tsx: fxa poised for aggressive growth 2010 annual general meeting august 2010

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Page 1: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010
Page 2: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

TSX: FXA

POISED FOR AGGRESSIVE GROWTH

2010 Annual General Meeting August 2010

Page 3: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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.     

Page 4: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010
Page 5: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Afexa’s Products

Page 6: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Parallel Growth Drivers

MarketDiversification

ProductDiversification

Page 7: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 8: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 9: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Parallel Growth Drivers

MarketDiversification

Page 10: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 11: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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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

Page 12: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 13: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Market Diversification

Europe• Assessment of

regulatory requirements

Page 14: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 15: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Parallel Growth Drivers

ProductDiversification

Page 16: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Branching Out With

New Polymolecular Botanical Drugs

Page 17: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 18: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 19: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

ChemBioPrintProprietary 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

Page 20: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

ChemBioPrintProprietary 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

Page 21: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 22: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Discovery Pre-Clinical

Clinical Approval End-Product Launch

1 – 2 years 3 – 5 years 6 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

Page 23: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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-ClinicalDiscovery Clinical

Photo: Yellow plaque deposits in artery

1 – 2 years 3 – 5 years 6 months – 2 years

High cholesterol affects ~40% of Canadian Adults

Page 24: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

ClinicalDiscovery Pre-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 years 3 – 5 years 6 months – 2 years

Page 25: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Discovery Pre-Clinical Clinical

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 years 3 – 5 years 6 months – 2 years

Page 26: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Discovery Pre-Clinical Clinical

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 years 3 – 5 years 6 months – 2 years

•Positive pre-clinical lab studies in leukemia – McGill University

Page 27: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Discovery Pre-Clinical Clinical Approval 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 years 3 – 5 years 6 months – 2 years

Page 28: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

• 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 LaunchClinicalDiscovery Pre-Clinical

1 – 2 years 3 – 5 years 6 months – 2 years

•Approx. 285 million people worldwide are affected by diabetes

•Growing by approx. 7 million per year

Page 29: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

ClinicalDiscovery Pre-Clinical

1 – 2 years 3 – 5 years 6 months – 2 years

Page 30: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

• 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

Clinical Approval End-Product LaunchPre-ClinicalDiscovery

1 – 2 years 3 – 5 years 6 months – 2 years

Page 31: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

Discovery Pre-Clinical

Clinical Approval End-Product Launch

1 – 2 years 3 – 5 years 6 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

Page 32: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 33: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010

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

Page 34: TSX: FXA POISED FOR AGGRESSIVE GROWTH 2010 Annual General Meeting August 2010