UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K/A

Amendment No. 1 to Report on Form 6-K (Film No. 231147864)

Report of Foreign Private Issuer

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

under the Securities Exchange Act of 1934

Date of Report: September 5, 2023

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): ☐

Explanatory Note

This report on Form 6-K/A (this “Amendment”) filed by Cellectis S.A. (the “Company”) amends the Company’s report on Form 6-K, which included the Company’s unaudited Condensed Consolidated Interim Financial Statements as of, and for the three- and six-month periods ended, June 30, 2023 (the “Report”), filed with the U.S. Securities and Exchange Commission on August 7, 2023, solely to provide the financial statements formatted in iXBRL (Inline eXtensible Business Reporting Language) in accordance with Rule 405 of Regulation S-T and paragraph C.(6)(a)(ii) of the General Instructions to Form 6-K. Exhibit 101 includes information in Inline eXtensible Business Reporting Language.

Other than as expressly set forth above, this Amendment does not, and does not purport to, amend, revise, update or restate the information presented in the Report or reflect any events that have occurred after the Report was originally filed.

 

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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. 333-265826) and Form S-8 (Nos. 333-204205, 333-214884, 333-222482, 333-227717, 333-258514, 333-267760 and 333-273777), to the extent not superseded by documents or reports subsequently filed.

 

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EXHIBIT INDEX

 

Exhibit		Title
99.1		Cellectis S.A.’s interim report for the six-month period ended June 30, 2023.
101		The following materials from Cellectis S.A.’s Report on Form 6-K formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) the Condensed Consolidated Statements of Financial Position, (ii) the Condensed Consolidated Statements of Operations (Unaudited), (iii) the Condensed Consolidated Statements of Comprehensive Income (Loss), (iv) the Condensed Consolidated Statements of Cash Flow (Unaudited), (v) the Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited), and (vi) the Notes to the Interim Consolidated Financial Statements.

 

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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)
September 5, 2023	By:	/s/ André Choulika
		André Choulika
		Chief Executive Officer

 

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Exhibit 99.1

PRELIMINARY NOTE

The unaudited condensed Consolidated Financial Statements for the three- and six-month periods ended June 30, 2023, included herein, have been prepared in accordance with International Accounting Standard 34 (“IAS 34”)– Interim Financial Reporting as issued by the International Accounting Standards Board (“IASB”). The consolidated financial statements are presented in U.S. dollars. All references in this interim report to “$” and “U.S. dollars” mean U.S. dollars and all references to “€” and “euros” mean euros, unless otherwise noted.

This interim report, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act. All statements other than present and historical facts and conditions contained in this interim report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this interim report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties and are made in light of information currently available to us. Actual results, performance or events may differ materially from those projected in any forward-looking statement. Many important factors may adversely affect such forward-looking statements and cause actual results to differ from those in any forward-looking statement, including, without limitation, inconclusive clinical trial results or clinical trials failing to achieve one or more endpoints; early data not being repeated in ongoing or future clinical trials; promising preclinical data not yielding positive clinical results; failures to secure required regulatory approvals; disruptions from failures by third-parties on whom we rely in connection with our clinical trials; delays or negative determinations by regulatory authorities; changes or increases in oversight and regulation; increased competition; manufacturing delays or problems; inability to achieve enrollment targets; disagreements with our collaboration partners or failures of collaboration partners to pursue product candidates; legal challenges, including product liability claims or intellectual property disputes; commercialization factors, including regulatory approval and pricing determinations; disruptions to access to raw materials or starting material; delays or disruptions at our in-house manufacturing facilities; proliferation and continuous evolution of new technologies; capital resource constraints; dislocations in the capital markets; and other important factors described under “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2023 (the “Annual Report”) and under “Risk Factors” in the interim reports that we file with the SEC. As a result of these factors, we cannot assure you that the forward-looking statements in this interim report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

We own various trademark registrations and applications, and unregistered trademarks and service marks, including Cellectis®, TALEN® and our corporate logos, and all such trademarks and service marks appearing in this interim report are the property of Cellectis. The trademarks Calyxt®, PlantSpring™, BioFactory™, Plant Cell Matrix™ and PCM™ are owned by Calyxt an equity method investee of the Company.. 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 (in the case of Calyxt, Inc., only until May 31, 2023), unless the context otherwise requires. References to “Calyxt” refer to Calyxt, Inc. (renamed Cibus, Inc,. as of May 31,, 2023) and its subsidiaries, taken as a whole. With respect to disclosures relating to the period before May 31, 2023, references to the “Group” refer to Cellectis S.A., Cellectis, Inc., Cellectis Biologics, Inc. and Calyxt, Inc., collectively until May 31, 2023. With respect to disclosures relating to the period after May 31, 2023, references to the “Group” refer to Cellectis S.A., Cellectis, Inc. and Cellectis Biologics, Inc.

