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TSX:ONC NASDAQ:ONCY


 Investor Presentation
     January 2010
Forward Looking Statements

               Today’s presentation contains certain forward looking statements
  relating to the company’s financial results, business prospects and the development and
 commercialization of REOLYSIN®, a therapeutic reovirus. These statements are based on
   management’s current expectations and beliefs and are subject to a number of factors
 which involve known and unknown risks, delays, uncertainties and other factors not under
the company’s control which may cause actual results, performance or achievements of the
   company to be materially different from the results, performance or other expectations
  implied by these forward looking statements. In any forward looking statement in which
    Oncolytics Biotech® Inc. expresses an expectation or belief as to future results, such
  expectations or beliefs are expressed in good faith and are believed to have a reasonable
   basis, but there can be no assurance that the statement or expectation or belief will be
achieved. These factors include results of current or pending clinical trials, risks associated
  with intellectual property protection, financial projections, market projections, actions by
 the FDA/HPB/MHRA and those other factors detailed in the company’s filings with SEDAR
and the Securities and Exchange Commission. Oncolytics does not undertake an obligation
       to update the forward looking statements, except as required by applicable laws.
Summary

REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
•   lead product is REOLYSIN®
•   SPA agreed with the FDA for first pivotal program –
    Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory
    head and neck cancer patients
•   this drug platform expanding to include NSCLC, melanoma and
    squamous cell lung cancer
Growing Intellectual Property Portfolio
•   broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
•   100L cGMP completed
Mode of Action

                 •   REOLYSIN is a proprietary
                     isolate of the reovirus, a
                     replication competent virus

                 •   asymptomatic in humans (does
                     not cause disease)

                 •   replicates in Ras-activated
                     cancers

                 •   at least 2/3 of carcinomas and
                     more than 90% of metastatic
                     disease has Ras involvement

                 •   at least 5M new patients per
                     year are predicted to develop
                     cancers with Ras involvement
REOLYSIN Pipeline
Indication                                     Preclinical   Phase 1   Phase 2   Phase 3

Head & neck (REO 018)
in combination with carboplatin + paclitaxel

NSCLC (KRAS screened) (REO 016)
in combination with carboplatin + paclitaxel


Melanoma      (REO 020)
in combination with carboplatin + paclitaxel

as monotherapy

Squamous cell carcinoma lung (REO 021)
in combination with carboplatin + paclitaxel

Pancreatic (REO 017)
in combination with gemcitabine

Sarcoma metastatic to lung      (REO 014)
as monotherapy

Ovarian
as monotherapy
with carboplatin + paclitaxel

Colorectal (KRAS screened) (REO 022)
in combination with irinotecan
Pivotal (Phase III) Program for REOLYSIN

 •   Phase III trial examining REOLYSIN in combination with
     paclitaxel/carboplatin in patients with platinum-refractory head and
     neck cancers
 •   randomized, two-arm, double-blind, multicentre, two-stage, adaptive
     trial
 •   first company to have an intravenously administered oncolytic virus
     approved under the SPA program
 •   primary endpoint: overall survival
     secondary endpoint: progression-free survival
     pharmacodynamic endpoints: tumour Ras pathway status and
     HPV status
 •   two-stage Phase III trial
      - 80 patients in first stage
      - adaptive design in second stage allows for detection of a range of
        increases in overall survival by enrolling from 100 to 400 patients, with
        the most probable being ~200
REOLYSIN clinical overview – Phase I/II
 Combination Program
Phase I/II    carboplatin/paclitaxel/REOLYSIN
Drug          • REOLYSIN, d1-5, iv carboplatin (AUC5), d1, and paclitaxel (175mg/m2), d1,
Combination     qw3. REOLYSIN was administered at a starting dose of 3x109 TCID50 and then
Program         increased to 1x1010 and 3x1010 TCID50 in cohorts of 3 patients
(UK)
              • there were no DLTs in the dose escalation. Toxicities were mainly grade 1 and 2
                and included: nausea, fatigue, vomiting, myalgia, fever, neutropenia,
                lymphopenia, thrombocytopenia and hypotension

