Interim Results

Proteome Sciences PLC 31 October 2000 Proteome Sciences plc Coveham House, Downside Bridge Road, Cobham, Surrey KT11 3EP. Tel: 01932 865065 Fax: 01932 868696 psplc@compuserve.com INTERIM STATEMENT FOR THE SIX MONTHS TO 30TH JUNE 2000 HIGHLIGHTS + Proteomics + Proteomics now recognised as a key scientific route to understanding and diagnosing disease. + Two tests now ready for commercialisation; one for the diagnosis of CJD and the other for the diagnosis of stroke. + Patents now granted or filed for disease diagnosis, prognosis and therapy in the following areas; neurodegenerative diseases, chronic heart disease, rejection after solid organ transplantation, cancer and diabetes/obesity. + Three patents filed relating to diabetes and obesity in the first half of the year. + Proteome Sciences is a founder shareholder in GeneProtTM, a company formed in March this year to sequence the human proteome. Second round funding has put a value on this Company close to $200 million. + Agreement reached to assign interest in certain colorectal patents to Europroteome SA in exchange for equity. Europroteome is expected to effect an IPO during 2001. + Gene expression + Intronn LLC, the US based subsidiary of Proteome Sciences, positioned for IPO in 2001. + CEO appointed in September of this year. + Two key patents granted and a further patent application filed during the period + Major grant application submitted and expected to receive considerable proportion of $3.2 million requested. + A number of collaborative research and partnering opportunities are being actively pursued for Intronn's SMaRT TM technology in addition to those already signed up which are addressing key disease states. + Intronn set to become a market leader in the analysis and purity of synthetic oligonucleotides, a market which is experiencing rapid growth. + Financial performance + Loss before tax of £606,799 (loss £502,560), in line with budget. + Cash at 30 June 2000 amounted to £4.3m. + Current cash resource should provide adequate funding through to 2003 at current levels of cash burn. Commenting on the results for the period, Christopher Pearce, Chief Executive, said: 'Proteome Sciences has had a very active six months during which substantial developments across both the proteomics and gene expression divisions of the Company have been made. 'In particular, having two diagnostic tests, for CJD and stroke, ready for immediate commercialisation and with Intronn making outstanding advances with its SMaRTTM technology I am confident of further strong progress during the rest of the year.' Set out below is the full text of the Interim Statement. Introduction The Company announces its interim financial results for the six months ended 30th June 2000, together with an update on its research programmes. Intellectual Property Over the period two key patents have been granted in the USA. At the same time the discoveries made across the scientific projects have resulted in four additional patent filings:- * two key patents relating to Intronn LLC's research in spliceosome mediated targeted transplicing (SMaRT TM) have been granted in the U.S. - the first of these relates to the SMaRT TM technology platform - the second includes the use of SMaRT TM in genomics as a means of exon tagging * a further three patent applications have been filed relating to the diabetes and obesity research undertaken at the Universities of Buckingham and Geneva. * a patent application has been filed as a method to detect the purity and length of synthetic oligonucleotides Intronn Considerable advances both in science and in corporate development have been made at Intronn LLC, Proteome Sciences' US subsidiary. Dr Gerard McGarrity was appointed as CEO in September 2000. Since then he has undertaken a major scientific review of Intronn to finalise the business plan and corporate strategy to complete the funding for Intronn ahead of preparing the business for IPO in 2001. An interim funding was completed in July which raised $500,000, the initial part of the $5m to $6m mezzanine total anticipated for the company. In the latest Annual Report and Accounts, mention was made that Intronn was in the process of submitting a major Phase 2 SBIR grant application to the NIH in the USA following its successful Phase 1 SBIR grant. The reviewers praised the Phase 2 SBIR grant application as one of the most innovative, thoughtful and exciting ones they had ever read. The application received a particularly high score at 119 (100 being perfection) and Intronn understands that it 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 TM and the wide range of applications that it can address. Driven by the advances in genetics, in particular the mapping of the human genome, the US market for synthetic oligonucleotides, which is likely to exceed $200m in 2000, is thereafter expected