A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today reported financial results for the quarter ended June 30, 2012 and highlighted recent corporate progress.
“With the recent closing of our common stock offering, we are in a strong financial position as we approach the commercialization phase with our lead product candidate, APF530, for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting,” said John B. Whelan, A.P. Pharma's president and chief executive officer. “As previously announced, we successfully completed our thorough QT and metabolism studies required for our APF530 New Drug Application resubmission. We now also have successfully completed our non-clinical human factors validation study. We remain on track to resubmit our New Drug Application for APF530 to the U.S. Food and Drug Administration in September 2012.”
- During June and July 2012, the Company appointed three individuals with extensive pharmaceutical industry experience to its board of directors: Stephen R. Davis, Barry D. Quart, Pharm.D., and Robert Rosen.
- On July 10, 2012, the Company announced that the U.S. Patent and Trademark Office had allowed three new patents covering APF530.
- On July 25, 2012, the Company announced that it had entered into definitive agreements relating to a common stock offering that resulted in gross proceeds to the Company of approximately $53.6 million. The transaction closed on July 30, 2012.
- In July 2012, the Company successfully completed its non-clinical human factors validation study, the results of which will be included in the Company’s New Drug Application (NDA) resubmission for APF530 planned for September 2012.
Results of OperationsA.P. Pharma’s net loss for the second quarter of 2012 was $4.6 million, or $0.02 per share, compared to a net loss of $1.9 million, or $0.05 per share, for the second 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. The prior-year quarter included contract revenue from an agreement with Merial Limited, which was terminated in May 2011.