Oncolytics Biotech® Inc. Announces 2015 First Quarter Results

CALGARY, May 7, 2015 /PRNewswire/ - Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended March  31, 2015.

"In the first quarter, we obtained Orphan Drug Designation from the U.S. FDA and the EMA in Europe for a number of different indications, which will support future development of REOLYSIN®," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also reported a range of clinical and preclinical data that furthered our understanding of how REOLYSIN® works and the specific benefits it can confer in combination with other approved therapies."

Selected Highlights

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

Clinical Program

  • Completion of patient enrollment in an ongoing, NCIC Clinical Trials Group sponsored randomized Phase II study of REOLYSIN® in patients with advanced or metastatic colorectal cancer (IND 210). The Company awaits preliminary data from this study;
  • Presentation of data from a single arm clinical study examining the use of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017);
  • 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

  • Application for Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of gastric cancer. The Company was granted designations by the FDA in ovarian, fallopian tube, primary peritoneal and pancreatic cancers as well as malignant glioma;
  • Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN® in the treatment of ovarian cancer, and subsequent to quarter end, for pancreatic cancer;
  • Subsequently, on May 5, 2015, the Company was granted Orphan Drug Designation from the FDA for the treatment of gastric cancer;

Basic Research

  • 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 AACR Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN®; and

Financial

  • At March 31, 2015 the Company reported $30.6 million in cash, cash equivalents and short-term investments.  At May 6, 2015, the Company had approximately $31.5 million in cash, cash equivalents and short-term investments.

The Year Ahead

The Company continues to actively focus on developing its go-forward clinical path, which could include one or more registration studies. In addition to actively speaking with key-opinion leaders, regulatory consultants and regulators themselves, Oncolytics expects to evaluate its growing library of clinical trial data in an effort to identify the most expeditious route to the commercial endpoint.


ONCOLYTICS BIOTECH INC.

INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)








As at



March 31,
 2015



December 31,
 2014

Assets







Current assets







Cash and cash equivalents



28,578,023



14,152,825

Short-term investments



2,060,977



2,031,685

Accounts receivable



45,706



191,751

Prepaid expenses



264,708



291,553

Total current assets



30,949,414



16,667,814








Non-current assets







Property and equipment



495,531



525,376

Total non-current assets



495,531



525,376








Total assets



31,444,945



17,193,190








Liabilities And Shareholders' Equity







Current Liabilities







Accounts payable and accrued liabilities



4,274,515



3,373,997

Total current liabilities



4,274,515



3,373,997








Shareholders' equity







Share capital








Authorized: unlimited
Issued:
March 31, 2015 - 109,708,373
December 31, 2014 - 93,512,494



254,219,570



237,657,056

Contributed surplus



25,963,399



25,848,429

Accumulated other comprehensive income



505,634



280,043

Accumulated deficit



(253,518,173)



(249,966,335)

Total shareholders' equity



27,170,430



13,819,193

Total liabilities and equity



31,444,945



17,193,190

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)











2015



2014

For the three month period ending March 31



$



$

Expenses







Research and development



2,425,539



4,178,334

Operating



1,182,734



1,391,254

Operating loss



(3,608,273)



(5,569,588)

Interest



56,435



87,987

Loss before income taxes



(3,551,838)



(5,481,601)

Income tax expense





(3,850)

Net loss



(3,551,838)



(5,485,451)

Other comprehensive income items that may be
reclassified to net loss







Translation adjustment



225,591



(18,694)








Net comprehensive loss



(3,326,247)



(5,504,145)

Basic and diluted loss per common share



(0.04)



(0.06)








Weighted average number of shares (basic and diluted)



99,557,654



85,148,242

  


ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)
















Share Capital

$


Contributed
Surplus

$


Warrants

$


Accumulated
Other
Comprehensive
Income

$


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





(18,694)


(5,485,451)


(5,504,145)

Issued, pursuant to Share Purchase Agreement


1,188,442






1,188,442

Exercise of stock options



376,892


(376,892)

















Share based compensation



304,597





304,597

As at March 31, 2014


229,801,006


25,172,701



61,004


(236,832,451)


18,202,260





























Share Capital

$


Contributed
Surplus

$


Warrants

$


Accumulated
Other
Comprehensive
Income

$


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 income





225,591


(3,551,838)


(3,326,247)

Issued, pursuant to Share Purchase Agreement


1,925,596






1,925,596














Issued, pursuant to "At the Market" Agreement


14,636,918






14,636,918

Share based compensation



114,970





114,970

As at March 31, 2015


254,219,570


25,963,399



505,634


(253,518,173)


27,170,430

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)











2015



2014

For the three month period ending March 31



$



$








Operating Activities







Net loss for the period



(3,551,838)



(5,485,451)


Amortization - property and equipment



45,130



39,657


Share based compensation



114,970



304,597


Impact of unrealized foreign exchange (gains) losses



(305,156)



24,070

Net change in non-cash working capital



949,705



(1,046,951)

Cash used in operating activities



(2,747,189)



(6,164,078)








Investing Activities







Acquisition of property and equipment



(11,940)



(15,980)

Purchase of short-term investments



(29,292)



(30,041)

Cash used in investing activities



(41,232)



(46,021)








Financing Activities







Proceeds from Share Purchase Agreement



1,925,596



1,188,442

Proceeds from "At the Market" equity distribution agreement



14,636,918



Cash provided by financing activities



16,562,514



1,188,442

Increase in cash



13,774,093



(5,021,657)

Cash and cash equivalents, beginning of period



14,152,825



25,220,328

Impact of foreign exchange on cash and cash equivalents



651,105



(42,764)

Cash and cash equivalents, end of period



28,578,023



20,155,907

 

To view the Company's Fiscal 2015 First 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.