RNS No 3750h
THERAPEUTIC ANTIBODIES INC
18 May 1999
THERAPEUTIC ANTIBODIES ANNOUNCES RESULTS FROM PHASE IIB SEPSIS
STUDY AND FIRST QUARTER FINANCIAL RESULTS
London, 18 May 1999 -- Therapeutic Antibodies Inc announces the
results of its CytoTAb Phase IIb sepsis study, an update of its
research and development portfolio and its financial results for
the first quarter.
HIGHLIGHTS
- Positive results from Phase IIb study of CytoTAb in
treatment of sepsis.
- Food and Drug Administration (FDA) has completed its review
of the CroTAb registration dossier.
- UK Medicines Control Agency (MCA) completes review of Welsh
manufacturing facility. Approval and Manufacturer's Licenses
granted.
- FDA inspection of Welsh manufacturing facility completed.
- All other development programmes remain on track.
- First quarter net loss narrowed to $3.38 million with
General and Administrative expenses cut 68% to $317,679.
SUMMARY
The Phase IIb study of CytoTAb for use in the treatment of
severe sepsis has produced positive results. This study was the
first of its kind to demonstrate a statistically significant
reduction in the amount of time patients spent on ventilation
and in intensive care. The Company is now seeking a
pharmaceutical partner to enable further development of CytoTAb.
Therapeutic Antibodies also announced that first quarter net
loss narrowed to $3.38 million, from $3.90 million a year
earlier, following a 68% reduction in general and administrative
expenses for the period. The results for the quarter ended 31
March 1999 will be filed on Form 10-Q with the Securities and
Exchange Commission in the US, copies of which may be obtained
from the Company's London or Nashville offices.
As announced in March, the Company must raise additional
financing by mid-1999. The Company is currently pursuing several
financing alternatives and is engaged in late stage discussions
with a strategic partner that may lead to a merger on a share
exchange basis at a value which approximates to the current
market value of Therapeutic Antibodies. The Company has also
entered into discussions with third parties relating to the sale
of additional debt or equity securities, the disposal of certain
non-core investments, entering into additional product licensing
arrangements and other combinations or collaborations with
strategic partners. There can be no assurance however that the
Company will obtain the required financing to continue funding
its operations.
Andrew Heath, Chief Executive, commented:
'The benefits of our focus on the Company's cost base are
evident in our first quarter performance. Our product
development is on-track and we eagerly await FDA approval for
our antivenom product CroTAb which we expect to market in the US
later this year. The promising sepsis trial results demonstrate
the viability of our technology and the strength of our product
pipeline.
It has been a productive start to the year. With our experienced
management team continuing to draw out the best in our Company
and the clear opportunities that lie ahead for our products, I
am confident about the outlook for Therapeutic Antibodies.'
REVIEW OF OPERATIONS
THE SEPSIS STUDY
The Phase IIb study of CytoTAb for use in the treatment of
severe sepsis has produced promising results which showed a
statistically significant reduction in the amount of time that
patients spent on ventilation and in intensive care. The Company
is now seeking a pharmaceutical partner to enable further
development of CytoTAb for this and other indications.
Sepsis is a group of symptoms characterised by major organ
failure resulting from an infection. This infection can stem
from illness, trauma, surgery and other sources and can result
in death. According to the US Center for Disease Control, there
are 400,000 cases of sepsis annually in the US with a 20% to 40%
mortality rate and economic cost of more than $10 billion.
Therapeutic Antibodies developed CytoTAb, a highly purified,
polyclonal antibody, to neutralise Tumor Necrosis Factor alpha
(TNF), a protein released by the body when it is confronted by
serious bacterial or viral infection or major physical trauma
and which is believed to contribute to the harmful effects of
sepsis.
The trial was designed to determine if treatment with CytoTAb
for five days would protect patients from additional injury
caused by TNF and hasten recovery of organ failure. Results from
the randomised, placebo controlled study of the 81 enrolled
patients revealed statistically significant reductions in
important clinical outcomes, including assisted ventilation and
intensive care unit (ICU) requirements.
