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The unaudited condensed Consolidated Financial Statements for the three-month period ended March 31, 2022, 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 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, the severity and duration of the evolving COVID-19 pandemic and the
resulting impact on macro-economic conditions; 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; disruptions to Calyxt s business, including disruptions resulting from
Calyxt s execution of its business model; Calyxt s ability to continue as a going concern; 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 3, 2022 (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
| PART I FINANCIAL INFORMATION | 3 | |||
| Item 1. | Financial Statements (Unaudited) | 3 | ||
| Item 2. | Management s Discussion & Analysis of Financial Condition and Results of Operations | 33 | ||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risks | 49 | ||
| Item 4. | Controls and Procedures | 49 | ||
| PART II OTHER INFORMATION | 50 | |||
| Item 1. | Legal Proceedings | 50 | ||
| Item 1A. | Risk Factors | 50 | ||
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 50 | ||
| Item 3. | Default Upon Senior Securities | 50 | ||
| Item 4. | Mine Safety Disclosures | 50 | ||
| Item 5. | Other Information | 50 | ||
| Item 6. | Exhibits | 50 |
PART I FINANCIAL INFORMATION
Item 1. Financial Statements (unaudited)
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| As of | ||||||||||||
| Notes | December 31, 2021 | March 31, 2022 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,854 | 1,698 | ||||||||||
| Property, plant, and equipment | 6 | 78,846 | 76,523 | |||||||||
| Right-of-use assets | 5 | 69,423 | 67,227 | |||||||||
| Non-current financial assets | 7 | 6,524 | 6,567 | |||||||||
| Total non-current assets | 156,647 | 152,016 | ||||||||||
| Current assets | ||||||||||||
| Trade receivables | 8.1 | 20,361 | 21,839 | |||||||||
| Subsidies receivables | 8.2 | 9,268 | 10,446 | |||||||||
| Other current assets | 8.3 | 9,665 | 7,524 | |||||||||
| Current financial assets | 9.1 | 499 | 499 | |||||||||
| Cash and cash equivalents | 9.2 | 185,636 | 154,868 | |||||||||
| Total current assets | 225,429 | 195,175 | ||||||||||
| TOTAL ASSETS | 382,076 | 347,191 | ||||||||||
| LIABILITIES | ||||||||||||
| Shareholders equity | ||||||||||||
| Share capital | 13 | 2,945 | 2,945 | |||||||||
| Premiums related to the share capital | 13 | 934,696 | 937,333 | |||||||||
| Currency translation adjustment | (18,021 | ) | (21,261 | ) | ||||||||
| Retained earnings | (584,129 | ) | (696,062 | ) | ||||||||
| Net income (loss) | (114,197 | ) | (31,911 | ) | ||||||||
| Total shareholders equity - Group Share | 221,293 | 191,044 | ||||||||||
| Non-controlling interests | 15,181 | 12,010 | ||||||||||
| Total shareholders equity | 236,474 | 203,054 | ||||||||||
| Non-current liabilities | ||||||||||||
| Non-current financial liabilities | 10 | 20,030 | 18,345 | |||||||||
| Non-current lease debts | 10 | 71,526 | 69,739 | |||||||||
| Non-current provisions | 16 | 4,073 | 3,716 | |||||||||
| Other non-current liabilities | 626 | |||||||||||
| Total non-current liabilities | 96,254 | 91,800 | ||||||||||
| Current liabilities | ||||||||||||
| Current financial liabilities | 2,354 | 12,607 | ||||||||||
| Current lease debts | 10 | 8,329 | 8,408 | |||||||||
| Trade payables | 10 | 23,762 | 20,921 | |||||||||
| Deferred revenues and contract liabilities | 12 | 301 | 581 | |||||||||
| Current provisions | 16 | 871 | 578 | |||||||||
| Other current liabilities | 11 | 13,731 | 9,242 | |||||||||
| Total current liabilities | 49,348 | 52,337 | ||||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | 382,076 | 347,191 |
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 | 2021 | 2022 | ||||||||||
| Revenues and other income | ||||||||||||
| Revenues | 3.1 | 25,601 | 1,697 | |||||||||
| Other income | 3.1 | 2,365 | 2,135 | |||||||||
| Total revenues and other income | 27,966 | 3,832 | ||||||||||
| Operating expenses | ||||||||||||
| Cost of revenue | 3.2 | (8,145 | ) | (385 | ) | |||||||
| Research and development expenses | 3.2 | (31,004 | ) | (29,479 | ) | |||||||
| Selling, general and administrative expenses | 3.2 | (8,779 | ) | (9,279 | ) | |||||||
| Other operating income (expenses) | 56 | 65 | ||||||||||
| Total operating expenses | (47,872 | ) | (39,078 | ) | ||||||||
| Operating income (loss) | (19,907 | ) | (35,247 | ) | ||||||||
| Net Financial gain (loss) | 4,561 | 490 | ||||||||||
| Net income (loss) | (15,346 | ) | (34,757 | ) | ||||||||
| Attributable to shareholders of Cellectis | (11,868 | ) | (31,911 | ) | ||||||||
| Attributable to non-controlling interests | (3,478 | ) | (2,846 | ) | ||||||||
| Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis | 15 | |||||||||||
| Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) | (0.28 | ) | (0.70 | ) | ||||||||
| Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) | (0.28 | ) | (0.70 | ) |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE
| For the three-month period ended March 31, | ||||||||
| 2021 | 2022 | |||||||
| Net income (loss) | (15,346 | ) | (34,757 | ) | ||||
| Actuarial gains and losses | 440 | 427 | ||||||
| Other comprehensive income (loss) that will not be reclassified subsequently to income or loss | 440 | 427 | ||||||
| Currency translation adjustment | (9,683 | ) | (3,108 | ) | ||||
| Other comprehensive income (loss) that will be reclassified subsequently to income or loss | (9,683 | ) | (3,108 | ) | ||||
| Total Comprehensive income (loss) | (24,589 | ) | (37,438 | ) | ||||
| Attributable to shareholders of Cellectis | (19,627 | ) | (34,724 | ) | ||||
| Attributable to non-controlling interests | (4,962 | ) | (2,714 | ) |
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 | 2021 | 2022 | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Net income (loss) for the period | (15,346 | ) | (34,757 | ) | ||||||||
| Adjustment to reconcile net income (loss) to cash provided by (used in) operating activities | ||||||||||||
| Adjustments for | ||||||||||||
| Amortization and depreciation | 3,766 | 5,609 | ||||||||||
| Net loss (income) on disposals | 57 | (1 | ) | |||||||||
| Net financial loss (gain) | (4,561 | ) | (490 | ) | ||||||||
| Expenses related to share-based payments | 30 | 2,907 | ||||||||||
| Provisions | 185 | (143 | ) | |||||||||
| Other non-cash items | 41 | |||||||||||
| Convertible note received for up-front license fee classified in non-current assets | 7 | (15,423 | ) | |||||||||
| Realized foreign exchange gain (loss) | 141 | (236 | ) | |||||||||
| Interest (paid) / received | (110 | ) | (736 | ) | ||||||||
| Operating cash flows before change in working capital | (31,219 | ) | (27,847 | ) | ||||||||
| Decrease (increase) in inventories | (3,735 | ) | ||||||||||
| Decrease (increase) in trade receivables and other current assets | (1,073 | ) | (195 | ) | ||||||||
| Decrease (increase) in subsidies receivables | (2,363 | ) | (1,372 | ) | ||||||||
| (Decrease) increase in trade payables and other current liabilities | (2,360 | ) | (7,483 | ) | ||||||||
| (Decrease) increase in deferred income | (179 | ) | 285 | |||||||||
| Change in working capital | (9,710 | ) | (8,765 | ) | ||||||||
| Net cash flows provided by (used in) operating activities | (40,929 | ) | (36,612 | ) | ||||||||
| Cash flows from investment activities | ||||||||||||
| Proceeds from disposal of property, plant and equipment | 65 | |||||||||||
| Acquisition of intangible assets | (22 | ) | ||||||||||
| Acquisition of property, plant and equipment | 6 | (8,191 | ) | (990 | ) | |||||||
| Net change in non-current financial assets | 7 | (132 | ) | (57 | ) | |||||||
| Sale (Acquisition) of current financial assets | 7 | 8,652 | ||||||||||
| Cash flows provided by (used in) investment activities | 307 | (982 | ) | |||||||||
| Cash flows from financing activities | ||||||||||||
| Proceeds from the exercise of Cellectis stock options | 13 | 11,818 | ||||||||||
| Proceeds from the exercise of Calyxt stock options | 13 | 209 | ||||||||||
| Increase in share capital Calyxt | 13 | 11,121 | ||||||||||
| Increase in borrowings | 10 | (30 | ) | |||||||||
| Interest paid on financial debt | (92 | ) | ||||||||||
| Payments on lease debts | 10 | (2,237 | ) | (3,322 | ) | |||||||
| Net cash flows provided by (used in) financing activities | 9,790 | 7,677 | ||||||||||
| (Decrease) increase in cash and cash equivalents | (30,832 | ) | (29,916 | ) | ||||||||
| Cash and cash equivalents at the beginning of the year | 241,148 | 185,636 | ||||||||||
| Effect of exchange rate changes on cash | (2,859 | ) | (852 | ) | ||||||||
| Cash and cash equivalents at the end of the period | 9 | 207,457 | 154,868 |
The accompanying notes form an integral part of these unaudited condensed Consolidated Interim Financial
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
$ in thousands, except share data
| Notes | Share Capital Ordinary Shares | Premiums related to share capital | Currency translation adjustment | Retained earnings (deficit) | Income (Loss) | Equity | Total Shareholders Equity | |||||||||||||||||||||||||||||||||
| Number of shares | Amount | Attributable to shareholders of Cellectis | Non- controlling interests | |||||||||||||||||||||||||||||||||||||
| As of January 1, 2021 | 42,780,186 | 2,785 | 872,134 | (4,089 | ) | (505,961 | ) | (81,074 | ) | 283,795 | 25,051 | 308,846 | ||||||||||||||||||||||||||||
