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Viralytics Ltd iralytics Ltd

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 li i d l f CAVATAK™ d d l d i li i f limited to, sales of CAVATAK™ products; development and commercialization 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 th f d l ki t t t t fi th t t l

lt

these forward-looking statements to confirm them to actual results.

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Who is Viralytics – Who is Viralytics – Clinical Develo Clinical Development ment p

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 CAVATAKTM. In pre-

clinical work CAVATAKTM 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 Australia with Stage 4 patients, using CAVATAKTM, Viralytics is aiming to commence a Phase II Melanoma

3D image of Coxsackievirus A21 (CAVATAKTM)

trial in USA in 2010.

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Who is Viralytics – Who is Viralytics – Phase I Phase I Melanoma Trials Resu Melanoma Trials Results

lts

Initial results Significant - Final Report Pending

Injected Tumour Response Trial X01/X02 (n=5) Trial X-03 (n=6) % Patients Reduction 2a 3b 35 7 Reduction 2a 3b 35.7 Stable 1c 2c 21.4 Progressive 2d 4d 42.9

Reduction + Stable 57.1% 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)

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Who is Viralytics – Who is Viralytics – Clinical Develo Clinical Development ment p

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

• f CAVATAKTM 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 CAVATAKTM

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CAVATAKTM. Page 3

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Who is Viralytics Who is Viralytics - Preclinical Proof of Conce Preclinical Proof of Concept p

Preclinical Proof of Concept has been achieved in a f

• Bioluminescent imaging - tumours

in mice eliminated with

range of cancers

in mice eliminated with CAVATAK™ treatment compared to treatment with a placebo

• Tumours were transplanted into

Melanoma

(MV3)

Tumours were transplanted into mice and stabilized for a week before commencing treatment with CAVATAK™

• Results were presented at the 4th

International Conference on Oncolytic Viruses as Cancer Breast Cancer

(MDA‐MB‐231

Therapeutics (March 2007, Arizona, USA) and published in Breast Cancer Research and

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Treatment (2008) Page 4

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Who is Viralytics – Who is Viralytics – Financial & Cor Financial & Corporate Summar

• rate Summary

p y p y

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

• n the OTC market.(VRACY)
• Market Capitalization @ $0.03 cent share

US$10 m p @ $ $

• 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 h t B k t 30 S t b 2009 US$ 0 92 Cash at Bank as at 30 September 2009 US$ 0.92m Convertible Note Facility – La Jolla Cove Investors US$ 5.25m Listed Options – expiry June 2010 US$ 2.75m Hi t i l I t t l US$ 1 10 Historical Investments – sale US$ 1.10m Total funding accessible to Company US$10.00m

• Investment in project to date

US$25 0m

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• Investment in project to date

US$25.0m Page 5

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Who is Viralytics - Who is Viralytics - Other Cor Other Corporate facts

• rate facts

p

• 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

p g g preclinical research. Ongoing research being carried out on other viruses. M C i ll i d The research facilities

• Management - Commercially experienced

management and scientific team with very lean

• verheads

e esea c ac t es leased by Viralytics at the University of Newcastle.

• Commercialization - Phase II licensing strategy

as well as licensing of pre-clinical assets

• pportunity

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Current Industry Structure Current Industry Structure

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.

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Current Industry Structure – Current Industry Structure – Major players ajor players

Company Virus Background Market Value/Funding Stage of Development Value/Funding

> $150m USD Mkt Value - Sept 09 Reolysin (Reovirus) Oncolytics Biotech Inc (Calgary, Canada) Public Listed Phase III Head and Neck, Phase II Lung, Pancreatic Ovarian, Melanoma, Glioma Crusade Labs (Scotand, UK) HSV1716 (GM Herpes Simplex Virus) Private Not Available Phase III Glioblastoma Biovex Inc (MA Oncovex (GM Herpes Private > $150m USD Phase III Melanoma & Head an Neck Biovex Inc (MA, USA) Oncovex (GM Herpes Simplex Virus) Private > $150m USD funding Phase III Melanoma & Head an Neck. $8.3m USD Series Jennerex (CA, USA) JX-594 (GM Vaccina Private Phase II Melanoma & Head an Neck. B Series A N/A Not Applicable M di NV1020 (GM H P bli Li t d N t A li bl Ph II C l /Li CG0070 (GM Adenovirus) Public Listed Multi-product Phase I Bladder cancer Cell Genesis (CA, USA) Virus) Medigene (Germany) NV1020 (GM Herpes Simplex Virus) Public Listed Multi-product Not Applicable Phase II Colon/Liver Wellstat Biologics C (MA USA) PV701 (Newcastle Di Vi ) Private Not Available Phase II Colorectal & Cervical cancer

