Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage
biopharmaceutical company focused on developing immunotherapies
based on allogeneic gene-edited CAR T-cells (UCART), today
announced its results for the fourth quarter of 2020, and full year
ending December 31, 2020.
Cellectis will hold a conference call for
investors on Friday, March 5, 2021 at 8:00 AM EST / 2:00 PM CET.
The call will include the Company’s fourth quarter results,
year-end results, and an update on business activities.
The live dial-in information for the conference call is:US &
Canada only: +1 877-407-3104
International: +1 201-493-6792
In addition, a replay of the call will be available until March
19th, by calling +1 877-660-6853 (Toll Free US & Canada); +1
201-612-7415 (Toll Free International).Conference ID: 13716471“2020
was a challenging but very fruitful year for Cellectis,” said Dr.
André Choulika, Chief Executive Officer of Cellectis. “We moved
forward with our three Cellectis-sponsored clinical studies, and
shared preliminary results for our BALLI-01 study at ASH. AMELI-01
for the treatment of relapsed or refractory acute myeloid lymphomia
(r/r AML) and BALLI-01 for the treatment of relapsed or refractory
B-cell acute lymphoblastic leukemia (r/r B-ALL) are enrolling
patients at dose level 2 with FCA (fludarabine, cyclophosphamide
and alemtuzumab) lymphodepletion regimen. Our MELANI-01 clinical
study for patients with relapsed or refractory multiple myeloma
(r/r MM) has restarted patient enrollment. We are planning to share
selected updated interim data in 2021.”
“In connection with the completion of our manufacturing
facilities in Raleigh, NC and Paris, FR, and the ongoing expansion
of our clinical trials and product candidate pipeline, we expanded
the level of expertise within our general management, clinical, and
global manufacturing teams, hiring renowned biopharma industry
experts. We are well positioned on all fronts moving into 2021 and
beyond, and are determined to start this year exactly how we
finished out the last; determined and committed to serve patients
with unmet medical needs,” Dr. Choulika continued.
“As we anticipate our manufacturing facilities
becoming fully functional in 2021, we are on track to achieve
manufacturing autonomy from buffers to starting materials to the
production of UCART products for clinical and commercial supply, a
significant milestone towards becoming a fully bio-pharmaceutical
company. We are excited for our manufacturing facilities to give
Cellectis the potential to support our ongoing and future clinical
studies, allowing strong clinical execution in the coming
years.”
Fourth Quarter 2020 and Recent
Highlights
Proprietary Allogeneic CAR T-Cell
Development Programs
Cellectis announced on November 4, 2020 the
release of two abstracts at the American Society of Hematology
(ASH) 2020 Annual Meeting, one oral presentation of preliminary
data from its BALLI-01 clinical trial and one Trials in Progress
poster presentation of its AMELI-01 clinical trial.
Cellectis’ first clinical data reported
at ASH 2020 Oral presentation; BALLI-01 investigating
UCART22 product candidate in r/r B-ALL
Preliminary results from Cellectis’ dose
escalation Phase 1 BALLI-01 study of UCART22 product candidate in
relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
were presented at the American Society of Hematology (ASH) Annual
Meeting. This is the first publicly released data from Cellectis’
BALLI-01 clinical trial.
As of the November 2, 2020 data cutoff, 7
patients were enrolled, and 5 patients received UCART22 after
fludarabine/cyclophosphamide preconditioning. One patient failed
screening and one patient was discontinued prior to the
administration of UCART22 due to an adverse event related to the
lymphodepletion regimen.
No patient experienced a DLT, ICANS, GvHD, or an
adverse event of special interest (AESI). No UCART22-related Grade
3 or higher adverse events (AE) or serious adverse events (SAEs)
were reported. Two patients experienced a Grade 1 cytokine release
syndrome, or CRS, and one patient experienced Grade 2 CRS. Three
patients experienced four treatment-emergent SAEs not related to
UCART22 treatment. No patient discontinued treatment due to a
UCART22-related treatment-emergent adverse event. Two patients in
Dose Level 1 achieved an objective response of complete remission
with incomplete hematologic recovery (CRi) at Day 28, one of which
attained a complete remission (CR) at Day 42 and received an
allogeneic bone marrow transplant after subsequent therapy with
inotuzumab. One patient in Dose Level 2 with refractory disease did
achieve a noteworthy reduction in bone marrow blasts (60% at
screening, 16% at Day-1, 65% at Day 14, down to 13% at Day 28)
after treatment with UCART22, but then progressed. Host lymphocyte
reconstitution was observed in all patients within the DLT period
(range Day 9-Day 28). Correlative analysis of UCART cell expansion
and persistence is ongoing. UCART22 demonstrated preliminary signs
of activity at low dose levels with fludarabine/cyclophosphamide
(FC) lymphodepletion regimen, without unexpected nor significant
treatment-related toxicities. Host immune recovery was observed
early, supporting activation of the addition of alemtuzumab to the
FC lymphodepletion regimen which is expected to result in a deeper
and more sustained cell depletion.
ASH 2020 Poster Presentation: AMELI-01 investigating
UCART123 product candidate in R/R AML
AMELI-01 is a Phase 1, multi-center clinical
study of Cellectis’ UCART123 product candidate designed to evaluate
the safety, tolerability and preliminary anti-leukemia activity of
UCART123 cells in patients with relapsed/refractory acute myeloid
leukemia (R/R AML).
