Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the
“Company”), a gene-editing company with clinical-stage
immuno-oncology programs using allogeneic chimeric antigen receptor
(CAR)-T cells and gene therapy programs for genetic diseases, today
announced results for the three-month and nine-month periods ending
September 30, 2021.
Cellectis will hold a conference call for
investors on Friday, November 5, 2021, at 8:00 AM ET / 2:00 PM CET.
The call will include the Company’s third quarter results, and an
update on business activities.
________________________1 Cash position
includes cash, cash equivalents and current financial assets and
restricted cash. Restricted cash was $6 million as of September 30,
2021.
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
November 19th, by calling +1 877-660-6853 (Toll Free US &
Canada); +1 201-612-7415 (Toll Free International).
Conference ID: 13724432
“2021 has been a productive year thus far for
Cellectis. We have made great progress during Q3 with both our
clinical trials and preclinical product candidate pipeline, and are
eager to share additional preliminary data from our BALLI-01
clinical trial and disclose initial pre-clinical data from
TALGlobin01, at ASH this year,” said Dr. André Choulika, Chief
Executive Officer of Cellectis. “With regard to our preclinical
UCART pipeline focusing on solid tumors, we have made notable
progress with UCARTMESO, targeting mesothelin - expressing solid
tumors, and are excited to share new pre-clinical data that support
anti-tumor activity at the Society for Immunotherapy of Cancer
(SITC) Annual Meeting later this month.
GMP production remains on track for Cellectis’
Manufacturing site in Raleigh, NC, where qualification of facility
equipment and systems was completed during Q3. Cellectis also
continues to expand its internal manufacturing capabilities with
its Paris site, which is now operational. Cellectis continues to
leverage its expertise in gene editing and clinical development to
transform the lives of patients with cancer and rare genetic
diseases, and we look forward to continuing this effort in Q4, into
2022, and beyond.”
Allogeneic CAR-T Cell Development
Programs
Sponsored Phase 1 Studies
Cellectis continues to make progress in its
proprietary programs enrolling patients in its three sponsored
Phase 1 dose escalation trials:
UCART22 is an allogeneic CAR-T
cell product candidate targeting CD22 being evaluated in patients
with relapsed or refractory B cell acute lymphoblastic leukemia
(r/r B-ALL) in the BALLI-01 Phase 1, multi-center
dose-escalation clinical study.
UCART123 is an allogeneic CAR
T-cell product candidate targeting CD123 being evaluated in
patients with relapsed or refractory acute myeloid leukemia (r/r
AML) in the AMELI-01 Phase 1, multi-center
dose-escalation clinical study.
UCARTCS1 is an allogeneic CAR
T-cell product candidate targeting CS1 being evaluated in patients
with relapsed or refractory multiple myeloma (r/r MM) in the
MELANI-01 Phase 1, multi-center dose-escalation
clinical study.
Cellectis to present updated clinical data on
BALLI-01 investigating UCART22 product candidate in R/R
B-ALL at the 2021 American Society of Hematology
Annual meeting
- Today, Cellectis announced the
release of an abstract, which was accepted for presentation at the
American Society of Hematology (ASH) 2021 Annual Meeting. The
Company was awarded a poster presentation, and will present updated
preliminary results from the Phase I, open-label, dose-escalation
BALLI-01 study in patients with R/R B-ALL.
- The abstract includes updated
preliminary data from the Phase I, open-label, dose-escalation
BALLI-01 study in patients with R/R B-ALL from the first cohort of
patients who received UCART22 after FCA (fludarabine,
cyclophosphamide and alemtuzumab) lymphodepletion. The data show
that the addition of alemtuzumab to fludarabine and
cyclophosphamide was well tolerated, deepened host T-cell depletion
and promoted CAR-T cell expansion.
- These data are encouraging and
support the continued enrollment into the study. Additional data
will be presented at the congress.
- ASH abstracts are now available on
www.hematology.org
Wholly-controlled UCART Preclinical
Programs
- Cellectis continues to build its
UCART pipeline and advance product candidates. The Company’s new
product candidate pipeline includes UCART preclinical programs
targeting B-cell lymphoma and solid tumors. Cellectis anticipates
the filing of two investigational new drug (IND) applications for
UCART20x22 and UCARTMESO in 2022.
UCART20x22, is in development
as the first allogeneic dual CAR-T cell product candidate which is
being developed for patients with B-cell Non-Hodgkin lymphoma.
UCARTMESO, is an allogeneic CAR-T cell product
candidate targeting mesothelin, which is being
developed for patients with mesothelin expressing
solid tumors.
