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 Oncolytic 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 regulatory authorities
including but not limited to the FDA, HPB and MHRA, and those other factors detailed
in the Company’s filings with SEDAR and the Securities and Exchange Commission.
Oncolytics Biotech® Inc. does not undertake an obligation to update these forward
looking statements, except as required by applicable laws.
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3. Oncolytics Overview
Conducted 30+ clinical
studies in 13 indications
400+ issued patents and
70+ pending
applications worldwide
1,100+ patients treated;
strong safety profile
Developing REOLYSIN®
(oncolytic virus) as a
cancer therapeutic
$20.41 million cash and
cash equivalents as at
the end of Q2, 2016
Manufacturing
at commercial scale
100L cGMP completed
3
4. What is REOLYSIN®?
A proprietary isolate
of wild-type reovirus
Serotype 3 Dearing
Non-pathogenic
Most humans show
evidence of exposure
by adulthood
4
5. Safety Profile of REOLYSIN®
General Safety
1,100+ patients treated, 1,000+ of these intravenously
No maximum tolerated dose (MTD) reached
Safety profile confirmed in a randomized setting
Monotherapy Safety
Mild toxicities (grade 1 or 2) including:
Transient grade 3 and 4 toxicities included lymphopenia or
neutropenia – symptoms usually last less than 6 hours
• Chills
• Fever
• Headache
• Cough
• Myalgia
• Runny nose
• Sore throat
• Fatigue
• Lymphopenia or neutropenia
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6. REOLYSIN®: Two Mechanisms of Action
1. In cancer cells with Ras pathway activating
(BRAF, Kras, Nras, Hras, and EGFR) and/or p53
mutations, REOLYSIN® acts as a directed
cytotoxin
2. REOLYSIN® also interacts with the immune
system in at least two known ways, thereby
functioning as an immune therapy
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8. Effect of Ras Pathway Activating and/or
p53 Mutations on PFS and OS: IND 211
Test Arm
(n=38)
Patients without
Mutations (months)
Patients with Mutations
(month)
P-Value
Median PFS 1.51 5.39 0.039
Median OS 4.76 11.53 0.031
Randomized Phase II study of non-squamous non-small cell
lung cancer (NSCLC) patients treated with pemetrexed and
REOLYSIN®
Test arm patients with Ras pathway activating and/or p53
mutations received greater PFS and OS benefit from
treatment with REOLYSIN® than test arm patients without
these mutations
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9. Effect of Ras Pathway Activating and/or
p53 Mutations on PFS and OS: IND 211
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10. Randomized PFS and OS in Female NSCLC
Patients: IND 211
Female Patients
(n=36)
Control Arm
(months)
Test Arm
(month)
P-Value
Median PFS 3.02 5.39 0.020
Median OS 7.59 10.68 0.145
Female patients on the test arm received greater PFS and OS
benefit than female patients on the control arm
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13. Cancer and Metastases
Approximately 8.5 million people die from cancer
each year, 4 million of them in the developed world
90% of cancer deaths are due to metastatic disease,
primarily in the liver, lung, lymph nodes and brain
An agent with specific, demonstrated activity in
metastatic disease is necessary
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14. REOLYSIN® and Metastases
REOLYSIN® should have therapeutic effects on
patients’ liver, lymph, lung and brain
metastases in based on:
1. Bio distribution patterns;
2. Ability to cross the blood brain barrier in
patients with brain metastases; and
3. Genetics of metastases
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15. REOLYSIN® and Liver Metastases
Single-arm drug combination studies in head and
neck cancer patients showed REOLYSIN® to
markedly reduce liver metastases in an “unusual”
manner
However, single arm study responses must be
considered to be anecdotal
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16. Post-Cycle 2
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Post-Cycle 6
Partial Response in Liver Metastases
Pre-Treatment
o Patient was diagnosed with sinu-nasal carcinoma
o Study participants were treated with REOLYSIN® in combination with
carboplatin and paclitaxel (Phase 1)
17. Pre-Treatment Post-Cycle 3
o Patient was diagnosed with metastatic nasopharyngeal cancer
