Oncolytics Biotech® Inc. Announces Third Quarter 2014 Results

CALGARY, Nov. 6, 2014 /PRNewswire/ – Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the third quarter ended September 30, 2014.

“During the quarter we reported on interim data that suggests that patients with a selected biomarker, in this case mutant KRAS, may derive benefit from REOLYSIN® in a randomized clinical study,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Biomarkers are playing an increasingly important role in predicting, following and treating cancer. We are examining their role in our other ongoing randomized clinical studies. Subsequent to quarter end, we established two financing facilities that will allow us to incrementally access capital in the quarters ahead.”

Selected Highlights

Since July 1, 2014, selected highlights announced by the Company include:

Clinical Program

  • Reported interim overall and KRAS-mutated patient data from an NCI-sponsored randomized Phase II study of REOLYSIN® in combination with carboplatin and paclitaxel in patients with recurrent or metastatic pancreatic cancer (NCI-8601).  There was no difference of note in the overall patient population.  In the patient population that had mutations in the KRAS gene (n = 23 in the control arm, n = 21 in the test arm), the median progression free survival in the test arm was 5.72 months (95% CI on the Kaplan-Meier curve = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI  on the Kaplan-Meier curve = 1.938 to 6.176). This translates into a 1.61 month (39%) improvement in median progression free survival in the test arm versus the control arm;
  • Reported that patient enrollment had been completed in an ongoing, NCI-sponsored randomized Phase II study of REOLYSIN® in combination with paclitaxel in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG-186H). The Company awaits early data from this study;

Financial

  • At September 30, 2014 the Company reported $17.0 million in cash, cash equivalents and short-term investments; and
  • Subsequent to quarter end, amendments to the previously announced share purchase agreement with Lincoln Park Capital Fund, LLC and entry into a $20 million “at-the-market” equity distribution agreement with Canaccord Genuity Inc.

ONCOLYTICS BIOTECH INC.

INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

September 30,

2014 

$

December 31,

2013

$

Assets

Current assets

Cash and cash equivalents

15,012,968

25,220,328

Short-term investments

2,031,685

2,001,644

Accounts receivable

84,865

105,853

Prepaid expenses

405,475

361,743

Total current assets

17,534,993

27,689,568

Non-current assets

Property and equipment

543,525

532,459

Total non-current assets

543,525

532,459

Total assets

18,078,518

28,222,027

Liabilities And Shareholders’ Equity

Current Liabilities

Accounts payable and accrued liabilities

3,298,610

6,008,661

Total current liabilities

3,298,610

6,008,661

Shareholders’ equity

Share capital
  Authorized: unlimited
  Issued:

   September 30, 2014 – 89,566,597

   December 31, 2013 – 84,803,818

235,040,463

228,612,564

Warrants

376,892

Contributed surplus

25,738,527

24,491,212

Accumulated other comprehensive income

188,140

79,698

Accumulated deficit

(246,187,222)

(231,347,000)

Total shareholders’ equity

14,779,908

22,213,366

Total liabilities and equity

18,078,518

28,222,027

               

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

Three Month

 Period

 Ending

 September

 30, 2014

$

Three Month

 Period

 Ending

 September

 30, 2013

$

Nine Month

 Period

 Ending

 September

 30, 2014

$

Nine Month

 Period 

Ending

 September

30, 2013

$

Expenses

Research and development

3,571,939

5,001,972

11,305,328

13,923,323

Operating

1,105,274

1,222,157

3,706,343

4,107,650

Operating loss

(4,677,213)

(6,224,129)

(15,011,671)

(18,030,973)

Interest

39,937

110,479

178,177

290,806

Loss before income taxes

(4,637,276)

(6,113,650)

(14,833,494)

(17,740,167)

Income tax expense

668

(6,728)

Net loss

(4,636,608)

(6,113,650)

(14,840,222)

(17,740,167)

Other comprehensive income items that may be

  reclassified to net loss

Translation adjustment

100,461

(33,513)

108,442

74,126

Net comprehensive loss

(4,536,147)

(6,147,163)

(14,731,780)

(17,666,041)

Basic and diluted loss per common share

(0.05)

(0.07)

(0.17)

(0.21)

Weighted average number of shares (basic and
 diluted)

88,592,863

84,758,818

86,786,937

83,112,919

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Share Capital

$

Contributed

 Surplus

$

Warrants

$

Accumulated

 Other

 Comprehensive

 Income

(Loss)

$

Accumulated

 Deficit

$

Total

$

As at December 31, 2012

198,155,091

24,126,265

376,892

(57,115)

(207,814,353)

14,786,780

Net loss and other comprehensive income

74,126

(17,740,167)

(17,666,041)

Issued, pursuant to a bought deal financing

30,218,797

30,218,797

Exercise of stock options

139,676

(34,687)

104,989

Share based compensation

191,356

191,356

As at September 30, 2013

228,513,564

24,282,934

376,892

17,011

(225,554,520)

27,635,881

Share Capital
$

Contributed

Surplus

$

Warrants

$

Accumulated

 Other

 Comprehensive

 Income

$

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 other comprehensive income

108,442

(14,840,222)

(14,731,780)

Issued, pursuant to Share Purchase Agreement

6,427,899

6,427,899

Expired warrants

376,892

(376,892)

Share based compensation

870,423

870,423

As at September 30, 2014

235,040,463

25,738,527

188,140

(246,187,222)

14,779,908

           

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

Three Month

 Period

 Ending

 September

 30, 2014

$

Three Month

 Period

 Ending

 September

 30, 2013
$

Nine Month

 Period

 Ending

 September

 30, 2014
$

Nine Month

Period

 Ending

 September

 30, 2013

$

Operating Activities

Net loss for the period

(4,636,608)

(6,113,650)

(14,840,222)

(17,740,167)

  Amortization – property and equipment

39,904

41,205

118,073

91,351

  Share based compensation

199,821

(59,497)

870,423

191,356

  Unrealized foreign exchange loss (gain)

243,290

34,179

193,301

(63,670)

Net change in non-cash working capital

(261,622)

(412,109)

(2,701,103)

(2,508,562)

Cash used in operating activities

(4,415,215)

(6,509,872)

(16,359,528)

(20,029,692)

Investing Activities

Acquisition of property and equipment

(113,782)

(103,512)

(131,001)

(250,814)

Purchase of short-term investments

(30,041)

(32,416)

Cash used in investing activities

(113,782)

(103,512)

(161,042)

(283,230)

Financing Activities

Proceeds from exercise of stock options and warrants

104,989

Proceeds from Share Purchase Agreement

2,736,749

6,427,899

Proceeds from public offering

30,218,797

Cash provided by financing activities

2,736,749

6,427,899

30,323,786

Increase in cash

(1,792,248)

(6,613,384)

(10,092,671)

10,010,864

Cash and cash equivalents, beginning of period

16,880,730

36,153,277

25,220,328

19,323,541

Impact of foreign exchange on cash and cash equivalents

(75,514)

(67,692)

(114,689)

137,796

Cash and cash equivalents, end of period

15,012,968

29,472,201

15,012,968

29,472,201

 

To view the Company’s 2014 Third Quarter Interim Consolidated Financial Statements, related Notes to the Interim Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly 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 2014 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.