lasmecabtagene timgedleucel (UCART22) / Cellectis, UT MD Anderson Cancer Center - LARVOL DELTA

In vitro evidence supporting the use of exogenous IL-2 support for allogeneic UCART22 cells to treat heavily pretreated R/R B-ALL patients (ASH 2025) - "UCART22 is an allogeneic non-alloreactive T-cell product gene edited with messenger ribonucleic acids (mRNAs) encoding Transcription Activator Like Effector Nucleases (TALEN®) to disrupt T-cell receptor alpha constant chain (TRAC) and CD52 genes and transduced with 3rd generation self-inactivated lentiviral vector to express anti-CD22 chimeric antigen receptor (CAR) and RQR8 (a depletion ligand which confers susceptibility to rituximab). This in vitro study suggests that exogenous IL2 may improve expansion and persistence of UCART22 which may enhance tumour killing. Whether or not this observation will translate into improved clinical outcomes for patients warrants further evaluation in the clinical setting."

Preclinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • CD52 • CD8 • IL2

Increased alemtuzumab exposure correlates with improved responses in heavily pretreated R/R ALL patients: Analysis of the balli-01 trial (ASH 2025) - "Fludarabine,cyclophosphamide and alemtuzumab (FCA) was investigated as an LD regimen. Alemtuzumab is a critical component of the LD regimen in the BALLI-01 trial. For thisallogeneic CAR-T therapy, it is important to ensure adequate exposure to alemtuzumab in order tooptimize cell expansion and mitigate the risk of early host T cell reconstitution which may compromiseresponse in these heavily pretreated ALL patients with few, if any, alternative treatment options."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • CD52

Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL) (ASH 2023) - "The fludarabine, cyclophosphamide, and alemtuzumab (FCA) LD regimen was also shown to extend host lymphocyte suppression and improve UCART22 expansion versus fludarabine and cyclophosphamide (FC) alone (Boissel N, et al...Cytokine release syndrome (CRS) occurred in 2/3 (67%) pts, with one G1 that resolved without treatment and one G2 that resolved after tocilizumab x1...Pt 3 was refractory to treatment, however this pt received bridging therapy with dasatinib for his ABL2 fusion, and on Day -1, only 47% of the leukemic cells expressed CD22 (down from 88% at screening)... As of 01 July 2023, 3 pts were enrolled into the first UCART22 P2 cohort at DL2. Pt 1 is a 17yo female with B-ALL with a hypodiploid karyotype and a germline TP53 mutation whose disease had previously failed to respond to multiagent chemotherapy, blinatumomab (blina), inotuzumab (ino), venetoclax (ven), allogeneic hematopoietic stem cell transplantation (HSCT), and autologous CD19 CAR T-cell therapy..."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Septic Shock • Transplantation • ABL2 • CD8 • IFNG • IL6 • TNFA • TP53

Second poster – Correlation between alemtuzumab exposure and response with lasme-cel (GlobeNewswire) - "The second poster highlights the correlation between alemtuzumab exposure and depth of response in the difficult-to-treat patients who have received lasme-cel (UCART22) in the course of the Phase 1 of BALLI-01, a clinical trial testing this allogeneic CAR-T product candidate targeting CD22 in relapsed/refractory acute lymphoblastic leukemia (ALL). 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....'We look forward to starting enrollment in our pivotal Phase 2 program in Q4 2025.'"

P1 data • Trial status • Acute Lymphocytic Leukemia

Cellectis Reports Second Quarter 2025 Financial Results & Business Updates (GlobeNewswire) - "Pipeline Highlights:...BALLI-01 study evaluating lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL): (i) In July 2025, Cellectis completed the multidisciplinary end-of-Phase 1 regulatory interactions with both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Preparations are currently underway in anticipation for an amendment to initiate a pivotal Phase 2 of lasme-cel in r/r B-ALL, which is expected in H2 2025; (ii) Cellectis will present the Phase 1 dataset and late-stage development strategy for lasme-cel in r/r B-ALL at an Investor R&D Day that will take place on October 16, 2025 in New York City."

European regulatory • FDA event • P1 data • Trial status • B Acute Lymphoblastic Leukemia

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Cellectis S.A. | N=40 ➔ 52 | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Jan 2026 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Pipeline Highlights (GlobeNewswire) - "Cellectis continues to focus on the enrollment of patients in the BALLI-01 study and expects to present the Phase 1 dataset and late-stage development strategy for lasme-cel in r/r B-ALL in the third quarter of 2025; Cellectis continues to focus on the enrollment of patients in the NATHALI-01 study and expects to present a Phase 1 readout for eti-cel in r/r NHL in late 2025."