- Cellectis announced the
presentation of pre-clinical data that supports anti-tumor activity
of UCARTMESO at the Society for Immunotherapy of Cancer’s 36th
Annual Meeting (SITC 2021) in Washington, D.C. and virtually on
November 10 to 14, 2021.
- Mesothelin is a tumor-associated
antigen that is highly and consistently expressed in mesothelioma
and pancreatic cancers and is also over-expressed in subsets of
other solid tumors (ovarian cancer, non-small cell lung cancer,
gastric cancer, triple-negative breast cancer). UCARTMESO also
leverages its TALEN® gene editing technology to overcome immune
suppression mediated by TGFβ.
- Full text of the abstract will be
made publicly available on the SITC website at 7:00 a.m. ET on
November 12, 2021.
Gene Therapy Programs
.HEAL is a gene therapy platform for genetic
diseases developed by Cellectis. The platform leverages the power
of TALEN® gene editing technology to perform genome surgery
resulting in highly efficient and precise gene inactivation,
insertion, and correction in hematopoietic stem cells (HSCs).
Cellectis has announced programs in sickle cell disease, lysosomal
storage disorders and primary immunodeficiencies.
Sickle Cell Disease
TALGlobin01, is an autologous ex vivo
TALEN®-edited CD34+ HSC therapy for the treatment of
SCD
TALGlobin01 is developed using both TALEN®
technology to induce a double strand DNA break in the SCD-causing
hemoglobin subunit beta (HBB) gene and adeno-associated virus (AAV)
particles containing a DNA repair template designed to correct the
faulty HBB gene via endogenous homology directed repair.
Cellectis to present preclinical data on TALGlobin01 for
the treatment of Sickle Cell Disease at the 2021 American Society
of Hematology Annual meeting
- Today, Cellectis announced the
release of an abstract, which was accepted for presentation at the
American Society of Hematology (ASH) 2021 Annual Meeting. The
Company will present its first preclinical data for product
candidate TALGlobin01 in a poster presentation.
- TALGlobin01 is an autologous
cell-based gene therapy product designed to repair the mutated
b-globin gene (HBB), and subsequently restore production of
Hemoglobin A in HBSS sickle cell disease.
- The data that will be presented are
the first demonstration that TALEN®-based engineering could be used
to correct the mutation in the beta-globin gene of homozygous
sickle cell anemia patient-derived hematopoietic stem and
progenitor cells. The data showed high level of hemoglobin A
expression, reversion of sickling phenotype, the capacity of
TALGlobin01 edited cells to engraft in vivo, and a low level of
off-target cleavage. Collectively, the data demonstrate high
efficiency and safety of TALEN® treatment in HSPCs and positioned
it as the best-in-class gene editing technology for gene therapy
product development.
- ASH abstracts are now available on www.hematology.org
Primary Immunodeficiencies
In collaboration with professor
Toni Cathomen, Scientific Director at the Center for
Chronic Immunodeficiency, Medical Center - University of Freiburg,
Germany, Cellectis is developing two gene edited HSC product
candidates to address primary immunodeficiencies.
The authors presented encouraging
preclinical data for RAG1 for Severe Combined
Immunodeficiency (SCID) and STAT3 for
Hyper IgE syndrome, at the European Society of Gene and
Cell Therapy (ESGCT) Congress held on October 19-22, 2021.
RAG1 Severe Combined Immunodeficiency
(SCID)
- Newborns with RAG1 SCID have
extremely low levels of B and T cells and a severe risk of
recurrent, life-threatening infections. RAG1 is an essential enzyme
specifically and temporarily expressed in the early development of
T and B cells, making traditional gene therapy approaches
challenging due to the need for tight and
precise spatio-temporal expression control.
- Previous attempts to treat the RAG1
deficiency via conventional gene therapy have produced
unsatisfactory results. These results highlight the need for tight
spatio-temporal control of RAG1 expression as key for functional
restoration and the use of a gene editing tool.
- Using Cellectis’ TALEN® technology
and .HEAL, Professor Cathomen engineered HSCs with a corrected copy
of RAG1 that replaced the existing, mutated copy of RAG1. The
precise replacement of the mutated gene enabled the corrected RAG1
gene to be expressed at its natural timing and stage of cell
development.
- 30% of gene correction was achieved
within the long-term HSC population.
- The presentation can be found on
Cellectis’ website
Hyper IgE syndrome
- Hyper IgE syndrome is
a rare primary immunodeficiency disease that
clinically manifests as skin inflammation and recurrent skin and
lung infections. Mutations in the transcription factor STAT3 have
been associated with Hyper IgE. Alternative splicing gives rise to
two STAT3 isoforms, STAT3α and STAT3β that display distinct
functions.
