Cell Pathways, Inc. Reports First Quarter 2003 Financial Results.Business Editors/Health/Medical Writers HORSHAM Horsham (hôr`shəm), town (1991 pop. 38,356) and district, West Sussex, SE England. Horsham is known primarily for its agricultural and merchandising activities, but it also serves as an engineering center. , Pa.--(BUSINESS WIRE)--May 14, 2003 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 first quarter ended March 31, 2003. Net loss for the first quarter of 2003 was $5.6 million or $0.14 per share compared to a net loss of $5.6 million, or $0.18 per share for the same period in 2002. The Company ended the quarter with $6.0 million in cash as compared to $10.9 million in cash at December December: see month. 31, 2002. Revenues recognized on sales of Gelclair(TM) Concentrated Oral Gel for the first quarter of 2003 were $522,000. Gelclair(TM) is approved for use in treating oral mucositis mucositis (mū´kōsī´tis), n an inflammation of the mucous membrane. mucositis, chronic atrophic senile, n , an inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood and ulceration ulceration /ul·cer·a·tion/ (ul?ser-a´shun) 1. the formation or development of an ulcer. 2. an ulcer. ul·cer·a·tion n. 1. Development of an ulcer. 2. of the mouth caused by chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. and radiotherapy radiotherapy /ra·dio·ther·a·py/ (-ther´ah-pe) treatment of disease by means of ionizing radiation; tissue may be exposed to a beam of radiation, or a radioactive element may be contained in devices (e.g. . The Company has contracts with Celgene Celgene Corporation NASDAQ: CELG is a manufacturer of drug therapies for cancer and inflammatory disorders. It is incorporated in Delaware and headquartered in Summit, New Jersey. Corportation and John O. Butler Company whereby Celgene and Butler promote Gelclair(TM) in the oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. and dental marketplaces, respectively. Cost of products sold related to Gelclair(TM) were $190,000 for the first quarter of 2003. There were no product sales of Gelclair(TM) in the first quarter of 2002 since the Company began promoting Gelclair(TM) in the second quarter of 2002. Research and development expenses were $3.5 million in the first quarter of 2003 as compared to $4.3 million for the same period in 2002, a decrease of $855,000 or 19.8%. This decrease was primarily the result of reductions in personnel, lower clinical study costs for Aptosyn(R) (exisulind), the Company's first drug candidate, a reduction in research supplies and fees associated with the Company's scientific advisory board. Partially offsetting these lower expenses were increases in expenses related to the development of the Company's second drug candidate, CP461. Selling, general and administrative expenses were $2.5 million in the first quarter of 2003 as compared to $2.3 million for the same period in 2002, an increase of $230,000 or 10.2%.This increase was due primarily to expenses for accounting, legal and consulting related to the Company's pending acquisition by OSI Pharmaceuticals OSI Pharmaceuticals, Inc. is an American pharmaceutical company based in Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. They specialize in the discovery and development of molecular targeted therapies, and are listed in the NASDAQ , Inc. and marketing expenses for Gelclair(TM). Partially offsetting these increases in expenses were decreases in personnel and marketing consulting expenses. In the first quarter of 2002, the Company recorded a non-cash reduction of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. settlement expense of $850,000 related to the then proposed securities class action litigation settlement. The reduction of expense related to and adjusted for the fair value of securities that were to be issued as part of the settlement. The settlement was finalized See finalization. in September 2002. There was no litigation settlement expense or reduction thereof, in the first quarter of 2003. In February 2003, the Company entered into an agreement with OSI Pharmaceuticals, Inc. whereby OSI Pharmaceuticals will acquire the Company in a stock-for-stock merger of the Company with a subsidiary of OSI Pharmaceuticals. A stockholders meeting for the purpose of seeking approval of the proposed transaction has been scheduled for June 10, 2003. Commenting on the quarter, Mr. Robert J. Towarnicki, Cell Pathways' chairman and chief executive officer, said, "First quarter 2003 was marked by two noteworthy events, the announcement of the proposed acquisition of Cell Pathways by OSI Pharmaceuticals and the completion of enrollment in our Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial of Aptosyn(R) and Taxotere Taxotere® Docetaxol, see there (TM) in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. ." 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 and development of products to treat and prevent cancer and to treat certain autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . The Company also markets Gelclair(TM) Concentrated Oral Gel, manufactured by Sinclair Pharmaceuticals, Ltd. of the United Kingdom. For additional information on Cell Pathways, Inc., visit the Company's web site at http://www.cellpathways.com. Note to Editors: Aptosyn(R) is a registered trademark of Cell Pathways, Inc., Gelclair(TM) is a trademark of Sinclair Pharmaceuticals Ltd. and Taxotere(TM) is a registered trademark of Aventis Pharmaceuticals Inc. This release contains "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. These statements are those which express plans, anticipation, intent, contingency contingency n. an event that might not occur. or future developments and/or otherwise are not statements of historical fact, including, statements regarding the acquisition by merger of the Company by OSI Pharmaceuticals. 