○ UCART22 Phase 1 dataset and late-stage development strategy expected in the third quarter of 2025; Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) granted by FDA and ODD granted by the European Commission to UCART22 for the treatment of ALL.
○ UCART20x22 Phase 1 study in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) ongoing with readout expected in late 2025.
○ AstraZeneca partnership: R&D activities 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.
○ Cash position of $264 million as of December 31, 20241 provides runway into mid-2027.
○ Conference call March 14, 2025 at 8:00 am ET / 1:00 pm CET.
NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) ( Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today provided financial results for the fourth quarter and full year 2024, ending December 31, 2024, and provided a business update.
“2024 has been an important year for Cellectis: we are now developing three programs in collaboration with AstraZeneca. So far, we announced the start of one allogeneic CAR T for hematological malignancies, one program of an allogeneic CAR T for solid tumors, and first program of an in vivo gene therapy for a genetic disorder.
We are thrilled to grow this strategic collaboration with AstraZeneca, a top leader of the pharmaceutical industry, aimed at shaping the future of next generation of cell and gene therapy. We are excited about the huge opportunities this partnership will bring in the months ahead” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.
“AstraZeneca’s additional equity investment of $140M in Cellectis and the drawdown of the final tranche of the finance contract with the European Investment Bank (EIB) give us confidence that our cash runway is funded until mid-2027.
In 2025, Cellectis will continue to focus its efforts and expenses on advancing its core clinical trials BALLI-01 and NATHALI-01, while building the next generation of genomic medicines to address areas of high unmet patient needs within, our partnership with AstraZeneca, and within our proprietary preclinical pipeline.
We expect to present the Phase 1 data set and late-stage development strategy in the third quarter of 2025 for UCART22, for the treatment of r/r ALL. For our product candidate UCART20x22, in r/r NHL, we continue to focus on the enrollment of patients and expects readout in late 2025.”
Pipeline Highlights
UCART Clinical Programs
BALLI-01 study evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
NATHALI-01 study evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL)
UCART123 in relapsed or refractory acute myeloid leukemia (r/r AML)
Research Data & Preclinical Programs
Innovative strategy for T cell engineering to enhance efficacy against solid tumors
Breaking barriers in solid tumors with SMART allogeneic CAR T-cells
Controlling C-to-T editing with TALE base editors
MUC1 CAR T-cells for treating Triple-Negative Breast Cancer
SMART DUAL CAR T-cell approach for treating recalcitrant solid tumors
Partnerships
Servier and Allogene – Allogeneic CAR T
Allogene’s investigational oncology products utilize Cellectis technologies.
cema-cel: ALPHA3 Trial in Large B-Cell Lymphoma (LBCL)
ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma (RCC)
AstraZeneca – Joint Research and Collaboration Agreement
Corporate Updates
AstraZeneca’s Additional Investment
Drawdown of the second and third tranche of the European Investment Bank financing
Appointments
Annual Shareholders Meeting
2024 Financial Results
Cash: As of December 31, 2024, Cellectis had $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into mid-2027.
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 $140.0 million cash received from AstraZeneca as part of its equity investment in Cellectis, $21.6 million cash received from European Investment Bank (“EIB”) pursuant to the disbursement of the Tranche B and Tranche C under the Finance Contract with EIB, $42.8 million of cash-in from our revenue, partially offset by cash payments from Cellectis to suppliers of $47.0 million, Cellectis’ wages, bonuses and social expenses paid of $39.6 million, the payments of lease debts of $11.1 million and the repayment of the “ PGE Polska ” loan of $5.0 million.
We currently foresee focusing our cash spending at Cellectis in 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 and Raleigh.
Revenues and Other Income: Consolidated revenues and other income were $49.2 million for the twelve months ended December 31, 2024 compared to $9.2 million for the twelve months ended December 31, 2023. This $40.0 million increase between the twelve months ended December 31, 2023 and 2024 was mainly attributable to (i) recognition of a $35.5 million revenue in 2024 based on the progress of our performance obligation rendered under the three programs under the AZ JRCA and (ii) the recognition of the $5.4 million following 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”), compensated with a slight decrease in other income by $0.7 million.