Commenting on the sepsis trial results, Dr. Gordon Bernard,
Professor of Medicine at Vanderbilt University said:
'The exciting results from the sepsis trial considerably
exceeded our expectations. The magnitude of the observed
beneficial effects, primarily the reduction in time spent on a
ventilator and in the ICU, was greater than anticipated
considering the relatively small sample size. This is a
promising result and CytoTAb should be carried forward to a
Phase III clinical trial to examine effects on patient
survival.'
Andrew Heath, Chief Executive of Therapeutic Antibodies added:
'We are delighted with the results from the sepsis trial which
endorses our belief in the ability of CytoTAb to mitigate the
effects of TNF in this condition and bodes well for our other
CytoTAb trials involving the neutralisation of TNF. Expenditure
by Therapeutic Antibodies on this project ceased with completion
of this trial and we look forward to finding a partner who can
join us in taking this product forward.'
REVIEW OF FACILITIES
During the first quarter, the UK Medicines Control Agency (MCA)
completed its review of Therapeutic Antibodies' manufacturing
facility in Wales. The Company received MCA approval for the
plant in April and was granted its Manufacturer's Licenses. The
Company is very pleased with this endorsement of the facility
and of the significant effort that went in to preparing the
facility for commercial production.
As part of the approval process for CroTAb, the FDA undertook an
inspection of the Company's Welsh manufacturing facility. This
was completed during the first quarter and full FDA approval and
product launch are expected later this year.
PRODUCT PORTFOLIO
CroTAb - The initial review of the Company's rattlesnake
antivenom by the FDA has now been completed. The Company is now
addressing the issues raised by the FDA response to its PLA
submission and full FDA approval and product launch are expected
later this year. The Company will receive a further milestone
payment from Altana Inc. when CroTAb receives FDA approval.
DigiTAb - The Company continues its work to compile a Product
License Application (PLA) for DigiTAb, a product designed to
combat the effects of digoxin toxicity, and is on schedule to
submit its PLA to the FDA by mid 1999.
TriTAb - This is tailored to offset the toxic effects of
overdoses of tricyclic antidepressants. No specific therapy
presently exists for this frequently severe and often fatal type
of overdose. The Company continues enrolment in its pilot adult
and pediatric studies and data from these studies, which mark
the first administration of this product in humans, is expected
to be available during the third quarter. With these studies
nearing completion, the Company is currently planning the Phase
II/III study in overdose patients to commence this year.
CytoTAb - An antibody product has been shown in clinical trials
to be safe and effective in neutralising circulating TNF (tumor
necrosis factor alpha).
Sepsis - The Company announced today promising results from
the Phase IIb study for the use of CytoTAb in the treatment of
sepsis. The results showed that CytoTAb produced a statistically
significant reduction in the amount of time that patients spent
on assisted ventilation and in intensive care.
The Company is now seeking a pharmaceutical partner to enable
further development of CytoTAb for this and other indications.
Crohn's Disease - The FDA cleared the Investigational New
Drug (IND) application in December 1998 for this pilot study of
CytoTAb in Crohn's disease and the first three patients were
enrolled in the first quarter of 1999. Patient enrolment
continues and the Company plans to have results of this study
available later this year.
Coronary Artery Bypass Graft - Originally this study was
planned to be conducted under an Investigator IND. The Company
has now decided this study will be conducted as a Company
sponsored IND and plans to commence this study later this year.
Cerebral Malaria - The malaria program is being pursued in
collaboration with F.H. Faulding & Co. Limited. Enrolment of 100
patients in the Phase II study in Bangkok, Thailand was
completed at the end of last year, several months earlier than
expected. Results from this study are expected by mid 1999.
