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,
2016
$
|
December 31,
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
Month
Period
Ending
September
30, 2016
$
|
Three
Month
Period
Ending
September
30, 2015
$
|
Nine Month
Period
Ending
September
30, 2016
$
|
Nine Month
Period
Ending
September 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
diluted)
|
120,552,638
|
|
117,963,979
|
|
119,455,440
|
|
110,757,811
|
|
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
|
|
|
|
|
|
|
|
Share
Capital
$
|
Contributed
Surplus
$
|
Accumulated
Other
Comprehensive
Income
$
|
Accumulated
Deficit
$
|
Total
$
|
|
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
Surplus
$
|
Accumulated
Other
Comprehensive
Income
$
|
Accumulated
Deficit
$
|
Total
$
|
|
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
Month
Period
Ending
September
30, 2016
$
|
Three
Month
Period
Ending
September
30, 2015
$
|
Nine Month
Period
Ending
September
30, 2016
$
|
Nine Month
Period
Ending
September
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.