SAN DIEGO and VANCOUVER, British Columbia, Nov. 13, 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 financial results for the third quarter 2018 and recent
corporate highlights.
"During the third quarter, we reported top-line six-month biopsy
data from two additional patients following a single administration
of topsalysin in our ongoing Phase 2b
clinical trial in low to intermediate risk localized prostate
cancer," said Randall E. Woods,
president and CEO of Sophiris. "Both patients were considered
partial responders, bringing the total number of patients with a
partial response to 15 out of the 37. We continue to believe that
the data obtained to date from the single administration of
topsalysin supports advancing topsalysin into a single Phase 3
trial for the treatment of localized prostate cancer. We remain on
track to report data by the end of next month from patients who
received a second administration of topsalysin as part of our Phase
2b trial. Finally, we are preparing
for Phase 3 guidance meetings with regulatory agencies. We expect
these meetings to take place in the first half of 2019, after which
we will provide an update on our Phase 3 trial design."
Third Quarter Corporate Highlights:
- Updates from Phase 2b trial in
localized prostate cancer. In the third quarter, Sophiris
reported top-line six-month follow-up biopsy data from the final
two patients enrolled in the trial with pre-identified,
clinically-significant localized prostate cancer that were treated
with a single administration of topsalysin.
Based on the six-month follow-up biopsy results, 27% of patients
(10/37) demonstrated a clinical response. Of the 10 clinical
responders in the Phase 2b trial, six
patients experienced a complete ablation with no histological
evidence of the targeted tumor remaining. In addition, 41% of
patients (15/37) were considered partial responders, meaning that
while an effect was seen, some clinically-significant lesion
remained as identified by targeted biopsy. 68% of patients (25/37)
demonstrated a partial or clinical response to the single
administration of topsalysin.
The Phase 2b study was designed to
include an option for qualified patients to receive a second
administration of topsalysin six-months after the first
administration, provided: (1) the patient did not have any
clinically-significant adverse events to either topsalysin or the
dosing procedure and (2) some response to the first administration
was observed following a targeted biopsy. The objective of
re-administering topsalysin is to assess the safety of giving a
second administration of topsalysin and to determine if additional
clinical benefit is observed six-months after the second
administration.
The Company expects to have six-month follow-up safety and biopsy
data from patients who received a second administration of
topsalysin in its ongoing Phase 2b
trial in localized prostate cancer patients next month.
- Preparations for Phase 3 trial in localized prostate
cancer. The Company believes that the data generated in the
single-administration portion of the Phase 2b prostate cancer study supports the advancement
of the program into a single Phase 3 pivotal trial. Currently, the
Company is in the process of preparing information for regulatory
guidance meetings with the U.S. Food and Drug Administration and
the European Medicines Agency which are expected to take place in
the first half of 2019, after which the Company will provide an
update on the Phase 3 trial design. The Company will evaluate
whether future clinical development will include an option to
administer a second dose of topsalysin once the Company receives
more information from the 10 patients who have received a second
dose.
- Interest only period extended under loan and security
agreement. In September the Company announced that it had met
the requirements within its existing loan and security agreement
with Silicon Valley Bank to extend the interest only period to
March 31, 2019. The Company will
begin making interest and principal payments starting on
April 1, 2019 and ending on the final
payment date of September 1,
2021.
Financial Results:
At September 30, 2018, the Company
had cash, cash equivalents and securities available-for-sale of
$14.5 million and working capital of
$11.7 million. The Company
expects that its existing cash and cash equivalents will be
sufficient to fund its operations through June 2019, assuming no new clinical trials are
initiated. The Company will require significant additional funding
to advance topsalysin in clinical development. As of September 30, 2018, the outstanding principal
balance of the Company's term loan was $7
million on which the Company is currently making monthly
interest only payments.
For the three months ended September
30, 2018
The Company reported a net loss of $2.9
million or ($0.10) per share
for the three months ended September 30,
2018, compared to net loss of $2.7
million or ($0.09) per share
for the three months ended September 30,
2017.
Research and development expenses
Research and development expenses were $1.8 million for the three months ended
September 30, 2018, compared to
$1.6 million for the three months
ended September 30, 2017. The
increase in research and development costs is primarily
attributable to increases in the costs associated with
manufacturing activities for topsalysin offset in part by a
decrease in clinical costs associated with its Phase 2b clinical trial of topsalysin for the treatment
of localized prostate cancer.
General and administrative expenses
General and administrative expenses were $1.2 million for the three months ended
September 30, 2018, compared to
$1.7 million for the three months
ended September 30, 2017. The
decrease in general and administrative expense is primarily due to
decreases in marketing research activities and to a lesser extent a
decrease in personnel related expenses.
Gain on revaluation of the warrant liability
Gain on revaluation of the warrant liability was $0.2 million for the three months ended
September 30, 2018, compared to a
gain of $0.7 million for the three
months ended September 30, 2017. As
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 gain reported for the three months ended September 30, 2018, is associated with a decrease
in the fair value of the Company's warrant liability from
June 30, 2018, to September 30, 2018, 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 nine months ended September
30, 2018
The Company reported a net loss of $12.3
million or ($0.41) per share
for the nine months ended September 30,
2018 compared to a net loss of $4.7
million or ($0.15) per share
for the nine months ended September 30,
2017.
