january 2014 corporate presentation

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Corporate Presentation January 2014

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Page 1: January 2014 Corporate Presentation

Corporate Presentation January 2014

Page 2: January 2014 Corporate Presentation

Forward Looking Statements Today’s 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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Page 3: January 2014 Corporate Presentation

Oncolytics Overview • Expanding Clinical Program

• Lead product is REOLYSIN®, a broadly active novel cancer therapy

• Ongoing clinical trials include seven randomized studies: • Enrollment complete randomized international study (REO 018) of REOLYSIN®

in combination with carboplatin and pactliaxel in platinum-refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication

• Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers

• Strong Intellectual Property Portfolio • More than 370 patents issued worldwide

• Manufacturing at Commercial Scale • 100L cGMP completed, commercial manufacturing agreement in place

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Page 4: January 2014 Corporate Presentation

REOLYSIN® Overview • REOLYSIN® is a proprietary isolate of the reovirus

• Reovirus is a replication competent virus and is considered safe to humans

• REOLYSIN® has been safely administered to patients via intravenous, intratumoral and intrathecal injection

• Mechanism of Action: • In Ras-activated cells, one of the key cellular defence mechanisms against double-

stranded RNA viral infection, Protein Kinase-R (PKR), is deactivated • This specific vulnerability of constitutive Ras-activated cancer cells to the reovirus is the

basis of REOLYSIN®’s activity and specificity • Reovirus oncolysis is seen in cancer cells with constitute Ras pathway activation;

susceptible cancer cells therefore include those with either: • EGFR overexpression or mutation1; or • Ras mutation, which includes Kras mutation2

• Both of these mutations lead to activation of the Ras pathway 1 Evidence that the epidemal growth factor receptor on host cells confers reovirus infection efficiency. Strong et al. Virology 1993; 197(1): 405 2 The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12): 3351

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Page 5: January 2014 Corporate Presentation

REOLYSIN® Mechanism of Action

REOLYSIN® infects both tumor cells and normal, healthy cells

REOLYSIN® is a virus whose replication is stopped in a non- Ras-activated cell

Healthy cell remains undamaged

Tumor cells rupture to release progeny virus

Replicated viruses repeat cell lysis cycle in nearby tumor cells

REOLYSIN® replicates in Ras- activated tumor cells

REOLYSIN® infects both tumor cells and normal, healthy cells

Normal Cells

Ras-Activated Cells

REOLYSIN® administered to patients via IV

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Page 6: January 2014 Corporate Presentation

REO 013: REOLYSIN® Induced Tumour Responses

• Image shows positive (red staining) for reovirus in the metastatic lesions (yellow arrow) and negative for reovirus in the normal cells (red arrow)

• Nine out of ten patients showed the same pattern, i.e. targeted delivery to metastatic tumor lesions of the liver

• In addition, two of the ten patients had complete tumor necrosis

• This demonstrates that REOLYSIN® specifically accesses and replicates in metastatic colorectal cancer when delivered as a monotherapy

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Page 7: January 2014 Corporate Presentation

Market for Ras Pathway Mediated Cancers

• Estimated global cancer market was $77 billion in 2011; this is expected to rise to $105 billion in 2016

• At least five million new patients per year are expected to develop cancers with a Ras pathway involvement

• In the developed world alone, at least 2.6 million patients per year die of cancers that have metastasized

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Page 8: January 2014 Corporate Presentation

REOLYSIN® Clinical Program Overview

REOLYSIN® has been utilized in studies in over 620 patients

In total, nearly thirty ongoing or completed clinical trials including: • Seven randomized Phase II and Phase III clinical trials, including Phase III head

and neck cancer and Phase II trials for ovarian, pancreatic, prostate, colorectal, non-small cell lung and breast cancers

• Nine single arm studies in the following indications:

• Phase II trials: • Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck

carcinoma, metastatic melanoma and squamous cell carcinoma

• Phase I trials: • Company sponsored: colorectal cancer and advanced malignancies

• Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors

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Page 9: January 2014 Corporate Presentation

Selected REOLYSIN® Pipeline: Randomized Studies

Indication Combination Therapy n Preclinical Phase I Phase II Phase III Sponsor

REO 018: Head & Neck Cancer Carboplatin + paclitaxel 167

n/a

GOG-0186H: Ovarian, Fallopian Tube & Primary Peritoneal

Cancers Paclitaxel 110

NCI/ GOG

OSU-10045: Pancreatic Cancer Carboplatin + paclitaxel 70 NCI

IND 209: Prostate Cancer Docetaxel 80 NCIC

IND 210: Colorectal Cancer

FOLFOX-6 +

Avastin®

100 NCIC

IND 211: Non-Small Cell Lung Cancer

Docetaxel or pemetrexed 150 NCIC

IND 213: Breast Cancer Paclitaxel 100 NCIC

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Page 10: January 2014 Corporate Presentation

