Oncolytics Biotech(R) Inc. Announces Third Quarter 2012 Results
CALGARY, Nov. 8, 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
September 30, 2012.
“We continue to make progress across the entire breadth of our clinical
program and completed enrollment in multiple trials this quarter,” said
Dr. Brad Thompson, President and CEO of Oncolytics. “Our near term
focus remains on completing the initial follow-up on the expanded 167
patient group enrolled in the REO 018 study so that we can receive our
first randomized clinical data for REOLYSIN(®).”
Selected Highlights
During the quarter the Company has made a number of significant
announcements:
Management
-- Appointment of Dr. Alan Tuchman to the role of Chief Medical
Officer and Senior Vice President, Clinical and Medical
Development.
Clinical Trial Program
-- Expanded enrollment in the first stage of our Phase III head
and neck cancer clinical trial (REO 18) to include 167
patients, all of whom have now been enrolled, and introduced an
additional patient segregation to differentiate between
patients with local recurrent disease, with or without
metastases, and patients with distal metastases while
maintaining the blind;
-- Reaching the primary endpoint in the first stage of a U.S.
Phase II clinical trial in patients with squamous cell
carcinoma of the lung (SCCLC) using intravenous administration
of REOLYSIN in combination with carboplatin and paclitaxel (REO
021);
-- Completion of enrollment in a U.K. Phase I clinical trial using
intravenously-administered REOLYSIN in combination with
cyclophosphamide in patients with advanced malignancies (REO
012); and
-- Completion of enrollment in a U.S. Phase I clinical trial using
intravenously-administered REOLYSIN in combination with FOLFIRI
in patients with colorectal cancer (REO 022).
Since September 30, 2012, the Company also announced completion of
patient enrollment in a U.S. Phase II clinical trial using intravenous
administration of REOLYSIN in combination with gemcitabine (Gemzar®) in
patients with advanced or metastatic pancreatic cancer (REO 017).
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
September 30, December 31,
2012 2011
$ $
Assets
Current assets
Cash and cash equivalents 26,007,318 32,918,751
Short-term investments 1,969,228 1,936,787
Accounts receivable 89,842 55,392
Prepaid expenses 592,927 721,576
Total current assets 28,659,315 35,632,506
Non-current assets
Property and equipment 426,983 392,111
Total non-current assets 426,983 392,111
Total assets 29,086,298 36,024,617
Liabilities And Shareholders'
Equity
Current Liabilities
Accounts payable and accrued
liabilities 6,711,147 6,504,238
Total current liabilities 6,711,147 6,504,238
Shareholders' equity
Share capital
Authorized: unlimited
Issued:
September 30, 2012 - 76,661,085
December 31, 2011 - 71,251,335 198,049,608 177,282,566
Warrants 3,030,519 2,653,627
Contributed surplus 20,700,110 21,142,519
Accumulated other comprehensive (83,022) (117,501)
loss
Accumulated deficit (199,322,064) (171,440,832)
Total shareholders' equity 22,375,151 29,520,379
Total liabilities and equity 29,086,298 36,024,617
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Month Three Month Nine Month
Period Period Nine Month Period
Ending Ending Period Ending
September September Ending September
30, 2012 30, September 30,
$ 2011 30, 2012 2011
$ $ $
Expenses
Research and 8,129,328 5,315,134 24,673,201 13,769,876
development
Operating 1,175,227 1,019,335 3,485,368 3,214,969
Operating (9,304,555) (6,334,469) (28,158,569) (16,984,845)
loss
Write down of -- -- -- (735,681)
asset
available for
sale
Change in -- -- -- 36,000
fair value of
warrant
liability
Interest 74,053 102,445 287,509 317,148
Loss before (9,230,502) (6,232,024) (27,871,060) (17,367,378)
income taxes
Income tax (13,400) -- (10,172) --
expense
Net loss (9,243,902) (6,232,024) (27,881,232) (17,367,378)
Other
comprehensive
(loss) income
- translation
adjustment (47,462) (9,587) 34,479 28,744
Net (9,291,364) (6,241,611) (27,846,753) (17,338,634)
comprehensive
loss
Basic and (0.12) (0.09) (0.37) (0.25)
diluted loss
per common
share
Weighted 76,607,281 71,221,218 75,903,566 70,800,114
average
number of
shares (basic
and diluted)
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Month Nine Month
Three Month Period Nine Month Period
Period Ending Period Ending
Ending September Ending September
September 30, September 30,
30, 2012 2011 30, 2012 2011
$ $ $ $
Operating
Activities
Net loss for (17,367,378)
the period (9,243,902) (6,232,024) (27,881,232)
Amortization
- property
and
equipment 26,422 21,258 83,993 68,525
Share based
compensation (121,685) 181,183 (49,489) 224,525
Change in
fair value
of warrant
liability -- -- -- (36,000)
Write down
of asset
available
for sale -- -- -- 735,681
Unrealized
foreign
exchange
loss 983 (121,391) 17,145 98,736
Net change
in non-cash
working
capital 1,514,620 (427,319) 301,108 930,195
Cash used in
operating (15,345,716)
activities (7,823,562) (6,578,293) (27,528,475)
Investing
Activities
Acquisition
of property
and
equipment (25,238) (62,087) (118,865) (111,194)
Purchase of
short-term
investments -- -- (32,441) 1,679,940
Cash used in
investing
activities (25,238) (62,087) (151,306) 1,568,746
Financing
Activities
Proceeds
from
exercise of
stock
options and
warrants 101,750 54,985 987,219 14,793,582
Proceeds
from public
offering -- -- 19,763,795 --
Cash
provided by
financing
activities 101,750 54,985 20,751,014 14,793,582
Increase in
cash (7,747,050) (6,585,395) (6,928,767) 1,016,612
Cash and
cash
equivalents,
beginning of
period 33,802,813 46,640,231 32,918,751 39,296,682
Impact of
foreign
exchange on
cash and
cash
equivalents (48,445) 188,466 17,334 (69,992)
Cash and
cash
equivalents,
end of
period 26,007,318 40,243,302 26,007,318 40,243,302
To view the Company’s Third 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 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.
