Cellectis Provides Business Updates and Financial Results for Third
Quarter 2024
-
UCART22 and UCART20x22: enrollment ongoing, Phase 1 dataset and
late-stage development strategy to be presented in 2025
-
AstraZeneca partnership: R&D activities are ongoing on
three programs – one allogeneic CAR T for hematological
malignancies, one allogeneic CAR T for solid tumors, and one in
vivo gene therapy for a genetic disorder
-
Appointed Adrian Kilcoyne, M.D., MPH, MBA, an industry leader
in the advancement of cell therapy treatment, as Chief Medical
Officer
- Cash
position of $264 million as of September 30,
20241; cash runway projection into
2027
-
Conference call scheduled for 8:00 am ET / 2:00 pm CET on
November 5, 2024
NEW YORK, Nov. 04, 2024 (GLOBE NEWSWIRE) --
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 reported financial results for
the nine-month period ending September 30, 2024.
“This quarter, we were thrilled to welcome Dr.
Kilcoyne to Cellectis as Chief Medical Officer. Dr. Kilcoyne joins
us at a pivotal time for the Company, bringing extensive experience
in drug development as we are progressing in our clinical programs.
We expect to present Phase 1 dataset and late-stage development
strategy in 2025 for UCART22 in ALL and UCART20x22 for NHL” said
André Choulika, Ph.D., Chief Executive Officer at Cellectis.
“Additionally, we are excited to announce that
research and development activities have started for three programs
under our collaboration and research agreement with AstraZeneca:
one allogeneic CAR T for hematological malignancies, one allogeneic
CAR T for solid tumors, and one in vivo gene
therapy for a genetic disorder.
Cellectis is confident about the continued
progress of its ongoing clinical trials in hematological
malignancies and is excited about our strategic collaboration with
AstraZeneca, with whom we continue to advance our ambition in cell
and gene therapy to bring potentially lifesaving therapies to
patients with unmet medical needs."
________________________
1 Cash position includes cash, cash equivalents,
restricted cash and fixed-term deposits classified as current
financial assets. Restricted cash was $5 million as of September
30, 2024. Fixed-term deposits classified as current financial
assets were $100 million as of September 30, 2024.
Pipeline Highlights
UCART Clinical Programs
- Cellectis continues to focus on the
enrollment of patients in the BALLI-01 study, evaluating UCART22 in
relapsed or refractory B-cell acute lymphoblastic leukemia. We
expect to present the Phase 1 dataset and late-stage development
strategy in 2025.
- Cellectis continues to focus on the
enrollment of patients in the NATHALI-01 study, evaluating
UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma.
We expect to present the Phase 1 dataset and late-stage development
strategy in 2025.
- The Company decided to focus its
current development efforts on the BALLI-01 and NATHALI-01 studies
and therefore to deprioritize the development of UCART123,
currently evaluated in relapsed or refractory acute myeloid
leukemia. Up to now, this study has provided important insights
into the role of CD123-targeted allogeneic CAR-T therapy in
relapsed refractory acute myeloid leukemia and the future
development of our allogeneic CAR-T platform.
MUC1 CAR T-cells for treating
Triple-Negative Breast Cancer
-
On September 3, 2024, Cellectis published a scientific article in
Science Advances suggesting that TALEN®-edited MUC1 CAR T-cells
could be a potential treatment option for advance-stage triple
negative breast cancer (TNBC) patients with limited therapeutic
options. In this article, Cellectis described its CAR T-cell
engineering strategy using TALEN® and synthetic biology to
multi-armor CAR T-cells with synergistic functionalities to
overcome the immunosuppressive tumor microenvironment of solid
tumors.
Partnerships
Servier and Allogene – Allogeneic
CAR-T
Allogene’s investigational oncology products
utilize Cellectis technologies.
- Allogene announced that the pivotal
Phase 2 ALPHA3 trial was initiated in June 2024. This study is
evaluating the use of cemacabtagene ansegedleucel (cema-cel) as
part of the first line (1L) treatment regimen for patients with
LBCL who are likely to relapse after standard 1L treatment.
Allogene announced that ALPHA3 is the first pivotal trial to offer
CAR T as part of 1L treatment consolidation.
