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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