ONCOLYTICS BIOTECH INC. CALGARY, Nov. 3, 2016 /PRNewswire/ - Oncolytics Biotech(®) Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the third quarter ended September 30, 2016.
"During the quarter we reported additional statistically significant, randomized clinical data that further strengthened the linkage between genetic status and survival outcomes in patients with adenocarcinoma of the lung," said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. "In parallel with reporting data from sponsored Phase 2 randomized studies, we continued to push ahead with preparations for a registration study."
Selected Highlights
Since July 1, 2016, selected highlights announced by the Company include:
Clinical Program
-- Additional data from a randomized, sponsored Phase II clinical study of
REOLYSIN(®) in non-small cell lung cancer (IND 211), which showed that:
-- progression free survival ("PFS") was statistically significantly
better for female patients in the test arm (n=20) than for those in
the control arm (n=16) in patients with adenocarcinoma. Median PFS
was 5.39 months compared with 3.02 months, respectively (p=0.0201);
-- evolving overall survival ("OS") demonstrated a strong trend towards
survival benefit for female patients in the test arm with
adenocarcinoma (n=20, six of whom remained alive at the time of the
analysis) over those in the control arm (n=16, three of whom
remained alive at the time of the analysis). Median OS was 10.68
months compared with 7.59 months, respectively (p=0.145) (Figure B).
By contrast, no PFS or OS benefit was noted for the male patients
with adenocarcinoma; and
-- patients with adenocarcinoma treated with REOLYSIN(®) with one or
more target biomarkers (EGFR, Hras, Kras, Nras, Braf and/or p53
mutations) had a greater PFS (p=0.039) and OS (p=0.031) than
patients treated with REOLYSIN(® )without any of these biomarkers.
The presence of these biomarkers may account, at least in part, for
the difference between the survival outcomes for male and female
patients; target biomarkers were present in a higher proportion of
the female patients in the study than the male patients (66.7%
versus 43.6%). As a result, pre-screening for target biomarkers in
patients with adenocarcinoma of the lung is warranted.
Financial
At September 30, 2016, the Company reported $17.7 million in cash, cash equivalents and short-term investments. At November 2, 2016, the Company had approximately $16.7 million in cash, cash equivalents and short-term investments.
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
September 30, December 31,
2016 2015
$ $
--- ---
Assets
Current assets
Cash and cash
equivalents 15,612,729 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 44,991 340,059
Prepaid expenses 356,741 506,669
---------------- ------- -------
Total current assets 18,103,261 26,923,980
-------------------- ---------- ----------
Non-current assets
Property and equipment 333,926 459,818
---------------------- ------- -------
Total non-current assets 333,926 459,818
------------------------ ------- -------
Total assets 18,437,187 27,383,798
============ ========== ==========
Liabilities And
Shareholders' Equity
Current Liabilities
Accounts payable and
accrued liabilities 2,809,008 2,709,492
-------------------- --------- ---------
Total current
liabilities 2,809,008 2,709,492
------------- --------- ---------
Shareholders' equity
Share capital
Authorized: unlimited
Issued:
September 30, 2016 -
120,873,222
December 31, 2015 - 118,151,622 262,218,228 261,324,692
Contributed surplus 26,536,601 26,277,966
Accumulated other
comprehensive income 492,637 760,978
Accumulated deficit (273,619,287) (263,689,330)
------------------- ------------ ------------
Total shareholders'
equity 15,628,179 24,674,306
------------------- ---------- ----------
Total liabilities and
equity 18,437,187 27,383,798
===================== ========== ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Three Nine Month Nine Month
Month Month Period Period
Period Period Ending Ending
Ending Ending September September 30,
September September 30, 2016 2015
30, 2016 30, 2015 $ $
$ $
--- ---
Expenses
Research and development 2,141,737 1,704,784 6,358,822 6,601,877
Operating 1,222,447 1,176,023 3,708,317 3,780,812
--------- --------- --------- --------- ---------