- Allogene announced that enrollment
is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase
1 ALPHA2 trial of cema-cel, and that initial data readout from the
CLL cohort is projected by early 2025.
- Allogene announced that a Phase 1
data update of the TRAVERSE trial of ALLO-316 from approximately 20
patients with CD70 positive RCC is planned by YE 2024. In October
2024, Allogene announced that the U.S. Food and Drug Administration
(FDA) granted Regenerative Medicine Advanced Therapy (RMAT)
designation to ALLO-316 for the treatment of adult patients with
CD70 positive advanced or metastatic renal cell carcinoma
(RCC).
AstraZeneca – Joint Research and
Collaboration Agreement
- Under the terms of the joint
research and collaboration agreement entered into by Cellectis and
AstraZeneca Ireland Limited (“AstraZeneca”) on November 1, 2023
(the “AZ JRCA”), AstraZeneca is leveraging Cellectis’ proprietary
gene editing technologies and manufacturing capabilities to design
novel cell and gene therapy candidate products. As part of the AZ
JRCA, 25 genetic targets have been exclusively reserved for
AstraZeneca, from which up to 10 candidate products could be
explored for development. AstraZeneca has an option for a worldwide
exclusive license on the candidate products, to be exercised before
IND filing.
- Research and development activities
under three cell and gene therapy programs have already started
under the AZ JRCA: one allogeneic CAR T for hematological
malignancies, one allogeneic CAR T for solid tumors, and
one in vivo gene therapy for a genetic
disorder.
-
Under the AZ JRCA, $47m have been triggered so far (of which $25m
upfront and $22m reached development milestones for the three
initial projects), in addition to reimbursement of research costs
incurred under the AZ JRCA.
Appointment
- On August 7, 2024, Cellectis
announced the appointment of Adrian Kilcoyne, M.D., MPH, MBA as its
Chief Medical Officer.
- Before joining Cellectis, Dr.
Kilcoyne was Chief Medical Officer and Head of Research and
Development at Celularity, advancing their oncology allogeneic
CAR-T and NK Cell therapy programs. Prior to this, he was Chief
Medical Officer at Humanigen. He has held numerous Oncology
leadership roles across Research and Development, Medical Affairs,
Commercial, Health Economic Outcome Research and Evidence
Generation in both large pharmaceutical and biotechnology companies
such as AstraZeneca and Celgene. Dr. Kilcoyne graduated from
Trinity College, Dublin Medical School. He initially trained in
Gynecological Oncology at the Hammersmith Hospital in London and
subsequently in Public Health Medicine at Oxford during which time
he completed a Master’s in Public Health. Dr. Kilcoyne then trained
in pharmaceutical medicine and completed his MBA.
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”).
As from June 1, 2023, and the deconsolidation of
Cibus, Inc. (formerly Calyxt, Inc.) (“Cibus”) which corresponded to
the Plants operating segment, we view our operations and manage our
business in a single operating and reportable segment corresponding
to the Therapeutics segment. For this reason, we are no longer
presenting financial measures broken down between our two
reportable segments – Therapeutics and Plants. In the appendices of
this Q3 2024 financial results press release, Cibus' results are
isolated under "Income (loss) from discontinued operations" for the
9-month period ended September 30, 2023, and are no longer included
for the 9-month period ended September 30, 2024, due to the
deconsolidation.
Cash: As of September 30, 2024,
Cellectis had $264 million in consolidated cash, cash equivalents,
restricted cash and fixed-term deposits classified as
current-financial assets. This compares to $156 million in
consolidated cash, cash equivalents, restricted cash and fixed-term
deposits classified as current-financial assets as of December 31,
2023. This $108 million increase is mainly due to $140 million cash
received from AstraZeneca as part of its equity investment in
Cellectis, $16 million cash received from European Investment Bank
(“EIB”) pursuant to the disbursement of the €15 million Tranche B
under the Finance Contract with EIB, $8 million of cash-in from our
financial investments, $27 million of cash-in from our revenue,
partially offset by cash payments from Cellectis to suppliers of
$42 million, including $30 million to R&D suppliers and $12
million to SG&A suppliers, Cellectis’ wages, bonuses and social
expenses paid of $32 million, the payments of lease debts of $8
million and the repayment of the “PGE” loan of $4 million.
