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Annual & Special Meeting of Shareholders November 8, 2007

Annual & Special Meeting of Shareholders November 8, 2007. 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 November 8, 2007

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  1. Annual & Special Meeting of ShareholdersNovember 8, 2007

  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. Our Business Model • Late stage development of proprietary, large market human cancer therapies. • Supported by cash flow from globally marketed products in animal health. • Today: - Revenues of $27 million+ -Phase III product (Urocidin for bladder cancer): -2 pivotal studies (1st fast tracked; SPA on 2nd) - CFIA conditional license for E. coli O157:H7 cattle vaccine in Canada 3

  5. Corporate Highlights • Phase III oncology product • UrocidinTM(MCC) - for non-muscle invasive bladder cancer in humans - promising Phase II safety and efficacy • Most significant pipeline products • MCC for other human cancers (peritoneal – ovarian, colorectal; others) • E. coli O157:H7 cattle vaccine (in North American regulatory pathway) • Other food safety vaccines (e.g., Salmonella, Campylobacter) • Solid margin animal health business • Revenues of C$27.5M in Fiscal ’07 • Contributes significant earnings before interest, taxes, depreciation and amortization (EBITDA) • Supports infrastructure (e.g., manufacturing, regulatory affairs, quality assurance, quality control) 4

  6. Corporate Objectives • Signing of a marketing partnership agreement for Urocidin. • Licensing of E. coli O157:H7 cattle vaccine. • Successful completion of Phase III trials with Urocidin in the treatment of non-muscle invasive bladder cancer. • Obtaining financing as required to complete priority projects. 5

  7. Nigel C. Phillips, Ph.D., C.Biol. Senior Vice-President and Chief Scientific Officer 6

  8. Tuberculosis (infection with Mycobacterium tuberculosis) associated with reduced incidence of lung cancer (1870’s) Mycobacterial cell wall compositions possessing anticancer activity The MCC Journey ? 7

  9. Origins - Mycobacteria and mycobacterial cell walls have immune stimulant and anticancer activity (1890’s – 1970’s) Rabinowitsch, 1897. Lydia Rabinowitsch, one of the first female microbiologists, showed that at the site of injection of Mycobacterium butyricum, local granulomatous reactions developed and that the reaction can be strengthened by the addition of butter or paraffin oil. Rabinowitsch, L. Zeitschrift fuer Hygiene26, 90-111 (1897) Friedmann, 1903. Friedmann used mycobacteria from amphibia as immunomodulators and made money by selling this product. Killed mycobacteria isolated from tortoises were shown to stimulate nonspecific immunity. Friedmann, F.F. Centralblatt fuer bakteriologie 34, 793-804 (1903), Deutsche medizinische Wochenschrift 50, 953-954 (1903) Freund & McDermott, 1942. These researchers showed that a mixture of killed M. tuberculosis and paraffin oil is a potent adjuvant that allows the induction of profound immune responses (antibody responses and delayed-type hypersensitivity reactions). Further improvement was achieved by the mixing of paraffin oil and killed mycobacteria (complete Freund's adjuvant), which was also shown to be capable of stimulating immune response to an added antigen. Freund, J. & McDermott, K. Proc. Soc. Exp. Biol. Med. 49, 548-553 (1942) Zbar et al., 1976. Zbar and coworkers showed that cell wall skeleton prepared from bacillus Calmette-Guérin (BCG) emulsified in oil had anticancer activity. Zbar, B. et al., Cancer Immunol. Immunother. 1, 127-137 (1976) Morales et al.,1976. Morales and colleagues demonstrated that patients with recurrent superficial bladder tumors could be treated by vesical and intradermal administration of Bacillus Calmette-Guérin. Morales, A. et al., J. Urol. 116, 180-183 (1976) The MCC Journey 8

  10. Mycobacteria and Bioniche MCWE United States patent 4,744,984, 1985 to Vetrepharm Research Inc. Mycobacterial cell wall extract formulated in mineral oil emulsions with antiviral activity Subsequently shown to be an immune stimulant effective as an anticancer agent Commercialized by Vetrepham, now Bioniche Animal Health Antiviral Immune stimulant Anticancer The MCC Journey 9

