- Enrollment ongoing in Phase 1 dose-escalation
trials AMELI-01 in r/r AML patients, BALLI-01 in r/r B-ALL patients
and MELANI-01 in r/r MM patients
- Expanding collaboration with Servier on
UCART19 products, including ALLO-501 and ALLO-501A sublicensed to
Allogene
- Entered into new research collaboration with
Iovance Biotherapeutics for use of TALEN® technology to develop
gene-edited TIL for cancer therapeutics
- Construction of in-house manufacturing sites
on track in Paris, France and Raleigh, North Carolina
- Cash position1 of $364M as of December 31,
2019
Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS -
Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused
on developing immunotherapies based on gene-edited allogeneic CAR
T-cells (UCART), today announced its results for the fourth quarter
2019 and full year ended December 31, 2019.
Earnings Call Details
Cellectis to hold a conference call for investors on March 5,
2020 at 7:30 a.m. EST – 1:30 p.m. CET. The call will include the
Company's fourth quarter 2019 and year-end financial results.
US & Canada only: +1 877-407-3104
International: +1 201-493-6792
In addition, a replay of the call will be available until March
19, 2020 by calling +1 877-660-6853 (Toll Free US & Canada); +1
201-612-7415 (Toll Free International)
Conference ID: 13688263
“Cellectis had strong achievements in 2019, as we are moving
forward with the first three Phase 1 clinical trials for our wholly
controlled product candidates which started in the fourth quarter –
AMELI-01, BALLI-01 and MELANI-01 – in relapsed/refractory Acute
Myeloid Leukemia (r/r AML), B-cell Acute Lymphoblastic Leukemia
(r/r B-ALL) and Multiple Myeloma (r/r MM) patients, respectively,”
said Dr. André Choulika, Chairman and CEO, Cellectis. “We further
established Cellectis’ position as a leader in the allogeneic and
gene-edited cell therapy field through a series of new
partnerships, publications and patents. 2020 will be a pivotal year
for Cellectis, as we believe our clinical progress will start to
show proof-of-concept for our wholly-owned allogeneic CAR T-cell
product candidates. Hand-in-hand with our clinical advancements, we
are on track with the construction of our in-house manufacturing
sites, which are designed to deliver independence and protect our
two decades of know-how and expertise in gene editing and cell
therapy.”
Fourth Quarter 2019 and Recent
Highlights
Proprietary Allogeneic CAR T-Cell Development
Programs
- UCART123 in relapsed/refractory AML patients
In January 2020, the first patient was dosed in our AMELI-01
study, the Phase 1 dose escalation clinical trial evaluating a new
version of our UCART123 product candidate in r/r AML. This trial is
part of an Investigational New Drug (IND) from the US Food and Drug
Administration (FDA) for a new UCART123 construct and an optimized
production process, and is evaluating the safety, expansion,
persistence and clinical activity of the product candidate in
patients with relapsed/refractory AML. AMELI-01 replaces the first
US clinical trial assessing the first version of UCART123 product
candidate.
AMELI-01 is designed to find the safe and optimal therapeutic
dose for UCART123 exploring four different dose levels.
- UCART22 in relapsed/refractory B-ALL patients
In December 2019, Cellectis announced the first patient was
dosed in our BALLI-01 study, the Phase 1 dose escalation clinical
trial evaluating the safety, expansion, persistence and clinical
activity of UCART22 in patients with r/r B-ALL.
BALLI-01 is designed to find the safe and optimal therapeutic
dose for UCART22 exploring three different dose levels.
Cellectis is planning on filing a protocol amendment with the US
FDA to evaluate the addition of alemtuzumab to the lymphodepletion
regimen compared to the current regimen with UCART22 in B-ALL. The
optimal lymphodepletion regimen prior to the administration of
CAR-T product candidates remains an area of investigation in the
field of CAR T-cell therapy. As the inventor of the CD52 knockout
concept that is already incorporated in the current UCART123,
UCART19 and UCART22 constructs to make them compatible with
alemtuzumab treatment, Cellectis would explore an alemtuzumab-based
lymphodepletion regimen in a separate cohort of patients to guide
the future development of UCART22 therapy in CD22+ B-ALL.
