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Corporate Presentation
February 2014
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.
2
Oncolytics Overview
o

o
o

Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include seven randomized studies:
o Enrollment complete randomized international study (REO 018) of
REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive
study to a planned Phase III registration study in this indication
o 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
o More than 370 patents issued worldwide
Manufacturing at Commercial Scale
o 100L cGMP completed, commercial manufacturing agreement in place

3
REOLYSIN® Overview
REOLYSIN® is a proprietary isolate of the reovirus

o

o

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:

o
o

o
o
o

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:
o
o

o
1
2

EGFR overexpression or mutation1; or
Ras mutation, which includes Kras mutation2

Both of these mutations lead to activation of the Ras pathway

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

4
REOLYSIN® Mechanism of Action
Normal Cells

REOLYSIN®
administered to
patients via IV

REOLYSIN®
infects both tumor
cells and normal,
healthy cells

REOLYSIN®
Healthy cell
is a virus whose
remains
replication is
undamaged
stopped in a nonRas-activated cell

Ras-Activated Cells

REOLYSIN®
infects both tumor
cells and normal,
healthy cells

REOLYSIN®
replicates in Rasactivated tumor
cells
5

Replicated viruses
Tumor cells
rupture to release repeat cell lysis cycle
in nearby tumor cells
progeny virus
REO 013: REOLYSIN® Induced Tumour Response
o

o

o

o

Image shows positive (red
staining) for reovirus in the
metastatic lesions (blue 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
6
Market for Ras Pathway Mediated Cancers
o

o

o

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

7
REOLYSIN® Clinical Program Overview
REOLYSIN® has been utilized in studies in over 1,000 patients
In total, nearly thirty ongoing or completed clinical trials including:
o 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
o Nine single arm studies in the following indications:
o Phase II trials:
o

o

Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma,
metastatic melanoma and squamous cell carcinoma

Phase I trials:
o
o

Company sponsored: colorectal cancer and advanced malignancies
Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors

8
REOLYSIN®: Randomized Pipeline
Indication

Combination
Therapy

n

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

Preclinical

9

Phase I

Phase II

Phase III

Sponsor
Phase III (Pivotal) Program for REOLYSIN®
in Squamous Cell Head & Neck Cancers
o

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
o

o

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

Patients in the REO 018 study were stratified for:
o

ECOG performance status (0-1 versus 2)

o

Time of progression/relapse after prior platinum-based chemotherapy

o

o

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

REO 018 Endpoints:
o
o

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

o

o

Primary Endpoint: Overall Survival (OS)
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
10
REO 018: Tumor Specific Response Data
o
o

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
o

o

o

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
o

This is a statistically significant difference, with a p-value of 0.025

11
REO 018: Percentage Change in Metastatic Lesions at
First Post-Treatment Scan (Control vs. Test)
100.00%

Percent Change (Target Lesions)

80.00%
60.00%
40.00%
20.00%
Control

0.00%
0

0.1

0.2

0.3

0.4

0.5

0.6

-20.00%
-40.00%
-60.00%
-80.00%
-100.00%

p=0.03
12

0.7

0.8

0.9

1

Test
REO 018: Top-Line Efficacy Data
o
o

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
o

o

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)
o

o

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 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)

13
REO 018: Top-Line Safety Data
o
o
o

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
o

o

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)
o

On this basis, Oncolytics intends to explore the potential
chemoprotective and neuroprotective properties of REOLYSIN® in
future clinical studies

14
REO 016: Non-Small Cell Lung Cancer
o

o

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
o

o

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

15
REO 016: Biomarker Correlations with
REOLYSIN® Efficacy
o

o
o
o
o

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

16
REO 016: Partial Response in Lung
(EGFR Over-Expression)

Post-Cycle 2

Pre-Treatment
17
REO 021: Squamous Cell Carcinoma of
the Lungs
o

o

o

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%
18
REO 021: Best Overall Percentage
Response in Target Lesions (Final Data)
40

Percent Change (Target Lesions)

20

0

-20

-40

-60

-80

-100

Patients by Increasing Overall Percentage Tumour Shrinkage
19
REO 021: Partial Response in Lung

