Slide 1: Biotron Limited Investor Update May 2014
BIOTRON LIMITED (ASX:BIT) Investor Update May 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: Financial Information
Financial InformaHon Key Financial Metrics Shareholder Register Ticker Code ASX: BIT No. shareholders 2100 Share Price (26 May 2014) A $0.09 Top 20 shareholder ownership 78.6 million (34.44%) Market cap A $20.4 million Director/Management ownership 14.6 million (6.40%) 12 Month Trading Range A $0.07
Slide 4: Investment Proposition
Investment ProposiHon • HCV market is high growth, mul,-‐billion dollar market • Treatment gaps remain • Phase 2a/2 clinical trials with BIT225 have demonstrated efficacy • BIT225 is well posi,oned to fill significant HCV treatment gaps • HCV Genotype 3 • HIV/HCV co-‐infected pa,ents • Cirrho,c pa,ent
Slide 5: Global Market for Hepatitis C
Global Market for HepaHHs C • Worldwide market for Hepa,,s C forecast to grow from $4.7bn in 2012 to over $18bn by 2018 • 180 million people infected worldwide (3% world popula,on) • 5 million pa,ents in US • 30 million pa,ents in China • New drugs have demonstrated significant pricing power • Gilead
Slide 6: Biotron - Overview
Biotron -‐ Overview • Focused on crea,ng shareholder value with clinical programs for lead drug, BIT225 • Novel approach to trea,ng HCV and HIV infec,ons • Unique mechanism of ac,on • Significant value has been already created • Completed Phase 2 clinical trials have demonstrated efficacy against HCV
Slide 7: Biotron - Technology
Biotron -‐ Technology • Leader in developing viroporin inhibitors for the treatment of viral infec,ons • Target proteins are present in influenza (M2), HIV (Vpu), Hep C (p7), Dengue and West Nile (M protein), SARS (E protein) and others • Rapid proprietary primary screening assays for target protein
Slide 8: Biotron - Advanced Pipeline Overview
Biotron -‐ Advanced Pipeline Overview INDICATION COMPOUND DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Hep C BIT225 HIV/Hep C BIT225 HIV BIT225 Next generaHon -‐ BIT314 HCV Dengue Leads Slide 6
Slide 9: BIT225 – First of a New Class of HCV DAA Drugs
BIT225 – First of a New Class of HCV DAA Drugs ü Novel, oral, small molecule compound 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 BIT225 -‐ ASSEMBLY/ ü Pan-‐genotype ac,vity: BUDDIN
Slide 10: BIT225 – Strategic Positioning
BIT225 – Strategic PosiHoning • Novel target and mechanism of ac,on • Target difficult to treat popula,ons • Current DAAs are poor in certain pa,ent groups • Gen 3 and Cirrho,cs • Issues with some DAAs (e.g. protease inhibitors) in HIV/HCV co-‐infecteds • Poten,ally safe to use in combina,on with IFN
Slide 11: BIT225 – Differentiated Product Profile
BIT225 – DifferenHated Product Profile HCV HCV HIV/HCV Drug Class CirrhoHcs Genotype 1 Genotype 3 co-‐infected Interferon & Ribavirin ü " NS5A inhibitors ü ü ü NS5B polymerase inhibitors ü ü NS3/NS4A protease inhibitors ü û BIT225 (p7 inhibitor) ü ü ü ? Slide 9
Slide 12: BIT225 Development Strategy
BIT225 Development Strategy • Mul,ple pathways to demonstrate clinically relevant improvements in efficacy • Improved SVR rates in difficult-‐to-‐treat popula,ons • Shorter treatment dura,on • Interferon and Ribavirin (IFN/RBV) free regimens • Demonstrate 3 months safety and efficacy with new and old SO
Slide 13: 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 14: Phase 1 Trials
Phase 1 Trials • BIT225-‐001 & BIT225-‐003 Trials • Phase 1 studies to demonstrate safety and iden,fy ini,al dose response • 35mg to 600mg BIT225 single dose escala,on in 48 healthy volunteers • 35mg and 200mg BIT225 BID for 7 days in 18 HCV-‐infected pa,ents • Results and Conclusions • BIT225 wa
Slide 15: Phase 2a - BIT225-005
Phase 2a -‐ BIT225-‐005 • Phase 2a trial • Double blind, placebo controlled trial in treatment naïve HCV Genotype 1 pa,ents (n=24) • 200mg and 400mg BID doses of BIT225 for 28 days with SOC IFN/RBV for 48weeks; randomized 1:1:1 • Results • BIT225 demonstrated good an,viral ac,vity against HCV Geno
Slide 16: BIT225 - Clinical Activity in BIT225-005
BIT225 -‐ Clinical AcHvity in BIT225-‐005 n=8 Placebo + IFN/RBV IFN/RBV IFN/RBV BIT225 200 mg BID + IFN/RBV EVR ETVR n=8 IFN/RBV IFN/RBV n=8 BIT225 400 mg BID + IFN/RBV Week 4 12 48 BIT225-‐005: HCV RNA Response (Baseline Adjusted Median Change) Median log reducHon % Complete EVR % ETVR Treatment
Slide 17: Phase 2 - BIT225-006
Phase 2 -‐ BIT225-‐006 • Phase 2 trial • On-‐going, open label study in HIV/HCV Gen 1 & 3 co-‐infected pa,ents on stable ART regimens (n=12) • 300mg BID BIT225 for 28 days in combina,on with IFN/RBV, with a 7 day lead in with IFN/RBV prior to commencing BIT225 • Results (Interim) • 7 pa,ents ach
Slide 18: BIT225 - Clinical Activity in BIT225-006 (interim data)
BIT225 -‐ Clinical AcHvity in BIT225-‐006 (interim data) NB All paFents were stable on ART before and throughout the study; BIT225 300 mg BID + IFN/RBV – n=4 HCV Genotype 1 HIV remained undetectable during the treatment period n=12 IFN/RBV IFN/RBV BIT225 300 mg BID + IFN/RBV – HCV Genotype 3 n=8 E
Slide 19: HIV – Towards a Cure + BIT225
HIV – Towards a Cure • Currently, pa,ents need to stay on an,retroviral drugs (ART) to • BIT225 targets HIV Vpu; interferes with assembly and budding of keep virus levels under control new virions • Industry is now focused on developing drugs to eradicate or cure • Phase 2a trial demonstrated BIT225
Slide 20: BIT225 Profile
BIT225 Profile • Efficacy • Pan-‐genotypic ac,vity in vitro • Clinical efficacy demonstrated in HCV Gen 1 and Gen 3 and HCV in HCV/HIV co-‐infected pa,ents • Accelerated decline in HCV viral load over IFN/RBV • Safety • Safety profile generally consistent with IFN/RBV • Well tolerated in doses up to 400
Slide 21: 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: -‐ Randomized, placebo-‐controlled, double
Slide 22: BIT225-009: HCV Phase 2 Combination Trial with DAA (proposed)
BIT225-‐009: HCV Phase 2 CombinaHon Trial with DAA (proposed) n=25 Placebo + DAA+ RBV HCV Genotype 3 BIT225+DAA+ RBV n=25 HCV Genotype 3 Week 4 8 12 NB – Trial design and dosing is yet to be finalized and is subject to regulatory approval Design: Aims: -‐ Randomized, placebo-‐controlled, double-‐
Slide 23: Potential to Create Further Value of BIT225 Program
PotenHal to Create Further Value of BIT225 Program • cirrho,c pa,ents HCV • Safety profile suggests suitability for this hard to treat popula,on with major unmet need • HIV/HCV co-‐infected study • In combina,on with DAA(s) • Supported by DDI study • Poten,al for part-‐funding from bodies such as A
Slide 24: Investment Highlights
Investment Highlights • Novel approach to trea,ng Hepa,,s C and HIV infec,ons • Phase 2 clinical trials have demonstrated efficacy • Strategically posi,oned for use in hard-‐to-‐treat subpopula,ons of Hepa,,s C, including • Genotype 3 • HCV/HIV co-‐infected • Cirrho,cs • Next trials will demonstrat
Slide 25: www.biotron.com.au
Dr Michelle Miller Managing Director +61 412 313329 mmiller@biotron.com.au www.biotron.com.au