- The α/β ratio needs to be tightly
regulated, which represents a major challenge for traditional gene
therapy approaches.
- Cellectis has developed a strategy
applicable in HSCs and T-cells to insert a corrected version of the
STAT3 gene into the patient’s genome to restore its
functionality.
- In T-cells isolated from patients,
60% integration was achieved. More importantly, the α/β isoforms
ratio was restored.
- The presentation can be found on
Cellectis’ website
Licensed Allogeneic CAR-T Cell Development
Programs
-
Allogene to present new clinical data from the ALPHA, ALPHA2 and
UNIVERSAL trials at the ASH 2021 Annual Meeting
ALLOGENE/SERVIER: ALLO-501 and ALLO-501A
in patients with relapsed/refractory non-Hodgkin lymphoma (r/r
NHL)
- ALPHA2 study abstract selected for
oral presentation at ASH 2021 highlights the benefits of
consolidation dosing with ALLO-501A in patients with
relapsed/refractory large B-cell lymphoma
- ALLO-501A is a next generation
anti-CD19 AlloCAR T engineered without the rituximab recognition
domains in ALLO-501. The Phase 1 dose escalation portion of the
ALPHA2 trial in relapsed/refractory LBCL was designed to confirm
that the profile of ALLO-501A is similar to ALLO-501 prior to
advancing ALLO-501A into a pivotal Phase 2 trial.
- ALPHA study abstract selected for
poster presentation at ASH 2021 continues to show durability of
responses to ALLO-501 in patients with non-Hodgkin lymphoma.
- ALLO-501 is a first generation
anti-CD19 AlloCAR T product for the treatment of
relapsed/refractory NHL. Updated data from ALPHA highlight that
allogeneic CAR T therapy can be effectively and conveniently
delivered to enrolled patients with relapsed/refractory NHL with
responses observed across all cell doses and tumor histologies
(DLBCL and follicular lymphoma (FL)). In CAR T naïve patients
(n=36), response rates continued to be similar to those seen in
autologous CAR T therapy trials and the modified-intent-to-treat
(mITT) population remained nearly identical to the intent-to-treat
(ITT) population.
CD19 AlloCAR T™ program utilizes Cellectis
technologies. ALLO-501 and ALLO-501A are being jointly developed
under a collaboration agreement between Servier and Allogene based
on an exclusive license granted by Cellectis to Servier. Servier
grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in
the U.S., while Servier retains exclusive rights for all other
countries.
ALLOGENE: ALLO-715 in patients with relapsed/refractory
multiple myeloma (r/r MM)
- UNIVERSAL study abstract selected
for oral presentation at ASH 2021 reports meaningful activity of a
single dose of ALLO-715 in patients with relapsed/refractory
multiple myeloma
- ALLO-715 is an allogeneic CAR
T-cell therapy that targets B-cell maturation antigen (BCMA).
UNIVERSAL is a Phase 1 trial in adults with relapsed/refractory MM
who have received greater than three prior lines of therapy. Data
from the UNIVERSAL trial featured at ASH represents one of several
strategies that Allogene is pursuing that targets BCMA in MM.
The anti-BCMA AlloCAR T™ program, which utilize
the Cellectis TALEN® technologies, are licensed exclusively from
Cellectis by Allogene and Allogene holds global development and
commercial rights to these AlloCAR T programs.
Manufacturing Facility
Paris Starting Materials Manufacturing
Facility
- The site is now fully operational,
focusing on plasmids and mRNA GMP production for our TALEN® gene
editing tools.
- AAV production has been implemented
and is being used for gene correction on .HEAL projects, together
with specific RNAs.
- Production of starting materials is
on track with respect to pipeline project needs, and the shipments
to our Raleigh facility.
Raleigh GMP Manufacturing
Facility
- Qualification of facility,
equipment, and systems was completed successfully in Q3 to enable
start of GMP production on schedule in Q4.
- Two engineering runs to final vial
of the first UCART product to be manufactured in Raleigh were
completed in Q3, and an engineering run of the second UCART product
was started in Q3.
- Qualification of the second UCART
production suite equipment remains on track to enable start of
engineering runs of the third UCART product in early 2022.
New appointment
Board appointment
- Today, Cellectis announced that
Donald A Bergstrom, M.D., Ph.D., has been appointed as a Board
Observer on the Company’s Board of Directors. Dr. Bergstrom,
currently serves as Executive Vice President, Head of Research and
Development at Relay Therapeutics, Inc., a clinical-stage precision
medicines company. He brings with him over 15 years of experience
in the biopharmaceutical and medical industries.
