CALGARY, May 5, 2017 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) today announced its financial results and operational highlights for the quarter ended March 31, 2017.

"The last six months – particularly defining our clinical development plan and data announced at AACR – have been exciting for us," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The compelling and statistically significant overall survival data from the IND 213 study in metastatic breast cancer presented at AACR led us to select this indication as our registration pathway. This is part of our broader clinical development plan, which is focused on exploiting REOLYSIN's mechanism of action incorporating both cancer cell lysis and immune system priming and activation." 

Selected Highlights

Since January 1, 2017, selected highlights announced by the Company include:

Clinical Results

  • Presented at the American Academy of Cancer Research (AACR) Annual Meeting, in Washington, D.C., by the Canadian Cancer Trials Group at Queen's University in Kingston, Ontario covering findings from IND 213, an open-label, randomized, phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN® given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer. Results showed a statistically significant improvement in median overall survival from 10.4 months in the control arm to 17.4 months in the test arm.
  • Announced registration pathway and clinical development plan with the dual objectives of obtaining regulatory approval for REOLYSIN based on the compelling metastatic breast cancer survival data recently presented at the AACR Annual Meeting, in Washington, D.C., and expanding REOLYSIN into commercially valuable new treatment areas that include immunotherapy and immunomodulatory (IMiD) agents in collaboration with pharmaceutical partners.
  • Announced, in collaboration with Celgene and cancer charity Myeloma UK, the launch of MUK eleven, a first-of-its-kind immunotherapy trial that aims to modulate the immune system to target myeloma. The phase 1b trial will study REOLYSIN in combination with Celgene's IMiD's, Imnovid® (pomalidomide) and Revlimid® (lenalidomide), as a rescue treatment in relapsing myeloma patients.

Corporate

  • Appointed Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO.

Financial

  • At March 31, 2017, the Company reported $10.1 million in cash, cash equivalents and short-term investments.
  • As at May 4, 2017, the Company had an unlimited number of authorized common shares with 121,836,722 common shares issued and outstanding, and 8,032,827 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027).

 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)




As at

March 31,
2017
$

December 31,
2016
$

Assets



Current assets



Cash and cash equivalents

10,102,393


12,034,282


Short-term investments


2,088,800


Accounts receivable

36,484


54,406


Prepaid expenses

182,897


260,841


Total current assets

10,321,774


14,438,329





Non-current assets



Property and equipment

301,534


319,955


Total non-current assets

301,534


319,955





Total assets

10,623,308


14,758,284


Liabilities And Shareholders' Equity



Current Liabilities



Accounts payable and accrued liabilities

3,348,766


4,068,664


Total current liabilities

3,348,766


4,068,664





Shareholders' equity



Share capital






Authorized: unlimited
Issued:
March 31, 2017 – 121,258,222
December 31, 2016 – 121,258,222

262,311,325


262,321,825


Contributed surplus

26,776,933


26,643,044


Accumulated other comprehensive income

533,312


554,060


Accumulated deficit

(282,347,028)


(278,829,309)


Total shareholders' equity

7,274,542


10,689,620


Total liabilities and equity

10,623,308


14,758,284


 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)





2017

2016

For the three month period ending March 31

$

$




Expenses



Research and development

2,268,071


2,726,129


Operating

1,300,300


1,360,412


Operating loss

(3,568,371)


(4,086,541)


Interest

50,715


69,621


Loss before income taxes

(3,517,656)


(4,016,920)


Income tax (expense) recovery

(63)


145


Net loss

(3,517,719)


(4,016,775)


Other comprehensive income items that may be
reclassified to net loss



Translation adjustment

(20,748)


(170,059)







Net comprehensive loss

(3,538,467)


(4,186,834)


Basic and diluted loss per common share

(0.03)


(0.03)







Weighted average number of shares (basic and diluted)

121,258,222


118,119,985


  

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, 2015

261,324,692


26,277,966


760,978


(263,689,330)


24,674,306


Net loss and other comprehensive loss



(170,059)


(4,016,775)


(4,186,834)


Issued, pursuant to "At the Market" Agreement

274,805





274,805


Share issue costs

(375,349)





(375,349)


Share based compensation


81,640




81,640


As at March 31, 2016

261,224,148


26,359,606


590,919


(267,706,105)


20,468,568









Share Capital

$

Contributed
Surplus

$

Accumulated
Other
Comprehensive
Income

$

Accumulated
Deficit

$

Total

$

As at December 31, 2016

262,321,825


26,643,044


554,060


(278,829,309)


10,689,620


Net loss and other comprehensive loss



(20,748)


(3,517,719)


(3,538,467)


Share issue costs

(10,500)





(10,500)


Share based compensation


133,889




133,889


As at March 31, 2017

262,311,325


26,776,933


533,312


(282,347,028)


7,274,542



 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)





2017

2016

For the three month period ending March 31

$

$




Operating Activities



Net loss for the period

(3,517,719)


(4,016,775)



Amortization - property and equipment                         

24,036


45,942



Share based compensation

133,889


81,640



Unrealized foreign exchange loss

52,032


141,295


Net change in non-cash working capital

(637,646)


724,655


Cash used in operating activities

(3,945,408)


(3,023,243)





Investing Activities



Acquisition of property and equipment

(5,836)



Redemption (purchase) of short-term investments

2,088,800


(27,823)


Cash provided by (used in) investing activities

2,082,964


(27,823)





Financing Activities



"At the Market" equity distribution agreement

(10,500)


(100,544)


Cash used in financing activities

(10,500)


(100,544)


Decrease in cash

(1,872,944)


(3,151,610)


Cash and cash equivalents, beginning of period

12,034,282


24,016,275


Impact of foreign exchange on cash and cash equivalents

(58,945)


(631,257)


Cash and cash equivalents, end of period

10,102,393


20,233,408


 

To view the Company's Fiscal 2017 First Quarter 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 under the Company's profile at www.sedar.com and on Oncolytics' website at http://oncolytics.creativepace.com/investor-centre/financials/.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, an immuno-oncology viral-agent, as a potential treatment for a variety of tumor types. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers. Oncolytics' clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis; immuno-therapy combinations to produce adaptive immune responses; and immune modulator (IMiD) combinations to facilitate innate immune responses. Oncolytics is currently planning its first registration study in breast cancer, as well as studies in combination with checkpoint inhibitors and IMID/targeted therapies in solid and hematological malignancies. 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 2017 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.