REDWOOD CITY, Calif.,
Aug. 11, 2011 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain, reported financial results today for
the second quarter and six months ended June
30, 2011.
Net loss for the second quarter of 2011 was $4.8 million, or $0.25 per share, compared with a net loss of
$3.5 million, or $5.41 per share, for the second quarter of 2010.
Common shares used in calculating basic and diluted earnings
per share were 19,375,000 in the second quarter of 2011 compared to
654,000 common shares in the second quarter of 2010.
During the second quarter of 2011, AcelRx recognized revenue of
$40,000 resulting from reimbursement
for work completed under a research grant from the US Army Medical
Research and Material Command, or USAMRMC, for development of our
ARX-04 product candidate, which became effective June 1, 2011. Research and development
expenses for the three months ended June 30,
2011 totaled $3.0 million,
compared with $2.0 million for the
three months ended June 30, 2010.
The increase was primarily due to development expenses for
ARX-01 as AcelRx prepared for its planned Phase 3 trials.
General and administrative expenses were $1.6 million for the quarter ended June 30, 2011, compared with $1.3 million for the quarter ended June 30, 2010. The increase results primarily
from expenses associated with operation as a public company.
For the six months ended June 30,
2011, AcelRx reported a net loss of $8.0 million, or $0.53 per share, compared with a net loss of
$7.2 million, or $11.26 per share for the same period in 2010.
Common shares used in calculating basic and diluted earnings
per share were 15,059,000 for the six months ended June 30, 2011 compared to 641,000 common shares
for the same period in the prior year.
As of June 30, 2011, AcelRx had
cash, cash equivalents and investments of $37.8 million, compared with $3.7 million as of December 31, 2010. In February 2011, AcelRx completed its initial
public offering, resulting in net proceeds to AcelRx of
$34.9 million. In June 2011, AcelRx entered into a $20 million secured loan agreement with Hercules
Technology Growth Capital, or Hercules. Upon execution of the
agreement, AcelRx received $10
million in the first tranche of the loan.
"During the second quarter of 2011, we made significant strides
towards initiation of Phase 3 studies for ARX-01, our lead product
candidate for acute post-operative pain, and towards initiation
later this year of the Phase 2 study for ARX-04, our product
candidate for management of acute pain, being developed under a
grant from USAMRMC," said Richard
King, President and CEO of AcelRx. "We remain on track
to initiate enrollment in the first ARX-01 Phase 3 study, an
efficacy study in major abdominal surgery later this year, to be
followed by initiation of the second Phase 3 study, a head-to-head
comparison of ARX-01 to the standard of care, intravenous
patient-controlled analgesia, or IV PCA, in early 2012. We
anticipate data from these studies to be available in the first
half of 2012," said Mr. King.
Development Updates
- The contract research organization, PharmaNet has been engaged
to conduct the first two ARX-01 Phase 3 studies. Clinical
sites have been identified for our first planned Phase 3 study, the
abdominal surgery study, and each site has provided a completed
capability assessment to PharmaNet as part of the site selection
process.
- The ARX-01 system design for the dispensing device has been
finalized, and AcelRx has completed two of a total of four planned
user studies. The remaining two user studies, and final
software validation are planned to be completed in the second half
of 2011, and are required for review by FDA prior to initiation of
the ARX-01 Phase 3 studies.
- Construction of the NanoTab commercial manufacturing facility
has been completed at our contract manufacturer Patheon, Inc., and
facility qualification is underway. This facility will
manufacture clinical and commercial supplies.
- The ARX-04 Phase 2 study will evaluate two different doses of
sufentanil in patients suffering from moderate-to-severe acute
pain. PharmaNet has been retained to conduct the Phase 2
study, and the clinical trial sites for this study have been
selected.
Financial Outlook
AcelRx anticipates that research and development expenses will
increase over the next several years as it seeks to complete Phase
3 development of ARX-01. The development of ARX-02, a product
candidate for the treatment of cancer breakthrough pain, and
ARX-03, a product candidate for mild sedation and pain relief in
procedures conducted in a physician's office, will not advance
until additional funding or the identification of a partner to
support these efforts is secured. The development of ARX-04 beyond
Phase 2 and initial preparations for Phase 3 is dependent on
additional funding from the USAMRMC or the identification of a
partner to support these efforts. Additionally, AcelRx
anticipates increases in general and administrative expenses due to
costs associated with operating as a public company and expansion
of its corporate infrastructure to support ongoing development of
its product candidates.
AcelRx believes its current cash, cash equivalents and
investments, including the drawing, at AcelRx's option, of the
second $10 million tranche pursuant
to the $20 million Hercules loan
facility are sufficient to fund operations into the first quarter
of 2013.
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 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
USAMRMC.
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, including the anticipated timing for the clinical
trials, 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' U.S. 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 Reports on Form 10-Q. 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.
SELECTED
FINANCIAL DATA
|
|
(in
thousands, except per share data)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
Statement of Operations
Data
|
|
|
|
|
|
|
|
|
Research grant
revenue
|
$
40
|
|
$
-
|
|
$
40
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
(1)
|
3,029
|
|
2,033
|
|
4,975
|
|
4,795
|
|
General and administrative
(1)
|
1,630
|
|
1,276
|
|
3,220
|
|
1,948
|
|
Total operating
expenses
|
4,659
|
|
3,309
|
|
8,195
|
|
6,743
|
|
Loss from operations
|
(4,619)
|
|
(3,309)
|
|
(8,155)
|
|
(6,743)
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
(156)
|
|
(214)
|
|
(1,514)
|
|
(458)
|
|
Interest income and Other income
(expense), net
|
12
|
|
(14)
|
|
1,702
|
|
(18)
|
|
Net loss
|
$
(4,763)
|
|
$
(3,537)
|
|
$ (7,967)
|
|
$ (7,219)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share
|
$
(0.25)
|
|
$
(5.41)
|
|
$ (0.53)
|
|
$ (11.26)
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
and diluted net loss per common share
|
19,375
|
|
654
|
|
15,059
|
|
641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following noncash, stock-based compensation
expense
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
204
|
|
$
423
|
|
$ 325
|
|
$ 547
|
|
General and administrative
|
262
|
|
317
|
|
464
|
|
319
|
|
Total non-cash, stock-based
expense
|
$
466
|
|
$
740
|
|
$ 789
|
|
$ 866
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet
Data
|
|
|
|
|
|
|
|
|
|
June 30,
2011
|
|
December 31,
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments
|
$
37,802
|
|
$
3,682
|
|
|
|
|
|
Total assets
|
40,987
|
|
6,830
|
|
|
|
|
|
Total liabilities
|
12,572
|
|
16,781
|
|
|
|
|
|
Total stockholders' equity
(deficit)
|
28,415
|
|
(9,951)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE AcelRx Pharmaceuticals, Inc.