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2011 President’s Address to Shareholders AUGUST 2011.

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Presentation on theme: "2011 President’s Address to Shareholders AUGUST 2011."— Presentation transcript:

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2 2011 President’s Address to Shareholders AUGUST 2011

3 Forward-Looking Statements
Advisory Regarding Forward-Looking Statements This presentation contains certain forward-looking information and statements within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “would”, “project”, “could”, “should”, “contemplate”, “potential”, “depend”, “forecast”, “believe”, “plans”, “targets”, “intends” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements reflect the Company’s beliefs and are based on information currently available to us. These statements require Afexa to make assumptions that it believes are reasonable and are subject to inherent risks and uncertainties. Actual results and developments may differ materially from the results and developments discussed in the forward-looking statements as certain of these risks and uncertainties are beyond Afexa’s control. The forward-looking information and statements included in this news release are not guarantees of future performance and should not be unduly relied upon. Examples of such forward-looking statements in this presentation include, but are not limited to:   the expectation of positive and sustained growth and diversification for the Company and increased market penetration within Canada and internationally; the Company’s goal to bring to market a basket of natural health products; the Company’s belief that it will continue to be profitable and self-fund operations; whether the Company’s product candidates, including in the areas of cholesterol management, COLD-FX pediatrics, allergy, cancer support, brain health, glucose management and TLR modulators will be successful in clinical trials leading to regulatory approvals and commercialization; the expectation that Afexa will continue as a market leader in Canada; whether Afexa will seek US botanical drug registration in the U.S. for one or more of its products and, if it does, whether Afexa will be successful in gaining such regulatory approval; whether international market diversification will take place and if it does, whether Afexa will be successful in penetrating international markets; whether Afexa will be successful in achieving suitable collaborations for international marketing; whether the Company will meet its timelines for new product candidates; whether Afexa will maintain its uniqueness in the marketplace; and whether or not all of the corporate initiatives will lead to value creation and strengthening of the share price. The Company believes the expectations and assumptions reflected in the forward-looking information and statements contained herein are reasonable. However, no assurance can be given that these expectations and assumptions are correct and that the results, performance or achievements expressed in, or implied by, forward-looking statements within this disclosure will occur, or if they do, whether any benefits may be derived from them. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. The forward-looking information and statements contained in this presentation speak only as at the date of this AGM, and the Company assumes no obligation to publicly update or revise them to reflect new events or circumstances, except as may be required pursuant to applicable laws. Investors are encouraged to consult SEDAR filings for more details on forward-looking statements and associated risks.

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5 Applying the Science to North America’s Greatest Health Concerns
COLDS FLU COLD SORES CHOLESTEROL MANAGEMENT CHOLESTEROL MANAGEMENT PEDIATRIC COLDS AND FLU Where science, natural medicines and healthcare empowerment come together. ALLERGIES CANCER BRAIN HEALTH CHRONIC VIRAL INFECTIONS DIABETES

6 Dr. Jacqueline Shan Tracey Ramsay Chief Scientific Officer
Chief Marketing Officer and Sr. Vice President Sales

7 Three “Assets”, One Mission
Pioneer evidence-based natural medicines that empower people to achieve their health potential

8 Our Three “Assets” Serial Developer Our science Our pipeline
Clinical trials Regulatory approvals

9 The globalization of COLD-FX
Our Three “Assets” The globalization of COLD-FX International regulatory approvals Partner to commercialize outside of Canada

10 Our Three “Assets” Canadian Commercial Business
National platform to develop existing products and launch new products into the marketplace

11 Afexa: A Serial Developer

12 Serial Development Dr. Jacqueline Shan Chief Scientific Officer

13 Multi-Centre Seniors Clinical Trial
Randomized controlled multi-centre Canadian clinical trial involving 783 community-dwelling seniors Well tolerated and reduction in cardiovascular AEs with CVT-E002 intake vs placebo Examined efficacy of CVT-E002 at 400 and 800 mg/d over cold/flu season for providing added protection on top of flu shot Reduction in duration (4.9d vs 3.1d and 2.9d for placebo, 400 mg/d and 800 mg/d, p=.05) Relative risk reduction in incidence of cold/flu of 31% and 33% for 400 mg/d and 800 mg/d versus placebo (p=0.04 and 0.03) Reduction in symptom severity (total symptom score for 23 vs 17 and 15.3 for placebo, 400 mg/d, and 800 mg/d, p=.05)

