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: May 6, 2020

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on Form F-3 (No. 333-217086) and Form S-8 (Nos. 333-204205, 333-214884, 333-222482 and 333-227717), to the extent not superseded by documents or reports subsequently filed.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-month period ended March 31, 2020.


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)

May 6, 2020     By:  

/s/ André Choulika

      André Choulika
      Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

  

Title

99.1    Cellectis S.A.’s interim report for the three-month period ended March 31, 2020.

 

EX-99.1

Exhibit 99.1

PRELIMINARY NOTE

The unaudited condensed Consolidated Financial Statements for the three-month period ended March 31, 2020, included herein, have been prepared in accordance with International Financial Reporting Standards (“IFRS”) 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,” “scheduled,” “should,” “will” or the negative of these and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those projected in any forward-looking statement. Factors that may cause actual results to differ from those in any forward-looking statement include, 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, proliferation and continuous evolution of new technologies; disruptions to Calyxt’s business; 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 5, 2020 (the “Annual Report”) and under “Risk Factors” in this interim report. 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 trademark Calyxt® is owned by Calyxt. All other trade names, trademarks and service marks of other companies appearing in this interim report are the property of their respective holders. Solely for convenience, the trademarks and trade names in this interim report may be referred to without the ® 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 whole.

 

1


INDEX

 

PART I – FINANCIAL INFORMATION      3  
Item 1.  

Condensed Financial Statements (Unaudited)

     3  
Item 2.  

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

     31  
Item 3.  

Quantitative and Qualitative Disclosures About Market Risks

     47  
Item 4.  

Controls and Procedures

     47  
PART II – OTHER INFORMATION      48  
Item 1.  

Legal Proceedings

     48  
Item 1A.  

Risk Factors

     48  
Item 2.  

Unregistered Sales of Equity Securities and Use of Proceeds

     49  
Item 3.  

Default Upon Senior Securities

     49  
Item 4.  

Mine Safety Disclosures

     49  
Item 5.  

Other Information

     49  
Item 6.  

Exhibits

     49  

 

2


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, 2019     March 31, 2020  
ASSETS        

Non-current assets

       

Intangible assets

        1,108       1,094  

Property, plant, and equipment

     6        23,712       36,811  

Right-of-use assets

     5        45,612       47,814  

Other non-current financial assets

        5,517       7,484  
     

 

 

   

 

 

 

Total non-current assets

        75,949       93,204  

Current assets

       

Inventories

        2,897       3,591  

Trade receivables

     7.1        2,959       3,003  

Subsidies receivables

     7.2        9,140       11,230  

Other current assets

     7.3        15,617       13,969  

Current financial assets

     8.1        20,385       59,005  

Cash and cash equivalents

     8.2        340,522       287,133  
     

 

 

   

 

 

 

Total current assets

        391,520       377,931  
     

 

 

   

 

 

 

TOTAL ASSETS

        467,469       471,135  
     

 

 

   

 

 

 
LIABILITIES        

Shareholders’ equity

       

Share capital

     12        2,767       2,767  

Premiums related to the share capital

     12        843,478       846,839  

Currency translation adjustment

        (22,641     (29,254

Retained deficit

        (406,390     (508,590

Net income (loss)

        (102,091     20,081  
     

 

 

   

 

 

 

Total shareholders’ equity - Group Share

        315,123       331,843  

Non-controlling interests

        40,347       38,744  
     

 

 

   

 

 

 

Total shareholders’ equity

        355,470       370,588  

Non-current liabilities

       

Non-current lease debts

     9        46,540       48,699  

Non-current provisions

     15        2,855       2,841  
     

 

 

   

 

 

 

Total non-current liabilities

        49,395       51,540  
     

 

 

   

 

 

 

Current liabilities

       

Current lease debts

     9        1,067       1,342  

Trade payables

     9        29,264       26,873  

Deferred revenues and contract liabilities

     11        20,033       543  

Current provisions

     15        3,743       3,260  

Other current liabilities

     10        8,497       16,990  
     

 

 

   

 

 

 

Total current liabilities

        62,604       49,008  
     

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

        467,469       471,135  
     

 

 

   

 

 

 

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

 

3


Cellectis S.A.

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS

For the three-month period ended March 31,

$ in thousands, except per share amounts

 

            For the three-month period ended
March 31,
 
     Notes      2019     2020  

Revenues and other income

       

Revenues

     3.1        1,036       50,128  

Other income

     3.1        2,395       1,778  
     

 

 

   

 

 

 

Total revenues and other income

        3,431       51,907  
     

 

 

   

 

 

 

Operating expenses

       

Cost of revenue

     3.2        (586     (4,600

Research and development expenses

     3.2        (14,508     (20,724

Selling, general and administrative expenses

     3.2        (11,488     (12,146

Other operating income (expenses)

        33       (25
     

 

 

   

 

 

 

Total operating expenses

        (26,550     (37,495
     

 

 

   

 

 

 

Operating income (loss)

        (23,119     14,412  
     

 

 

   

 

 

 

Financial gain (loss)

        5,396       2,190  
     

 

 

   

 

 

 

Income tax

        —         —    
     

 

 

   

 

 

 

Net income (loss)

        (17,723     16,602  
     

 

 

   

 

 

 

Attributable to shareholders of Cellectis

        (15,248     20,081  

Attributable to non-controlling interests

        (2,476     (3,480

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

     14       

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

        (0.36     0.47  

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

        (0.36     0.47  

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

 

4


UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

For the three-month period ended March 31,

$ in thousands

 

     For the three-month period ended
March 31,
 
     2019     2020  

Net income (loss)

     (17,723     16,601  
  

 

 

   

 

 

 

Actuarial gains and losses

     —         (45
  

 

 

   

 

 

 

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

     —         (45
  

 

 

   

 

 

 

Currency translation adjustment

     (5,459     (6,207

Commodity derivative contracts

     —         (55
  

 

 

   

 

 

 

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

     (5,459     (6,261
  

 

 

   

 

 

 

Total Comprehensive income (loss)

     (23,182     10,294  
    

Attributable to shareholders of Cellectis

     (20,965     13,405  

Attributable to non-controlling interests

     (2,217     (3,111

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

 

5


Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS

For the three-month period ended March 31,

$ in thousands

 

            For the three-month period ended
March 31,
 
     Notes      2019     2020  

Cash flows from operating activities

       
     

 

 

   

 

 

 

Net income (loss) for the period

        (17,723     16,602  
     

 

 

   

 

 

 

Reconciliation of net income (loss) and of the cash provided by (used in) operating activities

       

Adjustments for

       

Amortization and depreciation

        1,527       2,053  

Net loss (income) on disposals

        —         9  

Net financial loss (gain)

        (5,396     (2,196

Expenses related to share-based payments

        5,092       4,776  

Provisions

        332       (308

Other non cash items

        —         93  

Interest (paid) / received

        2,027       753  
     

 

 

   

 

 

 

Operating cash flows before change in working capital

        (14,142     21,781  
     

 

 

   

 

 

 

Decrease (increase) in inventories

        (788     (702

Decrease (increase) in trade receivables and other current assets

        (1,459     1,074  

Decrease (increase) in subsidies receivables

        (2,480     (2,239

(Decrease) increase in trade payables and other current liabilities

        (3,436     659  

(Decrease) increase in deferred income

        (94     (19,114
     

 

 

   

 

 

 

Change in working capital

        (8,256     (20,323
     

 

 

   

 

 

 

Net cash flows provided by (used in) operating activities

        (22,398     1,458  
     

 

 

   

 

 

 

Cash flows from investment activities

       

Proceeds from disposal of property, plant and equipment

        —         —    

Acquisition of intangible assets

        (3     (43

Acquisition of property, plant and equipment

        (1,812     (7,912

Net change in non-current financial assets

        (2,802     (1,977

Sale (Acquisition) of current financial assets

        162       (38,620
     

 

 

   

 

 

 

Net cash flows provided by (used in) investing activities

        (4,456     (48,552
     

 

 

   

 

 

 

Cash flows from financing activities

       

Shares of Calyxt issued to third parties

        125       —    

Payments on lease debts

        (1,403     (1,899
     

 

 

   

 

 

 

Net cash flows provided by (used in) financing activities

        (1,278     (1,899
     

 

 

   

 

 

 

(Decrease) increase in cash and cash equivalents

        (28,131     (48,992
     

 

 

   

 

 

 

Cash and cash equivalents at the beginning of the year

        451,501       340,522  

Effect of exchange rate changes on cash

        (1,913     (4,397
     

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     8        421,457       287,133  
     

 

 

   

 

 

 

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

 

6


Cellectis S.A.