Additional objectives include the determination
of the maximum tolerated dose or suitable lower dose for expansion;
characterization of the expansion, trafficking and persistence of
UCART123 cells; assessment of cytokine, chemokine and C-reactive
protein expression after UCART123 cell infusion; and assessment of
immune cell depletion, reconstitution and immune response.
MELANI-01 clinical trial in r/r MM
patients – clinical hold lifted
The MELANI-01 clinical study is a Phase 1, multicenter clinical
trial designed to evaluate the safety, expansion, persistence and
clinical activities of UCARTCS1 in patients with r/r MM. On
November 17, 2020, Cellectis announced that the FDA lifted the
clinical hold on the Phase 1 MELANI-01 trial evaluating the
UCARTCS1 product candidate in patients with r/r MM.Cellectis worked
closely with the FDA during this period to address the agency’s
requests. Cellectis continues to work with the clinical site staff
and investigators to efficiently obtain the required local
approvals to reopen the trial and resume patient enrollment.
Partnered Allogeneic CAR T-Cell
Development Programs
UCART19, ALLO-501 and ALLO-501A (targeting CD19) are being
jointly developed under a collaboration agreement between Servier
and Allogene based on an exclusive license granted by Cellectis to
Servier. UCART19, ALLO-501 and ALLO-501A use Cellectis
technologies. Servier grants to Allogene exclusive rights to
UCART19, ALLO-501 and ALLO-501A in the U.S. while Servier retains
exclusive rights for all other countries.
BCMA and CD70 are CAR targets exclusively
licensed by Cellectis. ALLO-715 (targeting BCMA) and ALLO-316
(targeting CD70) utilize TALEN® gene-editing technology pioneered
and owned by Cellectis. Allogene has an exclusive license to the
Cellectis technology for allogeneic products directed at the BCMA
and CD70 targets. Allogene holds global development and commercial
rights for these investigational candidates.
ALLO-715 in relapsed/refractory Multiple
Myeloma
In December 2020, Allogene Therapeutics announced positive
initial results from its Phase 1 UNIVERSAL clinical study of
ALLO-715 in relapsed/refractory multiple myeloma (r/r MM). Data
were presented at an oral session of the American Society of
Hematology (ASH) annual meeting. This study utilizes ALLO-647,
Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its
differentiated lymphodepletion regimen.
As of the October 30, 2020 data cutoff, 35
patients were enrolled with 31 patients evaluable for safety and 26
patients evaluable for efficacy. ALLO-715 in combination with the
lymphodepletion regimens, each including ALLO-647, were well
tolerated with no graft-vs-host disease (GvHD) or immune effector
cell-associated neurotoxicity syndrome (ICANS) observed. Grade 1
and Grade 2 cytokine release syndrome, or CRS, was reported in 14
patients (45%) and was manageable with standard therapies.
Infection events of Grade 3 of higher in the trial reported in 5
patients (16%) was similar to what has been reported in other
advanced multiple myeloma studies. Adverse events of Grade 3 or
higher, reported as serious adverse events, occurred in 19% of
patients. A single Grade 5 event related to progressive
myeloma and the cyclophosphamide and ALLO-647 conditioning regimen
was reported. At dose level 3 of ALLO-715 (320M cells) within the
FCA lymphodepletion regimen, 6 of 10 (60%) patients achieved an
overall response rate (ORR) and 4 of 10 (40%) patients achieved a
very good partial response (VGPR) or better (VGPR+). A minimal
residual disease (MRD) assessment was completed in five of the six
patients achieving VGPR+ across all cohorts and all lymphodepletion
regimens, and all achieved an MRD negative status. With a median
follow-up for efficacy of 3.2 months, 6 of 9 (67%) responding
patients treated at dose level 3 (320M cells) or dose level 4 (480M
cells) of ALLO-715 remain in response as of the October 2020 data
cutoff.
In December 2020, Allogene announced that the FDA had approved
the IND for ALLO-715 in combination with nirogacestat, a
SpringWorks Therapeutics’ investigational gamma secretase
inhibitor, in patients with r/r MM.
ALLO-501 and ALLO-501A in relapsed/refractory
non-Hodgkin Lymphoma
In February 2020, Allogene announced that the
FDA had approved the IND for a Phase 1 clinical study for
ALLO-501A, in relapsed or refractory non-Hodgkin lymphoma (NHL),
the ALPHA2 study. ALLO-501A was created to eliminate the rituximab
recognition domains in ALLO-501, allowing for use in a broader
patient population, including those NHL patients with recent
rituximab exposure.
In May 2020, Allogene, in collaboration with
Servier, reported results from the ALPHA study, a Phase 1 clinical
study for ALLO-501 in relapsed or refractory Non-Hodgkin Lymphoma
(NHL), at the American Society of Clinical Oncology (ASCO) annual
meeting. This study utilizes ALLO-647, Allogene's anti-CD52
monoclonal antibody (mAb), as a part of its differentiated
lymphodepletion regimen.