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PART I – FINANCIAL INFORMATION		3
Item 1.	Condensed Consolidated Financial Statements (Unaudited)	3
Item 2.	Management’s Discussion & Analysis of Financial Condition and Results of Operations	39
Item 3.	Quantitative and Qualitative Disclosures About Market Risks	51
Item 4.	Controls and Procedures	51
PART II – OTHER INFORMATION		51
Item 1.	Legal Proceedings	51
Item 1A.	Risk Factors	51
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	51
Item 3.	Default Upon Senior Securities	51
Item 4.	Mine Safety Disclosures	51
Item 5.	Other Information	51
Item 6.	Exhibits	51

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

Cellectis S.A.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

$ in thousands

 

			As of
	Notes		December 31, 2022				June 30, 2023
ASSETS
Non-current assets
Intangible assets				718				695
Property, plant, and equipment	8			63,621				59,231
Right-of-use assets	7			44,275				41,457
Non-current financial assets	9			8,791				13,006
Total non-current assets				117,406				114,389
Current assets
Trade receivables	10.1			772				422
Subsidies receivables	10.2			14,496				19,488
Other current assets	10.3			9,078				7,869
Current financial assets	11.1			7,907				1,120
Cash and cash equivalents	11.2			89,789				84,386
Total current assets				122,043				113,285
Total assets held for sale	5			21,768				-
TOTAL ASSETS				261,216				227,674
LIABILITIES
Shareholders’ equity
Share capital	15			2,955				3,491
Premiums related to the share capital	15			583,122				476,224
Currency translation adjustment				(28,605	)			(37,050	)
Retained earnings				(333,365	)			(305,392	)
Net income (loss)				(106,139	)			(40,715	)
Total shareholders’ equity - Group Share				117,968				96,558
Non-controlling interests				7,973				0
Total shareholders’ equity				125,941				96,558
Non-current liabilities
Non-current financial liabilities	12			20,531				40,270
Non-current lease debts	12			49,358				46,157
Non-current provisions	18			2,390				2,641
Total non-current liabilities				72,279				89,068
Current liabilities				-
Current financial liabilities	12			5,088				5,185
Current lease debts	12			7,872				8,270
Trade payables	12			21,456				19,229
Deferred revenues and contract liabilities	14			59				241
Current provisions	18			477				1,029
Other current liabilities	13			13,179				8,093
Total current liabilities				48,131				42,047
Total liabilities related to asset held for sale	5			14,864				-
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY				261,216				227,674

 

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

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Cellectis S.A.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

$ in thousands, except per share amounts

 

			For the six-month period ended June 30,
	Notes		2022 *				2023
Revenues and other income
Revenues	4.1			2,972				317
Other income	4.1			3,551				5,242
Total revenues and other income				6,523				5,560
Operating expenses
Cost of revenue	4.2			(714	)			(389	)
Research and development expenses	4.2			(52,231	)			(43,225	)
Selling, general and administrative expenses	4.2			(10,893	)			(8,914	)
Other operating income (expenses)				774				(83	)
Total operating expenses				(63,064	)			(52,612	)
Operating income (loss)				(56,541	)			(47,053	)
Financial income	4.4			12,263				33,041
Financial expenses	4.4			(3,050	)			(21,461	)
Net Financial gain (loss)				9,213				11,580
Income tax				—				(258	)
Income (loss) from continuing operations				(47,328	)			(35,731	)
Income (loss) from discontinued operations				(6,883	)			(10,377	)
Net income (loss)				(54,211	)			(46,108	)
Attributable to shareholders of Cellectis				(50,858	)			(40,715	)
Attributable to non-controlling interests				(3,352	)			(5,393	)
Basic / Diluted net income (loss) per share attributable to    shareholders of Cellectis	17
Basic net income (loss) attributable to shareholders of Cellectis per    share ($ /share)				(1.12	)			(0.76	)
Diluted net income (loss) attributable to shareholders of Cellectis per    share ($ /share)				(1.12	)			(0.76	)
Basic net income (loss) attributable to shareholders of Cellectis per    share ($ /share) from discontinued operations				(0.08	)			(0.09	)
Diluted net income (loss) attributable to shareholders of Cellectis per    share ($ /share) from discontinued operations				(0.08	)			(0.09	)

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation (Note 5)

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

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UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED COMPREHENSIVE INCOME (LOSS)

For the six-month period ended June 30,

$ in thousands

 

			For the six-month period ended June 30,
			2022 *				2023
Net income (loss)				(54,211	)			(46,108	)
Actuarial gains and losses				1,218				(42	)
Other comprehensive income (loss) that will not be reclassified    subsequently to income or loss from continued operations				1,218				(42	)
Currency translation adjustment				(20,315	)			2,272
Other comprehensive income (loss) that will be reclassified    subsequently to income or loss from continuing operations				(20,315	)			2,272
Other comprehensive income (loss) from discontinued operations				8,337				(1,233	)
Total Comprehensive income (loss)				(64,971	)			(45,111	)
Attributable to shareholders of Cellectis				(61,246	)			(41,172	)
Attributable to non-controlling interests				(3,725	)			(3,939	)

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation (Note 5)

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

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Cellectis S.A.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

($ in thousands, except per share amounts)

 

		For the three-month period ended June 30,
		2022 *				2023
Revenues and other income
Revenues			1,307				178
Other income			1,416				1,823
Total revenues and other income			2,723				2,001
Operating expenses
Cost of revenue			(329	)			(55	)
Research and development expenses			(25,630	)			(22,144	)
Selling, general and administrative expenses			(4,830	)			(3,950	)
Other operating income (expenses)			753				490
Total operating expenses			(30,036	)			(25,660	)
Operating income (loss)			(27,313	)			(23,659	)
Financial revenues			9,992				32,266
Financial expenses			(1,691	)			(16,284	)
Financial gain (loss)			8,301				15,982
Income tax			—				(258	)
Income (loss) from continuing operations			(19,012	)			(7,935	)
Income (loss) from discontinued operations			(442	)			(5,647	)
Net income (loss)			(19,454	)			(13,583	)
Attributable to shareholders of Cellectis			(18,946	)			(10,648	)
Attributable to non-controlling interests			(506	)			(2,935	)
Basic / Diluted net income (loss) per share attributable to shareholders    of Cellectis
Basic net income (loss) attributable to shareholders of Cellectis per share    ($ /share)			(0.42	)			(0.19	)
Diluted net income (loss) attributable to shareholders of Cellectis per share    ($ /share)			(0.42	)			(0.19	)
Basic net income (loss) attributable to shareholders of Cellectis per share    ($ /share) from discontinued operations			0.00				(0.05	)
Diluted net income (loss) attributable to shareholders of Cellectis per share    ($ /share) from discontinued operations			0.00				(0.05	)