This comparative study might not start before the completion of
the second cohort of the current BALLI-01 study.
- UCARTCS1 in relapsed/refractory MM patients
In October 2019, the first patient was dosed in our MELANI-01
study, the Phase 1 dose escalation clinical trial evaluating the
safety, expansion, persistence and clinical activity of UCARTCS1 in
patients with relapsed/refractory multiple myeloma (r/r MM).
MELANI-01 is designed to find the safe and optimal therapeutic
dose for UCARTCS1 exploring three different dose levels.
Enrollment in the AMELI-01, BALLI-01 and MELANI-01 studies is
ongoing as planned. As of today, Cellectis is enrolling patients in
the first cohort of all three Phase 1 dose escalation clinical
studies.
Partnered Allogeneic CAR T-Cell Development Programs
Cellectis and Servier announced today the execution of the
amendment confirming the terms of the term sheet signed on February
18, 2020. Under this amendment, Cellectis grants Servier an
expanded exclusive worldwide license to develop and commercialize
all next generation gene-edited allogeneic CAR T-cell products
targeting CD19, including rights to UCART19/ALLO-501, and
ALLO-501A, an anti-CD19 candidate in which the rituximab
recognition domains have been removed, either directly or through
its US sublicensee Allogene Therapeutics.
In this amendment, financial terms are improved to include an
additional USD 27.6 million (EUR 25 million) upfront payment, as
well as up to USD 410 million (EUR 370 million) in clinical and
commercial milestones. The royalty rate is increased from tiered
high single-digit royalties to flat low double-digit royalties
based on net sales of products.
In addition, Cellectis regains exclusive control over the five
undisclosed allogeneic CAR T-cell targets previously covered by the
initial agreement.
GMP Manufacturing
In March 2019, Cellectis executed a lease agreement for an
82,000 square foot commercial-scale manufacturing facility in
Raleigh, North Carolina. This new site is being designed to provide
GMP manufacturing for clinical supplies and commercial
manufacturing upon regulatory approval. In addition, Cellectis is
building a 14,000 square foot manufacturing facility in Paris,
France. This facility is designed to produce Cellectis’ critical
raw and starting material supplies for UCART clinical studies and
commercial products. Construction of Cellectis’ in-house GMP Paris
and GMP Raleigh manufacturing facilities are on track for their
anticipated go-live dates.
Cellectis also announced in October 2019 that it had entered
into a manufacturing service agreement with Lonza, covering
clinical manufacturing of Cellectis’ allogeneic UCART product
candidates. Lonza is responsible for implementing Cellectis’
manufacturing processes at their GMP facility in Geleen,
Netherlands, as per current Good Manufacturing Practices (cGMP)
that meet the highest quality and safety standards outlined by the
FDA.
Scientific publications
Cellectis published a paper in November 2019 in Nature
Communications that describes a proof-of-concept for rewiring the
cell pathway to create highly intelligent T-cells that can
recognize cancerous tumors and cause a micro secretion of
therapeutic proteins onto these tumors, which ultimately reshapes
the tumor microenvironment and improves the T-cells ability to
fight cancer. By utilizing gene editing techniques to rewire the
TCRα, CD25 and PD1 genes, the study enabled CAR T-cells to micro
secrete the pro-inflammatory cytokine, IL-12, in a tumor and
time-dependent manner, paving the way for a next generation of
tightly controlled, highly active and potentially safer CAR T-cell
treatments.
