Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS),
a clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies, today provided business updates and preliminary
financial results for the six-month period ending June 30, 2023.
Full report of the financial results for the second quarter of 2023
will be released in the coming days.
“We are proud of our team and the strong
execution this quarter. Our clinical data presented for UCART22 at
the European Hematology Association (EHA) were positive for
patients with r/r B-ALL who have failed multiple lines of treatment
including multi-agent chemoimmunotherapy, CD19 directed CAR T-cell
therapy, and allogeneic stem cell transplant. We are looking
forward to releasing new data later this year on our UCART22
product candidate manufactured in-house,” said André Choulika,
Ph.D., Chief Executive Officer at Cellectis.
“In addition, we have made progress with our
pipeline in 2023 and continue to focus on our core clinical trials
BALLI-01 (evaluating UCART22), NATHALI-01 (evaluating UCART20x22)
and AMELI-01 (evaluating UCART123). This quarter, Cellectis
presented an encore of the clinical data on the AMELI-01 clinical
trial at the American Society of Gene and Cell Therapy (ASGCT) 2023
annual meeting. These preliminary data support the continued
administration of UCART123 after FCA lymphodepletion in patients
with r/r AML.
Cellectis’ innovation team also presented
preclinical data on a gene editing process to develop a bona fide
HBB gene correction of sickle cell mutation, and a comprehensive
analysis to better design efficient TALE Base Editors (TALE-BE) at
the International Society for Cell and Gene Therapy (ISCT) 2023
annual meeting. These achievements showcase once more the power of
our gene-editing platform and our TALEN®, the technology of choice
for therapeutic gene editing, and that we are continuing to deliver
constant breakthrough innovation to treat diseases with unmet
medical needs.
Despite an unprecedented challenging market
environment for cell and gene therapy companies, Cellectis remains
focused in its mission to develop innovative cancer therapy product
candidates.”
Pipeline Highlights
UCART Clinical Development
Programs
BALLI-01 (evaluating UCART22) in
relapsed or refractory B-cell acute lymphoblastic leukemia (r/r
B-ALL)
- UCART22 is an allogeneic CAR T-cell
product candidate targeting CD22 and is being evaluated in patients
with r/r B-ALL in the BALLI-01 Phase 1/2a clinical study.
- On June 9, Cellectis presented
updated clinical and translational data at the European Hematology
Association (EHA). These data support the preliminary safety and
efficacy of UCART22 in a heavily pretreated r/r B-ALL population.
UCART22 is currently the most advanced allogeneic CAR T-cell
product in development for r/r B-ALL.
- In the poster presented at EHA,
Cellectis included data from patients who received UCART22 after
fludarabine, cyclophosphamide (FC) and FC with alemtuzumab (FCA)
lymphodepletion (LD). Compared to the clinical update on BALLI-01
at ASH 2021, we have included data from six additional patients who
received UCART22 at dose level 3 (DL3), as of the December 31, 2022
data cutoff.
- UCART22 administered after FC or
FCA LD regimen was well tolerated. No dose limiting toxicities
(DLTs) nor immune effector cell-associated neurotoxicity syndrome
(ICANS) were observed.
- For FCA-dose level 3, 50% of the
six patients responded. Host lymphocytes remained suppressed
through Day 28 for all patients who received FCA LD. Peak ferritin
levels correlated with UCART22 cell expansion and cytokine release
syndrome (CRS). UCART22 continues to be well tolerated, with no
treatment emergent serious adverse events (TESAEs) or DLTs
reported. UCART22 cell expansion was detected in 9 of 13 patients
in the FCA LD arm and associated with clinical activity.
- The BALLI-01 study is currently
enrolling patients after FCA LD with Cellectis’ in-house
manufactured product. The next data set is expected to be released
later this year.
NATHALI-01 (evaluating UCART20x22) in
relapsed or refractory B-cell non-Hodgkin lymphoma (r/r
B-NHL)
-
UCART20x22 is Cellectis’ first dual allogeneic CAR T-cell product
candidate targeting both CD20 and CD22 and is being evaluated in
patients with r/r B-NHL in the NATHALI-01 Phase 1/2a clinical
study2.
-
The NATHALI-01 clinical study is ongoing. Cellectis expects to
provide first-in-human data later this year.AMELI-01
(evaluating UCART123) in relapsed or refractory acute myeloid
leukemia (r/r AML)
- UCART123 is an allogeneic CAR T-cell product candidate
targeting CD123 and is being evaluated in patients with r/r AML in
the AMELI-01 Phase 1 dose-escalation clinical study.
- On May 17, Cellectis presented an
encore of the clinical data on the AMELI-01 clinical trial that
were unveiled at the ASH 2022 annual meeting, at the American
Society of Gene and Cell Therapy (ASGCT) 2023 annual meeting. These
preliminary data support the continued administration of UCART123
after FCA lymphodepletion in patients with r/r AML.
