Full Press Release Details
The unaudited condensed Consolidated Financial Statements for the three-month period ended March 31, 2023, included
herein, have been prepared in accordance with International Accounting Standard 34 ( IAS 34 ) Interim Financial Reporting as issued by the International Accounting Standards Board ( IASB ). The consolidated financial
statements are presented in U.S. dollars. All references in this interim report to $ and U.S. dollars mean U.S. dollars and all references to and euros mean euros, unless otherwise noted.
This interim report, including Management s Discussion and Analysis of Financial Condition and Results of
Operations, contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act. All statements other than present and
historical facts and conditions contained in this interim report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking
statements. When used in this interim report, the words anticipate, believe, can, could, estimate, expect, intend, is designed to, may,
might, plan, potential, predict, objective, should, or the negative of these and similar expressions identify forward-looking statements. These forward-looking statements are
subject to numerous risks and uncertainties and are made in light of information currently available to us. Actual results, performance or events may differ materially from those projected in any forward-looking statement. Many important factors may
adversely affect such forward-looking statements and cause actual results to differ from those in any forward-looking statement, including, without limitation, inconclusive clinical trial results or clinical trials failing to achieve one or more
endpoints; early data not being repeated in ongoing or future clinical trials; promising preclinical data not yielding positive clinical results; failures to secure required regulatory approvals; disruptions from failures by third-parties on whom we
rely in connection with our clinical trials; delays or negative determinations by regulatory authorities; changes or increases in oversight and regulation; increased competition; manufacturing delays or problems; inability to achieve enrollment
targets; disagreements with our collaboration partners or failures of collaboration partners to pursue product candidates; legal challenges, including product liability claims or intellectual property disputes; commercialization factors, including
regulatory approval and pricing determinations; disruptions to access to raw materials or starting material; delays or disruptions at our in-house manufacturing facilities; proliferation and continuous
evolution of new technologies; capital resource constraints; Calyxt s ability to consummate its proposed merger with Cibus Global, LLC; Calyxt s ability to continue as a going concern and finance its continuing operations; management
changes; dislocations in the capital markets; and other important factors described under Risk Factors and Special Note Regarding Forward-Looking Statements in our Annual Report on Form
20-F filed with the Securities and Exchange Commission (the SEC ) on March 14, 2023 (the Annual Report ) and under Risk Factors in the interim reports that we file with
the SEC. As a result of these factors, we cannot assure you that the forward-looking statements in this interim report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.
In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame
or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
We own various trademark registrations and applications, and unregistered trademarks and service marks, including Cellectis , TALEN and our corporate logos, and all such trademarks and service marks appearing in this interim report are the property of Cellectis.
The trademarks Calyxt , PlantSpring , BioFactory , Plant Cell Matrix and PCM are owned by Calyxt. All other trade names, trademarks and service marks of other companies appearing in this interim report
are the property of their respective holders. Solely for convenience, the trademarks and trade names in this interim report may be referred to without the and symbols, but such references, or the failure of such symbols to appear, should not be construed as any indication that their respective owners will not assert, to the fullest extent under
applicable law, their rights thereto. We do not intend to use or display other companies trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
As used in this interim report, the terms Cellectis, we, our, us, and
the Company refer to Cellectis S.A. and its subsidiaries, taken as a whole, unless the context otherwise requires. References to Calyxt refer to Calyxt, Inc. and its subsidiaries, taken as a whole. References to the
Group refer to Cellectis S.A., Cellectis, Inc., Cellectis Biologics, Inc. and Calyxt, Inc., collectively.
