Immix Biopharma (IMMX) Status Update summary

Unmet clinical need and current treatment landscape

• Over 23,000 U.S. patients have relapsed/refractory AL amyloidosis, with no FDA-approved drugs for this subgroup.

• Disease causes multi-organ failure, especially heart, kidney, and liver, leading to high morbidity and mortality.

• First-line therapy (daratumumab-based) achieves ~60% response, but options are limited after failure, with short-lived responses.

• Stem cell transplant is only suitable for a select few, with modest outcomes.

• Off-label and experimental therapies are used, but with low response rates and significant side effects.

NEXICART-2 trial interim results and safety

• NXC-201, a BCMA-targeted CAR T-cell therapy, is the first and only CAR T trial in AL amyloidosis.

• Phase I/II trial enrolled heavily pretreated patients, most with cardiac involvement; median age 67.

• NXC-201 achieved a 70% complete response rate (7/10 patients), with all patients normalizing disease markers and organ responses observed.

• The remaining 3 patients were bone marrow MRD negative, predicting future complete responses.

• No dose-limiting toxicities or neurotoxicity reported; only mild, manageable CRS observed.

Clinical significance and future outlook

• Safety profile and rapid response make NXC-201 a promising option, even for patients post-stem cell transplant.

• Durability of response is a key focus for ongoing evaluation, with early data suggesting potential for long-term benefit.

• One-time treatment is highly attractive compared to ongoing therapies, with potential for outpatient administration.

• If approved, NXC-201 could become the first FDA-approved therapy for relapsed AL amyloidosis and a top consideration after first-line failure.

• Results were presented at ASCO 2025, with a KOL event scheduled to discuss clinical significance.