AGM Statement

Proteome Sciences PLC 04 August 2004 Proteome Sciences plc PRESS RELEASE For immediate release 4th August, 2004 AGM STATEMENT At the Annual General Meeting of Proteome Sciences plc ('Proteome Sciences') held at 12 noon today, the following statement was read out by Steve Harris, Chairman : I propose to make a short address to shareholders to cover the three main questions most asked by investors about Proteome Sciences : 1. What is the annual cash burn? 2. How much cash have you got? 3. What is happening with commercialisation? I will address each of these and talk about our prospects ahead of opening the meeting to shareholders for questions, but before that I would like to clarify the situation in respect of our biomarkers on the Biosite Point of Care Panel. We released a holding statement on 29th July and have been spending the intervening period understanding the reasons for this decision and the implications, if any, for Proteome Sciences biomarkers. I am pleased to be able to report to you that the underlying value of Proteome Sciences stroke markers is not affected by Biosite's decision and more importantly, to reassure you that there are no adverse implications either for the biomarkers we have discovered in other diseases or for the research which we are undertaking in other areas. I will now take you through the background and try to explain what has occurred and why it does not impact on our main research programmes in plasma and serum. Biosite have been evaluating and developing antibodies to Proteome's stroke markers for approximately 18 months, and have yet to complete the process for all of the markers delivered. Of the earlier markers, a number were selected for the final candidate list for the first point of care panel. When testing human serum, that is blood from which the white and red blood cells have been removed, Proteome's markers were found to be highly sensitive and specific for both stroke and transient ischaemic attack (mini-stroke) at very early time points of disease (between 60 minutes and 24 hours) as was shown in the recent data presented at the 5th World Stroke Congress in Vancouver on 28th June. Biosite's proposed point of care panel currently uses whole blood in which the blood cells remain. In whole blood there is a risk that during sample collection and handling the blood cells can break open, a process called haemolysis, and proteins can leak into the fluid. Biosite has now tested the sensitivity of its current final candidate markers list for haemolysis and found a number, including several of Proteome's markers, that were affected by haemolysis. The problem of haemolysis is well understood within the diagnostics industry, and many markers of disease are sensitive to it and, where applicable, the diagnostic companies provide users with guidance on how to treat haemolysed samples. Most tests requiring high sensitivity and specificity use plasma or serum and not whole blood where the additional sample complexity creates more noise. As a consequence, this should not have any negative implications for the commercialisation of the stroke markers for the main market application, high throughput diagnosis, which accounts for over 90% of the total market size where it is normal practice to use serum or plasma in central laboratories running high throughput equipment. Proteome has retained the rights for the high throughput applications in stroke and is actively pursuing licensing deals with major diagnostics manufacturers with discussions in an advanced state with several companies. The specific issues surrounding Proteome's leading candidate stroke markers should not be interpreted more widely. Shareholders should be aware that even within the stroke programme we have delivered and continue to deliver a significant number of new markers to Biosite of which only a small number have been found to be affected by haemolysis. At this stage Biosite have not had time to complete the testing process for all of Proteome Sciences biomarkers for haemolysis against highly characterised stroke patient samples and they continue to evaluate these in parallel to the wider stroke trials they will shortly commence. The terms of the exclusive license agreement with Biosite for Point of Care applications included certain 'non performance provisions' so that in the event that Biosite did not utilise Proteome Sciences biomarkers in a timely manner, the rights of these biomarkers for Point of Care application revert back to Proteome Sciences. We believe that Biosite are the right partner for the development of our stroke biomarkers in Point of Care applications and we will continue to assist their diligent efforts in resolving this issue. Reverting now back to the three main questions that people most ask about our company: 1. What is the annual cash burn? 2. How much cash have you got? 3. What is happening with commercialisation? Firstly the cash burn. In the recently published Annual Report and Accounts we decided to try and simplify the process for shareholders by separating cash and non cash operating costs and establishing a headline figure which excludes the non cash items to show a realistic rate of cash burn for the Company. Presented in this way, the results show a headline loss of £4.25m, which compares favourably and a little lower than the cash burn of £4.5m expected for 2003. This excludes the non cash items which