With cash and cash equivalents of $159 million
and $100 million term deposit classified as current financial
assets as of September 30, 2024, the Company believes its cash and
cash equivalents and deposits will be sufficient to fund its
operations into 2027.
Revenues and Other Income:
Consolidated revenues and other income were $34.1 million for the
nine months ended September 30, 2024 compared to $7.2 million for
the nine months ended September 30, 2023. This $26.8 million
increase between the nine months ended September 30, 2023 and 2024
was mainly attributable to (i) recognition of a $28.3 million
revenue in 2024 based (a) on the progress of our performance
obligation rendered under the three programs under the AZ JRCA and
(b) the reaching of a development milestone under the License,
Development and Commercialization Agreement dated March 6, 2019
between Les Laboratoires Servier and Institut de Recherches
Internationales Servier (together “Servier”) and Cellectis as
amended (the “Servier License Agreement”), and (ii) a $1.5 million
decrease in other income.
R&D Expenses: Consolidated
R&D expenses were $69.7 million for the nine months ended
September 30, 2024, compared to $62.7 million for the nine months
ended September 30, 2023. R&D personnel expenses increased by
$2.1 million from $25.7 million in 2023 to $27.8 million in 2024
mainly due to a reversal in September 2023 in non-cash stock-based
compensation expense. R&D purchases, external expenses and
other increased by $4.9 million (from $37.0 million in 2023 to
$41.9 million in 2024) mainly related to increase in manufacturing
activities to support our R&D pipeline.
SG&A Expenses: Consolidated
SG&A expenses were $14.2 million for the nine months ended
September 30, 2024 compared to $12.1 million for the nine months
ended September 30, 2023. SG&A personnel expenses increased by
$0.5 million (from $5 million in 2023 to $5.6 million in 2024).
SG&A purchases, external expenses and other increased by $1.5
million (from $7.1 million in 2023 to $8.6 million in 2024).
Other operating income and
expenses: Other operating income and expenses were a $0.9
million net income for the nine months ended September 30, 2024
compared to a $0.1 million net expense for the nine months ended
September 30, 2023. Other operating income increased by $1 million
primarily due to the recognition of revenues from American
Depository Shares (“ADS”) movements of $0.5 million and $0.3
million related to the subleased portion of our premises in
New-York.
Net financial gain (loss): We
had a consolidated net financial gain of $5.7 million for the nine
months ended September 30, 2024, compared to a $7 million loss for
the nine months ended September 30, 2023. This $12.6 million
difference reflects mainly (i) a $14.3 million gain in change in
fair value of SIA derivative instrument, (ii) a $5.6 million
increase in gain from our financial investments, (iii) a $2.6
million gain in change in fair value of EIB Tranche A and Tranche
B, (iv) the loss in fair value measurement on Cytovia convertible
note recognized in the nine months period ended September 30, 2023
of $7.9 million, partially offset by (i) an increase of $1.8
million in interest expense on Tranche A and Tranche B of the EIB
Finance Contractand (ii) a $5.3 million increase in foreign
exchange loss, (iii) a decrease in net foreign exchange gain of
$8.6 million and (iv) a $1.5 million increase of the loss in fair
value of our investment in Cibus.
Net income (loss) from discontinued
operations: Net income from discontinued operations of
$8.4 million for the nine months ended September 30, 2023
corresponded to Calyxt’s results. Since Cibus has been
deconsolidated since June 1, 2023, there is no longer any "Income
(loss) from discontinued operations" for the nine months ended
September 30, 2024.
Net Income (loss) Attributable to
Shareholders of Cellectis: Consolidated net loss
attributable to shareholders of Cellectis was $42.7 million (or a
$0.49 loss per share) for the nine months ended September 30, 2024,
compared to a $59.3 million loss (or a $1.09 loss per share) for
the nine months ended September 30, 2023, of which $75 million was
attributed to Cellectis continuing operations. The $24 million
change in net loss was primarily driven by (i) an increase in
revenues and other income of $26.8 million, (ii) a $12.6 million
change from a net financial loss of $7 million to a net financial
gain of $5.7 million and (iii) a decrease in net other operating
expense of $1 million, and (iv) a $8.4 million decrease in net
income from discontinued operations attributable to shareholders of
Cellectis, partially offset by (i) an increase of $6.4 million in
purchases, external expenses and other, and a (ii) an increase of
$0.8 million in wages and (iii) an increase of $1.7 million in
non-cash stock based compensation expense.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: Consolidated adjusted net
loss attributable to shareholders of Cellectis was $40.4 million
(or a $0.46 loss per share) for the nine months ended September 30,
2024, compared to a net loss of $56.8 million (or a $1.05 loss per
share) for the nine months ended September 30, 2023.
