RNS No 6895d
THERAPEUTIC ANTIBODIES INC
19th March 1998
THERAPEUTIC ANTIBODIES INC.
ANNOUNCES YEAR-END RESULTS
London, 19 March 1998 - Therapeutic Antibodies Inc ("TAb")
today announced its year end results for the twelve months
ended 31 December 1997. Attached is a summary of these results
which will be included in the Company's Annual Report on Form
10K to be filed with the Securities and Exchange Commission in
the United States.
Highlights
* US$23M distribution deal signed with Altana Inc. covering
the rights to distribute CroTAb(registered trademark),
DigiTAb(registered trademark) and TriTAb(registered trademark)
in the United States with US$1M in initial milestone fees
earned in 1997.
* For the twelve months ended 31 December 1997, total sales,
contract and licensing revenues more than doubled to
US$1,505,843 from US$744,107 in 1996.
* Investment in research and development increased 25
percent to US$11,462,352 from US$9,185,126 in 1996 in line
with expectations. The accelerated rate of clinical
studies was the primary element contributing to this
increase.
* The net loss for the year amounted to US$16,847,718
(US$0.74 per share) compared with US$12,746,117 (US$0.68 per
share) in 1996.
* FDA clearance of Investigator IND's associated with
TriTAb(registered trademark) and CytoTAb(registered
trademark) for acute Graft vs Host Disease.
* Progression of patient enrollment in Phase II
CytoTAb(registered trademark) Malaria and Phase IIb
CytoTAb(registered trademark) Sepsis.
* Enrollment in the pivotal clinical study for
DigiTAb(registered trademark) was completed.
Commenting on the year end results, Chairman Martin S. Brown,
said:
"The past year was one in which we made significant gains in
the implementation of our strategic imperatives. We made
important progress in conducting clinical studies across our
product portfolio. We upgraded our manufacturing and quality
control infrastructure to prepare for commercial production.
We completed a valuable marketing and distribution alliance.
Furthermore, we recently strengthened our global organisation
with the appointment of a new CEO, Andrew J. Heath. Dr.
Heath's medical expertise and pharmaceutical experience fit
remarkably well with our corporate mission and circumstance.
These are the factors that provide continued confidence in our
future."
Enquiries:
Therapeutic Antibodies Inc. Martin S. Brown
001 615 327 1027 Cindy Miller
Brunswick Stephen Breslin
0171 404 5959 Neil Boom
Frank De Maria
Chairman's Statement
The Company has achieved a major milestone in this past year,
having announced a strategic alliance with Altana Inc. to
commercialise our emergency medicine product portfolio in the
United States. This announcement is coupled with continued
progress in the development of CroTAb(registered trademark),
DigiTAb(registered trademark) and TriTAb(registered trademark)
which comprise this emergency room product line and which
represent a significant potential revenue base for our Company.
We are now preparing to develop these products at an
accelerated pace and believe the Altana alliance lays the
foundation for their successful commercialisation in the United
States.
TAb also continues to make progress in its CytoTAb(registered
trademark) programme. During 1997, the Company completed its
Phase I study in malaria and subsequently launched a Phase II
trial in this disease. In addition, we concluded our 100
patient Phase IIa study of patients suffering from severe
sepsis and based on the positive data obtained, launched a
Phase IIb trial. Later in the year, we announced the
development of an Investigator IND for use of
CytoTAb(registered trademark) in cancer patients for the
treatment of TNF-related complications after marrow on blood
stem cell transplantation, including acute graft vs host
disease. Our ongoing clinical programmes in these areas will
total more than 25 medical centres on three continents,
including many leading centres of excellence in these diseases.
At the time of our public offering on the London Stock
Exchange, we provided projections as to the clinical and
regulatory progress of our trials for the next two years. To
date, we have made significant progress towards our goals.
While we have had some delays in our CroTAb(registered
trademark) and CytoTAb(registered trademark) sepsis programmes,
the bulk of our programmes and initiatives have proceeded as
planned. More importantly, on the trials we have concluded,
the results reinforce our belief in the commercial viability
for your products.
