Slide 1: Biotron Limited Investor Briefing
BIOTRON LIMITED (ASX:BIT) Investor Briefing October 2013
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward‐looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not histor
Slide 3: Biotron Limited Overview
Biotron Limited Overview • Clinical stage antiviral drug development company • Clinical programs for Hepatitis C virus (HCV) and HIV • Earlier stage programs include Dengue and others • Spun out from Australian National University, Canberra, Australia • Headquartered in Sydney, Australia • IPO Jan 2
Slide 4: Key Financials and Facts
Key Financials and Facts KEY FINANCIALS BOARD AND MANAGEMENT BIOTRON ASX Code LIMITED price BIT history chart Mr Michael Hoy Chairman Recent Share Price (21 October 2013) A$0.10 Dr Michelle Miller CEO & Managing Director 52 Week High A$0.15 Dr Denis Wade Non-Executive Director 52 Week Low A$0.08 Dr
Slide 5: Biotron - Advanced Pipeline of Clinical Programs
Biotron - Advanced Pipeline of Clinical Programs VIRAL INDICATION DISCOVERY PRECLINICAL PHASE 1a PHASE 1b PHASE 2a PHASE 2b STATUS TARGET • Ph 2a complete; Hep C p7 • Ph 2b (3 mth dosing) scheduled for 4Q13 HIV Vpu • Ph 2a complete • Ph 2 completed HIV/Hep C Vpu/p7 clinical phase Next • Ready for IN
Slide 6: Hepatitis C Virus – The Silent Killer
Hepatitis C Virus – The Silent Killer • 180 m people infected worldwide (3% world population); 130 m are chronically infected; 4 m patients in US (2.7 m chronically infected) • Majority of infected patients remain untreated or untreatable • Up to 50% patients don’t respond to current treatment • Sta
Slide 7: Direct-Acting Antiviral Drugs
Direct-Acting Antiviral Drugs • Industry focus is on developing direct-acting antiviral drugs (DAAs) • Future treatments expected to be combination of different classes of DAAs • Genotype differences in treatment response • Potential for virus resistance with some classes of DAAs • Main focus is on
Slide 8: HCV – Scene of Billion Dollar Deals
HCV – Scene of Billion Dollar Deals Nov 2011 – Gilead (GILD) acquired Pharmasset (VRUS) for US$11 billion - PSI-7977 was in early Phase 3 trials Jan 2012 – BMS acquired Inhibitex (INHX) for US$2.5 billion - INX-189 was in Phase 2 trials
Slide 9: BIT225 – New Class of HCV DAA Drug
BIT225 – New Class of HCV DAA Drug Novel, oral, small molecule compound Only one of its class (p7 inhibitor) in clinical trials Inhibits viral assembly; active at later stage of virus life cycle to polymerase and protease inhibitors Doesn’t readily generate resistance Synergistic in vitro
Slide 10: BIT225 – Proven Clinical Activity Against HCV
BIT225 – Proven Clinical Activity Against HCV BIT225 Interferon + Ribavirin BIT225-005 Placebo 0 4 wks 12 wks 48 wks 12 WEEKS 48 WEEKS Treatment Early Virological Response* Sustained Virological Response* 400 mg BIT225 + IFN/RBV 86% 100% 200 mg BIT225 + IFN/RBV 88% 88% Placebo + IFN/RBV 63% 75% *vir
Slide 11: BIT225 – HIV / HCV Co-Infected Trial
BIT225 – HIV / HCV Co-Infected Trial • Phase 2 HIV/HCV trial - completed clinical phase in July 2013 – ~30% of HIV-infected people in the USA are also HCV-infected – Significantly worse prognosis than mono-infected patients BIT225-006 BIT225 Interferon + Ribavirin ART 0 1 wk 5 wks 48 wks – 28 days d
Slide 12: HIV – Towards a Cure
HIV – Towards a Cure • 34 million people worldwide living with HIV • Anti-HIV drugs (ART) have improved the quality of life for HIV+ patients * • BUT – ART does not eradicate HIV infection • Sustained, low-level HIV replication occurs in ART-treated patients • Reservoirs of infection hide virus from
Slide 13: Proven Clinical Activity Against HIV
BIT225 – Proven Clinical Activity Against HIV 16 Placebo • Phase 2a trial of BIT225 in HIV+ve’s completed in late 2012 BIT225 HIV-1 Replication (pg/200uL) 14 – Randomised, placebo controlled, double-blind trial 12 – 24 patients, HIV+, treatment-naïve 10 8 – 10 days dosing with BIT225 (monotherapy) 6
Slide 14: BIT225 – Multiple Market Opportunities
BIT225 –Multiple Market Opportunities • Hepatitis C • Potential for future combination cocktails with polymerase and protease inhibitors • Unique mode of action • Good drug-drug interaction profile • Limited alternative classes for combinations (prevention of resistance) • Potential to fill gaps lef
Slide 15: BIT225 - HCV Phase 2 Three-Month Dosing Trial
BIT225 - HCV Phase 2 Three-Month Dosing Trial BIT225 Interferon + Ribavirin BIT225-008 Placebo 0 4 wks 12 wks 24 wks 48 wks - Randomised, placebo-controlled, double-blind trial (end for Gen 3) (end for Gen 1) - Treatment naïve, HCV gen 1 and 3 - 3 months dosing with BIT225 in combination with IFN/RB
Slide 16: Biotron Outlook 2013/14
Biotron Outlook 2013/14 4Q13 1Q14 2Q14 3Q14 4Q14 4Q13 - Commence Mid ‘14- HCV Ph2 HCV (3 month Complete Preliminary, interim dosing with IFN/RBV) enrolment of data from Ph 2, 3 (BIT225-008) BIT225-008 month HCV trial HIV IND (BIT225-008) Additional data Submit an from the Phase 2a Investigational HI
Slide 17: Dr Michelle Miller
Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au