CALGARY, July 29 /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 June 30, 2010.
“We have recently passed a number of key milestones in our clinical program, most notably the opening of enrollment in our Phase 3 head and neck cancer study, the expansion of the study to other jurisdictions internationally, and the reporting of positive results from an earlier study with an emphasis on squamous cell carcinoma of the head and neck,” said Dr. Brad Thompson, President and CEO of Oncolytics. “While our Phase 3 study remains our primary focus, we have also successfully expanded our clinical program to include other indications as REOLYSIN(R) may be effective in treating a variety of cancers.”
Selected Highlights
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Since April 1, 2010 the Company has announced:
Clinical Trial Results
- A poster presentation at the American Society of Clinical Oncology
2010 Annual Meeting, entitled "A Phase I/II study of oncolytic
reovirus plus carboplatin/paclitaxel in patients with advanced
solid cancers with emphasis on squamous cell carcinoma of the head
and neck (SCCHN)," showing that of 19 head and neck cancer
patients evaluable for response, eight (42%) had partial responses
and six (32%) had stable disease; mean overall survival in 24
treated head and neck cancer patients was more than eight months;
- Publication of a paper entitled "Two-Stage Phase I Dose-Escalation
Study of Intratumoural Reovirus Type 3 Dearing and Palliative
Radiotherapy in Patients with Advanced Cancers," in the online
version of the journal Clinical Cancer Research that showed that
100% of 14 evaluable patients were stable disease or better (7
partial responses, and 7 stable disease);
- A poster presentation at the American Association for Cancer
Research's 101st Annual Meeting in Washington, DC entitled
"Reovirus replication in ovarian and peritoneal tumors after
intravenous administration," covering correlative results from a
Phase 1/2 study with reovirus in patients with ovarian, primary
peritoneal and fallopian tube carcinoma, sponsored by the National
Cancer Institute under its Clinical Trials Agreement with
Oncolytics;
Clinical Program
- Opening of enrollment in the Phase 3 trial examining REOLYSIN in
combination with paclitaxel and carboplatin in patients with
platinum-refractory head and neck cancers;
- Receipt of a No Objection Letter from Health Canada to conduct its
Phase 3 trial examining REOLYSIN in combination with paclitaxel
and carboplatin in patients with platinum-refractory head and neck
cancers;
- Receipt of approval from the Belgian Federal Agency for Medicines
and Health Products (FAMHP) to conduct its Phase 3 trial examining
REOLYSIN in combination with paclitaxel and carboplatin in
patients with platinum-refractory head and neck cancers;
- Start of enrollment in a U.S. Phase 2 clinical trial using
intravenous administration of REOLYSIN in combination with
gemcitabine (Gemzar(R)) in patients with advanced pancreatic
cancer at the Cancer Therapy & Research Center at the University
of Texas Health Science Center in San Antonio;
- Poster presentations at the ASCO 2010 Annual Meeting covering the
structures of a "Phase II study of reovirus with paclitaxel (P)
and carboplatin (C) in patients with metastatic non-small cell
lung cancer (NSCLC) who have Kras or EGFR-activated tumors" and a
"Phase I/II trial of reovirus serotype 3-Dearing strain in
patients with recurrent ovarian cancer";
- The decision to initiate a U.S. Phase I study of REOLYSIN in
combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil
(5-FU) + Irinotecan) in patients with oxaliplatin
refractory/intolerant Kras mutant colorectal cancer (REO 022);
- 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);
Preclinical 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;
- 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; and
Intellectual Property
- Grant of the Company's 35th U.S. Patent, # 7,731,951 entitled
"Viruses for the Treatment of Cellular Proliferative Disorders."
The patent claims cover methods for treating cell proliferative
disorders by administering modified vaccinia virus to
proliferating cells having an activated Ras-pathway.
Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at,
June 30, December 31,
2010 2009
$ $
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ASSETS
Current
Cash and cash equivalents 23,205,961 32,448,939
Short-term investments 1,679,937 1,679,937
Accounts receivable 58,645 64,787
Prepaid expenses 718,418 507,408
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25,662,961 34,701,071
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Property and equipment 222,312 208,320
Long term investment 684,000 684,000
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26,569,273 35,593,391
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 3,639,572 4,226,933
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Shareholders' equity
Share capital
Authorized: unlimited number of common shares
Issued: 61,569,969
(December 31, 2009 - 61,549,969) 131,980,274 131,908,274
Warrants 2,073,441 4,511,441
Contributed surplus 16,157,171 13,734,743
Deficit (127,281,185) (118,788,000)
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22,929,701 31,366,458
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26,569,273 35,593,391
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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, 2010 30, 2009 30, 2010
$ $ $
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Revenue
Rights revenue - - -
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- - -
Expenses
Research and development 3,561,168 3,239,210 6,400,481
Operating 1,133,319 980,721 2,082,743
Stock based compensation 1,399 8,544 2,428
Foreign exchange loss/(gain) (349,229) 3,103 (2,850)
Amortization - intellectual
property - 90,375 -
Amortization - property and
equipment 14,621 16,536 29,506
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4,361,278 4,338,489 8,512,308
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Loss before the following: 4,361,278 4,338,489 8,512,308
Interest income (9,304) (3,732) (19,123)
Gain on sale of BCY LifeSciences Inc. - - -
Loss on sale of Transition
Therapeutics Inc. - - -
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Loss before income taxes 4,351,974 4,334,757 8,493,185
Future income tax recovery - - -
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Net loss and comprehensive loss
for the period 4,351,974 4,334,757 8,493,185
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Basic and diluted loss per share 0.07 0.09 0.14
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Weighted average number of shares
(basic and diluted) 61,556,343 47,449,182 61,553,173
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Cumulative
from
inception
Six Month on April 2,
Period 1998 to
Ending June June 30,
30, 2009 2010
$ $
-----------------------------------------------------------
Revenue
Rights revenue - 310,000
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- 310,000
Expenses
Research and development 6,051,865 92,538,772
Operating 1,967,485 30,702,275
Stock based compensation 20,181 5,195,545
Foreign exchange loss/(gain) 59,138 766,293
Amortization - intellectual
property 180,750 3,615,000
Amortization - property and
equipment 33,840 591,587
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8,313,259 133,409,472
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Loss before the following: 8,313,259 133,099,472
Interest income (20,856) (6,582,569)
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 8,292,403 128,374,185
Future income tax recovery - (1,093,000)
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Net loss and comprehensive loss
for the period 8,292,403 127,281,185
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-----------------------------------------------------------
Basic and diluted loss per share 0.18
---------------------------------------------
---------------------------------------------
Weighted average number of shares
(basic and diluted) 45,659,353
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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, 2010 30, 2009 30, 2010
$ $ $
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OPERATING ACTIVITIES
Net loss for the period (4,351,974) (4,334,757) (8,493,185)
Deduct non-cash items
Amortization - intellectual
property - 90,375 -
Amortization - property and
equipment 14,621 16,536 29,506
Stock based compensation 1,399 8,544 2,428
Other non-cash items (415,280) - (46,483)
Net changes in non-cash working
capital 384,452 (1,414,201) (792,229)
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(4,366,782) (5,633,503) (9,299,963)
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INVESTING ACTIVITIES
Capital assets (39,851) - (43,498)
Purchase of short-term
investments - - -
Redemption of short-term
investments - 1,925,600 -
Investment in BCY LifeSciences Inc. - - -
Investment in Transition
Therapeutics Inc. - - -
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(39,851) 1,925,600 (43,498)
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options 54,000 351,835 54,000
Proceeds from acquisition of
private company - 1,800,120 -
Proceeds from private placements - - -
Proceeds from public offerings - 6,172,819 -
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54,000 8,324,774 54,000
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(Decrease) increase in
cash and cash equivalents
during the period (4,352,633) 4,616,871 (9,289,461)
Impact of foreign exchange on
cash and cash equivalents 415,280 - 46,483
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Cash and cash equivalents,
beginning of the period 27,143,314 7,366,481 32,448,939
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Cash and cash equivalents,
end of the period 23,205,961 11,983,352 23,205,961
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Cumulative
from
inception
Six Month on April 2,
Period 1998 to
Ending June June 30,
30, 2009 2010
$ $
-----------------------------------------------------------
OPERATING ACTIVITIES
Net loss for the period (8,292,403) (127,281,185)
Deduct non-cash items
Amortization - intellectual
property 180,750 3,615,000
Amortization - property and
equipment 33,840 591,587
Stock based compensation 20,181 5,195,545
Other non-cash items - 1,447,854
Net changes in non-cash working
capital (1,578,220) 2,862,509
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(9,635,852) (113,568,690)
-----------------------------------------------------------
INVESTING ACTIVITIES
Capital assets (3,349) (866,566)
Purchase of short-term
investments - (51,096,801)
Redemption of short-term
investments 5,846,634 48,998,380
Investment in BCY LifeSciences Inc. - 464,602
Investment in Transition
Therapeutics Inc. - 2,532,343
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5,843,285 31,958
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FINANCING ACTIVITIES
Proceeds from exercise of
warrants and stock options 373,085 30,565,278
Proceeds from acquisition of
private company 1,800,120 1,800,120
Proceeds from private placements - 38,137,385
Proceeds from public offerings 6,172,819 66,320,777
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8,346,024 136,823,560
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(Decrease) increase in
cash and cash equivalents
during the period 4,553,457 23,286,828
Impact of foreign exchange on
cash and cash equivalents - (80,867)
-----------------------------------------------------------
Cash and cash equivalents,
beginning of the period 7,429,895 -
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Cash and cash equivalents,
end of the period 11,983,352 23,205,961
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To view the Company’s Second 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 July 29, 2010