SAN DIEGO and VANCOUVER, British Columbia, Aug. 10, 2017 /PRNewswire/ -- Sophiris Bio
Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a late stage
clinical biopharmaceutical company developing topsalysin (PRX302)
for the treatment of patients with urological diseases, today
reported financial results for the three and six months ended
June 30, 2017 and key corporate
highlights.
Key Corporate Highlights:
- Phase 2b Localized Prostate Cancer Study Underway. On
June 8, 2017, the Company announced
that the first patient had been dosed in its Phase 2b study to
evaluate the safety and tolerability of a single dose of topsalysin
in focally treating men with clinically significant localized
prostate cancer. Topsalysin (PRX302) is an innovative,
first-in-class pore-forming protein engineered to be activated only
in the presence of enzymatically-active PSA, which is only found
within the prostate. This study is enrolling approximately 40
patients at clinical sites in the UK and US. The Company expects to
receive the 24- week biopsy data for all patients from the first
dose of topsalysin in the first quarter of 2018 assuming enrollment
is completed as expected.
The Phase 2b study includes an option to re-treat patients with a
second dose of topsalysin, with a targeted biopsy to occur 24 weeks
following the second dose. The Company expects to have complete
data on all patients who receive a second dose by the fourth
quarter of 2018 assuming enrollment is completed as expected.
- Added to Russell Microcap Index®. In
June 2017, the Company was added to
the Russell Microcap® Index. Russell indices are widely used
by investment managers and institutional investors for index funds
and as benchmarks for both passive and active investment
strategies.
- Filing of New Form S-3. In anticipation of the
expiration of the company's existing Form S-3 shelf registration
statement filed in September 2014,
Sophiris will file a new Form S-3 today with the Securities and
Exchange Commission to register securities which could be issued in
the future.
"Topsalysin is a highly potent ablative agent, which we
administer by an ultrasound-guided injection directly into a tumor,
previously confirmed by biopsy. We are using state of the art
commercially available software in order to increase the precision
by which the physician administers topsalysin into the
pre-identified tumor," said Randall E.
Woods, president and CEO of Sophiris. "We are working toward
completion of enrollment, and we would like to thank the
investigators, study coordinators and patients for their
participation in this exciting study."
Financial Results:
At June 30, 2017, the Company had
cash, cash equivalents and securities available-for-sale of
$24.0 million and working capital of
$23.4 million. The Company
expects that its cash and cash equivalents will be sufficient to
fund its operations through the end of 2018. The Company is
currently not planning on pursuing a second Phase 3 trial in BPH,
unless the Company can secure a development partner to fund a new
clinical trial or the Company obtains other financing.
For the three months ended June 30,
2017
The Company reported net income of $0.6
million or $0.02 per share for
the three months ended June 30, 2017
compared to a net loss of $4.1
million or ($0.21 per share)
for the three months ended June 30,
2016. The net income for the three months ended June 30, 2017 was driven by a non-cash gain
related to the revaluation of the Company's warrant liability. See
an additional discussion below related to this item.
Research and development expenses
Research and development expenses were $1.4 million for the three months ended
June 30, 2017, compared to
$1.0 million for the three months
ended June 30, 2016. The increase in
research and development costs are primarily attributable to
increases in the costs associated with the Company's Phase 2b
clinical trial for the focal treatment of localized prostate
cancer, costs associated with manufacturing activities for
topsalysin and non-cash stock-based compensation expense. These
increases are partially offset by decreases in costs associated
with our completed Phase 2a proof of concept clinical trial for low
to intermediate risk prostate cancer and personnel related
costs.
General and administrative expenses
General and administrative expenses were $1.4 million for the three months ended
June 30, 2017 and 2016. General and
administrative expense included non-cash stock-based compensation
expense of $0.3 million for the three
months ended June 30, 2017 as
compared to $0.1 million for the
three months ended June 30, 2016.
This increase was offset by decreases for personnel related
costs.
