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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.
2
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)
3
Randomized Clinical Trial Program
for REOLYSIN®: Active Studies
4
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
5
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
6
REO 016: Single-Arm Non-Small Cell Lung Cancer
(NSCLC) Study Demonstrates Biomarker Utility
7
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
8
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
10
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
11
REO 021: Squamous Cell Carcinoma (SCC), Partial
Response in Lung
12
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)
13
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
14
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)
15
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%
17
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:
18
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
20
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
21
GM-CSF + REOLYSIN®:
Effect on Overall Survival
20
0
20
40
60
80
100
0 20 40 60
Days
PercentSurvival
IL2 + REO
IL2 alone
G-CSF + REO
G-CSF alone
GM-CSF + REO
GM-CSF
REOLYSIN® + Anti-PD-1: Effect on
Overall Survival
21
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®
22
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.
25
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
26
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
27
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
30
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
3131
Corporate
Presentation
April 2015

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Corporate presentation (april 2015)

  • 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 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) 3
  • 4. Randomized Clinical Trial Program for REOLYSIN®: Active Studies 4 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
  • 5. 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 5
  • 6. 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 6
  • 7. REO 016: Single-Arm Non-Small Cell Lung Cancer (NSCLC) Study Demonstrates Biomarker Utility 7 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.
  • 8. 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 8
  • 10. 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 10
  • 11. 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 11
  • 12. REO 021: Squamous Cell Carcinoma (SCC), Partial Response in Lung 12 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)
  • 13. REO 016: Non-Small Cell Lung Cancer (NSCLC), Partial Response in Lung (EGFR Over-Expression) 13 Pre-Treatment Post-Cycle 2
  • 14. 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 14
  • 15. 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) 15
  • 17. 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% 17
  • 18. 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: 18
  • 20. 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 20
  • 21. 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 21
  • 22. GM-CSF + REOLYSIN®: Effect on Overall Survival 20 0 20 40 60 80 100 0 20 40 60 Days PercentSurvival IL2 + REO IL2 alone G-CSF + REO G-CSF alone GM-CSF + REO GM-CSF
  • 23. REOLYSIN® + Anti-PD-1: Effect on Overall Survival 21
  • 24. 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® 22
  • 25. 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. 25
  • 26. 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 26
  • 27. 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 27
  • 28. 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
  • 29. 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
  • 30. 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 30 Financial runway extends well into 2017 with ATM and Equity Line facilities.
  • 31. 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 3131