Oncolytics Biotech® 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.”

Selected Highlights

Since January 1, 2011, the Company has made a number of significant
announcements:

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);

Manufacturing

• 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;

Preclinical Program

• 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;

Financial

• 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;

Corporate

• 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
				December 31,			December 31,			January 1,
				2011			2010			2010
				$			$			$
Assets
Current assets
Cash and cash equivalents				32,918,751			39,296,682			32,448,939
Short-term investments				1,936,787			3,609,246			1,679,937
Accounts receivable				55,392			284,988			64,787
Prepaid expenses				721,576			278,934			507,408
Total current assets				35,632,506			43,469,850			34,701,071
Non-current assets
Property and equipment				392,111			226,911			208,320
Long term investment				—			—			684,000
Total non-current assets				392,111			226,911			892,320
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 and accrued liabilities				6,504,238			2,500,682			4,226,933
Warrant liability				—			5,536,800			1,023,051
Total current liabilities				6,504,238			8,037,482			5,249,984
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 comprehensive loss				(117,501)			(156,660)			—
Accumulated deficit				(171,440,832)			(142,396,131)			(117,737,070)
Total shareholders’ equity				29,520,379			36,394,960			30,343,407
Total liabilities and equity				36,024,617			44,432,442			35,593,391

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 sale			(735,681)				—
Change in fair value of warrant liability			36,000				(4,841,949)
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) – translation adjustment			39,159				(156,660)
Net comprehensive loss			(29,005,542)				(24,815,721)
Basic and diluted loss per common share			(0.41)				(0.39)
Weighted average number of shares (basic and diluted)			70,911,526				62,475,403

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
		Share Capital		Warrants		Contributed Surplus		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
		$		$		$		$		$		$
As at January 1, 2010		131,908,274		2,437,460		13,734,743		—		(117,737,070)		30,343,407
Net loss and comprehensive loss		—		—		—		(156,660)		(24,659,061)		(24,815,721)
Issue of common shares, public offering		22,639,719		4,120,201		—		—		—		26,759,920
Exercise of warrants		787,508		(11,009)		—		—		—		776,499
Exercise of stock options		104,109		—		(24,295)		—		—		79,814
Expired warrants		—		(2,438,000)		2,438,000		—		—		—
Share based compensation		—		—		3,251,041		—		—		3,251,041
As at December 31, 2010		155,439,610		4,108,652		19,399,489		(156,660)		(142,396,131)		36,394,960
Net loss and comprehensive income		—		—		—		39,159		(29,044,701)		(29,005,542)
Exercise of warrants		21,487,080		(1,455,025)		—		—		—		20,032,055
Exercise of stock options		355,876		—		(62,473)		—		—		293,403
Share based compensation		—		—		1,805,503		—		—		1,805,503
As at December 31, 2011		177,282,566		2,653,627		21,142,519		(117,501)		(171,440,832)		29,520,379

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 equipment			92,590				63,156
		Share based compensation			1,805,503				3,251,041
		Change in fair value of warrant liability			(36,000)				4,841,949
		Write down of asset available for sale			735,681				—
		Unrealized foreign exchange loss			115,234				343,821
Net change in non-cash working capital					3,790,510				(1,717,978)
Cash used in operating activities					(22,541,183)				(17,877,072)
Investing Activities
Acquisition of property and equipment					(257,790)				(81,846)
Acquisition of investment					—				(51,681)
Redemption (purchase) of short-term investments					1,672,459				(1,929,309)
Cash provided by (used in) investing activities					1,414,669				(2,062,836)
Financing Activities
Proceeds from exercise of stock options and warrants					14,824,658				528,211
Proceeds from public offering					—				26,759,921
Cash provided by financing activities					14,824,658				27,288,132
Increase (decrease) in cash					(6,301,856)				7,348,224
Cash and cash equivalents, beginning of year					39,296,682				32,448,939
Impact of foreign exchange on cash and cash equivalents					(76,075)				(500,481)
Cash and cash equivalents, end of year					32,918,751				39,296,682

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.