UNAUDITED STATEMENTS OF CHANGES IN CONSOLIDATED SHAREHOLDERS’ EQUITY

For the three-month period ended March 31,

$ in thousands, except share data

 

          Share Capital
Ordinary Shares
                                  Equity        
    Notes     Number of
shares
    Amount     Premiums
related to
share
capital
    Treasury
shares
reserve
    Currency
translation
adjustment
    Retained
earnings
(deficit)
    Income
(Loss)
    attributable
to
shareholders
of Cellectis
    Non
controlling
interests
    Total
Shareholders’
Equity
 

As of January 1, 2019

      42,430,069       2,765       828,525       —         (16,668     (326,628     (78,693     409,301       40,970       450,272  

Net Loss

      —         —         —         —         —         —         (15,248     (15,248     (2,476     (17,723

Other comprehensive income (loss)

      —         —         —         —         (5,717     —         —         (5,717     259       (5,459
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

      —         —         —         —         (5,717     —         (15,248     (20,965     (2,217     (23,182

Allocation of prior period loss

      —         —         —         —         —         (78,693     78,693       —         —         —    

Capital Increase

      —         —         (1     —         —         1       —         —         —         —    

Transaction with subsidiaries

      —         —         —         —         —         56       —         56       69       125  

Treasury shares

      —         —         —         —         —         —         —         —         —         —    

Exercise of share warrants, employee warrants and stock options

    11       —         —         —         —         —         —         —         —         —         —    

Non-cash stock-based compensation expense

    12       —         —         2,758       —         —         —         —         2,758       2,334       5,092  

Other movements

      —         —         —         —         —         —         —         —         —         —    
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of March 31, 2019

      42,430,069       2,765       831,282       —         (22,385     (405,264     (15,248     391,150       41,156       432,307  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

              —           20,081       20,081       (3,480     16,601  

Other comprehensive income (loss)

              (6,593     (83       (6,676     369       (6,307
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

      —         —         —         —         (6,593     (83     20,081       13,405       (3,111     10,294  

Allocation of prior period loss

                (102,091     102,091       —         —         —    

Capital Increase

      —                     —         —         —    

Transaction with subsidiaries

                (26       (26     26       —    

Non-cash stock-based compensation expense

          3,361         (20         3,341       1,482       4,823  

Other movements

                    —         —         —    
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of March 31, 2020

      42,465,669       2,767       846,839       —         (29,254     (508,590     20,081       331,843       38,744       370,588  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

 

7


NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2020

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 best-in-class products in the field of immuno-oncology. Our 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 cancer 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. 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. In addition to our focus on immuno-oncology, we are exploring the use of our gene-editing technologies in other therapeutic applications, as well as through our subsidiary, Calyxt, to deliver plant-based solutions that are healthy and sustainable.

Cellectis S.A., Cellectis, Inc., Cellectis Biologics Inc. (which was incorporated on January 18, 2019) and Calyxt, Inc. are sometimes referred to as a consolidated group of companies as the “Group.”

Note 2. Accounting principles

2.1 Basis for preparation

The Interim Consolidated Financial Statements of Cellectis as of and for the three-month period ended March 31, 2020 were approved by our Board of Directors on May 6, 2020.

The Interim Consolidated Financial Statements are presented in U.S. dollars. See Note 2.2.

The Interim Consolidated Financial Statements for the three-month period ended March 31, 2020 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 for the three-month period ended March 31, 2020 have been prepared using the same accounting policies and methods as those applied for the year ended December 31, 2019, 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”).

 

8


Application of new or amended accounting standards or new amendments

The following pronouncements and related amendments have been adopted by us from January 1, 2020 but had no significant impact on the Interim Consolidated Financial Statements:

 

   

Amendments to References to the Conceptual Framework in IFRS Standards (Effective for the accounting periods as of January 1, 2020)

 

   

Amendment to IFRS 3 “Business Combinations” (Effective for the accounting periods as of January 1, 2020 and not yet adopted by the European Union)

 

   

Amendments to IAS 1 “Presentation of financial statements” and IAS 8 “Accounting policies, changes in accounting estimates and errors” (Effective for the accounting periods as of January 1, 2020)

 

   

Amendments to IFRS 9 “Financial instruments”, IAS 39 “Financial instruments: Recognition and Measurement” and IFRS 7 “Financial instruments: Disclosures” (Effective for the accounting periods as of January 1, 2020) - Interest Rate Benchmark Reform

Accounting standards, interpretations and amendments issued but not yet effective

The following pronouncements and related amendments are applicable for first quarter accounting periods beginning after January 1, 2021. 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:

 

   

IFRS 17 “Insurance Contracts” (Effective for accounting periods beginning after January 1, 2021 and not yet adopted by the European Union)

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 flow 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 Consolidated Statements of Changes in Shareholders’ Equity.

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.

 

9


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 three-month period ended March 31, 2020 and March 31, 2019, the consolidated group of companies (sometimes referred to as the “Group”) includes Cellectis S.A., Cellectis, Inc., Cellectis Biologics, Inc. and Calyxt, Inc. Cellectis Biologics, Inc. was incorporated on January 18, 2019.

As of March 31, 2020, Cellectis S.A. owns 100% of Cellectis, Inc., which owns 100% of Cellectis Biologics, Inc., and approximately 68.8% of Calyxt’s outstanding shares of common stock.

Calyxt’s shares of common stock are traded on NASDAQ under the symbol “CLXT”.

Non-controlling interests

Non-controlling shareholders held a 31.1% interest in Calyxt Inc. as of December 31, 2019 and a 31.2% interest in Calyxt Inc. as of March 31, 2020. These non-controlling interests were generated during the initial public offering of Calyxt Inc and a subsequent follow-on offering, as well as through vesting and exercises of equity awards.

Note 3. Information concerning the Group’s Consolidated Operations

3.1 Revenues and other income

Revenues by country of origin and other income

 

     For the three-month period ended March 31,  
     2019      2020  
     $ in thousands  

From France

     878        47,751  

From USA (1)

     158        2,377  
  

 

 

    

 

 

 

Revenues

     1,036        50,128  
  

 

 

    

 

 

 

Research tax credit

     2,370        1,848  

Subsidies and other

     25        (69
  

 

 

    

 

 

 

Other income

     2,395        1,778  
  

 

 

    

 

 

 

Total revenues and other income

     3,431        51,907  
  

 

 

    

 

 

 

 

(1)

Revenues from USA concern Calyxt only.

 

10


Revenues by nature

 

     For the three-month period ended March 31,  
     2019      2020  
     $ in thousands  

Recognition of previously deferred upfront payments

     —          19,470  

Other revenues

     427        27,557  
  

 

 

    

 

 

 

Collaboration agreements

     427        47,027  
  

 

 

    

 

 

 

Licenses

     441        768  

Products & services

     168        2,334  
  

 

 

    

 

 

 

Total revenues

     1,036        50,128  
  

 

 

    

 

 

 

Recognition of previously deferred upfront payments reflects the recognition of $19.4 million of deferred upfront and milestone payments on released targets, which is associated with the amendment signed in March 2020 to our collaboration agreement with Les Laboratoires Servier and Institut de Recherche Servier (“Servier”).

Other revenues include the recognition of a $27.6 million upfront payment received in March 2020 also associated with the amendment by which Cellectis granted Servier an expanded exclusive worldwide license to develop and commercialize, either directly or through its US sublicensee, Allogene Therapeutics, all next generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to UCART19/ALLO-501 and ALLO-501A.

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

Products and services revenues mainly include the revenues of plants activities which are primarily attributable to the commercialization of Calyxt’s high oleic soybean meal for $2.0 million and high oleic soybean oil for $0.3 million in the first quarter 2020.

3.2 Operating expenses

 

                           
     For the three-month period ended March 31,  
     2019      2020  

Cost of goods sold

     (34      (3,884

Royalty expenses

     (553      (716
  

 

 

    

 

 

 

Cost of revenue

     (586      (4,600
  

 

 

    

 

 

 

 

 

11


                           
     For the three-month period ended March 31,  
     2019        2020  

Research and development expenses

       

Wages and salaries

     (4,577)          (6,486)  

Social charges on stock option grants

     —            —    

Non-cash stock based compensation expense

     (1,148)          (2,604)  
  

 

 

      

 

 

 

Personnel expenses

     (5,726)          (9,089)  
  

 

 

      

 

 

 

Purchases and external expenses

     (7,585)          (9,967)  

Other

     (1,198)          (1,668)  
  

 

 

      

 

 

 

Total research and development expenses

                 (14,508)                        (20,724)  
  

 

 

      

 

 

 

 

                           
     For the three-month period ended March 31,  
     2019      2020  

Selling, general and administrative expenses

     

Wages and salaries

     (2,925      (4,786

Social charges on stock option grants

     (19      —    

Non-cash stock based compensation expense

     (3,943      (2,172
  

 

 

    

 

 

 

Personnel expenses

     (6,888      (6,958
  

 

 

    

 

 

 

Purchases and external expenses

     (3,717      (4,329

Other

     (883      (859
  

 

 

    

 

 

 

Total selling, general and administrative expenses

     (11,488      (12,146
  

 

 

    

 

 

 

 

                           
     For the three-month period ended March 31,  
     2019      2020  

Personnel expenses

     

Wages and salaries

     (7,503      (11,272

Social charges on stock option grants

     (19      —    

Non-cash stock based compensation expense

     (5,092      (4,776
  

 

 

    

 

 

 

Total personnel expenses

     (12,614      (16,047
  

 

 

    

 

 

 

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 period ended March 31, 2020, Cellectis’ CODM is composed of:

 

   

The Chairman and Chief Executive Officer;

 

   

The Executive Vice President Technical Operation ;

 

   

The Executive Vice President Strategic Initiatives;

 

   

The Executive Vice President Global Quality;

 

   

The Chief Scientific Officer;

 

   

The Chief Financial Officer;

 

   

The General Counsel;

 

   

The VP Corporate Development; and

 

12


   

The Chief Regulatory & Compliance Officer.

