REDWOOD CITY, Calif.,
March 24, 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 or breakthrough pain, today reported financial results for
the fourth quarter and year ended December
31, 2010.
Net loss for the fourth quarter of 2010 was $3.5 million, or $5.23 per common share, compared with a net loss
of $3.7 million, or $6.05 per common share, for the fourth quarter of
2009. Net loss for the year ended December
31, 2010 was $14.3 million, or
$21.84 per common share, compared to
a net loss of $20.1 million, or
$34.93 per common share, for the year
ended December 31, 2009.
Research and development expenses for the twelve and three
months ended December 31, 2010
totaled $8.2 million and $1.9 million, compared to $15.5 million and $2.3
million for the twelve and three months ended December 31, 2009. General and administrative
expenses were $4.0 million and
$1.0 million for the year and quarter
ended December 31, 2010, compared to
$3.5 million and $1.0 million for the year and quarter ended
December 31, 2009.
As of December 31, 2010, AcelRx
had cash, cash equivalents and short-term investments of
$3.7 million, compared to
$12.5 million as of December 31, 2009. On February 16, 2011, AcelRx closed its initial
public offering of 8.0 million shares of common stock resulting in
net proceeds to AcelRx of $35.6
million. We intend to utilize these funds primarily
for advancement of our lead program, our hospital-based,
patient-controlled analgesia (PCA) product, the Sufentanil NanoTab
PCA System (ARX-01).
"We are pleased with our progress towards initiating the Phase 3
program for ARX-01 in acute post-operative pain," said Richard King, President and Chief Executive
Officer of AcelRx. "We anticipate initiating enrollment in the
first Phase 3 study of ARX-01, an abdominal surgery efficacy study,
in the second half of 2011. Further, we anticipate starting
our second Phase 3 study, a head-to-head trial comparing ARX-01 to
the current standard of care, intravenous (IV) PCA morphine, in
early 2012. Top-line data from both trials is expected in the first
half of 2012."
"ARX-01 is a preprogrammed, handheld, sublingual PCA system
delivering the high therapeutic index opioid, sufentanil, that has
been designed to address the need for effective and well tolerated
post-operative pain control in the hospital setting, and to
overcome the deficiencies of the current standard of care, IV PCA.
The 2010 Decision Resources Acute Pain Report projects that the
post-operative pain market for the United
States, Europe and
Japan will reach $6.5 billion in 2018. We believe that ARX-01 has
the opportunity to become the new standard of care for
patient-controlled management of moderate-to-severe post-operative
pain," said Mr. King.
Financial Outlook
AcelRx anticipates that research and development expenses will
increase over the next several years as AcelRx seeks to complete
the Phase 3 development of ARX-01 and subsequently advance the
development of its other product candidates for cancer breakthrough
pain and mild sedation for painful procedures in a physician's
office, ARX-02 and ARX-03. AcelRx does not intend to initiate the
third ARX-01 Phase 3 study, an efficacy study in orthopedic hip and
knee replacement surgeries, nor advance the development of ARX-02
and ARX-03 until additional funding is obtained. Additionally,
AcelRx anticipates increases in general and administrative expenses
due to costs associated with operating as a public company.
AcelRx believes its current cash, cash equivalents and
short-term investments, including initial public offering net
proceeds of $35.6 million, are
sufficient to fund operations through at least the second quarter
of 2012.
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(TM) PCA System, which has completed Phase
2 clinical development, is designed to solve the problems
associated with post-operative intravenous patient-controlled
analgesia (IV PCA) 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.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to AcelRx
Pharmaceuticals' financial performance, clinical trial update and
future financial performance, including 2011 financial outlook, and
statements relating to the timing of the clinical trials and
product candidate development. These forward-looking
statements are based on the company's 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 Pharmaceutical's product
development activities and clinical trials; its ability to obtain
and maintain regulatory approval of its product candidates; its
ability to obtain funding for its operations; its plans to
research, develop and commercialize its product
candidates; its ability to attract collaborators with
development, regulatory and commercialization expertise; the
accuracy of AcelRx Pharmaceutical's estimates regarding expenses,
capital requirements and needs for financing; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' Securities and Exchange Commission filings
and reports, including its Registration Statement on Form S-1
(including a prospectus) and its Annual Report on Form 10-K for the
year ended December 31, 2010, when it
becomes available. 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.
