Cellectis Provides Business Update and Reports Financial
Results for First Quarter 2022
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 a business update and announced its
results for the three-month period ending March 31, 2022.
“Cellectis made progress with our pipeline this
quarter. We took a notable step forward with the first pre-clinical
data on UCART20x22, the allogeneic dual CAR T-cell product
candidate being developed for patients with relapsed or refractory
non-Hodgkin’s lymphoma (NHL). We were proud to see that the data
demonstrated a robust pre-clinical proof-of-concept with strong
activity against tumor cell lines expressing either a single
antigen, CD20 or CD22, or both simultaneously.
We were proud to publish preclinical data in
Nature Communications, providing validation of our product
candidate UCART123, being developed for patients with relapsed or
refractory acute myeloid leukemia (AML). This is the first
preclinical data published on UCART123 supporting the rationale for
using allogeneic CD123-directed CAR T cells to treat AML and
blastic plasmacytoid denditric cell neoplasm (BPDCN). These
preclinical results reinforce our commitment to deliver therapies
for cancer patients with unmet medical needs.
The development of our partnerships was an
exciting highlight for Cellectis. In March, our partner Iovance
Biotherapeutics announced that the U.S. Food and Drug
Administration (FDA) allowed an Investigational New Drug
Application (IND) to proceed for its first TALEN®-edited Tumor
Infiltrating Lymphocytes (TIL) therapy, developed using Cellectis’
technology. In April, we received a $20 million convertible note,
representing the upfront collaboration consideration under our
collaboration agreement with Cytovia Therapeutics. Cellectis is
developing custom TALEN® for Cytovia to develop gene-edited
iPSC-derived Natural Killer cells. These announcements validated
our belief that TALEN®’s status as technology of choice for gene
editing.
Based on our current operating plan, our cash
position of $142 million at the end of the first quarter 2022
(excluding Calyxt, Inc.), is expected to fund our operations into
early 2024.
As we approach several developmental milestones
during the second half of this year, we are excited to expand our
CAR T platform by the expected filing of an IND for UCART20x22, and
release of batches of this product from our in-house manufacturing
facility. UCART20x22 is expected to be Cellectis’ first product
candidate with fully integrated in-house development,” said André
Choulika, CEO of Cellectis.
Pipeline highlights
Cellectis continues to make progress, enrolling
patients throughout its three sponsored Phase 1 dose escalation
trials:
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 being evaluated in patients with r/r B-ALL in the
BALLI-01, multicenter, Phase 1 dose escalation clinical study.
-
BALLI-01 is currently enrolling patients at dose level 3 (DL3) with
Fludarabine, Cyclophosphamide and Alemtuzumab (FCA) preconditioning
regimen.
-
Cellectis plans to initiate dosing patients with UCART22 product
candidate that is expected to be fully manufactured in-house in the
second half of 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 being
evaluated in patients with r/r AML in the AMELI-01, multi-center
Phase 1 dose-escalation clinical study.
- AMELI-01 is
currently enrolling patients at dose level 2 (DL2) (6.25 × 105
cells/kg) with FCA preconditioning regimen.
MELANI-01 (evaluating UCARTCS1) in relapsed or
refractory multiple myeloma (r/r MM)
- UCARTCS1 is an
allogeneic CAR T-cell product candidate targeting CS1 and is being
evaluated in patients with r/r MM in the MELANI-01, multi-center
Phase 1 dose-escalation clinical study.
- Cellectis is currently enrolling
patients at dose level 1 (DL1) with Fludarabine and
Cyclophosphamide (FC) preconditioning regimen.
UCART Preclinical Data and Programs
UCART123:
- On April 28, Cellectis published two
manuscripts in Nature Communications providing preclinical
validation of UCART123 to treat AML.
Preclinical data showed that:
- Cellectis’
product candidate UCART123 effectively eliminates AML cells in
vitro and in vivo in mouse models with significant benefits in
overall animal survival and minimal impact against normal
hematopoietic progenitors.
- UCART123
demonstrates cytotoxic activity against primary AML samples with
minimum toxicity against normal hematopoietic progenitor
cells.
- Support
Cellectis’ rationale of using allogeneic CD123 CAR T cells to treat
AML.
UCART20x22:
-
UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product
candidate being developed for patients with relapsed or refractory
non-Hodgkin lymphoma (r/r NHL).
-
On April 8, Cellectis released its first preclinical data at the
American Association for Cancer Research (AACR) Annual Meeting. The
poster presentation highlighted the following results:
- UCART20x22 shows strong activity
against tumor cell lines expressing either a single antigen, CD20
or CD22, or both simultaneously.
- In vivo pre-clinical models
demonstrates that UCART20x22 efficiently eradicates tumors
expressing both or either antigen, and sustained presence of
UCART20x22 cells was observed in the bone marrow after tumor
clearance.
- In vitro assays against primary
cells from NHL patients with diverse CD22 and CD20 antigen levels
demonstrate that UCART20x22 has potent and specific cytotoxic
activity.
-
UCART20x22 would be Cellectis’ first product candidate fully
designed, developed and manufactured in-house from day zero,
showcasing the Company’s transformation into an end-to-end cell and
gene therapy platform from discovery, product development and
manufacturing to clinical development.
-
An Investigational New Drug application (IND) for UCART20x22 is
expected to be filed this year.
Licensed Allogeneic CAR-T Cell Development
Programs
Allogene Therapeutics, Inc.’s CAR T programs
utilize Cellectis technologies. ALLO-501 and ALLO-501A are
anti-CD19 products being jointly developed under a collaboration
agreement between Les Laboratoires Servier (“Servier”) and Allogene
Therapeutics, Inc. (“Allogene”) based on an exclusive license
granted by Cellectis to Servier1. 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’s anti-BCMA and anti-CD70 programs are licensed
exclusively from Cellectis by Allogene and Allogene holds global
development and commercial rights to these programs.
Servier and Allogene: anti-CD19 programs
- Enrollment in
the Phase 1 ALLO-501A ALPHA2 trial in relapsed/refractory (r/r)
Large B Cell Lymphoma (LBCL) has re-opened with the goal of
offering AlloCAR T™ to patients while Allogene prepares to launch
the pivotal Phase 2 ALPHA2 trial. Allogene has announced that
subject to FDA discussion, including with respect to chemistry,
manufacturing and controls (CMC), Allogene plans to proceed to the
Phase 2 portion of the ALPHA2 trial in adult patients with r/r LBCL
in mid-2022.
Allogene: anti-BCMA and anti-CD70
programs
Anti-BCMA program
- Allogene announced that enrollment
had previously resumed in trials targeting BCMA for the treatment
of patients with r/r multiple myeloma (MM), including the UNIVERSAL
trial with ALLO-715 and the IGNITE trial with TurboCAR™ candidate,
ALLO-605. During the quarter, preclinical data was published
by Allogene demonstrating the superior long-term in vitro
myeloma-killing activity of allogeneic anti-BCMA CAR T cells from
healthy donors compared with anti-BCMA CAR T cells from patients
with MM. The findings were published in Cancer Research
Communications, a journal of the American Association for Cancer
Research (AACR).
- In May 2022, Allogene announced
that U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation (ODD) for ALLO-605 for the
treatment of MM. Allogene intends to provide an update on its
CD19 and BCMA programs by the end of the
year.
Anti-CD70 program
- ALLO-316 is Allogene’s first
AlloCAR T candidate for solid tumors. The Phase 1 TRAVERSE trial is
designed to evaluate the safety, tolerability, anti-tumor efficacy,
pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with
advanced or metastatic clear cell renal cell carcinoma (RCC).
Allogene announced that the trial, now in its second dose level
cohort, continues to accrue patients.
- In April 2022, Allogene presented
preclinical data at the 2022 AACR Annual Meeting which support the
ongoing clinical evaluation of ALLO-316 for the treatment of
patients with RCC and other CD70 expressing cancers. The findings
were simultaneously published in AACR’s Cancer
Research.
- In March 2022, Allogene announced
that the FDA granted ALLO-316 Fast Track Designation (FTD) based on
its potential to address the unmet need for patients with difficult
to treat RCC who have failed standard RCC
therapies.
Manufacturing Facilities
-
Cellectis’ starting materials manufacturing facility in Paris,
France is focusing on the production of starting materials
including plasmids and mRNA for our TALEN® gene editing technology,
as well as viral vectors for use in clinical manufacturing.
-
Cellectis’ UCART GMP manufacturing facility in Raleigh, North
Carolina is focusing on release testing of batches of product
candidates UCART22 and UCART20x22 as well as manufacturing
additional batches of these products.
Partnerships:
Iovance Biotherapeutics, Inc. (“Iovance”)
- On March 15,
2022 Iovance announced that the FDA allowed an IND to proceed for
its first genetically modified TIL therapy, IOV-4001, for the
treatment of unresectable or metastatic melanoma and stage III or
IV NSCLC.
- IOV-4001
leverages the gene editing TALEN® technology licensed from
Cellectis to inactivate the gene coding for the PD-1 protein. By
removal of this important barrier for T cells to attack cancer,
IOV-4001 has the potential to become an optimized, next generation
TIL therapy for several solid tumor cancers. Iovance announced that
a clinical study of IOV-4001 in patients with metastatic melanoma
or stage III or IV NSCLC is expected to begin this year.
- A poster
highlighting preclinical activity, clinical-scale manufacturing
process development, and characterization of IOV-4001 was presented
by Iovance at the AACR 2022 Annual Meeting. In the abstract,
anti-tumor activity of IOV-4001 was shown to be superior to
non-edited TIL, as well as to non-edited TIL in combination with
anti-PD-1, in a murine model.
- In January 2020,
Iovance and Cellectis entered into a research collaboration and
exclusive worldwide license agreement whereby Iovance licensed
certain TALEN® technology from Cellectis. The worldwide exclusive
license enables Iovance to use certain TALEN® technology addressing
multiple gene targets to modify TIL for therapeutic use in several
cancer indications.
Cytovia Therapeutics, Inc.
(“Cytovia”)
- On April 27,
2022, Cellectis received a $20 million convertible note (the “2022
Convertible Note”) in payment of the upfront collaboration
consideration provided for pursuant to the research collaboration
and non-exclusive license agreement entered between Cellectis and
Cytovia in February 2021. The 2022 Convertible Note superseded and
replaced the equity compensation initial requirement under the
collaboration and license agreement with Cytovia.
- The terms of the
note provide for conversion into common stock of the combined
company upon completion of the business combination of Cytovia with
Iselworth Healthcare Acquisition Corp., a special purpose
acquisition company. In connection with this convertible note,
Cellectis received a warrant to purchase additional shares of the
combined company representing up to 35% of the shares issued upon
conversion of the note at a predetermined exercise price, with the
number of shares issuable upon exercise and the exercise subject to
certain adjustments.
- Cellectis is
developing custom TALEN®, which Cytovia uses to edit iPSCs. Cytovia
is responsible for the differentiation and expansion of the
gene-edited iPSC master cell bank into NK cells and is conducting
the pre-clinical evaluation, clinical development, and
commercialization of the mutually-agreed-upon selected therapeutic
candidates. Cellectis has granted Cytovia a worldwide license under
the patent rights over which Cellectis has control in this field,
including in China, in order for Cytovia to modify NK cells to
address multiple gene-targets for therapeutic use in several cancer
indications.
Financial Results
The interim condensed consolidated financial
statements of Cellectis, which consolidate the results of Calyxt,
Inc. of which Cellectis owned approximately 56.1% of outstanding
shares of common stock (as of March 31, 2022), 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 Q1 2022 financial results press release.
Cash: As of March 31, 2022,
Cellectis, including Calyxt, had $160 million in consolidated cash,
cash equivalents, current financial assets and restricted cash of
which $142 million are attributable to Cellectis on a stand-alone
basis. This compares to $191 million in consolidated cash, cash
equivalents, current financial assets and restricted cash as of
December 31, 2021, of which $177 million was attributable to
Cellectis on a stand-alone basis. This net decrease of $31 million
primarily reflects (i) $33 million of net cash flows used in
operating, investing and lease financing activities of Cellectis,
(ii) $7 million of net cash flows used in operating, capital
expenditures and lease financing activities of Calyxt and (iii) $2
millions of unfavorable FOREX impact which was partially offset by
(iv) $10 million of net proceeds from capital raise at Calyxt.
Based on the current operating plan, Cellectis excluding Calyxt
anticipates that the cash, cash equivalents, and restricted cash of
$142 million as of March 31, 2022 will fund its operations into
early 2024.
Revenues and Other Income:
Consolidated revenues and other income were $4 million for the
three months ended March 31, 2022 compared to $28 million for the
three months ended March 31, 2021. 99% of consolidated revenues and
other income was attributable to Cellectis in the first three
months of 2022. This decrease between the three months ended March
31, 2022 and 2021 was mainly attributable to (i) a decrease of
revenue pursuant to the recognition of a $15.0 million convertible
note obtained as consideration for a “right-to-use” license granted
to Cytovia and a $5.0 million Allogene milestone during the
three-month period ended March 31, 2021, while revenue related to
collaboration agreements for the three months of 2022 consists of
the recognition of two milestones related to Cellectis’ agreement
with Cytovia for $1.5 million and (ii) a decrease in other revenues
of $5 million relating to the timing of revenue stream from the
Calyxt’s business model for its PlantSpring technology and
BioFactory compared to the Calyxt’s sales in the prior year of
soybean products.
Cost of Revenues: Consolidated
cost of revenues were $0.4 million for the three months ended March
31, 2022 compared to $8 million for the three months ended March
31, 2021. This decrease is driven by Calyxt’s business model for
its PlantSpring and BioFactory compared to the sales of soybean
products under its prior business model.
R&D Expenses: Consolidated
R&D expenses were $29 million for the three months ended March
31, 2022 compared to $31 million for the three months ended March
31, 2021. 90% of consolidated R&D expenses was attributable to
Cellectis in the first three months of 2022. The $2 million
decrease between the first three months of 2022 and 2021 was
primarily attributable to (i) a decrease of purchases, external
expenses and other by $2 million (from $18 million in 2021 to $16
million in 2022) due to lower consumables, subcontracting costs and
depreciation and amortization for the therapeutic segment, and (ii)
a $1 million decrease in social charges on stock option partially
offset by an increase of $2 million in wages and salaries mainly
driven by the increased R&D headcount in the therapeutic
segment.
SG&A Expenses: Consolidated
SG&A expenses were $9 million for the three months ended March
31, 2022 and 2021. 65% of consolidated SG&A expenses was
attributable to Cellectis in the first three months of 2022. The
$0.5 million increase primarily reflects a $1 million increase in
purchases, external expenses and other (from $4 million in 2021 to
$5 million in 2022) and (ii) a $3 million increase in non-cash
stock-based compensation expense mainly explained by the favorable
impact in 2021 of the recapture of non-cash stock-based
compensation from the forfeiture of certain of Calyxt’s former
CEO’s unvested stock options, restricted stock units, and
performance stock units following his departure, partially offset
by (i) a $3 million decrease in wages and salaries and (ii) a $0.3
million decrease in social charges on stock option grants.
Net Income (loss) Attributable to
Shareholders of Cellectis: The consolidated net loss
attributable to shareholders of Cellectis was $32 million (or $0.70
per share) for the three months ended March 31, 2022, of which $28
million was attributed to Cellectis, compared to $12 million (or
$0.28 per share) for the three months ended March 31, 2021, of
which $6 million was attributed to Cellectis. This $20 million
increase in net loss between first three months 2022 and 2021 was
primarily driven by a decrease in revenues and other income of $24
million, a decrease in financial gain of $4 million and a decrease
of $1 million in non-controlling interest, partially offset by a $9
million decrease in operating expenses.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $29 million
(or $0.64 per share) for the three months ended March 31, 2022, of
which $26 million is attributed to Cellectis, compared to a net
loss of $11 million (or $0.26 per share) for the three months ended
March 31, 2021, of which $4 million was attributed to Cellectis.
Please see "Note Regarding Use of Non-GAAP Financial Measures" for
reconciliation of GAAP net income (loss) attributable to
shareholders of Cellectis to adjusted net income (loss)
attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending
at Cellectis for the Full Year of 2022 in the following areas:
- Supporting the development of our
pipeline of product candidates, including the manufacturing and
clinical trial expenses of UCART123, UCART22, UCARTCS1 and new
product candidates, and
- Operating our state-of-the-art
manufacturing capabilities in Paris (France), and Raleigh (North
Carolina, U.S.A); and
- Continuing strengthening our
manufacturing and clinical departments.
CELLECTIS S.A.
(unaudited)
STATEMENT OF CONSOLIDATED FINANCIAL
POSITION
($ in thousands, except per share
data)
|
|
As of |
|
|
December 31, 2021 |
|
March 31, 2022 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
1 854 |
|
|
1 698 |
|
Property, plant, and
equipment |
|
78 846 |
|
|
76 523 |
|
Right-of-use assets |
|
69 423 |
|
|
67 227 |
|
Non-current financial
assets |
|
6 524 |
|
|
6 567 |
|
Total non-current
assets |
|
156 647 |
|
|
152 016 |
|
|
|
|
|
|
Current
assets |
|
|
|
|
Trade receivables |
|
20 361 |
|
|
21 839 |
|
Subsidies receivables |
|
9 268 |
|
|
10 446 |
|
Other current assets |
|
9 665 |
|
|
7 524 |
|
Cash and cash equivalent and
Current financial assets |
|
186 135 |
|
|
155 367 |
|
Total current
assets |
|
225 429 |
|
|
195 175 |
|
TOTAL
ASSETS |
|
382 076 |
|
|
347 191 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Share capital |
|
2 945 |
|
|
2 945 |
|
Premiums related to the share
capital |
|
934 696 |
|
|
937 333 |
|
Currency translation
adjustment |
|
(18 021 |
) |
|
(21 261 |
) |
Retained earnings |
|
(584 129 |
) |
|
(696 062 |
) |
Net income (loss) |
|
(114 197 |
) |
|
(31 911 |
) |
Total shareholders’
equity - Group Share |
|
221 293 |
|
|
191 044 |
|
Non-controlling interests |
|
15 181 |
|
|
12 010 |
|
Total shareholders’
equity |
|
236 474 |
|
|
203 054 |
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Non-current financial
liabilities |
|
20 030 |
|
|
18 345 |
|
Non-current lease debts |
|
71 526 |
|
|
69 739 |
|
Non-current provisions |
|
4 073 |
|
|
3 716 |
|
Non-current liabilities |
|
626 |
|
|
- |
|
Total non-current
liabilities |
|
96 254 |
|
|
91 800 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Current financial
liabilities |
|
2 354 |
|
|
12 607 |
|
Current lease debts |
|
8 329 |
|
|
8 408 |
|
Trade payables |
|
23 762 |
|
|
20 921 |
|
Deferred revenues and deferred
income |
|
301 |
|
|
581 |
|
Current provisions |
|
871 |
|
|
578 |
|
Other current liabilities |
|
13 731 |
|
|
9 242 |
|
Total current
liabilities |
|
49 348 |
|
|
52 337 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
382 076 |
|
|
347 191 |
|
Cellectis S.A.
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONS
For the three-month period ended March
31,
$ in thousands, except per share
amounts
|
|
For the three-month period ended March 31, |
|
|
2021 |
|
|
2022 |
|
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
25 601 |
|
|
1 697 |
|
Other income |
|
2 365 |
|
|
2 135 |
|
Total revenues and
other income |
|
27 966 |
|
|
3 832 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(8 145 |
) |
|
(385 |
) |
Research and development
expenses |
|
(31 004 |
) |
|
(29 479 |
) |
Selling, general and
administrative expenses |
|
(8 779 |
) |
|
(9 279 |
) |
Other operating income
(expenses) |
|
56 |
|
|
65 |
|
Total operating
expenses |
|
(47 872 |
) |
|
(39 078 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(19 907 |
) |
|
(35 247 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
4 561 |
|
|
490 |
|
|
|
|
|
|
Net income
(loss) |
|
(15 346 |
) |
|
(34 757 |
) |
Attributable to shareholders of Cellectis |
|
(11 868 |
) |
|
(31 911 |
) |
Attributable to non-controlling interests |
|
(3 478 |
) |
|
(2 846 |
) |
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0,28 |
) |
|
(0,70 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0,28 |
) |
|
(0,70 |
) |
CELLECTIS S.A.
