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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT FILED PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT
(DATE OF EARLIEST EVENT REPORTED): JULY 10, 2001
ZONAGEN, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 0-21198 76-0233274
(STATE OR OTHER JURISDICTION OF (COMMISSION FILE NUMBER) (I.R.S. EMPLOYER IDENTIFICATION NO.)
INCORPORATION OR ORGANIZATION)
2408 TIMBERLOCH PLACE, SUITE B-4
THE WOODLANDS, TEXAS 77380
(ADDRESS OF PRINCIPAL
EXECUTIVE OFFICES
AND ZIP CODE)
(281) 719-3400
(REGISTRANT'S TELEPHONE NUMBER,
INCLUDING AREA CODE)
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ITEM 9. REGULATION FD DISCLOSURE
Zonagen, Inc. (the "Company") is furnishing the following information
under Item 9 of this Current Report on Form 8-K in accordance with Regulation FD
promulgated by the Securities and Exchange Commission:
At the Annual Meeting of Stockholders of the Company held July 10,
2001, Company representatives stated that the mechanistic rat study of
Vasomax(R) concerning brown fat proliferations was ongoing and that the Company
had completed the gross part of the interim 6-month assessment. The Company
representatives stated that no hibernomas had been found in any animals, young
or old. The Company representatives also stated that the Company will be sending
the interim analysis to the Food and Drug Administration ("FDA") as soon as
completed, which the Company hopes can occur before the end of the summer.
The Company representatives stated that the interim findings are not
conclusive and no results concerning the mechanistic rat study may be based
upon, or inferred from, the interim findings. The Company anticipates that final
data from the study will not be available for FDA submission until the first
half of 2002.
Safe Harbor Statement under the Private Securities Litigation Reform Act
of 1995:
Statements made in this filing which relate to future events are made
pursuant to the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based upon current expectations and the Company
assumes no obligation to update this information. Because actual results may
differ materially from expectations, the Company cautions readers not to place
undue reliance on these statements. These forward-looking statements involve
risks and uncertainties, including, but not limited to, those relating to the
uncertainties involving the Company's early stage of development, clinical trial
results and FDA approval in the United States and approval of regulatory
authorities in other jurisdictions, substantial dependence on one product,
history of operating losses, future capital needs and uncertainty of additional
funding, uncertainty of protection for patents and proprietary technology,
litigation, governmental regulation, limited sales and marketing experience and
dependence upon collaborators, manufacturing uncertainties and reliance on third
parties, competition and technology change, product liability and availability
of insurance, and other risks identified in the Company's Annual Report on Form
10-K for the year ended December 31, 2000, as filed with the Securities and
Exchange Commission.
The information in this Current Report is furnished pursuant to Item 9
and shall not be deemed to be "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934 or otherwise subject to the liabilities of that
section. This Current Report will not be deemed an admission as to the
materiality of any information contained herein that is required to be disclosed
solely by Regulation FD.
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SIGNATURES
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.
ZONAGEN, INC.
Date: July 11, 2001
By: /s/ JOSEPH S. PODOLSKI
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Joseph S. Podolski
Chief Executive Officer
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