Cellectis Provides Business Update and Reports Financial Results
for First Quarter 2023
Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS),
a clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies, today provided a business update and announced its
results for the three-month period ending March 31, 2023.
“Cellectis took a notable step forward this
quarter with the first patient being dosed in France with our
in-house manufactured product candidate UCART22 in the BALLI-01
clinical study. UCART22 is currently the most advanced allogeneic
CAR T-cell product in development for relapsed or refractory B-cell
acute lymphoblastic leukemia. We believe that our off-the-shelf
treatment approach, coupled with our ability to manufacture UCART
product candidates entirely in-house, gives us a main advantage on
the market: it potentially maximizes the chances for eligible
patients to be treated without delay,” said André Choulika, Ph.D.,
CEO of Cellectis.
“Cellectis also announced last month that it
implemented the use of Sanofi’s alemtuzumab as a Cellectis
Investigational Medicinal Product, coded as CLLS52, as part of the
lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial,
for UCART123 in the AMELI-01 clinical trial, and for UCART20x22 in
the NATHALI-01 clinical trial. This follows the partnership and
supply agreements we entered with Sanofi regarding alemtuzumab.
“This quarter, Cellectis announced the closing
of the global offering of 25 million dollars of its Depository
Shares, launched in February – the net proceeds of the global
offering and option of the Company is 22.8 million dollars – and in
April, the drawdown of the 20 million euros under the Finance
Contract for up to 40 million euros credit facility made with the
European Investment Bank in December 2022. Cellectis plans to use
the net proceeds of the funds to focus on the development of its
pipeline of allogeneic CAR T-cell product candidates UCART22,
UCART20x22 and UCART123, the Company decided to stop enrollment and
treatment of patients with UCARTCS1. Indeed, to accelerate the
speed of enrollment of patients in the MELANI-01 study, evaluating
UCARTCS1, the Company would have had to invest meaningful amount of
resources. To optimize its resources, Cellectis decided to focus
its development efforts on the BALLI-01, AMELI-01 and NATHALI-01
studies.
“We are excited about the drive in our clinical
trials, building on the momentum of our lead product candidates in
our pipeline, and the upcoming milestones for 2023.”
Pipeline Highlights
UCART Clinical Developments
Programs
BALLI-01 (evaluating UCART22) in
relapsed or refractory B-cell acute lymphoblastic leukemia (r/r
B-ALL)
- UCART22 is an allogeneic CAR T-cell
product candidate targeting CD22 and is being evaluated in patients
with r/r B-ALL in the BALLI-01 Phase 1/2a clinical study.
- On April 11, Cellectis announced
that the first patient in Europe was dosed in France with its
in-house manufactured product candidate UCART22 and completed the
28-day Dose Limiting Toxicity period.
- UCART22 is currently the most
advanced allogeneic CAR T-cell product in development for relapsed
or refractory B-cell acute lymphoblastic leukemia. Last December,
Cellectis presented updated clinical data on its BALLI-01 clinical
trial at a Live Webcast.
- The BALLI-01 study is now enrolling
patients after FCA (fludarabine, cyclophosphamide and alemtuzumab)
lymphodepletion.
NATHALI-01 (evaluating UCART20x22) in
relapsed or refractory B-cell non-Hodgkin lymphoma (r/r
NHL)
- UCART20x22 is Cellectis’ first
allogeneic dual CAR T-cell product candidate targeting both CD20
and CD22 and is being evaluated in patients with r/r NHL in the
NATHALI-01 Phase 1/2a clinical study.
- The NATHALI-01 study is now
enrolling patients.
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.
-
On May 17, Cellectis will present clinical data on the AMELI-01
clinical trial in an oral presentation at the American Society of
Gene and Cell Therapy (ASGCT) 2023 Annual Meeting. These data were
presented in an oral presentation at the 64th American Society of
Hematology (ASH) annual meeting last December. Details from the
presentation will be available following the event on the Cellectis
website at:
https://www.cellectis.com/en/investors/scientific-presentations/
- The AMELI-01 study is now enrolling
patients after FCA (fludarabine, cyclophosphamide and alemtuzumab)
lymphodepletion in a two-dose regimen arm.
