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Investor Presentation October 2009 Andy Sheldon President & CEO Pierre Labbé VP & CFO

Medicago Investor Presentation - October 20, 2009

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Page 1: Medicago Investor Presentation - October 20, 2009

Investor PresentationOctober 2009

Andy SheldonPresident & CEO

Pierre LabbéVP & CFO

Page 2: Medicago Investor Presentation - October 20, 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 - October 20, 2009

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Company overview

Focus Influenza vaccines

TechnologyNon-transgenic tobacco plants &

VLPs

Headquarters + GMP facility Quebec City, Canada

Employees 60

Patents issued or pending 170+

Product pipelinePandemic vaccine – Phase I

Seasonal vaccine - Preclinical

Page 4: Medicago Investor Presentation - October 20, 2009

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Pandemic influenza vaccine supply challenges

Speed :― Current technologies not fast enough to be ahead of pandemic wave― Up to 7 months before first dose available― 2-dose egg-based products may delay protection until pandemic wave

has passed

Capacity : ― Non-availability of vaccines for 90% of world population― 8-12 months before vaccine available for developing world Limited

number of facilities worldwide: US, Canada, UK, Germany, France & Italy (4 manufacturers)

Yield: ― Virus might not grow well in current manufacturing settings― Swine flu yielding 25-50% less than current products

Efficacy:― Stockpiled vaccines might not match correct pandemic strain ― Current approved vaccines do not provide cross-protection

Page 5: Medicago Investor Presentation - October 20, 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 6: Medicago Investor Presentation - October 20, 2009

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A rapid manufacturing platform for proteins and vaccines

• From plants to vaccines in 5 days

• Start commercial production of any new vaccine in less than 4 weeks

• Substrate easy to supply (plants in greenhouses)

• Scale-up only requires additional greenhouse space

• Potential to produce biosimilars, enzymes for biofuels, biodefense products and antibodies

Page 7: Medicago Investor Presentation - October 20, 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 4: Genetic material introduced into plants

May 4‐8: Plants incubated in greenhouse for vaccine production

May 15: First purified vaccine lot

Page 8: Medicago Investor Presentation - October 20, 2009

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Novel vaccine technology - Virus Like Particles (VLPs)

• Ability to produce influenza VLPs using genetic sequence of only one gene of the influenza virus (Hemagglutinin)

• No genetic material (non-infectious)• Cross-protection against different strains of influenza

Influenza Virus

Medicago purified VLP

HA spikes

Page 9: Medicago Investor Presentation - October 20, 2009

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Criteria for licensure of influenza vaccines *

Medicago results

% 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

*Criteria according to CHMP - European Committee for Medicinal Products for Human Use

High level of antibodies after single dose of 5ug

Lead product: H5N1 VLP vaccine

Immunogenicity study in key ferret model

Page 10: Medicago Investor Presentation - October 20, 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

Cross protection against different strains of influenza

Medicago’s vaccine is

formulated with this strain

Page 11: Medicago Investor Presentation - October 20, 2009

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Lethal challenge study in ferrets with VietNam strain

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 12: Medicago Investor Presentation - October 20, 2009

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Pandemic flu vaccine path to market

Q3 09 Q1 10 Q2 10 2011Q4 09

Start Phase I

Phase I results

Start multi-site Phase II

Phase II results

Q3 10 Q4 10 2012

IND submission

Potential commercialization

6-month safety data

2013

Page 13: Medicago Investor Presentation - October 20, 2009

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International development strategy

Provide countries worldwide with a rapid, affordable and effective manufacturing solution within their borders

Genopole® (France) Agreement for commercial facility in France

o 10 M € (capital) & 3 M €(operations)

o Subject to successful Phase I o Pandemic and seasonal

influenza vaccines

Ajanta Pharma (India)

Tabuk Pharma (Saudi)