Right Upper Lung Mass (8.3 cm)

Right Upper Lung Mass (4.1 cm)

Right Upper Lung Mass (3.6 cm)

Right Pleural Met (2.2 cm)

Right Pleural Met (0.8 cm)

Right Pleural Met (0.4 cm)

Pre-Treatment

Post-Cycle 2

20

Post-Cycle 4
Randomized Canadian Studies of REOLYSIN®
o

Patients are currently being enrolled in four randomized Phase II
studies in Canada:
o

o

o

o

o

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)
21
Randomized U.S. Studies of REOLYSIN®
o

Patients are currently being enrolled in two
randomized Phase II studies in the United States:
o

o

o

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)
22
REOLYSIN® and Safety
o

o
o

o

o

More than 1,000 patients treated, more than 900 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

23
Intellectual Property
o
o

More than 370 patents issued worldwide, including 51 US
and 16 Canadian
Reovirus issue patent claims cover:
o
o
o
o
o

o

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

24
Manufacturing

o
o

Now produced at 100L under cGMP with final formulation
Commercial manufacturing agreement with SAFC in place
25
Market & Capital Data
Exchanges

NASDAQ:ONCY

(all amounts in CAD)

Shares Outstanding (September 30,
2013)
Warrants Expiring

Price

Feb 8, 2014

$4.20

$4.40
(average)

Options

Fully Diluted (September 30, 2013)
Cash/Cash Equivalents
(September 30, 2013)

26

TSX:ONC

84,758,818
303,945

6,076,844

91,139,607
$29.5M
Oncolytics Summary
o

o
o

Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include seven randomized studies:
o Enrollment complete randomized international study (REO 018) of
REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive
study to a planned Phase III registration study in this indication
o 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
o More than 370 patents issued worldwide
Manufacturing at Commercial Scale
o 100L cGMP completed, commercial manufacturing agreement in place

27
Corporate Presentation
February 2014

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February Corporate Presentation 2014

