Biotron Limited · ASX:BIT
Biotron — Investor Presentation (December 2014)
16 slides from Biotron's investor presentation, December 2014
Slide 1: Biotron Limited Investor Presentation
BIOTRON LIMITED (ASX:BIT) Investor Presenta;on Dr Michelle Miller Managing Director December 2014 +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au
Slide 2: Forward Looking Statements
Forward Looking Statements This presentaBon may contain forward-‐looking statements with respect to the financial condiBon, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objecBves of its management. These statements are statements tha
Slide 3: BIT225 Snapshot
BIT225 Snapshot -‐ First in class Prepared drug aond based n anbove ew drug target a\er the for treatment August of H Board mIV and HepaBBs C virus (HCV) eeBng -‐ Guided Seven the wtrials clinical ording of the parospectus completed; dra\ nother is fully and the recruited use with of proceeds prel
Slide 4: 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 acBvaBon reported Phase 2, three-‐month dosing HCV G1 & G3 Fully recruited; preliminary interim data anBcipated 1Q15 tria
Slide 5: BIT225 - Proven Clinical Track Record
BIT225 -‐ Proven Clinical Track Record -‐ Over 180 paBents and healthy volunteers dosed with BIT225 to date -‐ PosiBve data recorded in all trials -‐ HCV G1 (BIT225-‐005) – 100% receiving 400mg (28 days in combinaBon with 48 weeks IFN/ RBV) were virus-‐free at 48 weeks -‐ Co-‐infected HIV/HC
Slide 6: 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 genera;on -‐ BIT314 HCV Dengue Leads Slide 4
Slide 7: Large and Growing Global Market for Hepatitis C
Large and Growing Global Market for Hepa;;s C • Forecast to grow to over $19bn by 2016 • 180 million people infected worldwide (3% world populaBon) • EsBmated 3 to 5 million paBents in US & 30 million paBents in China • New drugs have demonstrated significant pricing power • Gilead’s Sovaldi (Sofosbu
Slide 8: 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 infecBvity ü Pan-‐genotype acBvity: BIT225 -‐ ASSEMBLY/ BUDDING INHIBITOR ü
Slide 9: BIT225 Clinical Program – Trials to Date
BIT225 Clinical Program – Trials to Date • BIT225-‐001: Phase 1a, single dose, dose escalaBng study in healthy volunteers (48 subjects; Aust) • BIT225-‐003: Phase 1b, 7-‐day, repeat dose study in HCV+ paBents (35 and 200 mg BID; 18 subjects; Aust) • BIT225-‐004: Phase 2a, 10-‐day, repeat dose s
Slide 10: BIT225 - Clinical Activity in HCV and HIV/HCV Patients
BIT225 -‐ Clinical Ac;vity in HCV and HIV/HCV Pa;ents BIT225-‐005 (HCV G1) BIT225-‐006 (HIV/HCV) NB All paCents 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 11: 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 12: HIV – Towards a Cure
HIV – Towards a Cure • InfecBon 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 paBents need to stay on anBretroviral drugs (
Slide 13: 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 • PotenBal benefits on immune aging and HIV-‐associated demenBa • PotenBal for use in fu
Slide 14: Investment Proposition
Investment Proposi;on • HCV and HIV are high growth, mulB-‐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-‐acBng HCV drugs • PotenBal to fill significant HCV treatment gap
Slide 15: Outlook for 2015
Outlook for 2015 • Complete BIT225-‐008 HCV trial currently in progress • Fully recruited; preliminary interim data expected 1Q15 • InvesBgaBonal New Drug applicaBon(s) (INDs) • Engaged with FDA -‐ pre-‐IND consultaBon HCV combinaBon trial with DAA • Complete IND-‐related acBviBes • Modeling of
Slide 16: Financial Information
Financial Informa;on Key Financial Metrics 12 Month Share Price Performance Ticker Code ASX: BIT Ticker Code ASX: BIT Share Price (1 Dec 2014) A $0.105 Market cap A $29.2 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.067 – 0.29 Market cap A $26.3 million Shares Outstanding