-
The oral presentation reviewed preliminary data from patients who
received UCART123 at one of the following dose levels: dose level 1
(DL1) 2.5x105 cells/kg; dose level 2 (DL2) 6.25x105 cells/kg;
intermediate dose level 2 (DL2i) 1.5x106 cells/kg; or dose level 3
(DL3) 3.30x106 cells/kg after lymphodepletion with FC ([n=8], DL1 –
DL3) or FCA ([n=9], DL2 & DL2i).
-
The data presented showed that adding alemtuzumab to the FC LD
regimen was associated with sustained host lymphodepletion and
significantly higher UCART123 cell expansion, that correlated with
improved anti-tumor activity.
-
25% (n=2) of patients at DL2 in the FCA arm achieved meaningful
response; one patient who failed five prior lines of therapy
including allogeneic stem cell transplant experienced a durable
minimal residual disease (MRD)-negative complete response that
continued beyond 12 months, as of December 2022.
-
The AMELI-01 study is currently enrolling patients after FCA
lymphodepletion in a two-dose regimen arm.
Research Data & Preclinical Programs
UCART20x22
- On June 5, 2023, Cellectis
presented preclinical data on its product candidate UCART20x22, at
the International Society for Cell & Gene Therapy (ISCT) 2023
annual event.
- Cellectis provided pre-clinical
proof-of-concept data for UCART20x22 to overcome current mechanisms
of resistance to CAR T-cell therapies in B-NHL, while providing a
potential therapeutic alternative to CD19 targeting and allowing a
reduction in the time from treatment decision to infusion.
- Cellectis demonstrated that
UCART20x22 displays robust activity in vitro and in vivo, against
targets expressing heterogeneous levels of CD22 and CD20. We have
used in vitro cytotoxicity assays against different tumor cell
lines, showing strong activity whether these cells express a single
antigen (CD20 or CD22) or both antigens simultaneously, as well as
IFNg release in response to antigen specific stimulation.
Article published in Cancer Immunology
Research
- On May 31, 2023, Cellectis
published an article in Cancer Immunology Research demonstrating
pre-clinical proof-of-concept data of UCART20x22 product candidate,
to overcome current mechanisms of resistance to CAR T-cell
therapies in B-NHL.
- In this study, we demonstrated that
allogeneic CD20x22 CAR T-cells exhibit robust, sustained and
dose-dependent activity in vitro and in vivo, while efficiently
targeting primary Non-Hodgkin Lymphoma samples with heterogeneous
levels of CD20 and CD22.
HBB gene correction of sickle cell mutation
- Encouraging preclinical data on
gene editing process using Cellectis TALEN® technology to develop
highly efficient HBB gene correction of sickle cell mutation, were
presented in a poster presentation at the ISCT 2023 annual
event.
- These results showed that non-viral
DNA delivery associated with TALEN® gene editing reduces the
toxicity usually observed with viral DNA delivery and allows high
levels of HBB gene correction in long-term repopulating
hematopoietic stem cells.
-
Cellectis leveraged TALEN® technology to develop a gene editing
process leading to highly efficient HBB gene correction via
homology directed repair, while mitigating potential risks
associated to HBB gene knock-out. Furthermore, we compared viral
(TALEN-V) and non-viral (TALEN-NV) DNA template delivery strategies
in mobilized healthy donor (HD) or non-mobilized homozygous sickle
patient (HbSS) hematopoietic stem and progenitor cells
(HSPCs).
-
Both strategies led to high and comparable efficiencies of HBB gene
correction in vitro in HD and HbSS, without affecting viability,
purity or clonogenic potential of corrected HSPCs.
The poster presentation highlighted the
following data:
-
TALEN®-mediated engineering efficiently corrects the mutated HBB
gene in clinically relevant HSPCs and promote phenotype correction
in fully mature RBCs.
-
Cellectis optimized TALEN® gene editing process mitigates potential
safety challenges by reducing the frequency of HBB gene
inactivation (<10% β-thal cells).
-
Non-viral DNA template-mediated HBB repair mitigates p53 DNA damage
response activation, preserves edited LT-HSCs fitness and enables
their efficient engraftment in vivo using an immunodeficient murine
model.
TALE Base Editors (TALE-BE)
- A comprehensive analysis to better
design efficient TALE Base Editors (TALE-BE) using Cellectis’
TALEN® technology was presented in a poster at ISCT annual
meeting.
-
Cellectis developed a strategy that allowed to comprehensively
characterize editing efficiencies in function of the TC position
within the TALE-BE editing windows. This method is specifically
taking advantage of the highly precise and efficient TALEN®
mediated ssODN knock-in in primary T cells, allowing to focus on
how target composition and spacer variations can affect TALE-BE
activity/efficiency.
The poster presentation highlighted the
following data:
- Determined optimal spacer length (13/15 bp) for highly
efficient TALE-BE for both C40/C40 and C11/C11 scaffolds.
- Determined optimal common sequence context for high editing
rates.
