CALGARY, Nov. 5, 2015 /PRNewswire/ - Oncolytics
Biotech® Inc. (TSX:ONC, OTCQX:ONCY) ("Oncolytics" or the
"Company") today announced its financial results and operational
highlights for the third quarter ended September 30, 2015.
"During the quarter, we announced exciting initial clinical data
from our multiple myeloma study showing statistically significant
increases in the production of caspase-3 and upregulation of PD-L1
along with an early objective response rate of 100%," said Dr.
Brad Thompson, President and CEO of
Oncolytics. "We also announced one and two-year survival data
versus historical controls from our pancreatic (REO 017) cancer
trial. This data is very often suggestive of broader immune system
involvement which led us to file a US Phase 1b study in pancreatic
adenocarcinoma; the first to examine REOLYSIN® in
combination with the checkpoint inhibitor
KEYTRUDA®."
Selected Highlights
Since July 1, 2015, selected
highlights announced by the Company include:
Clinical Program
- A poster presentation at the 15th International
Myeloma Workshop titled "Combination Carfilzomib and the Viral
Oncolytic Agent REOLYSIN® in Patients with Relapsed
Multiple Myeloma: A Pilot Study Investigating Viral Proliferation,"
highlighting data including 100% of patients (8 of 8) experiencing
an objective response as measured by changes in blood monoclonal
protein and significant increases in the production of caspase-3
(p=0.005) and upregulation of PD-L1 (p=0.005);
- An oral presentation at the International Association for the
Study of Lung Cancer (IASLC) 16th World Conference on
Lung Cancer titled "Oncolytic Reovirus in Combination with
Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated
Malignancies, Long Term Results," covering updated results,
including one- and two-year survival data, from the Company's REO
016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC);
- Presentation of final data from a single arm clinical study
examining the use of REOLYSIN® in combination with
gemcitabine in patients with advanced pancreatic cancer (REO 017),
which showed an increase in median overall survival, as well as an
approximate two-fold increase in one-year survival rates, and a
five-fold increase in two-year survival rates when compared to
gemcitabine therapy alone as seen in historical data;
- Completion of enrollment in two randomized Phase 2 studies
sponsored and conducted by the NCIC Clinical Trials Group; IND 211
is a study of REOLYSIN® in combination with chemotherapy
in patients with previously treated advanced or metastatic
non-small cell lung cancer and IND 209 is a study of
REOLYSIN® in combination with chemotherapy in patients
with recurrent or metastatic castration resistant prostate
cancer;
- Subsequent to quarter end, confirmation that, following
submission to the U.S. Food and Drug Administration ("FDA") for
review, the Investigational New Drug Application containing the
protocol titled "A Phase Ib study of pembrolizumab
(KEYTRUDA®) in combination with REOLYSIN®
(pelareorep) and chemotherapy in patients with advanced pancreatic
adenocarcinoma", the Company's first trial examining REOLYSIN in
combination with a checkpoint inhibitor, was active; and
Financial
- At September 30, 2015 the Company
reported $30.0 million in cash, cash
equivalents and short-term investments. At November 5, 2015, the Company had approximately
$28.7 million in cash, cash
equivalents and short-term investments, which is expected to
provide sufficient funds to support several small early-stage
immunotherapy combination studies as well as both a run-in and a
registration study in muscle invasive bladder cancer.
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ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
(unaudited)
|
|
|
|
|
September
30,
|
December
31,
|
|
2015
|
2014
|
|
$
|
$
|
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
27,962,462
|
14,152,825
|
|
Short-term
investments
|
2,060,977
|
2,031,685
|
|
Accounts
receivable
|
53,040
|
191,751
|
|
Prepaid
expenses
|
480,611
|
291,553
|
|
Total current
assets
|
30,557,090
|
16,667,814
|
|
|
|
|
Non-current
assets
|
|
|
|
Property and
equipment
|
443,468
|
525,376
|
|
Total non-current
assets
|
443,468
|
525,376
|
|
|
|
|
Total
assets
|
31,000,558
|
17,193,190
|
|
|
|
|
Liabilities And
Shareholders' Equity
|
|
|
|
Current
Liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
3,276,279
|
3,373,997
|
|
Total current
liabilities
|
3,276,279
|
3,373,997
|
|
|
|
|
Shareholders'
equity
|
|
|
|
Share
capital
|
|
|
|
Authorized: unlimited
|
|
Issued:
|
|
|
September 30, 2015 –
