UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: November 4, 2021
Commission File Number: 001-36891
Cellectis S.A.
(Exact Name of registrant as specified in its charter)
8, rue de la Croix Jarry
75013 Paris, France
+33 1 81 69 16 00
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
EXHIBIT INDEX
Exhibit | Title | |
99.1 | Press release, dated November 4, 2021. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Cellectis S.A. | ||
(Registrant) | ||
Date: November 4, 2021 | /s/ André Choulika | |
André Choulika | ||
Chief Executive Officer | ||
EXHIBIT 99.1
Cellectis Provides Business Update and Reports Financial Results for Third Quarter and First Nine Months 2021
· Sponsored programs at ASH 2021 - preliminary clinical data to be presented at ASH 2021 for product candidate UCART22 and preclinical data from Cellectis gene therapy product candidate TALGlobin01
· Partnered programs at ASH 2021 – ALPHA2 and UNIVERSAL abstracts selected for oral presentations, ALPHA abstract selected for poster presentation
· Preclinical data for RAG1 deficiency Severe Combined Immunodeficiency (SCID) and STAT3 for Hyper IgE syndrome presented at ESGCT 2021
· Preclinical data supporting anti-tumor activity of UCARTMESO to be presented at SITC 2021 on November 12, 2021
· Qualification of facility equipment and systems completed for
· Raleigh GMP manufacturing site; Paris GMP manufacturing site now operational, focusing on the production of starting and raw materials for Cellectis’ UCART product candidates
· Donald A Bergstrom, M.D., Ph.D., appointed as a Board Observer on Cellectis’ Board of Directors
· Cash position1 of $216 million as of September 30, 2021
NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the “Company”), a gene-editing company with clinical-stage immuno-oncology programs using allogeneic chimeric antigen receptor (CAR)-T cells and gene therapy programs for genetic diseases, today announced results for the three-month and nine-month periods ending September 30, 2021.
Cellectis will hold a conference call for investors on Friday, November 5, 2021, at 8:00 AM ET / 2:00 PM CET. The call will include the Company’s third quarter results, and an update on business activities.
________________________
1 Cash position includes cash, cash equivalents and current financial assets and restricted cash. Restricted cash was $6 million as of September 30, 2021.
The live dial-in information for the conference call is:
US & Canada only: +1 877-407-3104
International: +1 201-493-6792
In addition, a replay of the call will be available until November 19th, by calling +1 877-660-6853 (Toll Free US & Canada); +1 201-612-7415 (Toll Free International).
Conference ID: 13724432
“2021 has been a productive year thus far for Cellectis. We have made great progress during Q3 with both our clinical trials and preclinical product candidate pipeline, and are eager to share additional preliminary data from our BALLI-01 clinical trial and disclose initial pre-clinical data from TALGlobin01, at ASH this year,” said Dr. André Choulika, Chief Executive Officer of Cellectis. “With regard to our preclinical UCART pipeline focusing on solid tumors, we have made notable progress with UCARTMESO, targeting mesothelin - expressing solid tumors, and are excited to share new pre-clinical data that support anti-tumor activity at the Society for Immunotherapy of Cancer (SITC) Annual Meeting later this month.
GMP production remains on track for Cellectis’ Manufacturing site in Raleigh, NC, where qualification of facility equipment and systems was completed during Q3. Cellectis also continues to expand its internal manufacturing capabilities with its Paris site, which is now operational. Cellectis continues to leverage its expertise in gene editing and clinical development to transform the lives of patients with cancer and rare genetic diseases, and we look forward to continuing this effort in Q4, into 2022, and beyond.”
Allogeneic CAR-T Cell Development Programs
Sponsored Phase 1 Studies
Cellectis continues to make progress in its proprietary programs enrolling patients in its three sponsored Phase 1 dose escalation trials:
UCART22 is an allogeneic CAR-T cell product candidate targeting CD22 being evaluated in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r B-ALL) in the BALLI-01 Phase 1, multi-center dose-escalation clinical study.
UCART123 is an allogeneic CAR T-cell product candidate targeting CD123 being evaluated in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in the AMELI-01 Phase 1, multi-center dose-escalation clinical study.
UCARTCS1 is an allogeneic CAR T-cell product candidate targeting CS1 being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the MELANI-01 Phase 1, multi-center dose-escalation clinical study.
