On February 28, 2024 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2023 (Press release, Arcellx, FEB 28, 2024, View Source [SID1234640624]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 $200M investment, extending our cash runway into 2027 and deepened our collaboration by expanding into lymphomas. Additionally, we presented robust long-term data from our Phase 1 expansion study of anito-cel at the 65th ASH (Free ASH Whitepaper) Annual Meeting. These data support the potential for anito-cel to be a best-in-class treatment option for patients with relapsed or refractory multiple myeloma. In parallel to these milestones, we continued to scale our organization to deliver both operationally and strategically, strengthening our foundation with key progress in manufacturing, development, research, and commercial readiness. This year is poised to be another year of meaningful progress for our organization. We are focused on completing enrollment in the iMMagine-1 trial, initiating our clinical trial in earlier lines of multiple myeloma, and completing the technical transfer to Kite. Patients with relapsed or refractory multiple myeloma still have limited therapeutic options, and with our partners at Kite, we are committed to delivering anito-cel to help as many patients as possible. We believe that with our technology coupled with Kite’s recognized global leadership and established manufacturing expertise, we are well positioned to achieve this goal. Additionally, we continue to invest in research and believe the differentiation of the D-Domain technology provides an opportunity for us to expand our development pipeline in other therapeutic areas."
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 $200 million equity investment at $61.68 per share and an $85 million upfront cash payment.
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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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, 100% overall response rate (ORR) was achieved in all patients and 29 of 38 (76%) evaluable patients achieved a complete response (CR) or a stringent complete response (sCR). Additionally, anito-cel continued to be well tolerated with no delayed neurotoxicity or parkinsonian symptoms observed. Median duration of response, progression free survival (PFS), and overall survival were not reached at the time of the October 15, 2023 data cut. Anito-cel continued to be well-tolerated at the time of the October 15, 2023 data cut.
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 $729.2 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.
Collaboration revenue:
Collaboration revenue was $63.1 million and zero for the quarters ended December 31, 2023 and 2022, respectively. Collaboration revenue was $110.3 million and zero for the twelve months ended December 31, 2023 and 2022, respectively. The revenue results 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 $28.8 million and $25.9 million for the quarters ended December 31, 2023 and 2022, respectively, an increase of $2.9 million. This increase was driven primarily by an increase in personnel and facility costs. Research and development expenses were $133.8 million and $149.6 million for the twelve months ended December 31, 2023 and 2022, respectively, a decrease of $15.8 million. This decrease was primarily driven by the accounting treatment for our Lonza manufacturing services agreement, which resulted in a non-cash expense in both years ended December 31, 2023 and 2022. This decrease was partially offset by an increase in personnel costs, which includes non-cash stock-based compensation expense.
G&A expenses:
General and administrative expenses were $19.4 million and $14.1 million for the quarters ended December 31, 2023 and 2022, respectively, an increase of $5.3 million. General and administrative expenses were $66.4 million and $41.7 million for the twelve months ended December 31, 2023 and 2022, respectively, an increase of $24.7 million. The increases were driven primarily by non-cash stock-based compensation expense.
Net income or loss:
Net income was $20.5 million for the quarters ended December 31, 2023 and net loss was $39.0 million for the quarter ended December 31, 2022. Net loss for the twelve months ended December 31, 2023 and 2022 were $70.7 million and $188.7 million, respectively.