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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.