Oncolytics Biotech® Inc. Announces Third Quarter 2011 Results
CALGARY, Nov. 10, 2011 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended September 30, 2011.
"During the quarter we achieved significant increases in the number of enrolling countries in the first stage of our Phase III head and neck cancer study," said Dr. Brad Thompson, President and CEO of Oncolytics. "We currently have approval to conduct the trial in 12 countries in North America and Europe and are focusing on completing enrolment for this stage."
Selected Highlights
Since July 1, 2011, the Company has made a number of significant announcements:
Clinical Trial Results
- The presentation of interim preliminary results from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. As of the presentation date, response evaluation in 21 patients showed six partial responses (PR) (28.6%), 13 stable disease (SD) (61.9%) and two progressive disease (PD) (9.5%), translating into a clinical benefit rate (complete response (CR) + PR + SD) of 90.5% and a response rate (CR + PR) of 28.6%;
Preclinical Program
- The posting of a study in the online version of Molecular Therapy, a publication of The American Society of Gene and Cell Therapy, investigating the timing of chemotherapy delivery that optimizes the efficacy of systemic REOLYSIN. The paper, authored by Kottke et al., was entitled "Precise Scheduling of Chemotherapy Primes VEGF-producing Tumors for Successful Systemic Oncolytic Virotherapy." It describes when best to administer taxanes with reovirus to optimize viral delivery to the tumor mass. The researchers demonstrated that this drug combination yielded superior results to either treatment alone. They were able to reproducibly cure nearly half of the treated animals by employing this optimized schedule of paclitaxel/REOLYSIN;
Corporate
- The appointment of Gerard Kennealey, MD as Senior Vice President of Clinical Development and Chief Medical Officer (CMO). Dr. Kennealey most recently held the position of Vice President of Scientific Affairs at Cephalon Inc.; and
- The appointment of George M. Gill, MD as Senior Vice President of Regulatory Affairs and Chief Safety Officer. Dr. Gill has been an officer of Oncolytics since 2002.
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) |
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As at, | September 30, 2011 $ |
December 31, 2010 $ |
January 1, 2010 $ |
|
Assets | ||||
Current assets | ||||
Cash and cash equivalents | 40,243,302 | 39,296,682 | 32,448,939 | |
Short-term investments | 1,929,306 | 3,609,246 | 1,679,937 | |
Accounts receivable | 77,511 | 284,988 | 64,787 | |
Prepaid expenses | 533,149 | 278,934 | 507,408 | |
Total current assets | 42,783,268 | 43,469,850 | 34,701,071 | |
Non-current assets | ||||
Property and equipment | 269,580 | 226,911 | 208,320 | |
Long term investment | - | - | 684,000 | |
Total non-current assets | 269,580 | 226,911 | 892,320 | |
Asset held for sale | - | 735,681 | - | |
Total assets | 43,052,848 | 44,432,442 | 35,593,391 | |
Liabilities And Shareholders' Equity | ||||
Current Liabilities | ||||
Accounts payable and accrued liabilities | 3,477,615 | 2,500,682 | 4,226,933 | |
Warrant liability | - | 5,536,800 | 1,023,051 | |
Total current liabilities | 3,477,615 | 8,037,482 | 5,249,984 | |
Shareholders' equity | ||||
Share capital | ||||
Authorized: unlimited Issued: September 30, 2011 - 71,239,918 December 31, 2010 - 67,958,302 January 1, 2010 - 61,549,969 |
177,240,848 |
155,439,610 |
131,908,274 |
|
Warrants | 2,653,627 | 4,108,652 | 2,437,460 | |
Contributed surplus | 19,572,183 | 19,399,489 | 13,734,743 | |
Accumulated other comprehensive loss | (127,916) | (156,660) | - | |
Deficit | (159,763,509) | (142,396,131) | (117,737,070) | |
Total shareholders' equity | 39,575,233 | 36,394,960 | 30,343,407 | |
Total liabilities and equity | 43,052,848 | 44,432,442 | 35,593,391 |
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) |
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Three Month Period Ending September 30, 2011 $ |
Three Month Period Ending September 30, 2010 $ |
Nine Month Period Ending, September 30, 2011 $ |
Nine Month Period Ending, September 30, 2010 $ |
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Expenses | |||||||
Research and development | 5,315,134 | 2,711,392 | 13,769,876 | 8,990,422 | |||
Operating | 1,019,335 | 1,307,640 | 3,214,969 | 3,419,889 | |||
6,334,469 | 4,019,032 | 16,984,845 | 12,410,311 | ||||
Loss before the following | (6,334,469) | (4,019,032) | (16,984,845) | (12,410,311) | |||
