AcelRx Pharmaceuticals Reports Third Quarter 2012 Financial Results

     AcelRx Pharmaceuticals Reports Third Quarter 2012 Financial Results

PR Newswire

REDWOOD CITY, Calif., Nov. 6, 2012

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

  oIn 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.
  oDosing 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.
  oDuring 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.
  oThe 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.
  oIn 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    $        $       $    719  $    448
                           166            408
Operating expenses:
Research and development  6,948          3,947        17,113       8,922
^(1)
General and               1,410          1,866        5,290        5,086
administrative ^(1)
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 183            21           608          1,722
income (expense), net
Net loss                  $          $        $(22,841)    $(13,729)
                          (8,582)       (5,761)
Basic and diluted net     $         $       $  (1.09)  $  (0.83)
loss per common share     (0.38)        (0.30)
Shares used in computing
basic and diluted net     22,633         19,459       20,962       16,594
loss per common share
 (1) Includes the following non-cash, stock-based
compensation expense:
 Research and  $        $       $    762  $    578
development                258           253
 General and   304            304          871          768
administrative
 Total  $        $     
non-cash, stock-based      562           557      $  1,633   $  1,346
expense
Selected Balance Sheet
Data
                          September 30,  December
                          2012           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'       (327)          17,468
equity (deficit)







SOURCE AcelRx Pharmaceuticals, Inc.

Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, +1-650-216-3511,
jwelch@acelrx.com
 
Press spacebar to pause and continue. Press esc to stop.