SAN DIEGO and VANCOUVER, British Columbia, Nov. 9, 2016 /PRNewswire/ -- Sophiris Bio Inc.
(NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical
company developing topsalysin (PRX302) for the treatment of
urological diseases, today announced financial results for the
three and nine months ended September 30,
2016.
Business Highlights:
- On August 26, 2016, the Company
announced the closing of a public offering in which the Company
raised net proceeds of $27.4 million.
The Company plans to use the proceeds from this offering to fund a
Phase 2b clinical trial for the treatment of localized prostate
cancer and working capital and general corporate purposes, which
may include research and development expenses, general and
administrative expenses and manufacturing expenses.
- During the third quarter of 2016, the Company received proceeds
of $1.7 million from the exercise of
warrants and stock options.
- In September 2016, the Company
repaid the outstanding principal balance of the loan with Oxford
Finance LLC with a total payment of $4.2
million.
- On October 12, 2016 the Board of
Directors of Sophiris Bio Inc. approved the appointment of
Allison Hulme, Ph.D., the Company's
chief operating officer and head of research and development, as a
director of the Company.
"Sophiris has been successful in building on a series of
positive clinical milestones that we believe will enable us to
further the development of topsalysin," said Randall Woods, president and CEO of Sophiris
Bio. "In the wake of announcing positive data from our Phase 2a
proof-of-concept study in localized prostate cancer as well as from
our Phase 3 trial in BPH that met its primary endpoint, the Company
was able to raise additional funds in the public market in the
third quarter to strengthen our balance sheet and enable us to fund
an additional clinical trial. Over the past quarter, we have made
significant progress in preparing to initiate a Phase 2b clinical
trial of topsalysin for the treatment of localized prostate cancer,
which is expected to report initial results by the end of
2017."
Financial Results:
At September 30, 2016, we had
cash, cash equivalents and securities available-for-sale of
$31.3 million and net working capital
of $29.8 million. We expect that
our cash and cash equivalents will be sufficient to fund our
operations into the second quarter of 2018. At this point in time
we do not plan on pursuing a second Phase 3 trial in BPH unless we
obtain additional financing.
For the three months ended September
30, 2016
The Company reported a net loss of $4.3
million ($0.17 per share) for
the three months ended September 30,
2016 compared to a net loss of $3.7
million ($0.22 per share) for
the three months ended September 30,
2015.
Research and development expenses
Research and development expenses were $0.6 million for the three months ended
September 30, 2016, compared to
$2.6 million for the three months
ended September 30, 2015. The
decrease in research and development costs are primarily
attributable to a decrease in the costs associated with the
Company's Phase 3 PLUS-1 clinical trial and our Phase 2a proof of
concept clinical trial for localized prostate cancer both of which
were completed prior to the third quarter.
General and administrative expenses
General and administrative expenses were $3.0 million for the three months ended
September 30, 2016 compared to
$0.9 million for the three
months ended September 30, 2015. The
increase is primarily due to the inclusion of $1.4 million in offering expenses which were
allocated to the fair value of the warrants issued in our public
offering in August 2016. The balance
of the offering expenses were recorded as a reduction to
equity. The increase was also related to an increase in
personnel related costs and professional services.
Loss on revaluation of warrant liability.
Loss on revaluation of the warrant liability was $0.3 million for the three months ended
September 30, 2016. The non-cash loss
is associated with the change in the fair value of our warrant
liability.
For the nine months ended September
30, 2016
The Company reported a net loss of $10.6
million ($0.51 per share) for
the nine months ended September 30,
2016 compared to a net loss of $11.7
million ($0.69 per share) for
the nine months ended September 30,
2015.
Research and development expenses
Research and development expenses were $2.5 million for the nine months ended
September 30, 2016 compared to
$8.2 million for the nine months
ended September 30, 2015. The
decrease in research and development costs are primarily
attributable to a decrease of $5.2
million in the costs associated with the Company's completed
Phase 3 PLUS-1 clinical trial of topsalysin for the treatment of
BPH and to a lesser extent a decrease in costs associated with our
Phase 2a proof of concept clinical trial for localized prostate
cancer and manufacturing activities for topsalysin.
General and administrative expenses
General and administrative expenses were $5.6 million for the nine months ended
September 30, 2016 compared to
$3.0 million for the nine months
ended September 30, 2015. The
increase is primarily due to the inclusion of $1.6 million in offering costs which were
allocated to the warrants issued in connection with our offerings
which closed in May and August of 2016. The increase, to a lesser
extent, is due to an increase in personnel, legal, accounting,
consulting and professional services. These increases were
partially offset by a decrease in non-cash stock-based compensation
expense.
