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 receivable 51,421 284,988 64,787
Prepaid expenses 840,444 278,934 507,408
Total current assets 49,461,402 43,469,850 34,701,071
Non-current assets
Property and 228,751 226,911 208,320
equipment
Long term investment 684,000
Total non-current 228,751 226,911 892,320
assets
Asset held for sale 735,681
Total assets 49,690,153 44,432,442 35,593,391
Liabilities And Shareholders Equity
Current Liabilities
Accounts payable and accrued 4,186,139 2,500,682 4,226,933
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 Equity 49,690,153 44,432,442 35,593,391
ONCOLYTICSBIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
ThreeMonth ThreeMonth SixMonth Six
PeriodEnding PeriodEnding PeriodEnding, MonthPeriodEnding,
June 30, 2011 June30, 2010 June30, 2011 June 30, 2010
$ $ $ $
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 the (6,551,754) (4,385,156) (10,650,376) (8,391,279)
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 income (7,164,238) (3,984,852) (11,135,354) (8,522,645)
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 comprehensive (7,239,449) (3,960,974) (11,173,685) (8,643,674)
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 the (7,164,238) (3,984,852) (11,135,354) (8,522,645)
period
Amortization - 29,992 14,621 47,267 29,506
property and
equipment
Stock based 40,469 1,399 43,342 2,428
compensation
Change in fair (391,000) (36,000) 150,489
value of warrant
liability
Write down of 735,681 735,681
asset available
for sale
Unrealized 28,978 (293,534) 220,127 (74,546)
foreign exchange
loss (gain)
Net change in 1,417,496 384,452 1,357,514 (792,229)
non-cash working
capital
Cash used in (4,911,622) (4,268,914) (8,767,423) (9,206,997)
operating
activities
Investing
Activities
Redemption of 1,679,940 1,679,940
short-term
investments
Acquisition of (33,831) (39,851) (49,107) (43,498)
property and
equipment
Cash provided by 1,646,109 (39,851) 1,630,833 (43,498)
(used in)
investing
activities
Financing
Activities
Proceeds from 23,300 54,000 14,738,597 54,000
exercise of stock
options and
warrants
Cash provided by 23,300 54,000 14,738,597 54,000
financing
activities
Increase (3,242,213) (4,254,765) 7,602,007 (9,196,495)
(decrease) in
cash
Cash and cash 49,912,873 27,143,314 39,296,682 32,448,939
equivalents,
beginning of
period
Impact of foreign
exchange on cash
and cash
equivalents (30,429) 410,378 (258,458) 46,483
Cash and cash 46,640,231 23,298,927 46,640,231 23,298,927
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.
Released July 28, 2011