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 financial results for the
nine-month period ending September 30, 2023.
On November 1st 2023, Cellectis and AstraZeneca
Holdings B.V. (“AstraZeneca”) entered into a joint research
collaboration agreement (the “Collaboration Agreement”), pursuant
to which AstraZeneca makes an upfront payment of $25 million, an
investment agreement relating to an initial equity investment of
$80 million (the “Initial Investment Agreement”) and a non-binding
memorandum of understanding relating to an additional equity
investment subject to conditions set forth in the MOU of $140
millions (the “MOU”).
This research collaboration will leverage
Cellectis’ gene editing technologies and manufacturing capabilities
to accelerate the development of next-generation therapeutics in
areas of high unmet need, including oncology, immunology and rare
diseases. Cellectis has exclusively reserved 25 genetic targets for
AstraZeneca, from which up to 10 novel candidate products could be
explored for development. Cellectis’ clinical-stage assets,
UCART22, UCART123 and UCART20x22 will remain under Cellectis’
ownership and control.
Pipeline Highlights
UCART Clinical Development
Programs
BALLI-01 (evaluating UCART22) in
relapsed or refractory B-cell acute lymphoblastic leukemia (r/r
B-ALL)
Cellectis will present a poster at the ASH
Annual Meeting with updated results of the Phase I BALLI-01 Trial
of UCART22 (P2), an anti-CD22 allogeneic CAR T- cell product
manufactured in-house, in patients with relapsed or refractory
(r/r) CD22+ B-Cell acute lymphoblastic leukemia (B-ALL).
The poster presentation highlights the following
data:
- In vitro comparability studies suggested that UCART22 process 2
(P2) (manufactured in-house) is more potent than UCART22 process 1
(P1) (manufactured by an external CDMO), and as of July 1st, 2023,
3 patients were enrolled into the first UCART22 P2 cohort at dose
level 2 (1 million cells/kg).
- UCART22 P2 was administered after fludarabine,
cyclophosphamide, and alemtuzumab (FCA) lymphodepletion and was
well tolerated. No DLTs or ICANS was observed, and the CRS observed
was Grade 1 or 2.
- There was a higher preliminary response rate (67%) at dose
level 2 with one million cells/kg with UCART22 P2 compared to 50%
response rate with a dose 5 times higher at dose level 3 of UCART22
P1 that was manufactured by an external CDMO.
- UCART22 expansion was observed in the responding patients and
correlated with increases in serum cytokines and inflammatory
markers.
- The study continues to enroll
patients at dose level 2i (2.5 million cells/kg) with UCART22
P2.
NATHALI-01 (evaluating UCART20x22) in
relapsed or refractory B-cell non-Hodgkin lymphoma (r/r
B-NHL)
Cellectis will present a poster at the ASH
Annual Meeting with the initial preliminary results from the
NATHALI-01 trial (NCT05607420), a Phase 1/2a dose-finding and
expansion study evaluating UCART20x22 in r/r B-cell NHL.
The poster presentation highlights the following
data:
- As of July 1st, 2023, 3 patients
were enrolled and treated at dose level 1 (50 million cells).
Cytokine release syndrome (CRS) Grade 1 or 2 occurred in all
patients, and all CRS resolved with treatment. No immune effector
cell associated neurotoxicity (ICANS) or graft versus host disease
(GvHD) was observed. There were no UCART20x22 dose limiting
toxicities (DLTs), and there was 1 DLT in connection with CLLS52
(alemtuzumab).
- All patients responded at Day 28,
with 1 partial metabolic response and 2 complete metabolic
responses in patients who had failed prior autologous CD19 CAR
T-cell therapies.
- UCART20x22 expansion correlated
with increases in serum cytokine and inflammatory marker levels as
well as with CRS.
- These initial data support the
continued study of UCART20x22 in r/r B-cell NHL.
AMELI-01 (evaluating UCART123) in relapsed or refractory
acute myeloid leukemia (r/r AML)
-
UCART123 is an allogeneic CAR T-cell product candidate targeting
CD123 and is being evaluated in patients with r/r AML in the
AMELI-01 Phase 1 dose-escalation clinical study.
-
The AMELI-01 study is currently enrolling patients after FCA
lymphodepletion in a two-dose regimen arm.