Cellectis to present updated clinical data on BALLI-01 investigating UCART22 product candidate in R/R B-ALL at the 2021 American Society of Hematology Annual meeting
Wholly-controlled UCART Preclinical Programs
UCART20x22, is in development as the first allogeneic dual CAR-T cell product candidate which is being developed for patients with B-cell Non-Hodgkin lymphoma.
UCARTMESO, is an allogeneic CAR-T cell product candidate targeting mesothelin, which is being developed for patients with mesothelin expressing solid tumors.
Gene Therapy Programs
.HEAL is a gene therapy platform for genetic diseases developed by Cellectis. The platform leverages the power of TALEN® gene editing technology to perform genome surgery resulting in highly efficient and precise gene inactivation, insertion, and correction in hematopoietic stem cells (HSCs). Cellectis has announced programs in sickle cell disease, lysosomal storage disorders and primary immunodeficiencies.
Sickle Cell Disease
TALGlobin01, is an autologous ex vivo TALEN®-edited CD34+ HSC therapy for the treatment of SCD
TALGlobin01 is developed using both TALEN® technology to induce a double strand DNA break in the SCD-causing hemoglobin subunit beta (HBB) gene and adeno-associated virus (AAV) particles containing a DNA repair template designed to correct the faulty HBB gene via endogenous homology directed repair.
Cellectis to present preclinical data on TALGlobin01 for the treatment of Sickle Cell Disease at the 2021 American Society of Hematology Annual meeting
Primary Immunodeficiencies
In collaboration with professor Toni Cathomen, Scientific Director at the Center for Chronic Immunodeficiency, Medical Center - University of Freiburg, Germany, Cellectis is developing two gene edited HSC product candidates to address primary immunodeficiencies.
The authors presented encouraging preclinical data for RAG1 for Severe Combined Immunodeficiency (SCID) and STAT3 for Hyper IgE syndrome, at the European Society of Gene and Cell Therapy (ESGCT) Congress held on October 19-22, 2021.
RAG1 Severe Combined Immunodeficiency (SCID)
Hyper IgE syndrome
Licensed Allogeneic CAR-T Cell Development Programs
ALLOGENE/SERVIER: ALLO-501 and ALLO-501A in patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL)
CD19 AlloCAR T program utilizes Cellectis technologies. ALLO-501 and ALLO-501A are being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S., while Servier retains exclusive rights for all other countries.
ALLOGENE: ALLO-715 in patients with relapsed/refractory multiple myeloma (r/r MM)
The anti-BCMA AlloCAR T program, which utilize the Cellectis TALEN® technologies, are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.
Manufacturing Facility
Paris Starting Materials Manufacturing Facility
Raleigh GMP Manufacturing Facility
New appointment
Board appointment
Financial Results
The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis is a 64.2% stockholder (as of September 30, 2021), 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 2021 and First Nine Months 2021 financial results press release. Third Quarter and First Nine Months 2021 Financial Result.
Cash: As of September 30, 2021, Cellectis, including Calyxt, had $216 million in consolidated cash, cash equivalents, current financial assets and restricted cash of which $201 million are attributable to Cellectis on a stand-alone basis. This compares to $274 million in consolidated cash, cash equivalents, current financial assets and restricted cash as of December 31, 2020, of which $244 million was attributable to Cellectis on a stand-alone basis. This net decrease of $58 million primarily reflects (i) $92 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $15 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt and (iii) $6 million of unfavorable FOREX impact which was partially offset by (iv) $45 million of net equity proceeds raised from sales under the Company’s “At-The-Market” (ATM) program in April 2021 and (v) $10 million of proceeds from stock options exercises at Cellectis. Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash of $201 million as of September 30, 2021 will fund its operations into early 2023.
Revenues and Other Income: Consolidated revenues and other income were $11 million for the three months ended September 30, 2021 compared to $9 million for the three months ended September 30, 2020. Consolidated revenues and other income were $53 million for the nine months ended September 30, 2021 compared to $67 million for the nine months ended September 30, 2020. 50% of consolidated revenues and other income was attributable to Cellectis in the first nine months of 2021. This decrease between the nine months ended September 30, 2021 and 2020 was mainly attributable to a $28 million upfront payment received in March 2020 and the recognition of $19 million of other previously-received upfront and milestone payments on the five released targets based on the March 2020 amendment of the License, Development and Commercialization Agreement signed with Servier as well as a decrease in licenses revenue. That was partially offset by (i) the recognition of $15 million in Cytovia stock or an upfront non-cash payment of $15 million if certain conditions are not met by December 31, 2021, (ii) the recognition of a $5 million milestone payment from Allogene related to the Phase 1 clinical study for ALLO-316, in advanced or metastatic clear cell renal cell carcinoma, (iii) $15 million from higher high oleic soybean revenues and by (iv) $1.5 million from the PPP Loan forgiveness at Calyxt.
