained sustained low-level interleukin 2 (IL-2) secretion when compared to non-responders. These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response. “These encouraging data demonstrate that not only can eti-cel drive responses in a very difficult-to-treat population, but that by optimizing exposure to alemtuzumab we may be able to create a favorable environment for CAR-T expansion and persistence." said Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Q4 2026. Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study Date/Time: Saturday, June 13 at 6:45 - 7:45pm, local timeSession: Poster Session 2Poster Number: 4758 Note: poster presentation will be uploaded to Cellectis’ website at the opening of the poster session. 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 “can,” “expected,” ”look-forward,” “may” or the negative of these and/or similar expressions. These forward-looking statements are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements include statements about the potential of the pivotal Phase 2 BALLI-01 trial 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, the sufficiency of cash to fund operations, the potential benefit of our product candidates. These forward-looking statements are made in light of information currently available to us 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 BALLI-01 Phase 1 data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results relating to a small number of patients – such results should not be viewed as predictive of future results. 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, [email protected] 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, [email protected] Attachment Press release_data_EHA_2026_ENGLISH
Investor releaseQuarter not tagged2026-05-12Cellectis Reports Financial Results for the First Quarter 2026
GlobeNewswire
Cellectis Reports Financial Results for the First Quarter 2026
Pivotal Phase 2 with lasme-cel in r/r B-ALL (BALLI-01 trial) Pivotal Phase 2 first interim analysis expected in Q4 2026 BLA submission anticipated in 2028 Phase 1 with eti-cel in r/r NHL (NATHALI-01 trial) Full Phase 1 dataset expected in Q4 2026 Innovation Preclinical data on TALE-based epigenetic editing, a non-DNA cutting approach, to be presented at ASGCT Servier (through Allogene): Interim pivotal data reported from the ALPHA3 trial of cema-cel (n=24) 58.3% of patients in the cema-cel arm achieved MRD negativity versus 16.7% in the observation arm Favorable safety profile: no cases of CRS, ICANS, GvHD, or Treatment-Related Serious Adverse Events Study accrual expected to be completed by year-end 2027, interim EFS analysis in mid-2027, primary EFS analysis in mid-2028 Cash, cash equivalents and fixed-term deposits of $188 million as of March 31, 20261 provide runway into Q4 2027 NEW YORK, May 11, 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 provided financial results for the first quarter 2026, ending March 31, 2026 and provided a business update. "The interim pivotal data published by Allogene on cema-cel, a product originally developed by Cellectis as UCART19, are a proud validation of our vision: that allogeneic, off-the-shelf cell therapy candidates could deliver transformative outcomes for cancer patients. We believe this approach has the potential to dramatically expand access to CAR-T beyond what autologous therapies can reach today” said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. “As we look ahead to Q4 2026, with the expected interim pivotal Phase 2 data for lasme-cel in relapsed or refractory B-ALL, and the full Phase 1 dataset for eti-cel in relapsed or refractory NHL, Cellectis is approaching its own defining moment. We are excited about what lies ahead." ________________________________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $2.3 million as of March 31, 2026 classified as current and non-current financial assets and fixed-term deposits of $150.6 million as of March 31, 2026, classified as current financial assets. Allogeneic CAR-T Pipeline Lasme-cel in relapsed or refractory B-cell acute lymph…Read full documentShow less
Pivotal Phase 2 with lasme-cel in r/r B-ALL (BALLI-01 trial) Pivotal Phase 2 first interim analysis expected in Q4 2026 BLA submission anticipated in 2028 Phase 1 with eti-cel in r/r NHL (NATHALI-01 trial) Full Phase 1 dataset expected in Q4 2026 Innovation Preclinical data on TALE-based epigenetic editing, a non-DNA cutting approach, to be presented at ASGCT Servier (through Allogene): Interim pivotal data reported from the ALPHA3 trial of cema-cel (n=24) 58.3% of patients in the cema-cel arm achieved MRD negativity versus 16.7% in the observation arm Favorable safety profile: no cases of CRS, ICANS, GvHD, or Treatment-Related Serious Adverse Events Study accrual expected to be completed by year-end 2027, interim EFS analysis in mid-2027, primary EFS analysis in mid-2028 Cash, cash equivalents and fixed-term deposits of $188 million as of March 31, 20261 provide runway into Q4 2027 NEW YORK, May 11, 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 provided financial results for the first quarter 2026, ending March 31, 2026 and provided a business update. "The interim pivotal data published by Allogene on cema-cel, a product originally developed by Cellectis as UCART19, are a proud validation of our vision: that allogeneic, off-the-shelf cell therapy candidates could deliver transformative outcomes for cancer patients. We believe this approach has the potential to dramatically expand access to CAR-T beyond what autologous therapies can reach today” said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. “As we look ahead to Q4 2026, with the expected interim pivotal Phase 2 data for lasme-cel in relapsed or refractory B-ALL, and the full Phase 1 dataset for eti-cel in relapsed or refractory NHL, Cellectis is approaching its own defining moment. We are excited about what lies ahead." ________________________________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $2.3 million as of March 31, 2026 classified as current and non-current financial assets and fixed-term deposits of $150.6 million as of March 31, 2026, classified as current financial assets. Allogeneic CAR-T Pipeline Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) - BALLI-01 The Pivotal Phase 2 BALLI-01 trial is ongoing. Phase 1 data highlights : 100% ORR in the target Phase 2 population 83% overall response rate (ORR) at recommended Phase 2 dose (RP2D) In target Phase 2 population: all patients became eligible to transplant Favorable safety profile: low rates of ≥ grade 3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) at 2.5% and 5% respectively 14.8 months median overall survival (OS) in patients who achieved minimal residual disease (MRD)-negative complete remission with incomplete hematology recovery (CR/CRi) The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026 (n=40). Cellectis anticipates submitting a Biologics License Application (BLA) in 2028. Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01 The Phase 1 NATHALI-01 trial is ongoing. Preliminary Phase 1 data highlights: At current dose level: 88% ORR, 63% complete response (CR) rate after 2+ prior lines of therapy 93% of subjects had prior CD19 CAR-T Cellectis expects to present the full Phase 1 dataset in Q4 2026, including results from the low dose interleukin-2 (IL-2) combination cohorts. TALE-based epigenetic editing platform to turn genes off without altering DNA On April 27, 2026, Cellectis announced new research on a TALE-based epigenetic editing approach, that does not cut or permanently modify the DNA sequence, making it a potentially safer alternative for genome editing, at the American Society of Gene and Cell Therapy (ASGCT) annual meeting, that is taking place on May 11-15, 2026. Key data highlights: Cellectis developed TALEM (Transcription Activator-Like Effector-based epigenetic Modulators), engineered fusion proteins that precisely target genomic loci to switch genes on or off through epigenetic editing, without cutting or permanently modifying the DNA sequence. Using a high-throughput screening system capable of rapidly assembling and testing hundreds of TALEM candidates, Cellectis demonstrated >90% stable gene silencing across two distinct targets: a gene highly expressed in liver cells and a gene implicated in T-cell exhaustion, a key challenge in cancer immunotherapy. The abstract is live on the ASGCT website. The poster will be available on Cellectis’ website on May 13, 2026 at 5 pm ET. Partnerships AstraZeneca – Joint Research and Collaboration Agreement Activities are continuing 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 (through its sublicensee Allogene) – Anti-CD19 CAR-T 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 sublicensed by Servier to Allogene in certain territories. On April 13, 2026, Cellectis highlighted the interim pivotal data announced by Allogene, from Allogene’s sponsored ALPHA3 trial evaluating cema-cel in first-line consolidation for large B-cell lymphoma (LBCL). Cema-cel is derived from the UCART19 product initially developed by Cellectis. Key data highlights reported by Allogene: The futility analysis (n=24) showed that 58.3% of patients in the cema-cel arm achieved MRD negativity versus 16.7% in the observation arm, a 41.6% absolute difference. 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. The cema-cel treatment was generally well-tolerated, with most patients (10/12) managed on an outpatient basis post-infusion and no cases of CRS, ICANS, graft-versus-host disease (GvHD), treatment-related Serious Adverse Events and no hospitalizations for treatment-related Adverse Events. 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 BLA submission. 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 of licensed CD19 products, including cema-cel developed in LBCL. Iovance In May 2026, Iovance announced that a Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and non-small cell lung cancer (NSCLC). Subsequent events On April 20, 2026, Life Technologies Corporation (“LTC”), a subsidiary of Thermo Fisher, purported to terminate license agreements between LTC and Cellectis in 2014, which grant Cellectis non-exclusive rights under certain patents, the Halle Patent Therapeutic License, the Halle Patent Research License, and the GeneArt and Seamless Cloning Patent Therapeutic License (the « LTC Agreements »). This purported termination follows TFS’s allegations that we failed to comply with our obligations under the LTC Agreements, as previously disclosed. Simultaneously therewith, LTC commenced an arbitration before the American Arbitration Association, naming Cellectis S.A. and Cellectis Bioresearch, Inc. as Respondents. LTC’s arbitration demand alleges that Cellectis has breached the LTC License Agreements by underpaying sublicense royalties and otherwise failing to comply with our obligations under the LTC Agreements. According to us, this termination is invalid and LTC’s claims under this arbitration demand are without merit. Financial Results Cash: As of March 31, 2026, Cellectis had $188 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into Q4 2027. This compares to $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2025. The $23 decrease was mainly driven by cash inflows of $13.0 million from revenue and $2.9 million of interest received from our financial and cash-equivalent investments, offset by payments to suppliers of $14.5 million, payroll-related payments (wages, bonuses and social charges) totaling $18.6 million, lease liability payments of $3.4 million, repayment of $1.4 million under the “PGE” loan, and capital expenditures of $0.3 million. We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina). Revenues and Other Income: Consolidated revenues and other income were $7.5 million for the three-month period ended March 31, 2026, compared to $12.0 million for the same period in 2025. This $4.5 million decrease between the three-month periods ended March 31, 2025 and 2026 