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The unaudited condensed Consolidated Financial Statements for the three and six-month
periods ended June 30, 2021, 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; 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; 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 on March 4, 2021 (the "Annual Report") and under "Risk Factors" in the interim reports that we file with the Securities and Exchange Commission. 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
and our corporate logos, and all such trademarks and service marks appearing in this interim report are the property of Cellectis. The trademark Calyxt
is 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
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.
| PART I - FINANCIAL INFORMATION | ||
| Item 1. | Condensed Financial Statements (Unaudited) | |
| Item 2. | Management's Discussion & Analysis of Financial Condition and Results of Operations | |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risks | |
| Item 4. | Controls and Procedures | |
| PART II - OTHER INFORMATION | ||
| Item 1. | Legal Proceedings | |
| Item 1A. | Risk Factors | |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | |
| Item 3. | Default Upon Senior Securities | |
| Item 4. | Mine Safety Disclosures | |
| Item 5. | Other Information | |
| Item 6. | Exhibits |
PART I - FINANCIAL INFORMATION
Item 1. Condensed Financial Statements (unaudited)
INTERIM STATEMENTS OF CONSOLIDATED FINANCIAL POSITION
| As of | ||||||||||||
| Notes | December 31, 2020 | June 30, 2021 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,584 | 1,584 | ||||||||||
| Property, plant, and equipment | 6 | 71,673 | 79,478 | |||||||||
| Right-of-use assets | 5 | 73,845 | 74,050 | |||||||||
| Other non-current financial assets | 7 | 7,007 | 22,101 | |||||||||
| Total non-current assets | 154,109 | 177,214 | ||||||||||
| Current assets | ||||||||||||
| Inventories | 1,606 | 2,468 | ||||||||||
| Trade receivables | 8.1 | 5,171 | 3,878 | |||||||||
| Subsidies receivables | 8.2 | 10,703 | 5,654 | |||||||||
| Other current assets | 8.3 | 29,643 | 16,733 | |||||||||
| Current financial assets | 9.1 | 27,091 | 3,393 | |||||||||
| Cash and cash equivalents | 9.2 | 241,148 | 248,226 | |||||||||
| Total current assets | 315,362 | 280,352 | ||||||||||
| TOTAL ASSETS | 469,471 | 457,565 | ||||||||||
| LIABILITIES | ||||||||||||
| Shareholders' equity | ||||||||||||
| Share capital | 13 | 2,785 | 2,947 | |||||||||
| Premiums related to the share capital | 13 | 863,912 | 920,591 | |||||||||
| Currency translation adjustment | ( 4,089 | ) | ( 9,602 | ) | ||||||||
| Retained earnings | ( 505,961 | ) | ( 586,284 | ) | ||||||||
| Net income (loss) | ( 81,074 | ) | ( 51,787 | ) | ||||||||
| Total shareholders' equity - Group Share | 275,573 | 275,865 | ||||||||||
| Non-controlling interests | 33,273 | 26,458 | ||||||||||
| Total shareholders' equity | 308,846 | 302,323 | ||||||||||
| Non-current liabilities | ||||||||||||
| Non-current financial liabilities | 10 | 28,836 | 23,475 | |||||||||
| Non-current lease debts | 10 | 75,764 | 75,763 | |||||||||
| Non-current provisions | 16 | 4,010 | 3,610 | |||||||||
| Other non-current liabilities | - | 948 | ||||||||||
| Total non-current liabilities | 108,610 | 103,797 | ||||||||||
| Current liabilities | ||||||||||||
| Current lease debts | 10 | 6,696 | 7,691 | |||||||||
| Trade payables | 10 | 24,609 | 28,254 | |||||||||
| Deferred revenues and contract liabilities | 12 | 452 | 423 | |||||||||
| Current provisions | 16 | 1,131 | 1,397 | |||||||||
| Other current liabilities | 11 | 19,127 | 13,681 | |||||||||
| Total current liabilities | 52,015 | 51,446 | ||||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 469,471 | 457,565 |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS
period ended June 30,
$ in thousands, except per share amounts
| For the six-month period ended June 30, | ||||||||||||
| Notes | 2020 | 2021 | ||||||||||
| Revenues and other income | ||||||||||||
| Revenues | 3.1 | 52,993 | 36,777 | |||||||||
| Other income | 3.1 | 3,494 | 5,804 | |||||||||
| Total revenues and other income | 56,487 | 42,581 | ||||||||||
| Operating expenses | ||||||||||||
