공시 • Jun 11
Cellectis S.A. Presents Final Phase 1 Results of Lasme-Cel and Preliminary Results on Eti-Cel At Eha 2026 Congress Cellectis S.A. presented 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 2026 Annual Congress. 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%). 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. The Pivotal Phase 2 BALLI-01 trial is open for recruitment. The first interim analysis is expected in Fourth Quarter 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 time. Session Title: Advances in the treatment of lymphoblastic leukemia. Session Room: K1. Abstract Number: 4689. Note: presentation slides will be uploaded to Cellectis' website concurrently with the live 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. The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Fourth Quarter 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 time. Session: Poster Session 2. Poster Number: 4758. Note: poster presentation will be uploaded to Cellectis' website at the opening of the poster session. 공시 • Jun 10
Cellectis S.A. Receives FDA RMAT Designation for Lasme-Cel, the First Allogeneic Car-T Therapy in A Pivotal Trial for Patients with R/R B-All Cellectis S.A. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The granting of RMAT designation reflects the FDA's recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL. The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) this Saturday, June 13 at 5:15 – 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston. The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials: BALLI-01 (NCT04150497). 공시 • May 22
Cellectis S.A., Annual General Meeting, Jun 25, 2026 Cellectis S.A., Annual General Meeting, Jun 25, 2026. Location: at the biopark auditorium, 11 rue watt, 4th floor, 75013., paris France New Risk • May 13
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$41m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$41m free cash flow). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$173m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Reported Earnings • May 13
First quarter 2026 earnings released: US$0.18 loss per share (vs US$0.18 loss in 1Q 2025) First quarter 2026 results: US$0.18 loss per share (improved from US$0.18 loss in 1Q 2025). Revenue: US$7.55m (down 37% from 1Q 2025). Net loss: US$17.8m (loss narrowed 2.0% from 1Q 2025). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 51% per year but the company’s share price has only increased by 26% per year, which means it is significantly lagging earnings growth. 공시 • May 05
Cellectis S.A. to Report Q1, 2026 Results on May 11, 2026 Cellectis S.A. announced that they will report Q1, 2026 results After-Market on May 11, 2026 
