Oncolytics Biotech® Inc. Announces Second Quarter 2012 Results

CALGARY, Aug. 2, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its
financial results and operational highlights for the  quarter ended
June 30, 2012.

“Early in the quarter, we announced that we had completed enrollment in
the first, 80-patient stage of our Phase III trial in head and neck
cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We
continued to make progress on this key clinical initiative during the
quarter with our independent Data Monitoring Committee recommending the
trial proceed based on a review of the safety data. We continue to
await the results of an ongoing data review which will enable us to
determine the next steps for the study.”

Selected Highlights

Since March 31, 2012, the Company has made a number of significant
announcements:

Clinical Trial Program

  • Completion of enrollment in the first, 80-patient stage of its Phase III
    clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with
    platinum-refractory head and neck cancers (REO 018);

  • Review by Company’s independent Data Monitoring Committee (DMC) of the
    safety data for the first stage of the Company’s Phase III trial in
    head and neck cancers and received a recommendation that enrollment
    continue in the study while awaiting the ongoing data review;

  • Entry into an agreement whereby the NCIC Clinical Trials Group (CTG) at
    Queen’s University in Kingston, Ontario, will sponsor and conduct a
    randomized Phase II study of REOLYSIN in patients with advanced or
    metastatic colorectal cancer enrolling up to 100 patients;

  • Entry into an agreement whereby the NCIC CTG will sponsor and conduct a
    randomized Phase II study of REOLYSIN in patients with advanced or
    metastatic non-small cell lung cancer enrolling up to 150 patients;

  • Entry into an agreement whereby the NCIC CTG will sponsor and conduct a
    randomized Phase II study of REOLYSIN in patients with advanced or
    metastatic breast cancer enrolling up to 100 patients; and

Clinical Trial Results

  • Publication of a paper entitled “Cell Carriage, Delivery, and Selective
    Replication of an Oncolytic Virus in Tumor in Patients,” in the June
    13, 2012 issue of the journal Science Translational Medicine (Vol. 4 Issue
    138 138ra77), covering findings from a U.K. translational clinical
    trial (REO 013) investigating intravenous administration of REOLYSIN in
    patients with metastatic colorectal cancer prior to surgical resection
    of liver metastases. The researchers found that
    intravenously-administered reovirus could specifically target and
    infect metastatic liver tumors in 90% of the patients, even though all
    patients treated had had a pre-existing immunity to the virus.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
 
      June 30,     December 31,
      2012
$
    2011
$
Assets            
Current assets            
Cash and cash equivalents     33,802,813     32,918,751
Short-term investments     1,969,228     1,936,787
Accounts receivable     89,574     55,392
Prepaid expenses     699,348     721,576
Total current assets     36,560,963     35,632,506
             
Non-current assets            
Property and equipment     428,167     392,111
Total non-current assets     428,167     392,111
             
Total assets     36,989,130     36,024,617
             
Liabilities And Shareholders’ Equity            
Current Liabilities            
Accounts payable and accrued liabilities     5,302,680     6,504,238
Total current liabilities     5,302,680     6,504,238
             
Shareholders’ equity            
Share capital            
  Authorized: unlimited            
  Issued:            
June 30, 2012 – 76,606,085            
December 31, 2011 – 71,251,335     197,947,858     177,282,566
Warrants     3,030,519     2,653,627
Contributed surplus     20,821,795     21,142,519
Accumulated other comprehensive loss     (35,560)     (117,501)
Accumulated deficit     (190,078,162)     (171,440,832)
Total shareholders’ equity     31,686,450     29,520,379
Total liabilities and equity     36,989,130     36,024,617

 
 
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
                         
      Three Month
Period
Ending June 30,
2012
$
    Three Month
Period
Ending June 30,
2011
$
    Six Month
Period
Ending June 30,
2012
$
    Six Month
Period
Ending June 30,
2011
$
                         
Expenses                        
Research and development     9,053,329     5,483,131     16,543,873     8,454,742
Operating     1,222,090     1,068,623     2,310,141     2,195,634
Operating loss     (10,275,419)     (6,551,754)     (18,854,014)     (10,650,376)
Write down of asset available for sale         (735,681)         (735,681)
Change in fair value of warrant liability                 36,000
Interest     93,389     123,197     213,456     214,703
Loss before income taxes     (10,182,030)     (7,164,238)     (18,640,558)     (11,135,354)
Income tax expense     3,228         3,228    
Net loss     (10,178,802)     (7,164,238)     (18,637,330)     (11,135,354)
Other comprehensive loss (income) – translation adjustment     116,200     (75,211)     81,941     (38,331)
                         
Net comprehensive loss     (10,062,602)     (7,239,449)     (18,555,389)     (11,173,685)
Basic and diluted loss per common share     (0.13)     (0.10)     (0.25)     (0.16)
Weighted average number of shares (basic and diluted)     76,542,861     71,209,164     75,547,842     70,586,073

 
 
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
                         
      Three Month
Period
Ending June 30,
2012
$
    Three Month
Period
Ending June 30,
2011
$
    Six Month
Period
Ending June 30,
2012
$
    Six Month
Period
Ending June 30,
2011
$
                         
Operating Activities                        
Net loss for the period     (10,178,802)     (7,164,238)     (18,637,330)     (11,135,354)
Amortization – property and equipment     29,510     29,992     57,571     47,267
Share based compensation     58,343     40,469     72,196     43,342
Change in fair value of warrant liability                 (36,000)
Write down of asset available for sale         735,681         735,681
Unrealized foreign exchange loss     61,171     28,978     16,162     220,127
Net change in non-cash working capital     (1,174,059)     1,417,496     (1,213,512)     1,357,514
Cash used in operating activities     (11,203,837)     (4,911,622)     (19,704,913)     (8,767,423)
Investing Activities                        
Acquisition of property and equipment     (61,695)     (33,831)     (93,627)     (49,107)
Purchase of short-term investments         1,679,940     (32,441)     1,679,940
Cash used in investing activities     (61,695)     1,646,109     (126,068)     1,630,833
Financing Activities                        
                         
Proceeds from exercise of stock options and warrants     422,886     23,300     885,469     14,738,597
Proceeds from public offering     (31,648)         19,763,795    
Cash provided by financing activities     391,238     23,300     20,649,264     14,738,597
Increase in cash     (10,874,294)     (3,242,213)     818,283     7,602,007
Cash and cash equivalents, beginning of period     44,622,078     49,912,873     32,918,751     39,296,682
Impact of foreign exchange on cash and cash equivalents     55,029     (30,429)     65,779     (258,458)
Cash and cash equivalents, end of period     33,802,813     46,640,231     33,802,813     46,640,231

To view the Company’s Second Quarter 2012 Consolidated Financial
Statements, related Notes to 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

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 human trials
including a Phase III trial in head and neck cancers 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 2012 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.