Cellectis Reports Third Quarter 2025 Financial Results and Provides Business Update
Cellectis (NASDAQ: CLLS) reported Q3 2025 results and a business update on Nov 7, 2025. Key clinical highlights: lasme-cel (UCART22) Phase 1 P2 ORR 68% (n=22), RP2D ORR 83% (n=12) and 100% in target Phase 2 population (n=9); median OS 14.8 months in MRD-negative CR/CRi patients. eti-cel (UCART20x22) preliminary ORR 86% and CR 57% (n=7); full Phase 1 dataset expected in 2026 and an ASH 2025 poster on Dec 7.
Finance: consolidated cash, cash equivalents and fixed-term deposits of $225M as of Sept 30, 2025 (runway into H2 2027); nine-month revenue $67.4M (vs $34.1M prior year); consolidated net loss attributable to shareholders $41.3M for nine months. Servier arbitration decision expected on or before Dec 15, 2025.
Cellectis (NASDAQ: CLLS) ha riportato i risultati del terzo trimestre 2025 e un aggiornamento sull'attività il 7 novembre 2025. Principali evidenze cliniche: lasme-cel (UCART22) Fase 1 P2 ORR 68% (n=22), RP2D ORR 83% (n=12) e 100% nella popolazione bersaglio della Fase 2 (n=9); median OS 14,8 mesi nei pazienti MRD-negativi CR/CRi. eti-cel (UCART20x22) ORR preliminare 86% e CR 57% (n=7); l'insieme completo del dataset di Fase 1 previsto per il 2026 e un poster ASH 2025 il 7 dicembre.
Cellectis (NASDAQ: CLLS) informó los resultados del tercer trimestre de 2025 y una actualización del negocio el 7 de noviembre de 2025. Puntos clínicos clave: lasme-cel (UCART22) Fase 1 P2 ORR 68% (n=22), ORR de RP2D 83% (n=12) y 100% en la población objetivo de la Fase 2 (n=9); OS mediana 14,8 meses en pacientes CR/CRi MRD-negativos. eti-cel (UCART20x22) ORR preliminar 86% y CR 57% (n=7); se espera el conjunto completo de datos de la Fase 1 para 2026 y un póster en ASH 2025 el 7 de diciembre.
Cellectis (NASDAQ: CLLS)는 2025년 11월 7일 3분기 실적 및 사업 업데이트를 발표했다. 주요 임상 하이라이트: lasme-cel (UCART22) 1상 P2 ORR 68% (n=22), RP2D ORR 83% (n=12) 및 2상 표적 집단에서 100%(n=9); MRD 음성 CR/CRi 환자에서 중위 OS 14.8개월. eti-cel (UCART20x22) 예비 ORR 86% 및 CR 57% (n=7); 1상 데이터 세트의 전체는 2026년에 발표될 예정이며 ASH 2025 포스터는 12월 7일에 발표될 예정이다.
Cellectis (NASDAQ: CLLS) a publié les résultats du T3 2025 et une mise à jour des activités le 7 novembre 2025. Points cliniques clés : lasme-cel (UCART22) Phase 1 P2 ORR 68 % (n=22), ORR RP2D 83 % (n=12) et 100 % dans la population cible de la Phase 2 (n=9) ; médiane de survie globale (OS) 14,8 mois chez les patients CR/CRi MRD-négatifs. eti-cel (UCART20x22) ORR préliminaire 86 % et CR 57 % (n=7) ; l'ensemble complet des données de la Phase 1 est attendu en 2026 et un poster ASH 2025 le 7 décembre.
Cellectis (NASDAQ: CLLS) berichtete am 7. November 2025 über die Ergebnisse des Q3 2025 und ein Geschäfts-Update. Wichtige klinische Highlights: lasme-cel (UCART22) Phase-1-P2 ORR 68% (n=22), RP2D ORR 83% (n=12) und 100% in der Zielpopulation der Phase-2 (n=9); medianes OS 14,8 Monate bei MRD-negativen CR/CRi-Patienten. eti-cel (UCART20x22) vorläufige ORR 86% und CR 57% (n=7); vollständiger Phase-1-Datensatz voraussichtlich 2026 und ein ASH 2025 Poster am 7. Dezember.