As of the May 2020 data cutoff, 22 patients were
evaluable for safety and 19 patients were evaluable for efficacy
with at least one month tumor assessment. ALLO-501 in combination
with the lymphodepletion regimen of fludarabine, cyclophosphamide
and ALLO-647 was well tolerated, with no dose-limiting toxicities,
graft-vs-host disease (GvHD) or immune effector cell-associated
neurotoxicity syndrome (ICANS) observed. Cytokine release syndrome,
or CRS, occurred in seven (32%) of the patients, was mainly mild to
moderate in severity, manageable with standard recommendations, and
all events resolved within a maximum of seven days. Four patients
(18%) experienced serious adverse events (“SAEs”): one patient had
Grade 2 pyrexia and Grade 2 cytomegalovirus (“CMV”) reactivation
which resolved in two days and six days, respectively; one patient
had Grade 3 rotavirus infection and Grade 3 hypokalemia which
resolved in 15 days and two days, respectively; one patient had
Grade 3 febrile neutropenia and Grade 3 hypotension which each
resolved in two days; and one patient had a Grade 3 upper GI
hemorrhage which resolved in one day and Grade 3 CMV reactivation
which resolved in 25 days. Across all dose levels, seven complete
responses (CR) and five partial responses (PR) were observed for an
overall response rate (ORR) of 63% and CR rate of 37%. With a
median follow-up of 3.8 months, nine of twelve (75%) responder
patients remain in response as of the May 2020 data cutoff. Higher
dose ALLO-647 were associated with higher CR rates, deeper
lymphodepletion and delayed host T cell recovery. Within the
overall efficacy analysis, higher response rates were observed in
CAR-T naïve patients, with an ORR of 75% and CR rate of 44%.
Allogene has reported that it is continuing the ALPHA Study to
further explore and optimize the lymphodepletion regimen and
treatment.
UCART19 in pediatric and adult relapsed/refractory
B-ALLIn December 2020, Servier published, in the Lancet
journal, pooled results of the UCART19 clinical studies: one in
adult Acute Lymphoblastic Leukemia (ALL), referred to as the CALM
study, and one in pediatric ALL, referred to as the PALL study.
Between June 2016 and October 2018, seven children and 14 adults
were enrolled in the two studies and received UCART19. Cytokine
release syndrome, or CRS, was the most common adverse event and was
observed in 19 patients (91%); three (14%) of whom had grade 3 or 4
CRS. Other adverse events were grade 1 or 2 neurotoxicity in eight
patients (38%), grade 1 acute skin graft-versus-host disease, or
GvHD, in two patients (10%), and grade 4 prolonged cytopenia in six
patients (32%). Two treatment-related deaths occurred; one caused
by neutropenic sepsis in a patient with concurrent CRS and one from
pulmonary hemorrhage in a patient with persistent cytopenia. 14
(67%) of 21 patients had a complete response (CR) or complete
response with incomplete (Cri) hematological recovery 28 days after
infusion. Patients not receiving alemtuzumab (n=4) showed no
UCART19 expansion or antileukemic activity. The median duration of
response was 4.1 months with ten (71%) of 14 responders proceeding
to a subsequent allogeneic stem-cell transplant. Progression-free
survival at 6 months was 27%, and overall survival was 55%.
According to the article, these two studies show, for the first
time, the feasibility of using allogeneic, genome-edited CAR T
cells to treat patients with aggressive leukemia. UCART19 exhibited
in-vivo expansion and antileukemic activity with a manageable
safety profile in heavily pretreated pediatric and adult patients
with relapsed or refractory B-cell acute lymphoblastic
leukemia.
The PALL study and the CALM study are now completed with no
additional patients planned for enrollment. All patients will
continue the long-term follow-up study as planned. Servier and
its development partner Allogene are reviewing the
development strategy.
ALLO-316 in advanced or metastatic clear cell renal cell
carcinoma
In December 2020, Allogene announced that the FDA had approved
the IND for a Phase 1 clinical study for ALLO-316, in advanced or
metastatic clear cell renal cell carcinoma.
New Partnerships
Cytovia Theraputics
In February 2021, Cellectis announced a
strategic research and development collaboration with Cytovia
Therapeutics to develop TALEN® gene-edited
iPSC-derived Natural Killer (NK) and Chimeric
Antigen Receptor (CAR)-NK cells.
As per the Cytovia Agreement, Cellectis is
eligible to receive an equity stake of $15 million in Cytovia stock
or an upfront cash payment of $15 million if certain conditions are
not met by December 31, 2021. Cellectis also received an option to
participate in certain future financing rounds by Cytovia. In
addition to this financial consideration, the Cytovia Agreement
provides for aggregate additional payment of up to $760 million of
development, regulatory and sales milestones from Cytovia to
Cellectis. Cellectis will also receive single-digit royalty
payments on the net sales of the partnered products commercialized
by Cytovia.
Cellectis will develop custom TALEN®, which
Cytovia will use to edit iPSCs to derive in NK and CAR-NK cells for
therapeutic use in several cancer indications. Cytovia will be
responsible for the differentiation and expansion of the
gene-edited iPSC master cell bank into NK cells and will conduct
the pre-clinical evaluation, clinical development, and
commercialization of the mutually-agreed-upon selected therapeutic
candidates. Cellectis is granting Cytovia a worldwide license
to its TALEN® gene-editing technology, enabling Cytovia to modify
NK cells addressing multiple gene targets for therapeutic use in
several cancer indications.
Iovance Biotherapeutics
On December 30, 2019, Cellectis and Iovance
Biotherapeutics 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.
2020 Corporate Updates
New Appointments
Board Appointment:
In November 2020, Jean-Pierre Garnier, M.D. was
appointed non-executive Chairman of the board of directors to work
hand in hand with André Choulika, Chief Executive Officer. Dr.
Garnier currently serves as Chairman of the board of directors of
Carmat, as a director of Radius Therapeutics, and as lead director
of Carrier Global Corp.