The Chief Medical Officer joined the CODM beginning April 13, 2020.

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) of products in the field of immuno-oncology and (ii) of novel therapies outside immuno-oncology to treat other human diseases. This approach is based on our gene editing and Chimeric Antigen Receptors (“CARs”) 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 delivering plant-based solutions that are healthy and sustainable. It corresponds to the activity of our U.S.-based majority-owned subsidiary, Calyxt, Inc., 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. The intersegments revenues represent the transactions between segments. Amounts due to Cellectis S.A. pursuant to inter segment transactions bear interest at a rate of the 12-monht Euribor plus 5% per annum.

With respect to corporate general and administrative expenses, Cellectis S.A. has provided Calyxt, Inc. 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 of 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, Inc. in euros at cost plus a mark-up ranging between zero to 10%, depending on the nature of the service.

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.

 

13


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

Details of key performance indicators by reportable segment for the three-month periods ended March 31

 

     For the three-month period ended
March 31, 2019
    For the three-month period ended
March 31, 2020
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     158       878       1,036       2,377       47,751       50,128  

External other income

     63       2,332       2,395       —         1,778       1,778  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     220       3,211       3,431       2,377       49,530       51,907  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (34     (553     (586     (3,879     (720     (4,600

Research and development expenses

     (2,024     (12,485     (14,508     (2,633     (18,091     (20,724

Selling, general and administrative expenses

     (6,059     (5,429     (11,488     (6,464     (5,682     (12,146

Other operating income and expenses

     3       29       33       (20     (5     (25
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (8,113     (18,437     (26,550     (12,996     (24,497     (37,495
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (7,893     (15,226     (23,119     (10,619     25,032       14,412  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     214       5,182       5,396       (334     2,523       2,190  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (7,679     (10,044     (17,723     (10,953     27,555       16,602  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-controlling interests

     (2,476     —         (2,476     (3,480     —         (3,480
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (5,203     (10,044     (15,248     (7,473     27,555       20,081  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

     64       1,057       1,120       (90     2,274       2,185  

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

     1,558       1,701       3,259       747       1,087       1,834  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     1,622       2,758       4,379       657       3,361       4,019  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (3,582     (7,286     (10,868     (6,817     30,917       24,100  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (371     (1,155     (1,527     (490     (1,555     (2,045

Additions to tangible and intangible assets

     347       1,305       1,652       148       13,828       13,975  

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 either of the CGUs at the end of three-month periods ended March 31, 2019 and March 31, 2020.

 

14


Note 5. Right-of-use assets

Accounting policy

Lease contracts recognition

Lease contracts, as defined by IFRS 16 “Leases”, are recorded in the statement of consolidated financial position, which leads to the recognition of:

 

   

an asset representing a right of use of the asset leased during the lease term of the contract “right-of-use”; and

 

   

a liability related to the payment obligation “lease debt”.

Measurement of the right-of use asset

At the commencement date, the right-of-use asset is measured at cost and comprises:

 

   

the amount of the initial measurement of the lease liability, to which is added, if applicable, any lease payments made at or before the commencement date, less any lease incentives received;

 

   

where relevant, any initial direct costs incurred by the lessee for the conclusion of the contract. These are incremental costs which would not have been incurred if the contract had not been concluded; and

 

   

estimated costs for restoration of the leased asset according to the terms of the contract.

Following the initial recognition, the right-of-use asset must be depreciated over the useful life of the underlying assets as lease term for the rental component.

Measurement of the lease liability

At the commencement date, the lease liability is recognized for an amount equal to the present value of the lease payments over the lease term.

Amounts involved in the measurement of the lease liability are:

 

   

fixed payments (including in-substance fixed payments; meaning that even if they are variable in form, they are in-substance unavoidable);

 

   

variable lease payments that depend on an index or a rate, initially measured using the index or the rate in force at the lease commencement date; amounts expected to be payable by the lessee under residual value guarantees; and

 

   

payments of penalties for terminating the lease, if the lease term reflects the lessee exercising an option to terminate the lease.

The lease liability is subsequently measured based on a process similar to the amortized cost method using the discount rate:

 

   

the liability is increased by the accrued interests resulting from the discounting of the lease liability, at the beginning of the lease period; and

 

   

payments made are deducted.

The interest cost for the period as well as variable payments, not taken into account in the initial measurement of the lease liability and incurred over the relevant period are recognized as costs.

In addition, the lease liability may be remeasured in the following situations:

 

   

the occurrence of a change in the lease term or a modification related to the assessment of the reasonably certain nature (or not) of the exercise of an option,

 

   

a remeasurement linked to residual value guarantees,

 

15


   

the occurrence of an adjustment to the rates and indices according to which the rents are calculated when rent adjustments occur.

Main contracts applicable

Based on its analysis, the Group has identified lease contracts according to the standard concerning office buildings, laboratories, production facilities and storage facilities.

For purposes of IFRS 16, the lease term reflects the Group’s reasonable expectation of the period during which the underlying asset will be used.

The discount rate used to calculate the lease debt is determined, for each portfolio of assets, according to the incremental borrowing rate at the contract date.

The incremental borrowing rate is the rate of interest that a lessee would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use asset in a similar economic environment.

The rental charges relating to short terms and low value lease remains classified as leases expenses in operating expenses.

Details of Right-of-use assets

IFRS 16 “Leases” is applicable for annual periods beginning on or after January 1, 2019. The consequence of the application of this standard is to recognize a right of use and lease liability on the balance sheet.

For the leaseback on Calyxt Headquarters, according to IFRS 16, the value of the right-of-use asset has been adjusted for the amount of the net deferred losses recognized in the statement of financial position immediately before the date of initial application, which was $1.8 million.

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

     43,112        2,500        45,612  
  

 

 

    

 

 

    

 

 

 

Additions

     3,383        706        4,089  

Depreciation expense

     (1,136      (279      (1,414

Translation adjustments

     (441      (31      (472
  

 

 

    

 

 

    

Net book value as of March 31, 2020

     44,918        2,896        47,814  
  

 

 

    

 

 

    

 

 

 

Gross value at end of period

     50,077        3,822        53,899  

Accumulated depreciation at end of period

     (5,159      (926      (6,085

 

16


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, 2019

     3,229       2,084       2,172       1,247       8,732  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     179       190       82       1,205       1,657  

Disposal of tangible assets

     —         —         —         —         —    

Reclassification

     7       (285     (1,066     (20     (1,364

Depreciation expense

     (28     (378     (154     —         (560

Translation adjustments

     25       42       18       18       103  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of March 31, 2019 as restated (*)

     3,412       1,653       1,051       2,451       8,567  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     7,815       11,935       2,249       3,249       25,247  

Accumulated depreciation and impairment at end of period

     (4,403     (10,282     (1,197     (798     (16,680

Net book value as of January 1, 2020

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

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Additions to tangible assets

     216       47       166       13,491       13,920  

Disposal of tangible assets

     —         (9     —         —         (9

Reclassification

     533       103       151       (787     —    

Depreciation expense

     (76     (312     (207     —         (595

Translation adjustments

     (45     (18     (14     (139     (216
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net book value as of March 31, 2020

     3,958       2,971       2,531       27,352       36,811  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross value at end of period

     8,438       13,875       4,431       28,150       54,893  

Accumulated depreciation and impairment at end of period

     (4,481     (10,904     (1,900     (798     (18,082

 

*

The variance with the figures released in 2019 first quarter financials of $1,309 is explained by an adjustment to the opening balance sheet related to the adoption of IFRS 16 that was recorded in technical equipment resulting from management’s finalization of its adoption analysis. The amount of which has been reclassified under “Right-of-use assets” and the lease debts in the statement of consolidated financial position.

As of March 31, 2020, no assets have been pledged as security for financial liabilities. There is no restriction on title of property, plant and equipment.

For the three-month period ended March 31, 2020, 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 Calyxt and Cellectis sites for $0.2 million and other equipment for $0.3 million.

Additions to our assets under construction as of March 31, 2020 primarily relates to Cellectis’ new facilities that are being constructed: a new raw materials manufacturing facility in Paris ($1.5 million), a new commercial manufacturing facility in Raleigh, North Carolina ($11.6 million). The balance relates to capital expenditure in the New-York office and in the Plants Segment.

 

17


Note 7. Trade receivables and other current assets

7.1 Trade receivables

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

Trade receivables

     3,513        3,524  

Valuation allowance

     (554      (520
  

 

 

    

 

 

 

Total net value of trade receivables

     2,959        3,003  
  

 

 

    

 

 

 

All trade receivables have payment terms of less than one year.

