For personal use only

HEXIMA LIMITED

ASX ANNOUNCEMENT

31 January 2022

Quarterly Activities Report and Appendix 4C

Completion of $11 million financing Important additions to the team cGMP manufacturing run complete

Cash at bank plus R&D Tax Rebate receivable of $14.3 million at year end

MELBOURNE, AUSTRALIA (31 January 2022): Hexima Limited (ASX:HXL) a clinical stage biotechnology company developing pezadeftide (formerly HXP124), as a potential new prescription topical treatment for onychomycosis, today files its Appendix 4C and quarterly activities report for the quarter ended 31 December 2021. Quarterly activities are set out in the attached NailMail, Hexima's quarterly communication to shareholders.

Hexima has now completed large scale cGMP manufacturing of pezadeftide at its European CMO. This is an important milestone. It marks the completion of a multi-year program of transferring and scaling-up the manufacturing technology for pezadeftide from the original pilot-scale site in Australia to a commercial scale CMO in Europe.

This announcement is authorised for release to ASX by Michael Aldridge, Managing Director & CEO Enquiries:

Dr Nicole van der Weerden Chief Operating Officer n.vanderweerden@hexima.com.au

To join our email database and receive company announcements please click here

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 (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 visit www.hexima.com.au. You can also find us on Twitterand LinkedInor email us at info@hexima.com.au.

ABOUT ONYCHOMYCOSIS

Onychomycosis is a common fungal nail infection in the nail plate and nail bed. Prevalence of onychomycosis has been estimated at between 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

LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086

1

For personal use only

HEXIMA LIMITED

ASX ANNOUNCEMENT

as 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.

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

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.5

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 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 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.

  • Tatchibana et al., Journal of Fungi, 2017
  • 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

LEVEL 4 LIMS 2, KINGSBURY DRIVE, LA TROBE UNIVERSITY VIC 3086

2

Q4 2021

NAILMAIL

INVESTOR NEWS

onlyQUARTERLY NEWSLETTER TO SHAREHOLDERS,

INVESTORS AND INTERESTED PARTIES. FOR FURTHER INFORMATION VISIT OUR WEBSITE AT HEXIMA.COM.AU.

useMAJOR ACHIEVEMENTS COVERED IN THIS REPORT personal

Finished the calendar year well capitalised with $14.3 million in cash at bank and R&D tax rebate receivable; Completed a successful $11 million placement and SPP at A$0.32 per share to fund preparations for phase III clinical trials. Funding was well supported by multiple new institutional investors and existing shareholders;

Appointed Dr Nancy Sacco as Chief Development Officer to lead development efforts into our US phase III development program, and Mr Philip Rose as Chief Commercial Officer;

Successfully completed cGMP manufacturing of pezadeftide, a key component of our IND to be filed with FDA;

Enhanced the Scientific Advisory Board with the

appointment of Dr Shari Lipner;

Presented at AusBiotech Invest, the preeminent opportunity Forfor Australian biotech companies to present to a network of

international partners and investors;

Submitted a poster which was accepted for publication at American Academy of Dermatology, the poster will be presented at the AAD in Boston on 25 March 2022.

Hexima expects to file an IND with FDA in the first quarter of 2022. The initiation of our first US clinical trial under that IND remains on track for mid 2022, and the Company's overall timetable of development activities including the release of its phase IIb data in Q2 2022 and the subsequent initiation of phase III remains on track.

ABOUT HEXIMA

Hexima 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.

HEXIMA LIMITED

Level 4, LIMS2

La Trobe University

VIC 3086 Australia

E: info@hexima.com.au

IMPORTANT DEVELOPMENTS AND MILESTONES Q4 2021

The final calendar quarter of 2021 reflects a period of important progress towards Hexima's goal of

delivering a new safe and effective topical treatment onlyfor onychomycosis with a more convenient shorter

course of therapy, and the Company remains poised to

deliver continued progress in the first quarter of 2022 a d beyond.

Financing

All final approvals for the $11 million placement and

SPP were completed at the Company's AGM held in useD c mber. A $10 million institutional placement was

succ ssfully completed with an associated SPP to hareholders raising a further $1 million, all at $0.32

per hare.

Proceeds from the financing will be used to accelerate

Hexima's business plans, particularly into the US and

personal

other international markets by:

completing the preparation and submission of an

Investigational New Drug (IND) Application to FDA

a

d conduct a clinical safety study in the US;

fi

alising all

development

including: clinical,

manufacturing,

toxicology

and CompliancePak

packaging unit and mobile app necessary prior to initiating a phase III clinical trial program;

ecuring executives and expertise with the necessary experience to conduct late-stage product development in the US market;

valuating the option for Hexima to raise capital in the future on attractive terms with US and international investors; and

exploring the potential for pezadeftide or one of its related defensin class peptides to be an Forattractive follow-on product candidate to treat l calized fungal infections (in addition to

nychomycosis).

