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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 12, 2022

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 [ X ]      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):

EXHIBIT INDEX

 

Exhibit Title
      
99.1 Press release, dated May 12, 2022

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)
   
  
Date: May 12, 2022     /s/ André Choulika    
  André Choulika
  Chief Executive Officer
  
EdgarFiling

EXHIBIT 99.1

Cellectis Provides Business Update and Reports Financial Results for First Quarter 2022

◦   UCART20x22 preclinical data presented at AACR demonstrated PoC with robust in vitro and in vivo anti-tumor activity

◦   Published two articles in Nature Communications providing preclinical validation for the evaluation of UCART123 to treat AML and BPDCN

◦   Received a $20 million convertible note under collaboration agreement with its partner Cytovia Therapeutics

◦   The US FDA has allowed an IND to proceed for Iovance Biotherapeutics’ first genetically modified TIL therapy, which is leveraging TALEN® gene editing technology

◦   Cash position [1] of $142 million as of March 31, 2022

◦   Conference call scheduled for 8AM ET/2PM CET on May 13, 2022

[1] Cash position includes cash, cash equivalents and current financial assets and restricted cash. Restricted cash was $5 million as of March 31, 2022, of which $0.5 million were classified as current financial assets.

NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today provided a business update and announced its results for the three-month period ending March 31, 2022.

“Cellectis made progress with our pipeline this quarter. We took a notable step forward with the first pre-clinical data on UCART20x22, the allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL). We were proud to see that the data demonstrated a robust pre-clinical proof-of-concept with strong activity against tumor cell lines expressing either a single antigen, CD20 or CD22, or both simultaneously.

We were proud to publish preclinical data in Nature Communications, providing validation of our product candidate UCART123, being developed for patients with relapsed or refractory acute myeloid leukemia (AML). This is the first preclinical data published on UCART123 supporting the rationale for using allogeneic CD123-directed CAR T cells to treat AML and blastic plasmacytoid denditric cell neoplasm (BPDCN). These preclinical results reinforce our commitment to deliver therapies for cancer patients with unmet medical needs.

The development of our partnerships was an exciting highlight for Cellectis. In March, our partner Iovance Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) allowed an Investigational New Drug Application (IND) to proceed for its first TALEN®-edited Tumor Infiltrating Lymphocytes (TIL) therapy, developed using Cellectis’ technology. In April, we received a $20 million convertible note, representing the upfront collaboration consideration under our collaboration agreement with Cytovia Therapeutics. Cellectis is developing custom TALEN® for Cytovia to develop gene-edited iPSC-derived Natural Killer cells. These announcements validated our belief that TALEN®’s status as technology of choice for gene editing.

Based on our current operating plan, our cash position of $142 million at the end of the first quarter 2022 (excluding Calyxt, Inc.), is expected to fund our operations into early 2024.

As we approach several developmental milestones during the second half of this year, we are excited to expand our CAR T platform by the expected filing of an IND for UCART20x22, and release of batches of this product from our in-house manufacturing facility. UCART20x22 is expected to be Cellectis’ first product candidate with fully integrated in-house development,” said André Choulika, CEO of Cellectis.

Pipeline highlights

Cellectis continues to make progress, enrolling patients throughout its three sponsored Phase 1 dose escalation trials:

BALLI-01 (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

AMELI-01 (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML)

MELANI-01 (evaluating UCARTCS1) in relapsed or refractory multiple myeloma (r/r MM)

UCART Preclinical Data and Programs

UCART123:

Preclinical data showed that:

UCART20x22:

Licensed Allogeneic CAR-T Cell Development Programs

Allogene Therapeutics, Inc.’s CAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Les Laboratoires Servier (“Servier”) and Allogene Therapeutics, Inc. (“Allogene”) based on an exclusive license granted by Cellectis to Servier1. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. Allogene’s anti-BCMA and anti-CD70 programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these programs.

Servier and Allogene: anti-CD19 programs

Allogene: anti-BCMA and anti-CD70 programs  

Anti-BCMA program

Anti-CD70 program

Manufacturing Facilities

Partnerships:

Iovance Biotherapeutics, Inc. (“Iovance”)

Cytovia Therapeutics, Inc. (“Cytovia”)

Financial Results

The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owned approximately 56.1% of outstanding shares of common stock (as of March 31, 2022), have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”).

We present certain financial metrics broken out between our two reportable segments – Therapeutics and Plants – in the appendices of this Q1 2022 financial results press release.

Cash: As of March 31, 2022, Cellectis, including Calyxt, had $160 million in consolidated cash, cash equivalents, current financial assets and restricted cash of which $142 million are attributable to Cellectis on a stand-alone basis. This compares to $191 million in consolidated cash, cash equivalents, current financial assets and restricted cash as of December 31, 2021, of which $177 million was attributable to Cellectis on a stand-alone basis. This net decrease of $31 million primarily reflects (i) $33 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $7 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt and (iii) $2 millions of unfavorable FOREX impact which was partially offset by (iv) $10 million of net proceeds from capital raise at Calyxt. Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash of $142 million as of March 31, 2022 will fund its operations into early 2024.

