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TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010.

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Presentation on theme: "TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010."— Presentation transcript:

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2 TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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 Afexa’s Products

6 Parallel Growth Drivers Market Diversification Product Diversification

7 A Strong Scientific Team Led by Founder and Chief Scientific Officer, Dr. Jacqueline Shan

8 Market and Product Diversification Well Under Way COLD-FX® is the Canadian market leader for flu and colds Profitable and able to self- fund full cycle of research, clinical studies, launch and marketing of new products A proven marketing and sales platform for launching new products into the Canadian marketplace A proven science-based company pioneering natural medicines that empower people to achieve their health potential Positioned to focus on opportunities outside Canada

9 Parallel Growth Drivers Market Diversification

10 Penetrating an Established Market Canada Expanding market penetration of commercialized products Focus of current marketing efforts Small household penetration generally across Canada Even higher growth potential in Québec Bringing new products to market

11 Consumer Purchases $ in Millions Source: Nielsen MarketTrack, National All Channels, Calendar Years Clean up. Move labels to actual lines. Needs a summary point showing % growth in coldfx Growing a Market Leader COLD-FX 5 year compound annual growth rate of 48% Total COLD-FX Total Tylenol Cold/Flu Total Advil Cold/Flu

12 Market Diversification United States COLD-FX ® currently must be sold as health supplement intended to boost immune system; this limits market potential Considering a New Drug Application (NDA) for Afexa product as a polymolecular botanical drug; larger market potential and expanded therapeutic claims

13 Market Diversification Europe Assessment of regulatory requirements

14 Market Diversification Asia Distributor agreement in Hong Kong Regulatory approval process under way in China Assessing Japan’s business opportunities Reviewing opportunities in other Asian countries

15 Parallel Growth Drivers Product Diversification

16 Branching Out With New Polymolecular Botanical Drugs

17 Polymolecular Botanical Drugs: Creating a New Class of Natural Medicines Also known as “botanical drugs” or “herbal drugs” In Canada considered to be novel proprietary botanical products with therapeutic claims supported by specific clinical trials Fundamentally differentiated from traditional herbal medicines COLD-FX belongs to this category of over-the-counter, non-traditional botanical products

18 Required to meet high clinical standards, similar to conventional pharmaceutical standards Track is multi-year to approval involving rigorous pre-clinical and clinical studies as well as toxicology testing, chemical standardization and scrutiny of plant sources and manufacturing processes Polymolecular Botanical Drugs: Creating a New Class of Natural Medicines

19 ChemBioPrint Proprietary Technology Biological Fingerprinting Polymolecular active constituents are tested for multiple biological or pharmacological responses indicating health and/or therapeutic benefit Chemical Fingerprinting Multiple chemical analysis combining different chromatographic detectors provides precise chemical identity of multiple active constituents of a product Consists of two-dimensional fingerprinting

20 ChemBioPrint Proprietary Technology Patented technology Applicable to all evidence-based multi-active component natural therapeutics For both discovery and standardization Pharmacologic and clinical validation Batch-to-batch consistency

21 Product Diversification: Multiple Paths Commercialize existing products beyond COLD-FX ® Advance multiple products through clinical trials Increase R&D into products with targeted applications License third-party products that fit the Afexa profile

22 DiscoveryPre- Clinical Approval End-Product Launch 1 – 2 years3 – 5 years6 months – 2 years Cholesterol Management COLD-FX ® Pediatrics Seasonal Allergy Cancer Support Oxidative Stress & Brain Health Glucose Management Blood Pressure Management TLR Therapeutics Anti-Viral Cancer Management Vaccine Adjuvant Product Development

23 Approval End-Product Launch New proprietary formulation Lip-01 to improve cholesterol levels Pilot open clinical study in progress. Preliminary data signals suggest similar efficacy as pre-clinical studies Cholesterol Management Pre-ClinicalDiscoveryClinical Photo: Yellow plaque deposits in artery 1 – 2 years3 – 5 years6 months – 2 years High cholesterol affects ~40% of Canadian Adults