Most recently, Dr. Garnier was Chairman of Idorsia, a public
bio-technology company based in. Switzerland and listed on the
Swiss Stock Exchange (SIX), which was spun off of Actelion LTD with
a billion-dollar investment from Johnson & Johnson (J&J).
Previous to his tenure at Idorsia, he was Chairman of Actelion
Ltd., a Swiss pharmaceuticals and bio-technology company. In 2017,
Actelion LTD was sold for $30 billion to J&J. Dr. Garnier holds
an MS in pharmaceutical science and a Ph.D. in pharmacology from
the Louis Pasteur University of Strasbourg, France. He subsequently
earned his MBA at Stanford University, California, as a Fulbright
Scholar.
Human Resources:Kyung Nam-Wortman joined
Cellectis in November 2020 as Cellectis’ Chief Human Resources
Officer. Ms. Nam-Wortman, who is based in Cellectis’ New York
office joined the Company’s executive committee. In her new role at
Cellectis, Ms. Nam-Wortman works closely with Cellectis CEO Dr.
André Choulika and the executive management team to ensure that the
Company advances its roadmap through the recruitment and retention
of top talent, working to enhance Cellectis’ dynamic and inclusive
culture, while optimizing the Company’s human resources
function.
Ms. Nam-Wortman joined Cellectis from Achillion
(recently acquired by Alexion in January 2020) where she served as
Senior Vice President, Head of Human Resources, Head of Information
Technology, Facilities and Internal Communications. At Achillion,
she was responsible for leading the strategic and operational
components of the aforementioned functions. In addition to her
experience in biotech/biopharma, Ms. Nam-Wortman has 14 years of
experience in the consulting industry focused on strategic and
organization change management from Delta Consulting Group and
IBM.
Clinical Development Appointments:
In April 2020, Carrie Brownstein, M.D., was appointed to the
role of Chief Medical Officer. In this role, Dr. Brownstein leads
clinical research and development, and is responsible for the
development and execution of the integrated development strategy of
Cellectis’ proprietary programs. Dr. Brownstein is based in the
Cellectis New York office, and joined the Company’s executive
committee.
Mark Frattini, M.D., Ph.D., joined Cellectis from Celgene/BMS in
August 2020 as Senior Vice President of Clinical Sciences. In his
new role, Dr. Frattini is responsible for Cellectis’ clinical
leadership, including clinical strategy and execution of the
Company’s current product candidates. Dr. Frattini also serves as a
core member of the senior clinical team, under the leadership of
Cellectis’ Chief Medical Officer, Dr. Brownstein, and manages a
team of physicians and clinical scientists.
Manufacturing/Technical Operations:
Steve Doares, Ph.D., joined Cellectis from Biogen in July 2020
as Senior Vice President, US Manufacturing and Site Head of the
Raleigh, North Carolina manufacturing facility. Dr. Doares is
responsible for the deployment of Cellectis’ proprietary
state-of-the-art gene-editing cell manufacturing facility in
Raleigh, which is being constructed to produce Cellectis’ current
immune-oncology UCART product candidates for clinical and
commercial supplies.
In May 2020, Leopold Bertea, Ph.D., was appointed to the role of
Senior Vice President of Europe Technical Operations. He is
responsible for ensuring execution across Technical Operations
functions, including process development, analytical development,
external supply, and the GMP Paris manufacturing facility that
supports the development and production of Cellectis’ proprietary
product candidates.
Dr. Bertea and Dr. Doares are jointly leading Cellectis’
technical operations, and succeed BillMonteith, who left the
Company on August 6, 2020 to pursue other opportunities. Both
joined the executive committee of the Company.
GMP Manufacturing
Construction of Cellectis’ in-house manufacturing facility in
Paris is now complete. The 14,000 square foot manufacturing
facility is designed to produce Cellectis’ critical raw and
starting material supplies for UCART clinical studies and
commercial products. GMP production has started on the Paris site
in Q4 2020.
Cellectis’ in-house manufacturing facility in Raleigh remains on
track for its anticipated go-live datefor the production of UCART
product candidates in 2021. The 82,000 square foot commercial-scale
manufacturing facility is designed to provide GMP manufacturing for
clinical supplies and commercial manufacturing upon regulatory
approval.
Intellectual Property:
In March 2020, Cellectis announced that the US
Patent and Trademark Office (USPTO) had granted to the Company a
new patent covering methods of preparing allogeneic T-cells for
immunotherapy with CRISPR-Cas9 technology. This patent US10,584,352
claims “a method of preparing and administering T-cells for
immunotherapy comprising the steps of: (a) providing primary human
T-cells from a donor, (b) genetically modifying the primary human
T-cells to eliminate expression of the T-cell receptor (TCR),
comprising expressing in the cells (i) a Cas9 endonuclease fused to
a nuclear localization signal (NLS), and (ii) a guide RNA that
directs said endonuclease to at least one targeted locus encoding
the TCR in the T-cell genome, (c) expanding the genetically
modified T-cells, and (d) administering at least 10,000 of the
expanded genetically modified T-cells to a patient.”
In January 2020, Cellectis was also granted
European Patent EP3116902, which claims “a method for preparing an
engineered T-cell comprising the steps of (a), inhibiting the
expression of beta 2-microglobulin (2M) and/of class II major
histocompatibility complex transactivator (CIITA) in a T-cell that
has been provided; and (b) inactivating at least one gene encoding
a component of the T-cell receptor (TCR) in said T-cell; and (c)
introducing into said T-cell an exogenous nucleic acid molecule
comprising a nucleotide sequence coding for a Chimeric Antigen
Receptor (CAR) directed against at least one antigen expressed at
the surface of a malignant or infected cell.”
