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 six-month period ending June 30, 2024.
"Over the past months, we have achieved a
significant milestone with the granting of ODD designations by the
Food and Drug Administration and the European Commission,
complemented by the FDA’S Rare Pediatric Disease Designation. We
have overcome major challenges, which reflects our ongoing
commitment to innovation. Driven by an unwavering belief in our
ability to revolutionize the healthcare field, we continue our
pursuit of advancement with the confidence that our work will lead
to the launch of a life-saving drug product. Our determination is
the engine of our future success” said André Choulika, Ph.D., Chief
Executive Officer at Cellectis.
________________________
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 June 30,
2024. Fixed-term deposits classified as current financial assets
were $119 million as of June 30, 2024.
Pipeline Highlights
UCART Clinical Programs
- On June 4, 2024, Cellectis received Orphan Drug Designation
(ODD) from the European Commission (EC) for UCART22, for the
treatment of acute lymphoblastic leukemia (ALL). The Orphan Drug
Designation in the European Union is granted by the EC based on a
positive opinion issued by the European Medicines Agency (EMA)
Committee for Orphan Medicinal Products. This designation may allow
certain regulatory, financial, and commercial incentives to develop
medicines for rare diseases where there are no satisfactory
treatment options.
- On July 25, 2024, the FDA designated UCART22 as a drug for a
Rare Pediatric Disease (RPDD). This designation may allow to obtain
a “Priority Review Voucher” at the time of Biologics License
Application (BLA). The FDA also granted ODD to UCART22 product
candidate for ALL treatment. Receiving ODD by the FDA may help to
expedite and reduce the cost of development, approval, and
commercialization of a therapeutic agent.
- Patients with relapsed/refractory ALL have limited, if any,
treatment options, especially for those who have failed prior CD19
directed CAR T-cell therapy and allogeneic stem cell transplant.
These designations for UCART22 mark an important step towards
developing allogeneic CAR T products that would be readily
available for all patients.
- On August 1, 2024, the FDA granted ODD to Cellectis’ CLLS52
(alemtuzumab), an Investigational Medicinal Product (IMP) used as
part of the lymphodepletion regimen associated with UCART22,
evaluated in the BALLI-01 clinical trial. The importance of adding
alemtuzumab to the lymphodepletion regimen has been demonstrated in
Cellectis’ BALLI-01 study, where the addition of this
lymphodepletion agent to the fludarabine and cyclophosphamide
regimen was associated with sustained lymphodepletion and
significantly higher UCART22 cell expansion allowing for greater
clinical activity.
- 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, in the NatHaLi-01 study,
evaluating UCART20x22 in relapsed or refractory B-cell non-Hodgkin
lymphoma, and in the AMELI-01 study, evaluating UCART123 in
relapsed or refractory acute myeloid leukemia. We expect to provide
updates in the advancements of BALLI-01 until the end of the year
2024.
Research Data & Preclinical
Programs
Non-viral Gene Therapy Approach for
Sickle Cell Disease
- On June 12, 2024, Cellectis announces the publication of a
scientific article in Nature Communications.
- Cellectis leverages TALEN® technology and a non-viral gene
repair template delivery to develop a clinically relevant gene
editing process in hematopoietic stem and progenitor cells (HSPCs).
This process enables efficient HBB gene correction with high
precision, specificity and minimal genomic adverse
events.
- Applying this HBB gene correction process to SCD patient-HSPCs
results in over 50% expression of normal adult hemoglobin in mature
red blood cells and in the correction of sickle phenotype, without
inducing β-thalassemic phenotype. Edited HSPCs engraft efficiently
in an immunodeficient murine model and maintain clinically relevant
levels of HBB gene correction events. This comprehensive
preclinical data package sets the stage for the therapeutic
application of autologous gene corrected HSPCs to address SCD.
Partnerships
Licensed Allogeneic CAR T-cell
Development Programs
Anti-CD19 Programs
Allogene’s investigational oncology products
utilize Cellectis technologies.
We have initiated an arbitration proceeding
through the Centre de Médiation et d'Arbitrage de Paris. We are
requesting that the arbitral tribunal issue a decision (i)
terminating the Servier License Agreement, and (ii) requiring
Servier to pay us fair financial compensation for losses incurred
due to the lack of development of the licensed products and for
non-payment of milestone payments for milestones that have been
achieved under the Servier License Agreement.
