Slide 1: HXP124: a game-changing treatment for fungal infections
For personal use only Hexima Limited HXP124: a game-changing treatment for fungal infections Public Offer and ASX Listing October 2020
Slide 2: Summary information
Hexima Limited For personal use only 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 at Thursday 15 October 2020 and does not purport
Slide 3: Overview
Overview For personal use only • Hexima is a Melbourne-based biotechnology company developing HXP124, a potential new topical treatment for onychomycosis • Onychomycosis (fungal nail infection) represents a large and growing market with substantial unmet need • Estimated to affect up to 14% of the p
Slide 4: Investment highlights
Investment highlights For personal use only The market for onychomycosis treatments is large and growing 1 The global market for all forms of onychomycosis treatments in 2018 was estimated at US$3.7 billion, the disease impacts >500 million people There is a well defined and unmet medical need for a
Slide 5: The market for onychomycosis treatments is large and growing
The market for onychomycosis treatments is large and growing For personal use only Key Insights Onychomycosis of the toenail is estimated to affect up to 14% of the population, growth in the market is primarily driven by an ageing population Risk factors include increasing age, athlete’s foot, diabe
Slide 6: Topical products are preferred over oral treatments, but existing products fail
Topical products are preferred over oral treatments, but existing products fail to meet fundamental patient needs For personal use only Patients with However, existing Patients therefore onychomycosis do topicals suffer from often stop not want to use the Topical products treatment because are there
Slide 7: HXP124 has the potential to become a game-changing, best-in-class treatment
HXP124 has the potential to become a game-changing, best-in-class treatment given its efficacy, safety and speed of action For personal use only Terbinafine Tavaborole Efinaconazole Ciclopirox HXP124 Product type Oral Topical Topical Topical Topical Fast acting x x x Best-practice treatment features
Slide 8: Plant defensins
Plant defensins For personal use only • The unique physical properties of defensins lend HXP124 to the task of safely penetrating the nail and clearing infection Evolved to Made using protect standard plants from yeast fungi Resistant to fermentation proteases & extremely Regulated as stable, biolog
Slide 9: HXP124 kills fungi more readily than other treatments
HXP124 kills fungi more readily than other treatments for nail infections For personal use only 100% HXP124 kills fungal cells within 30 minutes via a 90% novel mode of action 80% 70% Percent dead cells Ineffective killing by drugs currently on the 60% market means the fungus often regrows when
Slide 10: HXP124 penetrates nails faster and more efficiently than marketed products
HXP124 penetrates nails faster and more efficiently than current marketed products For personal use only Cumulative nail penetration • Topical treatments for fungal nail disease must Percent of drug that penetrates the nail 18% penetrate human nails to reach the nail bed, the 16% 16%1 main site of i
Slide 11: Successful phase I/IIa clinical trial
Successful phase I/IIa clinical trial For personal use only • Randomised, double blind cohort study • Patients treated nails daily with HXP124 (or vehicle) for 6 weeks with follow-up at 12 weeks • Total of 48 patients – 36 treated with HXP124, 12 treated with vehicle • Unblinded follow-up at 52 week
Slide 12: HXP124 is safe when applied to nails daily
HXP124 is safe when applied to nails daily for 42 days For personal use only The primary endpoint for the phase I/IIa study was safety and tolerability HXP124 is safe and well tolerated. No drug-related adverse events. HXP124 did not cause local irritation and did not enter the bloodstream. There wa
Slide 13: Phase I/IIa trial: effective and rapid anti-fungal treatment
During a phase I/IIa trial HXP124 delivered effective and rapid anti-fungal treatment for patients For personal use only Key Insights from Phase I/IIa clinical trial Mycological Cure at 12 weeks 90.0% 78.6% Mycological cure (culture and stain negative) 80.0% was achieved in 52% of HXP124-treated nai
Slide 14: Phase I/IIa trial: improved onychomycosis symptoms
During a phase I/IIa trial HXP124 substantially improved onychomycosis symptoms For personal use only Clinical efficacy (<10% infected nail area) over time 25.0% HXP124 cleared the affected nail area more 19.5% Patients with <10% infected nail area effectively than formulation not containing 20.0% 1