was mainly attributable to a $4.9 million decrease in revenues driven by the evolution of activities performed under the AZ JRCA. R&D Expenses: Consolidated R&D expenses were $27.2 million for the three-month period ended March 31, 2026, compared to $21.9 million for the same period in 2025, representing an increase of $5.3 million, mainly due to a $3.6 million increase in personnel expenses and a $2.0 million increase in purchases and external expenses. SG&A Expenses: Consolidated SG&A expenses were $5.6 million for the three-month period ended March 31, 2026, compared to $4.7 million for the same period in 2025. The $0.9 million increase was mainly due to a $0.4 million increase in stock-based compensation expenses and related social charges as well as a $0.4 million increase in purchases and other expenses. Net financial gain (loss): We had a consolidated net financial gain of $7.4 million for the three-month period ended March 31, 2026, compared to a $3.9 million net financial loss for the three-month period ended March 31, 2025. This $11.4 million increase in net financial result reflects a $5.6 million increase in financial income and a $5.8 million decrease in financial expenses. The rise in financial income was mainly attributable to (i) a $4.5 million increase in non-cash gains on fair value measurements primarily explained by a $6.5 million gain on the fair value measurement of the Tranches A, B and C of EIB warrants in the three months ended March 31, 2026 compared to a $1.8 million gain in the three months ended March 31, 2025, (ii) a $2.0 million increase in foreign exchange gains, partially offset by (iii) a $1.1 million decrease in income from cash, cash equivalents and financial assets. The decrease in financial expenses was mainly due to a (i) $6.5 million decrease in foreign exchange loss, partially offset by (ii) a $0.2 million increase in interests on financial liabilities. Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $17.8 million (or a $0.18 loss per share) for the three-month period ended March 31, 2026, compared to a $18.1 million net loss (or a $0.18 loss per share) for the three-month period ended March 31, 2025. The $0.4 million decrease in net loss was primarily driven by (i) a $11.4 million improvement in net financial result, from a net financial loss of $3.9 million as of March 31, 2025 to a net financial gain of $7.4 million as of March 31, 2026, partly offset by (ii) a $11.0 million increase in operating loss. Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $16.1 million (or a $0.16 loss per share) for the three-month period ended March 31, 2026, compared to a net loss of $17.2 million (or a $0.17 loss per share) for the three-month period ended March 31, 2025. The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with IAS 34 Interim Financial Reporting, and should be read in conjunction with the Group's last annual consolidated financial statements as at and for the year ended December 31, 2025. Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. Note Regarding Use of Non-IFRS Financial Measures Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis. 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 “anticipated,” “anticipates,” “believe,” “can,” “could,” “expected,” “expects,” “potential,” “potentially,” 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 our licensed partners. Forward-looking statements include statements about the potential of the pivotal Phase 2 BALLI-01 trial and pivotal Phase 2 ALPHA3 trial to be registrational phases, 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 submission), the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, the outcomes of our collaboration agreements, including with AstraZeneca, Servier, Allogene, and Iovance, the outcomes of the dispute with Life Technologies Corporation (“LTC”) and the arbitration initiated by LTC against us, and the financial position of Cellectis. These forward-looking statements are made in light of information currently available to us 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 BALLI-01 Phase 1 data, as well as the pivotal ALPHA 3 trial interim data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results and interim data relating to a small number of patients – such results should not be viewed as predictive of 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 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, [email protected] 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, [email protected] Attachment Earnings_Q1_2026_PR_English
Investor releaseQuarter not tagged2026-05-05Cellectis to Report First Quarter Financial Results on May 11, 2026
GlobeNewswire
Cellectis to Report First Quarter Financial Results on May 11, 2026
NEW YORK, May 04, 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 announced that it will report financial results for the first quarter 2026 ending March 31, 2026 on Monday, May 11, 2026 after the close of the US market. The press release will be available in the Investors section of Cellectis’ website: https://www.cellectis.com/en/investors/press-releases/ Cellectis will not host a conference call to discuss these results. Our investor relations team remains available for questions at [email protected] 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. For further information on Cellectis, please contact: Media contacts: Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14 33, [email protected] 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, [email protected] Attachment PRESS RELEASE_Q1 earnings announcement
Investor releaseQuarter not tagged2026-03-21Cellectis SA (CLLS) Q4 2025 Earnings Call Highlights: Promising Clinical Progress and Strategic ...
GuruFocus.com
Cellectis SA (CLLS) Q4 2025 Earnings Call Highlights: Promising Clinical Progress and Strategic ...
This article first appeared on GuruFocus. Cash Equivalents and Fixed Term Deposits: $211 million as of December 31, 2025, compared to $264 million as of December 31, 2024. Revenue: $36.9 million cashed in from revenue in 2025. Interest Received: $8.4 million from financial and cash equivalent investments. Cash Payments: $50.5 million to suppliers, $40 million for wages, bonuses, and social expenses, $11 million for leased debts, and $5.4 million for PGE loan repayment. Overall Response Rate for Lasm Cell: 83% at the recommended phase 2 dose. CR/CRI Rate for Lasm Cell: 42% at the recommended phase 2 dose. Overall Response Rate for Eisel: 88% in phase one interim results. Complete Response Rate for Eisel: 63% in phase one interim results. Warning! GuruFocus has detected 4 Warning Signs with CLLS. Is CLLS fairly valued? Test your thesis with our free DCF calculator. Release Date: March 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cellectis SA (NASDAQ:CLLS) achieved a 100% overall response rate in the target Phase 2 population for its allogenic CAR T candidate, Lasm cell, in relapsed or refractory B cell acute lymphoblastic leukemia. The company has initiated a pivotal Phase 2 trial for Lasm cell, with site openings in North America and Europe, and expects the first interim analysis in Q4 2026. Cellectis SA (NASDAQ:CLLS) reported encouraging Phase 1 interim results for its dual CAR T candidate, Eisel, with an 88% overall response rate and a 63% complete response rate in non-Hodgkin's lymphoma patients. The company has strong partnerships with Allogene and Iovance, with upcoming data readouts expected to further validate its gene editing platform. Cellectis SA (NASDAQ:CLLS) has managed its cash effectively, ensuring sufficient funds to support its pivotal trials into H2 2027. The biotechnology sector has faced significant challenges, with many programs shelved and companies retreating, impacting the overall market environment. Cellectis SA (NASDAQ:CLLS) faces competition from other companies moving away from CD52 preconditioning, which could impact its clinical strategies. The company is still in the early stages of its pivotal trials, with a BLA submission for Lasm cell not expected until the second half of 2028. There are uncertainties regarding the arbitration ruling with Allogene, which could af…Read full documentShow less
This article first appeared on GuruFocus. Cash Equivalents and Fixed Term Deposits: $211 million as of December 31, 2025, compared to $264 million as of December 31, 2024. Revenue: $36.9 million cashed in from revenue in 2025. Interest Received: $8.4 million from financial and cash equivalent investments. Cash Payments: $50.5 million to suppliers, $40 million for wages, bonuses, and social expenses, $11 million for leased debts, and $5.4 million for PGE loan repayment. Overall Response Rate for Lasm Cell: 83% at the recommended phase 2 dose. CR/CRI Rate for Lasm Cell: 42% at the recommended phase 2 dose. Overall Response Rate for Eisel: 88% in phase one interim results. Complete Response Rate for Eisel: 63% in phase one interim results. Warning! GuruFocus has detected 4 Warning Signs with CLLS. Is CLLS fairly valued? Test your thesis with our free DCF calculator. Release Date: March 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cellectis SA (NASDAQ:CLLS) achieved a 100% overall response rate in the target Phase 2 population for its allogenic CAR T candidate, Lasm cell, in relapsed or refractory B cell acute lymphoblastic leukemia. The company has initiated a pivotal Phase 2 trial for Lasm cell, with site openings in North America and Europe, and expects the first interim analysis in Q4 2026. Cellectis SA (NASDAQ:CLLS) reported encouraging Phase 1 interim results for its dual CAR T candidate, Eisel, with an 88% overall response rate and a 63% complete response rate in non-Hodgkin's lymphoma patients. The company has strong partnerships with Allogene and Iovance, with upcoming data readouts expected to further validate its gene editing platform. Cellectis SA (NASDAQ:CLLS) has managed its cash effectively, ensuring sufficient funds to support its pivotal trials into H2 2027. The biotechnology sector has faced significant challenges, with many programs shelved and companies retreating, impacting the overall market environment. Cellectis SA (NASDAQ:CLLS) faces competition from other companies moving away from CD52 preconditioning, which could impact its clinical strategies. The company is still in the early stages of its pivotal trials, with a BLA submission for Lasm cell not expected until the second half of 2028. There are uncertainties regarding the arbitration ruling with Allogene, which could affect future licensing and milestone payments. The transition of Cellectis SA (NASDAQ:CLLS)'s therapies to outpatient settings is not yet feasible, limiting potential market expansion. Q: How is the recruitment tracking in the pivotal study for Lasm cell, and when do you expect to complete enrollment for the dose selection portion? A: Adrian Kilcoyne, Chief Medical Officer, stated that recruitment is progressing well, with site openings on track. The first interim analysis of 40 patients is expected by the end of the year, focusing on dose optimization for aletuzumab. Q: Could you provide more details on the arbitration ruling regarding the direct licensing of 501 and its impact on eligibility for the $340 million in milestones? A: Arthur Stril, Chief Financial Officer, explained that the arbitral decision returned the product Yukar T19v1 (Allo 501) to Cellectis, allowing them to develop it independently. The ruling does not affect eligibility for milestones related to AO 501a or semerce, ensuring continued eligibility for up to $340 million in development and sales milestones. Q: Can you provide insights into the decision to include CD52 preconditioning in both studies, considering some competitors are moving away from it? A: Adrian Kilcoyne emphasized the importance of aletuzumab in optimizing lympho depletion, which correlates with better patient responses. Cellectis uses a lower dose compared to others, balancing efficacy and safety, and believes this approach is optimal despite some competitors moving away from CD52. Q: How should we think about the update for Eisel in the fourth quarter, particularly regarding the breadth of update and number of patients? A: Adrian Kilcoyne mentioned that by the end of the year, data will include cohorts with and without IL-2. The focus is on enhancing the already strong complete remission rate of 63% with the addition of low-dose IL-2, aiming for further improvements in efficacy. Q: Regarding the commercial opportunity for Lasm cell, how does it compare to the launch of CD19 auto therapy in ALL? A: Adrian Kilcoyne noted that Lasm cell targets CD22, differentiating it from CD19 therapies. The market is saturated with CD19s, and Lasm cell offers an alternative for patients who relapse post-CD19 treatment. Arthur Stril added that the off-the-shelf nature of Lasm cell allows for smoother launch logistics and competitive gross margins compared to autologous therapies. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-03-20Cellectis Reports Full Year 2025 Financial Results and Provides a Business Update
