Hexima Ltd · ASX:HXL
Hexima — Shareholder Meeting (November 2017)
25 slides from Hexima's shareholder meeting presentation, Nov 21, 2017
Slide 1: Annual General Meeting 2017
Annual General Meeting 2017 KPMG Level 36, 727 Collins St Melbourne Tuesday 21 November 2017 11.00am
Slide 2: Forward looking statements
Forward looking statements Certain statements in this presentation relate to the future, including forward looking statements relating to Hexima’s future expectations, beliefs, goals, plans, prospects, financial position and strategy. These forward looking statements involve known and unknown risks,
Slide 3: AGM 2017
AGM 2017 Dr Nicole van der Weerden – Chief Executive Officer
Slide 4: Key achievements for 2017
Key achievements for 2017 Successfully closed $3.9 mil rights issue to fund clinical development of HXP124 as a treatment for fungal nail infections. Demonstrated that HXP124 has excellent activity in an Infected Nail Model Completed pre-clinical toxicology program for HXP124. • Repeat dose derma
Slide 5: Key achievements for 2017
Key achievements for 2017 Three patent families granted in multiple Jurisdictions • Improved variants of defensins (human and plant applications) — USA, Japan, China, Mexico, Europe (previously granted in Australia) • Defensin-defensin synergy (human and plant applications) — Australia, South Afric
Slide 6: HXP124
HXP124 Hexima is developing a novel therapeutic (HXP124) for the treatment of fungal nail infections (onychomycosis). HXP124 has the potential to be superior to current therapies. • Potent, broad-spectrum antifungal molecule —Member of the Plant Defensin class of molecules • Readily penetrates nai
Slide 7: Global onychomycosis market
Global onychomycosis market US$3.06 billion in 2015 and projected to reach US$4.7 billion by 2021. Major deficiencies in current therapies. • Poor efficacy rates • Long treatment times • Oral therapies can be toxic • Expensive —Estimated that between 50 and 90% of individuals with fungal nail infe
Slide 8: HXP124 kills fungi better than current treatments for nail infections
HXP124 kills fungi better than current treatments for nail infections 100% 90% 80% Kills fungal cells within 30 min. 70% Percent living cells • Inefficient killing by the drugs 60% currently on the market means the 50% fungus is likely to become 40% resistant during long treatment 30% times and may
Slide 9: HXP124 is as effective as efinaconazole in an infected nail model
HXP124 is as effective as efinaconazole in an infected nail model MedPharm (UK) tested HXP124 in 2. HXP124 applied topically an “infected nail model” to provide additional confidence that HXP124 passes through nails and kills fungal nail adapter cells. human nail • Industry standard assay. 1. funga
Slide 10: HXP124 is as effective as efinaconazole in an infected nail model
HXP124 is as effective as efinaconazole in an infected nail model HXP124 killed over 95% of fungal cells within 7 days and was as efficient as Jublia® in this model. 40% (% relative to infected control) 2. HXP124 applied topically ATP levels* 30% nail adapter human nail 20% 1. fungal infection deve
Slide 11: FY 2017 progress
FY 2017 progress Pre-clinical animal toxicology studies are complete and clinical trials have been initiated. CY 2017 CY 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre-clinical animal toxicology studies Complete Phase I/IIa human clinical safety and efficacy studies On-track United States Food and Drug Administr
Slide 12: HXP124 was not toxic in a dermal irritation minipig study
HXP124 was not toxic in a dermal irritation minipig study 42-day GLP repeat-dose dermal toxicity study in minipigs • No Observable Adverse Effect Level (NOAEL) of 50 mg/kg (highest dose) • Very low absorption through the skin • No systemic toxicity effects at the highest dose (50 mg/kg) • Very slig
Slide 13: Pathway to ethics approval
Pathway to ethics approval In vitro pharmacology & efficacy studies Toxicology in animals GMP manufacture Formulation Safety pharmacology Drug stability studies Reviewed and Container closure approved by Clinical Dosage and administration trial Clinical trial Protocol Human Adver
