On August 6, 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 second quarter 2026 ending June 30, 2026.
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"The lasme-cel and eti-cel clinical results presented at EHA (Free EHA Whitepaper) 2026 are promising for patients with relapsed or refractory B-cell malignancies. We are also pleased to have received RMAT designation from the FDA for lasme-cel, which recognizes its potential to address an unmet medical need in B-ALL. We remain focused on advancing new options for people whose disease has returned or stopped responding to available therapies," said André Choulika, Ph.D., Co-Founder and Chief Executive Officer at Cellectis.
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.
In June 2026, Cellectis received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for lasme-cel for treatment of r/r CD22 positive B-ALL. This designation was granted based on the BALLI-01 clinical data, demonstrating promising efficacy and a manageable safety profile. It reflects the FDA’s recognition of the potential of lasme-cel to address the unmet medical need faced by patients with r/r B-ALL.
In June 2026, Cellectis presented full Phase 1 data from the BALLI-01 trial at an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Annual Congress.
45 patients were treated in third line and beyond (3L+), including 15 at the recommended Phase 2 dose (RP2D), and 7 in the target Phase 2 population.
Heavily pretreated population: A median of 5 prior lines of therapy in the target Phase 2 population (range 2–11); 82% had received prior blinatumomab, 56% a CD22-directed antibody drug conjugate (ADC), 53% CD19 CAR-T, and 47% a prior hematopoietic stem cell transplantation (HSCT).
Efficacy Data (target Phase 2 population)
100% overall response rate (ORR) (7/7)
57% complete remission/complete remission with incomplete count recovery (CR/CRi) (4/7), of whom 75% were minimal residual disease (MRD)-negative
All responding patients proceeded to HSCT
Safety Data
The therapy demonstrated a manageable safety profile, with grade ≥ 3 cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS), each occurring in 4% of patients.
Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in 2% of patients.
All events resolved.
In June 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the initiation of the Phase 2 study of BALLI-01 in the UK.
In July 2026, enrollments in the Phase 2 BALLI-01 study in France, Italy and Spain have been authorized.
The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026.
Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01
The Phase 1 NATHALI-01 trial is ongoing.
In June 2026, Cellectis presented translational data highlighting the key drivers of response at a poster presentation at the EHA (Free EHA Whitepaper) 2026 annual congress.
As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels.
Heavily pretreated population: median of 3 prior lines of therapy; 93% had received prior CD19-directed CAR-T therapy.
Efficacy Data (optimal dose cohort, n=8)
88% ORR
63% complete response (CR) rate
Higher alemtuzumab exposure was associated with a lower inflammatory homeostatic milieu prior to eti-cel infusion, enhanced eti-cel expansion, and higher response rates.
Responders demonstrated sustained low-level interleukin-2 (IL-2) secretion versus non-responders.
These findings support a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Subcutaneous low-dose IL-2 is also being evaluated to further enhance eti-cel expansion and response.
Cellectis expects to present the full Phase 1 dataset in Q4 2026.
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
In July 2026, Allogene announced that the FDA has granted RMAT and Fast Track designations to cema-cel for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease (MRD).
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.
Allogene – Anti-CD70 CAR-T
In July 2026, Allogene announced the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology. Allogene announced that ALLO-316 achieved a 31% confirmed response rate with the recommended Phase 2 regimen in patients with Stage IV RCC with high CD70 expression, and that the safety profile was manageable with proactive diagnostic and management strategies effective in mitigating IEC-HS.2
Allogene’s investigational allogeneic CAR-T oncology products utilize Cellectis technologies. The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.