  11. Mycobacteria and Bioniche MCC United States patent 6,326,357 1998 to Bioniche Life Sciences Inc. Mycobacterial cell wall-DNA complex with different formulation potential (suspension, emulsion, use of other carrier systems) Defined active component (DNA oligonucleotides) Immune stimulant and chemotherapeutic activities Broad application in the fields of immunology, oncology and vaccines Sufficient patent life to allow clinical development and commercialization (2018-2023) The MCC Journey 10

  12. MCWE emulsion MCWE emulsion MCC emulsion MCC suspension Veterinary applications High-grade bladder cancer (intravesical administration, Phase I/II) High-grade bladder cancer (intravesical administration, Phase II) High-grade bladder cancer (Phase III) andother oncology indications The MCC Journey 11

  13. Mycobacterium phlei MCC The MCC Journey • The challenge: • To go from a whole mycobacterium to a cell wall-DNA complex suspension using: • Cost effective methods • Reproducible methods • No chemicals • No biological materials • Terminal sterilization 12

  14. Challenges faced and overcome BSE prion contamination Use of culture media containing bovine products in original process “It is believed that variant CJD was acquired from eating food products containing the BSE agent. However, FDA wants to minimize any chance that the BSE agent could be introduced into biologic products during manufacture……In December 1993 and May 1996 FDA issued letters advising that bovine derived materials from animals born in or residing in countries where BSE had occurred should not be used to manufacture FDA-regulated products intended for administration to humans”. U.S. Department of Health and Human Services, Food and drug Administration, final Guidance for Industry Document, 2002 Bioniche has developed a new fermentation process that has resulted in the removal of all animal- and plant-sourced materials The MCC Journey 13

  15. Challenges faced and overcome Manufacturing process – enzymes and chemicals Enzymatic and chemical treatments used in original process Use of animal sourced enzymes (potential source of prion/viral contamination and immunogenicity) Chemical contamination of final product Environmental disposal issues Bioniche has developed a new manufacturing process that uses no enzymes or chemicals Elimination of safety issues as well as increasing efficiency The MCC Journey 14

  16. Challenges faced and overcome Manufacturing process - sterility Original process uses aseptic techniques Small scale with risk of contamination at each step Bioniche has developed a terminal sterilization step that ensures sterility of the final formulation Manufacturing process – formulation Original process used an oil emulsion containing an organomercury preservative Bioniche has developed a stable, particulate formulation that does not require oil or preservative The MCC Journey 15

  17. Where are we today? Defined mycobacterial-cell wall based anticancer composition (MCC) Strong patent protection and longevity appropriate for clinical development and commercialization Defined mechanism of action (immune stimulant and chemotherapeutic activities) Potential for application in other cancer indications after bladder cancer Strong technology platform The MCC Journey 16

  18. The MCC Journey MCC suspension “DIRECT” “INDIRECT” Inhibition of cancer cell proliferation, cell cycle arrest and apoptosis Immune system stimulation Monocytes, Macrophages, Dendritic cells Bladder cancer (Phase III) Breast cancer (Proof-of-principle) Colon cancer (Proof-of-principle) Ovarian cancer (Preclinical) Prostate cancer (Phase I) Chemotherapy combination Activation Chemokine/cytokine synthesis T-lymphocyte recruitment and activation Cytokine-mediated anticancer responses 17 N.C. Phillips, 1997 N.C. Phillips, 2007

  19. François Charette MD, MBA Senior Vice-President and Chief Medical Officer 18

  20. About Bladder Cancer • A common disease: • 4th most frequent cancer in men • 9th most frequent cancer in women • A serious disease: 1 out of 5 of these patients will die from bladder cancer. • Not many treatment options: • chemotherapy • a live mycobacterium called BCG • both have serious toxic side effects • Patients who have bladder cancer are difficult to treat. They often have recurrences and many will ultimately need a cystectomy (bladder removal). 19

  21. Urocidin Phase III Bladder Cancer Program FIRST TRIAL (protocol approved by FDA, Health Canada): • 105 patients • North America • Open-label trial showing the efficacy of Urocidin as therapy in non-invasive bladder cancer refractory (unresponsive) to Bacillus Calmette-Guérin (BCG). • Goal: show that Urocidin can result in complete response in up to 40%* of patients sustained at one year, and that less than 10% of patients are unable to tolerate treatment. *BCG + Interferon has a 20% response rate with side effects fast tracked by FDA 20

