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 financial results for the fourth quarter and full
year 2024, ending December 31, 2024, and provided a business
update.
“2024 has been an important year for Cellectis:
we are now developing three programs in collaboration with
AstraZeneca. So far, we announced the start of one allogeneic CAR T
for hematological malignancies, one program of an allogeneic CAR T
for solid tumors, and first program of an in vivo gene therapy for
a genetic disorder.
We are thrilled to grow this strategic
collaboration with AstraZeneca, a top leader of the pharmaceutical
industry, aimed at shaping the future of next generation of cell
and gene therapy. We are excited about the huge opportunities this
partnership will bring in the months ahead” said André Choulika,
Ph.D., Chief Executive Officer at Cellectis.
“AstraZeneca’s additional equity investment of
$140M in Cellectis and the drawdown of the final tranche of the
finance contract with the European Investment Bank (EIB) give us
confidence that our cash runway is funded until mid-2027.
In 2025, Cellectis will continue to focus its
efforts and expenses on advancing its core clinical trials BALLI-01
and NATHALI-01, while building the next generation of genomic
medicines to address areas of high unmet patient needs within, our
partnership with AstraZeneca, and within our proprietary
preclinical pipeline.
We expect to present the Phase 1 data set and
late-stage development strategy in the third quarter of 2025 for
UCART22, for the treatment of r/r ALL. For our product candidate
UCART20x22, in r/r NHL, we continue to focus on the enrollment of
patients and expects readout in late 2025.”
Pipeline Highlights
UCART Clinical Programs
BALLI-01 study evaluating UCART22 in
relapsed or refractory B-cell acute lymphoblastic leukemia (r/r
B-ALL)
- In July 2024, the FDA designated
UCART22 as a drug for a Rare Pediatric Disease (RPDD). This
designation may allow a “Priority Review Voucher” at the time of
Biologics License Application (BLA). The FDA also granted Orphan
Drug Designation (ODD) to UCART22 product candidate for the
treatment of ALL. In June 2024, Cellectis received Orphan Drug
Designation (ODD) from the European Commission (EC) for UCART22,
for the treatment of ALL.
- In August 2024, the FDA granted ODD
to Cellectis’ CLLS52 (alemtuzumab), an Investigational Medicinal
Product (IMP) used as part of the lymphodepletion regimen
associated with UCART22. 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.
- These designations for UCART22 and
CLLS52 mark an important step towards developing allogeneic CAR T
products that would be readily available for all patients.
- Cellectis continues to focus on the
enrollment of patients in the BALLI-01 study and expects to present
the Phase 1 dataset and late-stage development strategy for UCART22
in relapsed or refractory ALL in the third quarter of 2025.
NATHALI-01 study evaluating UCART20x22
in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r
NHL)
- Cellectis continues to focus on the
enrollment of patients in the NATHALI-01 study and expects to
present the Phase 1 dataset and late-stage development strategy for
UCART20x22 in relapsed or refractory NHL in late 2025.
UCART123 in relapsed or refractory acute
myeloid leukemia (r/r AML)
- In November 2024, 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. 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.
Research Data & Preclinical
Programs
Innovative strategy for T cell
engineering to enhance efficacy against solid tumors
- In February 2025, Cellectis
presented a poster ‘SMART CAR T’ strategy to enhance efficacy
against solid tumors at the American Association for Cancer
Research – Immuno-oncology (AACR-IO). Leveraging its proprietary
TALEN® gene editing technology, Cellectis has developed CAR T cells
capable of expressing a tumor-specific, inducible IL-2 variant
immunocytokine. This novel approach aims to enhance CAR T cell
efficacy against solid tumors by localizing IL-2 activity within
the tumor microenvironment, potentially offering a safer and more
effective method to boost CAR T cell expansion and anti-tumor
activity.
Breaking barriers in solid tumors with
SMART allogeneic CAR T-cells
- In November
2024, Cellectis presented pre-clinical data to enhance CAR T cell
activity against solid tumors while preventing potential toxicity
at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
Utilizing TALEN® gene editing, Cellectis developed allogeneic CAR
T-cells that leverage tumor microenvironment cues to target cancer
cells effectively. Key findings include tethering cytotoxic
activity to the tumor area and confining IL-12 to the tumor
microenvironment, which enhances CAR T-cell proliferation and
reduces side effects. This innovative approach aims to improve the
safety and efficacy of CAR T-cell therapies for solid tumors.