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Corp (MA, USA) Disease Virus)

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Historical Evidence of Oncolytic Virotherapy Historical Evidence of Oncolytic Virotherapy

Viruses and cancer – there are any number of documented cases of cancers i i t t i i ft bj t d t i t going into spontaneous remission after subjects were exposed to various types

• f viral infections. In the case below, regression of a case of Burkitt’s

Lymphoma was observed following a measles virus infection.

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Virotherapy irotherapy

What is Oncolytic Virotherapy?

It is the treatment of a range of cancers with a class of viruses (oncolytic viruses) to detect, target and destroy cancer cells; either through direct lysing of the cell and/or inducing the immune system to detect tumours and lysing of the cell and/or inducing the immune system to detect tumours and then mount its own defense against the cancer.

Reovirus Coxsackievirus Adenovirus Reovirus

25nm

Vaccinia virus Herpesvirus USA Corporate Presentation USA Corporate Presentation

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How Oncolytic Virotherapy Works How Oncolytic Virotherapy Works

Method of Action

Attachment and infection of a

1

Attachment and infection of a cancer cell – CAVATAK™ binds to ICAM-1 receptors to allow viral RNA infection into the cell

CAVATAK™ life cycle

2

Replication

• rapid

speed

• f

CAVATAK™ replication allows small doses to have a significant

1

CAVATAKTM

3

effect

3

Cell death releasing thousands

• f newly formed progeny virus in

2

6-10 hours

Every virus that successfully infects a cancer cell results in thousands of progeny cancer cell results in thousands of progeny viruses that can potentially go on to infect more cancer cells.

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Viralytics’ Future - Viralytics’ Future - Commercialization Strate Commercialization Strategy gy gy gy

Choice of Cancer Indications

• Expectation that CAVATAK™ will work best on destroying micro

metastases increasing long term survival of patients.

• Major markets are Breast and Prostate cancers. Long term survival

studies required to prove theory.

• Proof of concept needed in man before these studies are undertaken.
• Initial clinical trials will be undertaken in cancer indications where

efficacy can be shown in the short term – Melanoma, Head and Neck, Lung and Liver cancer. g Once efficacy can be proven in any of these indications the Company will d t k l t t di i th undertake long term studies in other cancers.

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Viralytics’ Future – Viralytics’ Future – Discover Discovery

Intellectual Property

Viralytics has a strong IP portfolio as set

• ut below. New IP is driven by Professor
• Shafren. New patent applications are being

developed and lodged developed and lodged.

• 20+ granted patents worldwide
• Granting of the company’s core patent in

the US and Europe covering CAVATAKTM

• Granting of the company’s core patent in

the US covering EVATAKTM

• 20+ pending applications worldwide
• 20+ pending applications worldwide

(CAVATAKTM and EVATAKTM)

• Scope of patent claims cover a number of

Coxsackie A viruses targeting ICAM-1 and Echoviruses targeting integrin 21

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Viralytics’ Future - Viralytics’ Future - Board of Directors Board of Directors

Paul Hopper , Independent Non-Executive Chairman Mr Hopper is based in Los Angeles, California and is a partner at the investment banking group Cappello Capital. He has over 20 years experience in the biotechnology and healthcare sectors and has been Chairman, Director or CEO of over ten listed biotech companies in the US and Australia. He is a Director of Fibrocell Sciences which has recently filed a BLA following completion of Phase 3 trials for a cell therapy, a Director of pSivida which will shortly complete Phase 3 trials for an

• phthalmic drug delivery device, and was the founder of a private US biotech which will commence

p g y , p Phase 3 trials for a biologic in melanoma in the US in 2010 Phillip Altman PhD, Independent Non-Executive Director Dr Altman has more than 30 years experience in senior management positions with Merrell-Dow, Hoechst Roussel and GD Searle with extensive experience in research clinical trials and regulatory Hoechst, Roussel and GD Searle, with extensive experience in research, clinical trials and regulatory

• affairs. He established one of Australia’s first CROs and managed more than one hundred clinical
• trials. He was responsible for the market approval of numerous new drugs and dosage forms since
• 1974. His PhD is in pharmacology and pharmaceutical chemistry.

