CALGARY, March 16, 2015 /CNW/ - Oncolytics
Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or
the "Company") today announced its financial results and
operational highlights for the year ended December 31, 2014.
"The activities of the Company in 2014 have laid the groundwork
enabling us to plan and execute our late stage clinical strategy,"
said Dr. Brad Thompson, President
and CEO of Oncolytics. "We are looking forward to finalizing the
plans for and initiating our registration studies for
REOLYSIN®."
Selected Highlights
Since January 1, 2014, selected
highlights announced by the Company include:
Clinical Program
- Completion of patient enrollment in an ongoing, NCIC Clinical
Trials Group sponsored randomized Phase II study of
REOLYSIN® in patients with advanced or metastatic
colorectal cancer (IND 210). The Company awaits preliminary data
from this study;
- Reporting completion of enrollment and 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). The Company awaits final data from this study,
which will be available once all remaining patients have
progressed;
- Completion of patient enrollment 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 preliminary data from this study;
- Reporting 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;
- Presentation by the Company's collaborators of preliminary
clinical data demonstrating that intravenously delivered
REOLYSIN® can cross the blood brain barrier to access
tumours in the brains of humans;
Regulatory
- Application for Orphan Drug Designation from the U.S. Food and
Drug Administration (FDA) for REOLYSIN® in the treatment
of ovarian and pancreatic cancers. The Company was granted
designations in ovarian, fallopian tube, primary peritoneal and
pancreatic cancer subsequent to year end;
- Application to the European Medicines Agency for Orphan
Designation for REOLYSIN® in the treatment of pancreatic
and ovarian cancers;
- Subsequent to year end, the Company applied to the U.S. FDA for
a fifth Orphan Drug Designation for high grade gliomas in
paediatric patients;
Basic Research
- Presentation of a poster entitled "Combination Therapy with
Reovirus and PD-1 Blockade Effectively Establishes Tumour Control
Via Innate and Adaptive Immune Responses" by the Company's research
collaborators, Vile et al., at the AACR Tumor Immunology and
Immunotherapy Conference;
- A series of presentations made by the Company's research
collaborators at the 8th Annual International Conference
on Oncolytic Virus Therapeutics held in Oxford, UK, covering:
- 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;
Governance
- The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company's Board of
Directors;
Financial
- Entry into and subsequent amendments to a share purchase
agreement with Lincoln Park Capital Fund, LLC;
- Entry into a $20 million
"At-the-Market" equity distribution agreement with Canaccord
Genuity Inc.; and
- At December 31, 2014 the Company
reported $16.2 million in cash, cash
equivalents and short-term investments. At March 13, 2015, the Company had approximately
$27.5 million in cash, cash
equivalents and short-term investments.
ONCOLYTICS BIOTECH
INC.
|
CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
|
|
As at December
31,
|
2014
$
|
|
2013
$
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
14,152,825
|
|
25,220,328
|
Short-term
investments
|
2,031,685
|
|
2,001,644
|
Accounts
receivable
|
191,751
|
|
105,853
|
Prepaid
expenses
|
291,553
|
|
361,743
|
Total current
assets
|
16,667,814
|
|
27,689,568
|
Non-current
assets
|
|
|
Property and
equipment
|
525,376
|
|
532,459
|
Total non-current
assets
|
525,376
|
|
532,459
|
|
|
|
Total
assets
|
17,193,190
|
|
28,222,027
|
Liabilities And
Shareholders' Equity
|
|
|
|
Current
Liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
3,373,997
|
|
6,008,661
|
Total current
liabilities
|
3,373,997
|
|
6,008,661
|
Shareholders'
equity
|
|
|
|
Share
capital
|
|
|
|
|
Authorized:
unlimited
Issued:
December 31, 2014 – 93,512,494
December 31, 2013 – 84,803,818
|
237,657,056
|
|
228,612,564
|
Warrants
|
—
|
|
376,892
|
Contributed
surplus
|
25,848,429
|
|
24,491,212
|
Accumulated other
comprehensive income
|
280,043
|
|
79,698
|
Accumulated
deficit
|
(249,966,335)
|
|
(231,347,000)
|
Total
shareholders' equity
|
13,819,193
|
|
22,213,366
|
Total
liabilities and equity
|
17,193,190
|
|
28,222,027
|
ONCOLYTICS BIOTECH
INC.
|
CONSOLIDATED
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
|
|
For the years ending
December 31,
|
2014
$
|
2013
$
|
2012
$
|
Expenses
|
|
|
|
Research and
development
|
13,824,252
|
18,506,064
|
31,402,625
|
Operating
|
4,998,694
|
5,392,660
|
5,285,425
|
Loss before the
following
|
(18,822,946)
|
(23,898,724)
|
(36,688,050)
|
Interest
|
210,390
|
371,485
|
345,003
|
Loss before
income taxes
|
(18,612,556)
|
(23,527,239)
|
(36,343,047)
|
Income tax
expense
|
(6,779)
|
(5,408)
|
(30,474)
|
Net
loss
|
(18,619,335)
|
(23,532,647)
|
(36,373,521)
|
Other
comprehensive income items that may be
|
|
|
|
|
reclassified to
net loss
|
|
|
|
|
Translation
adjustment
|
200,345
|
136,813
|
60,386
|
Net
comprehensive loss
|
(18,418,990)
|
(23,395,834)
|
(36,313,135)
|
Basic and
diluted loss per common share
|
(0.21)
|
(0.28)
|
(0.48)
|
Weighted
average number of shares (basic and diluted)
|
87,869,149
|
83,530,981
|
76,102,062
|
ONCOLYTICS BIOTECH
INC.
