corporate presentation (april 2015)

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Corporate Presentation April 2015

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Corporate Presentation

April 2015

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

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 End of Q1, 2017 (at current burn rates)

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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 >90% 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

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 including PD-1 and PD-L1 and induce an anti-tumour specific immune response mediated by NK and T cells

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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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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.

REOLYSIN®: Clinical History

o To date, over 1,100 patients have been treated with REOLYSIN®, which has been shown to be safe and well-tolerated by patients

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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REOLYSIN®: Reducing Tumour Burden

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 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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REO 021: Squamous Cell Carcinoma (SCC), 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)

REO 016: Non-Small Cell Lung Cancer (NSCLC), Partial Response in Lung (EGFR Over-Expression)

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Pre-Treatment Post-Cycle 2

REO 016 (NSCLC): Best Overall Responses by Tumour Shrinkage

-100

-80

-60

-40

-20

0

20

40

60

80

100

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

-100

-80

-60

-40

-20

0

20

40

60

80

100

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

Best Overall Percentage Tumour Shrinkage by Longest Dimension

Best Overall Percentage Tumour Shrinkage by Volume

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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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REOLYSIN®: Improving Survival (PFS & OS)

Top-Line Progression Free Survival (PFS) Results 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

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 of 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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Top-Line Overall Survival (OS) Results REO 018 (Head and Neck Cancer):

An intent-to-treat analysis performed on all 118 loco-regional patients showed a statistically significant improvement in the OS of the test arm versus that of the control arm (p=0.0146, hazard ratio=0.5099)

OS 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

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

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REOLYSIN®: Enhancing Long-Term Immune

Responses

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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Immune Preclinical Research

In melanoma models in mice, the combination of GM-CSF with REOLYSIN® improved overall survival

In brain cancer models in mice, the combination of a checkpoint inhibitor (anti PD-1) with REOLYSIN® improved overall survival

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GM-CSF + REOLYSIN®: Effect on Overall Survival

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0

20

40

60

80

100

0 20 40 60 Days

Perc

ent

Surv

ival

IL2 + REO

IL2 alone

G-CSF + REO

G-CSF alone

GM-CSF + REO

GM-CSF

REOLYSIN® + Anti-PD-1: Effect on Overall Survival

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Enhancing Immune Responses to Improve Survival

o Ongoing preclinical and clinical research has led to three clinical candidate programs:

1. Gemcitabine in combination with REOLYSIN®;

2. GM-CSF in combination with REOLYSIN®; or

3. A checkpoint inhibitor in combination with REOLYSIN®

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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 overall survival.

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REOLYSIN® and Safety

o More than 1,100 patients treated, more than 1,000 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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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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Orphan Drug Designations

Orphan Drug Designations obtained for REOLYSIN®: From the US FDA: ovarian, primary peritoneal, fallopian tube and

pancreatic cancers and malignant gliomas From the EMA: ovarian cancer

Potential benefits of Orphan Drug Designation in the US: A period of market exclusivity if regulatory approval is ultimately

received in the designated indication Potential tax credits for certain activities Eligibility for orphan drug grants Waiver of certain administrative fees

Potential benefits of Orphan Designation in the EU: Protocol assistance Market exclusivity for a ten-year period following regulatory approval

if it is ultimately received in the designated indication Potential fee reductions

28

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)

29

Market & Capital Data

(all amounts in CAD)

Exchanges NASDAQ:ONCY

TSX:ONC

Shares Outstanding (March 13, 2015) 107,372,669

Price

Options Outstanding (March 13, 2015) $3.49 (weighted average)

5,446,394

Fully Diluted (March 13, 2015) 112,819,063

Cash/Cash Equivalents (March 13, 2015) $27.5M

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Financial runway extends well into 2017 with ATM and Equity Line facilities.

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 1,100+ patients

o Strong intellectual property portfolio

o More than 370 patents issued worldwide

o Manufacturing at commercial scale

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Corporate Presentation

April 2015