7.2 Subsidies receivables

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

Research tax credit

     9,140        11,230  
  

 

 

    

 

 

 

Total subsidies receivables

     9,140        11,230  
  

 

 

    

 

 

 

Research tax credit receivables as of March 31, 2020 include the accrual for a French research tax credit related to 2019 for $7.9 million and an additional $1.8 million for the three-month period ended March 31, 2020. The remaining amount relates to refundable tax credits in the United States. 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 March 31, 2020.

7.3 Other current assets

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

VAT receivables

     3,044        3,337  

Prepaid expenses and other prepayments

     11,829        9,302  

Tax and social receivables

     150        295  

Deferred expenses and other current assets

     594        1,034  
  

 

 

    

 

 

 

Total other current assets

     15,617        13,969  
  

 

 

    

 

 

 

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.

 

18


During the year ended December 31, 2019, and the three-month period ended March 31, 2020, 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, 2019, and as of March 31, 2020, deferred expenses and other current assets mainly relates to commission fees with respect to a letter of credit relating to our GMP Raleigh facility, a Calyxt broker receivable and certain down payments to suppliers.

As of December 31, 2019, tax and social receivables relate mainly to social charges on personnel expenses and tax reimbursement. As of March 31, 2020, tax and social receivables relate mainly to social charges on personnel expenses.

Note 8. Current financial assets and Cash and cash equivalents

 

As of December 31, 2019    Carrying
amount
     Unrealized
Gains/(Losses)
     Estimated
fair value
 
            $ in thousands         

Current financial assets

     20,385        —          20,385  

Cash and cash equivalents

     340,522        —          340,522  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     360,907        —          360,907  
  

 

 

    

 

 

    

 

 

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

Current financial assets

     59,005        —          59,005  

Cash and cash equivalents

     287,133        —          287,133  
  

 

 

    

 

 

    

 

 

 

Current financial assets and cash and cash equivalents

     346,138        —          346,138  
  

 

 

    

 

 

    

 

 

 

8.1 Current financial assets

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

As of December 31, 2019 and March 31, 2020, restricted cash consists of:

i. deposit to secure commitment to supplier regarding the manufacturing facility construction for $20 million classified as short-term restricted cash, and

ii. deposits to secure a Calyxt furniture and equipment sale-leaseback for $1.5 million of which $0.4 million are classified as short-term restricted cash.

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 notes indexed to equity index performance. Their nominal value amounted to $38.6 million and their fair value amounted to $38.6 million in each case as of March 31, 2020 (there were none as of December 31, 2019).

 

19


8.2 Cash and cash equivalents

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

Cash and bank accounts

     270,630        217,712  

Money market funds

     13,722        13,546  

Fixed bank deposits

     56,170        55,876  
  

 

 

    

 

 

 

Total cash and cash equivalents

     340,522        287,133  
  

 

 

    

 

 

 

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.

Note 9. Financial liabilities

9.1 Detail of financial liabilities

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

Lease debts

     46,540        48,699  
  

 

 

    

 

 

 

Total non-current financial liabilities

     46,540        48,699  
  

 

 

    

 

 

 

Lease debts

     1,067        1,342  
  

 

 

    

 

 

 

Total current financial liabilities

     1,067        1,342  
  

 

 

    

 

 

 

Trade payables

     29,264        26,873  

Other current liabilities

     8,497        16,989  
  

 

 

    

 

 

 

Total Financial liabilities

     85,368        93,904  
  

 

 

    

 

 

 

9.2 Due dates of the financial liabilities

 

Balance as of March 31, 2020    Book value      Less than
One Year
     One to Five
Years
     More than
Five Years
 
     $ in thousands  

Lease debts

     50,042        1,342        18,938        29,762  
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

     50,042        1,342        18,938        29,762  
  

 

 

    

 

 

    

 

 

    

 

 

 

Trade payables

     26,873        26,873        —          —    

Other current liabilities

     16,989        16,989        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     93,904        45,204        18,938        29,762  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

20


Note 10. Other current liabilities

 

     As of December 31,      As of March 31,  
     2019      2020  
     $ in thousands  

VAT Payables

     130        5,747  

Accruals for personnel related expenses

     7,295        5,303  

Other

     1,072        5,940  
  

 

 

    

 

 

 

Total

     8,497        16,989  
  

 

 

    

 

 

 

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, 2019 and March 31, 2020 is mainly explained by the payment of annual bonus in the first three months of 2020

The increase in VAT payables between December 31, 2019 and March 31, 2020, is mainly driven by a French VAT of $5.5 million included in the upfront payment received from Servier in March 2020 which has been paid in April 2020.

The increase in other between December 31, 2019 and March 31, 2020, is mainly driven fixed assets accruals.

Note 11. Deferred revenues and contract liabilities

 

     As of December 31,
2019
     As of March 31,
2020
 
     $ in thousands  

Deferred revenues and contract liabilities

     20,033        543  

Others

     —          —    
  

 

 

    

 

 

 

Total Deferred revenue and contract liabilities

     20,033        543  
  

 

 

    

 

 

 

The deferred revenues and contract liabilities as of December 31, 2019 were mainly attributable to upfront payments and milestone payments for the collaboration agreements with Servier. During the three-month period ended March 31, 2020, we recognized as revenue $16.9 million related to upfront payments and $2.5 million related to milestone payments on released targets based on the amendment signed in March 2020 to our collaboration agreement with Servier.

 

21


Note 12. Share capital and premium related to the share capitals

 

Nature of the Transactions

   Share
Capital
     Share
premium
     Number of
shares
     Nominal
value
 
     $ in thousands      in $  

Balance as of January 1, 2019

     2,765        828,525        42,430,069        0.05  

Capital Increase

     —          (1      —          —    

Exercise of share warrants, employee warrants and stock options

     —          —          —          —    

Non-cash stock based compensation expense

     —          2,758        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of March 31, 2019

     2,765        831,282        42,430,069        0.05  
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of January 1, 2020

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

Capital Increase

     —          —          —          —    

Non-cash stock based compensation expense

     —          3,361        —          —    

Other movements

     —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance as of March 31, 2020

     2,767        846,839        42,465,669        0.05  
  

 

 

    

 

 

    

 

 

    

 

 

 

Capital evolution during the three-month period ended March 31, 2020.

 

   

During the three-month period ended March 31, 2020, no ordinary shares were issued.

Note 13. Non-cash share-based compensation

13.1 Detail of Cellectis equity awards

Holders of vested Cellectis stock options and 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 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 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.

 

22


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:

 

     2017    2018    2019

Weighted-Average fair values of stock options granted

   14.30€    8.84€    10.19€

Assumptions:

        

Risk-free interest rate

   0.03%    0.13% - 0.21%    -0.38% - 0.09%

Share entitlement per options

   1    1    1

Exercise price

   22.57€    18.37€ - 24.80€    11.06€ - 18.25€

Grant date share fair value

   24.01€    16€ - 17.78€    11.32€ - 17.80€

Expected volatility

   65.6%    63.3% - 63.4%    60.0% - 66.6%

Expected term (in years)

   6.12    6.25    5.78 - 6.25

Vesting conditions

   Service    Service    Service

Vesting period

   Graded    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 31,2018

     5,644,044        27.47  €      8,978,106       25.36  €      7.3y  

Granted

     —          —   €      1,650,800       17.90  €   

Exercised

     —          —   €      —         —   €   

Forfeited or Expired

     —          —   €      (956,524     24.01  €   

Balance as of December 31,2019

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

Granted

     —          —   €      —         —   €   

Exercised

     —          —   €      —         —   €   

Forfeited or Expired

     —          —   €      (119,821     24.08  €   

Balance as of March 31,2020

     7,156,879        26.06  €      9,552,561       24.22  €      6.5y  

Share-based compensation expense related to stock option awards was $3.3 million and $2.3 million for the three-months periods ended 2020 and 2019, respectively.

 

23


Warrants

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

Information on warrants activity follows:

 

     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, 2018

     687,252        27.74  €      918,927        26.74  €      7.2y  

Granted

     —          —   €      —          —   €   

Exercised

     —          —   €      —          —   €   

Forfeited or Expired

     —          —   €      —          —   €   

Balance as of December 31, 2019

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

Granted

     —          —   €      —          —   €   

Exercised

     —          —   €      —          —   €   

Forfeited or Expired

     —          —   €      —          —   €   

Balance as of March 31, 2020

     852,260        35.35  €      918,927        35.12  €      6.4y  

Share-based compensation expense related to warrants awards was $0.1 million and $0.3 million for the three-months periods ended 2020 and 2019, respectively.

Free shares

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

The free shares granted in 2018 and after are subject to a one-year vesting period for French employees and two-years for foreign citizens.

 

24


Information on free shares activity follows:

 

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

Unvested balance at December 31, 2018

     71,600        27.37  € 

Granted

     57,000        13.04  € 

Vested

     (35,600      25.74  € 

Cancelled

     (26,000      21.65  € 

Unvested balance at December 31, 2019

     67,000        13.98  € 

Granted

     6,500        14.54  € 

Vested

     —          —    € 

Cancelled

     (10,000      16.00  € 

Unvested balance at March 31, 2020

     63,500        13.72  € 

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 $19 thousand and $0.2 million for the three-months periods ended 2020 and 2019, respectively.

