EX-99.1 2 ex991pressreleaseq22013.htm Q2 2013 PRESS RELEASE EX99.1 Press Release Q2 2013


 
 
210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7

FOR IMMEDIATE RELEASE
 
Oncolytics Biotech® Inc. Announces Second Quarter 2013 Results
 
CALGARY, AB, August 1, 2013 --- 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, 2013.
    
“We are pleased to continue to demonstrate positive clinical results with the recent announcement of a disease control rate of 71.5% in our metastatic melanoma study,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are ready to commence the data analysis of stage 1 of our head and neck trial as soon as we can and we continue to enroll patients in our six other randomized trials.”

Selected Highlights
 
Clinical Trial Results
•
Reached the stage 1 endpoint in stage 1 of the U.S. Phase 2 clinical trial in patients with metastatic melanoma (REO 020) after only 14 patients were enrolled. The primary objective of this Phase 2 trial was to assess the antitumour effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives were to assess progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus partial response (PR) plus stable disease (SD)) and duration, and to assess the safety and tolerability of the treatment regimen in the study population. Three of the 14 patients exhibited a PR, and an additional seven patients had SD for a disease control rate of 71.5%.
    
Clinical Trial Program

•
Preparing to commence the data analysis of stage 1 of the randomized head and neck clinical study (REO 018) once sufficient patient events have occurred; and

Financial

•
Exited the second quarter with over $36.1 million of cash, cash equivalents and short-term investments.




ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
    
 
June 30,
December 31,
 
2013
$
2012
$
Assets
 
 
Current assets
 
 
Cash and cash equivalents
36,153,277

 
19,323,541

 
Short-term investments
2,001,644

 
1,969,228

 
Accounts receivable
46,740

 
44,979

 
Prepaid expenses
558,918

 
331,094

 
Total current assets
38,760,579

 
21,668,842

 
Non-current assets
 
 
Property and equipment
506,404

 
409,248

 
Total non-current assets
506,404

 
409,248

 
 
 
 
Total assets
39,266,983

 
22,078,090

 
Liabilities And Shareholders' Equity
 
 
Current Liabilities
 
 
Accounts payable and accrued liabilities
5,424,442

 
7,291,310

 
Total current liabilities
5,424,442

 
7,291,310

 
Shareholders' equity
 
 
Share capital
  Authorized: unlimited
  Issued:
 
 
June 30, 2013 - 84,758,818
 
 
December 31, 2012 - 76,710,285
228,513,564

 
198,155,091

 
Warrants
376,892

 
376,892

 
Contributed surplus
24,342,431

 
24,126,265

 
Accumulated other comprehensive loss
50,524

 
(57,115
)
 
Accumulated deficit
(219,440,870
)
 
(207,814,353
)
 
Total shareholders' equity
33,842,541

 
14,786,780

 
Total liabilities and equity
39,266,983

 
22,078,090

 





ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


 
Three Month Period Ending June 30, 2013
$
Three Month Period Ending June 30, 2012
$
Six Month Period Ending June 30, 2013
$
Six Month Period Ending June 30, 2012
$
Expenses
 
 
 
 
 
Research and development
3,804,307

 
9,053,329

 
8,921,351

 
16,543,873

 
Operating
1,320,742

 
1,222,090

 
2,885,493

 
2,310,141

 
Operating loss
(5,125,049
)
 
(10,275,419
)
 
(11,806,844
)
 
(18,854,014
)
 
Interest
105,368

 
93,389

 
180,327

 
213,456

 
Loss before income taxes
(5,019,681
)
 
(10,182,030
)
 
(11,626,517
)
 
(18,640,558
)
 
Income tax expense
—

 
3,228

 
—
 
3,228

 
Net loss
(5,019,681
)
 
(10,178,802
)
 
(11,626,517
)
 
(18,637,330
)
 
Other comprehensive income items that may be
  reclassified to net loss
 
 
 
 
Translation adjustment
73,451

 
116,200

 
107,639

 
81,941

 
Net comprehensive loss
(4,946,230
)
 
(10,062,602
)
 
(11,518,878
)
 
(18,555,389
)
 
Basic and diluted loss per common share
(0.06
)
 
(0.13
)
 
(0.14
)
 
(0.25
)
 
Weighted average number of shares (basic and diluted)
84,758,818

 
76,542,861

 
82,276,330

 
75,547,842

 





ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)

