Cellectis Provides Financial Results for the Second Quarter 2024
Cellectis provided its financial results for Q2 2024, reporting a cash position of $273 million as of June 30, 2024, and a cash runway projection into 2026. Key highlights include:
Pipeline Updates: UCART22 received ODD from both the FDA and the European Commission for ALL treatment, and RPDD from the FDA. CLLS52 (alemtuzumab) also received ODD from the FDA for ALL treatment.
Financial Performance: Consolidated revenues and other income increased to $16 million for the six months ended June 30, 2024, compared to $5.6 million for the same period in 2023. Consolidated net loss reduced to $19.6 million from $41.8 million, reflecting better financial management and increased revenues.
Partnerships: Cellectis announced a $140 million investment from AstraZeneca, which now owns approximately 44% of Cellectis' share capital.
Research: A significant publication in Nature Communications on their non-viral gene therapy approach for SCD.
Cellectis ha fornito i risultati finanziari per il secondo trimestre del 2024, riportando una posizione di liquidità di 273 milioni di dollari al 30 giugno 2024 e una previsione di liquidità fino al 2026. Tra i punti salienti:
Aggiornamenti sulla pipeline: UCART22 ha ricevuto la Designazione di Farmaco Orfano (ODD) sia dalla FDA che dalla Commissione Europea per il trattamento della leucemia linfoblastica acuta (ALL), e la Designazione di Farmaco per Malattie Rare (RPDD) dalla FDA. Anche CLLS52 (alemtuzumab) ha ricevuto ODD dalla FDA per il trattamento della ALL.
Performance finanziaria: I ricavi consolidati e altri redditi sono aumentati a 16 milioni di dollari per i sei mesi terminati il 30 giugno 2024, rispetto ai 5,6 milioni di dollari per lo stesso periodo del 2023. La perdita netta consolidata è stata ridotta a 19,6 milioni di dollari rispetto ai 41,8 milioni, riflettendo una migliore gestione finanziaria e un incremento dei ricavi.
Partnership: Cellectis ha annunciato un investimento di 140 milioni di dollari da parte di AstraZeneca, che ora detiene circa il 44% del capitale sociale di Cellectis.
Ricerca: Una pubblicazione significativa su Nature Communications riguardante il loro approccio di terapia genica non virale per la drepanocitosi (SCD).
Cellectis ha presentado sus resultados financieros para el segundo trimestre de 2024, reportando una posición de efectivo de 273 millones de dólares hasta el 30 de junio de 2024 y una proyección de efectivo hasta 2026. Los puntos destacados incluyen:
Actualizaciones de la pipeline: UCART22 recibió la Designación de Medicamento Huérfano (ODD) tanto de la FDA como de la Comisión Europea para el tratamiento de la leucemia linfoblástica aguda (ALL), y la Designación de Medicamento para Enfermedades Raras (RPDD) de la FDA. CLLS52 (alemtuzumab) también recibió ODD de la FDA para el tratamiento de la ALL.
Desempeño financiero: Los ingresos consolidados y otros ingresos aumentaron a 16 millones de dólares para los seis meses terminados el 30 de junio de 2024, en comparación con 5,6 millones de dólares durante el mismo período en 2023. La pérdida neta consolidada se redujo a 19,6 millones de dólares desde 41,8 millones, reflejando una mejor gestión financiera y mayores ingresos.
Asociaciones: Cellectis anunció una inversión de 140 millones de dólares por parte de AstraZeneca, que ahora posee aproximadamente el 44% del capital social de Cellectis.
Investigación: Una publicación significativa en Nature Communications sobre su enfoque de terapia génica no viral para la drepanocitosis (SCD).