R&D Expenses: Consolidated R&D expenses were $90.5 million for the twelve months ended December 31, 2024, compared to $87.6 million for the twelve months ended December 31, 2023. R&D personnel expenses decreased by $2.9 million from $37.2 million in 2023 to $34.3 million in 2024 mainly related to a $1.9 million decrease in non-cash stock-based compensation expense. R&D purchases, external expenses and other increased by $3.6 million (from $33.0 million in 2023 to $36.6 million in 2024) mainly related to increase in manufacturing activities to support our R&D pipeline.
SG&A Expenses: Consolidated SG&A expenses were $19.1 million for the twelve months ended December 31, 2024 compared to $16.8 million for the twelve months ended December 31, 2023. The $2.3 million increase is mainly due in purchases and external expenses primarily related to legal and finance external support while SG&A personnel expenses remain flat compared to year 2023.
Other operating income and expenses: Other operating income and expenses were a $0.9 million net income for the twelve months ended December 31, 2024 compared to a $1.3 million net expense for the twelve months ended December 31, 2023. Other operating income increase by $2.1 million is primarily related to non-recurring expenses recorded in 2023.
Net financial gain (loss): We had a consolidated net financial gain of $22.8 million for the twelve months ended December 31, 2024, compared to a $19.2 million loss for the twelve months ended December 31, 2023. This $42.0 million difference reflects mainly (i) a $20.0 million gain in change in fair value of SIA derivative instrument, (ii) a $7.7 million increase in gain from our financial investments, (iii) a $8.1 million net gain in change in fair value of EIB Tranche A and Tranche B warrants, (iv) a $3.1 million increase in foreign exchange net gain, (v) the non-recurring loss in fair value measurement on Cytovia convertible note recognized in the twelve months period ended December 31, 2023 of $7.8 million, partially offset by (i) an increase of $2.0 million in interest expense on Tranche A and Tranche B of the EIB Finance Contract and (ii) a $2.3 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 twelve months ended December 31, 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 twelve months ended December 31, 2024.
Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $36.8 million (or a $0.41 loss per share) for the twelve months ended December 31, 2024, compared to a $101.1 million loss (or a $1.77 loss per share) for the twelve months ended December 31, 2023, of which $116.8 million was attributed to Cellectis continuing operations. The $71.7 million change in net loss was primarily driven by (i) an increase in revenues and other income of $40.0 million, (ii) an increase of net financial gain of $42.0 million, partially offset by (iii) a $6.1 million increase in purchases and other external expenses and (iv) a non-recurring income from discontinued operations of $8.4 million in 2023 related to Calyxt, Inc. our former subsidiary.
Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $33.6 million (or a $0.37 loss per share) for the twelve months ended December 31, 2024, compared to a net loss of $94.0 million (or a $1.65 loss per share) for the twelve months ended December 31, 2023.
The year-end consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”).2
Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.
