CALGARY, March 14, 2013 /CNW/ - 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, 2012. "We were very pleased to present our first randomized clinical data from our head and neck cancer clinical study in 2012," said Dr. Brad Thompson, President and CEO of Oncolytics. "In addition, in order to support our program, which now includes seven randomized studies in different indications, we completed two financings over the last 14 months raising gross proceeds in excess of $50 million." Selected Highlights Since January 1, 2012, the Company has made a number of significant announcements including: Clinical Trial Results -- Reporting initial positive top line data from the first endpoint in the double-blinded randomized Phase III clinical study examining REOLYSIN(®) in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018). The endpoint examined initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study and was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators; -- Reaching the primary endpoint in the first stage of a U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021) and subsequently reporting positive percent overall tumour shrinkage data; -- Poster presentations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics reporting positive clinical data from a study in 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 (REO 016) and a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN( )in combination with gemcitabine (Gemzar(®)) in patients with advanced pancreatic cancer (REO 017); -- Publication of a paper entitled "Cell Carriage, Delivery, and Selective Replication of an Oncolytic Virus in Tumor in Patients," in the June 13,( )2012 issue of the journal Science Translational Medicine (Vol. 4 Issue 138 138ra77), covering findings 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. The researchers found that intravenously-administered reovirus could specifically target and infect metastatic liver tumors in 90% of the patients, even though all patients treated had had a pre-existing immunity to the virus; Clinical Trial Program -- Expansion of enrollment in the first stage of a Phase III head and neck cancer clinical trial (REO 18) to include 167 patients and introduction of an additional patient segregation to differentiate between patients with local recurrent disease, with or without metastases, and patients with distal metastases while maintaining the blind; -- Completion of patient enrollment in a U.S. Phase 2 clinical trial evaluating 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 (REO 016); -- Completion of patient enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar(®)) in patients with advanced or metastatic pancreatic cancer (REO 017); -- Completion of enrollment in a U.K. Phase I clinical trial using intravenously-administered REOLYSIN in combination with cyclophosphamide in patients with advanced malignancies (REO 012); -- Completion of enrollment in a U.S. Phase 1 clinical trial using intravenously-administered REOLYSIN in combination with FOLFIRI in patients with colorectal cancer (REO 022); -- Entry into multiple agreements whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct randomized Phase II studies of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer, advanced or metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer, and advanced or metastatic breast cancer; Management -- Appointment of Mr. Kirk Look to the role of Chief Financial Officer; -- Appointment of Dr. Alan Tuchman to the role of Chief Medical Officer and Senior Vice President, Clinical and Medical Development; Financial -- Closing of a bought deal financing in February 2012, which was increased post-announcement from $15 million to $18.5 million, for gross proceeds of $21.3 million following the full exercise of the over-allotment option by the syndicate of underwriters; and -- Subsequent to year-end, closing of an underwritten public offering of 8.0 million common shares, at a public offering price of US$4.00 per common share for aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, of approximately US$32.0 million. ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION December 31, December 31, 2012 2011 $ $ Assets Current assets Cash and cash equivalents 19,323,541 32,918,751 Short-term investments 1,969,228 1,936,787 Accounts receivable 44,979 55,392 Prepaid expenses 331,094 721,576 Total current assets 21,668,842 35,632,506 Non-current assets Property and equipment 409,248 392,111 Total non-current assets 409,248 392,111 Total assets 22,078,090 36,024,617 Liabilities And Shareholders' Equity Current Liabilities Accounts payable and accrued 7,291,310 6,504,238 liabilities Total current liabilities 7,291,310 6,504,238 Shareholders' equity Share capital Authorized: unlimited Issued: December 31, 2012 - 76,710,285 December 31, 2011 - 71,251,335 198,155,091 177,282,566 Warrants 376,892 2,653,627 Contributed surplus 24,126,265 21,142,519 Accumulated other comprehensive loss (57,115) (117,501) Accumulated deficit (207,814,353) (171,440,832) Total shareholders' equity 14,786,780 29,520,379 Total liabilities and equity 22,078,090 36,024,617 ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS 2012 2011 2010 For the years ending $ $ $ December 31, Expenses Research and development 31,402,625 23,386,685 13,882,565 Operating 5,285,425 5,334,582 6,003,870 Loss before the following (36,688,050) (28,721,267) (19,886,435) Write down of asset — (735,681) — available for sale Change in fair value of — 36,000 (4,841,949) warrant liability Interest 345,003 416,247 76,934 Loss before income taxes (36,343,047) (29,004,701) (24,651,450) Income tax expense (30,474) (40,000) (7,611) Net loss (36,373,521) (29,044,701) (24,659,061) Other comprehensive gain 60,386 39,159 (156,660) (loss) - translation adjustment Net comprehensive loss (36,313,135) (29,005,542) (24,815,721) Basic and diluted loss per (0.48) (0.41) (0.39) common share Weighted average number of 76,102,062 70,911,526 62,475,403 shares (basic and diluted) ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY Accumulated Other Comprehensive Share Contributed Accumulated Capital Warrants Surplus Income Deficit Total $ $ $ $ $ $ As at 155,439,610 4,108,652 19,399,489 (156,660) (142,396,131) 36,394,960 December 31, 2010 Net loss and — — — 39,159 (29,044,701) (29,005,542) comprehensive income Exercise of 21,487,080 (1,455,025) — — — 20,032,055 warrants Exercise of 355,876 — (62,473) — — 293,403 stock options Share based — — 1,805,503 — — 1,805,503 compensation As at 177,282,566 2,653,627 21,142,519 (117,501) (171,440,832) 29,520,379 December 31, 2011 Net loss and — — — 60,386 (36,373,521) (36,313,135) comprehensive income Issued, 19,386,903 376,892 — — — 19,763,795 pursuant to a bought deal financing Expiry of — (2,653,627) 2,653,627 — — — warrants Exercise of 1,485,622 — (400,632) — — 1,084,990 stock options Share based — — 730,751 — — 730,751 compensation As at 198,155,091 376,892 24,126,265 (57,115) (207,814,353) 14,786,780 December 31, 2012 ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS For the years ending 2012 2011 2010 December 31, $ $ $ Operating Activities Net loss for the year (36,373,521) (29,044,701) (24,659,061) Amortization - property 109,275 92,590 63,156 and equipment Share based compensation 730,751 1,805,503 3,251,041 Change in fair value of — (36,000) 4,841,949 warrant liability Write down of asset — 735,681 — available for sale Unrealized foreign 89,890 115,234 343,821 exchange loss Net change in non-cash 1,187,967 3,790,510 (1,717,978) working capital Cash used in operating (34,255,638) (22,541,183) (17,877,072) activities Investing Activities Acquisition of property (126,412) (257,790) (81,846) and equipment Acquisition of investment — — (51,681) Redemption (purchase) of (32,441) 1,672,459 (1,929,309) short-term investments Cash provided by (used in) (158,853) 1,414,669 (2,062,836) investing activities Financing Activities Proceeds from exercise of 1,084,990 14,824,658 528,211 stock options and warrants Proceeds from public 19,763,795 — 26,759,921 offering Cash provided by financing 20,848,785 14,824,658 27,288,132 activities Increase (decrease) in (13,565,706) (6,301,856) 7,348,224 cash Cash and cash equivalents, 32,918,751 39,296,682 32,448,939 beginning of year Impact of foreign exchange (29,504) (76,075) (500,481) on cash and cash equivalents Cash and cash equivalents, 19,323,541 32,918,751 39,296,682 end of year To view the Company's Fiscal 2012 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.comand 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 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. The Equicom Group Nick Hurst 300 - 5th Ave. SW, 10th Floor Calgary, Alberta T2P 3C4 Tel: 403.218.2835 Fax: 403.218.2830 firstname.lastname@example.org Dian Griesel, Inc. Susan Forman 396 West Broadway, 2nd Floor New York, NY 10012 Tel: 212.825.3210 Fax: 212.825.3229 email@example.com SOURCE: Oncolytics Biotech Inc. To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/March2013/14/c4836.html CO: Oncolytics Biotech Inc. ST: Alberta NI: BTC ERN -0- Mar/14/2013 10:30 GMT
Oncolytics Biotech® Inc. Announces 2012 Year End Results
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