CALGARY, May 12 /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 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.
| ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) | ||||||||||||||||||
| 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 | |||||||||||||||
| ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) | ||||||||||
| 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 | ||||||||
| ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) | ||||||||||||||||||||
| 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 | ||||||||||||||