P1 data • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

Cellectis Reports Financial Results for the Fourth Quarter and Full Year 2024 and Provides a Business Update (GlobeNewswire) - "Pipeline Highlights:...(i) BALLI-01 study evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL):...Cellectis continues to focus on the enrollment of patients in the BALLI-01 study and expects to present the Phase 1 dataset and late-stage development strategy for UCART22 in relapsed or refractory ALL in the third quarter of 2025; (ii) NATHALI-01 study evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL): Cellectis continues to focus on the enrollment of patients in the NATHALI-01 study and expects to present the Phase 1 dataset and late-stage development strategy for UCART20x22 in relapsed or refractory NHL in late 2025."

Enrollment status • P1 data • Pipeline update • Acute Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma

Cellectis announces the drawdown of the third tranche of €5 million under the credit facility agreement entered with the European Investment Bank (EIB) (GlobeNewswire) - "Cellectis...today announced that it has drawn down the final tranche of €5 million ('Tranche C') under the credit facility agreement for up to €40 million entered into with the European Investment Bank...With the drawdown of Tranche C, the Company has drawn down the full €40 million available under the Finance Contract. Tranche C is expected to be disbursed by the EIB by December 18, 2024. The Company plans to use the proceeds of Tranche C towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22 and UCART20x22."

Financing • Oncology

Cellectis Provides Business Updates and Financial Results for Third Quarter 2024 (GlobeNewswire) - "Cellectis continues to focus on the enrollment of patients in the BALLI-01 study, evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia. We expect to present the Phase 1 dataset and late-stage development strategy in 2025; Cellectis continues to focus on the enrollment of patients in the NATHALI-01 study, evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma. We expect to present the Phase 1 dataset and late-stage development strategy in 2025; The Company decided to focus its current development efforts on the BALLI-01 and NATHALI-01 studies and therefore to deprioritize the development of UCART123, currently evaluated in relapsed or refractory acute myeloid leukemia."

Pipeline update • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Cellectis S.A. | Trial primary completion date: Dec 2023 ➔ Jan 2026

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Cellectis Provides Financial Results for the Second Quarter 2024 (GlobeNewswire) - "Cellectis continues to focus on the enrollment of patients in the BALLI-01 study, evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia....We expect to provide updates in the advancements of BALLI-01 until the end of the year 2024."

P1 data • B Acute Lymphoblastic Leukemia

FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to Cellectis’ UCART22 product candidate for Acute Lymphoblastic Leukemia (ALL) Treatment (GlobeNewswire) - "Cellectis...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to UCART22 product candidate for the treatment of Acute Lymphoblastic Leukemia (ALL)....UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and evaluated in BALLI-01....The last clinical data presented by Cellectis at the American Society of Hematology in December 2023 were encouraging and suggested that UCART22-P2 (fully manufactured at Cellectis) is more potent with a preliminary response rate of 67% at Dose Level 2, compared to a 50% response rate at Dose Level 3 with UCART22-P1 (manufactured by an external CDMO)."

FDA event • Orphan drug • Acute Lymphocytic Leukemia

Cellectis Receives Orphan Drug Designation for UCART22, its Allogeneic CAR T Product for Patients with Acute Lymphoblastic Leukemia (GlobeNewswire) - "Cellectis...announced today that the European Commission (EC) has granted an Orphan Drug Designation (ODD) to its product candidate UCART22, for the treatment of Acute Lymphoblastic Leukemia (ALL). UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and evaluated in BALLI-01, a Phase 1/2 open-label dose-escalation and dose-expansion study, designed to evaluate the safety, expansion, persistence and clinical activity of UCART22 in patients with relapse/refractory ALL....Cellectis expects to provide updates on the progress of BALLI-01 by year-end 2024."

Orphan drug • P1/2 data • Acute Lymphocytic Leukemia

Cellectis Reports Financial Results for First Quarter 2024 (GlobeNewswire) - "UCART Clinical Programs: Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)...[and] in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL)....We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024."

Enrollment status • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

Cellectis announces the drawdown of the second tranche of €15 million under the credit facility agreement entered with the European Investment Bank (EIB) (GlobeNewswire) - "The Company plans to use the proceeds of Tranche B towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, and UCART123."

Financing • Hematological Malignancies • Oncology

Cellectis to Present Preliminary Results of NATHALI_01 and Updated Results of the BALLI_01 Phases I Trials at the American Society of Hematology (ASH) 65th Annual Meeting (GlobeNewswire) - P1 | N=40 | BALLI-01 (NCT04150497) | Sponsor: Cellectis S.A. | "Cellectis...announced today that...updated results of the Phase I BALLI-01 clinical trial evaluating UCART22 in patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia, (r/r B-ALL) will be presented at the American Society of Hematology 65th Annual Meeting (ASH 2023)....The poster presentation highlights the following data....As of July 1, 2023, 3 patients were enrolled into the first UCART22 P2 cohort at dose level 2 (1 million cells/kg)....There was a higher preliminary response rate (67%) at dose level 2 (1 million cells/kg) with UCART22 P2 (manufactured in-house by Cellectis) compared to 50% at dose level 3 (5 million cells/kg) with UCART22 P1 (manufactured by an external CDMO). UCART22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers."

