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 |
|||
|
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. | ||||||||
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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 |
88,592,863 |
84,758,818 |
86,786,937 |
83,112,919 |
||||
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ONCOLYTICS BIOTECH INC. | ||||||||||||
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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 |
||||||
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ONCOLYTICS BIOTECH INC. | ||||||||
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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 |
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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.
Oncolytics Biotech® Announces Poster Presentation at the 2018 Gastrointestinal Cancers Symposium Sponsored by ASCO in Patients with Relapsed Metastatic Adenocarcinoma of the Pancreas Read More
Oncolytics Biotech® Receives Favorable Final Advice Letter from the European Medicines Agency for REOLYSIN® in Metastatic Breast Cancer Read More
Exploring REOLYSIN®’s Objective Response Rate in Females with Colorectal Cancer Read More
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