- Prior to his tenure at Relay
Therapeutics, Dr. Bergstrom was Chief Medical Officer at Mersana
Therapeutics, where he led the advancement of two products based on
Mersana’s proprietary antibody-drug conjugate platform through
non-clinical development and into Phase 1 clinical trials. Prior to
Mersana, he was Global Head of Translational and Experimental
Medicine at Sanofi Oncology. At Sanofi, Dr. Bergstrom held roles of
increasing responsibility at Merck Research Laboratories,
culminating in his role as Oncology Franchise Lead, Experimental
Medicine. Dr. Bergstrom was also recently appointed to the Board of
Directors at Fusion Pharmaceuticals. Dr. Bergstrom holds an M.D.
from the University of Washington, Seattle, and a Ph.D. from the
Fred Hutchinson Cancer Research Center, where he also completed his
post-doctoral training. He was a resident in clinical pathology at
the University of Washington.
Financial Results
The interim condensed consolidated financial
statements of Cellectis, which consolidate the results of Calyxt,
Inc. of which Cellectis is a 64.2% stockholder (as of September 30,
2021), have been prepared in accordance with International
Financial Reporting Standards, as issued by the International
Accounting Standards Board (“IFRS”).
We present certain financial metrics broken out
between our two reportable segments – Therapeutics and Plants – in
the appendices of this Q3 2021 and First Nine Months 2021 financial
results press release. Third Quarter and First Nine Months 2021
Financial Result.
Cash: As of September 30, 2021,
Cellectis, including Calyxt, had $216 million in consolidated cash,
cash equivalents, current financial assets and restricted cash of
which $201 million are attributable to Cellectis on a stand-alone
basis. This compares to $274 million in consolidated cash, cash
equivalents, current financial assets and restricted cash as of
December 31, 2020, of which $244 million was attributable to
Cellectis on a stand-alone basis. This net decrease of $58 million
primarily reflects (i) $92 million of net cash flows used in
operating, investing and lease financing activities of Cellectis,
(ii) $15 million of net cash flows used in operating, capital
expenditures and lease financing activities of Calyxt and (iii) $6
million of unfavorable FOREX impact which was partially offset by
(iv) $45 million of net equity proceeds raised from sales under the
Company’s “At-The-Market” (ATM) program in April 2021 and (v) $10
million of proceeds from stock options exercises at Cellectis.
Based on the current operating plan, Cellectis excluding Calyxt
anticipates that the cash, cash equivalents, and restricted cash of
$201 million as of September 30, 2021 will fund its operations into
early 2023.
Revenues and Other Income:
Consolidated revenues and other income were $11 million for the
three months ended September 30, 2021 compared to $9 million for
the three months ended September 30, 2020. Consolidated revenues
and other income were $53 million for the nine months ended
September 30, 2021 compared to $67 million for the nine months
ended September 30, 2020. 50% of consolidated revenues and other
income was attributable to Cellectis in the first nine months of
2021. This decrease between the nine months ended September 30,
2021 and 2020 was mainly attributable to a $28 million upfront
payment received 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 as well as a decrease in licenses revenue. That was
partially offset by (i) the recognition of $15 million in Cytovia
stock or an upfront non-cash payment of $15 million if certain
conditions are not met by December 31, 2021, (ii) the recognition
of a $5 million milestone payment from Allogene related to the
Phase 1 clinical study for ALLO-316, in advanced or metastatic
clear cell renal cell carcinoma, (iii) $15 million from higher high
oleic soybean revenues and by (iv) $1.5 million from the PPP Loan
forgiveness at Calyxt.
Cost of Revenues: Consolidated
cost of revenues were $9 million for the three months ended
September 30, 2021 compared to $8 million for the three months
ended September 30, 2020. Consolidated cost of revenues was $29
million for the nine months ended September 30, 2021 compared to
$18 million for the nine months ended September 30, 2020. This
increase was primarily explained by the cost of products sold
during the period by Calyxt.
R&D
Expenses: Consolidated R&D expenses were $34
million for the three months ended September 30, 2021 compared to
$20 million for the three months ended September 30, 2020.
Consolidated R&D expenses were $97 million for the nine months
ended September 30, 2021 compared to $64 million for the nine
months ended September 30, 2020. 91% of consolidated R&D
expenses was attributable to Cellectis in the first nine months of
2021. The $33 million increase between the first nine months of
2021 and 2020 was primarily attributable to (i) higher wages and
salaries and social charges on stock option grants of $12 million,
to (ii) higher purchases, external and other expenses of $19
million and to (iii) higher non-cash stock-based compensation
expenses of $2 million.
