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Last close As at 25/03/2023
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GBP2m
Research: Healthcare
In a positive development, Midatech has announced the US FDA has granted fast-track designation for its lead clinical asset, MTX110 in recurrent glioblastoma (rGBM). This should allow to company to apply for a fast-track approval and a potentially faster market entry, provided supportive Phase II data are obtained. MTX110 is expected to start a Phase I study in (rGBM) in mid-2022 with early progression-free survival data expected by Q422. The stock closed up 24.4% following the announcement.
Midatech Pharma |
MTX110’s path to market fast-tracked in rGBM |
Regulatory update |
Pharma and biotech |
6 June 2022 |
Share price performance Business description
Analysts
Midatech Pharma is a research client of Edison Investment Research Limited |
In a positive development, Midatech has announced the US FDA has granted fast-track designation for its lead clinical asset, MTX110 in recurrent glioblastoma (rGBM). This should allow to company to apply for a fast-track approval and a potentially faster market entry, provided supportive Phase II data are obtained. MTX110 is expected to start a Phase I study in (rGBM) in mid-2022 with early progression-free survival data expected by Q422. The stock closed up 24.4% following the announcement.
Year end |
Revenue |
PBT* (£m) |
EPS* |
DPS |
DPS |
Yield |
12/18 |
1.94 |
(11.8) |
(339) |
0.0 |
N/A |
N/A |
12/19 |
0.67 |
(10.9) |
(50) |
0.0 |
N/A |
N/A |
12/20 |
0.34 |
(11.1) |
(23) |
0.0 |
N/A |
N/A |
12/21 |
0.58 |
(6.1) |
(6.8) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised.
In our last note, we highlighted MTX110’s potential longer time to market for rGBM (versus diffuse intrinsic pontine glioma) as a partial offset to its materially larger market opportunity. This announcement largely allays those concerns while keeping the upside option intact. We also see partnership and licensing discussions picking momentum after this news, which could potentially crystallise into a deal on the back of positive proof of concept or Phase II read-outs. We emphasise again the aggressive nature of the cancer (average survival of 12–18 months with standard of care, three months without treatment) and the small number of therapeutic options. These are temozolomide (chemotherapy), bevacizumab (anti-VEGF monoclonal antibody; not approved in Europe) and nitrosourea/gliadel wafer (chemotherapy), which together make a sizeable $2–5bn market, according to management.
The drug under focus, MTX110, uses the company’s proprietary MidaSolve technology to solubilise the chemotherapy drug panobinostat, which is then delivered through a convection-enhanced delivery system directly to the site of the tumour. The planned Phase I study is expected to start by mid-2022 across two clinical centres in the United States (Duke University and MD Anderson Cancer Center). The primary objectives will be to assess safety and tolerability in patients with rGBM (dose-escalation study estimated to recruit between 10 and 12 patients), but the study will also track preliminary efficacy signals such as progression free survival. Midatech expects to release preliminary data from the study by Q422.
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Research: Healthcare
Diurnal has dosed the first patient in its pivotal Phase III CONnECT clinical trial assessing DNL-0200/Efmody in adults with congenital adrenal hyperplasia (CAH) for the US and Japanese markets, marking a key step in the asset’s clinical progression. The year-long trial is the first blinded study in CAH, according to management. Headline data are expected in 2024 and are material to Efmody’s prospects in United States. We also believe positive results from this study could potentially create an uplift in sales for Efmody in Europe, where the market sentiment has been affected by the recent SMC decision.
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