september 2016 corporate presentation

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Corporate Presentation September 2016

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Page 1: September 2016 Corporate Presentation

Corporate PresentationSeptember 2016

Page 2: September 2016 Corporate Presentation

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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Page 3: September 2016 Corporate Presentation

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 scale100L cGMP completed

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Page 4: September 2016 Corporate Presentation

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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Page 5: September 2016 Corporate Presentation

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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Page 6: September 2016 Corporate Presentation

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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Page 7: September 2016 Corporate Presentation

Clinical Data: Progression Free Survival (PFS) & Overall Survival (OS)

Page 8: September 2016 Corporate Presentation

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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Page 9: September 2016 Corporate Presentation

Effect of Ras Pathway Activating and/or p53 Mutations on PFS and OS: IND 211

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Page 10: September 2016 Corporate Presentation

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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Page 11: September 2016 Corporate Presentation

Randomized PFS and OS by Gender in NSCLC Patients: IND 211

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Page 12: September 2016 Corporate Presentation

Clinical Data: Tumour Responses

Page 13: September 2016 Corporate Presentation

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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Page 14: September 2016 Corporate Presentation

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; and3. Genetics of metastases

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Page 15: September 2016 Corporate Presentation

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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Page 16: September 2016 Corporate Presentation

Post-Cycle 2

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Post-Cycle 6

Partial Response in Liver Metastases

Pre-Treatment

o Patient was diagnosed with sinu-nasal carcinomao Study participants were treated with REOLYSIN® in combination with

carboplatin and paclitaxel (Phase 1)

Page 17: September 2016 Corporate Presentation

Pre-Treatment Post-Cycle 3

o Patient was diagnosed with metastatic nasopharyngeal cancero 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% reduction17

Partial Response in Liver Metastases

Page 18: September 2016 Corporate Presentation

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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Page 19: September 2016 Corporate Presentation

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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Page 20: September 2016 Corporate Presentation

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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Page 21: September 2016 Corporate Presentation

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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Page 22: September 2016 Corporate Presentation

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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Page 23: September 2016 Corporate Presentation

REOLYSIN® Combination Therapy with Carfilzomib in Multiple Myeloma

VariableMean (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

Page 24: September 2016 Corporate Presentation

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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Page 25: September 2016 Corporate Presentation

Manufacturing & Intellectual Property

Page 26: September 2016 Corporate Presentation

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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Page 27: September 2016 Corporate Presentation

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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Page 28: September 2016 Corporate Presentation

Corporate & Financial

Page 29: September 2016 Corporate Presentation

Market & Capital Data

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Page 30: September 2016 Corporate Presentation

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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Page 31: September 2016 Corporate Presentation

Corporate Presentation

September 2016