In 1997, we completed our CytoTAb(registered trademark) for
Malaria Phase I trial in Thailand. This pilot placebo-
controlled study was conducted in 28 severely ill patients
suffering from severe malaria. Although this was a small
study, important data was acquired from this trial. None of
the patients treated with CytoTAb(registered trademark) showed
any early signs of hypersensitivity reactions and there was an
absence of fatal cases in the study group. In addition,
several important clinical measures by which severe malaria is
diagnosed seemed to improve in the patient population. These
measures include a reduction in the levels of Tumor Necrosis
Factor alpha (TNFa), reduced fever and improved parasite
clearance. We are encouraged by these results and today report
that TAb has launched an expanded 100 patient, placebo-
controlled, Phase II clinical trial in Thailand to obtain
further data on the effects of CytoTAb(registered trademark) in
patients with cerebral malaria.
Another programme which has received particular emphasis during
the past year is our anti-drug line. There are currently two
drugs in this programme, DigiTAb(registered trademark), a
product designed to reverse the effects of digoxin toxicity,
and TriTAb(registered trademark), a product designed to reverse
the effects of tricyclic anti-depressant toxicity. I am
pleased to report today that several critical milestones have
been accomplished in both of these products during the past
year which have implications for the efficacy and market
potential for these products. First, we completed a study in
the use of DigiTAb(registered trademark) in patients suffering
from Oleander overdose and a bioequivalence study comparing the
efficacy of DigiTAb(registered trademark) to that of
Digibind(registered trademark), a competing product. The
results of these two studies will be made available in the
coming months. Second, we have embarked on a Phase III study
for DigiTAb(registered trademark) which currently has 15
centres actively screening patients. Finally, the Company
recently announced in February 1998 that the FDA had cleared
our Investigator IND for TriTAb(registered trademark) which
will result in initiation of a pilot study during the coming
months.
CroTAb(registered trademark) is the first product for which we
are seeking FDA approval for manufacture and distribution in
the United States. The establishment of systems, preparation
of appropriate documentation and validation of processes and
procedures has required an intensive and time consuming effort.
As a result, we are in process of revising our launch date for
this product. Due to this comprehensive effort, we now have an
established foundation for future products based on the same
platform technology.
Efforts in 1997 were also dedicated to our Sepsis programme.
In light of the recent failures by others in the attempt to
treat patients suffering from this disease, we have re-examined
our own initiative in this area. In an effort to learn from
the efforts of others and to capitalise on the strengths of our
CytoTAb(registered trademark) product, we revised the Phase IIb
study protocol. Specifically, we have designed the study to
better learn which patient population will most benefit from
our product. Also, we have included more stringent criteria
for patients admitted to the study. We believe that a more
critical patient enrollment offers an increased opportunity for
success for our product and establishes criteria for patient
selection in a pivotal study. This will lengthen the study
and eventual launch date. We remain optimistic about the
future prospects for CytoTAb(registered trademark) as a
valuable medical treatment. We are also pleased to report that
the study is currently underway with 19 centres actively
enrolling patients throughout the United States.
As of 31 December, 1997, the Company had total cash equivalents
and short term investments totalling approximately US$7
million. Measures are being taken to conserve cash resources
while at the same time sustaining the progress of clinical
trials for products that promise the most success. Meanwhile,
we continue to evaluate opportunities to raise further funding
which may be required in order to carry out our current
business plan.
Prospects
We expect to reach several critical milestones within the next
12 months. Besides the CroTAb(registered trademark) PLA,
which is scheduled to be submitted to the FDA during the year,
we anticipate preparing a PLA for DigiTAb(registered trademark)
in the United States. As was mentioned previously, we have
just completed the DigiTAb(registered trademark)
bioequivalence study and expect to announce the results of this
pivotal trial during the year. In addition, two pilot clinical
trials will be completed during the year involving
TriTAb(registered trademark) and CytoTAb(registered trademark)
for graft vs host disease. We also expect to publish results
from two of our previously completed trials, CytoTAb(registered
trademark) for Malaria Phase I and DigiTAb(registered
trademark) for Oleander poisoning. During 1998, we anticipate
significant progress in three of our CytoTAb(registered
trademark) trials, Sepsis Phase IIb; Malaria Phase II, and
Jarisch Herxheimer Reaction Phase III studies.
Finally, our goals for 1998 include further licensing
agreements. We continue to explore possible strategic
alliances with pharmaceutical companies which we believe would
be suitable partners.
Management
The composition of the Board of Directors and senior management
has also changed since the beginning of the year 1997. We
recently appointed Dr. Andrew J. Heath as Chief Executive
Officer. Dr. Heath comes to us with considerable experience in
the clinical and pharmaceutical industry and offers a unique
blend of talents that will be of paramount utility as we move
further towards the commercialisation of our products. While I
remain Chairman of the Company, Dr. Heath has assumed
responsibility for the overall direction of TAb. I would also
like to extend my gratitude, and that of my fellow Directors,
to Mr. John Robb and Mr. Robin Baillie, both of whom departed
from the Board in 1997.
