Slide 1: Biotron Limited – BIO2011
BIOTRON LIMITED ASX:BIT BIO2011 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 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 148 m Listed options 108 m (exp Dec 2011) Current S/P A$0.10 52 wk high/ low A$0.15/ 0.051 Market cap A$15 m Cash at 31 March 11 A$1.3m* *excludes proceeds of share placement in April 2011, raising A$1.7m 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 • 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 (2.7m 7m chronic infection) • Majority remain asymptomatic for decades before developing cirrhosis or liver cancer • g US surgeon g general considers hepatitis p C is one of the most significant public hea
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 • p7 critical role in production of infectious HCV in infected cells • Phase Ia Ph I results lt ddemonstrated t t d BIT225 well-tolerated ll t l t d att doses d up to t 600mg with no dose-limiting toxicities • Phase Ib results Ph lt demonstrated d t t d 200 mg BIT225 sign
Slide 11: Rationale for Phase II Hep C Trial
Rationale for Phase II Hep C Trial • Future Hep C therapies expected to be a cocktail of drugs – In short-term new drugs to be used with current approved drugs interferon f ( (IFN) ) and ribavirin – Industry focus on developing new, specific direct-acting antiviral drugs g to use in combination – P7
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 g targeting g g HIV-Vpu p pprotein • New mode of action – inhibits budding of virus from infected cells • Targets HIV in viral reservoirs in vivo • Reservoirs are last of the holy grail in HIV • No existing drugs target this
Slide 14: Human Reservoir 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: 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 3Q 2011 • Potential to combine BIT225 with current or next generation Hep C drugs
Slide 16: 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