For personal use only Investor Presentation July 23, 2013
Disclaimer For personal use only Certain statements made in this presentation are forward looking statements within the meaning of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. These forward looking statements are not historical facts but rather are based on Viralytics’ current expectations, estimates, assumptions and projections about the industry in which Viralytics operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’, ‘expect’, ‘plan’, ‘believe’, ‘guidance’ and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. These forward looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of 2 Viralytics or which are difficult to predict, which could cause the actual results, performance or achievements of Viralytics to be materially different from those which may be expressed or implied by these statements. These statements are based on our management’s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally, and challenges inherent in new product development. Investors should be aware that there are no assurances that results will not differ from those projected and Viralytics cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Viralytics only as of the date of this presentation. Viralytics is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority. ’ Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
For personal use only Viralytics Ltd (ASX:VLA) is an Australian ASX listed biotechnology company focussed on 3 developing targeted oncolytic virotherapy to treat a range of cancers Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
Investment Highlights For personal use only - Lead product is CAVATAK ™ with broad anti-cancer activity - CAVATAK ™ ¡ advancing in Phase 2 clinical trial in the US – 38 of target 54 evaluable melanoma patients recruited to date – Strong interim results with solid progress towards achieving the primary endpoint – Activity in both injected and metastatic (secondary) tumours 4 – Well tolerated with no drug related serious adverse events – Full recruitment may occur by end 2013 - Planned Phase 1/2 intravenous trial in the UK in 2013 in solid cancers - Potential for synergy when used with other anti-cancer agents - Achieved GMP manufacture - Robust intellectual property/patent portfolio - Big Pharma interest in field with 2011 US$1.0 billion Amgen/Biovex deal Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
Corporate Snapshot For personal use only - Ticker Symbol: VLA - Share Price: A$0.31 - Outstanding Shares: 87.2m - Outstanding Options: 5.9m 5 - Market Cap: A$27m - Debt/Convertibles: NIL - Trading Range: A$0.20 – 0.465 (last 12 months) - Top 20 Shareholders Own: ~15% - Cash: A$5.1m (as at June 30, 2013) Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ For personal use only - 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 oncolytic and potential immunotherapeutic activity 6 - Targeted towards cancer cells and well tolerated in 66 patients to date - Potential intravenous as well as intratumoural use - Possible application across a range of common cancer types including prostate, lung, melanoma and bladder cancer Cancer Type * Estimated New Cases in the US in 2013 Rank Prostate #1 238,590 Lung #3 228,190 Melanoma #5 76,690 Bladder #6 72,570 * USA National Cancer Institute, 2013 Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
Melanoma For personal use only - 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 7 - Datamonitor Report 2012* - 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 July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ ¡– Preclinical Results For personal use only - Potent and relatively rapid cancer killing activity across a wide range of human cancers - Synergistic activity observed when used in combination with chemotherapy or radiation therapy - Significant reduction or elimination of human cancers including melanoma in mice after virus injection 8 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 July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ ¡– Phase 1 Results For personal use only - Five Australian studies – 28 patients - Intratumoural and intravenous dosing - CAVATAK ™ well tolerated - Evidence of tumour stabilisation in some patients 9 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 July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study (CAvatak in Late stage Melanoma) For personal use only – Phase 2 CALM clinical trial advancing in US under FDA IND – Underway at 9 prestigious US cancer centres – up to 2 more sites planned – 38 patients recruited to date (target of 54 evaluable patients) 10 – Late stage melanoma patients (Stage IIIC or IV) – Intratumoural injection (IT) – direct injection into the melanoma – Positive interim results presented by Lead Study Investigator, Dr Robert Andtbacka, at the World Congress of Melanoma on July 18, 2013 Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 11 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 12 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 13 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 14 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 15 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
CAVATAK ™ – Phase 2 CALM Study Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013) For personal use only 16 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute Investor Presentation July 23, 2013 Investor Presentation April 3, 2013 CONFIDENTIAL
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