Slide 1: Biotron Limited – Biotech Showcase 2018
BIOTRON LIMITED (ASX:BIT) Biotech Showcase 2018
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: Biotron Limited
Biotron Limited • Biotron is designing, developing and commercialising a plaUorm of an,viral drugs with a novel mode of ac,on – able to target a wide variety of viral infec,ons • Pipeline of programs in high value, high need markets • Progress in clinical lead program (BIT225) provides strong valida
Slide 4: Biotron Limited – Snap Shot
Biotron Limited – Snap Shot BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS HIV-1 ERADICATION HEPATITIS C VIRUS (HCV) HBV & EARLY STAGE PROGRAMS - Targe,ng HIV-1 in long- - New class of HCV drug - Pipeline of early stage lived reservoirs - Phase 2 completed programs, including: - Phase 2 trial in p
Slide 5: Key Achievements 2017
Key Achievements 2017 • Commenced Phase 2 HIV-1 clinical trial of BIT225 and Combina,on An,retroviral Therapy (cART) in Feb’17 • Dosing with BIT225/placebo completed; data pending (an,cipated 1Q18) • Demonstrated significant and accelerated reduc,on in HIV-1 viral load following addi,on of BIT225 in
Slide 6: HIV-1 Eradication
HIV-1 EradicaTon Current drugs do not eradicate HIV-1 virus • 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 • New mode of ac,ons drugs are needed to eradicate or cure HIV-1 infec,on Why is HIV-1 erad
Slide 7: Current Drugs Do Not Eradicate HIV-1
Current Drugs Do Not Eradicate HIV-1
Slide 8: Macrophages are Key HIV-1 Reservoirs
Macrophages are Key HIV-1 Reservoirs Study published in Nature Medicine in April 2017 confirmed that macrophages are key viral reservoirs
Slide 9: BIT225 Targets HIV-1 in Reservoir Cells
BIT225 Targets HIV-1 in Reservoir Cells • BIT225 inhibits assembly and budding of new virus in macrophage reservoirs • Phase 1b/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) • P
Slide 10: BIT225 – Proven Clinical Activity Against HIV-1
BIT225 – Proven Clinical AcTvity 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 11: HIV-1 Eradication: BIT225-009 Trial
HIV-1 EradicaTon: BIT225-009 Trial BIT225 or placebo added to ART • 36 HIV-1+ve, treatment-naïve subjects commencing ART • Randomised 2:1 (drug:placebo) • BIT225 or placebo added to ART for first 12 weeks of treatment • Read-out • Impact on virus levels; reduc,on of immune ac,va,on markers • Fully re
Slide 12: Biotron – New Approach to Anti-Viral Drug Development
Biotron – New Approach to AnT-Viral 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 wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue and West Nile (M protein), SARS (E
Slide 13: 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 14: Unlocking Value for Other Virus Targets
Unlocking Value for Other Virus Targets Library of compounds designed to target viroporins found in some viruses: Ini,ally >250 compounds designed and synthesised; library now ~350 OTHER “HITS” IN LIBRARY include: • Influenza A and B • Hepa,,s B virus (HBV) • Coronaviruses (Including SARS) • Epstein-
Slide 15: Unlocking Value for Other Virus Targets
Unlocking Value for Other Virus Targets Biotron’s Viroporin approach enables the targe,ng of a wide range of viral diseases; examples include: • Respiratory Viruses such as Respiratory Syncy,al Virus (RSV), Influenza, & Coronaviruses (leading cause of “common cold”) • Flaviviruses such as Zika Virus
Slide 16: Hepatitis B Virus Program
HepaTTs B Virus Program • Hepa,,s B virus (HBV) therapeu,c space has significant interest from pharma & biotech companies • Screening of Biotron’s compound library has iden,fied several compounds with ac,vity against HBV • Screening in Hep G2 and AD38 cell lines, as well as studies in primary human he
Slide 17: 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 18: HCV – Remains an Opportunity
HCV – Remains an Opportunity • The new HCV drugs may cause reac,va,on of HBV in HCV/HBV coinfected pa,ents • Resulted in US FDA “Black Box” Warning on new HCV drugs • 30 million HCV-infected people in China, compared to 3-5 million in USA • 93 million chronically infected with HBV in China, compared
Slide 19: Commercialisation and Partnering
CommercialisaTon and Partnering • HIV-1 Program - Significant value inflec,on points around HIV-1 program data expected in 2018 • 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 20: 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 18) A $0.03 • Listed on ASX in Jan 2001 (ASX:BIT) Market capitalisa,on A $11.4 million • Headqua
Slide 21: Investment Highlights
Investment Highlights TargeTng viroporin proteins with a rapid screening proprietary primary NOVEL ANTIVIRAL bacterial cell-based plahorm - a library of over 350 compounds with acTvity PLATFORM against a range of viruses. Clinical and Preclinical programs in indicaTons with high unmet clinical need
Slide 22: Dr Michelle Miller Managing Director
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au