Phase III (Pivotal) Program for REOLYSIN®

in Squamous Cell Head and Neck Cancers

• In Q3 2012, Oncolytics completed enrollment in REO 018, a randomized, two stage, two-arm, double-blind, multi-center trial examining REOLYSIN® in combination with carboplatin and paclitaxel in taxane-naïve patients with platinum-refractory recurrent head and neck cancers

• The study was approved and run in fourteen countries in North America and Europe

• Patients in the REO 018 study were stratified for:

• ECOG performance status (0-1 versus 2)

• Time of progression/relapse after prior platinum-based chemotherapy

• Disease location (patients with locally recurrent disease, with or without distal metastases, versus patients with metastatic disease only)

• REO 018 Endpoints:

• Primary Endpoint: Overall Survival (OS)

• Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response

• Pharmacodynamic Endpoints: Tumour Ras pathway status and HPV status

• The Company intends to treat REO 018 as a separate supportive study to a planned randomized, follow-on international Phase III head and neck registration study in patients with loco-regional head and neck cancer

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Page 11: January 2014 Corporate Presentation

REO 018: Tumor Specific Response Data

• Data announced December 13, 2012

• Endpoint examines initial percentage tumor changes between baseline and first post treatment scans in all patients, differentiating between loco-regional tumours and metastatic tumours • This is a measure of rate or velocity of response, not magnitude of response

• The endpoint was introduced to determine if REOLYSIN® adds tumor specific differential activity in metastatic and loco-regional disease in a randomized setting

• Of the total 105 patients with evaluable metastatic tumors, 86% (n=50) of those in the test, and 67% (n=55) in the control arm, arm had tumor stabilization (0% growth) or shrinkage • This is a statistically significant difference, with a p-value of 0.025

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Page 12: January 2014 Corporate Presentation

REO 018: Percentage Change in Metastatic Lesions at First Post-Treatment Scan (Control vs. Test)

-100.00%

-80.00%

-60.00%

-40.00%

-20.00%

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Control

Test

p=0.03

Perc

ent C

hang

e (T

arge

t Les

ions

)

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Page 13: January 2014 Corporate Presentation

REO 018: Top-Line Efficacy Data

• Data announced November 21, 2013

• An analysis was performed on an intent-to-treat basis of the 118 patients with loco-regional disease, with or without metastases • At the time of reporting, there had not been a sufficient number of events

to conduct a survival analysis of patients in the metastatic-only group

• Patients in the test arm (n=62) showed a median PFS of 94 days (13.4 weeks), versus 50 days (7.1 weeks) in the control arm (n=56) • Patients who received REOLYSIN® had increased benefit through five

cycles of therapy

• Of 88 patients who did not receive additional therapy following discontinuation of study treatment, those in the test arm (n=50) showed a median OS of 150 days (21.4 weeks), versus 115 days (16.4 weeks) in the control arm (n=38)

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Page 14: January 2014 Corporate Presentation

REO 018: Top-Line Safety Data

• Data announced November 21, 2013 for all 167 patients enrolled

• REOLYSIN was safe and well-tolerated by patients

• Patients on the test arm of the study experienced a higher incidence of flu-like symptoms consistent with earlier clinical trials of REOLYSIN® and treatment with a virus • Most commonly mild fever, chills, nausea and diarrhea

• Fewer patients required dose reductions of paclitaxel due to neuropathy or neurotoxicity on the test arm than the control arm (zero in the test arm versus six in the control; p=0.028) • On this basis, Oncolytics intends to explore the potential chemoprotective

and neuroprotective properties of REOLYSIN® in future clinical studies

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Page 15: January 2014 Corporate Presentation

REO 016: Non-Small Cell Lung Cancer • Single-arm (up to 36 patients), open-label, two-stage US Phase II

study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel

• For non-small cell lung cancer (NSCLC) patients who have been pre-screened for Kras and EGFR mutation status • 15-20% of NSCLC is Kras mutated, while up to 50% is EGFR

mutated or overexpressed, all of which cause Ras pathway activation

• First-line therapy study, i.e. patients will be offered REOLYSIN® / carboplatin / paclitaxel instead of standard of care if they are Kras or EGFR mutated or EGFR overexpressed

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Page 16: January 2014 Corporate Presentation

REO 016: Biomarker Correlations with REOLYSIN® Efficacy

• Of 36 evaluable patients, all of whom were Stage IV on entry, 89% exhibited SD or better (11 PR, 21 SD and 4 PD by RECIST)

• 20 of these 36 patients (56%) had one year or more of survival

• Of 24 patients with at least an EGFR mutation or amplification, 16 (66.7%) had one year or more of survival

• Of 13 patients with only an EGFR mutation or amplification, 9 (69.2%) had one year or more of survival

