6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

Date of Report: November 4, 2021

Commission File Number: 001-36891

 

 

Cellectis S.A.

(Exact Name of registrant as specified in its charter)

 

 

8, rue de la Croix Jarry

75013 Paris, France

+33 1 81 69 16 00

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☒             Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


Exhibits

The following document, which is attached as an exhibit hereto, is incorporated by reference herein.

This report on Form 6-K shall be deemed to be incorporated by reference in the registration statements of Cellectis S.A. on Form F-3 (No. 333-238881) and Form S-8 (Nos. 333-204205, 333-214884, 333-222482 and 333-227717), to the extent not superseded by documents or reports subsequently filed.

 

Exhibit   

Title

99.1    Cellectis S.A.’s interim report for the three and nine-month periods ended September 30, 2021.

 

2


EXHIBIT INDEX

 

Exhibit   

Title

99.1    Cellectis S.A.’s interim report for the three and nine-month periods ended September 30, 2021.

 

3


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

   

CELLECTIS S.A.

(Registrant)

November 4, 2021     By:  

/s/ André Choulika

      André Choulika
      Chief Executive Officer

 

4

EX-99.1

Exhibit 99.1

PRELIMINARY NOTE

The unaudited condensed Consolidated Financial Statements for the three and nine-month periods ended September 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”) under “Risk Factors” in the interim reports that we file with the Securities and Exchange Commission (the “SEC”) and other factors that we disclose in filings with the SEC from time to time. 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®, PlantSpringTM and BioFactoryTM 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.

 

5


PART I – FINANCIAL INFORMATION

     7  

Item 1.

  

Condensed Financial Statements (Unaudited)

     7  

Item 2.

  

Management’s Discussion  & Analysis of Financial Condition and Results of Operations

     43  

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risks

     61  

Item 4.

  

Controls and Procedures

     61  

PART II – OTHER INFORMATION

     62  

Item 1.

  

Legal Proceedings

     62  

Item 1A.

  

Risk Factors

     62  

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

     62  

Item 3.

  

Default Upon Senior Securities

     62  

Item 4.

  

Mine Safety Disclosures

     62  

Item 5.

  

Other Information

     62  

Item 6.

  

Exhibits

     62  

 

6


PART I – FINANCIAL INFORMATION

Item 1. Condensed Financial Statements (unaudited)

Cellectis S.A.

INTERIM STATEMENTS OF CONSOLIDATED FINANCIAL POSITION

$ in thousands

 

            As of  
     Notes      December 31, 2020     September 30, 2021  
                     

ASSETS

       

Non-current assets

       

Intangible assets

        1,584       2,551  

Property, plant, and equipment

     6        71,673       80,542  

Right-of-use assets

     5        73,845       71,899  

Other non-current financial assets

     7        7,007       22,045  
     

 

 

   

 

 

 

Total non-current assets

        154,109       177,037  

Current assets

       

Inventories

        1,606       1,674  

Trade receivables

     8.1        5,171       349  

Subsidies receivables

     8.2        10,703       7,971  

Other current assets

     8.3        29,643       14,753  

Current financial assets

     9.1        27,091       393  

Cash and cash equivalents

     9.2        241,148       210,709  
     

 

 

   

 

 

 

Total current assets

        315,362       235,849  
     

 

 

   

 

 

 

TOTAL ASSETS

        469,471       412,886  
     

 

 

   

 

 

 

LIABILITIES

       

Shareholders’ equity

       

Share capital

     13        2,785       2,946  

Premiums related to the share capital

     13        863,912       925,290  

Currency translation adjustment

        (4,089     (14,345

Retained earnings

        (505,961     (586,723

Net income (loss)

        (81,074     (89,201
     

 

 

   

 

 

 

Total shareholders’ equity - Group Share

        275,573       237,967  

Non-controlling interests

        33,273       24,180  
     

 

 

   

 

 

 

Total shareholders’ equity

        308,846       262,147  

Non-current liabilities

       

Non-current financial liabilities

     10        28,836       22,767  

Non-current lease debts

     10        75,764       73,730  

Non-current provisions

     16        4,010       3,851  

Other non-current liabilities

        —         787  
     

 

 

   

 

 

 

Total non-current liabilities

        108,610       101,136  
     

 

 

   

 

 

 

Current liabilities

       

Current lease debts

     10        6,696       8,079  

Trade payables

     10        24,609       22,809  

Deferred revenues and contract liabilities

     12        452       500  

Current provisions

     16        1,131       4,190  

Other current liabilities

     11        19,127       14,024  
     

 

 

   

 

 

 

Total current liabilities

        52,015       49,603  
     

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

        469,471       412,886  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

7


Cellectis S.A.

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS

$ in thousands, except per share amounts

 

            For the nine-month period ended
September 30,
 
     Notes      2020     2021  
                     

Revenues and other income

       

Revenues

     3.1        60,037       45,088  

Other income

     3.1        6,510       8,320  
     

 

 

   

 

 

 

Total revenues and other income

        66,547       53,408  
     

 

 

   

 

 

 

Operating expenses

       

Cost of revenue

     3.2        (18,159     (29,113

Research and development expenses

     3.2        (63,594     (96,663

Selling, general and administrative expenses

     3.2        (31,765     (27,894

Other operating income (expenses)

        (291     506  
     

 

 

   

 

 

 

Total operating expenses

        (113,810     (153,163
     

 

 

   

 

 

 

Operating income (loss)

        (47,263     (99,755
     

 

 

   

 

 

 

Net financial gain (loss)

        (4,733     2,728  
     

 

 

   

 

 

 

Income tax

        —         —    
     

 

 

   

 

 

 

Net income (loss)

        (51,996     (97,027
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (41,605     (89,201

Attributable to non-controlling interests

        (10,391     (7,827

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)

        (0.98     (2.00

Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share)

        (0.98     (2.00

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

8


UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

$ in thousands

 

     For the nine-month period ended
September 30,
 
     2020     2021  
              

Net income (loss)

     (51,996     (97,027
  

 

 

   

 

 

 

Actuarial gains and losses

     (17     366  
  

 

 

   

 

 

 

Other comprehensive income (loss) that will not be reclassified subsequently to income (loss)

     (17     366  
  

 

 

   

 

 

 

Currency translation adjustment

     9,611       (11,753

Commodity derivative contracts

     (58     —    
  

 

 

   

 

 

 

Other comprehensive income (loss) that will be reclassified subsequently to income (loss)

     9,553       (11,753
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (42,460     (108,414
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (32,574     (99,091

Attributable to non-controlling interests

     (9,885     (9,324

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

9


Cellectis S.A.

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS

$ in thousands, except per share amounts

 

            For the three-month period ended
September 30,
 
     Notes      2020     2021  
                     

Revenues and other income

       

Revenues

     3.1        6,179       8,312  

Other income

     3.1        3,063       2,516  
     

 

 

   

 

 

 

Total revenues and other income

        9,242       10,827  
     

 

 

   

 

 

 

Operating expenses

       

Cost of revenue

     3.2        (7,820     (9,213

Research and development expenses

     3.2        (20,103     (34,324

Selling, general and administrative expenses

     3.2        (10,301     (9,675

Other operating income (expenses)

        (374     18  
     

 

 

   

 

 

 

Total operating expenses

        (38,595     (53,195
     

 

 

   

 

 

 

Operating income (loss)

        (29,353     (42,368
     

 

 

   

 

 

 

Financial gain (loss)

        (4,250     2,296  
     

 

 

   

 

 

 

Income tax

        —         —    
     

 

 

   

 

 

 

Net income (loss)

        (33,602     (40,071
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (30,297     (37,413

Attributable to non-controlling interests

        (3,305     (2,658

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)

        (0.71     (0.82

Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share)

        (0.71     (0.82

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

10


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

$ in thousands

 

     For the three-month period ended
September 30,
 
     2020     2021  
              

Net income (loss)

     (33,602     (40,071
  

 

 

   

 

 

 

Actuarial gains and losses

     (160     229  
  

 

 

   

 

 

 

Other comprehensive income (loss) that will not be reclassified subsequently to income (loss)

     (160     229  
  

 

 

   

 

 

 

Currency translation adjustment

     10,245       (14,467

Commodity derivative contracts

     —         —    
  

 

 

   

 

 

 

Other comprehensive income (loss) that will be reclassified subsequently to income (loss)

     10,245       (14,467
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (22,622     (69,655
  

 

 

   

 

 

 

Attributable to shareholders of Cellectis

     (19,369     (62,056

Attributable to non-controlling interests

     (3,253     (7,599

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

11


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS

$ in thousands

 

            For the nine-month period ended
September 30,
 
     Notes      2020     2021  
                     

Cash flows from operating activities

       
     

 

 

   

 

 

 

Net income (loss)

        (51,996     (97,027
     

 

 

   

 

 

 

Adjustment to reconcile net income (loss) to cash provided by (used in) operating activities

        —      

Adjustments for

        —      

Amortization and depreciation

        6,776       11,538  

Net loss (income) on disposals

        27       2  

Net financial loss (gain)

        4,748       (2,728

Expenses related to share-based payments

        12,808       9,560  

Provisions

        (2,426     3,631  

Other non-cash items

        (20     —    

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          (15,503

Foreign exchange gain (loss)

          (1,988

Interest (paid) / received

        3,705       765  
     

 

 

   

 

 

 

Operating cash flows before change in working capital

        (26,378     (93,278
     

 

 

   

 

 

 

Decrease (increase) in inventories

        (3,353     (74

Decrease (increase) in trade receivables and other current assets

        (2,741     9,771  

Decrease (increase) in subsidies receivables

        1,112       2,211  

(Decrease) increase in trade payables and other current liabilities

        4,603       (2,172

(Decrease) increase in deferred income

        (19,617     62  
     

 

 

   

 

 

 

Change in working capital

        (19,996     9,797  
     

 

 

   

 

 

 

Net cash flows provided by (used in) operating activities

        (46,374     (83,480
     

 

 

   

 

 

 

Cash flows from investment activities

        —      

Acquisition of intangible assets

        (43     (880

Acquisition of property, plant and equipment

        (28,226     (18,254

Net change in non-current financial assets

        (2,480     (81

Sale (Acquisition) of current financial assets

        (20,856     26,698  
     

 

 

   

 

 

 

Cash flows provided by (used in) investment activities

        (51,604     7,483  
     

 

 

   

 

 

 

Cash flows from financing activities

       

Proceeds from the exercise of Cellectis stock options

        —         11,731  

Proceeds from the exercise of Calyxt stock options

        211       227  

Increase in share capital Cellectis

        183       46,597  

Increase in borrowings

        23,849       —    

Interest paid on financial debt

        —         (162

Payments on lease debts

        (9,598     (9,445
     

 

 

   

 

 

 

Net cash flows provided by (used in) financing activities

        14,645       48,948  
     

 

 

   

 

 

 

(Decrease) increase in cash and cash equivalents

        (83,333     (27,049
     

 

 

   

 

 

 

Cash and cash equivalents at the beginning of the year

        340,522       241,148  

Effect of exchange rate changes on cash

        3,753       (3,389
     

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     9        260,941       210,709  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

12


Cellectis S.A.

UNAUDITED STATEMENTS OF CHANGES IN CONSOLIDATED SHAREHOLDERS’ EQUITY

For the nine-month period ended September 30,

$ 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, 2020

       42,465,669       2,767       843,478       (22,641     (406,390     (102,091     315,123       40,347       355,470  

Net Loss

       —         —         —         —         —         (41,605     (41,605     (10,391     (51,996

Other comprehensive income (loss)

       —         —         —         9,087       (56     —         9,031       506       9,537  
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

       —         —         —         9,087       (56     (41,605     (32,574     (9,885     (42,460

Allocation of prior period loss

       —         —         —         —         (102,091     102,091       —         —         —    

Transaction with subsidiaries

       —         —         —         6       144       —         150       67       217  

Operation between shareholders

       —         —         —         (8     (201     —         (210     201       (8

Exercise of share warrants, employee warrants, stock options and free shares vesting

     13       20,464       1       182       —         —         —         183       —         183  

Non-cash stock-based compensation expense

     13       —         —         7,696       —         —         —         7,696       5,111       12,808  

Other movements

       —         —         (8     —         8       —         —         —         —    
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2020

       42,486,133       2,768       851,348       (13,556     (508,586     (41,605     290,369       35,841       326,210  
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of January 1, 2021

       42,780,186       2,785       863,911       (4,089     (505,961     (81,074     275,572       33,273       308,845  

Net Loss

                 (89,201     (89,201     (7,827     (97,027

Other comprehensive income (loss)

             (10,256     366       —         (9,890     (1,497     (11,387
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

       —         —         —         (10,256     366       (89,201     (99,091     (9,324     (108,415

Allocation of prior period loss

               (81,074     81,074       —           —    

Exercise of stock options Calyxt

               (75       (75     (42     (116

Capital Increase Cellectis (ATM)

       2,415,630       145       47,334             47,478         47,478  

Transaction costs (1)

           (881           (881       (881

Transaction with subsidiaries

               (8       (8     8       —    

Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis

     13       279,494       17       5,660         (1       5,675         5,675  

Non-cash stock-based compensation expense

     13           9,297         —           9,297       264       9,560  

Other movements

           (30       30         —         —         —    
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2021

       45,475,310       2,946       925,290       (14,345     (586,723     (89,201     237,967       24,180       262,147  
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

These costs correspond to the issuance costs related to Cellectis’ At-The-Market (“ATM”) financing program and were recorded as a reduction of share premium, in anticipation of share issuances that occurred in April 2021

The accompanying notes form an integral part of these unaudited condensed Interim Consolidated Financial Statements

 

13


NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2021

Note 1. The Company

Cellectis S.A. (hereinafter “Cellectis” or “we”) is a limited liability company (“société 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 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 HSC product candidates in genetic diseases.

