CALGARY, May 6, 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 first quarter ended
March 31, 2016.
"We recently reported data from two sponsored, randomized Phase
2 studies, highlighting reduced tumor burden in ovarian cancer and
improved longer term survival in pancreatic cancer," said Dr.
Brad Thompson. "The data from these
studies will be very useful in identifying potential indications
and study designs that we could advance into later stage studies in
the future."
Selected Highlights
Since January 1, 2016, selected
highlights announced by the Company include:
Clinical Program
- Treatment of the first patients in a Phase Ib study of
pembrolizumab (KEYTRUDA®) in combination with
REOLYSIN® and chemotherapy in patients with advanced
pancreatic adenocarcinoma, the Company's first trial examining
REOLYSIN® in combination with a checkpoint
inhibitor;
- Updated results from a randomized Phase 2 clinical trial of its
lead product, REOLYSIN®, in combination with paclitaxel
in patients with ovarian cancer (GOG-0186H), where an
intent-to-treat analysis, as assessed by CA-125 antigen levels,
showed statistically significantly reduction in tumor burden;
- Updated results from a randomized Phase 2 clinical trial of its
lead product, REOLYSIN®, in combination with carboplatin
and paclitaxel in patients with pancreatic cancer (NCI-8601), where
an intent-to-treat analysis of overall survival on patients with
confirmed treatment regimes, as assessed by the percentage of
patients surviving for two years, showed a statistically
significantly higher percentage of patients surviving two years in
the test arm versus the control arm (p = 0.001), the crossover arm
versus the control arm (p = 0.03) and the test plus crossover arms
versus the control arm (p = 0.0004);
Basic Research
- Two poster presentations covering preclinical work in multiple
myeloma and colorectal cancer being made by the Company's research
collaborators at the 2016 American Association of Cancer Research
annual meeting;
Financial
- Entry into an "at-the-market" equity distribution agreement
with Canaccord Genuity Corp. permitting Oncolytics at its sole
discretion, from time to time and until March 16, 2018, to sell common shares having an
aggregate offering value of up to $4.6
million; and
- At March 31, 2016 the Company
reported $22.3 million in cash, cash
equivalents and short-term investments. At May 5, 2016, the Company had approximately
$21.4 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.
ONCOLYTICS BIOTECH
INC.
|
INTERM
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
|
|
As at
|
|
March 31,
2016
$
|
|
December 31,
2015
$
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
20,233,408
|
|
24,016,275
|
Short-term
investments
|
|
2,088,800
|
|
2,060,977
|
Accounts
receivable
|
|
59,648
|
|
340,059
|
Prepaid
expenses
|
|
229,288
|
|
506,669
|
Total current
assets
|
|
22,611,144
|
|
26,923,980
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Property and
equipment
|
|
411,762
|
|
459,818
|
Total non-current
assets
|
|
411,762
|
|
459,818
|
|
|
|
|
|
Total
assets
|
|
23,022,906
|
|
27,383,798
|
|
|
|
|
|
Liabilities And
Shareholders' Equity
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
2,554,338
|
|
2,709,492
|
Total current
liabilities
|
|
2,554,338
|
|
2,709,492
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
Share
capital
|
|
|
|
|
|
Authorized:
unlimited
Issued:
March 31, 2016 - 118,697,122
December 31, 2015 - 118,151,622
|
|
261,224,148
|
|
261,324,692
|
Contributed
surplus
|
|
26,359,606
|
|
26,277,966
|
Accumulated other
comprehensive income
|
|
590,919
|
|
760,978
|
Accumulated
deficit
|
|
(267,706,105)
|
|
(263,689,330)
|
Total
shareholders' equity
|
|
20,468,568
|
|
24,674,306
|
Total
liabilities and equity
|
|
23,022,906
|
|
27,383,798
|
|
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS
|
|
|
|
|
|
|
|
2016
|
|
2015
|
For the three month
period ending March 31
|
|
$
|
|
$
|
Expenses
|
|
|
|
|
Research and
development
|
|
2,726,129
|
|
2,425,539
|
Operating
|
|
1,360,412
|
|
1,182,734
|
Operating
loss
|
|
(4,086,541)
|
|
(3,608,273)
|
Interest
|
|
69,621
|
|
56,435
|
Loss before
income taxes
|
|
(4,016,920)
|
|
(3,551,838)
|
Income tax
expense
|
|
145
|
|
—
|
Net
loss
|
|
(4,016,775)
|
|
(3,551,838)
|
Other
comprehensive income items that may be
reclassified
to net loss
|
|
|
|
|
Translation
adjustment
|
|
(170,059)
|
|
225,591
|
|
|
|
|
|
Net
comprehensive loss
|
|
(4,186,834)
|
|
(3,326,247)
|
Basic and
diluted loss per common share
|
|
(0.03)
|
|
(0.04)
|
|
|
|
|
|
Weighted
average number of shares (basic and diluted)
|
|
118,199,985
|
|
99,557,654
|
|
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
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
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
comprehensive income
|
—
|
|
—
|
|
(170,059)
|
|
(4,016,775)
|
|
(4,186,834)
|
Issued, pursuant to
Share Purchase
Agreement
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Issued, pursuant to
"At the Market"
Agreement
|
(100,544)
|
|
—
|
|
—
|
|
—
|
|
(100,544)
|
Share based
compensation
|
—
|
|
81,640
|
|
—
|
|
—
|
|
81,640
|
As at March 31,
2016
|
261,224,148
|
|
26,359,606
|
|
590,919
|
|
(267,706,105)
|
|
20,468,568
|
|
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
2016
|
|
2015
|
For the three month
period ending March 31
|
|
$
|
|
$
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
Net loss for the
period
|
|
(4,016,775)
|
|
(3,551,838)
|
|
Amortization -
property and equipment
|
|
45,942
|
|
45,130
|
|
Share based
compensation
|
|
81,640
|
|
114,970
|
|
Impact of unrealized
foreign exchange (gains) losses
|
|
141,295
|
|
(305,156)
|
Net change in
non-cash working capital
|
|
724,655
|
|
949,705
|
Cash used in
operating activities
|
|
(3,023,243)
|
|
(2,747,189)
|
|
|
|
|
|
Investing
Activities
|
|
|
|
|
Acquisition of
property and equipment
|
|
—
|
|
(11,940)
|
Purchase of
short-term investments
|
|
(27,823)
|
|
(29,292)
|
Cash used in
investing activities
|
|
(27,823)
|
|
(41,232)
|
|
|
|
|
|
Financing
Activities
|
|
|
|
|
Proceeds from Share
Purchase Agreement
|
|
—
|
|
1,925,596
|
Proceeds from "At the
Market" equity distribution agreement
|
|
(100,544)
|
|
14,636,918
|
Cash provided by
financing activities
|
|
(100,544)
|
|
16,562,514
|
(Decrease)
increase in cash
|
|
(3,151,610)
|
|
13,774,093
|
Cash and cash
equivalents, beginning of period
|
|
24,016,275
|
|
14,152,825
|
Impact of foreign
exchange on cash and cash equivalents
|
|
(631,257)
|
|
651,105
|
Cash and cash
equivalents, end of period
|
|
20,233,408
|
|
28,578,023
|
|
|
|
|
|
To view the Company's Fiscal 2016 First 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.