ViperaTAb - ViperaTAb, an antivenom for poisonous European
snakes, is commercially available in Scandinavia. Having been
granted Manufacturer's Licenses for the Welsh production
facility, the Company is now in a position to extend
availability of ViperaTAb on a named patient basis in the UK and
Europe.
FIRST QUARTER FINANCIAL RESULTS
During the course of 1998, the Company focused on reducing our
general and administrative expenses and the success of this
program is apparent in the results for the first three months of
1999. First quarter net loss narrowed to $3.38 million, from
$3.90 million a year earlier, following a 68% reduction in
general and administrative expenses during the period.
Total revenue during the quarter was $146,143, less than a year
earlier primarily reflecting lower licensing revenue and foreign
currency gains. The investment in research and development fell
7.4% to $2.37 million as the Company refocused its development
efforts on those products with the greatest commercial
potential.
For further information, please contact:
Stuart Wallis
Chairman
Therapeutic Antibodies Inc
Tel: 0171 553 1483
Andrew Heath
Chief Executive Officer
Therapeutic Antibodies Inc
Tel: 0171 606 8637
Laura Frost/William Clutterbuck
The Maitland Consultancy
Tel: 0171 379 5151
BACKGROUND ON THERAPEUTIC ANTIBODIES INC
Therapeutic Antibodies Inc is an international biopharmaceutical
company specialising 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.
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)
CONSOLIDATED BALANCE SHEETS
31 March 31 December
1999 1998
---------- -----------
$ $
ASSETS
Current assets:
Cash and cash
equivalents 3,497,279 7,760,328
Restricted cash 136,170 419,168
Trade receivables 70,724 67,677
Value added tax 294,485 326,849
receivable
Inventories 306,859 287,802
Other current assets 581,671 712,370
---------- ----------
Total current assets 4,887,188 9,574,194
Property and equipment, 10,927,311 11,074,766
net
Patent and trademark 695,311 678,306
costs, net
Other assets, net 81,400 94,236
---------- ----------
Total assets 16,591,210 21,421,502
========== ==========
LIABILITIES AND
STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and
accrued expenses 1,473,290 1,755,098
Accrued interest 91,475 122,486
Current portion of
notes payable 1,570,228 2,159,428
---------- ----------
Total current
liabilities 3,134,993 4,037,012
Notes payable, net of
current portion 4,715,579 4,744,216
Deferred revenue 325,133 342,363
Other liabilities - 275,477
---------- ----------
Total liabilities 8,175,705 9,399,068
---------- ----------
Stockholders' equity:
Common stock - par value
$.001 per share;
59,000,000 shares
authorized, 52,057,219
issued and outstanding 52,057 52,057
Additional paid-in
capital 87,086,104 87,074,215
Deficit accumulated
during the development (78,680,016) (75,301,311)
stage (1984-1999)
Other comprehensive
income (loss) (42,640) 197,473
---------- ----------
Total stockholders'
equity 8,415,505 12,022,434
---------- ----------
Total liabilities
and stockholders' 16,591,210 21,421,502
equity ========== ==========
THERAPEUTIC ANTIBODIES INC AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the
Cumulative
Development
Stage From
10 August 1984
For the three months (Inception)
Ended 31 March through
1999 1998 31 March 1999
--------------------- -------------
$ $ $
Revenues:
Sales and contract
revenue 64,688 89,691 3,582,765
Licensing revenue - 143,925 3,900,380
Interest income 64,314 86,849 2,226,362
Grant income 10,210 10,287 784,217
Foreign currency gains - 46,476 1,785,984
Value-added tax and
insurance recoveries - - 577,170
Other 6,931 8,214 307,819
--------- --------- -----------
146,143 385,442 13,164,697
========= ========= ===========
Expenses:
Cost of sales and
contract revenue 35,155 19,004 1,021,071
Research and