In January 2020, Cellectis announced the publication of a review
titled “Off-the-shelf’ allogeneic CAR T cells: development and
challenges” in Nature Reviews Drug Discovery by Prof. Stéphane
Depil, Dr. Philippe Duchateau, Prof. Stephan Grupp, Prof. Ghulam
Mufti and Dr. Laurent Poirot. The authors review the opportunities
and challenges presented by universal allogeneic CAR T-cell
therapies, such as the potential of taking T-cells from a healthy
donor instead of using patient-derived cells and the challenge that
graft-versus-host-disease (GvHD) poses during treatment.
Patent
In November 2019, Cellectis announced that European Patent
EP3004337, which claims a method of preparing T-cells for
immunotherapy using the CRISPR-Cas9 system, initially granted on
August 2, 2017, has been upheld by the European Patent Office (EPO)
following an opposition procedure initiated in May 2018.
European Patent EP3004337 claims a method of genetically
modifying T-cells by introduction into the cells and/or expression
in the cells of an RNA-guided endonuclease, and a specific guide
RNA that directs an endonuclease to at least one targeted locus in
the T-cell genome, where it is expressed from transfected mRNA and
guide RNA is expressed in the cells as a transcript from a DNA
vector. The patent also covers the expansion phase of the resulting
cells in vitro.
Other Partnerships
In January 2020, Cellectis and Iovance entered into a research
collaboration and exclusive worldwide license agreement whereby
Cellectis grants Iovance an exclusive license under certain TALEN®
technology in order to develop tumor infiltrating lymphocytes (TIL)
that have been genetically edited to create more potent cancer
therapeutics. This license enables Iovance Biotherapeutics’ use of
TALEN® technology addressing multiple gene targets to modify TIL
for therapeutic use in several cancer indications. Financial terms
of the license include development, regulatory and sales milestone
payments from Iovance Biotherapeutics to Cellectis, as well as
royalty payments based on net sales of TALEN®-modified TIL
products.
Financial Results
The consolidated financial statements of Cellectis, which
consolidate the results of Calyxt, Inc. of which Cellectis is a
68.9% stockholder, have been prepared in accordance with
International Financial Reporting Standards, or IFRS, as issued by
the International Accounting Standards Board (“GAAP”).
We present certain financial metrics broken out between our two
reportable segments – Therapeutics and Plants – in the appendices
of this Q4 2019 and Full Year 2019 financial results press
release.
Fourth Quarter and Full Year 2019 Financial Results
Cash: As of December 31, 2019, Cellectis, including
Calyxt, had $364 million in consolidated cash, cash equivalents,
current financial assets and restricted cash of which $304 million
are attributable to Cellectis on a stand-alone basis. This compares
to (i) $367 million in consolidated cash, cash equivalents, current
financial assets and restricted cash as of September 30, 2019 of
which $299 million was attributable to Cellectis on a stand-alone
basis and (ii) $453 million in consolidated cash, cash equivalents,
current financial assets and restricted cash as of December 31,
2018, of which $358 million were attributable to Cellectis on a
stand-alone basis. This net decrease of $89 million for the
twelve-month ended December 31, 2019 primarily reflects $69 million
in net cash flows used by operating activities, of which $37
million are attributable to Cellectis, and $13 million in
acquisitions of property, plant and equipment. We believe that the
consolidated cash, cash equivalents, current financial assets and
restricted cash position of Calyxt as of December 31, 2019 will be
sufficient to fund their operations to mid-2021 while amounts
attributable to Cellectis will be sufficient to fund operations
into 2022.
Revenues and Other Income: Consolidated revenues and
other income were $6 million for the three months ended December
31, 2019 compared to $3 million for the three months ended December
31, 2018. Consolidated revenues and other income were $23 million
for the year ended December 31, 2019 compared to $21 million for
the year ended December 31, 2018. 68% of consolidated revenues and
other income was attributable to Cellectis in 2019. This increase
of $2 million between the year ended December 31, 2019 and 2018 was
mainly attributable to a milestone of $5 million related to
ALLO-715 clinical development and higher Calyxt revenues due to the
commercialization of their first products, High Oleic Soybean Oil
and High Oleic Soybean Meal. That was partially offset by a
decrease in recognition of upfront payments already received and
R&D cost reimbursements in relation to the therapeutic
collaborations, and other income.
