Immix Biopharma (IMMX) investor relations material

Unmet need and market

• U.S. treatment-eligible relapsed/refractory AL amyloidosis population estimated at 30,506; 3,447 patients estimated to become relapsed/refractory annually.

• No FDA-approved therapies for relapsed/refractory AL amyloidosis; investigator-choice regimens show a reported 0–10% complete response rate.

• Darzalex sales attributable to AL amyloidosis estimated at $2.5–3.1bn annually, based on epidemiology, EHR/claims, and Australian expenditure analyses.

NXC-201 and clinical development

• NXC-201 is a BCMA-targeted CAR-T designed to eliminate plasma cells producing toxic light chains; construct features aim to reduce nonspecific activation and cytokine release while supporting cytotoxicity and expansion.

• NEXICART-2 is an open-label, single-arm U.S. Phase 1/2 study with registrational design; enrollment completed at 45 patients, with prior CD38 antibody and proteasome inhibitor exposure required.

• NEXICART-2 data cutoff was Aug. 4, 2026; FDA Breakthrough Therapy Designation was granted in Jan. 2026, alongside Orphan Drug and RMAT designations.

• NEXICART-3 is a planned randomized Phase 3 trial in newly diagnosed AL amyloidosis, comparing NXC-201 with DaraCyBorD; initiation planned for 1H 2027.

NEXICART-2 efficacy

• Complete hematologic response in 40/45 patients (89%); MRD negativity was cited as potentially supporting a future CR rate of up to 98%.

• Median time to CR was 3 months; toxic light chains normalized at median day 7, with MRD negativity assessed at day 25.

• Organ responses occurred in 20/21 evaluable patients (95%); reported rates were 100% for cardiac and 92% for renal responses.

• Median time to cardiac organ response was 26 days and to renal response 59 days; organ-response criteria included biomarker declines after treatment.