With its lead drug program under a dark cloud at the FDA and officials at Nasdaq frowning at its battered share price, A.P. Pharma stated today that it is "taking additional actions" to cut costs as it scrambles to conserve funds needed to continue operations into the second quarter. And the drug developer told investors that it plans to meet soon with the FDA on its complete response letter for APF530, a key step as it works out a new timeline for resubmitting its application and scouts for fresh financing.
Shares of A.P. Pharma ($APPA) went into a nosedive almost a year ago when the FDA rejected APF530, an anti-nausea drug. Regulators were concerned about the potential for improper administration and contamination given the two-syringe approach used to deliver it. And the FDA spelled out a series of actions that the biotech would have to take in order to gain an approval.
Redwood City, CA-based A.P. Pharma is no stranger to cost cutting. The developer announced two rounds of layoffs in the months leading up to the FDA's rejection. Its shares closed yesterday at 52 cents, putting the company in jeopardy of losing its listing on Nasdaq.
"A.P. Pharma's management team has focused its efforts on addressing the issues included in the APF530 Complete Response Letter and we have arranged Type B meetings with the FDA for later this quarter," said John Whelan, A.P. Pharma's acting chief executive officer. "We intend to discuss our plans for addressing the issues raised by the FDA, and to obtain clarification on what should be included in a resubmission of the program's New Drug Application. Following the meetings with the FDA, we expect to be in a position to determine the resources and timeline needed for resubmitting the New Drug Application for APF530."
- here's the A.P. release