13.2 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:

 

     2019    2020

Weighted-Average fair values of stock options granted

   $9.45    $5.19

Assumptions:

     

Risk-free interest rate

   2.5%    1.7%

Share entitlement per options

   1    1

Exercise price

   $13.01    $7.30

Grant date share fair value

   $13.01    $7.30

Expected volatility

   78.9%    77.4%

Expected term (in years)

   6.9    6.9

Vesting conditions

   Service    Service

Vesting period

   Graded    Graded

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.

 

25


The 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

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, 2018

     1,278,038  €    $ 7.45        3,201,887     $ 10.67        8.2y  

Granted

     —         —  $        1,590,000     $ 13.80     

Exercised

     —         —  $        (95,327   $ 3.61     

Forfeited or Expired

     —         —  $        (227,696   $ 14.68     

Other activity

          12,495     $ 13.29     

Balance as of December 31, 2019

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

Granted

     —         —  $        60,000     $ 7.30     

Exercised

     —         —  $        —       $ 0.00     

Forfeited or Expired

     —         —  $        (235,894   $ 15.61     

Balance as of March 31, 2020

     1,890,357     $ 8.73        4,305,465     $ 11.46        6.6y  

Stock-based compensation expense related to stock option awards was $1.0 million and $1.0 million for the three-months periods ended 2020 and 2019, respectively. The options granted under the plans were originally only exercisable upon a triggering event or initial public offering as defined by the plans.

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.

 

26


Information on restricted stock unit activity follows:

 

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

Unvested balance at December 31, 2018

     1,051,414      $ 14.11  

Granted

     100,000      $ 12.48  

Vested

     (324,043    $ 9.69  

Cancelled

     (13,845    $ 12.72  

Unvested balance at December 31, 2019

     813,526      $ 9.41  

Granted

     —        $ 0.00  

Vested

     (51,973    $ 9.80  

Cancelled

     (50,417    $ 10.45  

Unvested balance at March 31, 2020

     711,136      $ 10.33  

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 $0.3 million and $1.3 million for the three-months periods ended 2020 and 2019, 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  

Information on performance stock unit activity follows:

 

27


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

Unvested balance at December 31, 2019

     311,667      $ 7.06  

Granted

     —        $ —    

Vested

     —        $ —    

Cancelled

     —        $ —    

Unvested balance at March 31, 2020

     311,667      $ 7.06  

Share-based compensation expense related to performance stock units awards for the three-month period ended March 31, 2020 was $0.1 million.

Note 14. Earnings per share

 

     For the three-month period ended March 31,  
     2019      2020  

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

     (15,248      20,081  

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

     42,430,069        42,465,669  

Adjusted weighted average number of outstanding shares, net of effects of dilutive potential ordinary shares(1)

     42,457,133        42,498,423  

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

     

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

     (0.36      0.47  

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

     (0.36      0.47  

 

(1)

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)

Note 15. Provisions

 

     12/31/2019      Additions      Amounts
used
during the
period
    Reversals      OCI     3/31/2020  

Pension

     2,855        98        —         —          (112     2,841  

Loss on contract

     272        —          (271     —          —         —    

Employee litigation and severance

     639        171        (298     —          (15     498  

Commercial litigation

     2,832        —          —         —          (70     2,763  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

     6,598        269        (569     —          (197     6,101  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Non-current provisions

     2,855        98        —         —          (112     2,841  

Current provisions

     3,743        171        (569     —          (85     3,260  

During the three-month period ended March 31, 2020, additions mainly relate to (i) employee litigation for $0.2 million and (ii) pension service cost of the period for $0.1 million.

The amounts used during the period and the associated accrual reversals mainly relate to (i) fee payments in connection with the Montvale, New Jersey facility discontinuation and (ii) reversal of employee litigation.

 

28


Note 16. Commitments

 

As of March 31, 2020    Total      Less than
1 year
     1 - 3 years      3 - 5 years      More than
5 years
 
     $ in thousands  

Lease agreement

     72,146        3,903        18,805        9,769        39,669  

License agreements

     18,037        1,346        2,693        2,693        11,305  

Manufacturing agreements

     3,555        3,555        —          —          —    

Clinical & R&D agreements

     1,365        844        522        —          —    

Construction agreements

     22,035        22,035        —          —          —    

Other agreements

     9,385        9,313        72        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total contractual obligations

     126,523        40,995        22,092        12,462        50,974  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Obligations under the terms of lease agreements

We have entered into various lease agreements primarily including facility leases agreements for our sites in Paris, France, and in the United-States in New-York City (New York), Raleigh (North Carolina) and Roseville (Minnesota) for a defined term, as well as finance leases and sales and leaseback for equipment.

Obligations under the terms of license 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.

Obligations under the terms of manufacturing agreements

We have manufacturing agreements whereby we are obligated to pay for services rendered in the next 12 months regarding our products UCART123, UCARTCS1 and UCART22.

Obligations under the terms of Clinical & Research agreements

We have entered into clinical and research agreements where we are obligated to pay for services to be provided in the next 12 months regarding our research collaboration agreements, clinical trials and translational research projects.

Obligations under the terms of Construction agreements

We have entered into a construction agreement regarding our manufacturing facility based in Raleigh, North Carolina, where we committed to pay for construction work in the next 12 months.

 

29


Obligations under the terms of other agreements

Calyxt entered into seed and grain production agreements (Forward Purchase Contracts) with seed producers and growers. The seed contracts often require Calyxt to pay prices for the seed produced at an exchange-traded price of grain plus a premium. The grower contracts are linked to commodity futures market prices with the grower having the option to fix their price with us throughout the term of the agreement. These contracts allow for delivery of grain to Calyxt at harvest if so specified when the agreement is executed, otherwise delivery occurs on a date that Calyxt elects through August 31 of the following year. In all periods presented, we considered Forward Purchase Contracts as normal purchases and not derivatives. Any mark-to-market gains or losses associated with those contracts were reflected in inventory upon our purchase of the underlying grain.

Note 17 Subsequent events

None

 

30


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 best-in-class products in the field of immuno-oncology. Our 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 and are capable of being stored and distributed worldwide. Our gene-editing expertise also enables us to develop product candidates that feature additional safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity. In addition to our focus on immuno-oncology, we are exploring the use of our gene-editing technologies in other therapeutic applications, as well as to develop, through our 68.8% (as of March 31, 2020) ownership in Calyxt, plant-based solutions designed to be healthy and sustainable.

We currently conduct our operations through two business segments, Therapeutics and Plants. Our Therapeutics segment is mainly focused on the development of products in the field of immuno-oncology. Our Plants segment focuses on applying our gene-editing technologies to develop agricultural products with targeted traits through its own efforts or through alliances with other companies in the agricultural market.

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 product candidates, including preparing to conduct clinical studies of our product candidates, providing general and administrative support for these operations and protecting our intellectual property. In addition, by leveraging our plant-engineering platform and the transformative potential of gene editing, we aim to develop, through Calyxt, agricultural products focused on delivering human health benefits and plant products that are more sustainable than others available in the market today. We do not have any therapeutics products approved for sale and have not generated any revenues from immunotherapy product sales. Although Calyxt achieved commercialization in the first quarter of 2019, it has not yet generated significant revenue from sales of its initial high oleic soybean products.

We currently derive all of our Therapeutics revenues from payments pursuant to our collaboration agreements with Allogene Therapeutics, Inc. (“Allogene”) and Les Laboratoires Servier and Institut de Recherche Servier (“Servier”), patent licensing arrangements and royalties on licensed technologies.

 

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For the three-month period ended March 31, 2020, we received aggregate payments of $32.9 million from Servier pursuant to the collaboration agreements. As of March 31, 2020, we were eligible to receive potential development and commercial milestone payments pursuant to these agreements of (i) up to $410 million from Servier and (ii) up to $2.8 billion from Allogene. Under our agreement with Allogene, 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 our agreement with Servier, 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 under sublicenses.

We are also party to research and development agreements with MD Anderson Cancer Center pursuant to which we collaborate with this center to accelerate the pre-clinical and clinical development of UCARTCS1. Under this agreement, we fund the pre-clinical research activities performed at this center.

We are currently sponsoring clinical studies at three sites for the BALLI-01 Study, at four sites for the AMELI-01 Study and at three sites for the MELANI-01 Study, as follows:

 

   

AMELI-01 Study, the Phase 1 dose-escalation clinical trial under the protocol UCART123_01 for UCART123 targeting AML, which is being conducted at Weill Cornell Medical Center (New York, USA), MD Anderson Cancer Center (Texas, USA), H. Lee Moffitt Cancer Center (Florida, USA) and Dana Farber (Massachussetts, USA).

 

   

BALLI-01 Study, the Phase 1 dose-escalation clinical trial under the protocol UCART22-01 for UCART22 targeting B-ALL, which is being conducted at MD Anderson Cancer Center (Texas, USA), The University of Chicago Comprehensive Cancer Center (Illinois, USA), and Weill Cornell Medical Center (New York, USA).

