A.P. Pharma Reports Second Quarter Financial Results; Patient Enrollment for APF530 Phase 2 Trial Successfully Completed.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 the three months ended June 30, 2005. Recent and Financial Highlights
-- Patient enrollment in the open-label APF530 Phase 2 clinical trial
has been successfully completed. APF530 is designed for the
prevention of acute and delayed chemotherapy-induced nausea and
vomiting (CINV) and contains the anti-nausea drug granisetron,
formulated with the Company's proprietary Biochronomer(TM) system.
-- The Phase 2 study was designed for patients receiving moderately
emetogenic chemotherapy for cancer to evaluate pharmacokinetics,
safety and tolerability. Measures of efficacy were also introduced
into the study.
-- Three dose groups involving more than 40 patients were treated
in an ascending dose study.
-- Preliminary safety and pharmacokinetic data to date are very
encouraging, and all clinical endpoints were achieved.
Sustained plasma levels of granisetron were observed over five
days.
-- Greater than 90% of patients experienced only mild nausea, no
vomiting, and did not need to take any rescue medication in
either the acute or delayed phase of CINV.
-- Preparations are underway for a Phase 3 clinical trial planned to
begin in the fourth quarter of 2005.
-- Royalties for the second quarter of 2005 grew by 8%, driven by
sales of Carac(R), which increased by 25% compared with the prior
year's second quarter.
-- Cash, cash equivalents and marketable securities were $9.7 million
at June 30, 2005.
Financial Results A.P. Pharma reported an 8% increase in total royalties for the second quarter of 2005 to $1,187,000, compared with $1,103,000 for the second quarter of 2004. Second quarter royalties on sales of Carac by Sanofi-Aventis grew by 25% and royalties on sales of Retin-A Micro(R) by Johnson & Johnson grew by 1% over the corresponding quarter of the prior year. Contract revenues for the second quarter of 2005 totaled $63,000, compared with $181,000 for the second quarter of 2004. Total revenues for the second quarter of 2005 decreased $34,000, or 3%, to $1,250,000, compared with $1,284,000 for the second quarter for 2004. Research and development expense increased by $173,000, or 6%, to $3,078,000 for the second quarter of 2005, compared with $2,905,000 for the second quarter of the prior year. The increase is primarily attributable to the APF APF, n the abbreviation for acidulated phosphate fluoride. 530 Phase 2 clinical study, which was initiated during the second quarter of 2005, and manufacturing expenses that were incurred in anticipation of a Phase 3 clinical study, which is planned to be initiated in the fourth quarter of 2005. General and administrative expense increased by $3,000 to $823,000 for the second quarter of 2005, compared with $820,000 for the second quarter of 2004. The loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the in the second quarter of 2005 was $2,564,000, compared with a loss from continuing operations of $2,392,000 in the second quarter of 2004. The net loss for the second quarter of 2005 was $2,608,000, or $0.10 per share, compared with a net loss of $2,444,000, or $0.12 per share, in the second quarter of 2004. APF530 Clinical Update APF530, which contains the anti-nausea drug granisetron, formulated for·mu·late tr.v. for·mu·lat·ed, for·mu·lat·ing, for·mu·lates 1. a. To state as or reduce to a formula. b. To express in systematic terms or concepts. c. with the Company's proprietary Biochronomer(TM) bioerodible drug delivery system, is being developed for the prevention of both acute and delayed 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 ). Following a single subcutaneous injection Noun 1. subcutaneous injection - an injection under the skin injection, shot - the act of putting a liquid into the body by means of a syringe; "the nurse gave him a flu shot" prior to the initiation of chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. , APF530 is designed to provide therapeutic plasma levels of granisetron for four to five days in order to prevent CINV during this period. The Phase 2 study was designed as an open-label, dose-ascending trial in patients undergoing moderately emetogenic chemotherapy for cancer. Patients in the study received an injection of APF530 containing one of three doses of granisetron: 5, 10 or 15 milligrams. The primary endpoints include an evaluation of pharmacokinetics pharmacokinetics /phar·ma·co·ki·net·ics/ (fahr?mah-ko-ki-net´iks) the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. , safety and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol . In addition, efficacy endpoints were evaluated relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc emetic emetic (əmĕt`ĭk), substance that produces vomiting. Direct, or gastric, emetics, which act directly on the stomach, include syrup of ipecac, sulfate of zinc or copper, alum, ammonium carbonate, mustard in water, or copious quantities of events and the use of rescue medication. Preliminary data to date are very encouraging, and all clinical endpoints In a research trial, a clinical endpoint refers to a disease, symptom, or sign that constitutes one of the target outcomes of the trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the were achieved in the first patient group treated. From the Phase 1 study in healthy volunteers, it was anticipated that plasma levels of granisetron would be sustained over four to five days. Based on literature, it was anticipated that the plasma levels in chemotherapy patients would be approximately twice the drug levels seen in healthy volunteers, given equivalent doses. The pharmacokinetic data from the first APF530 patients who received 5 milligrams of granisetron