Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2016)
19 slides from Biotron's shareholder meeting presentation, Nov 22, 2016
Slide 1: Annual General Meeting
Annual General Mee+ng 22 November, 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 that
Slide 3: Biotron Snap Shot
Biotron Snap Shot • Biotron’s core exper,se is design and development of new an,viral drugs targe,ng viral ion channel proteins (viroporins) • Viroporins are present in broad range of viruses: • Influenza (M2), HIV-1 (Vpu), Hep C (p7), Dengue and West Nile (M protein), SARS (E protein) and others • B
Slide 4: Strategy Update
Strategy Update • Con,nue to posi,on Biotron as Clinical Stage An,-viral Development Company with: o Clinical programs for HIV-1 and Hepa,,s C virus (HCV) o A lead program, BIT225, as “First in Class” therapy for HIV-1 eradica,on o Valuable HCV clinical program, with a new class of direct-ac,ng an,v
Slide 5: BIT225 – Phase 2 Asset for Two Indications
BIT225 – Phase 2 Asset for Two Indica+ons • Demonstrates robustness of Biotron’s approach • BIT225 is a valuable Phase 2 asset with two indica,ons – HIV-1 and HCV • Both are mul,-billion dollar markets • Over 200 individuals dosed (healthy, HCV, HIV-1 and HIV-1/HCV co-infected) in trials • 7 clinica
Slide 6: HIV-1 Eradication – Towards a “Cure”
HIV-1 Eradica+on – Towards a “Cure” • Key market opportunity – significant unmet medical need • E.g. BIT225 @ US$100,000 per dose with 25% market penetra,on: • Poten,al US$60 billion current infected market • Poten,al US$2.25 billion new infec,ons • Long-term health implica,ons even in pa,ents on an,
Slide 7: 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 8: BIT225 – Proven Clinical Activity Against HIV-1
BIT225 – Proven Clinical Ac+vity Against HIV-1 16 Placebo • BIT225-004: Phase 1b/2a randomised, placebo controlled, 14 BIT225 HIV-1 Replica,on (pg/200uL) double-blind trial 12 • 21 pa,ents, HIV-1 posi,ve, treatment-naïve; 10 days 10 dosing with BIT225 (monotherapy) 8 Results demonstrated that: 6 1.
Slide 9: BIT225 HIV-1 Trials Designed to Show Clinical Benefit in Combination with ART
BIT225 HIV-1 Trials Designed to Show Clinical Benefit in Combina+on with ART 1 - BIT225-009 2 - Treatment Interrup+on Slide 13
Slide 10: HIV-1 Program Trials - I
HIV-1 Program Trials - I • BIT225-009 Overview • Phase 2 human clinical trial • 12 weeks BIT225 in combina,on with current an,retroviral treatment (ART) • Pa,ent popula,on is commencing ART treatment for first ,me • Double blind, placebo controlled study • Measuring BIT225 impact on: • HIV-1 second p
Slide 11: HIV-1 Program Trials - II
HIV-1 Program Trials - II • Treatment Interrup%on Study (ATI) • To look at impact on viral reservoir: • Treat with current ART drugs, with and without BIT225 • Take away drugs • Measure impact on viral rebound • Delay, change in dynamics, etc • Difficult to do in pa,ents as they would need to go off tr
Slide 12: Human Treatment Interruption Model
Human Treatment Interrup+on Model • Mice with human immune system • Can be infected with HIV-1 and treated with human drugs • Mimic Treatment Interrup,on trial in humans ADVANTAGES: • Less cost, risk, %me • Provide data to: • Guide for poten%al clinical use • Support outcome of 009 trial • Handle on
Slide 13: Creating Clear Value Inflection Points in HIV-1 Program
Crea+ng Clear Value Inflec+on Points in HIV-1 Program • Studies very carefully designed in conjunc,on with Key Opinion Leaders with industry feedback • Specifically designed to show poten,al partners how BIT225 can be used in combina,on with current ART • Phase 2 HIV-1 Trial ( BIT225-009) - • Expect t
Slide 14: HCV Program Update
HCV Program Update • Data package prepared for regulatory filings in US or elsewhere • Partner-ready for combina,on studies with other HCV drugs • BIT225 is pan-genotypic, new class of HCV drug • China remains a significant opportunity for HCV therapy • 30 – 50 million people infected (compared to 3 –
Slide 15: 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, MERS-CoV and Zika outbreaks have caused public heal
Slide 16: Compound Library is Rich Source of Hits
Compound Library is Rich Source of Hits X-axis: BIT compound ID Y-axis: Virus class Z-axis: Strength of hit Library is valuable to Biotron and poten+al partners as it is a new chemical space that has not been exploited in drug development to date
Slide 17: Preclinical – Early Stage Opportunities
Preclinical – Early Stage Opportuni+es • Technology core is an an,viral plaborm with new class of small molecules with broad range of ac,vity against different viruses • Extending earlier stage programs for other key viruses: • Iden,fying hits for other viruses including RSV, Zika, BK, and others • D
Slide 18: Summary
Summary Biotron well posi,oned for value growth in 2017: • Strong clinical program in HIV-1 • Defined value infec,on points based on poten,ally posi,ve data from BIT225-009 trial and ATI Study making Biotron “Partner Ready” • Regional HCV licensing strategy enabling addi,onal value op,misa,on • Exten
Slide 19: Contact
Contact Dr Michelle Miller CEO & Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au