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Corporate PresentationMay 2016
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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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
$22.6 million total current assets as at the end of Q1, 2016
Manufacturing at commercial scale100L cGMP completed
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What is REOLYSIN®?
A proprietary isolate of wild-type reovirus Serotype 3 Dearing
Non-pathogenicMost humans show
evidence of exposure by adulthood
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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 < 6 hours
• Chills• Fever• Headache
• Cough• Myalgia• Runny nose
• Sore throat• Fatigue• Lymphopenia or neutropenia
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Clinical Program for REOLYSIN®
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-7848Phase II
REO 009Phase I
REO 011Phase I/II
MC-1472Phase I
REO 015Phase II
REO 017Phase I/II
REO 018Phase III
REO 020Phase II
REO 022Phase II
GOG-0186HPhase II
REO 013 Brain Phase I
NCI-8601Phase II
IND 209Phase II
IND 210Phase II
NCI-7853Phase I/II
IND 213Phase II
NCI-9030Phase I
NCI-9603Translational
REO 014 Phase II
REO 016Phase II
REO 021Phase II
IND 211Phase II
REO 008 Phase II
COG-ADVL1014Phase I Orphan Status
Orphan Status
Orphan Status
REO 023Run-In Study
REO 019Phase I b
REO 024Phase I b
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REOLYSIN®: Two Mechanisms of Action
1. In cancer cells with Ras pathway activating mutations (Braf, Kras and EGFR), REOLYSIN® acts as a directed cytotoxin and thereby reduces tumour burden.
2. REOLYSIN® also interacts with the immune system in at least two known ways, thereby functioning as an immune therapy that extends overall survival.
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Reducing Tumour BurdenREOLYSIN® as a Directed Cytotoxin
Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer Prior studies in other indications have indicated that REOLYSIN® may be an effective
neoadjuvant agent due to its ability to rapidly reduce tumour burden (e.g. the REO 018 head and neck study)
We are initiating a study to confirm clinical response rates in muscle-invasive bladder cancer and, once confirmed, will proceed to a registration study
Multiple Myeloma We have completed and/or initiated three studies of REOLYSIN® in multiple myeloma
patients These studies have confirmed very high response rates in patients who have failed, or
are refractory to, standard of care We are preparing to file for a registration study in this indication of the basis of results
from studies in this indication to date
Registration Program for REOLYSIN®: Studies with Tumour Reduction Endpoints
9
Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® IntratumouralMonotherapy 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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REOLYSIN® Plus Carfilzomib Response Data in Multiple Myeloma
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
05 8 4 7 6 3 1 2
% C
HAN
GE O
F M
ON
OCL
ON
AL P
ROTE
IN
PATIENTS EVALUABLE FOR RESPONSE
Responses evaluated using International Myeloma Working Group (IMWG) Criteria :• Patients 1 & 2 = Very Good Partial Response (VGPR)
• Patients 3, 6 & 7 = Partial Response (PR)• Patients 4, 5 & 8 = Minor Response (MR)
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Colorectal Cancer: Randomized Tumour Specific Data Patients were treated with FOLFOX 6/Avastin® plus or
minus REOLYSIN® 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)
If patients had liver metastases (with or without other metastases), patients in the test arm had a 55% objective overall response rate (n=40) versus 28.6% in the control arm (n=42) (p=0.0077)
A 51% increased reduction in median total liver metastatic tumour volume in the test arm versus the control arm(Kaplan-Meier curve, p= 0.0378, n=27)
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Post-Cycle 2
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Post-Cycle 6
Partial Response in Metastatic Liver Tumors –REOLYSIN®/Paclitaxel/Carboplatin (Phase 1)
Pre-Treatment
• Diagnosis: Metastatic sinu-nasal carcinoma with marked progression of pelvic and hepatic disease • Prior Treatment: Radiotherapy
Pre-Treatment Post-Cycle 3
• Treatment History: Radiation (2 cycles); cisplatin, gemcitabine/carboplatin, carboplatin/5-FU (6 cycles); docetaxel (3 cycles)
• Liver metastases reduced from 59.4 mm at baseline to 19 mm post-Cycle 3
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Partial Response in Metastatic Nasopharyngeal Cancer – REOLYSIN®/Paclitaxel/Carboplatin (Phase 2)
Other Randomized Clinical Trial Data: Tumour-Specific ResponsesHead and Neck Cancer (REO 018) Velocityof Tumour Shrinkage: An analysis of 105 patients showed that 86%
of the test arm (n=50) versus 67% of the control arm (n=55) had tumour stabilization or shrinkage (p = 0.025)
Volumetric Tumour Reduction:• An analysis of 118 loco-regional patients with or without distal metastases
showed that the test arm had a 23% greater volumetric reduction than the control arm (p = 0.076)
• An analysis of 47 patients with distal metastases only showed that the test arm had a 30% greater volumetric reduction than the control arm (p = 0.021)
