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: August 2, 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 August 2, 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) | ||
August 2, 2017 |
By: |
/s/ André Choulika |
André Choulika |
||
|
Chief Executive Officer |
3
Exhibit 99.1
Cellectis Reports Financial Results for 2nd Quarter and First Six Months 2017
NEW YORK--(BUSINESS WIRE)--August 2, 2017--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), today announced its results for the three-month period ended June 30, 2017 and for the six-month period ended June 30, 2017.
____________________________
1 Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.1412, the daily reference rate reported by the European Central Bank (“ECB”) as of June 30, 2017.
Second Quarter 2017 and Recent Highlights
Cellectis - Therapeutics
UCART123: Cellectis’ most advanced, wholly controlled TALEN® gene-edited, allogeneic CAR T product candidate
UCART19: exclusively licensed to Servier
Manufacturing
IP/ Patent portfolio
Conferences
Corporate Governance
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 (“GAAP”).
Second Quarter 2017 Financial Results
Cash: As of June 30, 2017, Cellectis had €237.6 million in total cash, cash equivalents and current financial assets compared to €258.5 million as of March 31, 2017. This decrease of €20.9 million reflects (i) net cash flows used by operating activities of €10.0 million, (ii) capital expenditures of €0.7 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 €11.0 million; partially offset by (iv) the increase in equity mainly attributable to the exercise of share warrants for €0.8 million.
Revenues and Other Income: During the quarters ended June 30 2016 and 2017, we recorded €18.1 million and €8.2 million, respectively, in revenues and other income. This decrease is mainly due to a €10.0 million decrease in collaboration revenues of which €7.7 million represented milestone, revenues received during the second quarter of 2016 with the first patient dosed in Phase I clinical trial for UCART19, and a decrease of €2.0 million in recognition of upfront already paid to Cellectis.
Total Operating Expenses: Total operating expenses for the second quarter of 2017 were €26.2 million, compared to €28.2 million for the second quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €11.3 million and €14.4 million, respectively.
R&D Expenses: For the quarters ended June 30, 2016 and 2017, research and development expenses decreased by €2.6 million from €19.5 million in 2016 to €16.9 million in 2017. Personnel expenses decreased by €3.2 million from €11.6 million in 2016 to €8.4 million in 2017, primarily due to a €3.1 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 and other expenses increased by €0.5 million from €7.5 million in 2016 to €8.0 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.
SG&A Expenses: During the quarters ended June 30, 2016 and 2017, we recorded €8.6 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €0.5 million primarily reflects an increase of €0.6 million in personnel expenses from €6.5 million to €7.1 million, attributable, among other things, to an increase of €0.6 in wages and salaries and an increase of €0.1 million in non-cash stock-based compensation expense, partially offset by a decrease of €0.2 million in purchases and external expenses.
Financial Gain (Loss): The financial gain was €3.8 million for the second quarter of 2016 compared with a financial loss of €6.0 million for the second quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €11.5 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts and an increase of €1.9 million in fair value adjustment income on our foreign exchange derivatives and current financial assets.
Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended June 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of €6.3 million (€0.18 per share on both a basic and a diluted basis) and net loss attributable to shareholders of Cellectis of €24.1 million (€0.68 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the second quarter of 2017 was €12.8 million (€0.36 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €8.1 million (€0.23 per share on both a basic and a diluted basis), for the second quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis for the second quarter of 2017 and 2016 excludes non-cash stock-based compensation expense of €11.3 million and €14.4 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.
First Six Months 2017 Financial Results
Cash: As of June 30, 2017, Cellectis had €237.6 million in total cash, cash equivalents and current financial assets compared to € 276.2 million as of December 31, 2016. This decrease of €38.6 million primarily reflects (i) net cash flows used by operating activities of €25.2 million, (ii) capital expenditures of €1.4 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 €13.0 million; partially offset by an increase in equity mainly attributable to the exercise of share warrants for €1.0 million.
Cellectis expects that its cash, cash equivalents and current financial assets of €237.6 million as of June 30, 2017 will be sufficient to fund its current operations to 2019.
Revenues and Other Income: During the six-month periods ended June 30, 2016 and 2017, we recorded €27.6 million and €17.8 million, respectively, in revenues and other income. This decrease is mainly due to (i) a €10.4 million decrease in collaboration revenues of which €7.7 million represented milestones revenues received during the second quarter of 2016 with the first patient dosed in the Phase I clinical trial for UCART 19, a decrease of €3.5 million in recognition of upfront fees already paid to Cellectis and a decrease of €0.8 million in research and development cost reimbursements; partially offset by an increase of €1.5 million in revenue related to supply to Servier, partly offset by (ii) an increase of €0.7 million in research tax credits.
