Immix Biopharma — Positive newsflow continues for NEXICART-2

Immix Biopharma (NASDAQ: IMMX)

Last close As at 29/05/2025

USD2.25

0.30 (15.38%)

Market capitalisation

USD56m

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Research: Healthcare

Immix Biopharma — Positive newsflow continues for NEXICART-2

Immix Biopharma has announced a positive clinical update for the US-based Phase I/II NEXICART-2 trial, investigating lead CAR-T candidate NXC-201 as a potential treatment for relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). These interim results show that, at the data cut off of 28 January 2025, five out of seven (71%) patients had shown a complete response (CR). Furthermore, no relapses or safety concerns have been reported to date, consistent with Immix’s goal of making NXC-201 the first ‘outpatient’ CAR-T therapy. We view this latest update as encouraging for the NEXICART-2 trial, though we acknowledge that the data still correspond to a relatively small population. A more detailed presentation is due to be presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) on 3 June. Immix is also hosting a key opinion leader (KOL) event later the same day to discuss clinical experiences with NXC-201, as well as the evolving treatment landscape for r/r ALA. Separately, Immix also announced that NEXICART-2 now has 14 active US sites (10 more than the company’s prior update) and that it anticipates completing the trial ahead of schedule.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Healthcare

Clinical update

29 May 2025

Price $2.41
Market cap $67m

Net cash at 31 March 2025

$15.9m

Shares in issue

27.9m
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 personalised 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 I/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 normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Year end Revenue ($m) PBT ($m) EPS ($) DPS ($) P/E (x) Yield (%)
12/23 0.0 (13.0) (0.75) 0.00 N/A N/A
12/24 0.0 (18.6) (0.66) 0.00 N/A N/A
12/25e 0.0 (16.8) (0.57) 0.00 N/A N/A
12/26e 0.0 (25.7) (0.87) 0.00 N/A N/A

As per the announcement, NXC-201 has shown a CR rate of 71% (5/7 patients), an improvement from the prior figure of 50% (corresponding to the first four patients included in the trial, where three patients were on the lowest tested dose of the CAR-T therapy at 150m cells; all other patients included in the trial received a 450m cell dose). Updated results with a later data cut off (including an endpoint analysis) will be presented at ASCO 2025 by the lead investigator at the Memorial Sloan Kettering Cancer Center. We also expect incremental insights from the KOL event that Immix is hosting on 3 June.

We understand that a further interim update may also be reported in Q225/Q325 corresponding to at least 10 patients, potentially representing another near-term catalyst for investor attention. Provided the data continue to be supportive, Immix plans to file for regulatory approval once 40 patients have been treated with NXC-201. The latest update from the company confirmed that there are now 14 US sites actively enrolling patients for NEXICART-2. It also stated that the trial may be completed ahead of schedule (prior guidance estimated biologics license application submission from mid-2026).

We note that Immix has been awarded orphan drug designation for NXC-201 as a potential treatment for ALA by both the FDA and the EMA, an encouraging sign of the therapy's potential viability, in our view. NEXICART-2 (NCT06097832) is a US-based, open-label, single-arm, multi-site, dose-escalation/expansion Phase I/II trial, with the Memorial Sloan Kettering Cancer Center as the lead trial site. The trial has been designed to assess two doses of NXC-201, 150m CAR-T cells and 450m CAR-T cells, and aims to build in the positive results of the prior Israel-based NEXICART-1 trial. Immix recently reported its Q125 results; see our last update note.

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