reolysin

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TSX:ONC NASDAQ:ONCY Investor Presentation February 2009 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 ® . 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 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 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 1: Reolysin

TSX:ONC NASDAQ:ONCY

Investor PresentationFebruary 2009

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®. These statements are based on management’s current expectations and beliefs and are subject to a number of factors which involve known and e pectat o s a d be e s a d a e subject to a u be o acto s c o e o a dunknown 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 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 intellectualinclude 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.

Page 2: Reolysin

Oncolytics Biotech Inc.

• corporate focus is on the development of oncolytic viruses for the treatment of cancer

• lead product is REOLYSIN®

Mode of Action

• REOLYSIN contains the reovirus, a naturally occurring, replication competent virus

• asymptomatic in humans (does not cause disease)

• replicates in Ras-activated cancers

• at least 2/3 of carcinomas and more than 90% of metastatic disease has Ras involvement

• at least 5M new patients per year are predicted to develop cancers with Ras involvement

Page 3: Reolysin

Reovirus Growth in a Ras Activated Cell

Intellectual Property

• More than 200 patents issued worldwide including 31 U.S. and 9 CDN

• reovirus issued patent claims coverp- 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- methods for manufacturing reovirus and screening for susceptibility to reovirus

- pharmaceutical use of reoviruses in transplantation procedures

• more than 180 pending applications worldwide

Page 4: Reolysin

Manufacturing

• successful development of a proprietary cell growth medium

• cGMP material now produced at p40L with Sigma Aldrich

• 100L scale-up work completed

SAFC Pharma Carlsbad

• leading CMO for viral intermediates and final drug product

• commercial capabilities planned for 2009

Clinical Trial Program- Strategic Direction

• perform parallel studies in a number of indications either as a monotherapy or in combinationy

• determine the most promising indications of efficacy and safety [signal]

• use data from these trials to make strategic decisions regarding pivotal studies

• first pivotal trial will be a Phase II/III randomized trial using REOLYSIN + paclitaxel/carboplatin for patients with refractory head and neck cancers

Page 5: Reolysin

REOLYSIN Clinical Trial Program 2009

Clinical Sites - Oncolytics + NCI

T B k C

Mayo Clinic Rochester, USA Karmanos Cancer

Institute, Wayne State University, USA

Minnesota Oncology Hematology, USA

Albert Einstein College of Medicine/Montefiore

Medical Center,USA

St. James’s Hospital,UK

The Ohio State University,

USA

The University of Michigan Comprehensive

Cancer Center, USA Beatson Oncology Centre,UK

Tom Baker Cancer Center, Canada

University of Wisconsin, USA

University of California San Francisco, USA

Mayo Clinic Scottsdale, USA

The Royal Marsden Hospital Sutton, UK

Prince of Wales Hospital, Hong Kong

The Royal Marsden Hospital London, UK

Guy’s Hospital, UK

Cedars-Sinai Medical Center, USA

Southampton Hospital, UK

University of Alabama at Birmingham,

USAWashington University, USA

Mayo Clinic Jacksonville, USA

Howard University, USA

The Center for Cancer Care and Research, USA

The Royal Surrey Hospital and Mt. Alvernia, UKSidney Kimmel

Comprehensive Cancer Center at Johns Hopkins,

USA

Oncolytics sitesNCI sites

Christie Hospital, UK

Institute of Drug Development/Cancer

Therapy Research Center, USA

The Churchill Hospital, UK

Page 6: Reolysin

Safety

• >250 patients now treated, >160 intravenously at doses up to 3x1010 TCID50 daily

• no maximum tolerated dose (MTD) reached to date• no maximum tolerated dose (MTD) reached to date

• toxicities have been generally mild (grade 1 or 2) and included chills, fever, headache, cough, runny nose, sore throat and 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 usuallyfrequently observed from day 2 of treatment and usually lasted less than 6 hours

Systemic (IV) Administration

• largest potential patient population

• well tolerated in 51 patients in two completed Phase I studies

• demonstrable tumour regressions in a number of different cancer indications

Page 7: Reolysin

Clinical Overview - Systemic Monotherapy

Trial Patient Population Tumour Response

Phase I systemic administration (UK)

