ONCOLYTICS BIOTECH INC. CALGARY, Nov. 6, 2014 /PRNewswire/ - 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, December 31,
2014 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 Three Month Nine Month Nine Month
Period Period Period Period
Ending Ending Ending Ending
September September September September
30, 2013
$
30, 2014 30, 2013 30, 2014
$
$ $
=== ===
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
diluted)
=======
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Share Capital Contributed Warrants Accumulated Accumulated Total
$ Surplus $ Other Deficit $
$ Comprehensive $
Income
(Loss)
$
--- ---
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 Warrants Accumulated Accumulated Total
$
Surplus Other Deficit $
$
Comprehensive $
$
Income
$
--- ---
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 Three Month Nine Month Nine Month
Period Period Period Period
Ending Ending Ending Ending
September September September September
30, 2014 30, 2013 30, 2014 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.
