EX-99.1 2 q3-2012pressrelease.htm THIRD QUARTER 2012 PRESS RELEASE EX 99.1 Q3 - 2012 Press Release


 
 
210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7

FOR IMMEDIATE RELEASE
 
Oncolytics Biotech® Inc. Announces Third Quarter 2012 Results
 
CALGARY, AB, November 8, 2012 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the quarter ended September 30, 2012.
 
“We continue to make progress across the entire breadth of our clinical program and completed enrolment in multiple trials this quarter,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Our near term focus remains on completing the initial follow-up on the expanded 167 patient group enrolled in the REO 018 study so that we can receive our first randomized clinical data for REOLYSIN®.”

Selected Highlights
During the quarter the Company has made a number of significant announcements:

Management
Appointment Dr. Alan Tuchman to the role of Chief Medical Officer and Senior Vice President, Clinical and Medical Development.
 
Clinical Trial Program

Expanded enrollment in the first stage of our Phase III head and neck cancer clinical trial (REO 18) to include 167 patients, all of whom have now been enrolled, and introduced 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;

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);

Completion of enrolment in a U.K. Phase I clinical trial using intravenously-administered REOLYSIN in combination with cyclophosphamide in patients with advanced malignancies (REO 012); and

Completion of enrolment in a U.S. Phase I clinical trial using intravenously-administered REOLYSIN in combination with FOLFIRI in patients with colorectal cancer (REO 022).








Since September 30, 2012, the Company also announced completion of patient enrolment in a U.S. Phase II clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017).
 
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

September 30,
December 31,

2012
$
2011
$
Assets
 

 

Current assets
 

 

Cash and cash equivalents
26,007,318

32,918,751

Short-term investments
1,969,228

1,936,787

Accounts receivable
89,842

55,392

Prepaid expenses
592,927

721,576

Total current assets
28,659,315

35,632,506

Non-current assets
 

 

Property and equipment
426,983

392,111

Total non-current assets
426,983

392,111

 
 
 
Total assets
29,086,298

36,024,617

Liabilities And Shareholders’ Equity
 

 

Current Liabilities
 

 

Accounts payable and accrued liabilities
6,711,147

6,504,238

Total current liabilities
6,711,147

6,504,238

Shareholders’ equity
 

 

Share capital
  Authorized: unlimited
  Issued:
 
 
   September 30, 2012 - 76,661,085
 
 
   December 31, 2011 – 71,251,335
198,049,608

177,282,566

Warrants
3,030,519

2,653,627

Contributed surplus
20,700,110

21,142,519

Accumulated other comprehensive loss
(83,022
)
(117,501
)
Accumulated deficit
(199,322,064
)
(171,440,832
)
Total shareholders’ equity
22,375,151

29,520,379

Total liabilities and equity
29,086,298

36,024,617







  






ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)


Three Month Period Ending September 30, 2012
$
Three Month Period Ending September 30, 2011
$
Nine Month Period Ending September 30, 2012
$
Nine Month Period Ending September 30, 2011
$
Expenses
 
 
 

 

Research and development
8,129,328

5,315,134

24,673,201

13,769,876

Operating
1,175,227

1,019,335

3,485,368

3,214,969

Operating loss
(9,304,555
)
(6,334,469
)
(28,158,569
)
(16,984,845
)
Write down of asset available for sale



(735,681
)
Change in fair value of warrant liability



36,000

Interest
74,053

102,445

287,509

317,148

Loss before income taxes
(9,230,502
)
(6,232,024
)
(27,871,060
)
(17,367,378
)
Income tax expense
(13,400
)

(10,172
)

Net loss
(9,243,902
)
(6,232,024
)
(27,881,232
)
(17,367,378
)
Other comprehensive (loss) income - translation adjustment
(47,462
)
(9,587
)
34,479

28,744

Net comprehensive loss
(9,291,364
)
(6,241,611
)
(27,846,753
)
(17,338,634
)
Basic and diluted loss per common share
(0.12
)
(0.09
)
(0.37
)
(0.25
)
Weighted average number of shares (basic and diluted)
76,607,281

71,221,218

75,903,566

70,800,114

   












ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
 

Three Month Period Ending September 30, 2012
$
Three Month Period Ending September 30, 2011
$
Nine Month Period Ending September 30, 2012
$
Nine Month Period Ending September 30, 2011
$

 
 
 
 
Operating Activities
 
 
 

 

Net loss for the period
(9,243,902
)
(6,232,024
)
(27,881,232
)
(17,367,378
)
  Amortization - property and equipment
26,422

21,258

83,993

68,525

  Share based compensation
(121,685
)
181,183

(49,489
)
224,525

  Change in fair value of warrant liability



(36,000
)
  Write down of asset available for sale



735,681

  Unrealized foreign exchange loss
983

(121,391
)
17,145

98,736

Net change in non-cash working capital
1,514,620

(427,319
)
301,108

930,195

Cash used in operating activities
(7,823,562
)
(6,578,293
)
(27,528,475
)
(15,345,716
)
Investing Activities
 
 
 

 

Acquisition of property and equipment
(25,238
)
(62,087
)
(118,865
)
(111,194
)
Purchase of short-term investments


(32,441
)
1,679,940

Cash used in investing activities
(25,238
)
(62,087
)
(151,306
)
1,568,746

Financing Activities
 
 
 

 

Proceeds from exercise of stock options and warrants
101,750

54,985

987,219

14,793,582

Proceeds from public offering


19,763,795


Cash provided by financing activities
101,750

54,985

20,751,014

14,793,582

Increase in cash
(7,747,050
)
(6,585,395
)
(6,928,767
)
1,016,612

Cash and cash equivalents, beginning of period
33,802,813

46,640,231

32,918,751

39,296,682

Impact of foreign exchange on cash and cash equivalents
(48,445
)
188,466

17,334

(69,992
)
Cash and cash equivalents, end of period
26,007,318

40,243,302

26,007,318

40,243,302




To view the Company's Third Quarter 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.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 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.
 
FOR FURTHER INFORMATION PLEASE CONTACT:
 

The Equicom Group
Nick Hurst
300 - 5th Ave. SW, 10th Floor
Calgary, Alberta T2P 3C4
Tel: 403.218.2835
nhurst@equicomgroup.com
Dian Griesel Inc.
Tom Caden
398 West Broadway, 2nd Floor
New York, NY 10012
Tel: 212.825.3210
tcaden@dgicomm.com
 


 
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