Hexima Ltd · ASX:HXL
Hexima — Shareholder Meeting (November 2015)
27 slides from Hexima's shareholder meeting presentation, November 2015
Slide 1: AGM 2015
AGM 2015 Dr Nicole van der Weerden – Chief Operating Officer
Slide 2: Hexima Limited
Hexima Limited Research labs located in the La Trobe Institute for Molecular Science (LIMS) • 28 research scientists • 5 administration staff • 2 PhD students Greenhouse facilities located at the La Trobe R&D Park • PC2 accredited facility • Nine individual compartments —several compartments lease
Slide 3: Hexima's technology platforms
Hexima’s technology platforms Antifungal • Plant applications – transgenic crops, fungicides for seed coatings and crop sprays • Human applications – fungal nail infections (onychomycosis) Income generating programs • Insecticidal gene discovery program – crop protection • Contract field trial man
Slide 4: Fungal disease burden
Fungal disease burden Plants Humans Fungal diseases cause extensive Diseases range from superficial to crop losses each year life-threatening • Corn 10-12% (North America) • Fungal nail infections (onychomycosis) • Wheat 16% • Thrush and systemic candadaemia • Barley 15% • Keratitis • Rice 30% • C
Slide 5: Fungi that infect plants and humans are related
Fungi that infect plants and humans are related Plant and human fungal pathogens are very similar • In some cases plant pathogens also cause F. oxysporum human disease (plant pathogen) Hexima’s proprietary antifungal molecules are effective against both plant and human pathogens. T. rubrum (nail p
Slide 6: Plant defensins
Plant defensins Source of potent, broad spectrum antifungal agents. • Small, stable peptides abundant in plants • Highly soluble in water • Stable at extremes of pH (<2) and temperature (>95◦C) • Resistant to proteases and stable in serum • Manufacturable using yeast fermentation 9
Slide 7: Hexima antifungal peptides
Hexima antifungal peptides Hexima has built the world’s leading competency in plant defensins. • More than 10 unique, broad-spectrum, potent antifungal defensins • Covered by a broad IP portfolio —10 patent families Patent life for treatment of human infections to 2035. 10
Slide 8: Plant defensins protect transgenic cotton from fungal disease in the field
Plant defensins protect transgenic cotton from fungal disease in the field C T C C T T C Yr 1 Yr 2 Yr 3 Transgenic cotton line expressing plant defensin (T) had: • Higher tolerance to Fusarium wilt over 3 seasons • 2-4 fold increase in lint yields • 2-3 times the survival rate No adverse agronomic
Slide 9: DuPont-Pioneer transgenic corn program
DuPont-Pioneer transgenic corn program Collaboration with DuPont-Pioneer since 2008 to produce transgenic corn resistant to fungal disease. Plants with greater than 70% disease reduction for two major corn pathogens have been produced. Pioneer tested plants containing Hexima constructs in the fie
Slide 10: DuPont-Pioneer transgenic corn program
DuPont-Pioneer transgenic corn program Experiments to optimise field performance are in progress. A decision will be made at the end of 2015 on how to proceed with this program. 13
Slide 11: Fungal disease burden
Fungal disease burden Plants Humans Fungal diseases cause extensive Diseases range from superficial to crop losses each year life-threatening • Corn 10-12% (North America) • Fungal nail infections (onychomycosis) • Wheat 16% • Thrush and systemic candadaemia • Barley 15% • Keratitis • Rice 30% • C
Slide 12: Global onychomycosis market
Global onychomycosis market US$2.34 billion in 2012 and projected to reach US$3.1 billion by 2016. Deficiencies in current available therapies. • Poor efficacy rates • Long treatment times • Toxicity associated with oral therapies • Expensive —between 50 and 90% of individuals with fungal nail inf
Slide 13: HXP124: a broad-spectrum antifungal defensin
HXP124: a broad-spectrum antifungal defensin Active against a range of human fungal pathogens including Candida and the causative agents of fungal nail infections. Kills fungal cells within 30 min. • No activity against mammalian cells • No activity against bacterial cells No treatment Low dose Hi
Slide 14: HXP124: a broad-spectrum antifungal defensin
HXP124: a broad-spectrum antifungal defensin Living Dead Active against a range of human fungal pathogens including Candida and the causative agents of fungal nail infections. No treatment Low dose Kills fungal cells within 30 min. High dose • No activity against mammalian cells • No activity agai