24 ClinicalDiscoveryPre-Clinical COLD-FX Pediatrics Children 3-12 years old First clinical trial Safety Complete and successful Second clinical trial planned; randomized, double-blind, placebo-controlled Approval End-Product Launch 1 – 2 years3 – 5 years6 months – 2 years

25 DiscoveryPre-ClinicalClinical Allergy Clinical Trial Positive pre-clinical lab studies complete Randomized, placebo-controlled, double-blind clinical trial in progress Targeted to be completed in next 12 months Approval End-Product Launch 1 – 2 years3 – 5 years6 months – 2 years

26 DiscoveryPre-ClinicalClinical CLL Cancer Clinical Trial Clinical trial in Chronic Lymphocytic Leukemia (CLL) – National Cancer Institute and Wake Forest University Available preliminary data presented at American Society of Clinical Oncology (ASCO) June 2010 Available results indicating positive signals – further analysis in progress Reduced sore throat and trend of reduced incidence of moderate- severe Acute Respiratory Illness Reduced serious adverse events (SAE) suggesting improved disease tolerability Exploring potential effect on immune system through strengthening mucosal integrity Next clinical trial in CLL in planning phase with Wake Forest University Approval End-Product Launch 1 – 2 years3 – 5 years6 months – 2 years Positive pre-clinical lab studies in leukemia – McGill University

27 DiscoveryPre-ClinicalClinicalApproval End-Product Launch Brain Health Proprietary active ingredients for REMEMBER-FX ® and MEMORY-FX ® Clinical trials have shown: Improves memory in normal adults Improves working memory in schizophrenia patients Reduces oxidative stress Planning additional clinical trial for oxidative stress and brain function 1 – 2 years3 – 5 years6 months – 2 years

28 Clinical trial planned: open label; dose ranging; safety and effect size finding Discovered a potential polymolecular formulation extracted from two herbs Active constituents showed synergistic effect on increasing glucose uptake in cultured skeletal muscle cells Clinical trials showed reduced blood glucose levels Glucose Management Approval End-Product Launch Clinical DiscoveryPre-Clinical 1 – 2 years3 – 5 years6 months – 2 years Approx. 285 million people worldwide are affected by diabetes Growing by approx. 7 million per year

29 Approval End-Product Launch ~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 Blood Pressure Management ClinicalDiscoveryPre-Clinical 1 – 2 years3 – 5 years6 months – 2 years

30 TLR (Toll-like receptors) Modulators – a class of molecules targeting multi-organs and tissues including immune cells TLR modulators have shown promising therapeutic potential and supportive treatment for: Cancer Infectious diseases 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) properties TLR Therapeutics ClinicalApproval End-Product LaunchPre-ClinicalDiscovery 1 – 2 years3 – 5 years6 months – 2 years

31 DiscoveryPre- Clinical Approval End-Product Launch 1 – 2 years3 – 5 years6 months – 2 years Cholesterol Management COLD-FX ® Pediatrics Seasonal Allergy Cancer Support Oxidative Stress & Brain Health Glucose Management Blood Pressure Management TLR Therapeutics Anti-Viral Cancer Management Vaccine Adjuvant Product Development

32 Afexa’s Competitive Advantages Our patented ChemBioPrint discovery and standardization technology Our incredibly strong scientific team and clinical collaborators around the world Our leadership position in developing polymolecular botanical drugs Our leadership position in developing evidence-based natural health products in Canada, with an incredible success story with our flagship brand COLD-FX

33 Investing in Afexa Maturing Canadian science company with highly accepted commercial products and huge potential to leverage proven science across new medicines and markets Stock is under-valued and has tremendous upside potential and does not reflect the laboratory and clinical breakthroughs Board of Directors, composed of strong and knowledgeable individuals from a wide range of disciplines, provides oversight and guidance Full spectrum of in-house professionals capable of building strongly branded products from conceptualization to commercialization Market and product diversification well underway

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