| Cost of revenue | 3.2 | ( 10,428 | ) | ( 19,899 | ) | |||||||
| Research and development expenses | 3.2 | ( 43,587 | ) | ( 62,338 | ) | |||||||
| Selling, general and administrative expenses | 3.2 | ( 21,213 | ) | ( 18,219 | ) | |||||||
| Other operating income (expenses) | 86 | 488 | ||||||||||
| Total operating expenses | ( 75,142 | ) | ( 99,968 | ) | ||||||||
| Operating income (loss) | ( 18,655 | ) | ( 57,387 | ) | ||||||||
| Net Financial gain (loss) | ( 635 | ) | 431 | |||||||||
| Income tax | - | - | ||||||||||
| Net income (loss) | ( 19,290 | ) | ( 56,956 | ) | ||||||||
| Attributable to shareholders of Cellectis | ( 12,221 | ) | ( 51,787 | ) | ||||||||
| Attributable to non-controlling interests | ( 7,069 | ) | ( 5,169 | ) | ||||||||
| 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) | ( 0.29 | ) | ( 1.17 | ) | ||||||||
| Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) | ( 0.29 | ) | ( 1.17 | ) |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE
period ended June 30,
| For the six-month period ended June 30, | ||||||||
| 2020 | 2021 | |||||||
| Net income (loss) | ( 19,290 | ) | ( 56,956 | ) | ||||
| Actuarial gains and losses | 143 | 577 | ||||||
| Other comprehensive income (loss) that will not be reclassified subsequently to income or loss | 143 | 577 | ||||||
| Currency translation adjustment | ( 634 | ) | ( 6,969 | ) | ||||
| Commodity derivative contracts | ( 58 | ) | - | |||||
| Other comprehensive income (loss) that will be reclassified subsequently to income or loss | ( 691 | ) | ( 6,969 | ) | ||||
| Total Comprehensive income (loss) | ( 19,838 | ) | ( 63,348 | ) | ||||
| Attributable to shareholders of Cellectis | ( 13,206 | ) | ( 56,661 | ) | ||||
| Attributable to non-controlling interests | ( 6,632 | ) | ( 6,688 | ) |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS
For the three-month period ended June 30,
$ in thousands, except per share amounts
| For the three-month period ended June 30, | ||||||||||||
| Notes | 2020 | 2021 | ||||||||||
| Revenues and other income | ||||||||||||
| Revenues | 3.1 | 2,900 | 11,176 | |||||||||
| Other income | 3.1 | 1,716 | 3,439 | |||||||||
| Total revenues and other income | 4,616 | 14,615 | ||||||||||
| Operating expenses | ||||||||||||
| Cost of revenue | 3.2 | ( 5,827 | ) | ( 11,754 | ) | |||||||
| Research and development expenses | 3.2 | ( 22,862 | ) | ( 31,147 | ) | |||||||
| Selling, general and administrative expenses | 3.2 | ( 9,070 | ) | ( 9,343 | ) | |||||||
| Other operating income (expenses) | 111 | 150 | ||||||||||
| Total operating expenses | ( 37,647 | ) | ( 52,096 | ) | ||||||||
| Operating income (loss) | ( 33,031 | ) | ( 37,481 | ) | ||||||||
| Financial gain (loss) | ( 2,821 | ) | ( 4,129 | ) | ||||||||
| Income tax | - | - | ||||||||||
| Net income (loss) | ( 35,852 | ) | ( 41,610 | ) | ||||||||
| Attributable to shareholders of Cellectis | ( 32,263 | ) | ( 39,919 | ) | ||||||||
| Attributable to non-controlling interests | ( 3,589 | ) | ( 1,691 | ) | ||||||||
| 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) | ( 0.76 | ) | ( 0.88 | ) | ||||||||
| Diluted net income (loss) attributable to shareholders of Cellectis per share ( $ /share) | ( 0.76 | ) | ( 0.88 | ) |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE
For the three-month period ended June 30,
| 2020 | 2021 | |||||||
| Net income (loss) | ( 35,852 | ) | ( 41,610 | ) | ||||
| Actuarial gains and losses | 189 | 137 | ||||||
| Other comprehensive income (loss) that will not be reclassified subsequently to income or loss | 189 | 137 | ||||||
| Currency translation adjustment | 5,534 | 2,714 | ||||||
| Commodity derivative contracts | ( 3 | ) | - | |||||
| Other comprehensive income (loss) that will be reclassified subsequently to income or loss | 5,531 | 2,714 | ||||||
| Total Comprehensive income (loss) | ( 30,132 | ) | ( 38,759 | ) | ||||
| Attributable to shareholders of Cellectis | ( 26,611 | ) | ( 37,034 | ) | ||||
| Attributable to non-controlling interests | ( 3,521 | ) | ( 1,725 | ) |
The accompanying notes form an integral part of these una
udited condensed Interim Consolidated Financial Statements
UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS
period ended June 30,