SG&A Expenses: Consolidated
SG&A expenses were $10 million for the three months ended
September 30, 2021 and 2020. Consolidated SG&A expenses were
$28 million for the nine months ended September 30, 2021 compared
to $31 million for the nine months ended September 30, 2020. 59% of
consolidated SG&A expenses was attributable to Cellectis in the
first nine months of 2021. The $3 million decrease was attributable
to lower non-cash stock-based compensation expenses of $5 million
which was partially offset by higher wages and salaries and social
charges on stock option grants of $1 million and higher other
expenses of $1 million.
Net Income
(loss) Attributable
to Shareholders
of Cellectis: The consolidated
net loss attributable to shareholders of Cellectis was $37 million
(or $0.82 per share) for the three months ended September 30, 2021,
of which $33 million was attributed to Cellectis, compared to $30
million (or $0.71 per share) for the three months ended September
30, 2020, of which $25 million was attributed to Cellectis. The
consolidated net loss attributable to Shareholders of Cellectis was
$89 million (or $2.00 per share) for the nine months ended
September 30, 2021, of which $75 million loss was attributed to
Cellectis, compared to a loss of $42 million (or $0.98 per share)
for the nine months ended September 30, 2020, of which $21 million
was attributable to Cellectis. This $48 million increase in net
loss between first nine months 2021 and 2020 was primarily driven
by a decrease in revenues and other income of $13 million and by an
increase in operating expenses of $39 million partially offset by
$7 million increase in net financial gain.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $32 million
(or $0.71 per share) for the three months ended September 30, 2021,
of which $29 million is attributed to Cellectis, compared to a net
loss of $27 million (or $0.63 per share) for the three months ended
September 30, 2020, of which $22 million was attributed to
Cellectis. The consolidated adjusted net loss attributable to
Shareholders of Cellectis was $80 million (or $1.79 per share) for
the nine months ended September 30, 2021, of which $66 million loss
was attributable to Cellectis, compared to a loss of $30 million
(or $0.72 loss per share) for the nine months ended September 30,
2020, of which $13 million was attributable to Cellectis. Please
see "Note Regarding Use of Non-GAAP Financial Measures" for
reconciliation of GAAP net income (loss) attributable to
shareholders of Cellectis to adjusted net income (loss)
attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending
at Cellectis for the Full Year of 2021 in the following areas:
- Supporting the
development of our pipeline of product candidates, including the
manufacturing and clinical trial expenses of UCART123, UCART22,
UCARTCS1 and new product candidates, and
- Operating our
state-of-the-art manufacturing capabilities in Paris (France), and
Raleigh (North Carolina, U.S.A); and continuing strengthening our
manufacturing and clinical departments, including hiring talented
personnel
CELLECTIS
S.A.(unaudited)STATEMENT
OF CONSOLIDATED
FINANCIAL
POSITION($ in
thousands, except
per share
data)
|
|
As of |
|
|
December 31,2020 |
|
September 30,2021 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
1,584 |
|
|
2,551 |
|
Property, plant, and
equipment |
|
71,673 |
|
|
80,542 |
|
Right-of-use assets |
|
73,845 |
|
|
71,899 |
|
Other non-current financial
assets |
|
7,007 |
|
|
22,045 |
|
Total non-current
assets |
|
154,109 |
|
|
177,037 |
|
Current
assets |
|
|
|
|
Inventories |
|
1,606 |
|
|
1,674 |
|
Trade receivables |
|
5,171 |
|
|
349 |
|
Subsidies receivables |
|
10,703 |
|
|
7,971 |
|
Other current assets |
|
29,643 |
|
|
14,753 |
|
Cash and cash equivalent and
Current financial assets |
|
268,239 |
|
|
211,102 |
|
Total current
assets |
|
315,362 |
|
|
235,849 |
|
TOTAL
ASSETS |
|
469,471 |
|
|
412,886 |
|
LIABILITIES |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Share capital |
|
2,785 |
|
|
2,946 |
|