Scientific Publications
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) could
potentially poses during treatment.
In June 2020, Cellectis published a new research
paper in Frontiers in Bioengineering and Biotechnology. This
article describes an innovative and easy-to-implement procedure
which will streamline the manufacturing of allogeneic
‘off-the-shelf’ CAR T-cell therapies.
The methodology described in this article
defines a novel non-mechanical purification strategy to generate
TCRαβ negative (allogeneic) cells for CAR T-cell therapies. With an
early and transient expression of an anti-CD3 CAR in the engineered
donor T-cells, Cellectis programed these cells to self-eliminate
the remaining TCR+ cell population and obtained an ultrapure
TCRαβ(-) population (up to 99.9%) at the end of the CAR-T
production.
Financial Results
The condensed consolidated financial statements
of Cellectis, which consolidate the results of Calyxt, Inc. of
which Cellectis is a 64.7% (as of December 31, 2020) 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 2020 and Full Year 2020 financial results
press release.
Fourth Quarter and Full Year 2020
Financial Results
Cash: As of December 31, 2020,
Cellectis, including Calyxt, had $274 million in consolidated cash,
cash equivalents, current financial assets, and restricted cash of
which $244 million are attributable to Cellectis on a stand-alone
basis. This compares to $364 million in consolidated cash, cash
equivalents, current financial assets and restricted cash as of
December 31, 2019 of which $304 million was attributable to
Cellectis on a stand-alone basis. This net decrease of $90 million
primarily reflects (i) $28 million of proceeds received from
Servier in connection with the March 2020 amendment to the License,
Development and Commercialization Agreement and (ii) a $21 million
of principal amount of a loan from a bank syndicate in the form of
a state-guaranteed loan (Prêt Garanti par l’Etat) (the “PGE“),
(iii) $8 million of net proceeds received from Calyxt’s follow-on
offering on October 20, 2020, excluding 1,250,000 shares of Calyxt
common stock that Cellectis purchased for a purchase price of $5.0
million and $1.0 million of placement agent fees and other offering
expenses and (iv) $9 million of favorable FOREX impact which was
offset by (v) $112 million of net cash flows used in operating,
investing and lease financing activities of Cellectis, and (vi) $44
million of net cash flows used in operating and capital
expenditures activities of Calyxt. We believe that the consolidated
cash, cash equivalents, current financial assets and restricted
cash positions of Cellectis and Calyxt as of December 31, 2020 will
be sufficient to fund the two companies’ operations into late
2022.
Revenues and Other Income:
Consolidated revenues and other income were $16 million for the
three months ended December 31, 2020 compared to $6 million for the
three months ended December 31, 2019. Consolidated revenues and
other income were $83 million for the year ended December 31, 2020
compared to $23 million for the year ended December 31, 2019. 72%
of consolidated revenues and other income was attributable to
Cellectis in the Full Year of 2020. This increase between the year
ended December 31, 2020 and 2019 was mainly attributable to the $28
million upfront payment received from Servier in March 2020 and the
recognition of $19 million of other previously received upfront and
milestone payments on the five released targets based on the March
2020 amendment of the License, Development and Commercialization
Agreement signed with Servier. The remaining increase was explained
primarily by higher high oleic soybean meal revenues at Calyxt.
Cost of Revenues: Consolidated
cost of revenues were $19 million for the three months ended
December 31, 2020 compared to $6 million for the three months ended
December 31, 2019. Consolidated cost of revenues was $36 million
for the year ended December 31, 2020 compared to $11 million for
the year ended December 31, 2019. This increase was primarily
explained by the cost of products sold during the period by
Calyxt.
R&D Expenses: Consolidated
R&D expenses were $23 million for the three months ended
December 31, 2020 compared to $30 million for the three months
ended December 31, 2019. Consolidated R&D expenses were $87
million for the year ended December 31, 2020 compared to $92
million for the year ended December 31, 2019. 89% of consolidated
R&D expenses was attributable to Cellectis in the Full Year of
2020. The $5 million decrease between the Full Year of 2020 and
2019 was primarily attributable to (i) lower social charges on
stock option grants and non-cash stock-based compensation expenses
of respectively $1 million and $4 million and (ii) lower purchases,
external expenses, and other expenses of $8 million, partially
offset by(iv) higher employee expenses of $9 million.
SG&A Expenses: Consolidated
SG&A expenses were $12 million for the three months ended
December 31, 2020 compared to $9 million for the three months ended
December 31, 2019. Consolidated SG&A expenses were $44 million
for the year ended December 31, 2020 compared to $43 million for
the year ended December 31, 2019. 51% of consolidated SG&A
expenses was attributable to Cellectis in the Full Year of 2020.
The $1 million increase was attributable to (i) higher employee
expenses of $3 million and (ii) higher purchases, external
expenses, and other expenses of $4 million which was partially
offset by (iii) lower non-cash stock-based compensation expenses of
$6 million.
