SAN DIEGO and VANCOUVER, British Columbia, May 15, 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
first quarter financial results and key corporate highlights.
Key Corporate Highlights:
- Update on Phase 2b Localized Prostate Cancer Study. In
March 2017, the Company initiated its
Phase 2b open-label localized prostate cancer study with
investigational sites in both the UK and US. Five clinical trial
sites have been initiated and additional sites are in the process
of being initiated.
The Company is currently awaiting final regulatory clearance for
the diluent (the medium in which topsalysin is diluted prior to
dosing), which is anticipated this month, at which point the
investigational sites will begin dosing patients.
The Company expects to receive the six-month biopsy data for all
patients in the first quarter of 2018 assuming enrollment is
completed as expected. The Company expects to have complete data on
all patients who receive a second dose by the fourth quarter of
2018.
- Presented Proof-of-Concept and Phase 2a Data at Global
Urological Meetings. The Company presented positive data from
its Phase 2a clinical trial of topsalysin for the focal 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.
"We now have five clinical trial sites fully trained with
additional sites coming onboard," said Randall E. Woods, president and CEO of Sophiris.
"The regulatory approval of the diluent is the last remaining box
to check in the administrative work that enables the dosing of
patients which we anticipate being able to do in the very near
future."
Financial Results:
At March 31, 2017, the Company had
cash, cash equivalents and securities available-for-sale of
$25.7 million and working capital of
$25.6 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.
The Company reported a net loss of $2.6
million ($0.09 per share) for
the three months ended March 31, 2017
compared to a net loss of $2.2
million ($0.13 per share) for
the three months ended March 31,
2016.
Research and development expenses were $1.2 million for the three months ended
March 31, 2017, compared to
$0.9 million for the three months
ended March 31, 2016. The increase in
research and development expenses was primarily attributable to an
increase in the costs associated with the Company's on-going Phase
2b clinical trial for the focal treatment of localized prostate
cancer which was initiated in March
2017 and, to a lesser extent, an increase in costs
associated with manufacturing activities for topsalysin.
These increases were partially offset by a decrease in costs
associated with our completed Phase 2a proof of concept clinical
trial for low to intermediate risk prostate cancer.
General and administrative expenses were $1.4 million for the three months ended
March 31, 2017 compared to
$1.2 million for the three
months ended March 31, 2016. The
increase in general and administrative expenses was primarily due
to an increase in non-cash stock-based compensation expense which
was offset by a reduction in legal and professional services.
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 and expectations about further development of
topsalysin (PRX302), including the timing of expected results, or
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)
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
8,894
|
|
$
|
12,800
|
Securities
available-for-sale
|
|
16,800
|
|
|
16,201
|
Other
receivables
|
|
86
|
|
|
128
|
Prepaid
expenses
|
|
959
|
|
|
846
|
|
|
|
|
|
|
Total current
assets
|
|
26,739
|
|
|
29,975
|
|
|
|
|
|
|
Property and
equipment, net
|
|
1
|
|
|
4
|
Other long-term
assets
|
|
19
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
26,759
|
|
$
|
29,998
|
|
|
|
|
|
|
Liabilities and
shareholders' equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
360
|
|
$
|
459
|
Accrued
expenses
|
|
765
|
|
|
1,762
|
|
|
|
|
|
|
Total current
liabilities
|
|
1,125
|
|
|
2,221
|
|
|
|
|
|
|
Warrant
liability
|
|
13,482
|
|
|
13,396
|
Stock-based
compensation liability
|
|
23
|
|
|
57
|
|
|
|
|
|
|
Total
liabilities
|
|
14,630
|
|
|
15,674
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,111,153 and
30,107,644 shares issued and outstanding at March 31, 2017 and
December 31, 2016, respectively
|
|
131,246
|
|
|
131,245
|
Contributed
surplus
|
|
24,336
|
|
|
23,900
|
Accumulated other
comprehensive gain
|
|
86
|
|
|
99
|
Accumulated
deficit
|
|
(143,539)
|
|
|
(140,920)
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
12,129
|
|
|
14,324
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
26,759
|
|
$
|
29,998
|
|
|
|
|
|
|
Sophiris Bio
Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except
per share amounts)
(Unaudited)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2017
|
|
2016
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
$
|
1,208
|
$
|
929
|
General and
administrative
|
|
1,369
|
|
1,164
|
Total operating
expenses
|
|
2,577
|
|
2,093
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
|
-
|
|
(150)
|
Interest
income
|
|
51
|
|
5
|
Loss on revaluation of
warrant liability
|
|
(86)
|
|
-
|
Other expense,
net
|
|
(7)
|
|
(4)
|
Total other
expense
|
|
(42)
|
|
(149)
|
|
|
|
|
|
Net
loss
|
$
|
(2,619)
|
$
|
(2,242)
|
Basic and diluted
loss per share
|
$
|
(0.09)
|
$
|
(0.13)
|
Weighted average
number of outstanding
shares – basic and diluted
|
|
30,111
|
|
17,244
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sophiris-bio-reports-first-quarter-financial-results-and-key-corporate-highlights-300457754.html
SOURCE Sophiris Bio Inc.