Oncolytics Biotech® Inc. Announces 2015 Second Quarter Results

CALGARY, Aug. 6, 2015 /CNW/ - 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, 2015.

"Subsequent to quarter end we announced compelling overall, one- and two-year survival data from the REO 017 study in patients with advanced pancreatic cancer treated with gemcitabine and REOLYSIN®," said Dr. Brad Thompson, President and CEO of Oncolytics. "During the quarter we also added to our growing body of evidence that REOLYSIN® contributes to the upregulation of PD-1 and PD-L1 and so may play a role in immunotherapeutic treatment of cancer."

Selected Highlights

Since April 1, 2015, selected highlights announced by the Company include:

Clinical Program

  • Presentation of final data from a single arm clinical study examining the use of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;
  • An update on the planned registration program for REOLYSIN® including an initial focus on two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma;
  • Activation of an Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN®) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors";
  • Presentation of data showing up regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN® in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine's Immuno-oncology: Using the Body's Own Weapons conference, held in London, UK;

 

Regulatory

  • Granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of gastric cancer and malignant gliomas;
  • Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN® in the treatment of pancreatic cancer;

 

Basic Research

  • Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA, including findings around REOLYSIN®'s mechanism of action and its potential in new indications including chronic lymphocytic leukemia;
  • Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors meeting in Boston, MA, including content showing the combination of REOLYSIN®, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN® and GM-CSF alone, and REOLYSIN® and GM-CSF plus either one of the checkpoint inhibitors alone;
  • A series of presentations made by the Company's research collaborators at the American Association for Cancer Research Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN®;

 

Corporate

  • Linda Hohol resigned from the Board of Directors of the Company effective August 5, 2015. Ms. Hohol has served as a Director since June 2014; and

 

Financial

  • At June 30, 2015 the Company reported $32.1 million in cash, cash equivalents and short-term investments. At August 5, 2015, the Company had approximately $31.6 million in cash, cash equivalents and short-term investments.

 


ONCOLYTICS BIOTECH INC.

INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)





June 30,

2015

$

December 31,

2014

$

Assets



Current assets



Cash and cash equivalents

30,018,217


14,152,825


Short-term investments

2,060,977


2,031,685


Accounts receivable

61,261


191,751


Prepaid expenses

581,468


291,553


Total current assets

32,721,923


16,667,814







Non-current assets



Property and equipment

467,690


525,376


Total non-current assets

467,690


525,376





Total assets

33,189,613


17,193,190







Liabilities And Shareholders' Equity



Current Liabilities



Accounts payable and accrued liabilities

3,058,476


3,373,997


Total current liabilities

3,058,476


3,373,997





Shareholders' equity



Share capital




Authorized: unlimited
Issued:




June 30, 2015 – 117,710,372




December 31, 2014 - 93,512,494

261,015,977


237,657,056


Contributed surplus

26,019,074


25,848,429


Accumulated other comprehensive loss

464,517


280,043


Accumulated deficit

(257,368,431)


(249,966,335)


Total shareholders' equity

30,131,137


13,819,193


Total liabilities and equity

33,189,613


17,193,190


 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)







Three

Month

Period

Ending

June 30,

2015
$

Three

Month

Period

Ending

June 30,

2014
$

Six Month

Period

Ending

June 30,

2015
$

Six Month

Period

Ending

June 30,

2014
$

Expenses






Research and development

2,471,554


3,555,055


4,897,093


7,733,389



Operating

1,422,055


1,209,815


2,604,789


2,601,069


Operating (loss)

(3,893,609)


(4,764,870)


(7,501,882)


(10,334,458)



Interest income

44,122


50,253


100,557


138,240


(Loss) before income taxes

(3,849,487)


(4,714,617)


(7,401,325)


(10,196,218)



Income tax

(771)


(3,546)


(771)


(7,396)


Net (loss)

(3,850,258)


(4,718,163)


(7,402,096)


(10,203,614)


Other comprehensive income items that may be reclassified to net loss






Translation adjustment

(41,117)


26,675


184,474


7,981












Net comprehensive (loss)

(3,891,375)


(4,691,488)


(7,217,622)


(10,195,633)


Basic and diluted (loss) per common share

(0.03)


(0.05)


(0.07)


(0.12)


Weighted average number of shares (basic and diluted)

114,549,532


86,581,854


107,095,007


85,869,008


  


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, 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










Share Capital

$

Contributed

Surplus

$

Warrants

$

Accumulated

Other

Comprehensive

Loss

$

Accumulated

Deficit

$

Total

$

As at December 31, 2014

237,657,056


25,848,429



280,043


(249,966,335)


13,819,193









Net loss and comprehensive loss




184,474


(7,402,096)


(7,217,622)


Issued, pursuant to Share Purchase Agreement

4,305,396






4,305,396


Issued, pursuant to "At the Market" Agreement

19,053,525






19,053,525









Share based compensation


170,645





170,645


As at June 30, 2015

261,015,977


26,019,074



464,517


(257,368,431)


30,131,137


 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)







Three

Month

Period

Ending

June 30,

2015

$

Three

Month

Period

Ending

June 30,

2014

$

Six Month

Period

Ending

June 30,

2015

$

Six Month

Period

Ending

June 30,

2014

$






Operating Activities





Net loss for the period

(3,850,258)


(4,718,163)


(7,402,096)


(10,203,614)



Amortization - property and equipment

44,852


38,512


89,982


78,169



Share based compensation

55,675


366,005


170,645


670,602



Unrealized foreign exchange loss (gain)

1,634


(74,059)


(303,522)


(49,989)


Net change in non-cash working capital

(1,370,187)


(1,392,530)


(420,482)


(2,439,481)


Cash used in operating activities

(5,118,284)


(5,780,235)


(7,865,473)


(11,944,313)


Investing Activities





Acquisition of property and equipment

(17,657)


(1,239)


(29,597)


(17,219)


Purchase of short-term investments



(29,292)


(30,041)


Cash used in investing activities

(17,657)


(1,239)


(58,889)


(47,260)


Financing Activities





Proceeds from exercise of stock options and warrants





Proceeds from Share Purchase Agreement

2,379,800


2,502,708


4,305,396


3,691,150


Proceeds from "At the Market" equity distribution agreement

4,416,607



19,053,525



Cash provided by financing activities

6,796,407


2,502,708


23,358,921


3,691,150


Increase (decrease) in cash

1,660,466


(3,278,766)


15,434,559


(8,300,423)


Cash and cash equivalents, beginning of period

28,578,023


20,155,907


14,152,825


25,220,328


Impact of foreign exchange on cash and cash equivalents

(220,272)


3,589


430,833


(39,175)


Cash and cash equivalents, end of period

30,018,217


16,880,730


30,018,217


16,880,730


 

To view the Company's Fiscal 2015 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual 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 2015 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.

For further information: TMX Equicom, Nick Hurst, 300 5th Ave. SW, 10th Floor, Calgary, Alberta T2P 3C4, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@tmxequicom.com; TMX Equicom, Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@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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