Oncolytics Biotech® Reports 2018 Third Quarter Financial Results and Provides Corporate Update
12 Novembre 2018 - 1:00PM
- Checkpoint combination studies support
progression into registration pathway for metastatic breast cancer
and potential expansion of indications -
Oncolytics Biotech® Inc. (Nasdaq: ONCY) (TSX: ONC), currently
developing pelareorep, an intravenously delivered immuno-oncolytic
virus, today announced financial results and operational highlights
for the quarter ended September 30, 2018. All dollar amounts
are Canadian unless otherwise noted.
“The clinical progress and mechanistic
understandings achieved with pelareorep thus far in 2018 lay the
ground work for a transformational 2019. We continue to
advance towards a registration study in metastatic breast cancer as
we prepare to initiate our AWARE-1 window of opportunity clinical
study with pelareorep and Roche’s checkpoint inhibitor, Tecentriq,
in breast cancer patients,” said Dr. Matt Coffey, President and CEO
of Oncolytics Biotech. “Although we originally believed that
pelareorep acts foremost as a lytic agent directly killing tumor
cells, we have learned pelareorep replicates efficiently in cancer
cells to produce double stranded RNA and trigger an immune response
to the tumor by stimulating and recruiting NK cells and T cells to
target the tumor. This quarter we presented additional data
confirming pelareorep stimulates expression of PD-L1 on tumor
cells, thereby transforming those tumor cells into targets for the
highly valued immuno-oncology checkpoint inhibitors. This
expanded focus on innate and adaptive immune response better allows
us to prepare for our planned studies in metastatic breast cancer,
to validate recently identified therapeutic biomarkers for
pelareorep, and to efficiently explore the potential for pelareorep
to extend the effectiveness of checkpoint inhibitors into
additional patient populations.”
Selected highlights
since July 1, 2018
Clinical Updates
- Established plans with pelareorep to advance the phase 3
metastatic breast cancer program and for expansion into combination
trials with checkpoint inhibitors to enlist pelareorep’s
immune effects and to seek validation of key therapeutic and
prognostic biomarkers.
- Clinical trials announced in 2018 include: °
AWARE-1 window of opportunity (WOO) study with pelareorep in
combination with Roche’s Tecentriq® in breast cancer.
° Pelareorep plus Merck’s anti-PD-1 checkpoint inhibitor
Keytruda® in pancreatic cancer. ° Pelareorep plus
Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor Opdivo® in
multiple myeloma. ° Pelareorep plus Merck’s
anti-PD-1 checkpoint inhibitor Keytruda in multiple myeloma.
- Announced a Master Clinical Supply Agreement with F.
Hoffmann-La Roche Ltd (Roche) to supply Tecentriq for use in the
company’s clinical development program.
- Presented positive phase 2 clinical trial results for
pelareorep in the treatment of patients with KRAS mutant metastatic
colorectal cancer at the European Society for Medical Oncology
(ESMO) 2018 Congress. Thirty-six patients received treatment with
FOLFIRI/B (irinotecan, fluorouracil, leucovorin, plus bevacizumab)
and pelareorep. The six patients receiving treatment with the
recommended study dose had progression free survival of 65.6 weeks
and an overall survival of 107.5 weeks. Study results exceeded
expectations when compared to analogous historical data.
- Announced a publication demonstrating that intravenously
delivered oncolytic viruses, including pelareorep, effectively
target tumors even in the presence of neutralizing antibodies. A
publication in Cancer Immunology Research showed that pelareorep, a
systemically delivered oncolytic reovirus, can destroy tumor cells
via a monocyte-mediated process even after the virions have been
exposed to antibodies designed to neutralize the reovirus.
Corporate Updates
- Entered into a common stock purchase agreement for up to
US$26.0 million with Lincoln Park Capital Fund, LLC.
- Announced a US$30.0 million At-the-Market facility with
Canaccord Genuity.
Anticipated Milestones
- Initiate a phase 2 study with
pelareorep in combination with Merck’s Keytruda in advanced
pancreatic cancer in Q4 2018*.
