CALGARY, and SAN DIEGO, CA, Nov. 8,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN®, an intravenously delivered
immuno-oncolytic virus that activates the innate and adaptive
immune systems to turn 'cold' tumors 'hot', today announced its
financial results and operational highlights for the quarter ended
September 30, 2017.
"Towards the end of the third quarter we made a very important
announcement regarding feedback from the FDA following our
End-of-Phase 2 meeting. The favorable meeting resulted in the
support of our proposed target patient population of hormone
receptor positive, HER2 receptor negative metastatic breast cancer
patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics
Biotech. "With this support and guidance outlining a single, four
hundred patient study, we have prepared to file for breakthrough
designation which we expect to do very soon, prepared for
communications with the European regulators, conducted preliminary
preparations to file for a special protocol assessment, or SPA, and
advanced our business development activities. We expect to be
able to announce the results of these filings and communications
with the European regulators over the next several months as we
continue to prepare the company to relist its shares on NASDAQ in
2018."
Selected Highlights from Q2 and through the end of
July 2017
Clinical Updates
- Announced a favorable End-of-Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) for REOLYSIN in combination with
paclitaxel, for the treatment of hormone receptor positive, HER2
receptor negative (HR+/HER2-) metastatic breast cancer (mBC)
patients. The agency's guidance proposed a single, 400 patient
registration study to support a future Biologics License
Application submission in the U.S.
- Presented mBC data at the European Society for Medical Oncology
(ESMO) 2017 Congress, that demonstrated a doubling of overall
survival benefit for patients with HR double-positive,
HER2-negative breast cancer – a major genetic subgroup – when
treated with REOLYSIN/paclitaxel combination treatment versus
paclitaxel alone.
- Announced the first patient treated in our phase 1b MUK Eleven
collaborative study with Myeloma UK and Celgene, studying REOLYSIN
in combination with Celgene immunomodulatory drugs (IMiDs),
Revlimid® or Imnovid® as a rescue treatment in relapsing myeloma
patients.
- Presented the largest ever safety database for an oncolytic
virus at the ESMO 2017 Congress, that demonstrated REOLYSIN is safe
and well tolerated when administered in combination with
chemotherapy.
Corporate Updates
- Appointed Deborah Brown to the
Board of Directors, to expand the Board's experience with product
launches, market expansion, regulatory affairs, research and
development and business development.
Anticipated Milestones
|
•
|
First quarter
2018:
|
Results from
regulatory filings
|
|
•
|
First half of
2018:
|
Update on our
exploration of strategic and regional
alliances
|
|
NASDAQ
|
|
Preliminary MUK
eleven data
|
|
•
|
Mid-2018:
|
Initiate phase 3
registration study in mBC
|
Q3 2017 Financial Results
- At September 30, 2017, the
Company reported $14.0 million in
cash and cash equivalents. Cash runway expected to the end of
2018.
- As at November 7, 2017, the
Company had an unlimited number of authorized common shares with
140,700,722 common shares issued and outstanding, 7,448,327 options
outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from
2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,428,039 RSU's and PSU's
outstanding.
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
(unaudited)
|
|
|
|
|
|
September 30,
2017
$
|
|
December 31,
2016
$
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
14,033,644
|
|
12,034,282
|
|
Short-term
investments
|
—
|
|
2,088,800
|
|
Accounts
receivable
|
33,129
|
|
54,406
|
|
Prepaid
expenses
|
438,150
|
|
260,841
|
|
Total current
assets
|
14,504,923
|
|
14,438,329
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Property and
equipment
|
343,307
|
|
319,955
|
|
Total non-current
assets
|
343,307
|
|
319,955
|
|
|
|
|
|
Total
assets
|
14,848,230
|
|
14,758,284
|
|
|
|
|
|
Liabilities And
Shareholders' Equity
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
2,781,932
|
|
4,068,664
|
|
Total current
liabilities
|
2,781,932
|
|
4,068,664
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
Share
capital
|
|
|
|
|
Authorized:
unlimited
|
|
|
|
|
Issued:
|
|
|
|
|
September 30, 2017 –
140,671,722
|
|
|
|
|
December 31, 2016 –
121,258,222
|
270,899,669
|
|
262,321,825
|
|
Warrants
|
3,617,900
|
|
—
|
|
Contributed
surplus
|
26,887,579
|
|
26,643,044
|
|
Accumulated other
comprehensive income
|
361,726
|
|
554,060
|
|
Accumulated
deficit
|
(289,700,576)
|
|
(278,829,309)
|
|
Total
shareholders' equity
|
12,066,298
|
|
10,689,620
|
|