  22. Urocidin Refractory Trial • Patient enrolment started in November, 2006. • Investigator meeting held in April, 2007. • All 25 sites operational since September, 2007. • We have needed to screen three patients for every individual recruited for the trial. • Reasons for denying patient entry in the trial are numerous, but mostly have to do with the time since the last BCG treatment and other exclusion criteria. • This clinical trial should complete enrolment by mid-2008. 21

  23. The Refractory Patient • A typical patient in this clinical trial: • Male (69%) • 65years of age (age varies between 43 and 86 years) • Caucasian (98%) (American 67%, Canadian 33%) • 3 previous treatments with other therapies (1 to 8 prior treatments) • Has a recurrence on average 198days after the last treatment (59 to 381 days) • Diagnosed with Carcinoma In-Situ (CIS) (50%) • High grade Transitional Cell Carcinoma (TCC) (26%) • High grade TCC + CIS (24%) • Has not had treatment for other cancers in the last 5 years • Would prefer to avoid cystectomy (bladder removal) 22

  24. Timeline to Regulatory Submission • We need to recruit 105 “eligible and evaluable” patients and follow them for one year to obtain efficacy data to present to the FDA. This is expected to be completed by mid-2009. • We anticipate that we will have additional safety data generated as we recruit patients into the comparative trial (early 2008). • Both efficacy and safety data are necessary for a registration that (fast tracked) could mean market launch of the refractory indication by late 2010/2011. 23

  25. Urocidin Phase III Bladder Cancer Program • SECOND TRIAL (protocol approved by FDA): • Approximately 800 patients • North America, Australia and Europe • Randomized, double-blind, multi-centre trial comparing Urocidin to BCG as first-line therapy in non-invasive bladder cancer at high risk of recurrence or progression. • Goal: show that Urocidin is not inferior to, and is safer (better tolerated) than, BCG. • A Special Protocol Assessment (SPA) agreement establishes that the FDA should register the product if target trial results are met. SPA agreement with FDA 24

  26. Urocidin Comparative Study • We estimate that it will take approximately 3 years to recruit 800 patients. Between 80 and 90 sites are expected to be involved. • Feasibility work has started: A tight questionnaire with “open your books” qualification visits will be done to assure the best selection of sites. • Sites to be situated in North America, Western and Eastern Europe, Australia. • Recruitment can be completed in 3 years (2008-2010); the last patient enrolled will be followed for 2 years (2012); registration could be obtained in 2013. 25

  27. Graeme McRae President & CEO 26

  28. Target validation Hit Generation Lead optimization Biological validation FDA filing Phase 1 Phase 2 Phase 3 Drug Development Today 1 of 13 lead compounds reaches the market Clinical Research Pre-clinical Marketed NCE 1-2 yrs 2-4 yrs 2-6 yrs Ph. 4 Ph.3 Ph. 2 Ph.1 5-12 years 30%of drugs fail in Phase 1 10%of drugs fail in Phase 3 52%of drugs fail in Phase 2 Price Waterhouse Coopers: Pharma 2005 Silicon Rally: The Race to e-R&D Pharma 2005 An industrial revolution in R&D Winhover Information 27

  29. The Cost of Drug Development • R&D costs per drug: [1] 1987: US$231 million 2001: US$802 million • Preclinical + clinical costs (Phases 1 to 3) 2003: US$897 million • Preclinical + clinical costs (Phases 1 to 4) • 33% of the costs are attributable to clinical development • Average annual sales per drug: [2] • $300 million • $200 million for 90% of all new drugs Sources: [1] Tufts Center for Drug Development [2] Price Waterhouse Coopers 28

  30. Potential Market for Urocidin US EU25 6,600 first line 14,700 first line therapy failures therapy failures $70 M $150 M 22,000 intermediate 49,000 intermediate to high risk cases to high risk cases $230 M $500 M 44,000 non-muscle 98,000 non-muscle invasive cases invasive cases 63,000 new cases/yr. 140,000 new cases/yr. 600,000* people living with 392,000* people living with bladder cancer bladder cancer GLOBOCAN 2002 (figures are estimates) *80% of cases recur (five-year totals) 29

  31. Marketing Deals • Large, multinational companies (global): • PROS: • Significant resources available • Name recognition (perceived value at announcement) CONS: • Many projects get delayed due to personnel/priority changes • Overload sales and marketing costs = lower royalty • Small, focused companies (regional or global) • PROS: • Urocidin a top priority • Willingness to exchange milestones for higher share of profits to BLSI with commercialized product CONS: • Lack of name recognition • Fewer resources (if cannot complete, project must return to BLSI) 30

