Regulatory News:
Cellectis S.A. (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 three-month period ended June 30, 2018 and for the six-month
period ended June 30, 2018.
During the first half of 2018 Cellectis worked to speed up the clinical
development of its allogeneic CAR T-cell product candidates. An
amendment to the UCART123 Phase 1 protocol for AML enables the
acceleration of the development of this product candidate. We received
approval for our IND application for UCART22 in B-ALL and this UCART22
clinical trial is expected to start recruiting patients in the second
half of this year. UCART22 is the third allogeneic CAR T-cell product
candidate developed by Cellectis to enter the clinic. With the closing
of our recent follow-on offering, we strengthened Cellectis’ shareholder
base and secured financing for Cellectis to develop and manufacture more
fully owned product candidates, to establish commercial capabilities,
seek marketing approvals through the filing of one or more Biologics
License Applications and pursue other critical milestones for one or
more of our current product candidates.
_______________________
1 Including an $8.3 million investment from Cellectis.2
Cash position includes cash, cash equivalent and current financial
assets.
Second Quarter 2018 and Recent Highlights
UCART123
In May, the FDA approved an amendment to the protocol for the Phase 1
clinical trial of Cellectis’ UCART123 product candidate in patients with
acute myeloid leukemia (AML). The amendment allows an immediate 4x
increase of current dose level 1 from 6.25×104 to 2.5×105
UCART123 cells per kilogram and increases dose levels 2 and 3 to 6.25×105
and 5.05×106 UCART123 cells per kilogram, respectively.
The treatment interval was shortened from 42 days to 28 days between the
first 2 patients at each new dose tested (42 days only in case of
aplastic bone marrow), and then to 14 days for the subsequent patients.
The new protocol also allows for a potential second infusion of
UCART123. The MD Anderson Cancer Center has been added as new clinical
site for the AML study in addition to Weill Cornell Medical Center.
UCART22
In June, the FDA approved Cellectis’ Investigational New Drug (IND)
application to initiate a Phase 1 clinical trial for UCART22, Cellectis’
second wholly controlled TALEN® gene-edited product candidate, for the
treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult
patients. UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR
T-cell product candidate developed by Cellectis to be approved by the
FDA for clinical trials in the United States. UCART22 is designed to
target and kill CD22 expressing cells. Like CD19, CD22 is a cell surface
antigen expressed from the pre-B-cell stage of development through
mature B-cells and is expressed in more than 90% of patients with B-ALL.
Approximately 85% of ALL cases involve precursor B-cells (B-ALL).
Cellectis intends to begin the UCART22 Phase 1 study in the second half
of 2018. The clinical research for UCART22 will be led by Dr. Nitin
Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the
Department of Leukemia and University Chair in Cancer Medicine, at The
University of Texas MD Anderson Cancer Center in Houston.
UCART19 and Corporate Collaboration
In April, Allogene Therapeutics, Inc. (“Allogene”), a new biotechnology
company co-founded by Dr. Arie Belldegrun and Dr. David Chang, the
former CEO and CMO of Kite Pharma, Inc., respectively, announced that it
has entered into an asset contribution agreement with Pfizer, Inc.
(“Pfizer”), pursuant to which Allogene purchased Pfizer’s portfolio of
assets related to allogeneic CAR T-cell therapy, including the Research
Collaboration and License Agreement dated June 17, 2014 (as amended from
time to time, the “Collaboration Agreement”) signed between Pfizer and
Cellectis. Cellectis remains eligible to receive clinical and commercial
milestone payments of up to $2.8 billion, or $185 million per target for
15 targets, and tiered royalties in the high single digits on net sales
of any products that are commercialized by Allogene under the
Collaboration Agreement. As part of the transaction, Allogene has also
received Pfizer’s rights to UCART19, which were sub-licensed to Pfizer
by Les Laboratoires Servier (“Servier”), which has an exclusive license
to UCART19 from Cellectis under the Product Development, Option, License
and Commercialization Agreement between Servier and Cellectis dated as
of February 17, 2014 (the “Servier Agreement”).
