CALGARY, May 5, 2017 /PRNewswire/ - Oncolytics
Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or
the Company) today announced its financial results and operational
highlights for the quarter ended March 31,
2017.
"The last six months – particularly defining our clinical
development plan and data announced at AACR – have been exciting
for us," said Dr. Matt Coffey,
President and CEO of Oncolytics Biotech. "The compelling and
statistically significant overall survival data from the IND 213
study in metastatic breast cancer presented at AACR led us to
select this indication as our registration pathway. This is
part of our broader clinical development plan, which is focused on
exploiting REOLYSIN's mechanism of action incorporating both cancer
cell lysis and immune system priming and activation."
Selected Highlights
Since January 1, 2017, selected
highlights announced by the Company include:
Clinical Results
- Presented at the American Academy of Cancer Research (AACR)
Annual Meeting, in Washington,
D.C., by the Canadian Cancer Trials Group at Queen's
University in Kingston, Ontario
covering findings from IND 213, an open-label, randomized, phase 2
study to assess the therapeutic combination of
intravenously-administered REOLYSIN® given in
combination with paclitaxel versus paclitaxel alone in patients
with advanced or metastatic breast cancer. Results showed a
statistically significant improvement in median overall survival
from 10.4 months in the control arm to 17.4 months in the test
arm.
- Announced registration pathway and clinical development plan
with the dual objectives of obtaining regulatory approval for
REOLYSIN based on the compelling metastatic breast cancer survival
data recently presented at the AACR Annual Meeting, in Washington, D.C., and expanding REOLYSIN into
commercially valuable new treatment areas that include
immunotherapy and immunomodulatory (IMiD) agents in collaboration
with pharmaceutical partners.
- Announced, in collaboration with Celgene and cancer charity
Myeloma UK, the launch of MUK eleven, a first-of-its-kind
immunotherapy trial that aims to modulate the immune system to
target myeloma. The phase 1b trial will study REOLYSIN in
combination with Celgene's IMiD's, Imnovid®
(pomalidomide) and Revlimid® (lenalidomide), as a rescue
treatment in relapsing myeloma patients.
Corporate
- Appointed Oncolytics co-founder and long-serving senior
executive Matt Coffey PhD, MBA, as President and CEO.
Financial
- At March 31, 2017, the Company
reported $10.1 million in cash, cash
equivalents and short-term investments.
- As at May 4, 2017, the Company
had an unlimited number of authorized common shares with
121,836,722 common shares issued and outstanding, and 8,032,827
options outstanding (with exercise prices ranging between
$0.26 and $6.72 and expiry dates
ranging from 2017 to 2027).
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
(unaudited)
|
|
|
|
As at
|
March 31,
2017
$
|
December 31,
2016
$
|
Assets
|
|
|
Current
assets
|
|
|
Cash and cash
equivalents
|
10,102,393
|
|
12,034,282
|
|
Short-term
investments
|
—
|
|
2,088,800
|
|
Accounts
receivable
|
36,484
|
|
54,406
|
|
Prepaid
expenses
|
182,897
|
|
260,841
|
|
Total current
assets
|
10,321,774
|
|
14,438,329
|
|
|
|
|
Non-current
assets
|
|
|
Property and
equipment
|
301,534
|
|
319,955
|
|
Total non-current
assets
|
301,534
|
|
319,955
|
|
|
|
|
Total
assets
|
10,623,308
|
|
14,758,284
|
|
Liabilities And
Shareholders' Equity
|
|
|
Current
Liabilities
|
|
|
Accounts payable and
accrued liabilities
|
3,348,766
|
|
4,068,664
|
|
Total current
liabilities
|
3,348,766
|
|
4,068,664
|
|
|
|
|
Shareholders'
equity
|
|
|
Share
capital
|
|
|
|
|
|
Authorized:
unlimited
Issued:
March 31, 2017 – 121,258,222
December 31, 2016 – 121,258,222
|
262,311,325
|
|
262,321,825
|
|
Contributed
surplus
|
26,776,933
|
|
26,643,044
|
|
Accumulated other
comprehensive income
|
533,312
|
|
554,060
|
|
Accumulated
deficit
|
(282,347,028)
|
|
(278,829,309)
|
|
Total
shareholders' equity
|
7,274,542
|
|
10,689,620
|
|
Total
liabilities and equity
|
10,623,308
|
|
14,758,284
|
|
