Oncolytics Biotech(R) Inc. Announces Second Quarter 2013 Results
CALGARY, Aug. 1, 2013 /CNW/ - 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, 2013.
"We are pleased to continue to demonstrate positive clinical results with the recent announcement of a disease control rate of 71.5% in our metastatic melanoma study," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are ready to commence the data analysis of stage 1 of our head and neck trial as soon as we can and we continue to enroll patients in our six other randomized trials."
Selected Highlights
Clinical Trial Results
- Reached the stage 1 endpoint in stage 1 of the U.S. Phase 2 clinical trial in patients with metastatic melanoma (REO 020) after only 14 patients were enrolled. The primary objective of this Phase 2 trial was to assess the antitumour effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives were to assess progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus partial response (PR) plus stable disease (SD)) and duration, and to assess the safety and tolerability of the treatment regimen in the study population. Three of the 14 patients exhibited a PR, and an additional seven patients had SD for a disease control rate of 71.5%.
Clinical Trial Program
- Preparing to commence the data analysis of stage 1 of the randomized head and neck clinical study (REO 018) once sufficient patient events have occurred; and
Financial
- Exited the second quarter with over $36.1 million of cash, cash equivalents and short-term investments.
ONCOLYTICS BIOTECH INC. INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) |
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June 30, 2013 $ |
December 31, 2012 $ |
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Assets | |||||
Current assets | |||||
Cash and cash equivalents | 36,153,277 | 19,323,541 | |||
Short-term investments | 2,001,644 | 1,969,228 | |||
Accounts receivable | 46,740 | 44,979 | |||
Prepaid expenses | 558,918 | 331,094 | |||
Total current assets | 38,760,579 | 21,668,842 | |||
Non-current assets | |||||
Property and equipment | 506,404 | 409,248 | |||
Total non-current assets | 506,404 | 409,248 | |||
Total assets | 39,266,983 | 22,078,090 | |||
Liabilities And Shareholders' Equity | |||||
Current Liabilities | |||||
Accounts payable and accrued liabilities | 5,424,442 | 7,291,310 | |||
Total current liabilities | 5,424,442 | 7,291,310 | |||
Shareholders' equity | |||||
Share capital | |||||
Authorized: unlimited | |||||
Issued: | |||||
June 30, 2013 - 84,758,818 | |||||
December 31, 2012 - 76,710,285 | 228,513,564 | 198,155,091 | |||
Warrants | 376,892 | 376,892 | |||
Contributed surplus | 24,342,431 | 24,126,265 | |||
Accumulated other comprehensive loss | 50,524 | (57,115) | |||
Accumulated deficit | (219,440,870) | (207,814,353) | |||
Total shareholders' equity | 33,842,541 | 14,786,780 | |||
Total liabilities and equity | 39,266,983 | 22,078,090 | |||
ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) |
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Three Month Period Ending June 30, 2013 $ |
Three Month Period Ending June 30, 2012 $ |
Six Month Period Ending June 30, 2013 $ |
Six Month Period Ending June 30, 2012 $ |
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Expenses | |||||||
Research and development | 3,804,307 | 9,053,329 | 8,921,351 | 16,543,873 | |||
Operating | 1,320,742 | 1,222,090 | 2,885,493 | 2,310,141 | |||
Operating loss | (5,125,049) | (10,275,419) | (11,806,844) | (18,854,014) | |||
Interest | 105,368 | 93,389 | 180,327 | 213,456 | |||
Loss before income taxes | (5,019,681) | (10,182,030) | (11,626,517) | (18,640,558) | |||
Income tax expense | — | 3,228 | 3,228 | ||||
Net loss | (5,019,681) | (10,178,802) | (11,626,517) | (18,637,330) | |||
Other comprehensive income items that may be reclassified to net loss |
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Translation adjustment | 73,451 | 116,200 | 107,639 | 81,941 | |||
Net comprehensive loss | (4,946,230) | (10,062,602) | (11,518,878) | (18,555,389) | |||