Premiums related to the share
capital |
|
863,912 |
|
|
925,290 |
|
Currency translation
adjustment |
|
(4,089 |
) |
|
(14,345 |
) |
Retained earnings |
|
(505,961 |
) |
|
(586,723 |
) |
Net income (loss) |
|
(81,074 |
) |
|
(89,201 |
) |
Total shareholders’
equity - Group Share |
|
275,573 |
|
|
237,967 |
|
Non-controlling interests |
|
33,273 |
|
|
24,180 |
|
Total shareholders’
equity |
|
308,846 |
|
|
262,147 |
|
Non-current
liabilities |
|
|
|
|
Non-current financial
liabilities |
|
28,836 |
|
|
22,767 |
|
Non-current lease debts |
|
75,764 |
|
|
73,730 |
|
Non-current provisions |
|
4,010 |
|
|
3,851 |
|
Non-current liabilities |
|
0 |
|
|
787 |
|
Total non-current
liabilities |
|
108,610 |
|
|
101,136 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Current lease debts |
|
6,696 |
|
|
8,079 |
|
Trade payables |
|
24,609 |
|
|
22,809 |
|
Deferred revenues and deferred
income |
|
452 |
|
|
500 |
|
Current provisions |
|
1,131 |
|
|
4,190 |
|
Other current liabilities |
|
19,127 |
|
|
14,024 |
|
Total current
liabilities |
|
52,015 |
|
|
49,603 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
469,471 |
|
|
412,886 |
|
|
|
|
|
|
|
|
CELLECTIS
S.A.STATEMENT OF
CONSOLIDATED OPERATIONS
– Third
quarter(unaudited)($
in thousands,
except per share
data)
|
|
For the three-month periodended September 30, |
|
|
2020 |
|
2021 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
6,179 |
|
|
8,312 |
|
Other income |
|
3,063 |
|
|
2,516 |
|
Total revenues and
other income |
|
9,242 |
|
|
10,827 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(7,820 |
) |
|
(9,213 |
) |
Research and development
expenses |
|
(20,103 |
) |
|
(34,324 |
) |
Selling, general and
administrative expenses |
|
(10,301 |
) |
|
(9,675 |
) |
Other operating income
(expenses) |
|
(374 |
) |
|
18 |
|
Total operating
expenses |
|
(38,595 |
) |
|
(53,195 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(29,353 |
) |
|
(42,368 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
(4,250 |
) |
|
2,296 |
|
|
|
|
|
|
Net income
(loss) |
|
(33,602 |
) |
|
(40,071 |
) |
Attributable to shareholders of Cellectis |
|
(30,297 |
) |
|
(37,413 |
) |
Attributable to non-controlling interests |
|
(3,305 |
) |
|
(2,658 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.71 |
) |
|
(0.82 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.71 |
) |
|
(0.82 |
) |
|
|
|
|
|
|
|
CELLECTIS
S.A.STATEMENT OF
CONSOLIDATED OPERATIONS
– First nine
months(unaudited)($
in thousands,
except per share
data)
|
|
For the nine-month periodended September 30, |
|
|
2020 |
|
2021 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
60,037 |
|
|
45,088 |
|
Other income |
|
6,510 |
|
|
8,320 |
|
Total revenues and
other income |
|
66,547 |
|
|
53,408 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(18,159 |
) |
|
(29,113 |
) |
Research and development
expenses |
|
(63,594 |
) |
|
(96,663 |
) |
Selling, general and
administrative expenses |
|
(31,765 |
) |
|
(27,894 |
) |
Other operating income
(expenses) |
|
(291 |
) |
|
506 |
|
Total operating
expenses |
|
(113,810 |
) |
|
(153,163 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(47,263 |
) |
|
(99,755 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
(4,733 |
) |
|
2,728 |
|
|
|
|
|
|
Net income
(loss) |
|
(51,996 |
) |
|
(97,027 |
) |
Attributable to shareholders of Cellectis |
|
(41,605 |
) |
|
(89,201 |
) |
Attributable to non-controlling interests |
|
(10,391 |
) |
|
(7,827 |
) |
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.98 |
) |
|
(2.00 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.98 |
) |
|
(2.00 |
) |
|
|
|
|
|
|
|
CELLECTIS
S.A.DETAILS OF
KEY PERFORMANCE
INDICATORS BY
REPORTABLE SEGMENTS
– Third
Quarter(unaudited)
- ($ in
thousands)
|
|
For the three-month periodended September 30,
2020 |
|
For the three-month periodended September 30,
2021 |
$ in
thousands |
|
Plants |
Therapeutics |
Totalreportablesegments |
|
Plants |
Therapeutics |
Totalreportablesegments |
|
|
|
|
|
|
|
|
|
External revenues |
|
5,401 |
|
778 |
|
6,179 |
|
|
8,288 |
|
24 |
|
8,312 |