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Cellectis Reports Full Year 2025 Financial Results and Provides a Business Update
Pivotal Phase 2 with lasme-cel in r/r B-ALL (BALLI-01 trial) ongoing Phase 1: 83% ORR at RP2D and 100% ORR in the target Phase 2 population In target Phase 2 population: 100% of patients became eligible to transplant Pivotal Phase 2 first interim analysis expected in Q4 2026 BLA submission anticipated in 2028 Phase 1 with eti-cel in r/r NHL (NATHALI-01 trial) ongoing Best-in-class dual allogeneic CAR-T cell product targeting CD20 & CD22 At current dose level, 88% ORR; 63% CR rate after 2+ prior lines of therapy 93% of subjects had prior CD19 CAR-T Low-dose IL-2 cohort to be included in; Full Phase 1 dataset expected in Q4 2026 Partnerships Servier (through Allogene): Pivotal randomized Phase 2 ALPHA3 trial with cema-cel in 1L consolidation in LBCL: interim futility analysis evaluating MRD clearance and early safety results planned for April 2026 AstraZeneca: Activities progressing under the Joint Research and Collaboration Agreement Cash, cash equivalents and fixed-term deposits of $211 million as of December 31, 20251 provides runway into H2 2027 Conference call scheduled on March 20, 2026 at 8:00 am ET / 1:00 pm CET NEW YORK, March 19, 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 provided financial results for the fourth quarter and full year 2025, ending December 31, 2025 and provided a business update. “Lasme-cel demonstrated a potentially transformative efficacy profile in one of oncology’s most challenging settings, achieving 100% overall response rate in the target Phase 2 population. Critically, lasme-cel converted all patients in the target population into transplant-eligible candidates. The pivotal Phase 2 is now enrolling, and with a BLA submission anticipated in 2028, lasme-cel is on a clear regulatory path to potentially becoming the first off-the-shelf CAR-T therapy to address this high unmet medical need” said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. “With interim Phase 2 data for lasme-cel in r/r B-ALL, and full Phase 1 data for eti-cel in r/r NHL, both expected in Q4 2026, we are entering an important year for Cellectis, as we advance our ambition to bring life-saving off-the-shelf CAR-T therapies to patients who have run out o…Read full documentShow less
Pivotal Phase 2 with lasme-cel in r/r B-ALL (BALLI-01 trial) ongoing Phase 1: 83% ORR at RP2D and 100% ORR in the target Phase 2 population In target Phase 2 population: 100% of patients became eligible to transplant Pivotal Phase 2 first interim analysis expected in Q4 2026 BLA submission anticipated in 2028 Phase 1 with eti-cel in r/r NHL (NATHALI-01 trial) ongoing Best-in-class dual allogeneic CAR-T cell product targeting CD20 & CD22 At current dose level, 88% ORR; 63% CR rate after 2+ prior lines of therapy 93% of subjects had prior CD19 CAR-T Low-dose IL-2 cohort to be included in; Full Phase 1 dataset expected in Q4 2026 Partnerships Servier (through Allogene): Pivotal randomized Phase 2 ALPHA3 trial with cema-cel in 1L consolidation in LBCL: interim futility analysis evaluating MRD clearance and early safety results planned for April 2026 AstraZeneca: Activities progressing under the Joint Research and Collaboration Agreement Cash, cash equivalents and fixed-term deposits of $211 million as of December 31, 20251 provides runway into H2 2027 Conference call scheduled on March 20, 2026 at 8:00 am ET / 1:00 pm CET NEW YORK, March 19, 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 provided financial results for the fourth quarter and full year 2025, ending December 31, 2025 and provided a business update. “Lasme-cel demonstrated a potentially transformative efficacy profile in one of oncology’s most challenging settings, achieving 100% overall response rate in the target Phase 2 population. Critically, lasme-cel converted all patients in the target population into transplant-eligible candidates. The pivotal Phase 2 is now enrolling, and with a BLA submission anticipated in 2028, lasme-cel is on a clear regulatory path to potentially becoming the first off-the-shelf CAR-T therapy to address this high unmet medical need” said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. “With interim Phase 2 data for lasme-cel in r/r B-ALL, and full Phase 1 data for eti-cel in r/r NHL, both expected in Q4 2026, we are entering an important year for Cellectis, as we advance our ambition to bring life-saving off-the-shelf CAR-T therapies to patients who have run out of options”. ________________________________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $4.4 million as of December 31, 2025 classified as current and non-current financial assets and fixed-term deposits of $144.8 million as of December 31, 2025, classified as current financial assets. Allogeneic CAR-T Pipeline Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) - BALLI-01 In October 2025, Cellectis presented full Phase 1 lasme-cel clinical data at the Cellectis’ R&D Day. The presented data position lasme-cel as a potentially game-changing therapy for patients with r/r B-ALL. Data highlighted: Strong efficacy: 68% overall response rate (ORR) with lasme-cel Process 2, manufactured internally (n=22) 83% ORR at the recommended Phase 2 dose (RP2D) (n=12) 100% ORR in the target Phase 2 population (n=9) In the target Phase 2 population, the complete response or complete remission with incomplete hematology recovery (CR/Cri) rate was 56%, with approximately 80% of these patients achieving minimum residual disease (MRD)-negative status Favorable safety profile: Low rates of ≥ grade 3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) at 2.5% and 5% respectively Transplant eligibility in target Phase 2 population: All patients became eligible for transplant Strong survival benefit: 14.8 months median overall survival (OS) in patients who achieved MRD-negative CR/CRi The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026 (n=40). Cellectis anticipates submitting a Biologics License Application (BLA) in 2028. Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01 In December 2025, Cellectis presented encouraging Phase 1 preliminary data of eti-cel at the American Society of Hematology (ASH) annual meeting. The data showcased the potential of eti-cel in r/r NHL patients who have relapsed following multiple lines of therapy including, for 93% of patients, an autologous CD19 CAR-T, with an 88% ORR and 63% CR at the current dose level (n=8). Cellectis is initiating 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. Cellectis expects to present the full Phase 1 dataset in 2026, including results from the IL-2 combination. Circular single-stranded DNA (cssDNA) as a non-viral template for gene therapy In November 2025, Cellectis published a Nature Communications article establishing cssDNA as a highly efficient non-viral DNA donor template, for gene insertion in hematopoietic stem and progenitor cells (HSPCs). While viral vectors such as AAV6 are commonly used for gene insertion, they raise safety and efficacy concerns. Over the past decade, non-viral DNA templates delivery has emerged as promising alternatives. Cellectis’ research results mark a pivotal advance toward next-generation non-viral cell and gene therapies. Key findings: Superior efficiency: cssDNA achieved over 40% knock-in efficiency, outperforming linear DNA by 3-5 times. Versatility: the process successfully targets multiple loci in HSPCs and primary T cells. Better persistence: in murine models, cssDNA-edited cells showed superior engraftment and edit maintenance compared to AAV6-edited cells. TALE base editors (TALEB) safety and precision At ESGCT 2025, Cellectis presented a comprehensive safety study on TALE base editors (TALEB), which enable precise C-to-T DNA editing without causing double-strand breaks. Key study highlights: Safety assessment: researchers used advanced bioinformatics and experimental models to track potential off-target effects in the nuclear genome of primary T cells. No bias detected: the study found no evidence of unintended editing at CTCF binding sites, which are critical for genome organization and gene expression. These research results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications. Partnerships AstraZeneca – Joint Research and Collaboration Agreement 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 (through its sublicensee Allogene) – Anti-CD19 CAR-T 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. In December 2025, an arbitral tribunal has issued its decision in the arbitration proceedings against Les Laboratoires Servier and Institut de Recherches Internationales Servier IRIS SARL (“Servier”), relating to the License, Development and Commercialization Agreement entered into between Servier and Cellectis on March 6, 2019, as amended (the “Servier Agreement”). The Tribunal ruled on a partial termination of the License Agreement with respect to product UCART19 V1 (also referred to as “ALLO-501” by Allogene) and provided that Cellectis shall, at Allogene’s request, engage in good-faith discussions regarding the granting of a direct license to product UCART19 V1. All other claims brought by the parties were dismissed. Allogene – Anti-CD70 CAR-T According to Allogene, the TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, and Allogene is currently exploring partnering opportunities to advance the asset. Iovance According to Iovance, new data across several pipeline programs is anticipated throughout 2026, including a Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC. Corporate Annual Shareholders Meeting On June 26, 2025, Cellectis held a Shareholders General Meeting. 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/ Board composition The Cellectis Shareholders' Meeting appointed Mr. André Muller as a director of the Company's Board of Directors. 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 Mr. André Muller, Dr. Donald Bergstrom, and Dr. Rainer Boehm as the members of the Company’s Audit Committee. 