REDWOOD CITY, Calif.,
Nov. 6, 2012 /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 reported financial results for
the three and nine months ended September
30, 2012 and provided a corporate update.
Net loss for the third quarter of 2012 was $8.6 million, or $0.38 per share, compared with a net loss of
$5.8 million, or $0.30 per share, for the third quarter of
2011. During the third quarter of 2012, AcelRx recognized
revenue of $166,000 resulting from
reimbursement for work completed under a research grant from the
U.S. Army Medical Research and Materiel Command, or USAMRMC, for
development of its ARX-04 product candidate, a single dose
Sufentanil NanoTab® for the treatment of
moderate-to-severe acute pain.
Research and development expenses for the third quarter totaled
$6.9 million, compared with
$3.9 million for the quarter ended
September 30, 2011. The
increase was primarily due to expenditures associated with three
ongoing Phase 3 studies for ARX-01, the Sufentanil NanoTab PCA
System, AcelRx's lead product candidate for the treatment of
post-operative pain. General and administrative expenses were
$1.4 million for the quarter ended
September 30, 2012, compared with
$1.9 million for the third quarter of
2011. This decrease resulted primarily from lower
intellectual property and market research expenses.
For the nine months ended September 30,
2012, AcelRx reported a net loss of $22.8 million, or $1.09 per share, compared with a net loss of
$13.7 million, or $0.83 per share, for the same period in 2011.
As of September 30, 2012,
AcelRx had cash, cash equivalents and investments of $23.4 million, compared to $31.9 million at June 30,
2012 and $35.8 million at
December 31, 2011.
"We continue to make progress in the execution of our Phase 3
program for ARX-01. During the third quarter, we initiated
our third Phase 3 clinical trial, received four additional U.S.
patents related to our sufentanil NanoTab technology and we were
notified that ARX-01 was deemed sufficiently novel that we would be
allowed to use the centralized filing procedure for ARX-01 in
Europe," stated Richard King, president and CEO of AcelRx. "In
addition, we completed treatment of the final subject in our Phase
3 clinical trial comparing ARX-01 to IV PCA with morphine. We
expect to announce top line data from this first trial later this
month and results from our two other ARX-01 trials is expected in
the first quarter of 2013."
Review of Third Quarter Accomplishments and Corporate
Update
- In August 2012, AcelRx initiated
the third of three planned Phase 3 clinical trials for ARX-01, a
double-blind, placebo-controlled efficacy and safety trial in adult
patients with post-operative pain following hip or knee replacement
surgery. This study is designed to enroll approximately 400
patients and is being conducted at approximately 45 academic and
community hospitals in the U.S. The primary endpoint is the
sum of the pain intensity difference to baseline, over the 48 hour
study period, or SPID-48, which is the FDA standard for
post-operative acute pain studies.
- Dosing of the last patient in the Phase 3 open label, active
comparator study comparing efficacy and safety of the Sufentanil
NanoTab System to the commonly used IV PCA with morphine is
complete, and top line data are expected in November, 2012.
Top line results from the two placebo-controlled Phase 3
clinical studies, one treating post-operative pain in patients
following abdominal surgery and the other treating post-operative
pain in patients following hip or knee replacement, are both
expected during the first quarter of 2013.
- During the third quarter, the U.S. Patent and Trademark Office
issued four additional patents covering AcelRx's proprietary
NanoTab technology. AcelRx has now received a total of five
U.S. patents underpinning its four product development programs and
proprietary NanoTab technology.
- The European Medicines Agency, or EMA, notified AcelRx that it
will permit registration of the Sufentanil NanoTab PCA System via
the centralized procedure. This procedure will allow AcelRx
to submit a single Marketing Authorization Application to the EMA
for approval to market ARX-01 in all 27 EU member states, as well
as in the 4 European Free Trade Association countries.
- In early November 2012, AcelRx
dosed the first patient in a Phase 2 study for ARX-04, its single
dose sufentanil NanoTab product candidate for the management of
acute pain. The study is funded by a grant from the USAMRMC
and will enroll approximately 100 patients following bunionectomy
surgery, randomizing them into one of three groups to receive one
of two sufentanil NanoTab dosage amounts (20 mcg and 30 mcg) or
placebo.
Financial Outlook
AcelRx anticipates that research and
development expenses for the fourth quarter of 2012 and the first
half of 2013 will increase as AcelRx conducts and completes the
Phase 3 clinical trials for ARX-01. Development of ARX-04
through Phase 2 clinical work and Phase 3 preparatory work is
expected to be fully funded by a grant from USAMRMC. The
development of ARX-04 beyond Phase 2 and initial preparations for
Phase 3 is dependent on the identification of additional funding
from USAMRMC or other sources. Additionally, AcelRx
anticipates modest increases in general and administrative expenses
due to costs associated with expansion of its corporate
infrastructure to support ongoing development of its product
candidates.
