EX-99.1 2 ex991.htm NEWS RELEASE DATED NOVEMBER 6, 2014

Exhibit 99.1

 

Oncolytics Biotech® Inc. Announces Third Quarter 2014 Results

CALGARY, Nov. 6, 2014 /CNW/ - Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the third quarter ended September 30, 2014.

"During the quarter we reported on interim data that suggests that patients with a selected biomarker, in this case mutant KRAS, may derive benefit from REOLYSIN® in a randomized clinical study," said Dr. Brad Thompson, President and CEO of Oncolytics. "Biomarkers are playing an increasingly important role in predicting, following and treating cancer. We are examining their role in our other ongoing randomized clinical studies. Subsequent to quarter end, we established two financing facilities that will allow us to incrementally access capital in the quarters ahead."

Selected Highlights

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

Clinical Program

·Reported 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).  There was no difference of note in the overall patient population.  In the patient population that had mutations in the KRAS gene (n = 23 in the control arm, n = 21 in the test arm), the median progression free survival in the test arm was 5.72 months (95% CI on the Kaplan-Meier curve = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI  on the Kaplan-Meier curve = 1.938 to 6.176). This translates into a 1.61 month (39%) improvement in median progression free survival in the test arm versus the control arm;
·Reported that patient enrollment had been completed 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 early data from this study;

Financial

·At September 30, 2014 the Company reported $17.0 million in cash, cash equivalents and short-term investments; and
·Subsequent to quarter end, amendments to the previously announced share purchase agreement with Lincoln Park Capital Fund, LLC and entry into a $20 million "at-the-market" equity distribution agreement with Canaccord Genuity Inc.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
 

September 30,

2014 

$

 

December 31,

2013

$

Assets      
Current assets      
Cash and cash equivalents 15,012,968   25,220,328
Short-term investments 2,031,685   2,001,644
Accounts receivable 84,865   105,853
Prepaid expenses 405,475   361,743
Total current assets 17,534,993   27,689,568
       
Non-current assets      
Property and equipment 543,525   532,459
Total non-current assets 543,525   532,459
       
Total assets 18,078,518   28,222,027
       
Liabilities And Shareholders' Equity      
Current Liabilities      
Accounts payable and accrued liabilities 3,298,610   6,008,661
Total current liabilities 3,298,610   6,008,661
       
Shareholders' equity      
Share capital
  Authorized: unlimited
  Issued:
     
   September 30, 2014 – 89,566,597      
   December 31, 2013 – 84,803,818 235,040,463   228,612,564
Warrants   376,892
Contributed surplus 25,738,527   24,491,212
Accumulated other comprehensive income 188,140   79,698
Accumulated deficit (246,187,222)   (231,347,000)
Total shareholders' equity 14,779,908   22,213,366
Total liabilities and equity 18,078,518   28,222,027

               

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
 
 

Three Month

 Period

 Ending

 September

 30, 2014

$

Three Month

 Period

 Ending

 September

 30, 2013

$

Nine Month

 Period

 Ending

 September

 30, 2014

$

Nine Month

 Period 

Ending

 September

30, 2013

$

Expenses                
Research and development 3,571,939   5,001,972   11,305,328   13,923,323  
Operating 1,105,274   1,222,157   3,706,343   4,107,650  
Operating loss (4,677,213)   (6,224,129)   (15,011,671)   (18,030,973)  
Interest 39,937   110,479   178,177   290,806  
Loss before income taxes (4,637,276)   (6,113,650)   (14,833,494)   (17,740,167)  
Income tax expense 668     (6,728)    
Net loss (4,636,608)   (6,113,650)   (14,840,222)   (17,740,167)  

Other comprehensive income items that may be

  reclassified to net loss

               
                 
Translation adjustment 100,461   (33,513)   108,442   74,126  
                 
Net comprehensive loss (4,536,147)   (6,147,163)   (14,731,780)   (17,666,041)  
Basic and diluted loss per common share (0.05)   (0.07)   (0.17)   (0.21)  
Weighted average number of shares (basic and
 diluted)
88,592,863   84,758,818   86,786,937   83,112,919  

 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
 
 

Share Capital

$

Contributed

 Surplus

$

Warrants

$

Accumulated

 Other

 Comprehensive

 Income

(Loss)

$

Accumulated

 Deficit

$

Total

$

As at December 31, 2012 198,155,091   24,126,265   376,892   (57,115)   (207,814,353)   14,786,780  
                         
Net loss and other comprehensive income       74,126   (17,740,167)   (17,666,041)  
Issued, pursuant to a bought deal financing 30,218,797           30,218,797  
Exercise of stock options 139,676   (34,687)         104,989  
                         
Share based compensation   191,356         191,356  
As at September 30, 2013 228,513,564   24,282,934   376,892   17,011   (225,554,520)   27,635,881  
                         
  Share Capital
$

Contributed

Surplus

$

Warrants

$

Accumulated

 Other

 Comprehensive

 Income

$

Accumulated

 Deficit

$

Total

$

                         
As at December 31, 2013 228,612,564   24,491,212   376,892   79,698   (231,347,000)   22,213,366  
                         
Net loss and other comprehensive income       108,442   (14,840,222)   (14,731,780)  
Issued, pursuant to Share Purchase Agreement 6,427,899           6,427,899  
Expired warrants   376,892   (376,892)        
                         
Share based compensation   870,423         870,423  
As at September 30, 2014 235,040,463   25,738,527     188,140   (246,187,222)   14,779,908  

           

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
 
 

Three Month

 Period

 Ending

 September

 30, 2014

$

Three Month

 Period

 Ending

 September

 30, 2013
$

Nine Month

 Period

 Ending

 September

 30, 2014
$

Nine Month

Period

 Ending

 September

 30, 2013

$

                 
Operating Activities                
Net loss for the period (4,636,608)   (6,113,650)   (14,840,222)   (17,740,167)  
  Amortization - property and equipment 39,904   41,205   118,073   91,351  
  Share based compensation 199,821   (59,497)   870,423   191,356  
  Unrealized foreign exchange loss (gain) 243,290   34,179   193,301   (63,670)  
Net change in non-cash working capital (261,622)   (412,109)   (2,701,103)   (2,508,562)  
Cash used in operating activities (4,415,215)   (6,509,872)   (16,359,528)   (20,029,692)  
Investing Activities                
Acquisition of property and equipment (113,782)   (103,512)   (131,001)   (250,814)  
Purchase of short-term investments     (30,041)   (32,416)  
Cash used in investing activities (113,782)   (103,512)   (161,042)   (283,230)  
Financing Activities                
Proceeds from exercise of stock options and warrants       104,989  
Proceeds from Share Purchase Agreement 2,736,749     6,427,899    
Proceeds from public offering       30,218,797  
Cash provided by financing activities 2,736,749     6,427,899   30,323,786  
Increase in cash (1,792,248)   (6,613,384)   (10,092,671)   10,010,864  
Cash and cash equivalents, beginning of period 16,880,730   36,153,277   25,220,328   19,323,541  
Impact of foreign exchange on cash and cash equivalents (75,514)   (67,692)   (114,689)   137,796  
Cash and cash equivalents, end of period 15,012,968   29,472,201   15,012,968   29,472,201  

 

To view the Company's 2014 Third Quarter Interim Consolidated Financial Statements, related Notes to the Interim Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's quarterly 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 2014 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 06:30e 06-NOV-14