SAN DIEGO and VANCOUVER, British Columbia, March 27, 2017 /PRNewswire/ -- Sophiris Bio
Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a clinical
late-stage biopharmaceutical company developing topsalysin (PRX302)
for the treatment of patients with urological diseases, today
reported fourth quarter and full year 2016 financial results and
key corporate highlights.
Key Corporate Highlights:
- Advanced Topsalysin (PRX302) in Clinical Development for
Localized Prostate Cancer. During 2016, the Company reported
successful results with topsalysin in a completed Phase 2a study
for the focal treatment of localized prostate cancer. In 2017, the
Company continued the development of topsalysin for the focal
treatment of localized prostate cancer with the initiation of a
Phase 2b clinical study.
- Initiated 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. The primary objective
of the study is safety and tolerability of an injection of
topsalysin and the key efficacy variable is focal ablation of a
clinically significant lesion on biopsy after six months.
Approximately 40 patients with localized prostate cancer are
expected to be enrolled in the study and patient screening has
begun
Previously obtained multi-parametric magnetic resonance imaging
(mpMRI) of tumor lesions in each patient's prostate, mapped to
real-time three dimensional ultrasound will be used in the study to
guide an intrasprostatic injection of topsalysin to treat a single,
histological-proven, clinically significant lesion area in each
patient's prostate.
Six months following treatment with topsalysin, a targeted biopsy
of the treated area will be conducted. The Company expects to
receive the six-month biopsy data for all patients in late 2017 or
early 2018. Based upon the results of the 6-month biopsy, the study
includes an option to potentially re-treat the targeted lesion area
with a second dose of topsalysin, with a targeted biopsy to occur
six months following the second dose. In order to be eligible for a
second dose, the patient cannot have experienced a significant
adverse event attributable to topsalysin or the dosing procedure
from the first dose and the patient will need to have had a
clinical response from the first dose but still have the presence
of a clinically significant lesion area. The Company expects to
have final biopsy data on all patients who receive a second dose by
the third quarter of 2018.
- Reported Successful Results from a Phase 2a Localized
Prostate Cancer Study. In June
2016, the Company announced successful results from its
completed Phase 2a study of topsalysin in the focal treatment of
localized prostate cancer. Biopsy data at six months following
treatment in 18 patients showed that topsalysin demonstrated the
ability to ablate tumor cells in over half of the patients and two
patients experienced complete ablation of their targeted tumor with
no histological evidence of any tumor remaining at six months.
- Reported Positive Data at Important Urological
Meeting. The Company presented positive data from its
Phase 3 clinical trial of topsalysin as a treatment for the
symptoms of benign prostatic hyperplasia ("BPH") as a late breaking
poster at the 111th American Urological Association Annual Meeting.
A copy of the poster is available on the Company's website at
www.sophirisbio.com.
- Improved Financial Profile to Support Topsalysin Clinical
Plans. During 2016, the Company raised net proceeds of
$27.4 million and $7.0 million through two financing transactions.
As of December 31, 2016, the Company
had cash, cash equivalents and securities available-for-sale of
$29.0 million and working capital of
$27.8 million. The Company
expects that its cash, cash equivalents and securities
available-for-sale will allow the Company to operate through the
end of 2018.
"During 2016, Sophiris has made significant clinical development
progress in advancing topsalysin, a novel and first-in-class
targeted biologic," said Randall E.
Woods, president and CEO of Sophiris. "We believe that
topsalysin may be an effective treatment to address significant
unmet medical needs in two major commercial markets. Topsalysin
could potentially provide a new intermediate treatment that may
delay or even obviate the need for more radical treatment
approaches in both localized prostate cancer as well as BPH.
Topsalysin also has the potential to maintain or improve a
patient's quality of life post-treatment while at the same time
remaining attractive to payors."
Financial Results:
At December 31, 2016, the Company
had cash, cash equivalents and securities available-for-sale of
$29.0 million and working capital of
$27.8 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 such
new clinical trial or the Company obtains other financing.
For the three months ended December
31, 2016
The Company reported a net loss of $0.5
million ($0.02 per share) for
the three months ended December 31,
2016 compared to a net loss of $2.5
million ($0.15 per share) for
the three months ended December 31,
2015.
Research and development expenses were $1.0 million for the three months ended
December 31, 2016, compared to
$1.7 million for the three months
ended December 31, 2015. The decrease
in research and development expenses were primarily attributable to
a decrease in the costs associated with the Company's Phase 3
PLUS-1 clinical trial which was completed in November 2015 and its Phase 2a proof of concept
clinical trial for localized prostate cancer which was completed in
June 2016.
General and administrative expenses were $1.2 million for the three months ended
December 31, 2016 compared to
$0.7 million for the three
months ended December 31, 2015. The
increase in general and administrative expenses was primarily due
to an increase in personnel related costs.
Gain on revaluation of the warrant liability was $1.6 million for the three months ended
December 31, 2016. This non-cash gain
was associated with the change in the fair value of the Company's
warrant liability from September 30,
2016 to December 31, 2016.