Summary
Every year, as our Company grows, we uncover new and innovative
applications for our platform technology. The challenge ahead
of us will be to focus our efforts and our capital on those
areas which offer the greatest return for our Company and its
shareholders. While in continual pursuit of our original
mission, to provide highly purified polyclonal antibody
products for the treatment of disease, we believe we have never
been closer to accomplishing this mission than we are today.
Martin S. Brown
Chairman
19 March, 1998
Therapeutic Antibodies Inc. is an international
biopharmaceutical group specialising in the research,
development and production of highly purified polyclonal
antibodies for the treatment of diseases and other life-
threatening conditions for which satisfactory therapies have
generally not previously existed.
TAb's common shares are listed on the London Stock Exchange.
An electronic version of this news release, as well as
additional information about Therapeutic Antibodies Inc., is
available on the Company's home page at http://www.tab.co.uk
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS December 31, December 31,
1997 1996
_____________ _____________
Current assets:
Cash and cash equivalents $ 4,915,077 $20,502,536
Short-term investments 1,997,240 2,002,266
Trade receivables 594,267 101,281
Value added tax receivable 179,629 251,186
Inventories 489,138 400,167
Other current assets 409,929 474,412
_____________ _____________
Total current assets 8,585,280 23,731,848
Property and equipment, net 11,456,690 12,682,680
Patent and trademark costs,
net 598,924 529,228
Other assets, net 159,171 236,234
_____________ _____________
Total assets $ 20,800,065 $37,179,990
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and
accrued expenses $ 1,457,121 $936,591
Accrued interest 146,326 161,367
Current portion of notes
payable 2,545,701 1,446,327
_____________ _____________
Total current
liabilities 4,149,148 2,544,285
Notes payable, net of
current portion 6,059,072 8,592,755
Deferred revenue 559,467 656,170
Other liabilities 274,033 171,250
_____________ _____________
Total liabilities 11,041,720 11,964,460
_____________ _____________
Commitments
Stockholders' equity:
Common stock - par value $.001
per share; 30,000,000 shares
authorised; 23,252,825 -
December 31, 1997 and
22,353,692 -
December 31, 1996 issued
and outstanding 23,253 22,354
Additional paid-in capital 68,927,203 67,082,048
Deficit accumulated during
the development stage
(1984-1997) (59,412,383) (42,564,665)
Cumulative translation
adjustment 220,272 675,793
_____________ _____________
Total stockholders' equity 9,758,345 25,215,530
_____________ _____________
Total liabilities and
stockholders' equity $ 20,800,065 $37,179,990
============ ============
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the
Cumulative
Development
Stage from
For the Years Ended December 31, August 10,
1984
(inception)
Through
December 31,
1997
1997 1996 1995
$ $ $ $
Revenues:
Sales and
contract
revenue 392,888 600,607 488,347 2,791,117
Licensing
revenue 1,112,955 143,500 100,000 1,356,455
Interest
income 886,511 607,479 96,917 1,922,686
Grant income 205,569 118,535 39,509 732,519
Value added
tax and
insurance
recoveries - - - 577,170
Foreign
currency
gains - 1,733,357 3,054 1,785,984
Other 80,008 64,890 22,663 220,814
___________ ___________ ___________ ___________
2,677,931 3,268,368 750,490 9,386,745
___________ ___________ ___________ ___________
Expenses:
Cost of
sales and
contract
revenue 110,740 334,989 31,360 545,157
Research and
Development 11,462,352 9,185,126 6,321,674 42,042,457
General and
admini-
strative 3,561,541 2,721,889 1,729,262 12,943,167
Marketing
and
distri-
bution 614,598 361,262 518,210 1,976,553
Depreciation
and
amorti-
sation 1,643,922 1,387,916 856,756 5,511,670
Interest 1,001,959 1,201,335 388,258 3,730,583
Debt
conversion
expense - 801,597 - 801,597
Foreign
currency
losses 913,119 - - 913,119