Cost of Revenues: Consolidated cost of revenues were $9 million for the three months ended September 30, 2021 compared to $8 million for the three months ended September 30, 2020. Consolidated cost of revenues was $29 million for the nine months ended September 30, 2021 compared to $18 million for the nine months ended September 30, 2020. This increase was primarily explained by the cost of products sold during the period by Calyxt.
R&D Expenses: Consolidated R&D expenses were $34 million for the three months ended September 30, 2021 compared to $20 million for the three months ended September 30, 2020. Consolidated R&D expenses were $97 million for the nine months ended September 30, 2021 compared to $64 million for the nine months ended September 30, 2020. 91% of consolidated R&D expenses was attributable to Cellectis in the first nine months of 2021. The $33 million increase between the first nine months of 2021 and 2020 was primarily attributable to (i) higher wages and salaries and social charges on stock option grants of $12 million, to (ii) higher purchases, external and other expenses of $19 million and to (iii) higher non-cash stock-based compensation expenses of $2 million.
SG&A Expenses: Consolidated SG&A expenses were $10 million for the three months ended September 30, 2021 and 2020. Consolidated SG&A expenses were $28 million for the nine months ended September 30, 2021 compared to $31 million for the nine months ended September 30, 2020. 59% of consolidated SG&A expenses was attributable to Cellectis in the first nine months of 2021. The $3 million decrease was attributable to lower non-cash stock-based compensation expenses of $5 million which was partially offset by higher wages and salaries and social charges on stock option grants of $1 million and higher other expenses of $1 million.
Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $37 million (or $0.82 per share) for the three months ended September 30, 2021, of which $33 million was attributed to Cellectis, compared to $30 million (or $0.71 per share) for the three months ended September 30, 2020, of which $25 million was attributed to Cellectis. The consolidated net loss attributable to Shareholders of Cellectis was $89 million (or $2.00 per share) for the nine months ended September 30, 2021, of which $75 million loss was attributed to Cellectis, compared to a loss of $42 million (or $0.98 per share) for the nine months ended September 30, 2020, of which $21 million was attributable to Cellectis. This $48 million increase in net loss between first nine months 2021 and 2020 was primarily driven by a decrease in revenues and other income of $13 million and by an increase in operating expenses of $39 million partially offset by $7 million increase in net financial gain.
Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $32 million (or $0.71 per share) for the three months ended September 30, 2021, of which $29 million is attributed to Cellectis, compared to a net loss of $27 million (or $0.63 per share) for the three months ended September 30, 2020, of which $22 million was attributed to Cellectis. The consolidated adjusted net loss attributable to Shareholders of Cellectis was $80 million (or $1.79 per share) for the nine months ended September 30, 2021, of which $66 million loss was attributable to Cellectis, compared to a loss of $30 million (or $0.72 loss per share) for the nine months ended September 30, 2020, of which $13 million was attributable to Cellectis. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending at Cellectis for the Full Year of 2021 in the following areas:
CELLECTIS S.A.