Capital raise
In April, Cellectis closed a follow-on offering of 6,146,000 American
Depositary Shares (“ADS”) at a public offering price of $31.00 per ADS
resulting in gross proceeds of $190.5 million. In May, Calyxt closed a
follow-on offering of 4,057,500 ADS at a public offering price of $15.00
per ADS resulting in gross proceeds of $60.9 million. Cellectis
purchased 550,000 shares of common stock at the public offering price of
$15.00.
R&D
In June, Cellectis reported the publication of a study in Scientific
Reports, a Nature Publishing Group journal, describing the
development of the CubiCAR, an all-in-one Chimeric Antigen Receptor
(CAR) architecture with an embedded multi-functional tag for
purification, detection and elimination of CAR T-cells. This added
versatility has the potential to streamline the manufacturing of CAR
T-cells to allow their tracking and efficiently eliminate CAR T-cells in
clinical settings. This novel architecture was developed through a
collaboration of Cellectis and Allogene researchers.
Academic Collaboration
In May, Cellectis and the Wyss Institute for Biologically Inspired
Engineering at Harvard University announced that they will collaborate,
utilizing Cellectis’ TALEN® gene editing technology, to advance the Wyss
Institute’s efforts to recode the entire genome of cell lines derived
from humans and other species under the global Genome Project-Write, led
by Prof. George Church, Core Faculty member at the Wyss Institute,
Professor of Genetics at Harvard Medical School (HMS) and of Health
Sciences and Technology at Harvard and the Massachusetts Institute of
Technology (MIT). The Recode Project, a part of Genome Project-Write,
lays the technical foundation to extensively and functionally modify
existing genomes in cells and whole organisms, and aims to convert them
into research tools as well as clinical and biotechnological products.
Under the collaboration with Cellectis, Prof. Church and his team will
be given access to Cellectis’ TALEN® gene editing technology.
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 2018 Financial Results
Cash: As of June 30, 2018 Cellectis had $491.1 million in total
cash, cash equivalents and current financial assets compared to $282.1
million as of March 31, 2018. This increase of $209.0 million primarily
reflects the net cash provided by financing activities of $230.9
million, including (i) the net proceeds, after deducting underwriting
discounts and commissions and offering expenses, of $178.6 million from
the Cellectis follow-on offering, (ii) the net proceeds, after deducting
underwriting discounts, commissions and offering expenses and the
purchase price with respect to 550,000 shares of Calyxt common stock
purchased by Cellectis in the offering, of $48.8 million from Calyxt’s
follow-on offering and (iii) the exercise of Cellectis and Calyxt stock
options during the period for $5.1 million, partly offset by (i) the net
cash flows used by operating activities of $12.5 million, (ii) the
unrealized negative translation effect of exchange rate fluctuations on
U.S. dollar cash, cash equivalents and current financial assets of $9.2
million.
We believe that our cash, cash equivalents and current financial assets
of $491.1 million as of June 30, 2018 will be sufficient to fund our
operations until 2022.
Revenues and Other Income: During the quarters ended June 30,
2017 and 2018, we recorded $9.0 million and $8.3 million, respectively,
in revenues and other income. This decrease of $0.7 million is due to a
$1.5 million decrease in collaboration revenues, of which $0.4 million
represented decreased recognition of upfront fees already paid to
Cellectis and $1.1 million represented a decrease in research and
development cost reimbursements, partly offset by a $0.8 million
increase in research tax credit.
Total Operating Expenses: Total operating expenses for the second
quarter of 2017 were $28.8 million, compared to $30.0 million for the
second quarter of 2018. The non-cash stock-based compensation expenses
included in these amounts were $12.4 million and $9.1 million,
respectively.
