CALGARY, May 12 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended March 31, 2011.
"In order to maximize the future commercial potential for REOLYSIN®, we continue to expand and advance our clinical program through a combination of our own trials and sponsored initiatives that allow us to cost effectively expand the scope of our clinical work," said Dr. Brad Thompson, President and CEO of Oncolytics. "In the quarter we reported positive results from multiple trials and our strengthened balance sheet will enable us to expand the number of randomized studies we are running in 2011."
Selected Highlights
Since January 1, 2011 the Company has announced:
Clinical Trial Results
- Preliminary results from a U.S. Phase 2 clinical trial (REO 017) using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. Seventeen evaluable patients with pancreatic cancer were expected to be treated in the first stage and if three or more patients received clinical benefit, the study would then proceed to the next stage. This endpoint was met after six evaluable patients were enrolled;
- Completion of enrollment and interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. On initial histological analysis of the 10 treated patients, there was evidence of selective delivery of virus to tumour versus normal liver and viral replication in the majority (seven) of patients;
Ongoing Clinical Program
- The opening of enrollment in a U.S. Phase 1 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);
- Start of enrollment in a 2-Arm randomized Phase 2 study of carboplatin, paclitaxel plus REOLYSIN versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer sponsored by the NCI;
- Completion of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers (REO 015);
Financial
- Pursuant to the acceleration of the expiry date of those warrants issued on November 23, 2009, the Company received proceeds of approximately US$6.8 million resulting from the exercise of 1,943,000 warrants; and
- The exercise of 1,322,750 warrants, issued in connection with the financing that closed on November 8, 2010, providing the Company with proceeds of approximately $8.2 million.
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ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) |
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| As at, |
March 31, 2011 $ |
December 31, 2010 $ |
January 1, 2010 $ |
|||||||||||||||
| Assets | ||||||||||||||||||
| Current assets | ||||||||||||||||||
| Cash and cash equivalents | 49,912,873 | 39,296,682 | 32,448,939 | |||||||||||||||
| Short-term investments | 3,609,246 | 3,609,246 | 1,679,937 | |||||||||||||||
| Accounts receivable | 72,653 | 284,988 | 64,787 | |||||||||||||||
| Prepaid expenses | 389,839 | 278,934 | 507,408 | |||||||||||||||
| Total current assets | 53,984,611 | 43,469,850 | 34,701,071 | |||||||||||||||
| Non-current assets | ||||||||||||||||||
| Property and equipment | 224,912 | 226,911 | 208,320 | |||||||||||||||
| Long term investments | — | — | 684,000 | |||||||||||||||
| Total non-current assets | 224,912 | 226,911 | 892,320 | |||||||||||||||
| Asset held for sale | 735,681 | 735,681 | — | |||||||||||||||
| Total assets | 54,945,204 | 44,432,442 | 35,593,391 | |||||||||||||||
| Liabilities And Shareholders' Equity | ||||||||||||||||||
| Current Liabilities | ||||||||||||||||||
| Accounts payable and accrued liabilities | 2,339,270 | 2,500,682 | 4,226,933 | |||||||||||||||
| Warrant liability | 5,536,800 | 1,023,051 | ||||||||||||||||
| Total current liabilities | 2,339,270 | 8,037,482 | 5,249,984 | |||||||||||||||
| Shareholders' equity | ||||||||||||||||||
|
Share capital |
||||||||||||||||||
| Authorized: unlimited | ||||||||||||||||||
| Issued: | ||||||||||||||||||
| March 31, 2011 - 71,207,318 | ||||||||||||||||||
| December 31, 2010 - 67,958,302 | ||||||||||||||||||
| January 1, 2010 - 61,549,969 | 177,147,062 | 155,439,610 | 131,908,274 | |||||||||||||||
| Warrants | 2,653,627 | 4,108,652 | 2,437,460 | |||||||||||||||
| Contributed surplus | 19,366,032 | 19,399,489 | 13,734,743 | |||||||||||||||
| Accumulated other comprehensive loss | (193,540) | (156,660) | — | |||||||||||||||