P1 data • Acute Lymphocytic Leukemia

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Cellectis S.A. | Trial primary completion date: Jul 2023 ➔ Dec 2023

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

UPDATED RESULTS OF THE PHASE I BALLI-01 TRIAL OF UCART22, AN ANTI-CD22 ALLOGENEIC CAR-T CELL PRODUCT, IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) CD22+ B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) (EHA 2023) - P1/2 | "The fludarabine, cyclophosphamide, and alemtuzumab (FCA) LD regimen was well tolerated and associated with extended host lymphocyte suppression and UCART22 expansion (Jain N, et al...Pts received a median of 4 (2-8) prior Tx, including blinatumomab (blin,12 pts, 63%), inotuzumab (ino,10 pts, 53%), autologous CD19 CAR T-cell (CAR19, 8 pts, 42%), and prior HSCT (8 pts, 42%)...For FCA-DL3, 3/6 pts (50%) responded: 1 pt who failed 4 prior lines, including multiagent chemotherapy, blin, ino, CAR19, and allo HSCT, achieved an MRD neg CR lasting over 100 days after UCART22 infusion; 1 pt who failed 4 prior lines, including multiagent chemotherapy, venetoclax (ven), CAR19, and allo HSCT, achieved an MRD negative CRi consolidated with DLI after D90; and 1 pt who failed 3 prior lines, including multiagent chemotherapy, ven, CAR19, and allo HSCT, achieved an MRD negative MLFS up to D114... UCART22 continues to be safe and tolerable, with no Tx-related serious TEAEs or DLTs..."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Neutropenia • Oncology • ABL1 • BCR • CRLF2

Cellectis Presents Updated Clinical and Translational Data on BALLI-01 at the European Hematology Association (EHA) 2023 (GlobeNewswire) - P1 | N=40 | BALLI-01 (NCT04150497) | Sponsor: Cellectis S.A. | "Cellectis...presented today updated clinical and translational data on its clinical trial BALLI-01 (evaluating UCART22) at the European Hematology Association (EHA) 2023. The data presented support the preliminary safety and efficacy of UCART22 in a heavily pretreated relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) population....The poster presents data from six additional patients who received UCART22 at dose level 3 (DL3), 5 x 106 cells/kg, as of the December 31, 2022 data cutoff....UCART22 administered after FC or FCA LD regimen was well tolerated. No dose limiting toxicities (DLTs) nor immune effector cell-associated neurotoxicity syndrome (ICANS) were observed; 61% of patients reported cytokine release syndrome (CRS) (Grade 1 [N=9] or Grade 2 [N=2])....The next data set is expected to be released later this year."

P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Cellectis Announces Poster Presentation on BALLI-01 at the European Hematology Association (EHA) 2023 (Cellectis Press Release) - "Cellectis...announced today the publication of an abstract accepted for presentation at the hybrid congress of the European Hematology Association (EHA), which will take place from June 8 to 15, 2023 in Frankfurt. Cellectis will present, in a poster session, updated clinical and translational data on its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic Leukemia (r/r B-ALL)."

P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Cellectis Implements CLLS52 for the First Time in the Clinic with Sanofi’s Alemtuzumab (GlobeNewswire) - "Cellectis...announced it has implemented the use of alemtuzumab as a Cellectis Investigational Medicinal Product (IMP), coded as CLLS52, as part of the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial in relapsed/refractory B-cell ALL, for UCART123 in the AMELI-01 clinical trial in relapsed/refractory AML, and for UCART20x22 in the NatHaLi-01 clinical trial in relapsed/refractory B-cell NHL....Under the agreements, Sanofi is supplying alemtuzumab to support Cellectis’ clinical trials and the parties agreed to enter into discussions to execute a commercial supply of alemtuzumab under pre-agreed financial conditions."

Clinical protocol • Commercial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cellectis enters into warrant agreement with the European Investment Bank related to credit facility agreement and announces the drawdown of the first tranche of €20 million (GlobeNewswire) - "The Company plans to use the proceeds of Tranche A towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, UCART123 and UCARTCS1."

Commercial • Oncology

Cellectis Announces Dosing of the First Patient in Europe with its In-house Manufactured Product Candidate UCART22 (GlobeNewswire) - "Cellectis...announced that the first patient in Europe has been dosed in France with its in-house manufactured product candidate UCART22 and completed the 28-day Dose Limiting Toxicity period....UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALLI-01 clinical study, a Phase 1/2a open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with r/r B-cell ALL."

Trial status • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Cellectis Announces Closing of Global Offering and Exercise of Underwriters’ Option to Purchase Additional Shares (GlobeNewswire) - "The Company plans to use (i) approximately $17.0 million (€15.6 million) of the net proceeds of the Global Offering to fund the continued clinical development of UCART 123, UCART22, UCART20x22, and UCARTCS1, and (ii) any remainder for working capital and other general corporate purposes."

Commercial • Oncology