Arcellx, Inc. SEC 10-Q Report

Arcellx, Inc., a biotechnology company specializing in the development of innovative cell therapies for cancer and autoimmune diseases, has released its Form 10-Q report for the third quarter of 2024. The report provides a comprehensive overview of the company's financial performance and key business developments during the period.

Financial Highlights

Collaboration Revenue: $8.1 million, a decrease of $31.1 million compared to the same period in 2024 due to the completion of dosing and manufacturing of anito-cel in the iMMagine-1 trial.

Loss from Operations: $(68.9) million, an increase of $53.1 million compared to the same period in 2024, primarily due to higher research and development expenses.

Net Loss: $(62.3) million, an increase of $55.1 million compared to the same period in 2024, reflecting increased operating expenses.

Net Loss Per Share: $(1.13), compared to $(0.14) in the same period in 2024, reflecting the increased net loss.

Business Highlights

Product Development: Arcellx, Inc. is advancing its lead program, anito-cel, a BCMA-targeting ddCAR product candidate, through pivotal Phase 2 and Phase 3 trials for relapsed or refractory multiple myeloma (rrMM). The company has partnered with Kite Pharma Inc. for co-development and co-commercialization.

Clinical Trials: The company completed dosing in its pivotal Phase 2 iMMagine-1 trial for anito-cel in 2024 and presented preliminary data at the ASH Annual Meeting. Kite has initiated a global Phase 3 trial, iMMagine-3, for anito-cel in rrMM.

Pipeline Expansion: Arcellx is developing two clinical-stage ARC-SparX programs, ACLX-001 targeting BCMA in rrMM and ACLX-002 targeting CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

New Indications: The company is exploring the use of anito-cel for non-oncology indications, including autoimmune disorders such as generalized myasthenia gravis, with a Phase 1 trial initiated in 2024.

Manufacturing and Collaboration: Kite is responsible for manufacturing anito-cel for the iMMagine-3 trial following a successful technical transfer from Arcellx, which was completed and cleared by the FDA in May 2024.

Future Outlook: Arcellx plans to continue expanding its pipeline, develop its proprietary platforms, and explore additional indications for its product candidates. The company anticipates increased operating expenses as it advances its clinical programs and prepares for potential commercialization.

SEC Filing: Arcellx, Inc. [ ACLX ] - 10-Q - May. 08, 2025