Midatech Pharma — Patient recruitment begins in rGBM study

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Research: Healthcare

Midatech Pharma — Patient recruitment begins in rGBM study

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.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Midatech Pharma

Patient recruitment begins in rGBM study

Clinical development update

Pharma and biotech

15 November 2022

Price

6.5p

Market cap

£6m

Net cash (£m) at end-June 2022

6.4

Shares in issue

98.5m

Free float

69%

Code

MTPH

Primary exchange

AIM

Secondary exchange

N/A

Share price performance

Business description

Midatech Pharma is platform-based drug delivery specialist founded in 2000 and listed on AIM in 2014. Its three technology platforms, Q-Sphera (for a sustained release of drugs), MidaSolve (nano inclusion for local delivery) and MidaCore (gold nanoparticles for targeted delivery) are designed to re-engineer and reformulate existing therapeutic drugs with the aim of improving biodistribution and delivery. The realigned focus is now on the Q-Sphera development pipeline and the clinical asset MTX110 (for brain cancer).

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

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*
(£m)

EPS*
(p)

DPS
(p)

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.

General disclaimer and copyright

This report has been commissioned by Midatech Pharma and prepared and issued by Edison, in consideration of a fee payable by Midatech Pharma. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

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The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

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Sydney +61 (0)2 8249 8342

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Midatech Pharma and prepared and issued by Edison, in consideration of a fee payable by Midatech Pharma. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2022 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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