Sophiris
Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a
biopharmaceutical company developing treatments for urologic diseases,
today announced it has entered into a common stock purchase agreement
with Aspire Capital Fund, LLC, an Illinois limited liability company
(“Aspire Capital”). The Company intends to use the initial proceeds to
support a proof of concept study of PRX302 as a treatment for localized
prostate cancer. Aspire Capital has completed an initial purchase of
604,320 common shares at $3.31 per share for proceeds of $2 million and
has committed to purchase up to $13 million in additional shares over
the next 30 months at prices based on market price at the time of each
sale, subject to a Sophiris registration statement being declared
effective by the Securities and Exchange Commission (“SEC”).
“While we remain focused on our Phase 3 trial in benign prostatic
hyperplasia (BPH), this financing provides us with additional financial
flexibility and supports the advancement of PRX302 into another
important, underserved indication. The highly targeted mechanism by
which PRX302 selectively destroys prostate tissue in BPH also represents
a promising treatment approach for localized prostate cancer,” said
Randall E. Woods, president and chief executive officer. “The $2 million
proceeds from this transaction will enable us to fund an
investigator-sponsored proof of concept study in localized prostate
cancer. The remaining $13 million available under the purchase
agreement, if drawn down at the Company’s option, will be utilized to
fund future development of PRX302 in BPH and localized prostate cancer
as well as general corporate purposes.”
The Company will provide additional details around the design of the
proof of concept study in localized prostate cancer upon the initiation
of the study. Localized prostate cancer is a disease that is confined to
the prostate gland and has not spread to the tissue and lymph nodes that
surround the prostate gland or other parts of the body. PRX302 has been
engineered to be activated by enzymatically active prostate specific
antigen (PSA), which is found in the transition zone of the prostate as
well as in prostate cancer cells. In the 126 patients studied in
completed BPH clinical trials, PRX302 appears to be safe and well
tolerated with no impact on erectile function.
Under the terms of the common stock purchase agreement, Sophiris will
control the timing and amount of any sale of common shares to Aspire
Capital. Aspire Capital has no right to require any sales by Sophiris
but is obligated to make purchases as Sophiris directs, in accordance
with the purchase agreement. There are no limitations on the use of
proceeds, financial covenants or restrictions on future financings and
there are no rights of first refusal, participation rights, penalties or
liquidated damages in the purchase agreement. The purchase agreement may
be terminated by Sophiris at any time, at its discretion, without any
additional cost or penalty. Sophiris has issued 90,635 common shares to
Aspire Capital as a commitment fee in connection with the execution of
the purchase agreement. The common shares issued or to be issued under
the purchase agreement will be registered for resale pursuant to a
registration statement to be filed by Sophiris with the SEC. A complete
and detailed description of the purchase agreement and related
registration rights agreement is set forth in the Company's Current
Report on Form 8-K, filed today with the SEC.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities nor will there be any
sale of these securities in any state or other jurisdiction in which
such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such state or other
jurisdiction.
About PRX302
PRX302 (topsalysin) is a non-systemic treatment that is highly targeted
to prostate tissue. PRX302 has been engineered to be activated by
enzymatically active PSA which is found in the transition zone of the
prostate as well as in prostate cancer cells. Once activated, PRX302
forms disruptive pores in the membranes of prostate cells resulting in
selective cell death, leading to localized cell death and tissue
disruption without damage to neighboring tissue and nerves. PRX302 is
currently in a Phase 3 study as a treatment for the symptoms of BPH
(enlarged prostate).
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing treatments
for urologic diseases. PRX302 is a targeted treatment in Phase 3
development for the symptoms of benign prostatic hyperplasia (BPH) or
enlarged prostate. PRX302 is designed to be as efficacious as
pharmaceuticals, less invasive than the surgical interventions, and
without the sexual side effects seen with existing BPH treatments. For
more information, please visit www.sophiris.com.
Certain statements included in this press release may be considered
forward-looking, including expectations about the ability to develop
PRX302 for the treatment of localized prostate cancer, the ability to
facilitate an investigator sponsored trial, future development of PRX302
and our ability to satisfy the conditions under the purchase agreement.
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. All forward-looking statements are based on
Sophiris’ current beliefs as well as assumptions made by and information
currently available to Sophiris. Factors that may cause actual
results or events to differ materially from those expressed or implied
in forward looking statements include risks and uncertainties inherent
in clinical trials and product development, including risks relating to
the timing, cost and design of trials and the uncertain outcome of
trials and the availability of funds to complete product development and
other risks and uncertainties described in Sophiris’ s filings with the
SEC, including its annual report on Form 10-K for the year ended
December 31, 2013 and subsequent periodic reports on 10-Q and 8-K.
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.
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