Corporate Presentation October 2014

1. Corporate Presentation
October 14, 2014

2. Forward Looking Statements
This 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.
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3. Oncolytics Overview
o
Expanding Clinical Program
o
Lead product is REOLYSIN®, a broadly active novel cancer therapy
o
Ongoing clinical trials include five sponsored, randomized Phase II studies in the US and Canada:
o
Examining breast, non-small cell lung, colorectal, prostate and ovarian cancers
o
Strong Intellectual Property Portfolio
o
More than 370 patents issued worldwide
o
Manufacturing at Commercial Scale
o
100L cGMP completed, commercial manufacturing agreement in place
o
Cash Until Late-Q4 2015 (at current burn rates)
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4. REOLYSIN®: An Overview
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REOLYSIN® is a proprietary isolate of the reovirus
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Reovirus is considered safe to humans
o
REOLYSIN® has been safely administered to patients via intravenous, intratumoural and intrathecal injection
o
Mechanism of Action (MoA):
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Primary MoA is as a selective cytotoxin, where selectivity is based on whether cancer cells have constituative Ras pathway activation; susceptible cancer cells therefore include those with, amongst others:
o
EGFR overexpression or mutation;
o
Ras mutation, which includes KRAS mutation, or:
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BRAF mutation
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Secondary MoAs may include interferon up-regulation in target tissues, and tumour directed immune response
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5. Market for Ras Pathway Mediated Cancers
o
Estimated global cancer market was US$85 billion in 2013; this is expected to rise to US$109 billion by 2018
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At least five million new patients per year are expected to develop cancers with a Ras pathway involvement
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In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized, most of which have a Ras pathway involvement
o
We can select patients who are more likely to respond to REOLYSIN® by pre-screening for patients that lead to a Ras pathway activation
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6. REO 016: Single-Arm Non-Small Cell Lung Cancer (NSCLC) Study Demonstrates Biomarker Utility
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Molecular Abnormality
Number of Patients
Number of Patients Surviving One Year
Percentage of Patients Surviving One Year
BRAF mutation + EGFR amplification
4
4
100%
EGFR amplification
10
7
70%
EGFR mutation + EGFR amplification
3
2
67%
KRAS mutation + EGFR amplification
7
3
43%
KRAS mutation
12
4
33%
Total
36
20
56%

7. REOLYSIN®: Clinical History
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To date, over 1,000 patients have been treated with REOLYSIN®, which has been shown to be safe and well- tolerated
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Over 30 ongoing and completed studies of REOLYSIN® in North America and Europe examining a variety of:
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Modes of administration
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Therapeutic combinations
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Cancer indications and patient populations
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Ongoing preclinical research to bolster clinical program strategy, trial design, intellectual property portfolio and regulatory submissions
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8. Possible Registration Pathways for REOLYSIN®
I.
Studies using REOLYSIN® therapy prior to standard efficacy- based therapies (surgery, radical radiotherapy and chemotherapy) in order to reduce tumour burden, as measured by histopathology or scans; and/or
II.
Studies using REOLYSIN® in combination with chemotherapy and/or radiotherapy to improve survival, as measured by progression-free survival (EU) and overall survival (US) endpoints; and/or
III.
Studies using REOLYSIN® to enhance long-term immune responses, as measured by overall survival endpoints
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9. Registration Pathway for REOLYSIN® (I): Reducing Tumour Burden

10. Reovirus Replication in KRAS- Mutated Colorectal Cancer Tumours
Image shows a target cell in a KRAS- mutated colorectal cancer tumour
REOLYSIN® was delivered systemically
Each replicated virus within the cell presents in the image as a black dot
Proof of viral replication in tumours following systemic delivery
Picture courtesy of Scott Wadler, Cornell University
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11. REO 011: Head & Neck Cancer Patient with Partial Response in Liver Metastases
Prior treatment: radiation
Response maintained through 8 cycles
Pre-Treatment
Post-Cycle 6
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12. REO 018 Head and Neck Cancer: Randomized Tumor-Specific Response Data
Two endpoints:
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The first endpoint examined initial percentage tumour changes between baseline and first post treatment scans in all patients, differentiating between loco-regional tumours and metastatic tumours
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This is a measure of rate or velocity of response, not magnitude of response
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Of the total 105 patients with evaluable metastatic tumours, 86% (n=50) of those in the test, and 67% (n=55) in the control arm, arm had tumour stabilization (0% growth) or shrinkage
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This is a statistically significant difference, with a p-value of 0.025
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The second endpoint compared percentage tumour shrinkage at the same time points
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Patients with loco-regional disease with or without distal metastases on the test arm had a decrease in tumour volume of an average of 23% over control (p=0.076, n = 118)
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Patients with distal metastases only on the test arm had a decrease in tumour volume of an average of 30% over control (p=0.021, n=47)
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13. Registration Pathway for REOLYSIN® (II): Improving Survival (PFS & OS)

14. PFS: KRAS-Mutated Pancreatic Cancer Patients in NCI-8601 (n=44)
05101520020406080100Time (months) Survival probability (%) armcontroltest
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The median PFS for the test arm was 5.72 months, compared with 4.11 months for the control arm. This constituted a 1.61 month improvement for the test arm.