R&D Expenses: Consolidated R&D expenses were $30
million for the three months ended December 31, 2019 compared to
$21 million for the three months ended December 31, 2018.
Consolidated R&D expenses were $92 million for the year ended
December 31, 2019 compared to $77 million for the year ended
December 31, 2018. 87% of consolidated R&D expenses was
attributed to Cellectis in 2019. The $15 million increase between
the year ended December 31, 2019 and 2018 was primarily attributed
to higher employee expenses by $5 million, higher social charges on
stock option grants by $1 million, higher purchases and external
expenses by $9 million and higher other expenses by $6 million.
This increase was partially offset by the reduction of non-cash
stock-based compensation expenses by $6 million.
SG&A Expenses: Consolidated SG&A expenses were $9
million for the three months ended December 31, 2019 compared to
$11 million for the three months ended December 31, 2018.
Consolidated SG&A expenses were $43 million for the year ended
December 31, 2019 compared to $47 million for the year ended
December 31, 2018. 39% of consolidated SG&A expenses was
attributed to Cellectis in 2019. The $4 million decrease between
the year ended December 31, 2019 and 2018 was primarily attributed
to the reduction of non-cash stock-based compensation expenses by
$5 million and to lower purchases and external expenses by $3
million. This decrease was partially offset by higher employee
expenses and higher social charges on stock option grants by $2
million and higher other expenses by $1 million.
Net Loss Attributable to Shareholders of Cellectis: The
consolidated net loss attributable to shareholders of Cellectis was
$37 million (or $0.88 per share) for the three months ended
December 31, 2019, of which $29 million was attributed to
Cellectis, compared to $23 million (or $0.54 per share) for the
three months ended December 31, 2018, of which $17 million was
attributed to Cellectis. The consolidated net loss attributable to
Shareholders of Cellectis was $102 million (or $2.41 per share) for
the year ended December 31, 2019, of which $75 million was
attributed to Cellectis, compared to $79 million (or $1.93 per
share) for the year ended December 31, 2018, of which $60 million
was attributed to Cellectis. This $23 million increase in net loss
between the full year 2019 and the corresponding prior-year period
2018 was primarily driven by an increase in operating losses of $18
million, of which $10 million was attributed to Calyxt.
Adjusted Net Loss Attributable to Shareholders of
Cellectis: The consolidated adjusted net loss attributable to
shareholders of Cellectis was $31 million (or $0.73 per share) for
the three months ended December 31, 2019, of which $25 million is
attributed to Cellectis, compared to $16 million (or $0.37 per
share) for the three months ended December 31, 2018, of which $12
million was attributed to Cellectis. The consolidated adjusted net
loss attributable to shareholders of Cellectis was $79 million (or
$1.86 per share) for the year ended December 31, 2019, of which $60
million is attributed to Cellectis, compared to $44 million (or
$1.08 per share) for the year ended December 31, 2018, of which $31
million was attributed to Cellectis. Please see "Note Regarding Use
of Non-GAAP Financial Measures" for reconciliation of GAAP net
income (loss) attributable to shareholders of Cellectis to adjusted
net income (loss) attributable to shareholders of Cellectis.
We currently foresee focusing on our cash spending at Cellectis
for 2020 in the following areas:
- Supporting the development of our deep pipeline of product
candidates, including the manufacturing and clinical trials
expenses of UCART123, UCART22 and UCARTCS1;
- Building our state-of-the-art manufacturing capabilities in
Paris and Raleigh); and
- Strengthening our manufacturing and clinical departments,
including hiring talented personnel.
Calyxt plans to focus its cash spending for 2020 in the
following areas:
- Continuing to drive the commercialization of its High-Oleic
Soybean products - High-Oleic Soybean Oil and High-Oleic Soybean
Meal;
- Supporting its innovative products pipeline; and
- Strengthening its commercial and general and administrative
support.
