ZVA Cellectis Nom Eo 05

• 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."

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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 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).

*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)

*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

• PR_Earnings call Q3 2024_English_20241104 (2)

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