Biotron Limited · ASX:BIT
Biotron — Investor Presentation (November 2010)
17 slides from Biotron's investor presentation, November 2010
Slide 1: Biotron Limited – November 2010
Biotrorn November 2010
Slide 2: 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 • Key highlights • Successful implementa
Slide 3: 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 4: 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 5: 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 • USS surgeon general considers hepatitis C is one off the most significant public health threat
Slide 6: 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 7: Hep C Lead Product – BIT225
Hep C Lead Product – BIT225 BIT225 is a new investigational g oral small molecule drug g in development p for treating Hep C infection Completed two clinical trials: Phase Ia – Placebo-Controlled, Randomized Study of the Safety and Pharmacokinetics of BIT225 in Healthy Volunteers (48 patient,
Slide 8: BIT225 Clinical Information
BIT225 Clinical Information First-in-class drug targeting p7 protein of Hep C virus p7 - Critical role in production of infectious Hep C virus in infected cells Proposed as new target for therapeutic intervention Phase Ia results indicated that BIT225 was well-tolerated well tolerated at dos
Slide 9: 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 10: 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 11: BIT225 – Commercial Potential
BIT225 – Commercial Potential • Hep C worldwide market ~US$2.8 billion; predicted to expand to >US$10 billion • Over 170 million individuals infected causing severe liver disease, including cirrhosis and hepatocellular carcinoma • Low response rate L t due d tto compliance li iissues with ith IFN/ I
Slide 12: Very Strong Competitive Position
Very Strong Competitive Position • Successfully completed TWO human trials of BIT225 • Good safety and efficacy results • Potential to combine with current or next generation Hep C drugs • BIT225 is an oral drug (tablet) – current Hep C drugs are injectable • Strong patent protection – 5 patent fami
Slide 13: Biotron’s HIV Clinical Program
Biotron’s Biotron s HIV Clinical Program • First-in-class new anti-HIV drug • 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 source of HIV in the body • Eradic
Slide 14: Human Reservoirs cells infected with HIV – Untreated (A) and Treated with BIT225 (B)
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 Proposed p trial design: g Days 0 14 28 6 - 10 pts Placebo Drug-free follow-up 6 - 10 pts Drug (200mg 2x daily) Drug-free follow-up • Phase Ib/IIa trial protocols finalised • 12 - 20 subject trial in HIV+ patients •Trial designed g to demonstr
Slide 16: Capital Structure
Capital p Structure Shares on issue 121.8 m Listed options 108 m Unlisted options 6.4 m Cash at 30 Sept 10 A$1.44 m Market cap ((as of 9/11/10)) A$12.175 m Biotron Limited
Slide 17: Dr Michelle Miller
Dr 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