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    HXL   AU0000111932


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Hexima : 2021 Annual Financial Report

08/27/2021 | 01:31am EDT

Hexima Limited

Annual Report

For the year ended 30 June 2021

About Hexima

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 (formerly 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.



Table of Contents

Operational Highlights


Message from the Chair and Chief Executive Officer


Company Overview


- About Onychomycosis


- Pezadeftide as a Potential Treatment for Onychomycosis


- Phase IIb Clinical Trial (HXP124-ONY-002)


Financial Report


Company Directory



Hexima Limited | Annual Report | For the year ended 30 June 2021

Operational Highlights

Message from the Chairman and Chief Executive Officer

Equity capital raising and ASX-listing

During FY2021, Hexima raised a total of $8.5 million before costs in a private placement ($5.5 million) and public offering ($3.0 million). On 1 December 2020 Hexima's shares commenced trading on ASX under the ticker code "HXL". Hexima finished the financial year well-capitalized with $7.4 million in cash and short-term receivables.

Completion of enrolment into phase IIb study

Hexima's phase IIb clinical trial of pezadeftide (formerly HXP124 )for onychomycosis progressed according to plan in 2021 and in July 2021 Hexima was pleased to report the completion of patient enrolment into the study. This is an important achievement in pezadeftide's development program. All patients are in treatment and follow-up and Hexima expects to report the results of the study in Q2 2022.

Completion of manufacturing scale-up

Hexima completed multiple large-scale manufacturing batches with its European contract manufacturer to produce pezadeftide for toxicology studies. In this scale- up process, Hexima has resolved important challenges in manufacturing pezadeftide at scale and can now point confidently to both commercial-scale and low-cost manufacturing of pezadeftide.

Key patents granted

Hexima continued to strengthen its intellectual property position during FY2021. As at August 2021, Hexima has obtained granted patents covering the use of pezadeftide to treat onychomycosis in all major markets including the United States, Japan, Europe, China, Singapore, Mexico and Australia.

INN designation

The International Nonproprietary Names (INN) Programme and Classification of Medical Products of the World Health Organization (WHO) has selected "pezadeftide" as the non-proprietary name for Hexima's HXP124. The suffix"- deftide", representing defensin-derivedanti-microbial peptides, establishes pezadeftide as the first in a new class of anti-fungal molecules. The designation of pezadeftide as the first in a new class of anti-microbial peptides highlights the important role that Hexima is playing in developing novel, powerful and broad-spectrum fungicidal molecules as potentially valuable tools in the ever-escalating battle with constantly evolving fungal pathogens.

Formation of Scientific Advisory Board

Hexima has recruited a group of expert clinical opinion leaders to a Scientific Advisory Board (SAB) which held its first meeting in February 2021. The SAB members are internationally recognised Dermatologists and Podiatrists based in US, Australia and Japan. They include the lead clinicians from advanced clinical trials conducted for multiple successful therapeutic products developed

to treat onychomycosis in international markets. In its inaugural meeting, the SAB discussed the scientific and early clinical data supporting the unique activity of pezadeftide.

Dear Shareholder,

On behalf of the Board of Directors we are pleased to present Hexima's annual report for the 2021 financial year.

With our capital raising and listing on ASX almost a year behind us, we are very pleased to share with you the extraordinary progress achieved over the last year, anchoring the Company's plans for future development.

As stated upon our listing, Hexima is developing pezadeftide (which we previously referred to as HXP124) as a new topical prescription therapy for the treatment of onychomycosis (or fungal nail infection).

Onychomycosis is both a very common disease and has a significant unmet medical need. While common in the general population, in settings such as elderly care facilities the prevalence of this difficult to treat infection can be

50% or higher. Fungal nail infection is typically progressive, gradually invading the nail bed and resulting in discolored and disfigured nails, which are often painful and result in discomfort and emotional distress.

Currently the market for treatment options for onychomycosis remains poorly served, and available treatments have some significant shortcomings. Patients are often reluctant to use oral therapies because of the risk of serious side effects and the topical alternatives prescribe a long course of daily treatment for ~12 months. Only a small minority of treated patients actually clear their infected nails.

In our conversations with doctors, and particularly podiatrists, we are constantly struck with the repeated refrain: "…we see this infectious disease all the time, and we have no attractive treatment options".

In spite of the weakness of existing therapies, the market for treatments is large, estimated to be more than US$3.7 billion per year, as sufferers search for solutions.

Clinical and regulatory progress

FY21 saw the Company continue to make significant progress in our clinical, manufacturing and intellectual property development activities.

