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 of
the
Securities Exchange
Act of 1934
Date of Report: May 9, 2017
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): ⃞
EXHIBIT INDEX
Exhibit |
Title |
|
99.1 |
Press release, dated May 9, 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CELLECTIS S.A. |
||
(Registrant) | ||
May 9, 2017 |
By: |
/s/ André Choulika |
André Choulika |
||
|
Chief Executive Officer |
3
Exhibit 99.1
Cellectis Reports 1st Quarter 2017 Financial Results
- Clinical trial approval by the FDA for wholly-owned UCART123 in AML & BPDCN patients at Weill Cornell and MD Anderson
- IND clearance granted by the FDA to Servier and Pfizer related to the Phase I clinical trials of UCART19 in ALL patients
- Considering the IPO of Calyxt, Cellectis’ plant sciences subsidiary
- Cash position of $277 million1 (€259 million) as of March 31, 2017
NEW YORK--(BUSINESS WIRE)--May 9, 2017--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended March 31, 2017.
RECENT CORPORATE HIGHLIGHTS
Cellectis - Therapeutics
UCART123 - Cellectis’ most advanced, wholly controlled TALEN® gene-edited product candidate
UCART19, exclusively licensed to Servier
Scientific Conferences
Clinical Advisory Board
Calyxt Inc. – Cellectis’ plant science subsidiary
Financial Results
Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“IASB”).
First quarter 2017 Financial Results
Cash: As of March 31, 2017 Cellectis had €258.5 million in total cash, cash equivalents and current financial assets compared to €276.2 million as of December 31, 2016. This decrease of €17.7 million reflects (i) net cash flows used by operating activities of €15.3 million, (ii) capital expenditures of €0.5 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €1.9 million.
Cellectis expects that its cash, cash equivalents and current financial assets of €258.5 million as of March 31, 2017 will be sufficient to fund its current operations to 2019.
Revenues and Other Income: During the quarters ended March 31, 2016 and 2017, we recorded €9.5 million and €9.7 million, respectively, in revenues and other income. This increase primarily reflects (i) an increase of €0.8 million in research tax credit, (ii) a decrease of €0.4 million in collaboration revenues, due primarily to a decrease of €1.4 million in upfront recognition and a decrease of €0.3 million in R&D costs reimbursement, been partially offset by an increase of €1.3 million in supply agreements with Servier, and (iii) a decrease in revenue from licenses of €0.2 million.
Total Operating Expenses: Total operating expenses for the first quarter of 2017 were €28.2 million, compared to €29.9 million for the first quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €12.8 million and €13.4 million, respectively.
R&D Expenses: For the quarters ended March 31, 2016 and 2017, research and development expenses decreased by €0.5 million from €18.9 million in 2016 to €18.4 million in 2017. Personnel expenses decreased by € 2.1 million from €11.9 million in 2016 to €9.8 million in 2017, primarily due to a €1.7 million decrease in social charges on stock option grants and a €0.5 million decrease in non-cash stock based compensation expense, partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €1.5 million from €6.6 million in 2016 to €8.2 million in 2017, mainly due to increased expenses related to UCART123 and the development of other product candidates, including payments to third parties, purchases of biological materials and expenses associated with the use of laboratories and other facilities.
SG&A Expenses: During the quarters ended March 31, 2016 and 2017, we recorded €10.5 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €1.4 million primarily reflects (i) a decrease of €1.1 million in personnel expenses from €8.3 million to €7.2 million, attributable, to a decrease of €1.5 million of social charges on stock options grants and a decrease of €0.1 million of non-cash stock-based compensation expense, partly offset by a €0.5 million increase in wages and salaries, and (ii) a decrease of €0.4 million in purchases and external expenses.
Financial Gain (Loss): The financial loss was €9.1 million for the first quarter of 2016 compared with an almost nil financial result for the first quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €7.6 million due to the effect of exchange rate fluctuations on our USD cash and cash equivalent accounts, an increase of €1.0 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and a €0.2 million net gain realized on the repositioning of foreign exchange derivative instruments.
Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended March 31, 2016 and 2017, we recorded a net loss of €29.5 million (or €0.84 per share on both a basic and a diluted basis) and a net loss of €18.6 million (or €0.53 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first quarter of 2017 was €5.8 million (€0.16 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €16.1 million (€0.46 per share on both a basic and a diluted basis), for the first quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense of €12.8 million and €13.4 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.
