Last close As at 05/08/2026
USD9.54
▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for multiple myeloma (MM). The benefits of ODD include seven years of US market exclusivity post approval, tax credits for qualified clinical trials and exemption from the Prescription Drug User Fee. ODD is issued to drugs/biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/conditions that affect fewer than 200k people in the US. With NXC-201, Immix aims to differentiate against currently approved CAR-T therapies that are often associated with neurotoxicity and high-grade cytokine release syndrome (CRS). NXC-201 data appears to provide a competitive safety profile with no serious adverse events reported to date, positioning it as potentially the first outpatient CAR-T therapy. We believe the ODD marks a key milestone and believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be an important catalyst for the company.
Written by
Immix Biopharma |
NXC-201 gains Orphan Drug designation in MM |
Regulatory update |
Pharma and biotech |
25 August 2023 |
Share price performance
Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for multiple myeloma (MM). The benefits of ODD include seven years of US market exclusivity post approval, tax credits for qualified clinical trials and exemption from the Prescription Drug User Fee. ODD is issued to drugs/biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/conditions that affect fewer than 200k people in the US. With NXC-201, Immix aims to differentiate against currently approved CAR-T therapies that are often associated with neurotoxicity and high-grade cytokine release syndrome (CRS). NXC-201 data appears to provide a competitive safety profile with no serious adverse events reported to date, positioning it as potentially the first outpatient CAR-T therapy. We believe the ODD marks a key milestone and believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be an important catalyst for the company.
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 |
(12.26) |
(0.84) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(15.83) |
(0.97) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Immix has announced that the US FDA has granted ODD to NXC-201 as a potential treatment for MM. The ODD qualifies NXC-201 for a minimum of seven years of US market exclusivity, provided it obtains FDA approval. According to EvaluatePharma, the MM market is projected to be worth c $33bn by 2028, with J&J’s monoclonal antibody Darzalex and CAR-T therapy Carvykti claiming the largest portion of this figure. Like NXC-201, Carvykti is a BCMA-targeting therapy. However, Carvykti has been associated with neurotoxicity and cases of high-grade CRS. In our view, NXC-201 may offer differentiation, as to date it has had no reports of neurotoxicity or patient safety events greater than grade three CRS (which were associated with short onsets and durations). This may position it as the first outpatient CAR-T therapy, potentially allowing it to become more broadly accessible, which we believe may help from a regulatory point of view.
As a reminder, NXC-201 is being developed by majority-owned subsidiary Nexcella. The recent readout in April 2023 from 58 patients in the Phase Ib/IIa NEXICART-1 trial showed encouraging overall response rates of 92% for MM (n=50) and 100% for AL amyloidosis patients (n=8). Management plans to share updated MM clinical data at the 20th International Myeloma Society Annual Meeting in September 2023, which could be an important catalyst for investor attention, in our view. We note that Immix completed a pre-IND meeting with the FDA in June for NXC-201 clinical trials and is now preparing to submit an IND application.
Recently, Immix raised $9.6m (net proceeds) through a private placement by issuing c 3.2m shares at $1.94/share and c 1.9m pre-funded warrants at a discount of $0.0001/warrant to per share purchase price. We note that the latest fund raise will extend Immix’s cash runway into early Q125 as per our cash burn estimates.
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Research: Investment Companies
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