Anatara Lifesciences Ltd · ASX:ANR

Anatara Lifesciences — Investor Presentation (October 2015)

36 slides from Anatara Lifesciences's investor presentation, Oct 6, 2015

  1. Slide 1: Oral therapeutics for gastrointestinal disease

    For personal use only Oral therapeutics for gastrointestinal disease DetachTM – prevention and treatment of diarrhoea 6 October 2015

  2. Slide 2: Disclaimer

    Disclaimer For personal use only The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Anatara Lifesciences Ltd, ACN

  3. Slide 3: Key Financial Details

    Key Financial Details For personal use only ASX Code ANR Share Price1 $0.76 Market Cap $37.45 million Ordinary Shares2,3 49,288,246 Raised at IPO (October 2014) $7 million Placement and SPP (July 2015) $9 million Current Cash1 $13.7 million 1. As at 2nd October 2015 2. 13,036,095 shares held by dire

  4. Slide 4: Detach

    For personal use only Detach™ • Natural, non-antibiotic therapeutic that prevents and treats diarrhoea • Meets the need to reduce antibiotics in animal production • Unlike antibiotics, Detach™ will not contribute to antimicrobial resistance 4

  5. Slide 5: Market Opportunity is clear

    Market Opportunity is clear For personal use only • Pork is #1 consumed meat in the world. Global demand for meat is rising • Demand for non-antibiotic treatments continue to rise as authorities restrict use of antibiotics in farm animals • Consumers want their meat to be safe – and antibiotic free

  6. Slide 6: Need to combat anti-microbial resistance

    Need to combat anti-microbial resistance For personal use only • Antimicrobial resistance is a worldwide threat to public health • Tens of thousands of people die every year because of antibiotic resistant bacteria – so called “Super Bugs” (USA CDC, WHO) • Antibiotic resistance is driven by antibiot

  7. Slide 7: Detach - Poised for swift market entry

    Detach™ - Poised for swift market entry For personal use only • Launch planned in Australia for 2016 • Has a clear path to market • Proven efficacy (therapeutic claims) • Proven safety - active ingredient is GRAS (generally recognised as safe) • Manufacturing and global supply confirmed • Regulatory

  8. Slide 8: Diarrhoea affects hundreds of millions of pigs born each year

    Diarrhoea affects hundreds of millions of pigs born each year For personal use only 8

  9. Slide 9: Consumer Pressure - Food Quality & Food Safety

    Consumer Pressure - Food Quality & Food Safety For personal use only • McDonald's the world’s largest restaurant chain announced it will stop buying chicken raised on antibiotics used in humans • Other restaurants/suppliers have followed!! • This move will have a major impact on how animals are rear

  10. Slide 10: Consumer Pressure - Australia

    Consumer Pressure - Australia - Food Quality & Food Safety For personal use only 10

  11. Slide 11: Partnering/Deal Flow

    Partnering/Deal Flow For personal use only • Engaged with Top 12 animal health multi-nationals • Very strong & genuine level of interest • Due diligence on Detach™ is underway • First deal expected by 1st Qtr. 2016 • Australian distribution in place • Opportunity to move direct into Asian markets un

  12. Slide 12: Operations Update

    Operations Update For personal use only Manufacture • Completed GMP manufacture of three commercial scale batches of Detach™ • Stability studies for registration ongoing • Global market capacity assured Current 50 kg scale Regulatory (≈500,000 doses) • Appointment of Key EU and USA Regulatory Adviso

  13. Slide 13: Intellectual Property Update

    Intellectual Property Update For personal use only • PCT application filed (August 2015) • Second USA patent filed (August 2015) • Solid patent strategy in place for further patents to be filed in major territories • Claims cover the Detach™ formulation, as well as use of the active ingredient and c

  14. Slide 14: Field Trial Update

    Field Trial Update Previous Trials For personal use only • 21 positive field trials on commercial farms – Detach™ safe and effective in several thousand piglets Re-registration Trials – Successful weaner trial in Spain (ANR 12-001) – Successful sucker trial in Northern Victoria (ANR 14-001) – Succes