Wilsons Corporate Finance Limited and Canaccord Genuity (Australia) Limited acted as joint lead managers and bookrunners for the placement.

Hexima finished the year well capitalised with $14.3 million in cash at bank and R&D tax rebate receivable.

Advancing the Development Program

Important steps in advancing pezadeftide to market were achieved.

The Company has now completed large scale cGMP manufacturing of pezadeftide at its European CMO. This is an important milestone. It marks the completion of a multi-year program of transferring and scaling-up the manufacturing technology for pezadeftide from the original pilot-scale site in Australia to a commercial scale CMO in Europe.

Preparation of Hexima's IND filing with FDA is almost complete and the Company expects to file its IND in Q1 2022. This filing is in anticipation of a small, single centre safety study (ONY-003) that will be conducted in the US to understand the pharmacokinetic properties of pezadeftide when applied to more compromised fungal infected nails in a maximal use setting.

The phase IIb clinical trial (ONY-002) at centres in Australia and New Zealand continues to progress well. COVID-19 travel restrictions have not had a material impact and as previously announced the Company expects to report results in Q2 2022.

Building the Team

Dr Nancy Sacco, Chief Development Officer

In December 2021, Dr Nancy Sacco was appointed as Chief Development Officer - a critical role that will be central to the successful development and delivery of Hexima' s first product.

onlypr ducts. Dr Sacco holds a PhD from West Virginia University School of Medicine.

Dr Sacco brings over 20 years of strong leadership experience in the pharmaceutical industry, driving business objectives, including non-clinical discovery, late-stage clinical development, registration, and

approval of a range of important pharmaceutical

usePrior to this appointment, Dr Sacco held Vice President

and H ad of Clinical Development roles at Xentria, Inc.

and AnaptysBio, Inc., overseeing programs with

monoclonal antibodies for rare and dermatologic diseases.

In addition, Dr Sacco held executive leadership

positions at Revance Therapeutics, Inc. and Avexis, Inc personal(now Novartis), overseeing clinical operations

including the initiation and completion of pivotal studies evaluating safety and efficacy of innovative products (proprietary neurotoxin Daxibotulinum and AVV9 gene therapy ZolgenSMA, respectively).

Dr Sacco has also held roles of increasing

re ponsibilities at P&G Healthcare (Actonel), Pfizer (Lyrica), Astellas (Myrbetriq and Xtandi) and Takeda (Roze em and ACTOS).

Phil Rose, Chief Commercial Officer

Subsequent to the quarter end, Phil Rose was a ointed as Chief Commercial Officer.

ForMr. Rose has 30+ years of leadership experience in the pharmaceutical industry, which includes previous roles as President and CEO of the dermatology focused Obagi Medical Products, Vice President and General Manager of North America for Valeant (now Bausch Healthcare Companies) and Vice President Hospital Sales at Glaxo, Inc. (now GSK). In addition, Phil is a licenced and practicing Pharmacist.

Mr. Rose has served as a commercial consultant to the pharmaceutical industry and prior clients include Alza Corporation (now J&J), Reliant Pharmaceuticals (now GSK), Peplin, Inc. the developer of Picato (now LEO), and Hexima Limited since 2020.

These two key appointments are critical hires for Hexima as it moves towards initiating its phase III clinical trial program later in 2022.

Key elements of their employment contracts are set out below.

Each is eligible to participate in Hexima's ongoing LTI plan and on agreement to increase their time commitment to 100% each will become eligible for the package of U.S. employee benefits which Hexima offers, including health insurance and termination arrangements.

New SAB appoinment

Hexima also added Shari Lipner MD to its Scientific Advisory Board, enhancing its expertise in dermatology. Dr. Lipner is an Associate Professor of Clinical Dermatology, Associate Attending Physician, and Director of the Nail Division at the New York- Presbyterian Hospital/Weill Cornell Medical Center.

Dr. Lipner has authored over 250 peer-reviewed publications, numerous book chapters, lectures nationally and internationally, and is frequently sought out by the media for her expertise. Shari is a retained consultant to the Company.

Nancy Sacco

Phil Rose

Employment "at will"

Effective 1 December 2021

Effective 1 January 2022

Initial time commitment

40% moving to 100% on mutual agreement

50% moving to 100% on mutual agreement

Initial base salary

US$130,000 (based on 40% time commitment)

US$150,000 (based on 50% time commitment)

Target STI

25% of base salary

25% of base salary

Initial grant of LTI options (on move to 100% commitment)

600,000 (900,000)

600,000 (600,000)

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

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Hexima Limited published this content on 30 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 January 2022 21:50:01 UTC.