NEW YORK, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies, announced its results for the three-month and nine-month periods ending September 30, 2022.
“2022 has been a productive year thus far for Cellectis. Today, we were proud to announce that our UCART123 abstract was accepted for an oral presentation at the American Society of Hematology Annual Meeting. Acute myeloid leukemia presents a huge unmet medical need with a lack of cell therapy options, and these encouraging preliminary clinical data are a great step for patients with this condition,” said André Choulika, Ph.D., Chief Executive Officer of Cellectis.
“We continue to enroll patients in our three Cellectis-sponsored Phase 1 dose escalation clinical trials and are very excited to initiate the dosing of patients with our product candidates UCART22 and UCART20x22 that have been fully manufactured in-house. This quarter, our partnerships continued to be a highlight for Cellectis, as several of our licensed partners disclosed exciting milestones. Our licensed partner, Allogene Therapeutics, announced that it was entering into the potentially pivotal Phase 2 trial, for patients with large B-cell lymphoma. Iovance Biotherapeutics announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TALEN®-edited TIL therapy for the treatment of previously treated advanced melanoma or metastatic NSCLC. These achievements showcase once more that TALEN ® is a technology of choice for leading cell and gene therapy companies, and that we are continuing to deliver on our promise of constant innovation in order to advance the efforts of both our and our partner’s clinical trials. Cellectis remains steadfast in its mission to develop innovative cancer therapy product candidates, and I am proud of the progress we have made in our journey this year.”
Pipeline highlights
UCART Clinical Development Programs
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)
NatHaLi-01 (evaluating UCART20x22) in relapsed or refractory Non-Hogdkin Lymphoma (r/r NHL)
Research Data & Preclinical Programs
UCARTCS1
TALEN®-edited smart CAR T-cells
TALEN®-based gene therapy preclinical programs
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 Servier and Allogene based on an exclusive license granted by Cellectis to Servier (the “Servier Agreement”). 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. In September 2022, Servier communicated that it was discontinuing its involvement in the development of in-licensed CD19 products and purporting to provide Allogene with the ability to elect to obtain a license to the CD19 Products outside of the United States. We are evaluating all available options and contractual remedies to address the foregoing matters and other performance issues, which we believe may involve material breaches of the Servier Agreement by Servier.
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 program
Allogene: solid tumor program
Gene Editing Partnerships
Iovance Biotherapeutics, Inc. (“Iovance”)
Cytovia Therapeutics
Corporate Updates
Appointment
Financial Results
The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owned approximately 51.2% of outstanding shares of common stock (as of September 30, 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 Q3 2022 financial results press release.
Cash: As of September 30, 2022, Cellectis, including Calyxt, had $103 million in consolidated cash, cash equivalents, and restricted cash of which $95 million are attributable to Cellectis on a stand-alone basis. This compares to $191 million in consolidated cash, cash equivalents 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 $88 million primarily reflects (i) $81 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $17 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt, and (iii) a $10 million unfavorable foreign exchange (FOREX) impact which was partially offset by (i) $10 million of net proceeds from capital raised at Calyxt in February 2022, (ii) $6 million of cash received related to research tax credit prefinancing and (iii) $3 million of cash received related to licenses and milestone payments. Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash as of September 30, 2022 will fund Cellectis’ operations into early 2024.
Revenues and Other Income: Consolidated revenues and other income were $9 million for the nine months ended September 30, 2022 compared to $53 million for the nine months ended September 30, 2021. 99% of consolidated revenues and other income was attributable to Cellectis in the first nine months of 2022. This decrease between the nine months ended September 30, 2022 and 2021 was mainly attributable to (i) a decrease of revenue pursuant to the recognition of a $15 million convertible note obtained as consideration for a “right-to-use” license granted to Cytovia and a $5 million Allogene milestone during the nine-month period ended September 30, 2021, while revenue related to collaboration agreements for the nine months of 2022 consists of the recognition of two milestones related to Cellectis’ agreement with Cytovia for $2 million and the recognition of $1 million related to a change of control of a licensee pursuant to the terms of its license agreement with Cellectis and the amendment to the license agreement (extension of the option term) (ii) a decrease in other revenues of $24 million relating to a change in Calyxt’s business model for its PlantSpring technology and BioFactory, in which no significant revenue was yet recognized.