Basic and diluted loss per common share | (0.06) | (0.13) | (0.14) | (0.25) | |||
Weighted average number of shares (basic and diluted) | 84,758,818 | 76,542,861 | 82,276,330 | 75,547,842 | |||
ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) |
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Share Capital | Contributed Surplus |
Warrants | Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total | ||||||
$ | $ | $ | $ | $ | $ | ||||||
As at December 31, 2011 | 177,282,566 | 21,142,519 | 2,653,627 | (117,501) | (171,440,832) | 29,520,379 | |||||
Net loss and comprehensive loss | — | — | — | 81,941 | (18,637,330) | (18,555,389) | |||||
Issued, pursuant to a bought deal financing | 19,386,903 | — | 376,892 | — | — | 19,763,795 | |||||
Exercise of stock options | 1,278,389 | (392,920) | — | — | — | 885,469 | |||||
Share based compensation | — | 72,196 | — | — | 72,196 | ||||||
As at June 30, 2012 | 197,947,858 | 20,821,795 | 3,030,519 | (35,560) | (190,078,162) | 31,686,450 | |||||
Share Capital | Contributed Surplus |
Warrants | Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total | ||||||
$ | $ | $ | $ | $ | $ | ||||||
As at December 31, 2012 | 198,155,091 | 24,126,265 | 376,892 | (57,115) | (207,814,353) | 14,786,780 | |||||
Net loss and comprehensive loss | — | — | — | 107,639 | (11,626,517) | (11,518,878) | |||||
Issued, pursuant to a public offering | 30,218,797 | — | — | — | — | 30,218,797 | |||||
Exercise of stock options | 139,676 | (34,687) | — | — | — | 104,989 | |||||
Share based compensation | — | 250,853 | — | — | 250,853 | ||||||
As at June 30, 2013 | 228,513,564 | 24,342,431 | 376,892 | 50,524 | (219,440,870) | 33,842,541 | |||||
ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
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Three Month Period Ending June 30, 2013 $ |
Three Month Period Ending June 30, 2012 $ |
Six Month Period Ending June 30, 2013 $ |
Six Month Period Ending June 30, 2012 $ |
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Operating Activities | |||||||
Net loss for the period | (5,019,681) | (10,178,802) | (11,626,517) | (18,637,330) | |||
Amortization - property and equipment | 25,565 | 29,510 | 50,146 | 57,571 | |||
Share based compensation | 129,997 | 58,343 | 250,853 | 72,196 | |||
Unrealized foreign exchange loss | 209,804 | 61,171 | (97,849) | 16,162 | |||
Net change in non-cash working capital | (455,283) | (1,174,059) | (2,096,453) | (1,213,512) | |||
Cash used in operating activities | (5,109,598) | (11,203,837) | (13,519,820) | (19,704,913) | |||
Investing Activities | |||||||
Acquisition of property and equipment | (132,164) | (61,695) | (147,302) | (93,627) | |||
Purchase of short-term investments | — | — | (32,416) | (32,441) | |||
Cash used in investing activities | (132,164) | (61,695) | (179,718) | (126,068) | |||
Financing Activities | |||||||
Proceeds from exercise of stock options and warrants |
— | 422,886 | 104,989 | 885,469 | |||
Proceeds from public offering | 11,735 | (31,648) | 30,218,797 | 19,763,795 | |||
Cash provided by financing activities | 11,735 | 391,238 | 30,323,786 | 20,649,264 | |||
Increase in cash | (5,230,027) | (10,874,294) | 16,624,248 | 818,283 | |||
Cash and cash equivalents, beginning of period | 41,519,657 | 44,622,078 | 19,323,541 | 32,918,751 | |||
Impact of foreign exchange on cash and cash equivalents |
(136,353) | 55,029 | 205,488 | 65,779 | |||
Cash and cash equivalents, end of period | 36,153,277 | 33,802,813 | 36,153,277 | 33,802,813 | |||
To view the Company's Fiscal 2013 Second Quarter 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/financials.
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 2013 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.
For further information:
The Equicom Group
Nick Hurst
300 - 5th Ave. SW, 10th Floor
Calgary, Alberta T2P 3C4
Tel: 403.218.2835
Fax: 403.218.2830
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New York, NY 10012
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Fax: 212.825.3229
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