Research Data & Preclinical Programs
- Cellectis announced the publication
of a new research paper in Molecular Therapy – Methods &
Clinical Development, demonstrating the efficacy of its
TALEN-mediated gene correction of mutated PIK3CD gene in Activated
phosphoinositide 3-kinase delta syndrome 1 (APDS1) T-cells.
- Cellectis presented encouraging
data on gene editing process using TALEN®-based gene editing
platform, to overcome the challenges of the “cold” tumor
microenvironment in a poster at the CICON 2023 (CRI-ENCI-AACR 7th
International Cancer Immunotherapy Conference).
- Cellectis presented preclinical
data on MUC1-CAR T-cells to overcome key challenges of targeting
solid tumors in a poster session at the Society for Immunotherapy
of Cancer’s 38th Annual Meeting (SITC 2023).
- Cellectis presented preclinical
data on its program of gene therapy for HSPC at the European
Society of Gene and Cell Therapy (ESGCT) 30th annual congress.
- Cellectis presented a comprehensive
analysis of TALE-BE editing determinants at the European
Society of gene and Cell Therapy (ESGST) 30th annual congress.
Licensed Allogeneic CAR T-cell
Development Programs
Allogene Therapeutics, Inc.’s CAR T programs
utilize Cellectis technologies. ALLO-501 and ALLO-501A are
anti-CD19 products that were jointly developed under a
collaboration agreement between Les Laboratoires Servier
(“Servier”) and Allogene Therapeutics, Inc. (“Allogene”) until 15
December 2022 based on an exclusive license granted by Cellectis to
Servier2. Servier grants to Allogene exclusive rights to ALLO-501
and ALLO-501A in the U.S., Allogene continues the development for
this territory while Servier retains exclusive rights for all other
countries. Allogene’s anti-CD70 and anti-Claudin18.2 programs are
licensed exclusively from Cellectis to Allogene and Allogene holds
global development and commercial rights to these programs.
Servier and Allogene: anti-CD19
programs
- Allogene announced that its ALPHA2
study will enroll approximately 100 patients who have received at
least two prior lines of therapy and have not received prior
anti-CD19 therapy.
- Allogene announced it will have two
poster presentations from the ALPHA/ALPHA2 trials focused on
lymphodepletion in allogeneic cell therapy at ASH 2023. The first
poster is a comprehensive safety review of all 85 patients treated
in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r)
Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to
characterize the overall safety profile when ALLO-647 is added to
standard lymphodepletion. The second poster showcases translational
results from ALPHA2 generated through a collaboration with MD
Anderson Cancer Center. This study compared expansion kinetics
among 11 allogeneic CAR T recipients treated with the ALLO-501A
product candidate in the ALPHA2 trial. According to Allogene, this
study revealed the impact of recipient alloreactive CD8+ T cells in
allogeneic CAR T rejection and the results of this study could help
define strategies to improve allogeneic CAR T expansion,
persistence and efficacy.
Allogene: anti-CD70 and anti-Claudin18.2
programs
- Allogene announced that the Phase 1
dose escalation TRAVERSE trial in patients with advanced or
metastatic renal cell carcinoma (RCC) who have progressed on
standard therapies including an immune checkpoint inhibitor and a
VEGF-targeting therapy is ongoing.
- Allogene announced that SITC 2023
will include a review of research which provided early validation
of ALLO-182, an AlloCAR T candidate currently in the IND-enabling
phase of development targeting Claudin18.2 for the treatment of
patients with gastric and pancreatic cancers.
Corporate
Updates
Strategic Collaboration and Investment
Agreements with AstraZeneca
Under the terms of the Collaboration Agreement,
AstraZeneca will leverage Cellectis’ proprietary gene editing
technologies and manufacturing capabilities to design novel cell
and gene therapy candidate products. As part of the Collaboration
Agreement, 25 genetic targets have been exclusively reserved for
AstraZeneca, from which up to 10 candidate products could be
explored for development. AstraZeneca will have an option for a
worldwide exclusive license on the candidate products, to be
exercised before IND filing. Cellectis’ clinical-stage assets,
UCART22, UCART123 and UCART20x22 will remain under Cellectis’
ownership and control.
Pursuant to the Collaboration Agreement,
Cellectis’ research costs under the collaboration will be funded by
AstraZeneca and Cellectis will receive an upfront payment of $25
million. Under the terms of the Collaboration Agreement, Cellectis
is also eligible to receive an investigational new drug (IND)
option fee and development, regulatory and sales-related milestone
payments, ranging from $70 million up to $220 million, per each of
the 10 candidate products, plus tiered royalties.