(unaudited)
STATEMENT OF CONSOLIDATED FINANCIAL POSITION
($ in thousands, except per share data)
As of | ||||||
December 31, 2020 | September 30, 2021 | |||||
ASSETS | ||||||
Non-current assets | ||||||
Intangible assets | 1,584 | 2,551 | ||||
Property, plant, and equipment | 71,673 | 80,542 | ||||
Right-of-use assets | 73,845 | 71,899 | ||||
Other non-current financial assets | 7,007 | 22,045 | ||||
Total non-current assets | 154,109 | 177,037 | ||||
Current assets | ||||||
Inventories | 1,606 | 1,674 | ||||
Trade receivables | 5,171 | 349 | ||||
Subsidies receivables | 10,703 | 7,971 | ||||
Other current assets | 29,643 | 14,753 | ||||
Cash and cash equivalent and Current financial assets | 268,239 | 211,102 | ||||
Total current assets | 315,362 | 235,849 | ||||
TOTAL ASSETS | 469,471 | 412,886 | ||||
LIABILITIES | ||||||
Shareholders’ equity | ||||||
Share capital | 2,785 | 2,946 | ||||
Premiums related to the share capital | 863,912 | 925,290 | ||||
Currency translation adjustment | (4,089 | ) | (14,345 | ) | ||
Retained earnings | (505,961 | ) | (586,723 | ) | ||
Net income (loss) | (81,074 | ) | (89,201 | ) | ||
Total shareholders’ equity - Group Share | 275,573 | 237,967 | ||||
Non-controlling interests | 33,273 | 24,180 | ||||
Total shareholders’ equity | 308,846 | 262,147 | ||||
Non-current liabilities | ||||||
Non-current financial liabilities | 28,836 | 22,767 | ||||
Non-current lease debts | 75,764 | 73,730 | ||||
Non-current provisions | 4,010 | 3,851 | ||||
Non-current liabilities | 0 | 787 | ||||
Total non-current liabilities | 108,610 | 101,136 | ||||
Current liabilities | ||||||
Current lease debts | 6,696 | 8,079 | ||||
Trade payables | 24,609 | 22,809 | ||||
Deferred revenues and deferred income | 452 | 500 | ||||
Current provisions | 1,131 | 4,190 | ||||
Other current liabilities | 19,127 | 14,024 | ||||
Total current liabilities | 52,015 | 49,603 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 469,471 | 412,886 | ||||
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS – Third quarter
(unaudited)
($ in thousands, except per share data)
For the three-month period ended September 30, | ||||||
2020 | 2021 | |||||
Revenues and other income | ||||||
Revenues | 6,179 | 8,312 | ||||
Other income | 3,063 | 2,516 | ||||
Total revenues and other income | 9,242 | 10,827 | ||||
Operating expenses | ||||||
Cost of revenue | (7,820 | ) | (9,213 | ) | ||
Research and development expenses | (20,103 | ) | (34,324 | ) | ||
Selling, general and administrative expenses | (10,301 | ) | (9,675 | ) | ||
Other operating income (expenses) | (374 | ) | 18 | |||
Total operating expenses | (38,595 | ) | (53,195 | ) | ||
Operating income (loss) | (29,353 | ) | (42,368 | ) | ||
Financial gain (loss) | (4,250 | ) | 2,296 | |||
Net income (loss) | (33,602 | ) | (40,071 | ) | ||
Attributable to shareholders of Cellectis | (30,297 | ) | (37,413 | ) | ||
Attributable to non-controlling interests | (3,305 | ) | (2,658 | ) | ||
Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) | (0.71 | ) | (0.82 | ) | ||
Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) | (0.71 | ) | (0.82 | ) | ||
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS – First nine months
(unaudited)
($ in thousands, except per share data)
For the nine-month period ended September 30, | ||||||
2020 | 2021 | |||||
Revenues and other income | ||||||
Revenues | 60,037 | 45,088 | ||||
Other income | 6,510 | 8,320 | ||||
Total revenues and other income | 66,547 | 53,408 | ||||
Operating expenses | ||||||
Cost of revenue | (18,159 | ) | (29,113 | ) | ||
Research and development expenses | (63,594 | ) | (96,663 | ) | ||
Selling, general and administrative expenses | (31,765 | ) | (27,894 | ) | ||
Other operating income (expenses) | (291 | ) | 506 | |||
Total operating expenses | (113,810 | ) | (153,163 | ) | ||
Operating income (loss) | (47,263 | ) | (99,755 | ) | ||
Financial gain (loss) | (4,733 | ) | 2,728 | |||
Net income (loss) | (51,996 | ) | (97,027 | ) | ||
Attributable to shareholders of Cellectis | (41,605 | ) | (89,201 | ) | ||
Attributable to non-controlling interests | (10,391 | ) | (7,827 | ) | ||
Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) | (0.98 | ) | (2.00 | ) | ||
Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) | (0.98 | ) | (2.00 | ) | ||
CELLECTIS S.A.
