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Annual & Special Meeting of Shareholders Bioniche Life Sciences Inc. November 6, 2008

Annual & Special Meeting of Shareholders Bioniche Life Sciences Inc. November 6, 2008. Welcome, shareholders!. 1. Safe Harbour Statement. Except for historical data, the financial information circulated during this presentation contains statements that, by their very

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Annual & Special Meeting of Shareholders Bioniche Life Sciences Inc. November 6, 2008

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  1. Annual & Special Meeting of Shareholders Bioniche Life Sciences Inc.November 6, 2008

  2. Welcome, shareholders! 1

  3. Safe Harbour Statement Except for historical data, the financial information circulated during this presentation contains statements that, by their very nature, are forward-looking and, therefore, involve time periods, risks and other factors, known or unknown, which are beyond the Company’s control. Each of these factors may produce results or performances that differ significantly from expectations. No liability, present or future, derived from this can be assumed by Bioniche in any investment decision made following this presentation. 2

  4. Recent Accomplishments a aa a 3

  5. Rick Culbert President, Bioniche Food Safety 4

  6. Bioniche Food Safety • Strategy: vaccinate animals against pathogens they may introduce to the human food and water supply, and environment. • First initiative: cattle vaccine to reduce colonization and shed of E. coli O157:H7 bacteria (North American registrations in progress) • E. coli O157:H7 causes ≈73,000 cases of infection and ≈60 deaths per year in the U.S. (CDC) and a further 26,000 cases of infection per year in Canada; bacterium contains Shiga/Vero toxin 5

  7. Econiche Canadian License 6

  8. Vaccination as a Strategy to Reduce Shedding of E. coli O157:H7 in Cattle Populations • Stimulate immunity against type III secreted proteins that mediate bacterial attachment to intestinal cells Courtesy Dr. Brett Finlay Potter et al. 2004. Vaccine 22:362-369 Peterson et al. 2007. J Food Prot. 70(11) 2568-2577 Peterson et al. 2007. J Food Prot. 70(11) 2561-2567 7

  9. Does this Vaccine Work? Yes, as measured by various relevant outcomes - Dr. David Smith Colonization Fecal shedding Oral exposure Hide contamination Slide courtesy of Dr. David Smith 8

  10. How Much Intervention is Enough? Seasonal Occurrence of Human Illnesses • Repeatable overrepresentation of cases during May-October • 70% of reported cases in 6 months of the year • In winter, prevalence in cattle, percentage ground beef samples positive, and human cases are all substantially lower compared to summer • Target: winter-time burdens. Supported by data. 9

  11. Immunomodulation as an Intervention for E. coli O157:H7 E. coli O157 E. coli O157 Pre-harvest Harvest Consumers slide courtesy of Dr. Guy Loneragan 10

  12. Immunomodulation as an Intervention for E. coli O157:H7 E. coli O157 E. coli O157 Pre-harvest Harvest Consumers slide courtesy of Dr. Guy Loneragan 11

  13. E. coli Vaccine Status • Bioniche has completed most aspects of development: • proof of concept a • field studies a • adjuvant withdrawal trial a • pre-license serials a • field safety trials a • The Canadian regulator (CFIA) issued a full license in October, 2008. • For the USDA conditional license, a plan must be set to move to full licensure, one step of manufacture must be in the U.S. and three serial lots produced. • With a full U.S. license, product need not be manufactured there. • A $25 million production scale-up is beginning in Belleville, Ontario: • A $10 million repayable loan was provided by the Ontario government • A $5 million repayable loan was provided by Agriculture Canada • A $5 million repayable loan was provided by Industry Canada (ITO) • A $5 million repayable loan was obtained from BDC “Best new veterinary product for livestock” 12

