A.P. Pharma, Inc. (OTCQB:APPA), a specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2011 and highlighted its recent corporate progress. “A.P. Pharma has made significant strides in 2011, including productive meetings with the Food and Drug Administration and a private placement financing of up to $4.5 million in gross proceeds to fund our continued operations,” said John Whelan, A.P. Pharma's president and chief executive officer. “The entire A.P. Pharma team is highly focused on the work necessary to resubmit the APF530 New Drug Application during the first half of next year. We believe the progress we have made, coupled with the meetings with the Agency, put us in a strong position to successfully meet this new timeline.” Operational Highlights
- In February and March 2011, A.P. Pharma management and consultants met with the U.S. Food and Drug Administration (FDA) to discuss certain aspects of the Complete Response Letter issued by the FDA in March 2010 for the APF530 New Drug Application (NDA). The Company is targeting the first half of 2012 to resubmit the APF530 NDA.
- On April 25, 2011, the Company announced the appointment of John B. Whelan as president, chief executive officer and director, and the hiring of Michael Adam, Ph.D., as senior vice president and chief operating officer.
- On May 2, 2011, A.P. Pharma closed a previously announced private placement financing for $1.5 million in convertible notes, with an additional $3.0 million available to the Company at the investors’ discretion within two years of the closing date.
Cash and cash equivalents as of March 31, 2011 were $1.1 million, compared with $2.1 million at December 31, 2010. In April 2011, the Company entered into definitive agreements with investors for a private placement of up to $4.5 million in convertible notes. The Company received approximately $1.4 million in net proceeds at the initial closing of the transaction on May 2, 2011. The Company believes it has sufficient cash resources to fund operations through the second quarter of 2011. The Company plans to seek additional financing or strategic collaborative arrangements to fund its operations through the expected approval decision for APF530. Multiple factors, including market conditions, may prevent the Company from obtaining financing or a collaborative arrangement that is adequate to fund operations or on terms favorable to A.P. Pharma or its stockholders.
About APF530 A.P. Pharma's lead product, APF530, is in development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT 3 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. Intravenous and oral formulations containing granisetron are approved for the prevention of acute-onset CINV, but not delayed-onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy. About A.P. Pharma A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s primary focus is on its lead product, APF530, for the prevention of CINV. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is targeting the resubmission of the NDA for the first half of 2012. The Company has additional clinical and preclinical stage programs in the area of pain management, all of which utilize its bioerodible, injectable and implantable delivery systems. For further information, please visit the Company's web site at www.appharma.com.| A.P. Pharma, Inc. | |||||||||||
| Condensed Statements of Operations | |||||||||||
| (in thousands, except per share amounts) | |||||||||||
| (Unaudited) | |||||||||||
| Three Months EndedMarch 31, | |||||||||||
| 2011 | 2010 | ||||||||||
| Contract revenue | $ | 395 | $ | 241 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 1,141 | 2,331 | |||||||||
| General and administrative | 569 | 781 | |||||||||
| Total operating expenses | 1,710 | 3,112 | |||||||||
| Operating loss | (1,315 | ) | (2,871 | ) | |||||||
| Gain on sale of royalty interest | - | 2,500 | |||||||||
| Interest income (expense), net | (1 | ) | - | ||||||||
| Loss from continuing operations | (1,316 | ) | (371 | ) | |||||||
| Loss from discontinued operations | (103 | ) | (124 | ) | |||||||
| Net loss | $ | (1,419 | ) | $ | (495 | ) | |||||
| Basic and diluted net loss per share: | |||||||||||
| Loss from continuing operations | $ | (0.03 | ) | $ | (0.01 | ) | |||||
| Net loss | $ | (0.04 | ) | $ | (0.01 | ) | |||||
| Shares used to compute basic and diluted net loss per share | 39,869 | 39,420 | |||||||||
| A.P. Pharma, Inc. | |||||||||||
| Condensed Balance Sheets | |||||||||||
| (in thousands) | |||||||||||
| March 31, 2011 | December 31, 2010 | ||||||||||
| (Unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 1,085 | $ | 2,109 | |||||||
| Accounts receivable | 261 | 110 | |||||||||
| Prepaid expenses and other current assets | 157 | 282 | |||||||||
| Total current assets | 1,503 | 2,501 | |||||||||
| Property and equipment, net | 309 | 357 | |||||||||
| Other long-term assets | 53 | 53 | |||||||||
| Total assets | $ | 1,865 | $ | 2,911 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 309 | $ | 159 | |||||||
| Accrued expenses | 358 | 461 | |||||||||
| Deferred revenue | 212 | 237 | |||||||||
| Accrued disposition costs | 806 | 703 | |||||||||
| Total current liabilities | 1,685 | 1,560 | |||||||||
| Deferred revenue | 44 | 35 | |||||||||
| Total liabilities | 1,729 | 1,595 | |||||||||
| Stockholders' equity: | |||||||||||
| Common stock | 401 | 401 | |||||||||
| Additional paid-in capital | 149,579 | 149,340 | |||||||||
| Accumulated deficit | (149,844 | ) | (148,425 | ) | |||||||
| Total stockholders' equity | 136 | 1,316 | |||||||||
| Total liabilities and stockholders' equity | $ | 1,865 | $ | 2,911 | |||||||