A.P. Pharma Reports Second Quarter Financial Results.REDWOOD CITY Redwood City, city (1990 pop. 66,072), seat of San Mateo co., W Calif., on San Francisco Bay; inc. 1868. Manufactures include commmunications, electrical, electronic, and medical equipment. , Calif. -- A.P. Pharma, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :APPA), a specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2007. Highlights Financial: * $40 million equity financing Equity Financing The act of raising money for company activities by selling common or preferred stock to individual or institutional investors. In return for the money paid, shareholders receive ownership interests in the corporation. ($37.5 million net of expenses) successfully completed * Sufficient capital to complete APF APF, n the abbreviation for acidulated phosphate fluoride. 530 clinical trial and initiate new clinical programs * New shareholders include premier healthcare investors * Financing preceded by 1:4 reverse stock split * $2.5 million milestone payment received * Cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has $45.1 million as of June 30, 2007 * NASDAQ confirms Company in compliance with the Global Market continued listing requirements Listing requirements Requirements, including minimum shares outstanding, market value, and income, that are laid down by an exchange for any stock to be listed for trading. APF530: * Patient enrollment at active sites continues at a steady rate * New U.S. and international clinical sites being established to replace non-productive sites * Target continues to be filing NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any in late 2008 Results of Operations Our net loss for the second quarter was significantly reduced this quarter to $1.8 million, or $0.19 per share, compared with a $4.6 million net loss, or $0.72 per share, for the second quarter of 2006. Our loss was lower largely as a result of receipt of a $2.5 million milestone payment related to the sale of our rights to receive royalties from two former products, Retin-A Micro[R] and Carac[R]. Total operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. in the second quarter of 2007 was reduced to $4.6 million, compared with $4.8 million in the second quarter of 2006, despite a more active clinical program. The improvement was the result of aggressive cost-containment measures enacted pending the planned refinancing program. Research and development costs for the quarter declined 2% to $3.8 million, compared with $3.9 million in the second quarter of 2006. General and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. declined 7% to $0.9 million. The operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. for the second quarter of 2007 of $4.5 million was further reduced by the recognition of contract revenues following the initiation of a new development program utilizing our proprietary Biochronomer[TM] technology with a major animal healthcare company. Operations Update On June 19, 2007, we completed a public offering of 24,393,939 shares, which included 3,181,818 shares sold pursuant to the full exercise of an over-allotment option granted to the underwriters. The offering was preceded by a 1:4 reverse common stock split implemented in late May. Net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). received by the Company were approximately $37.5 million. With these funds, we are now able to focus on the key elements of our strategy, namely: * Maximize the value of our lead product, APF530, by completing the current Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. and pursuing partnering with successful trial results * Initiate, develop and undertake additional clinical trials for other product candidates * Expand our product pipeline by leveraging our existing technology * Enter into strategic partnerships and collaborations for future product development programs Currently, APF530 is in a pivotal Phase 3 clinical trial and patient enrollment in the active U.S. sites continues at a steady rate. As we replace non-productive clinical sites we plan to include a certain number of international sites in addition to new U.S. sites. We expect to complete patient enrollment in our APF530 trial in the first half of 2008 and to announce results of that trial in the third quarter of 2008. We expect to file our new drug application (NDA) for approval of APF530 in the fourth quarter of 2008. Additionally, with our new cash resources we are now in a position to re-activate and expand our product development programs, namely for APF112 and APF580. APF112 is targeted to provide extended post-surgical pain relief; we intend to complete additional preclinical work in 2007 followed by the initiation of a Phase 2b trial in the first half of 2008. APF580, incorporating an opiate opiate /opi·ate/ (o´pe-it) 1. any drug derived from opium. 2. hypnotic (2). o·pi·ate n. 1. , is designed to provide analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah) 1. absence of sensibility to pain. 2. the relief of pain without loss of consciousness. lasting up to seven days via a single injection. We plan to initiate and complete a Phase 1 study in the first half of 2008 and initiate a Phase 2 study by the end of the year. About APF530 Our lead product candidate using our proprietary Biochronomer[TM] technology is APF530, which contains granisetron, a drug approved for the prevention of chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. (CINV CINV Chemotherapy Induced Nausea and Vomiting ). We selected granisetron because it is a potent drug that blocks a specific receptor found in the gut that is responsible for triggering CINV. Additionally, the applicable granisetron U.S. patent will expire on December 29, 2007. APF530 is designed to provide at least five days' prevention of CINV. In September 2005, we completed a Phase 2 human clinical trial of APF530 that achieved all of its primary and secondary endpoints. In May 2006, we initiated our pivotal Phase 3 clinical trial of APF530. We believe that this clinical trial will lead to regulatory approval of APF530 for the prevention of acute and delayed onset CINV for patients undergoing both moderately and highly emetogenic, or vomit-inducing, chemotherapy. Our pivotal Phase 3 clinical trial, initiated in May 2006, is a multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , observer-blind, actively-controlled, double-dummy, parallel group study that will compare the efficacy of APF530 with Aloxi[R]. The trial will include approximately 1,350 patients, stratified stratified /strat·i·fied/ (strat´i-fid) formed or arranged in layers. strat·i·fied adj. Arranged in the form of layers or strata. in two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents This is a list of specific pharmacologic agents that are known to be of use in the treatment of cancer, otherwise known as chemotherapeutic agents. This list is organized by "type" of agent, though the subsections are not necessarily definitive and are subject to revision. . In each group, the patients are randomized to receive in the first chemotherapy treatment cycle either APF530 high dose (10 mg), APF530 low dose (5 mg) or the currently approved dose of Aloxi. In subsequent treatment cycles (up to three additional cycles), the patients are re-randomized to either of the two APF530 doses. Conference call Management will host an investment-community conference call today beginning at 11:00 a.m. Eastern time (8:00 a.m. Pacific time) to discuss the financial results, to provide a business update and to answer questions. To participate in the live call by telephone, please dial (888) 803-8275 from the U.S. or (706) 634-1287 from outside the U.S. A telephone replay will be available for 48 hours by dialing (800) 642-1687 from the U.S. or (706) 645-9291 from outside the U.S., and entering reservation number 10905888. The call will also be broadcast live on A.P. Pharma's website, www.appharma.com. A replay will be available for 30 days. About A.P. Pharma We are a specialty pharmaceutical company focused on developing pharmaceutical products using our proprietary Biochronomer polymer-based drug delivery technology. Our product development philosophy is based on incorporating approved therapeutics into our proprietary bioerodible drug delivery technology to create controlled release pharmaceuticals to improve treatments for diseases or conditions. Our lead product candidate, APF530, is currently in a pivotal Phase 3 clinical trial for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting, or CINV. Our primary focus is to advance our proprietary Biochronomer technology, consisting of bioerodible polymers designed to release drugs over a defined period. We have completed more than 100 in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. and in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. studies demonstrating that our Biochronomer technology is potentially applicable to a range of therapeutic areas, including pain management, prevention of nausea and vomiting, control of inflammation and treatment of ophthalmic diseases. We have also completed comprehensive animal and human toxicology studies that have established that our Biochronomer polymers are safe and well tolerated. Furthermore, our Biochronomer technology can be designed to deliver drugs over periods varying from days to several months. Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Reform Act of 1995. These forward-looking statements involve risks and uncertainties including uncertainties associated with timely development, approval, launch and acceptance of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law. [TABLE OMITTED] [TABLE OMITTED] |
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