Corporate Updates
Annual Shareholders’ Meeting
On June 25, 2026, Cellectis held a Shareholders General Meeting at the Biopark auditorium in Paris, France. At the meeting, during which approximately 56% of voting rights were exercised, resolutions 1 through 29 were adopted, while resolution 30 was rejected, consistent with the recommendations of the Board of Directors. The detailed results of the vote and the resolutions are available on Cellectis’ website: View Source
Financial Results
Cash, cash equivalent and fixed-term deposits: As of June 30, 2026, Cellectis had $169 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 $42 million change was primarily driven by payments to suppliers of $26.9 million, payroll-related payments (salaries, bonuses and social charges) totaling $28.5 million, lease liability payments of $5.4 million, repayments of $2.7 million under the "PGE" loan and capital expenditures of $0.5 million, partially offset by $16.8 million of cash received from customers and $4.9 million of interest received from our financial and cash-equivalent investments.
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 $14.5 million for the six-month period ended June 30, 2026, compared to $30.2 million for the six-month period ended June 30, 2025. The $15.8 million decrease between the six-month periods ended June 30, 2025 and 2026 was primarily attributable to a $16.4 million decrease in revenues mainly driven by the level of activities performed under the Research Plans of the AstraZeneca Joint Research Collaboration Agreement in the first half of 2026. It was partially offset by a $0.6 million increase, which was mainly attributable to a higher research tax credit resulting from increased eligible R&D expenses, as well as favorable foreign exchange effects.
R&D Expenses: Consolidated R&D expenses were $52.2 million for the six-month period ended June 30, 2026, compared to $45.0 million for the six-month period ended June 30, 2025. The $7.2 million increase was primarily driven by (i) a $4.5 million increase in personnel expenses reflecting changes in our R&D headcount and higher stock-based compensation expense associated with awards granted in 2026, whose grant-date fair value increased due to a higher underlying share price, and (ii) a $3.7 million increase in purchases and external expenses, primarily attributable to higher clinical development costs related to our BALLI-01 and NATHALI-01 studies, partially offset by (iii) a $1.0 million decrease in depreciation and amortization expenses.
SG&A Expenses: Consolidated SG&A expenses were $11.3 million for the six-month period ended June 30, 2026, compared to $9.8 million for the six-month period ended June 30, 2025. The $1.5 million increase was primarily attributable to a $1.2 million increase in personnel expenses, mainly reflecting higher stock-based compensation expense associated with awards granted in 2026, whose grant-date fair value increased due to a higher underlying share price. Purchases and external expenses increased slightly by $0.2 million, from $4.4 million in 2025 to $4.7 million in 2026.
Net financial gain (loss): The consolidated net financial gain for the six-month period ended June 30, 2026 was $9.2 million, compared to a $18.1 million net financial loss for the six-month period ended June 30, 2025. The $27.3 million difference reflects a $5.0 million increase in financial income and a $22.3 million decrease in financial expenses.
The $5.0 million increase in financial income was primarily attributable to (i) a $7.0 million increase in non-cash gains recognized from fair value measurements, mainly reflecting an $8.7 million gain on the fair value measurement of the Tranche A, B and C warrants issued to the European Investment Bank ("EIB") in the six months ended June 30, 2026, compared with a $1.2 million gain in the same period in 2025, partially offset by (ii) a $1.7 million decrease in interest income earned on cash, cash equivalents and financial assets, and (iii) a $0.4 million decrease in foreign exchange gains.
The $22.3 million decrease in financial expenses was primarily attributable to a $22.8 million decrease in foreign exchange losses mainly resulting from the appreciation of the US dollar against the euro.
Net Loss Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $39.6 million (or a $0.39 net loss per share) for the six-month period ended June 30, 2026, compared to a $41.9 million net loss (or a $0.42 net loss per share) for the six-month period ended June 30, 2025. The $2.3 million decrease in net loss was mainly due to (i) a $27.3 million improvement in net financial result, from a net financial loss of $18.1 million as of June 30, 2025 to a net financial gain of $9.2 million as of June 30, 2026, partly offset by (ii) a $24.9 million increase in operating loss.
