Preliminary Statement

Proteome Sciences PLC 16 May 2001 Proteome Sciences plc 16 May 2001 PRELIMINARY STATEMENT FOR THE 12 MONTHS TO 31 DECEMBER 2000 HIGHLIGHTS Proteome Sciences plc (Proteome Sciences), the AIM listed proteomics and modification of gene expression company, announces its preliminary results for the year ended 31 December 2000, statement and the following highlights: Strategic Overview * Establishment of one of most advanced proteomics facilities in Europe, representing a significant landmark in Proteome Sciences' development from its virtual model. * £4.3 million fund raising completed in April 2000. * High profile CEO appointed at Intronn. * Founder members of the Human Proteome Organisation (HUPO) council. * Dr Anthony Walker appointed as non-executive director (see separate announcement issued on 14 May 2001). Proteomics * CJD, stroke and organ transplant rejection markers ready for commercialisation. * Further CJD samples provided by CJD surveillance unit with assay under evaluation. * Four further diabetes and obesity patents filed. * Proteomics collaboration in neurodegenerative diseases with Institute of Psychiatry, King's College, London. * £450K Britech grant for new diagnostic markers and therapeutic targets in Alzheimer's. * Potential commercialisation of intellectual property of University of Michigan cancer programme through formation of a specialist cancer proteomics newco in the US. Gene Expression * Replacement of an internal exon using double splicing - a major scientific milestone with fundamental implications for the way gene therapy will be applied in the future. * SMaRT Biosciences Inc in process of incorporation. * Initial $6million funding to be completed at SMaRT Biosciences in the near future ahead of IPO in the US when the biotech market picks up. * Major $3m SBIR grant from the NIH in the US in cystic fibrosis. * Material Transfer Agreements signed: cystic fibrosis, haemophilia, HPV, cervical cancer, Alzheimer's and collagen disease - Intronn retains exclusive commercialisation of results. * Intronn poised to become market leader in the analysis of impurity and measurement of synthetic oligonucleotides. Financial * Cash balance at end of year £3.3million * Loss of £1.4million (1999 - £1.2million) * No further significant investment required for Intronn/SMaRT from Proteome Sciences. Commenting on the Company's progress and prospects, Christopher Pearce, Chief Executive of Proteome Sciences said:- 'The period has been the most significant in the Company's history from both a strategic and operational perspective. Of particular note, the full significance of proteins has been revealed following the sequencing of the human genome and the establishment of our leading edge high sensitivity proteomics facility. This will greatly increase the Company's ability to undertake strategic research partnerships with major pharmaceutical and biotechnology companies and represents a significant landmark in Proteome Sciences' development. 'Our two platform technologies in proteomics and the modification of gene expression are now perceived to be particularly relevant as keys to unlock value from functional genomics and have a broad range of applications. This, combined with the policy of retaining proprietary control of the data and results generated from our research programmes, positions us extremely well to exploit the substantial commercial value within Proteome Sciences through licensing deals and further strategic collaborations in the current year and beyond.' ENDS Enquiries:- Proteome Sciences plc Tel: +44 (0) 1932 865065 Christopher Pearce, Chief Executive Public Relations Ikon Associates Tel: +44 (0) 1483 271291 Adrian Shaw Mobile: +44 (0) 797 9900733 E-mail: adrian@ikonassociates.com Set out below is the full text of the Chairman's statement. Dear Shareholder, The year ended 31st December 2000 has been very active, productive and successful for the Company in respect of its activities in proteomics and in its gene expression division. This momentum has continued into 2001 and a number of major new milestones have been achieved. Considerable progress has been made both scientifically in proteomics towards the commercialisation of novel proteins discovered from Proteome Sciences' research programme and with SMaRTTM gene expression in the US for the broad range of applications of SMaRT. Over the period the Company has successfully concluded a £4.3m fund raising in 2000 and appointed a high profile CEO at Intronn, Dr Gerard McGarrity, to finalise the corporate strategy and to complete its funding ahead of preparing the business for a possible IPO in 2001. The recent announcement of the setting up of a high sensitivity proteomics research facility at King's College, London (KCL) is a further major development, establishing one of the most advanced proteomics facilities in Europe and increasing the opportunity to add more shareholder value through more comprehensive partnership agreements with