Controlling C-to-T editing with TALE
base editors
- In
October 2024, Cellectis showcased pre-clinical data that permit the
design of an efficient and specific TALE base editors (TALEB) at
the European Society of Gene and Cell Therapy (ESGCT) annual
congress.
- This
novel strategy characterizes C-to-T conversion efficiencies and
assesses TALEB activity using TALEN®-mediated ssODN knock-in in
primary T cells. This research has led to improved understanding of
TALEB, enabling the design of more efficient and specific tools
with potential therapeutic applications.
MUC1 CAR T-cells for treating
Triple-Negative Breast Cancer
- In
September 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. 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.
SMART DUAL CAR T-cell approach for
treating recalcitrant solid tumors
- In
August 2024, Cellectis published a Molecular Therapy article on
SMART DUAL CAR T-cell approach for recalcitrant solid tumors, while
mitigating potential safety risks. This innovative strategy uses
allogeneic CAR T-cells with a dual targeting mechanism to
effectively infiltrate and target triple-negative breast tumors
while minimizing on-target, off-tumor toxicity. This approach would
address key challenges in solid tumor therapy, including low CAR
T-cell infiltration and antigen heterogeneity.
Partnerships
Servier and Allogene – Allogeneic CAR T
Allogene’s investigational oncology products utilize Cellectis
technologies.
cema-cel: ALPHA3 Trial
in Large B-Cell Lymphoma (LBCL)
- Allogene announced that the pivotal
Phase 2 ALPHA3 trial, which initiated in June 2024, now has 40
sites activated and continues to generate strong enthusiasm from
both community cancer centers and academic institutions. This
groundbreaking study is evaluating consolidation treatment with
cema-cel as part of the 1L treatment regimen for patients with LBCL
with minimal residual disease (MRD) after standard 1L treatment
with R-CHOP or other chemoimmunotherapy. This randomized trial will
enroll approximately 240 patients and is designed to demonstrate a
meaningful improvement in event free survival (EFS) in patients
treated with cema-cel relative to patients who receive the current
standard of care (observation). Allogene announced that the
lymphodepletion selection and futility analysis are anticipated
around mid-2025, that efficacy analyses from the ALPHA3 trial are
expected to occur in 2026 and will include an interim EFS analysis
monitored by the independent Data Safety Monitoring Board in 1H
2026 and the data readout of the primary EFS analysis around YE
2026, and that a potential biologics license application (BLA)
submission is targeted for 2027.
- In February 2025, the Journal of
Clinical Oncology published data from Allogene’s Phase 1
ALPHA/ALPHA2 trials of cema-cel in relapsed/refractory LBCL,
demonstrating durable responses comparable to approved autologous
CD19 CAR T therapies.
ALLO-316: TRAVERSE Trial in Renal Cell
Carcinoma (RCC)
- In November 2024, Allogene
announced positive Phase 1 data from the TRAVERSE trial
highlighting a manageable safety profile and significant anti-tumor
activity of ALLO-316 in heavily pretreated patients with advanced
or metastatic renal cell carcinoma. Allogene further announced that
additional data from the Phase 1b expansion cohort, which is
evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T
cells), is expected to be announced in mid-2025.
AstraZeneca – Joint Research and Collaboration
Agreement
- Research and development activities
under three cell and gene therapy programs have started under the
joint research and collaboration agreement entered into by
Cellectis and AstraZeneca in November 2023 (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
paid to Cellectis up to December 31, 2024 (of which $25m upfront
and $22m reached development milestones for the three initial
programs), in addition to reimbursement of research costs incurred
under the AZ JRCA.