indicate that the plasma levels were four-fold greater, with sustained levels of granisetron measured at day 5. We believe these results are particularly important based on published data that suggest plasma levels of granisetron can potentially predict therapeutic response in patients for both acute and delayed CINV. To date, safety and tolerability data in patients receiving the APF530 doses have been excellent, with no drug-related serious adverse events. Injections of APF530 were well tolerated, and there was only one report of mild discomfort at the site of injection. Overall, side effects Side effects Effects of a proposed project on other parts of the firm. with regard to the APF530 formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation appear to be minimal. Efficacy assessments in the first two groups of this open-label study are excellent, with more than 90% of the patients achieving a "complete response," meaning that there were no episodes of vomiting vomiting, ejection of food and other matter from the stomach through the mouth, often preceded by nausea. The process is initiated by stimulation of the vomiting center of the brain by nerve impulses from the gastrointestinal tract or other part of the body. and no requirements for rescue medication, and that no more than mild nausea nausea, sensation of discomfort, or queasiness, in the stomach. It may be caused by irritation of the stomach by food or drugs, unpleasant odors, overeating, fright, or psychological stress. It is usually relieved by vomiting. was experienced. It is interesting to note that published response rates for other approved 5HT(3) antagonists antagonists, n muscles that counterbalance agonists during specific movements. opioid Neurology A pain-attenuating peptide that occurs naturally in the brain, which induces analgesia by mimicking endogenous opioids at opioid are considerably lower. Conference Call Information Management will be hosting an investment community conference call beginning at 11:00 a.m. Eastern Time (8:00 a.m. Pacific Time) today to discuss this announcement 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 8037521. Individuals interested in listening to the conference call via the Internet may do so by visiting www.appharma.com. A replay will be available on the Company's Web site for 30 days. About A.P. Pharma A.P. Pharma is a specialty pharmaceutical company focused on the development of ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based drug delivery systems. The Company's primary focus is the development and commercialization of its bioerodible injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. and implantable systems under the trade name Biochronomer. Initial target areas of application for the Company's drug delivery technology include anti-nausea, pain management, inflammation and ophthalmic ophthalmic /oph·thal·mic/ (of-thal´mik) ocular (1). oph·thal·mic adj. Of or relating to the eye; ocular. Ophthalmic Pertaining to the eye. applications. The Company's product development programs are funded by the sale of common stock in June 2004, royalties from topical topical /top·i·cal/ (top´i-k'l) pertaining to a particular area, as a topical antiinfective applied to a certain area of the skin and affecting only the area to which it is applied. top·i·cal adj. products currently marketed by pharmaceutical partners, proceeds from the divestitures of its cosmeceutical cos·me·ceu·ti·cal n. A cosmetic that has or is purported to have medicinal properties. and analytical analytical, analytic pertaining to or emanating from analysis. analytical control control of confounding by analysis of the results of a trial or test. standards product lines, and by fees it receives from collaborative partners. For further information visit the Company's Web site at www.appharma.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties, including, among others, uncertainty associated with timely development, approval, launch and acceptance of new products; establishment of new corporate alliances; and progress in research and development programs. Other risks and uncertainties associated with the Company's business and prospects are identified in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.
A.P. Pharma, Inc.
Statement of Operations Highlights
(in thousands, except per share data)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2005 2004 2005 2004
Royalties $ 1,187 $ 1,103 $ 2,469 $ 2,257
Contract Revenues 63 181 142 206
Total Revenues 1,250 1,284 2,611 2,463
Operating Expenses:
Research & Development 3,078 2,905 4,900 5,919
General & Administrative 823 820 1,672 1,566
Total Operating Expenses 3,901 3,725 6,572 7,485
Operating Loss (2,651) (2,441) (3,961) (5,022)
Interest Income and Other, Net 87 49 147 79
Loss from Continuing
Operations (2,564) (2,392) (3,814) (4,943)
Loss from Discontinued
Operations (44) (52) (50) (101)
Net Loss ($2,608) ($2,444) ($3,864) ($5,044)
Basic and Diluted Loss per
Share:
Loss from Continuing
Operations ($0.10) ($0.11) ($0.15) ($0.24)
Net Loss ($0.10) ($0.12) ($0.15) ($0.24)
Shares used in Calculating
Loss per Share:
Basic and Diluted 25,107 21,048 25,073 20,850
A.P. Pharma, Inc.
Balance Sheet Highlights
(in thousands)
June 30, 2005 December 31,
(Unaudited) 2004
Assets
Cash, Cash Equivalents and Marketable
Securities $ 9,747 $ 13,596
Accounts Receivable, Net 1,393 1,506
Other Current Assets 439 394
Total Current Assets 11,579 15,496
Property, Plant & Equipment, Net 1,115 1,235
Other Non-Current Assets 177 283
Total Assets $ 12,871 $ 17,014
Liabilities and Shareholders' Equity
Current Liabilities $ 2,430 $ 2,860
Shareholders' Equity 10,441 14,154
Total Liabilities and Shareholders'
Equity $ 12,871 $ 17,014
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