Revenues and Other Income: Consolidated revenues and other income were $4 million for the three months ended March 31, 2022 compared to $28 million for the three months ended March 31, 2021. 99% of consolidated revenues and other income was attributable to Cellectis in the first three months of 2022. This decrease between the three months ended March 31, 2022 and 2021 was mainly attributable to (i) a decrease of revenue pursuant to the recognition of a $15.0 million convertible note obtained as consideration for a “right-to-use” license granted to Cytovia and a $5.0 million Allogene milestone during the three-month period ended March 31, 2021, while revenue related to collaboration agreements for the three months of 2022 consists of the recognition of two milestones related to Cellectis’ agreement with Cytovia for $1.5 million and (ii) a decrease in other revenues of $5 million relating to the timing of revenue stream from the Calyxt’s business model for its PlantSpring technology and BioFactory compared to the Calyxt’s sales in the prior year of soybean products.

Cost of Revenues: Consolidated cost of revenues were $0.4 million for the three months ended March 31, 2022 compared to $8 million for the three months ended March 31, 2021. This decrease is driven by Calyxt’s business model for its PlantSpring and BioFactory compared to the sales of soybean products under its prior business model.

R&D Expenses: Consolidated R&D expenses were $29 million for the three months ended March 31, 2022 compared to $31 million for the three months ended March 31, 2021. 90% of consolidated R&D expenses was attributable to Cellectis in the first three months of 2022. The $2 million decrease between the first three months of 2022 and 2021 was primarily attributable to (i) a decrease of purchases, external expenses and other by $2 million (from $18 million in 2021 to $16 million in 2022) due to lower consumables, subcontracting costs and depreciation and amortization for the therapeutic segment, and (ii) a $1 million decrease in social charges on stock option partially offset by an increase of $2 million in wages and salaries mainly driven by the increased R&D headcount in the therapeutic segment.

SG&A Expenses: Consolidated SG&A expenses were $9 million for the three months ended March 31, 2022 and 2021. 65% of consolidated SG&A expenses was attributable to Cellectis in the first three months of 2022. The $0.5 million increase primarily reflects a $1 million increase in purchases, external expenses and other (from $4 million in 2021 to $5 million in 2022) and (ii) a $3 million increase in non-cash stock-based compensation expense mainly explained by the favorable impact in 2021 of the recapture of non-cash stock-based compensation from the forfeiture of certain of Calyxt’s former CEO’s unvested stock options, restricted stock units, and performance stock units following his departure, partially offset by (i) a $3 million decrease in wages and salaries and (ii) a $0.3 million decrease in social charges on stock option grants.

Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $32 million (or $0.70 per share) for the three months ended March 31, 2022, of which $28 million was attributed to Cellectis, compared to $12 million (or $0.28 per share) for the three months ended March 31, 2021, of which $6 million was attributed to Cellectis. This $20 million increase in net loss between first three months 2022 and 2021 was primarily driven by a decrease in revenues and other income of $24 million, a decrease in financial gain of $4 million and a decrease of $1 million in non-controlling interest, partially offset by a $9 million decrease in operating expenses.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $29 million (or $0.64 per share) for the three months ended March 31, 2022, of which $26 million is attributed to Cellectis, compared to a net loss of $11 million (or $0.26 per share) for the three months ended March 31, 2021, of which $4 million was attributed to Cellectis. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

We currently foresee focusing our cash spending at Cellectis for the Full Year of 2022 in the following areas:

CELLECTIS S.A.

(unaudited)

STATEMENT OF CONSOLIDATED FINANCIAL POSITION

($ in thousands, except per share data)

  As of
    December 31, 2021 March 31, 2022
     
     
ASSETS     
Non-current assets     
Intangible assets 1 854  1 698 
Property, plant, and equipment 78 846  76 523 
Right-of-use assets 69 423  67 227 
Non-current financial assets 6 524  6 567 
Total non-current assets  156 647  152 016 
     
Current assets     
Trade receivables 20 361  21 839 
Subsidies receivables 9 268  10 446 
Other current assets 9 665  7 524 
Cash and cash equivalent and Current financial assets 186 135  155 367 
Total current assets  225 429  195 175 
TOTAL ASSETS  382 076  347 191 
     
LIABILITIES     
Shareholders’ equity       
Share capital 2 945  2 945 
Premiums related to the share capital 934 696  937 333 
Currency translation adjustment (18 021) (21 261)
Retained earnings (584 129) (696 062)
Net income (loss) (114 197) (31 911)
Total shareholders’ equity - Group Share 221 293  191 044 
Non-controlling interests 15 181  12 010 
Total shareholders’ equity 236 474  203 054 
     
Non-current liabilities     
Non-current financial liabilities 20 030  18 345 
Non-current lease debts 71 526  69 739 
Non-current provisions 4 073  3 716 
Non-current liabilities 626  - 
Total non-current liabilities  96 254  91 800 
     
