EX-99.1 2 ex991pressreleaseq32013.htm THIRD QUARTER 2013 PRESS RELEASE EX99.1 Press Release Q3 2013


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


FOR IMMEDIATE RELEASE
 
Oncolytics Biotech® Inc. Announces Third Quarter 2013 Results
 
CALGARY, AB, November 7, 2013 --- 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, 2013.
 
“In recent months we have reported positive data in our squamous cell and non-squamous cell lung clinical trials both in terms of tumour response and survival,” said Dr. Brad Thompson, President and CEO of Oncolytics. “On the strength of this reported data, we intend to conduct randomized clinical studies in these indications that will further expand our lung cancer program.”

Selected Highlights
 
Since June 30, 2013, the Company has made a number of announcements including:
 
Clinical Trial Results
•
Reporting positive final results from a U.S. Phase 2 study examining the use of REOLYSIN® in combination with carboplatin and paclitaxel in patients with stage IV non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016). Response evaluation for 36 evaluable patients showed 11 partial responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras, three; EGFR mutated, one), 21 stable disease (SD), and four progressive disease (PD). The data also correlated a number of molecular abnormalities with best response, progression free survival (PFS) and one-year survival. Current data in these patients demonstrates that 20 of 36 evaluable patients (56%) survived a year or more. There were 13 patients with only EGFR mutations or amplifications, of whom nine (69.2%) survived a year or longer. Four of four (100%) patients with BRAF and EGFR amplification survived a year or longer; and

•
Reporting final tumour response and progression free survival (“PFS”) data from 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). Of the 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumour shrinkage. When evaluated for best response, which is the best percentage response recorded on study compared to baseline, 10 patients (40%) had partial responses (PRs), while a further 14 (56%) showed stable disease (SD), and one (4%), had progressive disease (PD). Using RECIST criteria to evaluate best overall response, 10 patients (40%) had partial responses (PRs), 12 (48%) showed stable disease (SD) and three (12%), had progressive disease (PD).  31.8% of patients with sufficient follow up had a PFS greater than six months.





ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
 
September 30,
2013
$
December 31, 2012
$
Assets
 

 

Current assets
 

 

Cash and cash equivalents
29,472,201

19,323,541

Short-term investments
2,001,644

1,969,228

Accounts receivable
35,402

44,979

Prepaid expenses
471,318

331,094

Total current assets
31,980,565

21,668,842

Non-current assets
 

 

Property and equipment
568,711

409,248

Total non-current assets
568,711

409,248

 
 
 
Total assets
32,549,276

22,078,090

Liabilities And Shareholders’ Equity
 

 

Current Liabilities
 

 

Accounts payable and accrued liabilities
4,913,395

7,291,310

Total current liabilities
4,913,395

7,291,310

Shareholders’ equity
 

 

Share capital
  Authorized: unlimited
  Issued:
 
 
   September 30, 2013 – 84,758,818
 
 
   December 31, 2012 – 76,710,285
228,513,564

198,155,091

Warrants
376,892

376,892

Contributed surplus
24,282,934

24,126,265

Accumulated other comprehensive loss
17,011

(57,115
)
Accumulated deficit
(225,554,520
)
(207,814,353
)
Total shareholders’ equity
27,635,881

14,786,780

Total liabilities and equity
32,549,276

22,078,090









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

 
Three Month Period Ending September 30, 2013
$
Three Month Period Ending September 30, 2012
$
Nine Month Period Ending September 30, 2013
$
Nine Month Period Ending September 30, 2012
$
Expenses
 
 
 

 

Research and development
5,001,972

8,129,328

13,923,323

24,673,201

Operating
1,222,157

1,175,227

4,107,650

3,485,368

Operating loss
(6,224,129
)
(9,304,555
)
(18,030,973
)
(28,158,569
)
Interest
110,479

74,053

290,806

287,509

Loss before income taxes
(6,113,650
)
(9,230,502
)
(17,740,167
)
(27,871,060
)
Income tax expense
—