Peter Molloy, Independent Non-Executive Director

• Mr. Molloy is based in La Jolla, California. Mr Molloy was most recently the managing director and

CEO of Biota Holdings Limited (2002-2005), Australia’s premier antiviral drug development company. His previous executive roles in the biotech sector have included president & CEO of SLIL Biomedical Corp a Madison Wisconsin based cancer and viral research company; managing director and CEO of Corp, a Madison Wisconsin based cancer and viral research company; managing director and CEO of Florigene Limited, a Melbourne based company focused on genetic modification of plants; and president of Moleculon Inc, a Boston based transdermal drug delivery company. Bryan Dulhunty – Managing Director: Refer to next section

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Viralytics Future – Viralytics Future – Mana Management Team ement Team g

Bryan Dulhunty CA, Managing Director and CEO Mr Dulhunty is a CA with over 25 years experience in CEO, CFO and Corporate y y p , p Governance roles for high growth companies. Bryan has lead the Viralytics team since 2006 and has significantly restructured the Company, cutting cash outflow by 50% while establishing and undertaking a clinical trial and cGMP manufacturing program. Bryan has been a director of a number of public and private biotech companies. y p p p Darren Shafren PhD, Chief Scientific Officer Dr Shafren is Associate Professor of Virology in the Faculty of Health, University of Newcastle with over 20 years experience in basic and molecular virology He is the Newcastle with over 20 years experience in basic and molecular virology. He is the inventor of the oncolytic virus technology acquired by Viralytics. Stephen Goodall MAppSc, MBA, Chief Operating Officer Mr Goodall has conducted biotechnology product development for over 25 years Mr Goodall has conducted biotechnology product development for over 25 years including process and product development, facilities design and construction and international registration of medical products. Gavin D Clark, Business Development Representative , p p Mr Clark is an experienced Business Development professional in the Biopharmaceuticals sector with 30 years in the industry. He has a prolific record of closing deals for both sides of large and small companies. USA Corporate Presentation USA Corporate Presentation

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Viralytics Future – Viralytics Future – Scientific Advisor Scientific Advisory Board Board y

USA

Professor Flossie Wong Staal based in San Diego Professor Flossie Wong-Staal – based in San Diego

• Recognized as one of the worlds top 50 women scientists. Her

specialty is virology. Further international appointments are pending.

Australia ust a a

Professor Chris Burrell (Chairman)

• One of Australia’s most pre-eminent virologists. Retired Head,

Infectious Disease Labs, Institute for Medical and Veterinary Science , y Professor Eric Gowens

• Senior Principal Research Fellow at the Macfarlane Burnet Institute,

Melbourne Melbourne Professor Ian Campbell

• Group leader of the VBCRC Cancer Genetics Laboratory, Peter

MacCallum Cancer Centre Melbourne

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MacCallum Cancer Centre, Melbourne Page 16

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Milestones for the Year Ahead Milestones for the Year Ahead

IND – Phase 2 Trial

• Pre Ind Meeting
• Ind Application
• Phase 2 Efficacy Study commenced

Phase 2 Efficacy Study commenced Phase I Trials to complete

• Head and Neck Trial
• Breast, Prostate and Melanoma trial
• New Phase I trials in new cancer

indications Development of Preclinical Brain Cancer Study Licensing Licensing

• Develop opportunities based on

growth of Virotherapy and Viralytics

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Investment Rationale Investment Rationale

UNMET NEED

There is a clear unmet need for cancer treatments that are less toxic than existing products as well as products that are more effective in prolonging life products as well as products that are more effective in prolonging life. Virotherapy offers the potential to meet both of these needs. py p

Virotherapy Product Advantages py g

• Potential low toxic side effects
• Resultant higher quality of life
• Potential to be more effective than existing treatments in extending life

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Investment Rationale Investment Rationale

Commercial Drivers for investing in cancer products

Growth in Market Size - It is predicted that by 2014 the world’s top selling drug will be the anti-cancer drug AVASTIN (US$9b in sales) and that 3 of the top 6 selling drugs will be cancer drugs, yet these products are not expected to solve the fundamental market requirements. G th i i t t f l i d t l Th i l i i t t Growth in interest from large industry players - There is clear growing interest in biologics from the Pharmaceutical companies. As reported in the New York Times on September 9 2009 “virtually every large pharmaceutical company … has discovered cancer Two industry trends are driving the push Recent scientific discovered cancer …… Two industry trends are driving the push. Recent scientific discoveries have suggested new targets for cancer drugs to attach, and as drug companies see profits beginning to wane, the high prices that cancer drugs can command have become an irresistible lure ” command have become an irresistible lure.