CELLECTIS S.A. |
||||||||||
STATEMENT OF CONSOLIDATED FINANCIAL POSITION | ||||||||||
(€ in thousands) | ||||||||||
As of | ||||||||||
December 31, 2016 |
March 31, 2017 |
|||||||||
ASSETS | ||||||||||
Non-current assets | ||||||||||
Intangible assets | 1 274 | 1 332 | ||||||||
Property, plant, and equipment | 16 033 | 16 068 | ||||||||
Other non-current financial assets | 656 | 886 | ||||||||
Total non-current assets | 17 963 | 18 286 | ||||||||
Current assets | ||||||||||
Inventories and accumulated costs on orders in process | 112 | 106 | ||||||||
Trade receivables | 3 441 | 5 035 | ||||||||
Subsidies receivables | 8 276 | 11 564 | ||||||||
Other current assets | 8 414 | 11 405 | ||||||||
Cash and cash equivalent and Current financial assets | 276 216 | 258 527 | ||||||||
Total current assets | 296 459 | 286 638 | ||||||||
TOTAL ASSETS | 314 422 | 304 924 | ||||||||
LIABILITIES | ||||||||||
Shareholders’ equity | ||||||||||
Share capital | 1 767 | 1 767 | ||||||||
Premiums related to the share capital | 473 306 | 485 991 | ||||||||
Treasury share reserve | (307) | (159) | ||||||||
Currency translation adjustment | 2 501 | 1 422 | ||||||||
Retained earnings | (157 695) | (218 505) | ||||||||
Net income (loss) | (60 776) | (18 567) | ||||||||
Total shareholders’ equity - Group Share | 258 795 | 251 948 | ||||||||
Non-controlling interests | 1 779 | 1 984 | ||||||||
Total shareholders’ equity | 260 574 | 253 932 | ||||||||
Non-current liabilities | ||||||||||
Non-current financial liabilities | 28 | 21 | ||||||||
Non-current provisions | 532 | 551 | ||||||||
Total non-current liabilities | 560 | 572 | ||||||||
Current liabilities | ||||||||||
Current financial liabilities | 1 641 | 379 | ||||||||
Trade payables | 9 223 | 12 170 | ||||||||
Deferred revenues and deferred income | 36 931 | 33 109 | ||||||||
Current provisions | 563 | 563 | ||||||||
Other current liabilities | 4 930 | 4 199 | ||||||||
Total current liabilities | 53 288 | 50 420 | ||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 314 422 | 304 924 | ||||||||
CELLECTIS S.A. | ||||||||||
STATEMENT OF CONSOLIDATED OPERATIONS – First quarter | ||||||||||
(unaudited) | ||||||||||
(€ in thousands, except per share data) | ||||||||||
For the three-month period |
||||||||||
2016 | 2017 | |||||||||
Revenues and other income | ||||||||||
Revenues | 6 978 | 6 328 | ||||||||
Other income | 2 521 | 3 334 | ||||||||
Total revenues and other income | 9 499 | 9 662 | ||||||||
Operating expenses | ||||||||||
Royalty expenses | (433) | (574) | ||||||||
Research and development expenses | (18 870) | (18 392) | ||||||||
Selling, general and administrative expenses | (10 529) | (9 143) | ||||||||
Other operating income and expenses | (76) | (99) | ||||||||
Total operating expenses | (29 908) | (28 208) | ||||||||
Operating income (loss) | (20 409) | (18 546) | ||||||||
Financial gain (loss) | (9 055) | (21) | ||||||||
Net income (loss) | (29 464) | (18 567) | ||||||||
Attributable to shareholders of Cellectis | (29 464) | (18 567) | ||||||||
Attributable to non-controlling interests |
- |
- | ||||||||
Basic earnings attributable to shareholders of Cellectis per share (€/share) | (0.84) | (0.53) | ||||||||
Diluted earnings attributable to shareholders of Cellectis per share (€/share) | (0.84) | (0.53) | ||||||||
Note Regarding Use of Non-GAAP Financial Measures
Cellectis S.A. presents Adjusted Income (Loss) attributable to shareholders of Cellectis in this press release. Adjusted 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, the most directly comparable financial measure calculated in accordance with IFRS. Because Adjusted 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 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 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 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 – First quarter | ||||||||||
(unaudited) | ||||||||||
(€ in thousands, except per share data) | ||||||||||
For the three-month period |
||||||||||
2016 | 2017 | |||||||||
Net Income (Loss) attributable to shareholders of Cellectis | (29 464) | (18 567) | ||||||||
Adjustment: | ||||||||||
Non-cash stock-based compensation expense | 13 414 | 12 788 | ||||||||
Adjusted Income (Loss) attributable to shareholders of Cellectis | (16 050) | (5 779) | ||||||||
Basic Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share) | (0.46) | (0.16) | ||||||||
Weighted average number of outstanding shares, basic (units) | 35 195 281 | 35 289 932 | ||||||||
Diluted Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share) | (0.46) | (0.16) | ||||||||
Weighted average number of outstanding shares, diluted (units) | 35 563 743 | 35 784 930 | ||||||||
About Cellectis
Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering - based on its flagship TALEN® products and meganucleases and pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells. Using its life-science-focused, pioneering genome-engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets. Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
Talking about gene editing? We do it.
TALEN® is a
registered trademark owned by the Cellectis Group.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “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 and include, but are not limited to, statements regarding the outlook for Cellectis’ future business and financial performance. Forward-looking statements are based on management’s current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances, many of which are beyond Cellectis’ control. Actual outcomes and results may differ materially due to global political, economic, business, competitive, market, regulatory and other factors and risks. Cellectis expressly disclaims any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in its views or expectations, or otherwise.
1 Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.0691, the daily reference rate reported by the European Central Bank (“ECB”) as of March 31, 2017
CONTACT:
For further information, please contact:
Media
contacts
Jennifer Moore, VP Communications
Phone: +1
917-580-1088
email: media@cellectis.com
or
Caitlin
Kasunich
KCSA Strategic Communications
Phone: +1 212.896.1241
email:
ckasunich@kcsa.com
or
Investor relations contact:
Simon
Harnest, VP Corporate Strategy and Finance
Phone: +1 646-385-9008
email:
simon.harnest@cellectis.com