Attacking Cancer with Oncolytic Virotherapeutics Bryan Dulhunty Managing Director bryan.dulhunty@viralytics.com | www.viralytics.com | Listed on the Australian Stock Exchange: VLA and OTC: VRACY
Today’s discussion 1. The exciting frontier of Oncolytic Virotherapeutics 2. The Viralytics story Our development I. Our lead drug - CAVATAK™ II. Clinical development III. Management and financial resources IV. bryan.dulhunty@viralytics.com | +61433 217876
1. The exciting frontier of Oncolytic Virotherapeutics bryan.dulhunty@viralytics.com | +61433 217876
What is Virotherapeutics Representative scales of viruses Vacciniavirus Herpesvirus Adenovirus Reovirus Coxsackievirus A21 Coxsackievirus A21 CAVATAK™ Viralytic’s lead candidate The treatment of cancer by infecting cancer cells with viruses , resulting in the destruction of cancer cells while leaving other cells undamaged. bryan.dulhunty@viralytics.com | +61433 217876
Can a virus be used to treat cancer? The world’s largest biotechnology company certainly believes so with its $1billion 2011 acquisition of Biovex bryan.dulhunty@viralytics.com | +61433 217876
Pushing the Virotherapeutics frontier Drivers of Virotherapeutics 400 Exponential increase o Strong scientific research in scientific papers published o Quality clinical trial data 300 o Commercial investment 200 100 0 2006 2008 2009 2005 2007 bryan.dulhunty@viralytics.com | +61433 217876
Virotherapeutics in development Company Product, Virus Ownership Commercial Value/Deals Stage of Development US $1 billion Phase III : Melanoma and Biovex Inc OncoVEX Acquired by Amgen 2011 amount Amgen paid for Head & Neck (USA) herpes virus (previously private) Biovex 2011 cancer Oncolytics Biotech REOLYSIN US $450 m Phase III : Head and Neck (Canada) Publically Listed - NASDAQ Reovirus Market Capitalisation cancer US $116 m Jennerex JX-594 Private European rights licensing Phase II : Liver cancer (USA) Pox virus development deal 2010 Phase II : Melanoma CAVATAK ™ impending US Trial. Viralytics Coxsackievirus US $50million Publically Listed - ASX Phase I : (Australia) EVATAK™ Market Capitalisation Melanoma, Breast, Prostate, Echovirus Gioblastoma bryan.dulhunty@viralytics.com | +61433 217876
2. The Viralytics story bryan.dulhunty@viralytics.com | +61433 217876
I. Our development Acquired portfolio of virus technologies from an Australian University 2005 Decision to commercialize Coxsackievirus A21 - trademarked CAVATAK™ 2006 CAVATAK™ receives orphan drug status from FDA US and European patents granted for CAVATAK™ 2008 Multiple Phase I intratumoral and intravenous studies commenced in a number of cancer indications using CAVATAK™ IND approval for Phase II melanoma trial using CAVATAK™ expected 2011 imminently bryan.dulhunty@viralytics.com | +61433 217876
Viralytics ’ Oncolytic Viruses CAVATAK ™ - naturally occurring, genetically unaltered Coxsackievirus A21 targeting the ICAM -1 receptor dominant on metastatic cancer EVATAK ™ - naturally occurring, genetically unaltered echovirus type 1 targeting integrin a2b1 bryan.dulhunty@viralytics.com | +61433 217876
Our pipeline - more than melanoma bryan.dulhunty@viralytics.com | +61433 217876
II. Our lead drug - CAVATAK TM Trademarked name of Coxsackievirus A21 o Enterovirus forming part of the common cold family of viruses o Has not been genetically altered o Infects and destroys a wide range of cancer cells (in tumors and o metastases) leaving healthy cells intact. Destruction of tumor cells elicits body’s own immune response against remaining cancer cells Superior dosing regime provides highly concentrated dose directly to o cancer as a result of CAVATAK™ size, unique exterior binding mechanism and speed of replication bryan.dulhunty@viralytics.com | +61433 217876
Mode of action Specific attachment 1 & infection of cancer cell 1 CAVATAK 3 2 Rapid replication of CAVATAK ™ 2 3 Cancer cell death Every virus that successfully infects a cancer cell results in thousands of progeny viruses that can potentially infect and destroy more cancer cells. bryan.dulhunty@viralytics.com | +61433 217876
Oncologist endorsement of CAVATAK ™ Intravenous Intratumoral “This is probably the lowest dose saline of virus administered that has had therapeutic benefit in an animal model that I have seen published” Professor Bell TM CAVATAK Virotherapy paves the way for new cancer treatment Lancet Oncology Vol 5, No. 3 2004 p135-196 bryan.dulhunty@viralytics.com | +61433 217876
