s  Therapies for major infectious

diseases and related cancers

Julie Phillips, CEO www.biodiem.com

(ASX:BDM)

Presentation overview

1.  Compelling investment case

2.  Recent achievements

3.  Strong global partnering network

4.  Robust product portfolio

5.  Development priorities

6.  Why invest in BioDiem?

2  

A compelling investment case

BioDiem has an extensive technology portfolio targeting multiple infectious diseases and cancers, supported by:

•  Existing license income with strong growth.

•  Existing licenses to WHO, Serum Institute of India & Changchun BCHT Biotech Co, China.

A strong pipeline of products with high value disease targets, including:

•  Large markets: influenza, schistosomiasis, hepatitis, TB.

•  High-value niche markets: fungal diseases, MRSA, sexually transmitted diseases, viral-related cancers.

•  Influenza vaccine on the market.

Global network with leading research institutions and companies

•  Including WHO, National Institutes of Health (USA), PATH (Program for Appropriate Technology in Health), Centres for Disease Control and Prevention (US), VIVALIS, and the Institute of Experimental Medicine.

•  Partnering strategy accelerates development, lowers cost, while retaining IP control. 3  

Multiple products targeting multiple diseases

Product Disease Targets Current Partners Development Status

LAIV Vaccine (Influenza)

Influenza – Seasonal & Pandemic

WHO SII (India) BCHT (China) IEM (Russia)

Marketed with license revenues of A$1.4m year to date Phase II (cell-based production technology)

Bird flu IEM/WHO Clinical trial commenced in Russia

LAIV Vector (Vaccine delivery) Vaccine development VIVALIS First stage of development project underway

BDM-I (Antimicrobial)

Bacterial infections (MRSA, tuberculosis)

US government backed research institutions Success in activity screening program

Fungal infections (Aspergillus, Scedosporium, yeasts

and others)

US government backed research institutions

University of Sydney

Positive screening results in difficult to treat fungi, patents granted for major indications

Parasitic diseases (schistosomiasis, others) QIMR program Success in activity screening program

SAVINE (Custom vaccines)

Nasopharyngeal carcinoma (NPC), tuberculosis In-house Seeking partner for more advanced data in animals

BDM-E (eye disease) RP (orphan eye disease)

Foundation Fighting Blindness University of Miami

Animal model data support activity in retinal disease, safety shown at doses used (in Phase I/II study).

New vaccine technologies

Dengue fever, hepatitis, various targets

University of Canberra, Australian National University Promising early-stage laboratory results 4  

Recent achievements

5  

Influenza  vaccine  licensed  to  WHO  

and  Indian  biotech,  SII.  

AUG   -­‐-­‐-­‐-­‐   DEC   JAN   FEB   MAR   APR   MAY  

2012  

SAVINE  vaccine  technology  acquired  

Influenza  vaccine  

licensed  to  Chinese  

biotech,  BCHT  

VIVALIS:  first  commercial  

partner  signed  for  LAIV  vector  

project  

$1.4  million  received  YTD  

for  LAIV  influenza  

vaccine  licenses  

BDM-­‐I  patents  granted  in  US:  STIs  /  protozoal  

infec[on  

In-­‐license  of  dengue  &  

hepa[[s  vaccine  technologies  

A  #me  of  accelera#ng  ac#vity..  

JUN  

Global partnering/commercialisation network

•  Successful partnering model supports :

-­‐  QLD  Ins[tute  of  Medical  Research  -­‐  Australian  Na[onal  University  -­‐  University  of  Canberra  

BCHT  

Serum  Ins[tute  

Ins[tute  of  Experimental  Medicine  

VIVALIS  

WHO  

Centres  for  Disease    Control  

PATH  

Na[onal  Ins[tutes  of  

Health  

USAMRIID   BioReliance  

–  Ongoing product development –  Growth in royalty revenues –  Reduced development costs –  Retention of full control of IP

Focused development plan

Three core development programs  

Target Product

1. Seasonal and pandemic flu vaccines LAIV vaccine – licensed in multiple countries

2. Vaccine development SAVINE, LAIV vector, flavivirus and hepatitis virus technologies for designing new vaccines

3. Infectious disease therapies •  Fungal disease: Aspergillosis •  Bacterial disease: MRSA •  Parasites: Schistosomiasis

BDM-I antimicrobial

7  

Flu  vaccines:  the  LAIV  vaccine  A  revenue-­‐genera1ng  cornerstone  

8  

A growing business in flu vaccines

•  Current major revenue generator and growth business.