Corporate Updates
AstraZeneca’s Additional Investment
- Following clearance from the French
Ministry of Economy and satisfaction of all other closing
conditions, AZ Holdings completed in May 2024 the additional equity
investment of $140 million in Cellectis, as previously announced by
Cellectis on November 1 and 15, 2023. Under the subsequent
investment agreement, AZ Holdings agreed to make a further equity
investment in Cellectis of $140 million by subscribing for two
newly created classes of convertible preferred shares of Cellectis:
10,000,000 Class A Preferred Shares and 18,000,000 Class B
Preferred Shares, in each case at a price of $5.00 per share (the
“Additional Investment”). The Additional Investment closed on May
6, 2024. Until they convert into ordinary shares, the Class A
Preferred Shares have single voting rights and will not be eligible
for double voting right under any circumstances, and the Class B
Preferred Shares do not carry voting rights for a period of 74
years, except with respect to any distribution of dividends or
reserves. Both class of preferred shares have a liquidation
preference (if any liquidation surplus remains after repayment of
Cellectis’ creditors and of par value to all shareholders) and are
convertible at any time, at AstraZeneca's election (and with 12
months’ prior notice in the case of the Class B Preferred Shares),
into the same number of ordinary shares with the same rights as the
outstanding ordinary shares.
- As of December 31, 2024,
considering the ordinary shares held by AZ Holdings as well as all
Class A Preferred Shares, which AZ Holdings has the right to
acquire within the next 60 days, AZ Holdings beneficially owns
approximately 32% of our ordinary shares. As of December 31, 2024,
considering the ordinary shares held by AZ Holdings and giving
effect to the conversion of all Class A Preferred Shares and Class
B Preferred Shares without regarding for when they may first be
converted, AZ Holdings would beneficially own approximately 44% of
our ordinary shares. As of December 31, 2024, AZ Holdings may
exercise voting power with respect to approximately 30% of the
voting rights outstanding with respect to our share capital
(inclusive of (i) the ordinary shares held by AZ Holdings and (i)
the voting rights of the Class A Preferred Shares, which vote
together with our ordinary shares).
Drawdown of the second and third tranche
of the European Investment Bank financing
- In January 2024, Cellectis drew
down the second tranche of €15 million (“Tranche B”) under the
credit facility agreement for up to €40 million entered into with
the European Investment Bank (“EIB”) on December 28, 2022.
- In December 2024, Cellectis drew
down the third tranche of €5 million (“Tranche C”) under the credit
facility agreement for up to €40 million entered into with the EIB
on December 28, 2022. With the drawdown of Tranche C, Cellectis has
drawn down the full €40 million available under the Finance
Contract.
Appointments
- In May 2024, pursuant to the SIA and implemented by the
Company's shareholders decision dated December 22, 2023, Mr. Marc
Dunoyer and Mr. Tyrell Rivers serve on the Company's board of
directors as members designated by AZ Holdings.
- In May 2024, Cellectis announced the appointment of Mr. Arthur
Stril as Interim Chief Financial Officer, following the resignation
of Bing Wang, Ph.D. Mr. Arthur Stril was appointed Chief Financial
Officer and Chief Business Officer in January 2025.
- In August 2024, Cellectis announced the appointment of Adrian
Kilcoyne, M.D., MPH, MBA as its Chief Medical Officer.
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/
2024 Financial Results
Cash: As of December 31, 2024,
Cellectis had $264 million in consolidated cash, cash equivalents,
restricted cash and fixed-term deposits classified as
current-financial assets. The Company believes its cash, cash
equivalents and fixed-term deposits will be sufficient to fund its
operations into mid-2027.
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 $140.0 million cash
received from AstraZeneca as part of its equity investment in
Cellectis, $21.6 million cash received from European Investment
Bank (“EIB”) pursuant to the disbursement of the Tranche B and
Tranche C under the Finance Contract with EIB, $42.8 million of
cash-in from our revenue, partially offset by cash payments from
Cellectis to suppliers of $47.0 million, Cellectis’ wages, bonuses
and social expenses paid of $39.6 million, the payments of lease
debts of $11.1 million and the repayment of the “PGE” loan of $5.0
million.
We currently foresee focusing our cash spending
at Cellectis in 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 and Raleigh.
Revenues and Other Income:
Consolidated revenues and other income were $49.2 million for the
twelve months ended December 31, 2024 compared to $9.2 million for
the twelve months ended December 31, 2023. This $40.0 million
increase between the twelve months ended December 31, 2023 and 2024
was mainly attributable to (i) recognition of a $35.5 million
revenue in 2024 based on the progress of our performance obligation
rendered under the three programs under the AZ JRCA and (ii) the
recognition of the $5.4 million following 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”),
compensated with a slight decrease in other income by $0.7
million.