Write down of asset available for sale | - | - | (735,681) | - | |||
Change in fair value of warrant liability | - | (2,521,950) | 36,000 | (2,672,439) | |||
Interest | 102,445 | 17,759 | 317,148 | 36,882 | |||
Loss before income taxes | (6,232,024) | (6,523,223) | (17,367,378) | (15,045,868) | |||
Income taxes | - | - | - | - | |||
Net loss | (6,232,024) | (6,523,223) | (17,367,378) | (15,045,868) | |||
Other comprehensive loss (gain) - translation adjustment |
(9,587) | (7,749) | 28,744 | (128,778) | |||
Net comprehensive loss | (6,241,611) | (6,530,972) | (17,338,634) | (15,174,646) | |||
Basic and diluted loss per share | (0.09) | (0.11) | (0.25) | (0.24) | |||
Weighted average number of shares (basic and diluted) |
71,221,218 | 61,570,046 | 70,800,114 | 61,558,859 |
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) |
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For the nine month period ending, September 30, 2011 | ||||||
Share capital | Contributed Surplus |
Warrants | Accumulated Other Comprehensive Income |
Deficit | Total Equity | |
$ | $ | $ | $ | $ | $ | |
As at December 31, 2010 | 155,439,610 | 19,399,489 | 4,108,652 | (156,660) | (142,396,131) | 36,394,960 |
Net loss and comprehensive loss for the period | — | — | — | 28,744 | (17,367,378) | (17,338,634) |
Exercise of warrants | 21,487,080 | — | (1,455,025) | — | — | 20,032,055 |
Exercise of stock options | 314,158 | (51,831) | — | — | — | 262,327 |
Stock based compensation | — | 224,525 | — | — | — | 224,525 |
As at September 30, 2011 | 177,240,848 | 19,572,183 | 2,653,627 | (127,916) | (159,763,509) | 39,575,233 |
For the nine month period ending, September 30, 2010 | ||||||
Share capital | Contributed Surplus |
Warrants | Accumulated Other Comprehensive Income |
Deficit | Total Equity | |
$ | $ | $ | $ | $ | $ | |
As at January 1, 2010 | 131,908,274 | 13,734,743 | 2,437,460 | — | (117,737,070) | 30,343,407 |
Net loss and comprehensive loss for the period | — | — | — | (128,778) | (15,045,868) | (15,174,646) |
Expired warrants | — | 2,438,000 | (2,438,000) | — | — | — |
Exercise of stock options | 83,812 | (20,987) | — | — | — | 62,825 |
Stock based compensation | — | 400,103 | — | — | — | 400,103 |
Other | — | — | 540 | — | — | 540 |
As at September 30, 2010 | 131,992,086 | 16,551,859 | — | (128,778) | (132,782,938) | 15,632,229 |
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
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Three Month Period Ending September 30, 2011 $ |
Three Month Period Ending September 30, 2010 $ |
Nine Month Period Ending, September 30, 2011 $ |
Nine Month Period Ending, September 30, 2010 $ |
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Cash Flows | ||||||
Operating Activities | ||||||
Net loss for the period | (6,232,024) | (6,523,223) | (17,367,378) | (15,045,868) | ||
Amortization - property and equipment | 21,258 | 15,981 | 68,525 | 45,487 | ||
Stock based compensation | 181,183 | 397,675 | 224,525 | 400,103 | ||
Change in fair value of warrant liability | - | 2,521,950 | (36,000) | 2,672,439 | ||
Write down of asset available for sale | - | - | 735,681 | - | ||
Unrealized foreign exchange loss (gain) | (121,391) | 204,241 | 98,736 | 84,591 | ||
Net change in non-cash working capital | (427,319) | (1,582,647) | 930,195 | (2,374,876) | ||
Cash used in operating activities | (6,578,293) | (4,966,023) | (15,345,716) | (14,218,124) | ||
Investing Activities | ||||||
Redemption (purchase) of short-term investments | - | (1,929,937) | 1,679,940 | (1,929,937) | ||
Acquisition of property and equipment | (62,087) | (8,701) | (111,194) | (52,199) | ||
Cash provided by (used in) investing activities | (62,087) | (1,938,638) | 1,568,746 | (1,982,136) | ||
Financing Activities | ||||||
Proceeds from exercise of stock options and warrants | 54,985 | 8,825 | 14,793,582 | 62,825 | ||
Cash provided by financing activities | 54,985 | 8,825 | 14,793,582 | 62,825 | ||
Increase (decrease) in cash | (6,585,395) | (6,895,836) | 1,016,612 | (16,137,435) | ||
Cash and cash equivalents, beginning of period | 46,640,231 | 23,205,961 | 39,296,682 | 32,448,939 | ||
Impact of foreign exchange on cash and cash equivalents | 188,466 | (211,990) | (69,992) | (213,369) | ||
Cash and cash equivalents, end of period | 40,243,302 | 16,098,135 | 40,243,302 | 16,098,135 |
To view the Company's Third Quarter 2011 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 3 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 2011 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.
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