Cellectis는 2024년 2분기 재무 결과를 발표하며, 2024년 6월 30일 현재 현금 보유액이 2억 7천3백만 달러에 달하고, 2026년까지의 현금 소진 예측을 보고했습니다. 주요 하이라이트는 다음과 같습니다:
파이프라인 업데이트: UCART22는 FDA와 유럽연합 집행위원회로부터 ALL 치료를 위한 희귀의약품 지정(ODD)을 받았으며, FDA로부터도 RPDD를 받았습니다. CLLS52(알렘투주맙)도 ALL 치료를 위해 FDA로부터 ODD를 받았습니다.
재무 성과: 2024년 6월 30일 종료된 6개월 동안의 통합 수익 및 기타 수익은 1천6백만 달러로 증가했으며, 2023년 같은 기간의 560만 달러와 비교됩니다. 통합 순손실은 4,180만 달러에서 1,960만 달러로 감소하여, 더 나은 재무 관리 및 수익 증가를 반영하고 있습니다.
파트너십: Cellectis는 아스트라제네카로부터 1억 4천만 달러의 투자를 발표했으며, 아스트라제네카는 현재 Cellectis의 약 44%의 주식 자본을 보유하고 있습니다.
연구: SCD에 대한 비바이러스 유전자 치료 접근 방식에 관한 Nature Communications의 중요한 논문이 발표되었습니다.
Cellectis a publié ses résultats financiers pour le deuxième trimestre de 2024, rapportant une position de trésorerie de 273 millions de dollars au 30 juin 2024, avec une prévision de trésorerie jusqu'en 2026. Les points clés incluent :
Mises à jour du pipeline : UCART22 a reçu la désignation de médicament orphelin (ODD) de la FDA et de la Commission européenne pour le traitement de la leucémie lymphoblastique aiguë (ALL), ainsi que la désignation de maladie pédiatrique rare (RPDD) de la FDA. CLLS52 (alemtuzumab) a également reçu l'ODD de la FDA pour le traitement de la ALL.
Performance financière : Les revenus consolidés et autres produits ont augmenté pour atteindre 16 millions de dollars pour les six mois clos le 30 juin 2024, contre 5,6 millions de dollars pour la même période en 2023. La perte nette consolidée a été réduite à 19,6 millions de dollars, contre 41,8 millions de dollars, ce qui reflète une meilleure gestion financière et une augmentation des revenus.
Partenariats : Cellectis a annoncé un investissement de 140 millions de dollars de la part d'AstraZeneca, qui possède désormais environ 44 % du capital social de Cellectis.
Recherche : Une publication significative dans Nature Communications concernant leur approche non virale de thérapie génique pour la drepanocytose (SCD).
Cellectis hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und berichtet von einer Liquiditätsposition von 273 Millionen Dollar zum 30. Juni 2024 sowie einer Liquiditätsprognose bis 2026. Wichtige Höhepunkte sind:
Pipeline-Updates: UCART22 erhielt die Orphan Drug Designation (ODD) sowohl von der FDA als auch von der Europäischen Kommission für die Behandlung von ALL und die Rare Pediatric Disease Designation (RPDD) von der FDA. Auch CLLS52 (Alemtuzumab) erhielt ODD von der FDA zur Behandlung von ALL.
Finanzielle Leistung: Die konsolidierten Einnahmen und sonstigen Erträge stiegen auf 16 Millionen Dollar für die sechs Monate bis zum 30. Juni 2024, verglichen mit 5,6 Millionen Dollar im gleichen Zeitraum 2023. Der konsolidierte Nettoverlust verringerte sich auf 19,6 Millionen Dollar von 41,8 Millionen Dollar, was auf ein besseres Finanzmanagement und steigende Einnahmen hinweist.
Partnerschaften: Cellectis gab eine Investition von 140 Millionen Dollar durch AstraZeneca bekannt, die nun etwa 44 % des Eigenkapitals von Cellectis hält.
Forschung: Eine bedeutende Veröffentlichung in Nature Communications über ihren nicht-viralen Gentherapieansatz für SCD.
- Cash position of $273 million, ensuring operations funding into 2026.
- Consolidated revenues and other income increased to $16 million from $5.6 million YoY.
- Reduced consolidated net loss to $19.6 million from $41.8 million YoY.