•  LAIV licensed to WHO as part of Global Pandemic Influenza Action Plan.

•  BioDiem has signed sublicenses with the Serum Institute of India Ltd (SII), and Changchun BCHT Biotechnology Co. (BCHT) of China.

•  H1N1 (pandemic) influenza vaccine launched in India by SII in July 2010 (Nasovac™).

−  Exclusive licence signed with Serum Institute of India for private sector sales in India.

•  Currently in production for seasonal influenza

•  Non-exclusive license signed with Serum Institute for Mexico, Argentina, Peru, South Africa, Bangladesh, Bhutan, Nepal, Pakistan and Sri Lanka.

•  BCHT deal for Chinese private sector market signed in February 2012

YTD flu vaccine licensing revenue of A$1.4 million

Flu vaccines

9  

Competitive advantages  

Live Attenuated Influenza Virus: LAIV

Advantages:

1.  Needle-free nasal delivery: no trained personnel, blood/sharps precautions necessary.

2.  Extensive clinical and market experience (>100m doses) in Russia with egg-based vaccine has established efficacy and safety in >500,000 adults and 140,000 children.

3.  High yields in egg-based production; can be manufactured in cell culture to meet pandemic need without reliance on eggs, such as during a bird flu pandemic.

4.  New licenses for LAIV are in negotiation.

BioDiem’s technology advantages allow it to compete in a market dominated by Big Pharma

Flu vaccines

New vaccines: Designing custom therapies

Our LAIV vector and a range of other versatile technologies for designing new

vaccines

11  

Versatile proprietary platform technologies

•  Opportunity to target multiple infectious diseases and related cancers

•  Licensing model to be pursued targeting other vaccine developers

•  Complementary technologies acquired, broadening disease target range

LAIV Vector: A viral vector can deliver a customised protein into the body to produce a Protective or Boosted immune response to fight a disease e.g. nasopharyngeal cancer.

SAVINE: the “scrambled antigen vaccine” technology allows design of customised proteins e.g. NPC SAVINE for Epstein Barr virus-related diseases.  

One in six cancers is linked to a virus infection

New vaccines

12  

A new partnership

•  May 2012: BioDiem collaborating with VIVALIS SA for LAIV vector technology plan

•  VIVALIS: A leading French vaccine technology provider

•  Initial phase of collaboration is to investigate synergy of LAIV and Vivalis’ proprietary cell line, EB66®

•  Successful results could lead to new agreement to develop BioDiem’s LAIV as a vector in Vivalis’ proprietary cell line.  

New vaccines

Next steps: Establishing proof of concept and designing customised virus-based vaccines

Case study for success:

•  Partnering and acquisition strategy to build vaccine development expertise paid off for Crucell, which was acquired by Johnson & Johnson in 2011 for $US 2.3 billion.

 

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Path to commercialisation

Test  LAIV  and  cell  line  system  (first  

stage)  (2012)  

Develop  vector  system  with  

commercial  partners  (2013)  

Package  vector  product  for  sale  or  

out  license  (2014)  

New vaccines

Goal: Confirm feasibility of LAIV vector and license to vaccine developers. Progress: 1.  Vivalis S.A. (NYSE Euronext Paris: VLS, France) agreement signed to test

in EB66 proprietary cell line 2.  Discussion with other cell line owners ongoing   Platform technology multiple new vaccine possibilities for cancers and

infectious diseases 14  

Infectious diseases: the BDM-I antimicrobial

Multiple targets and accelerated development program

15  

BDM-I broad spectrum antimicrobial

•  BDM-I’s broad activity could mean claiming a share of several major markets.

•  Microorganisms being targeted include bacteria, fungi, and parasites.

•  Increasing resistance to antibiotics is a major concern for healthcare systems worldwide.

•  Significant opportunity to target high value diseases.

•  Big Pharma are returning to this space, and looking to acquire

•  Pipelines are running dry so innovative products are in high demand

Next steps: An accelerated development program with rapid market access for life-threatening diseases

Infectious diseases

16  

Antibiotic resistant bacteria •  Methicillin-resistant Staphylococcus aureus

•  Cause serious and difficult-to-treat illness, most common in hospitals.

•  Increasingly of concern with more frequent multi-resistance.

•  Total antibiotic market worth US$42 billion in 2009.

•  New effective treatments have potential for extensive use. Major concern for hospitals

•  Few treatments with more resistance to standard therapy.

