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Cellectis Provides Business Updates and Financial Results for Third Quarter 2024

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Cellectis (CLLS) reported Q3 2024 business updates and financial results, highlighting ongoing enrollment in UCART22 and UCART20x22 clinical trials, with Phase 1 dataset expected in 2025. The company's cash position stands at $264 million as of September 30, 2024, projecting runway into 2027. Research and development activities have commenced on three programs under the AstraZeneca partnership. The company reported revenues of $34.1 million for the nine months ended September 30, 2024, compared to $7.2 million in the same period of 2023. Net loss was $42.7 million, an improvement from the $59.3 million loss in the previous year.

Cellectis (CLLS) ha comunicato aggiornamenti aziendali e risultati finanziari per il terzo trimestre del 2024, evidenziando l'avanzamento dell'arruolamento negli studi clinici UCART22 e UCART20x22, con la raccolta di dati della Fase 1 prevista per il 2025. La posizione di liquidità dell'azienda ammonta a 264 milioni di dollari al 30 settembre 2024, con previsioni per coprire le spese fino al 2027. Sono iniziati i lavori di ricerca e sviluppo su tre programmi nell'ambito della partnership con AstraZeneca. L'azienda ha riportato ricavi di 34,1 milioni di dollari per i nove mesi terminati il 30 settembre 2024, rispetto ai 7,2 milioni di dollari nello stesso periodo del 2023. La perdita netta ammonta a 42,7 milioni di dollari, con un miglioramento rispetto alla perdita di 59,3 milioni di dollari dell'anno precedente.

Cellectis (CLLS) informó sobre las actualizaciones empresariales y resultados financieros del tercer trimestre de 2024, destacando la continua inscripción en los ensayos clínicos UCART22 y UCART20x22, con un conjunto de datos de Fase 1 previsto para 2025. La posición de efectivo de la empresa se sitúa en 264 millones de dólares hasta el 30 de septiembre de 2024, proyectando fondos hasta 2027. Las actividades de investigación y desarrollo han comenzado en tres programas bajo la asociación con AstraZeneca. La empresa reportó ingresos de 34,1 millones de dólares durante los nueve meses que terminaron el 30 de septiembre de 2024, en comparación con 7,2 millones de dólares en el mismo período de 2023. La pérdida neta fue de 42,7 millones de dólares, una mejora con respecto a la pérdida de 59,3 millones de dólares del año anterior.

Cellectis (CLLS)는 2024년 3분기 사업 업데이트 및 재무 결과를 발표하며, UCART22 및 UCART20x22 임상 시험에 대한 지속적인 환자 모집을 강조했습니다. 1상 데이터셋은 2025년에 예상됩니다. 2024년 9월 30일 기준 회사의 현금 보유고는 2억 6,400만 달러로, 2027년까지 운영이 가능할 것으로 예상하고 있습니다. AstraZeneca와의 파트너십 하에 세 가지 프로그램에 대한 연구 및 개발 활동이 시작되었습니다. 회사는 2024년 9월 30일로 종료된 9개월 동안 3,410만 달러의 수익을 기록했으며, 2023년 같은 기간의 720만 달러와 비교됩니다. 순손실은 4,270만 달러로, 지난 해 5,930만 달러의 손실에서 개선되었습니다.

Cellectis (CLLS) a publié des mises à jour commerciales et des résultats financiers pour le troisième trimestre de 2024, soulignant l'inscription continue aux essais cliniques UCART22 et UCART20x22, avec un ensemble de données de Phase 1 attendu en 2025. La position de trésorerie de l'entreprise s'élève à 264 millions de dollars au 30 septembre 2024, projetant des fonds jusqu'en 2027. Les activités de recherche et développement ont été lancées sur trois programmes dans le cadre du partenariat avec AstraZeneca. L'entreprise a rapporté des revenus de 34,1 millions de dollars pour les neuf mois se terminant le 30 septembre 2024, contre 7,2 millions de dollars au cours de la même période en 2023. La perte nette était de 42,7 millions de dollars, une amélioration par rapport à la perte de 59,3 millions de dollars de l'année précédente.