MELANI-01 (evaluating UCARTCS1) in
relapsed or refractory multiple myeloma (r/r MM)
- UCARTCS1 is an allogeneic CAR
T-cell product candidate targeting CS1 and is being evaluated in
patients with r/r MM in the MELANI-01 Phase 1 dose-escalation
clinical study.
- To accelerate the speed of
enrollment of patients in the MELANI-01 study, the Company would
have had to invest meaningful amount of resources. To optimize its
resources, the Company decided to focus its development efforts on
the BALLI-01, AMELI-01 and NATHALI-01 studies and therefore to stop
enrollment and treatment of patients in the MELANI-01 study.
Research Data & Preclinical
Programs
TALEN®-edited MUC1 CAR
T-cells
- On April 17, Cellectis released
preclinical data on TALEN®-edited MUC1 CAR T-cells at the American
Association for Cancer Research (AACR) Annual Meeting 2023.
- The preclinical data presented in a
poster showed the capability of armored allogeneic MUC1 CAR T-cells
to excel in the immune suppressive tumor micro-environment
suggesting that they could be an effective option in treating
relapsed and refractory triple negative breast cancer (TNBC)
patients with limited therapeutic options.
- Poster of the presentation is
available on Cellectis’ website:
https://www.cellectis.com/en/investors/scientific-presentations/
Multiplex engineering for superior
generation of efficient CAR T-cells
-
On May 17, 2023, Cellectis will present preclinical data on
multiplex engineering for superior generation of CAR T-cells, at
the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual
Meeting. Details from the presentation will be available following
the event on the Cellectis website at:
https://www.cellectis.com/en/investors/scientific-presentations/
Licensed Allogeneic CAR T-cell
Development Programs
Servier and Allogene: anti-CD19
programs
Allogene continues to enroll patients in the
industry’s first potentially pivotal Phase 2 allogeneic CAR T
clinical trial with ALLO-501A. Allogene announced that the
single-arm ALPHA2 trial will enroll approximately 100 r/r large B
cell lymphoma (LBCL) patients who have received at least two prior
lines of therapy and have not received prior anti-CD19 therapy.
Allogene expects to complete enrollment in H1 2024.After the close
of the quarter, Allogene announced that pooled data from the Phase
1 ALPHA/ALPHA2 trials of ALLO-501/501A, in r/r LBCL would be
presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting June 2 – 6, 2023 in Chicago, Illinois.
Allogene: anti-BCMA and anti-CD70
programs
- Allogene presented interim data
from its Phase 1 TRAVERSE trial of ALLO-316, its first
investigational product candidate for solid tumors, during an oral
presentation at the American Association for Cancer Research (AACR)
Annual Meeting in April. The ongoing dose escalation study is
enrolling patients with advanced or metastatic renal cell carcinoma
(RCC) who have progressed on standard therapies that included an
immune checkpoint inhibitor and a VEGF-targeting therapy. The data
reported to date is primarily from the DL1 and DL2 cohorts.
- Anti-tumor activity was primarily
observed in patients with tumors confirmed to express CD70 (N=10).
Among 18 patients evaluable for efficacy, the disease control rate
(DCR) was 89%. In the 10 patients whose tumors were known to
express CD70, the disease control rate was 100%, which included
three patients who achieved partial remission (two confirmed, one
unconfirmed). The longest response lasted until month eight. There
was a trend toward greater tumor shrinkage in patients with higher
levels of CD70 expression. In patients evaluable for safety (N=19),
ALLO-316 demonstrated an adverse event profile generally consistent
with autologous CAR T therapies.
- Dose escalation in the TRAVERSE
trial is expected to be completed in 2023.
- During the quarter, data from the
Phase 1 UNIVERSAL trial with ALLO-715 for the treatment of r/r
multiple myeloma (MM) was published in Nature Medicine.