              • this combination resulted in a blunting of antiviral immune response as
                compared to monotherapy virus

              • response rates in 19 evaluable patients were partial response (PR) (5 pts),
                stable disease (SD) (8 pts) and progressive disease (PD) (6 pts). Of note, all
                PRs and 4/8 SDs were in H&N disease

              • a total disease control rate (CR+PR+SD) of 68% was achieved to date

              • positive results in head and neck disease led to the filing of two single arm
                Phase II studies in refractory head and neck disease (US & UK)
Interim Results Compared to Historical Controls

Second-Line Other Therapies in Platinum Refractory Patients

Study                    Reference           Response Rate     Median TTP   Median Survival
                                                               or PFS       (months)
                                                               (months)
Various treatments or    LĂ©on et al., 2005   2.6%              No Data      3
Best Supportive care

Various                  Vermorken, 2009     No data           1.9          4.5


Carboplatin/paclitaxel   Vermorken’s         10%               2.0          4.5 (refractory)
                         Estimate for                                       6.5 (pt failed)
                         control
                         arm in REO 018
                         Personal
                         communication
REOLYSIN +                                   RR 42% (8 PRs),   N/A          N/A
carboplatin/paclitaxel                       CBR 74%
H&N patients (N=19)                          (8 PRs, 6 SDs)
November 17, 2009
Phase I REOLYSIN/Paclitaxel/Carboplatin – Lung and Head &
Neck Tumours – Response Maintained for 8 Cycles
               Pre-treatment                                Pre-treatment




               Post 6 Cycles                                Post 6 Cycles




  Prior treatment: radiotherapy; cisplatin/fluorouracil – 6 cycles
Phase II REOLYSIN/Paclitaxel/Carboplatin
Combination Metastatic Nasopharyngeal




             Pre-treatment                         Post cycle 3
  prior treatment                         results
  • radiation - 2 cycles                  •target lesion - liver metastases
  • cisplatin, gemcitabine/carboplatin,              baseline - 59.4 mm
      carboplatin/5-FU - 6 cycles         •post cycle 3-19 mm
  • docetaxel - 3 cycles                  •response maintained through 8 cycles
UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in Poorly Differentiated SCC H&N




                                      Pre-treatment


                                      Post Cycle 3

                                      Treatment history:
                                      palliative RT
                                      cisplatin + 5FU
                                      carboplatin + 5FU
UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in SCC H&N

Pre-treatment
                             Rapid                     After 3 cycles
                             progression
                             in <3 weeks
                             before Study




  Treatment history: cisplatin + 5 FU; RT/cisplatin;
REOLYSIN: A Broader Market Opportunity


EGFR Inhibitors
contra-indicated:      Tumors with Ras pathway
KRas mutated
                              activation
- NSCLC
- Colorectal
   cancer
                                                               2008 Sales
                    Tumors with          Tumors with            Erbitux - $1.7B
                    Ras Mutation            EGFR
                                                               Tarceva - $457M
                                        Overexpressed
                    No Approved              or                Vectibix - $153 M
                     Therapies             Mutated




                    REOLYSIN is effective in both situations
Phase II NSCLC and Kras/EGFR

U.S. Phase II
   •   for NSCLC prescreened for Kras and EGFR mutation status
   •   15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR
       mutated or over expressed
   •   first line therapy study i.e. patients will be offered
       REOLYSIN/paclitaxel/carboplatin instead of standard of care
       if they are Kras or EGFR mutated or EGFR over expressed,
       all of which cause Ras pathway activation
   •   current standard of care includes EGFR inhibitors which have
       been shown to be ineffective in Kras mutated patients
Colorectal Cancer and Kras


  •   current standard of care for second-line patients also includes
      EGFR inhibitors
  •   45% of second-line colorectal patients have Kras mutations
  •   preclinical work completed using reovirus in combination with
      irinotecan
Increasing Vascular Efflux Through
Manipulation of VEGF Signalling
    Sunitinib
                   B-16 Melanoma Mouse Model

