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Viralytics Ltd iralytics Ltd For personal use only Oncolytic Virotherapy - Targeted Cancer Therapy 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 statements include, but are not limited to, sales of CAVATAK™ products; development and commercialization of li i d l f CAVATAK™ d d l d i li i f the Company’s product portfolio; development or acquisition of additional products; and other risks and uncertainties. Viralytics undertakes no duty to update any of th these forward-looking statements to confirm them to actual res ults. f d l ki t t t t fi th t t l lt USA Corporate Presentation USA Corporate Presentation
Who is Viralytics – Who is Viralytics – Clinical Develo Clinical Development p ment For personal use only What does Viralytics do What does Viralytics do : Viralytics develops oncolytic viruses to extend patient survival and improve the quality of life for cancer p q y patients. Viralytics’ lead product is CAVATAK TM . In pre- clinical work CAVATAK TM has shown significant potential to treat a large range of cancers. p g g State of Clinical Development: Having completed two Phase I melanoma studies in 3D image of Australia with Stage 4 patients, using CAVATAK TM , Coxsackievirus A21 Viralytics is aiming to commence a Phase II Melanoma (CAVATAK TM ) trial in USA in 2010. USA Corporate Presentation USA Corporate Presentation Page 1
Who is Viralytics – Who is Viralytics – Phase I Phase I Melanoma Trials Resu Melanoma Trials Resu lts lts For personal use only Initial results Significant - Final Report Pending Trial X01/X02 Trial X-03 Injected Tumour % Patients Response (n=5) (n=6) 2 a 2 a 3 b 3 b Reduction Reduction 35 7 35.7 Stable 1 c 2 c 21.4 2 d 4 d Progressive 42.9 Reduction + 57.1% Stable Stable Details of the trial are set out in Appendix 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) ) g ( ) Page 2 USA Corporate Presentation USA Corporate Presentation
Who is Viralytics – Who is Viralytics – Clinical Develo Clinical Development p ment For personal use only Other clinical trials that are currently being undertaken Viralytics has two further Phase I studies underway: Viralytics has two further Phase I studies underway: - Head and Neck intratumoral study in late stage patients being conducted in multiple sites in Australia; and - Melanoma, Breast and Prostate cancer intravenous study in late stage patients in multiple sites in Australia. Further details of these trials are set out in Appendix 2 Brain Cancer (glioblastomas) Collaboration Viralytics is undertaking an international collaboration to examine the potential Viralytics is undertaking an international collaboration to examine the potential of CAVATAK TM to treat glioblastomas with a leading North American neurosurgeon, Professor Guha. Orphan Drug Status Viralytics has received Orphan Drug Status for the treatment of melanoma with CAVATAK TM CAVATAK TM. Page 3 USA Corporate Presentation USA Corporate Presentation
Who is Viralytics Who is Viralytics - Preclinical Proof of Conce Preclinical Proof of Concept p For personal use only Preclinical Proof of Concept has been achieved in a range of cancers f • Bioluminescent imaging - tumours in mice eliminated with in mice eliminated with CAVATAK™ treatment compared Melanoma to treatment with a placebo (MV3) • Tumours were transplanted into Tumours were transplanted into mice and stabilized for a week before commencing treatment with CAVATAK™ • Results were presented at the 4 th Breast International Conference on Cancer Oncolytic Viruses as Cancer (MDA ‐ MB ‐ 231 Therapeutics (March 2007, Arizona, USA) and published in Breast Cancer Research and Treatment (2008) Page 4 USA Corporate Presentation USA Corporate Presentation