  15. Slide 15: 1st Re-Registration Trial ANR 12-001 Highlights (Spain)

    1st Re-Registration Trial ANR 12-001 Highlights (Spain) For personal use only Detach™ reduced scour • Reduced the incidence of scour by 40% (p<0.05) • Detach™ reduced injectable antibiotics by 55% (p<0.05) • A single dose of Detach™ as effective as daily doses of Zinc oxide (ZnO) Detach™ improved we

  16. Slide 16: 2nd Re-Registration Trial ANR 14-001 Highlights

    2nd Re-Registration Trial ANR 14-001 Highlights (Northern Victoria) For personal use only Detach™ reduced deaths • High mortality rate on this farm, so a severe test for Detach™ • 20 more piglets weaned in the Detach™ group Detach™ improved weights • Detach™ improved weight gain (224 g per pig) desp

  17. Slide 17: 3rd Re-Registration Trial ANR 15-001 Highlights

    3rd Re-Registration Trial ANR 15-001 Highlights (SE Queensland) For personal use only Detach™ reduced scour • Detach™ reduced incidence (by 41.4% and severity (by 44.5%) of scour (p<0.02). • Low incidence of disease on this farm, so a difficult test for Detach™ • Lower than expected weight gains of

  18. Slide 18: Detach - from farrow to finish

    DetachTM – from farrow to finish For personal use only Dose form Lead Indication Competition Suckers Antibiotics Oral drench Prevent scour (day 2 after birth to Sow vaccines (2 mL) (improved ADG1) weaning) Coccidiostats Prevent scour Weaner Oral drench (improved ADG Antibiotics (day of weaning) (4 m

  19. Slide 19: Commercialisation strategy

    Commercialisation strategy For personal use only Global Market Development • Australia – Home Test market, directly to pork producers (15 companies control 85% of the Australia pig industry) • Overseas - Co-development and commercialisation partners in Europe and US; expansion into Asia • Expansion

  20. Slide 20: Key News Flow

    Key News Flow USA Fee Waiver Granted For personal use only First Field Trial Complete Second Field Trial Complete Pork CRC Partnership Complete New patents filed Complete USA INAD Application Complete EU and USA Scientific Advice Meeting Scheduled – mid October Third Australian (4th Regn) Field Tria

  21. Slide 21: Development Milestones

    Development Milestones For personal use only Activity 2014 2015 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Detach™ for Pigs : Australia Launch Launch Detach™ for Pigs : Europe Detach™ for Pigs : USA Launch Detach™ For Humans Partner 21

  22. Slide 22: Thank you

    For personal use only Thank you “With the world’s meat production needs set to rise 100% by 2050, it is important we act now to develop non-antibiotic treatment options.” Dr Mel Bridges, Chairman – Anatara Lifesciences Mel Bridges, Chairman Paul Schober, CEO Tracey Mynott, CSO melbridges@parmacorp.c

  23. Slide 23: Board

    Board EXPERIENCE, EXECUTION, REVIEW, BUY-IN For personal use only Mel pic Paul G Jay Dr Mel Bridges Paul A. Grujic Dr Jay Hetzel Chairman Director Director Iain Tracie Steve Iain Ross Dr Tracie Ramsdale Stephen Denaro Director Director Company Secretary 23

  24. Slide 24: Management

    Management EXPERIENCE, EXECUTION, REVIEW, BUY-IN For personal use only Paul Tracey Damian Dr Paul Schober Dr Tracey L. Mynott Damian Wilson Chief Executive Officer Chief Scientific Officer Head of Business Development Kevin David Hayley Dr Kevin Woodward Dr David Venables Hayley van der Meer Regulat

  25. Slide 25: Detach - mechanism of action

    Detach™ – mechanism of action For personal use only Activity – Not an antibiotic, not an anti-viral, not an anti-parasitic – Detach™ does not kill bacteria, so will not select for resistance – Effective against the action of bacteria, protozoa and viruses Detach™ acts on the underlying cellular mech

  26. Slide 26: Detach temporarily modifies E. coli enterocyte receptors

    Detach™ temporarily modifies E. coli enterocyte receptors - Bacteria cannot attach, so do not cause disease For personal use only Enterocyte Brush Border K88 receptor Detach™ E. coli Chandler and Mynott. 1998. Gut 43:196-202. 26 Mynott, et al., 1996. Gut 38:28-32.