                   • transient destabilization and
                   permeabilization of tumor vasculature
                   enhances localization of circulating
                   REOLYSIN

                   • therapy is associated with increased
                   vascular permeability to circulating
                   virus and increased virus recovery from
    Avastin        tumors
Safety

•   >285 patients treated, >200 intravenously at doses up to 3x1010
    TCID50 daily

•   no maximum tolerated dose (MTD) reached to date

•   toxicities have been generally mild (grade 1 or 2) and included
    chills, fever, headache, cough, myalgia, runny nose, sore throat
    and fatigue, and grade 1 or 2 lymphopenia and neutropenia.
    Transient grade 3 and 4 toxicities included lymphopenia and
    neutropenia. These symptoms were more frequently observed
    from day 2 of treatment and usually lasted less than 6 hours
Intellectual Property

• more than 200 patents issued worldwide including
  33 U.S. and 11 CDN
• reovirus issued patent claims cover
   - compositions of matter comprising reovirus
   - pharmaceutical use of reoviruses to treat neoplasia and cellular
     proliferative diseases
   - combination therapy with radiation, chemotherapy and/or
     immune suppressants
   - methods for manufacturing reovirus and screening for
     susceptibility to reovirus
   - pharmaceutical use of reoviruses in transplantation procedures
• more than 180 pending applications worldwide
Manufacturing




•   successful development of a proprietary cell growth medium
•   commercial cGMP process established
•   cGMP now produced at 100L
Market & Capital Data

Exchanges                                   NASDAQ:ONCY
                                            TSX:ONC

Shares Outstanding (Dec. 9, 2009)           61,549,969

Warrants                  Price
Expiring:

 Feb. 22, 2010            $3.50             2,300,000
 Nov. 23, 2014            $3.50             1,700,000
 Dec. 2, 2014             $3.50               255,000

 Options                  $4.72 (average)   3,936,893

Fully Diluted (Dec. 9, 2009)                69,741,862

Est. Cash/Cash Equivalents                  C$36.0 M
(Dec. 6, 2009)

Monthly Burn Rate 2009 (Approx.)             C$1.3 M
Summary

REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
•   lead product is REOLYSIN®
•   SPA agreed with the FDA for first pivotal program - Phase III
    REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and
    neck cancer patients
•   this drug platform expanding to include NSCLC, melanoma and
    squamous cell lung cancer
Growing Intellectual Property Portfolio
•   broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
•   100L cGMP completed
TSX:ONC NASDAQ:ONCY