2025 Financial Results Cash: As of December 31, 2025, Cellectis had $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets. The Company believes its cash, cash equivalents, and fixed-term deposits will be sufficient to fund its operations into H2 2027. This compares to $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets as of December 31, 2024. This $53 million change includes $36.9 million of cash-in from our revenue, $8.4 million of interest received from our financial and cash-equivalent investments, $2.2 million cash-in from R&D tax credit, $3.2 million cash-in from VAT credit payments, and a $4.8 million foreign currency translation impact offset by cash payments from Cellectis to suppliers of $50.5 million, Cellectis’ wages, bonuses and social expenses paid of $40.0 million, the payments of lease debts of $10.8 million, the repayment of the Prêt Garanti par l’Etat (PGE) loan for $5.4 million and the payments of capital expenditures for $3.5 million. We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical development expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina). Revenues and Other Income: Consolidated revenues and other income were $79.6 million for the year ended December 31, 2025 compared to $49.2 million for the year ended December 31, 2024. This $30.4 million increase between the years ended December 31, 2024 and 2025 is mainly driven by the evolution of activities performed in connection with the research plans and fulfillment of our performance obligations under the Joint Research and Collaboration Agreement signed with AstraZeneca. Revenues as recorded in the year ended December 31, 2024 included a $5.4 million development milestone under the License Agreement signed with Servier. R&D Expenses: Consolidated R&D expenses were $93.5 million for the year ended December 31, 2025, compared to $90.5 million for the year ended December 31, 2024. This $3.0 million increase is mainly due to (i) a $4.2 million increase in personnel expenses driven by an evolution of our R&D headcount consistent with our roadmap, higher fair market value of stock-based compensation instruments due to underlying stock dynamics, and foreign exchange effects; (ii) a $0.3 million increase in depreciation and amortization; compensated by (iii) a $1.5 million decrease in purchases and external expenses. SG&A Expenses: Consolidated SG&A expenses were $19.8 million for the year ended December 31, 2025 compared to $19.1 million for the year ended December 31, 2024. The $0.7 million change is mainly due to a $0.6 million increase in purchases and external expenses. Other operating income and expenses: Other operating income and expenses decreased slightly by $0.2 million between the years ended December 31, 2024 and 2025, from $0.8 million in 2024 to $0.6 million in 2025. Net financial gain (loss): Net financial loss was $34.9 million for the year ended December 31, 2025, compared to a $22.8 million net financial gain for the year ended December 31, 2024. This $57.7 million difference reflects mainly a $28.3 million decrease in financial income and a $29.5 million increase in financial expenses between the years ended December 31, 2024 and 2025. The decrease in financial income is mainly attributable to (i) a $14.3 million gain in change in fair value of the derivative instrument component of the SIA, which was recorded last year before derecognition of the derivative in May 2024; (ii) a $7.2 million decrease in foreign exchange gains; (iii) a $1.8 million decrease in income from cash, cash equivalents and financial assets in line with the evolution of interest rates in 2025, (iv) a $ 5.7 million gain recognized in the year ended December 31, 2024 on the fair value measurement of the Tranches A, B and C warrants issued to the European Investment Bank ("EIB"), partially offset by (v) a $0.8 million increase in FX derivatives fair value gains. The increase in financial expenses is mainly attributable to a (i) $22.2 million increase in foreign exchange loss over the period due to the devaluation of the USD against the Euro, (ii) a $14.7 million loss on the fair value measurement of the Tranches A, B and C warrants issued to the EIB, (iii) a $0.7 million increase in interest on our financial and lease liabilities, partially offset by (iv) a $7.8 million decrease in the loss on fair value measurement of our investment in shares of Cibus which was entirely sold in Q1 2025. Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $67.6 million (or a $0.67 loss per share) for the year ended December 31, 2025, compared to a $36.8 million loss (or a $0.41 loss per share) for the year ended December 31, 2024. The $30.8 million change in net loss was primarily driven by (i) a $30.4 million increase in revenues and other income, offset by (ii) a $3.9 million increase in operating expenses and other operating income and (iii) a $57.7 million change from a net financial gain of $22.8 million as of December 31, 2024 to a net financial loss of $34.9 million as of December 31, 2025. Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $61.5 million (or a $0.61 loss per share) for the year ended December 31, 2025, compared to a net loss of $33.6 million (or a $0.37 loss per share) for the year ended December 31, 2024. The year-end consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”). Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. Note Regarding Use of Non-IFRS Financial Measures Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS® Accounting Standards. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS Accounting Standards. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense — a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis. 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 ”ambition,” “anticipates,” “anticipated,” “believe,” “can,” “expected,” “expects,” “foresee,” “planned,” “potential,” “potentially,” 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 our licensed partners. Forward-looking statements include statements about the potential of the pivotal Phase 2 BALLI-01 trial 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 submission), the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, the outcomes of our collaboration agreement, including with AstraZeneca, Servier, Allogene, and Iovance, and the financial position of Cellectis. These forward-looking statements are made in light of information currently available to us 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 BALLI-01 Phase 1 data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results relating to a small number of patients – such results should not be viewed as predictive of 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 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, [email protected] 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, [email protected] Attachment Earnings_Q4_2025_PR_English
TranscriptFY2025 Q42026-03-20FY2025 Q4 earnings call transcript
Earnings source - 74 paragraphs
FY2025 Q4 earnings call transcript
Hello and welcome everyone to today's Cellectis full-year 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded and that we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Arthur Stril, Chief Financial Officer and Chief Business Officer. Please go ahead.
Good morning and welcome everyone to Cellectis fourth quarter and full-year 2025 business update and financial results conference call. Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Adrian Kilcoyne, our Chief Medical Officer. Yesterday evening, Cellectis issued a 20-F and press release reporting our financial statements for the 12-month period ended December 31st, 2025, and a business update. The report and press release are available on our website at cellectis.com. As a reminder, we'll make statements regarding Cellectis financial outlook, including the sufficiency of cash to fund operations in addition to its manufacturing, regulatory and product development status, as well as product development status of its licensed partners.
These forward 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, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission, SEC, and the financial report, including the management report for the year ended on December 31st, 2025, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André Choulika.
Thank you, Arthur. Good morning and thank you everyone for joining us today. Cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century. On that foundation and idea, we pioneered the allogeneic CAR-T approach, ready on day one, built for all patients regardless of their condition. Today, I'm proud to say that Cellectis is one of the only companies running a pivotal phase II allogeneic CAR-T trial, specifically in B-cell acute lymphoblastic leukemia. The past several years have been among the most challenging in recent memory of biotechnology companies. Many programs were shelved and many companies were forced to retreat. While others stepped back, Cellectis stepped forward. We held the line. We managed our cash with rigor.
We invested where it matters, and we kept our team focused entirely on one thing, delivering clinical results for patients who are running out of time with no therapeutic solution. In 2025, that discipline paid off. In October, at our R&D day, we presented the full phase I data set for Lasme-cel, our allogeneic CAR-T candidate targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia. Lasme-cel achieved 100% overall response rate in the target phase II population. Critically, Lasme-cel converted all patients in the target population to transplant-eligible candidates. These results were achieved in patients in third line and beyond. Most of them have already failed CD19 CAR-T, blinatumomab, and inotuzumab. Their options were exhausted. This is clinical proof that an allogeneic CAR-T can deliver deep, durable responses in one of the most difficult cancer to treat.
Let me take a moment to explain why our bridge to transplant strategy is medically powerful. For patients with relapse or refractory B-ALL, only known path to long-term cure is a bone marrow stem cell transplant. To be eligible for transplant in a patient, a patient must first achieve deep remission, ideally minimal residual disease negative or MRD negative. The challenge is that heavily pre-treated patients, often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured. Window is narrow. This is precisely where our allogeneic CAR-T product, Lasme-cel, becomes a game changer. Off the shelf, immediately available. Lasme-cel has the potential to reach a patient in days, not weeks, rapidly eliminate residual disease and open the door to transplant. For the patients, it is the difference between a chance to a cure and no chance at all.
With that, our pivotal phase II trial now initiated, we will continue site openings in North America and Europe and enroll expansion in 2026. The first interim analysis of the pivotal phase II trial is expected Q4 2026. Turning to our second product candidate, Eti-cel, for patients with relapsed or refractory non-Hodgkin lymphoma. Eti-cel is a best-in-class allogeneic dual CAR-T targeting CD20 and CD22 simultaneously. Two differentiated antigens validated in oncology. This dual targeting is a deliberate answer to one of the most stubborn clinical problem in lymphoma, antigen escape. When cancer cells lose one surface marker to evade a single target therapy, they cannot hide from both. Eti-cel was built for that challenge.
At the ASH 2025 annual meeting in December 2025, Cellectis presented phase I interim results, which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients. These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-Hodgkin lymphoma patients. Trial is now investigating any potential impact of low-dose Interleukin-2 support to significantly enhance the expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. Cellectis expects to present the full phase I data set of Eti-cel this year. Now, a few words on our partners. Cellectis is not operating in isolation. Our gene editing platform has become the technological backbone of a broader allogeneic CAR-T ecosystem. Two of our key partners are approaching a pivotal moment.
Servier, through Allogene's Cema-cel program, is currently in a pivotal phase II study evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients. Allogene anticipates that the interim futility analysis is on track for Q2 2026. Our partnership with Iovance is another powerful testament to the versatility of our platform. Iovance is advancing IOV-4001 in PD-1-inactivated tumor-infiltrating lymphocytes or TIL cell therapy. In previously treated advanced melanoma patients leveraging our gene editing capacity, clinical results of IOV-4001 in melanoma are anticipated this year. R&D activities continue to advance under our 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.