CELLECTIS S.A. STATEMENT OF CONSOLIDATED
FINANCIAL POSITION ($ in thousands, except per share data)
As of
December 31, 2018
December 31, 2019*
ASSETS
Non-current assets
Intangible assets
1 268
1 108
Property, plant, and
equipment
10 041
23 712
Right-of-use assets
0
45 612
Other non-current financial
assets
1 891
5 517
Total non-current
assets
13 199
75 949
Current assets
Inventories
275
2 897
Trade receivables
2 971
2 959
Subsidies receivables
17 173
9 140
Other current assets
15 333
15 617
Cash and cash equivalent and
Current financial assets
451 889
360 907
Total current assets
487 641
391 520
TOTAL ASSETS
500 840
467 469
LIABILITIES
Shareholders’ equity
Share capital
2 765
2 767
Premiums related to the share
capital
828 525
843 478
Currency translation
adjustment
(16 668)
(22 640)
Retained earnings
(326 628)
(406 390)
Net income (loss)
(78 693)
(102 092)
Total shareholders’ equity -
Group Share
409 301
315 123
Non-controlling interests
40 970
40 347
Total shareholders’
equity
450 272
355 470
Non-current
liabilities
Non-current financial
liabilities
1 018
46 540
Non-current provisions
2 681
2 855
Total non-current
liabilities
3 699
49 395
Current liabilities
Current financial liabilities
333
1 067
Trade payables
15 883
29 264
Deferred revenues and deferred
income
20 754
20 033
Current provisions
1 530
3 743
Other current liabilities
8 369
8 497
Total current
liabilities
46 869
62 604
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY
500 840
467 469
(*) The 2019 Consolidated Financial
Statements have been prepared according to the new IFRS 16 “Leases”
standard with a new “right-of-use assets” category and an implied
significant increase of “lease debts” compared to the previous
period (see note 2.2 in the audited financial statements filed with
our annual report on Form 20-F for discussion of the application of
IFRS 16 “Lease” at January 1, 2019).
CELLECTIS S.A. STATEMENT OF CONSOLIDATED
OPERATIONS – Fourth quarter (unaudited) ($ in thousands, except per
share data)
For the three-month periods
ended December 31,
2018
2019
Revenues and other
income
Revenues
968
4 423
Other income
2 108
1 913
Total revenues and other
income
3 077
6 336
Operating expenses
Cost of revenue
(720)
(5 652)
Research and development
expenses
(21 266)
(30 325)
Selling, general and
administrative expenses
(10 517)
(8 773)
Other operating income
(expenses)
162
(81)
Total operating
expenses
(32 341)
(44 831)
Operating income
(loss)
(29 265)
(38 495)
Financial gain (loss)
3 200
(2 663)
Net income (loss)
(26 065)
(41 158)
Attributable to shareholders of
Cellectis
(23 075)
(37 210)
Attributable to non-controlling
interests
(2 990)
(3 948)
Basic net income (loss)
attributable to shareholders of Cellectis per share
($/share)
(0.54)
(0.88)
Diluted net income (loss)
attributable to shareholders of Cellectis per share
($/share)
(0.54)
(0.88)
CELLECTIS S.A. STATEMENT OF CONSOLIDATED
OPERATIONS – Full Year ($ in thousands, except per share
data)
For the year ended December
31,
2018
2019
Revenues and other
income
Revenues
12 731
15 190
Other income
8 701
7 800
Total revenues and other
income
21 432
22 990
Operating expenses
Cost of revenue
(2 739)
(11 392)
Research and development
expenses
(76 567)
(92 042)
Selling, general and
administrative expenses
(47 248)
(43 017)
Other operating income
(expenses)
31
(91)
Total operating
expenses
(126 523)
(146 542)
Operating income
(loss)
(105 091)
(123 552)
Financial gain (loss)
16 758
8 340
Net income (loss)
(88 333)
(115 212)
Attributable to shareholders of
Cellectis
(78 693)
(102 091)
Attributable to non-controlling
interests
(9 640)
(13 121)
Basic net income (loss)