Total Operating Expenses: Total operating expenses for the six-month period ended June 30, 2017 were €54.4 million, compared to €58.1 million for the six months ended June 30, 2016. The non-cash stock-based compensation expenses included in these amounts were €24.1 million and €27.8 million, respectively.
R&D Expenses: For the six-month periods ended June 30, 2016 and 2017, research and development expenses decreased by €3.1 million from €38.4 million in 2016 to €35.3 million in 2017. Personnel expenses decreased by €5.3 million from €23.5 million in 2016 to €18.2 million in 2017, primarily due to a €3.7 million decrease in non-cash stock based compensation expense, and a €1.7 million decrease in social charges on stock options; grants partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €2.0 million from €14.2 million in 2016 to €16.2 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.
SG&A Expenses: During the six-month periods ended June 30, 2016 and 2017, we recorded €19.1 million and €18.2 million, respectively, of selling, general and administrative expenses. The decrease of €0.9 million primarily reflects (i) a decrease of €0.4 million in personnel expenses from €14.8 million to €14.3 million, attributable, among other things, to a decrease of €1.5 million of social charges on stock options grants, partly offset by a €1.1 million increase in wages and salaries, and (ii) a decrease of €0.6 million in purchases and external expenses.
Financial Gain (Loss): The financial loss was €5.3 million for the six-month period ended June 30, 2016 compared with financial loss of €6.1 million for the six-month period ended June 30, 2017. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts for €3.9 million partially offset by the fair value adjustment on our derivative instrument and financial current asset for €3.0 million.
Net Income (Loss) Attributable to Shareholders of Cellectis: During the six-months periods ended June 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of €35.7 million (€ 1.01 per share on both a basic and a diluted basis) and a net loss attributable to shareholders of Cellectis of €42.7 million (€1.20 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the six-month period ended June 30, 2017 was €18.6 million (€0.52 per share on both a basic and a diluted basis) compared to adjusted loss attributable to shareholders of Cellectis of €7.9 million (€0.22 per share on both a basic and a diluted basis), for the six-month period ended June 30, 2016. Adjusted loss attributable to shareholders of Cellectis for the six-month periods ended June 30, 2017 and 2016 excludes a non-cash stock-based compensation expense of €24.1 million and €27.8 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.
CELLECTIS S.A. INTERIM STATEMENT OF CONSOLIDATED FINANCIAL POSITION (€ in thousands, except per share data) |
||||
As of | ||||
December 31, 2016
Audited |
June 30, 2017
Unaudited |
|||
ASSETS | ||||
Non-current assets | ||||
Intangible assets | 1,274 | 1,213 | ||
Property, plant, and equipment | 16,033 | 15,466 | ||
Other non-current financial assets | 656 | 835 | ||
Total non-current assets | 17,963 | 17,515 | ||
Current assets | ||||
Inventories | 112 | 114 | ||
Trade receivables | 3,441 | 4,346 | ||
Subsidies receivables | 8,276 | 13,500 | ||
Other current assets | 8,414 | 14,196 | ||
Cash and cash equivalent and Current financial assets | 276,216 | 237, 614 | ||
Total current assets | 296,459 | 269,771 | ||
TOTAL ASSETS | 314,422 | 287,286 | ||
LIABILITIES | ||||
Shareholders’ equity | ||||
Share capital | 1,767 | 1,793 | ||
Premiums related to the share capital | 473,306 | 496,752 | ||
Treasury share reserve | (307) | (199) | ||
Currency translation adjustment | 2,501 | (3,030) | ||
Retained earnings | (157,695) | (218,496) | ||
Net income (loss) | (60,776) | (42,653) | ||
Total shareholders’ equity - Group Share | 258,795 | 234,168 | ||
Non-controlling interests | 1,779 | 3,118 | ||
Total shareholders’ equity | 260,574 | 237,285 | ||
Non-current liabilities | ||||
Non-current financial liabilities | 28 | 18 | ||
Non-current provisions | 532 | 571 | ||
Total non-current liabilities | 560 | 589 | ||
Current liabilities | ||||
Current financial liabilities | 1,641 | 61 | ||
Trade payables | 9,223 | 15,040 | ||
Deferred revenues and deferred income | 36,931 | 28,605 | ||
Current provisions | 563 | 382 | ||
Other current liabilities | 4,930 | 5,323 | ||
Total current liabilities | 53,288 | 49,412 | ||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 314,422 | 287,286 | ||
CELLECTIS S.A. INTERIM STATEMENT OF CONSOLIDATED OPERATIONS – Second quarter (unaudited) (€ in thousands, except per share data) |
||||