Net Income (loss) Attributable to
Shareholders of Cellectis: The consolidated net loss
attributable to shareholders of Cellectis was $41 million (or $0.95
per share) for the three months ended December 31, 2020, of which
$34 million was attributed to Cellectis, compared to $37 million
(or $0.88 per share) for the three months ended December 31, 2019,
of which $29 million was attributed to Cellectis. The consolidated
net loss attributable to Shareholders of Cellectis was $81 million
(or $1.91 per share) for the year ended December 31, 2020, of which
$54 million loss was attributed to Cellectis, compared to a loss of
$102 million (or $2.41 per share) for the year ended December 31,
2019, of which $75 million was attributable to Cellectis. This $18
million decrease in net loss between Full Year 2020 and 2019 was
primarily driven by a significant increase in revenues of $59
million which was partially offset by an increase in operating
expenses of $21 million and a decrease in net financial gains of
$20 million.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $38 million
(or $0.88 per share) for the three months ended December 31, 2020,
of which $31 million is attributed to Cellectis, compared to a net
loss of $31 million (or $0.73 per share) for the three months ended
December 31, 2019, of which $25 million was attributed to
Cellectis. The consolidated adjusted net loss attributable to
Shareholders of Cellectis was $67 million (or $1.57 per share) for
the year ended December 31, 2020, of which $44 million loss was
attributable to Cellectis, compared to a loss of $79 million (or
$1.86 loss per share) for the year ended December 31, 2019, of
which $60 million was attributable to Cellectis. Please see "Note
Regarding Use of Non-GAAP Financial Measures" for reconciliation of
GAAP net income (loss) attributable to shareholders of Cellectis to
adjusted net income (loss) attributable to shareholders of
Cellectis.
We currently foresee focusing our cash spending
at Cellectis for the Full Year of 2021 in the following areas:
- Supporting the development of our
deep pipeline of product candidates, including the manufacturing
and clinical trial expenses of UCART123, UCART22, UCARTCS1 and new
product candidates, and
- Operating our state-of-the-art
manufacturing capabilities in Paris, France, and Raleigh, NC;
and
- Continuing strengthening our
manufacturing and clinical departments, including hiring talented
personnel.
CELLECTIS S.A.STATEMENT
OF CONSOLIDATED FINANCIAL POSITION($ in thousands,
except per share data)
|
|
As of |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
December 31, 2020 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
1,108 |
|
|
1,584 |
|
Property, plant, and
equipment |
|
23,712 |
|
|
71,673 |
|
Right-of-use assets |
|
45,612 |
|
|
73,845 |
|
Other non-current financial
assets |
|
5,517 |
|
|
7,007 |
|
Total non-current
assets |
|
75,949 |
|
|
154,109 |
|
|
|
|
|
|
Current
assets |
|
|
|
|
Inventories |
|
2,897 |
|
|
1,606 |
|
Trade receivables |
|
2,959 |
|
|
5,171 |
|
Subsidies receivables |
|
9,140 |
|
|
10,703 |
|
Other current assets |
|
15,617 |
|
|
29,643 |
|
Cash and cash equivalent and
Current financial assets |
|
360,907 |
|
|
268,239 |
|
Total current
assets |
|
391,520 |
|
|
315,362 |
|
TOTAL
ASSETS |
|
467,469 |
|
|
469,471 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Share capital |
|
2,767 |
|
|
2,785 |
|
Premiums related to the share
capital |
|
843,478 |
|
|
863,912 |
|
Currency translation
adjustment |
|
(22,641 |
) |
|
(4,089 |
) |
Retained earnings |
|
(406,390 |
) |
|
(505,961 |
) |
Net income (loss) |
|
(102,091 |
) |
|
(81,074 |
) |
Total shareholders’
equity - Group Share |
|
315,123 |
|
|
275,573 |
|
Non-controlling interests |
|
40,347 |
|
|
33,273 |
|
Total shareholders’
equity |
|
355,470 |
|
|
308,846 |
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Non-current financial
liabilities |
|
- |
|
|
28,836 |
|
Non-current lease debts |
|
46,540 |
|
|
75,764 |
|
Non-current provisions |
|
2,855 |
|
|
4,010 |
|
Total non-current
liabilities |
|
49,395 |
|
|
108,610 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Current lease debts |
|
1,067 |
|
|
6,696 |
|
Trade payables |
|
29,264 |
|
|
24,609 |
|
Deferred revenues and deferred
income |
|
20,033 |
|
|
452 |
|
Current provisions |
|
3,743 |
|
|
1,131 |
|
Other current liabilities |
|
8,497 |
|
|
19,127 |
|
Total current
liabilities |
|
62,604 |
|
|
52,015 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
467,469 |
|
|
469,471 |
|
CELLECTIS S.A.STATEMENT
OF CONSOLIDATED OPERATIONS – Fourth quarter
(unaudited) ($ in thousands, except per
share data)
|
|
For the three-month periods ended December
31, |
|
|
2019 |
|
2020 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
4,423 |
|
|
13,649 |
|
Other income |
|
1,913 |
|
|
1,983 |
|
Total revenues and
other income |
|
6,336 |
|
|
15,632 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(5,652 |
) |
|
(18,644 |
) |
Research and development
expenses |
|
(30,325 |
) |
|
(23,395 |
) |
Selling, general and
administrative expenses |
|
(8,773 |
) |
|
(12,490 |
) |
Other operating income
(expenses) |
|
(81 |
) |
|
(267 |
) |
Total operating
expenses |
|
(44,831 |
