-- Recently released ASH abstract for the
company's Phase 1 CART-ddBCMA trial demonstrated that median
duration of response, progression free survival, and overall
survival not reached with median follow-up of 22 months after
CART-ddBCMA infusion --
-- Company to present new patient data from its
Phase 1 CART-ddBCMA trial during an oral presentation with a
median follow-up of 26.5 months at the 65th ASH Annual Meeting in
December --
REDWOOD CITY, Calif.,
Nov. 13, 2023 /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 financial results for the third quarter ended September 30, 2023 and provided recent business
highlights.
"We are excited to have announced our upcoming oral presentation
at ASH in December. As published in our recently released ASH
abstract, median duration of response, progression free survival
and overall survival were not reached in patients with a
median follow-up of 22 months after infusion of CART-ddBCMA.
Additionally, CART-ddBCMA continues to be well-tolerated at the
time of the June 2, 2023 data cut
with no observed delayed neurotoxicities or parkinsonian symptoms
at the median follow-up of 22 months," said Rami Elghandour, Arcellx's Chairman and Chief
Executive Officer. "We look forward to presenting data from this
study with a median follow-up of 26.5 months for patients during an
oral presentation at ASH. We continue to believe in the
best-in-class potential for CART-ddBCMA for patients suffering from
relapsed or refractory multiple myeloma based on the safety and
efficacy profile. Additionally, we are excited to have resumed
enrollment in our iMMagine-1 study as we continue to advance the
program towards commercial availability."
Recent Business Progress
Announced oral presentation, a medical affairs booth, and an
investor live webcast at the 65th ASH Annual Meeting and
Exposition. On November 2, 2023
Arcellx announced that new clinical data from its CART-ddBCMA Phase
1 trial in patients with relapsed or refractory multiple myeloma
will be presented during an oral presentation at the 65th American
Society of Hematology (ASH) Annual Meeting and Exposition taking
place December 9-12, 2023 in
San Diego, California. The data in
the ASH abstract is from a June 2,
2023 data cut. The oral presentation at ASH will include new
data with median follow-up of 26.5 months and will be presented
during an oral presentation on Monday,
December 11, 2023 at 5 p.m. PT
during the Cellular Immunotherapies: Early Phase and
Investigational Therapies: CAR-T Cell Therapies for Multiple
Myeloma and B Cell Lymphomas.
The company will also have a medical affairs booth (#748) in
Hall E of the San Diego Convention
Center and will also host a live webcast event with an expert
panel of clinicians to discuss the clinical results on Monday, December 11, 2023, at 8 p.m. PT. The event will be accessible from
Arcellx's website at www.arcellx.com in the Investors
section. A replay of the webcast will be archived and available for
30 days following the event.
Third Quarter 2023 Financial Highlights
Cash, cash equivalents, and marketable
securities:
As of September 30, 2023, Arcellx had
cash, cash equivalents, and marketable securities of $482.7 million. Arcellx anticipates that its
cash, cash equivalents, and marketable securities will fund its
operations into 2026.
Collaboration revenue:
Collaboration revenue was $15.0
million and zero for the quarters ended September 30, 2023 and 2022, respectively. The
revenue results for the three months ended September 30, 2023 is 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 $43.8
million and $83.5 million for
the quarters ended September 30, 2023
and 2022, respectively, a decrease of $39.7
million. This decrease between periods was driven by
the accounting treatment for our Lonza manufacturing services
agreement, which resulted in a non-cash expense in both quarters
ended September 30, 2023 and 2022 for
the related right of use assets associated with the embedded lease
which was determined to have no alternative future use.
G&A expenses:
General and administrative expenses were $16.0 million and $10.4
million for the quarters ended September 30, 2023 and 2022, respectively, an
increase of $5.6 million. This
increase was driven primarily by personnel and professional
fees.
Net loss:
Net loss was $39.3 million and
$92.9 million for the quarters ended
September 30, 2023 and 2022,
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, CART-ddBCMA, is being
developed for the treatment of relapsed or refractory multiple
myeloma (rrMM) in a Phase 2 pivotal trial. CART-ddBCMA has been
granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced
Therapy designations by the U.S. Food and Drug
Administration.
Arcellx is also advancing its dosable and controllable CAR-T
therapy, ARC-SparX, through two clinical-stage programs: a Phase 1
study of ACLX-001 for rrMM, initiated in the second quarter of
2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia
and high-risk myelodysplastic syndrome, initiated in the fourth
quarter of 2022. For more information on Arcellx, please
visit www.arcellx.com. Follow Arcellx on X (formerly Twitter,
@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 CART-ddBCMA 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 CART-ddBCMA 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 clinical development of its product
candidates, including anticipated announcements of additional data;
the best-in-class potential of CART-ddBCMA for patients suffering
from rrMM based on the safety and efficacy profile; Arcellx and
Kite's plans to advance and commercialize CART-ddBCMA; 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 II, Item 1A (Risk Factors) in the Quarterly Report on
Form 10-Q for the quarter ended September
30, 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)
|
|
|
|
|
September
30,
|
December
31,
|
|
2023
|
2022
|
Cash, cash equivalents,
and marketable securities
|
$
482,676
|
$
254,835
|
Total assets
|
614,218
|
313,817
|
Total
liabilities
|
348,090
|
108,863
|
Total stockholders'
equity
|
266,128
|
204,954
|
ARCELLX,
INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|
2023
|
2022
|
2023
|
2022
|
Revenue
|
$
14,957
|
$
—
|
$
47,171
|
$
—
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
43,807
|
83,473
|
105,065
|
123,612
|
General and
administrative
|
16,012
|
10,402
|
46,985
|
27,643
|
Total operating
expenses
|
59,819
|
93,875
|
152,050
|
151,255
|
Loss from
operations
|
(44,862)
|
(93,875)
|
(104,879)
|
(151,255)
|
Other income,
net
|
5,520
|
1,001
|
14,386
|
1,568
|
Loss before income
taxes
|
(39,342)
|
(92,874)
|
(90,493)
|
(149,687)
|
Income tax provision (benefit)
|
6
|
-
|
(41)
|
-
|
Net loss
|
(39,336)
|
(92,874)
|
(90,534)
|
(149,687)
|
Other comprehensive
loss:
|
|
|
|
|
Unrealized gain (loss)
on marketable securities
|
(58)
|
(137)
|
156
|
(379)
|
Comprehensive
loss
|
$
(39,394)
|
$
(93,011)
|
$
(90,378)
|
$
(150,066)
|
Net loss per share
attributable to common stockholders—basic and diluted
|
$
(0.81)
|
(2.12)
|
$
(1.89)
|
$
(4.43)
|
Weighted-average common
shares outstanding—basic and diluted
|
48,438,094
|
43,819,365
|
47,777,446
|
33,814,418
|
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.