pharmaceutical and biotechnology companies. This creates a significant landmark in Proteome Sciences' corporate development, taking it a long way from the virtual model from which the Company has evolved. The advisory council for HUPO (Human Proteome Organisation) was created in February 2001 to increase the awareness of this discipline of science to society and to develop a broader understanding of the importance of proteins and proteomics, and the opportunities they offer in the diagnosis, prognosis and therapy of disease. Proteome Sciences is particularly well represented on this forum, with Christopher Pearce, the Company's chief executive, and three of our principal collaborators being members of the HUPO council. Review of Activities Last year I talked about our expectation that proteomics would arrive on centre stage in the field of drug discovery and development. The surprising revelation in February 2001 that humans have 30,000 genes, rather than the 100,000 to 150,000 predicted and that each gene may make several, or even several hundred, proteins, clearly establishes that proteins play a much more significant role than hitherto believed and confirms that other technologies, particularly proteomics, will be key in unlocking functional genomics. This has stimulated considerable activity in the pharmaceutical industry and engendered much media attention. The vast amount of sequence data produced needs to be made intelligible, and maximum value will be added to this process through function and ability to patent utility of function. The two areas addressed by Proteome Sciences, proteomics and modification of gene expression, fulfil these objectives. They are platform technologies with multiple applications, offering solutions in critical areas of unmet need. The science has now delivered and moves to commercialisation are in hand. Proteome Sciences will continue to focus as a pure research company and its partners, pharmaceutical and biotechnology companies, will bring the specialist skills in development and taking products to market. The platform technologies at Proteome Sciences are complementary to other companies and their techniques. In proteomics, Proteome Sciences retains proprietary control of the data and results generated from its own research rather than acting on a fees for service basis for third parties. In gene expression, SMaRTTM which is effected at the mRNA level, is complementary to existing antisense and ribosyme technology. Most importantly, Intronn was granted two key patents in the US during the year and this will provide SMaRTTM with a field dominating position. Proteomics Proteomics has been recognised as a key scientific tool in understanding disease and from which to develop diagnostic and therapeutic interventions. On the commercial front, Proteome Sciences developed three potential products from proteomics over the course of the last year. These are protein markers with high sensitivity, specificity and predictive accuracy from human blood samples to detect CJD, stroke and chronic rejection. These are being actively marketed to pharmaceutical/biotechnology companies and Proteome Sciences expects to conclude licensing agreements in 2001/2002. Details of the CJD marker have been disclosed to the CJD Surveillance Unit under a confidential disclosure agreement. Further samples have now been provided to Proteome Sciences and the assay is under evaluation. Discussions are in progress with the stroke and solid organ transplant markers and Proteome Sciences anticipates further progress with the diabetes and obesity programmes at the University of Buckingham and the University of Geneva. A license agreement is expected to be concluded with the University of Michigan shortly and the specialist consultant retained to outlicense the cancer research programme has encountered considerable interest. The fourth Siena Conference 'From Genome to Proteome' in September provided an ideal platform for Proteome Sciences to present some of its recent results including stroke, diabetes, obesity, chronic heart disease and transplant rejection to the core and strategic research areas of major pharmaceutical, diagnostics and genomics companies. This has been followed with further specialist meetings in London, Birmingham and York in 2001. Strong scientific progress has been made across the proteomic projects with a further 7 patent applications in diabetes and obesity and applications also for transmissable spongiform encephalopathy (TSE - CJD, BSE, Scrapie etc) and acute rejection. The new proteomics research facility at King's College, London (KCL) is a major strategic development in that it establishes Proteome Sciences' leading edge research capability, which will enable it for the first time to conduct external research programmes with corporate partners at its own facility. This will strengthen Proteome Sciences' ability to enter into strategic agreements with pharmaceutical and biotechnology companies and the ability to use