ONCOLYTICS BIOTECH INC. CALGARY, May 7, 2015 /PRNewswire/ - Oncolytics Biotech(®) Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended March 31, 2015.
"In the first quarter, we obtained Orphan Drug Designation from the U.S. FDA and the EMA in Europe for a number of different indications, which will support future development of REOLYSIN(®)," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also reported a range of clinical and preclinical data that furthered our understanding of how REOLYSIN(®) works and the specific benefits it can confer in combination with other approved therapies."
Selected Highlights
Since January 1, 2015, 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;
-- Presentation of data from a single arm clinical study examining the use
of REOLYSIN(®) in combination with gemcitabine in patients with
advanced pancreatic cancer (REO 017);
-- Presentation of data showing up regulation of PD-1 and PD-L1 from a
single arm clinical study examining the use of REOLYSIN(®) in patients
with primary glioblastomas or brain metastases (REO 013b) at the Royal
Society of Medicine's Immuno-oncology: Using the Body's Own Weapons
conference, held in London, UK;
Regulatory
-- Application for Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for REOLYSIN(®) in the treatment of gastric
cancer. The Company was granted designations by the FDA in ovarian,
fallopian tube, primary peritoneal and pancreatic cancers as well as
malignant glioma;
-- Granting of Orphan Drug Designation by the European Medicines Agency for
REOLYSIN(®) in the treatment of ovarian cancer, and subsequent to
quarter end, for pancreatic cancer;
-- Subsequently, on May 5, 2015, the Company was granted Orphan Drug
Designation from the FDA for the treatment of gastric cancer;
Basic Research
-- Presentation of clinical and preclinical data at the 2015 Immune
Checkpoint Inhibitors meeting in Boston, MA, including content showing
the combination of REOLYSIN(®), GM-CSF, anti-PD-1 and anti-CTLA-4
improved survival in immune competent mice versus REOLYSIN(®) and
GM-CSF alone and REOLYSIN(®) and GM-CSF plus either one of the
checkpoint inhibitors alone;
-- A series of presentations made by the Company's research collaborators
at the AACR Annual Meeting held in Philadelphia, PA covering preclinical
research in a range of indications, with a variety of treatment
combinations including REOLYSIN(®); and
Financial
-- At March 31, 2015 the Company reported $30.6 million in cash, cash
equivalents and short-term investments. At May 6, 2015, the Company had
approximately $31.5 million in cash, cash equivalents and short-term
investments.
The Year Ahead
The Company continues to actively focus on developing its go-forward clinical path, which could include one or more registration studies. In addition to actively speaking with key-opinion leaders, regulatory consultants and regulators themselves, Oncolytics expects to evaluate its growing library of clinical trial data in an effort to identify the most expeditious route to the commercial endpoint.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
As at March 31, December 31,
2015 2014
--- ---- ----
Assets
Current assets
Cash and cash equivalents 28,578,023 14,152,825
Short-term investments 2,060,977 2,031,685
Accounts receivable 45,706 191,751
Prepaid expenses 264,708 291,553
---------------- ------- -------
Total current assets 30,949,414 16,667,814
-------------------- ---------- ----------
Non-current assets
Property and equipment 495,531 525,376
---------------------- ------- -------
Total non-current assets 495,531 525,376
------------------------ ------- -------
Total assets 31,444,945 17,193,190
============ ========== ==========
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and accrued liabilities 4,274,515 3,373,997
---------------------------------------- --------- ---------
Total current liabilities 4,274,515 3,373,997
------------------------- --------- ---------
Shareholders' equity
Share capital
Authorized: unlimited 254,219,570 237,657,056
Issued:
March 31, 2015 - 109,708,373
December 31, 2014 - 93,512,494
Contributed surplus 25,963,399 25,848,429
Accumulated other comprehensive income 505,634 280,043
Accumulated deficit (253,518,173) (249,966,335)
------------------- ------------ ------------
Total shareholders' equity 27,170,430 13,819,193
-------------------------- ---------- ----------
Total liabilities and equity 31,444,945 17,193,190
============================ ========== ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
2015 2014
For the three month period ending March 31 $ $
========================================== === ===
Expenses
Research and development 2,425,539 4,178,334
Operating 1,182,734 1,391,254
--------- --------- ---------
Operating loss (3,608,273) (5,569,588)
Interest 56,435 87,987
-------- ------ ------
Loss before income taxes (3,551,838) (5,481,601)
Income tax expense - (3,850)
------------------ --- ------
Net loss (3,551,838) (5,485,451)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment 225,591 (18,694)
---------------------- ------- -------
Net comprehensive loss (3,326,247) (5,504,145)
====================== ========== ==========
Basic and diluted loss per common share (0.04) (0.06)
======================================= ===== =====
Weighted average number of shares (basic and diluted) 99,557,654 85,148,242
==================================================== ========== ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
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 comprehensive loss - - - (18,694) (5,485,451) (5,504,145)
Issued, pursuant to Share
Purchase Agreement 1,188,442 - - - - 1,188,442
Exercise of stock options - 376,892 (376,892) - - -
Share based compensation - 304,597 - - - 304,597
------------------------ --- ------- --- --- --- -------
As at March 31, 2014 229,801,006 25,172,701 - 61,004 (236,832,451) 18,202,260
==================== =========== ========== === ====== ============ ==========
Share Capital Contributed Warrants Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ Income $
$
As at December 31, 2014 237,657,056 25,848,429 - 280,043 (249,966,335) 13,819,193
Net loss and comprehensive
income - - - 225,591 (3,551,838) (3,326,247)
Issued, pursuant to Share
Purchase Agreement 1,925,596 - - - - 1,925,596
Issued, pursuant to "At the
Market" Agreement 14,636,918 - - - - 14,636,918
Share based compensation - 114,970 - - - 114,970
------------------------ --- ------- --- --- --- -------
As at March 31, 2015 254,219,570 25,963,399 - 505,634 (253,518,173) 27,170,430
==================== =========== ========== === ======= ============ ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
2015 2014
For the three month period ending March 31 $ $
------------------------------------------ --- ---
Operating Activities
Net loss for the period (3,551,838) (5,485,451)
Amortization - property and equipment 45,130 39,657
Share based compensation 114,970 304,597
Impact of unrealized foreign exchange (gains) losses (305,156) 24,070
Net change in non-cash working capital 949,705 (1,046,951)
-------------------------------------- ------- ----------
Cash used in operating activities (2,747,189) (6,164,078)
--------------------------------- ---------- ----------
Investing Activities
Acquisition of property and equipment (11,940) (15,980)
Purchase of short-term investments (29,292) (30,041)
---------------------------------- ------- -------
Cash used in investing activities (41,232) (46,021)
--------------------------------- ------- -------
Financing Activities
Proceeds from Share Purchase Agreement 1,925,596 1,188,442
Proceeds from "At the Market" equity distribution agreement 14,636,918 -
----------------------------------------------------------- ---------- ---
Cash provided by financing activities 16,562,514 1,188,442
------------------------------------- ---------- ---------
Increase in cash 13,774,093 (5,021,657)
Cash and cash equivalents, beginning of period 14,152,825 25,220,328
Impact of foreign exchange on cash and cash equivalents 651,105 (42,764)
------------------------------------------------------- ------- -------
Cash and cash equivalents, end of period 28,578,023 20,155,907
======================================== ========== ==========
To view the Company's Fiscal 2015 First Quarter 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.