accounted for £1.95m and the notional share of associates losses at Intronn of £573,000. As you can see, the £2.52m non cash items increase the headline loss by 59% when included in the loss after taxation of £6.78m in the P & L account. This presentation of headline losses clearly reflects a realistic and more meaningful rate of cash burn. At the year end cash stood at £6.2m. This in broad terms should cover the historic cash burn for approximately 18 months assuming no revenue. Our assumptions, however, are that we will be generating sustainable and growing revenue and royalties as we move into 2005. Additional costs will be taken out from the business following the move of our research facilities in Frankfurt. The Company is well funded and continues to have a low and predictable rate of cash burn with no major capital expenditure anticipated for the foreseeable future. Before moving into commercialisation, there is an additional and crucial factor that often is taken for granted or completely ignored. The research. Without good research and results together with a strong intellectual property position around our programmes, we would have nothing to commercialise. As you have seen from the Report and Accounts, there has been a strong flow of announcements since the end of the third quarter of 2003, which we believe have considerably enhanced and increased the asset value of the Company. This has been partly evidenced through the grant and issuance of ten patents. Many patent applications are filed, but only a small percentage of these are granted to diagnose and treat disease. We would appear to have been successful because of our early strategy to pursue differential protein expression in disease in the late 1990's and that early and continuing vision with the substantial patent portfolio we have established looks as though it will serve us in good stead for a long time into the future. We have been able to demonstrate the power of our ProteoSHOP toolbox which was launched in the middle of 2003 and through which in the period of less than 12 months we have established a very strong position in Alzheimer's disease. Typically it is considered that a patient will have had Alzheimer's disease for ten to fifteen years before there are any clinical symptoms, and onset increases dramatically in those over 65 With the considerable extension of life expectancy and the increase in an ageing global population, this is a major concern. No objective clinical assay currently exists and in March 2004 we announced a panel of CSF biomarkers, followed by the discovery of serum biomarkers at the end of June for the early detection of Alzheimer's disease. In parallel in a separate programme, we presented the discovery of novel kinase activity in the early development of Alzheimer's disease as potential new drug targets to prevent and / or delay the progression of Alzheimer's disease. The award of two grants in early 2004, one under the EU 6th Framework to address patient response to drugs for depression and the other for the early detection of Alzheimer's disease in blood and the discovery of new targets for therapy further endorses the quality and originality of our research and most importantly provides valuable access to cohorts of well characterised patient samples. Without samples we cannot undertake the research, and without the research we cannot commercialise the discoveries. What about commercialisation? At the end of December 2002 we announced the first commercialisation of our proprietary biomarkers in stroke for Point of Care application. In April 2003 we outlicenced the blood biomarkers we had discovered in BSE and scrapie to Idexx Laboratories Inc., the world leader in veterinary diagnostics. Good progress has been made to date and we expect to accelerate this over the next twelve months. This will be generated from all three main parts of the business : • Proprietary Biomarkers for diagnostic and therapeutic application • ProteoSHOP for external strategic alliances • Reagents From the biomarkers we expect to outlicence high throughput stroke applications, blood transfusion screening, Alzheimer's disease and cancer. From ProteoSHOP we expect to enter into a number of strategic alliances and from the reagents we anticipate concluding licences for several of the Sensitizer(R) family reagents. In addition to these, we have identified four major new areas of application for ProteoSHOP from which we are convinced that we can realise major economic value and for which our technical capabilities are ideally suited. These are for : • Toxicoproteomics • Responder Profiling - Responder vs Non Responder • Drug Recovery - Drugs failed under development at Pharma • Drug Refurbishment - Compounds that have gone off patent We are working diligently to convert our outstanding scientific position and proprietary biomarkers in proteomics into further commercial deals and this is our main priority. With increasing visibility of a full and widening pipeline of biomarkers and strategic alliances, we believe that the commercialisation process is well underway and having a significant impact on our business, shifting the equilibrium to generating sustainable and growing revenue and royalties as we move into 2005. We are very confident about our future prospects. This information is provided by RNS The company news service from the London Stock Exchange
UK 100

Latest directors dealings