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Investment Rationale Investment Rationale

Commercial Drivers for investing in Virotherapy products

The potential low toxicity and greatly increased quality of life provided by Virotherapy offers an ideal candidate for Government Reimbursement. This is a py commercial requirement if a product is to become widely used. Synergies with existing Cancer Therapies. There is clinical evidence that y g g p Virotherapy in combination with existing products increases the effectiveness of the treatment regime

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Investment Rationale Investment Rationale

Commercial Drivers for investing in VIRALYTICS Technology Advantage

CAVATAK™ has a number of critical advantages over competing viruses

• Genetically unaltered virus – improved safety and FDA regulatory pathway
• Mechanism of action is external to cells – only infects cells with ICAM

receptors (competitors product mechanism of action is internal to cell hence receptors (competitors product mechanism of action is internal to cell, hence they infect all cells similar to chemotherapeutic drugs)

• Small size (25nm). This enables CAVATAK™ to disseminate more widely in

th b d t t ti ll h ll i t t the body to potentially reach smaller micro metastases

• Fast replication cycle. 6 hours versus 48 hours for some competing viruses.

This potential leads to a 256 greater dose after 48 hours g

• Pipeline of viruses with different affinity to different cancers with some cross
• ver of cancers – these are in the pre-clinical stage with broad USA and

Europe patent coverage

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Europe patent coverage Page 21

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Investment Rationale Investment Rationale

Commercial Drivers for investing in Viralytics

• Financial Advantage
• Lower cost base in Australia

g y

• Very lean overheads and focused trial development strategy – monthly cash

burn of less than US$300K. (only 20% of many of our competitors)

• Relative to valuations of competing Virotherapy companies, Viralytics is

p g py p y undervalued

• Commercialization Advantage

Commercialization Advantage

• Successful completion of current Phase III trials is expected to result in the

first commercialization of a virotherapy product Viralytics is expected to have completed its Phase II study at a similar time

• Viralytics is expected to have completed its Phase II study at a similar time

to the completion of competitor Phase III studies. This would position the Company for a licensing deal or trade sale based on Phase II efficacy data

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Appendix 1a - ppendix 1a - 1st

st Phase I Melanoma Trial

Phase I Melanoma Trial

Completed 2008

First in Man Study Results

• Phase I trials conducted in Australia

CAVATAK™ Phase I trials conducted in Australia

• 5 late stage melanoma patients

received intratumoral treatment (2 in pilot study and 3 in initial Phase I pilot study and 3 in initial Phase I trial)

• Transient/stable reductions in some

injected tumours injected tumours

• Single dose range
• No product related serious adverse

t events

• Treatment well tolerated

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Appendix 1b - ppendix 1b - 2nd

nd Phase I Melanoma Trial

Phase I Melanoma Trial

Completed 2009

Phase I dose escalation intratumoral trial – late stage melanoma patients

• Trial conducted in Australia
• Trial conducted in Australia
• Dose escalation study (100-fold increase)
• 3 groups of 3 patients

3 groups of 3 patients

• Transient/stable reductions in some injected

tumours

• Possible activation of anti-tumour immune

responses

• No product related serious adverse events
• No product related serious adverse events
• Treatment well tolerated

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Appendix 2 - Appendix 2 - Other clinical trials being ther clinical trials being undertaken undertaken

Head and Neck Cancer Melanoma Breast and Head and Neck Cancer

Dose escalation intratumoral trial late stage patients

Melanoma, Breast and Prostate Cancer

Dose escalation intravenous trial

• Trial conducted in Australia
• Dose escalation study - 100 fold

increase – starting at highest level of late stage cancer patients

• Trial conducted in Australia

Dose escalation study (10 000 fold increase) g g melanoma trial

• Trial commenced February 2009
• Dosage escalation study - 1, 3 and 6
• Dose escalation study (10,000-fold increase)
• CAVATAK™ delivered by intravenous infusion
• 5 groups of 2 patients

