CALGARY, May 12 /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 March 31, 2010.
“We have recently seen a range of preclinical and clinical results that both improved our understanding of REOLYSIN(R)’s mechanism of action and provided evidence of synergies with currently approved therapeutics in an expanded range of potential indications,” said Dr. Brad Thompson, President and CEO of Oncolytics. “While much of this information will support future decisions with respect to our evolving clinical program, our near term focus will be on completing the final preparations to begin enrollment in our Phase III trial which we expect to begin in the second quarter.”
Selected Highlights
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Since January 1, 2010 the Company announced:
Clinical Trial Results
- A poster presentation, entitled "Reovirus replication in ovarian and
peritoneal tumors after intravenous administration," covering
correlative results from a Phase 1/2 study with reovirus, sponsored
by the National Cancer Institute under its Clinical Trials Agreement
with Oncolytics, in patients with ovarian, primary peritoneal and
fallopian tube carcinoma, was presented at the 101st AACR Annual
Meeting in Washington, DC. The authors reported that when REOLYSIN is
administered intravenously, the reovirus can be demonstrated to
localize and replicate in ovarian and peritoneal tumors;
Clinical Program
- Approval from the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA) to conduct a Phase 3 trial examining REOLYSIN in
combination with paclitaxel and carboplatin in patients with
platinum-refractory head and neck cancers. This is the same trial
that the Company previously reached an agreement on with the U.S.
Food and Drug Administration (FDA) under the Special Protocol
Assessment (SPA) process;
- The Cancer Therapy & Research Center at the University of Texas
Health Science Center (CTRC) had started patient enrolment in a U.S.
Phase 2 clinical trial using intravenous administration of REOLYSIN
in combination with carboplatin and paclitaxel in patients with
squamous cell carcinoma of the lungs (SCC lung cancer);
- Completion of Phase I patient enrollment in a Phase I/II clinical
trial to investigate the use of REOLYSIN for patients with recurrent
malignant gliomas (REO 007);
Collaborative Program
- A paper entitled "Antiangiogenic cancer therapy combined with
oncolytic virotherapy leads to regression of established tumors in
mice," co-senior authored by Dr. Richard Vile of the Department of
Immunology, Mayo Clinic, Rochester, Minnesota, USA, and Dr. Kevin
Harrington of the Institute of Cancer Research, London, UK, was
published in the online version of the Journal of Clinical
Investigation;
- A poster presentation at the AACR Annual Meeting entitled "Molecular
pathways associated with REOLYSIN and gemcitabine synergy in ras-
mutated human HCT116 cells," covering work done to better understand
the mechanisms associated with the cytotoxic synergies in this
combined approach in colorectal cancer cell lines;
- A poster presentation at the AACR Annual Meeting entitled "The
addition of REOLYSIN, an oncolytic reovirus, to irinotecan shows
synergistic anticancer activity in colorectal cancer cell lines,"
covering research done in vitro into a novel therapeutic approach for
treating patients with colorectal cancer tumors that harbor a
mutation in the Kras oncogene that have failed first line therapy;
and
- A poster presentation at the AACR Annual Meeting entitled "Reovirus
successfully purges multiple myeloma ex vivo and does not affect
human CD34+ cell engraftment in a murine transplantation model,"
covering the utility of reovirus in treating hematological
malignancies.
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
March 31, December 31,
2010 2009
$ $
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ASSETS
Current
Cash and cash equivalents 27,143,314 32,448,939
Short-term investments 1,679,937 1,679,937
Accounts receivable 33,013 64,787
Prepaid expenses 421,552 507,408
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29,277,816 34,701,071
Property and equipment 197,082 208,320
Long term investment 684,000 684,000
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30,158,898 35,593,391
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 2,932,622 4,226,933
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Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 61,549,969
(December 31, 2009 - 61,549,969) 131,908,274 131,908,274
Warrants 2,073,441 4,511,441
Contributed surplus 16,173,772 13,734,743
Deficit (122,929,211) (118,788,000)
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27,226,276 31,366,458
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30,158,898 35,593,391
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Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Cumulative
from
Three Month Three Month inception
Period Period on April 2,
Ending Ending 1998 to
March 31, March 31, March 31,
2010 2009 2010
$ $ $
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Revenue
Rights revenue - - 310,000
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Expenses
Research and development 2,839,313 2,812,655 88,977,604
Operating 949,424 986,764 29,568,956
Stock-based compensation 1,029 11,637 5,194,146
Foreign exchange loss 346,379 56,035 1,115,522
Amortization - intellectual
property - 90,375 3,615,000
Amortization - property and
equipment 14,885 17,304 576,966
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4,151,030 3,974,770 129,048,194
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Loss before the following 4,151,030 3,974,770 128,738,194
Interest income (9,819) (17,124) (6,573,265)
Gain on sale of BCY
LifeSciences Inc. - - (299,403)
Loss on sale of Transition
Therapeutics Inc. - - 2,156,685
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Loss before income taxes 4,141,211 3,957,646 124,022,211
Income taxes - - (1,093,000)
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Net loss and comprehensive
loss for the period 4,141,211 3,957,646 122,929,211
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Basic and diluted loss per share (0.07) (0.09)
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Weighted average number of
shares (basic and diluted) 61,549,969 43,849,637
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Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Cumulative
from
Three Month Three Month inception
Period Period on April 2,
Ending Ending 1998 to
March 31, March 31, March 31,
2010 2009 2010
$ $ $
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OPERATING ACTIVITIES
Net loss for the period (4,141,211) (3,957,646) (122,929,211)
Add/(deduct) non-cash items
Amortization - intellectual
property - 90,375 3,615,000
Amortization - property
and equipment 14,885 17,304 576,966
Stock-based compensation 1,029 11,637 5,194,146
Other non-cash items 363,895 - 1,858,232
Net change in non-cash working
capital (1,176,681) (164,019) 2,478,057
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Cash used in operating
activities (4,938,083) (4,002,349) (109,206,810)
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INVESTING ACTIVITIES
Purchase of property and
equipment (3,647) (3,349) (826,715)
Purchase of short-term
investments - (8,966) (51,096,801)
Redemption of short-term
investments - 3,930,000 48,998,380
Investment in BCY
LifeSciences Inc. - - 464,602
Investment in Transition
Therapeutics Inc. - - 2,532,343
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Cash provided by (used in)
investing activities (3,647) 3,917,685 71,809
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options - 21,250 30,511,278
Proceeds from private placements - - 38,137,385
Proceeds from acquisition of
private company - - 1,800,120
Proceeds from public offerings - - 66,320,777
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Cash provided by financing
activities - 21,250 136,769,560
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Net increase (decrease) in cash
and cash equivalents during
the period (4,941,730) (63,414) 27,634,559
Impact of foreign exchange on
cash and cash equivalents (363,895) - (491,245)
Cash and cash equivalents,
beginning of the period 32,448,939 7,429,895 -
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Cash and cash equivalents,
end of the period 27,143,314 7,366,481 27,143,314
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To view the Company’s First Quarter 2010 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 III 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 2010 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 May 12, 2010