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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 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Blank Checks | 0 | -2.27M | -2.7622 | 0.00 | 9.84k |
RNS No 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 QRFAILVDELITLAA
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