CALGARY, Nov. 10 /PRNewswire-FirstCall/ – 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, 2010.
“We are excited to be conducting our first Phase 3 study,” said Dr. Brad
Thompson, President and CEO of Oncolytics. “Moving into the fourth
quarter the Company’s fundamentals remain strong and we are well
positioned to execute on our clinical strategy in 2011 and beyond.”
Selected Highlights
Since July 1, 2010 the Company has announced:
Clinical Program
-- Receipt of a No Objection Letter from Health Canada to conduct the
Company's Phase 3 trial examining REOLYSIN® in combination with
paclitaxel and carboplatin in patients with platinum-refractory head and
neck cancers at centres in Canada;
-- A randomized Phase 2 trial of weekly paclitaxel versus weekly paclitaxel
with REOLYSIN in patients with persistent or recurrent ovarian,
fallopian tube or primary peritoneal cancer to be conducted by the
Gynecologic Oncology Group (GOG). 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,
will sponsor the trial under its Clinical Trials Agreement with
Oncolytics;
-- A presentation of interim data from a U.K. translational clinical trial
investigating intravenous administration of REOLYSIN in patients with
metastatic colorectal cancer prior to surgical resection of liver
metastases. The researchers concluded that reovirus can be successfully
delivered specifically to colorectal liver metastases following
intravenous administration as a monotherapy and that pre-operative
treatment was safe, suggesting that application of oncolytic viral
therapy can be widened to the neoadjuvant setting;
Preclinical Program
-- An abstract, entitled REOLYSIN induces endoplasmic reticular stress in
multiple myeloma and enhances the activity of bortezomib, indicating
that the combination of REOLYSIN and bortezomib significantly reduced
tumor burden in both xenograft and syngeneic multiple myeloma mouse
models. The authors concluded that REOLYSIN is a promising anticancer
agent that displays activity against multiple myeloma alone and in
combination with bortezomib and warrants further investigation for the
treatment of multiple myeloma and other malignancies;
Intellectual Property
-- Grant of U.S. Patent, # 7,803,385 entitled Reoviruses Having Modified
Sequences. This is a composition of matter patent that covers the
reovirus variant the Company is using in its clinical trial program and
expires in 2028; and
Financial
-- Completion of a bought deal financing issuing 6,256,000 units of the
Company at a price of $4.60 per Unit for gross proceeds to the Company
of approximately $28.77 million.
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
September 30, December 31,
2010 2009
$ $
ASSETS
Current
Cash and cash equivalents 16,098,135 32,448,939
Short-term investments 3,609,874 1,679,937
Accounts receivable 30,791 64,787
Prepaid expenses 499,261 507,408
20,238,061 34,701,071
Property and equipment 215,032 208,320
Long term investment 684,000 684,000
21,137,093 35,593,391
LIABILITIES AND SHAREHOLDERS EQUITY
Current
Accounts payable and accrued liabilities 1,809,914 4,226,933
Shareholders equity
Share capital
Authorized: unlimited number of common shares
Issued: 61,573,469
(December 31, 2009 - 61,549,969) 131,992,086 131,908,274
Warrants 2,073,441 4,511,441
Contributed surplus 16,551,859 13,734,743
Deficit (131,290,207) (118,788,000)
19,327,179 31,366,458
21,137,093 35,593,391
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF LOSS
AND COMPREHENSIVE LOSS
(unaudited)
Cumulative
Three Month Nine Month from
Period Three Month Period inception
Ending PeriodEnding Ending Nine Month on April 2,
September September September Period Ending 1998 to
30, 30, 30, September 30, September
2010 2009 2010 2009 30,2010
$ $ $ $ $
Revenue
Rights - - - - 310,000
revenue
- - - - 310,000
Expenses
Research and 2,500,607 1,954,367 8,901,088 8,006,232 95,039,379
development
Operating 895,659 736,024 2,978,402 2,703,509 31,597,934
Stock based 397,675 7,982 400,103 28,163 5,593,220
compensation
Foreign 216,859 (16,793) 214,009 42,345 983,152
exchange
loss/(gain)
Amortization - - - 180,750 3,615,000
-
intellectual
property
Amortization 15,981 15,772 45,487 49,612 607,568
- property
and equipment
4,026,781 2,697,352 12,539,089 11,010,611 137,436,253
Loss before 4,026,781 2,697,352 12,539,089 11,010,611 137,126,253
the
following:
Interest (17,759) (3,360) (36,882) (24,216) (6,600,328)
income
Gain on sale - - - - (299,403)
of BCY
LifeSciences
Inc.
Loss on sale - - - - 2,156,685
of Transition
Therapeutics
Inc.
Loss before 4,009,022 2,693,992 12,502,207 10,986,395 132,383,207
income taxes
Future income - - - - (1,093,000)
tax recovery
Net loss and 4,009,022 2,693,992 12,502,207 10,986,395 131,290,207
comprehensive
loss for the
period
Basic and 0.07 0.05 0.20 0.23
diluted loss
pershare
Weighted 61,570,046 49,465,849 61,558,859 46,942,128
average
numberof
shares (basic
and diluted)
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Cumulative
Three Month Three Month Nine Month Nine Month from
Period Period Period Period inception
Ending Ending Ending Ending on April 2,
September September September September 1998 to
30, 30, 30, 30, September 30,
2010 2009 2010 2009 2009
$ $ $ $ $
OPERATING
ACTIVITIES
Net loss for (4,009,022) (2,693,992) (12,502,207) (10,986,395) (131,290,207)
the period
Deduct
non-cash
items
Amortization - - - 180,750 3,615,000
-
intellectual
property
Amortization 15,981 15,772 45,487 49,612 607,568
- property
and
equipment
Stock based 397,675 7,982 400,103 28,163 5,593,220
compensation
Other 211,990 - 213,369 - 1,707,706
non-cash
items
Net changes (1,582,647) 60,253 (2,374,876) (1,517,967) 1,279,862
in non-cash
working
capital
(4,966,023) (2,609,985) (14,218,124) (12,245,837) (118,486,851)
INVESTING
ACTIVITIES
Capital (8,701) (1,325) (52,199) (4,674) (875,267)
assets
Purchase of (1,929,937) - (1,929,937) - (53,026,738)
short-term
investments
Redemption of - - - 5,846,634 48,998,380
short-term
investments
Investment in - - - - 464,602
BCY
LifeSciences
Inc.
Investment in - - - - 2,532,343
Transition
Therapeutics
Inc.
(1,938,638) (1,325) (1,982,136) 5,841,960 (1,906,680)
FINANCING
ACTIVITIES
Proceeds from 8,825 342,570 62,825 715,835 30,574,103
exercise of
warrants and
stock options
Proceeds from - - - 1,800,120 1,800,120
acquisition
of private
company
Proceeds from - - - - 38,137,385
private
placements
Proceeds from - (59,893) - 6,112,746 66,320,777
public
offerings
8,825 282,677 62,825 8,628,701 136,832,385
Increase (6,895,836) (2,328,633) (16,137,435) 2,224,824 16,438,854
(decrease) in
cash and cash
equivalents
during the
period
Impact of (211,990) - (213,369) - (340,719)
foreign
exchange on
cash and cash
equivalents
Cash and cash 23,205,961 11,983,352 32,448,939 7,429,895 -
equivalents,
beginning of
the period
Cash and cash 16,098,135 9,654,719 16,098,135 9,654,719 16,098,135
equivalents,
end of the
period
Released November 10, 2010