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, including, among others, the risk that the Company's stockholders do not approve the merger or that another condition to the closing of the merger is not satisfied and other risks and uncertainties discussed in the Company's filings with the Securities and Exchange Commission. Additional Information About the Merger and Where to Find It In connection with the proposed merger referred to above, OSI Pharmaceuticals has filed with the Securities and Exchange Commission (SEC) a registration statement on Form S-4. The registration statement has been declared effective, and it contains the proxy statement Proxy Statement A document containing the information that a company is required by the SEC to provide to shareholders so they can make informed decisions about matters that will be brought up at an annual stockholder meeting. of Cell Pathways for the meeting of its stockholders scheduled for June 10, 2003 to consider and vote upon the proposed merger. The proxy statement also serves as a prospectus of OSI Pharmaceuticals with respect to the shares of OSI Pharmaceuticals to be distributed to stockholders of Cell Pathways in the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE PROXY STATEMENT/PROSPECTUS REGARDING THE PROPOSED MERGER TRANSACTION AND ANY OTHER DOCUMENTS FILED WITH THE SEC, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT OSI (1) (Open System Interconnection) An ISO standard for worldwide communications that defines a framework for implementing protocols in seven layers. Control is passed from one layer to the next, starting at the application layer in one station, proceeding to the , CELL PATHWAYS, THE MERGER AND RELATED MATTERS. Investors and security holders may obtain a free copy of the proxy statement/prospectus and other documents filed by OSI Pharmaceuticals and Cell Pathways at the SEC's web site at http://www.sec.gov. In addition, they may obtain such documents from OSI Pharmaceuticals or from Cell Pathways free of charge by requesting them in writing from OSI Pharmaceuticals, Inc., 58 South Service Road, Suite 110, Melville, New York Melville is a hamlet and census-designated place in the town of Huntington in Suffolk County on Long Island, New York, in the United States. As of the 2000 census, 14,533 people resided there. 11747, Attention: Investor Relations Investor relations The process by which the corporation communicates with its investors. , telephone: (631) 962-2000, or from Cell Pathways, Inc., 702 Electronic Drive, Horsham, Pennsylvania 19044, Attention: Investor Relations, telephone: (215) 706-3800. OSI, Cell Pathways, their respective officers and directors and certain other members of management or employees may be deemed to be participants in the solicitation solicitation In criminal law, the act of asking, inducing, or directing someone to commit a crime. The person soliciting another becomes an accomplice to the crime. The term also refers to the act of obtaining bribes, as well as to the crime of a prostitute who offers sexual of proxies from stockholders of Cell Pathways with respect to the transactions contemplated by the merger agreement. A description of any interests that OSI Pharmaceuticals' or Cell Pathways' directors and executive officers have in the proposed merger is available in the proxy statement/prospectus. This press release is not an offer to sell shares of OSI Pharmaceuticals common stock which may be issued in the proposed merger with Cell Pathways. Such OSI Pharmaceuticals common stock is offered only by means of the proxy statement/prospectus referred to herein.
CELL PATHWAYS, INC.
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, 2003 December 31, 2002
----------------- -----------------
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 5,984,766 $ 10,920,335
Accounts receivable 330,018 472,012
Inventory 2,430,849 2,140,615
Other current assets 802,118 792,610
------------- -------------
Total current assets 9,547,751 14,325,572
OTHER ASSETS 3,039,195 3,144,112
------------- -------------
$ 12,586,946 $ 17,469,684
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES $ 6,405,341 $ 5,729,622
------------- -------------
LONG TERM LIABILITIES 21,583 36,668
------------- -------------
STOCKHOLDERS' EQUITY
Common Stock 394,759 393,637
Additional paid-in capital 152,565,427 152,524,388
Deferred Compensation (54,926) (58,672)
Deficit accumulated during the
development stage (146,745,238) (141,155,959)
------------- -------------
Total stockholders' equity 6,160,022 11,703,394
------------- -------------
$ 12,586,946 $ 17,469,684
============= =============
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended
March 31,
---------------------------
2003 2002
----------- -----------
PRODUCT SALES $ 522,414 $ --
----------- -----------
EXPENSES:
Cost of products sold 189,595 --
Research and development 3,456,436 4,311,246
Selling, general and administrative 2,489,371 2,259,476
Litigation settlement (1) -- (850,000)
----------- -----------
6,135,402 5,720,722
----------- -----------
Operating loss (5,612,988) (5,720,722)
INTEREST INCOME, net 23,709 88,821
----------- -----------
NET LOSS $(5,589,279) $(5,631,901)
=========== ===========
Basic and diluted net loss per common share $ (0.14) $ (0.18)
=========== ===========
Shares used in computing basic and diluted
net loss per common share 39,431,821 31,322,203
=========== ===========
(1) Reduction of expense amount was recorded to adjust the 2001
recorded preliminary securities class action settlement amount to
equal the fair value of the 1.7 million shares of common stock as of
March 31, 2002. These shares have not been included in the shares used
in computing basic and diluted net loss per common share for the three
months ended March 31, 2002 since the settlement was not finalized
until September 2002.
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