Oncolytics Biotech® Inc. Announces 2016 Second Quarter Results

CALGARY, Aug. 4, 2016 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the second quarter ended June 30, 2016.

"The key highlights for the quarter were preliminary data from randomized Phase 2 studies in colorectal and non-small cell lung cancer, which together suggested a possible linkage between gender, genetic status and survival outcomes in these common cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our ongoing randomized Phase 2 program continues to provide important data as to indications, patient populations and pre-screening methodologies that we can use to advance our later-stage clinical program."

Selected Highlights

Since April 1, 2016, selected highlights announced by the Company include:

Clinical Program

  • Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN® in non-small cell lung cancer (IND 211), presented following an abstract for the American Society of Clinical Oncology annual meeting, which correlated both patient gender (female) and genetic status to improved progression free and overall survival;
  • Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN® in advanced or metastatic colorectal cancer (IND 210), following an abstract for the American Society of Clinical Oncology annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)) and those patients of either gender with liver metastases (those treated with REOLYSIN® had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN® (p=0.0077));
  • Submission to the U.S. Food and Drug Administration of an Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN® (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver", which is now active;
  • Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN®, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);

Basic Research

  • A poster presentation covering preclinical work in squamous cell carcinoma of the head and neck being made at the 2016 American Society of Gene and Cell Therapy annual meeting;
  • Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company's research collaborators at the 2016 American Association of Cancer Research annual meeting;

Corporate

  • Formation of a Science and Technology Committee charged with supporting REOLYSIN®'s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and

Financial

  • At June 30, 2016 the Company reported $20.4 million in cash, cash equivalents and short-term investments. At August 3, 2016, the Company had approximately $19.5 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies and other clinical studies.

 

ONCOLYTICS BIOTECH INC.

INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)






June 30,

2016

$


December 31,

2015

$

Assets




Current assets




Cash and cash equivalents

18,320,981


24,016,275

Short-term investments

2,088,800


2,060,977

Accounts receivable

54,633


340,059

Prepaid expenses

530,470


506,669

Total current assets

20,994,884


26,923,980





Non-current assets




Property and equipment

372,854


459,818

Total non-current assets

372,854


459,818





Total assets

21,367,738


27,383,798





Liabilities And Shareholders' Equity




Current Liabilities




Accounts payable and accrued liabilities

2,780,705


2,709,492

Total current liabilities

2,780,705


2,709,492





Shareholders' equity




Share capital 





Authorized: unlimited





Issued:





June 30, 2016 – 118,900,812





December 31, 2015 - 118,151,622

261,975,522


261,324,692

Contributed surplus

26,438,232


26,277,966

Accumulated other comprehensive loss

460,092


760,978

Accumulated deficit

(270,286,813)


(263,689,330)

Total shareholders' equity

18,587,033


24,674,306

Total liabilities and equity

21,367,738


27,383,798

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)



Three
Month
Period
Ending
June 30,
2016
$

Three
Month
Period
Ending
June 30,
2015
$

Six Month
Period
Ending
June 30,
2016
$

Six Month
Period
Ending
June 30,
2015
$

Expenses






Research and development

1,490,956

2,471,554

4,217,085

4,897,093


Operating

1,125,458

1,422,055

2,485,870

2,604,789

Operating (loss)

(2,616,414)

(3,893,609)

(6,702,955)

(7,501,882)


Interest income

35,537

44,122

105,158

100,557

Loss before income taxes

(2,580,877)

(3,849,487)

(6,597,797)

(7,401,325)


Income tax

169

(771)

314

(771)

Net (loss)

(2,580,708)

(3,850,258)

(6,597,483)

(7,402,096)

 Other comprehensive income items that may be reclassified to net loss






Translation adjustment

(130,827)

(41,117)

(300,886)

184,474






Net comprehensive (loss)

(2,711,535)

(3,891,375)

(6,898,369)

(7,217,622)

Basic and diluted (loss) per common share

(0.02)

(0.03)

(0.06)

(0.07)

Weighted average number of shares (basic and diluted)

119,601,638

114,549,532

118,900,812

107,095,007

 


ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)








Share Capital

$

Contributed
Surplus

$

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








Share Capital

$

Contributed
Surplus

$

Accumulated
Other
Comprehensive
Loss

$

Accumulated
Deficit

$

Total

$

As at December 31, 2015

261,324,692

26,277,966

760,978

(263,689,330)

24,674,306

Net loss and comprehensive loss

(300,886)

(6,597,483)

(6,898,369)

Issued, pursuant to "At the Market" Agreement

609,830

609,830

Issued, pursuant to incentive share award plan

41,000

(41,000)

Share based compensation

201,266

201,266

As at June 30, 2016

261,975,522

26,438,232

460,092

(270,286,813)

18,587,033

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)







Three Month
Period Ending 
June 30, 
2016
$

Three Month
Period Ending
June 30, 
2015 
$

Six Month
Period Ending
June 30,
 2016
$

Six Month
Period Ending
June 30,
2015
$






Operating Activities





Net loss for the period

(2,580,708)

(3,850,258)

(6,597,483)

(7,402,096)


Amortization - property and equipment

44,675

44,852

90,617

89,982


Share based compensation

119,626

55,675

201,266

170,645


Unrealized foreign exchange loss (gain)

(243,914)

1,634

(102,619)

(303,522)

Net change in non-cash working capital

37,581

(1,370,187)

762,236

(420,482)

Cash used in operating activities

(2,622,740)

(5,118,284)

(5,645,983)

(7,865,473)

Investing Activities





Acquisition of property and equipment

(5,702)

(17,657)

(5,702)

(29,597)

Purchase of short-term investments

(27,823)

(29,292)

Cash used in investing activities

(5,702)

(17,657)

(33,525)

(58,889)

Financing Activities





Proceeds from Share Purchase Agreement

2,379,800

4,305,396

Proceeds from "At the Market" equity distribution agreement

710,374

4,416,607

609,830

19,053,525

Cash provided by financing activities

710,374

6,796,407

609,830

23,358,921

Increase (decrease) in cash

(1,918,068)

1,660,466

(5,069,678)

15,434,559

Cash and cash equivalents, beginning of period

20,233,408

28,578,023

24,016,275

14,152,825

Impact of foreign exchange on cash and cash equivalents

5,641

(220,272)

(625,616)

430,833

Cash and cash equivalents, end of period

18,320,981

30,018,217

18,320,981

30,018,217

 

To view the Company's Fiscal 2016 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's quarterly filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/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 2016 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: NATIONAL Equicom, Nick Hurst, 320 Front Street W, Suite 1600, Toronto, Ontario, M5V 3B6, Tel: 416.586.1942, nhurst@national.ca; NATIONAL Equicom, Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@national.ca; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor, New York, NY 10018, Tel: 212.825.3210, sforman@dgicomm.com

RELATED LINKS
http://www.oncolyticsbiotech.com

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