  14. 13

  15. Selected Outbreaks/Recalls • October, 2008; Niagara region, Ontario, Canada • 47 people affected; 12 lab confirmed; linked to iceberg lettuce (Aunt Mid’s Produce) • September-October, 2008; North Bay, Ontario, Canada • 230+ people affected; 45 lab confirmed (1 with HUS); linked with Harvey’s restaurant • September, 2008; 5 U.S. states + Chatham-Kent, Ontario, Canada • 39 people affected; linked to iceberg lettuce (Aunt Mid’s Produce) • September, 2007; 8 U.S. states • Topps Meat Co.; 40 people affected (2 with HUS); 21.7M lbs. recalled; Co. folded • September, 2007; North America • Dole Fresh Vegetables voluntary recall of packaged salads • November, 2006; 3 U.S. states • 99 people affected (43 confirmed); 9 hospitalized; 1 with HUS • Linked to consumption of lettuce at Taco Bell and other restaurants • September, 2006; 26 U.S. states • 205 people affected; 3 deaths; 31 with HUS • Linked to consumption of fresh spinach 14

  16. A Litigator’s Perspective “After changes in meat regulation dropped recall amounts from 23 million pounds in 2002 to only 181,900 pounds in 2006, 39 million pounds of E. coli tainted meat has been recalled since the spring of 2007. The numbers have just shot up in the last year and so have illnesses. If this was a serial killer – which, actually, it is – every resource in this country would have been mobilized against it. Nothing less is acceptable.” Bill Marler Food Poisoning Lawyer Marler Clark LLP Seattle, WA www.marlerblog.com 15

  17. Vaccine Market Potential • There are approximately 199 million cattle • in North America and Europe (beef cows, • dairy cows, calves): • North America • 113 million total (approx. 25 million on feedlots) • Three doses of vaccine per animal at an estimated $2.00 U.S./dose (higher price expected for non-fed cattle) • Europe • 86 million total • Three doses of vaccine per animal at an estimated 5-7 Euros/dose • Access to the EU will be delayed relative to NA First commercial vaccine use: September 21, 2007 Top Meadow Farms (RR#1 Clarksburg, Ontario, Canada) 16

  18. Educating and Informing Bioniche has developed a series of education tools to inform the public, industry professionals and government. 17

  19. A Producer’s Perspective • (Cattleman) “Paul Brown says he can’t afford to pay for the vaccine, but also admits he can’t afford not to. Not when it might protect the public.” • Laurie Graham, CBC News The National Monday, October 27, 2008 18

  20. The Canadian Government as a Customer There is a precedent for the government to step in when it is in the public’s best interest. Examples include: Gardasil and Rabies vaccines 19

  21. Politically Prudent • Food Safety • Innovative • Economically sound • Supports primary agriculture • Shows Canada as leader 20

  22. ScientificallyStrong • Antibiotics • Bacteriophages • Chlorate • Lactobacillus NP51 • Vaccination 21

  23. Vaccine Production • Currently using Product Development Laboratory at Belleville, Ontario facility for production: • Producing batches for regulatory and quality control review • Producing quantities to supply initial customers • Capacity: ~83,300 doses/month (1,000,000 doses/year) • Scaling up to min. 40M annual dose capacity at Belleville (by mid-2010): • Financing secured ($25 million) • Engineering designs completed • Detailed drawings being completed • Clearing space • Ordering equipment • Constructing facility (within existing building) • Installing and validating equipment • Producing vaccine 22

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  25. Cameron Groome Executive Vice-President, Corporate & Strategic Development 24

  26. Bladder Cancer – Treatment Issues CARCINOMA IN SITU ± TCC CIS/TCC OF THE BLADDER MUTATIONAL STATUS AND INTRINSIC RESISTANCE TO THERAPY FIELD EFFECTS VS CLONALITY PROGRESSION, METASTASIS AND DEATH RESIDENCE TIME IN THE BLADDER (1-3 HOURS) Bladder cancer is difficult to treat, needing a fast-acting and broadly efficacious local therapy. 25