R&D Expenses: Consolidated
R&D expenses were $90.5 million for the twelve months ended
December 31, 2024, compared to $87.6 million for the twelve months
ended December 31, 2023. R&D personnel expenses decreased by
$2.9 million from $37.2 million in 2023 to $34.3 million in 2024
mainly related to a $1.9 million decrease in non-cash stock-based
compensation expense. R&D purchases, external expenses and
other increased by $3.6 million (from $33.0 million in 2023 to
$36.6 million in 2024) mainly related to increase in manufacturing
activities to support our R&D pipeline.
SG&A Expenses: Consolidated
SG&A expenses were $19.1 million for the twelve months ended
December 31, 2024 compared to $16.8 million for the twelve months
ended December 31, 2023. The $2.3 million increase is mainly due in
purchases and external expenses primarily related to legal and
finance external support while SG&A personnel expenses remain
flat compared to year 2023.
Other operating income and
expenses: Other operating income and expenses were a $0.9
million net income for the twelve months ended December 31, 2024
compared to a $1.3 million net expense for the twelve months ended
December 31, 2023. Other operating income increase by $2.1 million
is primarily related to non-recurring expenses recorded in
2023.
Net financial gain (loss): We
had a consolidated net financial gain of $22.8 million for the
twelve months ended December 31, 2024, compared to a $19.2 million
loss for the twelve months ended December 31, 2023. This $42.0
million difference reflects mainly (i) a $20.0 million gain in
change in fair value of SIA derivative instrument, (ii) a $7.7
million increase in gain from our financial investments, (iii) a
$8.1 million net gain in change in fair value of EIB Tranche A and
Tranche B warrants, (iv) a $3.1 million increase in foreign
exchange net gain, (v) the non-recurring loss in fair value
measurement on Cytovia convertible note recognized in the twelve
months period ended December 31, 2023 of $7.8 million, partially
offset by (i) an increase of $2.0 million in interest expense on
Tranche A and Tranche B of the EIB Finance Contract and (ii) a $2.3
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 twelve months ended December 31, 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 twelve months ended
December 31, 2024.
Net Income (loss) Attributable to
Shareholders of Cellectis: Consolidated net loss
attributable to shareholders of Cellectis was $36.8 million (or a
$0.41 loss per share) for the twelve months ended December 31,
2024, compared to a $101.1 million loss (or a $1.77 loss per share)
for the twelve months ended December 31, 2023, of which $116.8
million was attributed to Cellectis continuing operations. The
$71.7 million change in net loss was primarily driven by (i) an
increase in revenues and other income of $40.0 million, (ii) an
increase of net financial gain of $42.0 million, partially offset
by (iii) a $6.1 million increase in purchases and other external
expenses and (iv) a non-recurring income from discontinued
operations of $8.4 million in 2023 related to Calyxt, Inc. our
former subsidiary.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: Consolidated adjusted net
loss attributable to shareholders of Cellectis was $33.6 million
(or a $0.37 loss per share) for the twelve months ended December
31, 2024, compared to a net loss of $94.0 million (or a $1.65 loss
per share) for the twelve months ended December 31, 2023.
The year-end consolidated financial statements
of Cellectis have been prepared in accordance with International
Financial Reporting Standards, as issued by the International
Accounting Standards Board (“IFRS”).2
Please see "Note Regarding Use of Non-IFRS
Financial Measures" for reconciliation of GAAP net income (loss)
attributable to shareholders of Cellectis to adjusted net income
(loss) attributable to shareholders of Cellectis.