Adjusted Net Loss Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $35.6 million (or a $0.35 net loss per share) for the six-month period ended June 30, 2026, compared to a net loss of $39.6 million (or a $0.40 net loss per share) for the six-month period ended June 30, 2025.
The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").
Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.
CELLECTIS S.A.
UNAUDITED INTERIM CONDENSED STATEMENTS OF CONSOLIDATED FINANCIAL POSITION
($ in thousands)
As of
December 31, 2025 June 30, 2026
ASSETS
Non-current assets
Intangible assets 535 1,117
Property, plant, and equipment 38,788 34,797
Right-of-use assets 23,658 19,196
Non-current financial assets 5,088 4,723
Other non-current assets 20,025 22,734
Deferred tax assets 382 382
Total non-current assets 88,476 82,949
Current assets
Trade receivables 14,398 5,075
Subsidies receivables 7,800 7,525
Other current assets 5,383 4,970
Cash, cash equivalents and current financial assets 208,663 166,847
Total current assets 236,244 184,417
TOTAL ASSETS 324,720 267,365
LIABILITIES
Shareholders’ equity
Share capital 5,903 5,924
Premiums related to the share capital 437,445 371,749
Currency translation adjustment (33,316 ) (32,679 )
Retained earnings (deficit) (266,538 ) (264,344 )
Net income (loss) (67,593 ) (39,584 )
Total shareholders’ equity 75,901 41,067
Non-current liabilities
Non-current financial liabilities 74,013 66,185
Non-current lease debts 27,725 23,823
Non-current provisions 1,329 1,332
Total non-current liabilities 103,067 91,340
Current liabilities
Current financial liabilities 10,460 7,500
Current lease debts 7,701 6,774
Trade payables 17,277 18,202
Deferred income and contract liabilities 96,803 90,918
Current provisions 1,169 917
Other current liabilities 12,342 10,647
Total current liabilities 145,752 134,958
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 324,720 267,365
Cellectis S.A.
UNAUDITED INTERIM CONDENSED STATEMENTS OF CONSOLIDATED OPERATIONS
For the six-month period ended June 30, 2026
($ in thousands, except share and per share amounts)
For the six-month period ended June 30,
2025 2026
Revenues and other income
Revenues 27,380 11,006
Other income 2,842 3,446
Total revenues and other income 30,222 14,452
Operating expenses
Research and development expenses (45,012 ) (52,165 )
Selling, general and administrative expenses (9,780 ) (11,329 )
Other operating income 804 353
Total operating expenses (53,988 ) (63,140 )
Operating loss (23,766 ) (48,688 )
Net Financial gain (loss) (18,098 ) 9,176
Income tax - (72 )
Net loss (41,863 ) (39,584 )
Basic and diluted net loss per share attributable to shareholders of Cellectis ($/share) (0.42 ) (0.39 )
Number of shares used for computing (basic and diluted) 100,231,292 100,587,696
UNAUDITED INTERIM CONDENSED STATEMENTS OF CONSOLIDATED OPERATIONS
For the three-month period ended June 30, 2026
($ in thousands, except share and per share amounts)
For the three-month period ended June 30,
2025 2026
Revenues and other income
Revenues 16,725 5,229
Other income 1,469 1,675
Total revenues and other income 18,193 6,904
Operating expenses
Research and development expenses (23,080 ) (24,976 )
Selling, general and administrative expenses (5,078 ) (5,739 )
Other operating income 378 290
Total operating expenses and other operating income (27,779 ) (30,425 )
Operating loss (9,586 ) (23,521 )
Net Financial gain (loss) (14,150 ) 1,727
Income tax - (25 )
Net loss (23,736 ) (21,819 )
Basic and diluted net loss per share attributable to shareholders of Cellectis ($/share) (0.24 ) (0.22 )
Number of shares used for computing (basic and diluted) 100,305,204 100,647,451
(Press release, Cellectis, AUG 6, 2026, View Source [SID1234669789])