Cellectis Provides Business Updates and Financial Results for Third Quarter 2024
Rhea-AI Summary
Cellectis (CLLS) reported Q3 2024 business updates and financial results, highlighting ongoing enrollment in UCART22 and UCART20x22 clinical trials, with Phase 1 dataset expected in 2025. The company's cash position stands at $264 million as of September 30, 2024, projecting runway into 2027. Research and development activities have commenced on three programs under the AstraZeneca partnership. The company reported revenues of $34.1 million for the nine months ended September 30, 2024, compared to $7.2 million in the same period of 2023. Net loss was $42.7 million, an improvement from the $59.3 million loss in the previous year.
Positive
- Strong cash position of $264 million with runway extended into 2027
- Significant revenue increase to $34.1 million, up from $7.2 million YoY
- Net loss improved to $42.7 million from $59.3 million YoY
- Secured $47 million in payments from AstraZeneca partnership
Negative
- R&D expenses increased to $69.7 million from $62.7 million YoY
- SG&A expenses rose to $14.2 million from $12.1 million YoY
- Deprioritization of UCART123 development program
News Market Reaction – CLLS
On the day this news was published, CLLS gained 1.14%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- UCART22 and UCART20x22: enrollment ongoing, Phase 1 dataset and late-stage development strategy to be presented in 2025
- AstraZeneca partnership: R&D activities are ongoing on three programs – one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder
- Appointed Adrian Kilcoyne, M.D., MPH, MBA, an industry leader in the advancement of cell therapy treatment, as Chief Medical Officer
- Cash position of
$264 million as of September 30, 20241; cash runway projection into 2027 - Conference call scheduled for 8:00 am ET / 2:00 pm CET on November 5, 2024
NEW YORK, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today provided business updates and reported financial results for the nine-month period ending September 30, 2024.
“This quarter, we were thrilled to welcome Dr. Kilcoyne to Cellectis as Chief Medical Officer. Dr. Kilcoyne joins us at a pivotal time for the Company, bringing extensive experience in drug development as we are progressing in our clinical programs. We expect to present Phase 1 dataset and late-stage development strategy in 2025 for UCART22 in ALL and UCART20x22 for NHL” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.
“Additionally, we are excited to announce that research and development activities have started for three programs under our collaboration and research agreement with AstraZeneca: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.
Cellectis is confident about the continued progress of its ongoing clinical trials in hematological malignancies and is excited about our strategic collaboration with AstraZeneca, with whom we continue to advance our ambition in cell and gene therapy to bring potentially lifesaving therapies to patients with unmet medical needs."
________________________
1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. Restricted cash was
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
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 and potential new product candidates,
- and operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA).
| CELLECTIS S.A. | |||||
| STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited) | |||||
| ($ in thousands) | |||||
| As of | |||||
| December 31, 2023 | September 30, 2024 | ||||
| ASSETS | |||||
| Non-current assets | |||||
| Intangible assets | 671 | 691 | |||
| Property, plant, and equipment | 54,681 | 48,956 | |||
| Right-of-use assets | 38,060 | 32,225 | |||
| Non-current financial assets | 7,853 | 7,651 | |||
| Other non-current assets | 0 | 11,120 | |||
| Deferred tax assets | 0 | 803 | |||
| Total non-current assets | 101,265 | 101,445 | |||
| Current assets | |||||
| Trade receivables | 569 | 11,180 | |||
| Subsidies receivables | 20,900 | 15,661 | |||
| Other current assets | 7,722 | 6,643 | |||
| Cash and cash equivalent and Current financial assets | 203,815 | 260,947 | |||
| Total current assets | 233,005 | 294,431 | |||
| TOTAL ASSETS | 334,270 | 395,876 | |||
| LIABILITIES | |||||
| Shareholders’ equity | |||||
| Share capital | 4,365 | 5,906 | |||
| Premiums related to the share capital | 522,785 | 607,153 | |||
| Currency translation adjustment | (36,690 | ) | (35,154 | ) | |
