Last close As at 05/08/2026
USD9.54
▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix Biopharma has released back-to-back updates, including EU orphan drug designation (ODD) for its lead CAR-T asset NXC-201, addressing amyloid light chain amyloidosis (ALA), and pricing of its $15m equity raise. This follows on the heels of the ODD grant for its lead asset by the FDA for two indications, ALA and multiple myeloma (MM), in H223. The EU ODD includes up to 10 years of EU market exclusivity (post-approval), reduced regulatory fees and access to the EU centralized authorization procedure. Achieving ODD in ALA in the EU is a key step forward for the clinical development of NXC-201. We believe the next readout from the ongoing NEXICART-1 trial and dosing of patients at US trial sites (NEXICART-2) across H124 will be the key upcoming catalysts for the company.
Written by
Immix Biopharma |
Updates galore: NXC-201 ODD (EU) and raise |
Regulatory and funding updates |
Pharma and biotech |
12 February 2024 |
Share price performance
Business description
Analysts
Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix Biopharma has released back-to-back updates, including EU orphan drug designation (ODD) for its lead CAR-T asset NXC-201, addressing amyloid light chain amyloidosis (ALA), and pricing of its $15m equity raise. This follows on the heels of the ODD grant for its lead asset by the FDA for two indications, ALA and multiple myeloma (MM), in H223. The EU ODD includes up to 10 years of EU market exclusivity (post-approval), reduced regulatory fees and access to the EU centralized authorization procedure. Achieving ODD in ALA in the EU is a key step forward for the clinical development of NXC-201. We believe the next readout from the ongoing NEXICART-1 trial and dosing of patients at US trial sites (NEXICART-2) across H124 will be the key upcoming catalysts 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 |
(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 receipt of ODD in ALA qualifies NXC-201 for a minimum of 10 years of EU market exclusivity, provided it is successful with regulatory approval. According to EvaluatePharma, the amyloidosis market is projected to grow at a CAGR of 18.3% to reach c $8.6bn by 2028 (from c $3.2bn in 2022), which represents a sizeable opportunity for Immix. The EU ODD is reserved for drugs/biologics therapies addressing life-threatening or chronically debilitating disease and affecting fewer than five in 10,000 people in the EU.
As a reminder, NXC-201 is Immix’s lead CAR-T asset and was awarded ODD by the FDA in both ALA and MM last year, which should provide seven years of market exclusivity in the US (post-approval). It is currently being evaluated in a Phase Ib/IIa study (NEXICART-1) in relapsed/refractory (r/r) ALA and r/r MM. The company has provided encouraging data for first 10 patients treated for r/r ALA, with an overall response rate (ORR) of 100% and a complete response rate (CR) of 70%. Management is targeting a biologic license application submission to the FDA in 2025 for r/r ALA once 30–40 ALA patients have been treated. Given the high unmet need in this space (no standard of care), we believe that the data, if compelling, may be adequate to file for regulatory approval.
In parallel, Immix announced the successful close of its fully-underwritten $15m (gross) common equity issue, initially announced on 5 February. The issuance adds 5.5m shares to the company’s share capital at $2.71/share (a c 10% discount to the last closing price on 5 February) and funds clinical trials for NXC-201 and working capital needs. At end-September 2023, Immix had a net cash balance of $19.6m and the additional capital from the equity fund-raise is anticipated to provide operational headroom through FY25 (previously Q424), past top-line results from the NEXICART-1 study, which, if positive, could pave the way for a partnering deal.
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Research: TMT
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