 Investor Presentation
     January 2010

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Reolysin

  • 1. TSX:ONC NASDAQ:ONCY Investor Presentation January 2010
  • 2. Forward Looking Statements Today’s presentation contains certain forward looking statements relating to the company’s financial results, business prospects and the development and commercialization of REOLYSIN®, a therapeutic reovirus. These statements are based on management’s current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company’s control which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward looking statements. In any forward looking statement in which Oncolytics Biotech® Inc. expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, market projections, actions by the FDA/HPB/MHRA and those other factors detailed in the company’s filings with SEDAR and the Securities and Exchange Commission. Oncolytics does not undertake an obligation to update the forward looking statements, except as required by applicable laws.
  • 3. Summary REOLYSIN - A Broadly Active Novel Cancer Therapy Focused Clinical Program • lead product is REOLYSIN® • SPA agreed with the FDA for first pivotal program – Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and neck cancer patients • this drug platform expanding to include NSCLC, melanoma and squamous cell lung cancer Growing Intellectual Property Portfolio • broad patent coverage in US, Europe and Canada Manufacturing at Commercial Scale • 100L cGMP completed
  • 4. Mode of Action • REOLYSIN is a proprietary isolate of the reovirus, a replication competent virus • asymptomatic in humans (does not cause disease) • replicates in Ras-activated cancers • at least 2/3 of carcinomas and more than 90% of metastatic disease has Ras involvement • at least 5M new patients per year are predicted to develop cancers with Ras involvement
  • 5. REOLYSIN Pipeline Indication Preclinical Phase 1 Phase 2 Phase 3 Head & neck (REO 018) in combination with carboplatin + paclitaxel NSCLC (KRAS screened) (REO 016) in combination with carboplatin + paclitaxel Melanoma (REO 020) in combination with carboplatin + paclitaxel as monotherapy Squamous cell carcinoma lung (REO 021) in combination with carboplatin + paclitaxel Pancreatic (REO 017) in combination with gemcitabine Sarcoma metastatic to lung (REO 014) as monotherapy Ovarian as monotherapy with carboplatin + paclitaxel Colorectal (KRAS screened) (REO 022) in combination with irinotecan
  • 6. Pivotal (Phase III) Program for REOLYSIN • Phase III trial examining REOLYSIN in combination with paclitaxel/carboplatin in patients with platinum-refractory head and neck cancers • randomized, two-arm, double-blind, multicentre, two-stage, adaptive trial • first company to have an intravenously administered oncolytic virus approved under the SPA program • primary endpoint: overall survival secondary endpoint: progression-free survival pharmacodynamic endpoints: tumour Ras pathway status and HPV status • two-stage Phase III trial - 80 patients in first stage - adaptive design in second stage allows for detection of a range of increases in overall survival by enrolling from 100 to 400 patients, with the most probable being ~200
  • 7. REOLYSIN clinical overview – Phase I/II Combination Program Phase I/II carboplatin/paclitaxel/REOLYSIN Drug • REOLYSIN, d1-5, iv carboplatin (AUC5), d1, and paclitaxel (175mg/m2), d1, Combination qw3. REOLYSIN was administered at a starting dose of 3x109 TCID50 and then Program increased to 1x1010 and 3x1010 TCID50 in cohorts of 3 patients (UK) • there were no DLTs in the dose escalation. Toxicities were mainly grade 1 and 2 and included: nausea, fatigue, vomiting, myalgia, fever, neutropenia, lymphopenia, thrombocytopenia and hypotension • this combination resulted in a blunting of antiviral immune response as compared to monotherapy virus • response rates in 19 evaluable patients were partial response (PR) (5 pts), stable disease (SD) (8 pts) and progressive disease (PD) (6 pts). Of note, all PRs and 4/8 SDs were in H&N disease • a total disease control rate (CR+PR+SD) of 68% was achieved to date • positive results in head and neck disease led to the filing of two single arm Phase II studies in refractory head and neck disease (US & UK)
  • 8. Interim Results Compared to Historical Controls Second-Line Other Therapies in Platinum Refractory Patients Study Reference Response Rate Median TTP Median Survival or PFS (months) (months) Various treatments or LĂ©on et al., 2005 2.6% No Data 3 Best Supportive care Various Vermorken, 2009 No data 1.9 4.5 Carboplatin/paclitaxel Vermorken’s 10% 2.0 4.5 (refractory) Estimate for 6.5 (pt failed) control arm in REO 018 Personal communication REOLYSIN + RR 42% (8 PRs), N/A N/A carboplatin/paclitaxel CBR 74% H&N patients (N=19) (8 PRs, 6 SDs) November 17, 2009