| PART I FINANCIAL INFORMATION | 3 | |||||
| Item 1. | Condensed Consolidated Financial Statements (Unaudited) | 3 | ||||
| Item 2. | Management s Discussion & Analysis of Financial Condition and Results of Operations | 39 | ||||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risks | 56 | ||||
| Item 4. | Controls and Procedures | 56 | ||||
| PART II OTHER INFORMATION | 57 | |||||
| Item 1. | Legal Proceedings | 57 | ||||
| Item 1A. | Risk Factors | 57 | ||||
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 57 | ||||
| Item 3. | Default Upon Senior Securities | 57 | ||||
| Item 4. | Mine Safety Disclosures | 57 | ||||
| Item 5. | Other Information | 57 | ||||
| Item 6. | Exhibits | 57 |
PART I FINANCIAL INFORMATION
Item 1. Financial Statements (unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of | ||||||||||||
| Notes | December 31, 2022 | March 31, 2023 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 718 | 713 | ||||||||||
| Property, plant, and equipment | 7 | 63,621 | 61,708 | |||||||||
| Right-of-use assets | 6 | 44,275 | 43,436 | |||||||||
| Non-current financial assets | 8 | 8,791 | 8,185 | |||||||||
| Total non-current assets | 117,406 | 114,042 | ||||||||||
| Current assets | ||||||||||||
| Trade receivables | 9.1 | 772 | 1,120 | |||||||||
| Subsidies receivables | 9.2 | 14,496 | 18,245 | |||||||||
| Other current assets | 9.3 | 9,078 | 9,703 | |||||||||
| Current financial assets | 10.1 | 7,907 | 4,647 | |||||||||
| Cash and cash equivalents | 10.2 | 89,789 | 83,515 | |||||||||
| Total current assets | 122,043 | 117,231 | ||||||||||
| Total assets held for sale | 4 | 21,768 | 20,135 | |||||||||
| TOTAL ASSETS | 261,216 | 251,408 | ||||||||||
| LIABILITIES | ||||||||||||
| Shareholders equity | ||||||||||||
| Share capital | 14 | 2,955 | 3,487 | |||||||||
| Premiums related to the share capital | 14 | 583,122 | 608,086 | |||||||||
| Currency translation adjustment | (28,605 | ) | (28,542 | ) | ||||||||
| Retained earnings | (333,365 | ) | (439,220 | ) | ||||||||
| Net income (loss) | (106,139 | ) | (30,074 | ) | ||||||||
| Total shareholders equity - Group Share | 117,968 | 113,735 | ||||||||||
| Non-controlling interests | 7,973 | 6,754 | ||||||||||
| Total shareholders equity | 125,941 | 120,489 | ||||||||||
| Non-current liabilities | ||||||||||||
| Non-current financial liabilities | 11 | 20,531 | 19,625 | |||||||||
| Non-current lease debts | 11 | 49,358 | 48,285 | |||||||||
| Non-current provisions | 17 | 2,390 | 2,540 | |||||||||
| Total non-current liabilities | 72,279 | 70,450 | ||||||||||
| Current liabilities | ||||||||||||
| Current financial liabilities | 5,088 | 5,188 | ||||||||||
| Current lease debts | 11 | 7,872 | 8,181 | |||||||||
| Trade payables | 11 | 21,456 | 22,324 | |||||||||
| Deferred revenues and contract liabilities | 13 | 59 | 342 | |||||||||
| Current provisions | 17 | 477 | 1,011 | |||||||||
| Other current liabilities | 12 | 13,179 | 6,094 | |||||||||
| Total current liabilities | 48,131 | 43,140 | ||||||||||
| Total liabilities related to asset held for sale | 4 | 14,864 | 17,328 | |||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | 261,216 | 251,408 |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
$ in thousands, except per share amounts
| For the three-month period ended March 31, | ||||||||||
| Notes | 2022 * | 2023 | ||||||||
| Revenues and other income | ||||||||||
| Revenues | 3.1 | 1,665 | 139 | |||||||
| Other income | 3.1 | 2,135 | 3,420 | |||||||
| Total revenues and other income | 3,800 | 3,559 | ||||||||
| Operating expenses | ||||||||||
| Cost of revenue | 3.2 | (385 | ) | (334 | ) | |||||
| Research and development expenses | 3.2 | (26,601 | ) | (21,081 | ) | |||||
| Selling, general and administrative expenses | 3.2 | (6,063 | ) | (4,964 | ) | |||||
| Other operating income (expenses) | 21 | (611 | ) | |||||||
| Total operating expenses | (33,028 | ) | (26,990 | ) | ||||||
| Operating income (loss) | (29,228 | ) | (23,431 | ) | ||||||
| Financial income | 2,270 | 775 | ||||||||
| Financial expenses | (1,358 | ) | (5,177 | ) | ||||||
| Net Financial gain (loss) | 912 | (4,402 | ) | |||||||
| Income (loss) from continuing operations | (28,316 | ) | (27,833 | ) | ||||||
| Income (loss) from discontinued operations | (6,441 | ) | (4,691 | ) | ||||||
| Net income (loss) | (34,757 | ) | (32,525 | ) | ||||||