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation (Note 5)

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

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CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

($ in thousands)

 

		For the three-month period ended June 30,
		2022 *						2023
Net income (loss)			(19,454	)					(13,583	)
Actuarial gains and losses			791						(21	)
Other comprehensive income (loss) that will not be reclassified    subsequently to income or loss from continued operations			791						(21	)
Currency translation adjustment			(15,282	)					4,751
Other comprehensive income (loss) that will be reclassified subsequently    to income or loss from continuing operations			(15,282	)					4,751
Other comprehensive income (loss) from discontinued operations			6,412						(4,906	)
Total Comprehensive income (loss)			(27,533	)					(13,760	)
Attributable to shareholders of Cellectis			(26,522	)					(11,139	)
Attributable to non-controlling interests			(1,011	)					(2,620	)

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation (Note 5)

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

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Cellectis S.A.

UNAUDITED INTERIM STATEMENTS OF CONSOLIDATED CASH FLOWS

$ in thousands

 

				For the six-month period ended June 30,
		Notes		2022 *				2023
Cash flows from operating activities
Net income (loss) for the period					(54,211	)			(46,108	)
Net loss for the period of discontinued operations					(6,807	)			(10,377	)
Net (loss) income for the period of continuing operations					(47,404	)			(35,730	)
Adjustment to reconcile net income (loss) to cash provided by (used in) operating    activities
Adjustments for
Intercompany transactions between continuing and discontinued operations (1)					76				—
Amortization and depreciation					9,402				8,875
Net loss (income) on disposals					155				0
Net financial loss (gain)		4.4			(9,213	)			(11,580	)
Income tax					—				258
Expenses related to share-based payments					4,327				3,265
Provisions					(113	)			671
Other non-cash items					(460	)			—
Realized foreign exchange gain (loss)					(381	)			15
Interest (paid) / received					86				1,416
Operating cash flows before change in working capital					(43,524	)			(32,810	)
Decrease (increase) in trade receivables and other current assets					(2,879	)			996
Decrease (increase) in subsidies receivables					(2,807	)			(4,649	)
(Decrease) increase in trade payables and other current liabilities					796				(7,441	)
(Decrease) increase in deferred income					202				180
Change in working capital					(4,687	)			(10,915	)
Net cash flows provided by (used in) operating activities of continuing operations					(48,212	)			(43,725	)
Net cash flows provided by (used in) operating activities of discontinued operations					(11,970	)			(3,644	)
Net cash flows provided by (used in) operating activities					(60,181	)			(47,369	)
Cash flows from investment activities
Calyxt’s cash and cash equivalents disposed of (2)					—				(1,642	)
Acquisition of property, plant and equipment		8			(1,541	)			(483	)
Net change in non-current financial assets		9			(252	)			489
Net cash flows provided by (used in) investing activities of continuing operations					(1,793	)			(1,636	)
Net cash flows provided by (used in) investing activities of discontinued operations					(744	)			79
Cash flows provided by (used in) investment activities					(2,537	)			(1,558	)
Cash flows from financing activities
Increase in share capital of Cellectis after deduction of transaction costs		15			—				23,561
Increase in borrowings		12			5,969				22,507
Decrease in borrowings		12			—				(2,547	)
Interest paid on financial debt					(176	)			(155	)
Payments on lease debts		12			(5,693	)			(5,550	)
Net cash flows provided by financing activities of continuing operations					100				37,817
Net cash flows provided by (used in) financing activities of discontinued operations					10,207				1,781
Net cash flows provided by (used in) financing activities					10,307				39,597
(Decrease) increase in cash and cash equivalents					(52,411	)			(9,329	)
Cash and cash equivalents at the beginning of the year					185,636				93,216
Effect of exchange rate changes on cash					(3,785	)			499
Cash from discontinued operations					11,316				—
Cash from continuing operations					118,123				84,386
Cash and cash equivalents at the end of the period		11			129,440				84,386

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation (Note 5)

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

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Cellectis S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

$ in thousands, except share data

 

