- First AML patient treated with
UCART123, our allogeneic CAR T product candidate in the Phase I
dose-escalation study arm; enrollment ongoing
- IND clearance granted by the FDA to
Servier and Pfizer related to the Phase I clinical trials of
UCART19 in ALL patients
- Closing of the Calyxt’s Nasdaq IPO with
$64.4 million in gross proceeds to Calyxt on July 25, 2017
- Strong cash position of $272 million1
(€238 million) as of June 30, 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
- First patient administration of
UCART123 product candidate - in Acute Myeloid Leukemia (AML),
marking the start of the Phase I dose escalation study.
- For AML patients, the Phase I clinical
trial is being conducted at Weill Cornell Medicine New York -
Presbyterian Hospital, and led by Gail J. Roboz, MD, Director of
the Clinical and Translational Leukemia Programs and Professor of
Medicine.
- For Blastic Plasmacytoid Dendritic Cell
Neoplasm (BPDCN) patients, the Phase I clinical trial is being
conducted at MD Anderson Cancer Center, and is led by Naveen
Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD,
Professor and Department Chair, Department of Leukemia, Division of
Cancer Medicine.
UCART19: exclusively licensed to Servier
- IND clearance obtained for Servier, in
collaboration with Pfizer, to proceed with UCART19 Phase I clinical
trials in the U.S. in patients with relapsed /refractory acute
lymphoblastic leukemia (ALL).
- UCART19 Phase I clinical trials in
pediatric and adult ALL patients are ongoing at University College
London (UCL) and Kings College London (KCL), in the UK, sponsored
by Servier.
Manufacturing
- On-going manufacturing of UCART CS1, an
allogeneic CAR T-cell product candidate for Multiple Myeloma.
- Signed a Development and Manufacturing
Agreement on July 27, 2017 with MolMed S.p.A for the development
and manufacturing of UCAR T-cell product candidates
IP/ Patent portfolio
- U.S. patent 8,921,332, which claims the
use of chimeric restriction endonucleases for directing chromosomal
gene editing in cells by homologous recombination (HR), initially
issued on Dec. 30, 2014, was upheld by the United States Patent and
Trademark Office (USPTO) after a reexamination initiated in October
2015.
- Grant by the European Patent Office of
patent No. EP3004337, covering a method of using RNA-guided
endonucleases, such as Cas9 or Cpf1 for the genetic engineering of
T-cells
Conferences
- Presentation of data on Cellectis’
UCART product candidates at the ASGCT 20th Annual Meeting in
Washington, D.C., USA.
- Presentations on Cellectis-controlled
programs and Pfizer/Cellectis collaboration programs at the 2017
American Association for Cancer Research (AACR) Annual Meeting:
- Wholly-controlled Program UCART22: An
Allogeneic Adoptive Immunotherapy for Leukemia Targeting CD22 with
CAR T-cells;
- Collaboration Programs:
- Allogeneic EGFRvIII Chimeric Antigen
Receptor T-cells for Treatment of Glioblastoma and
- Differential Modulation of the PD-1
Pathway Impacts the Anti-Tumor Activity of CAR T- cells.
- Company’s founder, Chairman and CEO,
Dr. André Choulika participated at the 2017 Milken Institute Global
Conference as a panelist for a session titled, “Humankind vs.
Cancer: The Scorecard” on Wednesday, May 3, 2017.
Corporate Governance
- Cellectis Shareholders’ General Meeting
was held at the Company’s head office in Paris on June 26, 2017. At
the meeting, more than 73% of voting rights were exercised, and all
resolutions recommended by the board of directors, were adopted,
including:
- the appointment of two new directors to
the board of directors, Mr. Rainer Boehm and Mr. Hervé Hoppenot;
and
- the renewal of the term of office of
director of Mr. Laurent Arthaud, Mr. Pierre Bastid and Mrs. Annick
Schwebig.
Calyxt Inc. – Cellectis’ plant science
subsidiary
- Calyxt closed its IPO with $64.4
million in gross proceeds to Calyxt from the sale of approximately
8 million shares at $8 per share, including the full exercise of
the underwritter’s overallotment option and Cellectis’ purchase of
$20.0 million of shares in the IPO. Calyxt’s shares of common stock
are traded on NASDAQ under the symbol “CLXT”. Cellectis owns
approximately 79.9% of Calyxt’s outstanding shares of common
stock.
- Calyxt launched, under a services
agreement with University of Minnesota U.S. field trials for
powdery mildew-resistant spring wheat variety, representing its
fourth gene-edited crop to undergo trials
- Joseph B. Saluri was named as General
Counsel and Executive Vice President, Corporate Development. Mr.
Saluri brings to Calyxt over 24 years of legal, business
development, strategic planning and project management experience
in the global agri-business space.
- Calyxt signed an agreement with a
third-party for the sale and leaseback of its Roseville, MN,
greenhouse and warehouse facility and construction of the remaining
facility. The completion of the sale is conditioned on Calyxt and
the buyer entering into a new facility construction agreement and a
lease in respect of the property in the forms contemplated by the
sale agreement.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170802006265/en/
Media:Jennifer Moore, VP of Communications,
917-580-1088media@cellectis.comorCaitlin Kasunich, KCSA Strategic
Communications, 212-896-1241ckasunich@kcsa.comorIR:Simon
Harnest, VP of Corporate Strategy and Finance,
646-385-9008simon.harnest@cellectis.com
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