A.P. Pharma, Inc.
(OTCBB: APPA.OB), a specialty pharmaceutical company, today reported financial results for the quarter ended June 30, 2013.
“Over the past couple of months, the new management team and Board of Directors have focused on advancing the Company and its lead program,” said Barry Quart, PharmD., A.P. Pharma’s Chief Executive Officer. “These activities included our evaluation of, and plan to address, the U.S. Food and Drug Administration’s Complete Response Letter received in March 2013 regarding our New Drug Application for APF530. We anticipate resubmitting the regulatory filing for APF530, our product candidate for the prevention of chemotherapy-induced nausea and vomiting, during the first quarter of 2014.”
“In addition to our financial results, today we announced our plans to rebrand and file for relisting of our common stock on the NASDAQ Capital Market, following a proposed reverse split of our common stock,” Dr. Quart continued. “We believe it is important to rebrand the Company’s identity as part of our recent corporate restructuring.”
Results of Operations
A.P. Pharma’s net loss for the second quarter of 2013 was $15.4 million, or $0.05 per share, compared to a net loss of $4.6 million, or $0.02 per share, for the second 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.
Cash and cash equivalents as of June 30, 2013 were $34.8 million, compared to $53.5 million at December 31, 2012. Net cash used in operating activities was $18.8 million for the six months ended June 30, 2013. The Company believes that its current cash resources are sufficient to fund its operations into 2014.
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.