Cellectis (CLLS) hat die Geschäftsupdates und finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und die fortlaufende Rekrutierung in den klinischen Studien UCART22 und UCART20x22 hervorgehoben, wobei Datensätze der Phase 1 für 2025 erwartet werden. Die Liquiditätsposition des Unternehmens beläuft sich zum 30. September 2024 auf 264 Millionen Dollar, was einen Finanzbedarf bis 2027 voraussetzt. Die Forschungs- und Entwicklungstätigkeiten wurden für drei Programme im Rahmen der Partnerschaft mit AstraZeneca aufgenommen. Das Unternehmen meldete für die neun Monate bis zum 30. September 2024 Einnahmen von 34,1 Millionen Dollar, verglichen mit 7,2 Millionen Dollar im gleichen Zeitraum 2023. Der Nettoverlust betrug 42,7 Millionen Dollar, eine Verbesserung gegenüber dem Verlust von 59,3 Millionen Dollar im Vorjahr.

Positive
  • Strong cash position of $264 million with runway extended into 2027
  • Significant revenue increase to $34.1 million, up from $7.2 million YoY
  • Net loss improved to $42.7 million from $59.3 million YoY
  • Secured $47 million in payments from AstraZeneca partnership
Negative
  • R&D expenses increased to $69.7 million from $62.7 million YoY
  • SG&A expenses rose to $14.2 million from $12.1 million YoY
  • Deprioritization of UCART123 development program

Insights

The Q3 2024 financial results show significant improvements in Cellectis' financial position. The company's cash position strengthened to $264 million, up from $156 million at the end of 2023, primarily driven by $140 million from AstraZeneca's equity investment. Revenue increased substantially to $34.1 million for the nine months, compared to $7.2 million in the same period last year.

The net loss narrowed to $42.7 million from $59.3 million year-over-year, reflecting improved operational efficiency and strategic partnerships. The extended cash runway into 2027 provides substantial operational flexibility for clinical development programs. The AstraZeneca partnership has already triggered $47 million in payments, demonstrating early success in the collaboration.

The clinical pipeline shows focused progress with two key programs: UCART22 for leukemia and UCART20x22 for lymphoma, both expected to deliver Phase 1 data in 2025. The strategic decision to deprioritize UCART123 demonstrates disciplined portfolio management. The AstraZeneca collaboration's expansion into three distinct programs - including both hematological and solid tumor targets - significantly broadens the therapeutic potential.

The appointment of Dr. Kilcoyne as CMO brings valuable cell therapy expertise at a important time. The published research on MUC1 CAR T-cells for triple-negative breast cancer represents a promising advance into solid tumors, historically a challenging area for CAR-T therapy.

  • UCART22 and UCART20x22: enrollment ongoing, Phase 1 dataset and late-stage development strategy to be presented in 2025

  • AstraZeneca partnership: R&D activities are ongoing on three programs – one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder

  • Appointed Adrian Kilcoyne, M.D., MPH, MBA, an industry leader in the advancement of cell therapy treatment, as Chief Medical Officer

  • Cash position of $264 million as of September 30, 20241; cash runway projection into 2027

  • Conference call scheduled for 8:00 am ET / 2:00 pm CET on November 5, 2024

NEW YORK, Nov. 04, 2024 (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 business updates and reported financial results for the nine-month period ending September 30, 2024.

“This quarter, we were thrilled to welcome Dr. Kilcoyne to Cellectis as Chief Medical Officer. Dr. Kilcoyne joins us at a pivotal time for the Company, bringing extensive experience in drug development as we are progressing in our clinical programs. We expect to present Phase 1 dataset and late-stage development strategy in 2025 for UCART22 in ALL and UCART20x22 for NHL” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

“Additionally, we are excited to announce that research and development activities have started for three programs under our collaboration and research agreement with AstraZeneca: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.

Cellectis is confident about the continued progress of its ongoing clinical trials in hematological malignancies and is excited about our strategic collaboration with AstraZeneca, with whom we continue to advance our ambition in cell and gene therapy to bring potentially lifesaving therapies to patients with unmet medical needs."

________________________
1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. Restricted cash was $5 million as of September 30, 2024. Fixed-term deposits classified as current financial assets were $100 million as of September 30, 2024.

Pipeline Highlights

UCART Clinical Programs

  • Cellectis continues to focus on the enrollment of patients in the BALLI-01 study, evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia. We expect to present the Phase 1 dataset and late-stage development strategy in 2025.