attributable to shareholders of Cellectis per share
($/share)
(1.93)
(2.41)
Diluted net income (loss)
attributable to shareholders of Cellectis per share
($/share)
(1.93)
(2.41)
CELLECTIS S.A. DETAILS OF KEY PERFORMANCE
INDICATORS BY REPORTABLE SEGMENTS – Fourth quarter (unaudited) - ($
in thousands)
For the three-month periods
ended December 31, 2018
For the three-month periods
ended December 31, 2019
$ in thousands
Plants
Therapeutics
Total reportable
segments
Plants
Therapeutics
Total reportable
segments
External revenues
4
964
968
3 732
691
4 423
External other income
172
1 937
2 108
-
1 913
1 913
External revenues and other
income
176
2 901
3 077
3 732
2 604
6 336
Cost of revenue
(240)
(481)
(720)
(5 363)
(289)
(5 652)
Research and development
expenses
(2 725)
(18 541)
(21 266)
(3 533)
(26 792)
(30 325)
Selling, general and
administrative expenses
(6 436)
(4 081)
(10 517)
(6 830)
(1 943)
(8 773)
Other operating income and
expenses
(68)
230
162
8
(89)
(81)
Total operating
expenses
(9 469)
(22 873)
(32 341)
(15 718)
(29 113)
(44 831)
Operating income (loss) before
tax
(9 293)
(19 971)
(29 265)
(11 986)
(26 509)
(38 495)
Financial gain (loss)
418
2 782
3 200
(148)
(2 515)
(2 663)
Net income (loss)
(8 875)
(17 189)
(26 065)
(12 134)
(29 024)
(41 158)
Non controlling interests
2 990
-
2 990
3 948
-
3 948
Net income (loss) attributable
to shareholders of Cellectis
(5 886)
(17 189)
(23 075)
(8 186)
(29 024)
(37 210)
R&D non-cash stock-based
expense attributable to shareholder of Cellectis
153
4 388
4 541
659
3 297
3 956
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis
1 767
911
2 678
1 495
739
2 234
Adjustment of share-based
compensation attributable to shareholders of Cellectis
1 920
5 299
7 219
2 154
4 036
6 190
Adjusted net income (loss)
attributable to shareholders of Cellectis
(3 966)
(11 890)
(15 856)
(6 032)
(24 988)
(31 020)
Net cash used in operating
activities
(6 652)
(13 950)
(20 602)
(7 313)
4 431
(2 882)
CELLECTIS S.A. DETAILS OF KEY PERFORMANCE
INDICATORS BY REPORTABLE SEGMENTS – Full Year ($ in
thousands)
For the year ended December
31, 2018
For the year ended December
31, 2019
$ in thousands
Plants
Therapeutics
Total reportable
segments
Plants
Therapeutics
Total reportable
segments
External revenues
236
12 495
12 731
7 294
7 896
15 190
External other income
178
8 523
8 701
-
7 800
7 800
External revenues and other
income
414
21 018
21 432
7 294
15 696
22 990
Cost of revenue
(595)
(2 144)
(2 739)
(9 275)
(2 117)
(11 392)
Research and development
expenses
(8 638)
(67 929)
(76 567)
(12 390)
(79 652)
(92 042)
Selling, general and
administrative expenses
(21 067)
(26 180)
(47 248)
(26 090)
(16 927)
(43 017)
Other operating income and
expenses
(50)
81
31
25
(116)
(91)
Total operating
expenses
(30 351)
(96 172)
(126 523)
(47 730)
(98 812)
(146 542)
Operating income (loss) before
tax
(29 937)
(75 154)
(105 091)
(40 436)
(83 116)
(123 552)
Financial gain (loss)
1 420
15 339
16 758
294
8 045
8 340
Net income (loss)
(28 517)
(59 816)
(88 333)
(40 142)
(75 071)
(115 212)
Non controlling interests
9 640
-
9 640
13 121
-
13 121
Net income (loss) attributable
to shareholders of Cellectis
(18 877)
(59 816)
(78 693)
(27 021)
(75 071)
(102 091)
R&D non-cash stock-based
expense attributable to shareholder of Cellectis
838
16 852
17 689
1 619
10 010
11 629
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis
5 218
11 655
16 873
6 673
4 940
11 613
Adjustment of share-based
compensation attributable to shareholders of Cellectis
6 056
28 507
34 563
8 292
14 950
23 242
Adjusted net income (loss)
attributable to shareholders of Cellectis
(12 821)
(31 309)
(44 130)
(18 729)
(60 121)
(78 849)