| Deficit | (146,367,247) | (142,396,131) | (117,737,070) | |||||||||||||||
| Total shareholders' equity | 52,605,934 | 36,394,960 | 30,343,407 | |||||||||||||||
| Total Liabilities And Equity | 54,945,204 | 44,432,442 | 35,593,391 | |||||||||||||||
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ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) |
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| For the three month period ending March 31, |
2011 $ |
2010 $ |
||||||||
| Expenses | ||||||||||
| Research and development | 2,971,611 | 3,041,814 | ||||||||
| Operating | 1,127,011 | 964,309 | ||||||||
| 4,098,622 | 4,006,123 | |||||||||
| Loss before the following | (4,098,622) | (4,006,123) | ||||||||
| Change in fair value of warrant liability | 36,000 | (541,489) | ||||||||
| Interest | 91,506 | 9,819 | ||||||||
| Loss before income taxes | (3,971,116) | (4,537,793) | ||||||||
| Income taxes | — | — | ||||||||
| Net loss | (3,971,116) | (4,537,793) | ||||||||
| Other comprehensive loss - translation adjustment | (36,880) | (144,907) | ||||||||
| Net comprehensive loss | (4,007,996) | (4,682,700) | ||||||||
| Basic and diluted loss per share | (0.06) | (0.07) | ||||||||
| Weighted average number of shares (basic and diluted) | 69,956,058 | 61,549,969 | ||||||||
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ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) |
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| For the three month period ending, March 31, 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 | — | — | — | (144,907) | (4,537,793) | (4,682,700) | ||||||||||||||
| Expired warrants | — | 2,438,000 | (2,438,000) | — | — | — | ||||||||||||||
| Stock based compensation | — | 1,029 | — | — | — | 1,029 | ||||||||||||||
| Other | — | — | 540 | — | — | 540 | ||||||||||||||
| As at March 31, 2010 | 131,908,274 | 16,173,772 | — | (144,907) | (122,274,863) | 25,662,276 | ||||||||||||||
| For the three month period ending, March 31, 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 | — | — | — | (36,880) | (3,971,116) | (4,007,996) | ||||||||||||||
| Exercise of warrants | 21,487,080 | — | (1,455,025) | — | — | 20,032,055 | ||||||||||||||
| Exercise of stock options | 220,372 | (36,330) | — | — | — | 184,042 | ||||||||||||||
| Stock based compensation | — | 2,873 | — | — | — | 2,873 | ||||||||||||||
| As at March 31, 2011 | 177,147,062 | 19,366,032 | 2,653,627 | (193,540) | (146,367,247) | 52,605,934 | ||||||||||||||
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ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
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| For the three month period ending March 31, |
2011 $ |
2010 $ |
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| Cash Flows | ||||||||||
| Operating Activities | ||||||||||
| Net loss for the period | (3,971,116) | (4,537,793) | ||||||||
| Amortization - property and equipment | 17,275 | 14,885 | ||||||||
| Stock based compensation | 2,873 | 1,029 | ||||||||
| Change in fair value of warrant liability | (36,000) | 541,489 | ||||||||
| Unrealized foreign exchange loss | 191,149 | 218,988 | ||||||||
| Net change in non-cash working capital | (59,982) | (1,176,681) | ||||||||
| Cash used in operating activities | (3,855,801) | (4,938,083) | ||||||||
| Investing Activities | ||||||||||
| Acquisition of property and equipment | (15,276) | (3,647) | ||||||||
| Cash used in investing activities | (15,276) | (3,647) | ||||||||
| Financing Activities | ||||||||||
| Proceeds from exercise of stock options and warrants | 14,715,297 | — | ||||||||
| Cash provided by financing activities | 14,715,297 | — | ||||||||
| Increase (decrease) in cash | 10,844,220 | (4,941,730) | ||||||||
| Cash and cash equivalents, beginning of period | 39,296,682 | 32,448,939 | ||||||||
| Impact of foreign exchange on cash and cash equivalents | (228,029) | (363,895) | ||||||||
| Cash and cash equivalents, end of period | 49,912,873 | 27,143,314 | ||||||||
To view the Company's First 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.
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