As of September 30, 2021, Cellectis S.A. also owns 64.2% of the outstanding shares of common stock of Calyxt, Inc., our plant-based synthetic biotechnology subsidiary, which leverages its proprietary PlantSpringTM technology platform to engineer plant metabolism for customers’ innovative, high-value, and sustainable materials and products for use in helping customers meet their sustainability targets and financial goals.

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.”

COVID-19 Update

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 nine months ended September 30, 2021.

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 nine months 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

 

14


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 nine months ended September 30, 2021, the COVID-19 pandemic did not have a material impact on Calyxt’s operations. However, a resurgence or prolonging of the COVID-19 pandemic, governmental response measures, and resulting disruptions could rapidly offset such improvements. Moreover, the effects of the COVID-19 pandemic on the financial markets remain substantial and broader economic uncertainties persist, which may make obtaining capital challenging and have exacerbated the risk that such capital, if available, may not be available on terms acceptable to Calyxt. There continues to be significant uncertainty relating to the COVID-19 pandemic and its impact, and many factors could affect Calyxt’s results and operations, including, but not limited to, those described in Calyxt’s Part I, Item 1A, “Risk Factors” of its 2020 Form 10-K.

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 nine-month periods ended, September 30, 2021 were approved by our Board of Directors on November 4, 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 nine-month periods ended September 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 nine-month periods ended September 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:

 

   

Interest Rate Benchmark Reform – Phase 2: Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16. The amendments provide temporary reliefs which address the financial reporting effects when an interbank offered rate (IBOR) is replaced with an alternative nearly risk-free interest rate (RFR).

 

15


   

Amendments to IFRS 16 Leases: COVID-19-Related Rent Concessions beyond September 30, 2021 (issued on March 31, 2021 and effective for the accounting periods as of April 1, 2021).

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 or January 1, 2023, as specified below. 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:

 

   

Amendments to IAS 37 – Onerous Contracts: Cost of Fulfilling a Contract (Effective for the accounting periods as of January 1, 2022)

 

   

Amendments to IAS 16 – Property, Plant and Equipment: Proceeds before Intended Use (Effective for the accounting periods as of January 1, 2022)

 

   

Amendments to IFRS 3 – Reference to the Conceptual Framework (Effective for the accounting periods as of January 1, 2022)

 

   

Amendments to IAS 8 – Definition of Accounting Estimates (issued on 12 February 2021 and Effective for the accounting periods as of January 1, 2023)

 

   

Amendments to IAS 1 and IFRS Practice Statement 2 –Disclosure of Accounting Policies (Effective for the accounting periods as of January 1, 2023)

 

   

Amendments to IAS 12 – Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction (issued on 8 May 2021 and Effective for the accounting periods as of January 1, 2023)

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.

 

16


2.3 Consolidated entities and non-controlling interests

Accounting policy

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.

Consolidated entities

For the nine-month periods ended September 30, 2021 and September 30, 2020, the consolidated group of companies (sometimes referred to as the “Group”) includes Cellectis S.A., Cellectis, Inc., Cellectis Biologics, Inc. and Calyxt.

As of September 30, 2021, Cellectis S.A. owns 100% of Cellectis, Inc., which owns 100% of Cellectis Biologics, Inc., and approximately 64.2% of Calyxt’s outstanding shares of common stock.

On September 21, 2021, Calyxt entered into an ATM financing program with Jefferies, acting as sole selling agent. Under the terms of the ATM program, Calyxt may, from time-to-time, issue common stock having an aggregate offering value of up to $50.0 million. At its discretion Calyxt determines the timing and number of shares to be issued under the ATM program.

As of September 30, 2021, Calyxt had not issued any shares of common stock under the ATM program. As of the date of this report, Calyxt has issued approximately 1.2 million shares of common stock under the ATM program for proceeds of $3.7 million net of commissions and payments for other share issuance costs.

Non-controlling interests

Non-controlling shareholders held a 35.3% interest in Calyxt as of December 31, 2020 and a 35.8% interest in Calyxt as of September 30, 2021. These non-controlling interests were generated during the initial public offering of Calyxt and a subsequent follow-on offering, as well as through vesting and exercises of equity awards.

 

17


Note 3. Information concerning the Group’s Consolidated Operations

3.1 Revenues and other income

3.1.1 For the nine-month period ended September 30

Revenues by country of origin and other income

 

     For the nine-month period ended
September 30,
 
     2020      2021  
               
     $ in thousands  

From France

     50,077        20,085  

From USA (1)

     9,960        25,004  
  

 

 

    

 

 

 

Revenues

     60,037        45,088  
  

 

 

    

 

 

 

Research tax credit

     6,522        6,780  

Subsidies and other (2)

     (12      1,540  
  

 

 

    

 

 

 

Other income

     6,510        8,320  
  

 

 

    

 

 

 

Total revenues and other income

     66,547        53,408  
  

 

 

    

 

 

 

 

(1)

Revenues from USA concern Calyxt only.

(2)

For the nine months ended September 30, 2021, this includes only Calyxt’s PPP loan, which as of September 30, 2021, had been forgiven and recognized as other income, as disclosed in note 10.1.

Revenues by nature

 

     For the nine-month period ended
September 30,
 
     2020      2021  
               
     $ in thousands  

Recognition of previously deferred upfront payments

     20,063        —    

Other revenues from collaboration agreements

     28,103        19,865  
  

 

 

    

 

 

 

Collaboration agreements

     48,166        19,865  
  

 

 

    

 

 

 

Licenses

     1,885        115  

Products & services

     9,986        25,108  
  

 

 

    

 

 

 

Total revenues

     60,036        45,088  
  

 

 

    

 

 

 

Recognition of other revenues from collaboration agreements for the nine-month period ended September 30, 2021 mainly reflects (i) the recognition of $15.0 million of upfront amounts related to the grant of a right-of-use license as part of the agreement signed between Cellectis and Cytovia on February 12, 2021 and (ii) the recognition of a $5.0 million milestone related to Cellectis’ agreement with Allogene. The agreement with Cytovia provides for several types of financial compensation to Cellectis, including equity or cash compensation of $15 million committed at the signature of the contract, as well as cash milestones payments, cash upfront payment upon delivery of products and single-digit royalties.

Revenues related to licenses include royalties received under our various license agreements.

 

18


Products and services revenues mainly include the revenues of plants activities which are primarily attributable to Calyxt’s seed and grain crop sales for $25.0 million during the first nine months of 2021.

3.1.2 For the three-month period ended September 30

Revenues by country of origin and other income

 

     For the three-month period ended
September 30,
 
     2020      2021  
               
     $ in thousands  

From France

     767        24  

From USA (1)

     5,412        8,288  
  

 

 

    

 

 

 

Revenues

     6,179        8,312  
  

 

 

    

 

 

 

Research tax credit

     2,991        2,509  

Subsidies and other

     71        7  
  

 

 

    

 

 

 

Other income

     3,063        2,516  
  

 

 

    

 

 

 

Total revenues and other income

     9,242        10,827  
  

 

 

    

 

 

 

 

(1)

Revenues from United States concern Calyxt only.

Revenues by nature

 

     For the three-month period ended
September 30,
 
     2020      2021  
               
     $ in thousands  

Recognition of previously deferred upfront payments

     (0      —    

Other revenues from collaboration agreements (1)

     116        (149
  

 

 

    

 

 

 

Collaboration agreements

     116        (149
  

 

 

    

 

 

 

Licenses

     651        115  

Products & services

     5,413        8,345  
  

 

 

    

 

 

 

Total revenues

     6,179        8,312  
  

 

 

    

 

 

 

 

(1)

For the three months ended September 30, 2021, the negative impact corresponds to Cytovia’s convertible note revaluation which has been reclassified to financial result in the three months ended June 30, 2021.

 

19


3.2 Operating expenses

3.2.1 For the nine-month period ended September 30

 

     For the nine-month period ended
September 30,
 
     2020      2021  
               

Cost of goods sold

     (16,265      (27,512

Royalty expenses

     (1,894      (1,601
  

 

 

    

 

 

 

Cost of revenue

     (18,159      (29,113
  

 

 

    

 

 

 
     For the nine-month period ended
September 30,
 
Research and development expenses    2020      2021  
               

Wages and salaries

     (20,053      (30,845

Social charges on stock option grants

     —          (920

Non-cash stock-based compensation expense

     (5,819      (7,983
  

 

 

    

 

 

 

Personnel expenses

     (25,871      (39,749
  

 

 

    

 

 

 

Purchases and external expenses

     (32,214      (48,341

Other

     (5,509      (8,573
  

 

 

    

 

 

 

Total research and development expenses

     (63,594      (96,663
  

 

 

    

 

 

 
     For the nine-month period ended
September 30,
 
Selling, general and administrative expenses    2020      2021  
               

Wages and salaries

     (11,940      (12,308

Social charges on stock option grants

     —          (357

Non-cash stock-based compensation expense

     (6,989      (1,577
  

 

 

    

 

 

 

Personnel expenses

     (18,929      (14,242
  

 

 

    

 

 

 

Purchases and external expenses

     (9,663      (9,393

Other

     (3,173      (4,258
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (31,765      (27,894
  

 

 

    

 

 

 
     For the nine-month period ended
September 30,
 
Personnel expenses    2020      2021  
               

Wages and salaries

     (31,993      (43,153

Social charges on stock option grants

     —          (1,278

Non-cash stock-based compensation expense

     (12,808      (9,560
  

 

 

    

 

 

 

Total personnel expenses

     (44,800      (53,991
  

 

 

    

 

 

 

 

20


3.2.2 For the three-month period ended September 30

 

     For the three-month period ended
September 30,
 
     2020      2021  
               

Cost of goods sold

     (7,148      (8,807

Royalty expenses

     (672      (407
  

 

 

    

 

 

 

Cost of revenue

     (7,820      (9,213
  

 

 

    

 

 

 
     For the three-month period ended
September 30,
 
Research and development expenses    2020      2021  
               

Wages and salaries

     (6,766      (9,982

Social charges on free shares and stock option grants

     —          (76

Non-cash stock-based compensation expense

     (730      (3,454
  

 

 

    

 

 

 

Personnel expenses

     (7,496      (13,511
  

 

 

    

 

 

 

Purchases and external expenses

     (10,650      (17,444

Other

     (1,956      (3,369
  

 

 

    

 

 

 

Total research and development expenses

     (20,103      (34,324
  

 

 

    

 

 

 
     For the three-month period ended
September 30,
 
Selling, general and administrative expenses    2020      2021  
               

Wages and salaries

     (4,045      (3,125

Social charges on free shares and stock option grants

     —          (7

Non-cash stock-based compensation expense

     (2,586      (2,086
  

 

 

    

 

 

 

Personnel expenses

     (6,630      (5,218
  

 

 

    

 

 

 

Purchases and external expenses

     (2,420      (2,974

Other

     (1,251      (1,483
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (10,301      (9,675
  

 

 

    

 

 

 
     For the three-month period ended
September 30,
 
Personnel expenses    2020      2021  
               

Wages and salaries

     (10,811      (13,107

Social charges on free shares and stock option grants

     —          (83

Non-cash stock-based compensation expense

     (3,316      (5,540
  

 

 

    

 

 

 

Total personnel expenses

     (14,126      (18,730
  

 

 

    

 

 

 

 

21


3.3 Reportable segments

Accounting policies

Reportable segments are identified as components of the Group that have discrete financial information available for evaluation by the Chief Operating Decision Maker (“CODM”), for purposes of performance assessment and resource allocation.

For the three-month and nine-month periods ended September 30, 2021, Cellectis’ CODM is composed of:

 

 

The Chief Executive Officer;

 

 

The Executive Vice President Strategic Initiatives;

 

 

The Executive Vice President Global Quality (until March 31, 2021);

 

 

The Senior Vice President Europe Technical Operations;

 

 

The Senior Vice President of US Manufacturing;

 

 

The Chief Scientific Officer;

 

 

The Chief Financial Officer;

 

 

The General Counsel;

 

 

The Chief Business Officer;

 

 

The Chief Regulatory & Pharmaceutical Compliance Officer;

 

 

The Chief Medical Officer; and

 

 

The Chief Human Resources Officer.

