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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
                                    ===============  ===============
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 19, 2001
Words:1427
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