UNIVERSAL is the first allogeneic anti-BCMA CAR T to demonstrate
proof-of-concept in MM with response rates that are similar to an
approved autologous CAR T therapy. Allogene is evaluating
manufacturing processes improvements across its BCMA candidates to
achieve optimal performance.
Partnerships
Cytovia Therapeutics, Inc. (“Cytovia”)
- On January 20, Cellectis announced
that it has amended certain financial terms of the $20 million
convertible note issued by its partner, Cytovia Therapeutics, in
payment of the upfront collaboration consideration provided for
pursuant to the research collaboration and non-exclusive license
agreement between Cellectis and Cytovia.
- The amended and restated note
provides for automatic conversion into common stock of Cytovia in
the case of certain fundamental transactions pursuant to which
Cytovia becomes a public reporting company and for conversion at
Cellectis’ option in connection with certain financing
transactions, upon a company sale and at final maturity. In each
case such conversion is subject to a 9.9% ownership cap, with the
balance issuable in the form of pre-funded warrants. Among other
changes, the amended and restated note increases the applicable
interest rate of the note to 10% per annum, subject to a 10% step
up upon the occurrence and continuation of an event of default,
provides for the repayment of 50% of the outstanding amount on
April 30, 2023 and extends the final maturity date for the
repayment of the remaining outstanding amount to June 30,
2023.
Corporate Updates
Global offering and American Depositary
Shares (ADS)
- On January 4, 2023, Cellectis
established an At-The-Market (ATM) Program on Nasdaq. Cellectis has
filed a prospectus supplement with the Securities and Exchange
Commission (“SEC”), pursuant to which it may offer and sell to
eligible investors a maximum gross amount of up to $60.0 million of
American Depositary Shares (“ADS”), each representing one ordinary
share of Cellectis, nominal value €0.05 per share, from time to
time in sales deemed to be an “at the market offering” pursuant to
the terms of a sales agreement with Jefferies LLC (“Jefferies”),
acting as sales agent. The timing of any sales will depend on a
variety of factors.
- On February 2, 2023 Cellectis
announced the launch of the Cellectis Follow-on Offering in which
it offered $22 million of its ADS. Jefferies LLC and Barclays
Capital Inc. (the “Underwriters”) acted as joint book-running
managers for the Global Offering. Pricing occurred on February 2,
2023, at $2.50 per ADS for 8,800,800 ADSs. On February 7, 2023,
Cellectis has announced the exercise by the Underwriters of their
option (the “Option”) to purchase an additional 1,107,800 ordinary
shares (the “Additional Ordinary Shares”) of the Company to be
delivered in the form of an aggregate of 1,107,800 ADSs (the
“Additional ADSs”). As a consequence, the total number of ordinary
shares issued in the form of ADSs amounted to 9,907,800 for the
base offering plus the Option exercise bringing the gross proceed
to $24.8 million. The aggregate net proceeds to the Company, after
deducting underwriting commissions and estimated offering expenses,
amounted to approximately $22.8 million.
- The Company plans to use
approximately $17.0 million (€15.6 million) of the net proceeds of
the Global Offering to fund the continued clinical development of
UCART 123, UCART22 and UCART20x22 and any remainder for working
capital and other general corporate purposes.
Calyxt and Cibus Merger
Agreement
- On January 13, 2023, Calyxt and
Cibus, and the other parties thereto entered into the definitive
Merger Agreement under which Calyxt and Cibus will merge in an
all-stock transaction. Under the terms of the Merger Agreement,
Calyxt will issue shares of its common stock to Cibus shareholders
in an exchange ratio such that upon completion of the merger,
Calyxt shareholders are expected to own approximately 5% of the
combined company, subject to adjustments permitted by the Merger
Agreement. The Boards of Directors of both companies unanimously
approved the Calyxt Merger. Concurrent with the execution of the
merger agreement, certain officers of Calyxt, all of Calyxt’s
directors, and Cellectis executed support agreements in favor of
the Calyxt Merger. On March 1, 2023, as stated in the Merger
Agreement, Calyxy’s Board authorized the grant of 3,487,503 RSUs to
all employees. These awards will vest upon completion of the
Transactions, and accordingly, the expense associated with these
awards will be recognized over the period from the date of grant to
the estimated closing date of the Transactions. Consequently, after
the completion of the Transaction, and subject to the issuance of
some or all of such RSUs, Cellectis will own approximately 2.4% of
Calyxt.