We view our operations and manage our business in two operating and reportable segments that are engaged in the following activities:

 

 

Therapeutics: This segment is focused on the development (i) gene-edited allogeneic Chimeric Antigen Receptor T-cells product candidates (UCART) in the field of immuno-oncology (UCART) and (ii) gene-edited hematopoetic stem cells (HSC) product candidates in other therapeutic indications. These approaches are based on our core proprietary technologies. All these activities are supported by Cellectis S.A., Cellectis, Inc. and Cellectis Biologics, Inc. The operations of Cellectis S.A., the parent company, are presented entirely in the Therapeutics segment which also comprises research and development, management and support functions.

 

 

Plants: This segment is focused on using Calyxt’s proprietary PlantSpringTM 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 diversified product offerings will primarily be delivered through its proporietary BioFactory production system. It corresponds to the activity of our U.S.-based majority-owned subsidiary, Calyxt, which is currently based in Roseville, Minnesota.

There are inter-segment transactions between the two reportable segments, including allocation of corporate general and administrative expenses by Cellectis S.A. and allocation of research and development expenses to the reportable segments.

 

22


With respect to corporate general and administrative expenses, Cellectis S.A. has provided Calyxt, with general sales and administrative functions, accounting and finance functions, investor relations, intellectual property, legal advice, human resources, communication and information technology under a Management Services Agreement. Effective with the end of the third quarter 2019, Calyxt has internalized nearly all of the services previously provided by Cellectis under this agreement. Under the Management Services Agreement, Cellectis S.A. charges Calyxt, in euros at cost plus a mark-up ranging between zero to 10%, depending on the nature of the service. Amounts due to Cellectis S.A. pursuant to inter-segment transactions bear interest at a rate of the 12-month Euribor plus 5% per annum.

The intersegment revenues represent the transactions between segments. Intra-segment transactions are eliminated within a segment’s results and intersegment transactions are eliminated in consolidation as well as in key performance indicators by reportable segment.

Information related to each reportable segment is set out below. Segment revenues and other income, research and development expenses, selling, general and administrative expenses, and cost of revenue and other operating income and expenses, and adjusted net income (loss) attributable to shareholders of Cellectis (which does not include non-cash stock-based compensation expense) are used by the CODM for purposes of making decisions about allocating resources to the segments and assessing their performance. The CODM does not review any asset or liability information by segment or by region.

Adjusted net income (loss) attributable to shareholders of Cellectis S.A. is not a 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, our management believes 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.

The net income (loss) by segment includes the impact of the operations between segments while the intra-segment operations are eliminated.

 

23


Details of key performance indicators by reportable segment for the nine-month periods ended September 30,

 

     For the nine-month period ended
September 30, 2020
    For the nine-month period ended
September 30, 2021
 
                                      
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 
                                      

External revenues

     9,960       50,077       60,037       25,004       20,085       45,088  

External other income

     —         6,510       6,510       1,528       6,792       8,320  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     9,960       56,587       66,547       26,532       26,876       53,408  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (16,600     (1,558     (18,159     (27,512     (1,601     (29,113

Research and development expenses

     (7,391     (56,203     (63,594     (8,358     (88,304     (96,663

Selling, general and administrative expenses

     (16,227     (15,538     (31,765     (11,520     (16,373     (27,894

Other operating income and expenses

     (148     (142     (291     25       481       506  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (40,367     (73,442     (113,810     (47,366     (105,797     (153,163
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (30,407     (16,855     (47,263     (20,834     (78,921     (99,755
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net financial gain (loss)

     (510     (4,223     (4,733     (875     3,603       2,728  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (30,917     (21,078     (51,996     (21,709     (75,318     (97,027
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-controlling interests

     10,391       —         10,391       7,827       —         7,827  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (20,528     (21,077     (41,605     (13,883     (75,318     (89,201
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     556       5,005       5,561       682       6,922       7,604  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     2,936       2,691       5,627       (208     1,901       1,693  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     3,492       7,696       11,188       474       8,823       9,297  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (17,037     (13,381     (30,418     (13,409     (66,495     (79,904
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (1,485     (5,290     (6,776     (1,834     (9,651     (11,485

Additions to tangible and intangible assets

     973       40,983       41,956       377       14,446       14,822  

 

24


Details of key performance indicators by reportable segment for three-month periods ended September 30,

 

     For the three-month period ended
September 30, 2020
    For the three-month period ended
September 30, 2021
 
                                      
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     5,401       778       6,179       8,288       24       8,312  

External other income

     —         3,063       3,063       0       2,516       2,516  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     5,401       3,841       9,242       8,288       2,540       10,827  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (7,481     (339     (7,820     (8,807     (407     (9,213

Research and development expenses

     (2,071     (18,031     (20,103     (2,523     (31,802     (34,324

Selling, general and administrative expenses

     (4,278     (6,024     (10,301     (3,992     (5,683     (9,675

Other operating income and expenses

     (115     (259     (374     18       (1     18  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (13,943     (24,652     (38,595     (15,304     (37,892     (53,195
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (8,542     (20,812     (29,353     (7,016     (35,352     (42,368
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     (373     (3,877     (4,250     (291     2,588       2,296  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (8,914     (24,688     (33,602     (7,307     (32,764     (40,071
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-controlling interests

     3,305       —         3,305       2,658       —         2,658  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (5,610     (24,688     (30,297     (4,650     (32,764     (37,413
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     (539     2,022       1,483       151       3,219       3,370  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     1,059       1,030       2,089       707       986       1,693  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     520       3,052       3,572       858       4,204       5,062  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (5,090     (21,636     (26,726     (3,792     (28,560     (32,351
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (505     (2,115     (2,620     (615     (3,708     (4,323

Additions to tangible and intangible assets

     636       10,962       11,598       69       3,426       3,495  

 

25


Note 4. Impairment tests

Our cash-generating units (“CGUs”) correspond to the operating/reportable segments: Therapeutics and Plants.

No indicator of impairment has been identified for any intangible or tangible assets in the CGUs at September 30, 2021.

Note 5. Right-of-use assets

Details of Right-of-use assets

The breakdown of right-of-use assets is as follows:

 

     Building
lease
     Office and
laboratory
equipment
     Total  
                      
     $ in thousands  

Net book value as of January 1, 2020

     43,111        2,500        45,612  
  

 

 

    

 

 

    

 

 

 

Additions to tangible assets

     19,666        2,865        22,532  

Depreciation expense

     (3,581      (986      (4,567

Translation adjustments

     636        101        737  
  

 

 

    

 

 

    

 

 

 

Net book value as of September 30, 2020

     59,833        4,481        64,313  
  

 

 

    

 

 

    

 

 

 

Gross value at end of period

     67,598        6,151        73,749  

Accumulated depreciation at end of period

     (7,765      (1,671      (9,436

Net book value as of January 1, 2021

     62,424        11,421        73,845  
  

 

 

    

 

 

    

 

 

 

Additions

     (139      6,024        5,884  

Depreciation expense

     (4,310      (2,336      (6,646

Translation adjustments

     (1,017      (168      (1,185
  

 

 

    

 

 

    

 

 

 

Net book value as of September 30, 2021

     56,957        14,941        71,899  
  

 

 

    

 

 

    

 

 

 

Gross value at end of period

     70,252        19,487        89,739  

Accumulated depreciation at end of period

     (13,295      (4,546      (17,840

 

26


Note 6. Property, plant and equipment

 

     Lands and
Buildings
    Technical
equipment
    Fixtures,
fittings
and other
equipment
    Assets under
construction
    Total  
                                
     $ in thousands  

Net book value as of January 1, 2020

     3,330       3,160       2,435       14,787       23,712  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     3,065       935       462       37,438       41,900  

Disposal of tangible assets

     —         (9     (17     (1     (27

Reclassification

     4,719       600       240       (5,559     0  

Depreciation expense

     (481     (976     (618     —         (2,075

Translation adjustments

     365       47       31       119       562  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of September 30, 2020

     10,998       3,757       2,532       46,784       64,071  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     16,176       15,901       4,908       46,784       83,769  

Accumulated depreciation and impairment at end of period

     (5,178     (12,144     (2,376     (0     (19,698

Net book value as of January 1, 2021

     16,765       4,436       3,171       47,301       71,673  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     2,943       4,762       1,066       6,052       14,822  

Disposal of tangible assets

     —         (0     56       (58     (2

Reclassification

     (1,686     52,246       (611     (50,242     (293

Depreciation expense

     (1,398     (2,760     (540     —         (4,698

Translation adjustments

     (643     (163     (54     (100     (961
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of September 30, 2021

     15,982       58,520       3,087       2,953       80,542  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     22,780       74,871       4,874       2,953       105,478  

Accumulated depreciation and impairment at end of period

     (6,799     (16,351     (1,786     (0     (24,936

For the nine-month period ended September 30, 2021, we continued our investments in research and development equipment in both the United States of America and France. The addition in tangible assets reflects improvements of Cellectis sites for $3.0 million and other equipment for $5.8 million ($4.8 million of technical equipment and $1.0 million of other equipment).

Assets under construction as of September 30, 2021 primarily relates to Cellectis’ raw and starting materials manufacturing facility and offices in Paris ($1.2 million), and the manufacturing facility in Raleigh, North Carolina ($1.0 million), and the balance relates to capital expenditure in Cellectis’ New York office and in the Plants Segment. The assets put into service in 2021 mainly concern Cellectis’

 

27


Raleigh manufacturing facilities and offices for $47.2 million, with the remaining part relating to Cellectis Paris’ manufacturing facility for $2.0 million and Calyxt.

Note 7. Non-current financial assets

On February 12, 2021, Cellectis entered into an agreement with Cytovia Therapeutics, Inc. (“the Cytovia agreement”). The consideration to Cellectis includes a convertible note for $15 million issued by Cytovia to Cellectis upon the signature of the contract (which may be settled in cash or converted to equity of Cytovia under certain conditions). This convertible note does not bear interest. As of September 30, 2021, management has determined that the fair value of the note approximates its carrying value. The fair value measurement of the convertible note is categorized within Level 1. No credit loss is expected related to this convertible note.

As of September 30, 2021, non-current financial assets include also a $2.6 million deposit for the Cellectis facility in Raleigh and $1.9 million related to an equipment lease with Stonebriar Commercial Finance LLC.

Note 8. Trade receivables and other current assets

8.1 Trade receivables

 

     As of December 31,
2020
     As of September 30,
2021
 
     $ in thousands  

Trade receivables

     5,787        378  

Valuation allowance

     (616      (30
  

 

 

    

 

 

 

Total net value of trade receivables

     5,171        349  
  

 

 

    

 

 

 

All trade receivables have payment terms of less than one year. The trade receivables as of September 30, 2021 are mainly due to Calyxt’s soybean products sales.

8.2 Subsidies receivables

 

     As of December 31,
2020
     As of September 30,
2021
 
               
     $ in thousands  

Research tax credit

     10,703        7,971  
  

 

 

    

 

 

 

Total subsidies receivables

     10,703        7,971  
  

 

 

    

 

 

 

Research tax credit receivables as of September 30, 2021 include the accrual for a French research tax credit related to 2021 for $6.9 million, and to previous periods for $1.1 million. During December 2018, the French Tax Authority initiated an audit related to the 2014, 2015, 2016 and 2017 French research tax credits. Based on our current evaluation of the status of the audit, we do not believe that a provision should be recorded as of September 30, 2021.

 

28


8.3 Other current assets

 

     As of December 31,
2020
     As of September 30,
2021
 
               
     $ in thousands  

VAT receivables

     3,093        1,834  

Prepaid expenses and other prepayments

     14,113        12,403  

Tax and social receivables

     227        78  

Deferred expenses and other current assets

     12,210        439  
  

 

 

    

 

 

 

Total other current assets

     29,643        14,753  
  

 

 

    

 

 

 

Prepaid expenses and other prepayments primarily include advances to our sub-contractors on research and development activities. These mainly relate to advance payments to suppliers of biological raw materials and to third parties participating in product manufacturing.

During the year ended December 31, 2020, and the nine-month period ended September 30, 2021, we prepaid certain manufacturing costs related to our product candidates UCART 123, UCART 22 and UCART CS1 of which the delivery of products or services is expected in the coming months.

As of December 31, 2020, deferred expenses and other current assets mainly relates to a $6.2 million receivable following Cellectis’ employees’ option exercises which was subsequently received, a Calyxt broker receivable and certain down payments to suppliers for $2.7 million, as well as a right of $3.0 million to obtain equipment at our Raleigh facility which generated an equivalent financial liability. As of September 30, 2021, deferred expenses and other current assets mainly relates to down payments to suppliers for Cellectis’ manufacturing facility in Paris. All equipment at our Raleigh facility has been received.

