RNS No 6802c
THERAPEUTIC ANTIBODIES INC
16th November 1998
THERAPEUTIC ANTIBODIES ANNOUNCES
THIRD QUARTER RESULTS
London, 16 November 1998 - Therapeutic Antibodies Inc announces
third quarter total revenue more than tripled to $1.24 million
following an increase in sales and contract revenue and a
further milestone payment from Altana Inc. related to progress
with CroTAb.
The Company also announces the recent completion of an #11.5
million ($19.5 million) refinancing through the elimination of
debt and the private placement of new shares of Common Stock.
The third quarter was marked by the appointment of a new
chairman, further advances in product development and continued
progress in its partnership agreements with Altana Inc. and G.D.
Searle & Co., the pharmaceutical division of Monsanto Co.
The results for the third quarter ended 30 September 1998 will
be filed on Form 10-Q with the Securities and Exchange
Commission (SEC) in the United States.
HIGHLIGHTS:
- Appointment of Stuart Wallis as Chairman and restructuring
of the Board of Directors.
- Receipt of $1 million milestone payment from Altana tied to
the acceptance of the CroTAb PLA and ELA for review by the
Food and Drug Administration (FDA).
- Sales and contract revenue rose to $174,473 in the third
quarter of 1998 from $110,610 in the third quarter of 1997.
- Investment in R & D decreased by 8% to $2.54 million in
third quarter 1998 from $2.77 million for the same period
in 1997.
- Enrollment of first patient in TriTAb Phase I/II clinical
trial.
- Collaboration initiated for the Searle Project and
extensive planning completed.
Commenting on the results, Chief Executive Andrew Heath said:
'With the appointment of Stuart Wallis as Chairman and James
Christie as head of global operations, the restructuring of the
Board and the successful refinancing, the Company has the
expertise and necessary funding to drive it toward its goal of
profitability. During the year, the Company has focused its
development program on those opportunities with the greatest
commercial significance and has established a further
partnership with a leading pharmaceutical company. The third
quarter performance highlights the benefit of this strategy.'
THIRD QUARTER REPORT
Chief Executive's Statement
Revenue from licensing and sales and contracts increased
significantly in the third quarter, bolstered by a further $1
million milestone payment from Altana related to the acceptance
for FDA review of CroTAb. Following the review and refocusing
of its product portfolio, the Company has made strong progress
with the development of its products including the initiation of
enrollment for clinical trials for TriTAb and the completion of
enrollment for the malaria Phase II study for CytoTAb.
Stuart Wallis joined the Company as Chairman in September at
which time the Board was restructured to simplify decision
making and sharpen the focus on building shareholder value. In
October, James Christie was appointed head of global operations,
bringing with him from Centocor extensive experience in both the
production of biological pharmaceutical products and taking new
products through to market.
We recently announced the successful completion of an #11.5
million ($19.5 million) refinancing which provides the funds
necessary to build on the progress we have made to date. This
financing included the private placement of 21,300,000 new
shares of Common Stock. It also included the conversion of #1.7
million ($2.9 million) in loan notes and the conversion of #1.2
million ($2 million) of preferred stock into a total of
7,390,561 new shares of Common Stock.
The Company has indicated that it is considering alternatives
for moving the legal domicile of the holding company to the UK.
A decision is likely to be made by the end of the year.
Review of Operations
Altana Agreement - The Company received a further $1 million
milestone payment from Altana triggered by the acceptance of the
CroTAb PLA and ELA for review by the US Food and Drug
Administration. CroTAb is a new antivenom product designed to
neutralize the effects of most poisonous snakes native to North
America. Under the terms of the US distribution agreement,
Altana will pay up to $23 million in milestone and bonus
payments for the Company's emergency medicine products.
Searle Agreement - Collaboration on the research project with
G.D. Searle & Co., the pharmaceutical division of Monsanto Co.,
was initiated following the completion of extensive planning.
TriTAb - The first patient has now been enrolled in the Phase
I/II clinical trial. TriTAb is a polyclonal antibody product
tailored to offset the toxic effects of overdoses with tricyclic
antidepressants.
CytoTAb - CytoTAb is a polyclonal antibody product which has
been shown to be safe and effective in neutralizing TNF (tumor
necrosis factor). The Company is now concentrating on the
following indications for CytoTAb:
New Indications - In October, two IND's were submitted to the
FDA to determine the feasibility of CytoTAb. The first was an
IND submitted by the Company for Crohn's disease and the second
was an Investigator IND to study CytoTAb in patients undergoing
the coronary artery bypass graft (CABG) procedure. The clinical
trials for these indications are expected to commence in 1999.
