Bioxyne Limited · ASX:BXN

Bioxyne — Bls Pharmaceuticals — Investor Presentation (July 2012)

20 slides from Bioxyne's investor presentation, Jul 12, 2012

  1. Slide 1: Investor Presentation

    For personal use only Investor Presentation July 16th 2012 1

  2. Slide 2: HI-164OV – Executive Summary

    HI-­‐164OV – ExecuLve Summary EXECUTIVE SUMMARY Clinical: For personal use only § First-­‐in-­‐class oral therapeu,c vaccine for reduc,on of number and severity of COPD exacerba,ons § Two separate Phase 2a and a Phase 2b safety and efficacy randomized trials completed § 320-­‐pa,ent, mul,-­‐center,

  3. Slide 3: Clinical

    For personal use only CLINICAL

  4. Slide 4: HI-164 OV – Pharmacodynamics

    HI-­‐164 OV has a well established mechanism of acLon HI-­‐164 OV – PHARMACODYNAMICS § The oral therapeu,c vaccine is an enteric-­‐coated tablet containing ac,ve substance For personal use only which is killed non-­‐typeable Hemophilus influenzae bacteria (NTHi). § Tablet bypasses the stomach and d

  5. Slide 5: HI-164 OV – Phase 2b study design

    HI-­‐164 OV – Phase 2b study design PHASE 2B STUDY DESIGN For personal use only 2 tablets daily on empty stomach for 3 consecutive days = 3 cycles 28 days apart Active (HI-­‐164OV) Placebo Enteric-­‐coated tablets (500mg) Enteric-­‐coated tablets Contain 45mg HI-­‐164 (active substance) (colour, tas

  6. Slide 6: HI-164 OV – Phase 2b key findings

    HI-­‐164 OV – Phase 2b key findings PHASE 2B CLINICAL DATA For personal use only Phase 2b clinical study (n=320) : Did not meet 1o or 2o outcome measures However post-­‐hoc subgroup analysis of age group under 65 years showed • Significant (p <0.05) improvements in primary and secondary outcomes • Pla

  7. Slide 7: HI-164 OV – Key Phase 2b efficacy results in <65 year subgroup

    HI-­‐164 OV – Key Phase 2b efficacy results in <65 year subgroup PHASE 2B CLINICAL DATA SUMMARY For personal use only Significant (p <0.05) improvements in primary and secondary outcomes in the < 65 years paLent subgroup* HI-­‐H005 | Analysis in patients < 64 years (N=35 Active, 56 Placebo) Outcome met

  8. Slide 8: HI-164 OV – Key Phase 2b efficacy results

    HI-­‐164 OV – Key Phase 2b efficacy results PHASE 2B CLINICAL DATA SUMMARY For personal use only Source: Bioxyne data on file. • Post hoc analysis showed early and sustained separaLon of the KM curves in the < 65 years subgroup for Lme to first exacerbaLon. This subgroup analysis was not protocol specifi

  9. Slide 9: Phase 2a study (HI-H002) data

    Phase 2a study (HI-­‐H002) data (n=38 paLents) PHASE 2A CLINICAL DATA ANALSIS For personal use only Outcome measure HI-164OV (18) Placebo (20) % protection (p value) Number of acute episodes per subject Total 1.22 1.45 16 (0.55) Antibiotic-treated 0.83 1.15 28 (0.33) Corticosteroid-treated 0.28 0.75

  10. Slide 10: HI-164 OV – US Development Timeline

    HI-­‐164 OV – US Development Timeline US DEVELOPMENT TIMELINE Drug substance (transfer from Pharmasynth to Lonza) For personal use only • Potency assay transfer, op,misa,on, qualifica,on • Transfer other specifica,on assays • Transfer of manufacture documenta,on and materials • Scale-­‐up to produc,on

  11. Slide 11: Regulatory

    For personal use only REGULATORY

  12. Slide 12: HI-164OV – Regulatory Engagement

    HI-­‐164OV – Regulatory Engagement REGISTRATION STATUS Australia: Australian clinical studies with HI164-­‐OV have been conducted under the TGA For personal use only Clinical Trial No,fica,on scheme (CTN) where ethics commikees reviewed and approved the studies. Signed approvals were sent to the TGA

  13. Slide 13: Chemistry, Manufacturing, and Controls

    For personal use only CHEMISTRY, MANUFACTURING, AND CONTROLS

  14. Slide 14: HI-164OV – Chemistry, Manufacturing, and Controls (CMC)

    HI-­‐164OV – Chemistry, Manufacturing, and Controls (CMC) CMC § HI-­‐164OV is an enteric-­‐coated tablet containing 45mg of drug substance. Drug For personal use only substance is lyophilised inac,vated whole cells of the bacterial species non-­‐typeable Haemophilus influenzae strain 164 (NTHi164) §

  15. Slide 15: Intellectual Property

    For personal use only INTELLECTUAL PROPERTY

  16. Slide 16: HI-164OV – Intellectual Property

    HI-­‐164OV – Intellectual Property INTELLECTUAL PROPERTY § Bioxyne is protec,ng HI-­‐164OV with a mul,faceted patent strategy aimed at For personal use only protec,ng all aspects of the use of oral immunotherapy with H. influenzae in COPD and severe allergic asthma. § Patents have been applied to p

  17. Slide 17: HI-164OV – Intellectual Property

    HI-­‐164OV – Intellectual Property INTELLECTUAL PROPERTY CHART For personal use only Patent Sponsor/ US Patent or US Ref Title Type of Patent Inventors Company PublicaLon No. Hunter Immunology US20110206765 Dunkley,M., & PT011 Non Typeable Haemophilus influenzae vaccines and their uses U,lity Ltd (Pu

  18. Slide 18: Commercial

    For personal use only COMMERCIAL

  19. Slide 19: HI-164OV – Forecast assumptions based on possible scenarios

    HI-­‐164OV – Forecast assumpLons based on 2 possible scenarios COMMERCIAL MODEL ASSUMPTIONS For personal use only § The commercial model has been developed with 2 scenarios. § The first being a targeted therapeu,c for the under 65 year age group. § The assump,ons driving the model include a penetr

  20. Slide 20: For personal use only

    For personal use only 20

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