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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
SEPTEMBER 22, 2000
Date of report
(Date of earliest event reported)
CELL PATHWAYS, INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE
(State or Other Jurisdiction of Incorporation)
0001066284 23-2969600
(Commission File Number) (IRS Employer Identification No.)
702 ELECTRONIC DRIVE
HORSHAM, PA 19044
(Address of Principal Executive Offices)
215-706-3800
(Registrant's Telephone Number, Including Area Code)
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ITEM 5. OTHER EVENTS
On September 25, 2000, the U.S. Food and Drug Administration issued a "not
approvable" letter noting deficiencies in the Company's New Drug Application
(NDA) for Aptosyn(TM) (exisulind) for the orphan drug indication of familial
polyposis (FAP) and finding the information provided as to the safety and
efficacy of Aptosyn(TM) (exisulind) to be inadequate for the FAP indication. The
Company has announced its intention to amend the NDA and to request a meeting
with the FDA to address the deficiencies and the possible requirement for
additional clinical data.
Certain statements made herein, and oral statements made in respect hereof,
constitute "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are those which
express plan, anticipation, intent, contingency 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; early stage of
development; the costs, delays and uncertainties inherent in basic
pharmaceutical research, drug development, clinical trials and the regulatory
approval process, with respect to both the Company's current product candidates
and its future product candidates, if any; dependence on the development and
market acceptance of Aptosyn(TM) (exisulind) for one or more significant disease
indications; the limitations on, or absence of, the predictive value of data
obtained in laboratory tests, animal models and human clinical trials when
planning additional steps in product development; the uncertainty of obtaining
regulatory approval of any compound for any disease indication; the delay,
uncertainty and adversity arising from the recent action of the FDA is issuing a
"not approvable" letter with respect to the New Drug Application ("NDA")
submitted for Aptosyn(TM) (exisulind) for the orphan drug condition of familial
adenomatous polyposis, a rare disease that puts those afflicted at high risk of
developing colon cancer; the uncertainty of the effect of product approval, if
achieved, on the market price of the Common Stock; the timing and scope of any
approval which might be received for any compound for any indication in the
future; acceptance by providers of healthcare reimbursement; the validity, scope
and enforceability of patents; the actions of competitors; dependence upon third
parties; product liability; and the need for further financing. These and other
risks are detailed in the Company's reports filed from time to time under the
Securities Act of 1933 and/or the Securities Exchange Act of 1934, including the
sections entitled "Business," "Risk Factors," "Management's Discussion and
Analysis of Financial Condition and Results of Operations" and "Other Events" in
the Company's reports on Form 10-K for the year ended December 31, 1999 and Form
10-Q for each of the first three quarters of 2000 and in such registration
statements on Form S-3 as may be filed 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 database. Given the uncertainties affecting pharmaceutical
companies in the development stage, current and prospective investors 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
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to above which characterize the Company's development stage business. The
Company undertakes no obligation to update or revise the statements made herein
or the factors which may relate thereto.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CELL PATHWAYS, INC.
Dated: September 29, 2000 By: /s/ Robert J. Towarnicki
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Robert J. Towarnicki
President, Chief Executive Officer and
Director (Principal Executive Officer)
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