- Determined that editing efficiency of the C11/C11 scaffold is
highly dependent on Cytosine position requirements, resulting in
more stringent activity in a context of 15 bp spacer size and
decreasing the effects of bystander editing.
We believe that the knowledge obtained will
allow to better design efficient TALE-BE while improving the
specificity profiles of this innovative editing platform.
Novel treatment paradigm for successful CAR T
immunotherapy against stroma-rich solid tumors
- On May 12, 2023, Cellectis
published an article in Frontiers Bioengineering demonstrating the
efficacy of its TALEN® engineered FAP UCART-cells in
cancer-associated fibroblast (CAF) depletion, reduction of
desmoplasia and tumor infiltration.
- Over 90% of epithelial cancers
including breast, colorectal, pancreatic and lung adenocarcinomas
express the CAF-specific surface marker, fibroblast activation
protein α (FAP), which makes it a promising CAR T-cell target. In
this study, Cellectis proposed a novel and versatile approach of
combination CAR T-cell therapy that can be extended to most
stroma-rich cold tumors with relevant tumor-antigen targeting CAR
T-cells which otherwise are recalcitrant to cell therapy.
Preclinical data showed that:
-
In a mouse xenograft model, successful implantation of injected
CAFs in the tumors was confirmed by positive staining of
spindle-like cells with human-specific FAP antibody, recapitulating
a physiologically relevant TNBC tumor with tumor and stromal
compartments.
-
FAP UCART-cells alone significantly reduced tumor growth.
-
In vitro and in vivo results show that FAP UCART-cells enable the
reprogramming of the cold, stroma-rich triple negative breast
cancer (TNBC) TME, making the tumor susceptible to subsequent Meso
UCART infiltration and cytotoxicity and improving the overall
antitumor activity of the treatment.
-
In the context of combination therapy with anti-PD1 checkpoint
inhibitor, maximal anti-tumor activity and survival benefits were
observed upon FAP UCART-cell treatment followed by Meso UCART-cell
treatment.
Licensed Allogeneic CAR T-cell
Development Programs
Servier and Allogene: anti-CD19
programs
- Allogene announced that it is
enrolling patients “in the industry’s first potentially pivotal
Phase 2 allogeneic CAR T clinical trial with ALLO-501A across sites
in the United States and Canada”. The European Medicines Agency
(EMA) recently approved the ALPHA2 Clinical Trial Application
(CTA).
- Allogene’s single-arm ALPHA2 trial
in relapsed/refractory (R/R) large B cell lymphoma (LBCL) will
enroll approximately 100 patients who have received at least two
prior lines of therapy and have not received prior anti-CD19
therapy. Allogene has announced that it expects to complete
enrollment in 1H 2024 with the first data readout by the end of
2024.
- Long-term follow up data from the
Phase 1 of Allogene’s ALPHA/ALPHA2 trials in LBCL was presented at
both the American Society of Clinical Oncology (ASCO) Annual
Meeting with an encore presentation at the European Hematology
Association Congress and International Conference on Malignant
Lymphoma (ICML) Lugano in June 2023. The Phase 1 trials enrolled
heavily pre-treated patients with a median of three prior lines of
therapy. Data from 33 CAR T-naïve LBCL patients receiving Alloy™
cell product including 12 patients treated with the Phase 2
regimen, are the first to demonstrate the potential for an
allogeneic CAR T product to induce complete responses at rates and
durability similar to approved autologous therapies.
Allogene: anti-BCMA and anti-CD70 program
- The ongoing Phase 1 dose escalation
of Allogene’s TRAVERSE study is enrolling patients with advanced or
metastatic renal cell carcinoma (RCC) who have progressed on
standard therapies including an immune checkpoint inhibitor and a
VEGF-targeting therapy.
- Allogene’s TRAVERSE trial is now
deploying an investigational in vitro companion diagnostic (IVD)
assay designed to prospectively assess CD70 expression levels in
patients. Allogene has announced that dose escalation in the
TRAVERSE trial is expected to be completed in 2023.
Corporate Updates
- On June 28, 2023, Cellectis
reported results from the annual shareholders’ general meeting held
on June 27, 2023, at the Company’s Paris headquarters. At the
meeting, during which more than 72% of shares were exercised,
Resolutions 1 through 28 were adopted and resolution 29 was
rejected, according to the management recommendations. The detailed
results of the vote and the resolutions are available on the
company’s website:
https://www.cellectis.com/en/investors/general-meetings/
At the end of the meeting, the terms of office
of Ms. Annick Schwebig and Mr. Hervé Hoppenot ended and Ms. Annick
Schwebig and Mr. Hervé Hoppenot departed the board of directors as
of such date.
During the annual shareholders meeting, Cécile
Chartier, Ph.D., was appointed as a director of the Cellectis’
Board of Directors, with immediate effect.