Cellectis (NASDAQ: CLLS) أعلنت عن نتائج الربع الثالث 2025 وتحديثًا للأعمال في 7 نوفمبر 2025. النقاط السريرية الرئيسية: lasme-cel (UCART22) المرحلة 1 P2 ORR 68% (n=22)، ORR RP2D 83% (n=12) و100% في مجموعة المرحلة 2 المستهدفة (n=9); البقاء الوسيط على قيد الحياة OS 14.8 شهراً لدى مرضى CR/CRi MRD‑negatives. eti-cel (UCART20x22) ORR أولية 86% وCR 57% (n=7); من المتوقع مجموعة بيانات المرحلة 1 الكاملة في 2026 ونشر poster لـ ASH 2025 في 7 ديسمبر.
- lasme-cel P2 ORR 68% (n=22)
- lasme-cel RP2D ORR 83% (n=12)
- lasme-cel target Phase 2 ORR 100% (n=9)
- eti-cel preliminary ORR 86% and CR 57% (n=7)
- Nine-month revenues $67.4M (+$33.3M YoY)
- Consolidated net loss attributable to shareholders $41.3M (nine months)
- Consolidated net financial loss $25.6M (nine months) vs prior year gain
- Cash and equivalents declined by $39M vs Dec 31, 2024
Insights
Early clinical signals for lasme-cel and eti-cel are promising, supporting continued pivotal development and data readouts into 2026.
lasme-cel (UCART22) shows high response depth: Process 2 ORR
The eti-cel (UCART20x22) Phase 1 signals (ORR
Cash runway into H2 2027, revenue growth from AstraZeneca collaboration, and an impending arbitration decision shape near-term corporate risk and optionality.
Financials show consolidated cash, cash equivalents and fixed-term deposits of
The upcoming arbitral decision with Servier expected on or before
- Presented data underscore the potential of lasme-cel (UCART22) and eti-cel (UCART20x22) to improve outcomes in r/r B-ALL and r/r NHL:
Lasme-cel in r/r B-ALL (BALLI-01)
-
- ORR of
68% with lasme-cel Process 2 (n=22),83% at RP2D (n=12) and100% in the target Phase 2 population (n=9) - Median OS of 14.8 months in patients who achieved MRD-negative CR/CRi
- First interim analysis for the BALLI-01 trial expected in Q4 2026
- ORR of
Eti-cel in r/r NHL (NATHALI-01)
-
- ORR of
86% and57% CR rate (n=7) - Development update to be presented at the ASH 2025 annual meeting
- Full Phase 1 dataset expected to be shared in 2026
- ORR of
- Servier arbitration: arbitral decision expected to be rendered on or before December 15, 2025
- Cash, cash equivalents and fixed-term deposits of
$225 million as of September 30, 20251 provides runway into H2 2027
NEW YORK, Nov. 07, 2025 (GLOBE NEWSWIRE) -- 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, today provided financial results for the third quarter 2025 ending September 30, 2025 and business updates.
“We are proud of the promising data from our core clinical product candidates. Our lasme-cel program for r/r B-ALL and eti-cel program for r/r NHL demonstrated their ability to induce deep and meaningful responses, underscoring their potential to improve outcomes in diseases with high unmet medical needs” said André Choulika, Ph.D., Chief Executive Officer at Cellectis. “We look forward to sharing an additional development update on eti-cel at the ASH 2025 Annual Meeting and to provide the first interim analysis for the pivotal Phase 2 BALLI-01 trial in Q4 2026. Together, these milestones strengthen our leadership in allogeneic CAR-T innovation and position Cellectis for a transformative year ahead."
_______________
1 Cash, cash equivalents and fixed-term deposits include restricted cash of
Pipeline Highlights
UCART Clinical Programs
BALLI-01 study evaluating lasme-cel (UCART22)
- Clinical data from the Phase 1 BALLI-01 study with lasme-cel for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), were presented at the Cellectis’ R&D Day that took place on October 16, 2025. The presented data position lasme-cel as a potentially game-changing therapy for patients with r/r B-ALL.