  27. Bladder Cancer – Treatment Options • First-Line Treatment of Non-Muscle-Invasive Bladder • Cancer (NMIBC) • Intravesical immunotherapy with BCG is the current standard of care. • BCG is a live mycobacterium (an attenuated strain of M. bovis) with the potential to cause systemic and life threatening infections. • BCG-induced cystitis affects up to half of treated patients and is one of the main reasons that patients halt therapy. • 20-30% stop treatment during induction (first 6 weeks). • Over 80% cannot tolerate a 3-year maintenance regimen. (17%: Lamm, 2000). • BCG has limited efficacy in its initial and durable responses. (≈50-80% initial response, ≈ half recurring: • Okeke, 2005) 26

  28. Bladder Cancer – Treatment Options • Patients Refractory to BCG Immunotherapy • Intra-vesicular treatment options are much less effective. • Reported CR rates vary with definitions of “refractory.” • Repeat BCG ± interferon, if tolerated (immunotherapy) • Response rate ≤ 20% • Valrubicin (Valstar®) (chemotherapy) • Response rate - 21%1 (FDA: 8%2) • Mitomycin C (chemotherapy) • Response rate ≤ 20%3 1 FDA public documents and Steinberg, G, et al. Efficacy and Safety of Valrubicin for the Treatment of bacillus Calmette-Guerin Refractory Carcinoma in Situ of the Bladder. J Urol, 2000. 163: p. 761-767 2 http://www.fda.gov/cder/foi/nda/98/20892.htm 3 Malmstrom, P.U., et al., 5-year followup of a randomized prospective study comparing mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. Swedish-Norwegian Bladder Cancer Study Group. J Urol, 1999. 161(4): p. 1124-7. 27

  29. MCC is prepared from Mycobacterium phlei, a non-pathogenic mycobacterium MCC is a well characterized M. phlei cell wall composition that contains bioactive DNA oligonucleotides The DNA is associated with immune stimulant and anticancer activity The cell wall functions as a biological drug delivery and immune stimulation system (recognition by cell receptors) MCC is sterile Urocidin is an MCC formulation for the treatment of bladder cancer Mycobacterial Cell Wall-DNA Complex (MCC) 28

  30. Urocidin™ Versus BCG MCC suspension BCG • Inactive Viable • No biocontainment requirement Biocontainment required • No infective potential Potential for infection • A well-defined dose A highly-variable dose ( ~10 fold range in CFU) • Inhibition of proliferation Weak inhibition of proliferation • Induces apoptosis Does not appear to induce apoptosis • Anticancer cytokines/ chemokines Inflammatory cytokines • Independent of p21/p53/pRb/MDR Dependent on p53/p21/pRb/MDR? • Bifunctional agent Immune stimulant • Current & formal toxicology studies From 1908 Vx ►1976 bladder Ca. Rx 29

  31. MCCPhase III Bladder Cancer Program • PART ONE (protocol approved by FDA, Health Canada): • 105 evaluable patients • North America; leading centres across Canada and the U.S. • Open-label study showing the therapeutic efficacy of MCC suspension in non-muscle-invasive bladder cancer refractory (unresponsive) to BCG. • Patient enrolment commenced in November/06 • Three year completion target • Trial result targets: • Primary endpoint: >>20% CR, sustained at one year • (Valrubicin, the only other FDA approved product for this indication, had a 8-21% response rate) • Safety target: less than 10% unable to tolerate treatment Fast tracked by FDA • Since commencement, five meetings of the independent DSMC have recommended to “continue the trial unmodified”. 30

  32. MCCPhase III Bladder Cancer Program • PART TWO (protocol approved by FDA): • Approximately 800 patients • North America, Australia and Europe • Randomized, double-blind, multi-centre study comparing MCC to BCG as first-line therapy in non muscle-invasive bladder cancer at high risk of recurrence or progression • Trial result targets: • Safety target is superiority to BCG (fewer drug-related AEs) • Efficacy target is non-inferiority to BCG (primary efficacy endpoint will be duration of disease-free survival of patients after two years) • A Special Protocol Assessment (SPA) agreement establishes that the FDA will register the product if target trial results are met. SPA agreement with FDA Fast tracked by FDA 31