- Significant $140 million investment from AstraZeneca, increasing its ownership to 44%.
- Increased R&D expenses to $45.8 million from $43.6 million YoY.
- Increased SG&A expenses to $9 million from $8.9 million YoY.
Insights
Cellectis' Q2 2024 results show mixed signals. The company reported a
Revenue increased substantially to
Cellectis has made significant regulatory progress with its lead candidate UCART22. The company received Orphan Drug Designation from both the FDA and European Commission, as well as Rare Pediatric Disease Designation from the FDA for UCART22 in acute lymphoblastic leukemia (ALL). These designations could provide regulatory and financial benefits during development and commercialization.
The company is advancing multiple clinical trials, including BALLI-01 (UCART22), NatHaLi-01 (UCART20x22) and AMELI-01 (UCART123). The addition of alemtuzumab to the lymphodepletion regimen in BALLI-01 has shown promising results, with improved UCART22 cell expansion and clinical activity. However, detailed clinical data are still pending and investors should watch for updates expected by the end of 2024 to gauge the true potential of Cellectis' pipeline.
Cellectis has initiated an arbitration proceeding against Servier regarding their license agreement for anti-CD19 CAR-T cell therapies. The company is seeking termination of the agreement and financial compensation for alleged lack of development and non-payment of milestone payments. This legal action could have significant implications for Cellectis' future revenues and partnerships.
Simultaneously, Allogene (Servier's sublicensee) has expanded its territory rights for these therapies to include the EU and UK, with an option for China and Japan. This complex legal landscape creates uncertainty around the future of Cellectis' anti-CD19 programs and potential revenue streams. Investors should closely monitor the outcome of the arbitration and its potential impact on Cellectis' intellectual property position and future collaborations in the CAR-T space.
- ODD and RPDD granted by the FDA and ODD granted by the European Commission to UCART22 for the treatment of ALL
- ODD granted by the FDA to CLLS52 (alemtuzumab) for ALL treatment
- Cash position of
$273 million as of June 30, 20241; cash runway projection into 2026
NEW YORK, Aug. 06, 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 six-month period ending June 30, 2024.
"Over the past months, we have achieved a significant milestone with the granting of ODD designations by the Food and Drug Administration and the European Commission, complemented by the FDA’S Rare Pediatric Disease Designation. We have overcome major challenges, which reflects our ongoing commitment to innovation. Driven by an unwavering belief in our ability to revolutionize the healthcare field, we continue our pursuit of advancement with the confidence that our work will lead to the launch of a life-saving drug product. Our determination is the engine of our future success” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.
________________________
1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. Restricted cash was
Pipeline Highlights
UCART Clinical Programs
- On June 4, 2024, Cellectis received Orphan Drug Designation (ODD) from the European Commission (EC) for UCART22, for the treatment of acute lymphoblastic leukemia (ALL). The Orphan Drug Designation in the European Union is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. This designation may allow certain regulatory, financial, and commercial incentives to develop medicines for rare diseases where there are no satisfactory treatment options.
- On July 25, 2024, the FDA designated UCART22 as a drug for a Rare Pediatric Disease (RPDD). This designation may allow to obtain a “Priority Review Voucher” at the time of Biologics License Application (BLA). The FDA also granted ODD to UCART22 product candidate for ALL treatment. Receiving ODD by the FDA may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent.
- Patients with relapsed/refractory ALL have limited, if any, treatment options, especially for those who have failed prior CD19 directed CAR T-cell therapy and allogeneic stem cell transplant. These designations for UCART22 mark an important step towards developing allogeneic CAR T products that would be readily available for all patients.
- On August 1, 2024, the FDA granted ODD to Cellectis’ CLLS52 (alemtuzumab), an Investigational Medicinal Product (IMP) used as part of the lymphodepletion regimen associated with UCART22, evaluated in the BALLI-01 clinical trial. The importance of adding alemtuzumab to the lymphodepletion regimen has been demonstrated in Cellectis’ BALLI-01 study, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART22 cell expansion allowing for greater clinical activity.
