Cell Pathways, Inc. Reports First Quarter 2001 Financial Results.Business Editors/Health & Medical Writers HORSHAM, Pa.--(BW HealthWire)--April 19, 2001 Cell Pathways, Inc. (Nasdaq:CLPA CLPA CC-Link Partner Association CLPA Club Loisirs et Plein Air (Montpellier, France) CLPA Child Labour Programme of Action (national plan to eliminate child labour in South Africa) ) today reported financial results for the three months ended March 31, 2001. The Company reported a net loss in the first quarter ended March 31, 2001 of $4.8 million or $1.8 million less than the same period in 2000. For the first quarter of 2001, net loss per share was $0.15 on 31.1 million common shares outstanding versus a net loss per share of $0.24 on 26.7 million common shares outstanding for the first quarter of 2000. The Company ended the quarter with $44.2 million in cash, cash equivalents and short-term investments, a reduction of $5.4 million from the balance at December 31, 2000. In the first quarter of 2001, the Company recognized revenue of $317,000, from its agreement with Aventis Pharmaceuticals Inc. to promote Nilandron(R) (nilutamide) for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Revenues from this agreement commenced in the fourth quarter of 2000. Research and development expenses were $3.8 million for the three months ended March 31, 2001, a decrease of $1.6 million or 30% from the same period in 2000. This decrease was primarily the result of purchases of raw materials made in the first quarter of 2000 to produce Aptosyn(TM) (exisulind), the Company's lead drug, for clinical and commercial purposes. Also, clinical trial expenses were lower in the first quarter of 2001 versus the same period in 2000. During the first quarter of 2000, the Company recorded a non-cash charge Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. of approximately $621,000, related to compensation expense for stock options granted to scientific advisory board members due to an increase in the Company's stock price. Selling, general and administrative expenses were $1.9 million for the three months ended March 31, 2001, an increase of $311,000 or 19% from the same period of 2000. This increase was due principally to sales and marketing expenses related to the promotion of Nilandron(R) in the first quarter of 2001. Interest income, net of expense, was $641,000 in the first quarter of 2001, an increase of $167,000 from the same period in 2000 due to higher average cash balances. Robert Towarnicki, chairman and chief executive officer, said "during the first quarter of 2001, we took several important steps towards advancing the company's goal to become a leading cancer therapeutic company: -- initiated a Phase III, double-blinded clinical trial in non-small cell lung cancer using Aptosyn(TM) in combination with Taxotere(R) (docetaxel) to evaluate this combination in 600 patients. Patient accrual is currently underway through our primary investigational site, US Oncology, a nationwide group of 825 physicians and 56 centers specializing in the treatment of cancer patients; -- presented a number of important scientific papers that relate to the company's research and the mechanism of action for the company's SAANDs technology at the annual meeting of the American Association for Cancer Research. (AACR); -- continued the development of the company's second drug candidate, CP461; -- filed a shelf registration statement with the Securities and Exchange Commission (SEC) that registers $25 million worth of common stock of the company. The filing of the registration statement positions the company to sell securities under market conditions at prices deemed in the Company's business interest." Cell Pathways, Inc., headquartered in Horsham, Pennsylvania Horsham is a census-designated place (CDP) in Montgomery County, Pennsylvania, United States. The population was 14,779 at the 2000 census. Horsham is located entirely within Horsham Township, Pennsylvania. , is a development stage pharmaceutical company focused on the research, development and commercialization of novel and unique medications to prevent and treat cancer. For additional information on Cell Pathways, Inc., visit the Company's web-site at http:www.cellpathways.com. Certain statements in this release, and oral statements made in respect of this release, constitute "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. " within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Such statements are those which express plan, anticipation, intent, contingency contingency n. an event that might not occur. or future development and/or otherwise are not statements of historical fact. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors, the absence of approved products; history of operating losses 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. and the need for further financing; early stage of development; the costs, delays and uncertainties inherent in science, basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both our current product candidates and our future product candidates, if any; dependence on the development and market acceptance of Aptosyn(TM) (exisulind) for one or more significant disease indications; limitations on, or absence of, the predictive value pre·dic·tive value n. The likelihood that a positive test result indicates disease or that a negative test result excludes disease. predictive value a measure used by clinicians to interpret diagnostic test results. of data obtained in laboratory tests, animal models and human clinical trials when planning additional steps in product development; uncertainty of obtaining regulatory approval of any compound for any disease indication; uncertainty and adversity ad·ver·si·ty n. pl. ad·ver·si·ties 1. A state of hardship or affliction; misfortune. 