Please see "Note Regarding Use of Non-IFRS
Financial Measures" for reconciliation of GAAP net income (loss)
attributable to shareholders of Cellectis to adjusted net income
(loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending
at Cellectis for 2024 in the following areas:
- supporting the development of our
pipeline of product candidates, including the manufacturing and
clinical trial expenses of UCART22, UCART20x22 and potential new
product candidates,
- and operating our state-of-the-art
manufacturing capabilities in Paris (France), and Raleigh (North
Carolina, USA).
|
CELLECTIS S.A. |
|
STATEMENT OF CONSOLIDATED FINANCIAL POSITION
(unaudited) |
|
($ in thousands) |
|
|
| |
As of |
|
|
December 31, 2023 |
|
September 30, 2024 |
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
671 |
|
|
691 |
|
|
Property, plant, and equipment |
54,681 |
|
|
48,956 |
|
|
Right-of-use assets |
38,060 |
|
|
32,225 |
|
|
Non-current financial assets |
7,853 |
|
|
7,651 |
|
| Other
non-current assets |
0 |
|
|
11,120 |
|
|
Deferred tax assets |
0 |
|
|
803 |
|
|
Total non-current assets |
101,265 |
|
|
101,445 |
|
|
Current assets |
|
|
|
| Trade
receivables |
569 |
|
|
11,180 |
|
|
Subsidies receivables |
20,900 |
|
|
15,661 |
|
| Other
current assets |
7,722 |
|
|
6,643 |
|
| Cash
and cash equivalent and Current financial assets |
203,815 |
|
|
260,947 |
|
|
Total current assets |
233,005 |
|
|
294,431 |
|
|
TOTAL ASSETS |
334,270 |
|
|
395,876 |
|
|
LIABILITIES |
|
|
|
|
Shareholders’ equity |
|
|
|
| Share
capital |
4,365 |
|
|
5,906 |
|
|
Premiums related to the share capital |
522,785 |
|
|
607,153 |
|
|
Currency translation adjustment |
(36,690 |
) |
|
(35,154 |
) |
|
Retained earnings |
(304,707 |
) |
|
(405,798 |
) |
| Net
income (loss) |
(101,059 |
) |
|
(42,683 |
) |
|
Total shareholders’ equity - Group Share |
84,695 |
|
|
129,424 |
|
|
Non-controlling interests |
0 |
|
|
0 |
|
|
Total shareholders’ equity |
84,695 |
|
|
129,424 |
|
|
Non-current liabilities |
|
|
|
|
Non-current financial liabilities |
49,125 |
|
|
61,575 |
|
|
Non-current lease debts |
42,948 |
|
|
36,683 |
|
|
Non-current provisions |
2,200 |
|
|
2,427 |
|
|
Deferred tax liabilities |
158 |
|
|
118 |
|
|
Total non-current liabilities |
94,431 |
|
|
100,802 |
|
|
Current liabilities |
|
|
|
|
Current financial liabilities |
5,289 |
|
|
5,350 |
|
|
Current lease debts |
8,502 |
|
|
8,508 |
|
| Trade
payables |
19,069 |
|
|
18,511 |
|
|
Deferred revenues and deferred income |
110,325 |
|
|
122,006 |
|
|
Current provisions |
1,740 |
|
|
899 |
|
| Other
current liabilities |
10,219 |
|
|
10,376 |
|
|
Total current liabilities |
155,144 |
|
|
165,650 |
|
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
334,270 |
|
|
395,876 |
|
|
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONS |
|
For the three-month period ended September 30,
2024 |
|
($ in thousands, except per share amounts) |
|
|
|
|
For the three-month period ended
September 30, |
| |
2023* |
|
2024 |
|
| |
|
|
|
Revenues and other income |
|
|
|
|
Revenues |
155 |
|
|
16,200 |
|
| Other
income |
1,489 |
|
|
1,851 |
|
|
Total revenues and other income |
1,644 |
|
|
18,050 |
|
|
Operating expenses |
|
|
|
|
Research and development expenses |
(19,075 |
) |
|
(23,829 |
) |
|
Selling, general and administrative expenses |
(3,227 |
) |
|
(5,167 |
) |
| Other
operating income (expenses) |
(12 |
) |
|
175 |
|
|
Total operating expenses |
(22,314 |
) |
|
(28,820 |
) |
| |
|
|
|
|
Operating income (loss) |
(20,671 |
) |
|
(10,769 |
) |
| |
|
|
|
|
Financial gain (loss) |
3,295 |
|
|
(12,346 |
) |
| |
|
|
|
|
Income tax |
(106 |
) |
|
59 |
|
|
Income (loss) from continuing operations |
(17,482 |
) |
|
(23,056 |
) |
|
Income (loss) from discontinued operations |
0 |
|
|
0 |
|
|
Net income (loss) |
(17,482 |
) |
|
(23,056 |
) |
|
Attributable to shareholders of Cellectis |
(17,482 |
) |
|
(23,056 |
) |
|
Attributable to non-controlling interests |
(0 |
) |
|
0 |
|
|
Basic and diluted net income (loss) attributable to
shareholders of Cellectis, per share ($/share) |
(0.31 |
) |
|
(0.23 |
) |
|
Diluted net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
(0.31 |
) |
|
(0.23 |
) |
|
Basic and diluted net income (loss) attributable to
shareholders of Cellectis from discontinued operations, per share
($ /share) |
0.00 |
|
|
0.00 |
|
|
Diluted net income (loss) attributable to shareholders of
Cellectis from discontinued operations, per share ($
/share) |
0.00 |
|
|
0.00 |
|
|
|
|
|
|
|
Number of shares used for computing |
|
|
|
|
Basic |
55,583,768 |
|
|
100,093,635 |
|
|
Diluted |
55,583,768 |
|
|
100,093,635 |
|
*These amounts reflect Calyxt's adjustments as presented in
Cellectis 2023 20F (Note 3)
|
Cellectis S.A. |
|
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONS |
|
For the nine-month period ended September 30,
2024 |
|
($ in thousands, except per share amounts) |
|
|
|
|
For the nine-month period ended
September 30, |
| |
2023* |
|
2024 |
| |
|
|
|
Revenues and other income |
|
|
|
|
Revenues |
472 |
|
|
28,789 |
|
| Other
income |
6,731 |
|
|
5,263 |
|
|
Total revenues and other income |
7,203 |
|
|
34,052 |
|
|
Operating expenses |
|
|
|
|
Research and development expenses |
(62,690 |
) |
|
(69,670 |
) |
|
Selling, general and administrative expenses |
(12,141 |
) |
|
(14,153 |
) |
| Other
operating income (expenses) |
(96 |
) |
|
896 |
|
|
Total operating expenses |
(74,926 |
) |
|
(82,926 |
) |
| |
|
|
|
|
Operating income (loss) |
(67,723 |
) |
|
(48,874 |
) |
| |
|
|
|
|
Financial gain (loss) |
(6,952 |
) |
|
5,677 |
|
| |
|
|
|
|
Income tax |
(365 |
) |
|
514 |
|
|
Income (loss) from continuing operations |
(75,040 |
) |
|
(42,683 |
) |
|
Income (loss) from discontinued operations |
8,392 |
|
|
0 |
|
|
Net income (loss) |
(66,648 |
) |
|
(42,683 |
) |
|
Attributable to shareholders of Cellectis |
(59,264 |
) |
|
(42,683 |
) |
|
Attributable to non-controlling interests |
(7,384 |
) |
|
0 |
|
|
Basic net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
(1.09 |
) |
|
(0.49 |
) |
|
Diluted net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
(1.09 |
) |
|
(0.49 |
) |
|
Basic net income (loss) attributable to shareholders of
Cellectis from discontinued operations, per share ($
/share) |
0.29 |
|
|
0.00 |
|
|
|
|
|
|
|
Diluted net income (loss) attributable to shareholders of
Cellectis from discontinued operations, per share ($
/share) |
0.29 |
|
|
0.00 |
|
|
|
|
|
|
|
Number of shares used for computing |
|
|
|
|
Basic |
54,231,943 |
|
|
87,355,605 |
|
|
Diluted |
54,231,943 |
|
|
87,355,605 |
|
*These amounts reflect Calyxt's adjustments as presented in
Cellectis 2023 20F (Note 3)
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
(unaudited)
For the three-month period ended September 30,
2024
($ in thousands, except per share data) |
| |
| |
For the three-month period ended
September 30, |
| |
2023* |
|
2024 |
|
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
(17,482 |
) |
|
(23,056 |
) |
|
Adjustment: |
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
(2,653 |
) |
|
566 |
|
|
Adjusted net income (loss) attributable to shareholders of
Cellectis |
(20,135 |
) |
|
(22,490 |
) |
|
Basic adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) |
(0.36 |
) |
|
(0.22 |
) |
|