- Initiate a phase 1 study with
pelareorep in combination with Bristol-Myers Squibb’s Opdivo in
multiple myeloma in Q4 2018*.
- Initiate AWARE-1, a phase 1b WOO
study with pelareorep in the neoadjuvant breast cancer setting in
Q1 2019.
- Initiate a phase 1b study with
pelareorep in combination with Merck’s Keytruda in multiple myeloma
in Q1 2019*.
- Data from AWARE-1 study with
pelareorep in breast cancer
mid-2019.
- Initiate registration study with
pelareorep in mBC – guidance to be provided after AWARE-1 data is
available.
- Preliminary data from MUK eleven
study with pelareorep in multiple myeloma mid-2019*.
* Guidance provided by principle
investigator
Financial
- At September 30, 2018, the company
reported $16.2 million in cash and cash equivalents.
- As at November 8, 2018, the company
had an unlimited number of authorized common shares with 17,059,123
common shares issued and outstanding, 16,443,500 warrants
exercisable into 1,730,894 common shares with a $9.025 strike price
and 1,093,407 options and share units.
- Operating expense for the third
quarter of 2018 was $1.5 million compared to $1.3 million for the
prior year period. R&D expense in the third quarter 2018 was
$1.9 compared to $1.7 million for the third quarter of 2017.
- The net loss for the third quarter
of 2018 was $3.3 million or $0.20 per share compared to a net loss
of $3.0 million or $0.20 per share for the period one year ago, on
a consolidated basis.
Webcast and Conference
CallOncolytics management will host a conference
call for Analysts and Institutional Investors at 8:30 a.m. ET
today, Monday, November 12, 2018. The live call may be accessed by
dialing (888) 231-8191 for callers in North America. Overseas
callers should contact investor relations for the toll-free dial
information for their country. A replay of this call will be
available approximately two hours after the call is ended at
855-859-2056, using the replay code 6463668 and will be available
for six months.
A live audio webcast of the call will be
accessible on the Investor Relations page of Oncolytics' website
at www.oncolyticsbiotech.com and will be archived for six
months.
| |
| |
| ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION(unaudited) |
| |
| As
at |
September 30, 2018 $ |
December 31, 2017 $ |
|
Assets |
|
|
| Current
assets |
|
|
| Cash and cash
equivalents |
16,214,347 |
|
11,836,119 |
|
| Contract
receivable |
— |
|
4,767,100 |
|
| Other receivables |
56,895 |
|
37,726 |
|
| Prepaid expenses |
1,450,030 |
|
1,176,063 |
|
|
Total current assets |
17,721,272 |
|
17,817,008 |
|
| Non-current
assets |
|
|
| Property
and equipment |
428,588 |
|
333,441 |
|
|
Total non-current assets |
428,588 |
|
333,441 |
|
|
|
|
|
|
Total assets |
18,149,860 |
|
18,150,449 |
|
| Liabilities And
Shareholders’ Equity |
|
|
| Current
Liabilities |
|
|
| Accounts payable and
accrued liabilities |
2,239,514 |
|
3,684,023 |
|
| Contract liability |
927,400 |
|
1,545,645 |
|
| Other
liabilities |
76,529 |
|
— |
|
|
Total current liabilities |
3,243,443 |
|
5,229,668 |
|
| Non-current
liabilities |
|
|
| Contract liability |
5,802,887 |
|
4,636,935 |
|