Dosage escalation study 1, 3 and 6 doses

• 3 groups of 3 patients
• Tumour and biomarker measurement
• No product related serious adverse events
• Treatment well tolerated
• 2 sites now recruiting – 7 patients to recruit

Tumour and biomarker measurement will monitor CAVATAK™ anti-tumour activity

• 3 sites recruiting - 7 patients to recruit

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Appendix 3 -Scientific Publications ppendix 3 -Scientific Publications

Cancer Indication Publication

Melanoma Au, G.G., Lindberg, A.M., Barry, R.D., Shafren, D.R., 2005 Oncolysis of l i t h l t b C ki A21 vascular maignant human melanoma tumours by Coxsackie A21. International Journal of Oncology. 6, 1471-1476. Shafren, D.R., Au, G.G., Nguyen, T., Newcombe, N.G., Haley, E.S., Beagley, L., Johansson, E.S., Hersey, P., Barry, R.D.,2004. Therapy of malignant human melanoma tumours by a common cold producing enterovirus, Coxsackievirus A21. Clinical Cancer Research. 10, 53-60 Breast Cancer Skelding, K.A., Barry, R.D., Shafren, D.R., 2008. Systemic targeting of metastatic human breast toumor xenografts by Coxsackievirus A21. Breast Cancer Research and Treatment. [Epub ahead of print] Prostate Cancer Berry, L.J., Au, G.G., Barry, R.D., Shafren, D.R., 2008. Potent oncolytic activity of human enterviruses against human prostate cancer. Prostate. 68(6), 577-587. ( ), Ovarian Cancer Shafren, D.R., Sylvester, D., Johansson, E.S., Campbell, I.G., Barry, R.D.,

• 2005. Oncolysis of human ovarian cancers by Echovirus Type 1.

International Journal of Cancer. 115, 320-328. M lti l M l A G G Lincz L F Enno A Shafren D R 2007 Oncolytic Multiple Myeloma Au, G.G., Lincz, L.F., Enno, A., Shafren, D.R., 2007. Oncolytic Cosxackievirus A21 as a novel therapy for multiple myeloma. British Journal

• f Haematology.137(2) 133-141.

Other

The Company has numerous other publications on CoxsackieA21.

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These are available on request

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Appendix 4 - ppendix 4 - Press and Media 2009, Australasia ress and Media 2009, Australasia

1. PharmAsia Cover Article August 2009 See media pack

• r web site -

M di Media 2. Today Tonight ( a major Australian Current Affairs TV program) 5 min film clip DVD on request 3. NBN Regional TV – The Innovators program To review, go to link on Viralytics website September 2009 Web link available on b it web site 4. a) Money Magazine – Major Monthly national Business Magazine b) Eureka Report– The Speculator (Coverage provided by David Hazelhurst. One of Australia most widely respected investment advisors. He has significantly outperformed the 7 Jan 2009 See media pack

• r web site -

Media ASX index in 28 of the past 30 years) 5. PriceWaterhouseCoopers – Bioforum feature article in quarterly publication Jan-Mar 2009 See media pack

• r web site -

Media Other Press Articles 6. Western Australian daily newspaper – “WA joins testing of virus cancer therapy” 24 Oct 2009 See media pack

• r web site -

Media 7. Melbourne Herald Sun – “Healthy Competition” 13 Oct 2009 See media pack

• r web site -

Media

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Viralytics Ltd iralytics Ltd

Contact Us

• Mr. Bryan Dulhunty

Managing Director & CEO

• Mr. David Batista

Senior Managing Partner Viralytics Limited 8/33 Ryde Road Pymble NSW 2073 Viriathus Capital LLC 44 Wall Street, 12th Floor New York NY 10005 Pymble NSW 2073 Australia Phone: +61 2 9499 3200 New York, NY 10005 Phone: +1 212 372 4879 Fax: +1 212 380 1921 Fax: +61 2 9499 3300 Email: viralytics@viralytics.com Web: www viralytics com Fax: +1 212 380 1921 Email: david.batista@viriathus.com Web: www.viriathus.com Web: www.viralytics.com

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