ONCOLYTICS BIOTECH INC. CALGARY, March 16, 2015 /PRNewswire/ - Oncolytics Biotech(®) Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2014.
"The activities of the Company in 2014 have laid the groundwork enabling us to plan and execute our late stage clinical strategy," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are looking forward to finalizing the plans for and initiating our registration studies for REOLYSIN(®)."
Selected Highlights
Since January 1, 2014, selected highlights announced by the Company include:
Clinical Program
-- Completion of patient enrollment in an ongoing, NCIC Clinical Trials
Group sponsored randomized Phase II study of REOLYSIN(® )in patients
with advanced or metastatic colorectal cancer (IND 210). The Company
awaits preliminary data from this study;
-- Reporting completion of enrollment and 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). The Company
awaits final data from this study, which will be available once all
remaining patients have progressed;
-- Completion of patient enrollment 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 preliminary data from
this study;
-- Reporting 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;
-- Presentation by the Company's collaborators of preliminary clinical data
demonstrating that intravenously delivered REOLYSIN(®) can cross the
blood brain barrier to access tumours in the brains of humans;
Regulatory
-- Application for Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for REOLYSIN(®) in the treatment of ovarian and
pancreatic cancers. The Company was granted designations in ovarian,
fallopian tube, primary peritoneal and pancreatic cancer subsequent to
year end;
-- Application to the European Medicines Agency for Orphan Designation for
REOLYSIN(®) in the treatment of pancreatic and ovarian cancers;
-- Subsequent to year end, the Company applied to the U.S. FDA for a fifth
Orphan Drug Designation for high grade gliomas in paediatric patients;
Basic Research
-- Presentation of a poster entitled "Combination Therapy with Reovirus and
PD-1 Blockade Effectively Establishes Tumour Control Via Innate and
Adaptive Immune Responses" by the Company's research collaborators, Vile
et al., at the AACR Tumor Immunology and Immunotherapy Conference;
-- A series of presentations made by the Company's research collaborators
at the 8(th) Annual International Conference on Oncolytic Virus
Therapeutics held in Oxford, UK, covering:
-- 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;
Financial
-- Entry into and subsequent amendments to a share purchase agreement with
Lincoln Park Capital Fund, LLC;
-- Entry into a $20 million "At-the-Market" equity distribution agreement
with Canaccord Genuity Inc.; and
-- At December 31, 2014 the Company reported $16.2 million in cash, cash
equivalents and short-term investments. At March 13, 2015, the Company
had approximately $27.5 million in cash, cash equivalents and short-term
investments.
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As at December 31, 2014 2013
$ $
--- --- ---
Assets
Current assets
Cash and cash
equivalents 14,152,825 25,220,328
Short-term investments 2,031,685 2,001,644
Accounts receivable 191,751 105,853
Prepaid expenses 291,553 361,743
---------------- ------- -------
Total current assets 16,667,814 27,689,568
-------------------- ---------- ----------
Non-current assets
Property and equipment 525,376 532,459
---------------------- ------- -------
Total non-current assets 525,376 532,459
------------------------ ------- -------
Total assets 17,193,190 28,222,027
============ ========== ==========
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and
accrued liabilities 3,373,997 6,008,661
-------------------- --------- ---------
Total current
liabilities 3,373,997 6,008,661
------------- --------- ---------
Shareholders' equity
Share capital
Authorized: unlimited 237,657,056 228,612,564
Issued:
December 31, 2014 - 93,512,494
December 31, 2013 - 84,803,818
Warrants - 376,892
Contributed surplus 25,848,429 24,491,212
Accumulated other
comprehensive income 280,043 79,698
Accumulated deficit (249,966,335) (231,347,000)
------------------- ------------ ------------
Total shareholders'
equity 13,819,193 22,213,366
------------------- ---------- ----------
Total liabilities and
equity 17,193,190 28,222,027
===================== ========== ==========
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the years
ending
December 31, 2014 2013 2012
$ $ $
=== === === ===
Expenses
Research and
development 13,824,252 18,506,064 31,402,625
