ONCOLYTICS BIOTECH INC. CALGARY, Aug. 7, 2014 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the second quarter ended June 30, 2014.
"Our randomized clinical program continued to advance during the quarter as we recently reported the completion of enrollment in a Phase II study using REOLYSIN(®) in combination with carboplatin and paclitaxel in pancreatic cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also strengthened our board, adding two directors with significant financial and public company experience."
Selected Highlights
Since April 1, 2014, selected highlights announced by the Company include:
Clinical and Preclinical Data
-- Completion of patient enrollment in a two-arm randomized phase II study
of carboplatin, paclitaxel plus REOLYSIN(®) versus carboplatin and
paclitaxel alone in the first line treatment of patients with recurrent
or metastatic pancreatic cancer (OSU-10045);
-- Early results from a translational study looking at intravenous
administration of REOLYSIN(®) to patients with primary or metastatic
brain tumors was presented at the ASCO Annual Meeting in Chicago, IL;
-- Final data from the Company's randomized, double-blinded clinical study
examining REOLYSIN(®) in combination with carboplatin and paclitaxel in
patients with second-line, platinum-refractory, taxane-naïve head and
neck cancers;
-- A series of presentations by research collaborators at the 8(th) Annual
International Confe(r)ence on Oncolytic Virus Therapeutics held in
Oxford, UK covering:
-- early clinical research showing that intravenously delivered
REOLYSIN(® )can cross the blood brain barrier to access tumours in
the brains of humans;
-- preclinical research examining the synergies associated with
treatment in animal models with GM-CSF prior to administering
REOLYSIN(®);
-- preclinical research focused on identifying biomarkers predictive of
sensitivity/resistance to reovirus in head and neck cancer cell
lines; and
-- preclinical research into the treatment of hepatocellular carcinoma
associated with infection by Hepatitis B and Hepatitis C.
Governance
-- The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to
the Company's board of directors; and
Financial
-- At June 30, 2014 the Company reported $18.9 million in cash, cash
equivalents and short-term investments.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
June 30, December 31,
2014 2013
$ $
--- ---
Assets
Current assets
Cash and cash equivalents 16,880,730 25,220,328
Short-term investments 2,031,685 2,001,644
Accounts receivable 54,391 105,853
Prepaid expenses 609,538 361,743
---------------- ------- -------
Total current assets 19,576,344 27,689,568
-------------------- ---------- ----------
Non-current assets
Property and equipment 470,217 532,459
---------------------- ------- -------
Total non-current assets 470,217 532,459
------------------------ ------- -------
Total assets 20,046,561 28,222,027
------------ ---------- ----------
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and accrued liabilities 3,667,076 6,008,661
---------------------------------------- --------- ---------
Total current liabilities 3,667,076 6,008,661
Shareholders' equity
Share capital
Authorized: unlimited Issued:
June 30, 2014 - 87,537,397
December 31, 2013 - 84,803,818 232,303,714 228,612,564
Warrants - 376,892
Contributed surplus 25,538,706 24,491,212
Accumulated other comprehensive loss 87,679 79,698
Accumulated deficit (241,550,614) (231,347,000)
------------------- ------------ ------------
Total shareholders' equity 16,379,485 22,213,366
-------------------------- ---------- ----------
Total liabilities and equity 20,046,561 28,222,027
---------------------------- ---------- ----------
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Month Three Month Six Month Six Month
Period Period Period Period
Ending June Ending June Ending June Ending June
30, 2014 30, 2013 30, 2014 30, 2013
$ $ $ $
--- --- --- ---
Expenses
Research and development 3,555,055 3,804,307 7,733,389 8,921,351
Operating 1,209,815 1,320,742 2,601,069 2,885,493
--------- --------- --------- --------- ---------
Operating loss (4,764,870) (5,125,049) (10,334,458) (11,806,844)