		Share Capital Ordinary Shares																			Equity
	Notes	Number of shares			Amount			Premiums related to share capital				Currency translation adjustment			Retained earnings (deficit)			Income (Loss)			attributable to shareholders of Cellectis			Non controlling interests			Total Shareholders’ Equity
As of January 1, 2022			45,484,310			2,945			934,696				(18,021	)		(584,129	)		(114,197	)		221,293			15,181			236,474
Net Loss			—			—			—				—			—			(50,858	)		(50,858	)		(3,352	)		(54,211	)
Other comprehensive income (loss)			—			—			—				(11,605	)		1,218			—			(10,387	)		(373	)		(10,760	)
Total comprehensive income (loss)			—			—			—				(11,605	)		1,218			(50,858	)		(61,246	)		(3,725	)		(64,971	)
Allocation of prior period loss			—			—			—				—			(114,197	)		114,197			—			—			—
Issuance of Calyxt's common stock and    exercise of Calyxt's pre-funded warrants			—			—			—				—			1,402			—			1,402			1,331			2,733
Transaction with subsidiaries			—			—			—				—			2,152			—			2,152			(2,152	)		—
Exercise of share warrants, employee    warrants, stock-options and free-shares    vesting Cellectis			26,500			1			—				—			(1	)		—			0			—			0
Non-cash stock-based compensation    expense	16		—			—			5,331				—			—			—			5,331			954			6,285
Other movements			—			—			(372,744	)			—			372,744			—			—			—			—
As of June 30, 2022			45,510,810			2,946			567,284				(29,626	)		(320,812	)		(50,858	)		168,933			11,588			180,522
As of January 1, 2023			45,675,968			2,955			583,122				(28,605	)		(333,365	)		(106,139	)		117,968			7,973			125,941
Net Loss																			(40,715	)		(40,715	)		(5,393	)		(46,108	)
Other comprehensive income (loss)													(415	)		(42	)		—			(458	)		1,454			997
Total comprehensive income (loss)													(415	)		(42	)		(40,715	)		(41,172	)		(3,939	)		(45,111	)
Allocation of prior period loss																(106,139	)		106,139			—						—
Capital increase of Cellectis (1)			9,907,800			536			24,482													25,017						25,017
Transaction costs related to Cellectis’    capital increase (2)									(1,455	)						—						(1,455	)					(1,455	)
Operation between shareholders (3)																342						342			(342	)		—
Loss of control over Calyxt (4)																—						—			(4,440	)		(4,440	)
OCI Reclassification pursuant to Calyxt's    deconsolidation (5)													(8,030	)		(12	)					(8,042	)		—			(8,042	)
Non-cash stock-based compensation    expense	16								4,053							—						4,053			852			4,905
Other movements (6)									(133,976	)						133,824						(152	)		(105	)		(257	)
As of June 30, 2023			55,583,768			3,491			476,224				(37,050	)		(305,392	)		(40,715	)		96,558			0			96,558

 

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

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NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2023

 

 

25

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26

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33

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37

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38

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

Overview

We are a clinical stage biotechnological company, employing our core proprietary technologies to develop products based on gene-editing with a portfolio of allogeneic Chimeric Antigen Receptor T-cells (“UCART”) product candidates in the field of immuno-oncology and gene-edited hematopoietic stem and progenitor cells (“HSPC”) product candidates in other therapeutic indications.

Our UCART product candidates, based on gene-edited T-cells that express chimeric antigen receptors, or CARs, seek to harness the power of the immune system to target and eradicate cancers. We believe that CAR-based immunotherapy is one of the most promising areas of cancer research, representing a new paradigm for cancer treatment. We are designing next-generation immunotherapies that are based on gene-edited CAR T-cells. Our gene-editing technologies allow us to create allogeneic CAR T-cells, meaning they are derived from healthy donors rather than the patients themselves. We believe that the allogeneic production of CAR T-cells will allow us to develop cost-effective, “off-the-shelf” products that are capable of being stored and distributed worldwide. Our gene-editing expertise also enables us to develop product candidates that feature additional safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity.

Together with our focus on immuno-oncology, we are using, through our. HEAL platform, our gene editing technologies to develop HSPC product candidates in genetic diseases. HEAL is a new gene editing platform developed by Cellectis that leverages the power of TALEN® technology, to allow highly efficient gene inactivation, insertion and correction in HSPCs. Through the date of this interim report, Cellectis has announced preclinical programs in sickle cell disease, lysosomal storage disorders and primary immunodeficiencies.

We were (through May 31, 2023) conducting our operations through two business segments, Therapeutics and Plants. Our Therapeutics segment is focused on the development of products in the field of immuno-oncology and monogenic diseases. Our Plants segment, carried out (until May 31, 2023) through our ownership interest in Calyxt (48.0% as of May 31, 2023), is focused on engineering synthetic biology solutions through its PlantSpring platform for manufacture using its proprietary and differentiated BioFactory production system for a diverse base of target customers across an expanded group of end markets. Following the consummation of the Merger between Calyxt and Cibus Global on May 31, 2023, Cellectis lost control over Calyxt, and Calyxt was deconsolidated.

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

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

As of June 30, 2023, we were eligible to receive potential development and commercial milestone payments pursuant to (i) the License, Development and Commercialization Agreement dated March 6, 2019 between Les Laboratoires Servier and Institut de Recherches Internationales Servier (together “Servier”) and Cellectis, as amended on March 4, 2020 (the “Servier License Agreement”) of up to $410 million and (ii) the License Agreement dated March 7, 2019 between Allogene Therapeutics, Inc. (“Allogene”) and Cellectis (the “Allogene License Agreement”) of up to $2.8 billion. Under the Allogene License Agreement, we are eligible to receive tiered royalties on annual worldwide net sales of any products that are commercialized by Allogene that contain or incorporate, are made using or are claimed or covered by, our intellectual property licensed to Allogene under the Allogene License Agreement at rates in the high single-digit percentages. Under the Servier License Agreement, we are eligible to receive flat low double-digit royalties based on annual net sales of commercialized products as well as a low double-digit royalty on certain development milestone payments received by Servier. During the year ended December 31, 2021, we received $10.0 million from Allogene relating to milestones under the Allogene License Agreement.

