Immix Biopharma — NXC-201 receives FDA RMAT designation

Immix Biopharma (NASDAQ: IMMX)

Last close As at 12/02/2025

USD1.99

0.02 (1.02%)

Market capitalisation

USD55m

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Research: Healthcare

Immix Biopharma — NXC-201 receives FDA RMAT designation

Immix Biopharma has been granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration (FDA) for the company’s novel sterically optimized CAR-T treatment, NXC-201, which is being developed as a potential treatment for relapsed/refractory amyloid light chain amyloidosis (r/r ALA). The RMAT designation offers several operational and regulatory benefits, which could streamline the clinical development and subsequent approval process for NXC-201, for example by enabling frequent interactions with the FDA. We note that NXC-201 has already been awarded orphan drug designation by the FDA and the European Medicines Agency (EMA), reflecting a robust position in what could be key markets for the therapy. NXC-201 is currently being evaluated in the US-based NEXICART-2 trial, and the next update (expected in H125) may represent a near-term catalyst for Immix, in our view.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Analyst, Healthcare

Healthcare

Regulatory update

13 February 2025

Price $1.99
Market cap $55m

Net cash at 30 September 2024

$19.7m

Shares in issue

27.5m
Free float 60.0%
Code IMMX
Primary exchange NASDAQ
Secondary exchange N/A
Price Performance

Business description

Immix Biopharma is a clinical-stage biopharma company developing personalized therapies for oncology and immunology. Lead asset NXC-201 is a BCMA-targeting CAR-T asset, being evaluated for amyloid light chain amyloidosis with plans to expand to autoimmune indications. A Phase Ib/II trial, NEXICART-2, is ongoing in the US, with top-line results expected in mid-CY26. The company is also seeking strategic options for legacy asset IMX-110, targeting solid tumors.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.

Year end Revenue ($m) PBT ($m) EPS ($) DPS ($) P/E (x) Yield (%)
12/22 0.0 (7.6) (0.55) 0.00 N/A N/A
12/23 0.0 (13.0) (0.75) 0.00 N/A N/A
12/24e 1.0 (20.1) (0.72) 0.00 N/A N/A
12/25e 7.0 (17.9) (0.61) 0.00 N/A N/A

As per the announcement, Immix has been awarded the RMAT designation for NXC-201 as a potential treatment for r/r ALA. Key benefits of this regulatory designation include regular consultations with the FDA through the development phases, flexibility in the clinical trial design as well as potential for accelerated approval and priority review. To qualify for RMAT designation, NXC-201 was determined to have been an advanced regenerative medicine therapy that targets a serious condition, with the potential to treat, modify, reverse or cure a serious or life-threatening disease. As the FDA also requires preliminary clinical evidence of ‘the potential to address unmet medical needs’, the attainment of the designation was also supported by the positive initial indications of NXC-201’s efficacy in r/r ALA. We therefore believe that this is a positive step for the clinical development and regulatory pathway of the candidate. NXC-201, to our knowledge, is the only CAR-T therapy in active clinical trials for r/r ALA, a rare autoimmune condition with an annual incidence of c 4,000 cases in the US alone.

As a reminder, and as discussed in our recent outlook note for Immix, NXC-201 is being investigated in the NEXICART-2 trial, a US-based open-label, single-arm, multi-site dose escalation/expansion Phase Ib/II trial, designed to assess the safety and efficacy of NXC-201. An encouraging interim update was presented in December 2024, showing that all four patients that had been treated at that stage had normalized their disease markers within 30 days of dosing. Further, two out of four were classified as complete responders (CR) and management estimated that the remaining two could also achieve CR status within the coming months. Following the completion of the six-patient safety run, the trial has moved to the Phase II dose expansion stage, and management has guided that the pace for enrollment has accelerated. The next update is anticipated in H125, consistent with prior guided timelines, and could be an important catalyst for investor attention.

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