As a condition to the signing of the
Collaboration Agreement, AstraZeneca has agreed to make an initial
equity investment of $80 million in Cellectis by subscribing for
16,000,000 ordinary shares, at a price of $5.00 per share (the
“Initial Investment”). The new shares are issued to AstraZeneca by
the board of directors of Cellectis pursuant to the
17th resolution of Cellectis’ shareholders meeting held on
June 27, 2023. Following settlement and delivery of the new
shares (expected to be on November 6, 2023), AstraZeneca will own
approximately 22% of the share capital, and 21% of the
voting rights of the Company, will have the right to nominate
a non-voting observer on the board of directors of Cellectis,
and will have the right to participate pro rata in
Cellectis’s future share offerings.
Additionally, the MOU contemplates that
AstraZeneca will make a potential 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” convertible preferred shares and 18,000,000 “class B”
convertible preferred shares, in each case at a price of $5.00 per
share (the “Additional Investment”). Until they convert into
ordinary shares, the “class A" convertible preferred shares
would have single voting rights and would not carry any double
voting right at any moment, and the “class B” would carry no voting
rights except on any distribution of dividends or reserves. Both
class of preferred shares would enjoy a liquidation preference (if
any liquidation surplus remains after repayment of Cellectis’
creditors and of par value to all shareholders) and would be
convertible into the same number of ordinary shares with the same
rights as the outstanding ordinary shares. The MOU is
non-binding and the Additional Investment remains to be confirmed
by both parties following a consultation process with Cellectis’
works council. If confirmed, the closing of the Additional
Investment will remain subject to (i) Cellectis’ shareholders’
approval at a two-thirds majority of the votes cast by voting
shareholders, (ii) clearance of such investment from the French
Ministry of Economy according to the foreign direct investment
French regulations, and (iii) other customary closing conditions.
Immediately following the Additional Investment, it is anticipated
that AstraZeneca would own approximately 44% of the share
capital of the Company and 30% of the voting rights of the Company
(based on the number of voting rights outstanding immediately after
the completion of the Initial Investment) and would have the right
to nominate two directors to the board of directors of
Cellectis. Further, certain business decisions are subject to
AstraZeneca’s approval, including, in particular, winding up any
company of the Cellectis group, issuing securities senior to or
pari passu with the convertible preferred shares or any shares
without offering AstraZeneca the option to purchase its pro rata
share of such securities (subject to customary exceptions,
including issuances under employee equity incentive plans),
declaring or paying dividends, prepaying indebtedness before due,
and disposing of any material assets concerning gene editing tools
or manufacturing facilities and selling, assigning, licensing,
encumbering or otherwise disposing of certain material IP
rights.
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”).
On January 13, 2023, Calyxt, Cibus Global LLC
(Cibus) and certain other parties named therein, entered into an
Agreement and Plan of Merger (the “Merger Agreement”), pursuant to
which, subject to the terms and conditions thereof, Calyxt and
Cibus will merge in an all-stock transaction (the “Calyxt Merger”).
As a consequence of the foregoing, Calyxt met the “held-for-sale”
criteria specified in IFRS 5 and was classified as a discontinued
operation until May 31, 2023.
On June 1, 2023, Calyxt and Cibus closed the
merger transaction and now operate under the name Cibus, Inc.
Consequently, Calyxt was deconsolidated and Calyxt's cash, cash
equivalent and restricted cash are no longer included in the
Group's cash, cash equivalent and restricted cash since June 1,
2023.
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.
The results of Calyxt until the date of deconsolidation are
isolated under “Income (loss) from discontinued operations” in the
appendices of this Q3 2023 financial results press release.
Cash: As of September 30, 2023,
Cellectis, had $72 million in consolidated cash, cash equivalents,
and restricted cash. This compares to $95 million in consolidated
cash, cash equivalents and restricted cash as of December 31, 2022.
This $23 million difference mainly reflects $79 million of cash
out, which include $23 million for R&D suppliers, $12 million
for SG&A suppliers, $32 million for staff costs, $8 million for
rents and taxes, $4 millions of reimbursement of the “PGE” loan,
and a $2 million unfavorable impact on Forex partially offset by a
$23 million net cash inflow from the capital raise closed in
February, a $21 million net cash inflow from EIB loan, a $6 million
of net cash received from research tax credit prefinancing, a $1
million cash inflow related to the grant and refundable advance
from BPI, $3 millions of financial investments’ capital gain and
interests, a $1 million reimbursement of social charges paid on
stock options, and a $2 million net cash inflow from licenses and
other cash receipts.