 

   

MELANI-01 Study, the Phase 1 dose-escalation under the protocol UCARTCS1_01 for UCARTCS1 targeting multiple myeloma, which is being conducted at MD Anderson Cancer Center (Texas, USA), Hackensack University Medical Center (New Jersey, USA), and Weill Cornell Medicine (New York, USA).

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

COVID-19 Update

The COVID-19 pandemic and government actions to contain it have resulted in significant disruptions to various public and commercial activities, caused disruptions to global and regional supply chains, and weighed heavily on global and regional economic conditions.

In response to the COVID-19 pandemic and in accordance with governmental orders, we have implemented proactive measures to protect the health and safety of our employees, including restricting employee travel, requiring remote work arrangements for non-laboratory employees, implementing social distancing and enhanced sanitary measures in our facilities, and cancelling attendance at events and conferences. Calyxt has made similar modifications.

 

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While implementing these health and safety measures, we have continued to advance our proprietary allogeneic CAR T-cell programs. During the first quarter of 2020, Cellectis continued to enroll patients in its AMELI-01, BALLI-01 and MELANI-01 clinical trials, and each of the trials currently continues to progress through its respective dose levels. The allogeneic CAR T-cell product candidates for these trials have been manufactured, shipped and received by the respective clinical trial centers during the second half of 2019, and our clinical vials currently in storage are expected to cover at least the dose escalation portion of each of our three ongoing Phase 1 trials.

In addition, construction has continued on our raw materials manufacturing facility in Paris and our commercial manufacturing facility in Raleigh, North Carolina. In the absence of additional or expanded government restrictions to contain the COVID-19 pandemic, we anticipate that the construction of the Paris facility will be completed and the facility will become operational during 2020 and that the construction of the Raleigh facility will be completed in 2020 and commissioned and qualified in 2021.

With respect to the three out-licensed programs, Allogene Therapeutics has announced that the ALPHA clinical trial evaluating UCART19 in R/R Diffused Large B-cell Lymphoma and Follicular Lymphoma, and the UNIVERSAL clinical trial evaluating UCARTBCMA in R/R multiple myeloma, have continued to enroll and dose patients, while the PALL/CALM UCART19 clinical trial in R/R B-cell acute lymphoblastic leukemia, which is sponsored by Servier, has halted recruitment due to the COVID-19 crisis.

At Calyxt, there has been limited disruption to date on research and development and seed distribution. However, the COVID-19 pandemic has resulted in significantly lower demand for high oleic soybean oil, corresponding to overall lower industry demand resulting from disruptions to the food industry. Potential disruptions to protein processing facilities may also impact demand for high oleic soybean meal among Calyxt’s protein producer customers. Calyxt is responding to demand, pricing and market uncertainties by adjusting its short-term crush strategy and evaluating operating expense reductions to increase financial flexibility and liquidity.

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 I.A. “Risk Factors.”

Key events of the three-month period ended March 31, 2020

Since the beginning of 2020, Cellectis has made the following key achievements:

 

   

On January 6, 2020, Cellectis announced the publication of a review titled “Off-the-shelf’ allogeneic CAR T cells: development and challenges” in Nature Reviews Drug Discovery by Prof. Stéphane Depil, Dr. Philippe Duchateau, Prof. Stephan Grupp, Prof. Ghulam Mufti and Dr. Laurent Poirot. The authors review the opportunities and challenges presented by universal allogeneic CAR T-cell therapies, such as the potential of taking T-cells from a healthy donor instead of using patient-derived cells and the challenge that graft-versus-host-disease (GvHD) poses during treatment.

 

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On January 12, 2020, Cellectis and Iovance Biotherapeutics entered into a research collaboration and exclusive worldwide license agreement whereby Cellectis grants Iovance an exclusive license under certain TALEN® technology in order to develop tumor infiltrating lymphocytes (TIL) that have been genetically edited to create more potent cancer therapeutics. This license enables Iovance Biotherapeutics’ use of TALEN® technology addressing multiple gene targets to modify TIL for therapeutic use in several cancer indications. Financial terms of the license include development, regulatory and sales milestone payments from Iovance Biotherapeutics to Cellectis, as well as royalty payments based on net sales of TALEN®-modified TIL products.

 

   

On January 15, 2020, Cellectis announced the first patient dosing in AMELI-01, the Phase 1 dose escalation clinical trial evaluating a new UCART123 product candidate in relapsed/refractory acute myeloid leukemia (AML). This trial, sponsored by Cellectis, is part of an Investigational New Drug (IND) from the US Food and Drug Administration for a new UCART123 construct and an optimized production process, and will evaluate the safety, expansion, persistence and clinical activity of the product candidate in patients with relapsed/refractory AML. AMELI-01 replaced the first US clinical trial assessing the UCART123 product candidate.

 

   

On March 4, 2020, Cellectis and Servier entered into an amendment to our License, Development and Commercialization Agreement dated March 6, 2019 (as so amended, the “Servier License Agreement”). Under this amendment, Cellectis grants Servier an expanded exclusive worldwide license to develop and commercialize all next generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to UCART19/ALLO-501, and ALLO- 501A, an anti-CD19 candidate in which the rituximab recognition domains have been removed, either directly or through its US sublicensee Allogene Therapeutics. In this amendment, financial terms were improved to include an additional $27.6 million (EUR 25 million based on the currency exchange rate at this date) upfront payment, as well as up to $410 million (EUR 370 million based on the currency exchange rate at this date) in clinical and commercial milestones. The royalty rate was increased from tiered high single-digit royalties to flat low double-digit royalties based on net sales of products. In addition, Cellectis regained exclusive control over the five undisclosed allogeneic CAR T-cell targets previously covered by the initial agreement.

 

   

On March 10, 2020, Cellectis announced that a new patent from the US Patent and Trademark Office (USPTO) had been granted to Cellectis for methods of preparing allogeneic T-cells for immunotherapy with CRISPR-Cas9 technology. The patent (US10,584,352) claims “a method of preparing and administering T-cells for immunotherapy comprised of providing primary human T-cells from a healthy donor and genetically modifying the primary human T-cells to eliminate expression of the T-cell receptor (TCR), which contains expression on the Cas9 endonuclease fused to a nuclear localization signal (NLS) and guide RNA that directs said endonuclease to at least one targeted locus encoding the TCR in the T-cell genome, and further the expansion of the genetically modified T-cells, as well as the administration of at least 10,000 of the expanded genetically modified T-cells to a patient.” This patent complements the European patent (EP3004337), claiming a method of preparing T-cells for immunotherapy using the CRISPR-Cas9 system, initially granted on August 2, 2017 and upheld by the European Patent Office (EPO) in November 2019 following an opposition procedure initiated in May 2018. In January 2020, Cellectis was also granted European Patent (EP3116902), which claims “an engineered isolated CAR T-cell, which expression of beta 2-microglobulin (B2M) is inhibited, while at least one gene encoding a component of the T-cell receptor (TCR) is inactivated.”

 

34


Since the beginning of 2020, Calyxt Inc., Cellectis’ majority-owned plant science subsidiary, has made the following achievements:

 

   

On January 23, 2020, Calyxt has appointed Bobby Williams, Ph.D. to the newly created role of Director of Gene Editing to further expand Calyxt’s innovation, product pipeline, and trait discovery efforts and inform product advancement decisions. Dr. Williams has been on the forefront of advancements in plant sciences, and is an expert in the gene editing field. His accomplishments include developing new gene silencing technology and leading efforts to discover small RNAs to precisely engineer beneficial crop traits. In addition, Dr. Williams led gene discovery initiatives to improve crop traits to support sustainability, specifically drought resistance, improved nitrogen efficiency and yield enhancement.

 

   

On February 7, 2020, Calyxt achieved its 2020 contracted acreage target, successfully contracting 100,000 soybean acres with U.S. farmers. The achievement of 100,000 contracted acres for 2020 represents 178% growth over Calyxt’s ~36,000 planted acres in 2019. This achievement surpasses the company’s stated goal of doubling its soybean acreage annually.

 

   

On March 24, 2020 Calyxt launched its new website to showcase how Calyxt is harnessing the ‘Power and Possibilities of Plants’.

Key events post March 31, 2020

For Cellectis:

 

   

On April 13, 2020, Cellectis announced the appointment of Carrie Brownstein, M.D., to the role of Chief Medical Officer. In Dr. Brownstein’s new role, she will oversee clinical research and development for Cellectis’ UCART clinical trial programs. Dr. Brownstein joins Cellectis from Celgene, with a strong track record in hematology and myeloid diseases. She is assuming her new position based in the Cellectis New York office and is joining the Company’s executive committee.

