Oncolytics Biotech® Inc. Announces 2016 Third Quarter Results

CALGARY, Nov. 3, 2016 /PRNewswire/ – 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.