A.P. Pharma Announces First Quarter 2012 Financial Results and Recent Corporate Progress
REDWOOD CITY, Calif.--(BUSINESS WIRE)--May. 10, 2012-- A.P. Pharma, Inc. (OTCBB:APPA.OB), a specialty pharmaceutical company, today reported financial results for its first quarter ended
"In the first quarter of 2012, we completed several key studies to support the resubmission of our New Drug Application for APF530, which is expected to occur in mid-2012," said
March 2012, the Company announced the results from two phase 1 clinical studies requested by the U.S. Food and Drug Administration( FDA) in its Complete Response Letter for APF530. The results of these studies will be included in the resubmission of the New Drug Application (NDA).
- The Company completed a thorough QT study for APF530 showing that granisetron, the active drug used in APF530, does not have an effect on cardiac repolarization as measured by prolongation of the QT interval.
- A separate metabolism study was completed that showed how the human body processes APF530 and corroborated preclinical animal data.
- The Company is awaiting the review of its non-clinical human factors validation study protocol by the
FDAand anticipates performing this study in the second quarter of 2012. The validation study protocol is based on previously completed formative studies, and the results will be included in the NDA resubmission.
March 26, 2012, the Company announced the appointment of Thomas Ottoboni, Ph.D. as Vice President of Pharmaceutical Development.
May 8, 2012, the Company received $3 millionof cash through the issuance of convertible notes pursuant to a second closing of the private placement financing for up to $4.5 millionannounced in April 2011.
Results of Operations
A.P. Pharma's net loss for the first quarter of 2012 was
Cash and cash equivalents as of
(financial tables follow)
A.P. Pharma, Inc.
Condensed Statements of Operations
|(in thousands, except per share amounts)|
Three Months Ended
|Research and development||3,329||1,141|
|General and administrative||1,440||569|
|Total operating expenses||4,769||1,710|
|Interest expense, net||(61||)||(1||)|
|Loss from continuing operations||(4,830||)||(1,316||)|
|Loss from discontinued operations||(91||)||(103||)|
|Basic and diluted net loss per share:|
|Loss from continuing operations||$||(0.02||)||$||(0.03||)|
Shares used to compute basic and diluted net loss per share
A.P. Pharma, Inc.
|Condensed Balance Sheets|
March 31, 2012
December 31, 2011
|Cash and cash equivalents||$||13,444||$||17,974|
|Prepaid expenses and other current assets||306||266|
|Total current assets||13,750||18,240|
|Property and equipment, net||1,114||1,075|
|Other long-term assets||130||130|
|Liabilities and Stockholders' Equity|
|Accrued disposition costs||1,173||1,082|
|Convertible notes payable to related parties, net of discount||143||103|
|Total current liabilities||3,361||3,693|
|Additional paid-in capital||174,791||173,989|
|Total stockholders' equity||11,633||15,752|
|Total liabilities and stockholders' equity||$||14,994||$||19,445|
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 capital resources and liquidity, timely development and regulatory approval of product candidates, 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
Investor Relations Contact:
Office Phone: 646-597-6979
Mobile Phone: 917-282-3242
A.P. Pharma, Inc.
John B. Whelan, President, Chief Executive Officer and Chief Financial Officer
Office Phone: 650-366-2626