8.24.15 corporate presentation

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Corporate Presentation August 24, 2015

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Corporate Presentation

August 24, 2015

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Forward Looking StatementsThis 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

Manufacturing at commercial scale100L cGMP completed

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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 cellsand 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 SafetyGeneral 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 ProgramGLIOMA

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

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Ongoing Randomized Phase 2 Studies

Five Randomized

Phase 2 Studies

• Ovarian• Colorectal• Breast• NSCLC• Prostate

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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)10

FDA EMA• ovarian • primary peritoneal • ovarian• pancreatic • fallopian tube • pancreatic• malignant gliomas • gastric

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What Does REOLYSIN® Do?

Reduces Tumour Burden

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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 patientso 86% of test arm (n=50) had

tumour stabilization or shrinkageo 67% of control arm (n=55) had

tumour stabilization or shrinkageo p-value 0.025

Second Endpoint: VolumeLoco-regional patients with or without distal metastaseso 23% improvement in test arm vs.

control for tumour volume decreaseo p-value 0.076, n=118

Patients with distal metastases only o 30% improvement in test arm vs.

control for tumour volume decreaseo 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 cancero 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?

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What Does REOLYSIN® Do? Improves Overall Survival

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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) ResultsREO 017 (Pancreatic Cancer) – Comparison with ACCORD 11 and MPACT Studies:

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What Does REOLYSIN® Do? Enhances Long-Term

Immune Responses

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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)); or3. 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 • MC1374 – Ph 1 IV combined with GM-CSF -

pediatric (ongoing)

Registration Program for REOLYSIN®

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Registration Program for REOLYSIN®

Next Steps A small “run-in” study assessing response in gliomas has been initiated

(Mayo Clinic’s MC1374)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

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Manufacturing & Intellectual

Property

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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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Corporate & Financial

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Market & Capital Data

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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-L1 (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