Current liabilities       
Current financial liabilities 2 354  12 607 
Current lease debts 8 329  8 408 
Trade payables 23 762  20 921 
Deferred revenues and deferred income 301  581 
Current provisions 871  578 
Other current liabilities 13 731  9 242 
Total current liabilities  49 348  52 337 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY  382 076  347 191 

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,
  2021  2022 
    
Revenues and other income    
Revenues 25 601  1 697 
Other income 2 365  2 135 
Total revenues and other income 27 966  3 832 
Operating expenses    
Cost of revenue (8 145) (385)
Research and development expenses (31 004) (29 479)
Selling, general and administrative expenses (8 779) (9 279)
Other operating income (expenses) 56  65 
Total operating expenses (47 872) (39 078)
     
Operating income (loss) (19 907) (35 247)
     
Financial gain (loss) 4 561  490 
     
Net income (loss) (15 346) (34 757)
Attributable to shareholders of Cellectis (11 868) (31 911)
Attributable to non-controlling interests (3 478) (2 846)
Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (0,28) (0,70)
     
Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (0,28) (0,70)

CELLECTIS S.A.

DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – First three-months

(unaudited) - ($ in thousands)

  For the three-month period ended March 31, 2021 For the three-month period ended March 31, 2022
$ in thousands PlantsTherapeuticsTotal reportable segments PlantsTherapeuticsTotal reportable segments
         
External revenues 4 988 20 613 25 601  32 1 665 1 697 
External other income - 2 365 2 365  - 2 135 2 135 
External revenues and other income 4 988 22 978 27 966  32 3 800 3 832 
Cost of revenue (7 369)(776)(8 145) (0)(385)(385)
Research and development expenses (3 025)(27 979)(31 004) (2 878)(26 601)(29 479)
Selling, general and administrative expenses (4 118)(4 660)(8 779) (3 216)(6 063)(9 279)
Other operating income and expenses (24)80 56  43 21 65 
Total operating expenses (14 536)(33 336)(47 872) (6 050)(33 028)(39 078)
Operating income (loss) before tax (9 548)(10 358)(19 907) (6 019)(29 228)(35 247)
Net financial gain (loss) (290)4 851 4 561  (422)912 490 
Net income (loss)  (9 839)(5 507)(15 346) (6 441)(28 316)(34 757)
Non-controlling interests 3 478 - 3 478  2 846 - 2 846 
Net income (loss) attributable to shareholders of Cellectis (6 361)(5 507)(11 868) (3 595)(28 316)(31 911)
R&D non-cash stock-based expense attributable to shareholder of Cellectis 262 1 305 1 567  (11)1 680 1 669 
SG&A non-cash stock-based expense attributable to shareholder of Cellectis (1 295)323 (973) 342 636 979 
Adjustment of share-based compensation attributable to shareholders of Cellectis (1 033)1 628 595  332 2 316 2 648 
Adjusted net income (loss) attributable to shareholders of Cellectis (7 394)(3 879)(11 273) (3 263)(26 000)(29 263)
Depreciation and amortization (604)(3 186)(3 791) (708)(4 934)(5 641)
Additions to tangible and intangible assets 268 6 332 6 601  363 581 945 

Note Regarding Use of Non-IFRS Financial Measures

Cellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial 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. In particular, we believe that the elimination of Non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis.

RECONCILIATION OF IFRS TO NON-IFRS NET INCOME – First three-months

(unaudited)

($ in thousands, except per share data)

  For the three-month period ended March 31,
  2021  2022 
    
Net income (loss) attributable to shareholders of Cellectis  (11 868) (31 911)
Adjustment:       
Non-cash stock-based compensation expense attributable to shareholders of Cellectis		 595  2 648 
Adjusted net income (loss) attributable to shareholders of Cellectis (11 273) (29 263)
     
Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0,26) (0,64)
     
Weighted average number of outstanding shares, basic (units) (1) 42 866 517  45 486 477 
     
Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) (0,26) (0,64)
     
Weighted average number of outstanding shares, diluted (units) (1) 43 461 047  45 486 477 

(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)

About Cellectis 
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 22 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs.  

As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases.  

Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).  

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

For more information, visit www.cellectis.com     
Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.

For further information, please contact: 

Media contacts: 
Pascalyne Wilson, Director, Communications, +33776991433, media@cellectis.com

Margaret Gandolfo, Senior Manager, Communications, +1 (646) 628 0300 

Investor Relation contact: 
Arthur Stril, Chief Business Officer, +1 (347) 809 5980, investors@cellectis.com

Ashley R. Robinson, LifeSci Advisors, +1 (617) 430 7577

Forward-looking Statements 

This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “intend”, “expect,” “plan,” “scheduled,” “could,” “would” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners. Forward-looking statements include statements about advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings, the operational capabilities at our manufacturing facilities, the potential of our preclinical programs, and the sufficiency of cash to fund operations. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development as well as the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2021 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

1 Servier is a global independent pharmaceutical group

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