Arcellx Provides Fourth Quarter and Year-End 2023 Financial Results and Business Highlights
- Expanded strategic partnership with Kite Pharma, Inc., securing a $200M investment and extending cash runway into 2027.
- Presented positive long-term data from anito-cel Phase 1 expansion trial, demonstrating high response rates and durable outcomes in patients with multiple myeloma.
- Strengthened organizational capabilities in manufacturing, research, and development to support future clinical trials and commercial readiness.
- Achieved $729.2M in cash, cash equivalents, and marketable securities, providing financial stability and funding for operations into 2027.
- Collaboration revenue of $63.1M in Q4 2023, reflecting successful partnerships and revenue recognition from collaboration agreements.
- Net income of $20.5M in Q4 2023, showcasing positive financial performance and potential for growth in the coming years.
- Net loss of $39.0M in Q4 2022 and $70.7M for the full year 2023 indicates previous financial challenges and ongoing investment in research and development.
- Decrease in research and development expenses in 2023 may raise concerns about the company's commitment to innovation and future pipeline development.
- Increase in general and administrative expenses in 2023, driven by non-cash stock-based compensation, could impact overall profitability and financial sustainability.
Insights
The equity investment and upfront cash payment received by Arcellx from the expanded strategic partnership with Kite Pharma are significant liquidity events that bolster the company's financial position. The $200 million equity investment at a premium price of $61.68 per share suggests a strong vote of confidence in Arcellx's technology and pipeline, potentially serving as a positive signal to the market. Furthermore, the extension of the cash runway into 2027 provides Arcellx with a substantial buffer to advance its clinical programs without the immediate need for additional capital raises, which could have been dilutive to existing shareholders.
Collaboration revenue of $63.1 million for Q4 2023, compared to none in Q4 2022, indicates the materialization of the partnership with Kite into tangible financial results. This revenue growth, along with a reported net income of $20.5 million for Q4 2023 versus a net loss in the same quarter the previous year, reflects a positive trajectory in terms of financial performance. However, investors should consider the sustainability of these revenues, as collaboration payments can be variable and linked to specific milestones.
The reported data from the Phase 1 expansion trial of anito-cel showing a 100% overall response rate and 76% achieving complete or stringent complete response is quite remarkable in the context of relapsed or refractory multiple myeloma, a patient population with limited treatment options. The lack of observed delayed neurotoxicity or parkinsonian symptoms suggests a favorable safety profile, which is a critical factor in the adoption of new therapies. The robust long-term responses could position anito-cel as a potential best-in-class treatment, which would have significant implications for market share and competitive dynamics within the multiple myeloma treatment landscape.
It is also noteworthy that the median duration of response, progression-free survival and overall survival were not reached at the time of the data cut, indicating the possibility of sustained efficacy. These clinical outcomes, if maintained over time, could lead to regulatory advantages and a strong value proposition to payers, which in turn could drive market adoption and sales growth upon commercialization.
The strategic partnership expansion into lymphomas represents an entry into a broader market, potentially increasing the total addressable market for Arcellx's pipeline products. Lymphoma, being a more prevalent cancer than multiple myeloma, could offer a larger patient pool for anito-cel, subject to successful clinical development and regulatory approvals. The collaboration with Kite, leveraging their global leadership and established manufacturing expertise, could accelerate market access and penetration for anito-cel upon approval.
Investors should monitor the progress of the iMMagine-1 trial and the initiation of the clinical trial in earlier lines of multiple myeloma, as these developments could impact the company's valuation by providing further validation of anito-cel's efficacy and safety. The technical transfer to Kite is another critical factor, as successful execution is key to ensuring manufacturing scalability and supply chain readiness, which are essential for commercial success in the biotechnology sector.
-- 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
"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
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
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,
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
Collaboration revenue:
Collaboration revenue was
R&D expenses:
Research and development expenses were
G&A expenses:
General and administrative expenses were
Net income or loss:
Net income was
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
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
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.
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