With cash and cash equivalents of $67.4 million
as of September 30, 2023, our anticipated borrowing of €15.0
million under Tranche B of the €40.0 million Finance Contract with
EIB and the $105 million from AstraZeneca's agreements, the Company
believes it has sufficient resources to continue operating for at
least twelve months following the consolidated financial
statements’ publication. Additionally, the MOU contemplates that
AstraZeneca will make a potential further equity investment in
Cellectis of $140M by subscribing for two newly created classes of
convertible preferred shares of Cellectis (the “Additional
Investment”). The MOU is non-binding and the Additional Investment
remains to be confirmed by both parties following a consultation
process with Cellectis’ works council. If confirmed, the closing of
the Additional Investment will remain subject to (i) Cellectis’
shareholders’ approval at a two-thirds majority of the votes cast
by voting shareholders, (ii) clearance of such investment from the
French Ministry of Economy according to the foreign direct
investment French regulations, and (iii) other customary closing
conditions.
With cash and cash equivalents of $67.4 million
as of September 30, 2023, our anticipated borrowing of €15.0
million under Tranche B of the €40.0 million Finance Contract with
EIB and the $105 million from AstraZeneca's payments under the
Collaboration Agreement and the Initial Investment Agreement, the
Company believes it has sufficient resources to continue operating
until Q2 2025. Concurrent with the potential additional $140
million, we expect that the Company would extend its cash runway
into 2026.
Revenues and Other Income:
Consolidated revenues and other income were $7.2 million for the
nine months ended September 30, 2023 compared to $8.4 million for
the nine months ended September 30, 2022. The decrease of $1.0
million reflects the recognition of two milestones related to
Cellectis’ agreement with Cytovia for $1.5 million in 2022 and
a milestone of $1.0 million with another partner while recognition
of revenues in 2023 is not material, and partially offset by the
increase of the research tax credit for $0.6 million and the
partial recognition of a grant signed with “BPI” of $0.8
million.
R&D Expenses: Consolidated
R&D expenses were $62.1 million for the nine months ended
September 30, 2023, compared to $76.1 million for the nine months
ended September 30, 2022. The $13.9 million decrease was primarily
attributable to (i) a $8.9 million decrease in personal expenses
due to departures not replaced and decrease in stock-based
compensation expenses consecutive to the non-achievement of certain
performance obligations of October 2020 free shares plan (ii) a
$5.0 million decrease in purchases, external expenses and other
(from $41.4 million in 2022 to $36.4 million in 2023) mainly due to
continuing internalization of our manufacturing and quality
activities to support our R&D pipeline.
SG&A Expenses: Consolidated
SG&A expenses were $12.1 million for the nine months ended
September 30, 2023, compared to $15.8 million for the nine months
ended September 30, 2022. The $3.7 million decrease primarily
reflects (i) a $2.4 million decrease in purchases, external
expenses and (from $9.5 million in 2022 to $7.1 million in 2023)
mainly explained by the implementation of our ERP in 2022 (ii) a
$1.3 million decrease in personal expenses and non-cash stock-based
compensation expenses.
Net financial gain (loss):
Consolidated net financial gain was $14.9 million for the nine
months ended September 30, 2023, compared to 11.0 million for the
nine months ended September 30, 2022. The $3.9 million increase
primarily reflects (i) a $22.8 million increase of financial
income, mainly attributable to the profit from Calyxt’s
deconsolidation, partially offset by (ii) the loss in fair value on
our retained investment in Calyxt since deconsolidation for $6.2
million, (iii) a $7.9 million decrease in the net value of
Cytovia’s note receivable.