| Retained earnings | (304,707 | ) | (405,798 | ) | |
| Net income (loss) | (101,059 | ) | (42,683 | ) | |
| Total shareholders’ equity - Group Share | 84,695 | 129,424 | |||
| Non-controlling interests | 0 | 0 | |||
| Total shareholders’ equity | 84,695 | 129,424 | |||
| Non-current liabilities | |||||
| Non-current financial liabilities | 49,125 | 61,575 | |||
| Non-current lease debts | 42,948 | 36,683 | |||
| Non-current provisions | 2,200 | 2,427 | |||
| Deferred tax liabilities | 158 | 118 | |||
| Total non-current liabilities | 94,431 | 100,802 | |||
| Current liabilities | |||||
| Current financial liabilities | 5,289 | 5,350 | |||
| Current lease debts | 8,502 | 8,508 | |||
| Trade payables | 19,069 | 18,511 | |||
| Deferred revenues and deferred income | 110,325 | 122,006 | |||
| Current provisions | 1,740 | 899 | |||
| Other current liabilities | 10,219 | 10,376 | |||
| Total current liabilities | 155,144 | 165,650 | |||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 334,270 | 395,876 | |||
| UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS | |||||
| For the three-month period ended September 30, 2024 | |||||
| ($ in thousands, except per share amounts) | |||||
| For the three-month period ended September 30, | |||||
| 2023* | 2024 | ||||
| Revenues and other income | |||||
| Revenues | 155 | 16,200 | |||
| Other income | 1,489 | 1,851 | |||
| Total revenues and other income | 1,644 | 18,050 | |||
| Operating expenses | |||||
| Research and development expenses | (19,075 | ) | (23,829 | ) | |
| Selling, general and administrative expenses | (3,227 | ) | (5,167 | ) | |
| Other operating income (expenses) | (12 | ) | 175 | ||
| Total operating expenses | (22,314 | ) | (28,820 | ) | |
| Operating income (loss) | (20,671 | ) | (10,769 | ) | |
| Financial gain (loss) | 3,295 | (12,346 | ) | ||
| Income tax | (106 | ) | 59 | ||
| Income (loss) from continuing operations | (17,482 | ) | (23,056 | ) | |
| Income (loss) from discontinued operations | 0 | 0 | |||
| Net income (loss) | (17,482 | ) | (23,056 | ) | |
| Attributable to shareholders of Cellectis | (17,482 | ) | (23,056 | ) | |
| Attributable to non-controlling interests | (0 | ) | 0 | ||
| Basic and diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.31 | ) | (0.23 | ) | |
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.31 | ) | (0.23 | ) | |
| Basic and diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.00 | 0.00 | |||
| Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.00 | 0.00 | |||
| Number of shares used for computing | |||||
| Basic | 55,583,768 | 100,093,635 | |||
| Diluted | 55,583,768 | 100,093,635 | |||
*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)
| Cellectis S.A. | |||||
| UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS | |||||
| For the nine-month period ended September 30, 2024 | |||||
| ($ in thousands, except per share amounts) | |||||
| For the nine-month period ended September 30, | |||||
| 2023* | 2024 | ||||
| Revenues and other income | |||||
| Revenues | 472 | 28,789 | |||
| Other income | 6,731 | 5,263 | |||
| Total revenues and other income | 7,203 | 34,052 | |||
| Operating expenses | |||||
| Research and development expenses | (62,690 | ) | (69,670 | ) | |
| Selling, general and administrative expenses | (12,141 | ) | (14,153 | ) | |
| Other operating income (expenses) | (96 | ) | 896 | ||
| Total operating expenses | (74,926 | ) | (82,926 | ) | |
| Operating income (loss) | (67,723 | ) | (48,874 | ) | |
| Financial gain (loss) | (6,952 | ) | 5,677 | ||
| Income tax | (365 | ) | 514 | ||
| Income (loss) from continuing operations | (75,040 | ) | (42,683 | ) | |
| Income (loss) from discontinued operations | 8,392 | 0 | |||
| Net income (loss) | (66,648 | ) | (42,683 | ) | |
| Attributable to shareholders of Cellectis | (59,264 | ) | (42,683 | ) | |
| Attributable to non-controlling interests | (7,384 | ) | 0 | ||
| Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (1.09 | ) | (0.49 | ) | |
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (1.09 | ) | (0.49 | ) | |
| Basic net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.29 | 0.00 | |||
| Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | 0.29 | 0.00 | |||
| Number of shares used for computing | |||||
| Basic | 54,231,943 | 87,355,605 | |||
| Diluted | 54,231,943 | 87,355,605 | |||
*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)
Note Regarding Use of Non-IFRS Financial Measures
Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS.