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 the clinical trial of our wholly-controlled UCART123, UCARTCS1 and UCART22 product candidates and initiate additional clinical trials for other wholly-controlled product candidates;

 

35


   

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

 

   

continue, through Calyxt, to advance the research and development of our current and future agricultural product candidates;

 

   

initiate additional clinical studies for, or additional pre-clinical development of, our immuno-oncology product candidates;

 

   

conduct and multiply, though Calyxt, additional field trials of our agricultural product candidates;

 

   

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

 

   

change or add additional manufacturers or suppliers of biological materials;

 

   

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, germplasm or other biological material;

 

   

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

 

   

maintain, protect and expand our intellectual property portfolio;

 

   

build our manufacturing facilities and secure arrangements for clinical and commercial manufacturing;

 

   

seek to attract and retain new and existing skilled personnel;

 

   

create additional infrastructure to support our operations as a public company; 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-party funding and collaborations, and licensing arrangements. However, we may be unable to raise

 

36


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 three months ended March 31, 2020 have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

 

37


Results of Operations

Comparison for the three-month period ended March 31, 2019 and 2020

Revenues.

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Collaboration agreements

     427        47,027        10915.5     1,1248.6

Other revenues

     609        3,102        409.4     424.8

Revenues

     1,036        50,128        4739.4     4,885.7

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

The increase in revenues of $49.1 million between the three-month periods ended March 31, 2019 and 2020 primarily reflects an increase of revenue pursuant to our collaboration agreements of $46.6 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. The increase in other revenues of $2.5 million relates to higher high oleic soybean meal revenues at Calyxt.

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Research tax credit

     2,370        1,848        -22.0     -19.7

Other income

     25        (69      -377.4     -385.8

Other income

     2,395        1,778        -25.7     -23.5

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

The decrease in other income of $0.6 million, or 25.7%, between the three-month periods ended March 31, 2019 and 2020 reflects a decrease of $0.5 million in research tax credits, due to lower research and development purchases and external expenses during the three-month period ended March 31, 2020 that are eligible for the tax credit.

Cost of revenue

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Cost of goods sold

     (34      (3,884      n.a       n.a  

Royalty expenses

     (553      (716      29.6     33.5

Cost of revenue

     (586      (4,600      684.4     708.1

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

 

38


The increase in cost of goods sold of $3.8 million between the three-month periods ended March 31, 2019 and 2020 reflects the cost of soybean products sold in the period at Calyxt.

Research and development expenses.

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Personnel expenses

     (5,726      (9,089      58.7     63.5

Purchases, external expenses and other

     (8,783      (11,635      32.5     36.5

Research and development expenses

     (14,508      (20,724      42.8     47.2

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

Between the three-month periods ended March 31, 2019 and 2020, research and development expenses increased by $6.2 million or 42.8%. Personnel expenses increased by $3.4 million from $5.7 million in 2019 to $9.1 million in 2020 primarily due to a $1.5 million increase in non-cash stock-based compensation expense and a $1.9 million increase in wages and salaries as a result of increases in R&D headcount in both the therapeutic and plants segments. Purchases, external expenses and other increased by $2.8 million from $8.8 million in 2019 to $11.6 million in 2020 of which $2.5 million relates to Cellectis and $0.3 million to Calyxt.

Selling, general and administrative expenses.

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Personnel expenses

     (6,888      (6,958      1.0     4.1

Purchases, external expenses and other

     (4,600      (5,188      12.8     16.2

Selling, general and administrative expenses

     (11,488      (12,146      5.7     8.9

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

Between the three-month periods ended March 2019 and 2020, the increase in selling, general and administrative expenses of $0.7 million, or 5.7%, primarily reflects a $0.6 million increase in purchases, external expenses and other in 2020 of which $0.1 million relates to Cellectis and $0.5 million to Calyxt.

Other operating income and expenses.

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Other operating income (expenses)

     33        (25      -175.3     -177.6

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

 

39


No material variation between the three-month period ended March 31, 2019 and 2020.

Financial gain (loss).

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Financial income

     6,399        3,574        -44.1     -42.4

Financial expenses

     (1,003      (1,385      38.1     42.3

Financial gain (loss)

     5,396        2,190        -59.4     -58.2

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

The decrease in financial income of $2.8 million, or 44.1%, between the three-month periods ended March 31, 2019 and 2020 was mainly attributable to a decrease of $1.1 million in foreign exchange gain (from a $4.1 million gain in 2019 to a $3.0 million gain in 2020), a decrease of interest received from financial investment of $1.2 million and the decrease in fair value adjustment for $0.5 million in relation with the decrease in interest rates compared to March 31, 2019 as well as the closing of an investment fund.

The increase in financial expenses of $0.4 million, or 38.1%, between the three-month periods ended March 31, 2019 and 2020 was mainly attributable to $0.3 million increase in foreign exchange loss (from a $0.4 million loss in 2019 to a $0.7 million loss in 2020) and the increase in financial expenses related to the increase in lease debt for $0.2 million, partially offset by $0.1 million decrease in other financial expenses.

Net income (loss)

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Net income (loss)

     (17,723      16,602        -193.7     -196.5

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

The increase in net income of $34.3 million between the three-month period ended March 31, 2019 and 2020 was mainly due to (i) a $48.5 million increase in revenues and other income and (ii) a $0.3 million decrease in non-cash stock-based compensation expense, partially offset by (i) a $3.2 million decrease in financial result, (ii) a $4.0 million increase of cost of revenue, (iii) an increase of $3.5 million in purchases, external expenses and other and (iv) a $3.8 million increase in wages.

 

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Non-controlling interests

 

     For the three-month period
ended March 31,
     % change     % change at U.S.
dollar-euro
constant rate*
 
     2019      2020      2020 vs 2019  

Gain (loss) attributable to non-controlling interests

     (2,476      (3,480      40.6     44.8

 

*

Variation at U.S. dollar-euro constant rate which eliminates exchange rate fluctuations impact

During the three-month period ended March 31, 2020, we recorded $3.5 million in loss attributable to non-controlling interests. The increase in net loss attributable to non-controlling interests of $1.0 million is a result of increase in Calyxt’s net loss.

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, and 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, Inc. 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, Inc. 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.

 

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The following table summarizes segment revenues and segment operating profit (loss) for the three-month ended period 2019 and 2020:

 

     For the three-month period
ended March 31, 2019
    For the three-month period ended
March 31, 2020
 
$ in thousands    Plants     Therapeutics     Total
reportable
segments
    Plants     Therapeutics     Total
reportable
segments
 

External revenues

     158       878       1,036       2,377       47,751       50,128  

External other income

     63       2,332       2,395       —         1,778       1,778  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

External revenues and other income

     220       3,211       3,431       2,377       49,530       51,907  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenue

     (34     (553     (586     (3,879     (720     (4,600

Research and development expenses

     (2,024     (12,485     (14,508     (2,633     (18,091     (20,724

Selling, general and administrative expenses

     (6,059     (5,429     (11,488     (6,464     (5,682     (12,146

Other operating income and expenses

     3       29       33       (20     (5     (25
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (8,113     (18,437     (26,550     (12,996     (24,497     (37,495
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss) before tax

     (7,893     (15,226     (23,119     (10,619     25,032       14,412  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Financial gain (loss)

     214       5,182       5,396       (334     2,523       2,190  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     (7,679     (10,044     (17,723     (10,953     27,555       16,602  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non controlling interests

     (2,476     —         (2,476     (3,480     —         (3,480
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to shareholders of Cellectis

     (5,203     (10,044     (15,248     (7,473     27,555       20,081  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

     64       1,057       1,120       (90     2,274       2,185  

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

     1,558       1,701       3,259       747       1,087       1,834  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjustment of share-based compensation attributable to shareholders of Cellectis

     1,622       2,758       4,379       657       3,361       4,019  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income (loss) attributable to shareholders of Cellectis

     (3,582     (7,286     (10,868     (6,817     30,917       24,100  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization

     (371     (1,155     (1,527     (490     (1,555     (2,045

Additions to tangible and intangible assets

     347       1,305       1,652       148       13,828       13,975  

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 increased by $46.3 million, from $3.2 million for the three-month period ended March 31, 2019, to $49.5 million for the three-month period ended March 31, 2020. The increase was primarily due to an increase of $46.6 million in collaboration agreement revenues, partially offset by a $0.5 million decrease in research tax credits, as described in sections “Revenues” and “Other income” under “Results of Operations” for the consolidated Group

The increase in total operating expenses of $6.1 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020 resulted primarily from (i) higher personnel expenses of $3.2 million attributable to an increase of $2.6 million in personnel wages and salaries and $0.6 million in non-cash stock-based compensation expenses and, (ii) an increase of $2.7 million in purchases, external expenses and other and, (iii) an increase of $0.2 million in royalty expenses.

Operating loss before tax for our Therapeutics segment decreased by $40.3 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020.

Adjusted net loss attributable to shareholders of Cellectis for our Therapeutics segment decreased by $38.2 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020.

Plants segment

External revenues and other income in our Plants segment increased by $2.2 million from $0.2 million for the three-month period ended March 31, 2019 to $2.4 million for the three-month period ended March 31, 2020 due to higher high oleic soybean meal revenues.

The increase in total operating expenses of $4.9 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020 resulted primarily from an increase in Calyxt’s activities, which contributed to (i) an increase in cost of goods sold of $3.8 million, (ii) an increase of $1.0 million in personnel wages and salaries and (iii) an increase of $1.0 million in purchases, external expenses and other, partially offset by a decrease of $0.9 million in non-cash stock-based compensation expenses.

Operating loss before tax for our Plants segment increased by $2.7 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020.