- 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, in the NatHaLi-01 study, evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma, and in the AMELI-01 study, evaluating UCART123 in relapsed or refractory acute myeloid leukemia. We expect to provide updates in the advancements of BALLI-01 until the end of the year 2024.
Research Data & Preclinical Programs
Non-viral Gene Therapy Approach for Sickle Cell Disease
- On June 12, 2024, Cellectis announces the publication of a scientific article in Nature Communications.
- Cellectis leverages TALEN® technology and a non-viral gene repair template delivery to develop a clinically relevant gene editing process in hematopoietic stem and progenitor cells (HSPCs). This process enables efficient HBB gene correction with high precision, specificity and minimal genomic adverse events.
- Applying this HBB gene correction process to SCD patient-HSPCs results in over
50% expression of normal adult hemoglobin in mature red blood cells and in the correction of sickle phenotype, without inducing β-thalassemic phenotype. Edited HSPCs engraft efficiently in an immunodeficient murine model and maintain clinically relevant levels of HBB gene correction events. This comprehensive preclinical data package sets the stage for the therapeutic application of autologous gene corrected HSPCs to address SCD.
Partnerships
Licensed Allogeneic CAR T-cell Development Programs
Anti-CD19 Programs
Allogene’s investigational oncology products utilize Cellectis technologies.
We have initiated an arbitration proceeding through the Centre de Médiation et d'Arbitrage de Paris. We are requesting that the arbitral tribunal issue a decision (i) terminating the Servier License Agreement, and (ii) requiring Servier to pay us fair financial compensation for losses incurred due to the lack of development of the licensed products and for non-payment of milestone payments for milestones that have been achieved under the Servier License Agreement.
In May 2024, Allogene announced the execution of an Amendment and Settlement Agreement (the "Servier Amendment"), which amended the license agreement between Servier and Allogene, under which Servier exclusively sublicensed to Allogene its rights under the License Agreement between Cellectis and Servier (the "Servier License"), for the development and commercialization of allogeneic anti-CD19 CAR T cell product candidates in the U.S. (the "Allogene Sublicense"). Allogene disclosed that, pursuant to the Servier Amendment to the Allogene Sublicense, the licensed territory was expanded to include the European Union and the United Kingdom, and Allogene was granted an option to further extend its licensed territory to include China and Japan subject to certain conditions.
Corporate Updates
Collaboration and Investment Agreements with AstraZeneca
- On May 6, 2024, Cellectis announced the completion of the subsequent investment of
$140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN) (the “Additional Investment”). - AstraZeneca subscribed for 10,000,000 “class A” convertible preferred shares and 18,000,000 “class B” convertible preferred shares, in each case at a price of
$5.00 per convertible preferred share, issued by the Board of Directors of Cellectis. - On the completion date of the Additional Investment, AstraZeneca owned approximately
44% of the share capital and30% of the voting rights of the Company (based on the number of voting rights outstanding at the time). - Following the Additional Investment, Mr. Marc Dunoyer and Dr. Tyrell Rivers have been nominated members of the board of directors of Cellectis, designated by AstraZeneca.
Annual Shareholders Meeting
- On June 28, 2024, Cellectis held a shareholders’ general meeting at the Biopark auditorium in Paris, France.
- At the meeting, during which approximately
40% of shares were exercised, resolutions 1 through 28 were adopted and resolution 29 was rejected, consistent with the recommendations of the management. The detailed results of the vote and the resolutions are available on Cellectis’ website: https://www.cellectis.com/en/investors/general-meetings/
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 Calyxt, 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 Q2 2024 financial results press release, Calyxt's results are isolated under "Income (loss) from discontinued operations" for the 6-month period ended June 30, 2023, and are no longer included for the 6-month period ended June 30, 2024, due to the deconsolidation.
