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Oncolytics Biotech® Inc. Announces Second Quarter 2014 Results

CALGARY, Aug. 7, 2014 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the second quarter ended June 30, 2014.

"Our randomized clinical program continued to advance during the quarter as we recently reported the completion of enrollment in a Phase II study using REOLYSIN® in combination with carboplatin and paclitaxel in pancreatic cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also strengthened our board, adding two directors with significant financial and public company experience."

Selected Highlights

Since April 1, 2014, selected highlights announced by the Company include:

Clinical and Preclinical Data

  • Completion of patient enrollment in a two-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 (OSU-10045);
  • Early results from a translational study looking at intravenous administration of REOLYSIN® to patients with primary or metastatic brain tumors was presented at the ASCO Annual Meeting in Chicago, IL;
  • Final data from the Company's randomized, double-blinded clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers;
  • A series of presentations by research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK covering:
    • early clinical research showing that intravenously delivered REOLYSIN® can cross the blood brain barrier to access tumours in the brains of humans;
    • preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN®;
    • preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and
    • preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C.

Governance

  • The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company's board of directors; and

Financial

  • At June 30, 2014 the Company reported $18.9 million in cash, cash equivalents and short-term investments.

 



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






June 30,

2014

$


December 31,

2013

$

Assets




Current assets




Cash and cash equivalents

16,880,730


25,220,328

Short-term investments

2,031,685


2,001,644

Accounts receivable

54,391


105,853

Prepaid expenses

609,538


361,743

Total current assets

19,576,344


27,689,568





Non-current assets




Property and equipment

470,217


532,459

Total non-current assets

470,217


532,459





Total assets

20,046,561


28,222,027





Liabilities And Shareholders' Equity




Current Liabilities




Accounts payable and accrued liabilities

3,667,076


6,008,661

Total current liabilities

3,667,076


6,008,661





Shareholders' equity








Share capital
  Authorized: unlimited   Issued:




   June 30, 2014 – 87,537,397




   December 31, 2013 – 84,803,818

232,303,714


228,612,564

Warrants


376,892

Contributed surplus

25,538,706


24,491,212

Accumulated other comprehensive loss

87,679


79,698

Accumulated deficit

(241,550,614)


(231,347,000)

Total shareholders' equity

16,379,485


22,213,366

Total liabilities and equity

20,046,561


28,222,027

 

 


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










Three Month
Period
Ending June
30, 2014
$


Three Month
Period
Ending June
30, 2013
$


Six Month
Period
Ending June
30, 2014
$


Six Month
Period
Ending June
30, 2013
$









Expenses








  Research and development

3,555,055


3,804,307


7,733,389


8,921,351

  Operating

1,209,815


1,320,742


2,601,069


2,885,493

Operating loss

(4,764,870)


(5,125,049)


(10,334,458)


(11,806,844)

  Interest

50,253


105,368


138,240


180,327

Loss before income taxes

(4,714,617)


(5,019,681)


(10,196,218)


(11,626,517)

 Income tax expense

(3,546)



(7,396)


Net loss

(4,718,163)


(5,019,681)


(10,203,614)


(11,626,517)

Other comprehensive income items that may be

  reclassified to net loss
















Translation adjustment

26,675


73,451


7,981


107,639









Net comprehensive loss

(4,691,488)


(4,946,230)


(10,195,633)


(11,518,878)

Basic and diluted loss per common share

(0.05)


(0.06)


(0.12)


(0.14)

Weighted average number of shares
(basic and diluted)

86,581,854


84,758,818


85,869,008


82,276,330









  

 


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, 2012

198,155,091


24,126,265


376,892


(57,115)


(207,814,353)


14,786,780













Net loss and
comprehensive loss




107,639


(11,626,517)


(11,518,878)

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


250,853





250,853

As at June 30, 2013

228,513,564


24,342,431


376,892


50,524


(219,440,870)


33,842,541














Share Capital

$


Contributed
Surplus

$


Warrants

$


Accumulated
Other
Comprehensive
Loss

$


Accumulated
Deficit

$


Total

$













As at December 31, 2013

228,612,564


24,491,212


376,892


79,698


(231,347,000)


22,213,366













Net loss and
comprehensive loss




7,981


(10,203,614)


(10,195,633)

Issued, pursuant to Share
Purchase Agreement

3,691,150






3,691,150

Expired warrants


376,892


(376,892)
















Share based compensation


670,602





670,602

As at June 30, 2014

232,303,714


25,538,706



87,679


(241,550,614)


16,379,485

 

 

 


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










Three Month
Period
Ending June
30, 2014

$


Three Month
Period
Ending June
30, 2013

$


Six Month
Period
Ending June
30, 2014

$


Six Month
Period
Ending June
30, 2013

$









Operating Activities








Net loss for the period

(4,718,163)


(5,019,681)


(10,203,614)


(11,626,517)

  Amortization - property and equipment

38,512


25,565


78,169


50,146

  Share based compensation

366,005


129,997


670,602


250,853

  Unrealized foreign exchange loss

(74,059)


209,804


(49,989)


(97,849)

Net change in non-cash working capital

(1,392,530)


(455,283)


(2,439,481)


(2,096,453)

Cash used in operating activities

(5,780,235)


(5,109,598)


(11,944,313)


(13,519,820)

Investing Activities








Acquisition of property and equipment

(1,239)


(132,164)


(17,219)


(147,302)

Purchase of short-term investments



(30,041)


(32,416)

Cash used in investing activities

(1,239)


(132,164)


(47,260)


(179,718)

Financing Activities








Proceeds from exercise of stock options and

  warrants




104,989

Proceeds from Share Purchase Agreement

2,502,708



3,691,150


Proceeds from public offering


11,735



30,218,797

Cash provided by financing activities

2,502,708


11,735


3,691,150


30,323,786

Increase in cash

(3,278,766)


(5,230,027)


(8,300,423)


16,624,248

Cash and cash equivalents, beginning of period

20,155,907


41,519,657


25,220,328


19,323,541

Impact of foreign exchange on cash and cash

  equivalents

3,589


(136,353)


(39,175)


205,488

Cash and cash equivalents, end of period

16,880,730


36,153,277


16,880,730


36,153,277

 

To view the Company's Second Quarter 2014 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/for-investors/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 later-stage, randomized human trials in various indications 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 2014 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.

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