Partnership is a further testament to the industrial credibility of our gene editing platform and our manufacturing capabilities. 2026 will be a year of data, of milestones, and of momentum for Cellectis. We are grateful for your continued trust and support. We look forward to updating you through the year as we execute against each of these milestones. With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will provide further details on our clinical programs. Adrian, please go ahead.
Thank you, André. I will provide a focused clinical perspective on our Lasme-cel and Eti-cel programs. The phase I BALLI-01 study of Lasme-cel in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression. These patients were heavily pre-treated with a median of four prior lines of therapy. The median number of prior lines of therapy at the recommended phase II dose was higher at five. These heavily pre-treated patients have already relapsed following multiple targeted therapies. Most patients have been previously treated with blinatumomab and relapsed. Approximately 50% have also relapsed following CD19 CAR-T and inotuzumab, a CD22-directed antibody-drug conjugate. Therefore, there remains very few, if any, therapeutic options for these patients.
At the recommended phase II dose, Lasme-cel achieved an overall response rate of 83% and a CR/CRI rate of 42%. In the target phase II population, with an upper age cutoff of 50 years old, response rates were even higher, with 100% overall response and a CR/CRI rate of 56%. Importantly, of those subjects who achieved a CR/CRI, 80% achieved MRD negative status. Additionally, of the nine patients in the target phase II population, all became transplant eligible, with seven of nine receiving stem cell transplant at the time of data cut off. This is a very positive outcome for these patients. In patients who achieved MRD negative CR/CRI, median overall survival was 14.8 months, a meaningful survival benefit in this heavily pretreated population.
The safety profile of Lasme-cel was favorable and similar or lower than observed with other autologous CAR-T therapies. Greater than or equal to grade three cytokine release syndrome occurred in 2.5% of patients, and greater than or equal to grade three ICANS occurred in 5% of patients at the recommended phase II dose. The full phase I data has been submitted for presentation at the 2026 European Hematology Association Congress to be held in Stockholm in June. The phase I program also addressed two important additional questions. The first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external CDMO. The second is whether alemtuzumab, as part of the preconditioning lymphodepletion regimen, results in superior Lasme-cel expansion, and therefore efficacy compared to the standard lymphodepletion regimen.
Validating our decision to internalize our manufacturing capabilities, Cellectis manufactured product demonstrated meaningfully higher response rates than external CDMO manufactured product, with overall response rates of 68% and 28% respectively. Secondly, the data demonstrated that increased alemtuzumab exposure correlates with improved response. These data were outlined at the American Society of Hematology annual conference in December 2025. Additional data have also been submitted for presentation at the 2026 European Hematology Association Congress. We are now enrolling in the pivotal phase II program focused on the target phase II population of patients aged between 12 and 50 years of age. We are accelerating site openings and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America. As André highlighted, we expect to complete the first interim analysis of 40 patients in Q4 2026.
These data will be shared publicly in a forum to be determined. I will remind you that, as previously disclosed, the anticipated BLA submission is planned for the second half of 2028. Our second ongoing program, investigating our dual CAR-T, Eti-cel, targets CD20 and CD22 expressing tumors in third line and beyond non-Hodgkin lymphoma. This highly differentiated product offering important and much needed alternative targets to CD19 continues in phase one. The preliminary phase one data presented at ASH 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the six evaluable patients. Cellectis believes we can further enhance these already high response rates through the addition of low dose IL-2 support. The addition of low dose IL-2 offers the potential to further enhance CAR-T expansion, tumor killing and persistence without negatively impacting toxicities.
We expect to present the phase I data set, including the IL-2 cohort results later this year. We plan to progress this program to pivotal phase II in 2027 and anticipate a BLA submission in H2 2029. As you can see, 2026 promises to be an exciting year for Cellectis with a number of critical milestones and catalysts as we transform into a late-stage development organization. I look forward to sharing our progress later this year. With that, I would like to hand the call over to Arthur Stril, Cellectis's Chief Financial Officer and Chief Business Officer, for an overview of our financials for the fourth quarter and full-year 2025. Arthur, over to you.
Thank you, Adrian. Let me now walk you through our financial position. As André mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most, the development of Lasme-cel and Eti-cel, and the operation of our end-to-end manufacturing facilities in Paris and Raleigh. We believe our current cash position gives us the financial runway to execute on our pivotal phase II program for Lasme-cel and our phase I for Eti-cel, and deliver two key readouts in Q4 2026, the first interim analysis with 40 patients for Lasme-cel and the full phase I data set for Eti-cel. We are well positioned financially to execute on these two trials as our cash equivalents and fixed term deposits as of December 31st, 2025 remain sufficient to fund our operations into H2 2027.
We are also looking forward to the upcoming data readouts for our partnered programs, in particular Servier and Allogene Cema-cel in April 2026 and Iovance's IOV-4001 this year as well. Finally, we are excited that activities are progressing under our strategic collaboration with AstraZeneca, which has positively impacted our 2025 revenue. As of December 31st, 2025, our cash equivalents, restricted cash and fixed term deposits classified as current financial assets amount to $211 million compared to $264 million as of December 31st, 2024. This $53 million decrease is mainly due to $36.9 million cash in from revenue.
$8.4 million of interest received from our financial and cash equivalent investments, partially offset by cash payments from Cellectis to suppliers of $50.5 million. Cellectis wages, bonuses, and social expenses paid of $40 million. The payments of lease debts of $11 million and the repayment of the PGE loan of $5.4 million. You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 12 months ended December 31st, 2025. We very much look forward to a rich 2026, especially with Servier and Allogene's readouts for Cema-cel next month and our two readouts for Lasme-cel and Eti-cel later this year. We'll now turn the call over to the operator for questions.
Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. Our first question will come from Amin Makarem with Jefferies. Please go ahead.
Hey, team, thank you for taking our questions. Two from us. First, on the Lasme-cel and the BALLI-01 enrollment. How's recruitment tracking in the pivotal study, and when do you expect to complete enrollment for that dose selection portion? I have a follow-up.
Yeah. Thanks, Amin. I can take that. Currently we're doing very well. We're engaging many sites. The site opening is on track. We're certainly on track to complete our data analysis by the end of the year. That's just for the other people on the call. That's the first 40 patients interim analysis, and that's part of the dose optimization phase of the study, looking at two alternative doses of alemtuzumab, which is required by CDER. Yes, it's going well, Amin, and we're on track for a Q4 data sharing.
Thanks. For this dose optimization portion, as you evaluate the two alemtuzumab dose levels, what are the expectations there? What differences should we expect between the two arms in terms of efficacy signal, or are you expecting a meaningful difference in the safety, or you think the two arms are gonna be generally in the same ballpark?
We don't. It's very difficult to say, and I, you know, almost require a crystal ball to decide will there be a big difference in terms of both. We anticipate, however, that we have designed a very strong analysis plan to allow us to differentiate between the two components. That will be based on efficacy, safety, but also significantly important translational markers in terms of our CAR-T expansion, host T cell reconstitution, et cetera. We do believe, excuse me, that we will be able to define an optimized dose by the end of the year. We don't think that will be a significant challenge. However, we know that both of these doses of alemtuzumab, very importantly, they work. It's all about dose optimization now. It's not about finding an effective dose.
Okay. Helpful. Thanks.
Thank you. Our next question will come from Salveen Richter with Goldman Sachs. Please go ahead.
Taking my questions. Two questions from us. One is, could you provide more details on the Servier arbitration, given the ruling that you have to engage in discussions with Allo regarding the direct licensing of 501, and help us understand how this impacts your eligibility for the EUR 340 million in milestones into this interim data? Then secondly, could you talk about your decision to include CD52 preconditioning in both the studies in the context of safety, as we see some of the competitors moving away from CD52? Thank you.
Hi, Salveen. This is Arthur. Thanks for the question. I'll take the question on the arbitration and then hand it over to Adrian for the clinical question. As a reminder, the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCART19 v1, also named ALLO-501 by Allogene. This product has been brought back to Cellectis, and we are free to develop it or moving forward. The tribunal did not affect ALLO-501A or Cema-cel, so we remain fully eligible for up to EUR 340 million in development and sales milestones.
That is obviously under the Servier agreement, which has been then sub-licensed to Allogene. This does not impact any eligibility to upcoming developments, and sales milestone as well as royalties down the line, on Cema-cel, but it gave us back UCART19 v1 or ALLO-501, and we're free to do whatever we would like to do with it. I will hand it over to Adrian for the clinical question.
One thing I'd like to add, like, during our thinking is that once the pivotal trial is effective, then the milestone should be triggered. Like, we're definitely expecting to have this $20 million milestone paid one day.
Okay. I'll answer the alemtuzumab question. It's a great question. There's a few things. Just a few observations from our studies. One is that alemtuzumab is really important to optimize lymphodepletion. As I said earlier, the more optimal the lymphodepletion, the better the outcomes in terms of responses. You get a much deeper response. As part of our phase I program, we did test a lymphodepletion regimen without alemtuzumab, and we failed to get any MRD-negative responses. So we know that alemtuzumab is very effective. The second part is you were saying some people are moving away from it. Now, we believe, as I've said already, alemtuzumab is important, but we also believe that it's critically important that you get the right dose. It's like everything, too much is always too much.
We have, compared to other companies that are using alemtuzumab or alemtuzumab similars, we're using a much lower dose. We spent a lot of time in already optimizing our doses. We believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymphodepletion regimen. Also, let's not forget that alemtuzumab has been widely used in other clinical contexts, so it's got a very well-characterized safety profile, and we've been able to build into all our protocols very extensive risk mitigation. We believe we've got the right strategy with our alemtuzumab. I cannot answer why others may have transitioned away from it.