We have also entered into collaboration and license agreements with Iovance Biotherapeutics and Cytovia Therapeutics for certain uses of our TALEN technology.

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For the six-month period ended June 30, 2023, and 2022, we derived all of our Therapeutics revenues from milestones reached as part of our collaboration with Cytovia and royalties on licensed technologies. No other revenue was recorded under other collaboration and license agreements for such periods.

At the date of this Report, we are sponsoring clinical studies with respect to three proprietary Cellectis UCART product candidates at eight (8) sites for the AMELI-01 Study, at twelve (12) sites for the BALLI-01 Study, at seven (7) sites for the NATHALI-01 Study as follow:

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

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Partnered clinical trials update

Allogene continues to enroll patients in the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial with ALLO-501A. Allogene announced that the single-arm ALPHA2 trial will enroll approximately 100 r/r large B cell lymphoma (LBCL) patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. Allogene expects to complete enrollment in H1 2024.

In April 2023, Allogene presented interim data from its Phase 1 TRAVERSE trial of ALLO-316, its first investigational product candidate for solid tumors, during an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting. The ongoing dose escalation study is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies that included an immune checkpoint inhibitor and a VEGF-targeting therapy. The data reported to date is primarily from the DL1 and DL2 cohorts. Anti-tumor activity was primarily observed in patients with tumors confirmed to express CD70 (N=10). Among 18 patients evaluable for efficacy, the disease control rate (DCR) was 89%. In the 10 patients whose tumors were known to express CD70, the disease control rate was 100%, which included three patients who achieved partial remission (two confirmed, one unconfirmed). The longest response lasted until month eight. There was a trend toward greater tumor shrinkage in patients with higher levels of CD70 expression. In patients evaluable for safety (N=19), ALLO-316 demonstrated an adverse event profile generally consistent with autologous CAR T therapies. Dose escalation in the TRAVERSE trial is expected to be completed in 2023.

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

Key events of the six-month period ended June 30, 2023

Since the beginning of 2023, key achievements at Cellectis include:

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Cécile Chartier joined the Cellectis board of directors on June 27, 2023. Dr. Chartier is the Chief Scientific Officer of NextVivo, Inc. Prior to her tenure at NextVivo, Dr. Chartier was Vice President of Research at Iovance Biotherapeutics, Inc., where she led the development of next generation tumor-infiltrating lymphocytes (TIL) therapies through research to early-stage clinical trials. Prior to this, Dr. Chartier spent 12 years at OncoMed Pharmaceuticals, where she served as Senior Director of Target Validation and led multiple antibody therapeutics project teams through Research and Development to IND filing. Dr. Chartier also worked at Shering (US Berlex) and Transgene (France), where she focused on gene therapy. Dr. Chartier obtained her Ph. D. in molecular biology from the Université Louis Pasteur in Strasbourg, France, and pursued post-doctoral research at Harvard Medical School.

Since the beginning of 2023 and until deconsolidation, developments at Calyxt, include the following:

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 expect to incur losses for near-term future periods. We anticipate that such expenses will increase substantially if and as we:

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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 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 other 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 six-month ended June 30, 2023 have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

Results of Operations

Comparison for the six-month periods ended June, 2022 and 2023

Revenues.

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Collaboration agreements			2,530				—				-100.0	%
Other revenues			442				317				-28.3	%
Revenues			2,972				317				-89.3	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

The decrease in revenues of $2.7 million between the six-month periods ended June 30, 2022 and 2023 reflects the recognition of two milestones related to Cellectis’ agreement with Cytovia for $1.5 million and the recognition of $1.0 million related to the change of control of a licensee pursuant to the terms of its license agreement with Cellectis and the amendment to such license agreement (extension of its option term.

Other income

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Research tax credit			3,544				4,391				23.9	%
Other income			7				851				12616.2	%
Other income			3,551				5,242				47.6	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

The increase in other income of $1.7 million between the six months periods ended June 30, 2022 and 2023 reflects an increase of research tax credit of $0.8 million due to an increase of eligible expenses, and the recognition of a $0.8 million

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income related to the grant and refundable advance agreement signed with Bpifrance (“BPI”) to partially support a R&D program related to Cellectis’ UCART 20x22. We received on June 19, 2023 a $0.9 million refundable advance payment from BPI. This refundable advance is accounted for as a government loan as defined by IAS 20. Because this loan bears a below market interest rate, we measured the fair value of the loan using a market interest rate and recognize as a grant the difference between the cash the cash received and the estimated fair value of the loan. The fair value of the loan on June 19, 2023 was $0.4 million, resulting in a grant of $0.5 million. We recognized this $0.5 million grant in profit and loss of the six-month period ended June 30, 2023, in addition to the $0.3 million contractual grant, as the subsidized expenses have been incurred and the contractual conditions for obtaining the subsidy have been met.

Cost of revenue

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Cost of goods sold			0				0			-
Royalty expenses			(714	)			(389	)			-45.5	%
Cost of revenue			(714	)			(389	)			-45.5	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

Between the six-month periods ended June 30, 2022 and 2023, cost of revenues decreased by $0.3 million and is related to the decrease in collaboration agreement revenue.

Research and development expenses.

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Personnel expenses			(24,263	)			(19,990	)			-17.6	%
Purchases, external expenses and other			(27,968	)			(23,236	)			-16.9	%
Research and development expenses			(52,231	)			(43,225	)			-17.2	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

Between the six-month periods ended June 30, 2022 and 2023, research and development expenses decreased by $9.0 million. Personnel expenses decreased by $4.3 million from $24.3 million in 2022 to $20.0 million in 2023 primarily due to departures. Purchases, external expenses and other decreased by $4.7 million (from $28.0 million in 2022 to $23.2 million in 2023) mainly relating to lower consumables purchases and subcontracting expenses due to continuing internalization of our manufacturing and quality activities to support our R&D pipeline.