Cécile Chartier currently serves as Chief
Scientific Officer at NextVivo, Inc. Prior to her tenure at
NextVivo, Dr. Chartier was Vice President of Research at Iovance
Biotherapeutics, Inc. where she led the development of next
generation tumor-infiltrating lymphocytes (TIL) therapies through
research to early-stage clinical trials. Cécile’s extensive
experience in the development of next generation cell and gene
therapies coupled with her deep knowledge of the U.S. biotechnology
industry will be a huge asset to Cellectis.
Financial Results
The interim condensed consolidated financial
statements of Cellectis, 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 Q2 2023 financial results press release.
On January 13, 2023, Calyxt, Cibus Global LLC
(Cibus) and certain other parties named therein, entered into an
Agreement and Plan of Merger (the “Merger Agreement”), pursuant to
which, subject to the terms and conditions thereof, Calyxt and
Cibus will merge in an all-stock transaction (the “Calyxt Merger”).
As a consequence of the foregoing, Calyxt met the “held-for-sale”
criteria specified in IFRS 5 and was classified as a discontinued
operation until May 31, 2023.
On June 1, 2023, Calyxt and Cibus closed the
merger transaction and now operate under the name Cibus, Inc.
Consequently, Calyxt was deconsolidated and Calyxt’s cash, cash
equivalent and restricted cash are no longer included in the
Group’s cash, cash equivalent and restricted cash since June 1,
2023.
Cash: As of June 30, 2023,
Cellectis, had $89 million in consolidated cash, cash equivalents,
and restricted cash. This compares to $95 million in consolidated
cash, cash equivalents and restricted cash as of December 31, 2022.
This $6 million difference mainly reflects $55 million of cash out,
which include $15 million for R&D suppliers, $7 million for
SG&A suppliers, $23 million for staff costs, $7 million for
rents and taxes, $3 millions of reimbursement of the “PGE” loan,
and a $1 million unfavorable impact on Forex partially offset by a
$23 million net cash inflow from the capital raise closed in
February, a $21 million net cash inflow from EIB loan, a $1 million
cash inflow related to the grant and refundable advance from BPI,
$2 millions of financial investments’ capital gain and interests, a
$1 million reimbursement of social charges paid on stock options,
and a $2 million net cash inflow from licenses and other cash
receipts.
Based on the current operating plan, Cellectis
anticipates that the cash, cash equivalents, and restricted cash as
of June 30, 2023 will fund Cellectis’ operations into the third
quarter of 2024.
Revenues and Other Income:
Consolidated revenues and other income were $5.6 million for the
six months ended June 30, 2023 compared to $6.5 million for the six
months ended June 30, 2022. The decrease of $1.0 million reflects
the recognition of two milestones related to Cellectis’ agreement
with Cytovia for $1.5 million in 2022 and a milestone of $1.0
million with another partner while recognition of revenues in 2023
is not material, and partially offset by the increase of the
research tax credit for $0.8 million and the partial recognition of
a grant signed with “BPI” of $0.8 million.
R&D Expenses: Consolidated
R&D expenses were $43.2 million for the six months ended June
30, 2023, compared to $52.2 million for the six months ended June
30, 2022. The $9.0 million decrease was primarily attributable to
(i) a $3.4 million decrease in personal expenses due to departures
not replaced (ii) a $4.7 million decrease in purchases, external
expenses and other (from $28.0 million in 2022 to $23.2 million in
2023) mainly explained by internalization of our manufacturing and
quality activities to support our R&D pipeline and (iii) a $0.8
million decrease of non-cash stock-based compensation expenses
(from $3.1 million to $2.3 million).
SG&A Expenses: Consolidated
SG&A expenses were $8.9 million for the six months ended June
30, 2023, compared to $10.9 million for the six months ended June
30, 2022. The $2.0 million decrease primarily reflects (i) a $1.6
million decrease in purchases, external expenses and other (from
$6.4 million in 2022 to $4.9 million in 2023) mainly explained by
the implementation of our ERP in 2022 (ii) a $0.2 million decrease
in personal expenses and non-cash stock-based compensation
expenses.
Net financial gain (loss):
Consolidated net financial gain was $11.6 million for the six
months ended June 30, 2023, compared to $9.2 million for the six
months ended June 30, 2022. The $2.4 million increase primarily
reflects (i) a $20.8 million increase of financial income, mainly
attributable to the profit from Calyxt’s deconsolidation, partially
offset by (ii) the loss in fair value on our retained investment in
Calyxt since deconsolidation for $10.2 million, (iii) a $6.8
million decrease in the fair value of Cytovia’s note
receivable.
Net income (loss) from discontinued
operations: Pursuant to Calyxt deconsolidation income from
discontinued operation for the six-month period ended June 30,
2023, 2023 only include five months of activity. The $3.5 million
increase of net loss from discontinued operations between the
six-month period ended June 30, 2022 and 2023 is primarily driven
by (i) the increase of $9.2 million of net financial loss and (ii)
the increase of $1.5 million of other operating expenses partially
offset by (i) the decrease of $2.8 million of R&D expenses
(from $6.3 million in 2022 to $3.5 in 2023) and (ii) the decrease
of $4.5 million of SG&A expenses (from $6.8 million in 2022 to
$2.3 million in 2023).