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS
|
(unaudited)
|
|
|
|
|
2017
|
2016
|
For the three month
period ending March 31
|
$
|
$
|
|
|
|
Expenses
|
|
|
Research and
development
|
2,268,071
|
|
2,726,129
|
|
Operating
|
1,300,300
|
|
1,360,412
|
|
Operating
loss
|
(3,568,371)
|
|
(4,086,541)
|
|
Interest
|
50,715
|
|
69,621
|
|
Loss before
income taxes
|
(3,517,656)
|
|
(4,016,920)
|
|
Income tax (expense)
recovery
|
(63)
|
|
145
|
|
Net
loss
|
(3,517,719)
|
|
(4,016,775)
|
|
Other
comprehensive income items that may
be reclassified
to net loss
|
|
|
Translation
adjustment
|
(20,748)
|
|
(170,059)
|
|
|
|
|
|
|
Net
comprehensive loss
|
(3,538,467)
|
|
(4,186,834)
|
|
Basic and
diluted loss per common share
|
(0.03)
|
|
(0.03)
|
|
|
|
|
|
|
Weighted
average number of shares (basic and diluted)
|
121,258,222
|
|
118,119,985
|
|
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,
2015
|
261,324,692
|
|
26,277,966
|
|
760,978
|
|
(263,689,330)
|
|
24,674,306
|
|
Net loss and other
comprehensive loss
|
—
|
|
—
|
|
(170,059)
|
|
(4,016,775)
|
|
(4,186,834)
|
|
Issued, pursuant to
"At the Market" Agreement
|
274,805
|
|
—
|
|
—
|
|
—
|
|
274,805
|
|
Share issue
costs
|
(375,349)
|
|
—
|
|
—
|
|
—
|
|
(375,349)
|
|
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
|
|
|
|
|
|
|
|
|
Share
Capital
$
|
Contributed
Surplus
$
|
Accumulated
Other
Comprehensive
Income
$
|
Accumulated
Deficit
$
|
Total
$
|
As at December 31,
2016
|
262,321,825
|
|
26,643,044
|
|
554,060
|
|
(278,829,309)
|
|
10,689,620
|
|
Net loss and other
comprehensive loss
|
—
|
|
—
|
|
(20,748)
|
|
(3,517,719)
|
|
(3,538,467)
|
|
Share issue
costs
|
(10,500)
|
|
—
|
|
—
|
|
—
|
|
(10,500)
|
|
Share based
compensation
|
—
|
|
133,889
|
|
—
|
|
—
|
|
133,889
|
|
As at March 31,
2017
|
262,311,325
|
|
26,776,933
|
|
533,312
|
|
(282,347,028)
|
|
7,274,542
|
|
ONCOLYTICS BIOTECH
INC.
|
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(unaudited)
|
|
|
|
|
2017
|
2016
|
For the three month
period ending March 31
|
$
|
$
|
|
|
|
Operating
Activities
|
|
|
Net loss for the
period
|
(3,517,719)
|
|
(4,016,775)
|
|
|
Amortization -
property and
equipment
|
24,036
|
|
45,942
|
|
|
Share based
compensation
|
133,889
|
|
81,640
|
|
|
Unrealized foreign
exchange loss
|
52,032
|
|
141,295
|
|
Net change in
non-cash working capital
|
(637,646)
|
|
724,655
|
|
Cash used in
operating activities
|
(3,945,408)
|
|
(3,023,243)
|
|
|
|
|
Investing
Activities
|
|
|
Acquisition of
property and equipment
|
(5,836)
|
|
—
|
|
Redemption (purchase)
of short-term investments
|
2,088,800
|
|
(27,823)
|
|
Cash provided by
(used in) investing activities
|
2,082,964
|
|
(27,823)
|
|
|
|
|
Financing
Activities
|
|
|
"At the Market"
equity distribution agreement
|
(10,500)
|
|
(100,544)
|
|
Cash used in
financing activities
|
(10,500)
|
|
(100,544)
|
|
Decrease in
cash
|
(1,872,944)
|
|
(3,151,610)
|
|
Cash and cash
equivalents, beginning of period
|
12,034,282
|
|
24,016,275
|
|
Impact of foreign
exchange on cash and cash equivalents
|
(58,945)
|
|
(631,257)
|
|
Cash and cash
equivalents, end of period
|
10,102,393
|
|
20,233,408
|
|
To view the Company's Fiscal 2017 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 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
biotechnology company developing REOLYSIN, an immuno-oncology
viral-agent, as a potential treatment for a variety of tumor types.
The compound induces selective tumor lysis and promotes an inflamed
tumor phenotype through innate and adaptive immune responses to
treat a variety of cancers. Oncolytics' clinical development
program emphasizes three pillars: chemotherapy combinations to
trigger selective tumor lysis; immuno-therapy combinations to
produce adaptive immune responses; and immune modulator (IMiD)
combinations to facilitate innate immune responses. Oncolytics
is currently planning its first registration study in breast
cancer, as well as studies in combination with checkpoint
inhibitors and IMID/targeted therapies in solid and hematological
malignancies. 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 2017 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.