REDWOOD CITY, Calif.,
June 30, 2011 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx) today announced that
it has obtained a $20 million secured
loan agreement with Hercules Technology Growth Capital (Hercules).
Upon the execution of this agreement with Hercules, AcelRx received
$10 million in the first tranche of
the loan. The second tranche of up to $10 million can be drawn, at AcelRx's option, any
time prior to December 16, 2011.
In addition, AcelRx announced that approximately $2.8 million of the proceeds were used to repay
the remaining obligations under its loan and security agreement
entered into with Pinnacle Ventures LLC in 2008. AcelRx
expects to use the remainder of the capital to fund development
activities related to its ARX-01 product candidate and for general
corporate purposes.
General terms of the loan arrangement include interest-only
payments through June 2012, with the
possibility of extending the interest-only period through
September 2012 if certain product
candidate development conditions are met. Subsequently, the
principal, together with interest, will be repaid over the
following 36 months. Further information with respect to the
loan arrangement with Hercules is contained in a Current Report on
Form 8-K filed today by AcelRx with the Securities and Exchange
Commission.
"We are very pleased to add Hercules to an existing group of
supportive and experienced partners," said Richard King, AcelRx President and CEO.
"This loan provides AcelRx with the resources to complete our
third and last planned Phase 3 clinical trial for ARX-01, our
product candidate for the treatment of post-operative pain.
ARX-01 is designed to solve a number of issues experienced in
the management of post-surgical pain by non-invasively delivering
the high therapeutic index opioid sufentanil while eliminating
programming errors with a non-programmable device. This loan
is expected to extend our operating cash runway into the first
quarter of 2013."
Kathy Conte, Managing Director of
Hercules added, "Hercules is excited to invest in a team that is
looking to transform the management of post-operative pain with its
lead product, ARX-01."
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA,
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) 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, the
ARX-01 Sufentanil NanoTab PCA System, which is in preparation for
Phase 3 clinical development, 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 inherent potential for programming and
delivery errors associated with the complexity of infusion pumps.
AcelRx has two additional product candidates which have completed
Phase 2 clinical development: ARX-02 for the treatment of cancer
breakthrough pain, and ARX-03 for providing mild sedation, anxiety
reduction and pain relief for patients undergoing painful
procedures in a physician's office. A fourth product
candidate, ARX-04, is a single dose, fast-onset sufentanil product
for the treatment of moderate-to-severe acute pain that is expected
to enter Phase 2 clinical development in the second half of 2011
under a grant from the US Army Medical Research and Material
Command.
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 trials and operations, planned or anticipated
future clinical development of AcelRx Pharmaceuticals' product
candidates, the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates, and statements related to
future events under the loan and security agreement with Hercules,
including its ability to access the second tranche funds under such
agreement. These forward-looking statements are based on
AcelRx Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals'
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: the success, cost and timing of
AcelRx Pharmaceuticals' product development activities and clinical
trials; the uncertain clinical development process, including the
risk that planned clinical trials may not begin on time, have an
effective design, enroll a sufficient number of patients, or be
initiated or completed on schedule, if at all; its ability to
obtain adequate clinical supplies of the drug and device components
of its product candidates; its ability to attract funding partners
or collaborators with development, regulatory and commercialization
expertise; its ability to obtain sufficient financing to complete
development and registration of its product candidates in
the United States and Europe; its ability to obtain and maintain
regulatory approvals of its product candidates; the market
potential for its product candidates; the accuracy of AcelRx
Pharmaceuticals' estimates regarding expenses, capital requirements
and needs for financing; AcelRx Pharmaceuticals' ability to satisfy
the conditions required to access the second tranche funds under
the loan and security agreement with Hercules, extend the
interest-only period under such agreement and repay a portion of
the principal thereunder with common stock; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' Securities and Exchange Commission filings and
reports, including its Annual Report on Form 10-K for the year
ended December 31, 2010 and its
Quarterly Report on Form 10-Q for the period ended March 31, 2011. AcelRx Pharmaceuticals
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.
SOURCE AcelRx Pharmaceuticals, Inc.