Net Income (loss) Attributable to
Shareholders of Cellectis: The consolidated net loss
attributable to shareholders of Cellectis was $40.7 million (or
$0.76 per share) for the six months ended June 30, 2023, of which
$35.7 million was attributed to Cellectis continuing operations,
compared to $50.9 million (or $1.12 per share) for the six months
ended June 30, 2022, of which $47.3 million was attributed to
Cellectis continuing operations. This $10.1 million decrease in net
loss between the first six months of 2023 and 2022 was primarily
driven by (i) a $9.0 million decrease of R&D expenses, (ii) a
$2.0 million decrease of SG&A expenses and (iii) an increase of
$2.4 million of the financial gain due to the deconsolidation of
Calyxt compensated in part by the decrease of fair value of
Cytovia’s note receivable. These downward impacts on the net loss
were partially offset by (i) a decrease of $1.0 million of revenues
and other income, (ii) an increase of $1.5 million of loss from
discontinued operations attributable to Shareholders of
Cellectis.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $36.7
million (or $0.68 per share) for the six months ended June 30,
2023, compared to a net loss of $45.5 million (or $1.00 per share)
for the six months ended June 30, 2022.
Please see “Note Regarding Use of Non-IFRS
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 2023 in the following areas:
- Supporting the development of our
pipeline of product candidates, including the manufacturing and
clinical trial expenses of UCART123, UCART22, UCART 20x22 and
potential new product candidates;
- Operating our state-of-the-art
manufacturing capabilities in Paris (France), and Raleigh (North
Carolina, USA); and
- Continuing to strengthen our
manufacturing and clinical departments.
The selected, preliminary financial information
set forth above are unaudited and should be considered preliminary
and subject to change. We have provided such selected, preliminary
results above as our final results remain subject to the completion
of our normal closing procedures, final adjustments, developments
that may arise between now and the time the financial results are
finalized, and management’s and the audit and finances committee’s
final reviews. Accordingly, you should not place undue reliance on
this preliminary information, which may differ materially from our
actual final results. These preliminary results should not be
viewed as a substitute for our full quarterly financial statements
prepared in accordance with IFRS. In addition, they are not
necessarily indicative of the results to be achieved in any future
period. These preliminary results have been prepared by and are the
responsibility of management. Our independent registered public
accounting firm has not audited, compiled, performed any procedures
on or revised the preliminary financial information, and
accordingly does not express an opinion or any other form of
assurance with respect of the preliminary information. We plan to
report our full results for the second quarter in the coming
days.
|
CELLECTIS S.A. |
STATEMENT OF CONSOLIDATED FINANCIAL POSITION
(unaudited) |
($ in thousands) |
|
|
|
As of |
|
|
December 31, 2022 |
|
June 30, 2023 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
718 |
|
|
695 |
|
Property, plant, and
equipment |
|
63,621 |
|
|
59,231 |
|
Right-of-use assets |
|
44,275 |
|
|
41,457 |
|
Non-current financial
assets |
|
8,791 |
|
|
13,006 |
|
Total non-current
assets |
|
117,406 |
|
|
114,389 |
|
|
|
|
|
|
Current
assets |
|
|
|
|
Trade receivables |
|
772 |
|
|
422 |
|
Subsidies receivables |
|
14,496 |
|
|
19,488 |
|
Other current assets |
|
9,078 |
|
|
7,869 |
|
Cash and cash equivalent and
Current financial assets |
|
97,697 |
|
|
85,505 |
|
Total current
assets |
|
122,043 |
|
|
113,285 |
|
Total assets held for
sale |
|
21,768 |
|
|
0 |
|
TOTAL
ASSETS |
|
261,216 |
|
|
227,674 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Share capital |
|
2,955 |
|
|
3,491 |
|
Premiums related to the share
capital |
|
583,122 |
|
|
476,224 |
|
Currency translation
adjustment |
|
(28,605 |
) |
|
(37,050 |
) |
Retained earnings |
|
(333,365 |
) |
|
(305,392 |
) |
Net income (loss) |
|
(106,139 |
) |
|
(40,715 |
) |
Total shareholders’
equity - Group Share |
|
117,968 |
|
|
96,558 |
|
Non-controlling interests |
|
7,973 |
|
|
0 |
|
Total shareholders’
equity |
|
125,941 |
|
|
96,558 |
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Non-current financial