in house intellectual property from data and results already generated for protein markers for diagnosis, prognosis and therapeutic intervention. The laboratory facility will focus on high output proteomics, utilising high sensitivity protein separation techniques in a powerful combination with the latest mass spectrometry instrumentation. This brings together leading expertise in the two main disciplines with Dr. Michael Dunn (presently at the Heart and Lung Research Centre, Harefield Hospital, Imperial College, London and Chairman of the British Electrophoresis Society) heading the specialist protein separation team and Malcolm Ward (formerly of GlaxoSmithKline, Stevenage) leading the mass spectrometry and sequencing team. At the same time, Proteome Sciences has entered into a collaboration with the Institute of Psychiatry at KCL to address a range of neurodegenerative conditions including Alzheimer's, Parkinson's and motor neurone disease. With the Institute of Psychiatry's expertise in the pathogenic mechanisms for neurodegenerative diseases, this will create a powerful approach and should accelerate the discovery process for new therapeutic treatments and diagnostics. In April, Proteome Sciences and Mindset BioPharmaceuticals Ltd, an Israeli drug discovery and development company were awarded a £450,000 Britech grant for a new research programme in Alzheimer's (PRO-TAMAD) to discover new targets for therapy and new improved diagnostic markers. It has been estimated that there are about 500,000 Alzheimer's sufferers in Britain and, according to the American Alzheimer's Association, approximately 4 million people in the US have this disease. Most of them are over the age of 65 and half of all Americans over 85 are thought to have Alzheimer's. By 2005, it has been predicted that this will rise to over 14 million people in the US alone. For a disease that can span from 2 to 20 years, the cost in the US is currently estimated at $180bn annually. The PRO-TAMAD programme will further enhance Proteome Sciences' strong position in neurodegenerative disease. The appointment of an internal business development manager in April 2000 has been complemented by external consultants in oncology and licensing. This, in combination with the human genome sequence information, should lead to a number of collaborative research and license agreements with biotechnology and pharmaceutical companies in 2001. Gene Expression Over the course of the last year, considerable advances have been made at Intronn LLC, both in science and corporate development. SMaRT BioSciences Inc is currently in the process of incorporation and the intention is that this will shortly have all the personnel, results, data and intellectual property associated with SMaRTTM assigned into it. The other activities of Intronn relating to synthetic oligonucleotides and quality control markers will remain in Intronn. Dr Gerard McGarrity (formerly senior Vice President and Director of Development at Genetic Therapy Inc, a Novartis company and most recently Chief Scientific Officer at Cambridge Genetics Ltd) was appointed CEO at Intronn in September. Since then he has undertaken a major scientific review of Intronn to finalise the business plan and corporate strategy for SMaRT BioSciences Inc and to complete its funding ahead of preparing the business for a possible IPO in 2001. An interim funding was completed in July, which raised $500,000, the initial part of the $6m total anticipated, and this is expected to be completed in the near future. With this in place, SmaRT BioSciences will be ideally positioned to move quickly to secure a substantial equity round and IPO when the biotech funding window in the US is open. In April 2000, Intronn entered into its first Materials Transfer Agreement (MTA) with Dr John Engelhard at the University of Iowa to test the potential of SMaRTTM technology to repair the gene defects which cause cystic fibrosis in the most clinically relevant models of the disease, and for therapeutic intervention. A Phase 2 SBIR grant application in cystic fibrosis was made to the NIH in the USA, following the successful Phase 1 SBIR application in 1999. The Phase 2 application was praised by the reviewers as 'one of the most innovative, thoughtful and exciting ones they had ever read'. Intronn has again been successful with a major Phase 2 grant award and will receive a considerable proportion of the $3.2m grant for which it applied. This is a clear endorsement of the outstanding and innovative scientific approach established by SMaRT and is a good illustration of one specific model that it can address across a wide range of different diseases. At the present time, SMaRTTM is being applied to gene repair, exon tagging, exon swapping, gene knockdown, target validation, agricultural biotechnology and gene therapy. At the Keystone Symposium in Utah USA in January 2001, Intronn for the first time confirmed a new event, double splicing of pre mRNA. SMaRTTM was able to replace