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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
September 22, 1998
(Date of earliest event reported)
IMMUCELL CORPORATION
(Exact name of registrant as specified in its charter)
0-15507
(Commission file number)
DELAWARE 01-0382980
(State or other jurisdiction (I.R.S. Employer
of incorporation) Identification No.)
56 Evergreen Drive
Portland, ME 04103
(Address of principal executive offices and zip code)
(207) 878-2770
(Registrant's telephone number, including area code)
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Item 5. OTHER EVENTS
On September 22, 1998, the Registrant issued a press release
announcing negative clinical trial results of its product under
development, TravelGAM{TM} bovine anti-E. COLI immunoglobulins, and other
current news. The press release noted that the Company has no further
development plans for this product and that, later this year, the Company
intends to initiate a small study of the Company's other passive antibody
product under development for humans, DiffGAM{TM} bovine anti-CLOSTRIDIUM
DIFFICILE immunoglobulins, with results expected in late 1999.
The press release announcing these results is incorporated herein by
reference and filed as Exhibit 99.1 hereto.
Item 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
99.1 The Registrant's Press Release dated September 22, 1998.
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.
IMMUCELL CORPORATION
Date SEPTEMBER 22, 1998 /S/ MICHAEL F. BRIGHAM
Michael F. Brigham
Chief Financial Officer, Treasurer and
Secretary
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EXHIBIT INDEX
Exhibit Sequential
NUMBER DESCRIPTION PAGE NUMBERS(S)
99.1 The Registrant's Press Release 4
Dated September 22, 1998
FOR IMMEDIATE RELEASE Contact:
Michael F. Brigham
September 22, 1998
Chief Financial Officer
(207) 878-2770 Ext. 106
ImmuCell obtains negative clinical results on TravelGAM
PORTLAND, Maine -- September 22, 1998 -- ImmuCell Corporation
(NASDAQ/ICCC)
announced that preliminary results from a hospital-based,
challenge/protection Phase II clinical trial of TravelGAM{TM} bovine anti-
E. COLI immunoglobulins were negative, with no treatment effect detected.
The study, funded under a grant from the National Institutes of Health, was
designed to address discrepancies between the product's clinical success in
a 1995 study and the inconclusive results obtained in a field trial
completed earlier in 1998. The Company has no further development plans
for this product to prevent Travelers' Diarrhea.
The Company is now limiting its human passive antibody development efforts
to DiffGAM{TM} bovine anti-CLOSTRIDIUM DIFFICILE immunoglobulins, a
product intended to treat CLOSTRIDIUM DIFFICILE-associated diarrhea
("CDAD") . CDAD affects an estimated 1.6 million people in the U.S.
annually. If shown to be effective, DiffGAM could provide an alternative
to the use of oral antibiotics in the treatment of CDAD and a unique
clinical benefit by directly attacking the toxins produced by CLOSTRIDIUM
DIFFICILE. This anti-toxin action, in combination with the Company's
colonic delivery formulation, forms the basis for the Company's plan to
initiate a small effectiveness study later this year with results expected
in late 1999.
In other news, the Company announced that it had recently dissolved its
joint venture to develop diagnostic products to detect CRYPTOSPORIDIUM
PARVUM and other infectious disease organisms in drinking water and intends
to continue to develop and market these products directly. Simultaneously
with the dissolution of the joint venture, the relevant technology (that
had been previously licensed to the joint venture) was licensed directly to
the Company, subject to a royalty obligation. This change in structure was
precipitated by the Company's belief in the need to achieve greater market
focus. Product sales and gross margin will now be accounted for directly
on the Company's financial statements rather than being accounted for as
equity in earnings of the joint venture. CRYPTOSPORIDIUM caused a large
outbreak of cryptosporidiosis in Milwaukee in 1993 and a smaller outbreak
in Sydney, Australia this past summer.
The Company provided a recap of some mid year financial highlights. As of
June 30, 1998, the Company had cash of $1,352,000 ($0.56 per share) and
stockholders' equity of $2,489,000 ($1.02 per share). The Company earned a
net profit of approximately $139,000 ($0.05 profit per share) during the
six month period ended June 30, 1998, compared to a net loss of $52,000
($0.02 loss per share) during the comparable period ended June 30, 1997.
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ImmuCell Corporation is a biotechnology company engaged in the development
of animal health products to expand its commercialized line of products for
use by dairy and beef producers. The Company is also developing a human
application of its milk-derived passive antibody technology for use as an
alternative to antibiotics in the treatment of a gastrointestinal
infection. In addition, ImmuCell is marketing Crypto-Scan{TM}, a novel
drinking-water test that detects a major and growing menace
(CRYPTOSPORIDIUM) to drinking-water supplies worldwide, and the Company
owns 50% of a joint venture that is manufacturing bovine lactoferrin, a
nutritional milk protein derived from cheese whey.
THIS PRESS RELEASE CONTAINS "FORWARD LOOKING STATEMENTS" WITHIN THE MEANING
OF SECTION 27A OF THE SECURITIES ACT OF 1933, AND SECTION 21E OF THE
SECURITIES EXCHANGE ACT OF 1934. SUCH STATEMENTS INCLUDE, BUT ARE NOT
LIMITED TO, ANY STATEMENTS RELATING TO THE COMPANY'S CLINICAL TRIAL PLANS
AND INTENDED TIMELINESS AND ANY OTHER STATEMENTS THAT ARE NOT HISTORICAL
FACTS. SUCH STATEMENTS INVOLVE RISKS AND UNCERTAINTIES, INCLUDING, BUT NOT
LIMITED TO, THOSE RISKS AND UNCERTAINTIES RELATING TO DIFFICULTIES OR
DELAYS IN DEVELOPMENT, TESTING, REGULATORY APPROVAL, PRODUCTION AND
MARKETING OF THE COMPANY'S PRODUCTS, ANY INADEQUATE THERAPEUTIC EFFICACY OF
THE COMPANY'S PRODUCTS THAT COULD SLOW OR PREVENT PRODUCT DEVELOPMENT
EFFORTS, COMPETITION WITHIN THE COMPANY'S ANTICIPATED PRODUCT MARKETS, THE
UNCERTAINTY OF PRODUCT DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY, AND
OTHER RISKS DETAILED FROM TIME TO TIME IN FILINGS THE COMPANY MAKES WITH
THE SECURITIES AND EXCHANGE COMMISSION, INCLUDING ITS ANNUAL REPORT ON FORM
10-K AND ITS QUARTERLY REPORTS ON FORM 10-Q. SUCH STATEMENTS ARE BASED ON
MANAGEMENTS' CURRENT EXPECTATIONS, BUT ACTUAL RESULTS MAY DIFFER MATERIALLY
DUE TO VARIOUS FACTORS, INCLUDING THOSE RISKS AND UNCERTAINTIES MENTIONED
OR REFERRED TO IN THIS PRESS RELEASE.
