Hexima — Pezadeftide – a novel antifungal agent

Hexima — Pezadeftide – a novel antifungal agent

Hexima is a pure-play biotech focused on the progression of its sole clinical asset, pezadeftide. The company aims to develop pezadeftide as a novel topical treatment for onychomycosis (fungal nail infection). Pezadeftide belongs to a novel class of molecules known as plant defensins, which are stable, soluble and possess antimicrobial activity. Following encouraging safety and efficacy results from randomised, double-blind, ascending dose-controlled Phase I/IIa trials, a Phase IIb clinical study is currently underway, with results expected in Q222.

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Hexima

Pezadeftide – a novel antifungal agent

Healthcare

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14 January 2022

Price

A$0.41

Market cap

A$68m

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Share details

Code

HXL

Listing

ASX

Shares in issue

165m

Business description

Hexima is a biotechnology company focused on the development of its only clinical-stage asset, pezadeftide, for the treatment of onychomycosis. The market for onychomycosis is large (US$4.2bn) and competitive, especially with the introduction of new topical agents. After good Phase I/IIa data, pezadeftide is now in Phase IIb trails, with results expected in Q222.

Bull

Hexima has identified a clear demand for topical treatments in onychomycosis.

Demonstrated human safety and efficacy of pezadeftide.

Strong IP portfolio built around plant defensin platform.

Bear

Single product risk.

Partners and/or a capital raise will be needed in the near future to continue development.

The onychomycosis market is competitive.

Analysts

Harry Shrives

+44 (0)20 3077 5700

Jacob Thrane

+44 (0)20 3077 5700

Hexima is a pure-play biotech focused on the progression of its sole clinical asset, pezadeftide. The company aims to develop pezadeftide as a novel topical treatment for onychomycosis (fungal nail infection). Pezadeftide belongs to a novel class of molecules known as plant defensins, which are stable, soluble and possess antimicrobial activity. Following encouraging safety and efficacy results from randomised, double-blind, ascending dose-controlled Phase I/IIa trials, a Phase IIb clinical study is currently underway, with results expected in Q222.

Clear demand in a growing market

Onychomycosis is a fungal infection that is estimated to affect 10–14% of the global population and, if left untreated, can result in pain, difficulty wearing shoes and distress at the appearance of nails. The 2014 FDA approval of topical agent Jublia/Clenafin (current market leader with global sales of c US$230m in 2020), and subsequent entrants, have drastically increased the market size for onychomycosis therapeutics, highlighting a clear patient preference for topical treatments. The market value for onychomycosis treatment in 2020 was more than US$4.2bn, although topical treatments are only a subset of this. Hexima aims to capture a significant share of this market segment.

Plant defensins: A new class of therapeutics

Defensins represent a diverse class of plant-derived peptides that possess antimicrobial activity. Hexima has identified pezadeftide as a novel plant defensin with antifungal activity and has built a strong IP portfolio around this asset. Current standards of care in onychomycosis suffer from poor efficacy and long treatment times as well as toxicity with oral therapies. Hexima has shown pezadeftide to have a rapid and high activity against the various fungal causes of onychomycosis, the ability to penetrate the human nail plate easily and interestingly no activity against human cells. If approved, these attributes could allow pezadeftide to compete successfully with current onychomycosis treatment regimes.

Phase IIb trial underway

The Phase I/IIa trial of pezadeftide in onychomycosis was a randomised, double-blind, multiple ascending dose study to assess the safety, tolerability and effectiveness of pezadeftide, with a daily topical application over a six-week period. At the highest concentration investigated (2.0%), no treatment-related adverse events were reported in any participant and pezadeftide was shown to not be systemically absorbed. The Mycological Cure rate at 12 weeks was shown to be 69% compared to 29% for the control, and clinical efficacy was demonstrated. The Phase IIb trial will assess 2% pezadeftide for further safety and efficacy in three active arms to identify dosing frequency. Data are expected in Q222. In 2021, Hexima raised A$11m and in 2022 we expect the company to engage in partnering deals and/or capital raises to further develop pezadeftide.

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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

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This report has been prepared and issued by Edison. 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.

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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).

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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.

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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.

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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

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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