| Other liabilities |
54,128 |
|
— |
|
|
Total non-current liabilities |
5,857,015 |
|
4,636,935 |
|
|
|
|
|
|
Total liabilities |
9,100,458 |
|
9,866,603 |
|
| Shareholders’
equity |
|
|
| Share capital
Authorized: unlimited Issued: September 30, 2018 –
16,915,325 December 31, 2017 – 141,805,722
pre-consolidation December 31, 2017 – 14,926,840
post-consolidation |
283,742,409 |
|
271,710,138 |
|
| Warrants |
3,617,570 |
|
3,617,900 |
|
| Contributed
surplus |
27,894,420 |
|
27,028,238 |
|
| Accumulated other
comprehensive income |
459,142 |
|
373,730 |
|
|
Accumulated deficit |
(306,664,139 |
) |
(294,446,160 |
) |
|
Total shareholders’ equity |
9,049,402 |
|
8,283,846 |
|
|
Total liabilities and equity |
18,149,860 |
|
18,150,449 |
|
| |
| |
| ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS(unaudited) |
| |
|
|
Three MonthPeriodEndingSeptember30, 2018
$ |
Three MonthPeriodEndingSeptember30, 2017
$ |
Nine MonthPeriodEndingSeptember30, 2018
$ |
Nine MonthPeriodEndingSeptember30, 2017
$ |
| |
|
|
|
|
|
Expenses |
|
|
|
|
| Research and
development |
1,929,405 |
|
1,726,726 |
|
6,909,713 |
|
6,913,470 |
|
|
Operating |
1,468,262 |
|
1,309,607 |
|
4,869,617 |
|
4,054,450 |
|
| Loss before the
following |
(3,397,667 |
) |
(3,036,333 |
) |
(11,779,330 |
) |
(10,967,920 |
) |
|
Interest |
61,880 |
|
31,759 |
|
109,308 |
|
96,637 |
|
| Loss before
income taxes |
(3,335,787 |
) |
(3,004,574 |
) |
(11,670,022 |
) |
(10,871,283 |
) |
|
Income tax (expense) recovery |
(79 |
) |
168 |
|
(547,957 |
) |
16 |
|
| Net
loss |
(3,335,866 |
) |
(3,004,406 |
) |
(12,217,979 |
) |
(10,871,267 |
) |
| Other
comprehensive (loss) income items that may be reclassified to net
loss |
|
|
|
|
|
Translation adjustment |
(49,238 |
) |
(126,846 |
) |
85,412 |
|
(192,334 |
) |
|
Net comprehensive loss |
(3,385,104 |
) |
(3,131,252 |
) |
(12,132,567 |
) |
(11,063,601 |
) |
|
Basic and diluted loss per common share |
(0.20 |
) |
(0.20 |
) |
(0.78 |
) |
(0.80 |
) |
|
Weighted average number of shares (basic and
diluted) |
16,540,612 |
|
14,685,871 |
|
15,646,117 |
|
13,625,411 |
|
| |
|
|
| 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 |
— |
|
— |
|
— |
|
(192,334 |
) |
(10,871,267 |
) |
(11,063,601 |
) |
| Issued pursuant to "At
the Market" agreement |
1,479,065 |
|
— |
|
— |
|
— |
|
— |
|
1,479,065 |
|
| Issued pursuant to
public offering |
7,893,600 |
|
3,617,900 |
|
— |
|
— |
|
— |
|
11,511,500 |
|
| Issued pursuant to
stock option plan |
536,949 |
|
— |
|
(193,509 |
) |
— |
|
— |
|
343,440 |
|
| Share based
compensation |
— |
|
— |
|
438,044 |
|
— |
|
— |
|
438,044 |
|
| Share issue costs |
(1,331,770 |
) |
— |
|
— |
|
— |
|
— |
|
(1,331,770 |
) |
|
As at September 30, 2017 |
270,899,669 |
|
3,617,900 |
|
26,887,579 |
|
361,726 |
|
(289,700,576 |
) |
12,066,298 |
|
| |
|
|
|
|
|
|
| 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 |
— |
|
— |
|
— |
|
85,412 |
|
(12,217,979 |
) |
(12,132,567 |
) |
| 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
Common Stock Purchase Agreement |
1,906,152 |
|
— |
|
— |
|
— |
|
— |
|
1,906,152 |
|
| Issued pursuant to
stock option plan |
178,322 |
|
— |
|
(66,635 |
) |
— |
|
— |
