Hexima Ltd · ASX:HXL
Hexima — ShareCafe Hidden Gems Webinar (May 2021)
18 slides from Hexima's conference presentation, May 25, 2021
Slide 1: ShareCafe Presentation (ASX Announcement)
ASX Announcement For personal use only 25 May 2021 ShareCafe Presentation MELBOURNE, AUSTRALIA (25 May 2021): Hexima Limited (ASX:HXL) a clinical stage biotechnology company developing HXP124, a new prescription topical treatment for onychomycosis, presented to investors and shareholders at the Shar
Slide 2: Hexima's Approach
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.[6] For personal use only Hexima’s Approach Hexima embraces the signif
Slide 3: A game-changing treatment for onychomycosis
For personal use only Hexima Limited (ASX:HXL) A game-changing treatment for onychomycosis 21 May 2021
Slide 4: Novel topical product addresses clear unmet need in large and growing market
Hexima Limited (ASX:HXL) Novel topical product addresses clear unmet need in large and growing market For personal use only Lead program is pezadeftide (HXP124), a potential new topical treatment for onychomycosis (fungal Clinical-stage, infectious disease nail infections) focused biotechnology comp
Slide 5: Onychomycosis (fungal nail infection)
Onychomycosis (fungal nail infection) Common infectious disease with a significant healthcare burden For personal use only Pathophysiology Onychomycosis of the toenail is estimated to affect 10-14% of the US population, growth in the market is primarily driven by an ageing population. Left untreated
Slide 6: Existing therapies do not meet consumer needs
Existing therapies do not meet consumer needs Clear market need for a safe, convenient and more effective topical product For personal use only Topical treatments = long treatments, poor efficacy Oral drugs = better efficacy but potential for serious adverse events Patients with However, existing Pa
Slide 7: Successful phase I/IIa clinical trial
Successful phase I/IIa clinical trial HXP124-ONY-001 – Trial design For personal use only • Randomised, double blind, vehicle-controlled, ascending dose cohort study • Patients treated nails daily with pezadeftide (or vehicle) for 6 weeks with follow-up at 12 weeks • 36 patients treated with pezadef
Slide 8: Safe and well tolerated
Safe and well tolerated HXP124-ONY-001 – No systemic absorption and no local redness or irritation For personal use only The primary endpoint for the phase I/IIa study was safety and tolerability Pezadeftide is safe and well tolerated when applied daily for 6 weeks. No drug-related adverse events. P
Slide 9: Rapid and dramatic improvement in appearance of nails
Rapid and dramatic improvement in appearance of nails HXP124-ONY-001– Noticeable improvement in 2 weeks, almost clear in 12 weeks For personal use only Two stage process: 1. Penetrate the nail and kill the fungal infection 2. Healthy, uninfected nail grows clear 6
Slide 10: Effective and rapid anti-fungal activity
Effective and rapid anti-fungal activity HXP124-ONY-001 – Mycological cure rate 2-fold higher than current treatments For personal use only Key Insights from HXP124-ONY001 – Phase I/IIa clinical trial Mycological Cure at 12 weeks 60.0% Mycological cure* was achieved in 52.4% 52% of pezadeftide-treat
Slide 11: Rapidly cleared the affected nail area
Rapidly cleared the affected nail area HXP124-ONY-001 – Clear nail growth continued after dosing complete For personal use only Clinical efficacy (<10% infected nail area) Patients with <10% infected nail area Pezadeftide cleared the affected 25.0% nail area more effectively than 20.0% 19.5% formula
Slide 12: Pezadeftide: demonstrated potential to deliver the preferred solution
Pezadeftide: demonstrated potential to deliver the preferred solution in a consumer-driven market For personal use only Convenient, short course Effective, best-in-class Safe, topical medication of therapy mycological cure For patients who want… For physicians who want… For payers who want… An easy-
Slide 13: Australian Phase IIb clinical trial
Australian Phase IIb clinical trial HXP124-ONY-002 For personal use only • Three active arms versus vehicle to test optimal dosing strategy • Safety & efficacy assessed at 13, 24, 36 and 40 weeks, data expected Q2 2022 • Multi-center, randomised, double blind, vehicle-controlled study • Primary endp
Slide 14: Granted patents in major markets
Granted patents in major markets Additional protection via formulation patents and market exclusivity for biologics For personal use only Granted patents (exp 2035) in major Granted and markets covering the use pending patents 12-year US market of pezadeftide in the covering stabilising exclusivity
Slide 15: Development plan
Development plan Well-defined development path and clearly-defined milestones For personal use only 12
Slide 16: Pezadeftide: a potential solution for a large and poorly served market
Pezadeftide: a potential solution for a large and poorly served market For personal use only 13
Slide 17: Experienced management team
Experienced management team Proven track record of delivering value For personal use only Michael Aldridge Prof. Marilyn Anderson Dr. Nicole van der Weerden Dr. Peter Welburn Chief Executive Officer Chief Science Officer Chief Operating Officer Chief Development Officer • CEO Peplin, sold to Leo • F
Slide 18: 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 at: www.hexima.com.au 15