Last close As at 05/08/2026
USD9.54
▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix presented encouraging new data at the American Society of Hematology (ASH) 2023 meeting for its Nexcella subsidiary’s lead CAR-T asset, NXC-201, in amyloid light chain amyloidosis (ALA) patients. The update corresponds to 10 ALA patients treated with NXC-201, for which the overall response rate (ORR) stands at 100% (10/10). NXC-201 also maintains its competitive safety profile among this group, including no cases of neurotoxicity and only low-grade cytokine release syndrome associated with short onset and duration. The results to date are supportive of NXC-201 potentially becoming the first outpatient CAR-T therapy, in our view, offering a potentially desirable treatment option for a fragile patient population. While the current data come from the NEXICART-1 trial based in Israel, with the Investigational New Drug (IND) application in ALA patients recently accepted by the FDA, we believe the enrolment of patients at US trial sites (NEXICART-2) will be a key milestone for the clinical progression of NXC-201. Management has communicated that it intends to submit a Biologics License Application to the FDA once 30–40 ALA patients have been treated.
Written by
Immix Biopharma |
Encouraging stream of ALA data newsflow |
Clinical update |
Pharma and biotech |
12 December 2023 |
Share price performance
Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix presented encouraging new data at the American Society of Hematology (ASH) 2023 meeting for its Nexcella subsidiary’s lead CAR-T asset, NXC-201, in amyloid light chain amyloidosis (ALA) patients. The update corresponds to 10 ALA patients treated with NXC-201, for which the overall response rate (ORR) stands at 100% (10/10). NXC-201 also maintains its competitive safety profile among this group, including no cases of neurotoxicity and only low-grade cytokine release syndrome associated with short onset and duration. The results to date are supportive of NXC-201 potentially becoming the first outpatient CAR-T therapy, in our view, offering a potentially desirable treatment option for a fragile patient population. While the current data come from the NEXICART-1 trial based in Israel, with the Investigational New Drug (IND) application in ALA patients recently accepted by the FDA, we believe the enrolment of patients at US trial sites (NEXICART-2) will be a key milestone for the clinical progression of NXC-201. Management has communicated that it intends to submit a Biologics License Application to the FDA once 30–40 ALA patients have been treated.
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.
At ASH 2023, Immix has shared an update on the NEXICART-1 trial, which includes one new relapsed/refractory ALA patient. As of the data cut-off of 10 December 2023, the data show an ORR of 100%, a complete response (CR) rate of 70% (7/10) and an organ response rate of 60% (6/10). The best responder duration has been reported as 23.7 months, and it was stated that this response is ongoing. In our view, these results mark positive progress from the last data update, the details of which are discussed here. We highlight that the NEXICART-1 trial involves a frail and heavily pre-treated patient population (median of six lines of prior therapy) with significant organ involvement. This includes 8/10 patients with cardiac involvement, for which, the CR and the organ response rates were both 63% (5/8). The group also includes 4/10 patients with t(11;14) disease, for which the CR rate was 75% (3/4) and the organ response rate was 50% (2/4).
ALA is a rare but serious multisystem disease affecting the kidneys, heart, liver, intestine and nervous system, with approximately 4k new cases diagnosed in the US each year, and at present there are limited treatment options. We therefore believe that there is significant opportunity for Immix to address this unmet need. The company has already received Orphan Drug designation from the FDA, and with the recent clearance of its IND application, we expect the coming months will see new patients enrolled to US trial sites (this portion of the trial is being referred to as NEXICART-2). We believe this will mark a step toward NXC-201 potentially becoming the first outpatient CAR-T therapy; we continue to expect rolling updates from Immix as the information becomes available.
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Research: Financials
In H124, Record posted steady management fee growth of 3% y-o-y to £19.6m as the company benefited from a higher assets under management equivalent (AUME) base. Total revenues, however, were down 3% as performance fees in H123 outweighed those earned in H124. Profit before tax was down 17% y-o-y to £6.3m as Record incurred costs related to its expansion and modernisation initiatives. In line with its progressive dividend policy, Record increased its dividend by 5% y-o-y to 2.15p per share. After four years as CEO, Leslie Hill announced her retirement and will be succeeded by Dr Jan Witte (CEO of the subsidiary Record Currency Management) at the end of FY24 in March. He has also been appointed to the board as executive director with effect from 1 January 2024. Leslie will maintain her share ownership in Record and will assist senior management in Record’s transition phase.