- UCART19 Phase 1 trial on-going
- Successful cGMP Manufacturing for UCART123
- Strong cash position of $295 million1 as of September 30,
2016
- Additional grant of patent with broad claims covering
fundamental use of gene editing technologies
- Revenues and other income of $12 million2 in the 3rd quarter
of 2016
- Adjusted loss attributable to shareholders3 of $0.6 million2
in the 3rd quarter of 2016
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 September
30, 2016 and for the nine-month period ended September 30,
2016.
Recent Corporate
Highlights
UCART19 in collaboration with Servier /
Pfizer
- On June 20, 2016, Cellectis announced
that the first patient in Servier’s UCART19 Phase 1 clinical trial
had been dosed. The UCART19 Phase 1 clinical trial in ALL and CLL
patients is conducted at two clinical sites in the UK – at the
Great Ormond Street Hospital (GOSH), part of UCL, for the pediatric
arm of the trial, and at Kings College London for the adult arm of
the study.
- Interim data from the UCART19 Phase 1
clinical trial is expected to be announced at a scientific meeting
in H1 2017.
UCART123
- On November 15, 2016, Cellectis
announced the successful completion of large scale production runs
of UCART123, according to cGMP standards. Cellectis is planning to
file an IND for a Phase 1 clinical trial in AML and BPDCN patients
by YE 2016 in collaboration with the Weill Cornell Medical College
and the MD Anderson Cancer Center.
- Weill Cornell will present pre-clinical
data on UCART123 in an oral presentation at the 58th American
Society of Hematology (ASH) Annual Meeting and Exposition. The
meeting will be held from December 3 to 6, 2016 in San Diego.
Pfizer Partnership
- Cellectis and Pfizer are making
advances in their partnered programs. Notably, Pfizer will present
on the “Preclinical Evaluation of Allogeneic Anti-BCMA Chimeric
Antigen Receptor T Cells with Safety Switch Domains and
Lymphodepletion Resistance for the Treatment of Multiple Myeloma”
in an oral presentation at ASH in December 2016.
IP / Patent Portfolio
- Issuance of U.S. patent 9,458,439 –
which claims gene inactivation by use of chimeric restriction
endonucleases. This patent, granted by the USPTO to the Institut
Pasteur and Boston Children's Hospital, naming Dr. André Choulika
and Pr. Richard C. Mulligan as co-inventors, is exclusively
licensed to Cellectis.
Award
- Cellectis won EuropaBio’s 2016 Most
Innovative European Biotech SME Award for the healthcare category.
The Awards program is a unique annual initiative that recognizes
innovative biotech small- and medium-sized enterprises (SMEs) in
Europe and the crucial role that they play in answering some of
society’s greatest challenges through biotechnology.
Conferences
- Cellectis will participate in the
upcoming Oppenheimer Life Sciences Summit being held in NYC on
November 29, 2016 and will be presenting at the Piper Jaffray 28th
Annual Health Care Conference on November 30, 2016 in NYC.
Calyxt – Cellectis’ plant science
subsidiary
- Calyxt expanded its patent portfolio
with U.S. patent 9,458,439, which encompasses broad uses of
technologies such as CRISPR/Cas9, Zinc Finger Nucleases and
TAL-effector Nucleases for plant gene editing.
- On October 20, 2016 Cellectis hosted,
along with its agricultural biotech subsidiary Calyxt, the world’s
first dinner made with gene edited foods in New York.
- Calyxt has completed the 2016 expansion
of its high-oleic/no trans-fat soybean variety (CAL1501) in the
U.S. with a production of 1,200 tons of beans. In Spring 2016,
Calyxt planted 942 acres (381 hectares) in six U.S. states –
Illinois, Iowa, Michigan, Minnesota, South Dakota and Wisconsin. To
date, the Company has harvested approximately 45,000 bushels with
the intent to use a substantial portion of the harvest for its
first industrial scale crush.
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”).
