A.P.
Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company,
today reported financial results for the quarter ended September 30,
2013.
“During the third quarter, we made significant progress toward
resubmission of the NDA for Sustol™ (formerly known as APF530) targeted
for the end of the first quarter 2014,” said Dr. Barry Quart, CEO of
A.P. Pharma. “Today, we also separately announced an important expansion
of our pipeline including unveiling a new program targeting the relief
of post-surgical pain using our proprietary Biochronomer™ polymer
platform and plans to pursue the expansion of our lead program for the
treatment of chemotherapy induced nausea and vomiting.”
A.P. Pharma’s pain relief program utilizes the company’s polymer-based
Biochronomer drug delivery platform to continuously release anesthetic
agents directly at the source of pain over a period of several days. The
company is targeting a prolonged period of anesthetic release such that
therapeutic concentrations of active drug are achieved rapidly and
maintained for at least 72 hours. The potential benefit of A.P. Pharma’s
prolonged release profile is to achieve rapid pain relief, maintaining
higher levels of active drug at the site of the pain over time to
potentially provide greater relief from pain, and to maintain pain
relief for up to 5 days following surgery.
The company’s expansion of its leading drug program for the treatment of
chemotherapy-induced nausea and vomiting (CINV) is centered around a
post-approval study to commence in 2014 which is designed to demonstrate
the utility of its lead agent, Sustol™, in the treatment of delayed
onset CINV in patients receiving highly emetogenic chemotherapy (HEC)
agents. Currently there is no approved 5-HT3 receptor antagonist for the
treatment of delayed HEC.
Results of Operations
A.P. Pharma’s net loss for the third quarter of 2013 was $12.9 million,
or $0.04 per share, compared to a net loss of $6.1 million, or $0.02 per
share, for the third quarter of 2012. Loss from continuing operations
was higher in the current fiscal quarter primarily due to increased
spending related to manufacturing development expenses and higher
personnel costs, including stock compensation expense, and expenses
related to the resignation of the Company's former chief executive
officer during the third quarter of 2013.
Cash and cash equivalents as of September 30, 2013 were $22.6 million,
compared to $53.5 million at December 31, 2012. Net cash used in
operating activities was $31.1 million for the nine months ended
September 30, 2013. The Company believes that its current cash resources
are sufficient to fund its operations into 2014.
About APF530
A.P. Pharma's lead product candidate, APF530, is being developed for the
prevention of both acute- and delayed-onset chemotherapy-induced nausea
and vomiting (CINV). One of the most debilitating side effects of cancer
chemotherapy, CINV is a leading cause of premature discontinuation of
treatment. There is only one injectable 5-HT3 antagonist approved for
the prevention of delayed-onset CINV. APF530 contains the 5-HT3
antagonist granisetron formulated in the Company's proprietary
Biochronomer™ drug delivery system, which allows therapeutic drug levels
to be maintained for five days with a single subcutaneous injection.
Currently available intravenous and oral formulations of granisetron are
approved only for the prevention of acute-onset CINV. Granisetron was
selected for APF530 because it is widely prescribed by physicians based
on a well-established record of safety and efficacy.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products
using its proprietary Biochronomer™ polymer-based drug delivery
platform. This drug delivery platform is designed to improve the
therapeutic profile of injectable pharmaceuticals by converting them
from products that must be injected once or twice per day to products
that need to be injected only once every one or two weeks. The Company's
lead product, APF530, is being developed for the prevention of both
acute- and delayed-onset chemotherapy-induced nausea and vomiting. For
further information, please visit the Company's web site at www.appharma.com.
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A.P. Pharma, Inc.
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Condensed Statements of Operations
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(in thousands, except per share amounts)
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(Unaudited)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2013
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2012
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2013
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2012
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Operating expenses:
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Research and development
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$
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5,885
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$
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3,626
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$
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23,188
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$
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10,022
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General and administrative
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6,779
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2,428
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17,438
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5,181
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Total operating expenses
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12,664
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6,054
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40,626
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15,203
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Operating loss
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(12,664
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(6,054
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(40,626
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(15,203
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Interest expense, net
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(209
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(195
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(614
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(402
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Loss from continuing operations
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(12,873
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(6,249
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(41,240
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(15,605
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Income (loss) from discontinued operations
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-
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128
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-
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(6
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Net loss
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$
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(12,873
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$
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(6,121
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$
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(41,240
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$
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(15,611
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Basic and diluted net loss per share:
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Loss from continuing operations
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$
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(0.04
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$
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(0.02
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$
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(0.13
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$
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(0.07
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Net loss
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$
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(0.04
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$
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(0.02
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$
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(0.13
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$
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(0.07
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Shares used to compute basic and diluted net loss per share
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307,496
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274,488
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306,096
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225,063
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A.P. Pharma, Inc.
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Condensed Balance Sheets
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(in thousands)
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(Unaudited)
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September 30, 2013
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December 31, 2012
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Assets
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Current assets:
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Cash and cash equivalents
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$
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22,597
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$
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53,506
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Prepaid expenses and other current assets
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763
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584
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Total current assets
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23,360
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54,090
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Property and equipment, net
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2,857
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1,752
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Other long-term assets
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153
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130
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Total assets
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$
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26,370
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$
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55,972
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Liabilities and Stockholders' Equity
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Current liabilities:
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Accounts payable
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$
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2,250
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$
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1,912
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Accrued expenses
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2,360
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1,750
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Convertible notes payable to related parties, net of discount
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888
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492
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Total current liabilities
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5,498
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4,154
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Stockholders' equity:
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Common stock
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3,110
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3,024
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Additional paid-in capital
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242,589
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232,381
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Accumulated deficit
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(224,827
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(183,587
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Total stockholders' equity
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20,872
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51,818
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Total liabilities and stockholders' equity
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$
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26,370
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$
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55,972
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Forward-looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the potential approval of APF530 and the
potential timing for such approval, if approved at all, as well as risks
relating to qualifying for listing on the NASDAQ Capital Market, capital
resources and liquidity, satisfactory completion of clinical studies,
progress in research and development programs, launch and acceptance of
new products and other risks and uncertainties identified in the
Company's filings with the Securities and Exchange Commission. We
caution investors that forward-looking statements reflect our analysis
only on their stated date. We do not intend to update them except as
required by law.
Copyright Business Wire 2013