Page 14: Medicago Investor Presentation - October 20, 2009

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CAPEX$ 10 M > $ 200 M

Staff100 1000

From strain to vaccine 6 months4 weeks

Capacity20 m doses 55 m doses

Time to double capacity12-18 months 36-48 months

Surge capacity limitationVirtually unlimited

Eggs supply shortage

Medicago*

Egg-based*expected figures when plant is optimized

Manufacturing made easier

Page 15: Medicago Investor Presentation - October 20, 2009

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Financial summary

Public since August 2006

Stock listing TSX-V : MDG

Recent price (Oct. 19, 09) $0.63

52 week hi-low $0.82 -$0.15

Shares outstanding (b/fd) 97 M / 157 M

Market cap (approx.) $61 M

Average daily volume (last 6 months) 700,000 shares

Share ownershipPMI 46.4%

Avenir Luzerne (Credit Agricole) 5.3%Management & BOD 3.4%

Cash position (Oct. 1, 09) 11 mos.

Page 16: Medicago Investor Presentation - October 20, 2009

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Philip Morris International Partnership

Medicago $15.975 M investment

Secure resources to complete first clinical phase in 2009

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

PMI 46.4% ownership of MDG

Interested in exploring adjacent technologies

Synergies with current field of knowledge and R&D activities

Page 17: Medicago Investor Presentation - October 20, 2009

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Upcoming newsflow

Pandemic vaccines International development

- Phase I results

- 6-month safety data

- Start of Phase II

- Additional developments &/or firm agreements

Seasonal vaccine Corporate

-Immunogenicity study in mice

-Award of grant(s)

-Financing activities to support Phase II

Page 18: Medicago Investor Presentation - October 20, 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, Smithkline Beecham, Ayerst-Wyeth

Dr. Louis-Philippe Vézina,Chief Scientific Officer

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

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 - October 20, 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. Pierre Marc Johnson,Director

Lawyer, physician, former Premier of Quebec and former professor of law at McGill University. Sits on boards of ACE Aviation Holdings Corporation, Air Canada and HolcimCanada

Mr. Andy Sheldon,Director

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

Dr. Louis-Philippe Vézina,Director

CSO - Medicago Inc.

Page 20: Medicago Investor Presentation - October 20, 2009

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Summary of Medicago’s advantages

• Fast, inexpensive and easily scalable manufacturing solution

• Lower dosage and cross-protection

• Successful international development strategy with near-term commercial opportunities

• Highly credible partner

• 170+ patents filed &/or pending

Page 21: Medicago Investor Presentation - October 20, 2009

Additional information

Page 22: Medicago Investor Presentation - October 20, 2009

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Phase I overview

• Dose-escalating study to evaluate safety, tolerability and immune response

• 48 subjects - age 18-60

• Evaluating doses of 5, 10 and 20 micrograms

• Two doses, injected 21 days apart

• Location - Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward

Page 23: Medicago Investor Presentation - October 20, 2009

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Lowest dose to achieve CHMP criteria

In ferrets In humansCompany Vaccine

typeAdjv.

1st dose 2nd dose 1st dose 2nd dose

GSK Split Yes NONE

7.5 µg (2/3 criteria) 3.8 µg protected vsheterol. challenge

3.8 µg (1/3 criteria)

• 3.8 µg• Cross-react.

Yes NA NA NONE• 1.9 µg• Cross-react.

SANOFI Split

No NA NA NONE• None except 45 µg in children

NOVARTIS Subunit Yes NA NA NA• 7.5 µg (2/3 criteria)

PSCRec. protein

No NA NA NA• 90 µg did not met 1/40 criteria

NOVAVAXVLP HA+NA+M1

No NONE 15 µg NA• 45 µg met at least 2/3 criteria. Phase I/IIa = 15, 45, 90 µg

MEDICAGO VLP HA Yes 5 µg 1 µg 5 µg + AlOH• 1-5 µg + AlOH• Higher doses - AlOH

(1) One whole inactivated vaccine from St-Jude provided HI titer after 1st dose in ferrets NA; Data not available

Pandemic Influenza vaccine industry