Arcellx reports 97% ORR from anito-cel Phase 2; FDA clears ACLX-004 IND; Q2 net loss $52.8M

Arcellx, Inc.

Phase 2 iMMagine-1: 97% ORR, 68% CR/sCR at 12.6 months; no delayed neurotoxicity events observed.
FDA cleared IND for ACLX-004 (CD33/CD123) ARC-SparX platform for AML.
Q2 2025 net loss $52.8M vs $27.2M in Q2 2024; rev $7.6M (down from $27.4M).
Cash $537.6M expected to fund operations into 2028.
Plan to launch anito-cel at >160 US treatment centers within first year.

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