Selling, general and administrative expenses.

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Personnel expenses			(4,458	)			(4,041	)			-9.4	%
Purchases, external expenses and other			(6,435	)			(4,873	)			-24.3	%
Selling, general and administrative expenses			(10,893	)			(8,914	)			-18.2	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

Between the six-month periods ended June 30, 2022 and 2023, selling, general and administrative expenses decreased by $2.0 million. Personnel expenses decreased by $0.4 million (from $4.5 million in 2022 to $4.0 million in 2023). Purchases, external expenses and other decreased by $1.6 million (from 6.4 million in 2022 to $4.9 million in 2023) mainly explained by expenses associated with a new enterprise resource planning (ERP) software that was implemented in 2022.

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Other operating income and expenses.

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Other operating income (expenses)			774				(83	)			-110.8	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

Between the six-month periods ended June 30, 2022 and 2023, the other operating income decreased by $0.9 million dollars primarily due to the recognition of costs related to a commercial litigation of $0.5 million in 2023 and $0.5 million gain on disposal of the right-of-use asset related to the sub-leased portion of our premises in New-York recognized in the six month period ended June 30, 2022.

Net financial gain (loss).

 

		For the six-month period ended June 30,								% change
		2022 *				2023				2023 vs 2022
Financial income			12,263				33,041				169.4	%
Financial expenses			(3,050	)			(21,461	)			603.6	%
Net Financial gain (loss)			9,213				11,580				25.7	%

 

* These amounts reflect adjustments made in connection with the presentation of the discontinued operation

The increase in financial income of $20.8 million between the six-month periods ended June 30, 2022 and 2023 was mainly attributable to the profit from Calyxt’s deconsolidation of $21.8 million, an increase in gain from our financial investments of $1.1 million, an increase in the foreign exchange gain of $0.9 million (from a $8.3 million gain in 2022 to a $9.2 million gain in 2023, of which $8.0 million are reclassified from OCIs pursuant to Calyxt’s deconsolidation), and a $0.4 million gain on change in fair value of the EIB warrants, partially offset by a $3.6 million decrease in gain on fair value of Cytovia’s note receivable (in addition to the $6.8 million loss recognized in financial expenses in 2023).

The increase in financial expenses of $18.4 million between the six-month periods ended June 30, 2022 and 2023 is mainly attributable to the loss in fair value on our retained investment in Calyxt since deconsolidation for $10.2 million, a $6.8 million decrease in the fair value of Cytovia’s note receivable, a $1.4 million increase in foreign exchange loss (from a $0.9 million loss in 2022 to a $2.3 million loss in 2023) and an increase of loan interest for $0.4 million related to the EIB loan.

Income (loss) from discontinued operations

 

		For the six-month period ended June 30, 2023								% change
		2022				2023				2023 vs 2022
Income (loss) from discontinued operations			(6,883	)			(10,377	)			50.8	%

 

Income loss from discontinued operations include Calyxt loss until deconsolidation. All tables referring to the six-month period ended June 30, 2023 present Calyxt’s results over a five-month period from January 1, 2023 to May 31, 2023.

The $3.5 million increase in net loss from discontinued operations between the six-month periods ended June 30, 2022 and 2023 is primarily driven by (i) the increase of $9.2 million of net financial loss and (ii) the increase of $1.5 million of other operating expenses, partially offset by (i) the decrease of $2.8 million of R&D expenses (from $6.3 million in 2022 to $3.5 million in 2023) and (ii) the decrease of $4.5 million of SG&A expenses (from $6.8 million in 2022 to $2.3 million in 2023).

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Net income (loss)

 

		For the six-month period ended June 30,								% change
		2022				2023				2023 vs 2022
Net income (loss)			(54,211	)			(46,108	)			-14.9	%

 

Net income includes net income from discontinued operations.

The decrease in net loss of $8.1 million between the six-month periods ended June 30, 2022 and 2023 was mainly due to (i) a decrease of $6.3 million in purchases, external expenses and other, (ii) a decrease of $3.9 million in wages, (iii) a decrease of $1.1 million in non-cash stock based compensation expense, (iv) an increase in net financial gain of $2.4 million and (v) a decrease of cost of revenue of $0.3 million partially offset by (i) an increase of other operating expenses of $0.9 million, (ii) a $1.0 million decrease in revenues and other income and (iii) a $0.3 million increase in social charges on stock option grants expenses, (iv) an increase of income tax of $0.3 million and (v) a $3.5 million increase in net loss of discontinued operations.

Non-controlling interests

 

		For the six-month period ended June 30,								% change
		2022				2023				2023 vs 2022
Gain (loss) attributable to non-controlling interests			(3,352	)			(5,393	)			60.9	%

 

During the six-month periods ended June 30, 2023, we recorded $5.4 million in loss attributable to non-controlling interests. The increase in net loss attributable to non-controlling interests of $2.0 million is a consequence of Calyxt increase in net loss and partially offset by the reduction of Cellectis’s ownership interest in Calyxt and by the deconsolidation on June 1, 2023.

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.

