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Avantogen LimitedAvantogen Limited(ASX Code: ACU)(ASX Code: ACU)
Annual General Meeting20 November 2008
Dr William Ardrey (Chief Executive Officer) For
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Disclaimer
The presentation contains forward‐looking statements that involve inherent risks and uncertainties. Any statement describing the Company’s goals, expectations, intentions of beliefs is a forward‐looking statement and should be considered an at‐risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing technology and in the process of discovering, developing and commercialising treatments that can be proven safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services. This overview of Avantogen Limited does not purport to be all inclusive or contain all information which its recipients may require in order to make an informed assessment of the Company’s prospects.
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Avantogen Ltd Investments
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ACU Assets
• 34% Hawaii Biotech Inc• Clinical Trials for WNV initiated• Dengue clinical trial pending• Developing strong pipeline of vaccine candidates• Q3 2008: revenue from antigen sales
• 43% Avantogen Oncology Inc• RP‐101 pancreatic cancer drug licensed to SciClone for US$ 3M • In Phase 2b clinical trials
• 10% RESprotect GmbH• Bringing RP‐101 pancreatic cancer drug to non US markets – in clinical
trials
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Avantogen – Our Goals• COMMERCIALIZE health care
technologies
• Focused on LARGE market segments
• Obtain MONEY for technology (e.g. SciClone, PDVI/Gates Foundation)
• Rebalance portfolio towards the vaccine space
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33% HBI
43% AOI
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Achievements in FY 2007/2008
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• Successful capital raise approx. A$2 million
• Restructure of company – low costs, downsizing
• Licensing partner SciClone Pharmaceuticals
• Progressing 3 products with partners through clinical trials
• Appointment of eminent vaccinologist, Professor Ian Frazer, to scientific advisory board of HBIF
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2008 LA Award Recipient for AOI
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Thomson Reuters Recognition for HBI
The five most promising drugs entering Phase I trials
Drug Disease Company
MGCD‐265 Cancer MethylGeneENMD‐981693 Cancer EntreMedSphingomab™ Cancer LpathTherapeuticsSPC‐3649 Hepatitis C virus infection SantarisHBV‐002 West Nile virus infection Hawaii Biotech Inc.
Source: Thomson Pharma® , The Ones to Watch, 2008
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Key Investment Highlights
• 3 products in human clinical trials• 1 product headed for IND with US FDA for 2008/2009• Vaccine products for significant unmet medical need (dengue,
West Nile fever, influenza)• Strong board and management• Cost‐effective product development strategy: grants and partners
Avantogen is an Award Winning Clinical Stage Company in Revenue Partnerships with major
overseas listed Pharma companies
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ACU – Strong Product Pipeline
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Vaccines – the attractions for ACU• Global CAGR of vaccine market, 16%
• Novel & therapeutic vaccines fastest growing segment 38% (Source: Intercell AG)
• Antigen‐specific vaccines are the fastest growing sub segment of therapeutic vaccines
• HBI vaccine platform useful for making vaccines against emerging infectious diseases (safe as protein subunit used) and influenza (rapid upscale of production compared to current method)
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Hawaii Biotech Inc (HBI)
• Well advanced vaccine development:• Recombinant vaccine production platform• Specific vaccines in clinical trial• Strong pipeline – 8 vaccines
• US Govt grant funding past 4 years US$40 M
• Spin‐off from University of Hawaii
• Dengue Fever vaccine clinical trials funded by PDVI (Bill & Melinda Gates Foundation)
• Prof Ian Frazer on Scientific Advisory Board
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HBI Pipeline: Large Unmet Needs Globally
Vaccines in Vaccines in DevelopmentDevelopment
Disease IncidenceDisease Incidence Current Treatment and Current Treatment and ProphylaxisProphylaxis
Market OpportunityMarket Opportunity
Dengue 50 million cases a year globally
None >US$300M traveller’s market
West Nile Virus >100,000 infections in US since 1999
None >US$500M (elderly and immuno‐compromised)
Seasonal Influenza 3‐5 million severe infections globally; up to 500, 000 deaths worldwide
Antiviral drugs; Killed and live/attenuated Vaccines (egg‐based and cannot upscale rapidly);
>US$1.5B global market
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Source: WHO 2008
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World distribution of dengue viruses in 2005 • Dengue: a disease caused by a virus and transmitted by mosquitoes (Aedes
aegypti)
Source: Centers for Disease Control and Prevention
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West Nile Virus in the US
• Experts believe WNV is established as a seasonal epidemic in North America that flares up in the summer and continues into the fall
Source: Centers for Disease Control and Prevention
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Vaccine Adjuvant: GPI‐0100 Status
• Licensed to Endocyte Inc. under research agreement
• Licensing opportunities in both Cancer and Vaccines: GPI‐0100 boosts both arms of immune response and is stable and safe
• About to enter Phase 2 human clinical trials for renal cell carcinoma
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Avantogen Oncology Inc. (AOI)• 43% owned, US listed company (OTC: AVTO)• RP101 Pancreatic Cancer Drug ‐ Licensed to SciClone• $3M in payments received• First Phase IIb clinical trials underway ‐ patients dosed Q1
2008 • Next Milestone Payment ‐ $1M due on regulatory progress• Royalties payable • Buyout clause US$12M
• Nutraceuticals for cancer recovery: licensing partners sought
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RESprotect GmbH
• ACU owns rights (10% RESprotect GmbH) for the RP101 drug for Rest of World which is in advanced clinical trials for European approvals
• RP101 is an anti‐chemoresistance drug for use against pancreatic cancer
• Pancreatic cancer is the fourth most frequent cause of cancer death
• Estimated annual market size projected to grow to US$1.1B within 5 years in the US alone (Source: Wall St Journal, 2007)
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Investment Metrics
• ACU current issue: 602,376,179
• Share Price: 4c/share
• Market Cap: A$24M
• 52wk Range: 2.5c – 9.5c
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Going forward: What Next?
• Progress Clinical trials for vaccine candidates
• Rebranding ACU as ACUVAX, a vaccine company
• Finding Licensing Partners and Revenue Transactions
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"This is among the first (vaccines for WNV), so clearly when we are successful we might be the first available vaccine," Parks said.”
“…that the company has initiated a Phase 1 clinical trial study with its West Nile vaccine candidate. The study, being conducted with healthy subjects, is the first clinical trial forthe company.”
Key Excerpts from the NewsKey Excerpts from the News
"According to the Centers for Disease Control and Prevention, cases of WNV infections in humans have been reported in all states except Hawaii, Alaska and Maine. WNV has been reported in Europe, west and central Asia, Oceania, Africa, the Middle East, and since 1999, in North America.”
“This clinical study, which will be recruiting volunteers for four treatment groups, is being conducted at a Phase 1 trial site in Honolulu. Results should be known within a year.”
Elliot Parks said the study is "an important milestone in Hawaii Biotech's maturation into a clinical stage company." The company also is developing vaccines for dengue virus and seasonal and pandemic influenza.“ This sets the stage for us to do our clinical trial on another vaccine, dengue," Parks said. "We expect to be doing that within the year.“
ACU subsidiary, Hawaii Biotech Initiates Phase 1 Clinical Trial for West Nile Vaccine
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Dr William Ardrey, CEOAvantogen Ltd
Tel: 0400 544 502
Level 5, 320 Adelaide StBrisbane, QLD 4000
Australia
www.avantogen.com
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