  33. Big 3 Bladder Cancer Incidence & Prevalence Refractory approval will permit on-label use of Urocidin™ for 1/4 NMI cases. Further trials should expand this label to 3/4 of new and recurrent NMI diagnoses. Total Patient Pool - NMI/S BC – U.S., EU5+, Japan 350,000 pts (100%)1 215,000 pts4← →135,000 pts2 New Cases (~70% of new Dxs)3 Recurrent Cases per year (1/5 of non-cystectomized)5 39% 61% 94,500 27.3% 86,000 40,500 11.7% 24.4% 36.6% 129,000 Higher Risk (~30% of cases)6 Lower Risk (~70% of cases)7 Higher Risk (~40% of cases)8 Lower Risk Recurrent (~60% of cases)9 (I&II) (II) (II) (III) 36,500 56,500 103,000 69,000 Drug or Biologic Treated (90% treated)10 Drug or Biologic Treated (60% w. 1 peri-operative Rx)11 Drug or Biologic Treated (80% w. BCG regimen)12 Drug or Biologic Treated (80% w. BCG regimen)13 34,500 I – Refractory Approval ≈ 23% of pts & 12-21+ doses per pt. II – Comparative Approval ≈ 60% of pts & 12-21+ doses per pt. III – Potential Future Usage ≈ 15% of pts & 1 dose per pt. Total Urocidin™ NMI/S BC Applications ≈ 75% pts. BCG Treated (95% usage in such cases)14 (I) 11,500 BCG Failures (through induction)15 32

  34. Urocidin Partnership Discussions • The Company is in advanced discussions with multiple parties interested in a partnering transaction related to Urocidin. • We are seeking a partner/partners that will: • Financially support the completion of the Phase III program in return for marketing rights to the commercialized product. • Allow Bioniche to retain manufacturing. • Provide launch and marketing support for Urocidin. • Share profits (after cost of goods and marketing costs) with Bioniche. 33

  35. Patrick Montpetit Vice-President & Chief Financial Officer 34

  36. Financial Review Year End Fiscal 2008 & First Quarter Fiscal 2009 35

  37. Income Statement Highlights –Fiscal 2008 • Small growth of 2% in animal health sales attributed to the U.S. • Gross profits margins stable, despite Cdn. $ increases. • Reduction in overheads by 7% offset by marketing reorganization costs. • Investment in R&D remained stable with small increases in human health. 36

  38. Income Statement Highlights – Q1- Fiscal 2009 • Strong growth in sales of all key products, around the world. • Gross profits a bit less due to certain QC costs now accounted under COG. • Status quo on overheads with strong efforts from the marketing group. • Status quo on R&D investment. 37

  39. Product Performance Highlights • Strong growth during Q1 came from Canada, USA and Australia. • The marketing reorganization last year is reaping benefits. 38

  40. Balance Sheet HighlightsJune & September, 2008 • Not much change in the liquidity situation in terms of cash and working capital balances. • A portion of the revolving credit line was converted to access some liquidity. 39

  41. Activities of Note 40

  42. Activities of Note 41

  43. Graeme McRae Chairman, President & CEO 42

  44. State of the Industry • Under normal circumstances, we would see our Company rewarded in the capital markets for achievements such as the full Canadian license for Econiche. However, these are not normal times. • Stock market volatility and spending retrenchments are occurring around the world; investors who would normally commit new funds to promising companies like ours have suffered large losses and are reluctant to provide new capital. • Until the situation stabilizes - which it will - money is very expensive and difficult for us to obtain. • Our bankers have been placed under duress by the liquidity crisis and are passing the burden to their clients. 43

  45. Objectives for Fiscal 2009 • Securing necessary financing for operations. • Successfully concluding a marketing partnership deal/deals for Urocidin. • Obtaining a U.S. conditional license for Econiche. • Increasing sales of Econiche, per available supply. • Advancing construction of vaccine plant in Belleville. • Completing recruitment for first Phase III clinical trial with Urocidin. • Initiating second Phase III clinical trial with Urocidin. 44

  46. Please join us for a Receptionin the Spadina Foyer (cash bar) 45

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