For personal use only
MELBOURNE, AUSTRALIA (5 April 2022): Hexima Limited (ASX:HXL), wishes to remind investors of its webinar scheduled for today, 5 April 2022 at 9:00 AM AEST. The webinar follows the presentation by Chief Operating Officer Dr Nicole van der Weerden of pezadeftide's novel fungicidal mode of action at the annual meeting of the American Academy of Dermatology (AAD) on March 25th 2022 in Boston, MA.
A copy of the presentation to be delivered in the webinar is attached.
Hexima's CEO and COO will host the webinar to discuss recent progress, upcoming milestones and the mechanism of action of pezadeftide against fungal pathogens.
Investor Webinar: 5 April 2022, 9AM AEST
Registration link:https://bit.ly/3CTn5fP
Hexima (ASX:HXL) is a clinical stage, anti-infectives focused biotechnology company engaged in the research and development of defensin peptides for applications as human therapeutics. Our lead product candidate, pezadeftide (HXP124) applied in a topical formulation, is a potential new prescription treatment for toenail fungal infections (or onychomycosis). Hexima is currently conducting an Australian phase IIb clinical trial testing pezadeftide for the treatment of onychomycosis. Hexima holds granted, long-life patents protecting pezadeftide in major markets globally. For additional information please visitwww.hexima.com.au.You can also find us onTwitter andLinkedIn or email us atinfo@hexima.com.au.
LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086
5 April 2022
INVESTOR WEBINAR ON TODAY
Hosted by Hexima Managing Director and CEO, Mr Michael Aldridge and Chief Operating Officer, Dr Nicole van der Weerden
This announcement is authorised for release to ASX by Michael Aldridge, Managing Director & CEO Enquiries:
Dr Nicole van der Weerden Chief Operating Officern.vanderweerden@hexima.com.au
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ABOUT HEXIMA
ABOUT ONYCHOMYCOSIS
Onychomycosis is a common fungal nail infection in the nail plate and nail bed. Prevalence of onychomycosis has been estimated at 10% (Japan) and 13.8% (USA).1 Onychomycosis is an infectious disease and is difficult to treat with a significant healthcare burden. It causes pain in approximately 50% of patients and in the US results in close to four doctor's visits annually for treatment.2 Onychomycosis impacts a patient's quality of life with 51% unable to wear the shoes they would prefer and 66% distressed by the appearance of their nail.3 It is important to treat onychomycosis as the fungi in the nailcan be a source of secondary infection in other areas of the body or infect family members and spread to the environment.
For personal use only
Onychomycosis is the most common nail disorder accounting for 50% of all nail diseases. It is particularly prevalent in older, diabetic and immune compromised populations.2 The global market for treatments for onychomycosis was approximately US$3.7 billion in 2018.4
Approved prescription therapies for onychomycosis comprise either oral or topical medications. Oral medications are associated with adverse effects such as nausea, taste disturbance, and flatulence. They can also severely impact liver function and so often require liver function monitoring. The clinical and commercial success of topical medications has been constrained by an inability of anti-fungal agents to effectively penetrate the human nail and the lack of sufficient anti-fungal activity when in contact with the target pathogen.5
LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086
TREATMENT OF ONYCHOMYCOSIS
HEXIMA'S APPROACH
Hexima embraces the significant challenge of new product development for onychomycosis. Hexima has taken a very different approach, building on its many years of ground-breaking research into the evolutionary tools that plants use naturally to fight fungal infections. The result is pezadeftide, a new topical treatment for onychomycosis, with a novel and powerful fungicidal mode of action.
Historically, therapies for onychomycosis have generally focused on new forms of the traditional classes of antifungal agents or improving the topical delivery of systemic antifungal agents. Hexima's technology is a completely novel approach with fundamental differences that address the well-documented limitations of these traditional technologies.
Pezadeftide penetrates the nail more effectively than existing topical treatments and so can more readily target the fungal cells which proliferate in the nail bed. It is also more effective at rapidly killing fungal cells on contact. Together, these properties mean that pezadeftide has the potential to resolve the fungal infection more quickly, leading to faster and more complete clearing of the infected nail area. Consequently, pezadeftide offers the promise to capture significant value in a large and poorly served market.
