Slide 1: APMA Presentation and Investor Webinar
ASX Announcement 29 July 2021 APMA Presentation and Investor Webinar MELBOURNE, AUSTRALIA (29 July 2021): Hexima Limited (ASX:HXL) a clinical stage biotechnology company, will present clinical data from its phase I/IIa clinical trial of pezadeftide (HXP124) for the treatment of onychomycosis 1 at th
Slide 2: APMA 2021 Abstract
APMA 2021 ABSTRACT A phase I/IIa, randomized, double-blind, vehicle-controlled study of pezadeftide (HXP124), a novel topical treatment, in patients with onychomycosis. Van der Weerden N.1, Gaspar Y. 1, Anderson M. 1, Xie, A.2, Aldridge, M.1 and Welburn, P.1 1. Hexima Limited, La Trobe Institute for
Slide 3: Hexima Limited (ASX:HXL)
JULY 2021 HEXIMA LIMITED (ASX:HXL) A game-changing treatment for onychomycosis
Slide 4: Disclaimer
DISCLAIMER Summary information events and the future financial performance of Hexima. Forward looking words such as “expect”, “should”, “could”, “may”, This presentation has been prepared by Hexima Ltd and its subsidiaries (collectively “Hexima”). The information in this “predict”, “plan”, “will”, “
Slide 5: Significant progress in Q2 2021
AGENDA REVIEW OF QUARTERLY ACTIVITIES Significant progress in Q2 2021 • Presenting at APMA in Denver, CO • Completion of enrollment in phase IIb • Completion of large-scale manufacturing • Key patents granted in Europe and Mexico • INN designation for pezadeftide S LI DE 3
Slide 6: Developing a novel topical product addressing a clear unmet need
HEXIMA LIMITED (ASX:HXL) DE VE LOPING A NOVE L TOPIC A L PR ODUC T A DDR E S S ING A C L E A R UNM E T NE E D IN A L A R GE A ND GR OWING MA R KE T CLINICAL-STAGE, LARGE AND GROWING NOVEL, PROPRIETARY PEZADEFTIDE ADDRESSES WELL-DEFINED INFECTIOUS DISEASE-FOCUSED MARKET WITH SUBSTANTIAL MOLECULE WITH
Slide 7: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM PR OVE N TR A C K R E C OR D OF D E L IVE R ING VA LUE MICHAEL ALDRIDGE DR. NICOLE VAN DER WEERDEN DR. PETER WELBURN Chief Executive Officer Chief Operating Officer Chief Development Officer CEO Peplin, sold to Leo Pharma in Inventor on all Hexima’s key patents CSO and VP
Slide 8: American Podiatric Medical Association
AMERICAN PODIATRIC MEDICAL ASSOCIATION NA TIONA L OR GA NIZ A TION R E PR E S E NTING D OC TOR S OF POD IA TR IC M E D IC INE Critical prescriber base for the diagnosis “I see onychomycosis in my practice, and management of onychomycosis every day, every hour. It is something that is so common to wh
Slide 9: Phase I/IIa Clinical Trial: Trial Design
PHASE I/IIA CLINICAL TRIAL 12 12 HXP124-ONY-001 – TRIAL DESIGN WEEKS WEEKS Randomised, double blind, vehicle- COHORT 3 COHORT 4 controlled, ascending dose cohort study Pezadeftide 2% Pezadeftide 2% N=6 patients N=30 patients Patients treated nails daily with (randomised 2:1) (randomised 4:1) pezadef
Slide 10: Primary Endpoint: Safety and Tolerability
PRIMARY ENDPOINT SAFETY AND TOLERABILITY HXP124-ONY-001 – NO SYSTEMIC ABSORPTION AND NO LOCAL REDNESS OR IRRITATION Pezadeftide is safe and well tolerated NO DRUG-RELATED NO SYSTEMIC ADVERSE EVENTS ABSORPTION Pezadeftide Pezadeftide is safe and accumulated in nails and well tolerated when was still
Slide 11: Effective and Rapid Anti-Fungal Activity
EFFECTIVE AND RAPID ANTI-FUNGAL ACTIVITY HXP124-ONY-001 – MYCOLOGICAL CURE RATE FOR COHORT 4 30 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Mycological Cure at 12 weeks 75.0% 69.0% Mycological cure* was achieved in 69% 60.0% of pezadeftide-treated nails in Cohort 4 within 12 weeks (vehicle 29%) 4
Slide 12: Pezadeftide Rapidly Cleared the Affected Nail Area
PEZADEFTIDE RAPIDLY CLEARED THE AFFECTED NAIL AREA HXP124-ONY-001 – CLEAR NAIL GROWTH FOR COHORT 4 30 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Clinical Efficacy over time 15% 14% Pezadeftide cleared the affected nail Proportion of patients with area more effectively than vehicle <10% infected
