Oncolytics Biotech® Reports 2018 First Quarter Results
11 Mai 2018 - 1:00PM
Oncolytics Biotech® Inc. (TSX:ONC) (OTCQX:ONCYF), currently
developing REOLYSIN® (pelareorep), an intravenously delivered
immuno-oncolytic virus turning cold tumors hot, today announced
financial results and operational highlights for the quarter ended
March 31, 2018. All dollar amounts are Canadian unless
otherwise noted.
“The rapid and exciting evolution of Oncolytics
has continued in 2018. We have presented exciting immuno-oncology
data at a number of medical meetings which supports both our
rationale for a phase 3 registration study of pelareorep in
metastatic breast cancer and additional collaborations using
checkpoint inhibitors,” said Dr. Matt Coffey, President and CEO of
Oncolytics Biotech. “With this momentum we have begun to lay the
groundwork for value driving catalysts over the next 18 months,
including multiple near-term clinical programs evaluating the
efficacy of pelareorep in combination with checkpoint inhibitors in
a variety of cancer indications. Finally, management also advanced
plans to relist Oncolytics’ shares on the NASDAQ Capital Market
exchange and we continue to carefully evaluate the timing of this
action.”
Selected highlights
since January 1, 2018
Clinical Updates
- Presented posters highlighting data
from pelareorep studies at the American Association for Cancer
Research (AACR) Annual Meeting 2018. The presentations showed
preclinical models demonstrating pelareorep increased PD-L1
expression in microsatellite stable (MSS) colorectal cancer cells
(CRC) and demonstrated efficacy for pelareorep and anti-PD1 agent
combination.
- Presented positive pelareorep data
in combination with Keytruda® and anti-CD73 at the International
Oncolytic Virus Conference 2018. The poster highlighted the
effectiveness of pelareorep in combination with Keytruda® and/or an
anti-CD73 immunotherapy in prostate cancer cell lines.
- Presented poster highlighting
results from the REO 024 study at the 2018 Gastrointestinal Cancers
Symposium sponsored by ASCO. The poster described six efficacy
evaluable, second-line, pancreatic cancer patients, including two
with stable disease of 126 and 277 days and remarkably, one patient
that had a partial response and remained on study for 504 days,
through 35 cycles of treatment.
- Reached agreement with the U.S.
Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA) for the protocol design, clinical endpoints and
statistical analysis approach for the company's phase 3 study
evaluating pelareorep for the treatment of metastatic breast
cancer.
Corporate Updates
- Received shareholder approval for
the consolidation of the Company's common shares, which will enable
Oncolytics to meet requirements for listing on the NASDAQ Capital
Market.
Anticipated Milestones
- Initiate a phase 3 registration
study of pelareorep in combination with paclitaxel, for the
treatment HR+/HER2- mBC patients.
- Initiate a phase 2
partner-sponsored window of opportunity study of pelareorep in
combination with standard of care therapy in the neoadjuvant
setting in mBC in 2H 2018.
- Initiate multiple phase 2
partner-sponsored studies to generate important biomarker and
efficacy data of pelareorep in combination with checkpoint
inhibitors in 2H 2018.
- Expand the findings of REO 024 by
initiating a phase 2 study examining pelareorep in combination with
pembrolizumab (KEYTRUDA®) in patients with relapsed metastatic
adenocarcinoma of the pancreas.
- Re-list on NASDAQ.
Financial
- At March 31, 2018, the Company
reported $7.7 million in cash and cash equivalents.
