RNS No 6595w
THERAPEUTIC ANTIBODIES INCORPORATED
14th August 1998
THERAPEUTIC ANTIBODIES ANNOUNCES
SECOND QUARTER RESULTS
London, 14 August, 1998 - Therapeutic Antibodies Inc
today announced results for the second quarter ended 30
June, 1998, which will be filed as Form 10-Q with the
Securities and Exchange Commission (SEC) in the United
States.
The quarter was marked by increases in sales, contract
and licensing revenue, significant advances in product
and partnership development and successful completion of
the first stage of the Company's refinancing plan.
HIGHLIGHTS:
* Sales and contract revenue tripled to
US$400,077 from US$131,780 in the second
quarter of 1997
* Product licensing revenue totalled US$1,400,000
for the quarter
* Investment in R & D increased 4% to
US$2,985,756 from US$2,884,248 in the
equivalent period in 1997
* FDA acceptance of license applications for
CroTAb triggered a US$1 million milestone
payment from Altana Inc.
* R & D agreement signed with G. D. Searle & Co.,
(division of Monsanto Co.)
* Clinical trials started for TriTAb, the
Company's treatment for reversal of
antidepressant toxicity
* The Company completed an initial closing of
US$3,150,000 in interim funding to meet near-
term cash requirements
* U.S. military placed orders for ViperaTAb
Dr Andrew J Heath, Chief Executive, said:
"The second quarter has been an exceptionally active
period for us and I am extremely pleased with the
substantial progress that has been made, particularly in
the priority areas we identified earlier in the year.
Our product development program is being more closely
targeted against near-term commercial opportunities, with
special focus on the emergency medicine product line. We
are taking advantage of our technology platform to craft
strategic alliances with research based companies, such
as the agreement with Searle. As we begin to implement
our refinancing plan, we are committed to managing our
global business more efficiently thus assuring the best
use of our capital resources."
SECOND QUARTER REPORT
Chief Executive's Statement
I am very pleased to report that our second quarter was
marked by increases in sales, contract and licensing
revenue, advances in product and partnership development
and successful completion of the first stage of a
refinancing plan to meet near-term cash requirements. We
are now tackling the priority issues identified earlier
this year and expect to make continuing advances in the
second half.
In June, we announced the first stage of the Company's
refinancing, having completed an initial closing of
US$3,150,000 in interim funding. We have also made
important progress in our efforts to secure the longer
term capital required by the Company.
Review of Operations
Searle Agreement
The Company signed a research agreement with G. D. Searle
& Co., the pharmaceutical division of Monsanto Co.,
providing for collaboration in the identification,
development and commercialization of a new antibody-based
drug. Under the agreement, Searle forecasts paying the
Company US$8 million for research and development and
product supplies.
CroTAb
The Food and Drug Administration (FDA) accepted for
review the Company's license applications for CroTAb, a
new antivenom product designed to neutralize the effects
of bites from most poisonous snakes native to North
America. The FDA acceptance triggered a US$1 million
milestone payment from Altana under its distribution
agreement with the Company. Under terms of the
agreement, Altana will pay up to US$23 million for the US
rights to the Company's emergency medicine products.
CytoTAb
Following an intensive review of the Company's product
portfolio, the Company has adopted a new development
strategy for CytoTAb, a polyclonal antibody product,
which has been shown to be safe and effective in
neutralizing circulating TNF (tumor necrosis factor). As
a result, the Company will concentrate on the following
indications:
New Indications - The Company is commencing new pilot
studies to determine the feasibility of using CytoTAb in
Crohn's disease and cardiopulmonary bypass (CPB).
Initial trials in these indications will require
relatively few patients and can be conducted rapidly.
The clinical trials for these indications are planned to
be underway in 1999.
Cerebral Malaria - The current Phase II study is
continuing in Bangkok, with 84 of the anticipated 100
patients already enrolled. The enrollment is expected to
be complete by the end of the year, several months
earlier than previously expected.
Graft vs. Host Disease - A 12 patient study is underway
to evaluate the use of CytoTAb in patients who encounter
the disease as a result of bone marrow transplants.
