REDWOOD CITY, Calif.,
May 4, 2015 /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 provided a regulatory update on
Zalviso and reported financial results for the three months ended
March 31, 2015.
Zalviso Regulatory Update
On April 21, 2015, AcelRx
submitted a request to the Division of Anesthesia, Analgesia, and
Addiction Products (DAAAP or the Division) of the Food and Drug
Administration (FDA) for a Type B meeting. This past Friday the
Division notified the Company that the request for a meeting was
denied and restated the Division's view that a clinical study is
required. We are consulting with our regulatory, legal and clinical
advisors to determine our next steps. We will be considering all
options to determine a pathway forward for Zalviso including the
possibility of dispute resolution through one of the FDA prescribed
pathways as well as conducting additional clinical or Human Factors
studies.
"As part of the Type B meeting, we intended to share with the
Division the results of the bench testing and the Human Factors
studies they had requested as part of the CRL and Type A meeting,
and further discuss their desire for additional clinical work. We
continue to believe that an additional clinical study should not be
required to demonstrate the safety and efficacy of the Zalviso
System beyond what has already been established in the Phase 3
clinical studies, as well as the bench testing and Human Factors
studies," stated Howie Rosen interim
chief executive officer of AcelRx Pharmaceuticals. "We will provide
a further update as to our next steps once we finalize our plan for
moving forward towards gaining Zalviso approval in the U.S."
First Quarter Financial Results
Net loss for the first quarter of 2015 was $10.0 million, or $0.23 basic net loss per share, and $0.27 diluted net loss per share, compared to a
net loss of $9.6 million, or
$0.22 basic and diluted net loss per
share for the first quarter of 2014. The increase in the net loss
and net loss per share was due primarily to higher headcount
related expenses in the first quarter of 2015 as compared to the
first quarter of 2014. The cost reduction plan implemented at the
end of March 2015 reduced our
workforce by approximately 36%. The associated termination and
related costs are reflected as restructuring costs in the Statement
of Comprehensive Loss. Common shares used in calculating earnings
per share were 43.9 million for basic EPS and 44.4 million for
diluted EPS for the first quarter of 2015, compared to 43.2 million
for basic and diluted EPS for the first quarter of 2014.
For the quarter ended March 31,
2015, AcelRx recognized $181,000 of previously deferred revenue under the
collaboration agreement with Grunenthal, as compared to
$95,000 for the quarter ended
March 31, 2014.
Research and development expenses for the quarter ended
March 31, 2015 were $6.3 million, compared with $4.7 million for the quarter ended March 31, 2014. The increase was primarily
due to increased medical affairs personnel, which positions were
subsequently eliminated as part of the cost reduction plan, and the
initiation of SAP-301, a pivotal Phase 3 clinical study for ARX-04,
in the quarter ended March 31,
2015.
General and administrative expenses were $4.5 million for the first quarter of 2015,
compared with $3.9 million for the
first quarter of 2014. The increase was primarily due to
increased commercial personnel in anticipation of potential FDA
approval of Zalviso, which positions were subsequently eliminated
as part of the cost reduction plan in the quarter ended
March 31, 2015.
Other income and expense includes $2.2
million in non-cash income and $0.7
million in non-cash expense in the first quarter of 2015 and
2014, respectively, resulting from the liability accounting related
to the warrants issued in connection with the PIPE financing
completed in June 2012. These PIPE warrants are considered a
liability for accounting purposes and they are remeasured at the
end of each reporting period utilizing the Black-Scholes valuation
model. As of March 31, 2015, there
were approximately 0.5 million PIPE warrants outstanding.
As of March 31, 2015, AcelRx had
cash, cash equivalents and investments of $64.4 million, compared to $75.4 million at December
31, 2014. The net decrease in cash, cash equivalents and
investments was $11.0 million in the
first quarter of 2015.
ARX-04 Update
In March 2015, AcelRx reported
dosing of the first patient in a pivotal Phase 3 study of ARX-04,
SAP-301, a multi-center, double-blind, placebo-controlled study
that will evaluate the efficacy and safety of ARX-04 and placebo
for the treatment of moderate-to-severe acute pain following
ambulatory abdominal surgery. ARX-04 is a non-invasive, single-use
30 mcg sufentanil sublingual tablet in a disposable, pre-filled,
single-dose applicator (SDA).
"During the first quarter of 2015 we implemented a plan to
reduce operating costs and conserve capital," commented
Howie Rosen. "For the
remainder of 2015 we will focus our resources on moving Zalviso
forward toward marketing approval in the U.S., continuing
development of ARX-04 and supporting Grunenthal, our European
partner for Zalviso."
Conference Call
AcelRx will conduct a conference call and webcast today,
May 4, 2015 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
1-866-361-2335 for domestic callers, 1-855-669-9657 for Canadian
callers, or 1-412-902-4204 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 and selecting the Webcast link
for the Q1 2015 earnings conference call. 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.