Ovarian Cancer (GOG-0186H) The rate of full response was 9.26% in the test arm versus 1.85% in the
control arm (p = 0.0196) The rate of stable disease or better was 44.44% in the test arm versus
24.08% in the control arm (p = 0.0096)
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Improving Overall SurvivalREOLYSIN® as an Immune Therapy
Advanced Gliomas We have completed and/or initiated/about to initiate five studies of REOLYSIN® in
glioma patients including an ongoing Phase 1 IV combined with GM-CSF in pediatric patients, and a study assessing response in patients receiving REOLYSIN® and the standard of care (surgery followed by radiation and temozolomide)
Subject to confirmation of best approach, we will proceed to a pivotal trial, which will also measure overall survival
Patients With Metastases to the Liver We have completed enrolment in studies with head and neck cancer and colorectal
cancer (CRC), both with significant metastases of the liver. Subject to confirmation of results from the CRC study, we will proceed to a pivotal trial,
which will also measure overall survival
Registration Program for REOLYSIN®: Studies with Overall Survival Endpoints
18
Days after REOLYSIN® administration:
0 3 43 88 167 537
REO 003: REOLYSIN® IntratumouralMonotherapy 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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Patient Outcomes Are Influenced By Immune Status The survival rate of ovarian cancer patients with high PD-L1 expression on
entry is statistically significantly worse than that of patients with low PD-L1 expression on entry Five year survival was 80.2% for patients with low PD-L1 expression on entry and 52.6% for
those with high PD-L1 expression on entry (p = 0.016) Mean survival was 9.56 years for patients with low PD-L1 expression on entry and 6.48 years
for those with high PD-L1 expression on entry1
The survival rate of ovarian cancer patients with high intraepithelial CD8+ T lymphocyte counts on entry is statistically significantly better than that of patients with low CD8+ T lymphocyte counts Five year survival was 86.9% for patients with high CD8+ T lymphocyte counts on entry and
39% for those with low CD8+ T lymphocyte counts on entry (p < 0.001) Mean survival was 9.6 years for patients with high CD8+ T lymphocyte counts on entry and 4.7
years for those with low CD8+ T lymphocyte counts on entry1
1 Hamanishi et al. 2007. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. PNAS 104(9):3360-3365.
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REOLYSIN® in Multiple Myeloma
VariableREOLYSIN®
Monotherapy,Pre-Treatment
REOLYSIN®Monotherapy,
Post-TreatmentStatistics
REOLYSIN® + Carfilzomib,
Pre-Treatment
REOLYSIN® + Carfilzomib,
Post-Treatment
Statistics
CD8 58.0 (21.5) 63.9 (18.3) not significant 37.8 (8.5) 84.6 (26.8) p=0.060
PD-L1 20.8 (9.2) 30.6 (11.5) not significant 74.2 (49.5) 208.2 (31.1) p=0.005
caspase-3 5.4 (0.6) 6.2 (0.9) not significant 6.2 (0.8) 24.8 (4.3) p=0.005
Data supplied by Dr. G. Nuovo
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Top-Line Overall Survival (OS) Results
REO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:
Treatment nCA19.9 ≥20%
Decrease from Baseline
Median PFS
(months)
Median OS (months)
1-Year Survival
(%)
2-YearSurvival
(%)
Gemcitabine (ACCORD 11) (Conroy et al., 2011) 171 N/A 3.3 6.8 20 2
Gemcitabine (MPACT)(Van Hoff et al., 2013)(Goldstein et al., 2015)
430 44 3.7 6.6 22 5
Gemcitabine/REOLYSIN®(REO 017) 33 70 4.0 10.2 45 24
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Top Line Overall Survival (OS) Results
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REO 016 (Non-Small Cell Lung Cancer) – Comparison with Schiller et al., 2002:
Treatment n Median PFS (months)
Median OS (months)
1-Year Survival (%)
2-YearSurvival
(%)
Carboplatin and paclitaxel (Schiller et al., 2002) 290 3.1 8.1 34 11
Carboplatin, paclitaxel and REOLYSIN® (REO 016) 37 4.0 13.1 57 30
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)); or3. Checkpoint inhibitors in combination with REOLYSIN®
(first study: pancreatic cancer, standard of care plus REOLYSIN® plus pembrolizumab)
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Manufacturing & Intellectual Property
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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Patent Portfolio More than 400 patents issued worldwide,
including 56 US and 20 Canadian
Approximately 235 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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Corporate & Financial
Market & Capital Data(all amounts in CAD)
Exchanges OTCQX:ONCYF TSX:ONC FRA:ONY
Shares Outstanding (March 31, 2016)
118,697,122
Price
Options Outstanding (March 31, 2016)
$2.17 (weighted average)
8,561,394
Fully Diluted (March 31, 2016) 127,258,516
Total Current Assets (March 31, 2016)
$22.6 M
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Investment Highlights
Five ongoing randomized Phase II studies Ovarian, colorectal, non-small cell lung, prostate and breast cancers
Recently initiated first checkpoint inhibitor study in patients with pancreatic cancer
Preparing for registration study 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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Corporate PresentationMay 2016
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