As of December 31, 2020, and as of September 30, 2021, tax and social receivables relate mainly to social charges on personnel expenses.

Note 9. Current financial assets and Cash and cash equivalents

 

As of December 31, 2020    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated fair
value
 
                      
     $ in thousands  

Current financial assets

     27,091        —          27,091  

Cash and cash equivalents

     241,148        —          241,148  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     268,239        —          268,239  
  

 

 

    

 

 

    

 

 

 
As of September 30, 2021    Carrying
amount
     Unrealized Gains/(Losses)      Estimated fair
value
 
                      
     $ in thousands  

Current financial assets

     393        —          393  

Cash and cash equivalents

     210,709        —          210,709  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     211,102        —          211,102  
  

 

 

    

 

 

    

 

 

 

 

29


9.1 Current financial assets

Current financial assets include current restricted cash and other current financial assets.

As of September 30, 2021, current restricted cash consists of deposits to secure a Calyxt furniture and equipment sale-leaseback for $1.0 million of which $0.4 million are classified as short-term restricted cash and included within current financial assets. As of December 31, 2020, current restricted cash also included a deposit to secure commitment to suppliers regarding the manufacturing facility construction for $15 million. As of September 30, 2021, the construction of the facility is completed, and no cash amount is restricted in relation to that commitment.

Other current financial assets are measured at fair value through profit or loss and are classified as follows within the fair value hierarchy:

Instruments classified under level 1 are measured with reference to quoted prices in active markets; they consist of corporate debt securities and commercial paper. Their nominal value and their fair value amounted to $0.0 million in each case as of September 30, 2021 and to $11.7 million as of December 31, 2020.

9.2 Cash and cash equivalents

 

     As of December 31,
2020
     As of September 30,
2021
 
               
     $ in thousands  

Cash and bank accounts

     164,586        156,216  

Money market funds

     13,977        13,967  

Fixed bank deposits

     62,585        40,527  
  

 

 

    

 

 

 

Total cash and cash equivalents

     241,148        210,709  
  

 

 

    

 

 

 

Money market funds earn interest and are refundable overnight. Fixed bank deposits have fixed terms that are less than three months or are readily convertible to a known amount of cash and are subject to an insignificant risk of changes in value.

 

30


Note 10. Financial liabilities

10.1 Detail of financial liabilities

 

     As of December 31,
2020
     As of September 30,
2021
 
               
     $ in thousands  

Lease debts

     75,764        73,730  

State Guaranteed loan « PGE »

     22,701        21,480  

PPP loan

     1,518        —    

Other non-current financial liabilities

     4,617        1,288  
  

 

 

    

 

 

 

Total non-current financial liabilities and non-current lease debts

     104,600        96,497  
  

 

 

    

 

 

 

Lease debts

     6,696        8,079  
  

 

 

    

 

 

 

Total current financial liabilities

     6,696        8,079  
  

 

 

    

 

 

 

Trade payables

     24,609        22,809  

Other current liabilities

     19,127        14,024  
  

 

 

    

 

 

 

Total Financial liabilities

     155,032        141,410  
  

 

 

    

 

 

 

As of September 30, 2021, the other non-current financial liabilities is composed of Cellectis’ obtention in 2020 of a $1.3 million loan to finance leasehold improvement at its location in New York.

PPP loan corresponds to Calyxt’s obtention of a $1.5 million paycheck protection program (PPP) loan under the U.S. Coronavirus Aid, Relief and Economic Security (CARES) Act, for which Calyxt has obtained full forgiveness on April 8, 2021, from the Small Business Administration, which administers the PPP loan program, and recognized as other income in the three months ended June 30, 2021.

State Guaranteed loan (or “Prêt Garanti par l’Etat”, or “PGE”) corresponds to Cellectis’ obtention of an €18.5 million (or $21.4 million using exchange rate as of September 30, 2021) loan from a bank syndicate formed with HSBC, Société Générale, Banque Palatine and Bpifrance in the form of a PGE. Initiated by the French Government to support companies during the COVID-19 crisis, the PGE is a bank loan with a fixed interest rate ranging from 0.31% to 3.35%. After an initial interest-only term of two years, the loan will be amortized over up to four years at the option of the Company. The French government guarantees 90% of the borrowed amount.

10.2 Due dates of the financial liabilities

 

Balance as of September 30, 2021    Book value      Less than One
Year
     One to Five
Years
     More than Five
Years
 
                             
     $ in thousands  

Lease debts

     81,809        8,079        33,682        40,048  

Other financial liabilities

     22,767        1,021        21,231        515  
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

     104,577        9,101        54,913        40,563  
  

 

 

    

 

 

    

 

 

    

 

 

 

Trade payables

     22,809        22,809        —          —    

Other current liabilities

     14,024        14,024        —          —    

Total financial liabilities

     141,410        45,934        54,913        40,563  

 

31


Note 11. Other current liabilities

 

     As of December 31,
2020
     As of September 30,
2021
 
               
     $ in thousands  

VAT Payables

     81        246  

Accruals for personnel related expenses

     12,969        10,822  

Other

     6,077        2,957  
  

 

 

    

 

 

 

Total

     19,127        14,024  
  

 

 

    

 

 

 

Accruals for personnel are related to annual bonuses, vacations accruals and social expenses on stock options. The decrease in accruals for personnel related expenses between December 31, 2020 and September 30, 2021 is mainly explained by the timing of the yearly bonus accrual.

The decrease in other between December 31, 2020 and September 30, 2021, is mainly driven by fixed assets accruals.

Note 12. Deferred revenues and contract liabilities

 

     As of December 31, 2020      As of September 30, 2021  
               
     $ in thousands  

Deferred revenues and contract liabilities

     452        500  
  

 

 

    

 

 

 

Total Deferred revenue and contract liabilities

     452        500  
  

 

 

    

 

 

 

 

32


Note 13. Share capital and premium related to the share capitals

 

Nature of the Transactions

   Share
Capital
            Share
premium
           Number of
shares
     Nominal
value
 
                                          
     $ in thousands (except number of shares)      in $  

Balance as of January 1, 2020

     2,767           843,478          42,465,669        0.05  

Exercise of share warrants, employee warrants and stock options

     1           174          20,464        —    

Non-cash stock-based compensation expense

     —             7,696          —          —    
  

 

 

       

 

 

      

 

 

    

 

 

 

Balance as of September 30, 2020

     2,768        —          851,348       —          42,486,133        0.05  
  

 

 

       

 

 

      

 

 

    

 

 

 

Balance as of January 1, 2021

     2,785           863,911          42,780,186        0.05  

Capital increase (ATM)

     145           47,334          2,415,630        —    

Exercise of share warrants, employee warrants and stock options

     17           5,660          279,494        —    

Non-cash stock-based compensation expense

     —             9,297          —          —    

Transaction costs

     —             (881        —          —    

Other movements

     —             (30        —          —    
  

 

 

       

 

 

      

 

 

    

 

 

 

Balance as of September 30, 2021

     2,946           925,290          45,475,310        0.05  
  

 

 

       

 

 

      

 

 

    

 

 

 

Capital evolution during the nine-month period ended September 30, 2021

 

   

During the nine-month period ended September 30, 2021, 2,415,630 shares were issued through Cellectis’At-The-Market (“ATM”) financing program and 256,494 shares were issued as a result of the exercise of stock options and non-employee warrants.

 

   

During the nine-month period ended September 30, 2021, $0.9 million of issuance costs related to the Cellectis ATM financing program were recorded as a reduction of share premium, in conjunction with share issuances that occurred in April 2021.

 

   

During the nine-month period ended September 30, 2021, 23,000 free shares were converted to 23,000 ordinary shares.

Note 14. Non-cash stock-based compensation

14.1 Detail of Cellectis equity awards

Holders of vested Cellectis stock options and non-employee warrants are entitled to exercise such options and warrants to purchase Cellectis ordinary shares at a fixed exercise price established at the time such options and warrants are granted during their useful life.

For stock options and non-employee warrants, we estimate the fair value of each option on the grant date or other measurement date if applicable using a Black-Scholes option-pricing model, which requires us to make predictive assumptions regarding future stock price volatility, employee exercise behavior, dividend yield, and the forfeiture rate. We estimate our future stock price volatility based on Cellectis historical closing share prices over the expected term period. Our expected term represents the period of time that options granted are expected to be outstanding determined using the simplified method. The risk-free interest rate for periods during the expected term of the options is based on the French government securities with maturities similar to the expected term of the options in effect at

 

33


the time of grant. We have never declared or paid any cash dividends and do not presently plan to pay cash

dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero. Options may be priced at 100 percent or more of the fair market value on the date of grant, and generally vest over four years after the date of grant. Options generally expire within ten years after the date of grant.

Stock Options

The weighted-average fair values of stock options granted and the assumptions used for the Black-Scholes option pricing model were as follows:

 

     2020    2021

Weighted-Average fair values of stock options granted

   7.00€    5.79€

Assumptions:

     

Risk-free interest rate

   0.00%    0.00%

Share entitlement per options

   1    1

Exercise price

   8.27€ - 15.84€    11.51€ - 19.44€

Grant date share fair value

   9.14€ - 15.76€    11.22€ - 16.54€

Expected volatility

   61.3% - 62.8%    58.4% - 60.1%

Expected term (in years)

   6.15    6.15

Vesting conditions

   Service    Service

Vesting period

   Graded    Graded

Information on stock option activity follows:

 

     Options
Exercisable
     Weighted-
Average
Exercise Price
Per Share
    Options
Outstanding
    Weighted-
Average
Exercise Price
Per Share
    Remaining
Average
Useful Life
 

Balance as of December 31, 2019

     6,922,172        26.30  €      9,672,382       24.22  €      6.8y  

Granted

     —          —         479,000       12.54  €   

Exercised

     —          —         (291,053     17.86  €   

Forfeited or Expired

     —          —         (373,672     20.61  €   

Balance as of December 31, 2020

     8,002,398        25.28  €      9,486,657       23.97  €      5.9y  

Granted

     —          —         1,016,435       18.90  €   

Exercised

     —          —         (253,494     18.49  €   

Forfeited or Expired

     —          —         (761,482     23.10  €   

Balance as of September, 2021

     7,687,802        25.06  €      9,488,116       23.64  €      5.6y  

Share-based compensation expense related to stock option awards was $4.0 million and $7.1 million for the nine-month period ended September 30, 2021 and 2020, respectively.

 

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Non-Employee Warrants

 

     Warrants
Exercisable
     Weighted-
Average
Exercise
Price Per
Share
    Warrants
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
    Remaining
Average
Useful Life
 

Balance as of December 31, 2019

     852,260        35.35  €      918,927       35.12  €      6.9y  

Granted

     —          —         —         —      

Exercised

     —          —         (19,702     8.28 €   

Forfeited or Expired

     —          —         —         —      

Balance as of December 31, 2020

     899,225        27.15  €      899,225       27.15  €      5.3y  

Granted

     —          —         —         —      

Exercised

     —          —         (3,000     18.68  €   

Forfeited or Expired

     —          —         —         —      

Balance as of September 30, 2021

     896,225        27.18  €      896,225       27.18  €      4.6y  

No non-employee Warrants (or “Bons de Souscriptions d’Actions” or “BSA”) have been granted during the periods presented.

There was no share-based compensation expense related to non-employee warrants awards for the nine-month period ended September 30, 2021 while share-based compensation expense related to warrants awards was $0.3 million for the three-month period ended September 30, 2020.

Free shares

The free shares granted prior to 2018 are subject to a two-year vesting period and additional two-year holding period for French residents and four-years vesting period for foreign residents.

The free shares granted in 2018 and until 2021 are subject to at least one-year vesting and additional one-year vesting period for French residents and two-years vesting period for foreign residents. The vesting of free shares granted to executive officers of the Company in October 2020 are subject to performance conditions with a minimum vesting of a 3-year period.

The free shares granted in 2021 and after are subject to a three-year vesting period for all employees, provided that the free shares granted to executive officers are subject to performance conditions with a minimum vesting of a 3-year period.

 

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     Number of Free shares
Outstanding
     Weighted-Average
Grant Date Fair Value
 

Unvested balance at December 31, 2019

     67,000        13.98  € 

Granted (1)

     591,685        20.10  € 

Vested

     (3,000      23.84  € 

Cancelled

     (26,035      16.45  € 

Unvested balance at December 31, 2020

     629,650        19.59  € 

Granted

     503,016        8.43 € 

Vested

     (23,000      15.35  € 

Cancelled

     (155,855      15.46  € 

Unvested balance at September 30, 2021

     953,811        14.48  € 

 

(1)

423,285 free shares have been granted in October 2020 under the Amended Second Free Shares 2018 Plan and are under non-market performance vesting conditions and with a minimum vesting period of three years. These free shares have been granted to a large number of our employees. 330,041 free shares have been granted in March 2021 under the Amended Second Free Shares 2018 Plan with a minimum vesting period of three years, and 103,000 of which granted to executive officers are under non-market performance vesting conditions. These free shares have been granted to a large number of our employees.