In the Phase 1 of BALLI-01 study, 40 transplant ineligible third line or beyond (3L+) patients were dosed with lasme-cel: 18 patients (n=18) were dosed with product manufactured by an external CDMO (Process 1, or P1) and 22 patients (n=22) were dosed with Cellectis-manufactured product (Process 2, or P2).
Highlights include:
-
- Efficacy: lasme-cel demonstrated an overall response rate (ORR) of
68% with Process 2 product (n=22), and an ORR of83% at the recommended Phase 2 dose (RP2D; n=12) and100% in the target Phase 2 population (n=9) - Safety: in Phase 1 (n=40), lasme-cel was generally well tolerated; there was one case of grade 2 immune effector cell–associated hemophagocytic syndrome (IEC-HS), which resolved.
- Durability: among patients who achieved minimal residual disease (MRD)-negative complete remission or complete remission with incomplete hematologic recovery (CR/CRi), median overall survival was 14.8 months.
- Depth of response in target Phase 2 population: the CR/CRi rate was
56% , with approximately80% of these patients achieving MRD-negative status. - Transplant eligibility in target Phase 2 population: all patients (
100% ) became eligible for transplant, and78% proceeded to transplantation.
- Efficacy: lasme-cel demonstrated an overall response rate (ORR) of
- The survival curve for this study suggests a clear benefit: patients who proceeded to hematopoietic stem cell transplantation (HSCT) after lasme-cel therapy showed a trend to longer overall survival than those who did not undergo transplant.
The Phase 1 data showed that lasme-cel maintained its efficacy regardless of the number or type of prior lines of treatments, including CAR-T (60% of subjects), transplant (50% of patients), and blinatumomab (80% of subjects).
- Following successful End-of-Phase 1 meetings with the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Cellectis provided a registration path for lasme-cel in r/r ALL. The first interim analysis for the Phase 2 of the BALLI-01 trial is expected in Q4 2026. Cellectis anticipates submitting a Biologics License Application (BLA) in 2028.
Commercial Opportunity for Lasme-cel
- As part of the R&D Day presentation, the Company discussed the potential commercial opportunity for lasme-cel in r/r B-ALL.
If approved for commercialization, Cellectis estimates that lasme-cel could achieve up to approximately$700 million in potential peak gross sales across the U.S., EU4 (France, Germany, Italy, Spain) and UK in 2035, corresponding to an estimation of about 1,100 patients treated annually. Furthermore, gross peak sales could increase to up to approximately$1.3 billion with potential label expansion to second line and first line MRD+ consolidation. These estimates highlight that lasme-cel has the potential to drive meaningful growth of the CAR-T market in B-ALL, leading to a robust peak sales potential with attractive margins stemming from the allogeneic approach.
American Society of Hematology (ASH) 2025 annual meeting poster presentation
- On November 3, 2025, Cellectis announced the acceptance of an abstract for lasme-cel for poster presentation at the American Society of Hematology (ASH) 2025 annual congress, that will take place on December 6-9, 2025.
- The poster highlights the correlation between alemtuzumab exposure and depth of response in the difficult-to-treat r/r ALL patients who have received lasme-cel. Additionally, the data identifies a threshold exposure level of alemtuzumab above which achieving a complete response/complete response with incomplete hematologic recovery (CR/CRi) is more likely without any increase in toxicities.
The poster presentation will occur on December 8, 2025, 6:00 PM - 8:00 PM ET, in Room OCCC - West Halls B3-B4.
