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Research: Healthcare
The FDA has accepted Immix’s Investigational New Drug (IND) application for lead CAR-T asset NXC-201. In our view, this decision from the FDA represents encouraging progress for Immix in delivering, potentially, the first outpatient CAR-T therapy, provided the data continue to be supportive. This regulatory decision enables Immix to start dosing patients with amyloid light chain amyloidosis (ALA) in the US as part of the NEXICART Phase Ib/IIa clinical trial, which has previously been operating in Israel. Further, management has communicated that the favourable tolerability profile of the therapy to date could warrant a potential expansion into autoimmune indications; we await additional updates on this front. NXC-201 has demonstrated a desirable safety and efficacy profile in 72 patients with ALA or multiple myeloma (MM) to date, potentially supporting NXC-201 as the first outpatient CAR-T therapy.
Written by
Immix Biopharma |
CAR-T trial moves to US with outpatient potential |
Regulatory update |
Pharma and biotech |
22 November 2023 |
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Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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The FDA has accepted Immix’s Investigational New Drug (IND) application for lead CAR-T asset NXC-201. In our view, this decision from the FDA represents encouraging progress for Immix in delivering, potentially, the first outpatient CAR-T therapy, provided the data continue to be supportive. This regulatory decision enables Immix to start dosing patients with amyloid light chain amyloidosis (ALA) in the US as part of the NEXICART Phase Ib/IIa clinical trial, which has previously been operating in Israel. Further, management has communicated that the favourable tolerability profile of the therapy to date could warrant a potential expansion into autoimmune indications; we await additional updates on this front. NXC-201 has demonstrated a desirable safety and efficacy profile in 72 patients with ALA or multiple myeloma (MM) to date, potentially supporting NXC-201 as the first outpatient CAR-T therapy.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(1.31) |
(0.36) |
0.0 |
N/A |
N/A |
12/22 |
0.0 |
(7.70) |
(0.55) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(11.96) |
(0.70) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(17.38) |
(0.88) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
The FDA’s clearance of the IND application for NXC-201 allows Immix to expand the CAR-T trial to the US and start dosing patients with relapsed/refractory ALA, for which there are no approved treatment options. Management has communicated that multiple US sites are planning to enroll patients in the coming months; this portion of the trial is being referred to as NEXICART-2 (NCT06097832). We note that, at present, the only indication covered by this regulatory decision is ALA and we await further updates as to whether Immix will be expanding the trial to the US for patients with MM.
Previously, the Phase Ib/IIa trial for NXC-201, NEXICART-1 (NCT04720313), has been operating in Israel. In this portion of the study, 72 patients have been dosed to date (n=9 for ALA; n=63 for MM). As discussed in our prior update note, for the nine ALA patients with a median of six lines of prior therapy, a 100% overall response rate (ORR) has been reported, and there have been no cases of neurotoxicity (data cut-off: 20 September 2023). Of the 63 MM patients, 50 have received the recommended Phase II dose of 800m cells, the ORR was reported as 90% with a median follow-up of 11.9 months, and there has been a notably low neurotoxicity rate of 4% (data cut-off: 17 July 2023). In our view, these data for NXC-201 demonstrate an encouraging safety and efficacy profile and we expect rolling updates as the data become available.
While CAR-T therapies can provide effective treatments for some diseases, current options are not considered outpatient treatments due to the risk of side effects, meaning that they require long hospital stays (c 14 days), and accessibility is limited (c 5% of US hospitals are able to deliver CAR-T treatments). In our view, the FDA decision represents encouraging progress for Immix in delivering, potentially, the first outpatient CAR-T therapy, provided the data continue to be supportive.
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Research: Investment Companies
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