Oncolytics Biotech® Reports 2018 Second Quarter Results
03 Août 2018 - 1:00PM
Oncolytics Biotech® Inc. (Nasdaq: ONCY) (TSX: ONC), 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
June 30, 2018. All dollar amounts are Canadian unless
otherwise noted.
“The second quarter began with clinical updates
at three scientific conferences and an agreement with the FDA for
our Special Protocol Assessment, followed by the announcements of
two combination studies with Merck’s Keytruda and culminated in the
company’s relisting on Nasdaq,” said Dr. Matt Coffey, President and
CEO of Oncolytics Biotech. “The immuno-oncology data we have
presented at recent conferences, as well as the data we expect from
recently announced studies supports the potential for combination
with checkpoint inhibitors and other immunotherapy and anticancer
agents as we broaden our pipeline to demonstrate the ultimate value
of pelareorep. Our Nasdaq listing has already raised our
profile with institutional investors focusing on biotech and we
hope to see additional analyst coverage out of the U.S.”
Selected highlights
since April 1, 2018
Clinical Updates
- 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.
- Announced two combination studies with Merck’s Keytruda®:
- Investigating pelareorep in combination with Keytruda to treat
second line pancreatic cancer patients. The study, run by Dr.
Devalingham Mahalingam, will plan to enroll approximately 40
patients with advanced pancreatic cancer and will be conducted at
the Robert H. Lurie Comprehensive Cancer Center of Northwestern
University.
- Investigating pelareorep in combination with Keytruda,
Velcade® and dexamethasone to treat multiple myeloma patients.
The study, facilitated by Dr. Kevin Kelly, Associate Professor of
Clinical Medicine, will be conducted at the USC Norris
Comprehensive Cancer Center.
- Presented poster highlights from pelareorep studies at the
American Society of Clinical Oncology (ASCO) 2018 Annual Meeting.
The presentation demonstrated that pelareorep promotes the
expression of gene signatures predictive of a response to
immunotherapy in breast cancer and hepatocellular carcinoma and
that the tumor inflammation promoting effects in breast cancer
models provide a compelling explanation for the significant overall
survival benefit in hormone receptor positive metastatic breast
cancer patients in the phase 2, IND 213, study.
- 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.
Corporate Updates
- Announced a share consolidation on the basis of 1 new common
share for every 9.5 outstanding common shares.
- Announced the listing of the company’s shares of common stock
on the Nasdaq Capital Market and commenced trading on June 1, 2018,
under the symbol "ONCY".
- Closed an underwritten public share offering of 1,532,278
common shares at a purchase price of USD $5.83 for gross proceeds
of approximately USD $8.9 million.
- Expanded the clinical development
team in San Diego, including Senior Medical Personnel.
Anticipated Milestones
- Initiate a phase 2 window of
opportunity study of pelareorep in combination with a checkpoint
inhibitor and/or the standard of care in the neoadjuvant breast
cancer setting in 2H 2018.
- Initiate a phase 2 study in
combination with Merck’s Keytruda in multiple myeloma in 2H
2018.
- Initiate a phase 2 study in
combination with Merck’s Keytruda in advanced pancreatic cancer in
2H 2018.
- Data from window of opportunity
study in mBC in 1H 2019.
- Data from Keytruda combination
study in multiple myeloma in 2H 2019.
- Preliminary data from Keytruda
combination study in advanced pancreatic cancer in 1H 2020.
Financial
- At June 30, 2018, the company
reported $18.7 million in cash and cash equivalents.
- As at August 2, 2018, the company
had an unlimited number of authorized common shares with 16,531,956
common shares issued and outstanding, 16,443,500 warrants
exercisable into 1,730,894 common shares with a $9.025 strike price
and 1,153,080 options and share units.
