CALGARY, March 9 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the year ended December 31, 2009.
“In 2009, we executed on our business plan focused on preparing the Company for late stage clinical testing and ultimately commercial launch by making substantial clinical progress, strengthening our intellectual property position and balance sheet, and scaling up manufacturing to near commercial levels,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Our focus in the year ahead will be on advancing our first Phase 3 trial, which we expect to begin in the second quarter.”
Selected Highlights
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In the last 14 months the Company:
Clinical Trial Results
- Announced positive updated results from a U.K. Phase 1/2 combination
REOLYSIN(R) and paclitaxel/carboplatin trial for patients with
advanced head and neck cancers (REO 011). Of 19 evaluable patients
with head and neck cancer, mostly squamous cell carcinoma of the head
and neck refractory to prior platinum-based chemotherapy for
recurrent/metastatic disease, eight experienced partial responses
(PR) and six had stable disease (SD), for a clinical benefit rate
(complete response (CR) + PR + SD) of 74%;
- Presented updated U.S. Phase 2 sarcoma trial (REO 014) data at the
15th Annual Connective Tissue Oncology Society Meeting demonstrating
that 19 of 44 evaluable patients experienced stable disease ranging
from two to 20 months, resulting in a total clinical benefit rate of
43%;
- Announced positive results from a U.K. combination REOLYSIN and
docetaxel trial for patients with a variety of advanced cancers
(REO 010). 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%;
- Announced positive results of a U.K. Phase 2 REOLYSIN and radiation
combination clinical trial (REO 008). 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;
- Presented a poster at ASCO demonstrating that the combination of
REOLYSIN and gemcitabine in a U.K. Phase 1 trial (RE0 009) 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 and/or clinical
responses and five patients had SD for 4-8 cycles, for a total
disease control rate (CR+PR+SD) of 70%;
Clinical Program
- Completed 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;
- Received a letter of approval from the U.K. Medicines and Healthcare
products Regulatory Agency (MHRA) to conduct its Phase 3 trial
examining REOLYSIN in combination with paclitaxel and carboplatin in
patients with platinum-refractory head and neck cancers.
- Started patient enrolment in a U.S. Phase 2 Combination REOLYSIN and
paclitaxel/carboplatin clinical trial (REO 016) for patients with
non-small cell lung cancer with Kras 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
(REO 013) investigating REOLYSIN in patients with metastatic
colorectal cancer;
- Announced multi-trial clinical research collaboration with the Cancer
Therapy & Research Center (CTRC) at the University of Texas Health
Science Center involving up to five, open-label, Phase 2 studies
exploring the use of REOLYSIN in combination with chemotherapy for
various cancer indications. These indications are expected to include
melanoma, pancreatic cancer, squamous cell lung, liver and Kras
mutated colorectal cancers in combination with standard
chemotherapeutics;
- Started 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
CTRC;
Financial
- Announced the results of two warrant expiry date acceleration
programs for warrants generating proceeds of approximately
$14.9 million;
- Completed a public offering consisting of 3.45 million units at $2.00
per unit, for gross proceeds of $6.9 million;
- Completed a public offering consisting of 4,887,500 units at US$3.00
per unit, for gross proceeds of US$14.7 million;
- Completed the acquisition of an inactive private company with net
cash of $2.1 million by issuing 1,875,121 common shares;
Intellectual Property
- Announced 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;
- Announced the 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;
Manufacturing
- Completed of the lyophilized (freeze-dried) formulation development
program for REOLYSIN;
- Completed an initial 100-litre production run of REOLYSIN under cGMP
conditions; and
Management Team
- Appointed Dr. Alan Warrander to the role of Senior Vice President,
Global Licensing and Business Development.
Oncolytics Biotech Inc.