15. REO 018 Head and Neck Cancer: Top- Line Survival Data
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Patients with loco-regional disease with or without distal metastases in the test arm (n=62) showed a median PFS of 94 days (13.4 weeks), versus 50 days (7.1 weeks) in the control arm (n=56)
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Patients who received REOLYSIN® demonstrated increased benefit through five cycles of therapy
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An intent-to-treat analysis of the 118 loco-regional patients performed on all patients to the median PFS in each arm, censoring any patients who received post-discontinuation therapy at the date at which they commenced the first of these therapies, showed a statistically significant improvement in OS of the test arm versus the control arm (p=0.0146, hazard ratio=0.5099)
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16. Randomized Clinical Trial Program for REOLYSIN®: Active Studies
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Trial
Phase
Sponsor
n
Enrollment Status
IND 213: Intravenous REOLYSIN® in Combination with Paclitaxel in Patients with Advanced or Metastatic Breast Cancer
II
NCIC CTG
100
>50% complete
IND 211: Intravenous REOLYSIN® in Combination with Docetaxel or Pemetrexed in Patients with Previously- Treated Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
II
NCIC CTG
150
>75% complete
IND 210: Intravenous REOLYSIN® in Combination with FOLFOX-6 Plus Bevacizumab (Avastin®) in Patients with Advanced or Metastatic Colorectal Cancer
II
NCIC CTG
100
>90% complete
IND 209: Intravenous REOLYSIN® in Combination with Docetaxel in Patients with Recurrent or Metastatic Castration-Resistant Prostate Cancer
II
NCIC CTG
80
>75% complete
GOG-0186H: Intravenous REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
II
NCI/GOG
110
complete

17. Registration Pathway for REOLYSIN® (III): Enhancing Long-Term Immune Responses

18. Enhancing Immune Responses
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Ongoing preclinical research has led to two clinical candidate programs:
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GM-CSF in combination with REOLYSIN®; or
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A checkpoint inhibitor in combination with REOLYSIN®
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19. GM-CSF + REOLYSIN®: Effect on Overall Survival
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20. REOLYSIN® and Safety
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More than 1,000 patients treated, more than 900 intravenously at doses up to 3x1010 TCID50 daily
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No maximum tolerated dose (MTD) reached to date
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Monotherapy toxicities have generally been mild (grade 1 or 2) and included chills, fever, headache, cough, myalgia, runny nose, sore throat, fatigue and grade 1 or 2 lymphopenia and neutropenia
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Transient grade 3 and 4 toxicities included lymphopenia and neutropenia
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These symptoms were more frequently observed from day 2 of treatment and usually lasted less than 6 hours
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Safety profile has been confirmed in a randomized setting in Oncolytics’ REO 018 study of head and neck cancer patients
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21. Intellectual Property
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More than 370 patents issued worldwide, including 56 US and 20 Canadian
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Reovirus issue patent claims cover:
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Compositions of matter comprising reovirus
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Pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases
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Combination therapy with radiation, chemotherapy and/or immune suppressants
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Methods for manufacturing reovirus and screening for susceptibility to reovirus
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Pharmaceutical use of reoviruses in transplantation procedures
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Approximately 235 pending applications worldwide
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22. Manufacturing
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Now produced at 100L (commercial scale) under cGMP with final formulation
o
Commercial manufacturing agreement in place with Sigma- Aldrich® Fine Chemicals (SAFC)
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23. Market & Capital Data
(all amounts in CAD) Exchanges NASDAQ:ONCY TSX:ONC Shares Outstanding (June 30, 2014) 88,247,844 Price Options Outstanding (June 30, 2014) $3.49 (weighted average) 5,987,844 Fully Diluted (June 30, 2014) 94,235,688 Cash/Cash Equivalents (June 30, 2014) $18.9M
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24. Oncolytics Overview
o
Expanding Clinical Program
o
Lead product is REOLYSIN®, a broadly active novel cancer therapy
o
Ongoing clinical trials include five sponsored, randomized Phase II studies in the US and Canada:
o
Examining breast, non-small cell lung, colorectal, prostate and ovarian cancers
o
Strong Intellectual Property Portfolio
o
More than 370 patents issued worldwide
o
Manufacturing at Commercial Scale
o
100L cGMP completed, commercial manufacturing agreement in place
o
Cash Until Late-Q4 2015 (at current burn rates)
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25. Corporate Presentation
October 14, 2014