Oncolytics BIOTECH INC
technology changing life
annual report 2009
Oncolytics Biotech® Inc. is focused on the development of oncolytic viruses as a novel and effective approach to cancer treatment. Oncolytics’ clinical program includes
a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN®, its proprietary formulation of the human reovirus.
trads on the Toronto Stock Exchange
(symbol ONC) and on the NASDAQ (symbol ONCY).
Letter o Shareholers 1
Management’s Discusion an Analysis 4
Stmnt of Managemnt’ Responsibility 36
Auditors’ Report 37
Fiancial Satmens 39
Financial Sttments 42
ual and Secl Metig
d Spcial Meeting of the Shareholders will be hed at the Hilton Toronto Hotel, 145 Richmond Street West, Toronto, Ontari at 4:30 pm Easter Time
y 11, 2010.
2009 Message to Shareholders
In the last 12 months Oncolytics has made substantial clinical progress, strengthened our intellectual property position and balance sheet, and
scaled up manufacturing to near commercial levels. We have executed on our business plan focused on preparing the Company for late stage
clinical testing and ultimately commercial launch.
Transitioning to Late Stage Clinical Testing
In 2009, Oncolytics’ clinical program took a major step forward as we announced we had reached an agreement with the U.S. Food and Drug
Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN
combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA process generates an
agreement between Oncolytics and the FDA, confirming that the design and planned analyses of the Phase 3 study is adequate to provide the
necessary data that, depending upon outcome, could support a license application submission for REOLYSIN.
We intend to conduct the first stage of the trial, at up to 25 centres in mul