- As at May 3, 2018, we had an
unlimited number of authorized common shares with 142,334,722
common shares issued and outstanding, 16,445,000 warrants with a
$0.95 strike price and 11,339,608 options and share units.
|
ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION(unaudited) |
As
at |
March 31, 2018 $ |
December 31, 2017 $ |
Assets |
|
|
Current
assets |
|
|
Cash and cash
equivalents |
7,745,255 |
|
11,836,119 |
|
Contract
receivable |
4,899,720 |
|
4,767,100 |
|
Other receivables |
38,888 |
|
37,726 |
|
Prepaid expenses |
1,087,013 |
|
1,176,063 |
|
Total current assets |
13,770,876 |
|
17,817,008 |
|
Non-current
assets |
|
|
Property
and equipment |
356,281 |
|
333,441 |
|
Total non-current assets |
356,281 |
|
333,441 |
|
|
|
|
Total assets |
14,127,157 |
|
18,150,449 |
|
Liabilities And
Shareholders’ Equity |
|
|
Current
Liabilities |
|
|
Accounts payable and
accrued liabilities |
3,201,351 |
|
3,684,023 |
|
Contract
liability |
927,400 |
|
1,545,645 |
|
Total current liabilities |
4,128,751 |
|
5,229,668 |
|
Non-current
liabilities |
|
|
Contract liability |
5,255,180 |
|
4,636,935 |
|
Total non-current liabilities |
5,255,180 |
|
4,636,935 |
|
|
|
|
Total liabilities |
9,383,931 |
|
9,866,603 |
|
Shareholders’
equity |
|
|
Share capital
Authorized: unlimited Issued: March 31, 2018 –
142,325,222 December 31, 2017 – 141,805,722 |
272,230,453 |
|
271,710,138 |
|
Warrants |
3,617,900 |
|
3,617,900 |
|
Contributed
surplus |
27,567,356 |
|
27,028,238 |
|
Accumulated other
comprehensive income |
444,351 |
|
373,730 |
|
Accumulated deficit |
(299,116,834 |
) |
(294,446,160 |
) |
Total shareholders’ equity |
4,743,226 |
|
8,283,846 |
|
Total liabilities and equity |
14,127,157 |
|
18,150,449 |
|
|
ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS(unaudited) |
|
For the
three month period ending March 31, |
2018$ |
2017$ |
|
|
|
Expenses |
|
|
Research and
development |
2,934,891 |
|
2,268,071 |
|
Operating |
1,762,553 |
|
1,300,300 |
|
Loss before the
following |
(4,697,444 |
) |
(3,568,371 |
) |
Interest |
26,890 |
|
50,715 |
|
Loss before
income taxes |
(4,670,554 |
) |
(3,517,656 |
) |
Income tax expense |
(120 |
) |
(63 |
) |
Net
loss |
(4,670,674 |
) |
(3,517,719 |
) |
Other
comprehensive income (loss) items that may be reclassified
to net loss |
|
|
Translation adjustment |
70,621 |
|
(20,748 |
) |
Net comprehensive loss |
(4,600,053 |
) |
(3,538,467 |
) |
Basic and diluted loss per common share |
(0.03 |
) |
(0.03 |
) |
Weighted average number of shares (basic and
diluted) |
142,249,733 |
|
121,258,222 |
|
|
ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN
EQUITY(unaudited) |
|
|
Share Capital$ |
Warrants$ |
ContributedSurplus$ |
AccumulatedOtherComprehensiveIncome$ |
AccumulatedDeficit$ |
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 based
compensation |
— |
|
— |
|
133,889 |
|
— |
|
— |
|
133,889 |
|
Share issue costs |
(10,500 |
) |
— |
|
— |
|
— |
|
— |
|
(10,500 |
) |
As at March 31, 2017 |
262,311,325 |
|
— |
|
26,776,933 |
|
533,312 |
|
(282,347,028 |
) |
7,274,542 |
|
|
|
|
|
|
|
|
As at December 31,
2017 |
271,710,138 |
|
3,617,900 |
|
27,028,238 |
|
373,730 |
|
(294,446,160 |
) |
8,283,846 |
|
Net loss and other
comprehensive income |
— |
|
— |
|
— |
|
70,621 |
|
(4,670,674 |
) |
(4,600,053 |
) |
Issued pursuant to "At
the Market" Agreement |
553,650 |
|
— |
|
— |
|
— |
|
— |
|
553,650 |
|
Share based
compensation |
— |
|
— |
|
539,118 |
|
— |
|
— |
|
539,118 |
|
Share issue costs |
(33,335 |
) |
— |
|
— |
|
— |
|
— |
|
(33,335 |
) |
As at March 31, 2018 |
272,230,453 |
|
