CALGARY, Nov. 5 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and nine-month periods ended September 30, 2009.
“In the third quarter, we passed a number of key milestones in our evolving REOLYSIN(R) development program, including making progress on a number of Phase II clinical initiatives and in manufacturing,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Subsequent to quarter-end, we met our most important milestone to date in the advancement of our clinical program as we reached an agreement with the U.S. FDA on the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.”
Selected Third Quarter Highlights:
During the quarter, the Company announced:
- Conclusion of patient enrollment in the Phase II component of the
Company's U.K. REOLYSIN and paclitaxel/carboplatin clinical trial
(REO 11);
- Successful completion of the lyophilized (freeze-dried) formulation
development program for REOLYSIN;
- Successful completion of an initial 100-litre production run of
REOLYSIN under cGMP conditions;
- The grant of the Company's 32nd U.S. Patent, # 7,582,289, entitled
"Viruses for the Treatment of Cellular Proliferative Disorders" with
the claims covering methods of using modified parapoxvirus orf virus
to treat Ras-mediated cancers;
- Acceleration of the warrant expiry date on warrants issued in
connection with a financing completed in December 2008; and
- The start of enrollment in a U.S. Phase 2 clinical trial using
intravenous administration of REOLYSIN in combination with paclitaxel
and carboplatin in patients with metastatic melanoma being conducted
at the Cancer Therapy & Research Center at the University of Texas
Health Science Center (CTRC).
Latest Highlights
Subsequent to quarter end, the Company announced:
- An agreement with the U.S. Food and Drug Administration (FDA) under
the Special Protocol Assessment (SPA) process for the design of a
Phase 3 trial examining REOLYSIN in combination with paclitaxel and
carboplatin in patients with platinum-refractory head and neck
cancers;
- Acceleration of the warrant expiry date on warrants issued in
connection with a financing completed in May 2009;
- Grant of the Company's 33rd U.S. Patent, # 7,608,257, entitled
"Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells
With a Virus." The patent claims cover methods of using reovirus in
combination with currently approved chemotherapeutic agents to treat
patients that are refractory to those chemotherapeutic agents alone;
- The results of the two warrant expiry date acceleration programs for
warrants issued and amended in December 2008 and issued in 2009,
generating proceeds of approximately $14.9 million.
Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
September 30, December 31,
2009 2008
$ $
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ASSETS
Current
Cash and cash equivalents 9,654,719 7,429,895
Short-term investments - 5,846,634
Accounts receivable 59,314 86,322
Prepaid expenses 306,926 179,668
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10,020,959 13,542,519
Capital assets 218,988 263,926
Intellectual property - 180,750
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10,239,947 13,987,195
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 3,116,394 4,534,111
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Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 49,608,569
(December 31, 2008 - 43,830,748) 102,532,889 95,234,924
Warrants 4,755,846 3,425,110
Contributed surplus 13,377,964 13,349,801
Deficit (113,543,146) (102,556,751)
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7,123,553 9,453,084
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10,239,947 13,987,195
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Month Three Month Nine Month
Period Period Period
Ending Ending Ending
September September September
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 1,954,367 3,210,294 8,006,232
Operating 736,024 880,438 2,703,509
Stock based compensation 7,982 17,339 28,163
Foreign exchange loss/(gain) (16,793) 29,026 42,345
Amortization - intellectual
property - 90,375 180,750
Amortization - property and
equipment 15,772 11,853 49,612
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2,697,352 4,239,325 11,010,611
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Loss before the following: 2,697,352 4,239,325 11,010,611
Interest income (3,360) (98,493) (24,216)
Gain on sale of BCY
LifeSciences Inc. - - -
Loss on sale of Transition
Therapeutics Inc. - - -
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Loss before income taxes 2,693,992 4,140,832 10,986,395
Future income tax recovery - - -
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Net loss and comprehensive loss
for the period 2,693,992 4,140,832 10,986,395
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Basic and diluted loss per share 0.05 0.10 0.23
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Weighted average number of shares
(basic and diluted) 49,465,849 41,180,748 46,942,128
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Cumulative
from
Nine Month inception
Period on April 2,
Ending 1998 to
September September
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 9,650,595 82,538,009
Operating 3,250,830 27,540,534
Stock based compensation 54,955 4,797,007
Foreign exchange loss/(gain) (20,059) 631,772
Amortization - intellectual
property 271,125 3,615,000
Amortization - property and
equipment 35,233 546,763
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13,242,679 119,669,085
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Loss before the following: 13,242,679 119,359,085
Interest income (452,944) (6,558,221)
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 12,789,735 114,658,146
Future income tax recovery - (1,115,000)
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Net loss and comprehensive loss
for the period 12,789,735 113,543,146
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Basic and diluted loss per share 0.31
---------------------------------------------
---------------------------------------------
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 Nine Month
Period Period Period
Ending Ending Ending
September September September
30, 2009 30, 2008 30, 2009
$ $ $
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OPERATING ACTIVITIES
Net loss for the period (2,693,992) (4,140,832) (10,986,395)
Deduct non-cash items
Amortization - intellectual
property - 90,375 180,750
Amortization - property and
equipment 15,772 11,853 49,612
Stock based compensation 7,982 17,339 28,163
Other non-cash items - - -
Net changes in non-cash working
capital 60,253 (1,217,916) (1,517,967)
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(2,609,985) (5,239,181) (12,245,837)
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INVESTING ACTIVITIES
Capital assets (1,325) (10,927) (4,674)
Purchase of short-term
investments - (62,435) -
Redemption of short-term
investments - 9,813,364 5,846,634
Investment in BCY
LifeSciences Inc. - - -
Investment in Transition
Therapeutics Inc. - - -
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(1,325) 9,740,002 5,841,960
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options 342,570 - 715,835
Proceeds from acquisition
of private company - 1,800,120
Proceeds from private placements - - -
Proceeds from public offerings (59,893) - 6,112,746
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282,677 - 8,628,701
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Increase (decrease) in cash and
cash equivalents during the
period (2,328,633) 4,500,821 2,224,824
Cash and cash equivalents,
beginning of the period 11,893,352 8,179,341 7,429,895
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Cash and cash equivalents,
end of the period 9,654,719 12,680,162 9,654,719
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Cumulative
from
Nine Month inception
Period on April 2,
Ending 1998 to
September September
30, 2008 30, 2009
$ $
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OPERATING ACTIVITIES
Net loss for the period (12,789,735) (113,543,146)
Deduct non-cash items
Amortization - intellectual
property 271,125 3,615,000
Amortization - property and
equipment 35,233 546,763
Stock based compensation 54,955 4,797,007
Other non-cash items - 1,383,537
Net changes in non-cash working
capital (35,573) 2,750,154
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(12,463,995) (100,450,685)
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INVESTING ACTIVITIES
Capital assets (69,672) (818,418)
Purchase of short-term
investments (314,631) (49,416,864)
Redemption of short-term
investments 18,813,364 48,998,380
Investment in BCY
LifeSciences Inc. - 464,602
Investment in Transition
Therapeutics Inc. - 2,532,343
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18,429,061 1,760,043
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options - 16,016,903
Proceeds from acquisition
of private company - 1,800,120
Proceeds from private placements - 38,137,385
Proceeds from public offerings - 52,390,953
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- 108,345,361
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Increase (decrease) in cash and
cash equivalents during the
period 5,965,066 9,654,719
Cash and cash equivalents,
beginning of the period 6,715,096 -
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Cash and cash equivalents,
end of the period 12,680,162 9,654,719
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To view the 2009 Third 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 third 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 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 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.
SOURCE Oncolytics Biotech Inc.
Released November 5, 2009