Basic adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations ($
/share) |
0.00 |
|
|
0.00 |
|
|
|
|
|
|
|
Weighted average number of outstanding shares, basic
(units) (1) |
55,583,768 |
|
|
100,093,635 |
|
|
|
|
|
|
|
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) (1) |
(0.36 |
) |
|
(0.22 |
) |
|
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations
($/share) |
0.00 |
|
|
0.00 |
|
|
|
|
|
|
|
Weighted average number of outstanding shares, diluted
(units) (1) |
55,583,768 |
|
|
100,093,635 |
|
*These amounts reflect Calyxt's adjustments as presented in
Cellectis 2023 20F (Note 3)
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME
(unaudited)
For the nine-month period ended September 30,
2024
($ in thousands, except per share data) |
| |
| |
For the nine-month period ended
September 30, |
| |
2023* |
|
2024 |
|
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
(59,264 |
) |
|
(42,683 |
) |
|
Adjustment: |
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
2,466 |
|
|
2,283 |
|
|
Adjusted net income (loss) attributable to shareholders of
Cellectis |
(56,798 |
) |
|
(40,400 |
) |
|
Basic adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) |
(1.05 |
) |
|
(0.46 |
) |
|
Basic adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations ($
/share) |
0.33 |
|
|
0.00 |
|
|
|
|
|
|
|
Weighted average number of outstanding shares, basic
(units) (1) |
54,231,943 |
|
|
87,355,605 |
|
|
|
|
|
|
|
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) (1) |
(1.05 |
) |
|
(0.46 |
) |
|
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations
($/share) |
0.33 |
|
|
0.00 |
|
|
|
|
|
|
|
Weighted average number of outstanding shares, diluted
(units) (1) |
54,231,943 |
|
|
87,355,605 |
|
*These amounts reflect Calyxt's adjustments as presented in
Cellectis 2023 20F (Note 3)
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 25
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).
To find out more, visit our website:
www.cellectis.com
Follow Cellectis on social networks @cellectis
on LinkedIn and X (formerly Twitter)
TALEN® is a registered trademark owned by
Cellectis.
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
“future,” “projection,” “will,” “may,” “could,” “expect,”
“suggest,” “potential,” “will,” and “believe” or the negative of
these and similar expressions. These forward-looking statements are
based on our management’s current expectations and assumptions and
on information currently available to management. Forward-looking
statements include statements about the advancement, timing and
progress of clinical trials, the timing of our presentation of
clinical data, the potential of our candidate products programs,
the advancement and potential of partnered research and development
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,
including the risk of losing the orphan drug designation if it is
established that the product no longer meets the orphan drug
criteria before market authorization is granted (if any). With
respect to our cash runway, our operating plans, including product
candidates 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, 2023 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 contacts:
Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14
33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46
93
Investor Relations
contact:
Arthur Stril, Interim Chief Financial Officer,
investors@cellectis.com
- PR_Earnings call Q3 2024_English_20241104 (2)
Cellectis Nom Eo 05 (EU:ALCLS)
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Cellectis Nom Eo 05 (EU:ALCLS)
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