REDWOOD CITY, Calif.,
Nov. 8, 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 third quarter and nine months ended September 30, 2011.
Net loss for the third quarter of 2011 was $5.8 million, or $0.30 per share, compared with a net loss of
$3.6 million, or $5.38 per share, for the third quarter of 2010.
Common shares used in calculating basic and diluted earnings
per share were 19,459,000 in the third quarter of 2011 compared to
669,000 common shares in the third quarter of 2010.
During the third quarter of 2011, AcelRx recognized revenue of
$408,000 resulting from reimbursement
for work completed under a research grant from the US Army Medical
Research and Material Command, or USAMRMC, for development of its
ARX-04 product candidate. Research and development expenses
for the three months ended September 30,
2011 totaled $3.9 million,
compared with $1.5 million for the
three months ended September 30,
2010. The increase was primarily due to development
expenses for ARX-01 as AcelRx prepared for planned Phase 3 trials.
General and administrative expenses were $1.9 million for the quarter ended September 30, 2011, compared with $1.1 million for the quarter ended September 30, 2010. The increase results
primarily from expenses associated with operation as a public
company.
For the nine months ended September 30,
2011, AcelRx reported a net loss of $13.7 million, or $0.83 per share, compared with a net loss of
$10.8 million, or $16.63 per share for the same period in 2010.
Common shares used in calculating basic and diluted earnings
per share were 16,594,000 for the nine months ended September 30, 2011 compared to 651,000 common
shares for the same period in the prior year.
As of September 30, 2011, AcelRx
had cash, cash equivalents and investments of $32.0 million, compared with $37.8 million as of June
30, 2011 and $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 $20.0 million secured loan agreement with
Hercules Technology Growth Capital, or Hercules. Upon
execution of the agreement, AcelRx received $10.0 million in the first tranche of the loan,
$2.8M of which was used to pay down
existing debt.
"During the third quarter of 2011, we continued to move towards
initiation of our Phase 3 studies for ARX-01, our lead product
candidate for acute post-operative pain, and also towards
initiation of a Phase 2 study for ARX-04, our product candidate for
moderate-to-severe acute pain," said Richard King, President and CEO of AcelRx.
"We have made progress on the ARX-01 device related
activities that must be completed prior to initiation of Phase 3
clinical studies. We anticipate feedback from FDA on the
submitted software verification and validation protocols, and a
device reprocessing protocol, and currently expect that we will be
in a position to dose the first patient in the Phase 3 clinical
program in late 2011 or early 2012, with an expectation to complete
all Phase 3 clinical studies by the end of 2012," said Mr.
King.
Development Updates
- The contract research organization, or CRO, PharmaNet, has been
engaged to conduct the first two ARX-01 Phase 3 studies.
Clinical sites have been engaged for the abdominal surgery
study and a majority of the sites for the head-to-head comparator
study have been identified.
- We recently received correspondence from the FDA stating that a
final planned Human Factor study, though required for final product
approval, is not a prerequisite to initiating ARX-01 Phase 3
studies. There are, however, three additional device
assessments focused on software verification, software validation
and device reprocessing, originally planned as precursors to, or
associated with, the final Human Factor Study, which remain as
requirements from FDA prior to the start of Phase 3.
Protocols for these assessments have been submitted to the
FDA for review, and we await the agency's feedback. We plan
to conduct the software verification and validation and device
reprocessing studies prior to initiation of the Phase 3 clinical
program. We currently expect that we will be in a position to dose
the first patient in a Phase 3 placebo-controlled post-operative
pain study following major abdominal surgery in late 2011 or early
2012. The remaining Phase 3 studies, an active comparator study
comparing the sufentanil NanoTab PCA System to intravenous morphine
patient-controlled analgesia in post-operative patients, and a
placebo-controlled study in patients after major orthopedic
surgery, are expected to be initiated and completed in 2012. We
plan to complete the final Human Factor study alongside the Phase 3
clinical program.
- The NanoTab commercial manufacturing facility at AcelRx's
contract manufacturer, Patheon, Inc., has been built, tested and
qualified as a Good Manufacturing Practices, or GMP, facility.
AcelRx will manufacture clinical and commercial supplies at this
facility.
- In early October 2011, AcelRx
filed an Investigational New Drug application for ARX-04, its
product candidate for management of moderate-to-severe acute pain,
with the FDA, and plans to initiate the Phase 2 study later this
year with top line results available in the first half of 2012.
AcelRx has retained a CRO to conduct the Phase 2 ARX-04 study
and the clinical sites for this study have been selected and
retained.
Financial Outlook
AcelRx anticipates that research and development expenses will
increase over the next several quarters 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 the
identification of sources of additional funding 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 $10.0 million tranche pursuant
to the $20.0 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 fourth quarter 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, anticipated increases in
research and development and general and administrative expenses,
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, progress towards
initiation of its Phase 3 studies for ARX-01 and Phase 2 study for
ARX-04, the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates, anticipated feedback from the
FDA related to its Human Factor studies and software validation,
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; any delays or inability to obtain, regulatory
approval of its product candidates; 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 or 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
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
Statement of Operations
Data
|
|
|
|
|
|
|
|
|
Research grant
revenue
|
$
408
|
|
$
-
|
|
$
448
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
(1)
|
3,947
|
|
1,515
|
|
8,922
|
|
6,309
|
|
General and administrative
(1)
|
1,866
|
|
1,090
|
|
5,086
|
|
3,033
|
|
Total operating
expenses
|
5,813
|
|
2,605
|
|
14,008
|
|
9,342
|
|
Loss from operations
|
(5,405)
|
|
(2,605)
|
|
(13,560)
|
|
(9,342)
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
(377)
|
|
(197)
|
|
(1,891)
|
|
(656)
|
|
Interest income and Other income
(expense), net
|
21
|
|
(799)
|
|
1,722
|
|
(823)
|
|
Net loss
|
$
(5,761)
|
|
$
(3,601)
|
|
$ (13,729)
|
|
$ (10,821)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share
|
$
(0.30)
|
|
$
(5.38)
|
|
$
(0.83)
|
|
$ (16.63)
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
and diluted net loss per common share
|
19,459
|
|
669
|
|
16,594
|
|
651
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
(1)
Includes the following noncash, stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
253
|
|
$
92
|
|
$
578
|
|
$
638
|
|
General and administrative
|
304
|
|
148
|
|
768
|
|
469
|
|
Total non-cash, stock-based
expense
|
$
557
|
|
$
240
|
|
$ 1,346
|
|
$ 1,107
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet
Data
|
|
|
|
|
|
|
|
|
|
September
30, 2011
|
|
December 31,
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments
|
$
32,020
|
|
$
3,682
|
|
|
|
|
|
Total assets
|
36,703
|
|
6,830
|
|
|
|
|
|
Total liabilities
|
13,348
|
|
16,781
|
|
|
|
|
|
Total stockholders' equity
(deficit)
|
23,355
|
|
(9,951)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE AcelRx Pharmaceuticals, Inc.