| Attributable to shareholders of Cellectis | (31,911 | ) | (30,074 | ) | ||||||
| Attributable to non-controlling interests | (2,846 | ) | (2,450 | ) | ||||||
| Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis | 16 | |||||||||
| Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) | (0.70 | ) | (0.58 | ) | ||||||
| Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) | (0.70 | ) | (0.58 | ) | ||||||
| Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) from discontinued operations | (0.08 | ) | (0.04 | ) | ||||||
| Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) from discontinued operations | (0.08 | ) | (0.04 | ) |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE
three-month period ended March 31,
| For the three-month period ended March 31, | ||||||||
| 2022 * | 2023 | |||||||
| Net income (loss) | (34,757 | ) | (32,525 | ) | ||||
| Actuarial gains and losses | 427 | (21 | ) | |||||
| Other comprehensive income (loss) that will not be reclassified subsequently to income or loss from continued operations | 427 | (21 | ) | |||||
| Currency translation adjustment | (5,033 | ) | (2,479 | ) | ||||
| Other comprehensive income (loss) that will be reclassified subsequently to income or loss from continuing operations | (5,033 | ) | (2,479 | ) | ||||
| Other comprehensive income (loss) from discontinued operations | 1,925 | 3,673 | ||||||
| Total Comprehensive income (loss) | (37,438 | ) | (31,351 | ) | ||||
| Attributable to shareholders of Cellectis | (34,724 | ) | (30,033 | ) | ||||
| Attributable to non-controlling interests | (2,714 | ) | (1,318 | ) |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS
| For the three-month period ended March 31, | ||||||||||
| Notes | 2022 * | 2023 | ||||||||
| Cash flows from operating activities | ||||||||||
| Net income (loss) for the period | (34,757 | ) | (32,525 | ) | ||||||
| Net loss for the period of discontinued operations | (6,441 | ) | (4,691 | ) | ||||||
| Net (loss) income for the period of continuing operations | (28,316 | ) | (27,833 | ) | ||||||
| Adjustment to reconcile net income (loss) to cash provided by (used in) operating activities | ||||||||||
| Adjustments for | ||||||||||
| Intercompany transactions between continuing and discontinued operations (1) | 37 | 38 | ||||||||
| Amortization and depreciation | 4,901 | 4,456 | ||||||||
| Net loss (income) on disposals | 43 | |||||||||
| Net financial loss (gain) | (912 | ) | 4,402 | |||||||
| Expenses related to share-based payments | 2,316 | 1,620 | ||||||||
| Provisions | (143 | ) | 607 | |||||||
| Other non-cash items | 149 | |||||||||
| Realized foreign exchange gain (loss) | (126 | ) | (80 | ) | ||||||
| Interest (paid) / received | (7 | ) | 616 | |||||||
| Operating cash flows before change in working capital | (22,206 | ) | (16,025 | ) | ||||||
| Decrease (increase) in trade receivables and other current assets | (33 | ) | (1,277 | ) | ||||||
| Decrease (increase) in subsidies receivables | (1,372 | ) | (3,116 | ) | ||||||
| (Decrease) increase in trade payables and other current liabilities | (6,474 | ) | (6,211 | ) | ||||||
| (Decrease) increase in deferred income | 324 | 278 | ||||||||
| Change in working capital | (7,555 | ) | (10,326 | ) | ||||||
| Net cash flows provided by (used in) operating activities of continuing operations | (29,761 | ) | (26,352 | ) | ||||||
| Net cash flows provided by (used in) operating activities of discontinued operations | (6,851 | ) | (1,974 | ) | ||||||
| Net cash flows provided by (used in) operating activities | (36,612 | ) | (28,326 | ) | ||||||
| Cash flows from investment activities | ||||||||||
| Acquisition of property, plant and equipment | 7 | (626 | ) | (213 | ) | |||||
| Net change in non-current financial assets | 8 | (60 | ) | 346 | ||||||
| Net cash flows provided by (used in) investing activities of continuing operations | (686 | ) | 133 | |||||||
| Net cash flows provided by (used in) investing activities of discontinued operations | (296 | ) | 97 | |||||||
| Cash flows provided by (used in) investment activities | (982 | ) | 230 | |||||||
| Cash flows from financing activities | ||||||||||
| Increase in share capital of Cellectis after deduction of transaction costs | 14 | 23,385 | ||||||||
| Decrease in borrowings | 11 | (30 | ) | (1,269 | ) | |||||
| Interest paid on financial debt | (91 | ) | (74 | ) | ||||||
