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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): July 2, 1998 (June 29, 1998)
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THERAPEUTIC ANTIBODIES INC.
(Exact name of registrant as specified in its charter)
Delaware 0-25978 62-1212485
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification
Number)
1207 17th Avenue South
Suite 103
Nashville, Tennessee 37212
(Address of principal executive offices) (Zip Code)
(615) 327-1027
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS
On June 29, 1998, Therapeutic Antibodies Inc. (the "Company") announced
the completion of a private placement of $3,150,000 principal amount of
short-term subordinated promissory notes and warrants. The notes, which bear
interest at an annual rate of 15%, are repayable within 180 days of the dates of
issuance. Each purchaser of $250,000 principal amount of the notes was entitled
to receive a stock purchase warrant to purchase up to 25,000 shares of the
Company's Common Stock, par value $.001 per share. Warrants to purchase an
aggregate of 315,000 shares were issued to purchasers of the notes. The warrants
expire five years after the date of issuance. Proceeds of the sale of the notes
will be used to fund the Company's immediate working capital requirements and
for continuing development of the Company's polyclonal antibody products. The
Company is continuing to pursue long-term financing arrangements.
Also on June 29, 1998, the Company announced a new development strategy
for its CytoTAb(R) product. The Company will concentrate on its existing and new
studies of CytoTAb for Cerebral Malaria, Graft vs. Host Disease and certain
other indications where the patient populations are relatively homogenous and
the onset of high levels of Tumor Necrosis Factor can be readily predicted. The
Company will seek to utilize initial data from its various CytoTAb(R) studies to
attract collaborative partners in the pharmaceutical industry to fund larger
pivotal studies. The Company announced the closing of its current Sepsis Phase
IIb clinical study with 81 patients enrolled in order to provide an early
evaluation of the data. The Company expects to announce the results of the
Sepsis study by the end of 1998.
ITEM 7. EXHIBITS
20.1 Copy of the press release, dated June 29, 1998, relating to the
completion of the private placement and the Company's CytoTAb(R)program.
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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.
THERAPEUTIC ANTIBODIES INC.
By: /s/ A.J. KAZIMI
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A.J. Kazimi
President and Chief Operating Officer
Date: July 2, 1998
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Exhibit 20.1
[THERAPEUTIC ANTIBODIES LOGO]
FOR IMMEDIATE RELEASE
THERAPEUTIC ANTIBODIES INC ANNOUNCES
US$3,150,000 FINANCING AND
STRATEGIC PRODUCT PORTFOLIO REVIEW
(Nashville, Tenn) -- June 29, 1998 -- Therapeutic Antibodies Inc (TAb) announces
today the first stage of its refinancing, having completed an initial closing of
US$3,150,000 in interim funding. The Company also announces its new strategy for
the development of its CytoTAb(R) product.
The private placement, designed to meet TAb's near term capital
requirements, involved short-term interest bearing notes with warrants. The
notes carry a 15% coupon and are repayable in 180 days. The five-year warrants
provide for the purchase of up to an aggregate of 315,000 shares of Common Stock
at an exercise price equal to the current market price of TAb shares. TAb's
Chairman Martin S. Brown and Chief Executive Officer Andrew J. Heath both
participated in this financing and together subscribed for $375,000.
Following the appointment of TAb's new Chief Executive Officer, Dr.
Andrew J. Heath, the Company has undertaken a strategic review of its product
portfolio. As a result, TAb will be implementing a new development strategy for
CytoTAb(R), its purified anti-Tumor Necrosis Factor (TNF) antibody. Through work
carried out to date, CytoTAb(R) has been shown to be safe and effective in
neutralizing circulating TNF. The Company will now be concentrating on the
following indications:
- - Cerebral Malaria. The current Phase II study is continuing with 56 of
the 100 patients already enrolled and completion of enrollment targeted
by year end.
- - Graft vs Host disease. A 12-patient pilot study is underway to evaluate
the use of CytoTAb(R) in cancer patients who encounter acute Graft vs
Host disease as a result of bone marrow transplants.
- - New Studies. The Company is commencing new pilot clinical efforts to
determine the feasibility of using CytoTAb(R) in Crohn's disease,
melioidosis infections and coronary artery bypass graft (CABG) surgery.
Initial trials in these indications will require relatively few
patients and can be conducted rapidly.
-more-
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PAGE 2. THERAPEUTUC ANTIBODIES
TAb will now be directing its resources toward initial studies in
disorders where the patient populations are relatively homogenous and the onset
of high levels of TNF can be readily predicted. TAb will seek to provide initial
data which can be utilized to attract pharmaceutical partners to fund larger
pivotal studies. Therefore, the Company will close its current Sepsis Phase IIb
study with the 81 patients enrolled to date in order to provide an early
evaluation of the data. The Company expects to announce the study results by the
end of the year.
In addition, management has determined that due to declining market
potential, reflecting the availability of new therapies, it will not proceed
with the CytoTAb(R) renal transplant study, which had been scheduled to commence
this year.
Commenting on these developments, Dr. Heath said, "Having now been with
TAb for three months, I am delighted to announce progress is driving the Company
toward commercialization. We recently announced signing an agreement with
Searle/Monsanto, which, following its merger with American Home Products Corp.,
will become the third largest pharmaceutical company in the world. Following a
thorough review of our business and product portfolio, we have revised our goals
with regard to CytoTAb(R) to broaden the indications and pursue studies
compatible with the Company's resources. The first closing of this interim
funding provides the capital to meet our immediate financial requirements."
Therapeutic Antibodies is an international biopharmaceutical company
specializing in research, development and production of highly-purified
polyclonal antibodies for treatment of diseases and other life-threatening
conditions for which satisfactory therapies have generally not previously
existed.
TAb is headquartered in Nashville, Tennessee, adjacent to the
Vanderbilt University Medical Center. The Company's research laboratories are
located at the Medical College of St. Bartholomew's Hospital in London. TAb's
products are manufactured at the Company's production facilities in the U.K. and
Australia for worldwide distribution. The Company's Common Stock is listed on
the London Stock Exchange.
An electronic version of this news release, as well as additional
information about Therapeutic Antibodies Inc, is available at
http://www.tab.co.uk on the Company's home page.
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