•  Rapid spread; patient isolation

•  Carrier-status of staff as source of cross infection.

•  Increases patient stay, treatment cost, risk of death.

Results to date •  Successful lab screening studies show effect of BDM-I at

concentrations achievable in the body.

MRSA: a major issue for hospitals Infectious diseases: bacterial

17  

Fungal infection •  Deep-seated invasive infection of body cavities and organs

•  Can be rapidly fatal or cause chronic morbidity for patients with weak immune systems

•  Existing treatments can cause serious side effects and the fungus is increasingly resistant.

•  Antifungal market worth US$9.4 billion in 2010.

•  High-value entry for effective antifungals in life-threatening disease.

Results to date •  Activity of BDM-I has been shown in screening studies by Australian

and US research laboratories

Aspergillosis: an invasive fungus Infectious diseases: fungal

18  

Chronic parasitic infection •  Water-living parasites which enter through the skin.

•  Cause ongoing damage to organs.

•  Particularly affects children in developing countries.

•  Can stunt growth and mental development.

•  Can increase risk of bladder cancer.

Widespread population at risk •  More than 200 million people infected.

•  Range of parasite places 700 million at risk.

Potential to capture leading treatment position •  A “neglected disease” largely affecting developing countries.

•  Few competitors offers opportunity for effective treatment.

Results to date •  Successful screening studies show positive BDM-I effect on adult parasites

Schistosomiasis (bilharzia) Infectious diseases: parasites

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Infectious diseases

Next steps for BDM-I

20  

BDM-I has delivered a range of exciting results at world-class research facilities. The variety of possible indications gives the asset considerable scope for producing significant value to shareholders. BioDiem will build on our strong results to date by: 1.  Working with our international partners to progress research

into animal models of the disease

2.  Maintaining our model of collaborative research with minimal outlay by BioDiem while retaining control of IP

3.  Seeking discussion with potential licensing partners for the technology

 

New vaccine technologies: hepatitis target

21  

Infectious diseases

Hepatitis program

22  

This new technology will use a new form of the hepatitis D virus to target hepatitis D, B and possibly C infections. Hepatitis D

•  Currently no vaccines available. •  20% mortality. Liver transplant for severe cases.

Hepatitis B •  Approx. 800,000-1.4m chronically infected in US. •  Currently no complete cure. Existing treatments cost US$5k-$35K p.a.

Hepatitis C

•  The most common bloodborne infection in the US. •  Currently no vaccines available. New “triple cocktail” treatment achieves 80% cure

and costs $60K per patient treatment.

 Next steps: Collaborative R&D program in place with hepatitis D as first

demonstration target.  

New vaccine technologies: dengue fever target

23  

Dengue fever & related diseases

•  Technology licenced from Australian National University in June 2012.

•  Demonstration of vaccine effect in dengue fever model

•  No current vaccines on the market

•  Possible extension into other dangerous disease targets including:

Next Steps: Outlicence or joint collaboration for development for disease targets.

Infectious diseases

24  

West Nile virus Yellow fever

Japanese encephalitis

Tick-borne encephalitis

Murray Valley encephalitis

25  

A  closer  look  at  these  diseases  

Dengue Japanese encephalitis West Nile

Carrier (vector) Aedes mosquito Culex mosquito, occasionally Aedes mosquito

Culex mosquito, occasionally Aedes mosquito and others

Global cases/year 100 million 50,000 low

Mass  disease  in  endemic  regions  

Not  frequent,  but  oCen  severe  

Niche  disease,  low  incidence  

Infectious diseases

Adapted  from  Datamonitor  :  Stakeholder  Opinions:  Tropical  Diseases,  Dec  2010  

•  Mosquito-borne diseases of increasing interest due to climate-change induced habitat expansion. The size of populations at risk of exposure is increasing.

Orphan eye disease: BDM-E

A high-value niche market on track for out-licensing

26  

Tackling genetic eye disease A pre-packaged asset for sale

•  FDA granted Orphan Drug status to BDM-E compound for treatment of genetic eye disease retinitis pigmentosa (RP).

•  BioDiem’s studies show BDM-E has biological effect in inflammation and eye disease models. New intellectual property generated from these studies.

•  Clinical usage: no safety concerns at dosage used.

•  Results will be presented in July 2012 at International eye research conference.

•  Research collaboration with Uni of Miami and Foundation Fighting Blindness to evaluate the potential of BDM-E to treat retinitis pigmentosa

•  The study will examine the protective ability of BDM-E in a non-clinical disease model which mimics RP.