Cerebral Malaria - Enrollment of 100 patients in the Phase II
study in Thailand was completed several months earlier than
expected. The malaria program is being pursued in collaboration
with F.H. Faulding & Co. Limited.
Background on Therapeutic Antibodies Inc
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.
The Company 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. Therapeutic Antibodies Inc's
products are manufactured at the Company's production facilities
in Australia and the UK 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.
For further information, please contact:
Stuart Wallis - tel: 0171 553 1483
Chairman
Therapeutic Antibodies Inc
Andrew Heath - tel: 001 615 327 1027
Chief Executive Officer
Therapeutic Antibodies Inc
Laura Frost - tel: 0171 379 5151
The Maitland Consultancy
This release, and oral statements made from time to time by
Company representatives concerning the subject matter hereof,
may contain so-called 'forward looking statements'. These
statements can be identified by introductory words such as
'expects', 'plans', 'will', 'estimates', 'forecasts',
'projects', or words of similar meaning, and by the fact that
they do not relate strictly to historical or current facts.
Forward-looking statements frequently are used in discussing the
Company's growth strategy, operating and financial goals, plans
relating to regulatory submissions and approvals and development
programs. Many factors may cause actual results to differ from
the Company's forward-looking statements, including inaccurate
assumptions and a broad variety of risks and uncertainties, some
of which are known and others of which are not. No forward-
looking statement is a guarantee of future results or events,
and one should avoid placing undue reliance on such statements.
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATION BALANCE SHEETS
(Unaudited)
Sept 30, Dec 31,
1998 1997
$ $
ASSETS
Current assets:
Cash and cash equivalents 2,027,360 4,915,077
Restricted cash 727,376 -
Short-term investments - 1,997,240
Trade receivables 357,026 594,267
Value added tax receivable 219,319 179,629
Inventories 262,330 489,138
Other current assets 169,645 409,929
------------ ------------
Total current assets 3,763,056 8,585,280
Property and equipment, net 11,125,845 11,456,690
Patent and trademark costs, net 641,489 598,924
Other assets, net 109,112 159,171
------------ ------------
Total assets 15,639,502 20,800,065
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable and accrued 1,457,947 1,457,121
expenses
Accrued interest 177,624 146,326
Current portion of notes payable 6,276,392 2,545,701
------------ ------------
Total current liabilities 7,911,963 4,149,148
Notes payable, net of current 5,323,798 6,059,072
portion
Deferred revenue 359,120 559,467
Other liabilities 282,200 274,033
------------ ------------
Total liabilities 13,877,081 11,041,720
------------ ------------
Convertible redeemable preferred 2,000,000 -
stock
Stockholders' equity:
Common stock - par value $.001 per
share; 39,000,000 shares
authorised,
23,366,658 issued and outstanding - -
September 30, 1998; 30,000,000
shares authorised
23,252,825 issued and oustanding 23,366 23,253
December 31, 1997
Additional paid-in capital 69,231,395 68,927,203
Deficit accumulated during the (69,853,718) (59,412,383)
development stage (1984-1998)
Cumulative translation adjustment 361,378 220,272
------------ ------------
Total stockholders' equity (237,579) 9,758,345
------------ ------------
Total liabilities and stockholders' 15,639,502 20,800,065
equity
============ ============
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATION STATEMENTS OF OPERATIONS
(Unaudited)
For the Nine Months Ended
Sept 30 Sept 30
1998 1997
$ $
Revenues:
Sales and contract revenue 664,241 329,805
Licensing revenue 2,543,925 81,405
Interest income 170,208 733,464
Grant income 30,960 30,593
Foreign currency gains 13,372 -
Value-added tax and - -
insurance recoveries
Other 61,280 46,410
------------- -------------
3,483,986 1,221,677
------------- -------------
Expenses:
Cost of sales and contract 425,699 94,207
revenue
Research and development 8,095,376 8,250,487
General and administrative 2,817,892 2,520,279
Marketing and distribution 443,349 386,453
Depreciation and 1,191,948 1,236,566
amortization
Interest 951,056 804,883
Foreign currency losses - 961,056
Debt conversion expense - -
Other - 9,712
------------- -------------
13,925,320 14,263,643