In light of the Calyxt Merger contemplated by the Merger Agreement, Calyxt meets the “held-for-sale” criteria specified in IFRS 5 and qualifies as a discontinued operation in accordance with IFRS 5 until loss of control from the Group.

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.

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 six-month periods ended June 30, 2022 and 2023:

 

		For the six-month period ended June 30, 2022												For the six-month period ended June 30, 2023
$ in thousands		Plants (discontinued operations)				Therapeutics				Total reportable segments				Plants (discontinued operations)				Therapeutics				Total reportable segments
External revenues			73				2,972				3,045				43				317				360
External other income			—				3,551				3,551				—				5,242				5,242
External revenues and other    income			73				6,523				6,596				43				5,560				5,602
Cost of revenue			(0	)			(714	)			(714	)			(63	)			(389	)			(451	)
Research and development expenses			(6,297	)			(52,231	)			(58,527	)			(3,487	)			(43,225	)			(46,712	)
Selling, general and administrative    expenses			(6,801	)			(10,893	)			(17,695	)			(2,313	)			(8,914	)			(11,227	)
Other operating income and    expenses			242				774				1,016				(1,251	)			(83	)			(1,334	)
Total operating expenses			(12,856	)			(63,064	)			(75,920	)			(7,113	)			(52,612	)			(59,725	)
Operating income (loss) before tax			(12,783	)			(56,541	)			(69,324	)			(7,070	)			(47,053	)			(54,123	)
Net financial gain (loss)			5,900				9,213				15,113				(3,307	)			11,580				8,273
Income tax			—				—				—				—				(258	)			(258	)
Net income (loss) from discontinued    operations			(6,883	)							(6,883	)			(10,377	)							(10,377	)
Net income (loss)			(6,883	)			(47,328	)			(54,211	)			(10,377	)			(35,731	)			(46,108	)
Non-controlling interests			3,352				—				3,352				5,393				—				5,393
Net income (loss) attributable to    shareholders of Cellectis			(3,531	)			(47,328	)			(50,858	)			(4,984	)			(35,731	)			(40,715	)
R&D non-cash stock-based expense    attributable to shareholder of    Cellectis			216				3,134				3,349				188				1,900				2,088
SG&A non-cash stock-based    expense attributable to    shareholder of Cellectis			789				1,193				1,982				599				1,366				1,965
Adjustment of share-based    compensation attributable    to shareholders of Cellectis			1,005				4,327				5,331				788				3,265				4,053
Adjusted net income (loss)    attributable to shareholders    of Cellectis			(2,526	)			(43,001	)			(45,527	)			(4,196	)			(32,465	)			(36,662	)
Depreciation and amortization			(1,316	)			(9,434	)			(10,749	)			(7	)			(8,875	)			(8,882	)
Additions to tangible and intangible    assets			671				1,452				2,123				21				536				556

 

The total reportable segments include discontinued operations which is not presented in the Statement of income in accordance with IFRS 5 presentation.

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.

Therapeutics segment

External revenues and other income in our Therapeutics segment decreased by $1.0 million, from $6.5 million for the six-month period ended June 30, 2022, to $5.6 million for the six-month period ended June 30, 2023. The decrease was primarily due to milestones recognized with Cytovia and change of control of a licensee in 2022 while no milestone was recognized in 2023 and partially offset by the increase of research tax credit and the grant recognized following the signature of the grant and repayable advance contract with “BPI”.

The decrease in total operating expenses of $10.5 million from the six-month period ended June 30, 2022 to the six-month period ended June 30, 2023 resulted primarily from (i) a decrease of $6.3 million in purchases, external expenses and other, (ii) a decrease of $3.9 million in wages, (iii) a decrease of $1.1 million in non-cash stock based compensation expense and partially offset by (i) an increase of other operating expenses of $0.9 million and (ii) a $0.3 million increase in social charges on stock option grants expenses.

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Operating loss before tax for our Therapeutics segment decreased by $9.5 million from the six-month period ended June 30, 2022 to the six-month period ended June 30, 2023.

The increase in net financial gain of $2.4 million from the six-month period ended June 30, 2022 to the six-month period ended June 30, 2023 resulted primarily from Calyxt profit from deconsolidation and profit from our financial investments partially offset by Calyxt investment loss in fair value and Cytovia’s note receivable loss in fair value.

Adjusted net loss attributable to shareholders of Cellectis for our Therapeutics segment decreased by $10.5 million from the six-month period ended June 30, 2023 to the six-month period ended June 30, 2023.

Plants segment

Net income loss from discontinued operations include Calyxt loss until deconsolidation on May 31, 2023. All figures referring to the six-month period ended June 30, 2023 contain only five months of activity.

The decrease in total operating expenses of $5.7 million from the six-month period ended June 30, 2022 to the six-month period ended June 30, 2023 resulted primarily from a decrease in Calyxt’s activities, which contributed to (i) a decrease of $2.9 million in personnel wages and salaries, (ii) a decrease of $4.1 million in purchases, external and other expenses, and (iii) an increase of $0.3 million in non-cash stock based compensation expense. and partially offset by the increase of other operating expenses of $1.5 million mainly related to merger transaction costs.

Operating loss before tax for our Plants segment decreased by $5.7 million from the six-month period ended June 30, 2022, to the six-month period ended June 30, 2023.

The increase in net financial loss of $9.2 million from the six-month period ended June 30, 2022 to the six-month period ended June 30, 2023 resulted primarily from the decrease in fair value of common warrants related to the increase of Calyxt’s share price.

