ZVA Cellectis Nom Eo 05

• 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.

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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 June 30, 2024. Fixed-term deposits classified as current financial assets were $119 million as of June 30, 2024.

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 and 30% 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 $273 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 $117 million increase is mainly due to cash payments from Cellectis to suppliers of $26 million, including $18 million to R&D suppliers and $8 million to SG&A suppliers, Cellectis’ wages, bonuses and social expenses paid of $24 million, the payments of lease debts of $5 million and the repayment of the “PGE” loan of $3 million, partially offset by the $16 million cash received from EIB pursuant to the disbursement of the €15 million Tranche B, $5 million of cash-in from our financial investments, $14 million of cash-in from our revenue, $140 million cash received from AstraZeneca as part of its equity investment in Cellectis.

With cash and cash equivalents of $149 million and $119 million term deposit classified as current financial assets as of June 30, 2024, the Company believes its cash and cash equivalents and deposits will be sufficient to fund its operations into 2026 and therefore for at least twelve months following the unaudited interim condensed consolidated financial statements' publication.

Revenues and Other Income: Consolidated revenues and other income were $16.0 million for the six months ended June 30, 2024 compared to $5.6 million for the six months ended June 30, 2023. This $10.4 million increase between the six months ended June 30, 2023 and 2024 was mainly attributable to (i) recognition of a $12.3 million revenue in 2024 based (a) on the progress of our performance obligation rendered under the first research plan of the Joint Research and Collaboration Agreement (the “JRCA”) signed with AstraZeneca Ireland Limited (AZ Ireland) and (b) the reaching of a development milestone under the License Agreement signed with Servier, while revenues recognized for the six months ended June 30, 2023 were immaterial, (ii) a decrease of research tax credit of $1.1 million due to a decrease of eligible expenses, and (iii) the recognition in the six-month periods ended June 30, 2023 of $0.8 million representing the portion of an initial payments from BPI corresponding to a grant pursuant to our grant and repayable advance agreement with BPI signed in March 2023.

R&D Expenses: Consolidated R&D expenses were $45.8 million for the six months ended June 30, 2024, compared to $43.6 million for the six months ended June 30, 2023. R&D personnel expenses decreased by $0.8 million from $20.0 million in 2023 to $19.2 million in 2024 primarily due to a decrease in the average unit fair value of stock options and free share awards vesting between the two periods. R&D purchases, external expenses and other increased by $3.1 million (from $23.6 million in 2023 to $26.7 million in 2024) mainly related to increase in manufacturing activities to support our R&D pipeline.

SG&A Expenses: Consolidated SG&A expenses were $9.0 million for the six months ended June 30, 2024 compared to $8.9 million for the six months ended June 30, 2023. SG&A personnel expenses decreased by $0.2 million (from $4.0 million in 2023 to $3.8 million in 2024), with a $0.4 million increase in salaries being offset by a $0.6 million decrease in stock-based compensation expenses. SG&A purchases, external expenses and other increased by $0.3 million (from $4.9 million in 2023 to $5.2 million in 2024).

Other operating income and expenses: Other operating income and expenses were a $0.7 million net income for the six months ended June 30, 2024 compared to a $0.1 million net expense for the six months ended June 30, 2023. Other operating income and expenses decreased by $0.8 million primarily due to the recognition of costs related to a litigation of $0.5 million in 2023.

Net financial gain (loss): We had a consolidated net financial gain of $18.0 million for the six months ended June 30, 2024, compared to a $10.2 million loss for the six months ended June 30, 2023. This $28.3 million difference reflects mainly (i) a $14.3 million gain in change in fair value of SIA derivative instrument, (ii) a $3.2 million increase in gain from our financial investments, (iii) a $4.3 million gain in change in fair value of EIB tranche A and B, , (iv) a $5.5 million decrease of the loss in fair value of our investment in Cibus and (vi) the loss in fair value measurement on Cytovia convertible note recognized in the six months period ended June 30, 2023 of $6.8 million, partially offset by (i) a $1.3 million interest expense on EIB Tranche A and Tranche B loans and (ii) a $0.7 million increase in foreign exchange loss, and (iii) a decrease in net foreign exchange gain of $3.5 million.

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

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $19.6 million (or a $0.24 loss per share) for the six months ended June 30, 2024, compared to a $41.8 million loss (or a $0.78 loss per share) for the six months ended June 30, 2023, of which $57.6 million was attributed to Cellectis continuing operations. The $29.5 million change in net loss was primarily driven by (i) an increase in revenues and other income of $10.4 million, (ii) a decrease of $1.5 million in non-cash stock based compensation expense due to a decrease in the average unit fair value of stock options and free share awards vesting between the two periods, (iii) a $28.3 million change from a net financial loss of $10.2 million to a net financial gain of $18.0 million and (iv) a decrease in net other operating expense of $0.8 million, and (v) a $8.4 million decrease in net income from discontinued operations attributable to shareholders of Cellectis, partially offset by (i) an increase of $3.3 million in purchases, external expenses and other, and a (ii) an increase of $0.4 million in wages.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $17.9 million (or a $0.22 loss per share) for the six months ended June 30, 2024, compared to a net loss of $36.7 million (or a $0.68 loss per share) for the six months ended June 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, 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.
  
  

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

 *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.

*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)

 *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

Attachment

• 20240805_Cellectis Reports Financial Results for Second Quarter 2024 - V0508[7]

Grafico Azioni Cellectis Nom Eo 05 (TG:ZVA)
Storico
Da Nov 2024 a Dic 2024

Grafico Azioni Cellectis Nom Eo 05 (TG:ZVA)
Storico
Da Dic 2023 a Dic 2024