ONCOLYTICS BIOTECH
INC.INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION(unaudited)
| |
| As
at |
June 30, 2018 $ |
December 31, 2017 $ |
|
Assets |
|
|
| Current
assets |
|
|
| Cash and cash
equivalents |
18,741,347 |
|
11,836,119 |
|
| Contract
receivable |
— |
|
4,767,100 |
|
| Other receivables |
89,714 |
|
37,726 |
|
| Prepaid expenses |
1,489,212 |
|
1,176,063 |
|
|
Total current assets |
20,320,273 |
|
17,817,008 |
|
| Non-current
assets |
|
|
| Property
and equipment |
373,213 |
|
333,441 |
|
|
Total non-current assets |
373,213 |
|
333,441 |
|
|
|
|
|
|
Total assets |
20,693,486 |
|
18,150,449 |
|
| Liabilities And
Shareholders’ Equity |
|
|
| Current
Liabilities |
|
|
| Accounts payable and
accrued liabilities |
2,996,438 |
|
3,684,023 |
|
| Contract
liability |
927,400 |
|
1,545,645 |
|
|
Total current liabilities |
3,923,838 |
|
5,229,668 |
|
| Non-current
liabilities |
|
|
| Contract liability |
5,802,887 |
|
4,636,935 |
|
|
Total non-current liabilities |
5,802,887 |
|
4,636,935 |
|
|
|
|
|
|
Total liabilities |
9,726,725 |
|
9,866,603 |
|
| Shareholders’
equity |
|
|
| Share capital
Authorized: unlimited Issued: June 30, 2018 –
16,521,430 December 31, 2017 – 141,805,722
pre-consolidation December 31, 2017 – 14,926,918
post-consolidation |
282,458,995 |
|
271,710,138 |
|
| Warrants |
3,617,570 |
|
3,617,900 |
|
| Contributed
surplus |
27,710,089 |
|
27,028,238 |
|
| Accumulated other
comprehensive income |
508,380 |
|
373,730 |
|
|
Accumulated deficit |
(303,328,273 |
) |
(294,446,160 |
) |
|
Total shareholders’ equity |
10,966,761 |
|
8,283,846 |
|
|
Total liabilities and equity |
20,693,486 |
|
18,150,449 |
|
ONCOLYTICS BIOTECH
INC.INTERIM CONSOLIDATED STATEMENTS OF LOSS AND
COMPREHENSIVE LOSS(unaudited)
|
|
|
|
Three MonthPeriod EndingJune 30, 2018
$ |
Three MonthPeriod EndingJune 30, 2017
$ |
Six MonthPeriod EndingJune 30, 2018
$ |
Six MonthPeriod EndingJune 30, 2017
$ |
|
| |
|
|
|
|
|
|
Expenses |
|
|
|
|
|
| Research and
development |
2,045,417 |
|
2,918,673 |
|
4,980,308 |
|
5,186,744 |
|
|
Operating |
1,638,802 |
|
1,444,543 |
|
3,401,355 |
|
2,744,843 |
|
| Loss before the
following |
(3,684,219 |
) |
(4,363,216 |
) |
(8,381,663 |
) |
(7,931,587 |
) |
|
Interest |
20,538 |
|
14,163 |
|
47,428 |
|
64,878 |
|
| Loss before
income taxes |
(3,663,681 |
) |
(4,349,053 |
) |
(8,334,235 |
) |
(7,866,709 |
) |
|
Income tax expense |
(547,758 |
) |
(89 |
) |
(547,878 |
) |
(152 |
) |
| Net
loss |
(4,211,439 |
) |
(4,349,142 |
) |
(8,882,113 |
) |
(7,866,861 |
) |
| Other
comprehensive income (loss) items that may be reclassified to net
loss |
|
|
|
|
|
|
Translation adjustment |
64,029 |
|
(44,740 |
) |
134,650 |
|
(65,488 |
) |
|
Net comprehensive loss |
(4,147,410 |
) |
(4,393,882 |
) |
(8,747,463 |
) |
(7,932,349 |
) |
|
Basic and diluted loss per common share |
(0.27 |
) |
(0.32 |
) |
(0.58 |
) |
(0.60 |
) |
|
Weighted average number of shares (basic and
diluted) |
15,406,944 |
|
13,405,220 |
|
15,191,457 |
|
13,086,393 |
|
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 |
— |
|
— |
|
— |
|
(65,488 |
) |
(7,866,861 |
) |
(7,932,349 |
) |
| Issued pursuant to "At
the Market" agreement |
668,648 |
|
— |
|
— |
|
— |
|
— |
|
668,648 |
|
| Issued pursuant to
public offering |
7,893,600 |
|
3,617,900 |
|
— |
|
— |
|
— |
|
11,511,500 |
|
| Issued pursuant to
stock option plan |
461,823 |
|
— |
|
(166,473 |
) |
— |
|
— |
|
295,350 |
|
| Share based
compensation |
— |
|
— |
|
289,597 |
|
— |
|
— |
|
289,597 |
|
| Share issue costs |
(1,254,523 |
) |
— |
|
— |
|
— |
|
— |
|
(1,254,523 |
) |
|
As at June 30, 2017 |
270,091,373 |
|
3,617,900 |
|
26,766,168 |
|
488,572 |
|
(286,696,170 |
) |
14,267,843 |
|
| |
|
|
|
