SAN DIEGO and VANCOUVER, British Columbia, March 21, 2018 /PRNewswire/ -- Sophiris Bio Inc.
(NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical
company studying topsalysin (PRX302), a first-in-class,
pore-forming protein, in late-stage clinical trials for the
treatment of patients with urological diseases, today reported
fourth quarter and full year 2017 financial results and key
corporate highlights.
Recent Highlights and Upcoming Milestones:
- Advancement of Phase 2b
Localized Prostate Cancer Study. The Company announced in
December 2017 that it had completed
enrollment in its Phase 2b localized
prostate cancer study, the purpose of which is to evaluate the
safety and tolerability of topsalysin in treating men with
clinically significant localized prostate cancer. A total of 38
patients have been treated with topsalysin in the study. The
Company expects biopsy data from all patients receiving the first
dose of topsalysin to be available by the end of the second quarter
of 2018.
During the first quarter of 2018, the independent data monitoring
committee (IDMC) for the Phase 2b
trial met to review the reported adverse events from all patients
after the first administration of topsalysin. The IDMC unanimously
recommended the clinical trial continue without changes to the
protocol.
The Phase 2b study was designed to
include an option to re-treat patients who did not have any
clinically significant adverse events and who had a partial
response to the first administration of topsalysin but still had a
clinically significant lesion. These patients will have the option
to receive a second administration of topsalysin followed by an
additional targeted biopsy six months following their second
administration. The Company expects to have final biopsy data in
the fourth quarter of 2018 from all patients who receive a second
administration. This will be the first data potentially supporting
repeat administration of topsalysin.
- Presented Proof-of-Concept and Phase 2a Data at Global
Urological Meetings. In 2017, the Company presented
positive data from its Phase 2a clinical trial of topsalysin for
the treatment of localized prostate cancer at the 112th American
Urological Association Annual Meeting and at the 32nd European
Association of Urology Congress. Copies of the posters are
available on the Company's website at www.sophirisbio.com.
- Loan and Security Agreement with Silicon Valley
Bank. On September 8, 2017,
the Company and Silicon Valley Bank ("SVB") entered into a Loan and
Security Agreement pursuant to which SVB has agreed to lend the
Company up to $10.0 million (subject
to certain conditions) in two term loans. On September 12, 2017, the Company borrowed
$7.0 million from SVB under the Loan
and Security Agreement.
"Over the past 12 months Sophiris has made important progress
advancing topsalysin in clinically significant localized prostate
cancer and preparing for a potential Phase 3 registration study,"
said Randall E. Woods, president and
CEO of Sophiris. "With our Phase 2b
study enrolled, we are looking ahead to two key data events this
year. The first event is Phase 2b
results from the first administration of topsalysin, which are
expected to be available by end of the second quarter of 2018.
Complete data from patients who were eligible to receive a second
administration of topsalysin are expected to be available by the
end of the year. The management team has also been diligently
preparing for the design and execution of a Phase 3 registration
study for the treatment of clinically significant localized
prostate cancer in an effort to pave a clear path to
commercialization."
Financial Results:
At December 31, 2017, the Company
had cash, cash equivalents and securities available-for-sale of
$25.8 million and working capital of
$24.2 million. The Company
expects that its cash and cash equivalents will be sufficient to
fund its operations to the middle of 2019, assuming no new clinical
trials.
For the three months ended December
31, 2017
The Company reported a net loss of $4.0
million or $(0.13) per share
for the three months ended December 31,
2017, compared to a net loss of $0.5
million or $(0.02) per share
for the three months ended December
31, 2016.
Research and development expenses
Research and development expenses were $1.9 million for the three months ended
December 31, 2017, compared to
$1.0 million for the three months
ended December 31, 2016. The increase
in research and development costs is primarily attributable to
increases in the costs associated with the Company's Phase
2b clinical trial for the treatment
of localized prostate cancer, costs associated with manufacturing
activities for topsalysin, and to a lesser extent, an increase in
non-cash stock-based compensation expense. These increases are
partially offset by a decrease in personnel related costs.
General and administrative expenses
General and administrative expenses were $1.3 million for the three months ended
December 31, 2017, compared to
$1.2 million for the three months
ended December 31, 2016. The increase
in general and administrative expense is primarily due to increases
in market research activities and non-cash stock-based compensation
expense. These increases are partially offset by a decrease in
personnel related costs.
Gain (loss) on revaluation of the warrant liability
Loss on revaluation of the warrant liability was $0.6 million for the three months ended
December 31, 2017, compared to a gain
of $1.6 million for the three months
ended December 31, 2016. Because
these warrants may require the Company to pay the warrant holder
cash under certain provisions of the warrant, the Company accounts
for these warrants as a liability, and the Company is required to
calculate the fair value of these warrants each reporting date. The
non-cash loss reported for the three months ended December 31, 2017, is associated with an increase
in the fair value of the Company's warrant liability from
September 30, 2017, to December 31, 2017, 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 a material non-cash gain or
loss being reported in the Company's consolidated statement of
operations and comprehensive loss.
For the 12 months ended December 31,
2017
The Company reported a net loss of $8.6
million or $(0.29) per share
for the year ended December 31, 2017,
compared to a net loss of $11.2
million or $(0.49) per share
for the year ended December 31,
2016.