CELLECTIS S.A.STATEMENT OF
CONSOLIDATED FINANCIAL POSITION($ in
thousands) |
|
|
As of |
|
|
December 31, 2023 |
|
December 31, 2024 |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
671 |
|
|
1,116 |
|
Property, plant, and
equipment |
|
54,681 |
|
|
45,895 |
|
Right-of-use assets |
|
38,060 |
|
|
29,968 |
|
Non-current financial
assets |
|
7,853 |
|
|
7,521 |
|
Other non-current
assets |
|
0 |
|
|
11,594 |
|
Deferred tax assets |
|
0 |
|
|
382 |
|
Total non-current
assets |
|
101,265 |
|
|
96,476 |
|
Current
assets |
|
|
|
|
Trade
receivables |
|
569 |
|
|
6,714 |
|
Subsidies
receivables |
|
20,900 |
|
|
14,521 |
|
Other current
assets |
|
7,722 |
|
|
5,528 |
|
Cash and cash equivalent and
Current financial assets |
|
203,815 |
|
|
260,306 |
|
Total current
assets |
|
233,005 |
|
|
287,069 |
|
TOTAL
ASSETS |
|
334,270 |
|
|
383,544 |
|
LIABILITIES |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Share capital |
|
4,365 |
|
|
5,889 |
|
Premiums related to the share
capital |
|
522,785 |
|
|
494,288 |
|
Currency translation
adjustment |
|
(36,690 |
) |
|
(39,537 |
) |
Retained earnings |
|
(304,707 |
) |
|
(292,846 |
) |
Net income (loss) |
|
(101,059 |
) |
|
(36,761 |
) |
Total shareholders’
equity - Group Share |
|
84,695 |
|
|
131,033 |
|
Non-controlling
interests |
|
0 |
|
|
0 |
|
Total shareholders’
equity |
|
84,695 |
|
|
131,033 |
|
Non-current
liabilities |
|
|
|
|
Non-current financial
liabilities |
|
49,125 |
|
|
50,882 |
|
Non-current lease
debts |
|
42,948 |
|
|
34,245 |
|
Non-current
provisions |
|
2,200 |
|
|
1,115 |
|
Deferred tax
liabilities |
|
158 |
|
|
0 |
|
Total non-current
liabilities |
|
94,431 |
|
|
86,241 |
|
Current
liabilities |
|
|
|
|
Current financial
liabilities |
|
5,289 |
|
|
16,134 |
|
Current lease debts |
|
8,502 |
|
|
8,385 |
|
Trade
payables |
|
19,069 |
|
|
18,664 |
|
Deferred revenues and deferred
income |
|
110,325 |
|
|
112,161 |
|
Current provisions |
|
1,740 |
|
|
828 |
|
Other current
liabilities |
|
10,219 |
|
|
10,097 |
|
Total current
liabilities |
|
155,144 |
|
|
166,269 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
334,270 |
|
|
383,544 |
|
AUDITED STATEMENTS OF CONSOLIDATED OPERATIONSFor
the three-month period ended December 31, 2024 ($ in
thousands, except per share amounts) |
|
|
For the three-month period ended December
31, |
|
|
2023 |
|
|
2024 |
|
|
|
|
|
Revenues and other income |
|
|
|
|
Revenues |
|
283 |
|
|
28,916 |
|
Other
income |
|
1,707 |
|
|
4,300 |
|
Total revenues and other income |
|
1,990 |
|
|
33,216 |
|
Operating expenses |
|
|
|
|
Research and development expenses |
|
(25,693 |
) |
|
(44,694 |
) |
Selling, general and administrative expenses |
|
(4,671 |
) |
|
(10,099 |
) |
Other
operating income (expenses) |
|
(1,204 |
) |
|
128 |
|
Total operating expenses |
|
(31,568 |
) |
|
(54,665 |
) |
|
|
|
|
|
Operating income (loss) |
|
(29,578 |
) |
|
(21,449 |
) |
|
|
|
|
|
Financial gain (loss) |
|
(12,210 |
) |
|
4,770 |
|
|
|
|
|
|
Income tax |
|
(6 |
) |
|
(455 |
) |
Income (loss) from continuing operations |
|
(41,795 |
) |
|
(17,134 |
) |
Income (loss) from discontinued operations |
|
0 |
|
|
0 |
|
Net income (loss) |
|
(41,795 |
) |
|
(17,134 |
) |
Attributable to shareholders of Cellectis |
|
(41,795 |
) |
|
(17,134 |
) |
Attributable to non-controlling interests |
|
(0 |
) |
|
0 |
|
Basic net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
|
(0.64 |
) |
|
(0.17 |
) |
Diluted net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
|
(0.64 |
) |
|
(0.17 |
) |
Basic 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 |
|
65,234,522 |
|
|
100,093,873 |
|
Diluted |
|
65,234,522 |
|
|
100,093,873 |
|
Cellectis S.A. STATEMENTS OF CONSOLIDATED
OPERATIONSFor the year ended December 31, 2024
($ in thousands, except per share amounts) |
|
|