|
External other income |
|
- |
|
3,063 |
|
3,063 |
|
|
0 |
|
2,516 |
|
2,516 |
|
External revenues and
other income |
|
5,401 |
|
3,841 |
|
9,242 |
|
|
8,288 |
|
2,540 |
|
10,827 |
|
Cost of revenue |
|
(7,481 |
) |
(339 |
) |
(7,820 |
) |
|
(8,807 |
) |
(407 |
) |
(9,213 |
) |
Research and development
expenses |
|
(2,071 |
) |
(18,031 |
) |
(20,103 |
) |
|
(2,523 |
) |
(31,802 |
) |
(34,324 |
) |
Selling, general and
administrative expenses |
|
(4,278 |
) |
(6,024 |
) |
(10,301 |
) |
|
(3,992 |
) |
(5,683 |
) |
(9,675 |
) |
Other operating income and
expenses |
|
(115 |
) |
(259 |
) |
(374 |
) |
|
18 |
|
(1 |
) |
18 |
|
Total operating
expenses |
|
(13,943 |
) |
(24,652 |
) |
(38,595 |
) |
|
(15,304 |
) |
(37,892 |
) |
(53,195 |
) |
Operating income
(loss) before tax |
|
(8,542 |
) |
(20,812 |
) |
(29,353 |
) |
|
(7,016 |
) |
(35,352 |
) |
(42,368 |
) |
Financial gain (loss) |
|
(373 |
) |
(3,877 |
) |
(4,250 |
) |
|
(291 |
) |
2,588 |
|
2,296 |
|
Net income
(loss) |
|
(8,914 |
) |
(24,688 |
) |
(33,602 |
) |
|
(7,307 |
) |
(32,764 |
) |
(40,071 |
) |
Non controlling interests |
|
3,305 |
|
- |
|
3,305 |
|
|
2,658 |
|
- |
|
2,658 |
|
Net income
(loss) attributable to shareholders of Cellectis |
(5,610 |
) |
(24,688 |
) |
(30,297 |
) |
|
(4,650 |
) |
(32,764 |
) |
(37,413 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
|
(539 |
) |
2,022 |
|
1,483 |
|
|
151 |
|
3,219 |
|
3,370 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
|
1,059 |
|
1,030 |
|
2,089 |
|
|
707 |
|
986 |
|
1,693 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
|
520 |
|
3,052 |
|
3,572 |
|
|
858 |
|
4,204 |
|
5,062 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(5,090 |
) |
(21,636 |
) |
(26,726 |
) |
|
(3,792 |
) |
(28,560 |
) |
(32,351 |
) |
Depreciation and
amortization |
|
(505 |
) |
(2,115 |
) |
(2,620 |
) |
|
(615 |
) |
(3,708 |
) |
(4,323 |
) |
Additions to tangible and
intangible assets |
|
636 |
|
10,962 |
|
11,598 |
|
|
69 |
|
3,426 |
|
3,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CELLECTIS
S.A.DETAILS OF
KEY PERFORMANCE
INDICATORS BY
REPORTABLE SEGMENTS
– First
nine-months(unaudited)
- ($ in
thousands)
|
|
For the nine-month periodended September 30,
2020 |
|
For the nine-month periodended September 30,
2021 |
$ in
thousands |
|
Plants |
Therapeutics |
Totalreportablesegments |
|
Plants |
Therapeutics |
Totalreportablesegments |
|
|
|
|
|
|
|
|
|
External revenues |
|
9,960 |
|
50,077 |
|
60,037 |
|
|
25,004 |
|
20,085 |
|
45,088 |
|
External other income |
|
- |
|
6,510 |
|
6,510 |
|
|
1,528 |
|
6,792 |
|
8,320 |
|
External revenues and
other income |
|
9,960 |
|
56,587 |
|
66,547 |
|
|
26,532 |
|
26,876 |
|
53,408 |
|
Cost of revenue |
|
(16,600 |
) |
(1,558 |
) |
(18,159 |
) |
|
(27,512 |
) |
(1,601 |
) |
(29,113 |
) |
Research and development
expenses |
|
(7,391 |
) |
(56,203 |
) |
(63,594 |
) |
|
(8,358 |
) |
(88,304 |
) |
(96,663 |
) |
Selling, general and
administrative expenses |
|
(16,227 |
) |
(15,538 |
) |
(31,765 |
) |
|
(11,520 |
) |
(16,373 |
) |
(27,894 |
) |
Other operating income and
expenses |
|
(148 |
) |
(142 |
) |
(291 |
) |
|
25 |
|
481 |
|
506 |
|
Total operating
expenses |
|
(40,367 |
) |
(73,442 |
) |
(113,810 |
) |
|
(47,366 |
) |
(105,797 |
) |
(153,163 |
) |
Operating income
(loss) before tax |
|
(30,407 |
) |
(16,855 |
) |
(47,263 |
) |
|
(20,834 |
) |
(78,921 |
) |
(99,755 |
) |
Net financial gain (loss) |
|
(510 |
) |
(4,223 |
) |
(4,733 |
) |
|
(875 |
) |
3,603 |
|
2,728 |
|
Net income
(loss) |
|
(30,917 |
) |
(21,078 |
) |
(51,996 |
) |
|
(21,709 |
) |
(75,318 |
) |
(97,027 |
) |
Non controlling interests |
|
10,391 |
|
- |
|
10,391 |
|
|
7,827 |
|
- |
|
7,827 |
|
Net income
(loss) attributable to shareholders of Cellectis |
(20,528 |
) |
(21,077 |
) |
(41,605 |
) |
|
(13,883 |
) |
(75,318 |
) |
(89,201 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
|
556 |
|
5,005 |
|
5,561 |
|
|
682 |
|
6,922 |
|
7,604 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
|
2,936 |
|
2,691 |
|
5,627 |
|
|
(208 |
) |
1,901 |
|