- Cellectis currently holds a 48.2 %
equity interest in Calyxt. Following the closing of the merger,
Cellectis is expected to own approximately 2.4% of the equity
interests of the combined company.
Warrant agreement with the European
Investment Bank
- On April 4, Cellectis announced it
entered into the warrant agreement (the “Warrant Agreement”) and
finalized the related ancillary documents required under the credit
facility with the European Investment Bank (“EIB”) for up to €40
million previously announced on December 28, 2022. The Company also
announced the drawdown of the first tranche of €20 million
(“Tranche A”) under the Finance Contract, that has been disbursed
by the EIB in early April 2023.
- Cellectis plans to use the proceeds
of Tranche A towards the development of its pipeline of allogeneic
CAR T-cell product candidates: UCART22, UCART20x22, UCART123.
Financial results
The interim condensed consolidated financial
statements of Cellectis, which consolidate the results of Calyxt,
Inc. of which Cellectis owned approximately 48.2% of outstanding
shares of common stock (as of March 31, 2023), have been prepared
in accordance with International Financial Reporting Standards, as
issued by the International Accounting Standards Board
(“IFRS”).
We present certain financial metrics broken out
between our two reportable segments – Therapeutics and Plants – in
the appendices of this Q1 2023 financial results press release.
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 meets the “held-for-sale"
criteria specified in IFRS 5 and has been classified as a
discontinued operation.
Cash: As of March 31, 2023, Cellectis, excluding
Calyxt, had $88 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
difference mainly reflects $30 million of cash out, which include
$6 million of payments for R&D expenses, $4 million for
SG&A suppliers, $15 million for staff costs, $4 million for
rents and taxes, $1 million of reimbursement of the “PGE” loan and
a $23 million net cash inflow from the capital raise closed in
February.
Based on the current operating plan, Cellectis
(excluding Calyxt) anticipates that the cash and cash equivalents
as of March 31, 2023 will fund Cellectis’ operations into the third
quarter of 2024.
Revenues and Other Income:
Consolidated revenues and other income were $3.6 million for the
three months ended March 31, 2023 compared to $3.8 million for the
three months ended March 31, 2022. The slight decrease of $0.2
million between the three months ended March 31, 2023, and 2022
reflects the recognition of two milestones related to Cellectis’
agreement with Cytovia for $1.5 million in 2022 while
recognition of revenues in 2023 is not material and was almost
fully offset by an increase of the research tax credit for $1.0
million in addition to the recognition of a BPI R&D grant of
$0.3 million.
R&D Expenses: Consolidated
R&D expenses were $21.1 million three months ended March 31,
2023 compared to $26.6 million for the three months ended March 31,
2022. The $5.5 million decrease was primarily attributable to (i) a
$2.6 million decrease in personal expenses due to departures not
replaced (ii) a $3.0 million decrease in purchases, external
expenses and other (from $13.8 million in 2022 to $10.8 million in
2023) mainly explained by internalization of our manufacturing and
quality activities to support our R&D pipeline.
SG&A Expenses: Consolidated
SG&A expenses were $5.0 million for the three months ended
March 31, 2023 compared to $6.1 million for the three months ended
March 31, 2022. The $1.1 million decrease primarily reflects (i) a
$0.9 million decrease in purchases, external expenses and other
(from $3.7 million in 2022 to $2.9 million in 2023) mainly
explained by the implementation of our new enterprise resource
planning (ERP) software in 2022 (ii) a $0.2 million decrease in
personal expenses.