) |
|
(54,796 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(38,495 |
) |
|
(39,164 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
(2,663 |
) |
|
(7,567 |
) |
|
|
|
|
|
Net income
(loss) |
|
(41,158 |
) |
|
(46,730 |
) |
Attributable to shareholders of Cellectis |
|
(37,210 |
) |
|
(40,607 |
) |
Attributable to non-controlling interests |
|
(3,948 |
) |
|
(6,123 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.88 |
) |
|
(0.95 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.88 |
) |
|
(0.95 |
) |
CELLECTIS S.A.STATEMENT
OF CONSOLIDATED OPERATIONS – Full Year ($ in
thousands, except per share data)
|
|
For the year ended December 31, |
|
|
2019 |
|
2020 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
15,190 |
|
|
73,949 |
|
Other income |
|
7,800 |
|
|
8,507 |
|
Total revenues and
other income |
|
22,990 |
|
|
82,456 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(11,392 |
) |
|
(36,275 |
) |
Research and development
expenses |
|
(92,042 |
) |
|
(86,950 |
) |
Selling, general and
administrative expenses |
|
(43,017 |
) |
|
(44,201 |
) |
Other operating income
(expenses) |
|
(91 |
) |
|
(467 |
) |
Total operating
expenses |
|
(146,542 |
) |
|
(167,893 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(123,552 |
) |
|
(85,437 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
8,340 |
|
|
(12,046 |
) |
|
|
|
|
|
Net income
(loss) |
|
(115,212 |
) |
|
(97,483 |
) |
Attributable to shareholders of Cellectis |
|
(102,091 |
) |
|
(81,074 |
) |
Attributable to non-controlling interests |
|
(13,121 |
) |
|
(16,409 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(2.41 |
) |
|
(1.91 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(2.41 |
) |
|
(1.91 |
) |
CELLECTIS S.A.DETAILS OF
KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – Fourth
Quarter(unaudited) - ($ in thousands)
|
For the three-month periods ended December 31,
2019 |
|
For the three-month periods ended December 31,
2020 |
$ in
thousands |
Plants |
Therapeutics |
Total reportable segments |
|
Plants |
Therapeutics |
Total reportable segments |
|
|
|
|
|
|
|
|
External revenues |
3,732 |
|
691 |
|
4,423 |
|
|
13,424 |
|
225 |
|
13,649 |
|
External other income |
- |
|
1,913 |
|
1,913 |
|
|
- |
|
1,983 |
|
1,983 |
|
External revenues and
other income |
3,732 |
|
2,604 |
|
6,336 |
|
|
13,424 |
|
2,208 |
|
15,632 |
|
Cost of revenue |
(5,363 |
) |
(289 |
) |
(5,652 |
) |
|
(18,258 |
) |
(386 |
) |
(18,644 |
) |
Research and development
expenses |
(3,533 |
) |
(26,792 |
) |
(30,325 |
) |
|
(2,508 |
) |
(20,887 |
) |
(23,395 |
) |
Selling, general and
administrative expenses |
(6,830 |
) |
(1,943 |
) |
(8,773 |
) |
|
(5,449 |
) |
(7,041 |
) |
(12,490 |
) |
Other operating income and
expenses |
8 |
|
(89 |
) |
(81 |
) |
|
(17 |
) |
(250 |
) |
(267 |
) |
Total operating
expenses |
(15,718 |
) |
(29,113 |
) |
(44,831 |
) |
|
(26,232 |
) |
(28,564 |
) |
(54,796 |
) |
Operating income
(loss) before tax |
(11,986 |
) |
(26,509 |
) |
(38,495 |
) |
|
(12,808 |
) |
(26,356 |
) |
(39,164 |
) |
Financial gain (loss) |
(148 |
) |
(2,515 |
) |
(2,663 |
) |
|
(270 |
) |
(7,297 |
) |
(7,567 |
) |
Net income
(loss) |
(12,134 |
) |
(29,024 |
) |
(41,158 |
) |
|
(13,078 |
) |
(33,652 |
) |
(46,730 |
) |
Non controlling interests |
3,948 |
|
- |
|
3,948 |
|
|
6,123 |
|
- |
|
6,123 |
|
Net income (loss)
attributable to shareholders of Cellectis |
(8,186 |
) |
(29,024 |
) |
(37,210 |
) |
|
(6,955 |
) |
(33,652 |
) |
(40,607 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
659 |
|
3,297 |
|
3,956 |
|
|
247 |
|
1,785 |
|
2,032 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
1,495 |
|
739 |
|
2,234 |
|
|
580 |
|
529 |
|
1,109 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
2,154 |
|
4,036 |
|
6,190 |
|
|
827 |
|
2,314 |
|
3,141 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
(6,032 |
) |
(24,988 |
) |
(31,020 |
) |
|
(6,128 |
) |
(31,338 |
) |
(37,466 |
) |
Depreciation and
amortization |
(604 |
) |
(1,341 |
) |
(1,945 |
) |
|
(653 |
) |
(2,593 |
) |
(3,246 |
) |
Additions to tangible and
intangible assets |
(33 |
) |
6,043 |
|
6,010 |
|
|
887 |
|
7,477 |
|
8,364 |
|
CELLECTIS S.A.DETAILS OF
KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – Full
Year- ($ in thousands)
|
|
For the year ended December 31, 2019 |
|
For the year ended December 31, 2020 |
($ in
thousands) |
|
Plants |
Therapeutics |
Total reportable segments |
|
Plants |
Therapeutics |
Total reportable segments |
|
|
|
|
|
|
|
|
|
External revenues |
|
7,294 |
|
7,896 |
|
15,190 |
|
|
22,892 |
|
51,057 |
|
73,949 |
|
External other income |
|
- |
|
7,800 |
|
7,800 |
|
|
- |
|
8,507 |
|
8,507 |
|
External revenues and
other income |
|
7,294 |
|
15,696 |
|
22,990 |
|
|
22,892 |
|
59,564 |
|
82,456 |
|
Cost of revenue |
|
(9,275 |
) |
(2,117 |
) |
(11,392 |
) |
|
(34,324 |
) |
(1,951 |
) |
(36,275 |
) |
Research and development
expenses |
|
(12,390 |
) |
(79,652 |
) |
(92,042 |
) |
|
(9,903 |
) |
(77,048 |
) |
(86,951 |
) |
Selling, general and
administrative expenses |
|
(26,090 |
) |
(16,927 |
) |
(43,017 |
) |
|
(21,688 |
) |
(22,513 |
) |
(44,201 |
) |
Other operating income and
expenses |
|
25 |
|
(116 |
) |
(91 |
) |
|
(103 |
) |
(363 |
) |
(466 |
