Slide 1: ASX cover letter: Biotron presents at Biotech Showcase 2017
Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au For personal use only Website: www.biotron.com.au 13 January 2017 The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000 (26 pages by email) Dear Madam BIOTRON LIMITE
Slide 2: Biotron Limited, Biotech Showcase 2017
For personal use only BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2017
Slide 3: Forward Looking Statements
Forward Looking Statements For personal use only 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 statement
Slide 4: Investment Highlights
For personal use only 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
Slide 5: Corporate Snapshot
For personal use only 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 $
Slide 6: 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 For personal use only viral-encoded viroporin proteins • Viroporins are present in broad range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue and West
Slide 7: Viroporins
Viroporins For personal use only • 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 d
Slide 8: Compound Discovery Process
Compound Discovery Process For personal use only 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 V
Slide 9: Core Technology Drives Rich Compound Library
Core Technology Drives Rich Compound Library For personal use only 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
Slide 10: Biotron - Advanced Pipeline
Biotron - Advanced Pipeline For personal use only INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 HCV BIT225 HIV-1 BIT225 Next generaPon - BIT314 HCV Dengue Leads
Slide 11: HIV-1 Reservoirs
HIV-1 Reservoirs For personal use only • 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 c
Slide 12: HIV-1: Towards a Cure
HIV-1: Towards a Cure • Over 1.1 million people living with HIV-1 in the USA, For personal use only 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 leve
Slide 13: BIT225 Targets HIV-1 in Reservoir Cells
BIT225 Targets HIV-1 in Reservoir Cells • BIT225 inhibits assembly and budding of new virus in macrophages For personal use only • 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.
Slide 14: 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 For personal use only 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 d
Slide 15: HIV-1 Viral Dynamics: BIT225-009 Hu-Mouse ATI
HIV-1 Viral Dynamics For personal use only BIT225-009 Hu-Mouse ATI
Slide 16: BIT225 HIV-1 Eradication – Next Steps
BIT225 HIV-1 Eradication – Next Steps For personal use only 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
Slide 17: BIT225 – First of a New Class of HCV DAA Drugs
BIT225 – First of a New Class of HCV DAA Drugs For personal use only • 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 a
Slide 18: HCV BIT225 Program Snapshot
HCV BIT225 Program Snapshot - Prepared based on above azer the August Board mee,ng For personal use only - 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 requirement
Slide 19: HCV – Remains an Opportunity
HCV – Remains an Opportunity For personal use only • 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
Slide 20: Unlocking Value in Compound Library
Unlocking Value in Compound Library • Renewed industry interest in targe,ng viral diseases including For personal use only • 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 p
Slide 21: Dengue Virus Program
Dengue Virus Program • 2.5 billion people (40% world popula,on) live in areas at risk For personal use only 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 a
Slide 22: Hepatitis B Virus
For personal use only 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 un
Slide 23: Commercialisation and Partnering
For personal use only 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,
Slide 24: Key Milestones for 2017
Key Milestones for 2017 For personal use only • 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
Slide 25: Investment Highlights
For personal use only 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 hig
Slide 26: Dr Michelle Miller, Managing Director
For personal use only Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au