Cellectis Reports Financial Results for First Quarter 2024
Cellectis reported its Q1 2024 financial results revealing key business updates and financial highlights. Key points include:
Completion of a $140M equity investment by AstraZeneca, pushing the company's cash position to $143M as of March 31, 2024, and extending its cash runway projection into 2026.
Revenues for Q1 2024 were $6.5M, a significant increase from $3.6M in Q1 2023.
R&D expenses rose to $22.3M from $21.1M, while SG&A expenses were relatively stable at $5.1M.
The company recorded a consolidated net income of $5.6M, compared to a net loss of $30.1M in Q1 2023.
Key clinical programs BALLI-01, NATHALI-01, and AMELI-01 continue to progress with updates expected by year-end 2024.
The appointment of Arthur Stril as Interim CFO was announced, and AstraZeneca now owns approximately 44% of Cellectis' share capital.
- Completion of $140M equity investment by AstraZeneca.
- Cash position of $143M as of March 31, 2024.
- Revenues for Q1 2024 increased to $6.5M from $3.6M in Q1 2023.
- Projection of cash runway into 2026.
- Consolidated net income of $5.6M compared to a net loss of $30.1M in Q1 2023.
- Significant progress in key clinical programs BALLI-01, NATHALI-01, and AMELI-01.
- AstraZeneca now owns 44% of Cellectis' share capital.
- Decrease in cash position from $156M at the end of 2023 to $143M by March 31, 2024.
- Increase in R&D expenses to $22.3M from $21.1M.
- SG&A expenses increased marginally to $5.1M from $5M in the previous year.
- Net financial gain significantly influenced by non-operational factors such as changes in the fair value of investment agreements.
Insights
Cellectis' financial results for the first quarter of 2024 show a strong turnaround, with net income of
The additional $140 million investment from AstraZeneca significantly bolsters Cellectis' cash position, extending its cash runway into 2026. This is important for a clinical-stage biotech company, as it ensures financial stability while they focus on advancing their core clinical trials. Investors should note that despite the positive net income, the company's operating expenses remain high, indicating ongoing significant investment in R&D and clinical trials. This is typical for biotech firms at this stage, reflecting their growth and development focus.
For retail investors, it's essential to understand that while the current financial health appears positive, the company's future performance will largely depend on the success of its clinical trials and collaborations. The extended cash runway mitigates immediate financial risks, but the inherent risks of biotech R&D still apply.
The collaboration between Cellectis and AstraZeneca highlights a significant strategic partnership in the realm of gene editing and cell therapy. AstraZeneca's investment not only provides financial backing but also validates Cellectis' technology platform. The focus on advancing core clinical trials BALLI-01, NATHALI-01 and AMELI-01 is critical, as these programs are targeting severe unmet medical needs in hematologic malignancies.
For investors, it's important to note the potential market impact of these therapies. The success of these trials could lead to groundbreaking treatments for conditions like B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma, presenting considerable upside. However, the trials are still in relatively early stages and success is not guaranteed. Continued monitoring of trial updates is crucial.
In simple terms, gene editing technologies like those developed by Cellectis aim to modify patients' cells to treat or potentially cure disease. These technologies are at the cutting edge of medicine, but they carry substantial development risks. The partnership with a major player like AstraZeneca mitigates some risk by providing both expertise and financial support.
• Cellectis announced completion of the additional equity investment of
• Cash position of
• Conference call and webcast scheduled for tomorrow, May 29, 2024 at 8:00AM ET / 2:00PM CET
NEW YORK, May 28, 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 three-month period ending March 31, 2024.
“We are thrilled to have announced the closing of the additional equity investment of
“Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs.
“We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future,” said André Choulika, Ph.D., Chief Executive Officer at Cellectis.
__________________
1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current -financial assets. Restricted cash was
2 Cash runway includes the additional investment by AstraZeneca of
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 (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML).
- We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024.
Partnerships
Licensed Allogeneic CAR T-cell Development Programs
Anti-CD19 program
Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom.
- Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom.
- Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024.
- Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel.
Anti-CD70 program
The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.
- Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024.
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). - 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. - AstraZeneca owns approximately
44% of the share capital and30% of the voting rights of the Company (based on the number of voting rights currently outstanding).
Appointment
- On May 2, 2024, Cellectis announced the appointment of Mr. Arthur Stril as Interim Chief Financial Officer, following the resignation of Bing Wang, Ph.D.
- The appointment of Mr. Marc Dunoyer and Dr. Tyrell Rivers as members of the board of directors of Cellectis, decided by the extraordinary general meeting of the shareholders of Cellectis held on December 22, 2023, is effective as from May 3, 2024.
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 Q1 2024 financial results press release, Calyxt's results are isolated under "Income (loss) from discontinued operations" for the 3-month period ended March 31, 2023, and are no longer included for the 3-month period ended March 31, 2024, due to the deconsolidation.
