EX-99.1 2 ex991.htm NEWS RELEASE DATED MARCH 16, 2015

Exhibit 99.1

 

Oncolytics Biotech® Inc. Announces 2014 Year End Results

CALGARY, March 16, 2015 /CNW/ - 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 8th 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.

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
As at December 31,

2014

$

 

2013

$

Assets      
Current assets      
Cash and cash equivalents 14,152,825   25,220,328  
Short-term investments 2,031,685   2,001,644  
Accounts receivable 191,751   105,853  
Prepaid expenses 291,553   361,743  
Total current assets 16,667,814   27,689,568  
Non-current assets    
Property and equipment 525,376   532,459  
Total non-current assets 525,376   532,459  
     
Total assets 17,193,190   28,222,027  
Liabilities And Shareholders' Equity      
Current Liabilities      
Accounts payable and accrued liabilities 3,373,997   6,008,661  
Total current liabilities 3,373,997   6,008,661  
Shareholders' equity      
Share capital        
  Authorized: unlimited
Issued:
December 31, 2014 – 93,512,494
December 31, 2013 – 84,803,818
237,657,056   228,612,564  
Warrants   376,892  
Contributed surplus 25,848,429   24,491,212  
Accumulated other comprehensive income 280,043   79,698  
Accumulated deficit (249,966,335)   (231,347,000)  
Total shareholders' equity 13,819,193   22,213,366  
Total liabilities and equity 17,193,190   28,222,027  
           

 

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
 
For the years ending December 31,

2014

$

2013

$

2012

$

Expenses      
Research and development 13,824,252 18,506,064 31,402,625
Operating 4,998,694 5,392,660 5,285,425
Loss before the following (18,822,946) (23,898,724) (36,688,050)
Interest 210,390 371,485 345,003
Loss before income taxes (18,612,556) (23,527,239) (36,343,047)
Income tax expense (6,779) (5,408) (30,474)
Net loss (18,619,335) (23,532,647) (36,373,521)
Other comprehensive income items that may be      
  reclassified to net loss      
  Translation adjustment 200,345 136,813 60,386
Net comprehensive loss (18,418,990) (23,395,834) (36,313,135)
Basic and diluted loss per common share (0.21) (0.28) (0.48)
Weighted average number of shares (basic and diluted) 87,869,149 83,530,981 76,102,062

 

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
 
 

Share

 Capital
$

Warrants
$

Contributed

 Surplus
$

Accumulated

 Other

Comprehensive

 Income
$

Accumulated

 Deficit
$

Total
$
As at December 31, 2011 177,282,566 2,653,627 21,142,519 (117,501) (171,440,832) 29,520,379
             
Net loss and other comprehensive income 60,386 (36,373,521) (36,313,135)
Issued, pursuant to a bought deal financing 19,386,903 376,892 19,763,795
Expiry of warrants (2,653,627) 2,653,627
Exercise of stock options 1,485,622 (400,632) 1,084,990
Share based compensation 730,751 730,751
As at December 31, 2012 198,155,091 376,892 24,126,265 (57,115) (207,814,353) 14,786,780
             
Net loss and other comprehensive income 136,813 (23,532,647) (23,395,834)
Issued, pursuant to a bought deal financing 30,218,796 30,218,796
Expiry of warrants
Exercise of stock options 238,677 (59,437) 179,240
Share based compensation 424,384 424,384
As at December 31, 2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366
             
Net loss and other comprehensive income 200,345 (18,619,335) (18,418,990)
Issued, pursuant to Share Purchase Agreement 7,830,409 7,830,409
Issued, pursuant to "At the Market" Agreement 1,214,083 1,214,083
Expired warrants (376,892) 376,892
Share based compensation 980,325 980,325
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193

           

 

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the years ending December 31,

2014

$

2013

$

2012

$

       
Operating Activities      
Net loss for the year (18,619,335) (23,532,647) (36,373,521)
Amortization - property and equipment 163,501 131,623 109,275
Share based compensation 980,325 424,384 730,751
Unrealized foreign exchange loss 242,542 (89,721) 89,890
Net change in non-cash working capital (2,443,988) (1,374,172) 1,187,967
Cash used in operating activities (19,676,955) (24,440,533) (34,255,638)
Investing Activities    
Acquisition of property and equipment (152,750) (254,834) (126,412)
Redemption (purchase) of short-term investments (30,041) (32,416) (32,441)
Cash used in investing activities (182,791) (287,250) (158,853)
Financing Activities    
Proceeds from exercise of stock options and warrants 179,240 1,084,990
Proceeds from Share Purchase Agreement 7,830,409
Proceeds from "At the Market" equity distribution agreement 1,214,083
Proceeds from public offering 30,218,796 19,763,795
Cash provided by financing activities 9,044,492 30,398,036 20,848,785
(Decrease) increase in cash (10,815,254) 5,670,253 (13,565,706)
Cash and cash equivalents, beginning of year 25,220,328 19,323,541 32,918,751
Impact of foreign exchange on cash and cash equivalents (252,249) 226,534 (29,504)
Cash and cash equivalents, end of year 14,152,825 25,220,328 19,323,541

 

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.

%CIK: 0001129928

For further information: TMX Equicom, Nick Hurst, 300 5th Ave. SW, 10th Floor, Calgary, Alberta T2P 3C4, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@tmxequicom.com ;TMX Equicom, Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@tmxequicom.com; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor, New York, NY 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com

CO: Oncolytics Biotech Inc.

CNW 18:08e 16-MAR-15