RNS No 6997r
THERAPEUTIC ANTIBODIES INC
14th August 1997
THERAPEUTIC ANTIBODIES INC
ANNOUNCES SECOND QUARTER RESULTS
LONDON, 14 AUGUST, 1997 - Therapeutic Antibodies Inc (TAb)
today announced its second quarter results and product
development progress. The unaudited financial results will be
filed as Form 10-Q with the Securities and Exchange Commission
in the United States.
SECOND QUARTER FINANCIAL RESULTS:
TAb's revenues for the first six months of 1997 increased by
111% to $823,000 from $391,000 for the same period of 1996.
This increase is attributed to increases in interest income
and licensing fees. Interest income increased to $488,000 in
the first six months of 1997 from $33,000 in the first six
months of 1996. TAb received a licensing fee of $62,000 in
the first six months of 1997 for the execution of a
collaboration agreement for BrownTAb(TM), the Company's
Australian Brown snake antivenom. Product sales and contract
revenue of $219,000 for the six months ended June 30, 1997
remained about even with the amount in the first six months of
1996 of $223,000.
Expenses for the first half of 1997 increased by 27% to
$9,459,000 from $7,456,000 for the same period of 1996.
Research and development expenses during the same periods
increased by 39% to $5,475,000 from $3,947,000 as a result of
increased development activities primarily associated with the
Company's CroTAb(R), CytoTAb(TM), and DigiTAb(TM). These
costs are related to manufacturing TAb's products for clinical
trials, conducting clinical trials and ensuring that the
necessary quality control and assurance procedures are in
place. Costs associated with regulatory compliance, a
component of research and development expenses, have also
increased as more of the Company's products enter advanced
stages of development and as CroTAb(R) progresses through the
FDA licensing process.
The Company's net loss for the six months ended 30 June 1997
was $8.6 million compared to a net loss of $7.1 million for
the same period in 1996. These financial results meet the
Company's expectations for the period.
PRODUCT DEVELOPMENT PROGRESS:
CytoTAb(TM) - Anti-Tumor Necrosis Factor (TNF):
In light of recent developments in the sepsis field, the
Company has undertaken and completed a strategic review of its
CytoTAb(TM) program. As a result of this strategic review,
the Company is extending CytoTAb(TM)'s development to a
growing number of important indications in which the patient
populations are quite homogeneous and the onset of high levels
of TNF can be readily predicted. Furthermore, the sepsis
study is being adjusted in entry criteria and in subgroup
evaluation.
CytoTAb(TM) is a polyclonal antibody which binds to multiple
sites on the TNF target, demonstrating strong affinity and
avidity; and the Company believes that this results in more
complete neutralization. CytoTAb(TM) is distinguished from
monoclonal antibody products which bind to single sites.
CytoTAb(TM)'s ability to neutralize TNF was clearly
demonstrated in a study reported in the New England Journal of
Medicine (August 1996) where CytoTAb(TM) bound TNF associated
with Jarisch Herxheimer Reaction (JHR) with significant
mitigation of symptoms.
The status for CytoTAb(TM) indications is as follows:
* Sepsis: Very strict enrollment criteria is being
instituted for TAb's 300 patient Phase IIb sepsis study.
Its objective will be to identify a population that will
have the greatest likelihood of benefiting from
CytoTAb(TM) therapy. The patients enrolled in the study
will have severe sepsis and multi-organ failure. The
Company is seeking to test the hypothesis that treatment
with CytoTAb(TM) for five days will protect patients from
further multiple organ dysfunction caused by TNF, will
allow organ function recovery and will prolong life.
* Organ Transplant Rejection: An Investigational New Drug
(IND) application with the Food and Drug Administration
(FDA) is being submitted in order to begin clinical
evaluation of CytoTAb(TM) in OKT3 treatment in transplant
rejection patients.
* Malaria: A Phase II study of CytoTAb(TM) is being
launched this month in 100 patients with cerebral malaria
in Southeast Asia.
* Jarisch-Herxheimer Reaction: An IND application is being
prepared for the use of CytoTAb(TM) in the therapy of
this serious complication associated with the treatment
of syphilis in the United States. Proof of principle of
this application was clearly established in the above
mentioned study in the New England Journal of Medicine.
* Acute Graft vs. Host Disease: CytoTAb(TM) will be given
to stem cell and bone marrow transplant recipients to
prevent the severe TNF related complications associated
with Acute Graft vs. Host Disease.
