Slide 1: Biotron Limited Biotech Showcase 2017
BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017
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 that
Slide 3: Investment Highlights
Investment Highlights • Developing new class of an,viral drugs • Lead programs: BIT225 targe,ng HIV-1 eradica,on and Hepa,,s C virus (HCV) – mul,-billion dollar markets • Phase 1 / 2a trials completed in over 200 subjects – safety and efficacy validated • Several near term, value-adding milestones dri
Slide 4: Corporate Snapshot
Corporate Snapshot Key Financial Metrics Brief Biotron Overview Ticker Code ASX: BIT • Spun out from John Cur,n School of Medical Research at the Australian Na,onal University in 1999 Share Price (09 Jan 17) A $0.04 • Listed on ASX in Jan 2001 (ASX:BIT) Market capitalisa,on A $12.24 million • Headqu
Slide 5: Biotron – Leader in Viroporin-Targeting Drug Development
Biotron – Leader in Viroporin-TargePng Drug Development • Core exper,se is design and development of a new class of an,viral drugs targe,ng viral-encoded viroporin proteins • Viroporins are present in broad range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue and West Nile (M protein), SAR
Slide 6: 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 v
Slide 7: Compound Discovery Process
Compound Discovery Process Design of compounds to explore 3D space and determine SAR of target proteins; 1 expansion of compound library to increase ac,vity against target Addi,onal chemistry to 2 Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Influenza M
Slide 8: Core Technology Drives Rich Compound Library
Core Technology Drives Rich Compound Library Library of compounds designed to target viroporins: Ini,ally >250 compounds designed and synthesised; library now ~350 OTHER “HITS” IN LIBRARY include: • Influenza A and B • Coronaviruses (Including SARS) X-axis: compound ID • Epstein-Barr virus (EBV) Y-ax
Slide 9: Biotron - Advanced Pipeline
Biotron - Advanced Pipeline INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 HCV BIT225 HIV-1 BIT225 Next generaPon - BIT314 HCV Dengue Leads
Slide 10: 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 – Drugs to modify
Slide 11: 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 • Lon
Slide 12: 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: dkv3
Slide 13: BIT225 – Proven Clinical Activity Against HIV-1
BIT225 – Proven Clinical AcPvity Against HIV-1 • BIT225-004: Phase 1b/2a randomised, placebo controlled, double- 16 Placebo blind trial 14 BIT225 HIV-1 Replica,on (pg/200uL) – 21 pa,ents, HIV-1 posi,ve, treatment-naïve; 10 days dosing 12 with BIT225 (monotherapy) 10 • Results demonstrated that BIT22
Slide 14: HIV-1 Viral Dynamics
HIV-1 Viral Dynamics BIT225-009 Hu-Mouse ATI
Slide 15: BIT225 HIV-1 Eradication – Next Steps
BIT225 HIV-1 Eradication – Next Steps Crea,ng value inflec,on points with posi,ve trial data • Ini,ate Phase 2 HIV-1 Clinical Trial - 3 month trial in combina,on with ART (BIT225-009); Expect trial commencement early 2017 – Data expected in 3Q17 • Expected outcome(s) – Impact on kine7cs of viral load
Slide 16: BIT225 – First of a New Class of HCV DAA Drugs
BIT225 – First of a New Class of HCV DAA Drugs • Novel, oral, small molecule compound • Only one of its class (p7 inhibitor) in clinical POLYMERASE/PROTEASE INHIBITORS e.g. trials Sofosbuvir/Simeprevir • Inhibits viral assembly and infec,vity BIT225 - ASSEMBLY/ • Pan-genotype ac,vity: BUDDING INHIBI
Slide 17: HCV BIT225 Program Snapshot
HCV BIT225 Program Snapshot - Prepared based on above azer the August Board mee,ng - Four clinical trials I HCV-infected subjects completed (including one HIV-1/HCV coinfected - Guided the wording of the prospectus draz and the use of proceeds trial) - While capital requirements are determined based
Slide 18: HCV – Remains an Opportunity
HCV – Remains an Opportunity • Emerging evidence that Interferon sparing therapies may cause reac,va,on of Hepa,,s B (HBV) • Evidence of reac,va,on of hepa,,s B in co-infected pa,ents (HBV & HCV) presented at AASLD • 30 – 50 million HCV-infected subjects in China • High HCV/HBV co-infec,on rate in C
Slide 19: Unlocking Value in Compound Library
Unlocking Value in Compound Library • Renewed industry interest in targe,ng viral diseases including • Respiratory diseases e.g. Respiratory syncy,al virus (RSV) & Influenza • Hepa,,s B virus • Tropical diseases including Dengue • Ebola, Zika and MERS-CoV outbreaks have caused public health issues wo
Slide 20: 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-specific
Slide 21: Hepatitis B Virus
HepaPPs B Virus • Limited screening of Biotron compound library has generated interes,ng data • Hits iden,fied • Very experienced scien,fic advisory and opera,onal team in place for HBV • Seeking collabora,on to explore hits and develop program • Hepa,,s B remains a significant unmet need with a mul,-b
Slide 22: Commercialisation and Partnering
CommercialisaPon and Partnering • HIV-1 Program - Significant value inflec,on points around HIV-1 program data expected in 2017 • HCV Program - BIT225 par,cularly well suited to Asia, with high numbers of HCV- infected pa,ents including a high propor,on of HCV/HBV co-infected pa,ents • Early stage col
Slide 23: Key Milestones for 2017
Key Milestones for 2017 • Complete Analy,cal Treatment Interrup,on (ATI) Study in HIV-1 Infected Humanised Mice - Data expected Q2 2017 • Expected outcome(s) – Impact on kine7cs of viral load decay in combina7on with ART indica7ng impact on underlying viral reservoir • Complete Phase 2 HIV-1 Trial -
Slide 24: Investment Highlights
Investment Highlights TargePng viroporin proteins with a rapid screening proprietary primary NOVEL ANTIVIRAL bacterial cell-based plaform - a library of over 350 compounds with acPvity PLATFORM against a range of viruses. Clinical and Preclinical programs in indicaPons with high unmet clinical need
Slide 25: Dr Michelle Miller Managing Director
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au