Medlab Clinical — UK compassionate use for alternative to opioids

Medlab Clinical (ASX: MDC)

Currency in AUD

Last close As at 03/02/2023

AUD6.75

−0.77 (−10.24%)

Market capitalisation

AUD17m

Research: Healthcare

Medlab Clinical — UK compassionate use for alternative to opioids

Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA approval as an encouraging development as it allows Medlab to generate additional real-world data to support the anticipated Phase III clinical trial of synthetic NanaBis in FY23. Positive feedback from compassionate use may create patient advocates and key opinion leaders for the drug. In our view, this new approval provides further regulatory validation for Medlab’s NanaBis/NanaDol product and the NanoCelle platform in general. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Medlab Clinical

UK compassionate use for alternative to opioids

Regulatory update

Pharma and biotech

29 November 2022

Price

A$8.0

Market cap

A$18m

Net cash (A$m) at end-September 2022 (unaudited)

5.3

Shares in issue

2.3m

Free float

69%

Code

MDC

Primary exchange

ASX

Secondary exchange

NASDAQ listing pending (symbol MDLB)

Share price performance

Business description

Based in Australia, Medlab Clinical is developing therapeutics using its proprietary delivery platform NanoCelle. Its most advanced programme is in cancer pain management with lead drug candidate NanaBis, a medicinal cannabis product for cancer-related bone pain.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Harry Shrives

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Medlab Clinical is a research client of Edison Investment Research Limited

Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA approval as an encouraging development as it allows Medlab to generate additional real-world data to support the anticipated Phase III clinical trial of synthetic NanaBis in FY23. Positive feedback from compassionate use may create patient advocates and key opinion leaders for the drug. In our view, this new approval provides further regulatory validation for Medlab’s NanaBis/NanaDol product and the NanoCelle platform in general. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.

Year

end

Revenue (A$m)

PBT*

(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/21

8.1

(12.4)

(6.3)

0.0

N/A

N/A

06/22

6.0

(8.4)

(3.1)

0.0

N/A

N/A

06/23e

7.7

(8.8)

(3.8)

0.0

N/A

N/A

06/24e

7.7

(9.6)

(4.2)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

As a reminder, synthetic NanaBis, a 50:50 formulation of synthetic CBD and dronabinol (synthetic THC), is awaiting approval for the initiation of Phase III studies, which we view as the next significant catalyst for the share price performance. The company has prepared a Drug Master File and we expect Medlab to approach the FDA with an Investigational New Drug application in Q4 CY22/Q1 CY23. Importantly, for US approval, the trial will enrol patients at sites in the United States, UK and Australia. The company is also developing NanoCBD, a 100% CBD formulation to treat occupational stress and mental health issues.

The NanaDol approval follows the similar UK approval for NanoCBD in April 2022 and it will be supplied through the established distribution partner, WEP Clinical. Following the approval, the company is awaiting the certification required to ship NanaDol from Australia, which will allow NanaDol to be prescribed under compassionate use by clinicians in the UK. While the data collected will not be as controlled as a Phase III clinical trial, we see this as a cost-effective method to get clinically relevant data to support future drug applications. Management expects the medicine is likely to be available for UK patients in January 2023.

NanaDol will be made available to patients in the UK through doctor prescriptions only for pain (including cancer-related bone pain), an area that the medicine is targeting. Under the current arrangement, Medlab will be charging a ‘compassionate’ price (usually a discount to the expected list price), so we expect any additional revenue generated from compassionate use to be marginal.

General disclaimer and copyright

This report has been commissioned by Medlab Clinical and prepared and issued by Edison, in consideration of a fee payable by Medlab Clinical. 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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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

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London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

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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

General disclaimer and copyright

This report has been commissioned by Medlab Clinical and prepared and issued by Edison, in consideration of a fee payable by Medlab Clinical. 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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