  • Cellectis continues to focus on the enrollment of patients in the NATHALI-01 study, evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma. We expect to present the Phase 1 dataset and late-stage development strategy in 2025.

  • The Company decided to focus its current development efforts on the BALLI-01 and NATHALI-01 studies and therefore to deprioritize the development of UCART123, currently evaluated in relapsed or refractory acute myeloid leukemia. Up to now, this study has provided important insights into the role of CD123-targeted allogeneic CAR-T therapy in relapsed refractory acute myeloid leukemia and the future development of our allogeneic CAR-T platform.

MUC1 CAR T-cells for treating Triple-Negative Breast Cancer

  • On September 3, 2024, Cellectis published a scientific article in Science Advances suggesting that TALEN®-edited MUC1 CAR T-cells could be a potential treatment option for advance-stage triple negative breast cancer (TNBC) patients with limited therapeutic options. In this article, Cellectis described its CAR T-cell engineering strategy using TALEN® and synthetic biology to multi-armor CAR T-cells with synergistic functionalities to overcome the immunosuppressive tumor microenvironment of solid tumors.

Partnerships

Servier and Allogene – Allogeneic CAR-T

Allogene’s investigational oncology products utilize Cellectis technologies.

  • Allogene announced that the pivotal Phase 2 ALPHA3 trial was initiated in June 2024. This study is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for patients with LBCL who are likely to relapse after standard 1L treatment. Allogene announced that ALPHA3 is the first pivotal trial to offer CAR T as part of 1L treatment consolidation.

  • Allogene announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel, and that initial data readout from the CLL cohort is projected by early 2025.

  • Allogene announced that a Phase 1 data update of the TRAVERSE trial of ALLO-316 from approximately 20 patients with CD70 positive RCC is planned by YE 2024. In October 2024, Allogene announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC).

AstraZeneca – Joint Research and Collaboration Agreement

  • Under the terms of the joint research and collaboration agreement entered into by Cellectis and AstraZeneca Ireland Limited (“AstraZeneca”) on November 1, 2023 (the “AZ JRCA”), AstraZeneca is leveraging Cellectis’ proprietary gene editing technologies and manufacturing capabilities to design novel cell and gene therapy candidate products. As part of the AZ JRCA, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10 candidate products could be explored for development. AstraZeneca has an option for a worldwide exclusive license on the candidate products, to be exercised before IND filing.

  • Research and development activities under three cell and gene therapy programs have already started under the AZ JRCA: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.

  • Under the AZ JRCA, $47m have been triggered so far (of which $25m upfront and $22m reached development milestones for the three initial projects), in addition to reimbursement of research costs incurred under the AZ JRCA.

Appointment

  • On August 7, 2024, Cellectis announced the appointment of Adrian Kilcoyne, M.D., MPH, MBA as its Chief Medical Officer.

  • Before joining Cellectis, Dr. Kilcoyne was Chief Medical Officer and Head of Research and Development at Celularity, advancing their oncology allogeneic CAR-T and NK Cell therapy programs. Prior to this, he was Chief Medical Officer at Humanigen. He has held numerous Oncology leadership roles across Research and Development, Medical Affairs, Commercial, Health Economic Outcome Research and Evidence Generation in both large pharmaceutical and biotechnology companies such as AstraZeneca and Celgene. Dr. Kilcoyne graduated from Trinity College, Dublin Medical School. He initially trained in Gynecological Oncology at the Hammersmith Hospital in London and subsequently in Public Health Medicine at Oxford during which time he completed a Master’s in Public Health. Dr. Kilcoyne then trained in pharmaceutical medicine and completed his MBA.

Financial Results

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”).

As from June 1, 2023, and the deconsolidation of Cibus, Inc. (formerly Calyxt, Inc.) (“Cibus”) which corresponded to the Plants operating segment, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment. For this reason, we are no longer presenting financial measures broken down between our two reportable segments – Therapeutics and Plants. In the appendices of this Q3 2024 financial results press release, Cibus' results are isolated under "Income (loss) from discontinued operations" for the 9-month period ended September 30, 2023, and are no longer included for the 9-month period ended September 30, 2024, due to the deconsolidation.

