Arcellx Provides Fourth Quarter and Year-End 2024 Financial Results and Business Highlights
-- Presented positive preliminary data at ASH 2024 from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel in patients with RRMM which demonstrated
-- No delayed neurotoxicities observed with anito-cel, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in 155 patients dosed across the Phase 1 and iMMagine-1 studies as presented at ASH 2024 --
-- iMMagine-1 update planned for presentation mid-year 2025 --
-- Commercial launch of anito-cel in RRMM planned for 2026 --
-- Ended the quarter with
“2024 was a transformational year for Arcellx as our ASH data presentations for anito-cel, in partnership with Kite, continued to demonstrate anito-cel’s differentiated clinical profile for the potential treatment of patients with relapsed or refractory multiple myeloma,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “In our Phase 1 and iMMagine-1 studies, data demonstrate that anito-cel has the potential to provide a meaningful benefit to a broad population of patients. Our Phase 1 study demonstrated that the deep responses observed with anito-cel also translated to durable benefit for patients with a 30.2 month median progression-free survival in a challenging patient cohort and the preliminary data from our pivotal iMMagine-1 study demonstrated anito-cel also delivered deep responses for late line myeloma patients with a
Recent Business Progress
Presented positive preliminary data for the Phase 2 pivotal iMMagine-1 study of anito-cel in patients with relapsed or refractory multiple myeloma (RRMM) at the 66th ASH Annual Meeting and Exposition. The data presented on December 9, 2024 demonstrated deep and durable responses with a predictable and manageable safety profile in a high-risk fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. The data were from an October 31, 2024 data cutoff date, with a median follow-up of 9.5 months for the 86 patients who were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel.
Overall response rate was
Fourth Quarter and Full Year 2024 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of December 31, 2024, Arcellx had cash, cash equivalents, and marketable securities of
Collaboration revenue:
Collaboration revenue were
R&D expenses:
Research and development expenses were
G&A expenses:
General and administrative expenses were
Net losses:
Net losses were
About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in
About anitocabtagene autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a Phase 3 randomized controlled study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in
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.
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, statements regarding: the potential of anito-cel for providing meaningful benefit in patients suffering from multiple myeloma; the potential impact of anito-cel on rrMM patients and expected clinical profile; anito-cel tolerability and toxicity trends; Arcellx's plans for the research, pre-clinical and clinical development of its product candidates; expectations regarding the clinical trial sites and their experience; the anticipated timing for the presentation of updated iMMagine-1 preliminary data; Arcellx’s partnership with Kite; the potential commercial launch of anito-cel, subject to FDA approval; Arcellx’s ability to deliver cell therapies that will meet the key expectations of patients and clinicians and serve the multiple myeloma community; 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 I, Item 1A (Risk Factors) in the Annual Report on Form 10-K for the fiscal year ended December 31, 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) | ||||
December 31, |
December 31, |
|||
|
2024 |
|
2023 |
|
Cash, cash equivalents, and marketable securities | $ |
625,652 |
$ |
729,185 |
Total assets |
|
711,327 |
|
825,132 |
Total liabilities |
|
256,535 |
|
339,752 |
Total stockholders' equity |
|
454,792 |
|
485,380 |
ARCELLX, INC. | ||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||
(in thousands, except share and per share amounts) | ||||||
Year Ended December 31, |
||||||
|
2024 |
|
|
2023 |
|
|
Revenue | $ |
107,936 |
|
$ |
110,319 |
|
Operating expenses: | ||||||
Research and development |
|
157,093 |
|
|
133,849 |
|
General and administrative |
|
88,414 |
|
|
66,350 |
|
Total operating expenses |
|
245,507 |
|
|
200,199 |
|
Loss from operations |
|
(137,571 |
) |
|
(89,880 |
) |
Other income, net |
|
32,292 |
|
|
19,853 |
|
Loss before income taxes |
|
(105,279 |
) |
|
(70,027 |
) |
Income tax expense |
|
(2,069 |
) |
|
(663 |
) |
Net loss |
|
(107,348 |
) |
|
(70,690 |
) |
Other comprehensive loss: | ||||||
Unrealized gain on marketable securities |
|
301 |
|
|
768 |
|
Comprehensive loss | $ |
(107,047 |
) |
$ |
(69,922 |
) |
Net loss per share attributable to common stockholders—basic and diluted | $ |
(2.00 |
) |
$ |
(1.47 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
53,566,153 |
|
|
48,061,450 |
|
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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
Source: Arcellx, Inc.