Slide 1: Biotron Limited - Biotech Showcase 2016
BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2016
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: Financial Information
Financial InformaEon Key Financial Metrics Ticker Code 12 Month Share Price Performance ASX: BIT Share Price (8 Jan 2016) A $0.05 Ticker Code ASX: BIT Market cap A $16 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.041 – 0.165 Market cap A $26.3 million Shares Outstanding 31
Slide 4: Biotron Limited
Biotron Limited • Spun out from John Cur,n School of Medical Research at the Australian Na,onal University in 1999 • Listed on ASX in Jan 2001 (ASX:BIT) • Headquartered in Sydney, Australia • Directors • Michael Hoy Chairman • Michelle Miller CEO & Managing Director; ex-‐Johnson & Johnson Research;
Slide 5: Biotron – Leader in Viroporin-Targeting Drug Development
Biotron – Leader in Viroporin-‐TargeEng Drug Development • Viroporin proteins are present in influenza (M2), HIV-‐1 (Vpu), Hep C (p7), Dengue and West Nile (M protein), SARS (E protein) and others • Rapid proprietary primary bacterial cell-‐based screening assays for target proteins • Designed lib
Slide 6: Biotron - Advanced Pipeline
Biotron -‐ Advanced Pipeline INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Hep C BIT225 HIV-‐1/Hep C BIT225 HIV-‐1 BIT225 Next generaEon -‐ BIT314 HCV Dengue Leads Slide 4
Slide 7: Viroporins
Viroporins • Small hydrophobic proteins with ion channel ac,vity • Form hydrophilic pores in host cell membranes • Key stages of the viral cycle such as virus uncoa,ng, transport and matura,on are ion-‐influenced processes in many viral species • Crucial for viral pathogenicity due to involvement in
Slide 8: Biotron's Core Technology
Biotron’s Core Technology OTHER “HITS” IN LIBRARY include: Designed library of Compounds screened in compounds to target proprietary assay set up for viroporins: each virus target e.g. HIV-‐1 -‐ Influenza A and B Vpu; HCV p7; Influenza M2; -‐ Coronaviruses IniEally >250 compounds designed and synth
Slide 9: BIT225 Snapshot
BIT225 Snapshot -‐ First -‐ in class drug baased Prepared nd new on darug target bove aper for the treatment August oBf oard HIV-‐1 m and Hepa,,s C virus (HCV) ee,ng -‐ Seven clinical ttrials -‐ Guided he wcompleted; ording of athe nother is fully recruited prospectus with drap and data the exp
Slide 10: BIT225 – First of a New Class of HCV DAA Drugs
BIT225 – First of a New Class of HCV DAA Drugs ü Novel, oral, small molecule compound POLYMERASE/PROTEASE INHIBITORS e.g. Sofosbuvir/Simeprevir ü Only one of its class (p7 inhibitor) in clinical trials ü Inhibits viral assembly and infec,vity BIT225 -‐ ASSEMBLY/ BUDDING INHIBITOR ü Pan-‐genoty
Slide 11: 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 12: Positioning BIT225 within HCV Landscape
PosiEoning BIT225 within HCV Landscape • HCV market forecast to grow to over $19bn by 2016 • 180 million infected worldwide (3% world popula,on) • ~3 to 5 million in US • The race to cure pa,ents faster (and cheaper) is s,ll on • Recent new HCV drug combina,ons are good, but not op,mal • Lengthy tre
Slide 13: HIV-1: Towards a Cure
HIV-‐1: Towards a Cure • Over 1.1 million people living with HIV-‐1 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-‐1 pa,ents need to stay on an,retroviral drugs (ART) to keep virus levels under control
Slide 14: HIV-1 Reservoirs
HIV-‐1 Reservoirs • HIV-‐1 remains hidden in reservoirs, leading to chronic, life-‐long infec,on – Invisible to body’s immune defenses – Not sensi,ve to an,-‐HIV-‐1 drugs • Eradica,on will require mul,ple approaches; approaches include: – An,-‐latency agents for latently-‐infected T cells – D
Slide 15: BIT225 Targets HIV-1 in Reservoir Cells
BIT225 Targets HIV-‐1 in Reservoir Cells • BIT225 inhibits assembly and budding of new virus in macrophages • Phase 2a trial (004) demonstrated that BIT225 can reduce HIV-‐1 levels in macrophage cells in vivo, paralleling in vitro studies (Wilkinson et al, J An,microb Chemother. 2015 Nov 29. pii:
Slide 16: BIT225 – Proven Clinical Activity Against HIV-1
BIT225 – Proven Clinical AcEvity Against HIV-‐1 • BIT225-‐004: Phase 1b/2a randomised, placebo controlled, double-‐blind trial 16 Placebo BIT225 HIV-‐1 Replica,on (pg/200uL) 14 – 21 pa,ents, HIV-‐1 posi,ve, treatment-‐naïve; 10 days dosing with BIT225 12 (monotherapy) 10 • Results demonstrated
Slide 17: Unlocking Value in Compound Library
Unlocking Value in Compound Library • Renewed industry interest in targe,ng viral diseases including • Respiratory syncy,al virus (RSV) • Hepa,,s B virus • Tropical diseases including Dengue • Influenza (in par,cular drug resistant strains) • Ebola and MERS-‐CoV outbreaks have caused public health i
Slide 18: Dengue Virus Program
Dengue Virus Program • 2.5 billion people (40% world popula,on) 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 preven,on programs target the vector • No approved Dengue-‐speci
Slide 19: Investment Proposition
Investment ProposiEon • Unique core exper,se against novel viral targets • Demonstrated proof of concept of successful targe,ng of viroporins with BIT225 • Poten,al within compound library for significant other viral infec,ons e.g. Dengue, RSV, Hep B • BIT225 is a novel approach with demonstrated pro
Slide 20: Outlook for 2015/16
Outlook for 2015/16 • Report data from BIT225-‐008 HCV trial • SVR12 for G1 due 1Q16 • Inves,ga,onal New Drug applica,on (IND) • Finalise regulatory documenta,on containing an extensive data package • Partner for HCV combina,on studies • Progress protocol and regulatory documenta,on for key Phase 2
Slide 21: www.biotron.com.au
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au