reolysin
TRANSCRIPT
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.
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
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
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
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
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
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)
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
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
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
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
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
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
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
TSX:ONC NASDAQ:ONCY
Investor PresentationFebruary 2009