liabilities |
|
20,531 |
|
|
40,270 |
|
Non-current lease debts |
|
49,358 |
|
|
46,157 |
|
Non-current provisions |
|
2,390 |
|
|
2,641 |
|
Total non-current
liabilities |
|
72,279 |
|
|
89,068 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Current financial
liabilities |
|
5,088 |
|
|
5,185 |
|
Current lease debts |
|
7,872 |
|
|
8,270 |
|
Trade payables |
|
21,456 |
|
|
19,229 |
|
Deferred revenues and deferred
income |
|
59 |
|
|
241 |
|
Current provisions |
|
477 |
|
|
1,029 |
|
Other current liabilities |
|
13,179 |
|
|
8,093 |
|
Total current
liabilities |
|
48,131 |
|
|
42,047 |
|
Total liabilities
related to asset held for sale |
|
14,864 |
|
|
0 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
261,216 |
|
|
227,674 |
|
Cellectis S.A. |
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONS |
For the three-month period ended June 30,
2023 |
$ in thousands, except per share amounts |
|
|
|
For the three-month period endedJune 30, |
|
|
2022 * |
|
2023 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
1,307 |
|
|
178 |
|
Other income |
|
1,416 |
|
|
1,823 |
|
Total revenues and
other income |
|
2,723 |
|
|
2,001 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(329 |
) |
|
(55 |
) |
Research and development
expenses |
|
(25,630 |
) |
|
(22,144 |
) |
Selling, general and
administrative expenses |
|
(4,830 |
) |
|
(3,950 |
) |
Other operating income
(expenses) |
|
753 |
|
|
490 |
|
Total operating
expenses |
|
(30,036 |
) |
|
(25,660 |
) |
Operating income
(loss) |
|
(27,313 |
) |
|
(23,659 |
) |
Financial gain
(loss) |
|
8,301 |
|
|
15,982 |
|
Income
tax |
|
0 |
|
|
(258 |
) |
Income (loss) from continuing
operations |
|
(19,012 |
) |
|
(7,935 |
) |
Income (loss) from
discontinued operations |
|
(442 |
) |
|
(5,647 |
) |
Net income
(loss) |
|
(19,454 |
) |
|
(13,583 |
) |
Attributable to shareholders of Cellectis |
|
(18,946 |
) |
|
(10,648 |
) |
Attributable to non-controlling interests |
|
(506 |
) |
|
(2,935 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.42 |
) |
|
(0.19 |
) |
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.42 |
) |
|
(0.19 |
) |
Basic net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
0.00 |
|
|
(0.05 |
) |
Diluted net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
0.00 |
|
|
(0.05 |
) |
|
|
|
|
|
|
|
* These amounts reflect adjustments made in
connection with the presentation of the discontinued operation
CELLECTIS S.A. |
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONS |
For the six-month period ended June 30, 2023 |
$ in thousands, except per share amounts |
|
|
|
For the six-month period endedJune 30, |
|
|
2022 * |
|
2023 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
2,972 |
|
|
317 |
|
Other income |
|
3,551 |
|
|
5,242 |
|
Total revenues and
other income |
|
6,523 |
|
|
5,560 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(714 |
) |
|
(389 |
) |
Research and development
expenses |
|
(52,231 |
) |
|
(43,225 |
) |
Selling, general and
administrative expenses |
|
(10,893 |
) |
|
(8,914 |
) |
Other operating income
(expenses) |
|
774 |
|
|
(83 |
) |
Total operating
expenses |
|
(63,064 |
) |
|
(52,612 |
) |
Operating income
(loss) |
|
(56,541 |
) |
|
(47,053 |
) |
Financial gain
(loss) |
|
9,213 |
|
|
11,580 |
|
Income
tax |
|
0 |
|
|
(258 |
) |
Income (loss) from continuing
operations |
|
(47,328 |
) |
|
(35,731 |
) |
Income (loss) from
discontinued operations |
|
(6,883 |
) |
|
(10,377 |
) |
Net income
(loss) |
|
(54,211 |
) |
|
(46.108 |
) |
Attributable to shareholders of Cellectis |
|
(50,858 |
) |
|
(40,715 |
) |
Attributable to non-controlling interests |
|
(3,352 |
) |
|
(5,393 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(1.12 |
) |
|
(0.76 |
) |
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(1.12 |
) |
|
(0.76 |
) |
Basic net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
(0.08 |
) |
|
(0.09 |
) |
Diluted net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
(0.08 |
) |
|
(0.09 |
) |
|
|
|
|
|
|
|
* These amounts reflect adjustments made in
connection with the presentation of the discontinued operation
CELLECTIS S.A. |
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE
SEGMENTS – |
For the three-month period ended June 30,
2023 |
(unaudited) - ($ in thousands) |
|
|
For the three-month period endedJune 30, 2022 |
|
For the three-month period endedJune 30, 2023 |
$ in
thousands |
Plants(discontinuedoperations) |
Therapeutics |
Totalreportablesegments |
|