Cost of Revenues: Consolidated cost of revenues were $1 million for the nine months ended September 30, 2022 compared to $29 million for the nine months ended September 30, 2021. This decrease is driven by the change in Calyxt’s business model for its PlantSpring and BioFactory.
R&D Expenses: Consolidated R&D expenses were $85 million for the nine months ended September 30, 2022 compared to $97 million for the nine months ended September 30, 2021. 89% of consolidated R&D expenses was attributable to Cellectis in the first nine months of 2022. The $11 million decrease between the first nine months of 2022 and 2021 was primarily attributable to (i) a decrease of purchases, external expenses and other by $10 million (from $57 million in 2021 to $47 million in 2022) due to lower consumables, subcontracting costs and depreciation and amortization for the therapeutic segment, (ii) a $1 million decrease in social charges on stock option, and (iii) a $3 million decrease in non-cash stock-based compensation expense partially offset by an increase of $3 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 $25 million for the nine months ended September 30, 2022 compared to $28 million for the nine months ended September 30, 2021. 62% of consolidated SG&A expenses was attributable to Cellectis in the first nine months of 2022. The $3 million decrease primarily reflects (i) a $3 million decrease in wages and salaries, (ii) a $1 million decrease in purchases, external expenses and other (from $14 million in 2021 to $12 million in 2022) partially offset by (i) 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.
Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $79 million (or $1.74 per share) for the nine months ended September 30, 2022, of which $73 million was attributed to Cellectis, compared to $89 million (or $2.00 per share) for the nine months ended September 30, 2021, of which $75 million was attributed to Cellectis. This $10 million decrease in net loss between first nine months 2022 and 2021 was primarily driven by (i) an increase in net financial gain of $14 million, (ii) a decrease of $28 million of cost of revenue, (iii) a $11 million decrease of research and development and, (iv) a $3 million decrease of SG&A expenses partially offset by a decrease in revenues and other income of $45 million.
Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $72 million (or $1.58 per share) for the nine months ended September 30, 2022, of which $67 million is attributed to Cellectis, compared to a net loss of $80 million (or $1.79 per share) or the nine months ended September 30, 2021, of which $66 million was attributed to Cellectis. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending at Cellectis for the Full Year of 2022 in the following areas:
As of the date of this interim report, BALLI-01 (UCART22 Phase 1 open label Study) is currently enrolling patients at (i) dose level 3 (DL3) with an FCA preconditioning regimen and (ii) dose level 2 (DL2) using UCART22 batches manufactured from an upgraded Cellectis internal manufacturing Process 2 (P2) with an FCA preconditioning regimen.
CELLECTIS S.A.
(unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
($ in thousands, except per share data) As of December 31, 2021 Unaudited
September 30,
2022 ASSETS Non-current assets Intangible assets 1,854 1,511 Property, plant, and equipment 78,846 70,759 Right-of-use assets 69,423 58,112 Non-current financial assets 6,524 8,926 Total non-current assets 156,647 139,307 Current assets Trade receivables 20,361 802 Subsidies receivables 9,268 12,152 Other current assets 9,665 8,311 Cash and cash equivalent and Current financial assets 186,135 119,008 Total current assets 225,429 140,272 TOTAL ASSETS 382,076 279,580 LIABILITIES Shareholders’ equity Share capital 2,945 2,949 Premiums related to the share capital 934,696 579,047 Currency translation adjustment (18,021) (35,434)Retained earnings (584,129) (330,595)Net income (loss) (114,197) (79,326)Total shareholders’ equity - Group Share 221,293 136,641 Non-controlling interests 15,181 8,971 Total shareholders’ equity 236,474 145,612 Non-current liabilities Non-current financial liabilities 20,030 14,699 Non-current lease debts 71,526 63,592 Non-current provisions 4,073 2,646 Other non-current liabilities 626 - Total non-current liabilities 96,254 80,937 Current liabilities Current financial liabilities 2,354 10,379 Current lease debts 8,329 7,971 Trade payables 23,762 22,353 Deferred revenues and deferred income 301 320 Current provisions 871 425 Other current liabilities 13,731 11,582 Total current liabilities 49,348 53,030 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 382,076 279,580
Cellectis S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
For the three-month period ended September 30, 2022
$ in thousands, except per share amounts For the three-month period ended September 30, 2021 2022 Revenues and other income Revenues 8,312 217 Other income 2,516 1,704 Total revenues and other income 10,827 1,921 Operating expenses Cost of revenue (9,213) (367)Research and development expenses (34,324) (26,667)Selling, general and administrative expenses (9,675) (7,641)Other operating income (expenses) 18 (408)Total operating expenses (53,195) (35,082) Operating income (loss) (42,368) (33,162) Financial gain (loss) 2,296 1,896 Net income (loss) (40,071) (31,265)Attributable to shareholders of Cellectis (37,413) (28,467)Attributable to non-controlling interests (2,658) (2,798) Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.82) (0.63) Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.82) (0.63)
Cellectis S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
For the nine-month period ended September 30, 2022
$ in thousands, except per share amounts For the nine-month period ended September 30, 2021 2022 Revenues and other income Revenues 45,088 3,262 Other income 8,320 5,255 Total revenues and other income 53,408 8,517 Operating expenses Cost of revenue (29,113) (1,081)Research and development expenses (96,663) (85,194)Selling, general and administrative expenses (27,894) (25,336)Other operating income (expenses) 506 608 Total operating expenses (153,163) (111,003) Operating income (loss) (99,755) (102,485) Financial gain (loss) 2,728 17,009 Net income (loss) (97,027) (85,476)Attributable to shareholders of Cellectis (89,201) (79,326)Attributable to non-controlling interests (7,827) (6,150)Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (2.00) (1.74) Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (2.00) (1.74)
CELLECTIS S.A.
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – Third Quarter
(unaudited) - ($ in thousands) For the three-month period ended
September 30, 2021 For the three-month period ended
September 30, 2022$ in thousands PlantsTherapeuticsTotal reportable segments PlantsTherapeuticsTotal reportable segments External revenues 8,288 24 8,312 42 175 217 External other income 0 2,516 2,516 - 1,704 1,704 External revenues and other income 8,288 2,540 10,827 42 1,879 1,921 Cost of revenue (8,807)(407)(9,213) (0)(367)(367)Research and development expenses (2,523)(31,802)(34,324) (2,830)(23,837)(26,667)Selling, general and administrative expenses (3,992)(5,683)(9,675) (2,738)(4,903)(7,641)Other operating income and expenses 18 (1)18 (282)(125)(408)Total operating expenses (15,304)(37,892)(53,195) (5,850)(29,233)(35,082)Operating income (loss) before tax (7,016)(35,352)(42,368) (5,808)(27,353)(33,162)Financial gain (loss) (291)2,588 2,296 90 1,806 1,896 Net income (loss) (7,307)(32,764)(40,071) (5,718)(25,547)(31,265)Non controlling interests 2,658 - 2,658 2,798 - 2,798 Net income (loss) attributable to shareholders of Cellectis (4,650)(32,764)(37,413) (2,920)(25,547)(28,467)R&D non-cash stock-based expense attributable to shareholder of Cellectis 151 3,219 3,370 116 809 925 SG&A non-cash stock-based expense attributable to shareholder of Cellectis 707 986 1,693 434 521 955 Adjustment of share-based compensation attributable to shareholders of Cellectis 858 4,204 5,062 550 1,330 1,880 Adjusted net income (loss) attributable to shareholders of Cellectis (3,792)(28,560)(32,351) (2,370)(24,218)(26,587)Depreciation and amortization (615)(3,708)(4,323) (438)(4,305)(4,744)Additions to tangible and intangible assets 69 3,426 3,495 218 223 442
CELLECTIS S.A.
