CALGARY, May 8, 2014 /CNW/ - Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its
financial results and operational highlights for the first quarter
ended March 31, 2014.
"During the quarter we reported additional data from our head and neck
study which will help us with the design of our proposed registration
study for discussion with regulators," said Dr. Brad Thompson,
President and CEO of Oncolytics. "We also took steps to improve our
access to capital in order to support our clinical program, which
continues to move ahead."
Selected Highlights
Since January 1, 2014, specific highlights announced by the Company
include:
Clinical and Preclinical Data
-
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;
-
A series of presentations by research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in
Oxford, UK covering:
-
early clinical research showing that intravenously delivered REOLYSIN® can cross the blood brain barrier to access tumours in the brains of
humans;
-
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.
Financial
-
At March 31, 2014 the Company reported $22.2 million in cash, cash
equivalents and short-term investments; and
-
Entry into a share purchase agreement with Lincoln Park Capital Fund,
LLC that will provide an initial investment in Oncolytics of US$1.0
million and make available additional periodic investments of up to
US$25.0 million over a 30-month term.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
|
As at
|
March 31,
2014
|
December 31,
2013
|
|
Assets
|
|
|
|
Current assets
|
|
|
|
Cash and cash equivalents
|
20,155,907
|
25,220,328
|
|
Short-term investments
|
2,031,685
|
2,001,644
|
|
Accounts receivable
|
43,507
|
105,853
|
|
Prepaid expenses
|
295,802
|
361,743
|
|
Total current assets
|
22,526,901
|
27,689,568
|
|
|
|
|
|
Non-current assets
|
|
|
|
Property and equipment
|
508,782
|
532,459
|
|
Total non-current assets
|
508,782
|
532,459
|
|
|
|
|
|
Total assets
|
23,035,683
|
28,222,027
|
|
|
|
|
|
Liabilities And Shareholders' Equity
|
|
|
|
Current Liabilities
|
|
|
|
Accounts payable and accrued liabilities
|
4,833,423
|
6,008,661
|
|
Total current liabilities
|
4,833,423
|
6,008,661
|
|
|
|
|
|
Shareholders' equity
|
|
|
|
|
|
|
Share capital
Authorized: unlimited Issued:
March 31, 2014 - 85,810,718
December 31, 2013 - 84,803,818
|
229,801,006
|
228,612,564
|
|
Warrants
|
—
|
376,892
|
|
Contributed surplus
|
25,172,701
|
24,491,212
|
|
Accumulated other comprehensive loss
|
61,004
|
79,698
|
|
Accumulated deficit
|
(236,832,451)
|
(231,347,000)
|
|
Total shareholders' equity
|
18,202,260
|
22,213,366
|
|
Total liabilities and equity
|
23,035,683
|
28,222,027
|
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
|
For the three month period ending March 31
|
2014
$
|
2013
$
|
|
|
|
|
|
Expenses
|
|
|
|
Research and development
|
4,178,334
|
5,117,044
|
|
Operating
|
1,391,254
|
1,564,751
|
|
Operating loss
|
(5,569,588)
|
(6,681,795)
|
|
Interest
|
87,987
|
74,959
|
|
Loss before income taxes
|
(5,481,601)
|
(6,606,836)
|
|
Income tax expense
|
(3,850)
|
—
|
|
Net loss
|
(5,485,451)
|
(6,606,836)
|
|
|
|
Other comprehensive income items that may be reclassified to net loss
|
|
|
|
|
|
Translation adjustment
|
(18,694)
|
34,188
|
|
|
|
|
|
Net comprehensive loss
|
(5,504,145)
|
(6,572,648)
|
|
Basic and diluted loss per common share
|
(0.06)
|
(0.08)
|
|
|
|
|
|
Weighted average number of shares (basic and diluted)
|
85,148,242
|
79,766,258
|
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, 2012
|
198,155,091
|
24,126,265
|
376,892
|
(57,115)
|
(207,814,353)
|
14,786,780
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
—
|
—
|
—
|
34,188
|
(6,606,836)
|
(6,572,648)
|
|
Issued, pursuant to a public offering
|
30,207,062
|
—
|
—
|
—
|
—
|
30,207,062
|
|
Exercise of stock options
|
139,676
|
(34,687)
|
—
|
—
|
—
|
104,989
|
|
|
|
|
|
|
|
|
|
Share based compensation
|
—
|
120,856
|
—
|
—
|
—
|
120,856
|
|
As at March 31, 2013
|
228,501,829
|
24,212,434
|
376,892
|
(22,927)
|
(214,421,189)
|
38,647,039
|
|
|
|
|
|
|
|
|
|
|
Share Capital
|
Contributed
Surplus
|
Warrants
|
Accumulated
Other
Comprehensive
Loss
|
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 comprehensive loss
|
—
|
—
|
—
|
(18,694)
|
(5,485,451)
|
(5,504,145)
|
Issued, pursuant to Share Purchase
Agreement
|
1,188,442
|
—
|
—
|
—
|
—
|
1,188,442
|
|
Expired warrants
|
—
|
376,892
|
(376,892)
|
—
|
—
|
—
|
|
|
|
|
|
|
|
|
|
Share based compensation
|
—
|
304,597
|
—
|
—
|
—
|
304,597
|
|
As at March 31, 2014
|
229,801,006
|
25,172,701
|
—
|
61,004
|
(236,832,451)
|
18,202,260
|
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
For the three month period ending March 31
|
2014
$
|
2013
$
|
|
Operating Activities
|
|
|
|
Net loss for the period
|
(5,485,451)
|
(6,606,836)
|
|
|
Amortization - property and equipment
|
39,657
|
24,581
|
|
|
Share based compensation
|
304,597
|
120,856
|
|
|
Unrealized foreign exchange loss
|
24,070
|
(307,653)
|
|
Net change in non-cash working capital
|
(1,046,951)
|
(1,641,170)
|
|
Cash used in operating activities
|
(6,164,078)
|
(8,410,222)
|
|
Investing Activities
|
|
|
|
Acquisition of property and equipment
|
(15,980)
|
(15,138)
|
|
Purchase of short-term investments
|
(30,041)
|
(32,416)
|
|
Cash used in investing activities
|
(46,021)
|
(47,554)
|
|
Financing Activities
|
|
|
|
Proceeds from Share Purchase Agreement
|
1,188,442
|
—
|
|
Proceeds from exercise of stock options and warrants
|
—
|
104,989
|
|
Proceeds from public offering
|
—
|
30,207,062
|
|
Cash provided by financing activities
|
1,188,442
|
30,312,051
|
|
Increase in cash
|
(5,021,657)
|
21,854,275
|
|
Cash and cash equivalents, beginning of period
|
25,220,328
|
19,323,541
|
|
Impact of foreign exchange on cash and cash equivalents
|
(42,764)
|
341,841
|
|
Cash and cash equivalents, end of period
|
20,155,907
|
41,519,657
|
To view the Company's First Quarter 2014 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/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 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 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.
