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Investor Presentation August 2009

Medicago Investor Presentation 2009

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Page 1: Medicago Investor Presentation 2009

Investor PresentationAugust 2009

Page 2: Medicago Investor Presentation 2009

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Forward-Looking Statements

• All statements, other than statements of historical facts, included in this presentation regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “believe”, “anticipate”, “estimate”, “plan”, “expect”, “intend”, “may”, “project”, “will”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements, including the factors discussed under “Risk Factors” and in other sections of the prospectus. These factors and the other cautionary statements made in the prospectus should be read as being applicable to all related forward-looking statements wherever they appear in this presentation.

• Our statements of “belief” in respect of our product and partner product candidates are based primarily upon our results derived to date from our research and development program. We believe that we have a reasonable scientific basis upon which we have made such statements. It is not possible, however, to predict, based upon studies in vitro and animal studies whether a new therapeutic agent or technology will be proved to be safe and/or effective in humans. We cannot assure that the particular results expected by us will occur.

• Any forward-looking statements and statements of “belief” represent our estimates only as of the date of the prospectus and should not be relied upon as representing our estimates as of any subsequent date. Except as required by law, we do not assume any obligation to update any forward looking statements or statements of “belief”. We disclaim any intention or obligation to update or revise any forward-looking statements or statements of “belief”, whether as a result of new information, future events or otherwise.

Page 3: Medicago Investor Presentation 2009

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Medicago at a glance

Focus Influenza vaccines

Headquarters + cGMP facility Quebec City, QC

Employees 60

Patents (issued or pending) +170

Stock listing TSX-V : MDG

Recent price (August 4, 09) $0.46

Shares outstanding 93 M

Market cap (approx.) $41 M

Cash position (August 1, 09) 12 mos.

Page 4: Medicago Investor Presentation 2009

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Vaccines: an attractive market segment

$21 billion2008 world vaccine

market

13% growth over 2006

New cost-effective manufacturing platforms (plants, insect cells)

High probability of R&D success

High profit margins

Heightened awareness of value of effective vaccination

Increased government funding

Source: Datamonitor, Kalorama

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1918

1956

Spanish Flu

Asian Flu

Influenza: a constant threat

1968

Hong Kong Flu

H5N1

Today ?

Swine flu (H1N1)

3 pandemics every century…

25,000,000 deaths

70,000deaths

34,000 deaths

+250 deaths since 2003

+450deaths to date

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Pandemic Influenza vaccine supply challenges

• Current technologies not fast enough to be ahead of pandemic wave• 4-6 months before first dose available• 2-dose products may delay protection until pandemic wave has passed

• Limited number of facilities worldwide• Mainly US, Canada, UK, Germany, France & Italy (4 manufacturers)• Borders will likely close• 8-12 months before vaccine available for developing world

• Current approved vaccines require 2 doses to provide protection

• Stockpiled vaccines might not be formulated with correct pandemic strain

Page 7: Medicago Investor Presentation 2009

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“Early attempts at pandemic vaccine manufacture are so far producing two to four times less antigen than seasonal flu strains, raising the threat that the world’s production capacity is actually much less than hoped”(Nature News, July 21, 2009)

“FDA Officials said today that vaccine makers are only getting ~30% as much vaccine from H1N1 strains than they normally do when developing the seasonal flu vaccine” (FierceVaccines, July 23, 2009)

“GlaxoSmithKline says that it should be able to supply governments with what they need by early 2010” (FierceVaccines, July 23, 2009)

“The WHO has unofficially estimated that the world's labs may only be able to produce around 900 million doses for the A(H1N1) strain per year, for a planet that is home to 6.8 billion people. And there are already signs that the wealthiest countries will snap up more than their fair share in the rush to halt the outbreak, while Africa, Asia and Latin American will struggle to secure adequate amounts of vaccine.” (AFP, July 27, 2009)

“Only newer technologies, such as but not limited to virus-like particles, have the potential to produce tens of millions of dosages rapidly”(John M. Barry, White Paper on Novel H1N1, Massachusetts Institute of Technology, July 2009)

Current pandemic influenza challenges

Page 8: Medicago Investor Presentation 2009

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Med

icag

o pl

ant-

base

dva

ccin

e su

pply

4 months

Medicago pandemic vaccine = First responder solution

0 1 2 3 4 5 6 7 8 9

Pandemicstrain identified

Pandemic first wave begins

Months

Vaccine supplyCases

10

Egg-

base

dva

ccin

e

supp

ly

10 months

Page 9: Medicago Investor Presentation 2009

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Real-life scenario with influenza A (H1N1)

Medicago technologyEgg‐based technology

14 days7 months

Preparation of vaccine strain

Virus injected in eggsand incubated

Optimization of virus growth conditions 

Vaccine filling and release

Virus purified and inactivated

April 24 : Identification of genetic sequence of A (H1N1)

May 8: Genetic material introduced into plants

May 8‐12: Plants incubated in greenhouse for vaccine production

May 15: First purified vaccine lot

Page 10: Medicago Investor Presentation 2009

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Manufacturing platform – ProficiaTM

Fast, inexpensive and easily scalable• From plants to vaccines in 5 days• Start production of any new

pandemic vaccine in 1 month• Substrate easy to supply (plants in

greenhouses)• Simple process and manufacturing

facilities

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Vaccine Technology -VLP: Virus Like Particles