an internal exon using double splicing. This has been the goal that gene therapy has tried without success to achieve using ribosomes over the last fifteen years. This completed a further major milestone for the SMaRTTM technology platform and has profound implications for modification of gene expression and vector delivery in gene therapy. By achieving double splicing using PTM inserts in a space of less than 600 nucleotides, the need for using a vector delivery system may be eliminated as the process may be carried out using chemistry in a conventional pharmaceutical setting. This will change the way that gene therapy will be applied in the future. A CRADA (co-operative research and development agreement) was signed with the National Cancer Institute (NCI) within the National Institute of Health in the USA in April 2001. The agreement will involve Intronn and Dr Carl Baker at the NCI combining their expertise to develop RNA based treatments for human papillomavirus infection (HPV) and cervical cancer using SMaRTTM. A number of other MTA's have been signed following the Iowa agreement in April 2000 where Intronn has provided pre-transplicing molecules (PTMs). No additional external costs will be incurred under the MTAs and Intronn owns the PTMs and has exclusive commercialisation of any results. These cover cystic fibrosis (Duke University), factor VIII (haemophilia) (University of North Carolina), HPV and cervical cancer (NCI), Alzheimer's (King's College, London) and collagen disease (Salzburg General Hospital, Austria). The applications use different cell types and address diseases ranging from cancer, neurodegenerative, dermatological, genetic to haemophilia. Heads of Agreement were signed in July for a collaborative programme in agricultural biotechnology using SMaRT and other collaborative research and partnering opportunities are being actively addressed. Driven by the advances in genetics, in particular the mapping of the human genome, the US market for synthetic oligonucleotides, which was estimated to exceed $200m in 2000, is thereafter expected to grow at a very rapid rate: nucleic acid based therapeutics - there are 15 antisense products from nine US companies in clinical trials - and diagnostic (DNA chip) products are projected to reach $11bn in 2005. Purification and analysis of purity of synthetic oligonucleotides requires extensive methods and technologies. In order to achieve spliceosome mediated mRNA transplicing Intronn needed to utilise ultra pure synthetic oligonucleotides and therefore it had to develop new proprietary methods from its research to achieve this objective. Patent applications filed in this context cover a method for simple front end analysis and purification of synthetic oligonucleotides. Intronn is presenting its oligonucleotide technology to the FDA and National Institute of Standards and Technology (NIST) in the USA, and if accepted as the benchmark, Intronn is poised to become a market leader in the level of impurity and measurement of synthetic oligonucleotides. Commercialisation is proposed to be undertaken through licenses with oligonucleotide and DNA chip manufacturers. External Investments Over the course of the last year, Proteome Sciences has identified a new and complementary approach, in addition to outlicensing, which will maximise shareholder value and returns by converting elements of its intellectual property into equity stakes in specialist newcos with leading technology that plan future IPOs and listing. Certain of the group's interests relating to patent filings in a colorectal research project in Europe have been assigned to Europroteome SA in exchange for equity. BioMerieux has taken a stake in Europroteome SA and a funding was completed in 2000 valuing the company at approximately DM25m. Having established a new laboratory facility in Berlin and completed a second funding round, Europroteome is anticipated to effect an IPO in 2001. Because of its close relationship with University Cantonal Hospital, Geneva, Proteome Sciences was invited to be a seed investor in Geneva ProteomicsTM (GeneProtTM) - a company formed to sequence human proteomes using 51 mass spectrometers - in the first round of funding in April 2000. Since that time further funding rounds and investment by partners including Compaq and Bruker have been completed, capitalising the company in excess of $200m. In October GeneProtTM entered into an agreement with Novartis to sequence three disease proteomics for $43m, with further milestones which could trigger a further $41m of payments. This was the first major deal in proteomics since the announcement of the draft sequence of the human genome in June 2000 and sets a basis of valuation for future transactions in disease related proteomics. It is thought that GeneProtTM may seek an IPO in the future, possibly in 2001. Given the substantial level of interest in the main proteomic cancer programme undertaken at the University of Michigan, other than through