CALGARY, AB, July 28, 2011 /PRNewswire/ – 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, 2011.
“We continue to build upon and progress through our research and
development in an effort to maximize the future commercial potential of
REOLYSIN(®). In Q2, we focused our efforts on expanding our Phase III clinical
trial in head and neck cancer, and expanding our clinical trial program
by announcing a U.S. National Cancer Institute-sponsored clinical trial
in multiple myeloma,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “We also received positive data from early stage studies in
metastatic colorectal and non-small cell lung cancer studies, and
secured a leading manufacturer for the clinical and commercial supply
of REOLYSIN(®), both significant steps forward in our plans to expand our development
program.”
Selected Highlights
Since April 1, 2011 the Company has announced:
Clinical Trial Results
-- Interim data from a U.K. translational clinical trial (REO 013)
investigating intravenous administration of REOLYSIN in
patients with metastatic colorectal cancer prior to surgical
resection of liver metastases. On initial histological analysis
of the 10 treated patients, there was evidence of selective
delivery of virus to tumour versus normal liver and viral
replication in the majority (seven) of patients;
-- A presentation covering interim preliminary results from a
Phase 2 clinical trial using intravenous administration of
REOLYSIN in combination with paclitaxel and carboplatin in
patients with non-small cell lung cancer (NSCLC) with Kras or
EGFR-activated tumours at the International Association for the
Study of Lung Cancer World Conference on Lung Cancer. Response
evaluation as of the date of presentation in 21 patients showed
six partial responses (PR) (28.6%), 13 stable disease (SD)
(61.9%), and two progressive disease (PD) (9.5%), translating
into a clinical benefit rate (complete response (CR)+PR+SD) of
90.5% and a response rate (CR+PR) of 28.6%;
Ongoing Clinical Program
-- The Cancer Therapy Evaluation Program, Division of Cancer
Treatment and Diagnosis, U.S. National Cancer Institute (NCI),
which is part of the National Institutes of Health, has agreed
to sponsor a Phase I study of REOLYSIN alone in patients with
relapsed multiple myeloma;
-- A commercial supply agreement with SAFC, a Division of
Sigma-Aldrich Corporation, for the commercial manufacture of
REOLYSIN. Under the terms of the agreement, SAFC will perform
process validation of the product, will continue to supply
clinical requirements and will supply commercial material upon
approval of the product; and
Corporate
-- The appointment of George M. Gill, MD as Chief Medical Officer.
Dr. Gill has been Senior Vice President of Clinical Safety and
Regulatory Affairs and an officer of Oncolytics since 2002.
ONCOLYTICSBIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
June 30, December 31, January 1,
2011 2010 2010
As at, $ $ $
Assets
Current
assets
Cash and cash 46,640,231 39,296,682 32,448,939
equivalents
Short-term 1,929,306 3,609,246 1,679,937
investments
Accounts 51,421 284,988 64,787
receivable
Prepaid 840,444 278,934 507,408
expenses
Total current 49,461,402 43,469,850 34,701,071
assets
Non-current
assets
Property and 228,751 226,911 208,320
equipment
Long term -- -- 684,000
investment
Total 228,751 226,911 892,320
non-current
assets
Asset held -- 735,681 --
for sale
Total assets 49,690,153 44,432,442 35,593,391
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and 4,186,139 2,500,682 4,226,933
accrued liabilities
Warrant liability -- 5,536,800 1,023,051
Total current liabilities 4,186,139 8,037,482 5,249,984
Shareholders' equity
Share capital
Authorized: unlimited
Issued:
June 30, 2011 -
71,214,318
December 31, 2010 -
67,958,302
January 1, 2010 -
61,549,969 177,179,742 155,439,610 131,908,274
Warrants 2,653,627 4,108,652 2,437,460
Contributed surplus 19,397,121 19,399,489 13,734,743
Accumulated other
comprehensive
loss (194,991) (156,660) --
Deficit (153,531,485) (142,396,131) (117,737,070)
Total shareholders' equity 45,504,014 36,394,960 30,343,407
Total Liabilities And 49,690,153 44,432,442 35,593,391
Equity
ONCOLYTICSBIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
ThreeMonth ThreeMonth SixMonth Six
PeriodEnding PeriodEnding PeriodEnding, MonthPeriodEnding,
June 30, June30, 2010 June30, 2011 June 30, 2010
2011 $ $ $
$
Expenses
Research and 5,483,131 3,237,216 8,454,742 6,279,030
development
Operating 1,068,623 1,147,940 2,195,634 2,112,249
6,551,754 4,385,156 10,650,376 8,391,279
Loss before (6,551,754) (4,385,156) (10,650,376) (8,391,279)
the following
Write down of
asset
available for
sale (735,681) -- (735,681) --
Change in
fair value of
warrant
liability -- 391,000 36,000 (150,489)
Interest 123,197 9,304 214,703 19,123
Loss before (7,164,238) (3,984,852) (11,135,354) (8,522,645)
income taxes
Income taxes -- -- -- --
Net loss (7,164,238) (3,984,852) (11,135,354) (8,522,645)
Other
comprehensive
loss -
translation
adjustment (75,211) 23,878 (38,331) (121,029)
Net (7,239,449) (3,960,974) (11,173,685) (8,643,674)
comprehensive
loss
Basic and
diluted loss
per share (0.10) (0.06) (0.16) (0.14)
Weighted
average
number of
shares (basic
and diluted) 71,209,164 61,556,343 70,586,073 61,553,173
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
For the six month period ending, June 30, 2011
Accumulated
Other
Share Contributed Comprehensive
capital Surplus Warrants Income Deficit Total Equity
$ $ $ $ $ $
As at 155,439,610 19,399,489 4,108,652 (156,660) (142,396,131) 36,394,960
December 31,
2010
Net loss and -- -- -- (38,331) (11,135,354) (11,173,685)
comprehensive
loss for the
period
Exercise of 21,487,080 -- (1,455,025) -- -- 20,032,055
warrants
Exercise of 253,052 (45,710) -- -- -- 207,342
stock options
Stock based -- 43,342 -- -- -- 43,342
compensation
As at June 177,179,742 19,397,121 2,653,627 (194,991) (153,531,485) 45,504,014
30, 2011
For the six month period ending, June 30, 2010
Accumulated
Other
Share Contributed Comprehensive Total
capital Surplus Warrants Income Deficit Equity
$ $ $ $ $ $
As at January 131,908,274 13,734,743 2,437,460 -- (117,737,070) 30,343,407
1, 2010
Net loss and -- -- -- (121,029) (8,522,645) (8,643,674)
comprehensive
loss for the
period
Expired -- 2,438,000 (2,438,000) -- -- --
warrants
Exercise of 72,000 (18,000) -- -- -- 54,000
stock options
Stock based -- 2,428 -- -- -- 2,428
compensation
Other -- -- 540 -- -- 540
As at June 131,980,274 16,157,171 -- (121,029) (126,259,715) 21,756,701
30, 2010
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Month ThreeMonth Six Month SixMonthPeriodEnding,
PeriodEnding PeriodEnding PeriodEnding, June 30, 2010
June 30,2011 June 30,2010 June 30, 2011 $
$ $ $
Cash Flows
Operating
Activities
Net loss for (7,164,238) (3,984,852) (11,135,354) (8,522,645)
the period
29,992 14,621 47,267 29,506
Amortization
- property
and
equipment
Stock 40,469 1,399 43,342 2,428
based
compensation
Change in -- (391,000) (36,000) 150,489
fair value
of warrant
liability
Write down 735,681 -- 735,681 --
of asset
available
for sale
Unrealized 28,978 (293,534) 220,127 (74,546)
foreign
exchange
loss (gain)
Net change 1,417,496 384,452 1,357,514 (792,229)
in non-cash
working
capital
Cash used in (4,911,622) (4,268,914) (8,767,423) (9,206,997)
operating
activities
Investing
Activities
Redemption 1,679,940 -- 1,679,940 --
of
short-term
investments
Acquisition (33,831) (39,851) (49,107) (43,498)
of property
and
equipment
Cash 1,646,109 (39,851) 1,630,833 (43,498)
provided by
(used in)
investing
activities
Financing
Activities
Proceeds 23,300 54,000 14,738,597 54,000
from
exercise of
stock
options and
warrants
Cash 23,300 54,000 14,738,597 54,000
provided by
financing
activities
Increase (3,242,213) (4,254,765) 7,602,007 (9,196,495)
(decrease)
in cash
Cash and 49,912,873 27,143,314 39,296,682 32,448,939
cash
equivalents,
beginning of
period
Impact of
foreign
exchange on
cash and
cash
equivalents (30,429) 410,378 (258,458) 46,483
Cash and 46,640,231 23,298,927 46,640,231 23,298,927
cash
equivalents,
end of
period
To view the Company’s Second Quarter 2011 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
including a Phase 3 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 2011 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.
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