ViperaTAb
The U.S. military has recently placed orders for supplies
of ViperaTAb, the Company's Common Adder antivenom
product. The Company is delighted that the military will
be using ViperaTAb as it provides further endorsement of
one of the Company's most successful products to date.
TriTAb
The Company has accelerated its research program on
TriTAb, a polyclonal antibody product tailored to offset
the toxic effects of overdoses of tricyclic
antidepressants. A pilot clinical study was launched in
the second quarter, marking the first time the product
has been administered in humans. The Company expects
data from this pilot study to be available in the first
half of 1999.
Andrew J. Heath, M.D.
Chief Executive
August 1998
For further information, please contact:
Dr. Andrew J. Heath Therapeutic Antibodies 00 1 615 327 1027
A. J. Kazimi Therapeutic Antibodies 00 1 615 327 1027
Stephen Breslin/ Brunswick Group Ltd 0171 404 5959
Jessica Shepherd-Smith
Notes to Editors:
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.
Therapeutic Antibodies 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. The Company's products are manufactured at its
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.
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, December 31,
1998 1997
ASSETS
Current assets:
Cash and cash
equivalents $ 2,268,914 $ 4,915,077
Restricted cash 1,000,000 -
Short-term
investments - 1,997,240
Trade 141,980 594,267
receivables
Value added tax
receivable 123,769 179,629
Inventories 160,497 489,138
Other current 216,779 409,929
assets ______ ______
Total current 3,911,939 8,585,280
assets
Property and
equipment, net 11,287,699 11,456,690
Patent and
trademark costs, 620,224 598,924
net
Other assets, 126,013 159,171
net ______ ______
Total assets $ 15,945,875 $ 20,800,065
====== ======
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,216,693 $ 1,457,121
and accrued
expenses
Accrued interest 206,502 146,326
Current portion 5,299,410 2,545,701
of notes payable ______ ______
Total current
liabilities 6,722,605 4,149,148
Notes payable,
net of current 5,625,043 6,059,072
portion
Deferred revenue 364,496 559,467
Other 276,839 274,033
liabilities ______ ______
Total 12,988,983 11,041,720
liabilities ====== ======
Stockholders'
equity:
Preferred stock
- par value $.01
per share;
1,000,000 shares
authorised;
issued and
outstanding, none - -
Common stock -
par value $.001
per share;
39,000,000
shares
authorised,
23,366,658
issued and
outstanding June
30, 1998;
30,000,000
shares
authorised, - -
23,252,825
issued and
outstanding
December 31,
1997 23,366 23,253
Additional paid-
in capital 69,325,631 68,927,203
Deficit
accumulated
during the
development
stage (1984-
1998) (66,647,248) (59,412,383)
Cumulative
translation 255,143 220,272
adjustment ______ ______
Total
stockholders' 2,956,892 9,758,345
equity ______ ______
Total
liabilities and $ 15,945,875 $ 20,800,065
stockholders' ====== ======
equity
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the
Cumulative
Development
Stage from
August 10,
1984
For the Six Months For the Three Months (inception)
Ended Ended Through
June 30 June 30 June 30,
______________________ ______________________
1998 1997 1998 1997 1998
______ ______ ______ ______ ________
Revenues:
Sales
and
contract $ 489,768 $219,195 $ 400,077 $ 131,780 $3,280,885
revenue
Licens-
ing 1,543,925 62,305 1,400,000 - 2,900,380
revenue
Interest
income 144,295 488,230 57,446 204,372 2,066,981
Grant
income 20,623 20,432 10,336 10,226 753,142
Foreign
currency
gains 24,115 - - 28,297 1,810,099
Value-
added
tax and
insurance
recov-
eries - - - - 577,170
Other 31,758 32,636 23,544 17,479 252,572
______ ______ ______ ______ ______
2,254,484 822,798 1,891,403 392,154 11,641,229