Late-stage or advanced cancer

ti t h h

30% showed stable disease or better

- Colorectal cancer 2 patients : Stable disease at 3 and 6patients who have failed all other therapies. (N=33)

- Colorectal cancer 2 patients : Stable disease at 3 and 6 months; CEA tumor marker reduction of 27% and 68%

- Metastatic prostate cancer one patient: Stable disease at 4 months 50% decrease in PSA. Biopsy lymph node – EM: Viral replication. Pathology - Necrosis

- Metastatic bladder cancer one patient: Stable disease at 4 months. Minor tumor response (24% tumor reduction) in metastatic lesion (lymph node); patient later reported as disease free.

- Pancreatic cancer one patient: Stable disease at 4 months.

- NSC Lung Cancer one patient: Stable disease at 4 months.

- Endometrial cancer one patient: Stable disease at 5 months.

Clinical Overview - Systemic Monotherapy

Trial Patient Population Tumour Response

Phase I systemic administration (US)

Late-stage or advanced cancer

44% showed stable disease or better

O ti l i i b t (Kpatients who have failed all other therapies. (N=18)

-One partial response in progressive breast cancer (Krasmutated patient)

Page 8: Reolysin

Monotherapy Systemic Administration

Treatment Indication StatusPhase II IV REOLYSIN (ONC) Sarcoma Ongoing

Phase II IV REOLYSIN (NCI) Metastatic melanoma OngoingPhase I/II IV and IP REOLYSIN (NCI)

Ovarian, peritoneal and fallopian tube cancer

Ongoing

Translational IV REOLYSIN (University of Leeds)

Metastatic colorectal Ongoing

Interim Results Phase II Sarcoma Study

• Exceeded primary statistical endpoint of study in December 2008Baseline Cycle 10

• promising interim results; of the 33 pts evaluable for response:

- 5 pts with SD for more than 6 mos including 1 pt with SD for more than 17 mos

- 10 pts with SD for 3-6 cycles

• mild toxicity with constitutional “flu-like” symptoms the most commonly reported toxicity

• 43 patients treated to date

Page 9: Reolysin

Systemic Administration Combination REOLYSIN Chemotherapy Program

Treatment combination Indication StatusPhase I/II REOLYSIN + gemcitabine (UK) advanced

cancersongoing

Phase I/II REOLYSIN + docetaxel (UK) advancedcancers

complete

Phase I REOLYSIN + cyclophosphamide (UK) advancedcancers

ongoing

Phase I/II REOLYSIN + carboplatin/paclitaxel (UK) advanced cancers

ongoing

Phase II REOLYSIN + carboplatin/paclitaxel (UK) H&N ongoingPhase II REOLYSIN + carboplatin/paclitaxel (US) H&N ongoingPhase II REOLYSIN + carboplatin/paclitaxel (US) NSCLC

prescreened for Kras/EGFR

approved

Phase II/III REOLYSIN + carboplatin/paclitaxel H&N pending

REOLYSIN/Gemcitabine Combination – Metastatic Nasopharangeal

Baseline Post 8 cycles

Page 10: Reolysin

REOLYSIN/Docetaxel Combination

• 16 patients evaluable for response

- 2 significant partial responses

10 t bl di i l di 8 t bl di f th 4 l- 10 stable disease, including 8 stable disease for more than 4 cycles

• of note, a breast cancer patient with a CR in the liver, and prolonged stabilization for 7 cycles in a pancreatic cancer patient

• enrolment completed Dec. 08

REOLYSIN/Docetaxel Combination- Metastatic Breast Cancer

Liver mets at baseline CR after 6 cyclesprior treatment• radiation - 4 cycles• paclitaxel - 24 cycles• capecitabine - 8 cycles• zoladex

results• target lesion- liver metastases• baseline - 28 mm, post cycle 6 - 0 mm, CR

maintained for all 8 cycles• non target bone metastases- no change,

stable after all 8 cycles

Page 11: Reolysin

U.K./U.S. Combination REOLYSIN/Paclitaxel/Carboplatin Trial Results

• 22 patients treated to date, 19 evaluable

• 1 endometrial patient SD after all 8 cycles

• 1 melanoma patient has shown response after 3 cycles

• 12 head and neck cancer patients (11 platinum-failed)- 5 durable partial responses; (4 platinum-failed)