Gain (loss) on revaluation of the warrant liability
Gain on revaluation of the warrant liability was $3.3 million for the three months ended
June 30, 2017 compared to a loss of
$1.6 million for the three months
ended June 30, 2016. Because these
warrants may require us to pay the warrant holder cash under
certain provisions of the warrant, we account for these warrants as
a liability and we are required to calculate the fair value of
these warrants each reporting date. This non-cash gain is
associated with a reduction in the fair value of the Company's
warrant liability which is calculated using a Black-Scholes pricing
model. Certain inputs utilized in the Company's Black-Scholes fair
value calculation may fluctuate in future periods based upon
factors which are outside of the Company's control. A significant
change in one or more of these inputs used in the calculation of
the fair value may cause a significant change to the fair value of
the Company's warrant liability, which could also result in
material non-cash gain or loss being reported in the Company's
consolidated statement of operations and comprehensive loss.
For the six months ended June 30,
2017
The Company reported a net loss of $2.0
million or ($0.07 per share)
for the six months ended June 30,
2017 compared to a net loss of $6.3
million or ($0.35 per share)
for the six months ended June 30,
2016.
Research and development expenses
Research and development expenses were $2.6 million for the six months ended
June 30, 2017 compared to
$1.9 million for the six months ended
June 30, 2016. The increase in
research and development costs are primarily attributable to
increases in the costs associated with the Company's Phase 2b for
the focal treatment of localized prostate cancer, costs associated
with the manufacturing activities for topsalysin and the non-cash
stock-based compensation expense. These increases are partially
offset by decreases in costs associated with our completed Phase 2a
proof of concept clinical trial for low to intermediate risk
prostate cancer and personnel related costs.
General and administrative expenses
General and administrative expenses were $2.7 million for the six months ended
June 30, 2017 compared to
$2.5 million for the six months
ended June 30, 2016. The increase is
primarily due to an increase in professional services and non-cash
stock-based compensation expense. These increases are partially
offset by the decreases in personnel related costs, legal and
closing costs which were expensed as they were allocated to the
warrants issued in our completed financing during the six months
ended June 30, 2016.
Gain (loss) on revaluation of the warrant liability
Gain on revaluation of the warrant liability was $3.2 million for the six months ended
June 30, 2017 as compared to a loss
of $1.6 million for the six months
ended June 30, 2016. This non-cash
gain is associated with a reduction in the fair value of our
warrant liability.
About Sophiris
Sophiris Bio Inc. is a late-stage clinical biopharmaceutical
company developing topsalysin (PRX302) for the treatment of
patients with urological diseases. Topsalysin is in Phase 2
clinical development for the focal treatment of localized prostate
cancer as well as Phase 3 clinical development for the treatment of
the lower urinary tract symptoms of benign prostatic hyperplasia
(BPH). Topsalysin is a highly potent ablative agent that is
selective and targeted in that it is only activated by
enzymatically active PSA which is found in high concentrations in
the transition zone of the prostate and in and around prostate
tumor cells. More than 400 patients have received topsalysin, which
continues to appear to be safe and well tolerated. For more
information, please visit www.sophirisbio.com.
Certain statements included in this press release may be
considered forward-looking, including the quote of Sophiris'
President and CEO, expectations about further development of
topsalysin (PRX302), including the timing of expected results,
statements about warrant liability and statements related to
Sophiris' liquidity or capital requirements. Such statements
involve known and unknown risks, uncertainties and other factors
that may cause actual results, performance or achievements to be
materially different from those implied by such statements, and
therefore these statements should not be read as guarantees of
future performance or results. Some of the risks and uncertainties
that could cause actual results, performance or achievements to
differ include without limitation, risks associated with clinical
development, including the risk that the enrollment of the Phase 2b
study will not be completed when expected and that results will not
be available when expected and risks that the results of the Phase
2b study will not replicate the results of the completed Phase 2
study of topsalysin for the treatment of localized low to
intermediate risk prostate cancer or the study endpoint[s] will not
be achieved, and other risks and uncertainties identified by
Sophiris in its public securities filings with the SEC. All
forward-looking statements are based on Sophiris' current beliefs
as well as assumptions made by and information currently available
to Sophiris and relate to, among other things, anticipated
financial performance, business prospects, strategies, regulatory
developments, clinical trial results, market acceptance, ability to
raise capital and future commitments. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. Due to risks and
uncertainties, including the risks and uncertainties identified by
Sophiris in its public securities filings; actual events may differ
materially from current expectations. Sophiris disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Company Contact:
Peter
Slover
Chief Financial Officer
(858) 777-1760
Corporate Communications Contact:
Jason
Spark
Canale
Communications
(619) 849-6005
jason@canalecomm.com
Sophiris Bio
Inc.