Plants(discontinuedoperations) |
Therapeutics |
Totalreportablesegments |
|
|
|
|
|
|
|
|
External revenues |
42 |
|
1,307 |
|
1,348 |
|
|
1 |
|
178 |
|
179 |
|
External other income |
- |
|
1,416 |
|
1,416 |
|
|
- |
|
1,823 |
|
1,823 |
|
External revenues and
other income |
42 |
|
2,723 |
|
2,765 |
|
|
1 |
|
2,001 |
|
2,002 |
|
Cost of revenue |
0 |
|
(329 |
) |
(329 |
) |
|
(63 |
) |
(55 |
) |
(118 |
) |
Research and development
expenses |
(3,419 |
) |
(25,630 |
) |
(29,048 |
) |
|
(1,322 |
) |
(22,144 |
) |
(23,467 |
) |
Selling, general and
administrative expenses |
(3,585 |
) |
(4,830 |
) |
(8,415 |
) |
|
(976 |
) |
(3,950 |
) |
(4,927 |
) |
Other operating income and
expenses |
198 |
|
753 |
|
951 |
|
|
(1,074 |
) |
490 |
|
(584 |
) |
Total operating
expenses |
(6,806 |
) |
(30,036 |
) |
(36,842 |
) |
|
(3,435 |
) |
(25,660 |
) |
(29,095 |
) |
Operating income
(loss) before tax |
(6,764 |
) |
(27,313 |
) |
(34,077 |
) |
|
(3,434 |
) |
(23,659 |
) |
(27,093 |
) |
Financial gain (loss) |
6,322 |
|
8,301 |
|
14,623 |
|
|
(2,213 |
) |
15,982 |
|
13,769 |
|
Income
tax |
- |
|
- |
|
- |
|
|
- |
|
(258 |
) |
(258 |
) |
Net income (loss) from
discontinued operations |
(442 |
) |
|
(442 |
) |
|
(5,647 |
) |
|
(5,647 |
) |
Net income
(loss) |
(442 |
) |
(19,012 |
) |
(19,454 |
) |
|
(5,647 |
) |
(7,935 |
) |
(13,583 |
) |
Non controlling interests |
506 |
|
- |
|
506 |
|
|
(2,935 |
) |
- |
|
(2,935 |
) |
Net income (loss)
attributable to shareholders of Cellectis |
64 |
|
(19,012 |
) |
(18,946 |
) |
|
(2,712 |
) |
(7,935 |
) |
(10,648 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
226 |
|
1,454 |
|
1,681 |
|
|
103 |
|
797 |
|
900 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
447 |
|
557 |
|
1,003 |
|
|
326 |
|
849 |
|
1,174 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
673 |
|
2,011 |
|
2,684 |
|
|
428 |
|
1,646 |
|
2,074 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
737 |
|
(17,001 |
) |
(16,264 |
) |
|
(2,284 |
) |
(6,289 |
) |
(8,573 |
) |
Depreciation and
amortization |
(608 |
) |
(4,500 |
) |
(5,108 |
) |
|
(12 |
) |
(4,419 |
) |
(4,431 |
) |
Additions to tangible and
intangible assets |
308 |
|
870 |
|
1,178 |
|
|
21 |
|
311 |
|
332 |
|
CELLECTIS S.A. |
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE
SEGMENTS – |
For the six-month period ended June 30, 2023 |
(unaudited) - ($ in thousands) |
|
|
For the six-month period endedJune 30, 2022 |
|
For the six-month period endedJune 30, 2023 |
$ in
thousands |
Plants(discontinuedoperations) |
Therapeutics |
Totalreportablesegments |
|
Plants(discontinuedoperations) |
Therapeutics |
Totalreportablesegments |
|
|
|
|
|
|
|
|
External revenues |
73 |
|
2,972 |
|
3,045 |
|
|
43 |
|
317 |
|
360 |
|
External other income |
- |
|
3,551 |
|
3,551 |
|
|
- |
|
5,242 |
|
5,242 |
|
External revenues and
other income |
73 |
|
6,523 |
|
6,596 |
|
|
43 |
|
5,560 |
|
5,602 |
|
Cost of revenue |
(0 |
) |
(714 |
) |
(714 |
) |
|
(63 |
) |
(389 |
) |
(451 |
) |
Research and development
expenses |
(6,297 |
) |
(52,231 |
) |
(58,527 |
) |
|
(3,487 |
) |
(43,225 |
) |
(46,712 |
) |
Selling, general and
administrative expenses |
(6,801 |
) |
(10,893 |
) |
(17,695 |
) |
|
(2,313 |
) |
(8,914 |
) |
(11,227 |
) |
Other operating income and
expenses |
242 |
|
774 |
|
1,016 |
|
|
(1,251 |
) |
(83 |
) |
(1,334 |
) |
Total operating
expenses |
(12,856 |
) |
(63,064 |
) |
(75,920 |
) |
|
(7,113 |
) |
(52,612 |
) |
(59,725 |
) |
Operating income
(loss) before tax |
(12,783 |
) |
(56,541 |
) |
(69,324 |
) |
|
(7,070 |
) |
(47,053 |
) |
(54,123 |
) |
Net financial gain (loss) |
5,900 |
|
9,213 |
|
15,113 |
|
|
(3,307 |
) |
11,580 |
|
8,273 |
|
Income
tax |
- |
|
- |
|
- |
|
|
- |
|
(258 |
) |
(258 |
) |
Net income (loss) from
discontinued operations |
(6,883 |
) |
|
(6,883 |
) |
|
(10,377 |
) |
|
(10,377 |
) |
Net income
(loss) |
(6,883 |
) |
(47,328 |
) |
(54,211 |
) |
|
(10,377 |
) |
(35,731 |
) |
(46,108 |
) |
Non-controlling interests |
3,352 |
|
- |
|
3,352 |
|
|
5,393 |
|
- |
|
5,393 |
|
Net income (loss)
attributable to shareholders of Cellectis |
(3,531 |
) |
(47,328 |
) |
(50,858 |
) |
|
(4,984 |
) |
(35,731 |
) |
(40,715 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
216 |
|
3,134 |
|
3,349 |
|
|
188 |
|
1,900 |
|
2,088 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
789 |
|
1,193 |
|
1,982 |
|
|
599 |
|
1,366 |
|
1,965 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
1,005 |
|
4,327 |
|
5,331 |
|
|
788 |
|
3,265 |
|