For the year ended December 31, |
|
|
2023 |
|
|
2024 |
|
|
|
|
|
Revenues and other income |
|
|
|
|
Revenues |
|
755 |
|
|
41,505 |
|
Other
income |
|
8,438 |
|
|
7,712 |
|
Total revenues and other income |
|
9,193 |
|
|
49,217 |
|
Operating expenses |
|
|
|
|
Cost
of revenue |
|
(737 |
) |
|
0 |
|
Research and development expenses |
|
(87,646 |
) |
|
(90,536 |
) |
Selling, general and administrative expenses |
|
(16,812 |
) |
|
(19,085 |
) |
Other
operating income (expenses) |
|
(1300 |
) |
|
849 |
|
Total operating expenses |
|
(106,495 |
) |
|
(108,771 |
) |
|
|
|
|
|
Operating income (loss) |
|
(97,302 |
) |
|
(59,554 |
) |
|
|
|
|
|
Financial gain (loss) |
|
(19,163 |
) |
|
22,793 |
|
|
|
|
|
|
Income tax |
|
(371 |
) |
|
(0 |
) |
Income (loss) from continuing operations |
|
(116,835 |
) |
|
(36,761 |
) |
Income (loss) from discontinued operations |
|
8,392 |
|
|
0 |
|
Net income (loss) |
|
(108,443 |
) |
|
(36,761 |
) |
Attributable to shareholders of Cellectis |
|
(101,059 |
) |
|
(36,761 |
) |
Attributable to non-controlling interests |
|
(7,384 |
) |
|
0 |
|
Basic net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
|
(1.77 |
) |
|
(0.41 |
) |
Diluted net income (loss) attributable to shareholders of
Cellectis, per share ($/share) |
|
(1.77 |
) |
|
(0.41 |
) |
Basic net income (loss) attributable to shareholders of
Cellectis from discontinued operations, per share ($
/share) |
|
0.28 |
|
|
0.00 |
|
|
|
|
|
|
Diluted net income (loss) attributable to shareholders of
Cellectis from discontinued operations, per share ($
/share) |
|
0.28 |
|
|
0.00 |
|
|
|
|
|
|
Number of shares used for computing |
|
|
|
|
Basic |
|
57,012,815 |
|
|
90,566,346 |
|
Diluted |
|
57,012,815 |
|
|
90,566,346 |
|
Note Regarding Use of Non-IFRS Financial
Measures
Cellectis S.A. presents adjusted net income
(loss) attributable to shareholders of Cellectis in this press
release. Adjusted net income (loss) attributable to shareholders of
Cellectis is not a measure calculated in accordance with IFRS. We
have included in this press release a reconciliation of this figure
to net income (loss) attributable to shareholders of Cellectis,
which is the most directly comparable financial measure calculated
in accordance with IFRS.
Because adjusted net income (loss) attributable
to shareholders of Cellectis excludes non-cash stock-based
compensation expense—a non-cash expense, we believe that this
financial measure, when considered together with our IFRS financial
statements, can enhance an overall understanding of Cellectis’
financial performance. Moreover, our management views the Company’s
operations, and manages its business, based, in part, on this
financial measure. In particular, we believe that the elimination
of non-cash stock-based expenses from Net income (loss)
attributable to shareholders of Cellectis can provide a useful
measure for period-to-period comparisons of our core businesses.
Our use of adjusted net income (loss) attributable to shareholders
of Cellectis has limitations as an analytical tool, and you should
not consider it in isolation or as a substitute for analysis of our
financial results as reported under IFRS. Some of these limitations
are: (a) other companies, including companies in our industry which
use similar stock-based compensation, may address the impact of
non-cash stock- based compensation expense differently; and (b)
other companies may report adjusted net income (loss) attributable
to shareholders or similarly titled measures but calculate them
differently, which reduces their usefulness as a comparative
measure. Because of these and other limitations, you should
consider adjusted net income (loss) attributable to shareholders of
Cellectis alongside our IFRS financial results, including Net
income (loss) attributable to shareholders of Cellectis.