Cash: As of September 30, 2024, Cellectis had $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets. This compares to $156 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets as of December 31, 2023. This $108 million increase is mainly due to $140 million cash received from AstraZeneca as part of its equity investment in Cellectis, $16 million cash received from European Investment Bank (“EIB”) pursuant to the disbursement of the €15 million Tranche B under the Finance Contract with EIB, $8 million of cash-in from our financial investments, $27 million of cash-in from our revenue, partially offset by cash payments from Cellectis to suppliers of $42 million, including $30 million to R&D suppliers and $12 million to SG&A suppliers, Cellectis’ wages, bonuses and social expenses paid of $32 million, the payments of lease debts of $8 million and the repayment of the “PGE” loan of $4 million.

With cash and cash equivalents of $159 million and $100 million term deposit classified as current financial assets as of September 30, 2024, the Company believes its cash and cash equivalents and deposits will be sufficient to fund its operations into 2027.

Revenues and Other Income: Consolidated revenues and other income were $34.1 million for the nine months ended September 30, 2024 compared to $7.2 million for the nine months ended September 30, 2023. This $26.8 million increase between the nine months ended September 30, 2023 and 2024 was mainly attributable to (i) recognition of a $28.3 million revenue in 2024 based (a) on the progress of our performance obligation rendered under the three programs under the AZ JRCA and (b) the reaching of a development milestone under the License, Development and Commercialization Agreement dated March 6, 2019 between Les Laboratoires Servier and Institut de Recherches Internationales Servier (together “Servier”) and Cellectis as amended (the “Servier License Agreement”), and (ii) a $1.5 million decrease in other income.

R&D Expenses: Consolidated R&D expenses were $69.7 million for the nine months ended September 30, 2024, compared to $62.7 million for the nine months ended September 30, 2023. R&D personnel expenses increased by $2.1 million from $25.7 million in 2023 to $27.8 million in 2024 mainly due to a reversal in September 2023 in non-cash stock-based compensation expense. R&D purchases, external expenses and other increased by $4.9 million (from $37.0 million in 2023 to $41.9 million in 2024) mainly related to increase in manufacturing activities to support our R&D pipeline.

SG&A Expenses: Consolidated SG&A expenses were $14.2 million for the nine months ended September 30, 2024 compared to $12.1 million for the nine months ended September 30, 2023. SG&A personnel expenses increased by $0.5 million (from $5 million in 2023 to $5.6 million in 2024). SG&A purchases, external expenses and other increased by $1.5 million (from $7.1 million in 2023 to $8.6 million in 2024).

Other operating income and expenses: Other operating income and expenses were a $0.9 million net income for the nine months ended September 30, 2024 compared to a $0.1 million net expense for the nine months ended September 30, 2023. Other operating income increased by $1 million primarily due to the recognition of revenues from American Depository Shares (“ADS”) movements of $0.5 million and $0.3 million related to the subleased portion of our premises in New-York.

Net financial gain (loss): We had a consolidated net financial gain of $5.7 million for the nine months ended September 30, 2024, compared to a $7 million loss for the nine months ended September 30, 2023. This $12.6 million difference reflects mainly (i) a $14.3 million gain in change in fair value of SIA derivative instrument, (ii) a $5.6 million increase in gain from our financial investments, (iii) a $2.6 million gain in change in fair value of EIB Tranche A and Tranche B, (iv) the loss in fair value measurement on Cytovia convertible note recognized in the nine months period ended September 30, 2023 of $7.9 million, partially offset by (i) an increase of $1.8 million in interest expense on Tranche A and Tranche B of the EIB Finance Contractand (ii) a $5.3 million increase in foreign exchange loss, (iii) a decrease in net foreign exchange gain of $8.6 million and (iv) a $1.5 million increase of the loss in fair value of our investment in Cibus.

Net income (loss) from discontinued operations: Net income from discontinued operations of $8.4 million for the nine months ended September 30, 2023 corresponded to Calyxt’s results. Since Cibus has been deconsolidated since June 1, 2023, there is no longer any "Income (loss) from discontinued operations" for the nine months ended September 30, 2024.