development 2,374,625 2,565,670 55,780,300
General and
administrative 317,679 981,129 17,311,513
Marketing and
distribution 88,155 135,936 2,612,114
Depreciation and
amortization 415,800 373,968 7,489,421
Interest 133,635 212,884 5,169,766
Foreign currency
losses 159,799 - 1,313,621
Debt conversion - - 801,597
expense
Other
- - 345,310
3,524,848 4,288,591 91,844,713
--------- --------- ----------
Net loss (3,378,705) (3,903,149) (78,680,016)
========= ========= ==========
Redeemable preferred
stock dividends - - (32,877)
--------- --------- ----------
Net loss applicable to
common shareholders (3,378,705) (3,903,149) (78,712,893)
Other comprehensive
income (loss), before
and after tax:
Change in equity due to
foreign currency
translation adjustments (240,113) 84,650 (42,640)
--------- --------- ----------
Total comprehensive
loss (3,618,818) (3,818,499) (78,755,533)
========= ========= ==========
Basic and diluted net
loss per share (0.06) (0.17) (6.66)
========= ========= ==========
Weighted average shares
used in computing basic
and diluted net loss
per share 52,057,219 23,252,825 11,812,837
========== ========== ==========
THERAPEUTIC ANTIBODIES INC AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the
Cumulative
Development
Stage From
10 August 1984
For the three months (Inception)
Ended 31 March through
1999 1998 31 March 1999
--------------------- -------------
$ $ $
Cash flow from operating
activities:
Net loss (3,378,705) (3,903,149) (78,680,016)
Adjustments to reconcile
net loss to net cash
used in operating
activities:
Depreciation and
amortization 415,800 373,968 7,489,421
Disposal of property
and equipment - - 1,206,566
Foreign currency (gain)
loss 159,799 (46,476) (472,363)
Warrant expense - - 486,913
Stock-based
compensation expense 11,889 27,186 722,417
Debt conversion expense - - 801,597
Changes in:
Restricted cash 282,998 - (136,170)
Trade receivable 18,683 412,803 (135,322)
Inventories (19,056) 19,234 (192,685)
Other current assets 119,735 91,512 (589,527)
Accounts payable and
accrued expenses (266,771) (72,889) 1,620,432
Accrued interest (32,623) (14,641) 830,351
Deferred revenue (10,208) 23,548 818
Other (271,027) - (281,639)
Net cash used in ----------- ----------- ------------
operating activities (2,969,486) (3,088,904) (67,329,207)
----------- ----------- ------------
Cash flows from
investing activities:
Purchase of property
and equipment (408,686) (133,701) (15,682,036)
Patent and trademark
costs (27,189) (15,651) (787,843)
Purchase of short-term
investments - - (13,933,294)
Maturity of short-term
investments - 1,497,240 13,933,294
Other - - 69,750
Net cash provided by ----------- ----------- ------------
(used in) investing (435,875) 1,347,888 (16,400,129)
activities ----------- ----------- ------------
Cash flows from
financing activities:
Proceeds from notes
payable - - 20,450,244
Payments on notes
payable (653,824) (306,487) (10,177,718)
Proceeds from line of
credit - - 3,371,278
Payments on line of
credit - (43,836) (3,371,278)
Proceeds from
convertible debt, net - - 9,655,000
Payments on convertible
debt - - (4,320,325)
Proceeds from issuance
of stock, net - - 71,719,109
Proceeds from issuance
of warrants - - 65,000
Other - - (149,467)
Net cash (used in) --------- --------- ----------
provided by financing (653,824) (350,323) 87,241,843
activities --------- --------- ----------
Effect of exchange rate
changes on cash and cash (203,864) (21,246) (15,228)
equivalents -------- --------- ----------
Net (decrease) increase
in cash and cash (4,263,049) (2,112,585) 3,497,279
equivalents
Cash and cash
equivalents, beginning 7,760,328 4,915,077 -
of period --------- ---------- ----------
Cash and cash
equivalents, end of 3,497,279 2,802,492 3,497,279
period ========= ========== ==========
END
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