For the 12 months ended December 31,
2016
The Company reported a net loss of $11.2
million ($0.49 per share) for
the twelve months ended December 31,
2016 compared to a net loss of $14.2
million ($0.84 per share) for
the twelve months ended December 31,
2015.
Research and development expenses were $3.5 million for the twelve months ended
December 31, 2016 compared to
$9.9 million for the twelve months
ended December 31, 2015. The decrease
in research and development costs were primarily attributable to a
decrease of $5.9 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 the Company's Phase 2a proof of
concept clinical trial for localized prostate cancer which
commenced in May 2015 and was
completed in June 2016.
General and administrative expenses were $6.8 million for the twelve months ended
December 31, 2016 compared to
$3.6 million for the twelve
months ended December 31, 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 the Company's
offerings which closed in May and August of 2016. The increase, to
a lesser extent, is due to an increase in personnel related costs
of $0.8 million and legal,
accounting, consulting and professional fees of $0.7 million.
Loss on revaluation of the warrant liability was $0.3 million for the twelve months ended
December 31, 2016. The non-cash loss
was associated with the change in the fair value of the Company's
warrant liability.
Loss on early extinguishment of debt was $0.2 million for the twelve months ended
December 31, 2016. This consists of
the final payment and a prepayment fee which was offset by the
Company's unamortized debt premium resulting from the payoff of its
loan with Oxford.
About Sophiris
Sophiris Bio Inc. is a 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 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 and Media Contact:
Jason
Spark
Canale Communications
(619) 849-6005
jason@canalecomm.com
Sophiris Bio
Inc.
|
Consolidated
Balance Sheets
|
(In thousands, except
share amounts)
|
(Unaudited)
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
12,800
|
|
$
|
5,881
|
Securities
available-for-sale
|
|
16,201
|
|
|
2,500
|
Other
receivables
|
|
128
|
|
|
8
|
Prepaid
expenses
|
|
846
|
|
|
467
|
|
|
|
|
|
|
Total current
assets
|
|
29,975
|
|
|
8,856
|
|
|
|
|
|
|
Property and
equipment, net
|
|
4
|
|
|
17
|
Other long-term
assets
|
|
19
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
29,998
|
|
$
|
8,892
|
|
|
|
|
|
|
Liabilities and
shareholders' equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
459
|
|
$
|
909
|
Accrued
expenses
|
|
1,762
|
|
|
566
|
Current portion of
promissory notes
|
|
-
|
|
|
1,771
|
|
|
|
|
|
|
Total current
liabilities
|
|
2,221
|
|
|
3,246
|
|
|
|
|
|
|
Long-term promissory
notes
|
|
-
|
|
|
3,572
|
Warrant
liability
|
|
13,396
|
|
|
-
|
Stock-based
compensation liability
|
|
57
|
|
|
168
|
|
|
|
|
|
|
Total
liabilities
|
|
15,674
|
|
|
6,986
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,107,644 and
17,244,736 shares issued and outstanding at December 31, 2016
and 2015, respectively
|
|
131,245
|
|
|
113,880
|
Contributed
surplus
|
|
23,900
|
|
|
17,683
|
Accumulated other
comprehensive gain
|
|
99
|
|
|
99
|
Accumulated
deficit
|
|
(140,920)
|
|
|
(129,756)
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
14,324
|
|
|
1,906
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
29,998
|
|
$
|
8,892
|
|
|
|
|
|
|
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,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,007
|
$
|
1,669
|
|
$
|
3,538
|
$
|
9,862
|
General and
administrative
|
|
1,204
|
|
660
|
|
|
6,768
|
|
3,626
|
Total operating
expenses
|
|
2,211
|
|
2,329
|
|
|
10,306
|
|
13,488
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
-
|
|
(162)
|
|
|
(373)
|
|
(690)
|
Interest
income
|
|
26
|
|
4
|
|
|
37
|
|
22
|
Gain (loss) on
revaluation of warrant liability
|
|
1,639
|
|
-
|
|
|
(330)
|
|
-
|
Loss on early
extinguishment of debt
|
|
-
|
|
-
|
|
|
(180)
|
|
-
|
Other expense,
net
|
|
-
|
|
(12)
|
|
|
(12)
|
|
(41)
|
Total other income
(expense)
|
|
1,665
|
|
(170)
|
|
|
(858)
|
|
(709)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(546)
|
$
|
(2,499)
|
|
$
|
(11,164)
|
$
|
(14,197)
|
Basic and diluted
loss per share
|
$
|
(0.02)
|
$
|
(0.15)
|
|
$
|
(0.49)
|
$
|
(0.84)
|
Weighted average
number of outstanding shares – basic and diluted
|
|
30,108
|
|
16,989
|
|
|
23,002
|
|
16,881
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sophiris-bio-reports-fourth-quarter-and-full-year-2016-financial-results-and-key-corporate-highlights-300429284.html
SOURCE Sophiris Bio Inc.