117,981,672
|
|
|
|
|
December 31, 2014 -
93,512,494
|
261,229,719
|
237,657,056
|
|
Contributed
surplus
|
26,029,865
|
25,848,429
|
|
Accumulated other
comprehensive income
|
657,103
|
280,043
|
|
Accumulated
deficit
|
(260,192,408)
|
(249,966,335)
|
|
Total
shareholders' equity
|
27,724,279
|
13,819,193
|
|
Total
liabilities and equity
|
31,000,558
|
17,193,190
|
|
|
|
|
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ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND
COMPREHENSIVE LOSS
(unaudited)
|
|
|
|
|
|
|
Three
Month
Period
Ending
September
30, 2015
|
Three
Month
Period
Ending
September
30, 2014
|
Nine Month
Period
Ending
September
30, 2015
|
Nine Month
Period
Ending
September
30, 2014
|
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
Research and
development
|
|
1,704,784
|
3,571,939
|
6,601,877
|
11,305,328
|
|
Operating
|
|
1,176,023
|
1,105,274
|
3,780,812
|
3,706,343
|
|
Operating
loss
|
(2,880,807)
|
(4,677,213)
|
(10,382,689)
|
(15,011,671)
|
|
Interest
|
|
52,756
|
39,937
|
153,313
|
178,177
|
|
Loss before
income taxes
|
(2,828,051)
|
(4,637,276)
|
(10,229,376)
|
(14,833,494)
|
|
Income tax
expense
|
|
4,074
|
668
|
3,303
|
(6,728)
|
|
Net
loss
|
(2,823,977)
|
(4,636,608)
|
(10,226,073)
|
(14,840,222)
|
|
Other
comprehensive income items that may be
|
|
|
|
|
|
reclassified to
net loss
|
|
|
|
|
|
|
|
|
|
Translation
adjustment
|
|
192,586
|
100,461
|
377,060
|
108,442
|
|
|
|
|
|
|
Net
comprehensive loss
|
(2,631,391)
|
(4,536,147)
|
(9,849,013)
|
(14,731,780)
|
|
Basic and
diluted loss per common share
|
(0.02)
|
(0.05)
|
(0.09)
|
(0.17)
|
|
Weighted
average number of shares (basic and
|
117,963,979
|
88,592,863
|
110,757,811
|
86,786,937
|
|
diluted)
|
|
|
|
|
|
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ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN
EQUITY
(unaudited)
|
|
|
|
|
|
|
|
|
Share
Capital
|
Contributed
Surplus
|
Warrants
|
Accumulated
Other
Comprehensive
Income
(Loss)
|
Accumulated
Deficit
|
Total
|
|
$
|
$
|
$
|
$
|
$
|
$
|
|
As at December 31,
2013
|
228,612,564
|
24,491,212
|
376,892
|
79,698
|
(231,347,000)
|
22,213,366
|
|
|
|
|
|
|
|
|
Net loss and other
comprehensive income
|
—
|
—
|
—
|
108,442
|
(14,840,222)
|
(14,731,780)
|
|
Issued, pursuant to
Share Purchase Agreement
|
6,427,899
|
—
|
—
|
—
|
—
|
6,427,899
|
|
Expired
warrants
|
—
|
376,892
|
(376,892)
|
—
|
—
|
—
|
|
Share based
compensation
|
—
|
870,423
|
—
|
—
|
—
|
870,423
|
|
As at September
30, 2014
|
235,040,463
|
25,738,527
|
—
|
188,140
|
(246,187,222)
|
14,779,908
|
|
|
|
|
|
|
|
|
Share
Capital
|
Contributed
Surplus
|
Warrants
|
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
|
|
|
|
|
|
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH
FLOWS
(unaudited)
|
|
|
|
|
|
|
Three
Month
Period
Ending
September
30, 2015
|
Three
Month
Period
Ending
September
30, 2014
|
Nine
Month
Period
Ending
September
30, 2015
|
Nine
Month
Period
Ending
September
30, 2014
|
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
Net loss for the
period
|
(2,823,977)
|
(4,636,608)
|
(10,226,073)
|
(14,840,222)
|
|
Amortization -
property and equipment
|
44,761
|
39,904
|
134,743
|
118,073
|
|
Share based
compensation
|
10,791
|
199,821
|
181,436
|
870,423
|
|
Unrealized foreign
exchange loss (gain)
|
(182,131)
|
243,290
|
(485,653)
|
193,301
|
|
Net change in
non-cash working capital
|
92,792
|
(261,622)
|
(327,690)
|
(2,701,103)
|
|
Cash used in
operating activities
|
(2,857,764)
|
(4,415,215)
|
(10,723,237)
|
(16,359,528)
|
|
Investing
Activities
|
|
|
|
|
|
Acquisition of
property and equipment
|
(17,695)
|
(113,782)
|
(47,292)
|
(131,001)
|
|
Purchase of
short-term investments
|
—
|
—
|
(29,292)
|
(30,041)
|
|
Cash used in
investing activities
|
(17,695)
|
(113,782)
|
(76,584)
|
(161,042)
|
|
Financing
Activities
|
|
|
|
|
|
Proceeds from Share
Purchase Agreement
|
—
|
2,736,749
|
4,305,396
|
6,427,899
|
|
Proceeds from "At the
Market" equity distribution
|
|
|
|
|
|
agreement
|
|
213,742
|
—
|
19,267,267
|
—
|
|
Cash provided by
financing activities
|
213,742
|
2,736,749
|
23,572,663
|
6,427,899
|
|
Increase in
cash
|
(2,661,717)
|
(1,792,248)
|
12,772,842
|
(10,092,671)
|
|
Cash and cash
equivalents, beginning of period
|
30,018,217
|
16,880,730
|
14,152,825
|
25,220,328
|
|
Impact of foreign
exchange on cash and cash
|
|
|
|
|
|
equivalents
|
|
605,962
|
(75,514)
|
1,036,795
|
(114,689)
|
|
Cash and cash
equivalents, end of period
|
27,962,462
|
15,012,968
|
27,962,462
|
15,012,968
|
To view the Company's Fiscal 2015 Third 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.