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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Becket Invest Plc | LSE:TAB | London | Ordinary Share | GB00BMWKKL25 | ORD GBP0.01 |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.20 | 0.00 | 00:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Blank Checks | 0 | -2.27M | -2.7622 | 0.00 | 9.84k |
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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