Oncolytics Biotech® Inc. Announces 2015 Second Quarter Results

Donnerstag, 06.08.2015 12:35 von

PR Newswire

CALGARY, Aug. 6, 2015 /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, 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.

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