Who is Viralytics – Who is Viralytics – Financial & Cor Financial & Corporate Summar p p orate Summary y y For personal use only Listed Company Viralytics is listed on the Australia Securities Exchange (VLA) and is quoted Viralytics is listed on the Australia Securities Exchange (VLA) and is quoted on the OTC market.(VRACY) • Market Capitalization @ $0.03 cent share p @ $ US$10 m $ • Share Price – 52 week High/Low $0.054/$0.025 • Number of Ordinary Shares 322 m • Average Monthly Share Turnover 17.4 m • Top Three Shareholders own 10.5% • Funding C Cash at Bank as at 30 September 2009 h t B k t 30 S t b 2009 US$ 0 92 US$ 0.92m Convertible Note Facility – La Jolla Cove Investors US$ 5.25m Listed Options – expiry June 2010 US$ 2.75m Historical Investments – sale Hi t i l I t t l US$ 1.10m US$ 1 10 Total funding accessible to Company US$10.00m • Investment in project to date • Investment in project to date US$25 0m US$25.0m Page 5 USA Corporate Presentation USA Corporate Presentation
Who is Viralytics - Who is Viralytics - Other Cor Other Corporate facts p orate facts For personal use only • Research - Contracted to the University of Newcastle. Newcastle. • Intellectual Property - Broad patents granted in US and Europe and many other countries. p y – 5 patent families have patents pending. • Second product - EVATAK™ undergoing g g p preclinical research. Ongoing research being carried out on other viruses. The research facilities e esea c ac t es • Management - Commercially experienced C i ll i d M leased by Viralytics at management and scientific team with very lean the University of overheads Newcastle. • Commercialization - Phase II licensing strategy as well as licensing of pre-clinical assets opportunity Page 6 USA Corporate Presentation USA Corporate Presentation
Current Industry Structure Current Industry Structure For personal use only The expectation is there will be many virotherapy products on the market just as there are many chemotherapy products on the market • Currently there are approximately 8 companies world wide investigating y pp y p g g various types of oncolytic viruses • The Oncolytic Virotherapy industry has really only taken its current form in the last ten years with the appearance of comparatively well funded North last ten years with the appearance of comparatively well funded North American Companies. Prior to this Oncolytic Virotherapy had scientific interest but little funding to move research into clinical trials • Two companies have recently announced the commencement of three Phase Two companies have recently announced the commencement of three Phase III trials • Viralytics is Australia’s only listed company developing oncolytic viruses. Page 7 USA Corporate Presentation USA Corporate Presentation
Current Industry Structure – Current Industry Structure – Major players ajor players For personal use only Company Virus Background Market Stage of Development Value/Funding Value/Funding Oncolytics Biotech Reolysin (Reovirus) Public Listed > $150m USD Mkt Phase III Head and Neck, Inc (Calgary, Value - Sept 09 Phase II Lung, Pancreatic Ovarian, Canada) Melanoma, Glioma Crusade Labs HSV1716 (GM Private Not Available Phase III Glioblastoma (Scotand, UK) Herpes Simplex Virus) Biovex Inc (MA Biovex Inc (MA, Oncovex (GM Herpes Oncovex (GM Herpes Private Private > $150m USD > $150m USD Phase III Melanoma & Head an Neck Phase III Melanoma & Head an Neck. USA) Simplex Virus) funding Jennerex (CA, USA) JX-594 (GM Vaccina Private $8.3m USD Series Phase II Melanoma & Head an Neck. Virus) B Series A N/A Cell Genesis (CA, CG0070 (GM Public Listed Not Applicable Phase I Bladder cancer USA) Adenovirus) Multi-product Medigene M di NV1020 (GM H NV1020 (GM Herpes P bli Li t d Public Listed Not Applicable N t A li bl Ph Phase II Colon/Liver II C l /Li (Germany) Simplex Virus) Multi-product Wellstat Biologics PV701 (Newcastle Private Not Available Phase II Colorectal & Cervical cancer C Corp (MA, USA) (MA USA) Di Disease Virus) Vi ) Page 8 USA Corporate Presentation USA Corporate Presentation
Historical Evidence of Oncolytic Virotherapy Historical Evidence of Oncolytic Virotherapy For personal use only Viruses and cancer – there are any number of documented cases of cancers going into spontaneous remission after subjects were exposed to various types i i t t i i ft bj t d t i t of viral infections. In the case below, regression of a case of Burkitt’s Lymphoma was observed following a measles virus infection. Page 9 USA Corporate Presentation USA Corporate Presentation
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