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 Broad 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 Conducted over 30 clinical studies in 13 indications to date
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 Q1 2016 (at current burn rates)
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4. 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 >60% 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 >90% 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 complete
IND 209: Intravenous REOLYSIN® in Combination with
Docetaxel in Patients with Recurrent or Metastatic
Castration-Resistant Prostate Cancer
II NCIC CTG 80 >80% 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
5. REOLYSIN® Mechanism of Action
REOLYSIN®
infects both
tumour cells
and normal
healthy cells
REOLYSIN®
does not
replicate in
cells that are
not Ras
activated
Healthy cells
remain
undamaged
REOLYSIN®
Administered to
patients
prescreened for
RAS, EGFR, BRAF
and others
Normal Cells
REOLYSIN®
infects both
tumour cells
and normal
healthy cells
REOLYSIN®
replicates in
Ras activated
tumour cells
Tumour cells rupture to
release progeny virus
Progeny viruses repeat cell
infection cycle in nearby tumour
cells
Ras–Activated Cells
Productively infected cells upregulate interferon, and
others and induce an anti-tumour specific immune
response mediated by NK and T cells
6. Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® Intratumoural
Monotherapy Anaplastic Astrocytoma
Early Cytotoxic Activity Followed by Late Stage Immune-Mediated
Response Against the Residual Tumour
Viral replication mediated
tumour response
Post debulking Immune mediated tumour response
7. Ras Pathway
Specific Biomarkers
and Cancer
Breast
HER-2 (an EGFR variant)
Glioblastoma
EGFR, BRAF
Head & Neck
EGFR
Pancreas
KRAS
Melanoma
BRAF, S100
Colorectal
KRAS, EGFR
Non-Small Cell Lung
EGFR, BRAF, KRAS
Biomarkers are
increasingly used to assess
risk, diagnose, and identify
treatment options
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8. 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%
15-20% of NSCLC is KRAS mutated, while up to 50% is EGFR mutated or
overexpressed. Each of these result in Ras pathway activation.
9. REOLYSIN®: Clinical History
o To date, over 1,000 patients have been treated with
REOLYSIN®, which has been shown to be safe and well-
tolerated
o Over 30 ongoing and completed studies of REOLYSIN® in
North America and Europe, examining a variety of:
o Modes of administration
o Therapeutic combinations
o Cancer indications and patient populations
o Ongoing preclinical and clinical research bolsters clinical
program strategy, trial design, intellectual property portfolio
and supports regulatory submissions
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11. REO 011: Head & Neck Cancer Patient
with Partial Response in Liver Metastases
The patient had been previously been treated with radiation.
The response to REOLYSIN® was maintained through 8 cycles.
Pre-Treatment Post-Cycle 6
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12. REO 021: Partial Response in Lung
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Pre-Treatment Post-Cycle 2 Post-Cycle 4
Right Upper Lung Mass (8.3 cm)
Right Pleural Met (2.2 cm)
Right Upper Lung Mass (4.1 cm)
Right Pleural Met (0.8 cm)
Right Upper Lung Mass (3.6 cm)
Right Pleural Met (0.4 cm)
14. REO 018 Head and Neck Cancer: Randomized
Tumour-Specific Response Data
o This study demonstrated that REOLYSIN® increases both the magnitude and
velocity of tumour shrinkage
o 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 (a measure of velocity)
o 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
o This is a statistically significant difference, with a p-value of 0.025
o The second endpoint compared percentage tumour shrinkage at the same time
points
o 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)
o 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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16. Randomized Top-Line Survival Data
REO 018 (Head and Neck Cancer):
o An analysis of patients with loco-regional disease with or without distal metastases
showed a median PFS of 94 days (13.4 weeks) in the test arm (n=62), versus a PFS
of 50 days (7.1 weeks) in the control arm (n=56)
o Patients who received REOLYSIN® demonstrated increased benefit through
five cycles of therapy
o An intent-to-treat analysis of all 118 loco-regional patients performed on all
patients showed a statistically significant improvement in OS of the test arm versus
the control arm (p=0.0146, hazard ratio=0.5099)
o OS was measured 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
NCI-8601 (Pancreatic Cancer):
o An interim analysis of 44 patients with KRAS mutated pancreatic cancer showed
a median progression free survival in the test arm was 5.72 months (95% CI =
3.187 to 6.767) versus 4.11 months in the control arm (95% CI = 1.938 to
6.176), an improvement of 39%
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17. Enhancing Immune Responses to
Improve Survival
o Ongoing preclinical research has led to two
clinical candidate programs:
1. GM-CSF in combination with REOLYSIN®; or
2. A checkpoint inhibitor in combination with
REOLYSIN®
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20. 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, scans, or tumour specific
markers; and/or
II. Studies using REOLYSIN® in combination with chemotherapy
and/or radiotherapy and immune enhancing agents to
improve survival, as measured by progression-free survival
(EU) and overall survival (US) endpoints.
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21. REOLYSIN® and Safety
o More than 1,000 patients treated, more than 900 intravenously at
doses up to 3x1010 TCID50 daily
o No maximum tolerated dose (MTD) reached to date
o 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
o Transient Grade 3 and 4 toxicities included lymphopenia and
neutropenia
o These symptoms were more frequently observed from Day 2 of
treatment and usually lasted less than 6 hours
o Safety profile has been confirmed in a randomized setting in
Oncolytics’ REO 018 study of head and neck cancer patients
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22. Intellectual Property
o More than 370 patents issued worldwide, including 56 US
and 20 Canadian
o Reovirus issue patent claims cover:
o Compositions of matter comprising reovirus
o Pharmaceutical use of reoviruses to treat neoplasia and cellular
proliferative diseases
o Combination therapy with radiation, chemotherapy and/or
immune suppressants
o Methods for manufacturing reovirus and screening for
susceptibility to reovirus
o Pharmaceutical use of reoviruses in transplantation procedures
o Approximately 235 pending applications worldwide
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23. Manufacturing
o 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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25. Investment Highlights
o Five ongoing randomized Phase II studies, with
data readouts anticipated in 2015
o Indications: ovarian, colorectal, non-small
cell lung, prostate and breast cancers
o Preparing for registration study
o Safety data for 1,000+ patients
o Strong intellectual property portfolio
o More than 370 patents issued worldwide
o Manufacturing at commercial scale
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