Thank you. Our next question will come from Jack Allen with Baird.
Great. Thanks for taking the questions, and congrats to the team on all the progress. I guess the first one I wanted to ask was on Eti-cel, and how we should think about the update in the fourth quarter this year. Any additional color you're willing to provide as it relates to the breadth of update and number of patients and the durability of follow-up there would be great. I have a quick follow-up as well.
I can give you a top-line update on top of the data we already have. As we've shared already, at our current dose level, we're seeing 63% complete remission rates, 88% overall response rates. By the end of the year, you will see data in cohorts with and without IL-2. Now, we would acknowledge that 63% complete remission rate is actually a very strong result, and theoretically, we do not need to enhance that further, but we want to. We believe we can with the addition of low-dose IL-2. By the end of the year, you will see, you know, we're currently expanded at our recruiting sites rather significantly. We've doubled them. We anticipate we will be able to get a reasonable.
I cannot give you a number because I don't know what the recruitment rates are going to be. We will be towards the latter part of the year also not in the staggering phase, so we would anticipate a significant increase in recruitment. You will see some durability data, is what you asked about. For the patients in the later phase, there will hopefully be good durability signals. We have in our mind the durability levels we want to achieve, and it's around the six-month mark. Hopefully by the end of the year you'll be able to see a very clear picture. I think the efficacy question's already been answered. The question is can we enhance it even further into the seventies rather than in the mid-sixties.
Also it'll give us a very good signal. Is IL-2 really a potential game changer for allogeneic therapy? We obviously, based on our preclinical data, which is going to be presented at AACR and again some at EHA, that we believe it could offer a really a fundamental improvement for allogeneic cell therapies.
Great. Thanks for all that color. Then, we might be getting ahead of ourselves a little bit here, but on Lasme-cel and the commercial opportunity, I was wondering if you've been looking at Obe-cel from Autolus and if you have any thoughts around the initial commercial launch of that CD19 allo therapy in ALL.
I can give it from a medical perspective, and Arthur, maybe you want to talk a bit more broadly on the commercial opportunity. Let's not forget our patients are generally post CD19 failures, so we are not seeing this as a competition. We have a very differentiated target, CD22. We believe the market is pretty saturated with CD19s. It's not to say Obe-cel isn't a very good product. It is. Their data is very strong. These patients are very difficult to treat. Many of them will relapse, and they need to have an alternative target. We believe that this is not a competing product, but actually a very differentiated one. In terms of the market size, you may be aware we're starting to look at earlier lines of therapy.
We will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, which we think is a fantastic idea in the non-Hodgkin lymphoma space. We will be looking at that in the ALL space, so we believe that's a really important part for those incredibly difficult to treat patients frontline.
I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. I think the two primary differences is, one, you need to have leukapheresis access for the patients, and this is slow, this is very competitive, and this is controlled by hospitals, not by the pharma companies. Whereas obviously with off-the-shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect.
The second thing, obviously, is because of our off-the-shelf nature, we have very significant economies of scale, and we see it even at the pivotal stage, which will allow us to get extremely competitive gross margins, which was much more the types of what pharma is now used to with small molecules and antibodies. Whereas, pricing of autologous has been difficult, because of the significant cost of goods that make a very important impact on the margin. I think the fact that we're off the shelf will allow us for a much smoother launch in terms of pure access due to the off-the-shelf nature, and also in a much more economically competitive aspect, due to the economies of scale and the very favorable gross margins.
I don't think Obe-cel will be a very good competitor there.
Great.
One thing I'd like to add, Jack, like one thing that was interesting, I was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian. There was one ALL patient that was sitting in the backlog waiting for an available apheresis slot for a long time, along with, you know, non-Hodgkin lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, etc. This patient, like ALL, is very aggressive disease. Still this patient, I'm not going to say which type of product was about to be given to him because I don't know. The fact is that this patient was, like, in real distress waiting for this, like, apheresis spot. This is what you would consider as an autologous launch of yet another CD19 CAR-T, autologous CAR-T.
Got it. Thanks so much. That's very helpful, André Choulika.
Thank you. Our next question will come from Silvan Tuerkcan with Citizens. Please go ahead.
Yeah, good morning, and thank you for taking my questions. I just wanted to ask if you could just give us a brief recap of what you're expecting at EHA from these two programs that you have ongoing. Is it mainly longer follow-up? Thank you so much.
You will be aware that we shared our data at our R&D day back in October. We after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase II program. We wanted to ensure that lower dose is an acceptable dose to give to patients. There was going to be an updated dataset, the whole dataset, including those additional patients. It is. I would consider it a level of progression from the original phase I package that we presented. The data are not remarkably different, let me tell you, but it's an important addition to the data.
The second thing that we hope, we're assuming that it will be accepted, is really to try and understand what makes a product successful. Again, to build on the question from our Goldman Sachs colleagues, where they were talking about alemtuzumab, is the importance of that preconditioning and that day zero, not only from a level of lymphodepletion, but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome. The fact that we have now identified a really clear picture of optimal lymphodepletion, optimal environment in which you infuse your cells, we are now able to predict very early on are patients going to respond. All these data will be shared. I think we're excited by it so far.
Thank you.
Thank you. Our next question will come from Sebastiaan van der Schoot with VLK. Please go ahead.
Hi, guys. Good morning, and thanks for taking our question. I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic CAR-T. Maybe can you provide some insight on how the partnership with AstraZeneca is going? Can we expect any updates in the next 24 months? Thank you.
I can take the first part of that, Arthur, in terms of outpatient setting. Right now, the regulatory authorities require inpatient delivery of product. I think that's consistent with most autologous therapies as well in the CAR-T space. Once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? I think that may be a natural transition, but for that you need a body of evidence.
Hopefully that will be provided not only by the phase II program but also by clinical usage from that. Again, I think it's a very different offering in that, to Arthur's point, we do not need that leukapheresis, etc. I do think it'll take some time for this to be in the outpatient setting you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot in time transition to the outpatient setting.
I will take the question on AstraZeneca. So first of all, we're extremely pleased to count AstraZeneca as a strategic partner. As you have seen, they have continued to invest very heavily in the cell and gene therapy space, and they're one of the few companies that are betting very hard, not only on cell and gene therapy, but also on off-the-shelf treatments. I think we're very fortunate to have them as a key shareholder, but also a strategic R&D partner. The activities are going very well under the collaboration. There's a number of activities ongoing across a range of therapeutic areas. Do not expect updates in the short term. This is at the request of AstraZeneca.
They are essentially asking us for now to stay reasonably quiet, especially given the competitive nature of certain aspects that we are working on. Definitely, as we continue the dialogue with them around disclosure as and when the time is right, we will be providing update, and I think you will be interested in seeing what has been brewing with them.
Great. Thank you, guys.
Thank you. Once again, to ask a question, press star one on your telephone keypad. Our next question will come from Yanan Zhu with Wells Fargo.
Oh, great. Thanks for taking our questions. So first, regarding the Lasme-cel pivotal study. Was wondering for the Q4 readout, is the focus there, the three-month CR/CRi from the two arms in that first 40-patient cohort? And then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose, i.e., the final pivotal cohort? Will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts? I have a follow-up. Thanks.
Great. This is some great questions there. First and foremost, no. The decision for dose optimization is not based on the three-month CR/CRI. It's actually based at an earlier time cutoff of eight weeks. That's important. We will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term, but long-term outcomes, we have those answers by that first eight weeks. It's a composite of many of those that we will be presenting. In terms of that transition from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. Importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities.
The recruitment will continue for the remaining aging patients.
Great. Thanks for those very, very helpful color. The follow-up is mainly on the competitive landscape in terms of additional modalities, in vivo CAR-T, specifically. Can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction, at earliest stage efforts? Thanks.
I can have an initial thoughts on this. I think I know that André and Arthur also have views on the positioning of vivo CAR. You know, we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy. We don't believe these very difficult to treat tumors will be the destination for vivo CAR. We think in vivo CAR-T certainly have a place, but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients? We don't believe so. Yes, there will be in vivo CAR-T in some, maybe autoimmune may be a better destination. Any therapy that requires extensive gene editing and extensive patient management will probably, maybe it will be a bridge too far for in vivo CAR.
I know, André, you have a view on this as well.
I think their process, like in vivo CAR, is similar to autologous CAR-T. The only thing it allows is essentially try to, you know, leapfrog apheresis, which is a great thing. It's like it's a huge market access option that is given here. Nevertheless, it will still be totally linked in to the fitness of the cells of the patient or their presence. If it doesn't respond to blinatumomab, if you can't do an autologous, then you go for an in vivo. Well, if the cells are not really very well functional, it's not gonna work anymore because you need the T cells to be fit. That's one point.
The second point is, it will also be very much related to the current malignancies that are treated, which is essentially liquid tumors, B-cell malignancies, or multiple myeloma. The spread of this into solid tumor is going to be different. Finally, like, there's a lot of papers that are coming out, like a lot of cells are transduced by these vectors that are not T cells. Like, you need to restrict at the time. I think these technologies are going to come in the coming future, to try to restrict the cells to what needs to be transduced by the in vivo CAR-T and not to go and deliver. For example, I've seen a paper recently that shows more vector inside, for example, hepatic cells expressing CAR and then in T cells.
If you do this worldwide, like really broadly, then big questions at a time. Like, the genome is only 6.4 billion base pairs, like 23, 2x chromosomes. If you inject trillions and trillions of vectors in hundreds of patients, like thousands of patients, it's like, I hope that this will be safely integrated. If you go, for example, with an autologous CAR-T, you can master exactly when the cells are transduced. If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square. If you make the product in vivo, which is the case here, then you have to master how the product is made and not to have a lot of byproducts all around the place. That's like the initial concern.
I'm sure that this will be solved in coming decades.
