-- Earned a $68M milestone payment from Kite
for iMMagine-1 enrollment --
-- Submitted an abstract for the iMMagine-1
study at the 66th ASH Annual Meeting --
-- The global Phase 3 trial, iMMagine-3, has
been initiated by Kite --
-- U.S. FDA clears anito-cel IND application
for myasthenia gravis, an autoimmune disease --
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 second quarter ended June 30, 2024.
“We continue to make significant strides as we accelerate our
business,” said Rami Elghandour, Arcellx’s Chairman and Chief
Executive Officer. “We are thrilled about the momentum across our
multiple myeloma program being developed in partnership with Kite.
We believe anito-cel has the potential to be a best-in-class
treatment option, and with the strength of our Kite partnership, we
are well-positioned to change the treatment paradigm for multiple
myeloma patients. We look forward to presenting data from the
iMMagine-1 study by the end of this year. As iMMagine-1 continues
to mature, we’re also pleased with the progress in iMMagine-3,
which was initiated by our partner Kite. More broadly, we believe
that our novel synthetic binder, the D-Domain, which forms the
basis of our technology platform and our lead program anito-cel,
can be developed in oncology and non-oncology indications. We are
excited to share that the U.S. Food and Drug Administration has
cleared our IND application for the development of anito-cel to
treat patients with myasthenia gravis. Our progress this quarter
reflects our incredible team and their dedication to advancing our
mission of helping as many patients as possible by delivering on
the promise of our platform.”
Recent Business Progress
- The Company earned a $68 million clinical milestone payment
from Kite Pharma, Inc., a Gilead Company, for iMMagine-1
enrollment.
- The Company submitted an abstract to present data for the
iMMagine-1 study at the 66th ASH Annual Meeting and
Exposition.
- Kite has initiated the global Phase 3 trial, iMMagine-3. This
trial will evaluate anito-cel in patients exposed to an
immunomodulatory (lMiD) drug and an anti-CD38 monoclonal
antibody.
- The U.S. Food and Drug Administration (FDA) cleared an
Investigational New Drug (IND) application for anito-cel, Arcellx’s
BCMA CAR-T therapy, for myasthenia gravis, a chronic autoimmune
disease. Arcellx wholly owns and is solely developing this
program.
Second Quarter 2024 Financial
Highlights
Cash, cash equivalents, and marketable securities:
As of June 30, 2024, Arcellx had cash, cash equivalents, and
marketable securities of $646.8 million. Arcellx anticipates that
its cash, cash equivalents, and marketable securities will fund its
operations into 2027.
Collaboration revenue:
Collaboration revenue were $27.4 million and $14.3 million for
the quarters ended June 30, 2024 and 2023, respectively, an
increase of $13.1 million. This increase was primarily driven by an
increase in estimated transaction price from the expansion to the
license and collaboration agreement with Kite.
R&D expenses:
Research and development expenses were $41.0 million and $28.3
million for the quarters ended June 30, 2024 and 2023,
respectively, an increase of $12.7 million. This increase was
primarily driven by increased costs relating to other preclinical
pipeline programs and increased personnel costs, which include
non-cash stock-based compensation expense.
G&A expenses:
General and administrative expenses were $21.4 million and $15.5
million for the quarters ended June 30, 2024 and 2023,
respectively, an increase of $5.9 million. This increase was
primarily driven by increased personnel costs, which include
non-cash stock-based compensation expense.
Net income or loss:
Net losses were $27.2 million and $23.9 million for the quarters
ended June 30, 2024 and 2023, 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. For more information on Arcellx, please visit
www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn.
About Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease
characterized by severe muscle weakness. In gMG, the body’s immune
system mistakenly attacks proteins in the neuromuscular junction,
disrupting neuromuscular signaling and preventing muscle
contraction. Symptoms include muscle weakness, drooping eyelids,
impaired chewing, swallowing, and speaking. gMG affects over 70,000
people in the United States and there is no known cure.
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 momentum across
the multiple myeloma program being developed in partnership with
Kite, and the potential to change the treatment paradigm in
multiple myeloma; the anticipated timing for the presentation of
iMMagine-1 data; the best-in-class potential of anito-cel for
patients suffering from multiple myeloma; Arcellx’s belief that the
D-Domain can be developed in oncology and non-oncology indications;
and the sufficiency of cash, cash equivalents and marketable
securities and its ability to fund operations into 2027. 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 II, Item 1A
(Risk Factors) in the Quarterly Report on Form 10-Q for the quarter
ended June 30, 2024, 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) June 30, December
31,
2024
2023
Cash, cash equivalents, and marketable securities
$
646,816
$
729,185
Total assets
734,306
825,132
Total liabilities
247,142
339,752
Total stockholders' equity
487,164
485,380
ARCELLX, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (in thousands, except share and per share
amounts) Three Months Ended June 30, Six
Months Ended June 30,
2024
2023
2024
2023
Revenue
$
27,384
$
14,302
$
66,640
$
32,213
Operating expenses: Research and development
40,953
28,327
73,271
61,258
General and administrative
21,424
15,535
44,172
30,972
Total operating expenses
62,377
43,862
117,443
92,230
Loss from operations
(34,993
)
(29,560
)
(50,803
)
(60,017
)
Other income, net
8,132
5,424
16,744
8,866
Loss before income taxes
(26,861
)
(24,136
)
(34,059
)
(51,151
)
Income tax benefit (expense)
(341
)
282
(341
)
(47
)
Net loss
(27,202
)
(23,854
)
(34,400
)
(51,198
)
Other comprehensive loss: Unrealized gain (loss) on
marketable securities
(280
)
(93
)
(1,339
)
214
Comprehensive loss
$
(27,482
)
$
(23,947
)
$
(35,739
)
$
(50,984
)
Net loss per share attributable to common stockholders—basic and
diluted
$
(0.51
)
$
(0.50
)
$
(0.65
)
$
(1.08
)
Weighted-average common shares outstanding—basic and diluted
53,516,907
48,106,528
53,137,440
47,441,647
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version on businesswire.com: https://www.businesswire.com/news/home/20240807138005/en/
Investors: Myesha Lacy ir@arcellx.com 510-418-2412
Media: Laura Morgan Sam Brown lauramorgan@sambrown.com
951-333-9110
Arcellx (NASDAQ:ACLX)
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