Loss on revaluation of warrant liability.
Loss on revaluation of the warrant liability was $2.0 million for the nine months ended
September 30, 2016. The non-cash loss
is associated with the change in the fair value of our warrant
liability.
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing
topsalysin, a clinical-stage, targeted therapy for the treatment of
urological diseases. Topsalysin has successfully completed a Phase
3 clinical study for the treatment of the symptoms of benign
prostatic hyperplasia (BPH), and is designed to be as efficacious
as pharmaceuticals, less invasive than the surgical interventions,
and without the sexual side effects seen with existing treatments.
Topsalysin has also successfully completed a Phase 2a study for the
treatment of clinically significant, localized low to intermediate
risk prostate cancer prior to radical therapy. 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 and expectations about further development of
PRX302, or Sophiris' 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 results of the planned
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, 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 and Investor Relations:
|
Michael
Moore
NATIONAL
Equicom
Investor
Relations
(858)
886-7813
mmoore@national.ca
|
Jason
Spark
Canale
Communications
Corporate
Communications and
IR
(619)
849-6005
jason@canalecomm.com
|
Sophiris Bio
Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except
share amounts)
(Unaudited)
|
|
|
|
September
30
|
|
|
December
31,
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
31,055
|
|
$
|
5,881
|
Securities
available-for-sale
|
|
203
|
|
|
2,500
|
Other
receivables
|
|
13
|
|
|
8
|
Prepaid
expenses
|
|
490
|
|
|
467
|
|
|
|
|
|
|
Total current
assets
|
|
31,761
|
|
|
8,856
|
|
|
|
|
|
|
Property and
equipment, net
|
|
5
|
|
|
17
|
Other long-term
assets
|
|
-
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
31,766
|
|
$
|
8,892
|
|
|
|
|
|
|
Liabilities and
shareholders' equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
374
|
|
$
|
909
|
Accrued
expenses
|
|
1,588
|
|
|
566
|
Current portion of
promissory notes
|
|
-
|
|
|
1,771
|
|
|
|
|
|
|
Total current
liabilities
|
|
1,962
|
|
|
3,246
|
|
|
|
|
|
|
Long-term promissory
notes
|
|
-
|
|
|
3,572
|
Warrant
liability
|
|
15,035
|
|
|
-
|
Stock-based
compensation liability
|
|
195
|
|
|
168
|
|
|
|
|
|
|
Total
liabilities
|
|
17,192
|
|
|
6,986
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,107,644 and
17,244,736 shares issued and outstanding at September 30, 2016 and
December 31, 2015, respectively
|
|
131,245
|
|
|
113,880
|
Contributed
surplus
|
|
23,604
|
|
|
17,683
|
Accumulated other
comprehensive gain
|
|
99
|
|
|
99
|
Accumulated
deficit
|
|
(140,374)
|
|
|
(129,756)
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
14,574
|
|
|
1,906
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
31,766
|
|
$
|
8,892
|
|
|
|
|
|
|
Sophiris Bio
Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except
per share amounts)
(Unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
624
|
$
|
2,555
|
|
$
|
2,531
|
$
|
8,192
|
General and
administrative
|
|
3,043
|
|
921
|
|
|
5,564
|
|
2,967
|
Total operating
expenses
|
|
3,667
|
|
3,476
|
|
|
8,095
|
|
11,159
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(86)
|
|
(174)
|
|
|
(373)
|
|
(528)
|
Interest
income
|
|
3
|
|
4
|
|
|
11
|
|
18
|
Loss on revaluation of
warrant liability
|
|
(350)
|
|
-
|
|
|
(1,969)
|
|
-
|
Loss on early
extinguishment of debt
|
|
(180)
|
|
-
|
|
|
(180)
|
|
-
|
Other
expense
|
|
(4)
|
|
(9)
|
|
|
(11)
|
|
(29)
|
Total other
expense
|
|
(617)
|
|
(179)
|
|
|
(2,522)
|
|
(539)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(4,284)
|
$
|
(3,655)
|
|
$
|
(10,617)
|
$
|
(11,698)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share
|
$
|
(0.17)
|
$
|
(0.22)
|
|
$
|
(0.51)
|
$
|
(0.69)
|
Weighted average
number of outstanding shares – basic and diluted
|
|
25,215
|
|
16,845
|
|
|
20,617
|
|
16,845
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sophiris-bio-reports-third-quarter-2016-financial-results-and-key-business-highlights-300359986.html
SOURCE Sophiris Bio Inc.