to escalate at a very rapid rate. Nucleic acid-based therapeutics - there are 15 antisense products from 9 US companies in clinical trials - and diagnostic (DNA chip) products are projected to reach $11bn in 2005. Today purification and analysis of purity of these synthetic oligonucleotides requires expensive methods and technologies. Intronn, through its research programme and the patent applications relating thereto is poised to become a market leader with its proprietary methods for simple, reproducible and sensitive front end analysis and purification of synthetic oligonucleotides. The prospects for these activities look outstanding and it is proposed that the oligonucleotides programme will be spun out separately from SMaRT TM for commercialisation early in 2001. Heads of Agreement have been signed up in July for a collaborative programme in agbio using SMaRT TM and other collaborative research and partnering opportunities are being actively addressed. SMaRT TM is now being used across a broad range of applications in collaborations to address cystic fibrosis (the University of Iowa and Duke University), factor VIII (University of North Carolina), HPV and cervical cancer (National Cancer Institute, USA), Alzheimer's (Kings College, London) and collagen disease (General Hospital, Salzburg). Proteomics The announcement of the completion of the first draft sequencing of the human genome at the end of June was a major scientific landmark which engendered considerable media attention. This has stimulated significant activity in the pharmaceutical and biotechnology industry and for investors on both sides of the Atlantic. Whilst the first draft of the human genome was an enormous achievement, the vast amount of sequence data needs to be made intelligible and maximum value will be added to this process through function and the ability to patent utility of function. Genes (which are simple functional units of sequence data) control the body through the proteins they produce. By identifying the proteins that are implicated in a particular disorder (through proteomics and functional genomes) it is possible to see what is actually happening and has happened in a disease. Identification of disease related genes (genomics) only tells us what could happen. Consequently, the information generated by proteins is most valuable data as it not only allows accurate identification of the mechanism and markers of disease (diagnostics) but also provides real targets for drug discovery. Proteome Sciences shares the view that it is considerably easier and faster to go from disease-associated protein to drug, than it is to go from basic genomic sequence data to drug. Proteome Sciences is particularly well placed through its established proteomics research programmes in neurogenerative disease, chronic heart disease, rejection after solid organ transplantation, cancer and diabetes/ obesity to capitalise from the substantial proprietary libraries and data it has built up on differential protein expression in disease pathways. Not only is proteomics a key tool to unlock functional genomics, but Proteome Sciences has now developed early products from proteomics which address significant areas of unmet need. There has been considerable media focus on the implications of human consumption of BSE infected meat and the identification and consequent increases in the numbers of deaths from CJD/ nv CJD (new variant CJD) from the Phillips Report and the pressing requirement for a blood test to diagnose these conditions. Proteome Sciences has developed a blood test with high sensitivity for CJD and is actively involved in out licensing it to commercial partners. Details of this have been disclosed under a confidential disclosure agreement to the CJD Surveillance Unit where the assay is under evaluation. At the same time, it has developed a blood test for stroke with high sensitivity, specificity and predictive accuracy and this, combined with the markers from the other research programmes is being aggressively marketed through our business development team. The Fourth Siena Conference 'from Genome to Proteome' created and sponsored by Proteome Sciences attended by 450 people provided further reflection of the interest focused on proteomics, with over 500 prospective delegates unable to obtain places. There was substantial representation from the core and strategic research areas of major pharmaceutical, diagnostic and genomics companies. This provided an ideal platform for Proteome Sciences to present some of its latest results including stroke, CJD, diabetes, obesity, chronic heart disease and rejection after solid organ transplantation. This, and the major Bio Partnering meeting in London in October, have combined to generate considerable activity in commercialisation of the proteomics programme. Strong scientific progress has continued