Funding from our capital raising and listing on ASX in late 2020 provided the necessary resources to conduct our phase IIb clinical trial. This large multi-centre trial is designed to answer an important question: identify the course of therapy which maximises the efficacy of pezadeftide while retaining the important features of a convenient, short-course treatment in a topical format which is so important in this consumer driven market. As of writing, the clinical trial is fully enrolled and patients are in the treatment and follow-up phase. We are on track to announce the results of this trial in Q2 2022.

Hexima also continues to progress towards commercial scale for its sophisticated biotechnology manufacturing system used to make pezadeftide. The scale up of this system and delivery of pezadeftide according to rigorous quality standards was an important, challenging and successfully met milestone that lays the foundation for our phase III clinical trial program.

The Company's intellectual property portfolio is a corner stone of securing the value created in the pezadeftide product development program. Throughout FY21 Hexima was pleased to add Europe and Mexico patent protection to our already granted US and Japanese patents. A patent was also granted in China shortly after year end.

It should be noted that because the pezadeftide molecule is a biologic, we expect to enjoy regulated market exclusivity over and above formal patent protection for 12 years post product approval in the US (our largest potential market). Leading into FY22 Hexima will look

to pursue other patents protecting pezadeftide in major markets.

Hexima achieved several major milestones

in FY2021 and was

pleased to report the completion of patient enrolment into its phase IIb clinical trial in

July 2021.

Hexima's goal continues to be the development of pezadeftide as a safe and effective topical therapy with a patient-friendly, and convenient course of therapy. Our completed phase I/IIa trial delivered early but powerful evidence of this. Pezadeftide appears to deliver on each of the key characteristics that our market research indicates is critical for a new and successful treatment for onychomycosis: safety, efficacy and patient convenience.

In this large and underserved market, Hexima expects pezadeftide to represent the preferred treatment option for clinicians and patients alike.

It is a hugely valuable and increasingly tangible goal. Despite the challenges of the current environment, we are very pleased with the progress made in our clinical and product development activities over the course of the period.

FY21 activities undertaken by the Company also saw the formation of our international Scientific Advisory Board (SAB) to assist the Company's understanding of our market opportunity and moulding our product development efforts to ensure we address most effectively the market need. Our SAB comprises opinion leading dermatologists and podiatrists from the US, Australia and Japan. We have plans to augment this with European expertise over time.

Additionally, Hexima continues to prioritse engagement with clinicians on the front line of treating onychomycosis to further inform our clinical development and increase sector awareness of pezadeftide. To support this function, FY21 saw the beginnings of our engagement with the broader US podiatric community. We presented pezadeftide at the American Podiatric Medical Association annual scientific conference in Denver, Colorado.

Our informal interactions with podiatrists at the APMA conference was a refreshing affirmation that our goals in developing pezadeftide neatly align with the needs of this critical specialist group and their patients.



Hexima Limited | Annual Report | For the year ended 30 June 2021

Hexima Limited | Annual Report | For the year ended 30 June 2021

Message from the Chairman and Chief Executive Officer (continued)

Company Overview

About Onychomycosis

Outlook for FY22

Looking ahead Hexima's primary strategic goal is to continue the development of pezadeftide as a new and valuable prescription topical therapy for onychomycosis in major markets globally. Important elements of that strategy include:

• Retain US product rights and develop a prescription

product optimised to address the unmet medical need

of patients and clinicians in the US market.

• Deliver results from the ongoing phase IIb clinical trial

and define the optimal dosing strategy for pezadeftide.

• Establish a license and development collaboration

with a leading Japanese pharmaceutical company for

development of pezadeftide in the Japan market. Japan

is both a large market for therapies for onychomycosis

And while we have made important and valuable progress on each of these strategic initiatives during the course of this year, we expect further developments in these areas concurrent to the completion of pezadeftide's phase II clinical trial program.

Looking further out, we are making plans to move this valuable asset forward into its final phase III program in the US, and ensuring that we have all of the key aspects of the product presentation ready to test in that trial program; our final step before seeking approval to launch and market pezadeftide.

As we continue on this journey on behalf of the Board and management I wish to thank our shareholders for their continued support of Hexima's aspiration to improving the lives of patients suffering from onychomycosis.