______ ______ ______ ______ ______
Expenses:
Cost of
sales
and
contract 384,032 73,453 365,028 20,793 929,189
revenue
Research
and
develop-
ment 5,551,426 5,474,934 2,985,756 2,884,248 47,593,883
General
and
adminis-
trative 2,022,880 1,630,240 1,041,751 988,568 14,966,047
Marketing
and
distrib-
ution 259,236 246,935 123,300 159,281 2,235,789
Deprec-
iation
and
amortiz-
ation 801,651 771,414 427,683 403,662 6,313,321
Interest 470,124 535,359 257,240 252,992 4,200,707
Foreign
currency
losses - 715,691 22,361 - 913,119
Debt
conver-
sion
expense - - - - 801,597
Other - 10,496 - 10,496 334,825
______ ______ ______ ______ ______
9,489,349 9,458,522 5,223,119 4,720,040 78,288,477
______ ______ ______ ______ ______
Net
loss $(7,234,865) $(8,635,724) $(3,331,716) $(4,327,886) $(66,647,248)
====== ====== ====== ====== ======
Basic
and
diluted $ (0.31) $ (0.38) $ (0.14) $ (0.19) $ (6.40)
net loss ====== ====== ====== ====== ======
per
share
Weighted
average
shares
used in
computing
basic
and 23,257,950 22,569,850 23,263,075 22,776,008 10,416,239
diluted ====== ====== ====== ====== ======
net loss
per
share
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
For the
Cumulative
Development
Stage from
August 10,
For the Six Months 1984
Ended (inception)
June 30, Through
_______________________ June 30,
1998 1997 1998
______ ______ ______
Cash flow from
operating
activities:
Net loss $(7,234,865) $(8,635,724) $(66,647,248)
Adjustments to
reconcile net
loss to net
cash used in
operating
activities:
Depreciation
and 801,651 771,414 6,313,321
amortization
Disposal of
property and
equipment - - 927,238
Foreign
currency (24,115) 715,691 (896,980)
(gain)/loss
Warrant expense 48,820 - 242,814
Stock-based
compensation
expense 54,372 5,001 604,771
Debt conversion
expense - - 801,597
Changes in:
Trade 483,712 2,737 (25,520)
receivable
Inventories 328,640 (85,663) (46,324)
Other current
assets 194,587 (102,348) (213,520)
Accounts
payable and
accrued (208,910) 22,883 1,344,472
expenses
Accrued 65,620 105,405 841,845
interest
Deferred (197,711) (47,179) 31,896
revenue
Other - - (43,489)
______ ______ ______
Net cash used
in operating
activities (5,688,199) (7,247,783) (56,765,127)
______ ______ ______
Cash flows from
investing
activities:
(Increase) in
restricted cash (1,000,000) - (1,000,000)
Purchase of
property and
equipment (555,382) (544,758) (14,443,705)
Patent and
trademark costs (41,700) (107,802) (702,697)
Purchase of
short-term - (8,155,045) (13,933,294)
investments
Maturity of
short-term 2,094,508 1,000,000 13,933,293
investments
Other - - 69,750
______ ______ ______
Net cash
provided by
(used in)
investing 497,425 (7,807,605) (16,076,653)
activities ______ ______ ______
Cash flows from
financing
activities:
Proceeds from
notes payable 3,331,412 42,200 19,140,417
Payments on
notes payable (590,331) (556,461) (6,767,801)
Proceeds from
line of credit - 8,143 3,371,278
Payments on
line of credit (43,836) (100,296) (3,371,278)
Proceeds from
convertible
debt, net - - 9,655,000
Payments on
convertible - - (4,320,325)
debt
Proceeds from
issuance of
stock, net 51,250 1,145,373 57,062,830
Proceeds from
issuance of
warrants - - 65,000
Other (1,937) - (149,535)
______ ______ ______
Net cash
provided by
financing 2,746,558 538,959 74,685,585
activities ______ ______ ______
Effect of
exchange rate
changes on cash
and cash (201,948) (288,015) 425,109
equivalents ______ ______ ______
Net (decrease)
increase in
cash and cash
equivalents (2,646,164) (14,804,444) 2,268,914
Cash and cash
equivalents,
beginning of 4,915,077 20,502,536 -
period ______ ______ ______
Cash and cash
equivalents,
end of period $ 2,268,914 $5,698,092 $ 2,268,914
====== ====== ======
END
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