| Payments on lease debts | 11 | (2,811 | ) | (2,768 | ) | |||||
| Net cash flows provided by financing activities of continuing operations | (2,932 | ) | 19,275 | |||||||
| Net cash flows provided by (used in) financing activities of discontinued operations | 10,609 | 506 | ||||||||
| Net cash flows provided by (used in) financing activities | 7,677 | 19,780 | ||||||||
| (Decrease) increase in cash and cash equivalents | (29,916 | ) | (8,316 | ) | ||||||
| Cash and cash equivalents at the beginning of the year | 185,636 | 93,216 | ||||||||
| Effect of exchange rate changes on cash | (852 | ) | 669 | |||||||
| Cash from discontinued operations | 17,285 | 2,054 | ||||||||
| Cash from continuing operations | 137,583 | 83,515 | ||||||||
| Cash and cash equivalents at the end of the period | 10 | 154,868 | 85,570 |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial Statements
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
$ in thousands, except share data
| Share Capital Ordinary Shares | Equity | |||||||||||||||||||||||||||||||||||||
| Notes | Number of shares | Amount | Premiums related to share capital | Currency translation adjustment | Retained earnings (deficit) | Income (Loss) | attributable to shareholders of Cellectis | Non controlling interests | Total Shareholders Equity | |||||||||||||||||||||||||||||
| As of January 1, 2022 | 45,484,310 | 2,945 | 934,696 | (18,021 | ) | (584,129 | ) | (114,197 | ) | 221,293 | 15,181 | 236,474 | ||||||||||||||||||||||||||
| Net Loss | (31,911 | ) | (31,911 | ) | (2,846 | ) | (34,757 | ) | ||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | (3,240 | ) | 427 | (2,813 | ) | 132 | (2,682 | ) | ||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | (3,240 | ) | 427 | (31,911 | ) | (34,724 | ) | (2,714 | ) | (37,438 | ) | |||||||||||||||||||||||||||
| Allocation of prior period loss | (114,197 | ) | 114,197 | |||||||||||||||||||||||||||||||||||
| Capital increase of Calyxt | 623 | 623 | 488 | 1,110 | ||||||||||||||||||||||||||||||||||
| Operation between shareholders | 1,205 | 1,205 | (1,205 | ) | ||||||||||||||||||||||||||||||||||
| Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis | 14 | 6,500 | 0 | |||||||||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 15 | 2,648 | 2,648 | 260 | 2,907 | |||||||||||||||||||||||||||||||||
| Other movements | (11 | ) | 11 | |||||||||||||||||||||||||||||||||||
| As of March 31, 2022 | 45,490,810 | 2,945 | 937,333 | (21,261 | ) | (696,062 | ) | (31,911 | ) | 191,044 | 12,010 | 203,054 | ||||||||||||||||||||||||||
| As of January 1, 2023 | 45,675,968 | 2,955 | 583,122 | (28,605 | ) | (333,365 | ) | (106,139 | ) | 117,968 | 7,973 | 125,941 | ||||||||||||||||||||||||||
| Net Loss | (30,074 | ) | (30,074 | ) | (2,450 | ) | (32,525 | ) | ||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | 62 | (21 | ) | 41 | 1,132 | 1,173 | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | 62 | (21 | ) | (30,074 | ) | (30,033 | ) | (1,318 | ) | (31,351 | ) | |||||||||||||||||||||||||||
| Allocation of prior period loss | (106,139 | ) | 106,139 | |||||||||||||||||||||||||||||||||||
| Capital increase of Cellectis (1) | 9,907,800 | 532 | 24,298 | 24,830 | 24,830 | |||||||||||||||||||||||||||||||||
| Transaction costs related to Cellectis capital increase (2) | (1,445 | ) | (1,445 | ) | (1,445 | ) | ||||||||||||||||||||||||||||||||
| Operation between shareholders (3) | 287 | 287 | (287 | ) | ||||||||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 15 | 1,979 | 1,979 | 386 | 2,365 | |||||||||||||||||||||||||||||||||
| Other movements (4) | 132 | 18 | 149 | 149 | ||||||||||||||||||||||||||||||||||
| As of March 31, 2023 | 55,583,768 | 3,487 | 608,086 | (28,542 | ) | (439,220 | ) | (30,074 | ) | 113,735 | 6,754 | 120,489 |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial Statements
NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Cellectis S.A. (hereinafter Cellectis or we ) is a limited liability company
( soci t anonyme ) registered and domiciled in Paris, France.
We are a clinical stage biotechnological company,
employing our core proprietary technologies to develop products based on gene-editing with a portfolio of allogeneic Chimeric Antigen Receptor T-cells ( UCART ) product candidates in the field of
immuno-oncology and gene-edited hematopoietic stem and progenitors cells ( HSPC ) product candidates in other therapeutic indications.
