Slide 1: Biotron Limited: Mid-Clinical Stage Antiviral Drug Development Company
BIOTRON LIMITED (ASX:BIT) Mid-Clinical Stage Antiviral Drug Development Company Dr Michelle Miller Managing Director Investor Update +61 412 313329 20 August 2015 mmiller@biotron.com.au www.biotron.com.au
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 (ACN 086 399 144) and certain of the plans and objectives of its management. These statements are statements t
Slide 3: Financial Information
Financial Information Key Financial Metrics 12 Month Share Price Performance Ticker Code ASX: BIT Share Price (19 Aug 2015) A $0.10 Ticker Code ASX: BIT Market cap A $31.3 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.0864 – 0.1832 Shares Outstanding 313 million Market cap
Slide 4: BIT225 Snapshot
BIT225 Snapshot - First in classbased Prepared drug and new drug on above target after thefor treatment August of HIV Board and Hepatitis C virus (HCV) meeting - Guided Seven the wording clinical of the prospectus trials completed; draft another is fully and the use of proceeds recruited -- While ca
Slide 5: Significant Progress During Last 12 Months
Significant Progress During Last 12 Months ACTIVITY STATUS/OUTCOME Phase 2 HIV/HCV co-infected trial 100% SVR12 data reported for HIV/HCV G3 Phase 2a HIV trial Impact on immune activation reported Phase 2, three-month dosing HCV G1 & G3 Fully recruited; SVR12 G3 3Q15; SVR12 G1 1Q16 trial Improves de
Slide 6: Biotron's Core Technology & Pipeline
Biotron’s Core Technology & Pipeline PIPELINE Designed library of compounds to Compounds screened in target viroporins: proprietary assay set up for Leads PRE- PH 1 PH 2 PH 3 CLIN >250 compounds designed and each virus target e.g. HIV synthesised Vpu; HCV p7; Influenza M2; HCV Dengue M; Coronavirus
Slide 7: BIT225 - Proven Clinical Track Record
BIT225 - Proven Clinical Track Record - Over 200 patients and healthy volunteers dosed with BIT225 to date - Positive data recorded in all trials - HCV G1 (BIT225-005) – 100% receiving 400mg (28 days in combination with 48 weeks IFN/RBV) were virus-free at 48 weeks - Co-infected HIV/HCV GT3 (BIT225-
Slide 8: Large and Growing Global Market for Hepatitis C
Large and Growing Global Market for Hepatitis C • Forecast to grow to over $19bn by 2016 • 180 million infected worldwide (3% world population) • ~3 to 5 million in US & 30 million in China • New drugs have demonstrated significant pricing power • Gilead’s Sovaldi (Sofosbuvir) at US$84,000 for a 12
Slide 9: BIT225-008: Phase 2 HCV Three-Month Dosing Trial
BIT225-008: Phase 2 HCV Three-Month Dosing Trial Placebo + IFN/RBV n=20 IFN/RBV (G3 – to week 24; G1 – to week 48) (HCV Genotype 1 or 3) n=20 BIT225 200 mg BID + IFN/RBV IFN/RBV HCV Genotype 1 BIT225 200 mg BID + IFN/RBV n=20 IFN/RBV HCV Genotype 3 Week 12 24 36 48 60 Design: *SVR12 FOR G3 *SVR12 FO
Slide 10: HIV – Towards a Cure
HIV – Towards a Cure • Infection rates in Australia are at 20 year high • Over 1.1 million people living with HIV in the USA, with 1 in 6 unaware of diagnosis • US$11.9 bn sales in US, Europe and Japan in 2013; expected to grow to US$16.8 bn by 2020 • HIV patients need to stay on antiretroviral drug
Slide 11: BIT225 Targets HIV in Reservoir Cells
BIT225 Targets HIV in Reservoir Cells • BIT225 inhibits assembly and budding of new virus • Phase 2a trial (004) showed that BIT225 can reduce HIV levels in macrophage cells in vivo, paralleling in vitro studies • Potential benefits on immune aging and HIV-associated dementia • Potential for use in
Slide 12: Dengue Virus Program
Dengue Virus Program • 2.5 billion people (40% world population) live in areas at risk of Dengue • ~100 million people infected yearly • A leading cause of illness and death in tropics and subtropics • Transmission is by mosquito; most prevention programs target the vector • No approved Dengue-speci
Slide 13: Investment Proposition
Investment Proposition • HCV and HIV are high growth, multi-billion dollar markets • Significant treatment gaps remain • BIT225 is a novel approach with demonstrated promising efficacy in Phase 2a/2 clinical trials • Represents a new class of direct-acting HCV drugs • Potential to fill significant H
Slide 14: Outlook for 2015/16
Outlook for 2015/16 • Complete BIT225-008 HCV trial currently in progress • SVR12 for G3 due 3Q15; SVR12 for G1 due 1Q16 • Investigational New Drug application (IND) • Engaged with FDA - pre-IND consultation HCV combination trial with DAA • File HCV IND application late 2015 • Currently completing s