For the three-month period
ended June 30, |
||||
2016 | 2017 | |||
Revenues and other income | ||||
Revenues | 15,823 | 5,902 | ||
Other income | 2,317 | 2,248 | ||
Total revenues and other income | 18,140 | 8,150 | ||
Operating expenses | ||||
Royalty expenses | (291) | (512) | ||
Research and development expenses | (19,526) | (16,910) | ||
Selling, general and administrative expenses | (8,600) | (9,105) | ||
Other operating income and expenses | 259 | 337 | ||
Total operating expenses | (28,158) | (26,190) | ||
Operating income (loss) | (10,018) | (18,040) | ||
Financial gain (loss) | 3,763 | (6,045) | ||
Net income (loss) | (6,255) | (24,085) | ||
Attributable to shareholders of Cellectis | (6,255) | (24,085) | ||
Attributable to non-controlling interests |
- |
- | ||
Basic net income (loss) attributable to shareholders of Cellectis per share (€/share) | (0.18) | (0.68) | ||
Diluted net income (loss) attributable to shareholders of Cellectis per share (€/share) | (0.18) | (0.68) | ||
CELLECTIS S.A. INTERIM STATEMENT OF CONSOLIDATED OPERATIONS – FIRST SIX MONTHS (unaudited) (€ in thousands, except per share data) |
||||
For the six-month period
ended June 30, |
||||
2016 | 2017 | |||
Revenues and other income | ||||
Revenues | 22,801 | 12,230 | ||
Other income | 4,838 | 5,582 | ||
Total revenues and other income | 27,639 | 17, 812 | ||
Operating expenses | ||||
Royalty expenses | (723) | (1,086) | ||
Research and development expenses | (38,396) | (35,303) | ||
Selling, general and administrative expenses | (19,127) | (18,248) | ||
Other operating income and expenses | 180 | 238 | ||
Total operating expenses | (58,066) | (54,398) | ||
Operating income (loss) | (30,427) | (36,586) | ||
Financial gain (loss) | (5,292) | (6,067) | ||
Net income (loss) | (35,719) | (42,653) | ||
Attributable to shareholders of Cellectis | (35,719) | (42,653) | ||
Attributable to non-controlling interests |
- |
- | ||
Basic net income (loss) attributable to shareholders of Cellectis per share (€/share) | (1.01) | (1.20) | ||
Diluted net income (loss) attributable to shareholders of Cellectis per share (€/share) | (1.01) | (1.20) | ||
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, which is 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 – Second quarter (unaudited) (€ in thousands, except per share data) |
||||
For the three-month period
ended June 30, |
||||
2016 | 2017 | |||
Net income (loss) attributable to shareholders of Cellectis | (6,255) | (24,085) | ||
Adjustment: | ||||
Non-cash stock-based compensation expense | 14,383 | 11,288 | ||
Adjusted net income (loss) attributable to shareholders of Cellectis | 8,128 | (12,797) | ||
Basic Adjusted net income (loss) attributable to shareholders of Cellectis (€/share) | 0.23 | (0.36) | ||
Weighted average number of outstanding shares, basic (units) | 35,295,817 | 35,560,088 | ||
Diluted Adjusted net income (loss) attributable to shareholders of Cellectis (€/share) | 0.23 | (0.36) | ||
Weighted average number of outstanding shares, diluted (units) | 35,472,312 | 35,580,391 | ||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First six months (unaudited) (€ in thousands, except per share data) |
||||
For the six-month period
ended June 30, |
||||
2016 | 2017 | |||
Net income (loss) attributable to shareholders of Cellectis | (35,719) | (42,653) | ||
Adjustment: | ||||
Non-cash stock-based compensation expense | 27,797 | 24,076 | ||
Adjusted net income (loss) attributable to shareholders of Cellectis | (7,922) | (18,577) | ||
Basic Adjusted net income (loss) attributable to shareholders of Cellectis (€/share) | (0.22) | (0.52) | ||
Weighted average number of outstanding shares, basic (units) | 35,245,549 | 35,447,574 | ||
Diluted Adjusted net income (loss) attributable to shareholders of Cellectis (€/share) | (0.22) | (0.52) | ||
Weighted average number of outstanding shares, diluted (units) | 35,622,858 | 35,490,639 | ||
About Cellectis
Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies based on gene-edited T-cells (UCART). By capitalizing on its 17 years of expertise in gene editing – built on its flagship TALEN® technology and pioneering electroporation system PulseAgile – Cellectis uses the power of the immune system to target and eradicate cancer 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 NYSE 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 Cellectis
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.
CONTACT:
Media:
Jennifer Moore, VP of Communications,
917-580-1088
media@cellectis.com
or
Caitlin Kasunich,
KCSA Strategic Communications, 212-896-1241
ckasunich@kcsa.com
or
IR:
Simon
Harnest, VP of Corporate Strategy and Finance, 646-385-9008
simon.harnest@cellectis.com