Onychomycosis (fungal nail infection) is a common fungal infection of the nail plate and nail bed. Prevalence of onychomycosis has been estimated at between 10% (Japan) and 13.8% (USA).i Onychomycosis is an infectious disease and is difficult to treat. It has a significant healthcare burden, causing pain in approximately 50% of patients and in the US onychomycosis results in close to four doctor's visits annually for treatment.ii 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.iii It is important to treat onychomycosis as it is an infectious disease; the fungi in the nail can be a source of secondary infection in other areas of the body or infect family members and spread to the environment.

and also requires a degree of independent, Japan-

market specific


• Secure financing

on attractive terms to support the

initiation of our phase III clinical trial program in the US.

The upfront and milestone payments of a Japan market

licence and development collaboration may represent a

significant component of our financing plans.

• Explore the potential of pezadeftide and its related anti-

fungal defensin molecules for which we have patent

protection to represent a valuable follow-on product for

other localised fungal infections where there exists an

unmet medical need;

The Company looks forward to updating shareholders as we continue to progress forward throughout FY22.

With thanks

Jonathan West

Non-executive Chairman

Michael Aldridge

Managing Director and Chief Executive Officer









annuallybypatientsseeking treatment.4p.a.50%






Treatment of Onychomycosis

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.v

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 primarily the azole class 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

Hexima's primary strategic goal is to

continue the development of pezadeftide as a new and valuable prescription topical therapy for

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.v The global market for treatments for onychomycosis was approximately US$3.7 billion in 2018.iv




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.

onychomycosis in major

markets globally.



  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


Hexima Limited | Annual Report | For the year ended 30 June 2021

Hexima Limited | Annual Report | For the year ended 30 June 2021

Company Overview

Pezadeftide as a Potential Treatment for Onychomycosis

Company Overview

Phase IIb Clinical Trial (HXP124-ONY-002)

Hexima believes pezadeftide addresses the important short comings of available treatments for onychomycosis. It is a broad spectrum and powerful antifungal agent which penetrates nails very rapidly when applied topically. It is safe and well tolerated and in a 6-week phase I/IIa clinical trial demonstrated:

  • Short course of therapy, pezadeftide appears active following just 6-weeks of daily therapy
  • Better efficacy, clearing fungus from the nail two-times more effectively than current best-in-class (more than oral and topical) products at the same time point
  • Fast acting, dramatically improving the appearance of the infected nail in less than 12 weeks
  • Safe and well tolerated, with no treatment area irritation or treatment-related adverse events
  • Locally acting, pezadeftide effectively penetrates nails but is not detected in the blood stream and has not presented any systemic toxicity

This is a consumer driven market and based on our market research, there is a well-defined and under-served demand from consumers (clinicians and their patients) who are looking for such features in their treatment.

Hexima is conducting a phase IIb clinical trial at 15 sites in Australia and New Zealand. The trial has enrolled 117 patients with onychomycosis and seeks to identify the optimal course of therapy for pezadeftide. This study is comparing 12 weeks versus 31 weeks

of daily therapy as well as 12 weeks of daily therapy followed by once weekly therapy out to 36 weeks. Patients are randomly assigned to one of the three treatment arms. The patients receiving treatment with pezadeftide (active) are being compared to patients being treated with a formulation not containing pezadeftide (vehicle) at a ratio of 3:1. The identity of active versus vehicle treatments is blinded to both patient and clinician.






































Efinaconazole Ciclopirox

Efinaconazole Ciclopirox



  1. Internal Hexima research; 2. Kaken Pharma and Dow Pharma, Sugiura et al., 2014; 3. UCSF Medical Center, Hui et al., 2006;
  1. HXP124 PI/IIa clinical trial, HXP124-ONY-001 (ACTRN12618000131257);















Before treatment

2 weeks later - Noticeable

6 weeks later

12 weeks later (end of study)

improvement in just 2 weeks

(end of treatment)

Almost clear nail in just 12 weeks

Before treatment

2 weeks later - Noticeable

6 weeks later

12 weeks later (end of study)

improvement in just 2 weeks

(end of treatment)

Almost clear nail in just 12 weeks

The results of this clinical trial are intended to identify the optimum dosing regimen to take into Hexima's US phase III clinical trial program. Hexima expects this phase IIb clinical trial (HXP124-ONY-002; ANZCTR registration number ACTRN12620000697987) to represent its last large, multi-centre clinical trial ahead of initiating its phase III program.

Our goal is to demonstrate the

potential of pezadeftide

to be a safe and

effective treatment in a convenient, consumer friendly, topical format for this very common and difficult to treat infectious disease.



Hexima Limited | Annual Report | For the year ended 30 June 2021

Hexima Limited | Annual Report | For the year ended 30 June 2021

This is an excerpt of the original content. To continue reading it, access the original document here.


Hexima Limited published this content on 27 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 August 2021 05:30:05 UTC.

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