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GBP2m
Research: Healthcare
In a positive signal for its developmental pipeline, Midatech Pharma has announced the first patient recruitment in the Phase I study evaluating MTX110 (using a convection-enhanced delivery (CED) system) in recurrent glioblastoma (rGBM) at the Preston Robert Tisch Brain Tumor Center, Duke University, United States. Despite the aggressive nature of the cancer (average survival is 12–18 months with treatment) the rGBM space remains underserved (no new drug has been approved in over a decade) with development stymied by the challenges of crossing the blood brain barrier. MTX aims to overcome this issue by using a CED system to deliver therapeutic doses directly to the tumour site. We expect the release of preliminary data from the study (anticipated in H123) to be a key upcoming catalyst for the stock.
Midatech Pharma |
Patient recruitment begins in rGBM study |
Clinical development update |
Pharma and biotech |
15 November 2022 |
Share price performance Business description
Analysts
Midatech Pharma is a research client of Edison Investment Research Limited |
In a positive signal for its developmental pipeline, Midatech Pharma has announced the first patient recruitment in the Phase I study evaluating MTX110 (using a convection-enhanced delivery (CED) system) in recurrent glioblastoma (rGBM) at the Preston Robert Tisch Brain Tumor Center, Duke University, United States. Despite the aggressive nature of the cancer (average survival is 12–18 months with treatment) the rGBM space remains underserved (no new drug has been approved in over a decade) with development stymied by the challenges of crossing the blood brain barrier. MTX aims to overcome this issue by using a CED system to deliver therapeutic doses directly to the tumour site. We expect the release of preliminary data from the study (anticipated in H123) to be a key upcoming catalyst for the stock.
Year end |
Revenue (£m) |
PBT* |
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) |
0.0 |
N/A |
N/A |
12/20 |
0.34 |
(11.1) |
(22.9) |
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.
The Phase I study (MAGIC-G1) will be an open-label, dose-escalation study, recruiting patients across two cohorts (minimum of four patients each), with one cohort receiving MTX110 as monotherapy and the other receiving MTX110 in combination with lomustine (currently approved for patients with rGBM). The primary objectives will be to assess the feasibility and safety of intermittent infusions of MTX110 delivered through an implantable CED system, although the study will likely also track preliminary efficacy signals. The study will use the same single-catheter CED system used in the first Phase I study in diffuse intrinsic pontine gliomas (DIPG), which reported encouraging headline data in October 2020. We also note that the FDA granted the fast-track designation to MTX110 in rGBM in June 2022 allowing Midatech to apply for expedited approval and a potentially faster market entry, provided supportive Phase II data are obtained.
Previously, Midatech reported H122 results, which reiterated its focus on expanding its core Q-Sphera technology portfolio and leading MTX110 into the clinic in rGBM. Following expansion of the R&D collaboration agreement with Janssen for encapsulation of its experimental monoclonal antibody, the company is working on developing methods for encapsulation of bispecific T cell engager molecules and antibody-drug conjugates, both of which have shown utility in oncology and present considerable market opportunity. In addition, the company expects to report data in the next couple of months from the second Phase I study assessing MTX110 in DIPG, conducted by Columbia University.
The cash balance at end-H122 stood at £6.4m, which management estimates to be sufficient to extend the runway into Q123 (based on projected cash-burn rates), although additional capital may be required to fund further clinical activity. We see partnership and licensing discussions possibly regaining momentum with clinical traction, which could potentially crystallise into a deal on the back of positive proof-of-concept or Phase II readouts. Preliminary data from the Phase I DIPG and rGBM studies should be the key upcoming catalysts for the stock, in our opinion.
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Based on adjusted EBITDA, Pan African Resource’s performance in H222 was its third best on record and only fractionally (3.8% or ZAR47.8m) below its record level of ZAR1,264.8m in H122. Despite normalised headline earnings per share (HEPS) being slightly below our prior expectations, this could be attributed to operating costs that stuck at higher levels than we had previously anticipated (in common with much of the global mining industry), which were left unrelieved by only a modest depreciation of the rand versus the US dollar.
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