EX-99.1 2 ex991secondquarter2012pres.htm SECOND QUARTER 2012 PRESS RELEASE EX 99.1 Second Quarter 2012 Press Release


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

FOR IMMEDIATE RELEASE
 
Oncolytics Biotech® Inc. Announces Second Quarter 2012 Results
 
CALGARY, AB, August 2, 2012 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the quarter ended June 30, 2012.
 
“Early in the quarter, we announced that we had completed enrollment in the first, 80-patient stage of our Phase III trial in head and neck cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We continued to make progress on this key clinical initiative during the quarter with our independent Data Monitoring Committee recommending the trial proceed based on a review of the safety data. We continue to await the results of an ongoing data review which will enable us to determine the next steps for the study.”

Selected Highlights
 
Since March 31, 2012, the Company has made a number of significant announcements:
 
Clinical Trial Program
•
Completion of enrollment in the first, 80-patient stage of its Phase III clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018);

•
Review by Company's independent Data Monitoring Committee (DMC) of the safety data for the first stage of the Company's Phase III trial in head and neck cancers and received a recommendation that enrollment continue in the study while awaiting the ongoing data review;

•
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 advanced or metastatic colorectal cancer enrolling up to 100 patients;

•
Entry into an agreement whereby the NCIC CTG will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic non-small cell lung cancer enrolling up to 150 patients;

•
Entry into an agreement whereby the NCIC CTG will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic breast cancer enrolling up to 100 patients; and






Clinical Trial Results
•
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.


ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

June 30,
December 31,

2012
$
2011
$
Assets
 

 

Current assets
 

 

Cash and cash equivalents
33,802,813

32,918,751

Short-term investments
1,969,228

1,936,787

Accounts receivable
89,574

55,392

Prepaid expenses
699,348

721,576

Total current assets
36,560,963

35,632,506

Non-current assets
 

 

Property and equipment
428,167

392,111

Total non-current assets
428,167

392,111

 
 
 
Total assets
36,989,130

36,024,617

Liabilities And Shareholders’ Equity
 

 

Current Liabilities
 

 

Accounts payable and accrued liabilities
5,302,680

6,504,238

Total current liabilities
5,302,680

6,504,238

Shareholders’ equity
 

 

Share capital
  Authorized: unlimited
  Issued:
 
 
   June 30, 2012 – 76,606,085
 
 
   December 31, 2011 – 71,251,335
197,947,858

177,282,566

Warrants
3,030,519

2,653,627

Contributed surplus
20,821,795

21,142,519

Accumulated other comprehensive loss
(35,560
)
(117,501
)
Accumulated deficit
(190,078,162
)
(171,440,832
)
Total shareholders’ equity
31,686,450

29,520,379

Total liabilities and equity
36,989,130

36,024,617






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


Three Month Period Ending June 30, 2012
$
Three Month Period Ending June 30, 2011
$
Six Month Period Ending June 30, 2012
$
Six Month Period Ending June 30, 2011
$
Expenses
 
 
 

 

Research and development
9,053,329

5,483,131

16,543,873

8,454,742

Operating
1,222,090

1,068,623

2,310,141

2,195,634

Operating loss
(10,275,419
)
(6,551,754
)
(18,854,014
)
(10,650,376
)
Write down of asset available for sale
—

(735,681
)
—

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

—

—

36,000

Interest
93,389

123,197

213,456

214,703

Loss before income taxes
(10,182,030
)
(7,164,238
)
(18,640,558
)
(11,135,354
)
Income tax expense
3,228

—

3,228

—

Net loss
(10,178,802
)
(7,164,238
)
(18,637,330
)
(11,135,354
)
Other comprehensive loss (income) - translation adjustment
116,200

(75,211
)
81,941

(38,331
)
Net comprehensive loss
(10,062,602
)
(7,239,449
)
(18,555,389
)
(11,173,685
)
Basic and diluted loss per common share
(0.13
)
(0.10
)
(0.25
)
(0.16
)
Weighted average number of shares (basic and diluted)
76,542,861

71,209,164

75,547,842

70,586,073








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

Three Month Period Ending June 30, 2012
$
Three Month Period Ending June 30, 2011
$
Six Month Period Ending June 30, 2012
$
Six Month Period Ending June 30, 2011
$

 
 
 
 
Operating Activities
 
 
 

 

Net loss for the period
(10,178,802
)
(7,164,238
)
(18,637,330
)
(11,135,354
)
  Amortization - property and equipment
29,510

29,992

57,571

47,267

  Share based compensation
58,343

40,469

72,196

43,342

  Change in fair value of warrant liability
—

—

—

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

735,681

—

735,681

  Unrealized foreign exchange loss
61,171

28,978

16,162

220,127

Net change in non-cash working capital
(1,174,059
)
1,417,496

(1,213,512
)
1,357,514

Cash used in operating activities
(11,203,837
)
(4,911,622
)
(19,704,913
)
(8,767,423
)
Investing Activities
 
 
 

 

Acquisition of property and equipment
(61,695
)
(33,831
)
(93,627
)
(49,107
)
Purchase of short-term investments
—

1,679,940

(32,441
)
1,679,940

Cash used in investing activities
(61,695
)
1,646,109

(126,068
)
1,630,833

Financing Activities
 
 
 

 

Proceeds from exercise of stock options and warrants
422,886

23,300

885,469

14,738,597

Proceeds from public offering
(31,648
)
—

19,763,795

—

Cash provided by financing activities
391,238

23,300

20,649,264

14,738,597

Increase in cash
(10,874,294
)
(3,242,213
)
818,283

7,602,007

Cash and cash equivalents, beginning of period
44,622,078

49,912,873

32,918,751

39,296,682

Impact of foreign exchange on cash and cash equivalents
55,029

(30,429
)
65,779

(258,458
)
Cash and cash equivalents, end of period
33,802,813

46,640,231

33,802,813

46,640,231


To view the Company's Second 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 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 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
Fax: 403.218.2830
nhurst@equicomgroup.com
The Investor Relations Group
Erika Moran
20th Floor, 1251 Avenue of the Americas
New York, NY 10004
Tel: 212.825.3210
Fax: 212.825.3229
emoran@investorrelationsgroup.com
 


 
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