across the research, with a further three patents applications filed in diabetes and obesity. Proteome Sciences is close to concluding its exclusive licensing option with the University of Michigan in respect of the oncology programme in the USA. Agreement has been reached with Europroteome SA for the assignment of the group's interest in certain of its colorectal patents, in exchange for equity. Europroteome has recently received an injection of funds from BioMerieux, valuing the company at approximately Dm25m. It is anticipated that Europroteome will effect an IPO sometime in 2001. The appointment of an internal business development manager in the second quarter of the year, complemented by specialist external consultants in oncology and licensing, combined with the substantial increase in activity after the draft sequence of the human genome, should lead to the conclusion of collaborative research and license agreements with biotechnology and pharmacos, moving into 2001. Proteome Sciences was a founder shareholder in Geneva Proteomics TM (GeneProt TM ), a company formed in March 2000, to sequence the human proteome with a bank of 50 mass spectrometers. Since that time GeneProt TM has announced a successful second round of funding, capitalising the corporation at close to $200m. In October, GeneProt TM announced that it had entered into an agreement with Novartis to sequence three disease proteomes for $43m with further milestones which could trigger up to a further $41m of payments. This is the first major transaction in proteomics since the announcement of the sequence of the human genome and augers well for future transactions in disease related proteomics. Financial Update The financial results for the six months to 30th June 2000, show a loss before taxation of £606,799, compared with £502,560 in the corresponding period in 1999. This includes £219,000 for costs associated with the Placing and Open Offer in March and also incorporates a favourable movement in realised exchange gains of £238,044 (1999: £158,876). The results exclude any write back of provisions made in earlier years, as included in the 1999 results. Cash at 30th June 2000, totalled £4,268,823. This reflects the £4.4m received by way of the Placing and Open Offer to shareholders completed in May 2000. This should provide adequate funding to satisfy the existing level of cash burn through to 2003. Outlook The prospects for Proteome Sciences look most encouraging. With its two platform technologies in proteomics and modification of gene expression, (SMaRT TM) the company is uniquely positioned to address functional genomics. These offer vital tools to unlock the vast amount of data from the human genome, to simplify its navigation and to accelerate disease discovery and treatment. The Directors look forward to exploiting the considerable commercial opportunities that these provide and thus to demonstrate clearly the substantial value that has been established from the research programme. 31st October 2000 Enquiries:- Proteome Sciences plc, UK Tel: +44 (0) 1932 865065 Christopher Pearce, Chief Executive Officer e-mail: psplc@compuserve.com Ikon Associates Adrian Shaw Tel: +44(1) 483 271291 Unaudited consolidated profit and loss account for the six months ended 30th June 2000 Six months ended Six months ended Year ended 31st 30th June 2000 30th June 1999 December 1999 £ £ £ Administrative expenses (652,392) (426,206) (761,396) (Note 4) Realised exchange gains 238,044 158,876 71,072 Research and development (234,887) (252,205) (560,190) expenses Other operating expenses (139) (4,491) (5,614) ______ ______ ________ Operating loss (649,374) (524,026) (1,256,128) Interest receivable 47,923 23,208 32,817 Interest payable and (5,348) (1,742) (6,447) similar charges ______ ______ ________ Loss on ordinary (606,799) (502,560) (1,229,758) activities before taxation Tax on loss on ordinary - - - activities ______ ______ ________ Accumulated deficit for (606,799) (502,560) (1,229,758) the period Loss per share / Basic 0.71p 0.64p 1.57p and diluted Notes to the Financial information 1. There has been no change to any of the accounting policies set out in the 1999 statutory accounts 2. Following the loss of £606,799 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 six months ended 30th June 2000 is based on the loss for the financial period of £606,799 and on 85,533,704 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the period (six months ended 30th June 1999 - loss £502,560, number of Ordinary Shares in issue and ranking for dividend, 77,717,483). b) 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. Administrative expenses for the six months ended 30th June 2000, include £219,000 for costs associated with the Placing and Open Offer in March 2000. 5. 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.
UK 100

Latest directors dealings