In May 2024, Allogene announced the execution of
an Amendment and Settlement Agreement (the "Servier Amendment"),
which amended the license agreement between Servier and Allogene,
under which Servier exclusively sublicensed to Allogene its rights
under the License Agreement between Cellectis and Servier (the
"Servier License"), for the development and commercialization of
allogeneic anti-CD19 CAR T cell product candidates in the U.S. (the
"Allogene Sublicense"). Allogene disclosed that, pursuant to the
Servier Amendment to the Allogene Sublicense, the licensed
territory was expanded to include the European Union and the United
Kingdom, and Allogene was granted an option to further extend its
licensed territory to include China and Japan subject to certain
conditions.
Corporate Updates
Collaboration and Investment Agreements
with AstraZeneca
- On May 6, 2024, Cellectis announced the completion of the
subsequent investment of $140M in Cellectis by AstraZeneca
(LSE/STO/Nasdaq: AZN) (the “Additional Investment”).
- AstraZeneca subscribed for 10,000,000 “class A” convertible
preferred shares and 18,000,000 “class B” convertible preferred
shares, in each case at a price of $5.00 per convertible preferred
share, issued by the Board of Directors of Cellectis.
- On the completion date of the Additional Investment,
AstraZeneca owned approximately 44% of the share capital and 30% of
the voting rights of the Company (based on the number of voting
rights outstanding at the time).
- Following the Additional Investment, Mr. Marc Dunoyer and Dr.
Tyrell Rivers have been nominated members of the board of directors
of Cellectis, designated by AstraZeneca.
Annual Shareholders Meeting
- On June 28, 2024, Cellectis held a shareholders’ general
meeting at the Biopark auditorium in Paris, France.
- At the meeting, during which approximately 40% of shares were
exercised, resolutions 1 through 28 were adopted and resolution 29
was rejected, consistent with the recommendations of the
management. The detailed results of the vote and the resolutions
are available on Cellectis’ website:
https://www.cellectis.com/en/investors/general-meetings/
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
Calyxt, 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 Q2 2024 financial results press release,
Calyxt's results are isolated under "Income (loss) from
discontinued operations" for the 6-month period ended June 30,
2023, and are no longer included for the 6-month period ended June
30, 2024, due to the deconsolidation.
Cash: As of June 30, 2024,
Cellectis had $273 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 $117 million increase is mainly due to cash payments
from Cellectis to suppliers of $26 million, including $18 million
to R&D suppliers and $8 million to SG&A suppliers,
Cellectis’ wages, bonuses and social expenses paid of $24 million,
the payments of lease debts of $5 million and the repayment of the
“PGE” loan of $3 million, partially offset by the $16 million cash
received from EIB pursuant to the disbursement of the €15 million
Tranche B, $5 million of cash-in from our financial investments,
$14 million of cash-in from our revenue, $140 million cash received
from AstraZeneca as part of its equity investment in Cellectis.
With cash and cash equivalents of $149 million
and $119 million term deposit classified as current financial
assets as of June 30, 2024, the Company believes its cash and cash
equivalents and deposits will be sufficient to fund its operations
into 2026 and therefore for at least twelve months following the
unaudited interim condensed consolidated financial statements'
publication.
Revenues and Other Income:
Consolidated revenues and other income were $16.0 million for the
six months ended June 30, 2024 compared to $5.6 million for the six
months ended June 30, 2023. This $10.4 million increase between the
six months ended June 30, 2023 and 2024 was mainly attributable to
(i) recognition of a $12.3 million revenue in 2024 based (a) on the
progress of our performance obligation rendered under the first
research plan of the Joint Research and Collaboration Agreement
(the “JRCA”) signed with AstraZeneca Ireland Limited (AZ Ireland)
and (b) the reaching of a development milestone under the License
Agreement signed with Servier, while revenues recognized for the
six months ended June 30, 2023 were immaterial, (ii) a decrease of
research tax credit of $1.1 million due to a decrease of eligible
expenses, and (iii) the recognition in the six-month periods ended
June 30, 2023 of $0.8 million representing the portion of an
initial payments from BPI corresponding to a grant pursuant to our
grant and repayable advance agreement with BPI signed in March
2023.
R&D Expenses: Consolidated
R&D expenses were $45.8 million for the six months ended June
30, 2024, compared to $43.6 million for the six months ended June
30, 2023. R&D personnel expenses decreased by $0.8 million from
$20.0 million in 2023 to $19.2 million in 2024 primarily due to a
decrease in the average unit fair value of stock options and free
share awards vesting between the two periods. R&D purchases,
external expenses and other increased by $3.1 million (from $23.6
million in 2023 to $26.7 million in 2024) mainly related to
increase in manufacturing activities to support our R&D
pipeline.
