REDWOOD CITY, Calif.,
Aug. 9, 2012 /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, today reported financial results for
the three and six months ended June 30,
2012 and provided a development update.
Net loss for the second quarter of 2012 was $7.2 million, or $0.35 per share, compared with a net loss of
$4.8 million, or $0.25 per share, for the second quarter of
2011. Common shares used in calculating basic and diluted
earnings per share were 20,627,244 for the second quarter of 2012
compared to 19,374,909 common shares for the second quarter of
2011.
During the second quarter of 2012, AcelRx recognized revenue of
$224,000 resulting from reimbursement
for work completed under a research grant from the U.S. Army
Medical Research and Material Command, or USAMRMC, for development
of its ARX-04 product candidate, a Sufentanil NanoTab® for the
treatment of moderate-to-severe acute pain.
Research and development expenses for the quarter ended
June 30, 2012 totaled $5.4 million, compared with $3.0 million for the quarter ended June 30, 2011. The increase was primarily
due to expenditures required to conduct two 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 $1.8 million for the quarter ended June 30, 2012, compared with $1.6 million for the quarter ended June 30, 2011. The increase of $0.2 million resulted primarily from expenses
associated with commercial market research and patent prosecution
efforts.
For the six months ended June 30,
2012, AcelRx reported a net loss of $14.3 million, or $0.71 per share, compared with a net loss of
$8.0 million, or $0.53 per share for the same period in 2011.
Common shares used in calculating basic and diluted earnings per
share were 20,114,608 for the six months ended June 30, 2012 compared to 15,058,546 common
shares for the same period in the prior year.
As of June 30, 2012, AcelRx had
cash, cash equivalents and investments of $31.9 million, compared to $27.7 million at March 31,
2012 and $35.8 million at
December 31, 2011.
"AcelRx continues to successfully execute its product
development plans. We have initiated and are actively enrolling in
two ARX-01 Phase 3 clinical trials, which are expected to report
top-line data in the fourth quarter of 2012. We also expect
to initiate our third Phase 3 study in the third quarter. We
strengthened our intellectual property position with the recent
issuance of three U.S. patents associated with our sufentanil
NanoTabs, offering protection out to 2030," noted Richard King, President and CEO of AcelRx.
"In June, we completed a $10.0
million financing extending our cash horizon into the second
quarter of 2013."
Development Update
- In March 2012, AcelRx initiated
the first of three planned Phase 3 clinical trials for ARX-01, a
double-blind, placebo-controlled efficacy and safety trial of adult
patients with post-operative pain following open-abdominal surgery.
Patient recruitment for this study is ongoing and we expect
top-line data for this study in the fourth quarter of 2012.
- In April 2012, AcelRx initiated a
second Phase 3 clinical trial, an open-label active-comparator
study comparing ARX-01 to the current standard of care, IV PCA with
morphine, in patients with post-operative pain following
open-abdominal surgery or major orthopedic surgery. Patient
recruitment for this study is also ongoing, and we expect top-line
data in the fourth quarter of 2012.
- In the third quarter, AcelRx plans to initiate our third
planned Phase 3 clinical trial, a double-blind, placebo-controlled
efficacy and safety study of patients with post-operative pain
following hip and knee replacement surgeries with top-line data
expected in the first quarter of 2013.
Financial Outlook
AcelRx anticipates that research and development expenses for
the remaining two quarters of 2012 and into 2013 will increase as
AcelRx seeks to execute and complete three Phase 3 clinical trials
with ARX-01. Development of ARX-04 through Phase 2 clinical work
and Phase 3 preparatory work is expected to be funded by a grant
from USAMRMC, contingent on approval of the proposed clinical
protocol for the study by USAMRMC. The development of ARX-04
beyond Phase 2 and initial preparations for Phase 3 is dependent on
the identification of sources of additional funding. Additionally,
AcelRx anticipates modest 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 are sufficient to fund operations into the second
quarter of 2013.
Conference Call
AcelRx will conduct a conference call and webcast today,
August 9, at 4:30 p.m. ET/1:30 p.m.