• Ability to produce influenza virus-like particles in plants using only one gene of the influenza virus (Hemagglutinin)

• Particles resemble influenza virus but with no genetic material (non-infectious)

Influenza Virus

Medicago purified VLP

HA spikes

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Medicago strategy

Clinical development of pandemic and seasonal Influenza vaccines • Initiate Phase I (pandemic candidate)• Leverage clinical results of pandemic to accelerate development

of seasonal candidate• Execute agreements with target countries to enable domestic

vaccine production infrastructure

Explore other VLP opportunities outside of influenza

• VLPExpress: high throughput platform that will accelerate discovery and development

– leverages technology platform to address multiple applications• Value added development and manufacturing for selected

partners in vaccines, biofuels, biodefense, antibodies

Page 13: Medicago Investor Presentation 2009

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AType

H1, H2, H3, …Subtypeor lineage

H5 clade 2Clade H5

clade 1

Subclade H5 clade 2.1

H5 clade 2.2

H5 clade 2.3

Viet-Nam

Turkey

Indonesia

Lead product: H5N1 VLP vaccine

Cross protection against different strains of influenza

Page 14: Medicago Investor Presentation 2009

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Lethal challenge study in ferrets with Viet Nam strain

Lead product: H5N1 VLP vaccine

0

20

40

60

80

100

-2 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Day after challenge

%su

rviv

alra

te

Page 15: Medicago Investor Presentation 2009

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Days CHMP CriteriasStudy group

5 µg

14(post

1st inj.)

% 4-fold increase in HI titer >40% 100%

Mean geometric increase 2.5 15.6

% of HI titer of 1/40 70% 100%

Mean HI titer 78

* European Committee for Medicinal Products for Human Use (CHMP) criteria for licensure of influenza vaccines

High level of antibodies after single dose of 5ug in key ferret model

Immunogenicity study in ferrets

Lead product: H5N1 VLP vaccine

Page 16: Medicago Investor Presentation 2009

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2009 Milestones

Pandemic vaccine

H1N1 results from immunogenicity study in mice

Completion of preclinical studies

Submission of Medicago’s First CTA & Start Phase I with H5N1 Q3 09

Phase I results Q4 09

Seasonal vaccine

Immunogenicity study in mice Q4 09

International development

Pandemic vaccine production facility agreement with first country

Production facility agreement with Middle Eastern country 2009

Page 17: Medicago Investor Presentation 2009

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Philip Morris International Partnership

Medicago $15.975 M investment

Secure resources to initiate clinical development in 2009

PMI brings expertise in relation to tobacco genetics, genomics, and cultivation

PMI 49.8% ownership of MDG

Interested in exploring adjacent technologies

Synergies with current field of knowledge and R&D activities

Page 18: Medicago Investor Presentation 2009

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ManagementMr. Andy Sheldon, President and CEO

20 years managerial experience in the vaccine sector including approval of new products and signing of pandemic plan Shire Biologics, Biochem Pharma, Institut Mérieux, SmithklineBeecham, Ayerst-Wyeth

Dr. Louis-Philippe Vézina,Chief Scientific Officer

20 years experience in research in agronomy, molecular biology and protein production Laval University, Agriculture & AgriFoodCanada

Mr. Pierre Labbé,Chief Financial Officer

20 years of financial experience in public and private companies: Virginia Mines (TSX:VGQ), Sequoia Minerals Inc. and Mazarin Inc.(TSX-V:MAZ.H), Agrinove, and agrifood cooperative, Coopers & Lybrand

Ms. Irene Clement,Acting VP Regulatory Affairs

27 years experience in the biotech industry at Sanofi-Pasteur, Shire Biologics, ID Biomedical, GSK; obtained & maintained several licenses (30 products in 70 countries)

Ms. Nathalie Landry,VP Product Development

17 years of experience in the biotech industry. Previous experience in a biotech company holding various positions in R & D and product development.

Ms. Brigitte Barbeau,VP Manufacturing

20 years experience in QA/QC in commercial production of influenza vaccines GSK Biologicals, ID Biomedical, Shire Biologics

Mr. Frederic Ors,VP Business Development

11 years experience in biotech business development, IP management, and licensing in Europe and North America

Page 19: Medicago Investor Presentation 2009

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Board of Directors

Dr. Randal Chase, Chairman of the Board

Former President, Shire Biologics, Aventis PasteurFormer Director of Acambis (London and NASDAQ) and BioJect (NASDAQ)

Mr. Pierre Des Marais II,Director

Former board member: Rothmans, Imperial Oil, RBC, Sleeman Breweries, CN Railways, Carling O’Keefe, Canadair and Air Canada

Mr. Jonathan R. Goodman,Director

President and Chief Executive Officer, Paladin Labs Inc. (TSX)

Mr. Pierre Seccareccia,Director

Corporate DirectorFormer President PricewaterhouseCoopers, Montreal

Mr. Damien Levesque,Director

Director Avenir Luzerne

Mr. Andy Sheldon,Director

CEO – Medicago IncFormer VP Sale & Marketing Shire Biologics (NASDAQ)

Dr. Louis-Philippe Vézina,Director

CSO - Medicago Inc.