Slide 14: Clinical trial to begin recruiting patients in Dec 2017
Clinical trial to begin recruiting patients in Dec 2017 Randomised, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study in Healthy Volunteers with Mild to Moderate Onychomycosis. • Approval received from Human Research Ethics Committee (Nov 2017) • Patient screening to commence in early
Slide 15: Clinical trial design
Clinical trial design Cohort 3 Cohort 4 7 days HXP124 2% Highest safe dose N=6 patients N=24 patients (randomised 2:1) (randomised 3:1) 12-week follow up 12-week follow up 52-week follow up Cohort 2 7 days HXP124 1% N=6 patients (randomised 2:1) Cohort 1 HXP124 0.5% N=6 patients randomised 2 (drug):
Slide 16: Phase I/IIa clinical trial endpoints
Phase I/IIa clinical trial endpoints Primary endpoint • Safety and tolerability Secondary endpoints Day 0 Day 90 • Preliminary efficacy data —Mycological cure (clearance of fungi from the nail) Infected area —Partial cure (clear nail growth) Clear nail —Complete cure (mycological cure and clear na
Slide 17: Recruitment strategy
Recruitment strategy Clinical trial sites • Internal databases (Linear has 14,000 patients on file) • Targeted advertising campaign Recruitment vendor (Clinical Trial Group): • Dedicated website • Facebook ads and split testing • Facebook page • Email campaign • Targeted patient populations and di
Slide 18: HXP124 commercialisation plan
HXP124 commercialisation plan Proof-of-concept efficacy data is a major value creation step during drug development. If positive clinical efficacy data is obtained, Hexima intends to licence HXP124 to a pharmaceutical companie(s) to generate upfront and future milestone payments and licensing reve
Slide 19: Licencing HXP124 in Japan
Licencing HXP124 in Japan Hexima is continuing discussions with several Japanese companies regarding a licence for HXP124. • Hexima believes that the large, proven Japanese market for onychomycosis makes it a key target market for HXP124. • Hexima believes that a co-development process with a Japan
Slide 20: Summary
Summary Hexima is developing HXP124 as a superior therapeutic for onychomycosis. • Better nail penetration. • Rapidly kills fungal cells. • Anticipating shorter treatment regimen. —6 weeks vs 48 weeks. • Good safety profile A phase I/IIa clinical trial has been initiated. • Approved by HREC • Recr
Slide 21: Hexima's defensin platform is applicable to other fungal diseases
Hexima’s defensin platform is applicable to other fungal diseases Vulvovaginal candidiasis (thrush) • HXP124 and other Hexima lead candidates rapidly kill Candida spp • HXP124 is stabile in a topical formulation which is a significant advantage for this application • $50k Research Connections gran
Slide 22: Defensins are active in a rat model of vaginal thrush
Defensins are active in a rat model of vaginal thrush Topical treatment with defensin reduced the number of C. albicans cells in vaginal fluid by 70-87% within 3 days • Less effective than miconazole after 5 days —BUT - Miconazole is fungistatic and yeast cells re-emerge after 9-12 days • Need to a
Slide 23: C. albicans biofilm development
C. albicans biofilm development Candida biofilms on medical device implants are a major cause of systemic infections • Help protect the fungus from antifungal drugs Hexima’s defensins kill established Candida biofilms SEM of C. albicans in a biofilm. Growth and development of a C. albicans based b
Slide 24: Dow-DuPont Pioneer Insect Project
Dow-DuPont Pioneer Insect Project Project is funded by Dow-DuPont until December 2018 ~9000 diverse plant samples and 46,500 bacteria have been collected (in 3.8 yrs) Novel leads continue to progress through the development pipeline at Dow-DuPont Implications of the Dow-DuPont merger not yet cle
Slide 25: Focus for 2018
Focus for 2018 HXP124 clinical trial • Patient recruitment and enrolment • Dosing and safety assessments for dose escalation • Preliminary efficacy assessment Business development activities for HXP124 • Engaging with BD and licencing experts • Licencing discussions with preferred partners to be