Oncolytics Biotech® Inc. Announces 2016 Third Quarter Results

CALGARY, Nov. 3, 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 third quarter ended September 30, 2016.

"During the quarter we reported additional statistically significant, randomized clinical data that further strengthened the linkage between genetic status and survival outcomes in patients with adenocarcinoma of the lung," said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. "In parallel with reporting data from sponsored Phase 2 randomized studies, we continued to push ahead with preparations for a registration study."

Selected Highlights

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

Clinical Program

  • Additional data from a randomized, sponsored Phase II clinical study of REOLYSIN® in non-small cell lung cancer (IND 211), which showed that:
    • progression free survival ("PFS") was statistically significantly better for female patients in the test arm (n=20) than for those in the control arm (n=16) in patients with adenocarcinoma. Median PFS was 5.39 months compared with 3.02 months, respectively (p=0.0201);
    • evolving overall survival ("OS") demonstrated a strong trend towards survival benefit for female patients in the test arm with adenocarcinoma (n=20, six of whom remained alive at the time of the analysis) over those in the control arm (n=16, three of whom remained alive at the time of the analysis). Median OS was 10.68 months compared with 7.59 months, respectively (p=0.145) (Figure B). By contrast, no PFS or OS benefit was noted for the male patients with adenocarcinoma; and
    • patients with adenocarcinoma treated with REOLYSIN® with one or more target biomarkers (EGFR, Hras, Kras, Nras, Braf and/or p53 mutations) had a greater PFS (p=0.039) and OS (p=0.031) than patients treated with REOLYSIN® without any of these biomarkers. The presence of these biomarkers may account, at least in part, for the difference between the survival outcomes for male and female patients; target biomarkers were present in a higher proportion of the female patients in the study than the male patients (66.7% versus 43.6%). As a result, pre-screening for target biomarkers in patients with adenocarcinoma of the lung is warranted.

Financial
At September 30, 2016, the Company reported $17.7 million in cash, cash equivalents and short-term investments.  At November 2, 2016, the Company had approximately $16.7 million in cash, cash equivalents and short-term investments.

 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)





September 30,
2016
$

December 31,
2015
$

Assets



Current assets



Cash and cash equivalents

15,612,729

24,016,275

Short-term investments

2,088,800

2,060,977

Accounts receivable

44,991

340,059

Prepaid expenses

356,741

506,669

Total current assets

18,103,261

26,923,980

Non-current assets



Property and equipment

333,926

459,818

Total non-current assets

333,926

459,818




Total assets

18,437,187

27,383,798




Liabilities And Shareholders' Equity



Current Liabilities



Accounts payable and accrued liabilities

2,809,008

2,709,492

Total current liabilities

2,809,008

2,709,492




Shareholders' equity



Share capital    




Authorized: unlimited




Issued:




September 30, 2016 – 120,873,222




December 31, 2015 – 118,151,622

262,218,228

261,324,692

Contributed surplus

26,536,601

26,277,966

Accumulated other comprehensive income

492,637

760,978

Accumulated deficit

(273,619,287)

(263,689,330)

Total shareholders' equity

15,628,179

24,674,306

Total liabilities and equity

18,437,187

27,383,798

 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)







Three
Month
Period
Ending
September
30, 2016
$

Three
Month
Period
Ending
September
30, 2015
$

Nine Month
Period
Ending
September
30, 2016
$

Nine Month
Period
Ending
September 30,
2015
$

Expenses






Research and development

2,141,737


1,704,784


6,358,822


6,601,877



Operating

1,222,447


1,176,023


3,708,317


3,780,812


Operating loss

(3,364,184)


(2,880,807)


(10,067,139)


(10,382,689)



Interest

31,691


52,756


136,849


153,313


Loss before income taxes

(3,332,493)


(2,828,051)


(9,930,290)


(10,229,376)



Income tax expense

19


4,074


333


3,303


Net loss

(3,332,474)


(2,823,977)


(9,929,957)


(10,226,073)


Other comprehensive income items that may be

  reclassified to net loss






Translation adjustment

32,545


192,586


(268,341)


377,060











Net comprehensive loss

(3,299,929)


(2,631,391)


(10,198,298)


(9,849,013)


Basic and diluted loss per common share

(0.03)


(0.02)


(0.08)


(0.09)


Weighted average number of shares (basic and
 diluted)

120,552,638


117,963,979


119,455,440


110,757,811


 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)








Share Capital

$

Contributed
Surplus

$

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 other comprehensive income



377,060


(10,226,073)


(9,849,013)


Issued, pursuant to Share Purchase Agreement

4,305,396





4,305,396


Issued, pursuant to "At the Market" Agreement

19,267,267





19,267,267


Share based compensation


181,436




181,436


As at September 30, 2015

261,229,719


26,029,865


657,103


(260,192,408)


27,724,279









Share Capital
$

Contributed
Surplus
$

Accumulated
Other
Comprehensive
Income

$

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 other comprehensive loss



(268,341)


(9,929,957)


(10,198,298)


Issued, pursuant to "At the Market" Agreement

852,536





852,536


Issued, pursuant to incentive share award plan

41,000


(41,000)





Share based compensation


299,635




299,635


As at September 30, 2016

262,218,228


26,536,601


492,637


(273,619,287)


15,628,179


 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)







Three
Month
Period
Ending
September
30, 2016
$

Three
Month
Period
Ending
September
30, 2015
$

Nine Month
Period
Ending
September
30, 2016
$

Nine Month
Period
Ending
September
30, 2015
$






Operating Activities





Net loss for the period

(3,332,474)


(2,823,977)


(9,929,957)


(10,226,073)



Amortization - property and equipment

44,014


44,761


134,631


134,743



Share based compensation

98,369


10,791


299,635


181,436



Unrealized foreign exchange gain

(49,400)


(182,131)


(152,019)


(485,653)


Net change in non-cash working capital

216,611


92,792


978,847


(327,690)


Cash used in operating activities

(3,022,880)


(2,857,764)


(8,668,863)


(10,723,237)


Investing Activities





Acquisition of property and equipment

(4,851)


(17,695)


(10,553)


(47,292)


Purchase of short-term investments



(27,823)


(29,292)


Cash used in investing activities

(4,851)


(17,695)


(38,376)


(76,584)


Financing Activities





Proceeds from Share Purchase Agreement




4,305,396


Proceeds from "At the Market" equity distribution agreement

242,706


213,742


852,536


19,267,267


Cash provided by financing activities

242,706


213,742


852,536


23,572,663


(Decrease) increase in cash

(2,785,025)


(2,661,717)


(7,854,703)


12,772,842


Cash and cash equivalents, beginning of period

18,320,981


30,018,217


24,016,275


14,152,825


Impact of foreign exchange on cash and cash equivalents

76,773


605,962


(548,843)


1,036,795


Cash and cash equivalents, end of period

15,612,729


27,962,462


15,612,729


27,962,462


 

To view the Company's Fiscal 2016 Third 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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