corporate presentation-(september-2015-corrected)
TRANSCRIPT
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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Oncolytics Overview
Conducted 30+ clinical studies in 13 indications
400+ issued patents and 235 pending applications worldwide
1,100+ patients treated; strong safety profile
Developing REOLYSIN®(oncolytic virus) as a cancer therapeutic
$32.1 million cash as at the end of Q2, 2015
Manufacturingat commercial scale100L cGMP completed
What is REOLYSIN®?
� Proprietary isolate
of the reovirus
� Widely found
� Non-pathogenic
� Widespread human
exposure
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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
undamagedREOLYSIN®
Administered to
patients
PRE-SCREENED
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 then
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, including PD-1 and PD-L1, and induce an anti-
tumour specific immune response mediated by NK and
T cells
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REOLYSIN® and Safety
General Safety
� 1,100+ patients treated, 1,000+ intravenously
� No MTD reached
� Safety profile confirmed in a randomized setting
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Monotherapy Safety
� Mild toxicities (grade 1 or 2) including
� Transient grade 3 and 4 toxicities included lymphopenia or
neutropenia – symptoms usually last < 6 hours
• Chills
• Fever
• Headache
• Cough
• Myalgia
• Runny nose
• Sore throat
• Fatigue
• Lymphopenia or neutropenia
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REOLYSIN® Clinical Program
GLIOMA
PROSTATE
OVARIAN
COLORECTAL
LUNG
PANCREATIC
MYELOMA
MELANOMA
HEAD AND NECK
BREAST
BLADDER
Indication Studies
Ongoing Study Completed Study
REO 001 Phase I
REO 007Phase I/II
REO 002 Phase I
REO 003 Phase I/II
REO 004 Phase I
REO 005 Phase I
NCI (MAYO –MC0672 )Phase II
REO 009Phase I
REO 011Phase I/II
MAY0 (MC-1472)Phase I
REO 015Phase II
REO 017Phase I/II
REO 018Phase III
REO 020Phase II
REO 022Phase II
NCI (GOG-0186H)Phase II
REO 013 Brain Phase I
NCI 8601Phase II
IND 209Phase II
IND 210Phase II
NCI (OSU-07022)Phase I/II
IND 213Phase II
NCI (OSU-11148)Phase I
NCI 9603Translational
REO 014 Phase II
REO 016Phase II
REO 021Phase II
IND 211Phase II
REO 008 Phase II
NCI (COG-ADVL1014)Phase I
Orphan Status
Orphan Status
Orphan Status
REO 019Run-In Study
REOLYSIN® AddressableMarket
Breast140,514
Ovarian12,774
Soft tissue7,158
Brain13,710
Head & Neck27,468
Pancreas29,376
Prostate132,480
Melanoma44,322
Myeloma16,110
Colon & Rectum79,620
Lung & Bronchus132,720
1,000,000+ new U.S. cases a year
in studied indications,
of which REOLYSIN®
conservatively addresses 60%
Source: American Cancer Society – Cancer Facts and
Figures 2015 Estimated New Cases per Indication in
the U.S. in 2015
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Orphan Drug DesignationsOrphan Drug Designations obtained for REOLYSIN®:
Potential benefits of Orphan Drug Designation:
� A period of market exclusivity (US and EU)
� Potential tax credits for certain activities (US)
� Eligibility for orphan drug grants (US)
� Potential fee waivers and/or reductions (US and EU)
� Protocol assistance (EU)
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FDA EMA
• ovarian • primary peritoneal • ovarian
• pancreatic • fallopian tube • pancreatic
• malignant gliomas • gastric
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
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REO 021: Partial Response in Patient with
Squamous Cell Carcinoma of the Lung
Right Upper Lung Mass (8.3 cm)
Pre-Treatment
Right Pleural Met (2.2 cm)
Right Upper Lung Mass (4.1 cm)
Post-Cycle 2
Right Pleural Met (0.8 cm)
Right Upper Lung Mass (3.6 cm)
Post-Cycle 4
Right Pleural Met (0.4 cm)
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REO 018 Head and Neck Cancer: Randomized
Tumour-Specific Response Data
First Endpoint: Velocityo 105 patients
o 86% of test arm (n=50) had
tumour stabilization or shrinkage
o 67% of control arm (n=55) had
tumour stabilization or shrinkage
o p-value 0.025
Second Endpoint: VolumeLoco-regional patients with or without
distal metastases
o 23% improvement in test arm vs.
control for tumour volume decrease
o p-value 0.076, n=118
Patients with distal metastases only
o 30% improvement in test arm vs.
control for tumour volume decrease
o p-value 0.021, n=47
Study demonstrated that REOLYSIN® increased both the
magnitude and velocity of tumour shrinkage
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Registration Program for REOLYSIN®
Short-Term: Tumour Reduction Endpoints: � Neoadjuvant treatment of muscle-invasive bladder cancer
� Neoadjuvant = therapy used prior to a major therapeutic intervention
(usually surgery) in order to improve outcome
Next Steps:
� IND has been filed to conduct a small “run-in” study assessing
histopathological response in muscle invasive bladder cancer
o REOLYSIN® in combination with gemcitabine and cisplatin
� Subject to confirmation of response – proceed to pivotal trial
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� Studies demonstrate that REOLYSIN® increases both the
magnitude and velocity of tumor shrinkage
� Muscle invasive bladder cancer is the only cancer indication in
which US regulators have accepted histopathological response
as a registration endpoint in a neoadjuvant study to date
� Each patient enrolled in the study will be assessable for this
endpoint at a maximum of nine weeks after starting
treatment
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Why Muscle Invasive Bladder Cancer?