SG&A Expenses: Consolidated
SG&A expenses were $9.0 million for the six months ended June
30, 2024 compared to $8.9 million for the six months ended June 30,
2023. SG&A personnel expenses decreased by $0.2 million (from
$4.0 million in 2023 to $3.8 million in 2024), with a $0.4 million
increase in salaries being offset by a $0.6 million decrease in
stock-based compensation expenses. SG&A purchases, external
expenses and other increased by $0.3 million (from $4.9 million in
2023 to $5.2 million in 2024).
Other operating income and
expenses: Other operating income and expenses were a $0.7
million net income for the six months ended June 30, 2024 compared
to a $0.1 million net expense for the six months ended June 30,
2023. Other operating income and expenses decreased by $0.8 million
primarily due to the recognition of costs related to a litigation
of $0.5 million in 2023.
Net financial gain (loss): We
had a consolidated net financial gain of $18.0 million for the six
months ended June 30, 2024, compared to a $10.2 million loss for
the six months ended June 30, 2023. This $28.3 million difference
reflects mainly (i) a $14.3 million gain in change in fair value of
SIA derivative instrument, (ii) a $3.2 million increase in gain
from our financial investments, (iii) a $4.3 million gain in change
in fair value of EIB tranche A and B, , (iv) a $5.5 million
decrease of the loss in fair value of our investment in Cibus and
(vi) the loss in fair value measurement on Cytovia convertible note
recognized in the six months period ended June 30, 2023 of $6.8
million, partially offset by (i) a $1.3 million interest expense on
EIB Tranche A and Tranche B loans and (ii) a $0.7 million increase
in foreign exchange loss, and (iii) a decrease in net foreign
exchange gain of $3.5 million.
Net income (loss) from discontinued
operations: Net income from discontinued operations of
$8.4 million for the six months ended June 30, 2023 corresponded to
Calyxt’s results. Since Calyxt has been deconsolidated since June
1, 2023, there is no longer any "Income (loss) from discontinued
operations" for the six months ended June 30, 2024.
Net Income (loss) Attributable to
Shareholders of Cellectis: Consolidated net loss
attributable to shareholders of Cellectis was $19.6 million (or a
$0.24 loss per share) for the six months ended June 30, 2024,
compared to a $41.8 million loss (or a $0.78 loss per share) for
the six months ended June 30, 2023, of which $57.6 million was
attributed to Cellectis continuing operations. The $29.5 million
change in net loss was primarily driven by (i) an increase in
revenues and other income of $10.4 million, (ii) a decrease of $1.5
million in non-cash stock based compensation expense due to a
decrease in the average unit fair value of stock options and free
share awards vesting between the two periods, (iii) a $28.3 million
change from a net financial loss of $10.2 million to a net
financial gain of $18.0 million and (iv) a decrease in net other
operating expense of $0.8 million, and (v) a $8.4 million decrease
in net income from discontinued operations attributable to
shareholders of Cellectis, partially offset by (i) an increase of
$3.3 million in purchases, external expenses and other, and a (ii)
an increase of $0.4 million in wages.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: Consolidated adjusted net
loss attributable to shareholders of Cellectis was $17.9 million
(or a $0.22 loss per share) for the six months ended June 30, 2024,
compared to a net loss of $36.7 million (or a $0.68 loss per share)
for the six months ended June 30, 2023.
Please see "Note Regarding Use of Non-IFRS
Financial Measures" for reconciliation of GAAP net income (loss)
attributable to shareholders of Cellectis to adjusted net income
(loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash spending
at Cellectis for 2024 in the following areas:
- Supporting the development of our
pipeline of product candidates, including the manufacturing and
clinical trial expenses of UCART22, UCART20x22, UCART123 and
potential new product candidates, and
- Operating our state-of-the-art
manufacturing capabilities in Paris (France), and Raleigh (North
Carolina, USA); and
- Continuing strengthening our
manufacturing and clinical departments.
