A.P. Pharma, Inc. (OTCBB:APPA.OB), a specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2012 and highlighted recent corporate progress.
"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 John B. Whelan, A.P. Pharma's president and chief executive officer. "If approved, we believe that APF530 will provide an important treatment option for cancer patients and physicians in preventing chemotherapy-induced nausea and vomiting."
In 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
- 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 FDA and 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.
- On March 26, 2012, the Company announced the appointment of Thomas Ottoboni, Ph.D. as Vice President of Pharmaceutical Development.
- On May 8, 2012, the Company received $3 million of cash through the issuance of convertible notes pursuant to a second closing of the private placement financing for up to $4.5 million announced in April 2011.
Results of OperationsA.P. Pharma’s net loss for the first quarter of 2012 was $4.9 million, or $0.02 per share, compared to a net loss of $1.4 million, or $0.04 per share, for the first quarter of 2011. The net loss was higher in the current fiscal quarter primarily due to increased spending related to the planned NDA resubmission and higher personnel-related expenses, including stock compensation expense. Additionally, the prior year quarter included contract revenue from an agreement with Merial Limited, which is no longer in effect.
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