Great. Thanks for all the insights and congrats on the quarter.
Thank you.
Thank you. At this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks.
Thank you very much, everyone. Really appreciate all the questions here. As you can see, this will be a very exciting year, 2026, with a number of updates from our partners and from ourselves. I think we are poised for a new dawn of allogeneic CAR-T-cell therapy. Stay tuned for more updates, and looking forward to further discussions as our progress unfolds this year. Thank you very much.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
Investor releaseQuarter not tagged2026-03-19What To Expect From Cellectis SA (XPAR:ALCLS) Q4 2025 Earnings
GuruFocus.com
What To Expect From Cellectis SA (XPAR:ALCLS) Q4 2025 Earnings
This article first appeared on GuruFocus. Cellectis SA (XPAR:ALCLS) is set to release its Q4 2025 earnings on Mar 20, 2026. The consensus estimate for Q4 2025 revenue is $14.90 million, and the earnings are expected to come in at -$0.24 per share. The full year 2025's revenue is expected to be $58.42 million, and the earnings are expected to be -$0.73 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 4 Warning Signs with XPAR:ALCLS. Is XPAR:ALCLS fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Cellectis SA (XPAR:ALCLS) have increased from $55.17 million to $58.42 million for the full year 2025. For 2026, revenue estimates have declined from $69.51 million to $53.66 million. Earnings estimates have improved from -$0.87 per share to -$0.73 per share for the full year 2025, while they have remained flat at -$0.97 per share for 2026. In the previous quarter of 2025-09-30, Cellectis SA's (XPAR:ALCLS) actual revenue was $32.37 million, which beat analysts' revenue expectations of $6.01 million by 438.64%. Cellectis SA's (XPAR:ALCLS) actual earnings were $0.01 per share, which beat analysts' earnings expectations of -$0.24 per share by 103.72%. After releasing the results, Cellectis SA (XPAR:ALCLS) was down by 0.35% in one day. Based on the one-year price targets offered by 1 analyst, the average target price for Cellectis SA (XPAR:ALCLS) is $6.55, with a high estimate of $6.55 and a low estimate of $6.55. The average target implies an upside of 112.59% from the current price of $3.08. Based on GuruFocus estimates, the estimated GF Value for Cellectis SA (XPAR:ALCLS) in one year is $2.75, suggesting a downside of 10.71% from the current price of $3.08. Based on the consensus recommendation from 5 brokerage firms, Cellectis SA's (XPAR:ALCLS) average brokerage recommendation is currently 1.8, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Investor releaseQuarter not tagged2026-03-13Cellectis to Report Fourth Quarter and Full Year 2025 Financial Results on March 19, 2026
GlobeNewswire
Cellectis to Report Fourth Quarter and Full Year 2025 Financial Results on March 19, 2026
NEW YORK, March 12, 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 announced that it will report financial results for the fourth quarter and full year 2025 ending December 31, 2025 on Thursday, March 19, 2026 after the close of the US market. The publication will be followed by an investor conference call and webcast on Friday, March 20, 2026, at 8:00 AM ET / 1:00 PM CET. The call will include the Company’s fourth quarter and full year 2025 results and an update on business activities. Details for the call are as follows: Dial in information: Domestic: +1-800-579-2543 International: +1-785-424-1789 Conference ID: CLLSFY Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1747993&tp_key=8aa72cea7f 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. For further information on Cellectis, please contact: Media contacts: Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, [email protected] 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, [email protected] Attachment 20260312_FY 2025 earnings call announcement_ENGLISH.pdf
Investor releaseQuarter not tagged2025-11-08Cellectis Reports Third Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Cellectis Reports Third Quarter 2025 Financial Results and Provides Business Update
Presented data underscore the potential of lasme-cel (UCART22) and eti-cel (UCART20x22) to improve outcomes in r/r B-ALL and r/r NHL: Lasme-cel in r/r B-ALL (BALLI-01) ORR of 68% with lasme-cel Process 2 (n=22), 83% at RP2D (n=12) and 100% in the target Phase 2 population (n=9) Median OS of 14.8 months in patients who achieved MRD-negative CR/CRi First interim analysis for the BALLI-01 trial expected in Q4 2026 Eti-cel in r/r NHL (NATHALI-01) ORR of 86% and 57% CR rate (n=7) Development update to be presented at the ASH 2025 annual meeting Full Phase 1 dataset expected to be shared in 2026 Servier arbitration: arbitral decision expected to be rendered on or before December 15, 2025 Cash, cash equivalents and fixed-term deposits of $225 million as of September 30, 20251 provides runway into H2 2027 NEW YORK, Nov. 07, 2025 (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 provided financial results for the third quarter 2025 ending September 30, 2025 and business updates. “We are proud of the promising data from our core clinical product candidates. Our lasme-cel program for r/r B-ALL and eti-cel program for r/r NHL demonstrated their ability to induce deep and meaningful responses, underscoring their potential to improve outcomes in diseases with high unmet medical needs” said André Choulika, Ph.D., Chief Executive Officer at Cellectis. “We look forward to sharing an additional development update on eti-cel at the ASH 2025 Annual Meeting and to provide the first interim analysis for the pivotal Phase 2 BALLI-01 trial in Q4 2026. Together, these milestones strengthen our leadership in allogeneic CAR-T innovation and position Cellectis for a transformative year ahead." _______________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $4.4 million as of September 30, 2025 and fixed-term deposits of $168.2 million as of September 30, 2025, of which $137.6 million are classified as current financial assets and $30.6 million are classified as non-current financial assets (due to a fixed bank deposit investment maturing in October 2026, including accrued interest). Pipeline Highlights UCART Clinical Programs BALLI-01 study evaluating lasme-cel (UCART22) Clinical data fro…Read full documentShow less
Presented data underscore the potential of lasme-cel (UCART22) and eti-cel (UCART20x22) to improve outcomes in r/r B-ALL and r/r NHL: Lasme-cel in r/r B-ALL (BALLI-01) ORR of 68% with lasme-cel Process 2 (n=22), 83% at RP2D (n=12) and 100% in the target Phase 2 population (n=9) Median OS of 14.8 months in patients who achieved MRD-negative CR/CRi First interim analysis for the BALLI-01 trial expected in Q4 2026 Eti-cel in r/r NHL (NATHALI-01) ORR of 86% and 57% CR rate (n=7) Development update to be presented at the ASH 2025 annual meeting Full Phase 1 dataset expected to be shared in 2026 Servier arbitration: arbitral decision expected to be rendered on or before December 15, 2025 Cash, cash equivalents and fixed-term deposits of $225 million as of September 30, 20251 provides runway into H2 2027 NEW YORK, Nov. 07, 2025 (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 provided financial results for the third quarter 2025 ending September 30, 2025 and business updates. “We are proud of the promising data from our core clinical product candidates. Our lasme-cel program for r/r B-ALL and eti-cel program for r/r NHL demonstrated their ability to induce deep and meaningful responses, underscoring their potential to improve outcomes in diseases with high unmet medical needs” said André Choulika, Ph.D., Chief Executive Officer at Cellectis. “We look forward to sharing an additional development update on eti-cel at the ASH 2025 Annual Meeting and to provide the first interim analysis for the pivotal Phase 2 BALLI-01 trial in Q4 2026. Together, these milestones strengthen our leadership in allogeneic CAR-T innovation and position Cellectis for a transformative year ahead." _______________ 1 Cash, cash equivalents and fixed-term deposits include restricted cash of $4.4 million as of September 30, 2025 and fixed-term deposits of $168.2 million as of September 30, 2025, of which $137.6 million are classified as current financial assets and $30.6 million are classified as non-current financial assets (due to a fixed bank deposit investment maturing in October 2026, including accrued interest). Pipeline Highlights UCART Clinical Programs BALLI-01 study evaluating lasme-cel (UCART22) Clinical data from the Phase 1 BALLI-01 study with lasme-cel for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), were presented at the Cellectis’ R&D Day that took place on October 16, 2025. The presented data position lasme-cel as a potentially game-changing therapy for patients with r/r B-ALL. In the Phase 1 of BALLI-01 study, 40 transplant ineligible third line or beyond (3L+) patients were dosed with lasme-cel: 18 patients (n=18) were dosed with product manufactured by an external CDMO (Process 1, or P1) and 22 patients (n=22) were dosed with Cellectis-manufactured product (Process 2, or P2). Highlights include: Efficacy: lasme-cel demonstrated an overall response rate (ORR) of 68% with Process 2 product (n=22), and an ORR of 83% at the recommended Phase 2 dose (RP2D; n=12) and 100% in the target Phase 2 population (n=9) Safety: in Phase 1 (n=40), lasme-cel was generally well tolerated; there was one case of grade 2 immune effector cell–associated hemophagocytic syndrome (IEC-HS), which resolved. Durability: among patients who achieved minimal residual disease (MRD)-negative complete remission or complete remission with incomplete hematologic recovery (CR/CRi), median overall survival was 14.8 months. Depth of response in target Phase 2 population: the CR/CRi rate was 56%, with approximately 80% of these patients achieving MRD-negative status. Transplant eligibility in target Phase 2 population: all patients (100%) became eligible for transplant, and 78% proceeded to transplantation. The survival curve for this study suggests a clear benefit: patients who proceeded to hematopoietic stem cell transplantation (HSCT) after lasme-cel therapy showed a trend to longer overall survival than those who did not undergo transplant. The Phase 1 data showed that lasme-cel maintained its efficacy regardless of the number or type of prior lines of treatments, including CAR-T (60% of subjects), transplant (50% of patients), and blinatumomab (80% of subjects). Following successful End-of-Phase 1 meetings with the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Cellectis provided a registration path for lasme-cel in r/r ALL. The first interim analysis for the Phase 2 of the BALLI-01 trial is expected in Q4 2026. Cellectis anticipates submitting a Biologics License Application (BLA) in 2028. Commercial Opportunity for Lasme-cel As part of the R&D Day presentation, the Company discussed the potential commercial opportunity for lasme-cel in r/r B-ALL. If approved for commercialization, Cellectis estimates that lasme-cel could achieve up to approximately $700 million in potential peak gross sales across the U.S., EU4 (France, Germany, Italy, Spain) and UK in 2035, corresponding to an estimation of about 1,100 patients treated annually. Furthermore, gross peak sales could increase to up to approximately $1.3 billion with potential label expansion to second line and first line MRD+ consolidation. These estimates highlight that lasme-cel has the potential to drive meaningful growth of the CAR-T market in B-ALL, leading to a robust peak