Third Quarter 2016 Financial Results
Cash: As of September 30, 2016, Cellectis had €264.0
million in total cash, cash equivalents and current financial
assets compared to €269.7 million as of June 30, 2016. This
decrease of €5.7 million notably reflects (i) the net cash flows
used in operating activities of €1.7 million, which includes €9.2
million of cash receipts in the third quarter of 2016 in connection
with the achievement of two milestones under our collaboration
agreement with Servier that occurred during the second quarter of
2016, and (ii) capital expenditures of €2.2 million. The change was
also attributable to the unrealized negative translation effect of
exchange rate fluctuations on our U.S. dollar cash, cash
equivalents and current financial assets of €1.6 million.
Revenues and Other Income: During the quarters ended
September 30, 2015 and 2016, we recorded €10.0 million and €11.3
million, respectively, in revenues and other income. This is mainly
due to (i) the increase of €2.5 million in collaboration revenues,
notably due to the agreement to provide Servier with raw materials
and batches of UCART19 products, partly offset by (ii) the decrease
of €0.3 million in research tax credit and €0.8 million in
subsidies.
Total Operating Expenses and Other Operating Income:
Total operating expenses and other operating income for the third
quarter of 2016 were €22.9 million, compared to €23.4 million for
the third quarter of 2015. The non-cash stock-based compensation
expenses included in these amounts were €12.1 million and €9.5
million, respectively.
R&D Expenses: For the quarters ended 2015 and 2016,
research and development expenses decreased by €2.3 million from
€16.2 million in 2015 to €13.8 million in 2016. Personnel expenses
decreased by €1.1 million from €10.3 million in 2015 to €9.2
million in 2016, notably due to a €2.5 million decrease in social
charges on stock options and free share grants, partly offset by a
€0.4 million increase in wages and salaries, and a €0.9 million
increase in non-cash stock based compensation expense. Purchases
and external expenses and other expenses decreased by €1.2 million
from €5.8 million in 2015 to €4.6 million in 2016.
SG&A Expenses: During the quarters ended 2015 and
2016, we recorded €6.9 million and €8.7 million, respectively, of
selling, general and administrative expenses. The increase of €1.8
million primarily reflects (i) an increase of €0.9 million in
personnel expenses from €5.7 million to €6.7 million, attributable,
among other things, to an increase of €1.7 million of non-cash
stock-based compensation expense, partly offset by a decrease of
€1.0 million of social charges on stock options and free share
grants, and (ii) an increase of €0.9 million in purchases and
external expenses and other charges.
Financial Gain (Loss): The financial gain was €0.7
million for the third quarter of 2015 compared with a financial
loss of €1.0 million for the third quarter of 2016. 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.
Net Income (Loss) Attributable to Shareholders of
Cellectis: During the three months ended September 30, 2015 and
2016, we recorded a net loss of €12.8 million (or €0.36 per share
on both a basic and a diluted basis) and net loss of €12.6 million
(or €0.36 per share on both a basic and a diluted basis),
respectively. Adjusted loss attributable to shareholders of
Cellectis for the third quarter of 2016 was €0.5 million (€0.01 per
share on both a basic and a diluted basis) compared to adjusted
loss attributable to shareholders of Cellectis of €3.3 million
(€0.09 per share on both a basic and a diluted basis), for the
third quarter of 2015. Adjusted loss attributable to shareholders
of Cellectis for the third quarter of 2016 and 2015 excludes
non-cash stock-based compensation expense of €12.1 million and €9.5
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 Nine Months 2016 Financial Results
Cash: As of September 30, 2016, Cellectis had €264.0
million in total cash, cash equivalents and current financial
assets compared to € 314.2 million as of December 31, 2015. This
decrease of €50.3 million was primarily driven by (i) €30.8 million
of cash used in operating activities, notably in connection with
the initiation of industrial Good Manufacturing Practice (“GMP”)
production of UCART123, increased expenses in materials required of
GMP production of UCART 123 and other targets, a payment of €7.2
million of value added taxes related to proceeds received in the
fourth quarter of 2015 from Servier, partly offset by cash receipts
of €9.2 million in connection with the achievement of two
milestones under our collaboration agreement with Servier that
occurred during the second quarter of 2016 and (ii) €11.3 million
of cash used in investment activities, primarily through Calyxt’s
land acquisition and greenhouse construction in an aggregate amount
of €8.9 million. The decrease was also partially attributable to
the negative unrealized translation effect of exchange rate
fluctuations on our U.S. dollar cash, cash equivalents and current
financial assets accounts of €7.4 million.