R&D Expenses: For the quarters ended June 30, 2017 and 2018,
research and development expenses decreased by $0.6 million from $18.6
million in 2017 to $18.0 million in 2018. Personnel expenses decreased
by $0.8 million from $9.2 million in 2017 to $8.4 million in 2018,
primarily due to a $1.5 million decrease in non-cash stock based
compensation expense partly offset by an increase of $0.7 million in
wages and salaries. Purchases and external expenses increased by $1.1
million from $8.9 million in 2017 to $10.0 million in 2018, mainly due
to increased expenses related to payments to third parties participating
in product development, purchases of biological raw materials, expenses
for process development and expenses associated with the use of
laboratories and other facilities. Other expenses, which relate to
continuing leases and other commitments, decreased by $0.9 million for
the second quarter of 2018 compared to the second quarter of 2017.
SG&A Expenses: During the quarters ended June 30, 2017 and
2018, we recorded $10.0 million and $11.2 million, respectively, of
selling, general and administrative expenses. The increase of $1.2
million primarily reflects an increase of $1.9 million in purchases and
external expenses and an increase of $0.3 million in other expenses
related to taxes, various depreciation and amortization, partly offset
by a decrease of $1.0 million in personnel expenses from $7.9 million to
$6.9 million. This decrease in personnel expenses was attributable to a
decrease of $1.9 million in non-cash stock-based compensation expenses,
partly offset by an increase of $0.9 million in wages and salaries.
Financial Gain (Loss): The financial gain is $12.0 million for
the second quarter of 2018 compared with a financial loss of $6.7
million for the second quarter of 2017. The change in financial result
was mainly attributable to a $19.7 million increase in net foreign
exchange gain and a $1.7 million increase in interest income partly
offset by a $2.7 million decrease of foreign exchange derivatives fair
value adjustment.
Net Income (Loss) Attributable to Shareholders of Cellectis:
During the three-month period ended June 30 2017 and 2018, we recorded a
net loss attributable to shareholders of Cellectis of $26.5 million (or
$0.75 per share) and net loss attributable to shareholders of Cellectis
of $7.3 million (or $0.17 per share), respectively. Adjusted net loss
attributable to shareholders of Cellectis for the second quarter of 2017
was $14.1 million ($0.40 per share) compared to adjusted net income
attributable to shareholders of Cellectis of $1.3 million ($0.03 per
share), for the second quarter of 2018. Adjusted net income (loss)
attributable to shareholders of Cellectis for the second quarter of 2017
and 2018 excludes non-cash stock-based compensation expenses of $12.4
million and $8.5 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 net income
(loss) attributable to shareholders of Cellectis.
Six-month period 2018 Financial Results
Cash: As of June 30, 2018 Cellectis had $491.1 million in total
cash, cash equivalents and current financial assets compared to $297.0
million as of December 31, 2017. This increase of $194.1 primarily
reflects the net cash provided by financing activities of $234.4
million, including (i) the net proceeds, after deducting underwriting
discounts and commissions and offering expenses, of $178.6 million from
the Cellectis follow-on offering, (ii) the net proceeds, after deducting
underwriting discounts, commissions and offering expenses and the
purchase price with respect to 550,000 shares of Calyxt common stock
purchased by Cellectis in the offering, of $48.8 million from Calyxt’s
follow-on offering, and (iii) the exercise of Cellectis and Calyxt stock
options during the period for $8.4 million, partly offset by (i) the net
cash flows used by operating activities of $32.5 million, (ii) the
unrealized negative translation effect of exchange rate fluctuations on
U.S. dollar cash, cash equivalents and current financial assets of $7.1
million and (iii) the net cash provided by investing activities of $0.7
million.
Revenues and Other Income: During the six-month period ended June
30, 2017 and 2018, we recorded $19.3 million and $16.4 million,
respectively, in revenues and other income. This decrease of $2.9
million is mainly due to a $2.3 million decrease in collaboration
revenues, which corresponds to a decrease in research and development
cost reimbursements and a $0.7 million decrease in research tax credits,
partly offset by a $0.1 million increase in other licenses revenue.
Total Operating Expenses: Total operating expenses for the
six-month period ended June 30, 2017 were $58.9 million, compared to
$63.0 million for the six-month period ended June 30, 2018. The non-cash
stock-based compensation expenses included in these amounts were $26.1
million and $21.0 million, respectively.
