Slide 1: Fully Underwritten Rights Issue (ASX cover letter)
Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 For personal use only Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au 15 October 2014 The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000 (17 pages by email) Dear Madam FULLY UNDERWRI
Slide 2: About Biotron and BIT225
The Directors are pleased with the strong demand received from the institutional and sophisticated investors. The bookbuild closed significantly oversubscribed, indicating a level of demand in support of the potential of the Company’s drug development program, positive clinical trial results to date
Slide 3: Biotron Limited Investor Presentation October 2014
BIOTRON LIMITED For personal use only (ASX:BIT) Investor Presenta;on October 2014
Slide 4: Forward Looking Statements
Forward Looking Statements For personal use only 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 stateme
Slide 5: BIT225 Snapshot
BIT225 Snapshot -‐ First in class drug and new drug target for treatment of HIV and Hepa,,s C virus (HCV) -‐ Prepared based on above aVer the August Board mee,ng -‐ Seven clinical trials completed; one in progress For personal use only -‐-‐ Guided Over 170 tshe wording ubjects of wtith dosed he
Slide 6: Biotron - Advanced Pipeline Overview
Biotron -‐ Advanced Pipeline Overview For personal use only 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 2
Slide 7: Global Market for Hepatitis C
Global Market for Hepa;;s C • Worldwide market for Hepa,,s C forecast to grow from $4.7bn in 2012 to over $19bn by 2016 For personal use only • 180 million people infected worldwide (3% world popula,on) • Es,mated 3 to 5 million pa,ents in US • Es,mated 30 million pa,ents in China • New drugs have d
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 For personal use only ü Only one of its class (p7 inhibitor) in clinical trials POLYMERASE/PROTEASE INHIBITORS e.g. Sofosbuvir/Simeprevir ü Inhibits viral assembly and infec,vity ü Pan-‐genotype ac,vity: BIT225 -‐ ASSEMBL
Slide 9: 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) For personal use only • 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, 1
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) BIT225-‐006 (HIV/HCV) For personal use only NB All paBents 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 d
Slide 11: BIT225-008: Phase 2 HCV Three-Month Dosing Trial
BIT225-‐008: Phase 2 HCV Three-‐Month Dosing Trial Placebo + IFN/RBV For personal use only n=20 IFN/RBV (HCV Genotype 1 or 3) 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, placeb
Slide 12: HIV - Towards a Cure
HIV – Towards a Cure For personal use only • 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
Slide 13: BIT225 Targets HIV in Reservoir Cells
BIT225 Targets HIV in Reservoir Cells • BIT225 inhibits assembly and budding of new virions For personal use only • 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
Slide 14: Investment Proposition
Investment Proposi;on • HCV and HIV are high growth, mul,-‐billion dollar markets For personal use only • 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 signifi
Slide 15: Next Steps
Next Steps For personal use only • Complete HCV trial currently in progress • Preliminary data expected late 2014 • Engage with US FDA -‐ Inves,ga,onal New Drug applica,on(s) (INDs) • Complete IND-‐related ac,vi,es • File IND applica,on(s) • Con,nue commercialisa,on ac,vi,es aimed at avrac,ng part
Slide 16: The Offer
The Offer • En,tlement issue For personal use only • 2:9 @ 8 cents with 1:1 30/9/16 op,ons @ 12 cents • Raise $4.1 million before costs, to fund: • Comple,on of the BIT225-‐008 trial currently in progress in Thailand • Comple,on of ac,vi,es leading to filing INDs, including • Drug-‐drug interac,on s
Slide 17: Financial Information
Financial Informa;on Key Financial Metrics 12 Month Share Price Performance For personal use only Ticker Code ASX: BIT Ticker Code ASX: BIT Share Price (10 Oct 2014) A $0.15 Market cap A $34.2 million Share Price (15 Sept 2014) A $0.115 12 Month Trading Range A $0.075 – 0.315 Market cap A $26.3 mill