-- Expanded strategic partnership with Kite
--
-- Presented continued robust long-term responses
from Phase 1 expansion trial of anito-cel (formerly
CART-ddBCMA) in patients with relapsed or refractory multiple
myeloma --
-- Ended the quarter with $729.2M, extending cash runway into 2027 --
REDWOOD
CITY, Calif., Feb. 28, 2024 /PRNewswire/ --
Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining
cell therapy through the development of innovative immunotherapies
for patients with cancer and other incurable diseases, today
reported business highlights and financial results for the fourth
quarter and year ended December 31,
2023.
"In 2023, our team built upon the momentum that has propelled
Arcellx forward over the past two years," said Rami
Elghandour, Arcellx's Chairman and Chief Executive Officer.
"We expanded our partnership with Kite, through a $200M investment, extending our cash runway into
2027 and deepened our collaboration by expanding into
lymphomas. Additionally, we presented robust long-term data from
our Phase 1 expansion study of anito-cel at the 65th ASH Annual
Meeting. These data support the potential for anito-cel to be a
best-in-class treatment option for patients with relapsed or
refractory multiple myeloma. In parallel to these milestones, we
continued to scale our organization to deliver both operationally
and strategically, strengthening our foundation with key progress
in manufacturing, development, research, and commercial readiness.
This year is poised to be another year of meaningful progress for
our organization. We are focused on completing enrollment in the
iMMagine-1 trial, initiating our clinical trial in earlier lines of
multiple myeloma, and completing the technical transfer to
Kite. Patients with relapsed or refractory multiple myeloma
still have limited therapeutic options, and with our partners at
Kite, we are committed to delivering anito-cel to help as many
patients as possible. We believe that with our technology coupled
with Kite's recognized global leadership and established
manufacturing expertise, we are well positioned to achieve this
goal. Additionally, we continue to invest in research and believe
the differentiation of the D-Domain technology provides an
opportunity for us to expand our development pipeline in other
therapeutic areas."
Recent Business Progress
Expanded strategic partnership with Kite Pharma, Inc., a
Gilead Company, to include co-development of anito-cel for
lymphomas and Kite exercising its option to license ACLX-001.
On November 15, 2023, Arcellx and
Kite, a Gilead Company, announced an expansion in their existing
partnership, which was originally announced in December 2022. Kite has exercised its option to
negotiate a license for Arcellx's ARC-SparX program, ACLX-001. The
companies have also expanded the scope of the collaboration to
include lymphomas. Upon closing in December
2023, Arcellx received a $200
million equity investment at $61.68 per share and an $85 million upfront cash payment.
Presented continued robust long-term responses from lead
product candidate anito-cel evaluated in a Phase 1 expansion trial
in patients with relapsed or refractory multiple myeloma, at 65th
ASH Annual Meeting and Exposition. On December 11, 2023, Arcellx presented new clinical
data from its ongoing Phase 1 expansion study of autologous
anitocabtagene autoleucel (anito-cel), formerly known as
CART-ddBCMA, at the 65th ASH Annual Meeting and Exposition. The
data continued to demonstrate deep and durable responses in
patients with poor prognostic factors. Of the 38 evaluable patients
with a median follow-up of 26.5 months, 100% overall response rate
(ORR) was achieved in all patients and 29 of 38 (76%) evaluable
patients achieved a complete response (CR) or a stringent complete
response (sCR). Additionally, anito-cel continued to be well
tolerated with no delayed neurotoxicity or parkinsonian symptoms
observed. Median duration of response, progression free survival
(PFS), and overall survival were not reached at the time of the
October 15, 2023 data cut. Anito-cel
continued to be well-tolerated at the time of the October 15, 2023 data cut.
Fourth Quarter and Full Year 2023 Financial
Highlights
Cash, cash equivalents, and marketable
securities:
As of December 31, 2023, Arcellx had
cash, cash equivalents, and marketable securities of $729.2 million. Arcellx anticipates that its
cash, cash equivalents, and marketable securities will fund its
operations into 2027.
Collaboration revenue:
Collaboration revenue was $63.1
million and zero for the quarters ended December 31, 2023 and 2022, respectively.
Collaboration revenue was $110.3
million and zero for the twelve months ended December 31, 2023 and 2022, respectively. The
revenue results from the recognition of research and development
performed under the arrangement described in the recent license and
collaboration agreement with Kite Pharma, Inc. (Kite).
R&D expenses:
Research and development expenses were $28.8
million and $25.9 million for
the quarters ended December 31, 2023
and 2022, respectively, an increase of $2.9
million. This increase was driven primarily by an increase
in personnel and facility costs. Research and development expenses
were $133.8 million and $149.6 million for the twelve months ended
December 31, 2023 and 2022,
respectively, a decrease of $15.8
million. This decrease was primarily driven by the
accounting treatment for our Lonza manufacturing services
agreement, which resulted in a non-cash expense in both years ended
December 31, 2023 and 2022. This
decrease was partially offset by an increase in personnel costs,
which includes non-cash stock-based compensation expense.