14 COLD-FX: Our Lead Brand is #1 in Canada
TODAY GOAL: further expand consumer base and extend brand life Licensed by Health Canada Alternative formulation Development – tablets and liquid – #1 selling cold and flu remedy in Canada for last six years Clinical testing completed for use of active ingredient in allergy patients Continuing clinical studies involving seniors, children

15 Advancing COLD-FX Pediatric Clinical Trials
Children 3-12 years old First clinical trial Safety Complete and successful Second clinical trial in progress; randomized, double-blind, placebo-controlled Continue enrolment in upcoming cold and flu season

16 Allergy Clinical Trial Near Completion
Positive pre-clinical lab studies completed Randomized, placebo-controlled, double-blind clinical trial in progress Enrolment completed Data analysis in progress

17 HT1001 Brain Health Clinical Trials
By 2020 over one billion senior citizens will be alive on the planet Proprietary active ingredients for REMEMBER-FX® Clinical trials have shown: Improves memory in generally healthy adults Improved working memory in schizophrenia patients Reduced oxidative stress Planning additional clinical trial for oxidative stress and brain function

18 ChemBioPrint: A Proven Proprietary Approach
ChemBioPrint®: a enabling technology for: Discovering proprietary products and product standardization Chemical fingerprinting Identifies and characterizes the entire chemical profile of the polymolecular-based plant extract. Biological fingerprinting Measures the pharmacological effect of the active chemical components through a series of laboratory evaluations. Precise manufacturing Ensures measurable chemical and biological consistency from batch to batch of the natural medicines.

19 Advancing Cholesterol Management — Dilexaponan
High cholesterol affects ~40% of Canadian adults New proprietary polymolecular formulation Dilexaponan for cholesterol management Unique MOA, first-in-class therapeutic Promising lab studies Pilot open label dose-ranging clinical trial demonstrated LDL lowering and HDL raising effects Next clinical trial planned for this fiscal year

20 ~25% of people worldwide are affected by hypertension
Blood Pressure Management ~25% of people worldwide are affected by hypertension Two possible polymolecular based formulations extracted from various plants discovered in lab testing Planning further pre-clinical studies

21 Blood Glucose Management
Approx. 285 million people worldwide are affected by diabetes – growing by ~7 million per year New proprietary polymolecular formulation for blood glucose management Unique MOA, first-in-class therapeutic Promising lab studies Clinical trial in progress: open label, dose-ranging, safety and effect size finding Active constituents showed synergistic effect on increasing glucose uptake in cultured skeletal muscle cells

22 Toll-like Receptor Therapeutics
TLR (Toll-like receptors) Modulators – a class of molecules targeting multiple physiological and therapeutic sites, including immune cells TLR Modulators have shown promising therapeutic potential for numerous diseases and indications, including Cancer Infectious diseases such as hepatitis, HIV and others Allergies and asthma Adjuvants for vaccines Afexa’s research has discovered potential botanical TLR Modulators Preliminary lab studies have demonstrated their possible anti-H1N1 and Herpes 2 (HSV-2) effects

23 Taking COLD-FX Global CANADA HONG KONG CHINA UNITED STATES JAPAN

24 Globalization – China: 1.3 Billion People
Regulatory approval process underway in China Clear execution plan with a cost-effective path

25 United States – a Market of 311 Million
“Dietary supplement” not sufficient medical claim Previous successful CLL clinical trial Investigational New Drug Application submitted to U.S. FDA to test AFX-2 in CLL Patients Dose-range study planned for end of 2011 Orphan Drug Status potential

26 Cancer – Chronic Lymphocytic Leukemia (CLL)
U.S. National Cancer Institute sponsored Priority Project Led by independent Wake Forest Baptist Medical Centre, Winston-Salem, North Carolina Randomized controlled trial involving 293 CLL patients. Results: Reduced moderate-severe ARI symptoms by 20.1% (p=0.02); no effect on mild ARI symptoms Trend of reduced incidence of moderate-severe ARI Increased seroconversion (antibody levels) to 9 common upper respiratory viruses (p = 0.04) Reduced risk of SAEs (p = 0.02) Encouraging findings warrant exploration of higher doses

27 Significant Regulatory Milestone – U.S. FDA IND
Approximately 130,000 individuals in the U.S. suffer from CLL U.S. Phase 1B clinical trial in CLL authorized under an FDA IND Trial will examine safety and immunological effects of AFX-2 doses ranging from 400-3,200 mg/d Marks initiation of the Company’s strategy to ultimately obtain FDA approval as a polymolecular botanical drug Successful filing affirms strength of scientific, regulatory and quality capabilities and assets Evaluating strategy of developing orphan drug in CLL as potential first step in ultimately obtaining approval for cold/flu in generally healthy population Potential for reduced development cost and timeline CLL U.S. market potential for AFX-2 estimated at ~$ million/yr

