On May 11, 2026 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, reported financial results for the first quarter 2026, ending March 31, 2026 and provided a business update.
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"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."
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) (Free ASGCT Whitepaper) 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 (Free ASGCT Whitepaper) 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.
(Press release, Cellectis, MAY 11, 2026, View Source [SID1234665429])