1,693 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
|
3,492 |
|
7,696 |
|
11,188 |
|
|
474 |
|
8,823 |
|
9,297 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(17,037 |
) |
(13,381 |
) |
(30,418 |
) |
|
(13,409 |
) |
(66,495 |
) |
(79,904 |
) |
Depreciation and
amortization |
|
(1,485 |
) |
(5,290 |
) |
(6,776 |
) |
|
(1,834 |
) |
(9,651 |
) |
(11,485 |
) |
Additions to tangible and
intangible assets |
|
973 |
|
40,983 |
|
41,956 |
|
|
377 |
|
14,446 |
|
14,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 – Third
Quarter(unaudited)($
in thousands,
except per share
data)
|
|
For the three-month periodended September 30, |
|
|
2020 |
|
2021 |
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(30,297 |
) |
|
(37,413 |
) |
Adjustment: |
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
|
3,572 |
|
|
5,062 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(26,726 |
) |
|
(32,351 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.63 |
) |
|
(0.71 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) (1) |
|
42,486,133 |
|
|
45,471,977 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.63 |
) |
|
(0.71 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) (1) |
|
42,573,694 |
|
|
45,471,977 |
|
(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
nine-months(unaudited)($
in thousands,
except per share
data)
|
|
For the nine-month period ended September 30, |
|
|
2020 |
|
2021 |
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(41,605 |
) |
|
(89,201 |
) |
Adjustment: |
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
|
11,188 |
|
|
9,297 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(30,417 |
) |
|
(79,904 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.72 |
) |
|
(1.79 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) (1) |
|
42,474,764 |
|
|
44,599,935 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.72 |
) |
|
(1.79 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) (1) |
|
42,528,665 |
|
|
44,599,935 |
|
(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 gene editing company, developing first of its kind therapeutic
products. Cellectis utilizes an 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, and a platform to make therapeutic gene editing in
hemopoietic stem cells for various diseases. 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 treat diseases with unmet
medical needs. As part of its commitment to a cure,
Cellectis remains dedicated to its goal of providing lifesaving
UCART product candidates for multiple cancers including acute
myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL)
and multiple myeloma (MM). .HEAL is a new platform
focusing on hemopoietic stem cells to treat blood disorders,
immunodeficiencies and lysosomial storage
diseases. Cellectis headquarters are in Paris, France,
with 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.
For further information, please
contact:
Media contacts: Margaret Gandolfo, Senior
Manager, Communications, +1 (646) 628 0300 Pascalyne
Wilson, Director, Communications, +33776991433,
media@cellectis.com
Investor Relation
contact: Eric Dutang, Chief Financial
Officer, +1 (646) 630
1748, investor@cellectis.com
Forward-looking Statements
This presentation 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 our research and development projects and priorities, our
pre-clinical project development efforts and the timing of our
presentation of data. 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
numerous risks associated with biopharmaceutical product candidate
development as well as the duration and severity of the COVID-19
pandemic and governmental and regulatory measures implemented in
response to the evolving situation. With respect to our cash
runway, our operating plans, including product development plans,
may change as a result of various factors, including factors
currently unknown to us. 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.
- 20211104_CLLS Q3 Earnings 2021_ENGLISH
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Jul 2023 to Jul 2024