Slide 15: Phase I/IIa trial: improvement in nail appearance
During a phase I/IIa trial HXP124 delivered significant improvement in nail appearance within 12 weeks For personal use only Prior to treatment 12 weeks after treatment commenced 14 CONFIDENTIAL
Slide 16: HXP124 safety and efficacy profile
For personal use only Given HXP124’s safety & efficacy profile, Hexima believes it has the potential to deliver best-in-class cure rates without the toxic side effects of oral alternatives 15 CONFIDENTIAL
Slide 17: Proposed Australian Phase IIb clinical trials
Proposed Australian Phase IIb clinical trials For personal use only • Multi-center, randomised, double blind, vehicle-controlled study • Three active arms versus vehicle (132 subjects) • Comparing three dosing strategies • Safety & efficacy assessed at 13, 24, 36 and 40 weeks • Assessments align wit
Slide 18: HXP124 can be produced rapidly and economically
HXP124 can be produced rapidly and economically For personal use only HXP124 is produced in a non-proprietary yeast expression system with a highly competitive cost of goods HXP124 has been manufactured under Good Manufacturing Practice (GMP) conditions. Commercial-scale contract manufacturer engage
Slide 19: Strong protection for world-leading Intellectual Property
Hexima has developed strong protection for its world-leading Intellectual Property, creating a strong foundation from which to launch HXP124 For personal use only World-leading IP portfolio Hexima has built a world leading competency in plant defensins and a Globally recognised broad IP portfolio sc
Slide 20: Experienced senior executive team
Hexima is run by an experienced senior executive team who are invested in the success of the company For personal use only Board of Directors and Senior Executive Team Michael Aldridge Dr. Nicole van der Weerden Prof. Marilyn Anderson AO Prof. Jonathan West Mr Justin Yap Scott Robertson Dr Peter Wel
Slide 21: HXP124 presents a highly compelling commercial opportunity
Hexima considers that HXP124 presents a highly compelling commercial opportunity For personal use only Implications Market demand for greater efficacy with Strong Clinical shorter treatment durations than current HXP124 has a Profile topical agents, indicates potential for HXP124 meaningful and to b
Slide 22: Product development roadmap of HXP124
The product development roadmap of HXP124 involves several clearly defined activities over the mid-term For personal use only Detailed product development timeline 2020 2021 2022 2023 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase IIb clinical trial Manufacture scale-up Long-term animal toxicology
Slide 23: Committed to a sound strategic plan
Hexima is committed to the execution of a sound strategic plan, whilst preserving options to maximise shareholder returns For personal use only High-level strategic roadmap Raise capital for, conduct, and complete Phase IIb clinical trials in Australia Secure collaborative partnership in Japan Secur
Slide 24: Public Offer Indicative Capital Structure
Public Offer Indicative Capital Structure For personal use only • Hexima is raising A$3.0 million via a Public Offer at $0.20 per share and re-listing on the ASX • A priority will be given to existing shareholders under the Public Offer • A share sale facility will also be included in the Offer for
Slide 25: Use of Funds & Indicative Timetable
Use of Funds & Indictive Timetable For personal use only USE OF FUNDS AND EXISTING CASH A$ INDICATIVE TIMETABLE 2020 Existing Cash Balances as at 30 September 2020* $5.5m R&D tax incentive refund (expected November 2020) $1.9m Prospectus Lodgement Mid October Gross Proceeds of the Offer $3.0m Offer
Slide 26: HXP124 is well-positioned to become the market-leading treatment
HXP124 is well-positioned to become the market-leading treatment for onychomycosis globally For personal use only Hexima has extensive understanding of the HXP124 molecule, and is the world leader in this class of proteins HXP124’s high (>50%) mycological cure rate after just 6 weeks of daily applic
Slide 27: Contacts
Contacts For personal use only • Michael Aldridge, Chief Executive Officer m.aldridge@hexima.com.au +1 650 452 4684 • Dr Nicole van der Weerden, Chief Operating Officer n.vanderweerden@hexima.com.au +61 407 039 983 Further information is available (including audited annual accounts) at the Company’s