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $42.7 million (or a $0.49 loss per share) for the nine months ended September 30, 2024, compared to a $59.3 million loss (or a $1.09 loss per share) for the nine months ended September 30, 2023, of which $75 million was attributed to Cellectis continuing operations. The $24 million change in net loss was primarily driven by (i) an increase in revenues and other income of $26.8 million, (ii) a $12.6 million change from a net financial loss of $7 million to a net financial gain of $5.7 million and (iii) a decrease in net other operating expense of $1 million, and (iv) a $8.4 million decrease in net income from discontinued operations attributable to shareholders of Cellectis, partially offset by (i) an increase of $6.4 million in purchases, external expenses and other, and a (ii) an increase of $0.8 million in wages and (iii) an increase of $1.7 million in non-cash stock based compensation expense.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $40.4 million (or a $0.46 loss per share) for the nine months ended September 30, 2024, compared to a net loss of $56.8 million (or a $1.05 loss per share) for the nine months ended September 30, 2023.

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.

We currently foresee focusing our cash spending at Cellectis for 2024 in the following areas:

  • supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART22, UCART20x22 and potential new product candidates,
  • and operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA).

 

CELLECTIS S.A.
STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited)
($ in thousands)
 
 As of
 December 31, 2023 September 30, 2024
ASSETS    
Non-current assets    
Intangible assets671  691 
Property, plant, and equipment54,681  48,956 
Right-of-use assets38,060  32,225 
Non-current financial assets7,853  7,651 
Other non-current assets0  11,120 
Deferred tax assets0  803 
Total non-current assets 101,265  101,445 
Current assets    
Trade receivables569  11,180 
Subsidies receivables20,900  15,661 
Other current assets7,722  6,643 
Cash and cash equivalent and Current financial assets203,815  260,947 
Total current assets 233,005  294,431 
TOTAL ASSETS 334,270  395,876 
LIABILITIES    
Shareholders’ equity    
Share capital4,365  5,906 
Premiums related to the share capital522,785  607,153 
Currency translation adjustment(36,690) (35,154)
Retained earnings(304,707) (405,798)
Net income (loss)(101,059) (42,683)
Total shareholders’ equity - Group Share84,695  129,424 
Non-controlling interests0  0 
Total shareholders’ equity84,695  129,424 
Non-current liabilities    
Non-current financial liabilities49,125  61,575 
Non-current lease debts42,948  36,683 
Non-current provisions2,200  2,427 
Deferred tax liabilities158  118 
Total non-current liabilities 94,431  100,802 
Current liabilities    
Current financial liabilities5,289  5,350 
Current lease debts8,502  8,508 
Trade payables19,069  18,511 
Deferred revenues and deferred income110,325  122,006 
Current provisions1,740  899 
Other current liabilities10,219  10,376 
Total current liabilities 155,144  165,650 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 334,270  395,876 



UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS
For the three-month period ended September 30, 2024
($ in thousands, except per share amounts)
 
 For the three-month period ended
September 30,
 2023* 2024 
   
Revenues and other income   
Revenues155  16,200 
Other income1,489  1,851 
Total revenues and other income1,644  18,050 
Operating expenses   
Research and development expenses(19,075) (23,829)
Selling, general and administrative expenses(3,227) (5,167)
Other operating income (expenses)(12) 175 
Total operating expenses(22,314) (28,820)
    
Operating income (loss)(20,671) (10,769)
    
Financial gain (loss)3,295  (12,346)
    
Income tax (106) 59 
Income (loss) from continuing operations(17,482) (23,056)
Income (loss) from discontinued operations0  0 
Net income (loss)(17,482) (23,056)
Attributable to shareholders of Cellectis(17,482) (23,056)
Attributable to non-controlling interests(0) 0 
Basic and diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share)(0.31) (0.23)
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share)(0.31) (0.23)
Basic and diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share)0.00  0.00 
Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share)0.00  0.00 
    
Number of shares used for computing   
Basic55,583,768  100,093,635 
Diluted55,583,768  100,093,635 

*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)

 

Cellectis S.A.
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS
For the nine-month period ended September 30, 2024
($ in thousands, except per share amounts)
 