conventional research partnerships/out-licensing, Proteome Sciences is also exploring the possibility of converting its intellectual property into a specialist proteomics company in the US, with the major focus in cancer therapeutics and early diagnosis. We expect that the external investments that Proteome Sciences has established will play an important role in the commercialisation of the research programme, and will also demonstrate the substantial value of the data and results generated from its early involvement in proteomics associated with human diseases. Results In the twelve month period ended 31st December 2000, Proteome Sciences incurred a pre-tax loss of £1,405,447 (1999: £1,229,758). At the year end cash balances stood at £3.304m. With Intronn now raising its own funding in the US, it is not envisaged that Proteome Sciences will need to make any further significant investment into Intronn/SMaRT in the future. Current Outlook The sequence information from the human genome has dramatically elevated the importance and value of proteins in bio-medical research and this will have a substantial impact in accelerating the development of diagnostic and therapeutic intervention. Proteome Sciences has established a unique position with its platform technologies in proteomics and in modification of gene expression. These will be key value drivers to unlock functional genomics. The Company is exceptionally placed to capitalise from these technologies across Proteome Sciences substantial portfolio of research. The establishment of the high sensitivity proteomics facility at KCL creates a significant landmark in the Company's corporate development and will greatly increase its ability to undertake research partnerships with major pharmaceutical and biotechnology companies. The Board looks to the future with confidence and to exploiting the considerable commercial opportunities that this will provide. I would like to express my sincere thanks and appreciation to Professor Keith Mansford, who retired following the last Annual General Meeting, for the outstanding contribution he made to Proteome Sciences, in particular as Chairman of the Scientific Advisory Board and he has been succeeded in that position by Professor William Dawson. The Board is, however, pleased to announce that Dr. Anthony Walker, has been appointed as a non-executive Director. He is Chief Executive of Onyvax Limited, a cancer vaccine company, prior to which he had a distinguished career as a management consultant at Arthur D. Little and The Wilkerson Group to many of the major European pharmaceutical and biotechnology companies. As a final comment, I would like to pass on my sincere thanks and appreciation to all the employees, scientists, collaborators and consultants for their hard work and contribution to the progress at Proteome Sciences over the period. Steve Harris Chairman 16th May 2001 Year ended Year ended 31st December 31st December 2000 1999 £ £ Administrative expenses (1,149,995) (761,396) Realised exchange gains 303,158 71,072 Research and development expenses (695,018) (560,190) Other operating expenses (35) (5,614) __________ __________ Operating loss (1,541,890) (1,256,128) Interest receivable 158,135 32,817 Interest payable and similar charges (21,692) (6,447) __________ __________ Loss on ordinary activities before taxation (1,405,447) (1,229,758) Tax on loss on ordinary activities - - __________ __________ Loss for the financial year (1,405,447) (1,229,758) __________ __________ Loss per share Basic and diluted (1.59p) (1.57p) _________ _________ 1. There has been no change to any of the accounting policies set out in the 1999 statutory accounts. 2. Following the loss of £1,405,447 incurred in the period, the Directors do not recommend the payment of a dividend. 3. a. The calculation of the loss per share for the year ended 31st December 2000 is based on the loss for the year of £1,405,447 and on 88,552,458 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the year. a. The calculation of the loss per share for the year ended 31st December 1999 is based on the loss for the year of £1,229,758 and on 78,505,304 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the year. 4. The preceding financial information does not constitute statutory accounts as defined in Section 240 of the Companies Act 1985. The financial information for the year to 31st December 1999 is based on the statutory accounts for that year. These accounts, upon which the auditors issued an unqualified opinion, and which did not contain any statement under Section 237 (2) or (3) of the Companies Act 1985, have been delivered to the Registrar of Companies. The auditors have not yet reported on the full statutory accounts for the year ended 31st December 2000 which will be posted to shareholders later this month. After that time they will also be available at the Company's registered office: Coveham House, Downside Bridge Road, Cobham, Surrey KT11 3EP.
UK 100

Latest directors dealings