- 4 stable disease

• combination resulted in disease control in the majority of the patientsp

• expected response rate in platinum-failed H&N - 10%

• ONCY response rate in platinum-failed H&N - 36%, clinical benefit rate – 73%

Phase II REOLYSIN/Paclitaxel/Carboplatin Combination Metastatic Nasopharyngeal

Pre-treatment Post cycle 3prior treatment • radiation - 2 cycles• cisplatin, gemcitabine/carboplatin,

carboplatin/5-FU - 6 cycles• docetaxel - 3 cycles

results• target lesion- liver metastases

baseline - 59.4 mm• post cycle 3 -19 mm• Response maintained through 8 cycles

Page 12: Reolysin

REOLYSIN + Paclitaxel/Carboplatin Combination–Nasopharynx – Continuing Response After 8 Cycles

Pre-treatment Post Cycle 3

Pre-treatment Post Cycle 3Treatment history: Radiotherapy; 6 cycles of cisplatin; 3 cycles of 5-FU/cisplatin and; Zalutulumab

Pivotal (Phase II/III) Program for REOLYSIN

• first pivotal program announced November 2008

• randomized Phase II/III trial using REOLYSIN in combination with paclitaxel/carboplatin in patients with refractory head and neckpaclitaxel/carboplatin in patients with refractory head and neck cancers

• expected filing date – early 2009

Page 13: Reolysin

Reolysin: A Treatment For Tumours With RAS Pathway Activation

Tumours with RAS pathway Tumours with RAS pathway

Tumours with kRAS MutationTumours with

kRAS Mutation

Tumours with EGFR

Overexpression

Tumours with EGFR

Overexpression

p yActivation

p yActivation

Erbitux - $1.7BnTarceva - $457mm

EGFR Inhibitor 2008 Sales

Vectibix - $153mm

Phase II NSCLC and Kras/EGFR

U.S. Phase II

• for NSCLC prescreened for Kras and EGFR mutation status

• 15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR• 15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR mutated or over expressed

• first line therapy study ie. patients will be offered REOLYSIN/paclitaxel/carboplatin instead of standard of care if they are Kras or EGFR mutated or EGFR over expressed, all of which cause Ras pathway activation

• current standard of care includes EGFR inhibitors which have b h t b i ff ti i K t t d ti tbeen shown to be ineffective in Kras mutated patients

• A similar opportunity exists in second line colorectal cancer where 45% of patients have Kras mutations

Page 14: Reolysin

Market & Capital Data

Exchanges NASDAQ:ONCYTSX:ONC

Shares Outstanding 43,830,748

Warrants PriceExpiring:

Dec. 29, 2009 1.80 320,000Dec. 29, 2011 1.80 2,915,000Feb. 22, 2010 3.50 2,300,000Options 4.61 (average) 3,885,993

Fully Diluted (Dec 31 2008) 53 251 741Fully Diluted (Dec. 31, 2008) 53,251,741

Est. Cash/Cash Equivalents C$12.7 M (Sept. 30, 2008)

Monthly Burn Rate 2009 (Approx.) C$1.0 M

Summary

REOLYSIN - A Broadly Active Novel Cancer Therapy

Focused Clinical Program

• 10 clinical trials enrolling or approved (inc 5 Phase II trials)10 clinical trials enrolling or approved (inc. 5 Phase II trials)

• positive interim and final data emerging including durable clinical responses in lung, liver, and nodal metastatic disease

• first pivotal program - Phase II/III REOLYSIN and paclitaxel/carboplatin in refractory head and neck patients

Growing Intellectual Property Portfolio

b d t t i US E d C d• broad patent coverage in US, Europe and Canada

Manufacturing at Commercial Scale• 40L GMP production completed, 100L GMP underway

Page 15: Reolysin

TSX:ONC NASDAQ:ONCY

Investor PresentationFebruary 2009