Slide 1: Biotron Limited (ASX:BIT) Biotech Showcase
BIOTRON LIMITED (ASX:BIT) Biotech Showcase Room Mission I
Slide 2: Forward Looking Statements
Forward Looking Statements This presenta,on may contain forward-‐looking statements with respect to the financial condi,on, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objec,ves of its management. These statements are statements tha
Slide 3: BIT225 Snapshot
BIT225 Snapshot -‐ First in class Prepared drug aond based n anbove ew drug target aVer the for treatment August of H Board mIV and Hepa,,s C virus (HCV) ee,ng -‐ Guided Seven the wtrials clinical ording of the parospectus completed; draV nother is fully and the recruited use with of proceeds prel
Slide 4: 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 ac,va,on reported Phase 2, three-‐month dosing HCV G1 & G3 Fully recruited; preliminary interim data an,cipated 1Q15 tria
Slide 5: Biotron's Core Technology
Biotron’s Core Technology • Iden,fica,on of new class of viral proteins called viroporins – Small hydrophobic proteins with ion channel ac,vity – Key roles in produc,on and release of infec,ous virus – Present in influenza (M2), HIV (Vpu), Hep C (p7), Dengue (M) , SARS (E) and others • Designed librar
Slide 6: Biotron - Advanced Pipeline
Biotron -‐ Advanced Pipeline INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Hep C BIT225 HIV/Hep C BIT225 HIV BIT225 Next generaTon -‐ BIT314 HCV Dengue Leads Slide 4
Slide 7: Large and Growing Global Market for Hepatitis C
Large and Growing Global Market for HepaTTs C • Forecast to grow to over $19bn by 2016 • 180 million people infected worldwide (3% world popula,on) • Es,mated 3 to 5 million pa,ents in US & 30 million pa,ents in China • New drugs have demonstrated significant pricing power • Gilead’s Sovaldi at US$84
Slide 8: Hepatitis C Virus – Market Opportunity
HepaTTs C Virus – Market Opportunity Points to note: -‐ USA and Europe represent major markets but other, larger markets are emerging. -‐ Pricing in these markets will be challenging with current new DAA treatments Upper-middle Source: Evolving epidemiology of hepatitis C virus (Clin Microbiol Inf
Slide 9: BIT225 – First of a New Class of HCV Drugs
BIT225 – First of a New Class of HCV Drugs ü Novel, oral, small molecule POLYMERASE/PROTEASE ü Only one of its class (p7 inhibitor) in clinical trials INHIBITORS e.g. Sofosbuvir/Simeprevir ü Inhibits viral assembly and infec,vity ü Pan-‐genotype ac,vity: BIT225 -‐ ASSEMBLY/ BUDDING INHIBITOR ü
Slide 10: BIT225 - Proven Clinical Track Record
BIT225 -‐ Proven Clinical Track Record -‐ Over 180 pa,ents and healthy volunteers dosed with BIT225 to date -‐ Posi,ve data recorded in all trials -‐ HCV G1 (BIT225-‐005) – 100% receiving 400mg (28 days in combina,on with 48 weeks IFN/RBV) were virus-‐free at 48 weeks -‐ Co-‐infected HIV/HCV
Slide 11: BIT225 Clinical Program – Trials to Date
BIT225 Clinical Program – Trials to Date • BIT225-‐001: Phase 1a, single dose, dose escala,ng study in healthy volunteers (48 subjects; Aust) • BIT225-‐003: Phase 1b, 7-‐day, repeat dose study in HCV+ pa,ents (35 and 200 mg BID; 18 subjects; Aust) • BIT225-‐004: Phase 2a, 10-‐day, repeat dose s
Slide 12: BIT225 - Clinical Activity in HCV and HIV/HCV Patients
BIT225 -‐ Clinical AcTvity in HCV and HIV/HCV PaTents BIT225-‐005 (HCV G1) BIT225-‐006 (HIV/HCV) NB All paEents were stable on ART before Placebo + IFN/RBV IFN/RBV IFN/RBV BIT225 300 mg BID + and throughout the study; HIV remained n=8 IFN/RBV – n=4 HCV Genotype 1 undetectable during the treatment
Slide 13: BIT225-008: Phase 2 HCV Three-Month Dosing Trial
BIT225-‐008: Phase 2 HCV Three-‐Month Dosing Trial n=20 Placebo + IFN/RBV (HCV Genotype 1 or 3) IFN/RBV ETVR n=20 BIT225 200 mg BID + IFN/RBV HCV Genotype 1 IFN/RBV ETVR BIT225 200 mg BID + IFN/RBV HCV Genotype 3 IFN/RBV n=20 Week 12 24 48 Design: Aims: -‐ Randomised, placebo-‐controlled, double
Slide 14: HIV – Towards a Cure
HIV – Towards a Cure • Infec,on 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 pa,ents need to stay on an,retroviral drugs (
Slide 15: 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 • Poten,al benefits on immune aging and HIV-‐associated demen,a • Poten,al for use in fu
Slide 16: BIT225 – Proven Clinical Activity Against HIV
BIT225 – Proven Clinical AcTvity Against HIV • Phase 1b/2a randomised, placebo controlled, double-‐blind trial 16 Placebo BIT225 HIV-‐1 Replica,on (pg/200uL) 14 – 24 pa,ents, HIV-‐1 posi,ve, treatment-‐naïve 12 – 10 days dosing with BIT225 (monotherapy) 10 8 • Results demonstrated that: 6 1. BIT
Slide 17: Dengue Virus Program
Dengue Virus Program • 2.5 b illion people (40% world popula,on) live in areas at risk of Dengue • A leading cause of illness and death in tropics and subtropics • ~100 million people infected yearly • No approved vaccine or therapy • Transmission is by mosquito; most preven,on programs target the v
Slide 18: Investment Proposition
Investment ProposiTon • HCV and HIV are high growth, mul,-‐billion dollar markets • Treatment gaps remain • BIT225 is a novel approach with demonstrated promising efficacy in Phase 2a/2 clinical trials • Represents a new class of direct-‐ac,ng HCV drugs • Poten,al to fill significant HCV treatment gap
Slide 19: Outlook for 2015
Outlook for 2015 • Complete BIT225-‐008 Phase 2 HCV trial currently in progress • Fully recruited; preliminary interim data expected late 1Q15 • Inves,ga,onal New Drug applica,on(s) (INDs) • Engaged with FDA -‐ pre-‐IND consulta,on HCV combina,on trial with DAA • Complete IND-‐related ac,vi,es •
Slide 20: Financial Information
Financial InformaTon Key Financial Metrics 12 Month Share Price Performance Ticker Code ASX: BIT Ticker Code ASX: BIT Share Price (9 Jan 2015) A $0.125 Market cap A $35 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.067 – 0.29 Market cap A $26.3 million Shares Outstanding 27
Slide 21: www.biotron.com.au
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au