CALGARY, July 29 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and six-month periods ended June 30, 2009.
“Clinical results from our monotherapy and combination clinical trials with REOLYSIN(R) continued to emerge in the second quarter,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The results of these trials, and the response and clinical benefit rates as reported by our investigators, reinforce our belief that REOLYSIN has the potential to significantly improve treatment outcomes in patients with a broad range of cancers.”
Selected Second Quarter Highlights
- Presented updated U.S. Phase II sarcoma trial data at the American
Society of Clinical Oncology (ASCO) annual meeting. The interim
results demonstrated that the treatment was well tolerated, with 15
of 36, or 42% of evaluable patients experiencing stable disease (SD)
for more than 16 weeks, including five patients who had SD for more
than 24 weeks. Patient enrolment was completed in May;
- Presented a poster at ASCO demonstrating that the combination of
REOLYSIN and gemcitabine in a U.K. Phase I trial was well tolerated,
and resulted in disease control for a majority of the patients. Of
the ten patients evaluable for response, two patients (breast and
nasopharyngeal) had partial responses (PRs) and/or clinical responses
and five patients had SD for 4-8 cycles, for a total disease control
rate (CR (Complete Response)+PR+SD) of 70%;
- Presented a poster at ASCO that indicated REOLYSIN was well tolerated
and demonstrated anti-tumour activity in a U.S. Phase I systemic
administration monotherapy trial. Of 18 patients treated in the
trial, eight demonstrated SD or better as measured by Response
Evaluation Criteria in Solid Tumors (RECIST) including a patient with
progressive breast cancer who experienced a PR (34% shrinkage in
tumor volume);
- 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;
- Successfully completed the acquisition of an inactive private company
with net cash of $2.1 million by issuing 1,875,121 common shares, and
completed a public offering consisting of 3.45 million units at $2.00
per unit, for gross proceeds of $6.9 million;
- In early July, completed patient enrolment in the Phase II component
of our U.K. REOLYSIN and paclitaxel/carboplatin clinical trial; and,
- In mid-July, announced that we had completed the lyophilization
(freeze-drying) formulation development program for REOLYSIN.
Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
June 30, December 31,
2009 2008
$ $
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ASSETS
Current
Cash and cash equivalents 11,983,352 7,429,895
Short-term investments - 5,846,634
Accounts receivable 102,659 86,322
Prepaid expenses 435,485 179,668
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12,521,496 13,542,519
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Property and equipment 233,435 263,926
Intellectual property - 180,750
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12,754,931 13,987,195
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 3,228,045 4,534,111
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Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 49,395,169
(December 31, 2008 - 43,830,748) 102,203,004 95,234,924
Warrants 4,803,054 3,425,110
Contributed surplus 13,369,982 13,349,801
Deficit (110,849,154) (102,556,751)
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9,526,886 9,453,084
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12,754,931 13,987,195
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Month Three Month Six Month
Period Period Period
Ending June Ending June Ending June
30, 2009 30, 2008 30, 2009
$ $ $
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Revenue
Rights revenue - - -
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- - -
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Expenses
Research and development 3,239,210 4,046,904 6,051,865
Operating 980,721 1,319,498 1,967,485
Stock based compensation 8,544 18,023 20,181
Foreign exchange loss/gain 3,103 (58,347) 59,138
Amortization -
intellectual property 90,375 90,375 180,750
Amortization -
property and equipment 16,536 12,194 33,840
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4,338,489 5,428,647 8,313,259
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Loss before the following: 4,338,489 5,428,647 8,313,259
Interest income (3,732) (174,117) (20,856)
Gain on sale of BCY
LifeSciences Inc. - - -
Loss on sale of Transition
Therapeutics Inc. - - -
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Loss before income taxes 4,334,757 5,254,530 8,292,403
Future income tax recovery - - -
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Net loss and comprehensive loss
for the period 4,334,757 5,254,530 8,292,403
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Basic and diluted loss per share 0.09 0.13 0.18
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Weighted average number of shares
