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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) NOVEMBER 25, 1997
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CYGNUS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE 0-18962 94-2978092
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
400 PENOBSCOT DRIVE, REDWOOD CITY, CALIFORNIA 94063-4719
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 369-4300
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NOT APPLICABLE
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(Former name or former address, if changed since last report)
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Item 5 OTHER EVENTS
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On November 25, 1997, Cygnus, Inc. issued a press release announcing
the results of research clinical studies conducted on its GlucoWatch glucose
monitoring system. Cygnus, Inc. also issued a second press release,
announcing its intent to conduct a public offering of its convertible
subordinated notes. Copies of such press releases are attached hereto as
Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated herein by
reference.
Item 7 FINANCIAL STATEMENTS AND EXHIBITS
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(c) Exhibits. The following documents are filed as exhibits to this
--------- report:
99.1 Press Release, dated November 25, 1997, issued by
Cygnus, Inc. announcing the results of research
clinical studies.
99.2 Press Release, dated November 25, 1997, issued by
Cygnus, Inc. announcing a proposed public offering of
convertible subordinated notes.
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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.
CYGNUS, INC.
(Registrant)
Date: November 25, 1997 By: /s/ John C. Hodgman
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John C. Hodgman
Title: Chief Financial Officer
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EXHIBIT INDEX
Exhibit Description
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99.1 Press Release, dated November 25, 1997, issued by Cygnus,
Inc. announcing the results of research clinical studies.
99.2 Press Release, dated November 25, 1997, issued by Cygnus,
Inc. announcing a proposed public offering of convertible
subordinated notes.
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EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
Craig Carlson/Senior Vice President
(650) 369-4300
[LOGO]
FOR IMMEDIATE RELEASE
NEWS RELEASE
CYGNUS-Registered Trademark- ANNOUNCES RESULTS OF RESEARCH CLINICAL STUDIES
FOR THE GLUCOWATCH-Trademark-
Redwood City, CA - November 25, 1997 - Cygnus, Inc. (NASDAQ: CYGN) announced
the results from a series of research clinical studies conducted in 1997 for
its painless, bloodless and automatic glucose monitor, The GlucoWatch.
Based on the accuracy and precision data from these studies, Cygnus believes
that the GlucoWatch system performs comparably with currently marketed
glucose devices. Data from these studies demonstrate that the GlucoWatch
system is able to measure glucose levels with statistically significant
accuracy and precision across a variety of conditions. The results indicated
a correlation coefficient of 0.90, a mean absolute error of 0.20 and a mean
bias of 5.0%. These studies have shown that differences in physiological
factors (age, race, ethnicity, gender, body mass index) and environmental
factors (temperature and moderate levels of perspiration) do not affect the
accuracy and precision of the GlucoWatch system's glucose measurement.
Certain commonly used drugs also did not adversely affect the performance of
the GlucoWatch system in those studies. The accuracy and precision of the
GlucoWatch system did not vary significantly from the overall averages in the
groups in which these variables were tested. Another statistical measure of
the data, known as error grid analysis, supports the accuracy and precision
of the GlucoWatch (92% in the clinically desirable zones A and B). The
Company has recently initiated registration clinical studies for the
GlucoWatch. Cygnus anticipates filing an application for approval with the
FDA in the second quarter of 1998.
These research clinical studies were conducted on people with diabetes by
outside, independent clinical investigators using the commercial version of
the GlucoWatch. GlucoWatch measurements were compared to venous blood glucose
reference measurements every 20 or 30 minutes.
The Company believes the GlucoWatch system offers a combination of features
not available in currently marketed devices, such as: painless and bloodless
glucose extraction; automatic and frequent measurements; an electronic memory
to store and display glucose levels; the ability to download stored
information to personal computers to analyze glucose data and trends; alarms
indicating hypo- and hyperglycemic conditions; and event markers which record
factors that affect glucose levels, all in a discreet watch format. The
Company believes this unique combination of features will result in better
control of glucose levels, an improved quality of life for people with
diabetes and more cost-effective health care.
--more--
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The forward looking statements regarding future events and the future
performance of the Company contained in this press release involve risks and
uncertainties which may cause the Company's actual results in future periods
to be materially different from any future performance suggested herein. The
Company believes that the submission to the FDA for the GlucoWatch will be in
the form of a premarket notification (a "510(k) notification"), although the
final determination of the type of submission will not be made until FDA
submission. There can be no assurance that a 510(k) notification will be
accepted by the FDA. If a 510(k) notification is not accepted by the FDA, the
Company will be required to submit a premarket approval application ("PMA")
for this product. The FDA approval process for a PMA is typically more
involved and requires more time than a 510(k) notification and could
materially delay the introduction of the GlucoWatch. There can be no
assurance as to FDA acceptance or approval of the form or timing of a 510(k)
notification, a PMA or any similar FDA submission, that the results of the
registration clinical trials for submission to the FDA will be approved by
the FDA nor that the results will be comparable to the results obtained in
the research clinical studies performed to date. Delays or failure to receive
clearance following a 510(k) notification or approval of a PMA application
could have a significant adverse effect on the Company's business, financial
condition and results of operations. For more information, refer to Cygnus'
filings with the Securities and Exchange Commission, including its Form 10-K,
Form 10-Q and Form 8-K reports.
Cygnus is engaged in the development and manufacture of diagnostic and drug
delivery systems utilizing proprietary technologies to satisfy unmet medical
needs cost-effectively. The Company's current efforts are primarily focused
on two core areas: a painless, bloodless and automatic glucose monitoring
device (the GlucoWatch system) and transdermal drug delivery systems.
END
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EXHIBIT 99.2
FOR ADDITIONAL INFORMATION:
Craig Carlson/Senior Vice President
(650) 369-4300
[LOGO]
NEWS RELEASE
FOR IMMEDIATE RELEASE
CYGNUS-Registered Trademark- FILES FOR $75 MILLION CONVERTIBLE DEBT OFFERING
Redwood City, CA - November 25, 1997 - Cygnus, Inc. (NASDAQ: CYGN) announced
that it intends to conduct a public offering of up to $75 million of its
convertible subordinated notes, excluding any over-allotments. The proposed
notes would consist of interest-bearing securities convertible into newly
issued shares of the Company's Common Stock at any time prior to their
maturity in 2002. The Company has selected PaineWebber Incorporated and
Morgan Stanley Dean Witter as the managing underwriters of the offering,
which is currently expected to be completed in December 1997, depending on
market conditions.
The forward looking statements regarding future events and the future
performance of the Company contained in this press release involve risks and
uncertainties which may cause the Company's actual results in future periods
to be materially different from any future performance suggested herein. For
more information, refer to Cygnus' filings with the Securities and Exchange
Commission, including its Form 10-K, Form 10-Q and Form 8-K reports.
Cygnus is engaged in the development and manufacture of diagnostic and drug
delivery systems utilizing proprietary technologies to satisfy unmet medical
needs cost-effectively. The Company's current efforts are primarily focused
on two core areas: a painless, bloodless and automatic glucose monitoring
device (the GlucoWatch system) and transdermal drug delivery systems.
END