|
|
|
| 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 |
— |
|
— |
|
— |
|
134,650 |
|
(8,882,113 |
) |
(8,747,463 |
) |
| Issued pursuant to "At
the Market" Agreement |
553,650 |
|
— |
|
— |
|
— |
|
— |
|
553,650 |
|
| Issued pursuant to
public offering |
11,606,882 |
|
— |
|
— |
|
— |
|
— |
|
11,606,882 |
|
| Issued pursuant to
stock option plan |
38,269 |
|
— |
|
(14,359 |
) |
— |
|
— |
|
23,910 |
|
| Issued pursuant to
warrant agreement |
1,747 |
|
(330 |
) |
— |
|
— |
|
— |
|
1,417 |
|
| Share based
compensation |
— |
|
— |
|
696,210 |
|
— |
|
— |
|
696,210 |
|
| Share issue costs |
(1,451,691 |
) |
— |
|
— |
|
— |
|
— |
|
(1,451,691 |
) |
|
As at June 30, 2018 |
282,458,995 |
|
3,617,570 |
|
27,710,089 |
|
508,380 |
|
(303,328,273 |
) |
10,966,761 |
|
ONCOLYTICS BIOTECH
INC.INTERIM CONSOLIDATED STATEMENTS OF CASH
FLOWS(unaudited)
|
|
Three MonthPeriod EndingJune 30, 2018
$ |
Three MonthPeriod EndingJune 30, 2017
$ |
Six MonthPeriod EndingJune 30, 2018
$ |
Six MonthPeriod EndingJune 30, 2017
$ |
| |
|
|
|
|
| Operating
Activities |
|
|
|
|
| Net loss for the
period |
(4,211,439 |
) |
(4,349,142 |
) |
(8,882,113 |
) |
(7,866,861 |
) |
| Amortization - property
and equipment |
21,126 |
|
25,688 |
|
40,984 |
|
49,724 |
|
| Share based
compensation |
157,092 |
|
155,708 |
|
696,210 |
|
289,597 |
|
| Unrealized foreign
exchange gain |
(97,832 |
) |
(164,676 |
) |
(102,345 |
) |
(112,644 |
) |
| Net
change in non-cash working capital |
4,720,317 |
|
(216,906 |
) |
4,227,770 |
|
(854,552 |
) |
|
Cash provided by (used in) operating
activities |
589,264 |
|
(4,549,328 |
) |
(4,019,494 |
) |
(8,494,736 |
) |
| Investing
Activities |
|
|
|
|
| Acquisition of property
and equipment |
(37,443 |
) |
(80,050 |
) |
(80,062 |
) |
(85,886 |
) |
| Redemption of
short-term investments |
— |
|
— |
|
— |
|
2,088,800 |
|
|
Cash (used in) provided by investing
activities |
(37,443 |
) |
(80,050 |
) |
(80,062 |
) |
2,002,914 |
|
| Financing
Activities |
|
|
|
|
| Proceeds from "At the
Market" equity distribution agreement |
— |
|
570,027 |
|
520,315 |
|
559,527 |
|
| Proceeds from public
offering |
10,188,526 |
|
10,366,098 |
|
10,188,526 |
|
10,366,098 |
|
| Proceeds from exercise
of options |
23,910 |
|
295,350 |
|
23,910 |
|
295,350 |
|
| Proceeds
from exercise of warrants |
1,417 |
|
— |
|
1,417 |
|
— |
|
|
Cash provided by financing activities |
10,213,853 |
|
11,231,475 |
|
10,734,168 |
|
11,220,975 |
|
| Increase in
cash |
10,765,674 |
|
6,602,097 |
|
6,634,612 |
|
4,729,153 |
|
| Cash and cash
equivalents, beginning of period |
7,745,255 |
|
10,102,393 |
|
11,836,119 |
|
12,034,282 |
|
| Impact of
foreign exchange on cash and cash equivalents |
230,418 |
|
(28,192 |
) |
270,616 |
|
(87,137 |
) |
|
Cash and cash equivalents, end of period |
18,741,347 |
|
16,676,298 |
|
18,741,347 |
|
16,676,298 |
|
To view the Company's Fiscal 2018 Second Quarter
Consolidated Financial Statements, related Notes to the
Consolidated Financial Statements, and Management's Discussion and
Analysis, please see the Company's filings, which will be available
at www.sedar.com, www.sec.gov 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 conducting and planning
additional studies in combination with checkpoint inhibitors and
targeted and IMiD therapies in solid and hematological
malignancies, as it prepares for a phase 3 registration study in
metastatic breast cancer. 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; the collaboration between
Merck and USC using pelareorep, including the timing,
enrollment and potential benefits to the Company thereof; 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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