Net income (loss) from discontinued
operations: Pursuant to Calyxt deconsolidation income from
discontinued operation for the nine-month period ended September
30, 2023, 2023 only include five months of activity. The $2.2
million decrease in net loss from discontinued operations between
the nine-month periods ended September 30, 2022 and 2023 is
primarily driven by Calyxt's $5.7M net loss in the third quarter of
2022 compared with $0 in the third quarter of 2023 as Calyxt was
deconsolidated, partially offset by a 3.5M$ increase in the net
loss over the first two quarters between 2022 and 2023. This $3.5M
increase breaks down as follows: (i) an increase of $9.2 million of
net financial loss and (ii) an increase of $1.5 million of other
operating expenses, partially offset by (i) a decrease of $2.8
million of R&D expenses (from $6.3 million in 2022 to $3.5
million in 2023) and (ii) a decrease of $4.5 million of SG&A
expenses (from $6.8 million in 2022 to $2.3 million in 2023).
Net Income (loss) Attributable to
Shareholders of Cellectis: The consolidated net loss
attributable to shareholders of Cellectis was $58.2 million (or
$1.07 per share) for the nine months ended September 30, 2023, of
which $53.2 million was attributed to Cellectis continuing
operations, compared to $79.3 million (or $1.74 per share) for the
nine months ended September 30, 2022, of which $72.9 million was
attributed to Cellectis continuing operations. This $21.1 million
decrease in net loss between the first nine months of 2023 and 2022
was primarily driven by (i) a $13.9 million decrease of R&D
expenses, (ii) a $3.7 million decrease of SG&A expense, (iii)
an increase of $3.9 million of the financial gain due to the
deconsolidation of Calyxt compensated in part by the decrease of
fair value of Cytovia’s note receivable and, (iv) a decrease of
$2.2 million of loss from discontinued operations attributable to
Shareholders of Cellectis. These downward impacts on the net loss
were partially offset by (i) a decrease of $1.2 million of revenues
and other income.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $56.8
million (or $1.05 per share) for the nine months ended September
30, 2023, compared to a net loss of $72.1 million (or $1.58 per
share) for the nine months ended September 30, 2022.
Please see "Note Regarding Use of Non-IFRS Financial Measures" for
reconciliation of GAAP net income (loss) attributable to
shareholders of Cellectis to adjusted net income (loss)
attributable to shareholders of Cellectis.
We currently foresee focusing our cash
spending at Cellectis for 2023 in the following areas:
- Supporting the development of our
pipeline of product candidates, including the manufacturing and
clinical trial expenses of UCART123, UCART22, UCART 20x22 and
potential new product candidates;
- Operating our state-of-the-art
manufacturing capabilities in Paris (France), and Raleigh (North
Carolina, USA); and
- Continuing to strengthen our
manufacturing and clinical departments.
| |
|
|
|
CELLECTIS S.A. STATEMENT OF CONSOLIDATED
FINANCIAL POSITION (unaudited) ($ in
thousands) |
| |
|
|
| |
|
As of |
|
|
|
December 31, 2022 |
|
September 30, 2023 |
| |
|
|
|
|
|
ASSETS |
|
|
|
|
| Non-current
assets |
|
|
|
|
|
Intangible assets |
|
718 |
|
|
662 |
|
| Property, plant, and
equipment |
|
63,621 |
|
|
56,774 |
|
| Right-of-use assets |
|
44,275 |
|
|
39,146 |
|
| Non-current financial
assets |
|
8,791 |
|
|
16,624 |
|
| Total non-current
assets |
|
117,406 |
|
|
113,205 |
|
|
|
|
|
|
|
| Current
assets |
|
|
|
|
| Trade receivables |
|
772 |
|
|
393 |
|
| Subsidies receivables |
|
14,496 |
|
|
20,255 |
|
| Other current assets |
|
9,078 |
|
|
8,488 |
|
| Cash and cash equivalent and
Current financial assets |
|
97,697 |
|
|
67,358 |
|
| Total current
assets |
|
122,043 |
|
|
96,494 |
|
| Total assets held for
sale |
|
21,768 |
|
|
0 |
|
| TOTAL
ASSETS |
|
261,216 |
|
|
209,700 |
|
| |
|
|
|
|
|
LIABILITIES |
|
|
|
|
| Shareholders’
equity |
|
|
|
|
| Share capital |
|
2,955 |
|
|
3,492 |
|
| Premiums related to the share
capital |
|
583,122 |
|
|
473,325 |
|
| Currency translation
adjustment |
|
(28,605 |
) |
|
(37,505 |
) |
| Retained earnings |
|
(333,365 |
) |
|
(304,994 |
) |
