Cellectis Q1 Revenue at $7.5M, Below Consensus
Reports Q1 revenue $7.5M, consensus $9.37M. "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 Andre 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."
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- BALLI-01 Trial Results: Cellectis presented final Phase 1 data from the BALLI-01 trial at EHA 2026, showing a 100% overall response rate for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia, with 57% achieving complete remission, highlighting the therapy's significant efficacy.
- Patient Background Analysis: In the BALLI-01 study, 45 patients were treated, with a median of 5 prior lines of therapy in the target population, indicating the potential of this therapy to provide new treatment options for heavily pretreated patients.
- Safety Assessment: Lasme-cel demonstrated a manageable safety profile, with ≥ grade 3 cytokine release syndrome and neurotoxicity occurring in 4% of patients, and all adverse events resolved, indicating its acceptability in clinical use.
- NATHALI-01 Preliminary Data: Cellectis also showcased preliminary data from the NATHALI-01 study, targeting relapsed/refractory B-cell non-Hodgkin lymphoma with eti-cel, revealing an 88% overall response rate and 63% complete response rate, emphasizing the importance of optimizing treatment regimens.
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T therapy, lasme-cel, has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating recognition of its potential to address the urgent medical needs of patients with r/r B-ALL, a severe form of leukemia.
- Clinical Data Support: The RMAT designation is backed by Phase 1 BALLI-01 trial data, which demonstrates promising efficacy and a manageable safety profile, thereby enhancing investor confidence in the therapy's prospects.
- Future Presentation Plans: Cellectis is set to present final Phase 1 data for lasme-cel at the 2026 Congress of the European Hematology Association on June 13, which is expected to attract further attention and potentially drive subsequent clinical development.
- Stock Price Reaction: Following the announcement, Cellectis shares rose over 10% in after-hours trading to $3.30, reflecting the market's positive response to the therapy's designation and its potential commercial value.
- FDA Designation Impact: Cellectis' cell therapy lasmecabtagene timgedleucel has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation based on early-stage trial data, which, while not guaranteeing approval, provides early and frequent interaction with the FDA and potential acceleration of the approval process.
- Stock Reaction: Following the RMAT designation, Cellectis' stock surged over 24% in after-hours trading on Tuesday, indicating strong market recognition of the therapy's potential and reflecting investor optimism about the company's future developments.
- Analyst Rating: Barclays initiated coverage of Cellectis last month with an 'Overweight' rating and a $9 price target, representing a potential upside of approximately 201% from Tuesday's close, further bolstering market confidence in the company's prospects.
- Therapeutic Advantages: Cellectis views lasmecabtagene timgedleucel as a ready-to-use option for heavily pretreated patients, and unlike personalized autologous therapies, its use of healthy donor cells allows for quicker treatment response times, opening up previously inaccessible treatment settings.
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T cell therapy, lasmecabtagene timgedleucel (lasme-cel), has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential to address the urgent medical needs of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
- Clinical Trial Data Support: The RMAT designation is backed by promising Phase 1 data from the BALLI-01 trial, which will present final results at the European Hematology Association Congress on June 13, further bolstering market confidence in the therapy's efficacy and safety profile.
- Strategic Implications: Cellectis CEO André Choulika noted that the RMAT designation not only recognizes lasme-cel's potential but also strengthens dialogue with the FDA, facilitating the advancement of the therapy through pivotal clinical trials and enhancing the company's competitive position in the CAR-T market.
- Trial Enrollment Open: The pivotal Phase 2 of the BALLI-01 trial is now open for enrollment, with participant eligibility and clinical center information available on clinicaltrials.gov, marking a significant step forward for Cellectis in the field of cell and gene therapies.
- Annual Meeting Announcement: Cellectis has announced that it will hold its annual general meeting on June 25, 2026, at 2:30 p.m. CET at the Biopark auditorium in Paris, aiming to update shareholders on company developments and future strategies.
- Gene Editing Platform Advantage: As a clinical-stage biotechnology company, Cellectis leverages its pioneering gene-editing platform to develop life-saving cell and gene therapies, particularly showcasing unique competitive advantages in CAR T immunotherapies for oncology.
- End-to-End Control Capability: With in-house manufacturing capabilities, Cellectis is one of the few companies that can control the entire value chain of cell and gene therapies, providing it with a significant strategic position in the market.
- Global Business Presence: Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC, demonstrating its global business expansion and market penetration capabilities.
- Clinical Trial Progress: Cellectis' BALLI-01 trial for relapsed or refractory B-cell acute lymphoblastic leukemia shows a 100% objective response rate (ORR) in the target population, with the first interim analysis expected in Q4 2026, potentially paving the way for a future Biologics License Application (BLA).
- Favorable Safety Data: In the ALPHA3 trial for cema-cel, 58.3% of patients achieved minimal residual disease (MRD) negativity compared to 16.7% in the control group, with no serious adverse events reported, indicating strong safety and efficacy that could support future commercialization efforts.
- Strong Financial Position: As of March 31, 2026, Cellectis reported $188 million in cash and cash equivalents, providing a runway into Q4 2027; despite a $23 million decrease from 2025, the company demonstrates effective financial management.
- Increased R&D Spending: R&D expenses for Q1 2026 reached $27.2 million, up $5.3 million from the previous year, primarily due to increased personnel and external costs, reflecting the company's commitment to advancing its innovative therapies and enhancing future market competitiveness.