CONSOLIDATED BALANCE SHEETS
As at December 31
2009 2008
$ $
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ASSETS
Current
Cash and cash equivalents 32,448,939 7,429,895
Short-term investments 1,679,937 5,846,634
Accounts receivable 64,787 86,322
Prepaid expenses 507,408 179,668
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34,701,071 13,542,519
Property and equipment 208,320 263,926
Intellectual property - 180,750
Long term investment 684,000 -
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35,593,391 13,987,195
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 4,226,933 4,534,111
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Commitments and contingency
Shareholders' equity
Share capital
Authorized: unlimited
Issued: 61,549,969 (2008 - 43,830,748) 131,908,274 95,234,924
Warrants 4,511,441 3,425,110
Contributed surplus 13,734,743 13,349,801
Deficit (118,788,000) (102,556,751)
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31,366,458 9,453,084
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35,593,391 13,987,195
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the periods ended December 31
Cumulative
from inception
on April 2,
1998 to
December 31,
2009 2008 2007 2009
$ $ $ $
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Revenue
Rights revenue - - - 310,000
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- - - 310,000
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Expenses
Research and
development 11,606,514 13,351,875 12,385,743 86,138,291
Operating 3,782,507 4,311,575 3,826,195 28,619,532
Stock based
compensation 424,273 64,039 539,156 5,193,117
Foreign exchange
loss (gain) 179,716 (68,283) 8,862 769,143
Amortization -
intellectual
property 180,750 361,500 361,500 3,615,000
Amortization -
property and
equipment 64,930 48,754 40,714 562,081
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16,238,690 18,069,460 17,162,170 124,897,164
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Loss before
the following 16,238,690 18,069,460 17,162,170 124,587,164
Interest income (29,441) (519,256) (1,211,744) (6,563,446)
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 16,209,249 17,550,204 15,950,426 119,881,000
Income taxes 22,000 - - (1,093,000)
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Net loss and
comprehensive loss
for the period 16,231,249 17,550,204 15,950,426 118,788,000
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Basic and diluted
loss per
common share (0.33) (0.42) (0.39)
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Oncolytics Biotech Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the periods ended December 31
Cumulative
from inception
on April 2,
1998 to
December 31,
2009 2008 2007 2009
$ $ $ $
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OPERATING ACTIVITIES
Net loss and
comprehensive loss
for the period (16,231,249) (17,550,204) (15,950,426) (118,788,000)
Add/(deduct)
non-cash items
Amortization -
intellectual
property 180,750 361,500 361,500 3,615,000
Amortization -
property and
equipment 64,930 48,754 40,714 562,081
Stock based
compensation 424,273 64,039 539,156 5,193,117
Other non-cash
items 110,800 - - 1,494,337
Net change in
non-cash working
capital (613,383) 1,787,279 586,964 3,654,738
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Cash used in
operating
activities (16,063,879) (15,288,632) (14,422,092) (104,268,727)
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INVESTING ACTIVITIES
Acquisition of
property and
equipment (9,324) (111,577) (92,221) (823,068)
Purchase of
short-term
investments (1,679,937) (347,901) (949,496) (51,096,801)
Redemption of
short-term
investments 5,846,634 13,000,000 6,573,000 48,998,380
Investment in BCY
LifeSciences Inc. - - - 464,602
Investment in
Transition
Therapeutics Inc. - - - 2,532,343
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Cash provided by
investing
activities 4,157,373 12,540,522 5,531,283 75,456
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FINANCING ACTIVITIES
Proceeds from
exercise of stock
options and
warrants 15,210,210 41,600 51,000 30,511,278
Proceeds from
private placements - - - 38,137,385
Proceeds from
acquisition of
private company 1,800,120 - - 1,800,120
Proceeds from
public offerings 20,042,570 3,421,309 12,063,394 66,320,777
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Cash provided by
financing
activities 37,052,900 3,462,909 12,114,394 136,769,560
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Net increase in
cash and cash
equivalents
during the period 25,146,394 714,799 3,223,585 32,576,289
Impact of foreign
exchange on cash
and cash
equivalents (127,350) - - (127,350)
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Cash and cash
equivalents,
beginning of
period 7,429,895 6,715,096 3,491,511 -
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Cash and cash
equivalents, end
of period 32,448,939 7,429,895 6,715,096 32,448,939
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Cash interest
received 47,573 769,529 1,392,866
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To view the Company’s 2009 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s year end 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 March 9, 2010