Cellectis (NASDAQ:CLLS) highlighted clinical progress for its two lead allogeneic CAR-T programs and outlined upcoming milestones into 2026 during its full-year 2025 earnings call. Management also reviewed its cash position and discussed partnered programs with Servier/Allogene, Iovance, and AstraZeneca.
Lasme-cel: Phase 1 results and pivotal Phase 2 timeline
Chief Executive Officer André Choulika said Cellectis has initiated a pivotal Phase 2 trial of lasme-cel, its CD22-targeting allogeneic CAR-T for relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Choulika described Cellectis as “one of the only companies running a pivotal phase 2 allogeneic CAR-T trial” in B-ALL and emphasized the company’s “bridge to transplant” strategy, positioning lasme-cel as a rapid, off-the-shelf option intended to get heavily pre-treated patients into remission and become eligible for stem cell transplant.
At the recommended Phase 2 dose, Kilcoyne reported lasme-cel produced:
- 83% overall response rate (ORR) and 42% CR/CRi rate
- In the target Phase 2 population (age cutoff 50), 100% ORR and 56% CR/CRi
- Among patients achieving CR/CRi, 80% achieved MRD-negative status
- All 9 patients in the target Phase 2 population became transplant eligible, and 7 of 9 had received a stem cell transplant at the data cutoff
Kilcoyne added that in patients who achieved an MRD-negative CR/CRi, median overall survival was 14.8 months. On safety, he said grade 3 or higher cytokine release syndrome occurred in 2.5% of patients and grade 3 or higher ICANS occurred in 5% of patients at the recommended Phase 2 dose, describing the profile as favorable and similar to or lower than other autologous CAR-T therapies.
For the pivotal Phase 2 program, management said site openings in North America and Europe are continuing, with a target of about 75 recruiting centers. The company expects a first interim analysis of 40 patients in Q4 2026. In the Q&A, Kilcoyne clarified that the dose optimization decision is based on an earlier eight-week assessment rather than a three-month CR/CRi endpoint, and he said the protocol includes flexibility to continue recruiting while the company engages with regulators.
Kilcoyne also reiterated Cellectis’ previously disclosed timeline for a BLA submission in the second half of 2028 for lasme-cel.
Eti-cel: Dual-target NHL program and IL-2 cohort
Cellectis also discussed eti-cel, an allogeneic dual CAR-T targeting CD20 and CD22 for third line and beyond non-Hodgkin lymphoma (NHL). Choulika said the dual-target design is intended to address antigen escape. Kilcoyne said interim Phase 1 results presented at ASH 2025 showed an 88% ORR and 63% complete response rate at the current dose level in six evaluable patients.
The company is studying whether low-dose interleukin-2 support can enhance CAR-T expansion and persistence without worsening toxicity. Management expects to present the full Phase 1 data set, including results from the IL-2 cohort, later this year.
Looking further out, Kilcoyne said Cellectis plans to progress eti-cel to pivotal Phase 2 in 2027 and anticipates a BLA submission in H2 2029.
Manufacturing, lymphodepletion strategy, and EHA presentations
Kilcoyne said the Phase 1 lasme-cel program addressed whether internally manufactured product could match or improve outcomes versus product made by an external CDMO, and whether including alemtuzumab in lymphodepletion improved expansion and efficacy versus a standard regimen. He reported that internally manufactured product showed higher response rates than external CDMO-manufactured product, with ORRs of 68% versus 28%, respectively. He also said increased alemtuzumab exposure correlated with improved response.
In response to questions about alemtuzumab (CD52-directed lymphodepletion), Kilcoyne said Cellectis tested a regimen without alemtuzumab in Phase 1 and “failed to get any MRD-negative responses,” supporting its use. He added that the company uses a lower alemtuzumab dose than some others and has included risk mitigation in its protocols, noting the drug has a well-characterized safety profile in other settings.
Cellectis said the full Phase 1 lasme-cel data have been submitted for presentation at the 2026 European Hematology Association (EHA) Congress in June in Stockholm. In Q&A, management indicated EHA materials are expected to include an updated dataset with additional patients and further analyses aimed at understanding predictors of response and the role of the lymphodepletion “environment” at infusion.
Partner updates and Servier arbitration
Choulika and Chief Financial Officer Arthur Stril highlighted several partnered programs expected to generate updates:
- Servier/Allogene (cema-cel): A pivotal Phase 2 study evaluating cema-cel as consolidation therapy in first-line large B-cell lymphoma, with Allogene anticipating an interim futility analysis in Q2 2026.
- Iovance (IOV-4001): A PD-1-inactivated tumor-infiltrating lymphocyte therapy in advanced melanoma, with clinical results anticipated this year.
- AstraZeneca collaboration: Ongoing R&D work to develop up to 10 cell and gene therapy products; Stril said this collaboration positively impacted Cellectis’ 2025 revenue, while management cautioned that near-term updates are not expected at AstraZeneca’s request.
During the Q&A, Stril addressed an arbitration decision from December 2025 related to the Servier relationship. He said the tribunal ruled on a partial termination of the license agreement with respect to one product, UCART19 V1 (also referred to as ALLO-501), which “has been brought back to Cellectis,” leaving the company free to develop it. Stril added that the decision did not affect ALLO-501A or cema-cel and that Cellectis remains eligible for up to EUR 340 million in development and sales milestones under the Servier agreement (sublicensed to Allogene), as well as royalties.
Cash position and runway into 2027
Stril said Cellectis ended 2025 with $211 million in cash equivalents, restricted cash, and fixed-term deposits classified as current financial assets, compared with $264 million at the end of 2024. He said management believes the company’s cash position is sufficient to fund operations into H2 2027 and supports execution of the lasme-cel pivotal Phase 2 program and eti-cel Phase 1 work.
Stril attributed the year-over-year decrease in cash primarily to payments to suppliers of $50.5 million, wages/bonuses/social expenses of $40 million, lease debt payments of $11 million, and repayment of a PGE loan of $5.4 million, partially offset by $36.9 million in cash in from revenue and $8.4 million of interest received. He directed investors to the company’s press release for consolidated net loss figures.
About Cellectis (NASDAQ:CLLS)
Cellectis is a clinical‐stage biopharmaceutical company specializing in the development of gene‐edited cell therapies for oncology. Founded in 1999 and headquartered in Paris, France, the company also maintains operations in New York City and Raleigh, North Carolina. Cellectis applies its proprietary TALEN genome editing platform to engineer allogeneic chimeric antigen receptor T‐cell (CAR‐T) candidates designed to target blood cancers and solid tumors.
The company’s core business activities encompass the discovery, development and manufacturing of off‐the‐shelf immunotherapies.
