Oncolytics Biotech® Inc. Announces 2014 Year End Results

CALGARY, March 16, 2015 /PRNewswire/ – Oncolytics Biotech^® Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the year ended December 31, 2014.

“The activities of the Company in 2014 have laid the groundwork enabling us to plan and execute our late stage clinical strategy,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are looking forward to finalizing the plans for and initiating our registration studies for REOLYSIN^®.”

Selected Highlights

Since January 1, 2014, selected highlights announced by the Company include:

Clinical Program

• Completion of patient enrollment in an ongoing, NCIC Clinical Trials Group sponsored randomized Phase II study of REOLYSIN^® in patients with advanced or metastatic colorectal cancer (IND 210). The Company awaits preliminary data from this study;
• Reporting completion of enrollment and interim overall and KRAS-mutated patient data from an NCI-sponsored randomized Phase II study of REOLYSIN^® in combination with carboplatin and paclitaxel in patients with recurrent or metastatic pancreatic cancer (NCI-8601). The Company awaits final data from this study, which will be available once all remaining patients have progressed;
• Completion of patient enrollment in an ongoing, NCI-sponsored randomized Phase II study of REOLYSIN^® in combination with paclitaxel in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG-186H). The Company awaits preliminary data from this study;
• Reporting final data from the Company’s randomized, double-blinded clinical study examining REOLYSIN^® in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers;
• Presentation by the Company’s collaborators of preliminary clinical data demonstrating that intravenously delivered REOLYSIN^® can cross the blood brain barrier to access tumours in the brains of humans;

Regulatory

• Application for Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN^® in the treatment of ovarian and pancreatic cancers. The Company was granted designations in ovarian, fallopian tube, primary peritoneal and pancreatic cancer subsequent to year end;
• Application to the European Medicines Agency for Orphan Designation for REOLYSIN^® in the treatment of pancreatic and ovarian cancers;
• Subsequent to year end, the Company applied to the U.S. FDA for a fifth Orphan Drug Designation for high grade gliomas in paediatric patients;

Basic Research

• Presentation of a poster entitled “Combination Therapy with Reovirus and PD-1 Blockade Effectively Establishes Tumour Control Via Innate and Adaptive Immune Responses” by the Company’s research collaborators, Vile et al., at the AACR Tumor Immunology and Immunotherapy Conference;
• A series of presentations made by the Company’s research collaborators at the 8^th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK, covering:
  • Preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN^®;
  • Preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and
  • Preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C;

Governance

• The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company’s Board of Directors;

Financial

• Entry into and subsequent amendments to a share purchase agreement with Lincoln Park Capital Fund, LLC;
• Entry into a $20 million “At-the-Market” equity distribution agreement with Canaccord Genuity Inc.; and
• At December 31, 2014 the Company reported $16.2 million in cash, cash equivalents and short-term investments.  At March 13, 2015, the Company had approximately $27.5 million in cash, cash equivalents and short-term investments.

 

 

 

 

 

           

 

 

To view the Company’s Fiscal 2014 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s annual filings, which will be available on www.sedar.com and on www.oncolyticsbiotech.com/for-investors/financials.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.  Oncolytics’ clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN^®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company’s belief as to the potential of REOLYSIN^® as a cancer therapeutic; the Company’s expectations as to the success of its research and development programs in 2015 and beyond, the Company’s planned operations, the value of the additional patents and intellectual property; the Company’s expectations related to the applications of the patented technology; the Company’s expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN^® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN^®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

SOURCE Oncolytics Biotech Inc.