G&A expenses:
General and administrative expenses were $19.4 million and $14.1
million for the quarters ended December 31, 2023 and 2022, respectively, an
increase of $5.3 million. General and
administrative expenses were $66.4
million and $41.7 million for
the twelve months ended December 31,
2023 and 2022, respectively, an increase of $24.7 million. The increases were driven
primarily by non-cash stock-based compensation expense.
Net income or loss:
Net income was $20.5 million for the
quarters ended December 31, 2023 and
net loss was $39.0 million for the
quarter ended December 31,
2022. Net loss for the twelve months ended December 31, 2023 and 2022 were $70.7 million and $188.7
million, respectively.
About Arcellx, Inc.
Arcellx, Inc. is a clinical-stage biotechnology company reimagining
cell therapy by engineering innovative immunotherapies for patients
with cancer and other incurable diseases. Arcellx believes that
cell therapies are one of the forward pillars of medicine and
Arcellx's mission is to advance humanity by developing cell
therapies that are safer, more effective, and more broadly
accessible. Arcellx's lead product candidate, anito-cel, is being
developed for the treatment of relapsed or refractory multiple
myeloma (rrMM) in a Phase 2 pivotal trial. Anito-cel has been
granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced
Therapy designations by the U.S. Food and Drug
Administration.
Arcellx is also developing its dosable and controllable CAR T
therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM
and ACLX-002 in relapsed or refractory acute myeloid leukemia and
high-risk myelodysplastic syndrome. For more information on
Arcellx, please visit www.arcellx.com. Follow Arcellx on
X (Twitter) at @arcellx and LinkedIn.
About Arcellx and Kite Pharma Collaboration
Arcellx
and Kite, a Gilead Company, formed a global strategic collaboration
to co-develop and co-commercialize Arcellx's anito-cel candidate
for the treatment of patients with relapsed or refractory multiple
myeloma currently in a pivotal Phase 2 study. Kite and Arcellx will
jointly advance and commercialize the anito-cel asset in
the United States, and Kite will
commercialize the product outside the U.S.
Forward-looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements in this press release that are not purely historical
are forward-looking statements, including, without limitation,
Arcellx's plans for the research, pre-clinical and clinical
development of its product candidates; the best-in-class potential
of anito-cel for patients suffering from rrMM based on the safety
and efficacy profile; Arcellx and Kite's plans to advance and
commercialize anito-cel, including the timing of technology
transfer to Kite; plans to scale the organization and operations;
and the sufficiency of cash, cash equivalents and marketable
securities and its ability to fund operations through certain
regulatory milestones and timelines. The forward-looking statements
contained herein are based upon Arcellx's current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. These forward-looking statements are neither promises
nor guarantees and are subject to a variety of risks and
uncertainties, including risks that may be found in the section
entitled Part I, Item 1A (Risk Factors) in the Annual Report on
Form 10-K for the fiscal year ended December
31, 2023, filed with the Securities and Exchange Commission
(SEC) on or about the date hereof, and the other documents that
Arcellx may file from time to time with the SEC. These
forward-looking statements are made as of the date of this press
release, and Arcellx assumes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
ARCELLX,
INC.
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
|
(in
thousands)
|
|
|
|
|
December
31,
|
December
31,
|
|
2023
|
2022
|
Cash, cash equivalents,
and marketable securities
|
$
729,185
|
$
254,835
|
Total assets
|
825,132
|
313,817
|
Total
liabilities
|
339,752
|
108,863
|
Total stockholders'
equity
|
485,380
|
204,954
|
ARCELLX,
INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Year Ended December
31,
|
|
2023
|
2022
|
Revenue
|
$ 110,319
|
$
—
|
Operating
expenses:
|
|
|
Research and
development
|
133,849
|
149,555
|
General and
administrative
|
66,350
|
41,704
|
Total operating
expenses
|
200,199
|
191,259
|
Loss from
operations
|
(89,880)
|
(191,259)
|
Other income,
net
|
19,853
|
2,580
|
Loss before income
taxes
|
(70,027)
|
(188,679)
|
Income tax (expense) benefit
|
(663)
|
-
|
Net loss
|
(70,690)
|
(188,679)
|
Other comprehensive
loss:
|
|
|
Unrealized gain (loss)
on marketable securities
|
768
|
(201)
|
Comprehensive
loss
|
$ (69,922)
|
$
(188,880)
|
Net loss per share
attributable to common stockholders—basic and diluted
|
$
(1.47)
|
(5.19)
|
Weighted-average common
shares outstanding—basic and diluted
|
48,061,450
|
36,355,758
|
Investor Contact:
Myesha Lacy
Arcellx, Inc.
ir@arcellx.com
510-418-2412
Media Contact
Andrea Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163
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SOURCE Arcellx, Inc.