) |
Total operating
expenses |
|
(47,730 |
) |
(98,812 |
) |
(146,542 |
) |
|
(66,018 |
) |
(101,875 |
) |
(167,893 |
) |
Operating income
(loss) before tax |
|
(40,436 |
) |
(83,116 |
) |
(123,552 |
) |
|
(43,126 |
) |
(42,311 |
) |
(85,437 |
) |
Financial gain (loss) |
|
294 |
|
8,045 |
|
8,340 |
|
|
(776 |
) |
(11,270 |
) |
(12,046 |
) |
Net income
(loss) |
|
(40,142 |
) |
(75,071 |
) |
(115,212 |
) |
|
(43,902 |
) |
(53,581 |
) |
(97,483 |
) |
Non controlling interests |
|
13,121 |
|
- |
|
13,121 |
|
|
16,409 |
|
- |
|
16,409 |
|
Net income (loss)
attributable to shareholders of Cellectis |
|
(27,021 |
) |
(75,071 |
) |
(102,091 |
) |
|
(27,493 |
) |
(53,581 |
) |
(81,074 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
|
1,619 |
|
10,010 |
|
11,629 |
|
|
801 |
|
6,790 |
|
7,591 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
|
6,673 |
|
4,940 |
|
11,613 |
|
|
3,536 |
|
3,238 |
|
6,774 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
|
8,292 |
|
14,950 |
|
23,242 |
|
|
4,337 |
|
10,028 |
|
14,365 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(18,729 |
) |
(60,121 |
) |
(78,849 |
) |
|
(23,156 |
) |
(43,553 |
) |
(66,709 |
) |
Depreciation and
amortization |
|
(1,233 |
) |
(5,642 |
) |
(6,875 |
) |
|
(1,869 |
) |
(7,950 |
) |
(9,819 |
) |
Additions to tangible and
intangible assets |
|
2,998 |
|
14,668 |
|
17,666 |
|
|
1,786 |
|
48,813 |
|
50,599 |
|
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, |
|
|
2019 |
|
2020 |
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(37,210 |
) |
|
(40,607 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
6,190 |
|
|
3,141 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(31,020 |
) |
|
(37,466 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.73 |
) |
|
(0.88 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) (1) |
|
42,452,336 |
|
|
42,589,496 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.73 |
) |
|
(0.88 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) (1) |
|
42,466,423 |
|
|
42,849,877 |
|
(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($ in thousands, except per
share data)
|
|
For the year ended December 31, |
|
|
2019 |
|
2020 |
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(102,091 |
) |
|
(81,074 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
23,242 |
|
|
14,365 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(78,849 |
) |
|
(66,709 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(1.86 |
) |
|
(1.57 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) (1) |
|
42,442,136 |
|
|
42,503,447 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(1.86 |
) |
|
(1.57 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) (1) |
|
42,460,501 |
|
|
42,590,407 |
|
(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 share holders 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 21 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.
For further information, please
contact:
Media contacts:Margaret
Gandolfo, Communications Manager, 646-628-0300,
Margaret.gandolfo@cellectis.comConor McGoldrick, Zeno Group,
914-355-0927, Conor.Mcgoldrick@zenogroup.com
IR contact:Simon Harnest, Chief
Investment Officer, 646-385-9008,
simon.harnest@cellectis.com
DisclaimerThis press release
contains “forward-looking” statements within the meaning of
applicable securities laws, including the Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be
identified by words such as “at this time,” “anticipate,”
“believe,” “expect,” “on track,” “plan,” “scheduled,” and “will,”
or the negative of these and similar expressions. These
forward-looking statements, which are based on our management’s
current expectations and assumptions and on information currently
available to management, include statements about the timing and
progress of clinical trials (including with respect to patient
enrollment and follow-up), the timing of our presentation of data,
the adequacy of our supply of clinical vials, the timing of
completion of construction of our Raleigh, North Carolina
manufacturing facility, and operational capabilities at our
manufacturing facilities, and the sufficiency of cash to fund
operations. These forward-looking statements are made in light of
information currently available to us and are subject to numerous
risks and uncertainties, including with respect to the duration and
severity of the COVID-19 pandemic and governmental and regulatory
measures implemented in response to the evolving situation.
Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F and the financial
report (including the management report) for the year ended
December 31, 2020 and subsequent filings Cellectis makes with the
Securities Exchange Commission from time to time, as well as other
known and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results,
performance or achievements to be materially different from those
expressed or implied by the forward-looking statements. 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 equivalent,
current financial assets and restricted cash
PDF available at:
http://ml.globenewswire.com/Resource/Download/e238728a-799c-4b68-8df9-c9c1f2f9a738
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