Net income (loss) from discontinued
operations: The $1.7 million decrease of net loss from
discontinued operations between the three-month period ended March
31, 2022 and 2023 is primarily driven by (i) the decrease of $2.6
million of R&D expenses (from $3.2 million in 2022 to $1.3 in
2023) and SG&A expenses (from $2.9 million in 2022 to $2.2
million in 2023) partially offset by (i) the increase of $0.7
million of net financial loss and (ii) the increase of $0.2 million
of other operating expenses.
Net Income (loss) Attributable to
Shareholders of Cellectis including Calyxt: The
consolidated net loss attributable to shareholders of Cellectis was
$30.1 million (or $0.58 per share) for the three months ended March
31, 2023, of which $27.8 million was attributed to Cellectis
continuing operations, compared to $31.9 million (or $0.70 per
share) for the three months ended March 31, 2022, of which $28.3
million was attributed to Cellectis continuing operations. This
$1.8 million decrease in net loss between the three months of 2023
and 2022 was primarily driven by (i) a $5.3 million decrease of
research and development, (ii) a decrease of $1.7 million of loss
from discontinued operations, (iii) a $1.3 million decrease of
SG&A expenses partially offset by (i) an increase in net
financial loss of $5.3 million primarily due to the decrease of the
fair value of Cytovia’s convertible note on March 31, 2023 of $4.6
million compared to a $7.9 million on December 31, 2022, (ii) a
decrease of $0.2 million of revenues and other income, (iii) an
increase of other operating expenses of $0.6 million, (iv) a
decrease of $0.4 million in loss attributable to non-controlling
interests due to the decrease in Calyxt’s net loss.
Adjusted Net Income (Loss) Attributable
to Shareholders of Cellectis: The consolidated adjusted
net loss attributable to shareholders of Cellectis was $28.1
million (or $0.55 per share) for the three months ended March 31,
2023, of which $26.2 million is attributed to Cellectis, compared
to a net loss of $29.3 million (or $0.64 per share) for the three
months ended March 31, 2022, of which $26.0 million was attributed
to Cellectis.
Please see “Note Regarding Use of Non-IFRS
Financial Measures” for reconciliation of GAAP net income (loss)
attributable to shareholders of Cellectis to adjusted net income
(loss) attributable to shareholders of Cellectis.
We currently foresee focusing our cash
spending at Cellectis for 2023 in the following areas:
- Supporting the development of our pipeline of product
candidates, including the manufacturing and clinical trial expenses
of UCART123, UCART22, UCART 20x22 and potential new product
candidates, and
- Operating our state-of-the-art manufacturing capabilities in
Paris (France), and Raleigh (North Carolina, USA); and
- Continuing strengthening our manufacturing and clinical
departments.
|
CELLECTIS S.A. |
(unaudited) |
STATEMENT OF CONSOLIDATED FINANCIAL POSITION |
($ in thousands, except per share data) |
|
|
|
As of |
|
December 31, 2022 |
|
March 31, 2023 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
718 |
|
|
713 |
|
Property, plant, and
equipment |
63,621 |
|
|
61,708 |
|
Right-of-use assets |
44,275 |
|
|
43,436 |
|
Non-current financial
assets |
8,791 |
|
|
8,185 |
|
Total non-current
assets |
117,406 |
|
|
114,042 |
|
|
|
|
|
Current
assets |
|
|
|
Trade receivables |
772 |
|
|
1,120 |
|
Subsidies receivables |
14,496 |
|
|
18,245 |
|
Other current assets |
9,078 |
|
|
9,703 |
|
Cash and cash equivalent and
Current financial assets |