Cash: As of March 31, 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 loss from discontinued operations of
Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net income attributable to shareholders of Cellectis was
Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net income attributable to shareholders of Cellectis was
Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending at Cellectis for 2024 in the following areas:
- Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART22, UCART20x22, UCART123 and potential new product candidates, and
- Operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA); and
- Continuing strengthening our manufacturing and clinical departments.
| CELLECTIS S.A. STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited) ($ in thousands) | ||||||
| As of | ||||||
| December 31, 2023 | March 31, 2024 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Intangible assets | 671 | 677 | ||||
| Property, plant, and equipment | 54,681 | 52,051 | ||||
| Right-of-use assets | 38,060 | 35,787 | ||||
| Non-current financial assets | 7,853 | 7,870 | ||||
| Total non-current assets | 101,265 | 96,386 | ||||
| Current assets | ||||||
| Trade receivables | 569 | 16,036 | ||||
| Subsidies receivables | 20,900 | 23,100 | ||||
| Other current assets | 7,722 | 5,429 | ||||
| Current deferred tax assets | 409 | |||||
| Cash and cash equivalent and Current financial assets | 203,815 | 213,099 | ||||
| Total current assets | 233,005 | 258,073 | ||||
| TOTAL ASSETS | 334,270 | 354,459 | ||||
| LIABILITIES | ||||||
| Shareholders’ equity | ||||||
| Share capital | 4,365 | 4,376 | ||||
| Premiums related to the share capital | 522,785 | 523,596 | ||||
| Currency translation adjustment | (36,690 | ) | (37,243 | ) | ||
| Retained earnings | (304,707 | ) | (405,808 | ) | ||
| Net income (loss) | (101,059 | ) | 5,643 | |||
| Total shareholders’ equity - Group Share | 84,695 | 90,566 | ||||
| Non-controlling interests | 0 | 0 | ||||
| Total shareholders’ equity | 84,695 | 90,566 | ||||
| Non-current liabilities | ||||||
| Non-current financial liabilities | 49,125 | 62,618 | ||||
| Non-current lease debts | 42,948 | 40,587 | ||||
| Non-current provisions | 2,200 | 2,241 | ||||
| Non-current deferred tax liabilities | 158 | 0 | ||||
| Total non-current liabilities | 94,431 | 105,446 | ||||
| Current liabilities | ||||||
| Current financial liabilities | 5,289 | 5,174 | ||||
| Current lease debts | 8,502 | 8,404 | ||||
| Trade payables | 19,069 | 16,051 | ||||
| Deferred revenues and deferred income | 110,325 | 120,556 | ||||
| Current provisions | 1,740 | 960 | ||||
| Current deferred tax liabilities | 137 | |||||
| Other current liabilities | 10,219 | 7,165 | ||||
| Total current liabilities | 155,144 | 158,447 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 334,270 | 354,459 | ||||
| Cellectis S.A. UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS ($ in thousands, except per share amounts) | ||||||
| For the three-month period ended March 31, | ||||||
| 2023 | 2024 | |||||
| Revenues and other income | ||||||
| Revenues | 139 | 4,528 | ||||
| Other income | 3,420 | 1,970 | ||||
| Total revenues and other income | 3,559 | 6,498 | ||||
| Operating expenses | ||||||
| Research and development expenses | (21,415 | ) | (22,324 | ) | ||
| Selling, general and administrative expenses | (4,964 | ) | (5,104 | ) | ||
| Other operating income (expenses) | (611 | ) | 35 | |||
| Total operating expenses | (26,990 | ) | (27,791 | ) | ||
| Operating income (loss) | (23,431 | ) | (21,293 | ) | ||
| Financial gain (loss) | (4,402 | ) | 26,275 | |||
| Income tax | 0 | 262 | ||||
| Income (loss) from continuing operations | (27,833 | ) | 5,643 | |||
| Income (loss) from discontinued operations | (4,691 | ) | 0 | |||
| Net income (loss) | (32,525 | ) | 5,643 | |||
| Attributable to shareholders of Cellectis | (30,074 | ) | 5,643 | |||
| Attributable to non-controlling interests | (2,450 | ) | 0 | |||
| Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.58 | ) | 0.08 | |||
| Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) | (0.58 | ) | (0.15 | ) | ||
| Basic net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | (0.04 | ) | 0.00 | |||
| Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) | (0.04 | ) | 0.00 | |||
| Number of shares used for computing | ||||||
| Basic | 51,452,348 | 71,810,231 | ||||
| Diluted | 51,452,348 | 103,093,741 | ||||
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) ($ in thousands, except per share data) | |||||
| For the three-month period ended March 31, | |||||
| 2023 | 2024 | ||||
| Net income (loss) attributable to shareholders of Cellectis | (30,074 | ) | 5,643 | ||
| Adjustment: | |||||
| Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 1,979 | 887 | |||
| Adjusted net income (loss) attributable to shareholders of Cellectis | (28,095 | ) | 6,530 | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.55 | ) | 0.09 | ||
| Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) | (0.10 | ) | 0.00 | ||
| Weighted average number of outstanding shares, basic (units) | 51,452,348 | 71,810,231 | |||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.55 | ) | (0.14) | ||
| Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) | (0.10 | ) | 0.00 | ||
| Weighted average number of outstanding shares, diluted (units) | 51,452,348 | 103,093,741 | |||
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 over 24 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 “expect,” “will,” “believe,” and “may”, 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 the advancement, timing and progress of clinical trials, the timing of our presentation of clinical data, the potential of our clinical and preclinical 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. 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 Relation contacts:
Arthur Stril, Interim Chief Financial Officer, +1 (347) 809 5980, investors@cellectis.com
Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577
Attachment
FAQ
What was Cellectis' cash position as of March 31, 2024?
How much did Cellectis' Q1 2024 revenues increase compared to Q1 2023?
What is the projected cash runway for Cellectis?
How much equity investment did AstraZeneca complete in Cellectis in Q1 2024?
What was Cellectis' net income for Q1 2024?
Who was appointed as Interim CFO of Cellectis in May 2024?
What percentage of Cellectis' share capital is owned by AstraZeneca?
Which clinical programs is Cellectis focusing on in 2024?
