Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2014)
19 slides from Biotron's shareholder meeting presentation, Nov 13, 2014
Slide 1: Biotron Limited AGM 13 November 2014
BIOTRON LIMITED (ASX:BIT) AGM 13 November 2014
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: Significant Progress During Last 12 Months
Significant Progress During Last 12 Months ACTIVITY STATUS/OUTCOME Phase 2 HIV/HCV co-‐infected trial 100% SVR12 data reported for HIV/HCV G3 Phase 2a HIV trial Impact on immune ac,va,on reported Phase 2, three-‐month dosing HCV G1 & G3 Close to fully recruited; preliminary interim data an,cipated
Slide 4: In the Media
In the Media Biotron shares jump on trial result AAP -‐ March 2014 Biotron’s drug eradicates Hepa66s C in coinfected HIV pa6ents at 24 weeks Proac,ve Investors – March 2014 Biotron in HIV success Big Biotron Boost Northern Territory News Adver,ser (Adelaide) Biotron Ltd BIT225 Reverses HIV-‐Induce
Slide 5: In the Media
In the Media Hep C pioneers seeking billions “… Biotron is looking for a major partner …” Hepa66s C cure hope Biotron shares up on hep C cure drug Weekend Post – October 2014 Courier Mail – October 2014 Hep C cure rate helps Biotron Biotron’s hope for hep C cure Daily Telegraph – October 2014 Adver,
Slide 6: BIT225 Snapshot
BIT225 Snapshot -‐ First in class Prepared drug aond based n anbove ew drug target aner the for treatment August of H Board mIV and Hepa,,s C virus (HCV) ee,ng -‐ Guided Seven the wtrials clinical ording of the porospectus completed; dran and the use of proceeds ne in progress -‐-‐ While capital
Slide 7: BIT225 - Proven Clinical Track Record
BIT225 -‐ Proven Clinical Track Record -‐ Over 180 pa,ents and healthy volunteers dosed with BIT225 to date -‐ Posi,ve data recorded in all trials -‐ HCV G1 (BIT225-‐005) – 100% receiving 400mg (28 days in combina,on with 48 weeks IFN/ RBV) were virus-‐free at 48 weeks -‐ Co-‐infected HIV/HC
Slide 8: Biotron - Advanced Pipeline
Biotron -‐ Advanced Pipeline INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Hep C BIT225 HIV/Hep C BIT225 HIV BIT225 Next generaSon -‐ BIT314 HCV Dengue Leads Slide 6
Slide 9: Large and Growing Global Market for Hepatitis C
Large and Growing Global Market for HepaSSs C • Forecast to grow to over $19bn by 2016 • 180 million people infected worldwide (3% world popula,on) • Es,mated 3 to 5 million pa,ents in US & 30 million pa,ents in China • New drugs have demonstrated significant pricing power • Gilead’s Sovaldi (Sofosbu
Slide 10: BIT225 – First of a New Class of HCV Drugs
BIT225 – First of a New Class of HCV Drugs ü Novel, oral, small molecule POLYMERASE/PROTEASE ü Only one of its class (p7 inhibitor) in clinical trials INHIBITORS e.g. Sofosbuvir/Simeprevir ü Inhibits viral assembly and infec,vity ü Pan-‐genotype ac,vity: BIT225 -‐ ASSEMBLY/ BUDDING INHIBITOR ü
Slide 11: BIT225 Clinical Program – Trials to Date
BIT225 Clinical Program – Trials to Date • BIT225-‐001: Phase 1a, single dose, dose escala,ng study in healthy volunteers (48 subjects; Aust) • BIT225-‐003: Phase 1b, 7-‐day, repeat dose study in HCV+ pa,ents (35 and 200 mg BID; 18 subjects; Aust) • BIT225-‐004: Phase 2a, 10-‐day, repeat dose s
Slide 12: BIT225 - Clinical Activity in HCV and HIV/HCV Patients
BIT225 -‐ Clinical AcSvity in HCV and HIV/HCV PaSents BIT225-‐005 (HCV G1) BIT225-‐006 (HIV/HCV) NB All paEents were stable on ART before Placebo + IFN/RBV IFN/RBV IFN/RBV BIT225 300 mg BID + and throughout the study; HIV remained n=8 IFN/RBV – n=4 HCV Genotype 1 undetectable during the treatment
Slide 13: 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 14: HIV – Towards a Cure
HIV – Towards a Cure • Infec,on rates in Australia are at 20 year high • Over 1.1 million people living with HIV 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 pa,ents need to stay on an,retroviral drugs (
Slide 15: BIT225 Targets HIV in Reservoir Cells
BIT225 Targets HIV in Reservoir Cells • BIT225 inhibits assembly and budding of new virus • Phase 2a trial (004) showed that BIT225 can reduce HIV levels in macrophage cells in vivo, paralleling in vitro studies • Poten,al benefits on immune aging and HIV-‐associated demen,a • Poten,al for use in fu
Slide 16: Investment Proposition
Investment ProposiSon • HCV and HIV are high growth, mul,-‐billion dollar markets • Treatment gaps remain • BIT225 is a novel approach with demonstrated promising efficacy in Phase 2a/2 clinical trials • Represents a new class of direct-‐ac,ng HCV drugs • Poten,al to fill significant HCV treatment gap
Slide 17: Outlook for 2015
Outlook for 2015 • Complete BIT225-‐008 HCV trial currently in progress • Preliminary interim data expected 1Q14 • Inves,ga,onal New Drug applica,on(s) (INDs) • Engaged with FDA -‐ pre-‐IND consulta,on HCV combina,on trial with DAA • Complete IND-‐related ac,vi,es • Modeling of pharmacokine,c da
Slide 18: BIT225 – Progression to Commercialisation
BIT225 – Progression to CommercialisaSon • Strategy is guided by: • Advisory panels of US-‐based KOLs who are leaders of the field • Interac,on and feedback from US healthcare analysts who specialise in an,viral space • Interac,on and feedback from poten,al partners • Biotron con,nues to engage with
Slide 19: ASX:BIT
ASX:BIT Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au