Oncolytics Biotech® Inc. Announces 2014 Year End Results

CALGARY, March 16, 2015 /CNW/ - Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2014.

"The activities of the Company in 2014 have laid the groundwork enabling us to plan and execute our late stage clinical strategy," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are looking forward to finalizing the plans for and initiating our registration studies for REOLYSIN®."

Selected Highlights

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

Clinical Program

  • Completion of patient enrollment in an ongoing, NCIC Clinical Trials Group sponsored randomized Phase II study of REOLYSIN® in patients with advanced or metastatic colorectal cancer (IND 210). The Company awaits preliminary data from this study;
  • Reporting completion of enrollment and 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). The Company awaits final data from this study, which will be available once all remaining patients have progressed;
  • Completion of patient enrollment 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 preliminary data from this study;
  • Reporting final data from the Company's randomized, double-blinded clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers;
  • Presentation by the Company's collaborators of preliminary clinical data demonstrating that intravenously delivered REOLYSIN® can cross the blood brain barrier to access tumours in the brains of humans;

Regulatory

  • Application for Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of ovarian and pancreatic cancers. The Company was granted designations in ovarian, fallopian tube, primary peritoneal and pancreatic cancer subsequent to year end;
  • Application to the European Medicines Agency for Orphan Designation for REOLYSIN® in the treatment of pancreatic and ovarian cancers;
  • Subsequent to year end, the Company applied to the U.S. FDA for a fifth Orphan Drug Designation for high grade gliomas in paediatric patients;

Basic Research

  • Presentation of a poster entitled "Combination Therapy with Reovirus and PD-1 Blockade Effectively Establishes Tumour Control Via Innate and Adaptive Immune Responses" by the Company's research collaborators, Vile et al., at the AACR Tumor Immunology and Immunotherapy Conference;
  • A series of presentations made by the Company's research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK, covering:
    • Preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN®;
    • Preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and
    • Preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C;

Governance

  • The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company's Board of Directors;

Financial

  • Entry into and subsequent amendments to a share purchase agreement with Lincoln Park Capital Fund, LLC;
  • Entry into a $20 million "At-the-Market" equity distribution agreement with Canaccord Genuity Inc.; and
  • At December 31, 2014 the Company reported $16.2 million in cash, cash equivalents and short-term investments.  At March 13, 2015, the Company had approximately $27.5 million in cash, cash equivalents and short-term investments.

 

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION


As at December 31,

2014

$


2013

$

Assets




Current assets




Cash and cash equivalents

14,152,825


25,220,328

Short-term investments

2,031,685


2,001,644

Accounts receivable

191,751


105,853

Prepaid expenses

291,553


361,743

Total current assets

16,667,814


27,689,568

Non-current assets



Property and equipment

525,376


532,459

Total non-current assets

525,376


532,459




Total assets

17,193,190


28,222,027

Liabilities And Shareholders' Equity




Current Liabilities




Accounts payable and accrued liabilities

3,373,997


6,008,661

Total current liabilities

3,373,997


6,008,661

Shareholders' equity




Share capital





Authorized: unlimited
Issued:
December 31, 2014 – 93,512,494
December 31, 2013 – 84,803,818

237,657,056


228,612,564

Warrants


376,892

Contributed surplus

25,848,429


24,491,212

Accumulated other comprehensive income

280,043


79,698

Accumulated deficit

(249,966,335)


(231,347,000)

Total shareholders' equity

13,819,193


22,213,366

Total liabilities and equity

17,193,190


28,222,027

 

 

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS


For the years ending December 31,

2014

$

2013

$

2012

$

Expenses




Research and development

13,824,252

18,506,064

31,402,625

Operating

4,998,694

5,392,660

5,285,425

Loss before the following

(18,822,946)

(23,898,724)

(36,688,050)

Interest

210,390

371,485

345,003

Loss before income taxes

(18,612,556)

(23,527,239)

(36,343,047)

Income tax expense

(6,779)

(5,408)

(30,474)

Net loss

(18,619,335)

(23,532,647)

(36,373,521)

Other comprehensive income items that may be





reclassified to net loss





Translation adjustment

200,345

136,813

60,386

Net comprehensive loss

(18,418,990)

(23,395,834)

(36,313,135)

Basic and diluted loss per common share

(0.21)

(0.28)

(0.48)

Weighted average number of shares (basic and diluted)

87,869,149

83,530,981

76,102,062

 

 

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY



Share

 Capital
$

Warrants
$

Contributed

 Surplus
$

Accumulated

 Other

Comprehensive

 Income
$

Accumulated

 Deficit
$

Total
$

As at December 31, 2011

177,282,566

2,653,627

21,142,519

(117,501)

(171,440,832)

29,520,379








Net loss and other comprehensive income

60,386

(36,373,521)

(36,313,135)

Issued, pursuant to a bought deal financing

19,386,903

376,892

19,763,795

Expiry of warrants

(2,653,627)

2,653,627

Exercise of stock options

1,485,622

(400,632)

1,084,990

Share based compensation

730,751

730,751

As at December 31, 2012

198,155,091

376,892

24,126,265

(57,115)

(207,814,353)

14,786,780








Net loss and other comprehensive income

136,813

(23,532,647)

(23,395,834)

Issued, pursuant to a bought deal financing

30,218,796

30,218,796

Expiry of warrants

Exercise of stock options

238,677

(59,437)

179,240

Share based compensation

424,384

424,384

As at December 31, 2013

228,612,564

376,892

24,491,212

79,698

(231,347,000)

22,213,366








Net loss and other comprehensive income

200,345

(18,619,335)

(18,418,990)

Issued, pursuant to Share Purchase Agreement

7,830,409

7,830,409

Issued, pursuant to "At the Market" Agreement

1,214,083

1,214,083

Expired warrants

(376,892)

376,892

Share based compensation

980,325

980,325

As at December 31, 2014

237,657,056

25,848,429

280,043

(249,966,335)

13,819,193

           

 

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS


For the years ending December 31,

2014

$

2013

$

2012

$





Operating Activities




Net loss for the year

(18,619,335)

(23,532,647)

(36,373,521)

Amortization - property and equipment

163,501

131,623

109,275

Share based compensation

980,325

424,384

730,751

Unrealized foreign exchange loss

242,542

(89,721)

89,890

Net change in non-cash working capital

(2,443,988)

(1,374,172)

1,187,967

Cash used in operating activities

(19,676,955)

(24,440,533)

(34,255,638)

Investing Activities



Acquisition of property and equipment

(152,750)

(254,834)

(126,412)

Redemption (purchase) of short-term investments

(30,041)

(32,416)

(32,441)

Cash used in investing activities

(182,791)

(287,250)

(158,853)

Financing Activities



Proceeds from exercise of stock options and warrants

179,240

1,084,990

Proceeds from Share Purchase Agreement

7,830,409

Proceeds from "At the Market" equity distribution agreement

1,214,083

Proceeds from public offering

30,218,796

19,763,795

Cash provided by financing activities

9,044,492

30,398,036

20,848,785

(Decrease) increase in cash

(10,815,254)

5,670,253

(13,565,706)

Cash and cash equivalents, beginning of year

25,220,328

19,323,541

32,918,751

Impact of foreign exchange on cash and cash equivalents

(252,249)

226,534

(29,504)

Cash and cash equivalents, end of year

14,152,825

25,220,328

19,323,541

 

To view the Company's Fiscal 2014 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


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890