|
CELLECTIS S.A.STATEMENT OF CONSOLIDATED
FINANCIAL POSITION (unaudited)($ in
thousands) |
| |
| |
|
As of |
| |
|
December 31, 2023 |
|
June 30, 2024 |
|
ASSETS |
|
|
|
|
| Non-current
assets |
|
|
|
|
|
Intangible assets |
|
671 |
|
|
653 |
|
| Property, plant, and
equipment |
|
54,681 |
|
|
50,370 |
|
| Right-of-use assets |
|
38,060 |
|
|
33,671 |
|
| Non-current financial
assets |
|
7,853 |
|
|
16,650 |
|
| Total non-current
assets |
|
101,265 |
|
|
101,344 |
|
| Current
assets |
|
|
|
|
| Trade receivables |
|
569 |
|
|
9,741 |
|
| Subsidies receivables |
|
20,900 |
|
|
14,958 |
|
| Other current assets |
|
7,722 |
|
|
7,587 |
|
| Current deferred tax
assets |
|
|
|
710 |
|
| Cash and cash equivalent and
Current financial assets |
|
203,815 |
|
|
272,806 |
|
| Total current
assets |
|
233,005 |
|
|
305,803 |
|
| TOTAL
ASSETS |
|
334,270 |
|
|
407,147 |
|
|
LIABILITIES |
|
|
|
|
| Shareholders’
equity |
|
|
|
|
| Share capital |
|
4,365 |
|
|
5,897 |
|
| Premiums related to the share
capital |
|
522,785 |
|
|
606,146 |
|
| Currency translation
adjustment |
|
(36,690 |
) |
|
(38,077 |
) |
| Retained earnings |
|
(304,707 |
) |
|
(405,729 |
) |
| Net income (loss) |
|
(101,059 |
) |
|
(19,627 |
) |
| Total shareholders’
equity - Group Share |
|
84,695 |
|
|
148,610 |
|
| Non-controlling interests |
|
0 |
|
|
0 |
|
| Total shareholders’
equity |
|
84,695 |
|
|
148,610 |
|
| Non-current
liabilities |
|
|
|
|
| Non-current financial
liabilities |
|
49,125 |
|
|
58,348 |
|
| Non-current lease debts |
|
42,948 |
|
|
38,362 |
|
| Non-current provisions |
|
2,200 |
|
|
2,194 |
|
| Non-current deferred tax
liabilities |
|
158 |
|
|
0 |
|
| Total non-current
liabilities |
|
94,431 |
|
|
98,904 |
|
| Current
liabilities |
|
|
|
|
| Current financial
liabilities |
|
5,289 |
|
|
5,119 |
|
| Current lease debts |
|
8,502 |
|
|
8,357 |
|
| Trade payables |
|
19,069 |
|
|
18,213 |
|
| Deferred revenues and deferred
income |
|
110,325 |
|
|
117,754 |
|
| Current provisions |
|
1,740 |
|
|
884 |
|
| Current deferred tax
liabilities |
|
|
|
122 |
|
| Other current liabilities |
|
10,219 |
|
|
9,184 |
|
| Total current
liabilities |
|
155,144 |
|
|
159,633 |
|
| TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
334,270 |
|
|
407,147 |
|
| |
|
UNAUDITED STATEMENTS OF CONSOLIDATED
OPERATIONSFor the three-month period ended June
30, 2024($ in thousands, except per share
amounts) |
| |
| |
|
For the three-month period ended June 30, |
| |
|
2023* |
|
2024 |
| |
|
|
|
| Revenues and other
income |
|
|
|
|
|
Revenues |
|
178 |
|
|
8,061 |
|
| Other income |
|
1,823 |
|
|
1,442 |
|
| Total revenues and
other income |
|
2,001 |
|
|
9,504 |
|
| Operating
expenses |
|
|
|
|
| Research and development
expenses |
|
(22,200 |
) |
|
(23,518 |
) |
| Selling, general and
administrative expenses |
|
(3,950 |
) |
|
(3,882 |
) |
| Other operating income
(expenses) |
|
528 |
|
|
686 |
|
| Total operating
expenses |
|
(25,622 |
) |
|
(26,714 |
) |
| |
|
|
|
|
| Operating income
(loss) |
|
(23,621 |
) |
|
(17,211 |
) |
| |
|
|
|
|
| Financial gain
(loss) |
|
(5,844 |
) |
|
(8,251 |
) |
| |
|
|
|
|
| Income
tax |
|
(258 |
) |
|
193 |
|
| Income (loss) from continuing
operations |
|
(29,724 |
) |
|
(25,270 |
) |
| Income (loss) from
discontinued operations |
|
13,083 |
|
|
0 |
|
| Net income
(loss) |
|
(16,641 |
) |
|
(25,270 |
) |
|
Attributable to shareholders of Cellectis |
|
(11,707 |
) |
|
(25,270 |
) |
|
Attributable to non-controlling interests |
|
(4,934 |
) |
|
0 |
|
| Basic and diluted net
income (loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.20 |
) |
|
(0.28 |
) |
| Diluted net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.20 |
) |
|
(0.28 |
) |
| Basic and diluted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations, per share ($ /share) |
|
0.32 |
|
|
0.00 |
|
| Diluted net income
(loss) attributable to shareholders of Cellectis from discontinued
operations, per share ($ /share) |
|
0.32 |
|
|
0.00 |
|
| |
|
|
|
|
| Number of shares used for
computing |
|
|
|
|
|
Basic |
|
55,583,768 |
|
|
89,852,142 |
|
|
Diluted |
|
55,583,768 |
|
|
89,852,142 |
|
|
|
|
|
|
|
|
|
*These amounts reflect Calyxt's adjustments as presented in