PT, to discuss the company's financial results and
development programs. To listen to the conference call, dial in
approximately ten minutes before the scheduled call to (800)
860-2442, 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 Investors 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 Investors section of the
company's website at www.acelrx.com.
Upcoming Corporate Presentations
AcelRx is scheduled to present at the upcoming investor
conference:
- Canaccord Genuity 32nd Annual Growth Conference in
Boston on August 15, 2012 at 8:00
a.m. ET/5:00 a.m. PT.
Richard King, president and CEO of
AcelRx Pharmaceuticals, will provide a corporate overview.
The presentation will be webcast through the "Investors" section
of AcelRx's corporate website at www.acelrx.com, and a recording
will be made available for 90 days following the event. To access
the live webcast, please log on to the AcelRx website approximately
fifteen minutes prior to the presentation to register and download
any necessary audio software.
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, which is currently in 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 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, and AcelRx
plans to initiate a Phase 2 study funded by a grant from USAMRMC,
contingent on approval of the proposed clinical protocol for the
study by 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, planned or anticipated future clinical development of
AcelRx Pharmaceuticals' product candidates, including the
anticipated timing for clinical trials, progress towards initiation
of the remaining Phase 3 study for ARX-01 and the Phase 2 study for
ARX-04, receipt of approval of ARX-04 Phase 2 clinical protocol
from USAMRMC, strength of AcelRx Pharmaceuticals' intellectual
property portfolio, 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:
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 repay a
portion of the principal under the loan and security agreement with
Hercules with common stock; its ability to protect its intellectual
property portfolio; 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, 2011 and the Quarterly Report on
Form 10-Q for the three months ended March
31, 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
|
|
Six Months Ended
|
|
June 30,
|
|
June
30,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Statement of Operations Data
|
|
|
|
|
|
|
|
Research
grant revenue
|
$
|
224
|
|
$
|
40
|
|
$
|
553
|
|
$
|
40
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research
and development (1)
|
|
5,394
|
|
|
3,029
|
|
|
10,165
|
|
|
4,975
|
General
and administrative (1)
|
|
1,776
|
|
|
1,630
|
|
|
3,880
|
|
|
3,220
|
Total
operating expenses
|
|
7,170
|
|
|
4,659
|
|
|
14,045
|
|
|
8,195
|
Loss from
operations
|
|
(6,946)
|
|
|
(4,619)
|
|
|
(13,492)
|
|
|
(8,155)
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(598)
|
|
|
(156)
|
|
|
(1,192)
|
|
|
(1,514)
|
Interest
income and Other income (expense), net
|
|
350
|
|
|
12
|
|
|
425
|
|
|
1,702
|
Net
loss
|
$
|
(7,194)
|
|
$
|
(4,763)
|
|
$
|
(14,259)
|
|
$
|
(7,967)
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share
|
$
|
(0.35)
|
|
$
|
(0.25)
|
|
$
|
(0.71)
|
|
$
|
(0.53)
|
|
|
|
|
|
|
|
|
Shares
used in computing basic and diluted net
loss per
common share
|
|
20,627
|
|
|
19,375
|
|
|
20,115
|
|
|
15,059
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes the following
non-cash, stock-based compensation expense:
|
|
|
|
|
|
|
|
|
Research
and development
|
$
|
254
|
|
$
|
204
|
|
$
|
505
|
|
$
|
325
|
General and
administrative
|
|
276
|
|
|
262
|
|
|
566
|
|
|
464
|
Total
non-cash, stock-based expense
|
$
|
530
|
|
$
|
466
|
|
$
|
1,071
|
|
$
|
789
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, 2012
|
|
December 31, 2011
|
|
|
|
|
Selected Balance Sheet Data
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
|
31,933
|
|
$
|
35,785
|
|
|
|
|
Total
assets
|
|
36,644
|
|
|
40,835
|
|
|
|
|
Total
liabilities
|
|
29,016
|
|
|
23,367
|
|
|
|
|
Total
stockholders' equity
|
|
7,628
|
|
|
17,468
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE AcelRx Pharmaceuticals, Inc.