| Net Loss | (11,868 | ) | (11,868 | ) | (3,478 | ) | (15,346 | ) | ||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | (8,198 | ) | 440 | (7,759 | ) | (1,485 | ) | (9,243 | ) | |||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | (8,198 | ) | 440 | (11,868 | ) | (19,627 | ) | (4,962 | ) | (24,589 | ) | |||||||||||||||||||||||||||||
| Allocation of prior period loss | (80,974 | ) | 81,074 | 100 | 100 | |||||||||||||||||||||||||||||||||||
| Exercise of stock options Calyxt | 135 | 135 | 74 | 209 | ||||||||||||||||||||||||||||||||||||
| Transaction costs (1) | (493 | ) | 14 | (480 | ) | (480 | ) | |||||||||||||||||||||||||||||||||
| Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis | 13 | 258,994 | 16 | 5,702 | 5,717 | 5,717 | ||||||||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 14 | 598 | 598 | (568 | ) | 30 | ||||||||||||||||||||||||||||||||||
| Other movements | (21 | ) | (89 | ) | 21 | (89 | ) | (89 | ) | |||||||||||||||||||||||||||||||
| As of March 31, 2021 | 43,039,180 | 2,801 | 877,919 | (12,363 | ) | (586,339 | ) | (11,868 | ) | 270,150 | 19,595 | 289,745 | ||||||||||||||||||||||||||||
| 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 Calyxt | 623 | 623 | 488 | 1,110 | ||||||||||||||||||||||||||||||||||||
| Transaction with subsidiaries | 1,205 | 1,205 | (1,205 | ) | ||||||||||||||||||||||||||||||||||||
| Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis | 13 | 6,500 | ||||||||||||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 14 | 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 |
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 cells ( HSC ) product candidates in other therapeutic indications.
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 and 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 HSC product
candidates in genetic diseases.
As of March 31, 2022, Cellectis S.A. also owns 56.1% of the outstanding shares of common stock of
Calyxt, Inc., our plant-based synthetic biology subsidiary that leverages its proprietary PlantSpring technology platform to engineer plant metabolism to produce innovative, high-value, and sustainable materials and products for use in helping
customers meet their sustainability targets and financial goals. Calyxt s primary focus and commercialization strategy is on engineering synthetic biology solutions through its PlantSpring platform for manufacture using its proprietary and
differentiated 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.
While implementing health and safety measures in response to the COVID-19 pandemic, we continued to
advance our proprietary allogeneic CAR T-cell programs during the three months ended March 31, 2022.
Although the COVID-19 pandemic has slowed the enrollment of new patients, Cellectis continued to
enroll patients in its AMELI-01, BALLI-01 and MELANI-01 clinical trials during the three months ended March 31, 2022.
Despite the increasing availability of COVID-19 vaccines, the
COVID-19 pandemic and government actions to contain it continue to result in significant disruptions to various public and commercial activities. With respect to clinical trials for both our proprietary
allogeneic CAR T-cell programs and programs conducted by commercial partners, enrollment of new patients and the ability to conduct
patient follow-up is expected to continue to be
impacted by the COVID-19 pandemic. The exact timing of delays and overall impact of the COVID-19 pandemic to our business, preclinical studies, clinical trials and
manufacturing activities is currently unknown, and we are monitoring the pandemic as it continues to evolve.
At Calyxt, during the first
three months of 2022, the COVID-19 pandemic did not have a material impact on operations. However, a resurgence of the COVID-19 pandemic, governmental response measures,
and resulting disruptions could adversely affect Calyxt s operations and results.
The overall impact to Cellectis and
Calyxt s businesses will be dependent on future developments, which are highly uncertain and difficult to predict.
Note 2. Accounting principles
2.1 Basis for preparation
The Interim Consolidated Financial Statements of Cellectis as of, and for the three-month period ended, March 31, 2022 were approved by
our Board of Directors on May 12, 2022.
The Interim Consolidated Financial Statements are presented in U.S. dollars. See Note 2.2.
The Interim Consolidated Financial Statements as of, and for the three-month period ended March 31, 2022 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, 2022 have been prepared using the same
accounting policies and methods as those applied for the year ended December 31, 2021, 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, 2022 but had no significant impact on the
Interim Consolidated Financial Statements:
Accounting 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, 2023 or later, as specified below. 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: