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
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.
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.
If “Yes” is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b): 82 -
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EXHIBIT
NUMBER |
|
DESCRIPTION |
| |
|
|
| 99.1 |
|
News
Release Dated November 6, 2014 - Oncolytics Biotech® Inc. Announces Third Quarter 2014 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 6, 2014 |
By: |
/s/ Kirk Look |
| |
|
Kirk Look |
| |
|
Chief Financial Officer |
Exhibit 99.1
Oncolytics Biotech® Inc. Announces Third Quarter 2014 Results
CALGARY, Nov. 6, 2014 /CNW/ - 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.
%CIK: 0001129928
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
CO: Oncolytics Biotech Inc.
CNW 06:30e 06-NOV-14