2. A calamitous event. arising from the action of the U.S. Food and Drug Administration, or FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , in issuing a "not approvable" letter with respect to the New Drug Application, or 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 , submitted for Aptosyn(TM) (exisulind) for the orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the condition of familial adenomatous polyposis familial adenomatous polyposis Familial polyposis An AD condition affecting ±50,000–US, characterized by progressive development of hundreds of adenomatous colorectal polyps; progression to cancer Molecular pathology APC , or FAP (language) FAP - The assembly language for Sperry-Rand 1103 and 1103A. [Listed in CACM 2(5):16 (May 1959)]. , a rare disease that puts those afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, at high risk of developing colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. ; the timing and scope of any approval which might be received, or any failure to receive approval, for any compound for any indication in the future; the volatility of the market price of our common stock; our ability to sell securities registered under the shelf registration statement; acceptance of any product candidates by physicians and providers of healthcare reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. ; the actions of competitors; the pace of technological changes in the biopharmaceutical industry; dependence upon third parties; the validity, scope and enforceability of patents; the risk of our pending class action securities litigations; potential product liability claims; and availability of insurance. These and other risks are detailed in our reports filed from time to time under the Securities Act and/or the Securities Exchange Act, including the sections entitled en·ti·tle tr.v. en·ti·tled, en·ti·tling, en·ti·tles 1. To give a name or title to. 2. To furnish with a right or claim to something: "Business," "Risk Factors," "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" and "Other Events" in our annual reports on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , quarterly reports on Form 10-Q Form 10-Q See 10-Q. and periodic reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. and in such registration statements on Form S-3 as we may file from time to time. You are encouraged to read these filings as they are made. They are available over the Internet from the SEC in its EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king. database at http://www.sec.gov and from the Company. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. No forward-looking statement can be guaranteed; actual future results may vary materially. Both forward-looking statements and statements of historic fact must be understood in the context of the risks referred to above which characterize our development-stage business. We undertake no obligation to update or revise the statements made herein or the risk factors that may relate thereto there·to adv. 1. To that, this, or it. 2. Archaic In addition to that; furthermore. thereto Adverb Formal 1. to that or it 2. . Note to Editors: Aptosyn(TM) is a trademark of Cell Pathways, Inc., Taxotere(R)is a registered trademark of Aventis Pharmaceutical, Inc.
CELL PATHWAYS, INC.
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, December 31,
2001 2000
--------------- ---------------
ASSETS
CURRENT ASSETS
Cash, cash equivalents and
short term investments $ 44,150,898 $ 49,528,407
Accounts receivable 316,973 329,694
Other current assets 2,094,404 1,328,535
--------------- ---------------
Total current assets 46,562,275 51,186,636
OTHER ASSETS
2,870,220 2,894,957
--------------- ---------------
$ 49,432,495 $ 54,081,593
=============== ===============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES $ 5,083,068 $ 4,994,883
LONG TERM LIABILITIES 391,960 457,800
STOCKHOLDERS' EQUITY
Common Stock 311,009 310,734
Additional paid-in capital 140,330,627 140,235,478
Stock subscription receivable
from issuance of Common Stock (37,000) (37,000)
Deficit accumulated during the
development stage (96,647,169) (91,880,302)
--------------- ---------------
Total stockholders' equity 43,957,467 48,628,910
$ 49,432,495 $ 54,081,593
=============== ===============
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the three months ended
March 31,
--------------------------------
2001 2000
--------------- ---------------
REVENUES $ 316,973 $ --
EXPENSES:
Research and development 3,782,214 5,379,962
Selling, general and
administrative 1,942,632 1,631,211
--------------- ---------------
Operating loss (5,407,873) (7,011,173)
INTEREST INCOME, net 641,006 474,201
--------------- ---------------
NET LOSS $ (4,766,867) $ (6,536,972)
=============== ===============
Basic and diluted net loss per
Common share $ (0.15) $ (0.24)
Shares used in computing basic and
diluted net loss per Common share 31,089,838 26,682,240
=============== ===============
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion