Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (October 2007)
22 slides from Biotron's shareholder meeting presentation, Oct 5, 2007
Slide 1: AGM 5 October 2007
Biotron AGM 5 October 2007
Slide 2: Biotron Limited
BIOTRON LIMITED • Developing new generation antiviral drugs with large, expanding world markets. • Current major focus on drugs to treat HIV-1 and Hepatitis C virus. 1 Biotron Limited
Slide 3: Recent Key Highlights
RECENT KEY HIGHLIGHTS • Completed a Phase I human clinical trial of BIT225 – No dose-limiting toxicities – Excellent safety profile with good blood levels of the drug • Achieved estimated therapeutic levels of drug • Hepatitis C virus (HCV) – BIT225 demonstrated excellent activity in models of HCV i
Slide 4: BIT – Pipeline of Antiviral Products
BIT – PIPELINE OF ANTIVIRAL PRODUCTS DISCOVERY LEAD PRECLINICAL CLINICAL OPTIMISATION VIRION HIV HCV Flu Dengue Other Biotron’s Project Pipeline by Stage of Development 3 Biotron Limited
Slide 5: BIT225 – A Novel Approach to HIV Therapy
BIT 225 – A NOVEL APPROACH TO HIV THERAPY • First-in-class new anti-HIV drug • New mode of action • Targets HIV in viral reservoirs in vivo • No existing drugs target this source of HIV in the body 4 Biotron Limited
Slide 6: HIV – High Growth Market
HIV – HIGH GROWTH MARKET • 39.5 million people with HIV/AIDS at end of 2006 • 4.3 million people were newly infected with HIV in 2006 • In 2006 2.9 million people died of HIV/AIDS- related causes • US market alone worth >US$3.3 billion p.a. 5 Biotron Limited
Slide 7: New Treatments Needed
NEW TREATMENTS NEEDED • Resistance is a main cause of antiretroviral therapy failure ~ 26% newly diagnosed patients have resistant strains of virus ~ 78% of late-stage patients develop resistance to existing therapies • Unmet need for new drugs suitable for HAART* therapy that attack the virus in ne
Slide 8: BIT225 – A Novel Approach
BIT 225 – A NOVEL APPROACH • BIT-225 is a Viral Protein U (Vpu) inhibitor • No existing drugs target HIV Vpu protein – novel mode of action • Disturbs formation of new virus particles through budding process • Reduces infectivity of virus produced by infected cells 7 Biotron Limited
Slide 9: BIT225 Targets Different Stage of HIV Life Cycle
BIT – 225 TARGETS DIFFERENT STAGE OF HIV LIFE CYCLE BIT compounds interrupt budding process 8 Biotron Limited
Slide 10: Human cells infected with HIV – Untreated and Treated with BIT225
Human cells infected with HIV – Untreated (A) and Treated with BIT225 (B) A B Damaged, non- Healthy HIV infectious HIV 9
Slide 11: BIT225 Active in Viral Reservoir Cells
BIT- 225 ACTIVE IN VIRAL RESERVOIR CELLS - Eradication of HIV from reservoirs is essential to prevent development of AIDS - Current HIV drugs cannot eradicate the underlying seat of infection (termed the viral reservoir) BIT DRUGS 10 Biotron Limited
Slide 12: BIT225 Profile
BIT – 225 PROFILE • Good stability and half-life in vivo • Excellent safety profile in animals & humans in studies to date • Active against resistant strains of HIV • Synergistic with leading current HIV therapies • Simple chemistry for manufacture • Novel compound - new mechanism of action • Recent
Slide 13: BIT225 – HCV Program
BIT225 – HCV PROGRAM • During last 12 months BIT225 shown to have good antiviral activity in preclinical surrogate models of HCV infection • BIT225 highly synergistic with current leading HCV therapies – Triple combination of BIT225 with existing drugs resulted in significantly higher activity than
Slide 14: Hepatitis C Virus (HCV) Market
HEPATITIS C VIRUS (HCV) MARKET • 4x more prevalent than HIV • 4m patients in US (2.7m chronic infection); 170m worldwide • Worldwide market ~US$2.8 billion currently predicted to expand to >US$10b • US surgeon general considers hepatitis C is one of the most significant public health threats facing
Slide 15: Clinical Development Program for BIT225 in 07/08
CLINICAL DEVELOPMENT PROGRAM FOR BIT225 IN 07/08 Program for rest of 07/08 FY: 1. Phase Ib/IIa clinical trial in HCV+ patients - Dose-range finding and efficacy study 2. Phase Ib clinical trial in HIV+ patients - Repeat-dose study - Aim to generate data to lead on to Phase II study Will be major val
Slide 16: Anticipated Milestones 2007/08
ANTICIPATED MILESTONES 2007/08 BIT225 HIV & HCV Programs: • Submission of protocols to ethics and Q4 07 regulatory authorities • Commencement of Phase Ib/IIa clinical trial Q1 08 in HCV+ patients • Commencement of Phase Ib clinical trial in Q1 08 HIV+ patients • Results of these two trials mid-2008
Slide 17: Financial Summary
FINANCIAL SUMMARY • $ 1.38 million cash at 30 June 2007 • Expect to receive additional grant funding from AusIndustry 16 Biotron Limited
Slide 18: Dr Michelle Miller, CEO/Managing Director
Dr Michelle Miller CEO/Managing Director 02 9247 8212 mmiller@biotron.com.au www.biotron.com.au
Slide 19: Commentary for a Presentation to the 2007 Annual General Meeting
Level 8, 261 George Street Sydney NSW 2000 Tel: (61-2) 9247 8212 Fax: (61-2) 9247 3932 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au COMMENTARY FOR A PRESENTATION TO THE 2007 ANNUAL GENERAL MEETING 5 OCTOBER 2007 I am pleased to be able to present this update on the Company’s activ
Slide 20: Commentary: Slides 3-4
Slide 3 Biotron has an impressive portfolio of clinical and preclinical antiviral programs developing drugs targeting HIV, Hepatitis C virus (HCV), Dengue virus and Influenza virus. BIT225 is in clinical trials for treatment of HIV and HCV. In addition, the Company has earlier stage drug programs fo
Slide 21: Commentary: Slide 10
Slide 10 Critically, BIT225 specifically targets HIV in reservoir cells, in contrast to current therapies that work by reducing the levels of HIV in the blood to undetectable levels. However, these drugs have no effect on the underlying reservoir of infected cells where the HIV hides from the immune
Slide 22: Commentary: Slides 15-16
Slide 15 We expect to submit protocols for approval to human ethics committees before end of 2007, with trials in HIV and HCV patient populations expected to commence early in 2008. The trials are expected to conclude mid-2008. Slide 16 Cash balance at 30 June 2007 was $1.3 million. During 2007/08,