Cellectis expects that its cash, cash equivalents and Current
financial assets of €264.0 million as of September 30, 2016 will be
sufficient to fund its current operations through the end of
2018.
Revenues and Other Income: During the nine-month periods
ended September 30, 2015 and 2016, we recorded €27.2 million and
€38.9 million, respectively, in revenues and other income. This is
mainly due to the increase of (i) €9.6 million in collaboration
revenues mainly due to both the agreement to provide Servier with
raw materials and additional batches of UCART19 products and the
achievement of two milestones (totaling €11.7 million) under our
collaboration agreement with Servier and (ii) €3.1 million in
research tax credit, partly offset by a decrease of €0.9 million in
research subsidies, resulting from the termination of research
programs.
Total Operating Expenses and Other Operating Income:
Total operating expenses and other operating income for the
nine-month period ended September 30, 2016 were €80.9 million,
compared to €56.3 million for the nine months ended September 30,
2015. The non-cash stock-based compensation expenses included in
these amounts were €39.9 million and €17.5 million,
respectively.
R&D Expenses: For the nine months ended September 30,
2015 and 2016, research and development expenses increased by €15.8
million from €36.4 million in 2015 to €52.2 million in 2016.
Personnel expenses increased by €8.4 million from €24.3 million in
2015 to €32.7 million in 2016, notably due to a
€1.9 million increase in wages and salaries, and a
€12.6 million increase in non-cash stock based compensation
expense, partly offset by a €6.1 million decrease in social
charges on stock options and free share grants. Purchases and
external expenses increased by €7.6 million from €11.0 million in
2015 to €18.6 million in 2016, due to increased expenses related to
innovation and platform development, including 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 nine months ended September
30, 2015 and 2016, we recorded €19.1 million and €27.8 million,
respectively, of selling, general and administrative expenses. The
increase of €8.7 million primarily reflects (i) an increase of
€7.4 million in personnel expenses from €14.0 million to
€21.4 million, attributable, among other things, to a
€0.5 million increase in wages and salaries, and an increase
of €9.9 million of non-cash stock-based compensation expense,
partly offset by a decrease of €3.0 million of social charges
on stock options and free share grants, and (ii) an increase
of €1.0 million in purchases and external expenses.
Financial Gain (Loss): The financial gain was €0.5
million for the nine months ended September 30, 2015 compared with
financial loss of €6.3 million for the nine months ended September
30, 2016. 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.
Net Income (Loss) Attributable to Shareholders of
Cellectis: During the nine months ended September 30, 2015 and
2016, we recorded a net loss of €28.8 million (or € 0.85 per share
on both a basic and a diluted basis) and a net loss of €48.3
million (or €1.37 per share on both a basic and diluted basis),
respectively. Adjusted loss attributable to shareholders of
Cellectis for the nine months ended September 30, 2016 was €8.4
million (€0.24 per share on both a basic and a diluted basis)
compared to adjusted loss attributable to shareholders of Cellectis
of € 11.3 million (€0.33 per share on both a basic and a diluted
basis), for the nine months ended September 30, 2015. Adjusted loss
attributable to shareholders of Cellectis for the nine months ended
September 30, 2016 and 2015 excludes a non-cash stock-based
compensation expense of €39.9 million and €17.5 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.
