Slide 1: Biotron Limited
BIOTRON LIMITED ASX:BIT January 2012 Michelle Miller CEO & Managing Director
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward‐looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not histor
Slide 3: Biotron Limited Overview
Biotron Limited Overview • Clinical stage drug development company • Focus on developing novel small molecule antiviral drugs • Hepatitis C virus (HCV), HIV, Dengue and others • Established in 1999 • Spun out from the Australian National University, Canberra, Australia; • Headquartered in Sydney, Au
Slide 4: Key Financials and Facts
Key Financials and Facts KEY FINANCIALS BOARD AND MANAGEMENT ASX Code BIT Mr Michael Hoy Chairman Current Share Price (11 Jan ‘12) A$0.15 Dr Michelle Miller CEO & Managing 52 Week High A$0.165 Director 52 Week Low A$0.086 Dr Denis Wade Non-Executive Director Shares on Issue 228 million Mr Bruce Hund
Slide 5: Core Technology
Core Technology • Anti-viral drug market is very attractive – Ongoing need for new drugs to overcome viral resistance; – Patients are treated with cocktails i.e. combinations of different anti-viral drugs • Not developing “me too” drugs – Identified of new class of viral proteins called viroporins –
Slide 6: Pipeline
Pipeline VIRAL PRE- INDICATION DISCOVERY PHASE 1a PHASE 1b PHASE 2a PHASE 2b STATUS TARGET CLINICAL Ph 2a HEP C p7 complete Ph 1b HIV Vpu Recruiting Dengue M Influenza M2 Others various
Slide 7: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer • Leading cause of chronic liver disease and transplants • 180 m people infected worldwide (3% world population); 130 m are chronically infected • 4 m patients in US (2.7 m chronically infected) • 70% will develop liver diseases including cirrhosis and liver can
Slide 8: Hep C – An Expanding Market
Hep C – An Expanding Market Worldwide market ~US$2 billion; predicted to expand to >US$10 - 20 billion as new, safer drugs enter the market. Only small percentage currently receive treatment. USA and Europe represent major markets but other, larger markets are emerging. Smith Nature Reviews Drug Dis
Slide 9: Hep C – Scene of Billion Dollar Deals
Hep C – Scene of Billion Dollar Deals Nov 2011 – Gilead (GILD) acquires Pharmasset (VRUS) for US$11 billion - PSI-7977 recently advanced into Phase 3 Jan 2012 – BMS acquires Inhibitex (INHX) for US$2.5 billion - INX-189 currently in Phase 2
Slide 10: p7 – a New Target for HCV Drugs
p7 – a New Target for HCV Drugs p7 plays a critical role in production of infectious HCV in infected cells BIT225 acts as a viral assembly inhibitor PSI-7977, INX-189
Slide 11: BIT225 Clinical Information
BIT225 Clinical Information Phase Ia – 48 patient, single dose safety study in healthy volunteers Phase Ib - 18 patient, 7-day multiple dose study in patients with HCV Phase 2a – 24 patient, 28-day multiple dose study in patients with HCV (genotype 1) Combination trial with peg-IFN and Ribav
Slide 12: BIT225 + SOC Leads to 90% EVR at Months
BIT225 + SOC Leads to 90% EVR at 3 Months HCV RNA Change from Baseline (Log10) - Non-Compliers Removed - Median at timepoint - 0.000 -1.000 Log10 Change from -2.000 Baseline 400 mg 200 mg -3.000 Placebo -4.000 -5.000 DOSING PERIOD -6.000 0 7 14 21 28 35 42 49 56 63 70 77 84 91 Time point (Days) • 3
Slide 13: BIT225 – Missing Link in HCV Treatment?
BIT225 – Missing Link in HCV Treatment? • Industry moving to all oral DAA (direct acting antiviral) combinations • Current focus on NS5B+NS3/4 (+ribavirin) • Expect first combo approvals 2014/15 (if no hiccoughs) • BUT viral resistance is a potential issue for these new fast-acting drugs • Remember
Slide 14: BIT225 - HIV / HCV Co-Infected Population
BIT225 - HIV / HCV Co-Infected Population • BIT225 has potent anti-HIV activity – Unique mode of action targets HIV “hiding” in long-lived reservoir cells • Reservoirs are last of the holy grail in HIV; No existing drugs target this source of HIV in the body – Phase 1b/2a trial of BIT225 in HIV+ pat
Slide 15: Investment Summary
Investment Summary • World-class portfolio of anti-viral, first-in-class drugs • BIT225 has demonstrated potent anti-HCV activity • Market opportunity with new and existing classes of HCV drugs • Phase 1b/2a trial of novel approach to eliminating HIV underway • Anticipated to complete 1Q2012 • Uniqu
Slide 16: Michelle Miller Managing Director
Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au