Oncolytics Biotech(R) Inc. Announces 2011 Year End Results
CALGARY, March 15, 2012 /PRNewswire/ – 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, 2011.
“In the last year we made substantial progress as we announced positive
clinical trial results and started clinical trials in additional cancer
indications while maintaining the strength of our balance sheet,” said
Dr. Brad Thompson, President and CEO of Oncolytics. “Our primary focus
in the near term remains completing enrollment in the first stage of
our Phase III study in head and neck cancers with the support of an
increasing number of enrolling centres in Europe and North America.”
Since January 1, 2011, the Company has made a number of significant
Clinical Trial Results
-- Presented interim data from a Phase II clinical trial using intravenous administration of REOLYSIN®in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017) indicating that the clinical study had successfully reached its primary endpoint, and that the drug combination was active. Eight patients of 13 evaluable patients in the study had stable disease (SD) for 12 weeks or longer, for a clinical benefit rate (complete response (CR) + partial response (PR) + SD) of 62%. An additional patient had an unconfirmed PR of less than six weeks. 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; -- Presented positive results from a Phase II clinical trial (REO 015) using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Of the 13 patients evaluable for response, four had PRs, for an objective response rate of 31%. Six patients had SD or better for 12 weeks or longer for a disease control rate (SD or better) of 46%. Two of the four patients with PRs and both patients with SD had received prior treatment with taxanes; -- The presentation of interim preliminary results from a Phase II 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 PR (28.6%), 13 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%; -- 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
-- Entry into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer enrolling up to 80 patients; -- Agreement with the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, to sponsor a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma; -- 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 II 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 II clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers (REO 015);
-- SAFC®, a Division of Sigma-Aldrich Corporation, commenced validation activities designed to demonstrate the manufacturing process for the commercial production of REOLYSIN is robust and reproducible; -- A commercial supply agreement with SAFC for the commercial manufacture of REOLYSIN. Under the terms of the agreement, SAFC will perform process validation of the product, will continue to supply clinical requirements and will supply commercial material upon approval of the product;
-- 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;
-- Closed bought deal financing, that had been increased to $18.5 million from $15 million, for gross proceeds of $21.3 million following the full exercise of the over-allotment option by the syndicate of underwriters; -- 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; -- 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;
-- 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 December31, December31, January1, 2011 2010 2010 $ $ $ Assets Current assets Cash and cash 32,918,751 39,296,682 32,448,939 equivalents Short-term 1,936,787 3,609,246 1,679,937 investments Accounts receivable 55,392 284,988 64,787 Prepaid expenses 721,576 278,934 507,408 Total current 35,632,506 43,469,850 34,701,071 assets Non-current assets Property and 392,111 226,911 208,320 equipment Long term -- -- 684,000 investment Total non-current 392,111 226,911 892,320 assets Asset held for sale -- 735,681 -- Total assets 36,024,617 44,432,442 35,593,391 Liabilities And Shareholders' Equity Current Liabilities Accounts payable 6,504,238 2,500,682 4,226,933 and accrued liabilities Warrant liability -- 5,536,800 1,023,051 Total current 6,504,238 8,037,482 5,249,984 liabilities Shareholders' equity Share capital Authorized: unlimited Issued: December 31, 2011 - 71,251,335 December 31, 2010 - 67,958,302 January 1, 2010 - 61,549,969 177,282,566 155,439,610 131,908,274 Warrants 2,653,627 4,108,652 2,437,460 Contributed surplus 21,142,519 19,399,489 13,734,743 Accumulated other (117,501) (156,660) -- comprehensive loss Accumulated deficit (171,440,832) (142,396,131) (117,737,070) Totalshareholders' 29,520,379 36,394,960 30,343,407 equity Totalliabilities 36,024,617 44,432,442 35,593,391 and equity
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS 2011 2010 For the years ending December 31, $ $ Expenses Research and development 23,386,685 13,882,565 Operating 5,334,582 6,003,870 Loss before the following (28,721,267) (19,886,435) Write down of asset available for (735,681) -- sale Change in fair value of warrant 36,000 (4,841,949) liability Interest 416,247 76,934 Loss before income taxes (29,004,701) (24,651,450) Income tax expense (40,000) (7,611) Net loss (29,044,701) (24,659,061) Other comprehensive gain (loss) - 39,159 (156,660) translation adjustment Net comprehensive loss (29,005,542) (24,815,721) Basic and diluted loss per common (0.41) (0.39) share Weighted average number of shares 70,911,526 62,475,403 (basic and diluted)
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY Accumulated Other Contributed Comprehensive Accumulated ShareCapital Warrants Surplus Income Deficit Total $ $ $ $ $ $ As at January 131,908,274 2,437,460 13,734,743 -- (117,737,070) 30,343,407 1, 2010 Net loss and -- -- -- (156,660) (24,659,061) (24,815,721) comprehensive loss Issue of 22,639,719 4,120,201 -- -- -- 26,759,920 common shares, public offering Exercise of 787,508 (11,009) -- -- -- 776,499 warrants Exercise of 104,109 -- (24,295) -- -- 79,814 stock options Expired -- (2,438,000) 2,438,000 -- -- -- warrants Share based -- -- 3,251,041 -- -- 3,251,041 compensation 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
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS 2011 2010 For the years ending December 31, $ $ Operating Activities Net loss for the year (29,044,701) (24,659,061) Amortization - property and 92,590 63,156 equipment Share based compensation 1,805,503 3,251,041 Change in fair value of warrant (36,000) 4,841,949 liability Write down of asset available for 735,681 -- sale Unrealized foreign exchange loss 115,234 343,821 Net change in non-cash working 3,790,510 (1,717,978) capital Cash used in operating activities (22,541,183) (17,877,072) Investing Activities Acquisition of property and (257,790) (81,846) equipment Acquisition of investment -- (51,681) Redemption (purchase) of short-term 1,672,459 (1,929,309) investments Cash provided by (used in) 1,414,669 (2,062,836) investing activities Financing Activities Proceeds from exercise of stock 14,824,658 528,211 options and warrants Proceeds from public offering -- 26,759,921 Cash provided by financing 14,824,658 27,288,132 activities Increase (decrease) in cash (6,301,856) 7,348,224 Cash and cash equivalents, 39,296,682 32,448,939 beginning of year Impact of foreign exchange on cash (76,075) (500,481) and cash equivalents Cash and cash equivalents, end of 32,918,751 39,296,682 year
To view the Company’s Fiscal 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 2012 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.