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – First nine-months
(unaudited) - ($ in thousands) For the nine-month period ended
September 30, 2021 For the nine-month period ended
September 30, 2022$ in thousands PlantsTherapeuticsTotal reportable segments PlantsTherapeuticsTotal reportable segments External revenues 25,004 20,085 45,088 115 3,147 3,262 External other income 1,528 6,792 8,320 - 5,255 5,255 External revenues and other income 26,532 26,876 53,408 115 8,402 8,517 Cost of revenue (27,512)(1,601)(29,113) (0)(1,081)(1,081)Research and development expenses (8,358)(88,304)(96,663) (9,127)(76,067)(85,194)Selling, general and administrative expenses (11,520)(16,373)(27,894) (9,539)(15,797)(25,336)Other operating income and expenses 25 481 506 (40)649 608 Total operating expenses (47,366)(105,797)(153,163) (18,706)(92,297)(111,003)Operating income (loss) before tax (20,834)(78,921)(99,755) (18,591)(83,894)(102,485)Net financial gain (loss) (875)3,603 2,728 5,990 11,019 17,009 Net income (loss) (21,709)(75,318)(97,027) (12,601)(72,875)(85,476)Non-controlling interests 7,827 - 7,827 6,150 - 6,150 Net income (loss) attributable to shareholders of Cellectis (13,883)(75,318)(89,201) (6,451)(72,875)(79,326)R&D non-cash stock-based expense attributable to shareholder of Cellectis 682 6,922 7,604 332 3,943 4,274 SG&A non-cash stock-based expense attributable to shareholder of Cellectis (208)1,901 1,693 1,224 1,713 2,937 Adjustment of share-based compensation attributable to shareholders of Cellectis 474 8,823 9,297 1,555 5,656 7,211 Adjusted net income (loss) attributable to shareholders of Cellectis (13,409)(66,495)(79,904) (4,896)(67,219)(72,114)Depreciation and amortization (1,834)(9,651)(11,485) (1,754)(13,739)(15,493)Additions to tangible and intangible assets 377 14,446 14,822 890 1,675 2,565
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 – Third Quarter
(unaudited)
($ in thousands, except per share data) For the three-month period ended September 30, 2021 2022 Net income (loss) attributable to shareholders of Cellectis (37,413) (28,467)Adjustment: 5,062 1,880 Non-cash stock-based compensation expense attributable to shareholders of Cellectis Adjusted net income (loss) attributable to shareholders of Cellectis (32,351) (26,587) Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.71) (0.58) Weighted average number of outstanding shares, basic (units) (1) 45,471,977 45,540,315 Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) (0.71) (0.58) Weighted average number of outstanding shares, diluted (units) (1) 45,471,977 45,540,315
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME – First nine-months
(unaudited)
($ in thousands, except per share data) For the nine-month period ended September 30, 2021 2022 Net income (loss) attributable to shareholders of Cellectis (89,201) (79,326)Adjustment: 9,297 7,211 Non-cash stock-based compensation expense attributable to shareholders of Cellectis Adjusted net income (loss) attributable to shareholders of Cellectis (79,904) (72,114) Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1.79) (1.58) Weighted average number of outstanding shares, basic (units) (1) 44,599,935 45,511,626 Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) (1.79) (1.58) Weighted average number of outstanding shares, diluted (units) (1) 44,599,935 45,511,626
(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 ($/share). When we have adjusted net income, in accordance with IFRS, we use the Weighted average number of outstanding shares, diluted tocompute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/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,” “may” 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 our and our partners’ clinical trials (including with respect to patient enrollment and follow-up), the timing of presentation of data, the operational capabilities at our manufacturing facilities and the sufficiency of cash to fund operations. the potential of our preclinical programs and product candidates. 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. 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 Cash position includes cash, cash equivalent, current financial assets and restricted cash. Restricted cash was $5million as of September 30, 2022.
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