Other 217,418 20,371 5,008 334,825
___________ ___________ ___________ ___________
19,525,649 16,014,485 9,850,528 68,799,128
___________ ___________ ___________ ___________
Net loss (16,847,718) (12,746,117) (9,100,038) (59,412,383)
=========== ============ =========== ===========
Basic and
diluted net
loss per
share (0.74) (0.68) (0.57) (5.98)
=========== ============ =========== ===========
Weighted
average
shares used
in computing
basic and
diluted net
loss per
share 22,888,226 18,821,524 15,938,219 9,937,666
=========== ============ =========== ===========
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the
Cumulative
Development
For the Years Ended December 31, Stage from
August 10,
1984
(inception)
Through
December 31,
1997
1997 1996 1995
$ $ $ $
Cash flow
from
operating
activit-
ies:
Net loss (16,847,718) (12,746,117) (9,100,038) (59,412,383)
Adjust-
ments to
reconcile net
loss to net
cash
used in
operating
activities:
Depreci-
ation
and
amorti-
sation 1,643,922 1,387,916 856,756 5,511,670
Disposal
of
prope-
rty and
equip-
ment 282,806 532,817 111,615 927,238
Foreign
currency
loss
(gain) 913,119 (1,733,357) (3,054) (872,865)
Warrant
expense - 46,944 - 193,994
Stock-
based
compen-
sation
expense 487,968 62,431 - 550,399
Debt
conver-
sion
expense - 801,597 - 801,597
Changes
in:
Trade
receiv-
able (434,140) (52,373) 1,106,727 (509,232)
Invento-
ries (88,971) (7,073) (332,559) (374,964)
Other
current
assets 60,616 (128,813) (334,980) (408,107)
Accounts
payable
and
accrued
expenses 646,550 (340,411) (84,553) 1,553,382
Accrued
interest (777) (37,512) 154,858 776,225
Deferred
revenue (84,063) 313,670 - 229,607
Other - (234,301) 236,139 (43,489)
__________ __________ __________ __________
Net
cash
used in
operat-
ing
activi-
ties (13,420,688) (12,134,582) (7,389,089) (51,076,928)
__________ __________ __________ __________
Cash flows
from
investing
activit-
ies:
Decrease
in
restri-
cted
cash - - 1,126,000 -
Purchase
of
prope-
rty and
equip-
ment (1,257,448) (3,293,214) (2,491,020) (13,888,323)
Patent
and
trade-
mark
costs,
net (109,709) (198,502) (127,042) (660,997)
Purchase
of
short-
term
invest-
ments (11,931,028) (2,002,266) - (13,933,294)
Maturity
of
short-
term
invest-
ments 11,838,785 - - 11,838,785
Other - - - 69,750
__________ __________ __________ __________
Net cash
used in
invest-
ing
activit-
ies (1,459,400) (5,493,982) (1,492,062) (16,574,079)
__________ __________ __________ __________
Cash flows
from
financing
activit-
ies:
Proceeds
from
notes
payable 17,605 2,518,239 4,989,452 15,809,005
Payments
on notes
payable (1,299,211) (1,969,138) (2,144,704) (6,177,471)
Proceeds
from
line of
credit 61,897 123,371 1,311,053 3,371,278
Payments
on line
of
credit (118,505) (1,018,738) (1,741,540) (3,327,442)
Proceeds
from
convert-
ible
debt,
net - 5,432,500 4,222,500 9,655,000
Payments
on
convert-
ible
debt - (4,320,325) - (4,320,325)
Proceeds
from
issu-
ance of
stock,
net 1,358,086 32,326,264 5,548,125 57,011,580
Proceeds
from
issu-
ance of
warrants - - - 65,000
Other 39,184 (5,628) (151,032) (147,598)
__________ __________ __________ __________
Net cash
provided
by
financ-
ing
activit-
ies 59,056 33,086,545 12,033,854 71,939,027
__________ __________ __________ __________
Effect of
exchange
rates
changes on
cash
and cash
equival-
ents (766,427) 1,647,473 (348,775) 627,057
__________ __________ __________ __________
Net
(decrease)
increase in
cash and
cash
equivalents (15,587,459) 17,105,454 2,803,928 4,915,077
Cash and
cash
equival-
ents,
beginning
of period 20,502,536 3,397,082 593,154 -
__________ __________ __________ __________
Cash and
cash
equival-
ents, end
of period 4,915,077 20,502,536 3,397,082 4,915,077
========== ========== ========= =========
Supple
mental
cash flow
disclo-
sures:
Cash
payments
for
interest
(net of
amount
capita-
lised) 1,017,000 1,142,738 250,616 1,738,516
========= ========= ======== ==========
END
FR SFLSSUUAUFDD
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