------------- -------------
Net loss (10,441,334) (13,041,966)
============= =============
Basic and diluted net loss (0.45) (0.57)
per share
============= =============
Weighted average shares used 23,309,742 22,775,892
in computing basic and
diluted net loss per share
============= =============
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATION STATEMENTS OF OPERATIONS
(Unaudited)
For the
Cumulative
Development
Stage from
Aug 10, 1984
For the Three Months (inception)
Ended Through
Sept 30 Sept 30 Sept 30
1998 1997 1998
$ $ $
Revenues:
Sales and contract 174,473 110,610 3,455,358
revenue
Licensing revenue 1,000,000 19,100 3,900,380
Interest income 25,913 245,234 2,092,894
Grant income 10,337 10,161 763,479
Foreign currency gains - - 1,799,356
Value-added tax and - - 577,170
insurance recoveries
Other 29,522 14,558 282,094
------------ ------------ ------------
1,240,245 399,663 12,870,731
------------ ------------ ------------
Expenses:
Cost of sales and 41,667 20,754 970,856
contract revenue
Research and 2,543,950 2,775,553 50,137,833
development
General and 795,012 890,039 15,761,059
administrative
Marketing and 184,113 139,518 2,419,902
distribution
Depreciation and 390,297 465,152 6,703,619
amortization
Interest 480,932 269,524 4,681,639
Foreign currency 10,743 245,365 913,118
losses
Debt conversion - - 801,597
expense
Other - - 334,825
------------ ------------ ------------
4,446,714 4,805,905 82,724,448
------------ ------------ ------------
Net loss (3,206,469) (4,406,242) (69,853,717)
============ ============ ============
Basic and diluted net (0.14) (0.19) (6.56)
loss per share
============ ============ ============
Weighted average 23,366,658 22,779,226 10,645,599
shares used in
computing basic and
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
Aug 10, 1984
(Inception)
For the Nine Months Ended through
Sept 30 Sept 30
1998 1997 1998
$ $ $
Cash flow from
operating
activities:
Net loss (10,441,334) (13,041,966) (69,853,717)
Adjustments to
reconcile net loss
to net cash used in
operating
activities:
Depreciation and 1,191,948 1,236,566 6,703,618
amortization
Disposal of property - - 927,238
and equipment
Foreign currency (13,372) 961,056 (886,237)
(gain) loss
Warrant expense 195,280 - 389,274
Stock-based 81,558 57,388 631,957
compensation expense
Debt conversion - - 801,597
expense
Changes in:
Restricted cash (727,376) - (727,376)
Trade receivable 187,307 63,456 (321,925)
Inventories 226,807 (57,029) (148,157)
Other current assets 243,550 6,272 (164,557)
Accounts payable and 31,241 64,987 1,584,623
accrued expenses
Accrued interest 34,141 (84,543) 810,366
Deferred revenue (208,048) (49,211) 21,559
Other - - (43,489)
------------ ------------ ------------
Net cash used in (9,198,298) (10,843,024) (60,275,226)
operating activities
------------ ------------ ------------
Cash flows from
investing
activities:
Purchase of property (704,566) (975,017) (14,592,889)
and equipment
Patent and trademark (73,166) (141,766) (734,163)
costs
Purchase of short- - (9,865,277) (13,933,294)
term investments
Maturity of short- 2,094,508 5,800,412 13,933,293
term investments
Other - - 69,750
------------ ------------ ------------
Net cash provided by 1,316,776 (5,181,648) (15,257,303)
(used in) investing
activities
------------ ------------ ------------
Cash flows from
financing
activities:
Proceeds from notes 4,397,100 208,892 20,206,105
payable
Payments on notes (1,083,519) (1,024,919) (7,260,990)
payable
Proceeds from line 141,324 8,129 3,512,602
of credit
Payments on line of (62,377) (108,573) (3,389,819)
credit
Proceeds from - - 9,655,000
convertible debt,
net
Payments on - - (4,320,325)
convertible debt
Proceeds from 1,929,827 1,167,611 58,941,407
issuance of stock,
net
Proceeds from - - 65,000
issuance of warrants
Other (1,881) - (149,479)
------------ ------------ ------------
Net cash provided by 5,320,474 251,140 77,259,501
financing activities
------------ ------------ ------------
Effect of exchange (326,669) (644,209) 300,388
rate changes on cash
and cash equivalents
------------ ------------ ------------
Net (decrease) (2,887,717) (16,417,741) 2,027,360
increase in cash and
cash equivalents
Cash and cash 4,915,077 20,502,536 -
equivalents,
beginning of period
------------ ------------ ------------
Cash and cash 2,027,360 4,084,795 2,027,360
equivalents, end of
period
============ ============ ============
END
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