* Other indications: TAb is actively evaluating a variety
of indications such as acute congestive heart failure
(CHF) and coronary artery bypass graft surgery (CABG).
The Company believes that trials aimed at these
indications will require relatively few patients and can
be conducted rapidly.
The Company, in employing clearly defined patient populations
such as those in organ transplant rejection associated with
induced cytokine release syndrome, seizes unique opportunities
to treat TNF associated side effects. In some of these
conditions the timing and effects of cytokine release closely
resemble those of Jarisch-Herxheimer Reaction.
Antivenoms:
In its July 1997 issue, the Annals of Emergency Medicine
reported favorably on the Company's antivenom clinical trials
in the United States with its product CroTAb(R). The
publication, noted: "the antivenom produced remarkable results
... proving to be 5.2 times more potent that the current
antivenom." TAb is finalizing the applications for regulatory
approval of CroTAb(R).
Following a successful PhaseI/II trial, the Company initiated
during the second quarter a Phase III study of its
PulchellaTAb(TM) antivenom product for use in Southeast Asia.
Anti-Drugs:
TAb is completing the analysis of a clinical study with the
Company's digoxin-immune Fab antibodies. The study, conducted
in Sri Lanka, determined the clinical utility of these
antibodies in reversing certain cardiac toxicity. These
results, along with additional laboratory investigations, will
serve as a basis for expanded indications for this product.
MANUFACTURING AGREEMENT:
The Company is negotiating a new agreement with F.H. Faulding
& Co., Ltd., Australia's largest pharmaceutical company.
Under the agreement, F.H. Faulding & Co. will fill and finish
certain TAb products for commercial distribution at their FDA
approved manufacturing facilities.
Faulding and TAb are also collaborating in the development of
several of TAb's emergency room products in Australia and
Southeast Asia, as well as CytoTAb(TM) research efforts in
malaria.
TAb is an international biopharmaceutical group specializing
in 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.
CONTACTS:
Therapeutic Antibodies Inc
001 615-327-1027 Martin Brown
0171 982 6058 John Landon
Brunswick
0171 404-5959 Stephen Breslin
Frank De Maria
Copies of this announcement and Form 10-Q can be obtained
from:
Mr. Michael Hamblin
TAb London Ltd
14-15 Newbury Street
London, EC1 7HA
0171 606-8637
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the
Cumulative
Development
Stage
For the six For the Three from
Months Months August 10,
Ended June 30 Ended June 30 1984
(inception)
Through
June 30, 1997
1997 1996 1997 1996
________ _______ _________ ________ ________
Revenues:
Sales and contract
revenue $219,195 222,995 131,780 186,235 2,617,424
Licensing revenue 62,305 - - - 305,805
Interest income 488,230 32,908 204,372 13,913 1,524,405
Grant income 20,432 97,853 10,226 88,281 547,382
Value-added tax
and insurance
recoveries - - - - 577,170
Foreign currency
gains - - 28,297 - 1,785,984
Other 32,636 37,104 17,479 22,747 173,442
________ ________ ________ ________ ________
822,798 390,860 392,154 311,176 7,531,612
________ ________ ________ ________ ________
Expenses:
Cost of sales and
contract revenue 73,453 56,182 20,793 46,511 507,870
Research and
development 5,474,934 3,947,420 2,884,248 2,222,349 36,679,996
General and
administrative 1,630,240 1,171,726 988,568 611,934 10,386,909
Marketing and
distribution 246,935 169,333 159,281 107,271 1,608,890
Depreciation and
amortization 771,414 701,784 403,662 368,584 4,639,162
Interest 535,359 607,539 252,992 292,734 3,263,983
Debt conversion
expense - 801,597 - - 801,597
Foreign currency
losses 715,691 - - - 715,691
Other 10,496 - 10,496 - 127,903
________ ________ ________ ________ ________
9,458,522 7,455,581 4,720,040 3,649,383 58,732,001
________ ________ ________ ________ ________
Net loss $(8,635,724)(7,064,721)(4,327,886)(3,338,207)(51,200,389)
======== ======== ======== ======== ========
Net loss per
share $(0.38) $(0.42) $(0.19) $(0.19) $(5.43)
======== ======== ======== ======== ========
Weighted average
shares used in
computing net
loss per share 22,569,850 17,001,819 22,776,008 17,154,294 9,424,029