Cash: As of June 30, 2024, Cellectis had
With cash and cash equivalents of
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 and expenses were a
Net financial gain (loss): We had a consolidated net financial gain of
Net income (loss) from discontinued operations: Net income from discontinued operations 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.
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, UCART123 and potential new product candidates, and
- Operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA); and
- Continuing strengthening our manufacturing and clinical departments.
| CELLECTIS S.A. STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited) ($ in thousands) | ||||||
| As of | ||||||
| December 31, 2023 | June 30, 2024 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Intangible assets | 671 | 653 | ||||
| Property, plant, and equipment | 54,681 | 50,370 | ||||
| Right-of-use assets | 38,060 | 33,671 | ||||
| Non-current financial assets | 7,853 | 16,650 | ||||
| Total non-current assets | 101,265 | 101,344 | ||||
| Current assets | ||||||
| Trade receivables | 569 | 9,741 | ||||
| Subsidies receivables | 20,900 | 14,958 | ||||
| Other current assets | 7,722 | 7,587 | ||||
| Current deferred tax assets | 710 | |||||
| Cash and cash equivalent and Current financial assets | 203,815 | 272,806 | ||||
| Total current assets | 233,005 | 305,803 | ||||
| TOTAL ASSETS | 334,270 | 407,147 | ||||
| LIABILITIES | ||||||
| Shareholders’ equity | ||||||
| Share capital | 4,365 | 5,897 | ||||
| Premiums related to the share capital | 522,785 | 606,146 | ||||
| Currency translation adjustment | (36,690 | ) | (38,077 | ) | ||
| Retained earnings | (304,707 | ) | (405,729 | ) | ||
| Net income (loss) | (101,059 | ) | (19,627 | ) | ||
| Total shareholders’ equity - Group Share | 84,695 | 148,610 | ||||
| Non-controlling interests | 0 | 0 | ||||
| Total shareholders’ equity | 84,695 | 148,610 | ||||
| Non-current liabilities | ||||||
| Non-current financial liabilities | 49,125 | 58,348 | ||||
| Non-current lease debts | 42,948 | 38,362 | ||||
| Non-current provisions | 2,200 | 2,194 | ||||
| Non-current deferred tax liabilities | 158 | 0 | ||||
| Total non-current liabilities | 94,431 | 98,904 | ||||
| Current liabilities | ||||||
| Current financial liabilities | 5,289 | 5,119 | ||||
| Current lease debts | 8,502 | 8,357 | ||||
| Trade payables | 19,069 | 18,213 | ||||
| Deferred revenues and deferred income | 110,325 | 117,754 | ||||
| Current provisions | 1,740 | 884 | ||||
| Current deferred tax liabilities | 122 | |||||
| Other current liabilities | 10,219 | 9,184 | ||||
| Total current liabilities | 155,144 | 159,633 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 334,270 | 407,147 | ||||
| UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS For the three-month period ended June 30, 2024 ($ in thousands, except per share amounts) | ||||||
| For the three-month period ended June 30, | ||||||
| 2023* | 2024 | |||||
| Revenues and other income | ||||||
| Revenues | 178 | 8,061 | ||||
| Other income | 1,823 | 1,442 | ||||
| Total revenues and other income | 2,001 | 9,504 | ||||
| Operating expenses | ||||||
| Research and development expenses | (22,200 | ) | (23,518 | ) | ||
| Selling, general and administrative expenses | (3,950 | ) | (3,882 | ) | ||
| Other operating income (expenses) | 528 | 686 | ||||
| Total operating expenses | (25,622 | ) | (26,714 | ) | ||
| Operating income (loss) | (23,621 | ) | (17,211 | ) | ||
| Financial gain (loss) | (5,844 | ) | (8,251 | ) | ||
| Income tax | (258 | ) | 193 | |||
| Income (loss) from continuing operations | (29,724 | ) | (25,270 | ) | ||
| Income (loss) from discontinued operations | 13,083 | 0 | ||||
| Net income (loss) | (16,641 | ) | (25,270 | ) | ||
| Attributable to shareholders of Cellectis | (11,707 | ) | (25,270 | ) | ||
| Attributable to non-controlling interests | (4,934 | ) | 0 | |||
| Basic and diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.20 | ) | (0.28 | ) | ||
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.20 | ) | (0.28 | ) | ||