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – Third Quarter
(unaudited) - ($ in thousands)
For the three-month period ended September 30, 2020 | For the three-month period ended September 30, 2021 | |||||||||||||
$ in thousands | Plants | Therapeutics | Total reportable segments | Plants | Therapeutics | Total reportable segments | ||||||||
External revenues | 5,401 | 778 | 6,179 | 8,288 | 24 | 8,312 | ||||||||
External other income | - | 3,063 | 3,063 | 0 | 2,516 | 2,516 | ||||||||
External revenues and other income | 5,401 | 3,841 | 9,242 | 8,288 | 2,540 | 10,827 | ||||||||
Cost of revenue | (7,481 | ) | (339 | ) | (7,820 | ) | (8,807 | ) | (407 | ) | (9,213 | ) | ||
Research and development expenses | (2,071 | ) | (18,031 | ) | (20,103 | ) | (2,523 | ) | (31,802 | ) | (34,324 | ) | ||
Selling, general and administrative expenses | (4,278 | ) | (6,024 | ) | (10,301 | ) | (3,992 | ) | (5,683 | ) | (9,675 | ) | ||
Other operating income and expenses | (115 | ) | (259 | ) | (374 | ) | 18 | (1 | ) | 18 | ||||
Total operating expenses | (13,943 | ) | (24,652 | ) | (38,595 | ) | (15,304 | ) | (37,892 | ) | (53,195 | ) | ||
Operating income (loss) before tax | (8,542 | ) | (20,812 | ) | (29,353 | ) | (7,016 | ) | (35,352 | ) | (42,368 | ) | ||
Financial gain (loss) | (373 | ) | (3,877 | ) | (4,250 | ) | (291 | ) | 2,588 | 2,296 | ||||
Net income (loss) | (8,914 | ) | (24,688 | ) | (33,602 | ) | (7,307 | ) | (32,764 | ) | (40,071 | ) | ||
Non controlling interests | 3,305 | - | 3,305 | 2,658 | - | 2,658 | ||||||||
Net income (loss) attributable to shareholders of Cellectis | (5,610 | ) | (24,688 | ) | (30,297 | ) | (4,650 | ) | (32,764 | ) | (37,413 | ) | ||
R&D non-cash stock-based expense attributable to shareholder of Cellectis | (539 | ) | 2,022 | 1,483 | 151 | 3,219 | 3,370 | |||||||
SG&A non-cash stock-based expense attributable to shareholder of Cellectis | 1,059 | 1,030 | 2,089 | 707 | 986 | 1,693 | ||||||||
Adjustment of share-based compensation attributable to shareholders of Cellectis | 520 | 3,052 | 3,572 | 858 | 4,204 | 5,062 | ||||||||
Adjusted net income (loss) attributable to shareholders of Cellectis | (5,090 | ) | (21,636 | ) | (26,726 | ) | (3,792 | ) | (28,560 | ) | (32,351 | ) | ||
Depreciation and amortization | (505 | ) | (2,115 | ) | (2,620 | ) | (615 | ) | (3,708 | ) | (4,323 | ) | ||
Additions to tangible and intangible assets | 636 | 10,962 | 11,598 | 69 | 3,426 | 3,495 | ||||||||
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, 2020 | For the nine-month period ended September 30, 2021 | |||||||||||||
$ in thousands | Plants | Therapeutics | Total reportable segments | Plants | Therapeutics | Total reportable segments | ||||||||
External revenues | 9,960 | 50,077 | 60,037 | 25,004 | 20,085 | 45,088 | ||||||||
External other income | - | 6,510 | 6,510 | 1,528 | 6,792 | 8,320 | ||||||||
External revenues and other income | 9,960 | 56,587 | 66,547 | 26,532 | 26,876 | 53,408 | ||||||||
Cost of revenue | (16,600 | ) | (1,558 | ) | (18,159 | ) | (27,512 | ) | (1,601 | ) | (29,113 | ) | ||
Research and development expenses | (7,391 | ) | (56,203 | ) | (63,594 | ) | (8,358 | ) | (88,304 | ) | (96,663 | ) | ||
Selling, general and administrative expenses | (16,227 | ) | (15,538 | ) | (31,765 | ) | (11,520 | ) | (16,373 | ) | (27,894 | ) | ||
Other operating income and expenses | (148 | ) | (142 | ) | (291 | ) | 25 | 481 | 506 | |||||
Total operating expenses | (40,367 | ) | (73,442 | ) | (113,810 | ) | (47,366 | ) | (105,797 | ) | (153,163 | ) | ||
Operating income (loss) before tax | (30,407 | ) | (16,855 | ) | (47,263 | ) | (20,834 | ) | (78,921 | ) | (99,755 | ) | ||
Net financial gain (loss) | (510 | ) | (4,223 | ) | (4,733 | ) | (875 | ) | 3,603 | 2,728 | ||||
Net income (loss) | (30,917 | ) | (21,078 | ) | (51,996 | ) | (21,709 | ) | (75,318 | ) | (97,027 | ) | ||
Non controlling interests | 10,391 | - | 10,391 | 7,827 | - | 7,827 | ||||||||
Net income (loss) attributable to shareholders of Cellectis | (20,528 | ) | (21,077 | ) | (41,605 | ) | (13,883 | ) | (75,318 | ) | (89,201 | ) | ||
R&D non-cash stock-based expense attributable to shareholder of Cellectis | 556 | 5,005 | 5,561 | 682 | 6,922 | 7,604 | ||||||||
SG&A non-cash stock-based expense attributable to shareholder of Cellectis | 2,936 | 2,691 | 5,627 | (208 | ) | 1,901 | 1,693 | |||||||