o Study participants were treated with REOLYSIN® in combination with
carboplatin and paclitaxel (Phase 2)
o Liver metastases were reduced from 59.4mm at baseline to 19mm post-Cycle 3
– a 68.01% reduction
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Partial Response in Liver Metastases
18. Randomized Tumour Specific Data: Head
and Neck Cancer (REO 018)
Patients were treated with REOLYSIN® in combination
with carboplatin and paclitaxel
Loco-regional patients with or without distal metastases
experienced a 23% increased reduction in median total
tumour volume in the test arm versus the control arm
(median from Kaplan-Meier curve, p-value 0.076, n=118)
Patients with distal metastases (lymph node, lung, and
liver) experienced a 30% increased reduction in median
total tumour volume in the test arm versus the control
(median from Kaplan-Meier curve, p-value 0.021, n=47)
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19. Randomized Tumour Specific Data:
Colorectal Cancer (IND 210)
Patients were treated with FOLFOX-6/Avastin® plus
or minus REOLYSIN®
Patients in the test arm had a 53% objective overall
response rate (n=51) versus 35% in the control arm
(n=52) (p=0.06)
Patients with liver metastases (with or without other
metastases) had a 55% objective overall response
rate in the test arm (n=40) versus 28.6% in the
control arm (n=42) (p=0.0077)
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20. Randomized Tumour Specific Data in Female
Colorectal Cancer Patients (IND 210)
Female patients with or without metastases on the
test arm had a 63.2% objective response rate (n=19)
versus 23.8% on the control arm (n=21) (p=0.0054)
These patients also experienced a 51% increased
reduction in median total liver metastases volume in
the test arm versus the control arm (median from
Kaplan-Meier curve, p= 0.0378, n=27)
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21. Upcoming Colorectal Cancer Study
Oncolytics has filed for a Phase 2 study of REOLYSIN®
in combination with FOLFOX-6 and Avastin® in
female patients with colorectal cancer that is
metastatic to the liver
All patients will be prescreened for mutations in
EGFR, Kras, Nras, Hras, BRAF and/or p53
Primary Endpoint: Overall tumour response rate
Secondary Endpoint: Liver metastases specific
response rate
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22. REOLYSIN® and Multiple Myeloma
REOLYSIN® should have tumour effects in
multiple myeloma patients based on:
1. Bio distribution patterns;
• >90% infectivity of multiple myeloma cells in bone
marrow
2. Replicative induction with proteasome
inhibitors; and
3. Immune effects
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23. REOLYSIN® Combination Therapy with
Carfilzomib in Multiple Myeloma
Variable
Mean (SEM),
Pre-Treatment
(N=5)
Mean (SEM),
REOLYSIN® +
Carfilzomib (N=5)
Mean (SEM),
Carfilzomib Alone
(N=5)
CD8 37.8 (8.5) 84.6* (26.8) 5.2 (1.5)
PD-L1 74.2 (49.5) 208.2* (31.1) 9.4 (12.5)
caspase-3 6.2 (0.8) 24.8 (4.3)* 10.9 (2.9)
NK cells 16.8 (4.3) 20.6 (4.7) 0.9 (0.2)
CD68 199.0 (7.7) 188.9 (10.1) 197.5 (11.1)
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Data supplied by Dr. G. Nuovo
• Each value is number of positive cells/200X field
• * = significant difference from pretreatment at p = 0.001
24. Multiple Myeloma Registration Study
Oncolytics is preparing to file a Phase III registration
study of REOLYSIN® in combination with carfilzomib
in patients with multiple myeloma
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26. Manufacturing
Now produced at commercial scale (100L) under cGMP with final formulation
Commercial manufacturing agreement in place with Sigma-Aldrich® Fine
Chemicals (SAFC)
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27. Patent Portfolio
More than 400 patents issued worldwide,
including 60 US and 20 Canadian
More than 70 pending patent applications
worldwide
Issued patent claims for reovirus 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
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30. Investment Highlights
Preparing to file for lead registration study in
multiple myeloma
Positive safety data for 1,100+ patients
Strong intellectual property portfolio
• More than 400 issued patents worldwide
Manufacturing at commercial scale
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