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, Zalviso, is designed
to improve the management of moderate-to-severe acute pain in adult
patients in the hospital setting by utilizing a high therapeutic
index opioid, through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. AcelRx has
announced positive results from each of the three completed Phase 3
clinical trials for Zalviso, has submitted an NDA to the FDA
seeking approval for Zalviso in the treatment of moderate-to-severe
acute pain in adult patients in the hospital setting and on
July 25, 2014, received a Complete
Response Letter (CRL) from the FDA. In March
2015, AcelRx received correspondence from the FDA stating
that in addition to the bench testing and two Human Factors studies
AcelRx has performed to address dispensing issues raised in the
CRL, an additional clinical trial is needed to assess the risk of
inadvertent dispensing and overall risk of dispensing failures.
AcelRx submitted a formal meeting request to the FDA and this
request has been denied. AcelRx is currently evaluating its next
steps with regards to the U.S. regulatory process for Zalviso. In
March 2015, AcelRx initiated SAP-301,
a pivotal Phase 3 study for ARX-04, a product candidate for the
treatment of moderate-to-severe acute pain in a medically
supervised setting. 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 the process
and timing of anticipated future development of AcelRx's product
candidates, including Zalviso and ARX-04; AcelRx's plans to seek a
pathway forward towards gaining approval of Zalviso in the U.S.,
including meeting with outside advisors for consultation, potential
additional clinical studies, additional Human Factors studies,
additional data analyses, or the dispute resolution processes
provided for by the FDA; AcelRx's belief that an additional
clinical study should not be required to demonstrate the safety and
efficacy of the Zalviso System beyond what has already been
established in the Phase 3 clinical studies; anticipated
resubmission of the Zalviso NDA to the FDA, including the scope of
the resubmission and the timing of the resubmission and FDA review
time; and the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates, including Zalviso and
ARX-04.
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 Pharmaceuticals' ability to finalize the pathway
towards timely resubmission of the Zalviso NDA to the FDA,
including its ability to use dispute resolution processes provided
for by the FDA; potential additional clinical trials, Human Factors
studies, and/or additional data analyses necessary in order to
resubmit the Zalviso NDA; AcelRx's ability to receive regulatory
approval for Zalviso; any delays or inability to obtain and
maintain regulatory approval of its product candidates, including
Zalviso, in the United States and
Europe; its ability to obtain
sufficient financing to receive regulatory approval for and
commercialize Zalviso and complete clinical development of ARX-04;
the success, cost and timing of all product development activities
and clinical trials, including the Phase 3 ARX-04 trial or trials;
the market potential for its product candidates; the accuracy of
AcelRx's estimates regarding expenses, capital requirements and
needs for financing, as well as the charges and savings
attributable to the reduction in force; 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 filed with the SEC on March 13, 2015. 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
|
|
March
31,
|
|
2015
|
|
2014
|
Statement of
Comprehensive Loss Data
|
|
|
|
|
|
|
|
Collaboration
agreement revenue
|
$
181
|
|
$
95
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development (1)
|
6,306
|
|
4,711
|
General and
administrative (1)
|
4,521
|
|
3,925
|
Restructuring
costs
|
754
|
|
-
|
Total operating
expenses
|
11,581
|
|
8,636
|
Loss from
operations
|
(11,400)
|
|
(8,541)
|
|
|
|
|
Interest
expense
|
(806)
|
|
(472)
|
Interest income and
other income (expense), net(2)
|
2,180
|
|
(618)
|
Net loss
|
$
(10,026)
|
|
$
(9,631)
|
|
|
|
|
Basic net loss per
common share
|
$
(0.23)
|
|
$
(0.22)
|
|
|
|
|
Shares used in
computing basic net loss per common share
|
43,873
|
|
43,190
|
|
|
|
|
Diluted net loss per
common share
|
$
(0.27)
|
|
$
(0.22)
|
|
|
|
|
Shares used in
computing diluted net loss per common share
|
44,427
|
|
43,190
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash, stock-based compensation
expense:
|
|
|
|
|
|
Research and development
|
$
702
|
|
$
479
|
General and administrative
|
836
|
|
496
|
Total
|
$
1,538
|
|
$
975
|
|
|
|
|
(2) Interest income
and other income (expense) includes $2.2 million in non-cash income
and $0.7 million in non-cash charges for the three months ended
March 31, 2015 and 2014, respectively, related to warrants issued
in connection with a private placement equity financing, completed
in June 2012.
|
|
|
|
|
|
March 31,
2015
|
|
December 31,
2014
|
Selected Balance
Sheet Data
|
|
|
|
Cash, cash
equivalents and investments
|
$
64,441
|
|
$
75,350
|
Total
assets
|
75,592
|
|
86,447
|
Total
liabilities
|
34,507
|
|
39,791
|
Total stockholders'
equity
|
41,085
|
|
46,656
|
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SOURCE AcelRx Pharmaceuticals, Inc.