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Balance
Sheets
|
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|
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(in
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
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|
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|
|
2010
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2009
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ASSETS
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CURRENT
ASSETS:
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|
|
|
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|
Cash and cash
equivalents
|
$ 3,055
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|
$ 7,150
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|
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Short-Term Invesments
|
627
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|
5,396
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|
|
|
Prepaid expenses and other
current assets
|
2,097
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|
397
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|
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Total
Current Assets
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$
5,779
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|
$ 12,943
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|
|
|
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|
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Property and equipment,
net
|
800
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|
1,280
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|
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Restricted cash
|
205
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|
205
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|
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Other assets
|
46
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|
63
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TOTAL ASSETS
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$
6,830
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$ 14,491
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LIABILITIES & STOCKHOLDERS'
EQUITY
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CURRENT
LIABILITIES
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Accounts payable
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$
543
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$
917
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Accrued liabilities
|
859
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|
369
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Convertible notes (1)
|
6,805
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-
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Long-term debt, current
portion
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5,204
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|
4,726
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Total current
liabilities
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$ 13,411
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$
6,012
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Deferred rent
|
245
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|
425
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Long-term debt, net of current
portion
|
-
|
|
5,008
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Call option liability
|
596
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-
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Convertible preferred stock
warrant liability
|
2,529
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|
169
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TOTAL LIABILITIES
|
$ 16,781
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$ 11,614
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STOCKHOLDERS' EQUITY
(DEFICIT):
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Convertible preferred stock,
$0.001 par value - 46,736,123 shares authorized as of
December 31, 2010 and 2009; 7,151,802 and 7,132,527 shares
issued and outstanding as of December 31, 2010 and 2009
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$ 55,941
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$ 55,871
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Common stock, $0.001 par value -
71,000,000 shares authorized as of December 31, 2010 and 2009;
674,353 and 620,116 shares issued and outstanding as of December
31, 2010 and 2009
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3
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|
3
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Additional paid-in
capital
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2,668
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|
1,224
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Acumulated other comprehensive
income (loss)
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-
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(2)
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Deficit accumulated during the
development stage
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(68,563)
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(54,219)
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TOTAL STOCKHOLDERS' EQUITY
(DEFICIT)
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$ (9,951)
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$
2,877
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TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
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$
6,830
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$ 14,491
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(1)The
convertible debt balance is comprised of $8 million in convertible
notes outstanding as of December 31, 2010 less $1.2 million in debt
discount. The principal and the interest under these
convertible notes were subsequently converted into common stock
upon our initial public offering in February 2011.
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Statements
of Operations
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(in
thousands, except share and per share data)
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Three Months
Ended December 31,
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Year Ended
December 31,
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2010
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2009
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2010
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2009
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Operating
Expenses:
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Research and
development
|
$1,884
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|
$2,322
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|
$8,193
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$15,502
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General and
administrative
|
960
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|
1,019
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|
3,993
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|
3,529
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Total
operating expenses
|
$2,844
|
|
$3,341
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$12,186
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$19,031
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Loss from
operations
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($2,844)
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($3,341)
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($12,186)
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($19,031)
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Interest income
|
2
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|
0
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|
4
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|
33
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Interest
expense
|
(741)
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|
(277)
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|
(1,397)
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|
(1,242)
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Other income (expense),
net
|
59
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|
(79)
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|
(765)
|
|
121
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|
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|
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Net
loss
|
($3,524)
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($3,697)
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($14,344)
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($20,119)
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Net loss per
share of common stock, basic and diluted
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($5.23)
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($6.05)
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($21.84)
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($34.93)
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Shares used in computing
net loss per share of common stock, basic and diluted
(1)
|
674,353
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|
610,987
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|
656,650
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|
576,021
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(1) Weighted-average number of
common shares used in calculating net loss per common share – basic
and diluted for the year ended December 31, 2010 excludes (i) the
8,000,000 shares of common stock issued in the initial public
offering in February 2011, (ii) 8,555,713 shares of common stock
resulting from the conversion of our convertible preferred stock to
common shares upon the closing of the initial public offering, and
(iii) the issuance of 2,141,684 shares of common stock resulting
from the conversion of $8 million in convertible notes, and net
exercise of the associated warrants. Following the initial public
offering, the Company had 19,371,750 shares of common stock
outstanding.
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SOURCE AcelRx Pharmaceuticals, Inc.