Total
liabilities and equity
|
14,848,230
|
|
14,758,284
|
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three
Month
Period
Ending
September
30, 2017
$
|
|
Three
Month
Period
Ending
September
30, 2016
$
|
|
Nine
Month
Period
Ending
September
30, 2017
$
|
|
Nine
Month
Period
Ending
September
30, 2016
$
|
|
Expenses
|
|
|
|
|
|
Research and
development
|
1,726,726
|
|
2,141,737
|
|
6,913,470
|
|
6,358,822
|
|
Operating
|
1,309,607
|
|
1,222,447
|
|
4,054,450
|
|
3,708,317
|
|
Operating
loss
|
(3,036,333)
|
|
(3,364,184)
|
|
(10,967,920)
|
|
(10,067,139)
|
|
Interest
|
31,759
|
|
31,691
|
|
96,637
|
|
136,849
|
|
Loss before
income taxes
|
(3,004,574)
|
|
(3,332,493)
|
|
(10,871,283)
|
|
(9,930,290)
|
|
Income tax
expense
|
168
|
|
19
|
|
16
|
|
333
|
|
Net
loss
|
(3,004,406)
|
|
(3,332,474)
|
|
(10,871,267)
|
|
(9,929,957)
|
|
Other
comprehensive income items that may be
reclassified to
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation
adjustment
|
(126,846)
|
|
32,545
|
|
(192,334)
|
|
(268,341)
|
|
|
|
|
|
|
|
|
|
Net
comprehensive loss
|
(3,131,252)
|
|
(3,299,929)
|
|
(11,063,601)
|
|
(10,198,298)
|
|
Basic and
diluted loss per common share
|
(0.02)
|
|
(0.03)
|
|
(0.08)
|
|
(0.08)
|
|
Weighted
average number of shares (basic and
diluted)
|
139,515,885
|
|
120,552,638
|
|
129,441,461
|
|
119,455,440
|
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
Capital
$
|
|
Warrants
$
|
|
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
|
—
|
|
—
|
|
—
|
|
(268,341)
|
|
(9,929,957)
|
|
(10,198,298)
|
|
Issued pursuant to
"At the Market" Agreement
|
1,339,378
|
|
—
|
|
—
|
|
—
|
|
—
|
|
1,339,378
|
|
Issued pursuant to
incentive share award plan
|
41,000
|
|
—
|
|
(41,000)
|
|
—
|
|
—
|
|
—
|
|
Share issue
costs
|
(486,842)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(486,842)
|
|
Share based
compensation
|
—
|
|
—
|
|
299,635
|
|
—
|
|
—
|
|
299,635
|
|
As at September
30, 2016
|
262,218,228
|
|
—
|
|
26,536,601
|
|
492,637
|
|
(273,619,287)
|
|
15,628,179
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
Capital
$
|
|
Warrants
$
|
|
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
|
—
|
|
—
|
|
—
|
|
(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 issue
costs
|
(1,331,770)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,331,770)
|
|
Share based
compensation
|
—
|
|
—
|
|
438,044
|
|
—
|
|
—
|
|
438,044
|
|
As at September
30, 2017
|
270,899,669
|
|
3,617,900
|
|
26,887,579
|
|
361,726
|
|
(289,700,576)
|
|
12,066,298
|
|
ONCOLYTICS BIOTECH
INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH
FLOWS
(unaudited)
|
|
|
|
|
|
|
Three
Month
Period
Ending
September
30, 2017
$
|
|
Three
Month
Period
Ending
September
30, 2016
$
|
|
Nine Month
Period
Ending
September
30, 2017
$
|
|
Nine Month
Period
Ending
September
30, 2016
$
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
Net loss for the
period
|
(3,004,406)
|
|
(3,332,474)
|
|
(10,871,267)
|
|
(9,929,957)
|
|
Amortization -
property and equipment
|
20,591
|
|
44,014
|
|
70,315
|
|
134,631
|
|
Share based
compensation
|
148,447
|
|
98,369
|
|
438,044
|
|
299,635
|
|
Unrealized foreign
exchange gain
|
(6,414)
|
|
(49,400)
|
|
(119,058)
|
|
(152,019)
|
|
Net change in
non-cash working capital
|
(331,590)
|
|
216,611
|
|
(1,186,142)
|
|
978,847
|
|
Cash used in
operating activities
|
(3,173,372)
|
|
(3,022,880)
|
|
(11,668,108)
|
|
(8,668,863)
|
|
Investing
Activities
|
|
|
|
|
|
Acquisition of
property and equipment
|
(9,451)
|
|
(4,851)
|
|
(95,337)
|
|
(10,553)
|
|
Redemption (purchase)
of short-term investments
|
—
|
|
—
|
|
2,088,800
|
|
(27,823)
|
|
Cash (used in)
provided by investing activities
|
(9,451)
|
|
(4,851)
|
|
1,993,463
|
|
(38,376)
|
|
Financing
Activities
|
|
|
|
|
|
Proceeds from "At the
Market" equity distribution agreement
|
733,171
|
|
242,706
|
|
1,292,698
|
|
852,536
|
|
Proceeds from public
offering
|
—
|
|
—
|
|
10,366,098
|
|
—
|
|
Proceeds from
exercise of options
|
48,090
|
|
—
|
|
343,440
|
|
—
|
|
Cash provided by
financing activities
|
781,261
|
|
242,706
|
|
12,002,236
|
|
852,536
|
|
(Decrease)
increase in cash
|
(2,401,562)
|
|
(2,785,025)
|
|
2,327,591
|
|
(7,854,703)
|
|
Cash and cash
equivalents, beginning of period
|
16,676,298
|
|
18,320,981
|
|
12,034,282
|
|
24,016,275
|
|
Impact of foreign
exchange on cash and cash equivalents
|
(241,092)
|
|
76,773
|
|
(328,229)
|
|
(548,843)
|
|
Cash and cash
equivalents, end of period
|
14,033,644
|
|
15,612,729
|
|
14,033,644
|
|
15,612,729
|
To view the Company's Fiscal 2017 Third 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 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; 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 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 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.