97,697 |
|
|
88,162 |
|
Total current
assets |
122,043 |
|
|
117,231 |
|
Total assets held for
sale |
21,768 |
|
|
20,135 |
|
TOTAL
ASSETS |
261,216 |
|
|
251,408 |
|
|
|
|
|
LIABILITIES |
|
|
|
Shareholders’
equity |
|
|
|
Share capital |
2,955 |
|
|
3,487 |
|
Premiums related to the share
capital |
583,122 |
|
|
608,086 |
|
Currency translation
adjustment |
(28,605 |
) |
|
(28,542 |
) |
Retained earnings |
(333,365 |
) |
|
(439,220 |
) |
Net income (loss) |
(106,139 |
) |
|
(30,074 |
) |
Total shareholders’
equity - Group Share |
117,968 |
|
|
113,735 |
|
Non-controlling interests |
7,973 |
|
|
6,754 |
|
Total shareholders’
equity |
125,941 |
|
|
120,489 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
Non-current financial
liabilities |
20,531 |
|
|
19,625 |
|
Non-current lease debts |
49,358 |
|
|
48,285 |
|
Non-current provisions |
2,390 |
|
|
2,540 |
|
Total non-current
liabilities |
72,279 |
|
|
70,450 |
|
|
|
|
|
Current
liabilities |
|
|
|
Current financial
liabilities |
5,088 |
|
|
5,188 |
|
Current lease debts |
7,872 |
|
|
8,181 |
|
Trade payables |
21,456 |
|
|
22,324 |
|
Deferred revenues and deferred
income |
59 |
|
|
342 |
|
Current provisions |
477 |
|
|
1,011 |
|
Other current liabilities |
13,179 |
|
|
6,094 |
|
Total current
liabilities |
48,131 |
|
|
43,140 |
|
Total liabilities
related to asset held for sale |
14,864 |
|
|
17,328 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
261,216 |
|
|
251,408 |
|
|
|
|
|
|
|
CELLECTIS S.A. |
STATEMENT OF CONSOLIDATED OPERATIONS – First three
months |
(unaudited) |
($ in thousands, except per share data) |
|
|
|
|
|
For the three-month period ended March 31, |
|
|
2022 * |
|
2023 |
|
|
|
|
Revenues and other
income |
|
|
|
|
Revenues |
|
1,665 |
|
|
139 |
|
Other income |
|
2,135 |
|
|
3,420 |
|
Total revenues and
other income |
|
3,800 |
|
|
3,559 |
|
Operating
expenses |
|
|
|
|
Cost of revenue |
|
(385 |
) |
|
(334 |
) |
Research and development
expenses |
|
(26,601 |
) |
|
(21,081 |
) |
Selling, general and
administrative expenses |
|
(6,063 |
) |
|
(4,964 |
) |
Other operating income
(expenses) |
|
21 |
|
|
(611 |
) |
Total operating
expenses |
|
(33,028 |
) |
|
(26,990 |
) |
|
|
|
|
|
Operating income
(loss) |
|
(29,228 |
) |
|
(23,431 |
) |
|
|
|
|
|
Financial gain
(loss) |
|
912 |
|
|
(4,402 |
) |
|
|
|
|
|
Income (loss) from continuing
operations |
|
(28,316 |
) |
|
(27,833 |
) |
Income (loss) from
discontinued operations |
|
(6,441 |
) |
|
(4,691 |
) |
Net income
(loss) |
|
(34,757 |
) |
|
(32,525 |
) |
Attributable to shareholders of Cellectis |
|
(31,911 |
) |
|
(30,074 |
) |
Attributable to non-controlling interests |
|
(2,846 |
) |
|
(2,450 |
) |
Basic net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.70 |
) |
|
(0.58 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share
($/share) |
|
(0.70 |
) |
|
(0.58 |
) |
|
|
|
|
|
Basic net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
(0.08 |
) |
|
(0.04 |
) |
|
|
|
|
|
Diluted net income
(loss) attributable to shareholders of Cellectis per share ($
/share) from discontinued operations |
|
(0.08 |
) |
|
(0.04 |
) |
* These amounts reflect adjustments made in
connection with the presentation of the discontinued operation
|
CELLECTIS S.A. |
DETAILS OF KEY PERFORMANCE INDICATORS BY
REPORTABLE |
First three months |
(unaudited) |
|
|
|
|
|
|
|
For the three-month period endedMarch 31,
2022 |
|
For the three-month period endedMarch 31,
2023 |
$ in
thousands |
|
Plants (discontinued operations) |
Therapeutics |
Total reportable segments |
