0001279569-16-004591.txt : 20161103 0001279569-16-004591.hdr.sgml : 20161103 20161103142408 ACCESSION NUMBER: 0001279569-16-004591 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20161103 FILED AS OF DATE: 20161103 DATE AS OF CHANGE: 20161103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ONCOLYTICS BIOTECH INC CENTRAL INDEX KEY: 0001129928 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31062 FILM NUMBER: 161971144 BUSINESS ADDRESS: STREET 1: 1167 KENSINGTON CRES NW SUITE 210 STREET 2: CALGARY ALBERTA CANADA T2N 1X7 CITY: ALBERTA CANADA STATE: A0 ZIP: 00000 BUSINESS PHONE: 4036707380 MAIL ADDRESS: STREET 1: 210 - 1167 KENSINGTON CRES NW CITY: CALGARY STATE: A0 ZIP: T2N 1X7 6-K 1 oncolyticsform6k.htm FORM 6-K

 

 

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

 

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

 

For the month of November 2016

 

Commission File Number 000-31062

 

Oncolytics Biotech Inc.

 

(Translation of registrant’s name into English)

 

Suite 210, 1167 Kensington Crescent NW

Calgary, Alberta, Canada T2N 1X7

 

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

     
Form 20-F   þ   Form 40-F   ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   ☐

 

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   ☐

 

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

     
Yes   ☐ No þ

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):   82 -                  

 

 

 

 

 
 

 

 

 

 

EXHIBIT

NUMBER

  DESCRIPTION
     
99.1   News Release Dated November 3, 2016 - Oncolytics Biotech® Inc. Announces 2016 Third Quarter Results

 

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Oncolytics Biotech Inc.

(Registrant)

     
     
 Date:   November 3, 2016 By: /s/  Kirk Look
    Kirk Look
    Chief Financial Officer

 

EX-99.1 2 ex991.htm NEWS RELEASE DATED NOVEMBER 3, 2016

Exhibit 99.1

 

 

 

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.

 

%CIK: 0001129928

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

CO: Oncolytics Biotech Inc.

CNW 06:30e 03-NOV-16