  27. Slide 27: Detach Triple Mechanism of Action

    Detach™ Triple Mechanism of Action = Broad Spectrum Activity For personal use only Effective against diarrhoea caused by bacteria, viruses and parasites 2. Blocks toxin action 3. Blocks inflammatory action. 1. Prevents attachment of bacteria Detach Detach 27 Mynott, T.L. et al. 1997. Gastroenterol.

  28. Slide 28: Previous Detach Field Trials - Australia and Spain

    Previous Detach™ Field Trials – Australia and Spain For personal use only • Proven to be safe and effective in several thousand piglets • Reduced death, improved weight gains and reduced antibiotic use • Effective against a range of pathogens; K88+ and K99+ E. coli, rotavirus & coccidia Suckers (n =

  29. Slide 29: First Australian Re-registration Field Trial (ANR-14-001)

    First Australian Re-registration Field Trial (ANR-14-001) For personal use only • 1200 sow farm had a history of problems with pre-weaning scour • Current approaches such as sow vaccines and antibiotics (neomycin, trimethoprim/ sulfadiazine) failed to control the problem • Trial was blinded, randomi

  30. Slide 30: ANR 14-001 - Key Results

    ANR 14-001 – Key Results Detach™ reduced deaths For personal use only • Detach™ reduced deaths by approximately 50% (p<0.02). • 92% of Detach™ pigs weaned (or 20 more piglets) • 85% of control piglets weaned • Number of piglets weaned per litter is a KPI for the pork industry • Each weaned piglet ha

  31. Slide 31: ANR 14-001 Results

    ANR 14-001 Results For personal use only  DetachTM significantly reduced piglet mortality by 47.8%  DetachTM reduced severe morbidity, or life threatening disease Table 1 – Pre-weaning morbidity and mortality Treatment No. Pigs Morbidity No. % Score 4* deaths mortality1 Detach™ 233 28 19 8.2% Untr

  32. Slide 32: ANR 14-001 Results

    ANR 14-001 Results For personal use only DetachTM increased the average weight of each piglet at Day 21 by 224 g (5.7%) Table 2 - Weight gains and ADG from Day 2 to Day 21 Treatment No. Pens Litter size Average Weight Gain (g) Average ADG (Day 21) (min – max) (g/day) (min – max) Detach 21 10.19 4,18

  33. Slide 33: Second Australian Re-registration Field Trial (ANR-15-001)

    Second Australian Re-registration Field Trial (ANR-15-001) For personal use only • Grower facility had a history of problems with post-weaning disease due to E. coli • Trial was blinded, randomised and placebo controlled – Group 1 – DetachTM, 20 pens (280 piglets) – Group 2 – Control, 20 pens (280 p

  34. Slide 34: ANR 15-001 Results

    ANR 15-001 Results For personal use only Table 1 – Scour morbidity and mortality Treatment No. Pigs Scour Scour No. frequency severity deaths Detach™ 280 89 96 0 Untreated 280 152 173 4 % reduction 41.4%* 44.5%* *p<0.02 Table 2 - Weight gains and ADG from Day 21 (weaning) to Day 49 Treatment No. Pen

  35. Slide 35: Competition and Limitations

    Competition and Limitations For personal use only Description Example Limitations Azithromycin, Rifaximin Contributes to AMR/residues Antibiotics Lincospectin or Amoxycillin Pathogen specific ($0.31 to $3.50/pig) Multiple dosing Antimicrobial resistance Zinc Oxide Antimicrobial (widely used although

  36. Slide 36: Pork CRC - Strategic Partnership

    Pork CRC – Strategic Partnership For personal use only  Pork CRC - a Cooperative Research Centre, with funding by the Australian Government  The CRC program supports end user driven collaborations to address major challenges facing Australia  Pork CRC aim to provide and adopt new and novel techno

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