Last close As at 05/08/2026
USD9.54
▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix Biopharma’s US-based NEXICART-2 trial continues to make steady progress through the clinic, with the company reporting that the trial has advanced to the dose expansion level of 450m cells, after completing the 150m cell cohort. The Phase Ib/II trial is assessing Immix’s lead CAR-T asset NXC-201 as a first-in-class outpatient treatment for relapsed/ refractory amyloid light chain amyloidosis (r/r ALA). We highlight that both chosen doses in NEXICART-2 trial had elicited complete responses in the prior NEXICART-1 trial, which was based in Israel. We view the latest update as an encouraging sign that the current clinical trial is progressing as anticipated and we believe that the initial data readout, expected within Q424, could represent a near-term catalyst for investor attention.
Immix Biopharma |
US CAR-T trial progresses to dose expansion |
Clinical update |
Pharma and biotech |
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Share price performance
Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix Biopharma’s US-based NEXICART-2 trial continues to make steady progress through the clinic, with the company reporting that the trial has advanced to the dose expansion level of 450m cells, after completing the 150m cell cohort. The Phase Ib/II trial is assessing Immix’s lead CAR-T asset NXC-201 as a first-in-class outpatient treatment for relapsed/ refractory amyloid light chain amyloidosis (r/r ALA). We highlight that both chosen doses in NEXICART-2 trial had elicited complete responses in the prior NEXICART-1 trial, which was based in Israel. We view the latest update as an encouraging sign that the current clinical trial is progressing as anticipated and we believe that the initial data readout, expected within Q424, could represent a near-term catalyst for investor attention.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
0.0 |
(7.60) |
(0.55) |
0.0 |
N/A |
N/A |
12/23 |
0.0 |
(13.00) |
(0.75) |
0.0 |
N/A |
N/A |
12/24e |
2.0 |
(16.59) |
(0.61) |
0.0 |
N/A |
N/A |
12/25e |
6.0 |
(17.06) |
(0.58) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Having successfully completed the first cohort dosing at a level of 150m cells NXC-201 CAR-T cells, the NEXICART-2 trial has now advanced to the dose expansion cohort, dosing r/r ALA patients at 450m cells. Initially, one new patient will be dosed at this escalated level every 28 days until three patients have been dosed. This will be followed by multiple patients being dosed per month. We note that there is also an option to increase dosing to 800m CAR-T cells in the subsequent expansion stage, provided the initial doses are observed to be safe. As mentioned, the preceding NEXICART-1 trial tested NXC-201 at levels of 150m cells (n=1), 450m cells (n=2) and 800m cells (n=10). The results from this study showed an overall response rate of 92% (12 of 13 patients r/r ALA patients) and a best responder duration of 28 months. These data create a robust foundation for NEXICART-2, in our view. We believe that there is a sizeable opportunity for Immix as it is the only company, to our knowledge, developing a potentially outpatient CAR-T therapy for ALA, an indication with only limited treatment options and no standard of care.
As a reminder, NEXICART-2 is a US-based, open-label, single-arm, multi-site dose escalation/dose expansion, Phase Ib/II clinical trial, designed to evaluate the safety and efficacy of NXC-201, a B-cell maturation antigen (BCMA) targeting CAR-T therapy. The target population for the trial is patients with r/r ALA with adequate cardiac function who have not had prior BCMA-targeted treatments. The first patient was treated in July 2024 and, per the latest announcement, there are currently four active trial sites, with the Memorial Sloan Kettering Cancer Center as the lead site. An initial data readout is expected in Q424, followed by a further interim readout in mid-2025, both of which could potentially be major catalysts for the company. Management has guided that patient enrolment for NEXICART-2 should be complete within 18–24 months from its initiation, meaning top-line results are anticipated from mid-2026.
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Research: Financials
Helios Underwriting (Helios) delivered EPS growth of 35% to 7.7p in H124 and reported a net asset value (NAV) of 191p/share. While its combined ratio of 91.6% deteriorated from 88% in H123 and 85% in FY23 due to seasonal impacts on the 2024 year of account (YOA) and stricter reserving for its 2022 YOA, we forecast an improvement to 88.8% for FY24. Helios experienced cost pressures during the period as a result of abandoning its ‘follow-only’ syndicate initiative and the departure of its CEO. We expect a meaningful reduction in costs in FY25, including a saving in stop-loss reinsurance costs as the company is expected to reduce cover in light of very healthy syndicate solvency levels. We have significantly reduced our forecast underwriting capacity growth for the company to reflect its new strategy, aimed at consolidating its book and focusing on shareholder distribution. We have lifted our FY24 EPS forecast by 10% on higher underwriting and group income expectations and by 4% in FY25 on lower costs, but cut our longer-term EPS forecasts on lower growth expectations. This leaves our valuation unchanged at 280p/share.