Strong clinical updates, plus a $100 million dollar financing led by Morgan Stanley, position the company for the next phase of development.
IMMIX BIOPHARMA
(Nasdaq: IMMX)
The Global Leader in Relapsed/Refractory AL Amyloidosis
Immix Biopharma is working to overcome one of the most significant barriers to widespread CAR-T adoption: neurotoxicity. By addressing this challenge, ImmixBio aims to unlock access to CAR-T therapies in indications previously out of reach—beginning with AL Amyloidosis—and in settings where CAR-T was not previously feasible, such as the 95% of U.S. medical centers currently unable to administer these treatments.
Our Strategy Is To
Build on the proliferation of cell therapy expertise across the U.S. to deliver FDA approval submissions in AL amyloidosis and other serious diseases for NXC-201, our highly differentiated cell therapy candidate.
Demonstrate the power of overcoming neurotoxicity, divorcing the classical relationship between toxicity and efficacy.
Continue to expand into new indications and advance new cell therapies with similar transformative potential.
Download the Investor Presentation to learn more about our clinical
progress, technology, and strategic vision.
Key Reasons to Watch
Lead Program Advancing in U.S. Trials: NXC-201 is currently being evaluated in the NEXICART-2 clinical trial at leading institutions including Memorial Sloan Kettering Cancer Center.
Regulatory Momentum: FDA approval of the IND application for NXC-201 allows U.S. patient dosing and opens potential pathways into additional indications.
Differentiated CAR-T Profile: NXC-201 has demonstrated a favorable tolerability profile in clinical trials, supporting the potential to address diseases historically underserved by CAR-T therapies.
Scientific Leadership: ImmixBio has added recognized experts from top institutions to its Scientific Advisory Board, strengthening its clinical development strategy.
Scalable Platform Potential: The company’s N-GENIUS™ Cell Therapy Platform may support the development of additional therapies targeting other serious diseases.
*NXC-201 is an investigational therapy. Safety and efficacy have not been established.
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At ASH 2025 Oral Presentation, Immix Biopharma Reports Positive Phase 2 NXC-201 Results, Advancing Toward BLA Submission as a Potentially First- and Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
– NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee –
– In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95% –
– NEXICART-2 final readout and BLA submission planned in 2026 –
LOS ANGELES, CA, Dec. 07, 2025 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced positive phase 2 NXC-201 results in an oral presentation at ASH 2025 presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center. NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee. In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95%. NEXICART-2 final readout and BLA submission are planned for 2026.
“In the larger patient set Phase 2 results presented today at ASH, we are thrilled to see complete response rates continue to improve in NEXICART-2. These excellent results demonstrate the potential of NXC-201 to address the significant unmet medical need in relapsed/refractory AL Amyloidosis,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “This exciting Phase 2 milestone brings us one step closer to delivering this promising therapy to patients upon planned BLA submission in 2026.”
About Immix Biopharma, Inc.
Ticker
IMMX
Market Cap
~300M
Shares Outstanding
~56M
Immix Biopharma, Inc. (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company focused on advancing innovative cell therapies. The company’s lead candidate, NXC-201, is a proprietary BCMA-targeted CAR-T therapy being evaluated for relapsed/refractory AL Amyloidosis.
NXC-201 is currently in a U.S.-based Phase 1b/2a study (NEXICART-2, NCT06097832), conducted at more than a dozen centers including Memorial Sloan Kettering Cancer Center. Initial clinical results were featured in an oral presentation at ASCO 2025 by Dr. Heather Landau of MSKCC.
The therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and Orphan Drug Designation (ODD) in both the United States and the European Union.
Market Opportunity
Relapsed/Refractory AL Amyloidosis:
No FDA-approved therapies currently available
Represents a significant unmet medical need
Estimated to be a $3B+ global market opportunity
Cell therapy may offer a new therapeutic pathway if proven safe and effective
What Is NXC-201 CAR-T Therapy?
An Investigational Approach to Cell-Based Immunotherapy
Our immune systems are designed to detect and eliminate harmful cells. However, certain diseases like AL Amyloidosis originate from the body’s own cells and may avoid detection by the immune system.
NXC-201 is an investigational BCMA-targeted CAR-T (chimeric antigen receptor T-cell) therapy designed to address this challenge. The therapy involves collecting a patient’s own T cells and genetically modifying them using proprietary technology developed by Immix Biopharma. These modified cells—NXC-201 CAR-T cells—are then reintroduced into the patient’s body, where they are intended to recognize and engage cells expressing BCMA, a protein found on certain diseased cells.
In a clinical trial setting, NXC-201 is being evaluated in patients with relapsed/refractory AL Amyloidosis. Preliminary data from early trial cohorts have shown encouraging signals, including an overall response rate (ORR) of up to 92% in patients with relapsed/refractory AL Amyloidosis. However, these results are from ongoing studies and may not predict outcomes in future participants.
NXC-201 is an investigational product. It has not been approved by the FDA or any regulatory authority. Safety and efficacy have not been established.
Clinical Progress & Scientific Momentum
18 Clinical Trial Sites Now Open!
72 patients dosed to date across NXC-201 studies
U.S. manufacturing successfully completed for multiple clinical batches
Clinical data presented at ASCO, ASH, IMS, and other global conferences
Advisory board includes experts from Memorial Sloan Kettering, Stanford, and Columbia
Discover Immix Biopharma’s progress and potential
Immix Biopharma is working to bring new hope to patients with serious and difficult-to-treat diseases through the development of NXC-201. Backed by regulatory designations, early clinical data, and a strong institutional network, the company is advancing one of the few clinical-stage CAR-T programs focused on AL Amyloidosis.
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