3,617,900 |
|
27,567,356 |
|
444,351 |
|
(299,116,834 |
) |
4,743,226 |
|
|
ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF CASH
FLOWS(unaudited) |
|
For the
three month period ending March 31, |
2018$ |
2017$ |
|
|
|
Operating
Activities |
|
|
Net loss for the
period |
(4,670,674 |
) |
(3,517,719 |
) |
Amortization - property
and equipment |
19,858 |
|
24,036 |
|
Share based
compensation |
539,118 |
|
133,889 |
|
Unrealized foreign
exchange (gain) loss |
(4,513 |
) |
52,032 |
|
Net
change in non-cash working capital |
(492,547 |
) |
(637,646 |
) |
Cash used in operating activities |
(4,608,758 |
) |
(3,945,408 |
) |
Investing
Activities |
|
|
Acquisition of property
and equipment |
(42,619 |
) |
(5,836 |
) |
Redemption of
short-term investments |
— |
|
2,088,800 |
|
Cash (used in) provided by investing
activities |
(42,619 |
) |
2,082,964 |
|
Financing
Activities |
|
|
Proceeds from "At the
Market" equity distribution agreement |
520,315 |
|
(10,500 |
) |
Cash provided by (used in) financing
activities |
520,315 |
|
(10,500 |
) |
Decrease in
cash |
(4,131,062 |
) |
(1,872,944 |
) |
Cash and cash
equivalents, beginning of period |
11,836,119 |
|
12,034,282 |
|
Impact of
foreign exchange on cash and cash equivalents |
40,198 |
|
(58,945 |
) |
Cash and cash equivalents, end of period |
7,745,255 |
|
10,102,393 |
|
|
|
|
|
|
To view the Company's Fiscal 2018 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
REOLYSIN/Pelareorep REOLYSIN, also known as
pelareorep, is a non-pathogenic, proprietary isolate of the
unmodified reovirus: a first-in-class intravenously delivered
immuno-oncolytic virus for the treatment of solid tumors and
hematological malignancies. The compound induces selective tumor
lysis and promotes an inflamed tumor phenotype through innate and
adaptive immune responses to treat a variety of cancers.
About Oncolytics Biotech
Inc.Oncolytics is a biotechnology company developing
REOLYSIN®, also known as pelareorep, an intravenously delivered
immuno-oncolytic virus. The compound induces selective tumor lysis
and promotes an inflamed tumor phenotype -- turning "cold" tumors
"hot" -- 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 and immuno-therapy and immune modulator
(IMiD) combinations to produce innate and adaptive immune
responses. Oncolytics is currently planning its first registration
study in metastatic breast cancer, as well as studies in
combination with checkpoint inhibitors and targeted and IMiD
therapies in solid and hematological malignancies. For further
information, 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 and forward-looking information
under applicable Canadian securities laws (such forward-looking
statements and forward-looking information are collectively
referred to herein as “forward-looking statements”).
Forward-looking statements, including the Company's belief as to
the potential and mode of action of REOLYSIN, also known as
pelareorep, as a cancer therapeutic; 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 pelareorep as a cancer treatment, the success and timely
completion of clinical studies and trials, the Company's ability to
successfully commercialize pelareorep, 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.
Company ContactMichael MooreVice President,
Investor Relations & Corporate
Communications858-886-7813mmoore@oncolytics.ca |
Investor
RelationsRobert UhlWestwicke Partners858-356-5932
robert.uhl@westwicke.com |
Media
ContactJason SparkCanale Communications
619-849-6005jason@canalecomm.com |
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