(13,400
)
—

(10,172
)
Net loss
(6,113,650
)
(9,243,902
)
(17,740,167
)
(27,881,232
)
Other comprehensive income items that may be
  reclassified to net loss
 
 
 
 
Translation adjustment
(33,513
)
(47,462
)
74,126

34,479

Net comprehensive loss
(6,147,163
)
(9,291,364
)
(17,666,041
)
(27,846,753
)
Basic and diluted loss per common share
(0.07
)
(0.12
)
(0.21
)
(0.37
)
Weighted average number of shares (basic and
diluted)
84,758,818

76,607,281

83,112,919

75,903,566

  





ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
 
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
—

—

—

34,479

(27,881,232
)
(27,846,753
)
Issued, pursuant to a bought deal financing
19,386,903

—

376,892

—

—

19,763,795

Exercise of stock options
1,380,139

(392,920
)
—

—

—

987,219

 
 
 
 
 
 
 
Share based compensation
—

(49,489
)
—

—

—

(49,489
)
As at September 30, 2012
198,049,608

20,700,110

3,030,519

(83,022
)
(199,322,064
)
22,375,151

 
 
 
 
 
 
 
 
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
—

—

—

74,126

(17,740,167
)
(17,666,041
)
Issued, pursuant to a bought deal financing
30,218,797

—

—

—

—

30,218,797

Exercise of stock options
139,676

(34,687
)
—

—

—

104,989

 
 
 
 
 
 
 
Share based compensation
—

191,356

—

—

—

191,356

As at September 30, 2013
228,513,564

24,282,934

376,892

17,011

(225,554,520
)
27,635,881

    









ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
 
 
Three Month Period Ending September 30, 2013
$
Three Month Period Ending September 30, 2012
$
Nine Month Period Ending September 30, 2013
$
Nine Month Period Ending September 30, 2012
$
 
 
 
 
 
Operating Activities
 
 
 

 

Net loss for the period
(6,113,650
)
(9,243,902
)
(17,740,167
)
(27,881,232
)
  Amortization - property and equipment
41,205

26,422

91,351

83,993

  Share based compensation
(59,497
)
(121,685
)
191,356

(49,489
)
  Unrealized foreign exchange loss (gain)
34,179

983

(63,670
)
17,145

Net change in non-cash working capital
(412,109
)
1,514,620

(2,508,562
)
301,108

Cash used in operating activities
(6,509,872
)
(7,823,562
)
(20,029,692
)
(27,528,475
)
Investing Activities
 
 
 

 

Acquisition of property and equipment
(103,512
)
(25,238
)
(250,814
)
(118,865
)
Purchase of short-term investments
—

—

(32,416
)
(32,441
)
Cash used in investing activities
(103,512
)
(25,238
)
(283,230
)
(151,306
)
Financing Activities
 
 
 

 

Proceeds from exercise of stock options and warrants
—

101,750

104,989

987,219

Proceeds from public offering
—

—

30,218,797

19,763,795

Cash provided by financing activities
—

101,750

30,323,786

20,751,014

Increase in cash
(6,613,384
)
(7,747,050
)
10,010,864

(6,928,767
)
Cash and cash equivalents, beginning of period
36,153,277

33,802,813

19,323,541

32,918,751

Impact of foreign exchange on cash and cash equivalents
(67,692
)
(48,445
)
137,796

17,334

Cash and cash equivalents, end of period
29,472,201

26,007,318

29,472,201

26,007,318


To view the Company's Fiscal 2013 Third 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.
 
FOR FURTHER INFORMATION PLEASE CONTACT:
 

The Equicom Group
Nick Hurst
300 - 5th Ave. SW, 10th Floor
Calgary, Alberta T2P 3C4
Tel: 403.218.2835
Fax: 403.218.2830
nhurst@tmxequicom.com
Dian Griesel, Inc.
Susan Forman
335 West 38th Street, 3rd Floor
New York, NY 10018
Tel: 212.825.3210
Fax: 212.825.3229
sforman@dgicomm.com
 
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