Investor Presentation April 3, 2013
Disclaimer This presentation contains forward-looking statements that involve risks and uncertainties. These forward-looking statements are not guarantees of Viralytics future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Company’s results to differ materially from those expressed or implied by such forward-looking 2 statements include, but are not limited to, sales of CAVATAK™ products; development and commercialisation of the Company’s product portfolio; development or acquisition of additional products; and other risks and uncertainties. Viralytics undertakes no duty to update any of these forward-looking statements to confirm them to actual results. Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Viralytics Ltd (ASX:VLA) is an Australian ASX listed biotechnology cancer company focussed on developing 3 viruses which selectively target cancer cells. Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Overview - Lead product is CAVATAK™ with broad anti-cancer activity - CAVATAK™ program: - Completed five Australian Phase 1 trials with 28 patients - Current US Phase 2 trial in melanoma patients - Planned Phase 1/2 UK trial in lung, prostate, bladder and melanoma cancer patients 4 - Potential low toxicity unlike traditional chemotherapies - Achieved GMP manufacture - Robust intellectual property/patent portfolio - Big Pharma interest: 2011 US$1.0 billion Amgen/Biovex deal - One of only 2 listed oncolytic virus companies globally - Experienced Board/Management and Scientific team Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Corporate Snapshot - Ticker Symbol: VLA - Share Price: A$0.29 - Outstanding Shares: 87.2m - Outstanding Options: 5.9m - Market Cap: A$25m 5 - Debt/Convertibles: NIL - Trading Range: A$0.20 – 0.465 (last 12 months) - Average Daily Trading Volume: A$27,000 (last 12 months) - Top 20 Shareholders Own: ~15% - Cash: A$8.1m (as at December 31, 2012) - Founded: 2004 Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ - Proprietary formulation of the genetically unmodified human Coxsackievirus A21 (involved in common cold) - Binds to ICAM-1 receptor present in abundance on the surface of many cancer cell types - Acts to kill local and metastatic cancer cells, by direct cytolysis and by a 6 possible immune response - Targeted towards cancer cells thus potential for low toxicity - Possible application across a range of common cancer types including prostate, lung, melanoma and bladder cancer Cancer Type Rank * Estimated New Cases in the US in 2013 Prostate #1 238,590 Lung #3 228,190 Melanoma #5 76,690 Bladder #6 72,570 * USA National Cancer Institute, 2013 Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Melanoma - A malignant skin tumour that can grow and spread to lymph nodes and internal organs, potentially resulting in death - World Health Organization reports the incidence of malignant melanoma is increasing faster than any other cancer - Datamonitor Report 2012* 7 - Approximately 125,700 men and women were diagnosed with malignant melanoma in the big 7 markets (US, Japan, France, Germany, Italy, Spain, and the UK) in 2011 - Branded melanoma product sales to experience a dramatic increase from $1.1Bn to $2.4Bn in big 7 markets from 2012 – 2021 - Drug resistance and toxicity still major problems thus there are opportunities for developers to move into the market * Datamonitor Healthcare - Market and Product Forecasts Melanoma October 2012 Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ – Preclinical Results - Results show potent and relatively rapid cancer killing activity across a wide range of human cancers including melanoma, pancreatic, lung, prostate and breast cancer - Possible application in combination with select chemotherapeutic agents e.g. docetaxel - Significant reduction or total eradication of human cancers including 8 melanoma in mice after virus injection CAVATAK TM • Mice dosed with 10 8 TCID 50 CAVATAK TM intratumourally and then assessed 45 days later. • Melanoma presence shown by colour scale Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Manufacture - cGMP formulation produced at Sigma-Aldrich in the US - Purified from culture in mammalian cells - Highly stable at -70 °C storage - Simple manufacturing process 9 - Low manufacturing costs Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ – Phase 1 Results - Five Australian studies – 28 patients - Intratumoural and intravenous dosing - CAVATAK™ well tolerated - Evidence of tumour stabilisation in some patients 10 Name Type Disease Stage Indication No. of Patients VLA-01 Single Dose Intratumoural Stage IV Melanoma 2 VLA-02 Single Dose Intratumoural Stage IV Melanoma 3 VLA-03 Multi-dose Escalation Intratumoural Stage IV Melanoma 9 Melanoma, Colorectal, VLA-04 Single Dose Intravenous Stage IV 10 Breast, Prostate VLA-06 Multi-dose Intratumoural Stage IV Head and Neck 4 Total 28 Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study (Cavatak in Late stage Melanoma) – Phase 2 conducted under FDA IND – Currently recruiting with target of 63 late stage melanoma patients – Primary Endpoint: Stable Disease (or better) at 6 months from starting treatment – 8 Centres open – up to 7 more sites planned 11 – As at March 2013: – 25 patients recruited to date Achievement of interim efficacy milestone (≥ 3 objective tumour – responses within the first 35 patients) Name Type - Open Label Disease Stage Indication CALM VLA-07 Ten doses over 18 week period Stage IIIc or IV Melanoma Extension study of VLA 07 CALM VLA-08 Stage IIIc or IV Melanoma Further 9 doses at 3 week intervals Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ – Phase 2 CALM Study Update from Dr R Andtbacka (HemOnc Today, March 22, 2013) 12 Courtesy Dr R Andtbacka, Huntsman Cancer Institute Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ –Phase 2 CALM Study Update from Dr R Andtbacka (HemOnc Today, March 22, 2013) 13 Courtesy Dr R Andtbacka, Huntsman Cancer Institute Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ - Phase 1/2 STORM Study (Systemic Treatment of Resistant Malignancies) - Phase 1/2 study (VLA-09) in approximately 30 late stage melanoma, prostate, lung and metastatic bladder cancer patients - Plan to commence in 2013 in 3 prestigious UK cancer centres - Will investigate multiple intravenous dosing of CAVATAK™ in combination with and without standard chemotherapy (e.g. docetaxel) 14 - Clinical Protocol to be approved by UK regulatory agency prior to commencement - In vitro studies demonstrate potential benefits from a combination of CAVATAK™ and docetaxel - Greater market opportunity if safety and efficacy demonstrated by intravenous administration in solid tumours Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
Strong Intellectual Property Position 25 Patents granted No Infringements or + + + 7 Patent Families worldwide and 25 Minimal Royalties Disputes pending Date Patent Family Applications 2012 Genetically stable oncolytic virus 2012 Pharmaceutical composition 15 2006 Method and Composition in the treatment of Neoplasms 2006 Methods and Compositions for the treatment of Hematologic Cancers 2005 Modified Oncolytic Viruses 2004 A method of treating malignancy in a subject via direct picornaviral-mediated oncolysis 2001 A method of treating a malignancy in a subject and a pharmaceutical composition for use in same Orphan status in the USA: 7 years market exclusivity BLA approval in the USA: 12 years data exclusivity Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
CAVATAK™ Development/ Business Strategy Underway Future Phase 2 CALM ? Double Blind Placebo trial in melanoma Controlled Trial in patients Completed melanoma patients Phase 1 trials Intratumoural 2012 16 and ? Intravenous License to Big Pharma 2003 - 2012 Planned Q3/4 2013 Phase 1/2 CAVATAK TM / ? STORM trial in chemotherapy in solid tumour preferred solid patients tumour type Investor Presentation April 3, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL CONFIDENTIAL
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