  32. Partnering Discussions re: Urocidin • Discussions continuing; deal terms being discussed. • Board sub-committee established. • Bioniche preference for deal terms: • Up-front cash • Commitment to fund Phase III clinical program • Retention of manufacturing • Profit sharing/royalty stream on product sales (ideally 20%+) • Partnership deal on a Phase III product has 85% probability of getting product to market (vs. Phase I deal – 2% probability of reaching market). • We are committed to doing the right deal for shareholders; no matter how long it takes to complete the deal. 31

  33. E. coli O157:H7 Cattle Vaccine Vaccine Licensing Challenges • E. coli O157:H7 does not cause disease in the target animal (cattle). • The organism has a unique attachment mechanism involving the mucosal surfaces of the GI tract. • Reduction in the ability of the organism to colonize the GI tract is necessary, with an outcome of reduction in shedding. • Real need is in field – United States Department of Agriculture (USDA) asked for field efficacy studies – unable to control prevalence in field. 32

  34. E. coli O157:H7 Cattle Vaccine Regulatory Status 1. Canada (Canadian Food Inspection Agency – CFIA) • March, 2007 – submitted field efficacy data from UNL with proper design and controls – currently discussing stats applied to data with CFIA 2. U.S. (United States Department of Agriculture – USDA) • April, 2007 – efficacy report for BEC-26 submitted to USDA and is currently under their review with some disagreement on statistical approaches This will be the first vaccine of its kind to be registered. Regulators seem reluctant about setting a precedent. USDA Strategy • Meeting requested and agreed-to • Package of information sent to support Bioniche position 33

  35. 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: 60,000 doses/month (720,000 doses/year) • Planning to scale up to 40M annual dose capacity at Belleville (two-year process): • Completing engineering designs • Securing capital financing (approx. $35M) • Ordering equipment • Installing and validating equipment • Producing vaccine 34

  36. Selected Outbreaks/Recalls Sept 7 2006: Marion Graff, 77, of Manitowoc, Wis., dies. Jan 26 2007: Betty Howard, 83, of Richland, Wash., dies. Sept 20 2006: Kyle Allgood, 2, of Chubbuck, Idaho, dies. • 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 • June, 2007; St. Catharines, Ontario, Canada • 4 children hospitalized; linked to food consumption at a local restaurant • November, 2006; 3 U.S. states • 99 affected (43 confirmed); 9 hospitalized; 1 with HUS; linked to lettuce • September, 2006; 26 U.S. states • 205 affected; 3 deaths; 31 with HUS; linked to fresh spinach consumption Common denominator in all outbreaks: cattle 35

  37. A reduction of risk of contamination in: meat products, produce, water, the environment. A reduction of risk from direct contact at fairs, events and petting zoos. A healthier agricultural industry; safer farms for families/visitors. Enhanced consumer confidence. The support and praise of public health officials. What Can We Expect from the Vaccine? 36

  38. Education & Awareness Campaign 37

  39. Cattle Population (2004) • Canada: 14.6 million • U.S.: 94.8 million • Australia: 26.4 million • Argentina: 50.7 million • European Union: 134.8 million • Japan: 4.5 million • Brazil: 192.0 million TOTAL 517.8 million Vaccine Cost (N.A.): approximately $9 per animal Vaccine Cost (Europe): approximately 10 Euros per animal Market Potential for Vaccine 38

  40. Financial Highlights for Fiscal 2007announced September 25, 2007 • Revenues increased 3% to $27.5M. • Gross margin healthy at 56%. • Positive EBITDA before R&D of $1.3M. • Gross research and development expenses: $14.9M. • Net loss for the year was ($14.7M) or ($0.32) per share; compares to ($1.1M) or ($0.03) per share in 2006 (loss offset by one-time asset sale). 39

  41. Objectives for Fiscal 2008 • Obtaining a full Canadian license for our E. coli O157:H7 cattle vaccine. • Pursuing registration for our E. coli O157:H7 vaccine in the U.S. • Successful completion of a marketing partnership deal for our bladder cancer technology. • Successful execution of our Phase III clinical program with Urocidin. • Planning for early stage studies to support the use of our MCC technology in the treatment of other human cancers. 40

  42. Value Creating Eventsanticipated timing – subject to change a a a a a 41

  43. Please join us for a Receptionin the Carlton Room & Foyer 42

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