RECONCILIATION OF IFRS TO NON-IFRS NET
INCOME For the three-month period ended December
31, 2024($ in thousands, except per share
data) |
|
|
For the three-month period ended December 31, |
|
|
2023 |
|
|
2024 |
|
|
|
|
|
Net income (loss)
attributable to shareholders of Cellectis |
|
(41,795 |
) |
|
(17,134 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
(4,621 |
) |
|
1 450 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(37,174 |
) |
|
(15,684 |
) |
Basic adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.57 |
) |
|
(0.16 |
) |
Basic adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($ /share) |
|
0.00 |
|
|
0.00 |
|
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) |
|
65,234,522 |
|
|
100,093,873 |
|
|
|
|
|
|
Diluted adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
(1) |
|
(0.57 |
) |
|
(0.16 |
) |
Diluted adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($/share) |
|
0.00 |
|
|
0.00 |
|
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) |
|
65,234,522 |
|
|
100,093,873 |
|
RECONCILIATION OF IFRS TO NON-IFRS NET
INCOME For the year ended December 31,
2024($ in thousands, except per share
data) |
|
|
For the year ended December 31, |
|
|
2023 |
|
|
2024 |
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(101,059 |
) |
|
(36,761 |
) |
Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
7,086 |
|
|
3,167 |
|
Adjusted net income (loss) attributable to shareholders of
Cellectis |
|
(93,973 |
) |
|
(33,594 |
) |
Basic adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) |
|
(1.65 |
) |
|
(0.37 |
) |
Basic adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations ($
/share) |
|
0.31 |
|
|
0.00 |
|
|
|
|
|
|
Weighted average number of outstanding shares, basic
(units) |
|
57,012,815 |
|
|
90,566,346 |
|
|
|
|
|
|
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis ($/share) |
|
(1.65 |
) |
|
(0.37 |
) |
Diluted adjusted net income (loss) attributable to
shareholders of Cellectis from discontinued operations
($/share) |
|
0.31 |
|
|
0.00 |
|
|
|
|
|
|
Weighted average number of outstanding shares, diluted
(units) |
|
57,012,815 |
|
|
90,566,346 |
|
About Cellectis Cellectis
is a clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies. The company 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 develop gene therapies in other
therapeutic indications. With its in-house manufacturing
capabilities, Cellectis is one of the few end-to-end gene editing
companies that controls the cell and gene therapy value chain from
start to finish.
Cellectis’ headquarters are in Paris, France,
with locations in New York and Raleigh, NC. Cellectis is listed on
the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth
(ticker: ALCLS). To find out more, visit www.cellectis.com and
follow Cellectis on LinkedIn and X.
TALEN® is a registered trademark owned by
Cellectis. Cautionary
Statement 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 “expect,” “give us confidence,” “will,” “may,” “would,”
“aim,” “potentially,” “potential,” “could,” “foresee” 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,
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), the outcomes
of the collaboration with AstraZeneca, the timing of our
presentation of data and submission of regulatory filings, the
potential of our preclinical and innovation programs, the benefit
of adding alemtuzumab to the lymphodepletion regimen, 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
risk of losing the orphan drug designation or if it is established
that the product no longer meets the relevant criteria before
market authorization is granted (if any), and the risk that the
priority review voucher be not granted at the time of marketing
authorization. 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 as amended
and in our annual financial report (including the management
report) for the year ended December 31, 2024 and subsequent
filings Cellectis makes with the Securities Exchange Commission
from time to time, which are available on the SEC’s website at
www.sec.gov, 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, Chief Financial Officer & Chief Business Officer,
investors@cellectis.com
1 Cash position includes cash, cash equivalents,
restricted cash and fixed-term deposits classified as current
-financial assets. Restricted cash was $4.6 million as of December
31, 2024. Fixed-term deposits classified as current-financial
assets was $115.8 million as of December 31, 2024.2 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 FY 2024
financial results press release, Cibus' results are isolated under
"Income (loss) from discontinued operations" for the year ended
December 31, 2023, and are no longer included for the year ended
December 31, 2024, due to the deconsolidation.
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