Operating loss (3,364,184) (2,880,807) (10,067,139) (10,382,689)
Interest 31,691 52,756 136,849 153,313
-------- ------ ------ ------- -------
Loss before income taxes (3,332,493) (2,828,051) (9,930,290) (10,229,376)
Income tax expense 19 4,074 333 3,303
------------------ --- ----- --- -----
Net loss (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Other comprehensive income
items that may be
reclassified to net loss
Translation adjustment 32,545 192,586 (268,341) 377,060
---------------------- ------ ------- -------- -------
Net comprehensive loss (3,299,929) (2,631,391) (10,198,298) (9,849,013)
====================== ========== ========== =========== ==========
Basic and diluted loss per
common share (0.03) (0.02) (0.08) (0.09)
========================== ===== ===== ===== =====
Weighted average number of
shares (basic and 120,552,638 117,963,979 119,455,440 110,757,811
diluted)
=======
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
Share Capital Contributed 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 other
comprehensive income - - 377,060 (10,226,073) (9,849,013)
Issued, pursuant to
Share Purchase
Agreement 4,305,396 - - - 4,305,396
Issued, pursuant to
"At the Market"
Agreement 19,267,267 - - - 19,267,267
Share based
compensation - 181,436 - - 181,436
------------- --- ------- --- --- -------
As at September 30,
2015 261,229,719 26,029,865 657,103 (260,192,408) 27,724,279
=================== =========== ========== ======= ============ ==========
Share Capital Contributed Accumulated Accumulated Total
$ Surplus Other Deficit $
$ Comprehensive $
Income
$
---
As at December 31,
2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and other
comprehensive loss - - (268,341) (9,929,957) (10,198,298)
Issued, pursuant to
"At the Market"
Agreement 852,536 - - - 852,536
Issued, pursuant to
incentive share award
plan 41,000 (41,000) - - -
Share based
compensation - 299,635 - - 299,635
------------- --- ------- --- --- -------
As at September 30,
2016 262,218,228 26,536,601 492,637 (273,619,287) 15,628,179
=================== =========== ========== ======= ============ ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Three Nine Month Nine Month
Month Month Period Period
Period Period Ending Ending
Ending Ending September September
September September 30, 2016 30, 2015
30, 2016 30, 2015 $ $
$ $
--- ---
Operating Activities
Net loss for the period (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Amortization -property and
equipment 44,014 44,761 134,631 134,743
Share based compensation 98,369 10,791 299,635 181,436
Unrealized foreign exchange gain (49,400) (182,131) (152,019) (485,653)
Net change in non-cash
working capital 216,611 92,792 978,847 (327,690)
---------------------- ------- ------ ------- --------
Cash used in operating
activities (3,022,880) (2,857,764) (8,668,863) (10,723,237)
---------------------- ---------- ---------- ---------- -----------
Investing Activities
Acquisition of property and
equipment (4,851) (17,695) (10,553) (47,292)
Purchase of short-term
investments - - (27,823) (29,292)
---------------------- --- --- ------- -------
Cash used in investing
activities (4,851) (17,695) (38,376) (76,584)
---------------------- ------ ------- ------- -------
Financing Activities
Proceeds from Share
Purchase Agreement - - - 4,305,396
Proceeds from "At the
Market" equity
distribution agreement 242,706 213,742 852,536 19,267,267
----------------------- ------- ------- ------- ----------
Cash provided by financing
activities 242,706 213,742 852,536 23,572,663
-------------------------- ------- ------- ------- ----------
(Decrease) increase in cash (2,785,025) (2,661,717) (7,854,703) 12,772,842
Cash and cash equivalents,
beginning of period 18,320,981 30,018,217 24,016,275 14,152,825
Impact of foreign exchange
on cash and cash
equivalents 76,773 605,962 (548,843) 1,036,795
-------------------------- ------ ------- -------- ---------
Cash and cash equivalents,
end of period 15,612,729 27,962,462 15,612,729 27,962,462
========================== ========== ========== ========== ==========
To view the Company's Fiscal 2016 Third Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's quarterly filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/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 2016 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.
