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"The first quarter of 2009 was highlighted by the announcement of very positive results in several of our combination REOLYSIN(R) clinical trials," said Dr. Brad Thompson, President and CEO of Oncolytics. "We continue to report clinical benefit in the majority of patients treated with REOLYSIN in combination with chemotherapy or radiation, paving the way for our pivotal program to begin this year."
<<
Selected First Quarter Highlights:
- Announced positive interim results from a U.K. Phase I/II combination
REOLYSIN and paclitaxel/carboplatin trial for patients with advanced
head and neck cancers. Of 12 evaluable patients, five patients had
partial responses (PR) and four patients had stable disease (SD), for
a clinical benefit rate (complete response + partial response + stable
disease) of 75%;
- Announced positive results from a U.K. combination REOLYSIN and
docetaxel trial for patients with a variety of advanced cancers.
Fifteen of the 17 evaluable patients experienced SD or better,
including two PR, three minor responses and 10 SD, giving a clinical
benefit rate of 88%;
- Completed enrolment in a U.K. combination REOLYSIN and gemcitabine
clinical trial. Of the ten patients evaluable for response, two
patients (breast and nasopharyngeal) had PRs and five patients had SD,
for a clinical benefit rate of 70%;
- Started patient enrolment in a U.S. Phase 2 Combination REOLYSIN and
paclitaxel/carboplatin clinical trial for patients with non-small cell
lung cancer with K-RAS or EGFR-activated tumours. Eligible patients
include those who have not received chemotherapy treatment for their
metastatic or recurrent disease;
- Started patient enrolment in a U.K. translational clinical trial
investigating REOLYSIN in patients with metastatic colorectal cancer;
and
- Announced a multi-trial clinical research collaboration with the
Cancer Therapy & Research Center at the University of Texas Health
Science Center involving up to five, open-label, Phase 2 studies
exploring the use of REOLYSIN(R) in combination with chemotherapy for
various cancer indications. These indications are expected to include
melanoma, pancreatic cancer, squamous cell lung, liver and K-RAS
mutated colorectal cancers in combination with standard
chemotherapeutics.
Latest Highlights
Subsequent to quarter end, the Company announced:
- Positive results of a U.K. Phase II REOLYSIN and radiation combination
clinical trial. Of 14 evaluable patients, 13 patients had SD or better
in the treated target lesions, including four PRs and two minor
responses, for a clinical benefit rate of 93% in the treated lesions;
- The successful acquisition of PrivateCo., an inactive private company
with net cash of $2.1 million; and
- A proposed public offering consisting of up to 3.45 million units at
$2.00 per unit, for gross proceeds of up to $6.9 million.
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
March 31, December 31,
2009 2008
$ $
-------------------------------------------------------------------------
ASSETS
Current
Cash and cash equivalents 7,366,481 7,429,895
Short-term investments 1,925,600 5,846,634
Accounts receivable 68,411 86,322
Prepaid expenses 101,025 179,668
-------------------------------------------------------------------------
9,461,517 13,542,519
Property and equipment 249,971 263,926
Intellectual property 90,375 180,750
-------------------------------------------------------------------------
9,801,863 13,987,195
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 4,273,538 4,534,111
-------------------------------------------------------------------------
Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 43,855,748 (December 31, 2008 -
43,830,748) 95,256,174 95,234,924
Warrants 3,425,110 3,425,110
Contributed surplus 13,361,438 13,349,801
Deficit (106,514,397) (102,556,751)
-------------------------------------------------------------------------
5,528,325 9,453,084
-------------------------------------------------------------------------
9,801,863 13,987,195
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND
COMPREHENSIVE LOSS
(unaudited)
Three Month Three Month Cumulative
Period Period from inception
Ending Ending on April 2,
March 31, March 31, 1998 to March
2009 2008 31, 2009
$ $ $
-------------------------------------------------------------------------
Revenue
Rights revenue - - 310,000
-------------------------------------------------------------------------
Expenses
Research and development 2,812,655 2,393,397 77,344,432