Top-Line Overall Survival (OS) Results:
REO 018 (Head and Neck Cancer)
� An intent-to-treat analysis of 118 patients with loco-regional disease showed a statistically significant improvement in the OS of the test arm versus that of the control arm1
� p=0.0146
� hazard ratio=0.5099
1 Overall survival was measured to the median PFS in each arm, censoring any patients who received
post-discontinuation therapy from the date on which they commenced the first of these therapies.
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Top-Line Overall Survival (OS) Results
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
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Days Post Treatment:
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
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REOLYSIN®: Enhancing Immune Response
� REOLYSIN® acts as a selective cytotoxin – killing the
tumour cells in which it replicates
� We now know that administration of REOLYSIN®
also:
� Causes the immune system to recognize
and kill tumour cells as well
� Causes up-regulation of PD-1 and PD-L1
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REOLYSIN®: Immunology & Anti-PD-1 / PD-L1
� In some types of cancer (including pancreatic
cancer, glioblastoma and metastatic brain
lesions), REOLYSIN® has been shown to
upregulate PD-1 and PD-L1 (Appendix A)
� In cancers with low PD-1 and PD-L1 upregulation,
this enhances the activity of checkpoint inhibitors
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Immune Preclinical Research
� In ovarian cancer models in mice:� Combination of gemcitabine and reovirus type 3 improved
overall survival
� In melanoma models in mice:� Combination of GM-CSF with REOLYSIN® improved overall
survival
� In brain cancer models in mice:� Combination of a checkpoint inhibitor (anti-PD-1) with
REOLYSIN® improved overall survival
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Enhancing Immune Responses to
Improve Overall Survival
� Ongoing preclinical and clinical research has led to
three clinical programs:
1. Gemcitabine in combination with REOLYSIN® (REO 009
and REO 017);
2. GM-CSF in combination with REOLYSIN® (Mayo
(pediatric) and Leeds (adult)); or
3. Checkpoint inhibitors in combination with REOLYSIN®
(studies pending)
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Registration Program for REOLYSIN®
� Medium-Term: intravenous treatment of advanced
gliomas
� Long-Term: to be determined upon receipt of data
from ongoing single-arm and randomized studies in a
range of indications
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Medium-Term – Overall Survival Endpoints
� A key finding from REO 013 was that REOLYSIN® can cross the blood brain barrier
and subsequently infect and kill tumour in the brain, as well as primary gliomas and
metastatic lesions from other primary cancers outside brain
� We have completed and initiated four studies of REOLYSIN® in glioma patients:
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• REO 003 – Ph 1/2 local mono-therapy
• REO 007 – Phase 1/2 infusion mono-
therapy
• REO 013 – Ph 1 IV prior to surgical resection
• MC1472 – Ph 1 IV combined with GM-CSF -
pediatric (ongoing)
Registration Program for REOLYSIN®
Registration Program for REOLYSIN®
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Next Steps
� A small “run-in” study assessing response in gliomas has been initiated
(Mayo Clinic’s MC1472)
o Pediatric patients being treated with REOLYSIN® in combination with GM-CSF
� Second study assessing response in adult patients receiving REOLYSIN® and
the standard of care (surgery followed by radiation and temozolomide)
� Subject to confirmation of best approach – proceed to pivotal trial
Manufacturing
� Now produced at 100L (commercial scale) under cGMP with final formulation
� Commercial manufacturing agreement in place with Sigma-Aldrich® Fine Chemicals (SAFC)
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Patent Portfolio
� More than 400 patents issued
worldwide, including 56 US and
20 Canadian
� 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
� Approximately 235 pending
applications worldwide
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Market & Capital Data
(all amounts in CAD)
Exchanges NASDAQ:ONCY
TSX:ONC
Shares Outstanding (June 30, 2015) 117,710,372
Price
Options Outstanding (June 30, 2015) $3.16 (weighted
average)
5,531,394
Fully Diluted (June 30, 2015) 123,241,766
Cash/Cash Equivalents (June 30, 2015) $32.1 M
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Investment Highlights
� Five ongoing randomized Phase II studies� Ovarian, colorectal, non-small cell lung, prostate and breast cancers
� Preparing for registration study
� Safety data for 1,100+ patients
� Strong intellectual portfolio
� More than 400 patents worldwide
� Manufacturing at commercial scale
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Appendix A: Presence of Reoviral Protein, PD-1
& PD-1 (REO 013b Study)
Case Diagnosis Reoviral Protein PD-L1 PD-1
1 glioblastoma 1+ 2+ 2+
2 adenocarcinoma (colon metastasis) 1+ 2+ 2+
3 glioma, grade 3 1+ 2+ 2+
4 glioma, grade 3 negative 0 1+
5 melanoma metastasis negative 1+ 2+
6 glioblastoma 1+ 2+ 2+
7 glioblastoma negative weak 0
8 glioblastoma 1+ 1+ 2+
9 melanoma metastasis 2+ 3+ 2+
10 (control) adenocarcinoma (breast metastasis) negative 0 0
11 (control) glioblastoma negative 0 0
12 (control) glioblastoma negative 0 0
13 (control) glioblastoma negative 0 0
14 (control) glioblastoma negative 0 0
15 (control) adenocarcinoma (ovarian metastasis) negative 0 weak