Our UCART product candidates, based on gene-edited T-cells that express Chimeric Antigen Receptors
( CARs ), seek to harness the power of the immune system to target and eradicate cancers. We believe that CAR-based immunotherapy is one of the most promising areas of cancer research, representing a
new paradigm for cancer treatment. We are designing next-generation immunotherapies that are based on gene-edited CAR T-cells. Our gene-editing technologies allow us to create allogeneic CAR T-cells, meaning they are derived from healthy donors rather than the patients themselves. We believe that the allogeneic production of CAR T-cells will allow us to develop
cost-effective, off-the-shelf products that are capable of being stored and distributed worldwide. Our gene-editing expertise also enables us to develop
product candidates that feature additional safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist
mechanisms that inhibit immune-system activity.
Together with our focus on immuno-oncology, we are using, through our HEAL platform, our
gene-editing technologies to develop HSPC product candidates in genetic diseases.
As of March 31, 2023, Cellectis S.A. also owns
48.2% of the outstanding shares of common stock of Calyxt, Inc., through which our Plants segment is carried out. Calyxt is a plant-based synthetic biology company that leverages its proprietary PlantSpring technology platform to engineer plant metabolism to produce innovative, high-value materials and products for use in helping customers meet their sustainability targets and financial goals. The
production of Calyxt s plant-based chemistries occurs in its proprietary BioFactory production system.
Cellectis S.A., Cellectis,
Inc., Cellectis Biologics Inc. and Calyxt, Inc. (or Calyxt ) are sometimes referred to as a consolidated group of companies as the Group.
Note 2. Accounting principles
The Interim Consolidated Financial Statements of Cellectis as of, and for the three-month period ended, March 31,
2023 were approved by our Board of Directors on May 4, 2023.
The Interim Consolidated Financial Statements are presented in
thousands of U.S. dollars. See Note 2.2.
The Interim Consolidated Financial Statements as of, and for the three-month period ended
March 31, 2023 have been prepared in accordance with International Accounting Standard ( IAS ) 34 Interim Financial Reporting, as issued by the International Accounting Standards Board ( IASB ).
The Interim Consolidated Financial Statements as of and for the three-month period ended
March 31, 2023 have been prepared using the same accounting policies and methods as those applied for the year ended December 31, 2022, except as described below related to the new or amended accounting standards applied.
IFRS include International Financial Reporting Standards ( IFRS ), International Accounting Standards ( the IAS ), as well
as the interpretations issued by the Standards Interpretation Committee ( the SIC ), and the International Financial Reporting Interpretations Committee ( IFRIC ).
Application of new or amended accounting standards or new amendments
The following pronouncements and related amendments have been adopted by us from January 1, 2023 but had no significant impact on the
Interim Consolidated Financial Statements:
standards, interpretations and amendments issued but not yet effective
The following pronouncements and related amendments are
applicable for first quarter accounting periods beginning after January 1, 2024, or later, as specified below. The Group has not early adopted any of these pronouncements and amendments. We are currently evaluating if the adoption of these
pronouncements and amendments will have a material impact on our results of operations, financial position, or cash flows:
consolidated financial statements were prepared on a going concern basis. With cash and cash equivalents of $83,515 as of March 31, 2023, excluding Calyxt, the Company believes it has sufficient resources to continue operating for at least
twelve months following the consolidated financial statements publication.
2.2 Currency of the financial statements
The Interim Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of Cellectis, which is
the euro. We believe that this presentation enhances the comparability with peers, which primarily present their financial statements in U.S. dollars.
All financial information (unless indicated otherwise) is presented in thousands of U.S. dollars.
The statements of financial position of consolidated entities having a functional currency different from the U.S. dollar are translated into
U.S. dollars at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive income (loss) and statements of cash flows of such consolidated entities are
translated at the average period to date exchange rate. The resulting translation adjustments are included in equity under the caption Accumulated other comprehensive income (loss) in the Statements of Changes in Shareholders
2.3 Consolidated entities and non-controlling interests
control all the legal entities included in the consolidation. An investor controls an investee when the investor is exposed to variable returns from its involvement with the investee and has the ability to affect those returns through its power over
the investee. Control requires power, exposure to variability of returns and a linkage between the two.
To have power, the investor needs
to have existing rights that give it the current ability to direct the relevant activities that significantly affect the investee s returns.
In order to ascertain control, potential voting rights which are substantial are taken into consideration.