|
111,687 |
|
| Issued pursuant to
warrant agreement |
1,747 |
|
(330 |
) |
— |
|
— |
|
— |
|
1,417 |
|
| Share based
compensation |
— |
|
— |
|
932,817 |
|
— |
|
— |
|
932,817 |
|
| Share issue costs |
(2,214,482 |
) |
— |
|
— |
|
— |
|
— |
|
(2,214,482 |
) |
|
As at September 30, 2018 |
283,742,409 |
|
3,617,570 |
|
27,894,420 |
|
459,142 |
|
(306,664,139 |
) |
9,049,402 |
|
|
|
| |
| ONCOLYTICS BIOTECH INC.INTERIM
CONSOLIDATED STATEMENTS OF CASH
FLOWS(unaudited) |
| |
|
|
Three MonthPeriodEndingSeptember30, 2018
$ |
Three MonthPeriodEndingSeptember30, 2017
$ |
Nine MonthPeriodEndingSeptember30, 2018
$ |
Nine MonthPeriodEndingSeptember30, 2017
$ |
| |
|
|
|
|
| Operating
Activities |
|
|
|
|
| Net loss for the
period |
(3,335,866 |
) |
(3,004,406 |
) |
(12,217,979 |
) |
(10,871,267 |
) |
| Depreciation - property
and equipment |
26,698 |
|
20,591 |
|
67,682 |
|
70,315 |
|
| Share based
compensation |
236,607 |
|
148,447 |
|
932,817 |
|
438,044 |
|
| Unrealized foreign
exchange loss (gain) |
82,643 |
|
(6,414 |
) |
(19,702 |
) |
(119,058 |
) |
| Onerous lease
contract |
67,588 |
|
— |
|
67,588 |
|
— |
|
| Amortization - lease
incentive liability |
12,494 |
|
— |
|
12,494 |
|
— |
|
| Net
change in non-cash working capital |
(596,779 |
) |
(331,590 |
) |
3,630,991 |
|
(1,186,142 |
) |
|
Cash used in operating activities |
(3,506,615 |
) |
(3,173,372 |
) |
(7,526,109 |
) |
(11,668,108 |
) |
| Investing
Activities |
|
|
|
|
| Acquisition of property
and equipment |
(40,094 |
) |
(9,451 |
) |
(120,156 |
) |
(95,337 |
) |
| Redemption of
short-term investments |
— |
|
— |
|
— |
|
2,088,800 |
|
|
Cash (used in) provided by investing
activities |
(40,094 |
) |
(9,451 |
) |
(120,156 |
) |
1,993,463 |
|
| Financing
Activities |
|
|
|
|
| Proceeds from "At the
Market" equity distribution agreement |
— |
|
733,171 |
|
520,315 |
|
1,292,698 |
|
| Proceeds from public
offering |
— |
|
— |
|
10,188,526 |
|
10,366,098 |
|
| Proceeds from Common
Stock Purchase Agreement |
1,143,361 |
|
— |
|
1,143,361 |
|
— |
|
| Proceeds from exercise
of options |
87,777 |
|
48,090 |
|
111,687 |
|
343,440 |
|
| Proceeds
from exercise of warrants |
— |
|
— |
|
1,417 |
|
— |
|
|
Cash provided by financing activities |
1,231,138 |
|
781,261 |
|
11,965,306 |
|
12,002,236 |
|
| (Decrease)
increase in cash |
(2,315,571 |
) |
(2,401,562 |
) |
4,319,041 |
|
2,327,591 |
|
| Cash and cash
equivalents, beginning of period |
18,741,347 |
|
16,676,298 |
|
11,836,119 |
|
12,034,282 |
|
| Impact of
foreign exchange on cash and cash equivalents |
(211,429 |
) |
(241,092 |
) |
59,187 |
|
(328,229 |
) |
|
Cash and cash equivalents, end of period |
16,214,347 |
|
14,033,644 |
|
16,214,347 |
|
14,033,644 |
|
| |
To view the Company's Fiscal 2018 Third 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 PelareorepPelareorep 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 and has been demonstrated to be able to
escape neutralizing antibodies found in patients.
About Oncolytics Biotech
Inc.Oncolytics is a biotechnology company developing
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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