CELLECTIS S.A. STATEMENT OF CONSOLIDATED FINANCIAL POSITION ($ in thousands) | ||||||
As of | ||||||
December 31, 2023 | December 31, 2024 | |||||
ASSETS | ||||||
Non-current assets | ||||||
Intangible assets | 671 | 1,116 | ||||
Property, plant, and equipment | 54,681 | 45,895 | ||||
Right-of-use assets | 38,060 | 29,968 | ||||
Non-current financial assets | 7,853 | 7,521 | ||||
Other non-current assets | 0 | 11,594 | ||||
Deferred tax assets | 0 | 382 | ||||
Total non-current assets | 101,265 | 96,476 | ||||
Current assets | ||||||
Trade receivables | 569 | 6,714 | ||||
Subsidies receivables | 20,900 | 14,521 | ||||
Other current assets | 7,722 | 5,528 | ||||
Cash and cash equivalent and Current financial assets | 203,815 | 260,306 | ||||
Total current assets | 233,005 | 287,069 | ||||
Total Fina Elf ASSETS | 334,270 | 383,544 | ||||
LIABILITIES | ||||||
Shareholders’ equity | ||||||
Share capital | 4,365 | 5,889 | ||||
Premiums related to the share capital | 522,785 | 494,288 | ||||
Currency translation adjustment | (36,690 | ) | (39,537 | ) | ||
Retained earnings | (304,707 | ) | (292,846 | ) | ||
Net income (loss) | (101,059 | ) | (36,761 | ) | ||
Total shareholders’ equity - Group Share | 84,695 | 131,033 | ||||
Non-controlling interests | 0 | 0 | ||||
Total shareholders’ equity | 84,695 | 131,033 | ||||
Non-current liabilities | ||||||
Non-current financial liabilities | 49,125 | 50,882 | ||||
Non-current lease debts | 42,948 | 34,245 | ||||
Non-current provisions | 2,200 | 1,115 | ||||
Deferred tax liabilities | 158 | 0 | ||||
Total non-current liabilities | 94,431 | 86,241 | ||||
Current liabilities | ||||||
Current financial liabilities | 5,289 | 16,134 | ||||
Current lease debts | 8,502 | 8,385 | ||||
Trade payables | 19,069 | 18,664 | ||||
Deferred revenues and deferred income | 110,325 | 112,161 | ||||
Current provisions | 1,740 | 828 | ||||
Other current liabilities | 10,219 | 10,097 | ||||
Total current liabilities | 155,144 | 166,269 | ||||
Total Fina Elf LIABILITIES AND SHAREHOLDERS’ EQUITY | 334,270 | 383,544 |
AUDITED STATEMENTS OF CONSOLIDATED OPERATIONS For the three-month period ended December 31, 2024 ($ in thousands, except per share amounts) | ||||||
For the three-month period ended December 31, | ||||||
2023 | 2024 | |||||
Revenues and other income | ||||||
Revenues | 283 | 28,916 | ||||
Other income | 1,707 | 4,300 | ||||
Total revenues and other income | 1,990 | 33,216 | ||||
Operating expenses | ||||||
Research and development expenses | (25,693 | ) | (44,694 | ) | ||
Selling, general and administrative expenses | (4,671 | ) | (10,099 | ) | ||
Other operating income (expenses) | (1,204 | ) | 128 | |||
Total operating expenses | (31,568 | ) | (54,665 | ) | ||
Operating income (loss) | (29,578 | ) | (21,449 | ) | ||
Financial gain (loss) | (12,210 | ) | 4,770 | |||
Income tax | (6 | ) | (455 | ) | ||
Income (loss) from continuing operations | (41,795 | ) | (17,134 | ) | ||
Income (loss) from discontinued operations | 0 | 0 | ||||
Net income (loss) | (41,795 | ) | (17,134 | ) | ||
Attributable to shareholders of Cellectis | (41,795 | ) | (17,134 | ) | ||
Attributable to non-controlling interests | (0 | ) | 0 | |||
Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.64 | ) | (0.17 | ) | ||
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.64 | ) | (0.17 | ) | ||
Basic 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 | ||||||
Basic | 65,234,522 | 100,093,873 | ||||
Diluted | 65,234,522 | 100,093,873 |
Cellectis S.A. STATEMENTS OF CONSOLIDATED OPERATIONS For the year ended December 31, 2024 ($ in thousands, except per share amounts) | ||||||
For the year ended December 31, | ||||||
2023 | 2024 | |||||
Revenues and other income | ||||||
Revenues | 755 | 41,505 | ||||
Other income | 8,438 | 7,712 | ||||
Total revenues and other income | 9,193 | 49,217 | ||||
Operating expenses | ||||||
Cost of revenue | (737 | ) | 0 | |||
Research and development expenses | (87,646 | ) | (90,536 | ) | ||
Selling, general and administrative expenses | (16,812 | ) | (19,085 | ) | ||
Other operating income (expenses) | (1300 | ) | 849 | |||
Total operating expenses | (106,495 | ) | (108,771 | ) | ||
Operating income (loss) | (97,302 | ) | (59,554 | ) | ||
Financial gain (loss) | (19,163 | ) | 22,793 | |||
Income tax | (371 | ) | (0 | ) | ||
Income (loss) from continuing operations | (116,835 | ) | (36,761 | ) | ||
Income (loss) from discontinued operations | 8,392 | 0 | ||||
Net income (loss) | (108,443 | ) | (36,761 | ) | ||
Attributable to shareholders of Cellectis | (101,059 | ) | (36,761 | ) | ||
Attributable to non-controlling interests | (7,384 | ) | 0 | |||
Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (1.77 | ) | (0.41 | ) | ||
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (1.77 | ) | (0.41 | ) | ||
