Interim Results

Proteome Sciences PLC 30 September 2002 Proteome Sciences plc PRESS RELEASE INTERIM RESULTS FOR THE SIX MONTHS TO 30 JUNE 2002 30 September 2002 HIGHLIGHTS Proteomics • Acquisition of Xzillion completed in July 2002. Integration is well underway and on track. • Xzillion brings novel PSTT(TM) (protein sequence tagging) technology to Proteome Sciences. This is a unique proprietary solution for the identification and analysis of membrane proteins which are very important in the area of drug targeting and discovery. Current proteomics techniques are not effective in this area. • Other important developments during the period: • Patent granted to detect CJD and BSE in blood. • Announced blood test for diagnosis of stroke with high specificity and predictive accuracy - license agreement with strategic partner anticipated in coming months with test expected to be on market within next year and a half. • Completion of blood tests for acute and chronic organ rejection in final stages. • Collaborative research agreement signed with ReNeuron Holdings plc for drug target identification for stroke and other nuerodegenerative diseases. Corporate • Xzillion wholly acquired for £12.6 million from Aventis Research and Technologies GmbH &Co (Aventis R&T) funded by issue of Proteome Sciences shares at 70 pence per share giving Aventis R&T 15.8% holding. Dr Wolfgang Schuller, CEO of Aventis R&T joins board of Proteome Scienecs as non- executive director. • Aventis R&T is committed to support the commercialisation of Proteome Sciences technology to secure licensing deals and further strategic partnerships. • Placing in June 2002 raised £2.6 million at 58 pence per share, increased by a further £3.5million following acquisition of Xzillion in July. Intronn • Successful correction of cystic fibrosis gene defect and also mutant factor V111 (haemophilia) RNA repaired both using proprietary SMART(TM) transplicing technology. • Awarded $434,000 grant by National Cancer Institute. Veri-Q Inc • Signed licensing agreement with North Carolina State University relating to impurity levels in synthetic oligonucleotides. With respect to Proteome Sciences' progress and prospects, Christopher Pearce, Chief Executive of Proteome Sciences, commented: 'The acquisition of Xzillion combined with the creation of the proprietary research facility at King's College, London at the end of 2001, concludes the transition of Proteome Sciences from a virtual company to an established business with a genuinely leading position in applied proteomics. 'Of particular importance is our proprietary PST technology, which successfully addresses the complexity of membrane proteins which are known to be significant in relation to drug targeting. This places Proteome Sciences in a unique position to assist pharmaceutical companies in the critical area of drug discovery and development and in the provision of new generations of diagnostic and prognostic products and applications. 'With the business development team having now been significantly strengthened and expanded, license agreements are expected to be concluded in the coming months, with products launched in the market within the next year and a half. We are also in active discussions that we are confident will result in a number of strategic alliances with pharmaceutical, diagnostic and biotechnology companies. 'The outlook for the future is highly favourable as we continue to pursue the strategy adopted over these last years to focus the research to address the complex but high value area of differential protein expressions in disease using our expertise in combining high throughput and high sensitivity approaches.' ENDS The full text of the interim statement is attached. For further information please contact: Proteome Sciences plc Tel : +44 (0) 1932 865065 Christopher Pearce, Chief Executive e-mail :christopher.pearce@proteome.co.uk www.proteome.co.uk Public Relations Ikon Associates Adrian Shaw Tel : + 44 (0) 1483 535102 Mobile : + 44(0) 797 9900733 e-mail : adrian@ikonassociates.com Notes to Editors Proteome Sciences plc ('Proteome Sciences') applies high throughput combined with high sensitivity proteomics to identify and characterise differential protein expression in diseases for diagnostic, prognostic and therapeutic applications. It has to date developed sensitive blood assays for stroke, nvCJD, BSE and solid organ transplantation. The main focus of its research currently addresses neurological, neurodegenerative, diabetes/obesity, oncology and cardiovascular conditions. Commercialisation of these programmes will be effected through strategic alliances and licensing agreements. The Company is headquartered in Cobham, Surrey in the UK and has laboratories at Kings College Hospital, London and in Frankfurt. It employs 40 full time scientists in addition to its corporate and business development staff. The Company has been listed on the Alternative Investment Market since 1994. Proteome Sciences is also the largest shareholder in two US companies: • Intronn Inc., (31% interest) the company that has developed SMaRT(TM), a technology able to modify gene expression at the mRNA level; and • Veri-Q Inc., (55 % interest) which was formed to acquire synthetic oligonucleotide and quality control marker technologies. Chairman's Statement The main events of the year to date can be summarised as follows: Proteomics • Through the acquisition of Xzillion Proteomics GmbH & Co KG (Xzillion) in July, Proteome Sciences has achieved critical mass