REDWOOD
CITY, Calif., May 8, 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 first
quarter ended March 31, 2023.
"Delivering our novel CAR-T therapy to multiple myeloma patients
is at the heart of our mission," said Rami
Elghandour, Arcellx's Chairman and Chief Executive
Officer. "With the closing of our Kite partnership in the
first quarter, we believe we are well capitalized to fund our
operations through the first half of 2025. We remain laser-focused
on key drivers of our business which include completing
enrollment of iMMagine-1, initiating iMMagine-2 in earlier multiple
myeloma lines, and presenting longer-term data from our Phase 1
expansion study of CART-ddBCMA. This is a pivotal and exciting time
for our organization, and we are excited about our progress made to
date and look forward to continuing our momentum."
First Quarter 2023 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of March 31, 2023, Arcellx had
cash, cash equivalents, and marketable securities of $533.6 million. Arcellx expects that the cash,
cash equivalents, and marketable securities on hand, will fund its
operations through BLA filing of CART-ddBCMA planned for the first
half of 2025
Collaboration revenue:
Collaboration revenue was $17.9
million and zero for the quarters ended March 31, 2023 and 2022, respectively. The
revenue results for the three months ended March 31, 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). Revenue is being recognized on a percentage of
completion basis over the term of the contract with Kite.
R&D expenses:
Research and development expenses were $32.9
million and $18.1 million for
the quarters ended March 31, 2023 and
2022, respectively, an increase of $14.8
million. This increase was primarily driven by higher
external costs associated with the advancement of the company's
CART-ddBCMA clinical program and increased headcount.
G&A expenses:
General and administrative expenses were $15.4 million and $8.0
million for the quarters ended March
31, 2023 and 2022, respectively, an increase of $7.4 million. This increase was driven by
increased headcount and professional fees.
Net loss:
Net loss was $27.3 million and
$26.0 million for the quarters ended
March 31, 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 Twitter
(@arcellx) and LinkedIn.
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 Arcellx's plans for the
clinical development of its product candidates, including
anticipated announcements of additional data; and the sufficiency
of cash, cash equivalents and marketable securities and its ability
to fund operations. 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 March 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)
|
|
|
|
|
March
31,
|
December
31,
|
|
2023
|
2022
|
Cash, cash equivalents,
and marketable securities
|
$ 533,593
|
$
254,835
|
Total assets
|
622,943
|
313,817
|
Total
liabilities
|
319,226
|
108,863
|
Total stockholders'
equity
|
303,717
|
204,954
|
ARCELLX,
INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Three Months Ended
March 31,
|
|
2023
|
2022
|
Revenue
|
$
17,912
|
$
—
|
Operating
expenses:
|
|
|
Research and
development
|
32,932
|
18,057
|
General and
administrative
|
15,437
|
8,034
|
Total operating
expenses
|
48,369
|
26,091
|
Loss from
operations
|
(30,457)
|
(26,091)
|
Other income,
net
|
3,442
|
50
|
Loss before income
taxes
|
(27,015)
|
(26,041)
|
Income tax expense
|
329
|
-
|
Net loss
|
(27,344)
|
(26,041)
|
Other comprehensive
loss:
|
|
|
Unrealized gain (loss)
on marketable securities
|
307
|
(24)
|
Comprehensive
loss
|
$ (27,037)
|
$ (26,065)
|
Net loss per share
attributable to common stockholders—basic and diluted
|
(0.58)
|
(1.25)
|
Weighted-average common
shares outstanding—basic and diluted
|
46,769,380
|
20,760,722
|
Investor Contact:
Myesha Lacy
Arcellx, Inc.
ir@arcellx.com
510-691-6361
Media Contact
Andrea
Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163
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SOURCE Arcellx, Inc.