NatHaLi-01 study evaluating eti-cel (UCART20x22)
- At the R&D Day, Cellectis unveiled preliminary data on eti-cel, its allogeneic CAR-T product candidate for relapsed or refractory non-Hodgkin lymphoma (r/r NHL), demonstrating an encouraging ORR of
86% and CR rate of57% at the current dose level (n=7), with 4 out of 7 patients achieving a complete response. The preliminary high rate of complete responses underscores the potential of this innovative approach to transform outcomes for r/r NHL patients. Cellectis expects to present the full Phase 1 dataset for eti-cel, including low-dose IL-2 combination cohorts, in 2026. - On November 3, 2025, Cellectis announced the acceptance of an abstract for poster presentation at ASH 2025.
The poster provides a development update on eti-cel for patients with r/r NHL and outlines the addition of low dose interleukin-2 (IL-2) to further deepen and extend anti-tumor activity of eti-cel in patients with r/r NHL, supported by compelling preclinical data.
The poster presentation will occur on December 7, 2025 at 6:00 PM – 8:00 PM ET, in Room OCCC – West Halls B3-B4.
Innovation
Circular single-stranded DNA (CssDNA) as a non-viral template for gene therapy
- In October 2025, Cellectis presented findings in a poster, highlighting the strong potential of circular single-stranded DNA (CssDNA) as a universal, efficient non-viral template for gene therapy, at the European Society of Gene and Cell Therapy (ESGCT) annual congress.
Over the past decade, non-viral DNA template delivery has been used with engineered nucleases to target single-stranded DNA sequences in hematopoietic stem and progenitor cells (HSPCs).
While developed for gene therapy purposes, so far this method has been restricted to gene corrections. To expand this scope, Cellectis developed an editing process using its gene editing technology and kilobase-long circular single-stranded DNA donor templates.
The data presented show that:
-
- CssDNA editing process achieved high gene insertion frequency in viable HSPCs.
- CssDNA-edited HSPCs show a higher propensity to engraft and maintain gene edits in a murine model than adeno-associated viruses (AAV)-edited HSPCs.
TALE base editors (TALEB) off-targets in the nuclear genome
- At ESGCT 2025, the Company presented in a poster a comprehensive study of TALE base editors (TALEB) off-targets in the nuclear genome.
TALE base editors (TALEB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and an uracil glycosylase inhibitor (UGI).
These recent additions to the genome editing toolbox can directly edit double strand DNA, converting a cytosine (C) to a thymine (T) through the formation of an uracil (U) intermediate without the need of DNA break. Base editing has great potential in therapeutic applications. However, being able to avoid potential off-target effects is key toward this goal.
To evaluate TALEB safety, Cellectis combined advanced bioinformatic predictions with multiple experimental approaches to investigate potential off-target effects in the nuclear genome of primary T cells.
The study found no evidence of biases towards off-site C-to-T editing at sites flanked by CTCF binding sites, a key DNA-binding protein that regulates genome organization and gene expression at genome wide level.
These results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications.
AstraZeneca – Joint Research and Collaboration Agreement
- In its presentation during the Cellectis’ R&D Day held in October, AstraZeneca highlighted the significance of its strategic investment and research collaboration with Cellectis to accelerate its cell therapy and genomic medicine ambitions. The collaboration 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 arbitration
- With respect to the ongoing arbitration proceeding through the Centre de Médiation et d’Arbitrage de Paris, the arbitral decision is expected to be rendered on or before December 15, 2025.
Iovance
- In November 2025, Iovance reported that clinical results for IOV-4001, a PD-1 inactivated TIL cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026. Other potential indications for IOV-4001 are also in development.