 For the nine-month period ended
September 30,
 2023* 2024
   
Revenues and other income   
Revenues472  28,789 
Other income6,731  5,263 
Total revenues and other income7,203  34,052 
Operating expenses   
Research and development expenses(62,690) (69,670)
Selling, general and administrative expenses(12,141) (14,153)
Other operating income (expenses)(96) 896 
Total operating expenses(74,926) (82,926)
    
Operating income (loss)(67,723) (48,874)
    
Financial gain (loss)(6,952) 5,677 
    
Income tax (365) 514 
Income (loss) from continuing operations(75,040) (42,683)
Income (loss) from discontinued operations8,392  0 
Net income (loss)(66,648) (42,683)
Attributable to shareholders of Cellectis(59,264) (42,683)
Attributable to non-controlling interests(7,384) 0 
Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share)(1.09) (0.49)
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share)(1.09) (0.49)
Basic net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share)0.29  0.00 
    
Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share)0.29  0.00 
    
Number of shares used for computing   
Basic54,231,943  87,355,605 
Diluted54,231,943  87,355,605 

*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)


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 non-cash 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 three-month period ended September 30, 2024
($ in thousands, except per share data)
 
 For the three-month period ended
September 30,
 2023* 2024
    
Net income (loss) attributable to shareholders of Cellectis (17,482) (23,056)
Adjustment:     
Non-cash stock-based compensation expense attributable to shareholders of Cellectis(2,653) 566 
Adjusted net income (loss) attributable to shareholders of Cellectis(20,135) (22,490)
Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share)(0.36) (0.22)
Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) 0.00  0.00 
    
Weighted average number of outstanding shares, basic (units) (1)55,583,768  100,093,635 
    
Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1)(0.36) (0.22)
Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) 0.00  0.00 
    
Weighted average number of outstanding shares, diluted (units) (1)55,583,768  100,093,635 

*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)

 

RECONCILIATION OF IFRS TO NON-IFRS NET INCOME (unaudited)
For the nine-month period ended September 30, 2024
($ in thousands, except per share data)
 
 For the nine-month period ended
September 30,
 2023* 2024
    
Net income (loss) attributable to shareholders of Cellectis (59,264) (42,683)
Adjustment:     
Non-cash stock-based compensation expense attributable to shareholders of Cellectis2,466  2,283 
Adjusted net income (loss) attributable to shareholders of Cellectis(56,798) (40,400)
Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share)(1.05) (0.46)
Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) 0.33  0.00 
    
Weighted average number of outstanding shares, basic (units) (1)54,231,943  87,355,605 
    
Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1)(1.05) (0.46)
Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) 0.33  0.00 
    
Weighted average number of outstanding shares, diluted (units) (1)54,231,943  87,355,605 

*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)

About Cellectis  

Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis 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 make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with 25 years of experience and expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).  

To find out more, visit our website: www.cellectis.com

Follow Cellectis on social networks @cellectis on LinkedIn and X (formerly Twitter)

TALEN® is a registered trademark owned by Cellectis. 

Forward-looking Statements     

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 “future,” “projection,” “will,” “may,” “could,” “expect,” “suggest,” “potential,” “will,” and “believe” or the negative of these and similar expressions. These forward-looking statements are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements include statements about the advancement, timing and progress of clinical trials, the timing of our presentation of clinical data, the potential of our candidate products programs, the advancement and potential of partnered research and development programs and the sufficiency of cash to fund operations. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development, including the risk of losing the orphan drug designation if it is established that the product no longer meets the orphan drug criteria before market authorization is granted (if any). With respect to our cash runway, our operating plans, including product candidates development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2023 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, 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, Interim Chief Financial Officer, investors@cellectis.com

Attachment


FAQ

What is Cellectis (CLLS) cash position as of Q3 2024?

Cellectis reported a cash position of $264 million as of September 30, 2024, with a projected runway into 2027.

What are the key clinical trials Cellectis (CLLS) is currently focusing on?

Cellectis is focusing on BALLI-01 study evaluating UCART22 in B-cell acute lymphoblastic leukemia and NATHALI-01 study evaluating UCART20x22 in B-cell non-Hodgkin lymphoma, with Phase 1 datasets expected in 2025.

How much revenue did Cellectis (CLLS) generate in Q3 2024?

Cellectis reported revenues of $34.1 million for the nine months ended September 30, 2024, compared to $7.2 million in the same period of 2023.

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