 
Share Capital
Contributed Surplus
Warrants
Accumulated Other Comprehensive Loss
Accumulated Deficit
Total
 
$
$
$
$
$
$
As at December 31, 2011
177,282,566

 
21,142,519

 
2,653,627

 
(117,501
)
 
(171,440,832
)
 
29,520,379

 
 
 
 
 
 
 
 
Net loss and comprehensive loss
—

 
—

 
—

 
81,941

 
(18,637,330
)
 
(18,555,389
)
 
Issued, pursuant to a bought deal financing
19,386,903

 
—

 
376,892

 
—

 
—

 
19,763,795

 
Exercise of stock options
1,278,389

 
(392,920
)
 
—

 
—

 
—

 
885,469

 
 
 
 
 
 
 
 
Share based compensation
—

 
72,196

 
—
 
—

 
—

 
72,196

 
As at June 30, 2012
197,947,858

 
20,821,795

 
3,030,519

 
(35,560
)
 
(190,078,162
)
 
31,686,450

 
 
 
 
 
 
 
 
 
Share Capital
Contributed Surplus
Warrants
Accumulated Other Comprehensive 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 comprehensive loss
—

 
—

 
—

 
107,639

 
(11,626,517
)
 
(11,518,878
)
 
Issued, pursuant to a public offering
30,218,797

 
—

 
—

 
—

 
—

 
30,218,797

 
Exercise of stock options
139,676

 
(34,687
)
 
—

 
—

 
—

 
104,989

 
 
 
 
 
 
 
 
Share based compensation
—

 
250,853

 
—
 
—

 
—

 
250,853

 
As at June 30, 2013
228,513,564

 
24,342,431

 
376,892

 
50,524

 
(219,440,870
)
 
33,842,541

 






ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)


 
Three Month Period Ending June 30, 2013
$
Three Month Period Ending June 30, 2012
$
Six Month Period Ending June 30, 2013
$
Six Month Period Ending June 30, 2012
$
 
 
 
 
 
Operating Activities
 
 
 
 
Net loss for the period
(5,019,681
)
 
(10,178,802
)
 
(11,626,517
)
 
(18,637,330
)
 
Amortization - property and equipment
25,565

 
29,510

 
50,146

 
57,571

 
Share based compensation
129,997

 
58,343

 
250,853

 
72,196

 
Unrealized foreign exchange loss
209,804

 
61,171

 
(97,849
)
 
16,162

 
Net change in non-cash working capital
(455,283
)
 
(1,174,059
)
 
(2,096,453
)
 
(1,213,512
)
 
Cash used in operating activities
(5,109,598
)
 
(11,203,837
)
 
(13,519,820
)
 
(19,704,913
)
 
Investing Activities
 
 
 
 
Acquisition of property and equipment
(132,164
)
 
(61,695
)
 
(147,302
)
 
(93,627
)
 
Purchase of short-term investments
—

 
—

 
(32,416
)
 
(32,441
)
 
Cash used in investing activities
(132,164
)
 
(61,695
)
 
(179,718
)
 
(126,068
)
 
Financing Activities
 
 
 
 
Proceeds from exercise of stock options and
  warrants
—

 
422,886

 
104,989

 
885,469

 
Proceeds from public offering
11,735

 
(31,648
)
 
30,218,797

 
19,763,795

 
Cash provided by financing activities
11,735

 
391,238

 
30,323,786

 
20,649,264

 
Increase in cash
(5,230,027
)
 
(10,874,294
)
 
16,624,248

 
818,283

 
Cash and cash equivalents, beginning of period
41,519,657

 
44,622,078

 
19,323,541

 
32,918,751

 
Impact of foreign exchange on cash and cash
  equivalents
(136,353
)
 
55,029

 
205,488

 
65,779

 
Cash and cash equivalents, end of period
36,153,277

 
33,802,813

 
36,153,277

 
33,802,813

 

To view the Company's Fiscal 2013 Second Quarter 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/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 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 2013 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.
 
FOR FURTHER INFORMATION PLEASE CONTACT:
The Equicom Group
Nick Hurst
300 - 5th Ave. SW, 10th Floor
Calgary, Alberta T2P 3C4
Tel: 403.218.2835
Fax: 403.218.2830
nhurst@tmxequicom.com
Dian Griesel, Inc.
Susan Forman
396 West Broadway, 2nd Floor
New York, NY 10012
Tel: 212.825.3210
Fax: 212.825.3229
sforman@dgicomm.com
 
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