Cellectis 2023 20F (Note 3)
|
Cellectis S.A.UNAUDITED STATEMENTS OF
CONSOLIDATED OPERATIONSFor the six-month period
ended June 30, 2024($ in thousands, except per
share amounts) |
| |
| |
|
For the six-month period ended June 30, |
| |
|
2023* |
|
2024 |
| |
|
|
|
| Revenues and other
income |
|
|
|
|
|
Revenues |
|
317 |
|
|
12,589 |
|
| Other income |
|
5,242 |
|
|
3,412 |
|
| Total revenues and
other income |
|
5,560 |
|
|
16,002 |
|
| Operating
expenses |
|
|
|
|
| Research and development
expenses |
|
(43,614 |
) |
|
(45,841 |
) |
| Selling, general and
administrative expenses |
|
(8,914 |
) |
|
(8,986 |
) |
| Other operating income
(expenses) |
|
(83 |
) |
|
721 |
|
| Total operating
expenses |
|
(52,612 |
) |
|
(54,107 |
) |
| |
|
|
|
|
| Operating income
(loss) |
|
(47,053 |
) |
|
(38,105 |
) |
| |
|
|
|
|
| Financial gain
(loss) |
|
(10,246 |
) |
|
18,023 |
|
| |
|
|
|
|
| Income
tax |
|
(258 |
) |
|
455 |
|
| Income (loss) from continuing
operations |
|
(57,557 |
) |
|
(19,627 |
) |
| Income (loss) from
discontinued operations |
|
8,392 |
|
|
0 |
|
| Net income
(loss) |
|
(49,165 |
) |
|
(19,627 |
) |
|
Attributable to shareholders of Cellectis |
|
(41,781 |
) |
|
(19,627 |
) |
|
Attributable to non-controlling interests |
|
(7,384 |
) |
|
0 |
|
| Basic net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.78 |
) |
|
(0.24 |
) |
| Diluted net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.78 |
) |
|
(0.24 |
) |
| 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 |
|
53,541,010 |
|
|
80,881,026 |
|
|
Diluted |
|
53,541,010 |
|
|
80,881,026 |
|
|
|
|
|
|
|
|
|
*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 June
30, 2024($ in thousands, except per share
data) |
| |
| |
|
For the three-month period ended June 30, |
| |
|
2023* |
|
2024 |
| |
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(11,707 |
) |
|
(25,270 |
) |
| Adjustment: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
|
3,140 |
|
|
830 |
|
| Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(8,567 |
) |
|
(24,440 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.15 |
) |
|
(0.27 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($ /share) |
|
(0.04 |
) |
|
0.00 |
|
| |
|
|
|
|
| Weighted average
number of outstanding shares, basic (units) (1) |
|
55,583,768 |
|
|
89,852,142 |
|
| |
|
|
|
|
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.15 |
) |
|
(0.27 |
) |
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($/share) |
|
(0.04 |
) |
|
0.00 |
|
| |
|
|
|
|
| Weighted average
number of outstanding shares, diluted (units) (1) |
|
55,583,768 |
|
|
89,852,142 |
|
|
|
*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 six-month period ended
June 30, 2024($ in thousands, except per share
data)
| |
|
For the six-month period ended June 30, |
| |
|
2023* |
|
2024 |
| |
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(41,781 |
) |
|
(19,627 |
) |
| Adjustment: |
|
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
|
5,119 |
|
|
1,717 |
|
| Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(36,662 |
) |
|
(17,910 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.68 |
) |
|
(0.22 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($ /share) |
|
(0.09 |
) |
|
0.00 |
|
| |
|
|
|
|
| Weighted average
number of outstanding shares, basic (units) (1) |
|
53,541,010 |
|
|
80,881,026 |
|
| |
|
|
|
|
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.68 |
) |
|
(0.22 |
) |
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($/share) |
|
(0.09 |
) |
|
0.00 |
|
| |
|
|
|
|
| Weighted average
number of outstanding shares, diluted (units) (1) |
|
53,541,010 |
|
|
80,881,026 |
|
| |
*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).
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,” “would,” “expect,” 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 and CLLS52, the outcome of the
arbitration proceedings against Servier, 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, +1 (347) 809 5980, investors@cellectis.com
- 20240805_Cellectis Reports Financial Results for Second Quarter
2024 - V0508[7]
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