The fair value of free shares corresponds to the grant date share fair value.

We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero in determining fair value.

Share-based compensation expense related to free shares awards was $4.9 million and $0.3 million for the nine-month period ended September 30, 2021 and 2020, respectively.

14.2 Detail of Calyxt equity awards

Stock Options

The estimated fair values of stock options granted and the assumptions used for the Black-Scholes option pricing model were as follows:

 

     2020    2021
  

 

  

 

Weighted-Average fair values of stock options granted

   $3.32    $3.93

Assumptions:

     

Risk-free interest rate

   0.3%-1.7%    0.6%-1.1%

Share entitlement per options

   1    1

Expected volatility

   77.4%-81.2%    80.1%-82.0%

Expected term (in years)

   6.0-10.0    5.5 - 6.5

Vesting conditions

   Service    Service

Vesting period

   Graded    Graded

 

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Calyxt estimates the fair value of each option on the grant date or other measurement date if applicable using a Black-Scholes option-pricing model, which requires Calyxt to make predictive assumptions regarding future stock price volatility, employee exercise behavior, dividend yield, and the forfeiture rate. Calyxt estimates its future stock price volatility using the historical volatility of comparable public companies over the expected term of the option.

Calyxt’s expected term represents the period of time that options granted are expected to be outstanding determined using the simplified method.

The risk-free interest rate for periods during the expected term of the options is based on the U.S. Treasury zero-coupon yield curve in effect at the time of grant.

Calyxt has not paid and does not expect to pay dividends for the foreseeable future.

Options may be priced at 100 percent or more of the fair market value on the date of grant, and generally vest over six years after the date of grant. Options generally expire within ten years after the date of grant. Certain awards granted before Calyxt’s IPO contained accelerated vesting provisions if certain events occurred as defined in the option agreement.

 

     Options
Exercisable
     Weighted-
Average
Exercise
Price Per
Share
     Options
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
     Remaining
Average
Useful Life
 

Balance as of December 31, 2019

     1,789,567      $ 8.73        4,481,359     $ 11.73        6.8y  

Granted

     —          —          887,765     $ 4.67     

Exercised

     —          —          (58,575   $ 3.60     

Forfeited or Expired

     —          —          (689,376   $ 12.89     

Balance as of December 31, 2020

     2,347,663      $ 10.15        4,621,173     $ 10.30        6.2y  

Granted

     —          —          656,959     $ 5.70     

Exercised

     —          —          (61,372   $ 3.70     

Forfeited or Expired

     —          —          (602,892   $ 10.84     

Balance as of September 30, 2021

     2,685,450      $ 10.18        4,613,868     $ 9.66        5.8y  

Stock-based compensation expense related to stock option awards was an expense of $1.1 million, compared to an expense of $2.4 million for the nine-month period ended September 30, 2021 and 2020, respectively.

Restricted Stock Units

Units settled in stock subject to a restricted period may be granted to key employees under the 2017 Omnibus Plan. Restricted stock units generally vest and become unrestricted over five years after the date of grant.

 

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     Number of
Restricted Stock
Units Outstanding
     Weighted-Average
Grant Date
Fair Value
 

Unvested balance at December 31, 2020

     547,807      $ 9.49  

Granted

     346,981      $ 4.99  

Vested

     (165,137    $ 7.40  

Cancelled

     (153,631    $ 11.85  

Unvested balance at September 30, 2021

     576,020      $ 6.75  

The fair value of restricted stock units corresponds to the grant date share fair value.

Calyxt has not paid and does not expect to pay dividends for the foreseeable future.

Share-based compensation expense related to restricted stock units awards was a favorable impact of $0.3 million due to options forfeiture, compared to an expense of $0.9 million for the nine-month periods ended September 30, 2021 and 2020, respectively.

Performance Stock Unit

In June 2019, Calyxt granted performance stock units, which carry a market condition based on Calyxt share price. These awards contain a continuous service period of three years, the performance period, from the date of grant, followed by a restricted period of two years if the shares are issued following the performance period during which the grantee is required to provide continuous service and the awarded shares must be held by the grantee until the end of the period. The number of shares of common stock delivered following the performance period depends upon the change in Calyxt share price during the performance period. Calyxt granted a targeted 311,667 performance stock units. The performance criteria allow for the actual payout to be between zero and 120 percent of target. The fair value of the performance stock units and the assumptions used for the Monte Carlo simulation were as follows:

 

Date of grant

   06/28/2019  

Estimated fair values of performance stock units granted

   $ 7.06  

Assumptions:

  

Risk-free interest rate

     1.71

Expected volatility

     75.0

Expected term (in years)

     3.0 years  

 

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Information on performance stock unit activity follows:

 

     Number of
Performance
Stock Units
Outstanding
 

Unvested balance at December 31, 2020

     311,667  

Granted

     600,000  

Vested

     —    

Cancelled

     -166,667  

Unvested balance at September 30, 2021

     745,000  

The 600,000 performance stock units granted during the nine-months ended September 30, 2021 relate to shares of common stock of Calyxt that are issuable under an Employee Inducement Incentive Plan and were granted to Mr. Michael A. Carr in July 2021 as a material inducement to accept employment as Calyxt’s President and Chief Executive Officer.

Share-based compensation expense related to performance stock units awards was a favorable impact of $0.1 million due to options forfeiture, compared to an expense of $0.3 million for the nine-month periods ended September 30, 2021 and 2020, respectively.

Note 15. Earnings per share

15.1 For the nine-month periods ended September 30,

 

     For the nine-month period ended
September 30,
 
     2020      2021  

Net income (loss) attributable to shareholders of Cellectis ($ in thousands)

     (41,605      (89,201

Adjusted weighted average number of outstanding shares, used to calculate both basic and diluted net result per share

     42,474,764        44,599,935  

Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis

     

Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share)

     (0.98      (2.00

Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share)

     (0.98      (2.00

When we have adjusted net loss, in accordance with IFRS, we use the weighted average number of outstanding shares, basic to compute the diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the weighted average number of outstanding shares, diluted to compute the diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share).

 

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15.2 For the three-month periods ended September 30

 

     For the three-month period ended
September 30,
 
     2020      2021  

Net income (loss) attributable to shareholders of Cellectis ($ in thousands)

     (30,297      (37,413

Adjusted weighted average number of outstanding shares, used to calculate both basic and diluted net result per share

     42,486,133        45,471,977  

Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis per share ($ / share)

     

Basic net income (loss) per share ($ /share)

     (0.71      (0.82

Diluted net income (loss) per share ($ /share)

     (0.71      (0.82

When we have adjusted net loss, in accordance with IFRS, we use the weighted average number of outstanding shares, basic to compute the diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the weighted average number of outstanding shares, diluted to compute the diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share).

 

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Note 16. Provisions

 

     31/12/2020      Additions      Amounts
used
during
the
period
    Reversals     OCI     30/09/2021  
              
     $ in thousands  

Pension

     4,010        436        —         —         (594     3,851  

Loss on contract

     —          —          —         —         —         —    

Employee litigation and severance

     560        67        (101     (83     (27     416  

Commercial litigation

     571        3,781        (193     (244     (141     3,774  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total

     5,141        4,284        (294     (327     (763     8,041  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Non-current provisions

     4,010        436        —         —         (594     3,851  

Current provisions

     1,131        3,848        (294     (327     (168     4,190  

During the nine-month period ended September 30, 2021, additions mainly relate to (i) commercial litigation with suppliers for $3.8 million and (ii) pension service cost of the period for $0.4 million.

The amounts used and reversed during the period mainly relate to (i) the settlement of employee litigation for $0.2 million and (ii) the settlement of a commercial litigation for $0.4 million.

Note 17. Commitments

 

As of September 30, 2021

   Total      Less than 1
year
     1 - 3
years
     3 - 5
years
     More than 5
years
 
              
     $ in thousands  

License and collaboration agreements

     18,728        1,530        3,060        3,060        11,078  

Clinical & Research and Development agreements

     502        502        —          —          —    

IT licensing agreements

     1,101        445        655        —          —    

Other agreements

     73        73        —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total commitments

     20,403        2,550        3,715        3,060        11,078  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Obligations under the terms of license and collaboration agreements

We have entered into various license agreements with third parties that subject us to certain fixed license fees, as well as fees based on future events, such as research and sales milestones.

We also have collaboration agreements whereby we are obligated to pay royalties and milestone payments based on future events that are uncertain and therefore they are not included in the table above.

 

41


Obligations under the terms of Clinical & Research and Development agreements

We have entered into clinical and research and development agreements where we are obligated to pay for services to be provided regarding our research collaboration agreements, clinical trials and translational research projects.

Obligations under the terms of IT licensing agreements

We have entered into an IT licensing agreement and have related obligations to pay licensing fees.

Obligations under the terms of other agreements

As of September 30, 2021, other agreements relate to a license and service agreement at Calyxt for $0.1 million.

Note 18. Subsequent events

On September 21, 2021, Calyxt entered into an ATM financing program with Jefferies, acting as sole selling agent. Under the terms of the ATM program, Calyxt may, from time-to-time, issue common stock having an aggregate offering value of up to $50.0 million. At its discretion Calyxt determines the timing and number of shares to be issued under the ATM program.

As of September 30, 2021, Calyxt had not issued any shares of common stock under the ATM program. As of the date of this report, Calyxt has issued approximately 1.2 million shares of common stock under the ATM program for proceeds of $3.7 million net of commissions and payments for other share issuance costs.

 

42


Item 2. Management’s Discussion & Analysis of Financial Condition and Results of Operations

Overview

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, or 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 HSC product candidates in genetic diseases. HEAL is a new gene editing platform developed by Cellectis that leverages the power of TALEN® technology, to allow highly efficient gene inactivation, insertion and correction in HSPCs. Through the date of this interim report, Cellectis has announced preclinical programs in sickle cell disease, lysosomal storage disorders and primary immunodeficiencies.

We currently conduct our operations through two business segments, Therapeutics and Plants. Our Therapeutics segment is focused on the development of products in the field of immuno-oncology and monogenic diseases. Our Plants segment, carried out through our 64.2% (as of September 30, 2021) ownership in Calyxt, is using Calyxt’s proprietary PlantSpringTM technology platform to engineer plant metabolism produce innovative, high-value, and sustainable materials and products for use in helping customers meet their sustainability targets and financial goals. Calyxt’s diversified product offerings will primarily be delivered through its proporietary BioFactory production system, which Calyxt expects to be online by the end of 2021.

Since our inception in early 2000, we have devoted substantially all of our financial resources to research and development efforts. Our current research and development focuses primarily on our CAR T-cell immunotherapy and HSC product candidates, including conducting the pre-clinical activities, and preparing to conduct clinical studies of our UCART product candidates, providing general and administrative support for these operations and protecting our intellectual property.

We do not have any therapeutics products approved for sale and have not generated any revenues from therapeutic product sales.

For the nine-month period ended September 30, 2021, we derived all of our Therapeutics revenues from the receipt of a convertible note (to be settled in cash or equity of Cytovia, depending on certain conditions) in consideration for a license granted by a licensing arrangement with Cytovia, a milestone reached as part of our collaboration with Allogene and royalties on licensed technologies.

 

43


As of September 30, 2021, we were eligible to receive potential development and commercial milestone payments pursuant to (i) the License, Development and Commercialization Agreement dated March 6, 2019 between Servier and Cellectis, as amended on March 4, 2020 (the “Servier License Agreement”) of up to $410 million and (ii) the License Agreement dated March 7, 2019 between Allogene and Cellectis (the “Allogene License Agreement”) of up to $2.8 billion. Under the Allogene License Agreement, we are eligible to receive tiered royalties on annual worldwide net sales of any products that are commercialized by Allogene that contain or incorporate, are made using or are claimed or covered by, our intellectual property licensed to Allogene under the Allogene License Agreement at rates in the high single-digit percentages. Under the Servier License Agreement, we are eligible to receive flat low double-digit royalties based on annual net sales of commercialized products as well as a low double-digit royalty on certain development milestone payments received by Servier.

For the nine-month period ended September 30, 2021 no revenue was recorded under such agreements other than the revenue related to the Allogene and Cytovia agreements.