R&D Expenses: For the six-month periods ended June 30, 2017
and 2018, research and development expenses amounted to $38.2 million
and $36.4 million, respectively. Personnel expenses decreased by $2.6
million from $19.7 million in 2017 to $17.1 million in 2018, primarily
due to a $4.3 million decrease in non-cash stock-based compensation
expense, partly offset by a $1.7 million increase in wages and salaries.
Purchases and external expenses increased by $1.4 million from $17.5
million in 2017 to $18.9 million in 2018, mainly due to increased
expenses related to payments to third parties participating in product
development, purchases of biological raw materials, expenses related to
process development and expenses associated with the use of laboratories
and other facilities. Other expenses, which relate to continuing leasing
and other commitments, decreased by $0.6 million for the six-month
period ended June 30, 2018 compared to the corresponding period of 2017.
SG&A Expenses: During the six-month periods ended June 30,
2017 and 2018, we recorded $19.8 million and $25.2 million,
respectively, of selling, general and administrative expenses. The
increase of $5.5 million primarily reflects (i) an increase of
$3.5 million in purchases and external expenses, (ii) an increase of
$0.5 million in other expenses related to taxes, various depreciation
and amortization and (iii) an increase of $1.5 million in personnel
expenses from $15.5 million to $17.0 million, attributable to a
$2.2 million increase in wages and salaries, partly offset by a $0.8
million decrease in non-cash stock based compensation expense.
Financial Gain (Loss): The financial result was a loss of $6.6
million for the six-month period ended June 30, 2017 compared with a
financial gain of $10.0 million for the six-month period ended June 30,
2018. The change in financial result was mainly attributable to a $18.8
million increase in net foreign exchange gain and a $2.0 million
increase in interest income, partly offset by a $3.8 million decrease of
foreign exchange derivatives fair value adjustment and a $0.2 million
decrease on net gain realized on the repositioning of instruments.
Net Income (Loss) Attributable to Shareholders of Cellectis:
During the six-month periods ended June 30, 2017 and 2018, we recorded a
net loss attributable to shareholders of Cellectis of $46.2 million (or
$1.30 per share) and a net loss attributable to shareholders of
Cellectis of $32.4 million (or $0.83 per share), respectively. Adjusted
net loss attributable to shareholders of Cellectis for the six-month
period ended June 30, 2017 was $20.1 million ($0.57 per share) compared
to adjusted net loss attributable to shareholders of Cellectis of $12.7
million ($0.32 per share) for the six-month period ended June 30, 2018.
Adjusted net loss attributable to shareholders of Cellectis for the
six-month periods ended June 30, 2017 and 2018 excludes a non-cash
stock-based compensation expense of $26.1 million and $19.7 million,
respectively. Please see “Note Regarding Use of Non-GAAP Financial
Measures” for reconciliation of GAAP net income (loss) attributable to
shareholders of Cellectis to adjusted net income (loss) attributable to
shareholders of Cellectis.
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED FINANCIAL POSITION
($ in thousands)
As restated (*)
Unaudited
(*) 2017 Interim consolidated financial statements have been restated
for the purpose of IFRS15 application. Reconciliation between interim
consolidated financial statements presented in previous periods and 2018
interim consolidated financial statements is available in Note 2.2 of
the interim consolidated financial statements for the second quarter
2018.
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS – Second quarter
(unaudited)
($ in thousands, except per share data)
ended June 30,
–
CELLECTIS S.A.
STATEMENT OF CONSOLIDATED OPERATIONS – First six months
(unaudited)
($ in thousands, except per share data)
ended June 30,
–
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
Cellectis’ 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 – Second quarter
(unaudited)
($ in thousands, except per share data)
ended June 30,
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis
(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 – First six months
(unaudited)
($ in thousands, except per share data)
ended June 30,
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis
(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 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 18 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 Euronext
Growth (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.
Special Note Regarding Forward-Looking Statements
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 for the year ended December 31, 2017 and subsequent filings
Cellectis makes with the Securities and 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 actual
results could differ materially from those anticipated in the
forward-looking statements, even if new information becomes available in
the future.
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