|
Condensed
Consolidated Balance Sheets
|
(In thousands, except
share amounts)
|
(Unaudited)
|
|
|
|
June
30
|
|
|
December
31,
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
6,824
|
|
$
|
12,800
|
Securities
available-for-sale
|
|
17,205
|
|
|
16,201
|
Other
receivables
|
|
69
|
|
|
128
|
Prepaid
expenses
|
|
948
|
|
|
846
|
|
|
|
|
|
|
Total current
assets
|
|
25,046
|
|
|
29,975
|
|
|
|
|
|
|
Property and
equipment, net
|
|
2
|
|
|
4
|
Other long-term
assets
|
|
-
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
25,048
|
|
$
|
29,998
|
|
|
|
|
|
|
Liabilities and
shareholders' equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
506
|
|
$
|
459
|
Accrued
expenses
|
|
1,154
|
|
|
1,762
|
|
|
|
|
|
|
Total current
liabilities
|
|
1,660
|
|
|
2,221
|
|
|
|
|
|
|
Warrant
liability
|
|
10,162
|
|
|
13,396
|
Stock-based
compensation liability
|
|
-
|
|
|
57
|
|
|
|
|
|
|
Total
liabilities
|
|
11,822
|
|
|
15,674
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,111,153 and
30,107,644 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively
|
|
131,246
|
|
|
131,245
|
Contributed
surplus
|
|
24,824
|
|
|
23,900
|
Accumulated other
comprehensive gain
|
|
85
|
|
|
99
|
Accumulated
deficit
|
|
(142,929)
|
|
|
(140,920)
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
13,226
|
|
|
14,324
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
25,048
|
|
$
|
29,998
|
|
|
|
|
|
|
Sophiris Bio
Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive Income
(Loss)
|
(In thousands, except
per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,387
|
$
|
978
|
|
$
|
2,595
|
$
|
1,907
|
General and
administrative
|
|
1,367
|
|
1,357
|
|
|
2,736
|
|
2,521
|
Total operating
expenses
|
|
2,754
|
|
2,335
|
|
|
5,331
|
|
4,428
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
-
|
|
(137)
|
|
|
-
|
|
(287)
|
Interest
income
|
|
53
|
|
3
|
|
|
103
|
|
7
|
Gain (Loss) on
revaluation of warrant liability
|
|
3,320
|
|
(1,619)
|
|
|
3,234
|
|
(1,619)
|
Other expense,
net
|
|
(9)
|
|
(3)
|
|
|
(16)
|
|
(7)
|
Total other income
(expense)
|
|
3,364
|
|
(1,756)
|
|
|
3,321
|
|
(1,906)
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
|
610
|
$
|
(4,091)
|
|
$
|
(2,010)
|
$
|
(6,334)
|
|
Basic income
(loss) per share
|
$
|
0.02
|
$
|
(0.21)
|
|
$
|
(0.07)
|
$
|
(0.35)
|
|
Diluted income
(loss) per share
|
$
|
0.02
|
$
|
(0.21)
|
|
$
|
(0.07)
|
$
|
(0.35)
|
Weighted average
number of outstanding shares – basic
|
|
30,111
|
|
19,340
|
|
|
30,111
|
|
18,292
|
Weighted average
number of outstanding shares –diluted
|
|
30,515
|
|
19,340
|
|
|
30,111
|
|
18,292
|
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SOURCE Sophiris Bio Inc.