We are currently sponsoring clinical studies with respect to three proprietary Cellectis UCART product candidates at nine (9) sites for the AMELI-01 Study, at five (5) sites for the BALLI-01 Study, and at four (4) sites for the MELANI-01 Study, as follows:

 

   

The AMELI-01 Study is a Phase 1 dose-escalation clinical trial designed to evaluate the safety, expansion, persistence and clinical activities of UCART123 in-patients with relapsed or refractory acute myeloid leukemia (r/r AML). The AMELI-01 Study is currently open for patient recruitment at MD Anderson Cancer Center (Houston, Texas), H. Lee Moffitt Cancer Center & Research Institute (Tampa, Florida), Dana Farber Cancer Institute (Boston, Massachusetts), New York Presbyterian / Weill Cornell College of Cornell University (New York, New York), Northwestern University (Chicago, Illinois), University of Miami (Miami, Florida), the University of Pennsylvania (Philadelphia, Pennsylvania), Northwestern University (Evanston, Illinois) and the University of California, San Francisco Campus (San Francisco, California). AMELI-01 employs a modified toxicity probability interval dose escalation design to evaluate progressive dose levels of UCART123 in concert with fludarabine and cyclophosphamide (“FC”) or fludarabine, cyclophosphamide and alemtuzumab (“FCA”) regimens in patients with r/r AML. The AMELI-01 Study protocol allows for up to 28 patients to enroll in the dose escalation period and 18-37 patients in the dose expansion period of the Phase 1. As of the date of this interim report, the AMELI-01 Study is active at DL2i of the FCA lymphodepletion cohort.

 

   

The BALLI-01 Study is a Phase 1/2 dose-escalation and expansion clinical trial designed to evaluate the safety, expansion, persistence and clinical activities of UCART22 in-patients with relapsed or refractory acute lymphoblastic leukemia (r/r ALL). The BALLI-01 Study is currently open to patient recruitment at New York Presbyterian / Weill Cornell College of Cornell University (New York, New York), the University of Chicago (Chicago, Illinois), MD Anderson Cancer Center (Houston, Texas), University of California Los Angeles (Los Angeles, California) and Dana Farber Cancer Institute (Boston, Massachusetts). Similar to AMELI-01 Study, BALLI-01 Study protocol employs a modified toxicity probability interval dose escalation design to evaluate progressive dose levels of UCART22 in concert with FC or FCA regimens in patients with r/r ALL. The BALLI-01 Study protocol allows for up to 30 patients to enroll in the dose escalation period and 53 patients in the dose expansion period of the Phase 1/2a. As of the date of this interim report, the BALLI-01 Study is enrolling patients at DL2i in the dose escalation of the FCA lymphodepletion cohort, with at least one additional dose level planned.

 

44


   

The MELANI-01 Study is a Phase 1 dose-escalation clinical trial designed to evaluate the safety, expansion, persistence and clinical activities of UCARTCS1 in patients with relapsed or refractory multiple myeloma (r/r MM). The MELANI-01 Study is currently open to patient recruitment at Hackensack Meridian Health (Hackensack, New Jersey), MD Anderson Cancer Center (Houston, Texas), the University of California, San Francisco Campus (San Francisco, California), and Mayo Clinic (Rochester, Minnesota). The MELANI-01 Study protocol allows for up to 18 patients to enroll in the dose escalation period and 12-30 patients in the dose expansion period of the Phase1. As of the date of this interim report, the MELANI-01 Study is enrolling patients at DL -1, the first of the 3 planned dose levels.

In addition, we are evaluating four UCART preclinical programs, as follows:

 

   

UCART20x22, which is in development as the first allogeneic dual CAR T-cell candidate product for B-cell malignancies;

 

   

UCARTMESO, which is an allogeneic CAR T-cell candidate product for mesothelin expressing cancers;

 

   

UCARTMUC1, which is an allogeneic CAR T-cell candidate product for mucin-1 expressing epithelial cancers;

 

   

UCARTFAP, which is an allogeneic CAR-T candidate product targeting cancer associated fibroblasts (CAFs) in the tumor microenvironment.

Partnered clinical trial update

Under the Servier License Agreement, pursuant to which Servier grants US rights to Allogene, Allogene is pursuing a Phase 1 clinical study for ALLO-501A in relapsed or refractory non-Hodgkin lymphoma, which Allogene refers to as the ALPHA2 study.

On October 7, 2021, Allogene reported that, the U.S. Food and Drug Administration (“FDA”) has placed a hold on Allogene’s clinical trials. The clinical hold follows Allogene’s notification to the FDA of a chromosomal abnormality in an ALPHA2 study patient which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts). Allogene reported that an investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion or potential relationship to gene editing. Allogene reported that it expects to provide additional updates following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted by Allogene in anticipation for an ALLO-501A pivotal Phase 2 trial. The single case involves a patient with Stage IV transformed follicular lymphoma and a type of genetic rearrangement, known as c-myc rearrangement, whose cancer was refractory to two prior lines of immune-chemotherapy and additional radiation therapy. The patient could not receive an autologous anti-CD19 CAR T cell therapy due to manufacturing failure associated with inadequate expansion of autologous CAR T cells. Following infusion of ALLO-501A, the patient experienced Grade 1 cytokine release syndrome and Grade 2 immune effector cell-associated neurotoxicity syndrome, which required a course of high dose steroid therapy. The patient subsequently developed progressive pancytopenia and a bone marrow biopsy showed aplastic anemia and the presence of ALLO-501A CAR T cells with the chromosomal abnormality. Early translational data showed that the CAR T cells expanded, peaking on Day 28, and undergoing contraction thereafter. The patient had a partial response to ALLO-501Aand subsequently underwent allogeneic stem cell transplantation. Prolonged cytopenia requiring rescue stem cell transplantation has been reported in autologous CAR T therapies.

 

45


For a discussion of our operating capital requirements and funding sources, please see “Liquidity and Capital Resources” below.

COVID-19 Update

While implementing health and safety measures, we continued to advance our proprietary allogeneic CAR T-cell programs during the nine months ended September 30, 2021.

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 nine months 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 patient follow-up is expected 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 facility construction and initial production activity is currently unknown, and we are monitoring the pandemic as it continues to evolve.

At Calyxt, during the nine months ended September 30, 2021, the COVID-19 pandemic did not have a material impact on Calyxt’s operations. However, a resurgence or prolonging of the COVID-19 pandemic, governmental response measures, and resulting disruptions could rapidly offset such improvements. Moreover, the effects of the COVID-19 pandemic on the financial markets remain substantial and broader economic uncertainties persist, which may make obtaining capital challenging and have exacerbated the risk that such capital, if available, may not be available on terms acceptable to Calyxt. There continues to be significant uncertainty relating to the COVID-19 pandemic and its impact, and many factors could affect Calyxt’s results and operations, including, but not limited to, those described in Calyxt’s Part I, Item 1A, “Risk Factors” of its 2020 Form 10-K.

The overall impact to Cellectis’ and Calyxt’s businesses will be dependent on future developments, which are highly uncertain and difficult to predict. See Part II, Item 3.D. “Risk Factor” of our report on Form 20-F.

Key events of the nine-month period ended September 30, 2021

Since the beginning of 2021, Cellectis has made the following key achievements:

 

   

On February 16, 2021, Cytovia Therapeutics, Inc. and Cellectis announced that they entered into a research collaboration and non-exclusive license agreement to develop TALEN® gene-edited iPSC NK and CAR-NK cells. The financial terms of the partnership include up to $760 million of development, regulatory, and sales milestones from Cytovia to Cellectis for the first 5 TALEN® gene-edited iPSC- derived NK products (“partnership products”). Cellectis will also receive single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia. Cellectis will receive an equity stake of $15 million in Cytovia stock or a cash payment of $15 million in settlement of the convertible note if certain conditions are not met by December 31, 2021, as well as an option to invest in future financing rounds.

 

46


   

On March 29, 2021, Cellectis announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $125.0 million of American Depositary Shares (“ADS”), each ADS representing one ordinary share of Cellectis.

 

   

On April 9, 2021, Cellectis announced that it has completed sales of approximately $47 million of ADSs pursuant to the Company’s ATM program (the “ATM Sales”), through Jefferies LLC, acting as sales agent. In the ATM Sales, an aggregate of 2,415,630 new ADSs and the same number of underlying new ordinary shares have been issued to existing and new investors at an at-the-market price of $19.50 per new ADS. The settlement and delivery of the new ordinary shares took place on April 12, 2021.

 

   

On May 11, 2021, Cellectis entered into a partnership agreement and a supply agreement with Sanofi regarding alemtuzumab, an anti-CD52 monoclonal antibody, to be used as part of a lymphodepleting regimen in certain Cellectis sponsored UCART clinical trials. As part of the agreement, Sanofi will supply alemtuzumab to support Cellectis’ clinical studies and the parties agreed to enter into discussions to execute an agreement for the commercial supply of alemtuzumab under pre-agreed financial conditions.

 

   

The General Meeting of shareholders of Cellectis S.A. was held on June 1, 2021.

 

   

At the date of this interim report, Cellectis’ Paris manufacturing facility is now fully operational and has finalized the manufacturing of plasmid starting materials as well as the first mRNA batches for TALEN®, and the Raleigh, North Carolina, facility is nearing completion of qualification activities for the facility and its equipment and systems.

 

   

Cellectis, in collaboration with Professor Toni Cathomen, scientific director at the Center for Chronic Immunodeficiency Medical Center at the University of Freiburg, Germany, presented two oral presentations at the European Society of Gene and Cell Therapy (ESGCT) Congress, held October 19-22, 2021. The preclinical data supports further evaluation of Cellectis’ .HEAL platform for two product candidates targeting primary immunodeficiencies: RAG1 for Severe Combined Immunodeficiency (SCID) and STAT3 for Hyper IgE syndrome.

 

   

Cellectis will present preclinical data that support anti-tumor activity of UCARTMESO at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), to be held November 10 to 14, 2021. Cellectis will present a poster on UCARTMESO, an allogeneic CAR-T cell product candidate targeting mesothelin-expressing solid tumors. Mesothelin is a tumor-associated antigen that is highly and consistently expressed in mesothelioma and pancreatic cancer and is also over-expressed in subsets of other solid tumors (ovarian cancer, non-small cell lung cancer, gastric cancer, triple-negative breast cancer). UCARTMESO leverages Cellectis’ TALEN® gene editing technology to also resist immune suppression mediated by TGFß.

 

   

On November 4, 2021, Cellectis announced the release of two abstracts, which were accepted for presentation at the 63rd American Society of Hematology (ASH) Annual Meeting taking place from December 11-14, 2021. The Company will present preliminary clinical data from its BALLI-01 clinical trial in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), and preclinical data for TALGlobin01, its lead gene therapy product candidate for the treatment of sickle cell disease (SCD).

 

   

On November 4, 2021, Cellectis announced the appointment of Donald A Bergstrom, M.D., Ph.D., as observer of the Company’s Board of Directors.

 

47


Since the beginning of 2021, Calyxt, Cellectis’ majority-owned synthetic biology subsidiary, has made the following developments:

 

   

On February 19, 2021, Yves Ribeill, Ph.D., Chair of the Board of Directors of Calyxt, Inc., was appointed as the Executive Chair of the Board of Directors in connection with the departure of James Blome, Calyxt’s former Chief Executive Officer. Effective July 27, 2021 Michael A. Carr joined Calyxt, as its President, Chief Executive Officer, and member of its Board of Directors. Mr. Carr assumed the principal executive officer function for Calyxt as of August 6, 2021, upon the resignation of Dr. Ribeill as Calyxt’s Executive Chair.

 

   

On March 2, 2021, Calyxt announced that it had completed its initial appointments to its Scientific Advisory Board (SAB), chaired by Calyxt co-founder Dan Voytas, Ph.D. The SAB comprises world-renowned plant-biochemistry experts Anne Osbourn, Ph.D., Group Leader at the John Innes Center; Elizabeth Sattely, Ph.D., HHMI Investigator and Associate Professor of Chemical Engineering at Stanford University; Paul Bernasconi, Ph.D., Former Global Function Head for Molecular Biology at BASF Biosciences; and Seth Dobrin, Ph.D, the Global Chief Artificial Intelligence Officer at IBM, who joined the SAB on October 12, 2021. The SAB was formed to provide guidance to Calyxt to leverage and grow the business in new directions and to help realize Calyxt’s potential value.

 

   

On April 8, 2021, Calyxt was notified by the Small Business Administration that the full amount of Calyxt’s Paycheck Protection Program (PPP) loan ($1.5m) had been forgiven.

 

   

With respect to research and development, Calyxt announced on April 29, 2021 and May 4, 2021, respectively, that it had successfully completed a transformation of the hemp genome and the completion of its preliminary composition analysis of its next generation soybean product’s fatty acid profile.

 

   

On July 8, 2021, Calyxt announced further expansion of its hemp breeding platform with the addition of triploid breeding technology to create seedless hemp.

 

   

On July 15, 2021, Calyxt announced the appointment of Michael A. Carr as President and Chief Executive Officer, effective July 27, 2021. Mr. Carr will also serve as a member of Calyxt’s Board of Directors. Mr. Carr was most recently the Vice President of M&A, Strategy, and Innovation at Darling Ingredients, Inc., a global developer and producer of sustainable natural ingredients and renewable energy.