sales potential with attractive margins stemming from the allogeneic approach. American Society of Hematology (ASH) 2025 annual meeting poster presentation On November 3, 2025, Cellectis announced the acceptance of an abstract for lasme-cel for poster presentation at the American Society of Hematology (ASH) 2025 annual congress, that will take place on December 6-9, 2025. The poster highlights the correlation between alemtuzumab exposure and depth of response in the difficult-to-treat r/r ALL patients who have received lasme-cel. Additionally, the data identifies a threshold exposure level of alemtuzumab above which achieving a complete response/complete response with incomplete hematologic recovery (CR/CRi) is more likely without any increase in toxicities. The poster presentation will occur on December 8, 2025, 6:00 PM - 8:00 PM ET, in Room OCCC - West Halls B3-B4. NatHaLi-01 study evaluating eti-cel (UCART20x22) At the R&D Day, Cellectis unveiled preliminary data on eti-cel, its allogeneic CAR-T product candidate for relapsed or refractory non-Hodgkin lymphoma (r/r NHL), demonstrating an encouraging ORR of 86% and CR rate of 57% at the current dose level (n=7), with 4 out of 7 patients achieving a complete response. The preliminary high rate of complete responses underscores the potential of this innovative approach to transform outcomes for r/r NHL patients. Cellectis expects to present the full Phase 1 dataset for eti-cel, including low-dose IL-2 combination cohorts, in 2026. On November 3, 2025, Cellectis announced the acceptance of an abstract for poster presentation at ASH 2025. The poster provides a development update on eti-cel for patients with r/r NHL and outlines the addition of low dose interleukin-2 (IL-2) to further deepen and extend anti-tumor activity of eti-cel in patients with r/r NHL, supported by compelling preclinical data. The poster presentation will occur on December 7, 2025 at 6:00 PM – 8:00 PM ET, in Room OCCC – West Halls B3-B4. Innovation Circular single-stranded DNA (CssDNA) as a non-viral template for gene therapy In October 2025, Cellectis presented findings in a poster, highlighting the strong potential of circular single-stranded DNA (CssDNA) as a universal, efficient non-viral template for gene therapy, at the European Society of Gene and Cell Therapy (ESGCT) annual congress. Over the past decade, non-viral DNA template delivery has been used with engineered nucleases to target single-stranded DNA sequences in hematopoietic stem and progenitor cells (HSPCs). While developed for gene therapy purposes, so far this method has been restricted to gene corrections. To expand this scope, Cellectis developed an editing process using its gene editing technology and kilobase-long circular single-stranded DNA donor templates. The data presented show that: CssDNA editing process achieved high gene insertion frequency in viable HSPCs. CssDNA-edited HSPCs show a higher propensity to engraft and maintain gene edits in a murine model than adeno-associated viruses (AAV)-edited HSPCs. TALE base editors (TALEB) off-targets in the nuclear genome At ESGCT 2025, the Company presented in a poster a comprehensive study of TALE base editors (TALEB) off-targets in the nuclear genome. TALE base editors (TALEB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and an uracil glycosylase inhibitor (UGI). These recent additions to the genome editing toolbox can directly edit double strand DNA, converting a cytosine (C) to a thymine (T) through the formation of an uracil (U) intermediate without the need of DNA break. Base editing has great potential in therapeutic applications. However, being able to avoid potential off-target effects is key toward this goal. To evaluate TALEB safety, Cellectis combined advanced bioinformatic predictions with multiple experimental approaches to investigate potential off-target effects in the nuclear genome of primary T cells. The study found no evidence of biases towards off-site C-to-T editing at sites flanked by CTCF binding sites, a key DNA-binding protein that regulates genome organization and gene expression at genome wide level. These results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications. AstraZeneca – Joint Research and Collaboration Agreement In its presentation during the Cellectis’ R&D Day held in October, AstraZeneca highlighted the significance of its strategic investment and research collaboration with Cellectis to accelerate its cell therapy and genomic medicine ambitions. The collaboration 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 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. Iovance In November 2025, Iovance reported that clinical results for IOV-4001, a PD-1 inactivated TIL cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026. Other potential indications for IOV-4001 are also in development. Financial Results Cash, cash equivalent and fixed-term deposits: As of September 30, 2025, Cellectis had $225 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current and non-current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into H2 2027. This compares to $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2024, with no fixed-term deposits classified as non-current financial assets as of such date. This $39 million change includes $30.5 million of cash-in from our revenue, $7.1 million of interest received from our financial and cash-equivalent investments, $2.9 million cash-in from credit VAT, $1.5 million cash-in from other financial investments, offset by cash payments from Cellectis to suppliers of $35.5 million, Cellectis’ wages, bonuses and social expenses paid of $32.4 million, the payments of lease debts of $8.1 million, the repayment of the “PGE” loan of $4.0 million and the payments of capital expenditures for $3.0 million. We currently foresee focusing our cash spending in supporting the development of our pipeline of product candidates, including the manufacturing and clinical development expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina). Revenues and Other Income: Consolidated revenues and other income were $67.4 million for the nine-month period ended September 30, 2025, compared to $34.1 million for the nine-month period ended September 30, 2024. This $33.3 million increase between the nine-month period ended September 30, 2024 and 2025 was mainly driven by the evolution of activities performed in connection with the Research Plans and fulfillment of our performance obligations under the AstraZeneca Joint Research and Collaboration Agreement. As a reminder, revenues as recorded in the nine-month period ended September 30, 2024 included a $5.4 million development milestone under the License Agreement with Servier. R&D Expenses: Consolidated R&D expenses were $69.1 million for the nine-month period ended September 30, 2025, compared to $69.7 million for the nine-month period ended September 30, 2024, down by $0.6 million mainly driven by a decrease in purchases & external expenses of $2.1 million, offset by an increase of $1.7 million in R&D personnel expenses of which non-cash stock-based compensation increase by $1.0 million and wages and salaries increase by $0.7 million. SG&A Expenses: Consolidated SG&A expenses were $15.0 million for the nine-month period ended September 30, 2025, compared to $14.2 million for the nine-month period ended September 30, 2024. The $0.8 million change is mainly due to a non-cash stock-based compensation increase of $0.7 million and an increase of $0.1 million in purchases and external expenses. Other operating income and expenses: Other operating income increased slightly by $0.1 million between the nine-month periods ended September 30, 2024, and 2025. Net financial gain (loss): We had a consolidated net financial loss of $25.6 million for the nine-month period ended September 30, 2025, compared to an $5.7 million net financial gain for the nine-month period ended September 30, 2024. This $31.2 million difference reflects mainly (i) a one-off $14.3 million gain in change in fair value of the derivative instrument component of the Subsequent Investment Agreement dated November 7, 2023 between us and AstraZeneca Holdings (the “SIA”), which was recognized in the nine-month period ended September 30, 2024, (ii) a $5.8 million loss in the fair value remeasurement of the warrants issued to the European Investment Bank ("EIB"), as required by our finance contract entered into with EIB in December 2022 recorded in nine months period as of September 2025 to be compared to $3.9 million fair value gain recorded in 2024, (iii) a $16.7 million increase in foreign exchange loss and a $2.0 million increase in foreign exchange gain over the period due to the USD volatility, partially offset by (iv) a $7.5 million decrease in loss on fair value of our investment in shares of Cibus, Inc., which was entirely sold in the first quarter of 2025. Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $41.3 million (or a $0.41 net loss per share) for the nine-month period ended September 30, 2025, compared to a $42.7 million net loss (or a $0.49 net loss per share) for the nine-month period ended September 30, 2024. The $1.4 million change in net loss was primarily driven by (i) an increase in revenues and other income of $33.3 million offset by (ii) a $0.2 million increase in operating expenses and other operating income, (iii) a $31.2 million change from a net financial gain of $5.7 million as of September 30, 2024 to a net financial loss of $25.6 million as of September 30, 2025 and (iv) a decrease in deferred tax asset income of $0.5 million. Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $37.4 million (or a $0.37 loss per share) for the nine-month period ended September 30, 2025, compared to a net loss of $40.4 million (or a $0.46 loss per share) for the nine-month period ended September 30, 2024. Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. Note Regarding Use of Non-IFRS Financial Measures Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes stock-based compensation expense - a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis. 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,” “can,” “could,” “estimate,” “expectation,” “expected,” “illustrative,” “look forward,” “plan,” “potential,” “potentially, “positioned,” “projected,” “suggest,” and “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, include statements regarding the market market opportunities with respect to lasme-cel (and the assumptions on which such determinations are based, including with respect to addressable populations and potential pricing), the potential of the Phase 2 BALLI-01 trial 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 sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, and the financial position of Cellectis. These forward-looking statements are made in light of information currently available to us 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 BALLI-01 Phase 1 data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results relating to a small number of patients – such results should not be viewed as predictive of future results. With respect to the sufficiency of cash, cash equivalent and fixed-term deposits to fund our operations, which we refer to as our runway, we note that our operating plans, including product development plans, may change as a result of various factors. 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, 2024 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, [email protected] 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, [email protected] Attachment