Net cash used in operating
activities
(20 252)
(47 885)
(68 137)
(31 951)
(37 191)
(69 142)
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 – Fourth quarter (unaudited) ($ in thousands, except per
share data)
For the three-month periods
ended December 31,
2018
2019
Net income (loss) attributable
to shareholders of Cellectis
(23 075)
(37 210)
Adjustment:
Non-cash stock-based compensation
expense attributable to shareholders of Cellectis
7 219
6 190
Adjusted net income (loss)
attributable to shareholders of Cellectis
(15 856)
(31 020)
Basic Adjusted net income
(loss) attributable to shareholders of Cellectis ($/share)
(0.37)
(0.73)
Weighted average number of
outstanding shares, basic (units) (1)
42 430 040
42 452 336
Diluted Adjusted net income
(loss) attributable to shareholders of Cellectis ($/share)
(1)
(0.37)
(0.73)
Weighted average number of
outstanding shares, diluted (units) (1)
42 560 947
42 466 423
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 – Full Year (unaudited) ($ in thousands, except per share
data)
For the year ended December
31,
2018
2019
Net income (loss) attributable
to shareholders of Cellectis
(78 693)
(102 091)
Adjustment:
Non-cash stock-based compensation
expense attributable to shareholders of Cellectis
34 563
23 242
Adjusted net income (loss)
attributable to shareholders of Cellectis
(44 130)
(78 849)
Basic Adjusted net income
(loss) attributable to shareholders of Cellectis ($/share)
(1.08)
(1.86)
Weighted average number of
outstanding shares, basic (units) (1)
40 774 197
42 442 136
Diluted Adjusted net income
(loss) attributable to shareholders of Cellectis ($/share)
(1)
(1.08)
(1.86)
Weighted average number of
outstanding shares, diluted (units) (1)
41 285 578
42 460 501
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 developing the first of its kind 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. As a clinical-stage biopharmaceutical
company with over 20 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 target and eradicate cancer cells.
As part of its commitment to a cure, Cellectis remains dedicated
to its goal of providing life-saving UCART product candidates to
address unmet needs for multiple cancers including acute myeloid
leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), and
multiple myeloma (MM).
Cellectis headquarters are in Paris, France, with additional
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.
TALEN® is a registered trademark owned by Cellectis.
Disclaimer
This press release contains “forward-looking” statements that
are based on our management’s current expectations and assumptions
and on information currently available to management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Further information on the risk
factors that may affect company business and financial performance
is included in Cellectis’ Annual Report on Form 20-F and the
financial report (including the management report) for the year
ended December 31, 2019 and subsequent filings Cellectis makes with
the Securities Exchange Commission from time to time. 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.
1 Cash position includes cash, cash equivalents and current
financial assets and restricted cash. Restricted cash was $24
million as of December 31, 2019.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200304005821/en/
Media: Jennifer Moore, VP of Communications,
917-580-1088, media@cellectis.com Caitlin Kasunich, KCSA Strategic
Communications, 212-896-1241, ckasunich@kcsa.com IR: Simon
Harnest, VP of Corporate Strategy and Finance, 646-385-9008,
simon.harnest@cellectis.com
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