 

   

On September 16, 2021, Calyxt established an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell, through Jefferies LLC acting as agent pursuant to the Open Market Sale Agreement, shares of Calyxt having an aggregate offering price of up to $50,000,000.

 

   

On October 5, 2021, Calyxt announced the launch of a strategic initiative that will focus Calyxt on engineering synthetic biology solutions to meet the needs of a diversified base of potential customers across an expanded group of end markets, including the nutraceutical, cosmeceutical, personal care, pharmaceutical, advanced materials, and chemical industries, in addition to the agriculture end market. Calyxt intends to leverage its proprietary PlantSpring technology platform to engineer plant metabolism, with diversified product offerings primarily to be delivered through its proprietary BioFactory production system, with Calyxt’s pilot BioFactory expected to be online by the end of 2021.

 

48


Financial Operations Overview

We have incurred net losses in nearly each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from selling, general and administrative expenses associated with our operations. As we continue our intensive research and development programs, we expect to continue to incur significant expenses and may again incur operating losses in future periods. We anticipate that such expenses will increase substantially if and as we:

 

   

progress our sponsored clinical studies AMELI-01, BALLI-01 and MELANI-01, and initiate additional clinical trials for our other owned product candidates;

 

   

continue to advance the research and development of our current and future immuno-oncology product candidates;

 

   

advance research and development efforts for our HSC product candidates;

 

   

further develop and refine the manufacturing process for our product candidates;

 

   

complete construction of our Raleigh facility, bring online, and commence production at our in-house manufacturing facilities and change or add additional manufacturers or suppliers of biological materials to support our in-house manufacturing capabilities;

 

   

seek regulatory and marketing approvals for our product candidates, if any, that successfully complete development;

 

   

establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

 

   

seek to identify and validate additional product candidates;

 

   

acquire or in-license other product candidates, technologies or biological material;

 

   

make milestone or other payments under any in-license agreements;

 

   

maintain, protect and expand our intellectual property portfolio;

 

   

seek to attract and retain new and existing skilled personnel;

 

   

create additional infrastructure to support our operations as a public company;

 

   

continue, through Calyxt, to advance research and development of future synthetic biology innovations and solutions, and to execute upon the deployment of such innovations through Calyxt’s customer-driven solutions; and

 

   

experience any delays or encounter issues with any of the above.

We do not expect to generate material revenues from sales of our therapeutic product candidates unless and until we successfully complete development of, and obtain marketing approval for, one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital prior to completing clinical development of any of our therapeutic product candidates. Until such time that we can generate substantial revenues from sales of our product candidates, if ever, we expect to finance our operating activities through a combination of milestone payments received pursuant to our collaboration and license agreements, equity offerings, debt financings, government or other third-

 

49


party funding and collaborations, and licensing arrangements. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant to others rights to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to cease operations, in part or in full.

Our interim consolidated financial statements for the nine-month ended September 30, 2021 have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

 

50


Results of Operations

Comparison for the nine-month periods ended September 30, 2020 and 2021

Revenues.

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Collaboration agreements

     48,166        19,865        -58.8

Other revenues

     11,870        25,223        112.5

Revenues

     60,036        45,088        -24.9

The decrease in revenues of $14.9 million between the nine-month period ended September 30, 2020 and 2021 primarily reflects a decrease of revenue pursuant to our collaboration agreements of $28.3 million, mainly due to a $27.6 million upfront payment received in March 2020 and the recognition of $19.4 million of deferred upfront and milestone payments already received on released targets in each case in connection with the amendment signed in March 2020 to our collaboration agreement with Servier as well as a decrease in licenses revenue, while revenue related to collaboration agreements for the nine months of 2021 consists of the recognition of $15.0 million convertible note obtained as consideration for a license granted to Cytovia and a $5.0 million Allogene milestone. The increase in other revenues of $13.4 million relates to the sales of soybean products at Calyxt.

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Research tax credit

     6,522        6,780        4.0

Other income

     (12      1,540        -13171.6

Other income

     6,510        8,320        27.8

The increase in other income of $1.8 million between the nine-month period ended September 30, 2020 and 2021 reflects an increase of $0.3 million in research tax credits, due to higher research and development purchases and external expenses during the nine-month period ended September 30, 2021 that are eligible for the tax credit and $1.5 million related to Calyxt’s PPP loan forgiveness obtained in April 2021.

Cost of revenue

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Cost of goods sold

     (16,265      (27,512      69.1

Royalty expenses

     (1,894      (1,601      -15.5

Cost of revenue

     (18,159      (29,113      60.3

The increase in cost of goods sold of $11.2 million between the nine-month period ended September 30, 2020 and 2021 is driven by higher volumes of Calyxt’s products sold and higher average prices paid for grain as a result of increases in commodity market prices for soybeans. These increases were partially offset by the benefits resulting from the move to sell grain compared to selling oil and meal, as well as a $3.7 million year-over-year decrease in net realizable value adjustments to inventory as the year ago period included costs to write down excess seed inventory, and $3.1 million year-over-year benefit from unrealized commodity derivative gains.

 

51


Research and development expenses.

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Personnel expenses

     (25,871      (39,749      53.6

Purchases, external expenses and other

     (37,723      (56,914      50.9

Research and development expenses

     (63,594      (96,663      52.0

Between the nine-month periods ended September 30, 2020 and 2021, research and development expenses increased by $33.1 million. Personnel expenses increased by $13.9 million from $25.9 million in 2020 to $39.8 million in 2021 primarily due to a $10.8 million increase in wages and salaries mainly driven by the increased R&D headcount in the therapeutic segment, a $0.9 million increase in social charges on stock option mainly granted in March 2021, as well as a $2.2 million increase in non-cash stock-based compensation expense in relation with new grants at the end of 2020 and in 2021.

Purchases, external expenses and other increased by $19.2 million (from $37.7 million in 2020 to $56.9 million in 2021) due to higher consumables, subcontracting costs and depreciation and amortization for the therapeutic segment.

Selling, general and administrative expenses.

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Personnel expenses

     (18,929      (14,242      -24.8

Purchases, external expenses and other

     (12,836      (13,651      6.4

Selling, general and administrative expenses

     (31,765      (27,894      -12.2

Between the nine-month period ended September 2020 and 2021, the decrease in selling, general and administrative expenses of $3.9 million primarily reflects a $4.7 million decrease in personnel expenses from $18.9 million in 2020 to $14.2 million mainly due to a $5.4 million decrease in non-cash stock-based compensation expense mainly explained by the favorable impact of the recapture of Calyxt’s CEO non-cash stock-based compensation from the forfeiture of certain of his unvested stock options, restricted stock units, and performance stock units following his departure, partly offset by a $0.4 million increase in wages and salaries and $0.4 million increase in social charges on stock option grants. Purchases, external expenses and other increased by $0.8 million from $12.8 million in 2020 to $13.7 million in 2021.

Other operating income and expenses.

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Other operating income (expenses)

     (291      506        -274.1

 

52


The increase in other operating income and expenses between the nine-month periods ended September 30, 2020 and 2021 amounted to $0.8 million and is mainly related to the reversal of provisions for bad debt.

Net financial gain (loss).

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Financial income

     5,646        9,138        61.9

Financial expenses

     (10,379      (6,411      -38.2

Net Financial gain (loss)

     (4,733      2,728        -157.6

The increase in financial income of $3.5 million between the nine-month period ended September 30, 2020 and 2021 was mainly attributable to an increase of the foreign exchange gain of $4.6 million (from a $3.5 million gain in 2020 to a $8.1 million gain in 2021) partially offset by the decrease of interest received from financial investments of $1.1 million.

The decrease in financial expenses of $4.0 million between the nine-month period ended September 30, 2020 and 2021 was mainly attributable to the $5.6 million decrease in foreign exchange loss (from an $8.0 million loss in 2020 to a $2.4 million loss in 2021), partially offset by the increase in lease interest expenses for $1.6 million.

Net income (loss)

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Net income (loss)

     (51,996      (97,027      86.6

The increase in net loss of $45.0 million between the nine-month period ended September 30, 2020 and 2021 was mainly due to (i) a $13.1 million decrease in revenues and other income, (ii) an increase of $20.0 million in purchases, external expenses and others, (iii) a $11.0 million increase in cost of sales, (iv) an increase of $11.2 million in wages, and (v) an increase of $1.3 million in social charges on stock option grants expense (vi) partially offset by (i) a decrease of $3.2 million in non-cash stock based compensation expense, (ii) an increase in other operating results of $0.8 million and (iii) an increase in net financial gain of $7.5 million.

Non-controlling interests

 

     For the nine-month period ended
September 30,
     % change  
     2020      2021      2021 vs 2020  
                      

Gain (loss) attributable to non-controlling interests

     (10,391      (7,827      -24.7

During the nine-month period ended September 30, 2021, we recorded a $7.8 million loss attributable to non-controlling interests. During the nine-month period ended September 30, 2020, we recorded $10.4 million in loss attributable to non-controlling interests.

 

53


Segment Results

Information related to each of our reportable segments is set out below. Segment revenues and Other income, Research and development expenses, Selling, general and administrative expenses, Royalties and other operating income and expenses, and Adjusted net income (loss) attributable to shareholders of Cellectis (which does not include non-cash stock-based expense) are used by the CODM to measure performance of each segment. The CODM does not review any asset or liability information by segment or by region.

Adjusted Net Income (Loss) attributable to shareholders of Cellectis is not a 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.

There are inter-segment transactions between the two reportable segments, including the allocation of corporate general and administrative expenses by Cellectis S.A. and the allocation of research and development expenses among the reportable segments. With respect to corporate general and administrative expenses, Cellectis S.A. has provided Calyxt with general sales and administrative functions, accounting and finance functions, investor relations, intellectual property, legal advice, human resources, communication and information technology pursuant to a Management Services Agreement. Under the Management Services Agreement, Cellectis S.A. charges Calyxt in euros at cost plus a mark-up ranging between zero to 10%, depending on the nature of the service. Amounts due to Cellectis S.A. pursuant to inter-segment transactions bear interest at a rate of 12-month Euribor plus 5% per annum. Effective with the end of the third quarter of 2019, Calyxt has internalized nearly all of the services Cellectis provided.

The intersegment revenues represent the transactions between segments. Intra-segment transactions are eliminated within a segment’s results and intersegment transactions are eliminated in consolidation as well as in key performance indicators by reportable segment.

 

54


The following table summarizes segment revenues and segment operating profit (loss) for the nine-month period ended period 2020 and 2021:

 

     For the nine-month period ended
September 30, 2020
    For the nine-month period ended
September 30, 2021
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 
                                      

External revenues

     9,960       50,077       60,037       25,004       20,085       45,088  

External other income

     —         6,510       6,510       1,528       6,792       8,320  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     9,960       56,587       66,547       26,532       26,876       53,408  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (16,600     (1,558     (18,159     (27,512     (1,601     (29,113

Research and development expenses

     (7,391     (56,203     (63,594     (8,358     (88,304     (96,663

Selling, general and administrative expenses

     (16,227     (15,538     (31,765     (11,520     (16,373     (27,894

Other operating income and expenses

     (148     (142     (291     25       481       506  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (40,367     (73,442     (113,810     (47,366     (105,797     (153,163
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (30,407     (16,855     (47,263     (20,834     (78,921     (99,755
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net financial gain (loss)

     (510     (4,223     (4,733     (875     3,603       2,728  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (30,917     (21,078     (51,996     (21,709     (75,318     (97,027
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non controlling interests

     10,391       —         10,391       7,827       —         7,827  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (20,528     (21,077     (41,605     (13,883     (75,318     (89,201
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

R&D non-cash stock-based expense attributable to shareholder of Cellectis

     556       5,005       5,561       682       6,922       7,604  

SG&A non-cash stock-based expense attributable to shareholder of Cellectis

     2,936       2,691       5,627       (208     1,901       1,693  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     3,492       7,696       11,188       474       8,823       9,297  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (17,037     (13,381     (30,418     (13,409     (66,495     (79,904
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (1,485     (5,290     (6,776     (1,834     (9,651     (11,485

Additions to tangible and intangible assets

     973       40,983       41,956       377       14,446       14,822  

We allocate the share-based compensation to the share-related entity, (rather than the entity related to the employee that benefited from such compensation), considering that the share-based compensation is linked to entity’s performance. Consequently, all share-based compensation based on Cellectis shares is charged in the Therapeutics segment, even if some Calyxt employees are included in a Cellectis stock-option plan.