Interest 50,253 105,368 138,240 180,327
-------- ------ ------- ------- -------
Loss before income taxes (4,714,617) (5,019,681) (10,196,218) (11,626,517)
Income tax expense (3,546) - (7,396) -
------------------ ------ --- ------ ---
Net loss (4,718,163) (5,019,681) (10,203,614) (11,626,517)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment 26,675 73,451 7,981 107,639
---------------------- ------ ------ ----- -------
Net comprehensive loss (4,691,488) (4,946,230) (10,195,633) (11,518,878)
---------------------- ---------- ---------- ----------- -----------
Basic and diluted loss per common share (0.05) (0.06) (0.12) (0.14)
--------------------------------------- ----- ----- ----- -----
Weighted average number of shares 86,581,854 84,758,818 85,869,008 82,276,330
(basic and diluted)
------------------
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
Share Capital Contributed Warrants Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ 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 - - - 107,639 (11,626,517) (11,518,878)
comprehensive loss
Issued, pursuant to a 30,218,797 - - - - 30,218,797
bought deal financing
Exercise of stock options 139,676 (34,687) - - - 104,989
Share based compensation - 250,853 - - - 250,853
------------------------ --- ------- --- --- --- -------
As at June 30, 2013 228,513,564 24,342,431 376,892 50,524 (219,440,870) 33,842,541
------------------- ----------- ---------- ------- ------ ------------ ----------
Share Capital Contributed Warrants Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ Loss $
$
As at December 31, 2013 228,612,564 24,491,212 376,892 79,698 (231,347,000) 22,213,366
Net loss and - - - 7,981 (10,203,614) (10,195,633)
comprehensive loss
Issued, pursuant to Share 3,691,150 - - - - 3,691,150
Purchase Agreement
Expired warrants - 376,892 (376,892) - - -
Share based compensation - 670,602 - - - 670,602
------------------------ --- ------- --- --- --- -------
As at June 30, 2014 232,303,714 25,538,706 - 87,679 (241,550,614) 16,379,485
------------------- ----------- ---------- --- ------ ------------ ----------
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Month Three Month Six Month Six Month
Period Period Period Period
Ending June Ending June Ending June Ending June
30, 2014 30, 2013 30, 2014 30, 2013
$ $ $ $
--- --- --- ---
Operating Activities
Net loss for the
period (4,718,163) (5,019,681) (10,203,614) (11,626,517)
Amortization -
property and
equipment 38,512 25,565 78,169 50,146
Share based
compensation 366,005 129,997 670,602 250,853
Unrealized foreign
exchange loss (74,059) 209,804 (49,989) (97,849)
Net change in non-
cash working
capital (1,392,530) (455,283) (2,439,481) (2,096,453)
------------------ ---------- -------- ---------- ----------
Cash used in
operating
activities (5,780,235) (5,109,598) (11,944,313) (13,519,820)
------------ ---------- ---------- ----------- -----------
Investing Activities
Acquisition of
property and
equipment (1,239) (132,164) (17,219) (147,302)
Purchase of short-
term investments - - (30,041) (32,416)
------------------ --- --- ------- -------
Cash used in
investing
activities (1,239) (132,164) (47,260) (179,718)
------------ ------ -------- ------- --------
Financing Activities
Proceeds from
exercise of stock
options and - - - 104,989
warrants
Proceeds from
Share Purchase
Agreement 2,502,708 - 3,691,150 -
Proceeds from
public offering - 11,735 - 30,218,797
---------------- --- ------ --- ----------
Cash provided by
financing
activities 2,502,708 11,735 3,691,150 30,323,786
---------------- --------- ------ --------- ----------
Increase in cash (3,278,766) (5,230,027) (8,300,423) 16,624,248
Cash and cash
equivalents,
beginning of
period 20,155,907 41,519,657 25,220,328 19,323,541
Impact of foreign
exchange on cash
and cash 3,589 (136,353) (39,175) 205,488
equivalents
-----------
Cash and cash
equivalents, end
of period 16,880,730 36,153,277 16,880,730 36,153,277
----------------- ---------- ---------- ---------- ----------
To view the Company's Second Quarter 2014 Consolidated Financial Statements, related Notes to 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.