======== ======== ======== ======== ========
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
ASSETS June 30, December 31,
1997 1996
Current assets:
Cash and cash equivalents $5,698,092 $20,502,536
Short-term investments 8,848,193 2,002,266
Trade receivables 128,830 101,281
Value added tax receivable 211,478 251,186
Inventories 485,829 400,167
Other current assets 573,478 474,412
___________ ____________
Total current assets 15,945,900 23,731,848
Property and equipment, net 11,950,117 12,682,680
Patent costs, net 629,180 529,228
Other assets, net 199,036 236,234
___________ ____________
Total assets $28,724,233 $37,179,990
=========== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued $950,311 $ 936,591
expenses
Accrued interest 259,912 161,367
Current portion of notes payable 1,266,555 1,446,327
___________ ____________
Total current liabilities 2,476,778 2,544,285
Notes payable, net of current 8,042,461 8,592,755
portion
Deferred revenue 582,671 656,170
Other liabilities 166,450 171,250
___________ ____________
Total liabilities 11,268,360 11,964,460
___________ ____________
Stockholders' equity:
Common stock - par value $.001
per share; 30,000,000 shares
authorized; 23,178,323 -
June 30, 1997 and 22,353,692 - 23,178 22,354
December 31, 1996 issued and
outstanding
Additional paid-in capital 68,231,598 67,082,048
Deficit accumulated during the (51,200,389) (42,564,665)
development stage (1984-1997)
Cumulative translation adjustment 401,486 675,793
___________ ____________
Total stockholders' equity 17,455,873 25,215,530
___________ ____________
Total liabilities and $28,724,233 $37,179,990
stockholders' equity ========== ============
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited) For the Six Months For the
Ended Cumulative
June 30, Development
____________________ Stage from
August 10,
1984
(inception)
Through June
30 1997
1997 1996 _____________
Cash flows from operating
activities:
Net loss $(8,635,724) (7,064,721) (51,200,389)
Adjustments to reconcile net
loss to net cash used in
operating activities:
Depreciation and 771,414 701,784 4,639,162
amortisation
Foreign currency (gain) 715,691 - (1,070,293)
loss
Warrant expense - - 193,994
Compensation expense 5,001 - 67,432
Debt conversion expense - 801,597 801,597
Changes in:
Trade receivable 2,737 (129,710) (72,355)
Inventories (85,663) (5,656) (371,656)
Other current assets (102,348) 57,509 (571,071)
Accounts payable and 22,883 (81,875) 929,715
accrued expenses
Accrued interest 105,405 128,786 882,407
Deferred revenue (47,179) - 266,491
Other - - (43,489)
__________ __________ _____________
Net cash used in operating (7,247,783) (5,592,286) (45,548,455)
activities _____________ __________ __________
Cash flows from investing
activities:
Purchase of property and (544,758) (796,320) (12,531,201)
equipment
Patent costs (107,802) (80,331) (659,090)
Purchase of short term (8,155,045) - (10,157,311)
investments
Maturity of short term 1,000,000 - 1,000,000
investments
Other - (31,908) 69,750
__________ __________ _____________
Net cash used in investing (7,807,605) (908,559) (22,277,852)
activities __________ __________ ___________
Cash flows from financing
activities:
Proceeds from notes 42,200 5,538,772 15,833,600
payable
Payments on notes payable (556,461) (946,326) (5,434,721)
Proceeds from line of 8,143 - 3,317,524
credit
Payments on line of credit (100,296) (1,012,076) (3,309,233)
Proceeds from convertible - 1,081,732 9,655,000
debt,
net
Payments on convertible - - (4,320,325)
debt
Proceeds from issuance of 1,145,373 610,022 56,798,867
stock,
net
Proceeds from issuance of - - 65,000
warrants
Other - - (186,782)
__________ __________ _____________
Net cash provided by 538,959 5,272,124 72,418,930
financing activities __________ __________ _____________
Effect of exchange rate (288,015) (426) 1,105,469
changes on cash and cash __________ __________ _____________
equivalents
Net increase (decrease) in (14,804,444) (1,229,147) 5,698,092
cash and cash equivalents
Cash and cash equivalents 20,502,536 3,397,082 -
at beginning of period __________ __________ _____________
Cash and cash equivalents $5,698,092 $2,167,935 $5,698,092
at end of period ========== ========== =============
END
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