 

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Therapeutics segment

External revenues and other income in our Therapeutics segment decreased by $29.7 million, from $56.6 million for the nine-month period ended September 30, 2020, to $26.9 million for the nine-month period ended September 30, 2021. The decrease was primarily due to a decrease of $28.3 million in collaboration agreement revenues, as described in sections “Revenues” and “Other income” under “Results of Operations” for the consolidated Group.

The increase in total operating expenses of $32.4 million from the nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021 resulted primarily from (i) higher purchases, external expenses and other of $20.1 million, (ii) higher personnel expenses of $12.9 million attributable to an increase of $10.5 million in personnel wages and salaries, an increase of $1.3 million in social charges on stock option grants and an increase of $1.1 million in non-cash stock-based compensation expenses.

Operating loss before tax for our Therapeutics segment increased by $62.1 million from the nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021.

Adjusted net loss attributable to shareholders of Cellectis for our Therapeutics segment increased by $53.1 million from the nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021.

Plants segment

External revenues and other income in our Plants segment increased by $16.6 million from $10.0 million for the nine-month period ended September 30, 2020 to $26.5 million for the nine-month period ended September 30, 2021, driven by sales of a portion of the 2020 grain crop as compared to the first nine months of 2020, when the Company was primarily selling soybean oil and meal. As of September 30, 2021, the Company had sold substantially all of the 2020 grain crop.

The increase in total operating expenses of $7.0 million from nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021 resulted primarily from an increase in Calyxt’s activities, which contributed to (i) an increase in cost of goods sold of $11.2 million and (ii) an increase of $0.7 million in personnel wages and salaries mainly related to former CEO’s departure costs partially offset by (i) a decrease of $4.4 million in non-cash stock-based compensation expenses mainly explained by the favorable impact of the recapture of Calyxt’s CEO non-cash stock-based from the forfeiture of certain of his unvested stock options, restricted stock units, and performance stock units following his departure and other reductions in personnel costs and professional fees and (ii) a decrease of $0.2 million in purchases, external expenses and other and (iii) a decrease of $0.3 million royalties expenses.

Operating loss before tax for our Plants segment decreased by $9.6 million from the nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021.

Adjusted net loss attributable to shareholders of Cellectis for our Plants segment decreased by $3.6 million from the nine-month period ended September 30, 2020 to the nine-month period ended September 30, 2021.

 

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Liquidity and Capital Resources

Introduction

We have incurred losses and cumulative negative cash flows from operations since our inception in 2000, and we anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and selling, general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

We have funded our operations since inception primarily through private and public offerings of our equity securities, grant revenues, payments received under patent licenses, reimbursements of research tax credit claims and payments under our collaboration agreements with Allogene and Servier.

Our ordinary shares have been traded on the Euronext Growth market of Euronext in Paris since February 7, 2007 and our ADSs have traded on the Nasdaq Global Market in New York since March 30, 2015.

Liquidity management

As of September 30, 2021, we had current financial assets and cash and cash equivalents of $211.1 million comprising cash and cash equivalents of $210.7 million and current financial assets of $0.4 million corresponding to current restricted cash. Long term restricted cash amounts to $5.3 million and is classified in other non-current financial assets.

Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts, money market funds, fixed bank deposits primarily in France. The portion of cash and cash equivalents denominated in U.S. dollars is $135.4 million as of September 30, 2021. Current financial assets denominated in U.S. Dollars amounted to $0.4 million as of September 30, 2021.

On March 9, 2021, we commenced the ATM-program, which allows us to offer and sell, from time to time, ordinary shares in the form of ADSs, each representing one ordinary share of the Company, to certain eligible investors. We are not obligated to sell ADSs pursuant to the ATM program, and offers and sales occur only at our discretion and on our instructions and at-the- market prices. The ATM program provides for a total maximum gross amount of $125 million. On April 9, 2021, Cellectis completed an initial sale under the ATM program for gross proceeds of $47 million (equivalent to 40 million euros).

On September 21, 2021, Calyxt entered into an ATM financing program with Jefferies, acting as sole selling agent. Under the terms of the ATM program, Calyxt may, from time-to-time, issue common stock having an aggregate offering value of up to $50.0 million. At its discretion Calyxt determines the timing and number of shares to be issued under the ATM program.

As of September 30, 2021, Calyxt had not issued any shares of common stock under the ATM program. As of the date of this report, Calyxt has issued approximately 1.2 million shares of common stock under the ATM program for proceeds of $3.7 million net of commissions and payments for other share issuance costs.

 

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Historical Changes in Cash Flows

The table below summarizes our sources and uses of cash for the nine-month period ended September 30, 2020 and 2021:

 

     For the nine-month period ended
September 30,
 
     2020      2021  
               
     $ in thousands  

Net cash flows provided by (used in) operating activities

     (46,374      (83,480

Net cash flows provided by (used in) investing activities

     (51,604      7,483  

Net cash flows provided by (used in) financing activities

     14,645        48,948  
  

 

 

    

 

 

 

Total

     (83,333      (27,049
  

 

 

    

 

 

 

Effect of exchange rate changes on cash

     3,753        (3,389

For the nine-month period ended September 30, 2021, our net cash flows used in operating activities are mainly due to Cellectis cash payments of $49.1 million to suppliers, wages and social expenses of $39.2 million, Calyxt operating payments net of receipts of $15.1 million, partially offset by $9.0 million of tax credit, the collection of a $5.0 million Allogene milestone payment, $1.0 million of licensing revenue at Cellectis, and $4.9 million of taxes and others.

For the nine-month period ended September 30, 2020, our net cash flows used in operating activities are mainly due to Cellectis cash payments of $34.7 million to suppliers, wages and social expenses of $24 million, Calyxt operating payments of $28.1 million and $1.2 million of VAT, offset by $32.9 million of payments received from Servier pursuant to our collaboration agreements, $3.6 million from our licensing and other collaboration agreements, $7.9 million of R&D credit received and $0.5 million of other income.

For the nine-month period ended September 30, 2021, our net cash flows provided by investing activities primarily reflects our investments in R&D equipment and building fittings in both the United States and France of $19.1 million, including $5.2 million that relates to Cellectis’ new raw material manufacturing facility and offices in Paris, $13.5 million relates to the new commercial manufacturing facility in Raleigh, North Carolina, $0.4 million relates to our innovation center in New York, New York, and the remainder attributable to investing activity in the Plants segment, offset by $26.6 million of current and non-current financial assets variation.

For the nine-month period ended September 30, 2020, our net cash flows used in investing activities primarily reflects (i) our investments in R&D equipment and building fittings in both the United States and France of $33.0 million, including $5.3 million that relates to Cellectis’ new raw material manufacturing facility in Paris, $27.3 million relates to the new commercial manufacturing facility in Raleigh, North Carolina and the remainder attributable to investing activity in the Plants segment, with (ii) $20.9 million of new current financial assets and $2.5 million of new non-current financial assets.

For the nine-month period ended September 30, 2021, our net cash provided by financing activities reflects mainly the net proceeds of $46.6 million from sales under the Cellectis ATM-program in April, the collection of $12.0 million of proceeds from stock option exercises and is partially offset by the payments of lease debts for $9.5 million as well as $0.2 million of interest paid on the “PGE” loan.

For the nine-month period ended September 30, 2020, our net cash used by financing activities reflects mainly the collection of $20.6 million related to a state-guaranteed loan at Cellectis and the collection of $1.5 million related to the Paycheck Protection Program loan at Calyxt over the period, as well as the collection of a $1.5 million loan to finance leasehold improvement at our location in New-York and other income for $0.4 million and is partially offset by the payments on lease debts for $8.1 million.

 

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Operating capital requirements

Our cash consumption is driven by our internal operational activities, as well as our outsourced activities, including the pre-clinical research and development activities, manufacturing and technology transfer expenses payable to CMO providers, costs and expenses associated with our clinical trials, including payments to clinical research centers, CROs involved in the clinical trials, and third-parties providing logistics and testing services, as well as costs and expenses relating to construction and bringing online of our in-house manufacturing facilities. In addition, we incur significant annual payment and royalty expenses related to our in-licensing agreements with different parties including Life Technologies and University of Minnesota. We also incur substantial expenses related to audit, legal, regulatory and tax related services associated with our public company obligations in the United States and our continued compliance with applicable U.S. exchange listing and SEC requirements.

To date, we have not generated any revenues from therapeutic product sales. In addition to our cash generated by operations (including payments under our collaboration agreements), we have funded our operations primarily through private and public offerings of our equity securities, grant revenues, payments received under intellectual property licenses, and reimbursements of research tax credits.

We do not know when, or if, we will generate any revenues from therapeutic product sales. We do not expect to generate significant revenues from product sales unless and until we obtain regulatory approval of and commercialize one of our current or future therapeutic product candidates.

In August 2020, in connection with its transition to capital-efficient go-to-market strategy, Calyxt stopped processing soybeans into oil and meal and restructured its personnel involved in soybean processing and downstream product sales. In the fourth quarter of 2020, Calyxt announced having contracted to sell all its 2020 grain production (approximately four million bushels) of high oleic soybean to Archer Daniels Midland (ADM). As of September 30, 2021, Calyxt had sold substantially all of the 2020 grain crop. As Calyxt focuses on its demand-driven synthetic biology business model solutions, it is expected that most of its near-term revenues will be from product development activities for customers for both Calyxt’s BioFactory and agricultural production and technology licensing arrangements. Calyxt has not yet generated substantial revenue from product development activities for customers, and we do not know when, or if, Calyxt will generate substantial revenues from such activities.

We are subject to all risks incident in the development of new gene therapy products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We are also subject to all risks incident in the development of new synthetic biology innovations and solutions, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We anticipate that we will need additional funding in connection with our continuing operations, including for the further development of our existing product candidates and to pursue other development activities related to additional product candidates.

Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash of $201 million as of September 30, 2021 will fund its operations into early 2023. Calyxt’s current operating plans reflect a modest level of payments from customers from commercial activities in 2022, which when combined with planned spending and the current balance of cash and cash equivalents make it likely that it will require additional liquidity to continue operations under this business plan over the next 12 months. Absent payments from customers in excess of Calyxt’s operating plans or the ability to raise capital, Calyxt’s management believes it can implement various cost reduction and other cash-focused measures in order to manage liquidity for the next 12 months.

Until we can generate a sufficient amount of revenues from our products, if ever, we expect to finance a portion of future cash needs through public or private equity or debt offerings. Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. If we

 

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raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and these securities may have rights senior to those of our ordinary shares. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

Our assessment of the period of time through which our and Calyxt’s financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. This estimate takes into account our projected cash flow from operations (including payments we expect to receive pursuant to our strategic licensing agreements) and government funding of research programs, as well as Calyxt’s anticipated cash burn rate, anticipated expense reduction efforts, and its expectations regarding an effective advancement of synthetic biology strategic initiative and anticipated cash receipts from its customer-driven solutions. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

 

   

the initiation, progress, timing, costs and results of pre-clinical and clinical studies for our product candidates;

 

   

the capacity of manufacturing our products in France and in the United States;

 

   

the outcome, timing and cost of regulatory approvals by U.S. and non-U.S. regulatory authorities, including the possibility that regulatory authorities will require that we perform more studies than those that we currently expect;

 

   

the ability of our product candidates to progress through clinical development successfully;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

   

our need to expand our research and development activities;

 

   

our need and ability to hire additional personnel;

 

   

our need to implement additional infrastructure and internal systems, including manufacturing processes for our product candidates;

 

   

the effect of competing technological and market developments;

 

   

the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval; and

 

   

progress, timing and success of Calyxt’s business and its ability to successfully deploy synthetic biology solutions under customer-driven business model.

If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

 

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Off-Balance Sheet Arrangements.

As of September 30, 2021, we do not have any off-balance sheet arrangements as defined under SEC rules.

Item 3. Quantitative and Qualitative Disclosures About Market Risks

For quantitative and qualitative disclosures about market risk that affect us, see “Quantitative and Qualitative Disclosures About Market Risk in Item11 of Part I of the Annual Report. As a result of the continued wind-down of Calyxt’s soybean product line, Calyxt’s market risk related to commodity price sensitivity has been significantly reduced. As a result, Calyxt held no commodity derivative contracts as of September 30, 2021. There have been no other material changes in information that would have been provided in the context of Item 3 from the end of the preceding year until September 30, 2021.

Item 4. Controls and Procedures

We must maintain effective internal control over financial reporting in order to accurately and timely report our results of operations and financial condition. In addition, as a public company, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires, among other things, that we assess the effectiveness of our disclosure controls and procedures and the effectiveness of our internal control over financial reporting at the end of each fiscal year. We issued management’s annual report on internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act, as of December 31, 2020.

There have been no changes in the Company’s internal control over financial reporting during the nine-month period ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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PART II – OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.

Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors

Except for the supplemental risk factor disclosed in our report on Form 6-K filed with the SEC on October 5, 2021, there are no material changes to the risk factors described in Item 3.D. of Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2020.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

None.

Item 6. Exhibits

None.

 

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