| Net income (loss) |
|
(106,139 |
) |
|
(58,197 |
) |
| Total shareholders’
equity - Group Share |
|
117,968 |
|
|
76,123 |
|
| Non-controlling interests |
|
7,973 |
|
|
0 |
|
| Total shareholders’
equity |
|
125,941 |
|
|
76,123 |
|
|
|
|
|
|
|
| Non-current
liabilities |
|
|
|
|
| Non-current financial
liabilities |
|
20,531 |
|
|
43,248 |
|
| Non-current lease debts |
|
49,358 |
|
|
43,816 |
|
| Non-current provisions |
|
2,390 |
|
|
2,560 |
|
| Total non-current
liabilities |
|
72,279 |
|
|
89,625 |
|
|
|
|
|
|
|
| Current
liabilities |
|
|
|
|
| Current financial
liabilities |
|
5,088 |
|
|
5,058 |
|
| Current lease debts |
|
7,872 |
|
|
8,203 |
|
| Trade payables |
|
21,456 |
|
|
20,476 |
|
| Deferred revenues and deferred
income |
|
59 |
|
|
117 |
|
| Current provisions |
|
477 |
|
|
946 |
|
| Other current liabilities |
|
13,179 |
|
|
9,153 |
|
| Total current
liabilities |
|
48,131 |
|
|
43,953 |
|
| Total liabilities
related to asset held for sale |
|
14,864 |
|
|
0 |
|
| TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
261,216 |
|
|
209,700 |
|
| |
|
|
| |
|
|
|
Cellectis S.A.UNAUDITED STATEMENTS OF
CONSOLIDATED OPERATIONS For the three-month period
ended September 30, 2023$ in thousands, except per
share amounts |
| |
|
|
| |
|
For the three-month period endedSeptember 30, |
| |
|
2022 * |
|
2023 |
|
| |
|
|
|
| Revenues and other
income |
|
|
|
|
|
Revenues |
|
175 |
|
|
155 |
|
| Other income |
|
1,704 |
|
|
1,489 |
|
| Total revenues and
other income |
|
1,879 |
|
|
1,644 |
|
| Operating
expenses |
|
|
|
|
| Cost of revenue |
|
(367 |
) |
|
(181 |
) |
| Research and development
expenses |
|
(23,837 |
) |
|
(18,894 |
) |
| Selling, general and
administrative expenses |
|
(4,903 |
) |
|
(3,227 |
) |
| Other operating income
(expenses) |
|
(125 |
) |
|
(12 |
) |
| Total operating
expenses |
|
(29,233 |
) |
|
(22,314 |
) |
|
|
|
|
|
|
| Operating income
(loss) |
|
(27,353 |
) |
|
(20,671 |
) |
|
|
|
|
|
|
| Financial gain
(loss) |
|
1,807 |
|
|
3,295 |
|
|
|
|
|
|
|
| Income
tax |
|
0 |
|
|
(106 |
) |
| Income (loss) from continuing
operations |
|
(25,548 |
) |
|
(17,482 |
) |
| Income (loss) from
discontinued operations |
|
(5,718 |
) |
|
0 |
|
| Net income
(loss) |
|
(31,265 |
) |
|
(17,482 |
) |
|
Attributable to shareholders of Cellectis |
|
(28,467 |
) |
|
(17,482 |
) |
|
Attributable to non-controlling interests |
|
(2,798 |
) |
|
(0 |
) |
| Basic net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.63 |
) |
|
(0.31 |
) |
|
|
|
|
|
|
| Diluted net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(0.63 |
) |
|
(0.31 |
) |
|
|
|
|
|
|
| Basic net income
(loss) attributable to shareholders of Cellectis from discontinued
operations, per share ($ /share) |
|
(0.06 |
) |
|
0.00 |
|
|
|
|
|
|
|
| Diluted net income
(loss) attributable to shareholders of Cellectis from discontinued
operations, per share ($ /share) |
|
(0.06 |
) |
|
0.00 |
|
| |
|
|
|
|
|
|
| * These amounts
reflect adjustments made in connection with the presentation of the
discontinued operation |
| |
|
|
|
|
|
|
| |
|
|
|
Cellectis S.A.UNAUDITED STATEMENTS OF
CONSOLIDATED OPERATIONS For the nine-month period
ended September, 2023$ in thousands, except per
share amounts |
| |
|
|
| |
|
For the nine-month period endedSeptember 30, |
| |
|
2022 * |
|
2023 |
|
| |
|
|
|
| Revenues and other
income |
|
|
|
|
|
Revenues |
|
3,147 |
|
|
472 |
|
| Other income |
|
5,255 |
|
|
6,731 |
|
| Total revenues and
other income |
|
8,402 |
|
|
7,.203 |
|
| Operating
expenses |
|
|
|
|
| Cost of revenue |
|
(1,081 |
) |
|
(570 |
) |
| Research and development
expenses |
|
(76,067 |
) |
|
(62,119 |
) |
| Selling, general and
administrative expenses |
|
(15,797 |
) |
|
(12,141 |
) |
| Other operating income
(expenses) |
|
649 |
|
|
(96 |
) |
| Total operating
expenses |
|
(92,297 |
) |
|
(74,926 |
) |
|
|
|
|
|
|
| Operating income
(loss) |
|
(83,894 |
) |
|
(67,723 |
) |
|
|
|
|
|
|
| Financial gain
(loss) |
|
11,019 |
|
|
14,875 |
|
|
|
|
|
|
|
| Income
tax |
|
0 |
|
|
(365 |
) |
| Income (loss) from continuing
operations |
|
(72,875 |
) |
|
(53,213 |
) |
| Income (loss) from
discontinued operations |
|
(12,601 |
) |
|
(10,377 |
) |
| Net income
(loss) |
|
(85,476 |
) |
|
(63,590 |
) |
|
