Slide 1: Biotron Limited
BIOTRON LIMITED ASX:BIT January 2011 Michelle Miller g g Director CEO & Managing
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 Ltd Overview
Biotron Ltd Overview • Established in 1999 as a spin-out from the Australian National University, Canberra; Currently based in Sydney, Australia • IPO on ASX in Jan 2001 (ASX:BIT) • Focus on developing novel small molecule antiviral drugs • Hep C, HIV, Dengue and others • Key highlights • Successful
Slide 4: Capital Structure & Financials
Capital p Structure & Financials Shares on issue 121.8 m Listed options 108 m No. Shareholders ~1500 T 20 Top 42 1% (30 JJune 2010) 42.51% Current S/P A$0 12 A$0.12 52 wk high/ low A$0.15/ 0.051 Market cap p A$14.6 $ m ((10 Jan 11)) Cash at 30 Sept 10 A$1.44 m Biotron Limited
Slide 5: Core Technology
Core Technology • Identification of new class of viral proteins called viroporins – Small hydrophobic proteins with ion channel activity – Key roles in production and release of infectious virus – Present in influenza (M2), HIV (Vpu), Hep C (p7), Dengue (M) , SARS (E) and others • Ongoing need for n
Slide 6: Pipeline
Pipeline • Two clinical phase programs: – Hepatitis C virus (BIT225) and HIV – Both have very large, expanding world markets • Current status of pipeline: Clinical Trials Project Target Discovery Preclinical Phase I Ph Ib/IIa Ph II P C PoC Hep C p7 HIV Vpu Dengue M protein + other targets
Slide 7: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer • 170 m people infected worldwide; 4 m patients in US (2.7m chronic infection) • Majority remain asymptomatic for decades before developing cirrhosis or liver cancer • US surgeon general considers hepatitis C is one of the most significant public health threats
Slide 8: Hep C – An Expanding Market
Hep p C – An Expanding p g Market Worldwide market ~US$2.8 billion; predicted to expand to >US$10 billion as new, safer drugs enter the market. Only O l smallll percentage t currently tl receive i treatment. USA and Europe represent major markets but other, larger markets are emerging. g g Smith Nat
Slide 9: Hep C Lead Product – BIT225
Hep C Lead Product – BIT225 BIT225 is i a new investigational i ti ti l orall smallll molecule l l drug d i development in d l t for treating Hep C infection Completed two clinical trials: Phase Ia – 48 patient, single dose safety study in healthy volunteers; Status - completed p Phase Ib -
Slide 10: BIT225 Clinical Information
BIT225 Clinical Information Fi t i l First-in-class d drug ttargeting ti p77 protein t i off Hep H C virus i p7 - Critical role in production of infectious Hep C virus in infected cells Proposed as ne new target for therapeutic therape tic inter intervention ention Phase Ia results BIT225
Slide 11: Rationale for Phase II Hep C Trial
Rationale for Phase II Hep C Trial • Focused on developing saleable product to a pharmaceutical partner(s) • Future Hep C therapies expected to be a cocktail of drugs – In short short-term term new drugs to be used with current approved drugs interferon (IFN) and ribavirin – Industry focus on develo
Slide 12: Hep C Phase II Combination Trial
Hep p C Phase II Combination Trial Ph II Trial Period Trial design 0 2 4 Weeks 44 wks BIT225 (400mg) 8 pts + IFN/ribPlacebo Interferon + Ribavirin BIT225 (200 mg) Interferon + Ribavirin 8 pts + IFN/rib BIT225 (400 mg)) I t f Interferon + Ribavirin Rib i i 8 pts + IFN/rib – Pts randomly assigned to r
Slide 13: Biotron's HIV Clinical Program
Biotron’s Biotron s HIV Clinical Program • First-in-class new anti-HIV drug targeting HIV-Vpu protein • New e mode ode o of act action o – inhibits b ts budd budding g of o virus us from o infected ected ce cells s • Targets HIV in viral reservoirs in vivo • Reservoirs are last of the holy grail in
Slide 14: Human Reservoirs cells infected with HIV – Untreated and Treated with BIT225
Human Reservoirs cells infected with HIV – Untreated (A) and Treated with BIT225 (B) A B Damaged, non- Healthy HIV infectious HIV
Slide 15: HIV Phase Ib/IIa Proof-of-Concept Trial
HIV Phase Ib/IIa Proof-of-Concept Proof of Concept Trial • Phase Ib/IIa trial protocols finalised • 20 subject trial in HIV+ patients • Trial designed to demonstrate proof-of-concept •i.e. can reduce HIV loads in HIV-infected reservoir cells in man •Commencement is subject to funding availability
Slide 16: Investment Summary
Investment Summary • Developing first-in-class antiviral drugs • Successfully completed two human trials of BIT225 • Good safety and promising efficacy results • Pivotal Phase IIa Hep C trial results anticipated early 2Q 2011 • Potential P i l to combine bi BIT225 BIT22 with i h current or next gene
Slide 17: Michelle Miller, Managing Director
Michelle Miller M Managing i Di Director t +61 2 9805 0488 +61 61 412 313329 mmiller@biotron.com.au www biotron com au www.biotron.com.au