DETAILS OF KEY PERFORMANCE INDICATORS BY
REPORTABLE SEGMENTS – First
three-months
(unaudited) - ($ in
thousands)
|
|
For the three-month period ended March 31,
2021 |
|
For the three-month period ended March 31,
2022 |
$ in
thousands |
|
Plants |
Therapeutics |
Total reportable segments |
|
Plants |
Therapeutics |
Total reportable segments |
|
|
|
|
|
|
|
|
|
External revenues |
|
4 988 |
|
20 613 |
|
25 601 |
|
|
32 |
|
1 665 |
|
1 697 |
|
External other income |
|
- |
|
2 365 |
|
2 365 |
|
|
- |
|
2 135 |
|
2 135 |
|
External revenues and
other income |
|
4 988 |
|
22 978 |
|
27 966 |
|
|
32 |
|
3 800 |
|
3 832 |
|
Cost of revenue |
|
(7 369 |
) |
(776 |
) |
(8 145 |
) |
|
(0 |
) |
(385 |
) |
(385 |
) |
Research and development
expenses |
|
(3 025 |
) |
(27 979 |
) |
(31 004 |
) |
|
(2 878 |
) |
(26 601 |
) |
(29 479 |
) |
Selling, general and
administrative expenses |
|
(4 118 |
) |
(4 660 |
) |
(8 779 |
) |
|
(3 216 |
) |
(6 063 |
) |
(9 279 |
) |
Other operating income and
expenses |
|
(24 |
) |
80 |
|
56 |
|
|
43 |
|
21 |
|
65 |
|
Total operating
expenses |
|
(14 536 |
) |
(33 336 |
) |
(47 872 |
) |
|
(6 050 |
) |
(33 028 |
) |
(39 078 |
) |
Operating income
(loss) before tax |
|
(9 548 |
) |
(10 358 |
) |
(19 907 |
) |
|
(6 019 |
) |
(29 228 |
) |
(35 247 |
) |
Net financial gain (loss) |
|
(290 |
) |
4 851 |
|
4 561 |
|
|
(422 |
) |
912 |
|
490 |
|
Net income
(loss) |
|
(9 839 |
) |
(5 507 |
) |
(15 346 |
) |
|
(6 441 |
) |
(28 316 |
) |
(34 757 |
) |
Non-controlling interests |
|
3 478 |
|
- |
|
3 478 |
|
|
2 846 |
|
- |
|
2 846 |
|
Net income (loss)
attributable to shareholders of Cellectis |
|
(6 361 |
) |
(5 507 |
) |
(11 868 |
) |
|
(3 595 |
) |
(28 316 |
) |
(31 911 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
|
262 |
|
1 305 |
|
1 567 |
|
|
(11 |
) |
1 680 |
|
1 669 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
|
(1 295 |
) |
323 |
|
(973 |
) |
|
342 |
|
636 |
|
979 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
|
(1 033 |
) |
1 628 |
|
595 |
|
|
332 |
|
2 316 |
|
2 648 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(7 394 |
) |
(3 879 |
) |
(11 273 |
) |
|
(3 263 |
) |
(26 000 |
) |
(29 263 |
) |
Depreciation and
amortization |
|
(604 |
) |
(3 186 |
) |
(3 791 |
) |
|
(708 |
) |
(4 934 |
) |
(5 641 |
) |
Additions to tangible and
intangible assets |
|
268 |
|
6 332 |
|
6 601 |
|
|
363 |
|
581 |
|
945 |
|
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 – First three-months
(unaudited)
($ in thousands, except per share
data)
|
|
For the three-month period ended March 31, |
|
|
2021 |
|
|
2022 |
|
|
|
|
|
Net income (loss)
attributable to shareholders of Cellectis |
|
(11 868 |
) |
|
(31 911 |
) |
Adjustment:
Non-cash stock-based
compensation expense attributable to shareholders of Cellectis |
|
595 |
|
|
2 648 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(11 273 |
) |
|
(29 263 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0,26 |
) |
|
(0,64 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) (1) |
|
42 866 517 |
|
|
45 486 477 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0,26 |
) |
|
(0,64 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) (1) |
|
43 461 047 |
|
|
45 486 477 |
|
(1) When we have adjusted net loss, in
accordance with IFRS, we use the Weighted average number of
outstanding shares, basic to compute the Diluted adjusted net
income (loss) attributable to shareholders of Cellectis ($/share).
When we have adjusted net income, in accordance with IFRS, we use
the Weighted average number of outstanding shares, diluted to
compute the Diluted adjusted net income (loss) attributable to
shareholders of Cellectis ($/share)
About Cellectis Cellectis
is a clinical-stage 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 22 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 lysosomal 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).
AlloCAR T™ is a trademark of Allogene
Therapeutics, Inc.
For more information,
visit www.cellectis.com Follow
Cellectis on social media: @cellectis, LinkedIn and YouTube.
For further information, please
contact:
Media contacts: Pascalyne
Wilson, Director, Communications, +33776991433,
media@cellectis.com
Margaret Gandolfo, Senior Manager, Communications, +1 (646) 628
0300
Investor Relation contact: Arthur Stril,
Chief Business Officer, +1 (347) 809 5980,
investors@cellectis.com
Ashley R. Robinson, LifeSci Advisors, +1 (617) 430 7577
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,” “believe,” “intend”, “expect,” “plan,” “scheduled,”
“could,” “would” 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
(including with respect to patient enrollment and follow-up), the
timing of our presentation of data and submission of regulatory
filings, the operational capabilities at our manufacturing
facilities, the potential of our preclinical programs, 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 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, 2021 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 Servier is a global independent pharmaceutical group
- 20220512-Q1_2022_EARNINGS _FINAL.pdf
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