Adjusted net loss attributable to shareholders of Cellectis for our Plants segment increased by $3.2 million from the three-month period ended March 31, 2019 to the three-month period ended March 31, 2020.

 

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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 March 31, 2020, we had current financial assets and cash and cash equivalents of $346.1 million comprising cash and cash equivalents of $287.1 million and current financial assets of $59.0 million which include $ 20.4 million of current restricted cash. Long term restricted cash amounts to $5.4 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 equivalent denominated in U.S. dollars is $186.8 million as of March 31, 2020. Current financial assets denominated in U.S. Dollars amounted to $59.0 million as of March 31, 2020.

Historical Changes in Cash Flows

The table below summarizes our sources and uses of cash for the three-month periods ended March 31, 2019 and 2020:

 

     For the three-month period
ended March 31,
 
     2019      2020  
     $ in thousands  

Net cash flows provided by (used in) operating activities

     (22,398      1,458  

Net cash flows provided by (used in) investing activities

     (4,456      (48,552

Net cash flows provided by (used in) financing activities

     (1,278      (1,899
  

 

 

    

 

 

 

Total

     (28,131      (48,992
  

 

 

    

 

 

 

Effect of exchange rate changes on cash

     (1,913      (4,397

For the three-month period ended March 31, 2020, our net cash flows provided by operating activities are mainly due to Cellectis cash payments of $11.5 million to suppliers, wages and social expenses of $9.4 million, and Calyxt operating payments of $12.4 million, offset by $32.9 million of payments received from Servier pursuant to our collaboration agreements, $1.0 million of payments received from licenses, and $0.6 million of interest received as well as other variances. For the three-month period ended March 31, 2019, our net cash flows used in operating activities are mainly due to Cellectis cash payments of $12.6 million to suppliers, wages and social expenses of $6.2 million, and

 

44


Calyxt operating payments of $7.8 million, partially offset by $1.1 million of payments received from Servier and Allogene Therapeutics pursuant to our collaboration agreements, $0.1 million of payments received from licenses, $2.0 million of interest received and $1.0 million of VAT and other taxes reimbursement as well as other variances.

For the three-month period ended March 31, 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 $7.8 million, including $0.9 million that relates to Cellectis’ new raw material manufacturing facility in Paris, $6.0 relates to the new commercial manufacturing facility in Raleigh, North Carolina and the remainder attributable to investing activity in the Plants segment, with $38.6 million of new current financial assets and $2.0 million of new non-current financial assets as well as other variances. For the three-month period ended March 31, 2019, 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 $1.8 million included $1.2 million of assets under construction relates to Cellectis’ new raw material manufacturing facility in Paris ($0.5 million) and new commercial manufacturing facility in Raleigh, North Carolina ($0.3 million) and the remainder attributable to investing activity in the Plants segment, (ii) the reclassification of $2.5 million related to a letter of credit related to the Raleigh facility in non-current financial asset and (iii) a $0.1 deposit related to Paris Biopark lease extension as well as other variances.

For the three-month period ended March 31, 2020, our net cash used by financing activities reflects the payments on lease debts for $1.9 million. For the three-month period ended March 31, 2019, our net cash used by financing activities reflects the payments on lease debts for $1.4 million partially offset by Calyxt stock options exercises during the period for $0.1 million.

Operating capital requirements

Our cash consumption is driven by our internal operational activities, as well as our outsourced activities, including the preclinical activities and the manufacturing activities of the requisite raw materials for the manufacturing of UCART123, UCART22 and UCARTCS1, the technology transfer to CELLforCURE, MolMed and Lonza, and the GMP manufacturing of UCART123, UCART22 and UCARTCS1 at CELLforCURE, MolMed and Lonza. In addition, we incur significant annual payment and royalty expenses related to our in-licensing agreements with different parties including Institut Pasteur, LifeTechnologies and University of Minnesota. In addition, in 2017 and 2018, we initiated clinical studies at Weill Cornell and the MD Anderson Cancer Center, leading to additional cash burn through payments to the clinical research centers, the Contract Research Organization involved and the companies involved in the logistics and testing of the clinical sample material. We also incur substantial expenses related to audit, legal, regulatory and tax related services associated with our public company obligation 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 therapeutics. 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. Although Calyxt completed the first sales of its high oleic soybean oil and soybean meal in the first quarter of 2019, it has not yet generated significant revenues from sales of these products. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our therapeutic product candidates, and begin to commercialize any approved products.

 

45


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 agricultural products, 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.

We believe our cash and cash equivalents, our cash flow from operations (including payments we expect to receive pursuant to our collaboration agreements) and government funding of research programs will be sufficient to fund Cellectis’ operations into 2022 and Calyxt’s operations into late 2021. However, we may require additional capital for the further development of our existing product candidates and may also need to raise additional funds sooner to pursue other development activities related to additional product candidates.

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 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 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. 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 initiation, progress, timing, costs and results of field trials for our agricultural 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;

 

46


   

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

 

   

the ability of our agricultural product candidates to progress through late stage development successfully, including through field trials;

 

   

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; and

 

   

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

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.

Off-Balance Sheet Arrangements.

Calyxt enters into seed and grain production agreements with settlement value based on commodity market future pricing. Otherwise, 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. Our exposure to market risk has not changes materially since December 31, 2019.

 

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, 2019.

 

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There have been no changes in the Company’s internal control over financial reporting during the three-month period ended March 31, 2020, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

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

The risk factor disclosed below supplement the risk factors described in Item 3.D. of Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2019, and should be read in conjunction with those risk factors.

The extent to which the COVID-19 pandemic and resulting deterioration of worldwide economic conditions adversely impacts our business, financial condition, and operating results will depend on future developments, which are difficult to predict.

As a result of the COVID-19 pandemic, governmental authorities have implemented and are continuing to implement numerous and rapidly evolving measures to try to contain the virus, such as travel bans and restrictions, limits on gatherings, quarantines, shelter-in-place orders, and business shutdowns. In response to the COVID-19 pandemic and in accordance with governmental orders, we and Calyxt have also implemented proactive measures to protect the health and safety of employees. Many of the suppliers, vendors and service providers on whom we and Calyxt rely have also made similar modifications. There is no certainty that such measures will be sufficient to mitigate the risks posed by, or the impacts and disruptions of, the COVID-19 pandemic.

As a result of the COVID-19 pandemic and government actions to contain it, related volatility in the financial markets and deterioration of national and global economic conditions, we and Calyxt could experience material adverse operational and financial impacts, including:

 

   

Disruptions to, and delays in, the clinical trials for the product candidates that we are developing resulting from suspensions or delays in enrollment or difficulties in enrolling patients; increased patient withdrawals from, or restrictions imposed on, patients participating in, the clinical trials; diversion of healthcare resources away from the conduct of the clinical trials; or interruptions in data collection, monitoring and/or processing due to governmental restrictions imposed in response to the COVID-19 pandemic.

 

   

Disruptions and delays to our or Calyxt’s research and development programs resulting from a shutdown of our respective laboratory facilities due to expanded governmental restrictions or illness among laboratory personnel as a result of COVID-19, increased absenteeism among scientific or laboratory employees, or delays with respect to raw material or starting material necessary for research and development activities.

 

   

Construction delays with respect to our planned manufacturing facilities resulting from increased, expanded or additional government restrictions in Paris, France or Raleigh, North Carolina, or as a result of supply chain disruptions affecting contractors on whom the construction projects are dependent.

 

   

With respect to Calyxt, interruptions or delays in seed production or grain processing resulting from supply chain disruptions, including as a result of restrictions or disruptions to transportation or operational disruptions at warehousing, storage, crushing and/or refining facilities.

 

48


   

Prolonged, significant reductions in demand for Calyxt’s products resulting from continued or worsening operational disruptions among food industry customers and/or protein producer customers, excess inventories in Calyxt’s target markets, aggressive pricing in those markets for non-premium products, and overall reductions in demand arising from challenging economic circumstances.

 

   

Overall reduced operational productivity resulting from challenges associated with remote work arrangements, limited resources to employees, and increased cybsersecurity risks as a result of remote access to our and Calyxt’s information systems.

 

   

Constraints on financing opportunities resulting from dislocations in the capital markets, which may make it too costly or difficult for us or Calyxt to pursue public or private equity or debt financings on acceptable terms.

The degree to which COVID-19 impacts our or Calyxt’s business and results will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the severity, duration and geographic spread of the outbreak, and the global, national and regional actions to contain the virus and address its impact. The resumption of normal business operations after interruptions caused by COVID-19 may be delayed or constrained by lingering effects of COVID-19 on us, Calyxt or our respective suppliers and third-party service providers. Even after the COVID-19 outbreak has subsided, we or Calyxt may experience material and adverse impacts as a result of the global economic impact of the COVID-19 outbreak.

The impact of COVID-19 may also exacerbate other risks discussed under “Risk Factors” in Item 3.D. of Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2019, any of which could have a material effect on us. This situation is changing rapidly and additional impacts may arise that we are not aware of currently.

Except as described above, there have been no material changes from the risk factors previously disclosed in the Annual Report.

 

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.

 

49