|
Plants (discontinued operations) |
Therapeutics |
Total reportable segments |
|
|
|
|
|
|
|
|
|
External revenues |
|
32 |
|
1,665 |
|
1,697 |
|
|
42 |
|
139 |
|
180 |
|
External other income |
|
- |
|
2,135 |
|
2,135 |
|
|
- |
|
3,420 |
|
3,420 |
|
External revenues and
other income |
|
32 |
|
3,800 |
|
3,832 |
|
|
42 |
|
3,559 |
|
3,600 |
|
Cost of revenue |
|
(0 |
) |
(385 |
) |
(385 |
) |
|
- |
|
(334 |
) |
(334 |
) |
Research and development
expenses |
|
(2,878 |
) |
(26,601 |
) |
(29,479 |
) |
|
(2,165 |
) |
(21,081 |
) |
(23,246 |
) |
Selling, general and
administrative expenses |
|
(3,216 |
) |
(6,063 |
) |
(9,279 |
) |
|
(1,336 |
) |
(4,964 |
) |
(6,300 |
) |
Other operating income and
expenses |
|
43 |
|
21 |
|
65 |
|
|
(139 |
) |
(611 |
) |
(750 |
) |
Total operating
expenses |
|
(6,050 |
) |
(33,028 |
) |
(39,078 |
) |
|
(3,640 |
) |
(26,990 |
) |
(30,630 |
) |
Operating income
(loss) before tax |
|
(6,019 |
) |
(29,228 |
) |
(35,247 |
) |
|
(3,598 |
) |
(23,431 |
) |
(27,029 |
) |
Net financial gain (loss) |
|
(422 |
) |
912 |
|
490 |
|
|
(1,093 |
) |
(4,402 |
) |
(5,495 |
) |
Net income (loss) from
discontinued operations |
|
(6,441 |
) |
|
(6,441 |
) |
|
(4,691 |
) |
|
(4,691 |
) |
Net income
(loss) |
|
(6,441 |
) |
(28,316 |
) |
(34,757 |
) |
|
(4,691 |
) |
(27,833 |
) |
(32,525 |
) |
Non-controlling interests |
|
2,846 |
|
- |
|
2,846 |
|
|
2,450 |
|
- |
|
2,450 |
|
Net income (loss)
attributable to shareholders of Cellectis |
|
(3,595 |
) |
(28,316 |
) |
(31,911 |
) |
|
(2,241 |
) |
(27,833 |
) |
(30,074 |
) |
R&D non-cash stock-based
expense attributable to shareholder of Cellectis |
|
(11 |
) |
1,680 |
|
1,669 |
|
|
85 |
|
1,103 |
|
1,188 |
|
SG&A non-cash stock-based
expense attributable to shareholder of Cellectis |
|
342 |
|
636 |
|
979 |
|
|
274 |
|
517 |
|
791 |
|
Adjustment of
share-based compensation attributable to shareholders of
Cellectis |
|
332 |
|
2,316 |
|
2,648 |
|
|
359 |
|
1,620 |
|
1,979 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(3,263 |
) |
(26,000 |
) |
(29,263 |
) |
|
(1,882 |
) |
(26,213 |
) |
(28,095 |
) |
Depreciation and
amortization |
|
(708 |
) |
(4,934 |
) |
(5,641 |
) |
|
6 |
|
(4,456 |
) |
(4,450 |
) |
Additions to tangible and
intangible assets |
|
363 |
|
581 |
|
945 |
|
|
- |
|
245 |
|
245 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note Regarding
Use of Non-IFRS
Financial Measures
Cellectis S.A. presents adjusted net income
(loss) attributable to shareholders of Cellectis in this press
release. Adjusted net income (loss) attributable to shareholders of
Cellectis is not a measure calculated in accordance with IFRS. We
have included in this press release a reconciliation of this figure
to net income (loss) attributable to shareholders of Cellectis,
which is the most directly comparable financial measure calculated
in accordance with IFRS. Because adjusted net income (loss)
attributable to shareholders of Cellectis excludes Non-cash
stock-based compensation expense—a non-cash expense, we believe
that this financial measure, when considered together with our IFRS
financial statements, can enhance an overall understanding of
Cellectis’ financial performance. Moreover, our management views
the Company’s operations, and manages its business, based, in part,
on this financial measure. In particular, we believe that the
elimination of Non-cash stock-based expenses from Net income (loss)
attributable to shareholders of Cellectis can provide a useful
measure for period-to-period comparisons of our core businesses.
