Slide 1: Biotron Limited (ASX:BIT) Australia Biotech Invest
BIOTRON LIMITED (ASX:BIT) Australia Biotech Invest October 2015 Michelle Miller Managing Director +61 (0) 412 313 329 mmiller@biotron.com.au
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: BIT225 Snapshot
BIT225 Snapshot -‐ First in class Prepared drug aond based n anbove ew drug target aVer 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; draV ne in progress and (HCV Gt3 he use odf ata interim proceeds
Slide 4: Financial Information
Financial InformaPon Key Financial Metrics 12 Month Share Price Performance Ticker Code ASX: BIT Share Price (5 Oct 2015) A $0.054 Ticker Code ASX: BIT Market cap A $15 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.041 – 0.183 Shares Outstanding 313 million Market cap A $26
Slide 5: BIT225 - Proven Activity Against HCV
BIT225 -‐ Proven AcPvity Against HCV -‐ Independently shown to work against all HCV genotypes in vitro -‐ Over 200 pa,ents and healthy volunteers dosed with BIT225 to date -‐ BIT225 has consistently shown posi,ve data: -‐ HCV G1 (BIT225-‐005) – 100% receiving 400mg (28 days in combina,on with
Slide 6: BIT225 – First of a New Class of HCV Drugs
BIT225 – First of a New Class of HCV Drugs ü Novel, oral, small molecule compound POLYMERASE/PROTEASE INHIBITORS e.g. ü Only one of its class (p7 inhibitor) in clinical trials Sofosbuvir/Simeprevir ü Inhibits viral assembly and infec,vity BIT225 -‐ ASSEMBLY/ ü Pan-‐genotype ac,vity: BUDDING IN
Slide 7: Positioning of BIT225 for Hepatitis C
PosiPoning of BIT225 for HepaPPs C • New HCV drug combina,ons not op,mal • Cost of new treatments is excessive: • Sovaldi US$84,000 for 12 weeks; Harvoni US$94,500 for 12 weeks • Lengthy treatment – 12 weeks or more • Not pan-‐genotypic – BIT225 is pan-‐genotypic in vitro • Not as effec,ve against
Slide 8: What Interim Data from BIT225-008 Means
What Interim Data from BIT225-‐008 Means • Interim data from BIT225-‐008 (3 month dosing study in HCV gen 1 and gen 3): • We now have safety data with the new capsule formula,on out to 12 week dosing • i.e. sufficient for dosing studies with new HCV drugs • Prime aim of the trial • The gen 3 cohort
Slide 9: Outlook for 2015/16
Outlook for 2015/16 • Complete BIT225-‐008 HCV trial • HCV Gen 1 due 1Q16 • Inves,ga,onal New Drug applica,on • Complete IND-‐related ac,vi,es required by the FDA • Modeling of pharmacokine,c data from all trials to determine op,mal BIT225 dose and frequency in IND trials; Exposure/AE analysis (00