  • 9. Phase I REOLYSIN/Paclitaxel/Carboplatin – Lung and Head & Neck Tumours – Response Maintained for 8 Cycles Pre-treatment Pre-treatment Post 6 Cycles Post 6 Cycles Prior treatment: radiotherapy; cisplatin/fluorouracil – 6 cycles
  • 10. Phase II REOLYSIN/Paclitaxel/Carboplatin Combination Metastatic Nasopharyngeal Pre-treatment Post cycle 3 prior treatment results • radiation - 2 cycles •target lesion - liver metastases • cisplatin, gemcitabine/carboplatin, baseline - 59.4 mm carboplatin/5-FU - 6 cycles •post cycle 3-19 mm • docetaxel - 3 cycles •response maintained through 8 cycles
  • 11. UK Phase II REOLYSIN/Carbo/Taxol Combination Partial Response in Poorly Differentiated SCC H&N Pre-treatment Post Cycle 3 Treatment history: palliative RT cisplatin + 5FU carboplatin + 5FU
  • 12. UK Phase II REOLYSIN/Carbo/Taxol Combination Partial Response in SCC H&N Pre-treatment Rapid After 3 cycles progression in <3 weeks before Study Treatment history: cisplatin + 5 FU; RT/cisplatin;
  • 13. REOLYSIN: A Broader Market Opportunity EGFR Inhibitors contra-indicated: Tumors with Ras pathway KRas mutated activation - NSCLC - Colorectal cancer 2008 Sales Tumors with Tumors with Erbitux - $1.7B Ras Mutation EGFR Tarceva - $457M Overexpressed No Approved or Vectibix - $153 M Therapies Mutated REOLYSIN is effective in both situations
  • 14. Phase II NSCLC and Kras/EGFR U.S. Phase II • for NSCLC prescreened for Kras and EGFR mutation status • 15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR mutated or over expressed • first line therapy study i.e. patients will be offered REOLYSIN/paclitaxel/carboplatin instead of standard of care if they are Kras or EGFR mutated or EGFR over expressed, all of which cause Ras pathway activation • current standard of care includes EGFR inhibitors which have been shown to be ineffective in Kras mutated patients
  • 15. Colorectal Cancer and Kras • current standard of care for second-line patients also includes EGFR inhibitors • 45% of second-line colorectal patients have Kras mutations • preclinical work completed using reovirus in combination with irinotecan
  • 16. Increasing Vascular Efflux Through Manipulation of VEGF Signalling Sunitinib B-16 Melanoma Mouse Model • transient destabilization and permeabilization of tumor vasculature enhances localization of circulating REOLYSIN • therapy is associated with increased vascular permeability to circulating virus and increased virus recovery from Avastin tumors
  • 17. Safety • >285 patients treated, >200 intravenously at doses up to 3x1010 TCID50 daily • no maximum tolerated dose (MTD) reached to date • toxicities have been generally mild (grade 1 or 2) and included chills, fever, headache, cough, myalgia, runny nose, sore throat and fatigue, and grade 1 or 2 lymphopenia and neutropenia. Transient grade 3 and 4 toxicities included lymphopenia and neutropenia. These symptoms were more frequently observed from day 2 of treatment and usually lasted less than 6 hours
  • 18. Intellectual Property • more than 200 patents issued worldwide including 33 U.S. and 11 CDN • reovirus issued patent claims cover - compositions of matter comprising reovirus - pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases - combination therapy with radiation, chemotherapy and/or immune suppressants - methods for manufacturing reovirus and screening for susceptibility to reovirus - pharmaceutical use of reoviruses in transplantation procedures • more than 180 pending applications worldwide
  • 19. Manufacturing • successful development of a proprietary cell growth medium • commercial cGMP process established • cGMP now produced at 100L
  • 20. Market & Capital Data Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (Dec. 9, 2009) 61,549,969 Warrants Price Expiring: Feb. 22, 2010 $3.50 2,300,000 Nov. 23, 2014 $3.50 1,700,000 Dec. 2, 2014 $3.50 255,000 Options $4.72 (average) 3,936,893 Fully Diluted (Dec. 9, 2009) 69,741,862 Est. Cash/Cash Equivalents C$36.0 M (Dec. 6, 2009) Monthly Burn Rate 2009 (Approx.) C$1.3 M
  • 21. Summary REOLYSIN - A Broadly Active Novel Cancer Therapy Focused Clinical Program • lead product is REOLYSIN® • SPA agreed with the FDA for first pivotal program - Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and neck cancer patients • this drug platform expanding to include NSCLC, melanoma and squamous cell lung cancer Growing Intellectual Property Portfolio • broad patent coverage in US, Europe and Canada Manufacturing at Commercial Scale • 100L cGMP completed
  • 22. TSX:ONC NASDAQ:ONCY Investor Presentation January 2010