STATEMENT OF CONSOLIDATED FINANCIAL
POSITION
(unaudited)
(€ in thousands, except per share
data)
As of December 31, 2015
September 30, 2016 ASSETS Non-current
assets Intangible assets 956 1 180 Property, plant, and
equipment 5 043 15 141 Other non-current financial assets 845 612
Total non-current assets 6 844 16 933
Current assets Inventories and accumulated costs on orders
in process 158 106 Trade receivables 6 035 11 382 Subsidies
receivables 9 102 14 535 Other current assets 4 685 7 252 Cash and
cash equivalent and Current financial assets 314 238 263 968
Total current assets 334 218 297 243 TOTAL
ASSETS 341 062 314 177 LIABILITIES
Shareholders’ equity Share capital 1 759 1 767 Premiums
related to the share capital 420 682 460 474 Treasury share reserve
(184) (373) Currency translation adjustment (1 631) (1 933)
Retained earnings (137 188) (158 032) Net income (loss) (20 544)
(48 309)
Total shareholders’ equity - Group Share 262
894 253 595 Non-controlling interests 725 1 471
Total
shareholders’ equity 263 619 255 066
Non-current liabilities Non-current financial liabilities 66
37 Non-current provisions 437 581
Total non-current
liabilities 503 619 Current
liabilities Current financial liabilities 1 921 1 922 Trade
payables 6 611 9 176 Deferred revenues and deferred income 54 758
41 893 Current provisions 953 467 Other current liabilities 12 697
5 034
Total current liabilities 76 940 58 492
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 341 062
314 177
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS –
Third quarter
(unaudited)
(€ in thousands, except per share
data)
For the three-month periodended
September 30,
2015 2016 Revenues and
other income Revenues 7 600 10 091 Other income 2 379 1 215
Total revenues and other income 9 978 11 306
Operating expenses and other operating income
(expenses) Royalty expenses (334) (311) Research and
development expenses (1) (16 156) (13 824) Selling, general and
administrative expenses (1) (6 921) (8 712) Other operating income
0 (6) Redundancy plan 24 3 Other operating expenses (37) (10)
Total operating expenses and other operating income
(expenses) (23 425) (22 860)
Operating income (loss) (13 447) (11 555)
Financial gain (loss) 680 (1
035) Income (loss) from continuing operations (12 766)
(12 590)
Net income (loss) (12 766) (12 590)
Attributable to shareholders of Cellectis (12 766) (12 590)
Attributable to non-controlling interests
-
-
Basic earnings attributable to shareholders of
Cellectis per share (€/share) (0.36) (0.36)
Diluted earnings attributable to shareholders of
Cellectis per share (€/share) (0.36) (0.36)
___________________
(1) Cellectis reclassified certain expenses related to the year
ended December 31, 2015 from SG&A expenses to R&D expenses
in the fourth quarter of 2015. This reclassification is effective
starting in 2015, and is due to the increased level of efforts
towards our R&D activities in order to develop product
candidates and work toward clinical phases. Starting in 2015, we
classify personnel and other costs related to information
technology, human resources, business development, legal,
intellectual property and general management in Research and
development expense based on the time that employees spent
contributing to research and development activities versus general
and administrative activities. We approved the reclassification in
Q4 2015 and assess the performance of the consolidated company
based on this new classification.