4,053 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
(2,526 |
) |
(43,001 |
) |
(45,527 |
) |
|
(4,196 |
) |
(32,465 |
) |
(36,663 |
) |
Depreciation and
amortization |
(1,316 |
) |
(9,434 |
) |
(10,749 |
) |
|
(7 |
) |
(8,875 |
) |
(8,882 |
) |
Additions to tangible and
intangible assets |
671 |
|
1,452 |
|
2,123 |
|
|
21 |
|
536 |
|
556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note Regarding Use of Non-IFRS 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 IFRS TO NON-IFRS NET INCOME |
For the three-month period ended June 30,
2023 |
(unaudited) - ($ in thousands except per share
data) |
|
|
|
For the three-month period endedJune 30, |
|
|
2022 * |
|
2023 |
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(18,946 |
) |
|
(10,648 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
2,684 |
|
|
2,074 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(16,263 |
) |
|
(8,574 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.36 |
) |
|
(0.15 |
) |
Basic adjusted
earnings from discontinued operations attributable to shareholders
of Cellectis ($ /share) |
|
0.00 |
|
|
(0.05 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) |
|
45,497,127 |
|
|
55,583,768 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.36 |
) |
|
(0.15 |
) |
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
from discontinued operations |
|
0.02 |
|
|
(0.04 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) |
|
45,497,127 |
|
|
55,583,768 |
|
|
|
|
|
|
|
|
*These amounts reflect adjustments made in
connection with the presentation of the discontinued operation
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME
(unaudited) |
First six months |
($ in thousands, except per share data) |
|
|
|
For the six-month period endedJune 30, |
|
|
2022 * |
|
2023 |
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(50,858 |
) |
|
(40,715 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
5,331 |
|
|
4,053 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(45,527 |
) |
|
(36,662 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(1.00 |
) |
|
(0.68 |
) |
Basic adjusted
earnings from discontinued operations attributable to shareholders
of Cellectis ($ /share) |
|
(0.95 |
) |
|
(0.71 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) |
|
45,497,127 |
|
|
53,541,010 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(1.00 |
) |
|
(0.68 |
) |
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
from discontinued operations |
|
(0.95 |
) |
|
(0.71 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) |
|
45,497,127 |
|
|
53,541,010 |
|
|
|
|
|
|
|
|
*These amounts reflect adjustments made in
connection with the presentation of the discontinued operation
About Cellectis
Cellectis is a clinical-stage biotechnology
company using its pioneering gene-editing platform to develop
life-saving cell and gene therapies. 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
23 years of experience and 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. 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).
Forward-looking Statements
This 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
“anticipate”, “expect”, “plan”, “could” 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,
including information provided or otherwise publicly reported by
our licensed partners. Forward-looking statements include
statements about advancement, timing and progress of clinical
trials and preclinical studies, the timing of our presentation of
data, and the sufficiency of cash to fund operation. 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.
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, 2022 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.
For further information on Cellectis,
please contact:
Media contact:
Pascalyne
Wilson, Director, Communications, +33 (0)7 76 99 14
33, media@cellectis.com
Investor Relations
contacts:
Arthur Stril, Chief Business Officer, +1 (347)
809 5980, investors@cellectis.com
Ashley R. Robinson, LifeSci Advisors, +1
617 430 7577
1 Cash position includes cash, cash equivalents and restricted
cash. Restricted cash was $5 million as of June 30, 2023.2 This
project is partially funded by the French government, as part of
Plan France 2030. On March 8, 2023, BPIfrance and Cellectis entered
into a grant and refundable advance agreement to partially support
research and development program related to UCART20x22.
- Press release earnings Q22023
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