CALGARY, Nov. 4 /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, 2008.
Recent Pivotal Trial Decision
Oncolytics made a decision in early November to pursue a pivotal (Phase II/III) randomized trial using the combination of REOLYSIN(R) with paclitaxel/carboplatin in refractory patients with head and neck cancers. The decision was made following a review of results by the Company’s Board of Directors from the Company’s ongoing U.K. Phase I and Phase II combination REOLYSIN(R) and paclitaxel/carboplatin clinical trials. The results were presented November 1, 2008 at the International Society for Biological Therapy of Cancer (iSBTc) annual meeting in San Diego, CA.
Selected Third Quarter Highlights:
- Treatment of the 200th patient in clinical studies with REOLYSIN(R);
- Completion of patient enrolment in the dose escalation portion of its
U.K. clinical trial to evaluate the anti-tumour effects of systemic
administration of REOLYSIN(R) in combination with docetaxel
(Taxotere(R)) in patients with advanced cancers including bladder,
prostate, lung and upper gastro-intestinal;
- The U.S. National Cancer Institute (NCI), part of the National
Institutes of Health, started enrolment in a Phase II clinical trial
for patients with metastatic melanoma using systemic administration
of REOLYSIN(R);
- The start of patient enrolment in a U.S. Phase II clinical trial
using intravenous administration of REOLYSIN(R) in combination with
paclitaxel and carboplatin in patients with advanced head and neck
cancers;
- Initiation of a U.S. Phase II clinical trial using intravenous
administration of REOLYSIN(R) in combination with paclitaxel and
carboplatin in patients with NSCLC with K-RAS or EGFR-activated
tumours;
- The grant of the Company's 28th U.S. patent which covers methods of
purifying reassorted reovirus from an FDA-approved cell line.
Latest Highlights
Subsequent to quarter end, the Company announced:
- Eight of nine refractory head and neck cancer patients treated to
date have experienced either a partial response or stabilization of
disease in our Phase I and Phase II U.K. combination REOLYSIN(R) and
carboplatin/paclitaxel trials;
- Nine of eleven evaluable patients have experienced stable disease or
better for at least four cycles in our U.K. combination REOLYSIN(R)
and docetaxel trial;
- The selection of refractory head and neck cancers for the Company's
first pivotal trial;
- Results of two preclinical studies which demonstrated synergy in
vitro and in vivo with the combination of REOLYSIN(R) and
chemotherapy;
- Results of a preclinical study demonstrating that a single IV
administration of ReoT3D can result in substantial tumor growth delay
in melanoma-bearing nude mice;
- The grant of the Company's 29th U.S. patent, which covers methods of
selectively removing cancer cells ex vivo from blood stem cells and
other organs using reovirus; and,
- Successful completion of initial scale-up of its manufacturing
process for REOLYSIN(R) to the 100L commercial scale from the current
40L level.
Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
September 30, December 31,
2008 2007
$ $
(Restated)
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ASSETS
Current
Cash and cash equivalents 12,680,162 6,715,096
Short-term investments - 18,498,733
Accounts receivable 47,891 80,085
Prepaid expenses 307,697 260,300
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13,035,750 25,554,214
Property and equipment 235,542 201,103
Intellectual property 271,125 542,250
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13,542,417 26,297,567
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 2,800,857 2,821,227
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Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 41,180,748 (December 31, 2007
- 41,180,748) 92,759,665 92,759,665
Warrants 5,346,260 5,346,260
Contributed surplus 10,431,917 10,376,962
Deficit (97,796,282) (85,006,547)
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10,741,560 23,476,340
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13,542,417 26,297,567
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Cumulative
from
Three Month Three Month Nine Month Nine Month inception
Period Period Period Period on April 2,
Ending Ending Ending Ending 1998 to
September September September September September
30, 2008 30, 2007 30, 2008 30, 2007 30, 2008
$ $ $ $ $
(Restated) (Restated) (Restated)
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Revenue
Rights
revenue - - - - 310,000
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- - - - 310,000
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Expenses
Research
and
develop-
ment 3,210,294 3,134,340 9,650,595 9,621,760 70,750,311
Operating 880,438 812,939 3,250,830 2,711,962 23,856,466
Stock based
compen-
sation 17,339 38,909 54,955 142,878 4,759,760
Foreign
exchange
loss/gain 29,026 18,917 (20,059) 2,829 637,651
Amortization
- intellec-
tual
property 90,375 90,375 271,125 271,125 3,343,875
Amortization
- property
and
equipment 11,853 10,197 35,233 30,061 483,630
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4,239,325 4,105,677 13,242,679 12,780,615 103,831,693
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Loss
before
the
follow-
ing: 4,239,325 4,105,677 13,242,679 12,780,615 103,521,693
Interest
income (98,493) (319,221) (452,944) (946,826) (6,467,693)
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 4,140,832 3,786,456 12,789,735 11,833,789 98,911,282
Future
income
tax
recovery - - - - (1,115,000)
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Net loss
and
compre-
hensive
loss for
the
period 4,140,832 3,786,456 12,789,735 11,833,789 97,796,282
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Basic and
diluted
loss per
share 0.10 0.09 0.31 0.29
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Weighted
average
number of
shares
(basic
and
diluted) 41,180,748 41,120,748 41,180,748 40,181,777
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Cumulative
from
Three Month Three Month Nine Month Nine Month inception
Period Period Period Period on April 2,
Ending Ending Ending Ending 1998 to
September September September September September
30, 2008 30, 2007 30, 2008 30, 2007 30, 2008
$ $ $ $ $
(Restated) (Restated) (Restated)
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OPERATING
ACTIVITIES
Net loss
for the
period (4,140,832) (3,786,456) (12,789,735) (11,833,789) (97,796,282)
Deduct
non-cash
items
Amorti-
zation -
intel-
lectual
property 90,375 90,375 271,125 271,125 3,343,875
Amorti-
zation -
property
and
equip-
ment 11,853 10,197 35,233 30,061 483,630
Stock
based
compen-
sation 17,339 38,909 54,955 142,878 4,759,760
Other
non-cash
items - - - - 1,383,537
Net changes
in non-cash
working
capital (1,217,916) 316,534 (35,573) (46,262) 2,445,269
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(5,239,181) (3,330,441) (12,463,995) (11,435,987) (85,380,211)
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INVESTING
ACTIVITIES
Capital
assets (10,927) (11,386) (69,672) (49,691) (771,839)
Purchase
of short-
term
investments (62,435) (255,688) (314,631) (742,853) (49,383,594)
Redemption
of short-
term
invest-
ments 9,813,364 - 18,813,364 - 48,965,110
Investment
in BCY
LifeSciences
Inc. - - - - 464,602
Investment
in
Transition
Therapeutics
Inc. - - - - 2,532,343
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9,740,002 (267,074) 18,429,061 (792,544) 1,806,622
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FINANCING
ACTIVITIES
Proceeds
from
exercise
of
warrants
and stock
options - - - - 15,259,468
Proceeds
from
private
placements - - - - 38,137,385
Proceeds
from
public
offerings - - - 12,063,394 42,856,898
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- - - 12,063,394 96,253,751
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Increase
(decrease)
in cash
and cash
equiva-
lents
during
the
period 4,500,821 (3,597,515) 5,965,066 (165,137) 12,680,162
Cash and
cash
equiva-
lents,
beginning
of the
period 8,179,341 6,923,889 6,715,096 3,491,511 -
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Cash and
cash
equiva-
lents,
end of
the
period 12,680,162 3,326,374 12,680,162 3,326,374 12,680,162
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To view the 2008 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 Phase I/II and Phase II human trials using REOLYSIN(R), 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(R) as a cancer therapeutic; the Company’s expectations as to the success of its research and development programs in 2008 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(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN(R), 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 4, 2008