Basic net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.28 | 0.00 | ||||
Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.28 | 0.00 | ||||
Number of shares used for computing | ||||||
Basic | 57,012,815 | 90,566,346 | ||||
Diluted | 57,012,815 | 90,566,346 |
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 For the three-month period ended December 31, 2024 ($ in thousands, except per share data) | ||||||
For the three-month period ended December 31, | ||||||
2023 | 2024 | |||||
Net income (loss) attributable to shareholders of Cellectis | (41,795 | ) | (17,134 | ) | ||
Adjustment: Non-cash stock-based compensation expense attributable to shareholders of Cellectis | (4,621 | ) | 1 450 | |||
Adjusted net income (loss) attributable to shareholders of Cellectis | (37,174 | ) | (15,684 | ) | ||
Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.57 | ) | (0.16 | ) | ||
Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | 0.00 | 0.00 | ||||
Weighted average number of outstanding shares, basic (units) | 65,234,522 | 100,093,873 | ||||
Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.57 | ) | (0.16 | ) | ||
Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | 0.00 | 0.00 | ||||
Weighted average number of outstanding shares, diluted (units) | 65,234,522 | 100,093,873 |
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME For the year ended December 31, 2024 ($ in thousands, except per share data) | ||||||
For the year ended December 31, | ||||||
2023 | 2024 | |||||
Net income (loss) attributable to shareholders of Cellectis | (101,059 | ) | (36,761 | ) | ||
Adjustment: Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 7,086 | 3,167 | ||||
Adjusted net income (loss) attributable to shareholders of Cellectis | (93,973 | ) | (33,594 | ) | ||
Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (1.65 | ) | (0.37 | ) | ||
Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | 0.31 | 0.00 | ||||
Weighted average number of outstanding shares, basic (units) | 57,012,815 | 90,566,346 | ||||
Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (1.65 | ) | (0.37 | ) | ||
Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | 0.31 | 0.00 | ||||
Weighted average number of outstanding shares, diluted (units) | 57,012,815 | 90,566,346 |
About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish.
Cellectis’ headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit www.cellectis.com and follow Cellectis on LinkedIn and X.
TALEN® is a registered trademark owned by Cellectis.
Cautionary Statement
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “expect,” “give us confidence,” “will,” “may,” “would,” “aim,” “potentially,” “potential,” “could,” “foresee” 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, including information provided or otherwise publicly reported by our licensed partners. Forward-looking statements include statements about advancement, timing and progress of clinical trials (including with respect to patient enrollment), the outcomes of the collaboration with AstraZeneca, the timing of our presentation of data and submission of regulatory filings, the potential of our preclinical and innovation programs, the benefit of adding alemtuzumab to the lymphodepletion regimen, 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, as well as the risk of losing the orphan drug designation or if it is established that the product no longer meets the relevant criteria before market authorization is granted (if any), and the risk that the priority review voucher be not granted at the time of marketing authorization. With respect to our cash runway, our operating plans, including product 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 as amended and in our annual financial report (including the management report) for the year ended December 31, 2024 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, which are available on the SEC’s website at www.sec.gov, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
For further information on Cellectis, please contact:
Media contacts:
Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93
Investor Relations contact:
Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@cellectis.com
1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current -financial assets. Restricted cash was $4.6 million as of December 31, 2024. Fixed-term deposits classified as current-financial assets was $115.8 million as of December 31, 2024.
2 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 FY 2024 financial results press release, Cibus' results are isolated under "Income (loss) from discontinued operations" for the year ended December 31, 2023, and are no longer included for the year ended December 31, 2024, due to the deconsolidation.