Adjustment of share-based compensation attributable to shareholders of Cellectis | 3,492 | 7,696 | 11,188 | 474 | 8,823 | 9,297 | ||||||||
Adjusted net income (loss) attributable to shareholders of Cellectis | (17,037 | ) | (13,381 | ) | (30,418 | ) | (13,409 | ) | (66,495 | ) | (79,904 | ) | ||
Depreciation and amortization | (1,485 | ) | (5,290 | ) | (6,776 | ) | (1,834 | ) | (9,651 | ) | (11,485 | ) | ||
Additions to tangible and intangible assets | 973 | 40,983 | 41,956 | 377 | 14,446 | 14,822 | ||||||||
Note Regarding Use of Non-GAAP 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 GAAP TO NON-GAAP NET INCOME – Third Quarter
(unaudited)
($ in thousands, except per share data)
For the three-month period ended September 30, | ||||||
2020 | 2021 | |||||
Net income (loss) attributable to shareholders of Cellectis | (30,297 | ) | (37,413 | ) | ||
Adjustment: | ||||||
Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 3,572 | 5,062 | ||||
Adjusted net income (loss) attributable to shareholders of Cellectis | (26,726 | ) | (32,351 | ) | ||
Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.63 | ) | (0.71 | ) | ||
Weighted average number of outstanding shares, basic (units) (1) | 42,486,133 | 45,471,977 | ||||
Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.63 | ) | (0.71 | ) | ||
Weighted average number of outstanding shares, diluted (units) (1) | 42,573,694 | 45,471,977 |
(1) When we have adjusted net loss, in accordance with IFRS, we use the Weighted average number of outstanding shares, basic to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the Weighted average number of outstanding shares, diluted to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share)
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First nine-months
(unaudited)
($ in thousands, except per share data)
For the nine-month period ended September 30, | ||||||
2020 | 2021 | |||||
Net income (loss) attributable to shareholders of Cellectis | (41,605 | ) | (89,201 | ) | ||
Adjustment: | ||||||
Non-cash stock-based compensation expense attributable to shareholders of Cellectis | 11,188 | 9,297 | ||||
Adjusted net income (loss) attributable to shareholders of Cellectis | (30,417 | ) | (79,904 | ) | ||
Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) | (0.72 | ) | (1.79 | ) | ||
Weighted average number of outstanding shares, basic (units) (1) | 42,474,764 | 44,599,935 | ||||
Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) | (0.72 | ) | (1.79 | ) | ||
Weighted average number of outstanding shares, diluted (units) (1) | 42,528,665 | 44,599,935 |
(1) When we have adjusted net loss, in accordance with IFRS, we use the Weighted average number of outstanding shares, basic to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the Weighted average number of outstanding shares, diluted to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share)
About Cellectis
Cellectis is a gene editing company, developing first of its kind therapeutic products. 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 21 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 lysosomial 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).
For more information, visit www.cellectis.com
Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.
For further information, please contact:
Media contacts:
Margaret Gandolfo, Senior Manager, Communications, +1 (646) 628 0300
Pascalyne Wilson, Director, Communications, +33776991433, media@cellectis.com
Investor Relation contact:
Eric Dutang, Chief Financial Officer, +1 (646) 630 1748, investor@cellectis.com
Forward-looking Statements
This presentation 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 “at this time,” “anticipate,” “believe,” “expect,” “on track,” “plan,” “scheduled,” 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, include statements about our research and development projects and priorities, our pre-clinical project development efforts and the timing of our presentation of data. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development as well as the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2020 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.
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