| For the six-month period ended June 30, | ||||||||||||
| Notes | 2020 | 2021 | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Net income (loss) for the period | ( 19,290 | ) | ( 56,956 | ) | ||||||||
| Reconciliation of net income (loss) and of the cash provided by (used in) operating activities | ||||||||||||
| Adjustments for | ||||||||||||
| Amortization and depreciation | 4,199 | 7,173 | ||||||||||
| Net loss (income) on disposals | 9 | 4 | ||||||||||
| Net financial loss (gain) | 645 | ( 431 | ) | |||||||||
| Expenses related to share-based payments | 9,427 | 4,020 | ||||||||||
| Provisions | ( 1,897 | ) | 433 | |||||||||
| Other non-cash items | - | 2 | ||||||||||
| Gain upon the forgiveness of the Payroll Protection Program loan | 10.1 | - | ( 1,528 | ) | ||||||||
| Convertible note received for up-front license fee classified in non-current assets | 7 | ( 14,904 | ) | |||||||||
| Interest (paid) / received | 2,809 | ( 1,422 | ) | |||||||||
| Operating cash flows before change in working capital | ( 4,099 | ) | ( 63,610 | ) | ||||||||
| Decrease (increase) in inventories | ( 2,813 | ) | ( 866 | ) | ||||||||
| Decrease (increase) in trade receivables and other current assets | ( 2,159 | ) | 4,325 | |||||||||
| Decrease (increase) in subsidies receivables | 3,690 | 4,787 | ||||||||||
| (Decrease) increase in trade payables and other current liabilities | 3,782 | 2,330 | ||||||||||
| (Decrease) increase in deferred income | ( 19,167 | ) | ( 19 | ) | ||||||||
| Change in working capital | ( 16,667 | ) | 10,556 | |||||||||
| Net cash flows provided by (used in) operating activities | ( 20,766 | ) | ( 53,054 | ) | ||||||||
| Cash flows from investment activities | ||||||||||||
| Acquisition of intangible assets | ( 41 | ) | ( 23 | ) | ||||||||
| Acquisition of property, plant and equipment | ( 21,891 | ) | ( 13,641 | ) | ||||||||
| Net change in non-current financial assets | ( 1,958 | ) | ( 93 | ) | ||||||||
| Sale (Acquisition) of current financial assets | ( 29,993 | ) | 23,698 | |||||||||
| Net cash flows provided by (used in) investing activities | ( 53,882 | ) | 9,941 | |||||||||
| Cash flows from financing activities | ||||||||||||
| Proceeds from the exercise of stock options Cellectis | - | 11,818 | ||||||||||
| Proceeds from the exercise of stock options Calyxt | 179 | 227 | ||||||||||
| Increase in share capital Cellectis | 1,518 | 46,924 | ||||||||||
| Payments on lease debts | ( 3,594 | ) | ( 6,339 | ) | ||||||||
| Net cash flows provided by (used in) financing activities | ( 1,898 | ) | 52,630 | |||||||||
| (Decrease) increase in cash and cash equivalents | ( 76,546 | ) | 9,518 | |||||||||
| Cash and cash equivalents at the beginning of the year | 340,522 | 241,148 | ||||||||||
| Effect of exchange rate changes on cash | ( 3,266 | ) | ( 2,439 | ) | ||||||||
| Cash and cash equivalents at the end of the period | 9 | 260,711 | 248,226 |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements
UNAUDITED STATEMENTS OF CHANGES IN CONSOLIDATED SHAREHOLDERS' EQUITY
period ended June 30,
$ 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, 2020 | 42,465,669 | 2,767 | 843,478 | ( 22,641 | ) | ( 406,390 | ) | ( 102,091 | ) | 315,123 | 40,347 | 355,470 | ||||||||||||||||||||||||||||
| Net Loss | - | - | - | - | - | ( 12,221 | ) | ( 12,221 | ) | ( 7,069 | ) | ( 19,290 | ) | |||||||||||||||||||||||||||
| Other comprehensive income (loss) | - | - | - | ( 1,089 | ) | 104 | - | ( 985 | ) | 437 | ( 548 | ) | ||||||||||||||||||||||||||||
| Total comprehensive income (loss) | - | - | - | ( 1,089 | ) | 104 | ( 12,221 | ) | ( 13,206 | ) | ( 6,632 | ) | ( 19,838 | ) | ||||||||||||||||||||||||||
| Allocation of prior period loss | - | - | - | - | ( 102,091 | ) | 102,091 | - | - | - | ||||||||||||||||||||||||||||||
| Exercise of share warrants, employee warrants, stock options and free shares vesting | 13 | 20,464 | 1 | - | - | ( 1 | ) | - | - | - | - | |||||||||||||||||||||||||||||
| Transaction with subsidiaries | - | - | - | - | ( 155 | ) | - | ( 155 | ) | 155 | - | |||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 13 | - | - | 5,844 | - | - | - | 5,844 | 3,583 | 9,427 | ||||||||||||||||||||||||||||||