28 Asia – Evaluating a Massive Market
Exploring opportunities and assessing regulatory pathways in several countries

29 Europe Europe Assessment of regulatory requirements
Combined with U.S. pathway

30 ChemBioPrint: A Proven Proprietary Approach
ChemBioPrint®: an enabling technology for: Discovering proprietary products and product standardization Chemical fingerprinting Identifies and characterizes the entire chemical profile of the polymolecular-based plant extract. Biological fingerprinting Measures the pharmacological effect of the active chemical components through a series of laboratory evaluations. Precise manufacturing Ensures measurable chemical and biological consistency from batch to batch of the natural medicines.

31 Canadian Commercial Business

32 Canadian Commercial Business – A Foundation for Growth
Canada Grow FX portfolio markets and share through differentiation Accelerate growth through product diversification Accelerate growth through geographic diversification

33 Where Afexa fits in the health world
Unique Technology, Science and Vision Differentiated Market and Products Where Afexa fits in the health world

34 COLD-FX Market Leadership
Helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system. COLD-FX is highly recognized and known by consumers with 67% national awareness1 COLD-FX has been the #1 Pharmacist recommended Natural Cold Remedy in Canada by Pharmacy Post magazine for the 5th consecutive year 1Research Dimensions, Mar 2011

35 25% 56% 31% 35% >2,000 3 4 10 COLD-FX Clinically Proven
Over 10 clinical trials support COLD-FX proven efficacy and safety profile 25% Reduction in average number of colds & flu 56% Reduction in number of recurrent colds & flu 31% Reduction in severity of symptoms 35% Reduction in symptom duration >2,000 Patients studied in COLD-FX clinical trials 3 New clinical trials ongoing 4 Randomized-placebo controlled clinical trials proving efficacy and safety 10 Clinical trials completed Predy, G.N., et al. Efficacy of an extract of North American Ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ vol 173 (9)

36 COLD-FX – Cold and Flu Blockbuster Brand Market and Brand Leadership
COLD-FX is the number one selling cold and flu remedy in Canada1 10 20 30 40 50 60 70 Consumer Purchases ($ Millions) 1Nielsen Company Market Track National all channel dollar sales for the categories of Cold Remedies and Supplements and Products (“Point of Sale Data”), 52 weeks ended July 2, 2011)

37 Innovative Product Diversification Drives Growth
Brand and the Product Life Cycle

38 COLD-FX Geographic Diversification Drives Brand Growth and Penetration
National and regional brand strategies required to capitalize on growth potential Regional details:

39 IMMUNITY-FX: FX Product Differentiation
Strengthens your natural defenses and your overall health and wellness Maintains health and wellness even during periods of stress IMMUNITY-FX contains a patented, clinically proven ingredient, CVT-E002™, and an extract derived from the Reishi mushroom. IMMUNITY-FX has been granted National Sports Federation certification “Staying healthy is so important in order to train and perform consistently so I do everything I can to keep healthy and fuel up my immune system. That’s why I take IMMUNITY-FX!” – Paula Findlay (Multiple ITU World Championship Series Gold Medalist and 2012 Canadian Olympic Team Hopeful)

40 COLDSORE-FX: Product Diversification through Partnership
Canadian launch July 2011 COLDSORE-FX shortens healing time and relieves the pain associated with cold sores.

41 Canadian Commercial Business: Foundation for Geographic Diversification
Product development in multiple growth categories Pursue botanical drug registration in U.S. Continuing: Pursue regulatory approval for COLD-FX in China Expect significant improvement in revenue Launched COLDSORE-FX UNITED STATES CHINA JAPAN

42 Product development in multiple growth categories
Going Forward Continuing: Product development in multiple growth categories Pursue botanical drug registration in U.S. Pursue regulatory approval for COLD-FX as imported drug in China Expect significant improvement in revenue Launched COLDSORE-FX

43 Unique Business Three integrated businesses Profitable and exciting Canadian commercial business funds our cost-effective product development Seasonality makes cash flow guidance difficult

44 Afexa’s Executive Leadership Team
Michael Obert Chief Legal Officer and Senior Vice President Corporate Development Tracey Ramsay Chief Marketing Officer and Senior Vice President Sales Allan Cleiren Chief Financial Officer and Senior Vice President Operations Jack Moffatt President and CEO Jacqueline Shan Chief Scientific Officer

45 Afexa’s Team

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