  • 2. 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. 2
  • 3. Oncolytics Overview o o o Expanding Clinical Program o Lead product is REOLYSIN®, a broadly active novel cancer therapy o Ongoing clinical trials include seven randomized studies: o Enrollment complete randomized international study (REO 018) of REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication o 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 o More than 370 patents issued worldwide Manufacturing at Commercial Scale o 100L cGMP completed, commercial manufacturing agreement in place 3
  • 4. REOLYSIN® Overview REOLYSIN® is a proprietary isolate of the reovirus o o 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: o o o o o 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: o o o 1 2 EGFR overexpression or mutation1; or Ras mutation, which includes Kras mutation2 Both of these mutations lead to activation of the Ras pathway Evidence that the epidemal growth factor receptor on host cells confers reovirus infection efficiency. Strong et al. Virology 1993; 197(1): 405 The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12): 3351 4
  • 5. REOLYSIN® Mechanism of Action Normal Cells REOLYSIN® administered to patients via IV REOLYSIN® infects both tumor cells and normal, healthy cells REOLYSIN® Healthy cell is a virus whose remains replication is undamaged stopped in a nonRas-activated cell Ras-Activated Cells REOLYSIN® infects both tumor cells and normal, healthy cells REOLYSIN® replicates in Rasactivated tumor cells 5 Replicated viruses Tumor cells rupture to release repeat cell lysis cycle in nearby tumor cells progeny virus
  • 6. REO 013: REOLYSIN® Induced Tumour Response o o o o Image shows positive (red staining) for reovirus in the metastatic lesions (blue 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 6
  • 7. Market for Ras Pathway Mediated Cancers o o o 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 7
  • 8. REOLYSIN® Clinical Program Overview REOLYSIN® has been utilized in studies in over 1,000 patients In total, nearly thirty ongoing or completed clinical trials including: o 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 o Nine single arm studies in the following indications: o Phase II trials: o o Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma, metastatic melanoma and squamous cell carcinoma Phase I trials: o o Company sponsored: colorectal cancer and advanced malignancies Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors 8
  • 9. REOLYSIN®: Randomized Pipeline Indication Combination Therapy n 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 Preclinical 9 Phase I Phase II Phase III Sponsor
  • 10. Phase III (Pivotal) Program for REOLYSIN® in Squamous Cell Head & Neck Cancers o 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 o o The study was approved and run in fourteen countries in North America and Europe Patients in the REO 018 study were stratified for: o ECOG performance status (0-1 versus 2) o Time of progression/relapse after prior platinum-based chemotherapy o o Disease location (patients with locally recurrent disease, with or without distal metastases, versus patients with metastatic disease only) REO 018 Endpoints: o o Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response o o Primary Endpoint: Overall Survival (OS) 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 10
  • 11. REO 018: Tumor Specific Response Data o o 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 o o o 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 o This is a statistically significant difference, with a p-value of 0.025 11
  • 12. REO 018: Percentage Change in Metastatic Lesions at First Post-Treatment Scan (Control vs. Test) 100.00% Percent Change (Target Lesions) 80.00% 60.00% 40.00% 20.00% Control 0.00% 0 0.1 0.2 0.3 0.4 0.5 0.6 -20.00% -40.00% -60.00% -80.00% -100.00% p=0.03 12 0.7 0.8 0.9 1 Test
  • 13. REO 018: Top-Line Efficacy Data o o 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 o o 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) o o 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 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) 13
  • 14. REO 018: Top-Line Safety Data o o o 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 o o 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) o On this basis, Oncolytics intends to explore the potential chemoprotective and neuroprotective properties of REOLYSIN® in future clinical studies 14
  • 15. REO 016: Non-Small Cell Lung Cancer o o 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 o o 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 15
  • 16. REO 016: Biomarker Correlations with REOLYSIN® Efficacy o o o o o 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 16
  • 17. REO 016: Partial Response in Lung (EGFR Over-Expression) Post-Cycle 2 Pre-Treatment 17
  • 18. REO 021: Squamous Cell Carcinoma of the Lungs o o o 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% 18
  • 19. REO 021: Best Overall Percentage Response in Target Lesions (Final Data) 40 Percent Change (Target Lesions) 20 0 -20 -40 -60 -80 -100 Patients by Increasing Overall Percentage Tumour Shrinkage 19
  • 20. REO 021: Partial Response in Lung Right Upper Lung Mass (8.3 cm) Right Upper Lung Mass (4.1 cm) Right Upper Lung Mass (3.6 cm) Right Pleural Met (2.2 cm) Right Pleural Met (0.8 cm) Right Pleural Met (0.4 cm) Pre-Treatment Post-Cycle 2 20 Post-Cycle 4
  • 21. Randomized Canadian Studies of REOLYSIN® o Patients are currently being enrolled in four randomized Phase II studies in Canada: o o o o o 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) 21
  • 22. Randomized U.S. Studies of REOLYSIN® o Patients are currently being enrolled in two randomized Phase II studies in the United States: o o o 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) 22
  • 23. REOLYSIN® and Safety o o o o o More than 1,000 patients treated, more than 900 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 23
  • 24. Intellectual Property o o More than 370 patents issued worldwide, including 51 US and 16 Canadian Reovirus issue patent claims cover: o o o o o o 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 24
  • 25. Manufacturing o o Now produced at 100L under cGMP with final formulation Commercial manufacturing agreement with SAFC in place 25
  • 26. Market & Capital Data Exchanges NASDAQ:ONCY (all amounts in CAD) Shares Outstanding (September 30, 2013) Warrants Expiring Price Feb 8, 2014 $4.20 $4.40 (average) Options Fully Diluted (September 30, 2013) Cash/Cash Equivalents (September 30, 2013) 26 TSX:ONC 84,758,818 303,945 6,076,844 91,139,607 $29.5M
  • 27. Oncolytics Summary o o o Expanding Clinical Program o Lead product is REOLYSIN®, a broadly active novel cancer therapy o Ongoing clinical trials include seven randomized studies: o Enrollment complete randomized international study (REO 018) of REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive study to a planned Phase III registration study in this indication o 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 o More than 370 patents issued worldwide Manufacturing at Commercial Scale o 100L cGMP completed, commercial manufacturing agreement in place 27