| As of June 30, 2020 | 42,486,133 | 2,768 | 849,322 | ( 23,730 | ) | ( 508,533 | ) | ( 12,221 | ) | 307,606 | 37,453 | 345,059 | ||||||||||||||||||||||||||||
| As of January 1, 2021 | 42,780,186 | 2,785 | 863,911 | ( 4,089 | ) | ( 505,961 | ) | ( 81,074 | ) | 275,572 | 33,273 | 308,84 5 | ||||||||||||||||||||||||||||
| Net Loss | ( 51,787 | ) | ( 51,787 | ) | ( 5,169 | ) | ( 56,956 | ) | ||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( 5,451 | ) | 577 | ( 4,874 | ) | ( 1,519 | ) | ( 6,393 | ) | |||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | - | - | - | ( 5,451 | ) | 577 | ( 51,787 | ) | ( 56,661 | ) | ( 6,688 | ) | ( 63,349 | ) | ||||||||||||||||||||||||||
| Allocation of prior period loss | ( 81,074 | ) | 81,074 | - | - | - | ||||||||||||||||||||||||||||||||||
| Exercise of stock options Calyxt | 146 | 146 | 81 | 227 | ||||||||||||||||||||||||||||||||||||
| Capital Increase Cellectis (ATM) | 2,415,630 | 146 | 47,688 | - | 47,834 | - | 47,834 | |||||||||||||||||||||||||||||||||
| Transaction costs (1) | - | ( 910 | ) | - | ( 910 | ) | - | ( 910 | ) | |||||||||||||||||||||||||||||||
| Transaction with subsidiaries | ( 6 | ) | ( 6 | ) | 5 | ( 1 | ) | |||||||||||||||||||||||||||||||||
| Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis | 13 | 265,494 | 16 | 5,702 | 5,718 | - | 5,718 | |||||||||||||||||||||||||||||||||
| Non-cash stock-based compensation expense | 13 | 4,233 | 4,233 | ( 213 | ) | 4,020 | ||||||||||||||||||||||||||||||||||
| Other movements | ( 34 | ) | ( 62 | ) | 34 | ( 62 | ) | - | ( 62 | ) | ||||||||||||||||||||||||||||||
| As of June 30, 2021 | 45,461,310 | 2,947 | 920,591 | ( 9,602 | ) | ( 586,284 | ) | ( 51,787 | ) | 275,864 | 26,458 | 302,323 |
The accompanying notes form an integral part of these unaudited condensed Interim Consolidated 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.
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 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 platform, HEAL, our gene-editing technologies to develop HSC product candidates in genetic diseases.
As of June 30, 2021, Cellectis S.A. also owns 64.4% of the outstanding shares of common stock of Calyxt, Inc., our plant-based biotechnology platform subsidiary that is focused on deploying its core strengths in research and development, including gene editing, plant breeding, and trait development, toward developing high value, sustainable and plant-based innovations with substantial disruption potential.
Cellectis S.A., Cellectis, Inc., Cellectis Biologics Inc. and Calyxt, Inc. 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 six months ended June 30, 2021.
Although the COVID-19
pandemic has slowed the enrolment of new patients, Cellectis continued to enroll patients in its AMELI-01,
clinical trials during this first half of 2021, and each of the trials currently continues to progress through its respective dose levels.
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
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 half of 2021, 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- and six-month
periods ended, June 30, 2021 were approved by our Board of Directors on August 5, 2021.
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- and six-month
periods ended June 30, 2021 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- and six-month
periods ended June 30, 2021 have been prepared using the same accounting policies and methods as those applied for the year ended December 31, 2020, 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, 2021 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 accounting periods beginning after January 1, 2022. We do not anticipate that the adoption of these pronouncements and amendments will have a material impact on our results of operations, financial position or cash flows:
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' Equity.
2.3 Consolidated entities and non-controlling
We 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.
Consolidation of a subsidiary begins when the Group obtains control over the subsidiary and ceases when the Group loses control of the subsidiary.
All intra-Group assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group are eliminated in full in the consolidation.