• Of 4 patients with BRAF and EGFR amplifications, 4 (100%) had one year or more of survival

Page 17: January 2014 Corporate Presentation

REO 016: Partial Response in Lung (EGFR Over-Expression)

Pre-Treatment Post Cycle 2

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Page 18: January 2014 Corporate Presentation

REO 021: Squamous Cell Carcinoma (SCC) of the Lungs

• Single-arm (up to 36 patients), open-label US Phase II study of intravenously-administered REOLYSIN® in combination with carboplatin and paclitaxel

• Final results in 25 evaluable patients (all with metastatic disease) demonstrated that 92% (23 patients) exhibited overall tumour shrinkage, with mean shrinkage of 32.7%

• Of the 25 evaluable patients who received more than one cycle of therapy, 10 (40%) showed partial responses by RECIST, and a further 12 (48%) showed stable disease by RECIST, for a disease control rate (CR + PR + SD) of 92%

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Page 19: January 2014 Corporate Presentation

REO 021: Best Overall Percentage Response in Target Lesions (Final Data)

Per

cen

t Ch

ange

(T

arge

t Les

ion

s)

-100

-80

-60

-40

-20

0

20

40

Patients by Increasing Overall Percentage Tumour Shrinkage

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Page 20: January 2014 Corporate Presentation

REO 021: Partial Response in Lung

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 Upper Lung Mass (3.6 cm)

Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm)

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Page 21: January 2014 Corporate Presentation

Randomized Canadian Studies of REOLYSIN®

• Patients are currently being enrolled in four randomized Phase II studies in Canada: • IND 209: Intravenous Administration of REOLYSIN® in Combination

with Docetaxel for Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer

• IND 210: Intravenous Administration of REOLYSIN® in Combination with FOLFOX-6 Plus Avastin® versus FOLFOX-6 Plus Avastin® Alone in Patients with Advanced or Metastatic Colorectal Cancer

• IND 211: Intravenous Administration of REOLYSIN® in Combination with Docetaxel or Pemetrexed for Patients with Previously-Treated Advanced or Metastatic Non-Small Cell Lung Cancer

• IND 213: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer

• All four studies are sponsored by the National Cancer Institute of Canada’s Clinical Trials Group (NCIC CTG)

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Page 22: January 2014 Corporate Presentation

Randomized U.S. Studies of REOLYSIN®

• Patients are currently being enrolled in two randomized Phase II studies in the United States: • OSU-10045: Intravenous Administration of REOLYSIN® in Combination

with Paclitaxel and Carboplatin for Patients with Metastatic Pancreatic Cancer

• GOG-0186H: Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Both studies are sponsored by the U.S. National Cancer Institute (NCI), with GOG-0186H being conducted by the Gynecologic Oncology Group (GOG)

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Page 23: January 2014 Corporate Presentation

REOLYSIN® and Safety

• More than 620 patients treated, more than 530 intravenously at doses up to 3x1010 TCID50 daily

• No maximum tolerated dose (MTD) reached to date

• 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

• Transient grade 3 and 4 toxicities included lymphopenia and neutropenia

• These symptoms were more frequently observed from day 2 of treatment and usually lasted less than 6 hours

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Page 24: January 2014 Corporate Presentation

Intellectual Property

• More than 370 patents issued worldwide, including 51 US and 16 Canadian

• Reovirus issue patent claims 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

• Approximately 235 pending applications worldwide

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Page 25: January 2014 Corporate Presentation

Manufacturing

• Now produced at 100L under cGMP with final formulation

• Commercial manufacturing agreement with SAFC in place

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Page 26: January 2014 Corporate Presentation

Market & Capital Data (all amounts in CAD)

Exchanges NASDAQ:ONCY TSX:ONC

Shares Outstanding (September 30, 2013)

84,758,818

Warrants Expiring Price

Feb 8, 2014 $4.20 303,945

Options $4.40 (average)

6,076,844

Fully Diluted (September 30, 2013)

91,139,607

Cash/Cash Equivalents (September 30, 2013)

$29.5M

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Page 27: January 2014 Corporate Presentation

Oncolytics Summary • Expanding Clinical Program

• Lead product is REOLYSIN®, a broadly active novel cancer therapy

• Ongoing clinical trials include seven randomized studies: • Enrollment complete randomized international study (REO 018) of REOLYSIN®

in combination with carboplatin and pactliaxel in platinum-refractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication

• Six sponsored Phase II studies announced or ongoing in the US and Canada – breast, non-small cell lung, colorectal, prostate, pancreatic and ovarian cancers

• Strong Intellectual Property Portfolio • More than 370 patents issued worldwide

• Manufacturing at Commercial Scale • 100L cGMP completed, commercial manufacturing agreement in place

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Page 28: January 2014 Corporate Presentation

Corporate Presentation January 2014