|
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
|
|
|
Share
Capital
$
|
Warrants
$
|
Contributed
Surplus
$
|
Accumulated
Other
Comprehensive
Income
$
|
Accumulated
Deficit
$
|
Total
$
|
As at December 31,
2011
|
177,282,566
|
2,653,627
|
21,142,519
|
(117,501)
|
(171,440,832)
|
29,520,379
|
|
|
|
|
|
|
|
Net loss and other
comprehensive income
|
—
|
—
|
—
|
60,386
|
(36,373,521)
|
(36,313,135)
|
Issued, pursuant to a
bought deal financing
|
19,386,903
|
376,892
|
—
|
—
|
—
|
19,763,795
|
Expiry of
warrants
|
—
|
(2,653,627)
|
2,653,627
|
—
|
—
|
—
|
Exercise of stock
options
|
1,485,622
|
—
|
(400,632)
|
—
|
—
|
1,084,990
|
Share based
compensation
|
—
|
—
|
730,751
|
—
|
—
|
730,751
|
As at December 31,
2012
|
198,155,091
|
376,892
|
24,126,265
|
(57,115)
|
(207,814,353)
|
14,786,780
|
|
|
|
|
|
|
|
Net loss and other
comprehensive income
|
—
|
—
|
—
|
136,813
|
(23,532,647)
|
(23,395,834)
|
Issued, pursuant to a
bought deal financing
|
30,218,796
|
—
|
—
|
—
|
—
|
30,218,796
|
Expiry of
warrants
|
—
|
—
|
—
|
—
|
—
|
—
|
Exercise of stock
options
|
238,677
|
—
|
(59,437)
|
—
|
—
|
179,240
|
Share based
compensation
|
—
|
—
|
424,384
|
—
|
—
|
424,384
|
As at December 31,
2013
|
228,612,564
|
376,892
|
24,491,212
|
79,698
|
(231,347,000)
|
22,213,366
|
|
|
|
|
|
|
|
Net loss and other
comprehensive income
|
—
|
—
|
—
|
200,345
|
(18,619,335)
|
(18,418,990)
|
Issued, pursuant to
Share Purchase Agreement
|
7,830,409
|
—
|
—
|
—
|
—
|
7,830,409
|
Issued, pursuant to
"At the Market" Agreement
|
1,214,083
|
—
|
—
|
—
|
—
|
1,214,083
|
Expired
warrants
|
—
|
(376,892)
|
376,892
|
—
|
—
|
—
|
Share based
compensation
|
—
|
—
|
980,325
|
—
|
—
|
980,325
|
As at December 31,
2014
|
237,657,056
|
—
|
25,848,429
|
280,043
|
(249,966,335)
|
13,819,193
|
ONCOLYTICS BIOTECH
INC.
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
For the years ending
December 31,
|
2014
$
|
2013
$
|
2012
$
|
|
|
|
|
Operating
Activities
|
|
|
|
Net loss for the
year
|
(18,619,335)
|
(23,532,647)
|
(36,373,521)
|
Amortization -
property and equipment
|
163,501
|
131,623
|
109,275
|
Share based
compensation
|
980,325
|
424,384
|
730,751
|
Unrealized foreign
exchange loss
|
242,542
|
(89,721)
|
89,890
|
Net change in
non-cash working capital
|
(2,443,988)
|
(1,374,172)
|
1,187,967
|
Cash used in
operating activities
|
(19,676,955)
|
(24,440,533)
|
(34,255,638)
|
Investing
Activities
|
|
|
Acquisition of
property and equipment
|
(152,750)
|
(254,834)
|
(126,412)
|
Redemption (purchase)
of short-term investments
|
(30,041)
|
(32,416)
|
(32,441)
|
Cash used in
investing activities
|
(182,791)
|
(287,250)
|
(158,853)
|
Financing
Activities
|
|
|
Proceeds from
exercise of stock options and warrants
|
—
|
179,240
|
1,084,990
|
Proceeds from Share
Purchase Agreement
|
7,830,409
|
—
|
—
|
Proceeds from "At the
Market" equity distribution agreement
|
1,214,083
|
—
|
—
|
Proceeds from public
offering
|
—
|
30,218,796
|
19,763,795
|
Cash provided by
financing activities
|
9,044,492
|
30,398,036
|
20,848,785
|
(Decrease)
increase in cash
|
(10,815,254)
|
5,670,253
|
(13,565,706)
|
Cash and cash
equivalents, beginning of year
|
25,220,328
|
19,323,541
|
32,918,751
|
Impact of foreign
exchange on cash and cash equivalents
|
(252,249)
|
226,534
|
(29,504)
|
Cash and cash
equivalents, end of year
|
14,152,825
|
25,220,328
|
19,323,541
|
To view the Company's Fiscal 2014 Consolidated Financial
Statements, related Notes to the Consolidated Financial Statements,
and Management's Discussion and Analysis, please see the Company's
annual 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 2015 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.