Arcellx Q2 2025: $538M cash, 97% ORR, 68% CR/sCR, 6-, 12-, 18-month PFS rates.

• Arcellx reports 97% ORR, 68% CR/sCR in RRMM study. • Median follow-up of 12.6 months. • 6-, 12-, and 18-month PFS rates were 92%, 79%, and 66%. • No delayed neurotoxicities or immune-mediated enterocolitis observed. • Received FDA clearance for ACLX-004 IND application. • Ended Q2 with $538M in cash, expected to fund operations into 2028.

Arcellx, Inc. (NASDAQ: ACLX) has reported positive results from its Phase 2 pivotal iMMagine-1 study of anito-cel in patients with relapsed or refractory multiple myeloma (RRMM). The study, which presented data from a May 1, 2025 data cutoff date, demonstrated an overall response rate (ORR) of 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) [1].

The median follow-up period was 12.6 months, and the six-month, 12-month, and 18-month progression-free survival (PFS) rates were 92%, 79%, and 66%, respectively. The study also reported no delayed neurotoxicities or immune-mediated enterocolitis, highlighting anito-cel's safety profile [1].

Arcellx has secured FDA clearance for its Investigational New Drug application (IND) for ACLX-004, which targets CD33 and CD123 using the Company’s ARC-SparX platform. The company expects to launch anito-cel in over 160 authorized treatment centers in the United States within the first year on the market and to have an adequate supply to meet physician expectations [1].

The company ended the second quarter of 2025 with $538 million in cash, which is expected to fund its operations into 2028 [1]. Arcellx anticipates sharing longer-term data from the iMMagine-1 study later this year.

References:
[1] https://www.businesswire.com/news/home/20250807158527/en/Arcellx-Provides-Second-Quarter-2025-Financial-Results-and-Business-Highlights