Next Steps: Completion of data package. On track for sale or out license within 12

months

Eye diseases

27  

Anti-infectives market, US$53 billion in 2011

Operating within the largest healthcare markets

Vaccine market

US$20.2 billion in

2009

Antibiotics market US$42

billion in 2009

Antifungals

market, US$9.4 billion

in 2010

Company Vaccine  sales  2010

Compound  annual  growth  rate  %  

(2004-­‐2009),  Datamonitor  2010  

Key  products

$6.75  billion 21.5% Infant  combina1ons,  hepa11s,  influenza,  HPV,  rotavirus    

$5.01  billion 18.5% Infant  combina1ons,  meningococcal  vaccines,  influenza

$3.55  billion   25.3% HPV,  rotavirus,  MMR-­‐V  vaccines

$3.67  billion   26.7% (2004-­‐08)   Pneumococcal  vaccines

$2.92  billion 36.4% (2006-­‐09)   Influenza,  meningococcal  vaccines

28  

Financials and Board

As at 30 April 2012

Market Cap $8.17m

52 week range $0.07 - 0.18

Cash $1.32m

Shares 102,095,554

Shareholders 919

Listed Options 12,519,008

Revenue YTD $1.4m

Chairman: Hugh Morgan, AC •  President of BCA from 2003-2005. •  Chairman of the Order of Australia Association Foundation •  Lafarge International Advisory Board member •  Former Director of the Board of the Reserve Bank of Australia

CEO: Julie Phillips •  Extensive experience in clinical and regulatory affairs •  Previous Chief Executive Officer and Director of Australian

biotech start-ups •  Board member of the CRC for Asthma and Airways

Non-executive Director: Dr Larisa Rudenko •  Head of Virology at Institute of Experimental Medicine •  Developed Russian clinical trials for LAIV •  World expert in LAIV •  Published more than 225 papers and 42 patents •  Honoured Scientist of the Russian Federation  

Non-executive Director: Dr Arthur Li •  Deputy Chairman of The Bank of East Asia •  Emeritus Professor of Surgery at The Chinese University of Hong Kong •  Numerous Australian and HK appointments

Non-executive Director: Don Brooks •  Former Licensing Senior Counsel at Merck & Co. •  Former General Counsel for EntreMed •  Formerly outside Counsel to HGS, MedImmune and Genetics Therapy •  Numerous North American biotech consultancy roles

29  

Mul1ple  inflec1on  points  on  the  horizon  

Flu  vaccine  licensing  

BDM-­‐I    (An1microbial)  

New  vaccines  (vector)  

VIVALIS  collabora1on  first  stage  results  

Commercial  development  of  vector  system  

Package  vector  product  for  sale  or  out  license  

2012  –  2013  

30  

Enter  animal  models  for  major  indica1ons  

Secure  out  licensing  deal  for  

technology  

Secure  further  IP  protec1on  

Collaborate  with  partners  to  develop  to  market  

Cell-­‐based  LAIV  

agreement  Securing  of  new  licensees  in  new  markets  

Con1nue  building  revenue  growth  

Why invest in BioDiem?

•  BioDiem has successfully licensed its flu vaccine to the largest markets in the world.

•  A proven track record of new license growth, e.g. BCHT (China) and the Serum Institute of India.

•  Exposure to multiple opportunities for disease treatments with high market need.

•  Global partnering strategy with research leaders accelerates development and delivers more for each research and development dollar.

•  Potential to engineer multiple new vaccines from BioDiem’s technologies.

•  The research suggests exciting potential for BDM-I in multiple acute and chronic infectious diseases with a chance for accelerated regulatory approval.

31  

Therapies for major infectious

diseases and related cancers

Julie Phillips, CEO www.biodiem.com

(ASX:BDM)

Appendices

BDM-I: Work in progress

MIC Testing Results from NIH NIAID’s1 In Vitro Assessment for Antimicrobial Activity Service2

Pathogen MIC (µg/mL)

E. faecalis (drug resistant) 8

C. jejuni 0.5

S. aureus 4

MRSA 8

A. fumigatus 8

The results are encouraging and BioDiem will discuss with NIAID the potential to use NIAID’s Animal Models of Infectious Disease Service3 to further evaluate BDM-I’s activity.

1 (NIAID) is the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health (NIH). 2 http://www.niaid.nih.gov/LabsAndResources/resources/dmid/invitro/Pages/invitro.aspx 3 http://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx 34