1 Tatchibana et al., Journal of Fungi, 2017
2 Joseph et al, Supplement to Podiatry Today, 2013
3 Milobratovic et al., Mycoses, 2013
4 Persistence Market Research 2018
5 Wang et al., Onychomycosis: Diagnosis and Effective Management, 2018
ersonal use only
DISCLAIMER
Summary information
This presentation has been prepared by Hexima Ltd and its subsidiaries (collectively "Hexima"). The information in this presentation is of general background in summary form which is current as of April 2022 and does not purport to be complete. It does not contain all information relevant or necessary for an investment decision or that would be required to be included in a prospectus under the Corporations Act 2001 (Cth) (Corporations Act). The information in this presentation is subject to change without notice. No representation or warranty, express or implied, is made by Hexima or any of its advisers as to the accuracy, adequacy or reliability of any information contained in this presentation.
Not an offer
This presentation is not a prospectus or any other offering document under Australian law or any other law (and will not be lodged with ASIC). This presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction. The distribution of this presentation outside Australia may be restricted by law. Any recipient of this presentation who is outside Australia must seek advice on and observe any such restrictions. This presentation may not be reproduced or published, in whole or in part, for any purpose without the prior written permission of Hexima. An investment in securities is subject to known and unknown risks, some of which are beyond the control of Hexima, including possible loss of income and principal invested. Hexima does not guarantee any particular rate of return or the performance of Hexima, nor does it guarantee any particular tax treatment. Investors should have regard to potential risks outlined in this presentation when making their investment decision.
events and the future financial performance of Hexima. Forward looking words such as "expect", "should", "could", "may", "predict", "plan", "will", "believe", "forecast", "estimate", "target" or other similar expressions are intended to identify forward-looking statements. Any forward looking statements included in this document involve subjective judgment and analysis and are subject to significant uncertainties, risks and contingencies, many of which are outside the control of, and are unknown to, Hexima and its officers, employees, agents or associates. In particular, factors such as outcomes of clinical trials and regulatory decisions and processes may affect the future operating and financial performance of Hexima. This may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. The information also assumes the success of Hexima's business strategies. The success of the strategies is subject to uncertainties and contingencies beyond control, and no assurance can be given that the anticipated benefits from the strategies will be realised in the periods for which forecasts have been prepared or otherwise. Given these uncertainties, you are cautioned to not place undue reliance on any such forward looking statements. Hexima is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
Disclaimer
Not financial or product advice
This presentation is for information purposes only and is not a prospectus, product disclosure statement or other offer document under Australian law or the law of any other jurisdiction. This document is not a financial product or investment advice, or a recommendation to acquire securities in Hexima, nor is it legal or tax advice. It has been prepared without taking into account the objectives, financial situation or needs of individuals. You are solely responsible for seeking independent and professional advice in relation to the information contained in this presentation and any action taken on the basis of that information. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial and tax situation and needs and seek legal and taxation advice appropriate to their jurisdiction. No reliance may be placed for any purpose whatsoever on the information included in this presentation or on its accuracy or completeness.
Except as required by law, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness, reliability or correctness of the Information, opinions and conclusions, or as to the reasonableness of any assumption contained in this presentation. By receiving this presentation and to the extent permitted by law, you release Hexima and its officers, employees, agents and associates from any liability (including, without limitation, in respect of direct, indirect or consequential loss or damage or loss or damage arising by negligence) arising as a result of the reliance by you or any other person on anything contained in or omitted from this presentation. To the maximum extent permitted by law, Hexima and its respective advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents exclude and disclaim all liability, including without limitation for negligence or for any expenses, losses, damages or costs incurred by you as a result of the information in the presentation being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise. To the maximum extent permitted by law, Hexima and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this presentation.
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Financial data
All dollar values are in Australian dollars (A$) unless stated otherwise.
Performance
Past performance information given in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of future performance. The presentation includes forward-looking statements regarding future
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HEXIMA LIMITED (ASX:HXL)
ersonal use only
Lead program is pezadeftide (HXP124), a potential new topical treatment for onychomycosis (fungal nail infections)
Exploring other applications for its anti-fungal peptide platformOnychomycosis affects ~14% of the US population. Global market for treatments for onychomycosis US$3.7 bn
Current treatments do not meet patient needs
• Topical drugs - long course of treatment, limited efficacy
• Oral drugs - more effective but risk of toxic side effects
Patients and clinicians have a clear preference for a safe topical product with a more convenient shorter course of therapy and better efficacy
Pezadeftide is a patented biologic with a novel fungicidal mode of action
Rapidly penetrates the human nail to target the site of infection
Demonstrated in a phase I/IIa clinical trial to have a favourable safety profile and deliver effective and rapid anti-fungal treatment
Safe and well tolerated
High efficacy via consumer-friendly topical application
Short, convenient course of therapy, delivers rapid resolution of disease
Currently in Australian phase II clinical trial - results Q2 2022
Phase III 2022
•
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Hexima Limited published this content on 04 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 April 2022 22:37:02 UTC.