Slide 13: Extensive Nail Clearing in Just 12 Weeks
EXTENSIVE NAIL CLEARING IN JUST 12 WEEKS HXP124-ONY-001 – PERCENT CLEARING OF INFECTED NAIL AREA FOR COHORT 4 PATIENTS TREATED AT HIGH DOSE (2%) FOR 6 WEEKS Clearing of >40% of the infected nail area 30.0% 26.0% Pezadeftide cleared the affected nail area more effectively than vehicle (formulation no
Slide 14: Rapid and Dramatic Improvement in Appearance of Nails
RAPID AND DRAMATIC IMPROVEMENT IN APPEARANCE OF NAILS NOTIC E A B LE IM PR OVE M E NT IN J US T 2 WE E KS , A L MOS T C LE A R IN 12 W E E KS Pezadeftide penetrates the nail to kill the fungus, allowing healthy, uninfected nail to grow out CLICK HERE TO PLAY TIME-LAPSE VIDEO • Clear nail growth cont
Slide 15: Australian Phase IIb Clinical Trial
AUSTRALIAN PHASE IIB CLINICAL TRIAL H X P124-ONY-0 0 2 Enrolment completed WEEK WEEK WEEK WEEK July 2021 13 24 36 40 • Multi-center, randomised, double blind, 12 WEEK DA I LY DOS I N G vehicle-controlled study • Primary endpoint safety and tolerability, 12 WEEK DA I L Y DOS I N G F OL L OWED B Y ON
Slide 16: Potential to Deliver the Preferred Solution in a Consumer-Driven Market
POTENTIAL TO DELIVER THE PREFERRED SOLUTION IN A CONSUMER-DRIVEN MARKET Convenient, Effective, Safe, topical short course of best-in-class medication therapy mycological cure FOR PATIENTS WHO WANT FOR PHYSICIANS WHO WANT FOR PAYERS WHO WANT An easy-to-apply topical An effective product that will An
Slide 17: Development Plan
DEVELOPMENT PLAN WE LL-D E FINE D D E VE L OPM E NT PA TH END OF A ND C LE A R LY-D EF INED M IL E S TONE S PII MEETING FILE US IND GMP 2022 MANUFACTURE PH I/IIA CLINICAL TRIAL 2021 COMPLETED US CLINICAL SAFETY STUDY PHASE I I I TOXICOLOGY I ND- ENABLI NG TOXI COLOGY PRE-CLINICAL TOXICOLOGY SCALE- U
Slide 18: Pezadeftide: A Potential Solution for a Large and Poorly Served Market
PEZADEFTIDE: A POTENTIAL SOLUTION FOR A LARGE AND POORLY SERVED MARKET POORLY SERVED MARKET NEW AND UNIQUE SAFE CONVENIENT EFFECTIVE Affects 14% of the Novel molecule with No systemic effects Easy to apply Efficiently penetrates population unique mode of action the nail No local redness or Short tre
Slide 19: Pezadeftide Is Manufactured Rapidly and Economically
PEZADEFTIDE IS MANUFACTURED RAPIDLY AND ECONOMICALLY S C A LE -UP WITH E UR OPE A N C M O ON-TR A C K PICTURED Fermenter and Chromatographic purification at European CMO Pezadeftide is produced in a yeast expression system with a highly competitive cost of goods • Pezadeftide has been manufactured t
Slide 20: Granted Patents in Major Markets
GRANTED PATENTS IN MAJOR MARKETS ADDITIONAL PROTECTION VIA FORMULATION PATENTS AND MARKET EXCLUSIVITY FOR BIOLOGICS Clearly defined growth strategy Granted patents Granted and 12-year US market (exp 2035) in major pending patents exclusivity on FDA • Develop independently in markets covering the cov
Slide 21: End of Treatment
RAPID AND DRAMATIC IMPROVEMENT IN APPEARANCE OF NAILS HXP124-ONY-001– NOTICEABLE END OF TREATMENT IMPROVEMENT IN 2 WEEKS, ALMOST CLEAR IN 12 WEEKS Noticeable Almost improvement 12 WEEKS clear nail 2 WEEKS 6 WEEKS in just 2 weeks BEFORE in 12 weeks PRES EN TA TI ON TI TLE S LI DE 20
Slide 22: Contacts
CONTACTS Michael Aldridge Dr Nicole van der Weerden CHIEF EXECUTIVE OFFICER CHIEF OPERATING OFFICER m.aldridge@hexima.com.au n.vanderweerden@hexima.com.au hexima.com.au +1 650 452 4684 +61 407 039 983 S LI DE 19
Slide 23: About Hexima
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 (previously referred to as HXP124) applied in a topical formul
Slide 24: Notes and references
the infected nail area. Consequently, pezadeftide offers the promise to capture significant value in a large and poorly served market. Notes: 1. ClearView Healthcare Partners proprietary market research, 2019 2. Tatchibana et al., Journal of Fungi, 2017 3. Joseph et al, Supplement to Podiatry Today,