Research and development expenses
Research and development expenses were $8.7 million for the nine months ended
September 30, 2018 compared to
$4.2 million for the nine months
ended September 30, 2017. The
increase in research and development costs is primarily
attributable to increases in the costs associated with
manufacturing activities for topsalysin.
General and administrative expenses
General and administrative expenses were $3.5 million for the nine months ended
September 30, 2018 compared to
$4.4 million for the nine months
ended September 30, 2017. The
decrease in general and administrative expense is primarily due to
decreases in non-cash stock-based compensation expense and
marketing research activities and to lesser extent a decrease in
its personnel related costs.
Gain on revaluation of the warrant liability
Gain on revaluation of the warrant liability was $0.1 million for the nine months ended
September 30, 2018 as compared to a
gain of $3.9 million for the nine
months ended September 30, 2017. The
non-cash gain reported for the nine months ended September 30, 2018, is associated with a decrease
in the fair value of the Company's warrant liability from
December 31, 2017, to September 30, 2018.
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. For more information, please visit
www.sophirisbio.com.
Certain statements included in this press release may be
considered forward-looking, including the quotes of Sophiris'
President and CEO and expectations about further development of
topsalysin (PRX302), including the timing of expected results from
the Phase 2b trial, plans relating to
the design and execution of a Phase 3 clinical trial, plans
relating to manufacturing 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 final Phase 2b study
will not be available when expected and risks that the final safety
and/or efficacy data will not support including a second dose
option in any future trial risks relating to obtaining regulatory
guidance on the endpoints and design of a possible Phase 3 clinical
trial, risks that the manufacturing of clinical drug supply for
Phase 3 clinical trials will not be completed when expected or at
the expected costs, 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.
|
Condensed
Consolidated Balance Sheets
|
(In thousands, except
share amounts)
|
(Unaudited)
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
12,048
|
|
$
|
16,087
|
Securities
available-for-sale
|
|
2,498
|
|
|
9,757
|
Prepaid expenses and
other current assets
|
|
888
|
|
|
1,012
|
|
|
|
|
|
|
Total current
assets
|
|
15,434
|
|
|
26,856
|
|
|
|
|
|
|
Property and
equipment, net
|
|
4
|
|
|
2
|
Other long-term
assets
|
|
-
|
|
|
19
|
|
|
|
|
|
|
Total
assets
|
$
|
15,438
|
|
$
|
26,877
|
|
|
|
|
|
|
Liabilities and
shareholders' (deficit) equity:
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
400
|
|
$
|
832
|
Accrued
expenses
|
|
2,098
|
|
|
1,499
|
Current portion of
promissory note
|
|
1,212
|
|
|
372
|
|
|
|
|
|
|
Total current
liabilities
|
|
3,710
|
|
|
2,703
|
|
|
|
|
|
|
Long-term promissory
note
|
|
5,751
|
|
|
6,435
|
Warrant
liability
|
|
9,946
|
|
|
10,089
|
|
|
|
|
|
|
Total
liabilities
|
|
19,407
|
|
|
19,227
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
(deficit) equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common shares,
unlimited authorized shares, no par value; 30,111,153 shares issued
and outstanding at September 30, 2018 and December 31,
2017
|
|
131,247
|
|
|
131,247
|
Contributed
surplus
|
|
26,531
|
|
|
25,854
|
Accumulated other
comprehensive gain
|
|
99
|
|
|
97
|
Accumulated
deficit
|
|
(161,846)
|
|
|
(149,548)
|
|
|
|
|
|
|
Total
shareholders' (deficit) equity
|
|
(3,969)
|
|
|
7,650
|
|
|
|
|
|
|
Total liabilities
and shareholders' (deficit) equity
|
$
|
15,438
|
|
$
|
26,877
|
|
|
|
|
|
|
Sophiris Bio
Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except
per share amounts)
|
(Unaudited)
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,798
|
$
|
1,649
|
|
$
|
8,718
|
$
|
4,244
|
General and
administrative
|
|
1,155
|
|
1,685
|
|
|
3,494
|
|
4,422
|
Total operating
expenses
|
|
2,953
|
|
3,334
|
|
|
12,212
|
|
8,666
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(173)
|
|
(35)
|
|
|
(514)
|
|
(35)
|
Interest
income
|
|
80
|
|
56
|
|
|
258
|
|
159
|
Gain on revaluation of
warrant liability
|
|
153
|
|
670
|
|
|
143
|
|
3,905
|
Other income
(expense), net
|
|
21
|
|
(11)
|
|
|
27
|
|
(27)
|
Total other income
(expense)
|
|
81
|
|
680
|
|
|
(86)
|
|
4,002
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(2,872)
|
$
|
(2,654)
|
|
$
|
(12,298)
|
$
|
(4,664)
|
Basic and diluted
loss per share
|
$
|
(0.10)
|
$
|
(0.09)
|
|
$
|
(0.41)
|
$
|
(0.15)
|
Weighted average
number of outstanding shares – basic and diluted
|
|
30,111
|
|
30,111
|
|
|
30,111
|
|
30,111
|
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SOURCE Sophiris Bio Inc.