Attributable to shareholders of Cellectis |
|
(79,326 |
) |
|
(58,197 |
) |
|
Attributable to non-controlling interests |
|
(6,150 |
) |
|
(5,393 |
) |
| Basic net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(1.74 |
) |
|
(1.07 |
) |
|
|
|
|
|
|
| Diluted net income
(loss) attributable to shareholders of Cellectis, per share
($/share) |
|
(1.74 |
) |
|
(1.07 |
) |
|
|
|
|
|
|
| Basic net income
(loss) attributable to shareholders of Cellectis from discontinued
operations, per share ($ /share) |
|
(0.14 |
) |
|
(0.09 |
) |
|
|
|
|
|
|
| Diluted net income
(loss) attributable to shareholders of Cellectis from discontinued
operations, per share ($ /share) |
|
(0.14 |
) |
|
(0.09 |
) |
| |
|
|
|
|
|
|
| * These amounts
reflect adjustments made in connection with the presentation of the
discontinued operation |
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
INCOMEFor the three-month period ended September
30, 2023(unaudited) - ($ in thousands except per
share data) |
| |
|
|
| |
|
For the three-month period endedSeptember 30, |
| |
|
2022 * |
|
2023 |
|
|
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(28,467 |
) |
|
(17,482 |
) |
| Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
1,880 |
|
|
(2,653 |
) |
| Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(26,587 |
) |
|
(20,135 |
) |
|
|
|
|
|
|
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.58 |
) |
|
(0.37 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($ /share) |
|
(0.05 |
) |
|
0.00 |
|
|
|
|
|
|
|
| Weighted average
number of outstanding shares, basic (units) |
|
45,540,315 |
|
|
55.583.768 |
|
|
|
|
|
|
|
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.58 |
) |
|
(0.36 |
) |
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($/share) |
|
(0.05 |
) |
|
0.00 |
|
|
|
|
|
|
|
| Weighted average
number of outstanding shares, diluted (units) |
|
45,540,315 |
|
|
55.583.768 |
|
| |
|
|
|
|
|
|
| *These amounts
reflect adjustments made in connection with the presentation of the
discontinued operation |
| |
|
|
|
|
|
|
|
|
|
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME
(unaudited) For the nine-month period ended
September 30, 2023 ($ in thousands, except per
share data) |
| |
|
|
| |
|
For the nine-month period endedSeptember 30, |
| |
|
2022 * |
|
2023 |
|
|
|
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(79,326 |
) |
|
(58,197 |
) |
| Adjustment: Non-cash
stock-based compensation expense attributable to shareholders of
Cellectis |
|
7,211 |
|
|
1,400 |
|
| Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(72,115 |
) |
|
(56,797 |
) |
|
|
|
|
|
|
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(1.58 |
) |
|
(1.05 |
) |
| Basic adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($ /share) |
|
(0.11 |
) |
|
(0.08 |
) |
|
|
|
|
|
|
| Weighted average
number of outstanding shares, basic (units) |
|
45,511,626 |
|
|
54,231,943 |
|
|
|
|
|
|
|
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(1.58 |
) |
|
(1.05 |
) |
| Diluted adjusted net
income (loss) attributable to shareholders of Cellectis from
discontinued operations ($/share) |
|
(0.11 |
) |
|
(0.08 |
) |
|
|
|
|
|
|
| Weighted average
number of outstanding shares, diluted (units) |
|
45,511,626 |
|
|
54,231,943 |
|
| |
|
|
|
|
|
|
|
*These amounts reflect adjustments made in connection with the
presentation of the discontinued operation |
| |
About
Cellectis Cellectis is a
clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies. Cellectis utilizes an allogeneic approach for CAR-T
immunotherapies in oncology, pioneering the concept of
off-the-shelf and ready-to-use gene-edited CAR T-cells to treat
cancer patients, and a platform to make therapeutic gene editing in
hemopoietic stem cells for various diseases. As a clinical-stage
biopharmaceutical company with over 23 years of experience and
expertise in gene editing, Cellectis is developing life-changing
product candidates utilizing TALEN®, its gene editing technology,
and PulseAgile, its pioneering electroporation system to harness
the power of the immune system in order to treat diseases with
unmet medical needs. Cellectis’ headquarters are in Paris, France,
with locations in New York, New York and Raleigh, North Carolina.
Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and
on Euronext Growth (ticker:
ALCLS).
Forward-looking StatementsThis
press release contains “forward-looking” statements within the
meaning of applicable securities laws, including the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by words such as “anticipate”,
“expect”, “plan”, “could”, “will,” “accelerate,” “suggest,”
“eligible,” “encouraging”, “believe”, subject to,” “potential,” “up
to,” and “may” or the negative of these and similar expressions.
These forward-looking statements, which are based on our
management’s current expectations and assumptions and on
information currently available to management, including
information provided or otherwise publicly reported by our licensed
partners. Forward-looking statements include statements about the
potential payments for which Cellectis is eligible under the
Collaboration Agreement; the possible size of the proposed equity
investment by AstraZeneca, the preliminary results for the
NATHALI-01 and BALLI-01 clinical trials and the objectives of such
trials, which remain ongoing; the ability to progress our clinical
trials and to present any additional data from these trials;
clinical outcomes from our clinical trials, which may materially
change as more patient data becomes available, potential benefits
of our UCART product candidates, the operational capabilities
at our manufacturing facilities, and the sufficiency of cash to
fund our operations. These forward-looking statements are made in
light of information currently available to us and are subject to
numerous risks and uncertainties, including (i) the numerous risks
associated with biopharmaceutical product candidate development,
(ii) with respect to the AstraZeneca agreements, the risk that
conditions to closing, including necessary regulatory approvals,
are not satisfied in a timely manner or at all; the risks arising
from Cellectis’s reliance on AstraZeneca to conduct certain
development and commercialization activities, including the
potential for disagreements or disputes under the Collaboration
Agreement; the risk that AstraZeneca may exercise its discretion in
a manner that limits the resources contributed toward the
development of certain projects under the Collaboration Agreement
or may exercise its faculty to terminate without cause the
Agreement; the risk that subsequent studies and ongoing or future
clinical trials may not generate favorable data; and the risk that
the Company may not be able to secure additional capital on
attractive terms, if at all, and (iii) our cash runway, our
operating plans, including product development plans, may change as
a result of various factors, including factors currently unknown to
us. Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F and the financial
report (including the management report) for the year ended
December 31, 2022 and subsequent filings Cellectis makes with the
Securities Exchange Commission from time to time, as well as other
known and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results,
performance or achievements to be materially different from those
expressed or implied by the forward-looking statements. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
For further information on Cellectis,
please contact:
Media contact:
Patricia Sosa Navarro, Chief of Staff to the
CEO, +33 (0)7 76 77 46 93, media@cellectis.com
Investor Relations
contacts:
Arthur Stril, Chief Business Officer, +1 (347)
809 5980, investors@cellectis.com
Ashley R. Robinson, LifeSci Advisors, +1 617 430
7577
1 Cash position includes cash, cash equivalents
and restricted cash. Restricted cash was $5 million as of September
30, 2023.2 Servier is a global independent pharmaceutical
group.
- Press release earnings Q3 2023_ENGLISH
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cellectis (NASDAQ:CLLS)
Historical Stock Chart
From Apr 2023 to Apr 2024
