REDWOOD CITY, Calif.,
Dec. 19, 2013 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced that it has entered
into a new amended and restated credit facility with Hercules
Technology Growth Capital, Inc. (NYSE: HTGC) that extends AcelRx's
current relationship with Hercules, which was established in
June 2011. The new Hercules credit
facility provides for up to $40
million of new loans.
"The proceeds from this credit facility provide AcelRx with
additional operating capital and contingency funding for our
commercialization activities as we continue to prepare for the
launch, if approved, of Zalviso™," stated Richard King, president and CEO of AcelRx.
"These proceeds also provide the financial flexibility to fund
additional pipeline development programs should we decide to
advance any of our pipeline opportunities forward. We appreciate
the support of Hercules, and its confidence in ZalvisoTM
and the AcelRx management team."
AcelRx drew the first tranche of $15
million at the closing of the new credit facility.
AcelRx applied approximately $8.5
million of the proceeds to repay its outstanding obligations
under the prior credit facility with Hercules. This repayment
eliminated approximately $8.5 million
of remaining scheduled principal payments in 2014. The second
tranche of up to $10 million can be
drawn, at AcelRx's option, at any time prior to June 30, 2014. The third tranche of up to
$15 million is conditioned upon the
approval of Zalviso by the U.S. Food and Drug Administration (FDA),
and if approved, can be drawn at AcelRx's option, at any time
between December 15, 2014 and
March 15, 2015. AcelRx plans to
use the proceeds of the remaining tranches to provide additional
funding for the commercialization of Zalviso and as a potential
source of funding for clinical trials for other development
programs in its pipeline, and for general corporate
purposes.
General terms of the loan agreement include interest-only
payments for 15 months until April 1,
2015, with the possibility of extending the interest-only
period to two years until January 1,
2016, if the FDA approves Zalviso on or prior to
April 1, 2015. Following the
interest-only period, AcelRx will repay the loans in equal monthly
payments of principal and interest through the scheduled maturity
date on October 1, 2017 (which would
be extended until January 1, 2018 if
the Company obtains FDA approval of Zalviso on or prior to
April 1, 2015). Further
information with respect to the loan arrangement with Hercules, is
contained in a Current Report on Form 8-K to be filed on
December 19, 2013 by AcelRx with the
Securities and Exchange Commission.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute and breakthrough
pain. AcelRx's lead product candidate, Zalviso™, is designed to
solve the problems associated with post-operative intravenous
patient-controlled analgesia which has been shown to cause harm to
patients following surgery because of the side effects of morphine,
the invasive IV route of delivery and the complexity of infusion
pumps. AcelRx has announced positive results from each of the three
completed Phase 3 clinical trials for Zalviso, and has submitted an
NDA to the FDA seeking approval for Zalviso in the treatment of
moderate-to-severe acute pain in adult patients in the hospital
setting. AcelRx has also announced positive top-line results
for a Phase 2 trial for ARX-04, a product candidate for the
treatment of moderate-to-severe acute pain in a medically
supervised setting, funded through a grant from the U.S. Army
Medical Research and Materiel Command. The company has two
additional pain treatment product candidates, ARX-02 and ARX-03,
which have completed Phase 2 clinical development. For
additional information about AcelRx's clinical programs, please
visit www.acelrx.com.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to AcelRx
Pharmaceuticals' financial viability, the sufficiency of funds to
support its clinical and development program and operations,
planned or anticipated future clinical development of AcelRx
Pharmaceuticals' product candidates, the therapeutic and commercial
potential of Zalviso and the anticipated timing, therapeutic and
commercial potential of other AcelRx product candidates, and
statements related to future events under the credit facility with
Hercules, including its ability to access the third tranche funds
under such facility. These forward-looking statements are based on
AcelRx's current expectations and inherently involve significant
risks and uncertainties. AcelRx's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
AcelRx's ability to receive regulatory approval for Zalviso; any
delays or inability to obtain and maintain regulatory approval of
its product candidates, including Zalviso, in the United States and Europe; its ability to attract funding
partners or collaborators with development, regulatory and
commercialization expertise; its ability to obtain sufficient
financing to commercialize Zalviso; the market potential for its
product candidates; the accuracy of AcelRx's estimates regarding
expenses, capital requirements and needs for financing;
AcelRx's ability to satisfy the conditions required to access
the third tranche funds under the credit facility with Hercules,
extend the interest-only period or maturity date under such
facility; and other risks detailed in the "Risk Factors" and
elsewhere in AcelRx's U.S. Securities and Exchange Commission
filings and reports, including its Quarterly Report on Form 10-Q
filed with the SEC on November 5,
2013. AcelRx undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of
new information, future events or changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.