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Corporate Presentation May 2016
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May 2016 Corporate Presentation

Jan 25, 2017

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Page 1: May 2016 Corporate Presentation

Corporate PresentationMay 2016

Page 2: May 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: May 2016 Corporate Presentation

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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Page 4: May 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: May 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 < 6 hours

• Chills• Fever• Headache

• Cough• Myalgia• Runny nose

• Sore throat• Fatigue• Lymphopenia or neutropenia

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Page 6: May 2016 Corporate Presentation

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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Page 7: May 2016 Corporate Presentation

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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Page 8: May 2016 Corporate Presentation

Reducing Tumour BurdenREOLYSIN® as a Directed Cytotoxin

Page 9: May 2016 Corporate Presentation

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

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Page 10: May 2016 Corporate Presentation

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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Page 11: May 2016 Corporate Presentation

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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Page 12: May 2016 Corporate Presentation

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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Page 13: May 2016 Corporate Presentation

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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Page 14: May 2016 Corporate Presentation

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

Page 15: May 2016 Corporate Presentation

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)

Page 16: May 2016 Corporate Presentation

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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Page 17: May 2016 Corporate Presentation

Improving Overall SurvivalREOLYSIN® as an Immune Therapy

Page 18: May 2016 Corporate Presentation

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

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Page 19: May 2016 Corporate Presentation

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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Page 20: May 2016 Corporate Presentation

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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Page 21: May 2016 Corporate Presentation

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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Page 22: May 2016 Corporate Presentation

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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Page 23: May 2016 Corporate Presentation

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

Page 24: May 2016 Corporate Presentation

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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Page 25: May 2016 Corporate Presentation

Manufacturing & Intellectual Property

Page 26: May 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: May 2016 Corporate Presentation

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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Page 28: May 2016 Corporate Presentation

Corporate & Financial

Page 29: May 2016 Corporate Presentation

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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Page 30: May 2016 Corporate Presentation

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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Page 31: May 2016 Corporate Presentation

Corporate PresentationMay 2016