Investor Presentation April 3, 2013 Disclaimer This presentation - - PowerPoint PPT Presentation

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Investor Presentation April 3, 2013 Disclaimer This presentation - - PowerPoint PPT Presentation

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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

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Investor Presentation April 3, 2013

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Investor Presentation April 3, 2013

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Investor Presentation April 3, 2013

Disclaimer

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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 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.

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Viralytics Ltd (ASX:VLA) is an Australian ASX listed biotechnology cancer company focussed on developing viruses which selectively target cancer cells.

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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

  • 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

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Corporate Snapshot

  • Ticker Symbol:

VLA

  • Share Price:

A$0.29

  • Outstanding Shares:

87.2m

  • Outstanding Options:

5.9m

  • Market Cap:

A$25m

  • 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

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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

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

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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

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Melanoma

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  • 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*
  • 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

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CAVATAK™ – Preclinical Results

CAVATAKTM 8

  • 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

melanoma in mice after virus injection

  • Mice dosed with 108 TCID50 CAVATAKTM intratumourally and

then assessed 45 days later.

  • Melanoma presence shown by colour scale
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  • cGMP formulation produced at Sigma-Aldrich in the US
  • Purified from culture in mammalian cells
  • Highly stable at -70 °C storage
  • Simple manufacturing process
  • Low manufacturing costs

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Manufacture

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CAVATAK™ – Phase 1 Results

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  • Five Australian studies – 28 patients
  • Intratumoural and intravenous dosing
  • CAVATAK™ well tolerated
  • Evidence of tumour stabilisation in some patients

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 VLA-04 Single Dose Intravenous Stage IV Melanoma, Colorectal, Breast, Prostate 10 VLA-06 Multi-dose Intratumoural Stage IV Head and Neck 4 Total 28

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– 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 – As at March 2013: – 25 patients recruited to date – Achievement of interim efficacy milestone (≥ 3 objective tumour responses within the first 35 patients)

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CAVATAK™ – Phase 2 CALM Study

(Cavatak in Late stage Melanoma)

Name Type - Open Label Disease Stage Indication CALM VLA-07 Ten doses over 18 week period Stage IIIc or IV Melanoma CALM VLA-08 Extension study of VLA 07 Further 9 doses at 3 week intervals Stage IIIc or IV Melanoma

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CAVATAK™ – Phase 2 CALM Study

Update from Dr R Andtbacka (HemOnc Today, March 22, 2013)

12 Courtesy Dr R Andtbacka, Huntsman Cancer Institute

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CAVATAK™ –Phase 2 CALM Study

Update from Dr R Andtbacka (HemOnc Today, March 22, 2013)

Courtesy Dr R Andtbacka, Huntsman Cancer Institute

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  • 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)

  • 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

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CAVATAK™ - Phase 1/2 STORM Study

(Systemic Treatment of Resistant Malignancies)

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7 Patent Families 25 Patents granted worldwide and 25 pending Minimal Royalties No Infringements or Disputes

+ + + Date Patent Family Applications 2012 Genetically stable oncolytic virus 2012 Pharmaceutical composition 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

Strong Intellectual Property Position

Orphan status in the USA: 7 years market exclusivity BLA approval in the USA: 12 years data exclusivity

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CAVATAK™ Development/ Business Strategy

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Phase 1 trials Intratumoural and Intravenous Double Blind Placebo Controlled Trial in melanoma patients Phase 2 CALM trial in melanoma patients License to Big Pharma

2003 - 2012

Completed Underway Future Phase 1/2 STORM trial in solid tumour patients

2012

CAVATAKTM / chemotherapy in preferred solid tumour type Planned Q3/4 2013

? ? ?

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Amgen-Biovex

  • Biovex was a private US based biotech
  • Investigational product (OncoVEXGM CSF) contains a modified herpes virus

administered intratumourally

  • Completed a single, small, open-label Phase 2 study in 50 patients

(Overall Response Rate of 26%)

  • Initiated a 420 patient Phase 3 melanoma trial after $70M capital raising
  • Amgen acquired Biovex in 2011 and paid US$425 million cash upfront with

a potential further US$575 million milestone payments

  • Primary endpoint met in Phase 3 melanoma trial with a Durable Response

Rate of 16%

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Other Companies In The Field

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2 other significant companies: Oncolytics Biotech & Jennerex Compelling comparative value based on successful outcome of current Phase II trial

200 400 600 800 1000 1200 Amgen/Biovex Oncolytics Biotech Jennerex Viralytics US$1B US$260m US$116m (European rights only) US$25m

Company Commercial Value/ Deals Stage of Development Oncolytics Biotech (Canada) US ~$260 million Market Capitalisation Phase III: Head & Neck cancer Jennerex (USA) US ~$116 million European rights licensing development deal 2010 Phase II: Liver cancer Phase I: Intravenous study

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Summary

  • Lead product is CAVATAK™ with broad anti-cancer activity
  • Advancing Clinical Program
  • CAVATAK™ completed five Phase 1 trials with 28 patients
  • CAVATAK™ current US Phase 2 trial in melanoma patients
  • UK Phase 1/2 trial planned for intravenously administered CAVATAK™

in lung, prostate, bladder and melanoma cancer patients

  • Potential for low toxicity, unlike traditional chemotherapies
  • cGMP formulation produced at Sigma-Aldrich in the US
  • Robust intellectual property portfolio and long patent life
  • Potential benefits when used in combination with chemotherapy
  • Further indications under review in preclinical studies
  • Big Pharma interest– Amgen US$1.0 billion deal, subsequent positive
  • utcome in Phase 3 trial

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Leadership Team - Experience and Track Record

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Executive Dr Malcolm McColl | Chief Executive Officer – More than 20 years experience in the pharmaceutical and biotechnology sector including senior executive roles with major corporations in North America, Europe and Asia

  • Pacific. Significant partnering and transactional experience particularly in the oncology sector.

Associate Professor Darren Shafren | Chief Scientific Officer and Inventor of Technology – More than 25 years in Virology research focusing on oncolytic viruses and cancer cell interactions. The results of his research have been published in various internationally respected scientific journals, including Clinical Cancer Research and The Journal of Virology. Board Mr Paul Hopper | Executive Chairman – International and ASX biotech capital markets experience. Head of Life Sciences and Australia Desks at Los Angeles-based investment bank, Cappello Capital Corp. Dr Phillip Altman | Authority on clinical trials and regulatory affairs and Founder of Pharmaco, one of the first CROs in Australia. Mr Peter Molloy | Previously CEO of Biota, with international pharmaceutical experience including Pharmacia. Dr Leonard Post | Former director of BioVex and Senior Vice President of R&D at Onyx Pharmaceuticals. Extensive oncolytic virotherapy experience. US based.

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CAVATAK™

  • Dr. Malcolm McColl

Chief Executive Officer Email: malcolm.mccoll@viralytics.com Web: www.viralytics.com