Because adjusted net income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis.
| RECONCILIATION OF IFRS TO NON-IFRS NET INCOME (unaudited) For the three-month period ended September 30, 2024 ($ in thousands, except per share data) | |||||
| For the three-month period ended September 30, | |||||
| 2023* | 2024 | ||||
| Net income (loss) attributable to shareholders of Cellectis | (17,482 | ) | (23,056 | ) | |
| Adjustment: | |||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | (2,653 | ) | 566 | ||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (20,135 | ) | (22,490 | ) | |
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.36 | ) | (0.22 | ) | |
| Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | 0.00 | 0.00 | |||
| Weighted average number of outstanding shares, basic (units) (1) | 55,583,768 | 100,093,635 | |||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.36 | ) | (0.22 | ) | |
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | 0.00 | 0.00 | |||
| Weighted average number of outstanding shares, diluted (units) (1) | 55,583,768 | 100,093,635 | |||
*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)
| RECONCILIATION OF IFRS TO NON-IFRS NET INCOME (unaudited) For the nine-month period ended September 30, 2024 ($ in thousands, except per share data) | |||||
| For the nine-month period ended September 30, | |||||
| 2023* | 2024 | ||||
| Net income (loss) attributable to shareholders of Cellectis | (59,264 | ) | (42,683 | ) | |
| Adjustment: | |||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 2,466 | 2,283 | |||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (56,798 | ) | (40,400 | ) | |
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (1.05 | ) | (0.46 | ) | |
| Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | 0.33 | 0.00 | |||
| Weighted average number of outstanding shares, basic (units) (1) | 54,231,943 | 87,355,605 | |||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (1.05 | ) | (0.46 | ) | |
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | 0.33 | 0.00 | |||
| Weighted average number of outstanding shares, diluted (units) (1) | 54,231,943 | 87,355,605 | |||
*These amounts reflect Calyxt's adjustments as presented in Cellectis 2023 20F (Note 3)
About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with 25 years of experience and expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).
To find out more, visit our website: www.cellectis.com
Follow Cellectis on social networks @cellectis on LinkedIn and X (formerly Twitter)
TALEN® is a registered trademark owned by Cellectis.
Forward-looking Statements
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “future,” “projection,” “will,” “may,” “could,” “expect,” “suggest,” “potential,” “will,” and “believe” or the negative of these and similar expressions. These forward-looking statements are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements include statements about the advancement, timing and progress of clinical trials, the timing of our presentation of clinical data, the potential of our candidate products programs, the advancement and potential of partnered research and development programs and the sufficiency of cash to fund operations. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development, including the risk of losing the orphan drug designation if it is established that the product no longer meets the orphan drug criteria before market authorization is granted (if any). With respect to our cash runway, our operating plans, including product candidates development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2023 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
For further information on Cellectis, please contact:
Media contacts:
Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93
Investor Relations contact:
Arthur Stril, Interim Chief Financial Officer, investors@cellectis.com
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FAQ
What is Cellectis (CLLS) cash position as of Q3 2024?
What are the key clinical trials Cellectis (CLLS) is currently focusing on?
How much revenue did Cellectis (CLLS) generate in Q3 2024?