III. Clinical development Intratumoral delivery Melanoma o Phase I Australian trial in single dose studies completed. Safe, well tolerated: no SAEs reported. 57% experienced reductions in injected tumour volume or stabilisation following multiple single injections. 2 patients displayed stable disease (RECIST 1.0) o Phase II USA trial - FDA approval pending. 63 patient intratumoural trial, multiple tumours, multiple injections Head and Neck o Ongoing Phase I trial Intravenous delivery o Ongoing Phase I trial - solid tumour cancers - prostate, breast & melanoma bryan.dulhunty@viralytics.com | +61433 217876
Phase 1 melanoma trial results Trial X01/X02 Trial X-03 Injected Tumour % Patients Response (n=5) (n=6) 2 a 3 b Reduction 35.7 1 c 2 c Stable 21.4 2 d 4 d Progressive 42.9 Reduction + Stable 57.1 a) Reduction=decrease in longest diameter ≥20% (calipers) or visual tumour flattening b) Reduction= transient decrease in volume ≥25% (ultrasound) c) Stable= decrease in tumour volume of <25% or <20% increase in tumour volume (ultrasound) d) Progressive= increase in tumour volume of >20% (ultrasound) bryan.dulhunty@viralytics.com | +61433 217876
IND allowed Phase II CALM study To investigate CAVATAK ™ for the treatment of Late Stage Melanoma. IND application to the USA FDA submitted. Considering other countries for study. Site selection for study has commenced. Recruitment in the US will begin once the study is approved by the FDA. bryan.dulhunty@viralytics.com | +61433 217876
Corporate overview Listed - on the Australian Stock Exchange (VLA) and the OTC market (VRACY) . One of two publicly traded Virotherapy companies in the world Head Office - Sydney Research & Operations - Newcastle University, Australia Manufacturing - cGMP manufacture of CAVATAK™ in USA. bryan.dulhunty@viralytics.com | +61433 217876
Worldwide patent coverage PCT/AU2000/001461 A Method of Treating a Malignancy in a Subject and a Pharmaceutical Composition for Use in the Same . Granted: Australia, Europe, USA Pending: Canada, Japan, NZ Divisional Granted: Australia Divisional Pending: Australia, Europe, USA PCT/AU2003/001688 A Method of Treating a Malignancy in a Subject via Direct Picornaviral-Mediated Oncolysis. Granted: Australian, India, NZ, Singapore, South Africa, USA Pending: Canada, China, Europe, Japan, South Korea, Hong Kong Divisional Granted: India Divisional Pending: USA PCT/AU2005/000048 Modified Oncolytic Viruses. Granted: South Africa Pending: Australia, Hong Kong, India, Japan, New Zealand, USA PCT/AU2005/001257 Methods and Compositions for Treatment of Hematologic Cancers. Pending: Australia, Canada, China, Europe, Hong Kong, India, Japan, NZ, Singapore, South Africa, South Korea, USA PCT/AU2006/000051 Method and Composition for Treatment of Neoplasms. Pending: Australia, China, Europe, Hong Kong, India, USA bryan.dulhunty@viralytics.com | +61433 217876
IV. Management & financial resources Board Mr Paul Hopper | Chairman - US based director of NASDAQ listed Biotechs with extensive capital markets experience in US and Asia Dr Phillip Altman | extensive clinical trial background having established his own clinical research organization Mr Peter Molloy | prior MD of Biota Inc., ex large pharmaceutical executive - VP Strategic Marketing for Pharmacia Management Mr Bryan Dulhunty | Managing Director, long term capital intensive project specialist Professor Darren Shafren | CSO and Inventor of Technology bryan.dulhunty@viralytics.com | +61433 217876
Management capabilities Scientific Advisory Board Current SAB to be significantly strengthened through recruitment of internationally recognised members. Announcement to be made shortly. Collaborations International clinical collaborations are being formed to pursue clinical research of CAVATAK™ use with bladder, lung and pancreatic cancers. bryan.dulhunty@viralytics.com | +61433 217876
Financials US$ 60m Market Capitalisation A stable US$ 0.11 Share Price company US$ 5.6m Cash on Hand here for the US$ 3.5m p.a. Burn Rate - historical long term 587m Shares on Issue 5,700 Shareholders bryan.dulhunty@viralytics.com | +61433 217876
Forecast funding needs - 3 years Phase II Intratumoral trial US$5m Phase II Intravenous trial US$5m Scientific and clinical collaborations US$3m Development of EVATAK virus US$2m Ongoing research US$3m Corporate activities US$3m Total estimated 3 year spend US$21m bryan.dulhunty@viralytics.com | +61433 217876
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