Adjusted net loss attributable to shareholders of Cellectis for our Plants segment increased by $1.7 million from the six-month period ended June 30, 2022, to the six-month period ended June 30, 2023.

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 June 30, 2023, we had current financial assets and cash and cash equivalents of $85.5 million comprising cash and cash equivalents of $84.4 million and the Cytovia’s note receivable classified as current financial asset of $1.1 million. Long term restricted cash amounts to $4.7 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, and fixed bank deposits, in each case primarily in France. The portion of cash and cash equivalents denominated in U.S.

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dollars is $40.7 million as of June 30, 2023. Current financial assets denominated in U.S. Dollars amounted to $1.1 million as of June 30, 2023.

Historical Changes in Cash Flows

The table below summarizes our sources and uses of cash for the six-month period ended June 30, 2022 and 2023.

Cash flows from Calyxt, which is classified as discontinued operations in the financial statements as of December 31, 2022, are included in the figures presented below.

 

		For the six-month period ended June 30,
		2022				2023
		$ in thousands
Net cash flows provided by (used in) operating activities			(60,181	)			(47,369	)
Net cash flows provided by (used in) investing activities			(2,537	)			(1,558	)
Net cash flows provided by (used in) financing activities			10,307				39,597
Total			(52,411	)			(9,329	)
Effect of exchange rate changes on cash			(3,785	)			499

 

For the six-month period ended June 30, 2023, our net cash flows used in operating activities of $47.4 million are mainly due to cash payments from Cellectis to suppliers of $22.2 million, Cellectis’ wages and social expenses paid of $23.3 million, Cellectis’ taxes and others paid of $2.0 million, and Calyxt’s operating payments of $3.6 million, partially offset by $1.3 million of cash-in from licensing revenue of Cellectis, $1.0 million of cash-in on from tax refund related to stock-options and $1.8 million of cash-in from income on financial investments.

For the six-month period ended June 30, 2022, our net cash flows used in operating activities of $60.2 million are mainly due to Cellectis cash payments of $24.7 million to suppliers, wages and social expenses of $27.4 million, and Calyxt operating payments net of receipts of $13 million, partially offset by $1.3 million of licensing revenue at Cellectis, $0.8 million of tax credit, and $1.1 million of taxes and others.

For the six-month period ended June 30, 2023, our net cash flows provided by investing activities of $1.6 million primarily reflect mainly the cash and cash equivalents disposed of following the loss of control over Calyxt, of $1.6 million, the reimbursement of a security deposit from a supplier in the United States of $0.4 million and the decrease in current restricted cash of Calyxt of $0.1 million, partially offset by $0.5 million of investments in R&D equipment and building fittings under construction in France.

For the six-month period ended June 30, 2022, our net cash flows used in investing activities primarily reflect our investments in R&D equipment and building fittings in both the United States and France of $1.6 million, and the remainder attributable to investing activity in the Plants segment for $0.6 million.

For the six-month period ended June 30, 2023, our net cash flows provided by financing activities of $39.6 million reflect mainly the proceeds of $25.0 million from the Cellectis Follow-on Offering, the $21.6 million cash received from EIB pursuant to the disbursement of the Tranche A, the $0.8 million refundable advance received from BPI, $2.5 million of Interim Funding received by Calyxt from Cibus, partially offset by transaction costs related to the Cellectis Follow-on Offering of $1.5 million, the payments of lease debts of $6.3 million and the repayment of the “PGE” loan of $2.5 million.

For the six-month period ended June 30, 2022, our net cash flows provided by financing activities reflect mainly the net proceeds of $10.0 million from Calyxt’s follow-on Offering and capital raise including $0.9 million transaction costs and the payment of $6 million received in respect of the 2021 research tax credit pre-financing, partially offset by, the payments of lease debts for $5.9 million as well as $0.2 million of interest paid on the “PGE” loan along with interests and capital paid on a loan with our landlord in New-York.

Operating capital requirements

Our cash consumption is driven by our internal operational activities, including manufacturing activity conducted at our in-house manufacturing facilities, as well as our outsourced activities, including the pre-clinical research and development activities, manufacturing and technology transfer expenses payable to CMO providers, costs and expenses

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associated with our clinical trials, including payments to clinical research centers, CROs involved in the clinical trials, and third-parties providing logistics and testing services. In addition, we incur significant annual payment and royalty expenses related to our in-licensing agreements with different parties including Life Technologies and University of Minnesota. We also incur substantial expenses related to audit, legal, regulatory and tax related services associated with our public company obligations in the United States and our continued compliance with applicable U.S. exchange listing and SEC requirements.

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

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

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 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.

As of June 30, 2023, Cellectis, had cash and cash equivalents of $84.4 million. Based on the current operating plan and financial projections, we believe our cash and cash equivalents, are sufficient to continue operating for at least twelve months following the consolidated financial statements’ publication. Additionally, together with current financial assets, cash flow from operations government funding of research programs, and our anticipated borrowing of €15.0 million under Tranche B of the €40.0 million Finance Contract with EIB, will be sufficient to fund Cellectis’ Therapeutics’ operations into the third quarter of 2024.

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:

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

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Off-Balance Sheet Arrangements

As of June 30, 2023, 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. There have been no material changes in information that would have been provided in the context of Item 3 from the end of the preceding year until June 30, 2023.

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, 2022.

There have been no changes in the Company’s internal control over financial reporting during the six-month period ended June 30, 2023, 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

There are no material changes to the risk factors described in Item 3.D. of Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2022.

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

None

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

None.

Item 6. Exhibits

None.

 

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