Slide 15: HXP124 penetrates nails faster and more efficiently than current products
HXP124 penetrates nails faster and more efficiently than current marketed products 38% Topical treatments for fungal nail disease 40% must penetrate human nails. 35% 30% An in vitro nail adapter assay can be used Percent through nail 25% to assess nail penetration. 20% nail adapter 15% 15% cadaver
Slide 16: HXP124 is superior to current onychomycosis topical products
HXP124 is superior to current onychomycosis topical products Activity Mode‐of‐action Nail penetration (IC50) Fungicidal Kills cells within 30 min HXP124 3 µg/mL >30%, 24 h No resistance after 20 cycles of sub‐MIC treatment. HXP124 Only fungicidal at very Tavaborole high concentrations 2% after 72 h
Slide 17: HXP124 can be produced rapidly and economically in Australia
HXP124 can be produced rapidly and economically in Australia Produced in off-patent yeast expression system. Two-step purification process. • Highly pure protein (>99.99%) GMP manufacture completed by Pharmasynth under contract. 500 L fermentor in Pharmasynth’s GMP facility (Brisbane, AUS). 20
Slide 18: HXP124 Development Plan
HXP124 Development Plan Hexima will complete formulation work by December 2015. • Conducted by Tergus Pharma, USA Toxicology studies to begin in December 2015. Clinical trials to begin in the first-half of 2016. • Optimising trial design to reduce the time to proof-of-concept data Capital raisin
Slide 19: Hexima's defensin platform is applicable to a broad range of indications
Hexima’s defensin platform is applicable to a broad range of indications Vulvovaginal candidiasis (thrush) • HXP124 and other lead candidates are active against Candida spp • Stability in a topical formulation is a significant advantage for this indication • Molecules retain activity at low pH Fun
Slide 20: Summary
Summary Hexima has developed a defensin platform applicable to a range of applications. Hexima is developing HXP124 as a superior therapeutic for onychomycosis. • Better nail penetration. • Rapidly kills fungal cells. • Shorter treatment regimen. —4 weeks vs 48 weeks. Hexima expects to begin clin
Slide 21: Hexima's technology platforms
Hexima’s technology platforms Antifungal • Plant applications – transgenic crops, fungicides for seed coatings and crop sprays • Human applications – fungal nail infections Income generating programs • Insecticidal gene discovery program – crop protection • Contract field trial management • Leasin
Slide 22: GM insect resistance market
GM insect resistance market The 2012 global market for insect resistant GM plants was worth US$6.5bn, (43% of the GM seed and trait market). Resistance has developed to first generation Bt insect traits which increases the need to identify novel insecticidal genes. Bt corn accounted for 76% of co
Slide 23: Insecticidal gene discovery program
Insecticidal gene discovery program Collaboration funded by DuPont-Pioneer since 2014 to identify novel insect-active genes. Royalties to Hexima for any commercial outcomes. >20,000 samples collected and >10,000 screened for activity against insect pests of major crops. Several potential leads h
Slide 24: Hexima's technology platforms
Hexima’s technology platforms Antifungal • Plant applications – transgenic crops, fungicides for seed coatings and crop sprays • Human applications – fungal nail infections Income generating programs • Insecticidal gene discovery program – crop protection • Contract field trial management • Leasin
Slide 25: Multi Gene Expression Vehicle (MGEV)
Multi Gene Expression Vehicle (MGEV) Allows the DNA code for several proteins to be transferred into plants Without MGEV Promoter Protein 1 Terminator Promoter Protein 2 Terminator in a single unit. • Reduces the need for additional regulatory elements With MGEV Promoter Protein 1 Protein 2 Termina
Slide 26: Cyclic peptide production
Cyclic peptide production Cyclic peptides are promising therapeutic candidates with increased stability in biological fluids. • Production of cyclic peptides currently requires expensive resins and with low yields of pure protein. Hexima has developed technology for production of cyclic peptides,
Slide 27: Non-melanoma skin cancer
Non-melanoma skin cancer Lead anticancer molecule selected (NoD173) Additional technology will be required to deliver the molecule to skin cancer cells. Proof-of-concept work has been scaled-back to reduce cash burn. • Hexima will search for a commercial partner to continue this work. 30