Operating 4,998,694 5,392,660 5,285,425
--------- --------- --------- ---------
Loss before
the
following (18,822,946) (23,898,724) (36,688,050)
Interest 210,390 371,485 345,003
-------- ------- ------- -------
Loss before
income taxes (18,612,556) (23,527,239) (36,343,047)
Income tax
expense (6,779) (5,408) (30,474)
---------- ------ ------ -------
Net loss (18,619,335) (23,532,647) (36,373,521)
Other comprehensive income
items that may be
reclassified to net loss
Translation adjustment 200,345 136,813 60,386
---------------------- ------- ------- ------
Net
comprehensive
loss (18,418,990) (23,395,834) (36,313,135)
============== =========== =========== ===========
Basic and
diluted loss
per common
share (0.21) (0.28) (0.48)
============= ===== ===== =====
Weighted
average
number of
shares
(basic and
diluted) 87,869,149 83,530,981 76,102,062
=========== ========== ========== ==========
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Share Warrants Contributed Accumulated Accumulated Total
$ $
Capital Surplus Other Deficit
$ $ $
Comprehensive
Income
$
--- ---
As at December 31,
2011 177,282,566 2,653,627 21,142,519 (117,501) (171,440,832) 29,520,379
Net loss and other
comprehensive income - - - 60,386 (36,373,521) (36,313,135)
Issued, pursuant to a
bought deal financing 19,386,903 376,892 - - - 19,763,795
Expiry of warrants - (2,653,627) 2,653,627 - - -
Exercise of stock
options 1,485,622 - (400,632) - - 1,084,990
Share based
compensation - - 730,751 - - 730,751
------------- --- --- ------- --- --- -------
As at December 31,
2012 198,155,091 376,892 24,126,265 (57,115) (207,814,353) 14,786,780
Net loss and other
comprehensive income - - - 136,813 (23,532,647) (23,395,834)
Issued, pursuant to a
bought deal financing 30,218,796 - - - - 30,218,796
Expiry of warrants - - - - - -
Exercise of stock
options 238,677 - (59,437) - - 179,240
Share based
compensation - - 424,384 - - 424,384
------------- --- --- ------- --- --- -------
As at December 31,
2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366
Net loss and other
comprehensive income - - - 200,345 (18,619,335) (18,418,990)
Issued, pursuant to
Share Purchase
Agreement 7,830,409 - - - - 7,830,409
Issued, pursuant to
"At the Market"
Agreement 1,214,083 - - - - 1,214,083
Expired warrants - (376,892) 376,892 - - -
Share based
compensation - - 980,325 - - 980,325
------------- --- --- ------- --- --- -------
As at December 31,
2014 237,657,056 - 25,848,429 280,043 (249,966,335) 13,819,193
================== =========== === ========== ======= ============ ==========
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the years ending
December 31, 2014 2013 2012
$ $ $
--- --- --- ---
Operating Activities
Net loss for the year (18,619,335) (23,532,647) (36,373,521)
Amortization -
property and
equipment 163,501 131,623 109,275
Share based
compensation 980,325 424,384 730,751
Unrealized foreign
exchange loss 242,542 (89,721) 89,890
Net change in non-
cash working capital (2,443,988) (1,374,172) 1,187,967
--------------------- ---------- ---------- ---------
Cash used in operating
activities (19,676,955) (24,440,533) (34,255,638)
---------------------- ----------- ----------- -----------
Investing Activities
Acquisition of
property and
equipment (152,750) (254,834) (126,412)
Redemption (purchase)
of short-term
investments (30,041) (32,416) (32,441)
--------------------- ------- ------- -------
Cash used in investing
activities (182,791) (287,250) (158,853)
---------------------- -------- -------- --------
Financing Activities
Proceeds from exercise
of stock options and
warrants - 179,240 1,084,990
Proceeds from Share
Purchase Agreement 7,830,409 - -
Proceeds from "At the
Market" equity
distribution
agreement 1,214,083 - -
Proceeds from public
offering - 30,218,796 19,763,795
-------------------- --- ---------- ----------
Cash provided by
financing activities 9,044,492 30,398,036 20,848,785
--------------------- --------- ---------- ----------
(Decrease) increase in
cash (10,815,254) 5,670,253 (13,565,706)
Cash and cash
equivalents,
beginning of year 25,220,328 19,323,541 32,918,751
Impact of foreign
exchange on cash and
cash equivalents (252,249) 226,534 (29,504)
--------------------- -------- ------- -------
Cash and cash
equivalents, end of
year 14,152,825 25,220,328 19,323,541
==================== ========== ========== ==========
To view the Company's Fiscal 2014 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual 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 2015 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.