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS –
First Nine Months
(unaudited)
(€ in thousands, except per share
data)
For the nine-month periodended
September 30,
2015 2016 Revenues and
other income Revenues 23 356 32 892 Other income 3 845 6 053
Total revenues and other income 27 201 38 945
Operating expenses and other operating income
(expenses) Royalty expenses (1 153) (1 035) Research and
development expenses (1) (36 375) (52 220) Selling, general and
administrative expenses (1) (19 145) (27 839) Other operating
income 515 380 Redundancy plan 259 3 Other operating expenses (432)
(216)
Total operating expenses and other operating income
(expenses) (56 331) (80 926)
Operating income (loss) (29 130) (41 981)
Financial gain (loss) 515 (6
328) Income (loss) from continuing operations (28 615)
(48 309)
Net income (loss) (28 615) (48 309)
Attributable to shareholders of Cellectis (28 786) (48 309)
Attributable to non-controlling interests 171 -
Basic earnings attributable to shareholders of Cellectis per
share (€/share) (0.85) (1.37)
Diluted earnings attributable to shareholders of Cellectis per
share (€/share) (0.85) (1.37)
___________________
(1) Cellectis reclassified certain expenses related to the year
ended December 31, 2015 from SG&A expenses to R&D expenses
in the fourth quarter of 2015. This reclassification is effective
starting in 2015, and is due to the increased level of efforts
towards our R&D activities in order to develop product
candidates and work toward clinical phases. Starting in 2015, we
classify personnel and other costs related to information
technology, human resources, business development, legal,
intellectual property and general management in Research and
development expense based on the time that employees spent
contributing to research and development activities versus general
and administrative activities. We approved the reclassification in
Q4 2015 and assess the performance of the consolidated company
based on this new classification.
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 – Third quarter
(unaudited)
(€ in thousands, except per share
data)
For the three-month periodended
September 30,
2015 2016 Net Income
(Loss) attributable to shareholders of Cellectis (12
766) (12 590) Adjustment:
Non-cash stock-based compensation
expense
9 464 12 114
Adjusted Income (Loss) attributable to shareholders
of Cellectis (3 301) (475) Basic
Adjusted Income (Loss) attributable to shareholders of Cellectis
(€/share) (0.09) (0.01) Weighted
average number of outstanding shares, basic (units) 35 094
503 35 333 572 Diluted Adjusted Income
(Loss) attributable to shareholders of Cellectis (€/share)
(0.09) (0.01) Weighted average
number of outstanding shares, diluted (units) 35 475 034
35 713 432
RECONCILIATION OF GAAP TO NON-GAAP NET
INCOME – First nine months
(unaudited)
(€ in thousands, except per share
data)
For the nine-month periodended
September 30,
2015 2016 Net Income
(Loss) attributable to shareholders of Cellectis (28
786) (48 309) Adjustment:
Non-cash stock-based compensation
expense
17 481 39 911
Adjusted Income (Loss) attributable to
shareholders of Cellectis (11 305) (8 398)
Basic Adjusted Income (Loss) attributable to shareholders
of Cellectis (€/share) (0.33) (0.24)
Weighted average number of outstanding shares, basic
(units) 33 819 191 35 274 890
Diluted Adjusted Income (Loss) attributable to shareholders of
Cellectis (€/share) (0.33) (0.24)
Weighted average number of outstanding shares, diluted
(units) 34 152 422 35 695 907
As a foreign private issuer, we are not required under the
Exchange Act to file periodic reports and financial statements with
the SEC as frequently or as promptly as United States companies
whose securities are registered under the Exchange Act.
Notwithstanding the foregoing, we currently provide quarterly
interim consolidated financial data to the SEC, and commencing with
our first quarter interim report for the 2017 fiscal year, we
intend to file our periodic reports within the deadlines applicable
to domestic reporting companies.
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
16 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 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 the Cellectis Group.
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 Cash position amounted €264 million and was converted to
Dollars using Euro-US Dollar exchange rate as of September 30,
2016: 1.11612 Converted from Euro to Dollars using Euro-US Dollar
average exchange rate for the 3rd quarter of 2016: 1.11663 See the
section related to the reconciliation of Gaap to non-Gaap net
income. GAAP Net Loss attributable to shareholders amounted to $15
million (€13 million) in the 3rd quarter of 2016
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161122006146/en/
MediaJennifer Moore, +1 917-580-1088VP
Communicationsmedia@cellectis.comorCaitlin Kasunich, +1
212-896-1241KCSA Strategic
Communicationsckasunich@kcsa.comorInvestor relations
contact:Simon Harnest, +1 646-385-9008VP Corporate Strategy and
Financesimon.harnest@cellectis.com
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Sep 2023 to Sep 2024