Financial Results
Cash, cash equivalent and fixed-term deposits: As of September 30, 2025, Cellectis had
This compares to
We currently foresee focusing our cash spending in supporting the development of our pipeline of product candidates, including the manufacturing and clinical development 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
R&D Expenses: Consolidated R&D expenses were
SG&A Expenses: Consolidated SG&A expenses were
Other operating income and expenses: Other operating income increased slightly by
Net financial gain (loss): We had a consolidated net financial loss of
Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was
Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was
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. INTERIM CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited) ($ in thousands) | |||||||
| As of | |||||||
| December 31, 2024 | September 30, 2025 | ||||||
| ASSETS | |||||||
| Non-current assets | |||||||
| Intangible assets | 1,116 | 845 | |||||
| Property, plant, and equipment | 45,895 | 41,198 | |||||
| Right-of-use assets | 29,968 | 25,512 | |||||
| Non-current financial assets | 7,521 | 35,736 | |||||
| Other non-current assets | 11,594 | 18,179 | |||||
| Deferred tax assets | 382 | 382 | |||||
| Total non-current assets | 96,476 | 121,852 | |||||
| Current assets | |||||||
| Trade receivables | 6,714 | 8,056 | |||||
| Subsidies receivables | 14,521 | 16,411 | |||||
| Other current assets | 5,528 | 4,503 | |||||
| Cash and cash equivalent and Current financial assets | 260,306 | 192,223 | |||||
| Total current assets | 287,069 | 221,193 | |||||
| TOTAL ASSETS | 383,544 | 343,045 | |||||
| LIABILITIES | |||||||
| Shareholders’ equity | |||||||
| Share capital | 5,889 | 5,902 | |||||
| Premiums related to the share capital | 494,288 | 435,162 | |||||
| Currency translation adjustment | (39,537 | ) | (32,725 | ) | |||
| Retained earnings | (292,846 | ) | (266,586 | ) | |||
| Net income (loss) | (36,761 | ) | (41,275 | ) | |||
| Total shareholders’ equity - Group Share | 131,033 | 100,478 | |||||
| Non-controlling interests | - | - | |||||
| Total shareholders’ equity | 131,033 | 100,478 | |||||
| Non-current liabilities | |||||||
| Non-current financial liabilities | 50,882 | 63,399 | |||||
| Non-current lease debts | 34,245 | 29,252 | |||||
| Non-current provisions | 1,115 | 1,339 | |||||
| Total non-current liabilities | 86,241 | 93,990 | |||||
| Current liabilities | |||||||
| Current financial liabilities | 16,134 | 18,240 | |||||
| Current lease debts | 8,385 | 8,331 | |||||
| Trade payables | 18,664 | 16,095 | |||||
| Deferred revenues and deferred income | 112,161 | 94,008 | |||||
| Current provisions | 828 | 1,082 | |||||
| Other current liabilities | 10,097 | 10,820 | |||||
| Total current liabilities | 166,269 | 148,577 | |||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 383,544 | 343,045 | |||||
| Cellectis S.A. INTERIM CONDENSED STATEMENTS OF CONSOLIDATED OPERATIONS (unaudited) For the nine-month period ended September 30, 2025 ($ in thousands, except per share amounts) | ||||||
| For the nine-month period ended September 30, | ||||||
| 2024 | 2025 | |||||
| Revenues and other income | ||||||
| Revenues | 28,789 | 62,552 | ||||
| Other income | 5,263 | 4,834 | ||||
| Total revenues and other income | 34,052 | 67,386 | ||||
| Operating expenses | ||||||
| Research and development expenses | (69,670 | ) | (69,081 | ) | ||
| Selling, general and administrative expenses | (14,153 | ) | (14,988 | ) | ||
| Other operating income (expenses) | 896 | 958 | ||||
| Total operating expenses | (82,926 | ) | (83,111 | ) | ||
| Operating income (loss) | (48,874 | ) | (15,725 | ) | ||
| Financial gain (loss) | 5,677 | (25,550 | ) | |||
| Income tax | 514 | - | ||||
| Net income (loss) | (42,683 | ) | (41,275 | ) | ||
| Attributable to shareholders of Cellectis | (42,683 | ) | (41,275 | ) | ||
| Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.49 | ) | (0.41 | ) | ||
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.49 | ) | (0.41 | ) | ||
| Number of shares used for computing | ||||||
| Basic | 87,355,605 | 100,262,948 | ||||
| Diluted | 87,355,605 | 100,262,948 | ||||
| UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS For the three-month period ended September 30, 2025 ($ in thousands, except per share amounts) | ||||||
| For the three-month period ended September 30, | ||||||
| 2024 | 2025 | |||||
| Revenues and other income | ||||||
| Revenues | 16,200 | 35,172 | ||||
| Other income | 1,851 | 1,992 | ||||
| Total revenues and other income | 18,050 | 37,164 | ||||
| Operating expenses | ||||||
| Research and development expenses | (23,829 | ) | (24,069 | ) | ||
| Selling, general and administrative expenses | (5,167 | ) | (5,208 | ) | ||
| Other operating income (expenses) | 175 | 154 | ||||
| Total operating expenses | (28,820 | ) | (29,123 | ) | ||
| Operating income (loss) | (10,769 | ) | 8,041 | |||
| Financial gain (loss) | (12,346 | ) | (7,452 | ) | ||
| Income tax | 59 | - | ||||
| Net income (loss) | (23,056 | ) | 589 | |||
| Attributable to shareholders of Cellectis | (23,056 | ) | 589 | |||
| Attributable to non-controlling interests | - | - | ||||
| Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.23 | ) | 0.01 | |||
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.23 | ) | 0.01 | |||
| Number of shares used for computing | ||||||
| Basic | 100,093,635 | 100,325,229 | ||||
| Diluted | 100,093,635 | 101,708,538 | ||||
Note Regarding Use of Non-IFRS Financial Measures
Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS.