Conference Call
AcelRx will conduct a conference call
and webcast today, November 6, at
4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its financial
results and program updates. To listen to the conference call, dial
in approximately ten minutes before the scheduled call to (800)
860-2442 for domestic callers, (866) 605-3852 for Canadian callers,
or (412) 858-4600 for international callers. Those interested in
listening to the conference call live via the Internet may do so by
visiting the Investor Relations section of the company's website at
www.acelrx.com. A webcast replay will be available on the AcelRx
website for 90 days following the call by visiting the Investor
Relations section of the company's website at www.acelrx.com.
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, the ARX-01 Sufentanil NanoTab PCA System, is
currently in Phase 3 clinical development and is designed to solve
problems associated with post-operative intravenous
patient-controlled analgesia, including side effects of morphine,
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
that have completed Phase 2 clinical development: ARX-02 for the
treatment of cancer breakthrough pain and ARX-03 for mild sedation,
anxiety reduction and pain relief for patients undergoing painful
procedures in a physician's office. AcelRx has initiated a
Phase 2 study for a fourth product candidate, ARX-04, a sufentanil
formulation for the treatment of moderate-to-severe acute pain,
funded through a grant from the USAMRMC. 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,
anticipated increases in research and development and general and
administrative expenses, the sufficiency of funds to support its
clinical trials and operations, timing of interim and final results
of its clinical trials, planned or anticipated future clinical
development of AcelRx Pharmaceuticals' product candidates,
including the release ARX-01 top-line clinical trial data, the
release and anticipated timing of additional ARX-01 clinical trial
data, the anticipated timing for remaining clinical trials, and the
therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates. 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:
AcelRx ability to raise additional funds to support its clinical
trials and operations; the success, cost and timing of AcelRx
Pharmaceuticals' product development activities and clinical
trials, including timing, release and implications of interim or
final results of the ARX-01 Phase 3 clinical trials; the
uncertain clinical development process, including the risk that
planned clinical trials may not have an effective design, enroll a
sufficient number of patients, or be 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; sufficiency of its
intellectual property portfolio; the accuracy of AcelRx
Pharmaceuticals' estimates regarding expenses, capital requirements
and needs for financing; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities
and Exchange Commission filings and reports, including its
Quarterly Report on Form 10-Q for the three months ended
September 30, 2012. 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,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Statement of Comprehensive Loss
Data
|
|
|
|
|
|
|
|
Research
grant revenue
|
$
166
|
|
$
408
|
|
$
719
|
|
$
448
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research
and development (1)
|
6,948
|
|
3,947
|
|
17,113
|
|
8,922
|
General
and administrative (1)
|
1,410
|
|
1,866
|
|
5,290
|
|
5,086
|
Total
operating expenses
|
8,358
|
|
5,813
|
|
22,403
|
|
14,008
|
Loss from
operations
|
(8,192)
|
|
(5,405)
|
|
(21,684)
|
|
(13,560)
|
|
|
|
|
|
|
|
|
Interest
expense
|
(573)
|
|
(377)
|
|
(1,765)
|
|
(1,891)
|
Interest
income and Other income (expense), net
|
183
|
|
21
|
|
608
|
|
1,722
|
Net
loss
|
$
(8,582)
|
|
$
(5,761)
|
|
$(22,841)
|
|
$(13,729)
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share
|
$
(0.38)
|
|
$
(0.30)
|
|
$
(1.09)
|
|
$
(0.83)
|
|
|
|
|
|
|
|
|
Shares
used in computing basic and diluted net loss per common
share
|
22,633
|
|
19,459
|
|
20,962
|
|
16,594
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes the
following non-cash, stock-based compensation expense:
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
258
|
|
$
253
|
|
$
762
|
|
$
578
|
General and administrative
|
304
|
|
304
|
|
871
|
|
768
|
Total non-cash, stock-based expense
|
$
562
|
|
$
557
|
|
$
1,633
|
|
$
1,346
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet Data
|
|
|
|
|
|
|
|
|
September 30, 2012
|
|
December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
23,375
|
|
$
35,785
|
|
|
|
|
Total
assets
|
28,151
|
|
40,835
|
|
|
|
|
Total
liabilities
|
28,478
|
|
23,367
|
|
|
|
|
Total
stockholders' equity (deficit)
|
(327)
|
|
17,468
|
|
|
|
|
SOURCE AcelRx Pharmaceuticals, Inc.