IMMX · Immix Biopharma, Inc.

Immix Biopharma's completion of enrollment in the NEXICART-2 trial marks a critical milestone for its lead CAR-T therapy NXC-201, a sterically-optimized BCMA-targeted treatment designed to eliminate toxic light chains in relapsed/refractory AL Amyloidosis patients. This 40-patient, multi-site U.S. Phase 2 study has a registrational design, positioning it for potential BLA submission post-Q3 2026 topline data. The announcement builds on positive interim results from ASH 2025, reinforcing the therapy's promise as a one-and-done treatment addressing a disease causing organ failure and death. Strengthening leadership, the Company onboarded Richard Graydon, MD, PhD as Chief Medical Officer, bringing over 20 years of experience including successful BLA and NDA submissions for drugs like DARZALEX and KEYTRUDA at Merck and Johnson & Johnson. NXC-201's FDA designations—Breakthrough Therapy, RMAT, and Orphan Drug—signal regulatory support, potentially accelerating path to approval and commercial launch in a growing patient population estimated at 38,500 in the U.S. by 2026.