Research and development expenses
Research and development expenses were $6.2 million for the year ended December 31, 2017, compared to $3.5 million for the year ended December 31, 2016. The increase in research and
development costs is primarily attributable to increases in the
costs associated with the Company's Phase 2b for the treatment of localized prostate
cancer, costs associated with the manufacturing activities for
topsalysin, and to a lesser extent, an increase in the non-cash
stock-based compensation expense. These increases are partially
offset by decreases in costs associated with the Company's
completed Phase 2a proof of concept clinical trial for localized
prostate cancer and personnel related costs primarily related to
our completed reduction in work force in 2016.
General and administrative expenses
General and administrative expenses were $5.7 million for the year ended December 31, 2017, compared to $6.8 million for the year ended December 31, 2016. The decrease in general and
administrative expense is primarily due to the inclusion of
$1.6 million in offering costs that
were allocated to warrants issued in the Company's public offering
completed in 2016. Also contributing to the decrease in general and
administrative expense were decreases in costs associated with
professional services and personnel related costs. These decreases
are partially offset by increases in non-cash stock-based
compensation, market research activities and consulting
expenses.
Gain (loss) on revaluation of the warrant liability
Gain on revaluation of the warrant liability was $3.3 million for the year ended December 31, 2017, compared to a loss of
$0.3 million for the year ended
December 31, 2016. The non-cash gain
reported for the year ended December 31,
2017, is associated with a reduction in the fair value of
the Company's warrant liability from December 31, 2016 to December 31, 2017, as calculated using a
Black-Scholes pricing model.
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 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
that 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 and expectations about further development of
topsalysin (PRX302), including the timing of expected results,
plans relating to the design and execution of a Phase 3 clinical
trial and 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 results of the Phase
2b study 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 will not be achieved, risks that the Company will be able
to fund future clinical trials 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 Media Contact:
Jason Spark
Canale Communications
(619) 849-6005
jason@canalecomm.com
Investor Contact:
Bill Slattery, Jr.
Burns McClellan
(212) 213-0006
bslattery@burnsmc.com
Sophiris Bio
Inc.
|
Consolidated
Balance Sheets
|
(In thousands, except
share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
16,087
|
|
$
|
12,800
|
Securities
available-for-sale
|
|
9,757
|
|
|
16,201
|
Other
receivables
|
|
13
|
|
|
128
|
Prepaid
expenses
|
|
999
|
|
|
846
|
|
|
|
|
|
|
Total current
assets
|
|
26,856
|
|
|
29,975
|
|
|
|
|
|
|
Property and
equipment, net
|
|
2
|
|
|
4
|
Other long-term
assets
|
|
19
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
26,877
|
|
$
|
29,998
|
|
|
|
|
|
|
Liabilities and
shareholders' equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
832
|
|
$
|
459
|
Accrued
expenses
|
|
1,499
|
|
|
1,762
|
Current portion of
promissory notes
|
|
372
|
|
|
-
|
|
|
|
|
|
|
Total current
liabilities
|
|
2,703
|
|
|
2,221
|
|
|
|
|
|
|
Long-term promissory
notes
|
|
6,435
|
|
|
-
|
Warrant
liability
|
|
10,089
|
|
|
13,396
|
Stock-based
compensation liability
|
|
-
|
|
|
57
|
|
|
|
|
|
|
Total
liabilities
|
|
19,227
|
|
|
15,674
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,111,153 and
30,107,644 shares issued and outstanding at December 31, 2017
and 2016, respectively
|
|
131,247
|
|
|
131,245
|
Contributed
surplus
|
|
25,854
|
|
|
23,900
|
Accumulated other
comprehensive gain
|
|
97
|
|
|
99
|
Accumulated
deficit
|
|
(149,548)
|
|
|
(140,920)
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
7,650
|
|
|
14,324
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
26,877
|
|
$
|
29,998
|
|
|
|
|
|
|
Sophiris Bio
Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(In thousands, except
per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months
Ended December 31,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,942
|
$
|
1,007
|
|
$
|
6,186
|
$
|
3,538
|
General and
administrative
|
|
1,310
|
|
1,204
|
|
|
5,732
|
|
6,768
|
Total operating
expenses
|
|
3,252
|
|
2,211
|
|
|
11,918
|
|
10,306
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(172)
|
|
-
|
|
|
(207)
|
|
(373)
|
Interest
income
|
|
79
|
|
26
|
|
|
238
|
|
37
|
Gain (loss) on
revaluation of warrant liability
|
|
(597)
|
|
1,639
|
|
|
3,307
|
|
(330)
|
Loss on early
extinguishment of debt
|
|
-
|
|
-
|
|
|
-
|
|
(180)
|
Other expense,
net
|
|
(21)
|
|
-
|
|
|
(48)
|
|
(12)
|
Total other income
(expense)
|
|
(711)
|
|
1,665
|
|
|
3,290
|
|
(858)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(3,963)
|
$
|
(546)
|
|
$
|
(8,628)
|
$
|
(11,164)
|
Basic and diluted
loss per share
|
$
|
(0.13)
|
$
|
(0.02)
|
|
$
|
(0.29)
|
$
|
(0.49)
|
Weighted average
number of outstanding shares – basic and diluted
|
|
30,111
|
|
30,108
|
|
|
30,111
|
|
23,002
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Sophiris Bio Inc.