Our use of adjusted net income (loss) attributable to shareholders
of Cellectis has limitations as an analytical tool, and you should
not consider it in isolation or as a substitute for analysis of our
financial results as reported under IFRS. Some of these limitations
are: (a) other companies, including companies in our industry which
use similar stock-based compensation, may address the impact of
Non-cash stock- based compensation expense differently; and (b)
other companies may report adjusted net income (loss) attributable
to shareholders or similarly titled measures but calculate them
differently, which reduces their usefulness as a comparative
measure. Because of these and other limitations, you should
consider adjusted net income (loss) attributable to shareholders of
Cellectis alongside our IFRS financial results, including Net
income (loss) attributable to shareholders of Cellectis.
|
RECONCILIATION OF IFRS TO NON-IFRS NET INCOME – First
Quarter |
(unaudited) |
($ in thousands, except per share data) |
|
|
|
|
|
For the three-month period ended March 31, |
|
|
2022 * |
|
2023 |
|
|
|
|
Net income (loss) attributable to shareholders of
Cellectis |
|
(31,911 |
) |
|
(30,074 |
) |
Adjustment: |
|
|
|
|
|
|
Non-cash stock-based compensation expense attributable to
shareholders of Cellectis |
|
2,648 |
|
|
1,979 |
|
Adjusted net income
(loss) attributable to shareholders of Cellectis |
|
(29,263 |
) |
|
(28,095 |
) |
|
|
|
|
|
Basic Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.64 |
) |
|
(0.55 |
) |
Basic adjusted
earnings from discontinued operations attributable to shareholders
of Cellectis ($ /share) |
|
(0.07 |
) |
|
(0.04 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, basic (units) |
|
45,486,477 |
|
|
51,452,348 |
|
|
|
|
|
|
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis
($/share) |
|
(0.64 |
) |
|
(0.55 |
) |
Diluted Adjusted net
income (loss) attributable to shareholders of Cellectis ($/share)
from discontinued operations |
|
(0.07 |
) |
|
(0.04 |
) |
|
|
|
|
|
Weighted average
number of outstanding shares, diluted (units) |
|
45,486,477 |
|
|
51,452,348 |
|
*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). For more information, visit www.cellectis.com. Follow
Cellectis on social media: @cellectis, LinkedIn and
YouTube
Forward-looking Statements
This press release contains “forward-looking”
statements within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by words such as
“anticipate,” “believe,” “intend”, “expect,” “plan,” “scheduled,”
“could,” “would” and “will,” or the negative of these and similar
expressions. These forward-looking statements, which are based on
our management’s current expectations and assumptions and on
information currently available to management, including
information provided or otherwise publicly reported by our licensed
partners. Forward-looking statements include statements about
advancement, timing and progress of clinical trials (including with
respect to patient enrollment and follow-up), the timing of our
presentation of data and submission of regulatory filings, the
adequacy of our supply of clinical vials, the operational
capabilities at our manufacturing facilities, the sufficiency of
cash to fund operations, the adequacy and continuity of supply of
clinical supply and alemtuzumab, the ability of an anti-CD52 as
alemtuzumab to improve any efficacy and the potential benefit of
UCART product candidates. 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. With respect to our cash runway, our operating plans,
including product development plans, may change as a result of
various factors, including factors currently unknown to us.
Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F and the financial
report (including the management report) for the year ended
December 31, 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, please contact:
Media contact:
Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14
33, media@cellectis.com
Investor Relation 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 March 31,
2023.
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