Operating 986,764 1,050,894 25,823,789
Stock-based compensation 11,637 19,593 4,780,481
Foreign exchange loss 56,035 9,262 645,462
Amortization - intellectual
property 90,375 90,375 3,524,625
Amortization - property and
equipment 17,304 11,186 514,455
-------------------------------------------------------------------------
3,974,770 3,574,707 112,633,244
-------------------------------------------------------------------------
Loss before the following 3,974,770 3,574,707 112,323,244
Interest income (17,124) (180,334) (6,551,129)
Gain on sale of BCY LifeSciences Inc. - - (299,403)
Loss on sale of Transition
Therapeutics Inc. - - 2,156,685
-------------------------------------------------------------------------
Loss before income taxes 3,957,646 3,394,373 107,629,397
Future income tax recovery - - (1,115,000)
-------------------------------------------------------------------------
Net loss and comprehensive loss
for the period 3,957,646 3,394,373 106,514,397
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share (0.09) (0.08)
-----------------------------------------------------------
-----------------------------------------------------------
Weighted average number of shares
(basic and diluted) 43,849,637 41,180,748
-----------------------------------------------------------
-----------------------------------------------------------
Oncolytics Biotech Inc.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Cumulative
Three Month Three Month from
Period Period inception on
Ending Ending April 2, 1998
March 31, March 31, to March 31,
2009 2008 2009
$ $ $
-------------------------------------------------------------------------
OPERATING ACTIVITIES
Net loss for the period (3,957,646) (3,394,373) (106,514,397)
Add / (deduct) non-cash items
Amortization - intellectual
property 90,375 90,375 3,524,625
Amortization - property and
equipment 17,304 11,186 514,455
Stock-based compensation 11,637 19,593 4,780,481
Other non-cash items - - 1,383,537
Net change in non-cash working
capital (164,019) 24,681 4,104,102
-------------------------------------------------------------------------
Cash used in operating activities (4,002,349) (3,248,538) (92,207,197)
-------------------------------------------------------------------------
INVESTING ACTIVITIES
Purchase of property and equipment (3,349) (2,665) (817,093)
Purchase of short-term investments (8,966) (137,187) (49,425,830)
Redemption of short-term
investments 3,930,000 4,000,000 47,081,746
Investment in BCY LifeSciences Inc. - - 464,602
Investment in Transition
Therapeutics Inc. - - 2,532,343
-------------------------------------------------------------------------
Cash provided by (used in)
investing activities 3,917,685 3,860,148 (164,232)
-------------------------------------------------------------------------
FINANCING ACTIVITIES
Proceeds from exercise of warrants
and stock options 21,250 - 15,322,318
Proceeds from private placements - - 38,137,385
Proceeds from public offerings - 46,278,207
-------------------------------------------------------------------------
Cash provided by financing
activities 21,250 - 99,737,910
-------------------------------------------------------------------------
Net increase (decrease) in cash
and cash equivalents during the
period (63,414) 611,610 7,366,481
Cash and cash equivalents,
beginning of the period 7,429,895 6,715,096 -
-------------------------------------------------------------------------
Cash and cash equivalents, end of
the period 7,366,481 7,326,706 7,366,481
-------------------------------------------------------------------------
-------------------------------------------------------------------------
>>
To view the 2009 First Quarter Report which includes the Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's first quarter 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 Phase I/II and Phase II human trials using REOLYSIN, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. 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 2009 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.
%SEDAR: 00013081E
SOURCE: Oncolytics Biotech Inc.
Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858, cathy.ward@oncolytics.ca; The Equicom Group, Nick Hurst, 325, 300 5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916, nhurst@equicomgroup.com; The Investor Relations Group, Erika Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212) 825-3229, emoran@investorrelationsgroup.com
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