(basic and diluted) 47,449,182 41,180,748 45,659,353
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Cumulative
from
inception on
Six Month April 2,
Period 1998
Ending June to June
30, 2008 30, 2009
$ $
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Revenue
Rights revenue - 310,000
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- 310,000
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Expenses
Research and development 6,440,301 80,583,642
Operating 2,370,392 26,804,510
Stock based compensation 37,616 4,789,025
Foreign exchange loss/gain (49,085) 648,565
Amortization -
intellectual property 180,750 3,615,000
Amortization -
property and equipment 23,380 530,991
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9,003,354 116,971,733
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Loss before the following: 9,003,354 116,661,733
Interest income (354,451) (6,554,861)
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 8,648,903 111,964,154
Future income tax recovery - (1,115,000)
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Net loss and comprehensive loss
for the period 8,648,903 110,849,154
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Basic and diluted loss per share 0.21
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Weighted average number of shares
(basic and diluted) 41,180,748
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Month Three Month Six Month
Period Period Period
Ending June Ending June Ending June
30, 2009 30, 2008 30, 2009
$ $ $
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OPERATING ACTIVITIES
Net loss for the period (4,334,757) (5,254,530) (8,292,403)
Deduct non-cash items
Amortization - intellectual
property 90,375 90,375 180,750
Amortization - property
and equipment 16,536 12,194 33,840
Stock based compensation 8,544 18,023 20,181
Other non-cash items - - -
Net changes in non-cash
working capital (1,414,201) 1,157,662 (1,578,220)
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(5,633,503) (3,976,276) (9,635,852)
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INVESTING ACTIVITIES
Capital assets - (56,080) (3,349)
Purchase of short-term investments - (115,009) -
Redemption of short-term
investments 1,925,600 5,000,000 5,846,634
Investment in BCY
LifeSciences Inc. - - -
Investment in Transition
Therapeutics Inc. - - -
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1,925,600 4,828,911 5,843,285
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options 351,835 - 373,085
Proceeds from acquisition
of private company 1,800,120 - 1,800,120
Proceeds from private placements - - -
Proceeds from public offerings 6,172,819 - 6,172,819
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8,324,774 - 8,346,024
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Increase in cash and cash
equivalents during the period 4,616,871 852,635 4,553,457
Cash and cash equivalents,
beginning of the period 7,366,481 7,326,706 7,429,895
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Cash and cash equivalents,
end of the period 11,983,352 8,179,341 11,983,352
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Cumulative
from
inception on
Six Month April 2,
Period 1998
Ending June to June
30, 2008 30, 2009
$ $
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OPERATING ACTIVITIES
Net loss for the period (8,648,903) (110,849,154)
Deduct non-cash items
Amortization - intellectual
property 180,750 3,615,000
Amortization - property
and equipment 23,380 530,991
Stock based compensation 37,616 4,789,025
Other non-cash items - 1,383,537
Net changes in non-cash
working capital 1,182,343 2,689,901
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(7,224,814) (97,840,700)
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INVESTING ACTIVITIES
Capital assets (58,745) (817,093)
Purchase of short-term investments (252,196) (49,416,864)
Redemption of short-term
investments 9,000,000 48,998,380
Investment in BCY
LifeSciences Inc. - 464,602
Investment in Transition
Therapeutics Inc. - 2,532,343
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8,689,059 1,761,368
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options - 15,674,153
Proceeds from acquisition
of private company - 1,800,120
Proceeds from private placements - 38,137,385
Proceeds from public offerings - 52,451,026
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- 108,062,684
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Increase in cash and cash
equivalents during the period 1,464,245 11,983,352
Cash and cash equivalents,
beginning of the period 6,715,096 -
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Cash and cash equivalents,
end of the period 8,179,341 11,983,352
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To view the 2009 Second 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 second 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 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 29, 2009