| Basic and diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.32 | 0.00 | ||||
| Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.32 | 0.00 | ||||
| Number of shares used for computing | ||||||
| Basic | 55,583,768 | 89,852,142 | ||||
| Diluted | 55,583,768 | 89,852,142 | ||||
*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)
| Cellectis S.A. UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS For the six-month period ended June 30, 2024 ($ in thousands, except per share amounts) | ||||||
| For the six-month period ended June 30, | ||||||
| 2023* | 2024 | |||||
| Revenues and other income | ||||||
| Revenues | 317 | 12,589 | ||||
| Other income | 5,242 | 3,412 | ||||
| Total revenues and other income | 5,560 | 16,002 | ||||
| Operating expenses | ||||||
| Research and development expenses | (43,614 | ) | (45,841 | ) | ||
| Selling, general and administrative expenses | (8,914 | ) | (8,986 | ) | ||
| Other operating income (expenses) | (83 | ) | 721 | |||
| Total operating expenses | (52,612 | ) | (54,107 | ) | ||
| Operating income (loss) | (47,053 | ) | (38,105 | ) | ||
| Financial gain (loss) | (10,246 | ) | 18,023 | |||
| Income tax | (258 | ) | 455 | |||
| Income (loss) from continuing operations | (57,557 | ) | (19,627 | ) | ||
| Income (loss) from discontinued operations | 8,392 | 0 | ||||
| Net income (loss) | (49,165 | ) | (19,627 | ) | ||
| Attributable to shareholders of Cellectis | (41,781 | ) | (19,627 | ) | ||
| Attributable to non-controlling interests | (7,384 | ) | 0 | |||
| Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.78 | ) | (0.24 | ) | ||
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.78 | ) | (0.24 | ) | ||
| 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 | ||||||
| Basic | 53,541,010 | 80,881,026 | ||||
| Diluted | 53,541,010 | 80,881,026 | ||||
*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 June 30, 2024 ($ in thousands, except per share data) | ||||||
| For the three-month period ended June 30, | ||||||
| 2023* | 2024 | |||||
| Net income (loss) attributable to shareholders of Cellectis | (11,707 | ) | (25,270 | ) | ||
| Adjustment: | ||||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 3,140 | 830 | ||||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (8,567 | ) | (24,440 | ) | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.15 | ) | (0.27 | ) | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | (0.04 | ) | 0.00 | |||
| Weighted average number of outstanding shares, basic (units) (1) | 55,583,768 | 89,852,142 | ||||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.15 | ) | (0.27 | ) | ||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | (0.04 | ) | 0.00 | |||
| Weighted average number of outstanding shares, diluted (units) (1) | 55,583,768 | 89,852,142 | ||||
*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 six-month period ended June 30, 2024
($ in thousands, except per share data)
| For the six-month period ended June 30, | ||||||
| 2023* | 2024 | |||||
| Net income (loss) attributable to shareholders of Cellectis | (41,781 | ) | (19,627 | ) | ||
| Adjustment: | ||||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 5,119 | 1,717 | ||||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (36,662 | ) | (17,910 | ) | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.68 | ) | (0.22 | ) | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | (0.09 | ) | 0.00 | |||
| Weighted average number of outstanding shares, basic (units) (1) | 53,541,010 | 80,881,026 | ||||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.68 | ) | (0.22 | ) | ||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | (0.09 | ) | 0.00 | |||
| Weighted average number of outstanding shares, diluted (units) (1) | 53,541,010 | 80,881,026 | ||||
*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).
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,” “would,” “expect,” 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 and CLLS52, the outcome of the arbitration proceedings against Servier, 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, +1 (347) 809 5980, investors@cellectis.com
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