Slide 1: Biotron Limited Investor Briefing
BIOTRON LIMITED ASX:BIT Investor Briefing October 2012
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 • Headquartered in Sydney, Australia • Key recent highlights • Oct 2012 – Announced positive 48-week follow-up data from Pha
Slide 4: Key Financials and Facts
Key Financials and Facts KEY FINANCIALS BOARD AND MANAGEMENT ASX Code BIT Mr Michael Hoy Chairman Recent Share Price (23 Oct 2012) A$0.13 Dr Michelle Miller CEO & Managing Director 52 Week High A$0.19 Mr Bruce Hundertmark Non-Executive Director 52 Week Low A$0.08 Dr Susan Pond Non-Executive Director
Slide 5: Biotron's Pipeline
Biotron’s Pipeline VIRAL PRE- PHASE INDICATION DISCOVERY PHASE 1a PHASE 1b PHASE 2a STATUS TARGET CLINICAL 2b Ph 2a HEP C p7 complete Ph 1b/2a HIV Vpu In Progress Ph 2 To Hep C/HIV Vpu/p7 commence late 2012 Dengue M Next generation p7 for HCV
Slide 6: 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 7: Hep C – Scene of Billion Dollar Deals
Hep C – Scene of Billion Dollar Deals Nov 2011 – Gilead (GILD) acquired Pharmasset (VRUS) for US$11 billion - PSI-7977 recently advanced into Phase 3 Jan 2012 – BMS acquired Inhibitex (INHX) for US$2.5 billion - INX-189 currently in Phase 2 Feb 2012 – Roche licenses polymerase inhibitor (preclinical
Slide 8: Hep C – An Expanding Market
Hep C – An Expanding Market • Only small percentage currently receive treatment. • USA and Europe represent major markets but other, larger markets are emerging. • Worldwide market ~US$3 billion; predicted to expand to >US$10 - 20 billion as new, safer drugs enter the market. Smith Nature Reviews Dr
Slide 9: HCV Drug Targets – Simplified
HCV Drug Targets – Simplified 1. Hep C virus binds to and enters liver cell 2. Virus is uncoated; releasing HCV RNA and proteins 3. PROTEASE makes new HCV proteins PROTEASE INHIBITORS BLOCK STEP 3 6. New HCV viruses released from liver cell 4. POLYMERASE makes new HCV RNA POLYMERASE INHIBITORS BLOCK
Slide 10: BIT225 HCV Clinical Information
BIT225 HCV 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 R
Slide 11: BIT225 (400mg)+ SOC Leads to 100% Virus-Free
BIT225 (400mg)+ SOC Leads to 100% Virus-Free at 48 weeks Median log % Complete EVR % SVR (<50IU/ml at Treatment reduction (<50IU/ml at 12 48 weeks) at 35 days weeks) 400 mg BIT225 + SOC -4.957 86 100 200 mg BIT225 + SOC -4.351 88 88 Placebo + SOC -3.649 63 75 HCV RNA Change from Baseline (Log10) - N
Slide 12: 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 protease and polymerase inhibitors (+ribavirin) • Expect first combo approvals 2014/15 (if no hiccoughs…..) • BUT viral resistance is a potential issue for these new fa
Slide 13: BIT225 - HIV / HCV Co-Infected Population
BIT225 - HIV / HCV Co-Infected Population • BIT225 also 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
Slide 14: Future Outlook
Future Outlook By mid-2013 Biotron expects to have: • Completed final pharmacokinetic and resistance studies on participants in the Phase 2a HCV BIT225 IFN/RBV combination trial; • Completed the Phase 1b/2a HIV trial currently in progress; • Commenced and completed the anticipated Phase 2 HIV/HCV co
Slide 15: Michelle Miller, Managing Director
Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au