and the ability to combine high output with high-throughput proteomics, thereby providing a complete proteomics approach to address disease. • Xzillion's technology has been developed from a strong background in chemistry and is totally complementary to Proteome Sciences' existing activities. • Proprietary techniques have been developed: PST(TM) for protein sequence tagging, PSS(TM) for image analysis, TMT(TM) for tandem mass tags, Sensitiser(TM) for mass spectrometry and bioinformatics support for PST(TM) and TMT(TM). • PST(TM) offers a novel solution to address membrane proteins, an area of high complexity which has been poorly addressed by existing approaches, including 2DE. This will generate increased activity across a broad range of diseases where membrane proteins play an important role for drug targets and discovery. The technology is developed and is now ready to be applied externally by strategic alliances. • A patent was granted in January to detect CJD and BSE in blood. A number of other patents exploiting Proteome Sciences technology to test for the presence of TSE (transmissable spongiform encephalopathy) in CSF (cerebrospinal fluid) and blood have been filed. At the 5th Siena Meeting ' From Genome to Proteome' in September 2002, Proteome Sciences presented a paper showing the detection of a fatty acid binding protein in either the CSF or serum of CJD affected patients as a highly sensitive and specific marker of the disease. • A collaborative research agreement was concluded with ReNeuron Holdings plc to identify proteins expressed in brain repair in response to stroke as possible therapeutic entities or drug targets relevant for the treatment of stroke and other neurodegenerative diseases. • In May, Proteome Sciences released significant results from new data generated from its stroke research programme using blood. The data revealed that the assay had high specificity (100%), sensitivity (68.2%) and positive predictive accuracy (100%) in a non invasive procedure that should now enable the test to be used in clinical applications. The results have been provided to a short list of strategic licensing partners and a license agreement is anticipated this year, with a test expected on the market in approximately 12 to 18 months time. • The research projects relating to diabetes/obesity and for rejection following cardiac transplantation continue to make good progress and were presented at the Siena meeting. ELISA assays for the proteins identified in transplantation will be used to complete the development of non invasive tests from blood samples for acute and chronic rejection. Intronn, Inc. (Intronn) • A paper published by Dr John Engelhardt from the University of Iowa featured on the front cover of Nature Biotechnology earlier this year showed that SMaRT(TM) had successfully corrected the cystic fibrosis gene defect in a human lung cell model. • Intronn relocated from Raleigh-Durham, North Carolina to Rockville, Maryland in March 2002. A number of key appointments have been made including Dr Ed Otto as Chief Operating Officer (formerly COO at Genetic Therapy Inc. a subsidiary of Novartis). The headcount stands at 20. • At the American Society of Gene Therapy Annual Meeting in June, Dr Christopher Walsh of the University of North Carolina demonstrated that the mutant factor VIII (haemophilia) RNA was successfully repaired and that the 'RNA repair' was effected by using SMaRT(TM) trans-splicing. • Intronn was awarded a Phase I small business grant by the National Cancer Institute, USA for $434,000 to support a programme in molecular imaging, a new application for SMaRT(TM). Veri-Q, Inc. • Veri-Q concluded a licensing agreement in July 2002 with North Carolina State University in respect of the research relating to the levels of impurity in synthetic oligonucleotides. A paper was published in Analytical Biochemistry in June which shows that 31% of commercial DNA products from eight different suppliers had impurities. Veri-Q has developed and filed patents on antibodies against the protecting/de-protecting groups, which selectively identify and quantify picomoles of remaining protecting groups for applications in antisense therapeutics and oligonucleotide diagnostics. • A commercialisation strategy is underway which will involve the outlicensing of the technology for key applications in DNA assays and for quality control in synthetic oligonucleotide production and re-agents. Corporate • The acquisition of Xzillion in July 2002 for £12.6m was funded through the issue of 18 million Proteome Sciences ordinary shares each at a price of 70p per share. Xzillion had cash holdings of £3.5m at the date of acquisition. • Following the transaction, Aventis Research and Technologies GmbH & Co (Aventis R &T) owns a 15.8% shareholding in Proteome Sciences and is committed to support the commercialisation of Proteome Sciences technology to secure significant licensing deals and further strategic partnerships with a range of pharmaceutical, biotechnology and diagnostic companies. • Proteome Sciences raised £2.6 million at 58p per share by way of a placing completed in June, representing 5% of the ordinary share capital. • Dr. Wolfgang Schuller, CEO of Aventis R&T, joined the Board in July as a non-executive director. • James Green, the business development director, was appointed Commercial Director for Proteome Sciences in July. • Dr Anthony Walker has informed the Board that he has to stand down as a non executive director of Proteome Sciences due