CALGARY, Aug. 1, 2013 /CNW/ - 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.
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ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
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June 30,
2013
$
|
December 31,
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
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|
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|
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Liabilities And Shareholders' Equity
|
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Current Liabilities
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
5,424,442
|
|
7,291,310
|
|
|
Total current liabilities
|
5,424,442
|
|
7,291,310
|
|
|
|
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Shareholders' equity
|
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|
|
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Share capital
|
|
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|
Authorized: unlimited
|
|
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|
|
|
Issued:
|
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|
|
|
|
June 30, 2013 - 84,758,818
|
|
|
|
|
|
December 31, 2012 - 76,710,285
|
228,513,564
|
|
198,155,091
|
|
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Warrants
|
376,892
|
|
376,892
|
|
|
Contributed surplus
|
24,342,431
|
|
24,126,265
|
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|
Accumulated other comprehensive loss
|
50,524
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|
(57,115)
|
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Accumulated deficit
|
(219,440,870)
|
|
(207,814,353)
|
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Total shareholders' equity
|
33,842,541
|
|
14,786,780
|
|
|
Total liabilities and equity
|
39,266,983
|
|
22,078,090
|
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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
$
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Six Month
Period Ending
June 30, 2013
$
|
|
Six Month
Period Ending
June 30, 2012
$
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|
|
|
|
|
|
|
|
|
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Expenses
|
|
|
|
|
|
|
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|
Research and development
|
3,804,307
|
|
9,053,329
|
|
8,921,351
|
|
16,543,873
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|
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)
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|
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
|
|
|
|
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|
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
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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
|
|
|
|
|
|
|
|
|
|
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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
|
|
|
|
|
|
|
|
|
|
|
|
|
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Share based compensation
|
—
|
|
72,196
|
|
|
|
—
|
|
—
|
|
72,196
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|
As at June 30, 2012
|
197,947,858
|
|
20,821,795
|
|
3,030,519
|
|
(35,560)
|
|
(190,078,162)
|
|
31,686,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share Capital
|
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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
|
|
|
|
|
|
|
|
|
|
|
|
|
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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
|
|
|
|
|
|
|
|
|
|
|
|
|
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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
|
|
|
|
|
|
|
|
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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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
$
|
|
|
|
|
|
|
|
|
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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)
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|
Cash used in operating activities
|
(5,109,598)
|
|
(11,203,837)
|
|
(13,519,820)
|
|
(19,704,913)
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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
|
|
|
|
|
|
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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.
SOURCE: Oncolytics Biotech Inc.
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
Copyright CNW Group 2013