Because adjusted net income (loss) attributable to shareholders of Cellectis excludes stock-based compensation expense - a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis.
| RECONCILIATION OF IFRS TO NON-IFRS NET INCOME (unaudited) For the nine-month period ended September 30, 2025 ($ in thousands, except per share data) | ||||||
| For the nine-month period ended September 30, | ||||||
| 2024 | 2025 | |||||
| Net income (loss) attributable to shareholders of Cellectis | (42,683 | ) | (41,275 | ) | ||
| Adjustment: Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 2,283 | 3,860 | ||||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (40,400 | ) | (37,415 | ) | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.46 | ) | (0.37 | ) | ||
| Weighted average number of outstanding shares, basic (units) | 87,355,605 | 100,262,948 | ||||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.46 | ) | (0.37 | ) | ||
| Weighted average number of outstanding shares, diluted (units) | 87,355,605 | 100,262,948 | ||||
| RECONCILIATION OF IFRS TO NON-IFRS NET INCOME (unaudited) For the three-month period ended September 30, 2025 ($ in thousands, except per share data) | |||||
| For the three-month period ended September 30, | |||||
| 2024 | 2025 | ||||
| Net income (loss) attributable to shareholders of Cellectis | (23,056 | ) | 589 | ||
| Adjustment: | |||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 566 | 1,602 | |||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (22,490 | ) | 2,191 | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.22 | ) | 0.02 | ||
| Weighted average number of outstanding shares, basic (units) | 100,093,635 | 100,325,229 | |||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.22 | ) | 0.02 | ||
| Weighted average number of outstanding shares, diluted (units) | 100,093,635 | 101,708,538 | |||
About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish.
Cellectis’ headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit www.cellectis.com and follow Cellectis on LinkedIn and X.
Cautionary Statement
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expectation,” “expected,” “illustrative,” “look forward,” “plan,” “potential,” “potentially, “positioned,” “projected,” “suggest,” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements regarding the market market opportunities with respect to lasme-cel (and the assumptions on which such determinations are based, including with respect to addressable populations and potential pricing), the potential of the Phase 2 BALLI-01 trial to be a registrational phase, the advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings (including without limitation, the date of BLA filing), the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies, and the financial position of Cellectis. These forward-looking statements are made in light of information currently available to us and are subject to significant risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Among these are significant risks that the BALLI-01 Phase 1 data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results relating to a small number of patients – such results should not be viewed as predictive of future results. With respect to the sufficiency of cash, cash equivalent and fixed-term deposits to fund our operations, which we refer to as our runway, we note that our operating plans, including product development plans, may change as a result of various factors. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F as amended and in our annual financial report (including the management report) for the year ended December 31, 2024 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, which are available on the SEC’s website at www.sec.gov, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
For further information on Cellectis, please contact:
Media contacts:
Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93
Investor Relations contact:
Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@cellectis.com
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