to the pressure of other business commitments. • Following the acquisition of Xzillion, Dr Gunther Schmidt has agreed to assist in the integration of its activities within Proteome Sciences and to support the management of Xzillion with his scientific, strategic and patent expertise. Financial Results The financial results for the six months to June, 2002 show a loss before taxation of £1,507,365 compared with £509,108 in the corresponding period in 2001. The period to 30th June 2002 includes for the first time a share of associates' operating loss at Intronn, Inc. of £127,324 (In 200l the loss of £30,959 of Intronn LLC is shown under discontinued operations) and a realised exchange loss of £143,560 (2001: a realised exchange gain of £225,778) and costs at King's Laboratory of £276,786 (2001: £20,865). Cash at 30th June, 2002 stood at £2.6m. This was increased in July by the £3.5m cash holding at Xzillion at the date of acquisition. Future Prospects Through the acquisition of Xzillion in July and the creation of the proprietary research facility at King's College, London at the end of 2001, Proteome Sciences has concluded the transition from a virtual company to one having a complete approach in applied proteomics. The combination of high-throughput with high sensitivity has established new levels of high output proteomics capability. These will be key facilitators for drug discovery and development and will also provide new generations of diagnostic and prognostic products and applications. The PST(TM) technology is developed and amongst other areas, provides a novel solution to address the complexity of membrane proteins. These are one of the main targets for the pharmaceutical industry. The business development team has been significantly strengthened and expanded, and license agreements are expected to be concluded before the current year end, with products launched in the market in the next 12 to 18 months. Strong progress has been made throughout Proteome Sciences research programmes and these should result in a number of strategic alliances with pharmaceutical, diagnostic and biotechnology companies. Having established a leading position in applied proteomics, the prospects for Proteome Sciences appear highly favourable and clearly endorse the strategy adopted over these last years to focus the research to address the complex but high value area of differential protein expressions in disease. Unaudited consolidated profit and loss account for the six months ended 30th June, 2002 Six months ended Six months ended Year ended 31st 30th June 2002 30th June 2001 December 2001 £ £ £ Administrative expenses (730,347) (574,118) (1,455,005) Realised exchange (losses)/gains (143,560) 225,778 65,213 Research and development expenses (507,060) (205,566) (720,856) Other operating expenses - - - Operating Loss (1,380,967) (553,906) (2,110,648) Continuing operations (1,380,967) (522,947) (2,028,489) Discontinued operations - (30,959) (82,159) (1,380,967) (553,906) (2,110,648) Share of associates' operating loss (127,324) - (33,774) Interest receivable 7,321 62,260 104,197 Interest payable and similar charges (6,395) (17,462) (32,846) Loss on ordinary activities before taxation (1,507,365) (509,108) (2,073,071) Tax on loss on ordinary activities - - 69,919 Loss on ordinary activities after taxation (1,507,365) (509,108) (2,003,152) Minority interest - - 26,128 Loss for the period (1,507,365) (509,108) (1,977,024) Loss per share Basic and diluted (1.64p) (0.56p) (2.16p) Notes to the Financial Information 1. There has been no change to any of the accounting policies set out in the 2001 statutory accounts. 2. Following the loss of £1,507,365 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 2002 is based on the loss for the financial period of £1,507,365 and on 92,297,005 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the period (six months ended 30th June 2001 - loss £509,108, number of Ordinary Shares in issue and ranking for dividend, 91,538,400). b. The calculation of the loss per share for the year ended 31st December 2001 is based on the loss for the year of £1,977,024 and on 91,538,400 Ordinary Shares, being the number of shares in issue and ranking for dividend during the year. 4. In October 2001 Intronn LLC transferred the intellectual property for its SMaRT technology and substantially all of its assets and liabilities to a newly formed company, Intronn Inc, in exchange for the issue of common stock in Intronn Inc to the previous members of Intronn LLC and to certain of the holders of 8% Convertible Promissory Notes 2001 in Intronn LLC who did not elect to have notes redeemed for cash. In these accounts Intronn LLC has been treated as an associate company for the six months ended 30 June 2002, and Intronn Inc as a subsidiary company in the corresponding period in the previous year. Intronn Inc has both Common Stock and Series A Convertible Preferred Stock in issue, and upon full conversion of the latter the Company would own 30.87% of Intronn Inc's Common Stock. 5. Formal completion of the acquisition of Xzillion Proteomics GmbH & Co. KG (Xzillion) did not take place until the 4th July 2002 and the figures for the six months to the 30 June 2002 do not include the results of Xzillion. 6. 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 2001 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. This information is provided by RNS The company news service from the London Stock Exchange
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