Preliminary Results

EpiStem Holdings plc 10 October 2007 Preliminary Results to 30th June 2007 Epistem Holdings Plc (LSE: EHP), the UK epithelial stem cell company, announced today its preliminary results for the period to 30th June 2007. A Year of Progress for Epistem A strong turnover that positions us well for the future The 2006/07 financial year saw Epistem's transition from a biotechnology start-up to an AIM-listed plc company with outstanding opportunities in its chosen field. The maiden results for the Company were also impressive with year-on-year turnover up 50%. Epistem's shares were well received in the market with the stock post flotation showing a 20% premium on the admission price. The forecast outlook for 2007/08 anticipates strong advances in Epistem's revenue. These forecasts are based on growing demand for Epistem's stem cell technology based products and services, an experienced management team, and the increased number of commercial opportunities now beginning to emerge. This confluence of activities will define Epistem as one of the foremost and exciting companies in the biotechnology sector. Highlights • Admitted to AIM; £3m funds raised • 50% increase in revenues • Strengthened Management Team • New biomarker development programme with AstraZeneca plc • Radiation Damage Models for Intestinal Stem Cells chosen for the US National Institute of Health bio-defence programme and successful completion of the initial series of tests • Commenced manufacture of 250 candidate therapeutic proteins • Novel Therapies division enters its first out-licensing agreement • Protocol finalised and tested for plucked human hair model for use as a non-invasive bio-marker in oncology For further details please contact: Matthew Walls Chief Executive Officer - EpiStem Ltd +44 (0)161 606 7258 Thilo Hoffmann Landsbanki Securities (UK) Limited +44 (0) 20 7426 9000 Mike Wort, Anna Dunphy MC Bio-Communications Limited +44 (0)20 7744 7711 The Chairman's Statement: Dear Shareholder, I am delighted to present the maiden annual report for the Company following its admission to AIM on 4 April 2007. The overall report has been designed to provide a summary of the year's progress and to explain the background and opportunity behind our scientific and commercial plans for the exploitation of our unparalleled knowledge of adult epithelial stem cells. The financial results for the Group as presented in this report are prepared using merger accounting, thus reflecting the results for the Group's sole subsidiary for the year to 30 June 2007 and for the comparative period to 30 June 2006. Fuller details of the results for the period are covered in the CEO's review but, operationally and financially, the year to 30 June 2007 saw the Company generate revenues of £1.4m (2006: £0.9m). With a net CRO contribution of £0.25m (2006: £0.2m), and research and other operating costs of £1.5m (2006: £1.2m), the after tax loss reported for the year was £1.0m (2006: £0.9m). Cash held in the company at the end of June 2007 was £2.3m. During the year, the Group made significant progress on a number of key fronts: • Contract Research revenues grew by 50% to £1.4m (2006: £0.9m) underpinned by a three-year contract signed with the University of Maryland as part of a US government bio-defence initiative. • The first biomarker contracts were signed with both a large pharma and an emerging US biotech company. The rate of commercial progress has been rapid and the key risks lie in the technical execution and the validation of the underlying hypothesis that mRNA analysis of the plucked hair is a surrogate for what is happening to epithelial stem cells in the small intestine. • The first commercial contract for the exploitation of one of Epistem's identified proteins was signed with an early stage UK biotechnology company. Whilst the initial sums of money are not significant, it has demonstrated initial proof of principle, that even for a new use for a well known drug, Epistem can commercialise its output from its Novel Therapies division. This augurs well for the future. • Management was significantly strengthened through the appointment of Matthew Walls as CEO, who brings a welcome blend of experience, energy and commitment to the Group. • In April, Epistem achieved a successful flotation on the LSE AIM Market, one of the few biotech companies to do this during 2007 in the UK, and this was achieved through a dedicated team effort. Allied to the move to AIM, the Company strengthened its Board in July 2007 with the appointment of Dr Roger Lloyd as a non-executive director. Roger's wealth of experience as Head of Licencing at Astra Zeneca will be invaluable to the Group as it moves forward its discussions with large pharma for the commercial exploitation of its protein therapeutic targets. Current Trading Trading in the first three months of the new financial year has been buoyant and is at least 30% ahead of the comparative period last year. The outlook for Epistem is very positive, although we remain vigilant of the key challenges ahead. This positive outlook is driven, in particular, by the progress made with the biomarker programme and the substantial level of interest now being generated. The biomarker interest has also created a complementary platform to help support discussions around our Novel Therapies development programme. The Board recognises that the development of its novel protein therapies will require the support and participation of like-minded drug development companies to partner closely with Epistem to achieve our therapeutic goals. Finally I would like to thank both the Group's employees for their passion and commitment in ensuring Epistem's continued progress and you as shareholders whose support has underpinned a year of marked achievement. David Evans Chairman The Chief Executive's Review: Over the past year, Epistem has taken significant technical and commercial steps in developing itself as a globally-recognised drug discovery and early-stage development company, focused in the areas of cancer, gastrointestinal (GI) and other epithelial diseases. There have been a number of notable milestones in 2007, including a 50% year-on-year growth in company revenues, the commencement of our bio-defence collaboration with the US government, feasibility studies for a new proprietary plucked hair biomarker, signed heads of terms for the out-licencing of our first proprietary therapeutic and our recent well-received admission to AIM and £3.0m fundraising. Each of the Company's divisions has developed strongly over the past year and I am pleased to report that these developments have met fully with our 2007 business plan. Combined business model Epistem operates a combined business model that offers significant out-licencing opportunities from its drug and biomarker developments (Novel Therapies division), in addition to lower-risk activities providing drug testing services for third parties (Contract Research Services division). This combined business model also enables the Company to integrate its divisional expertise to produce a drug discovery and testing house for its own, proprietary novel protein therapeutics. Financial Review The Company reports turnover of £1.4m (2006: £0.9m) for the year ended 30 June 2007. This revenue figure is drawn almost entirely from the Contract Research Services division where increased demand for the Company's efficacy testing assays was the prime driver for the year-on-year growth. Revenues for the Company were mainly generated across the UK and US markets, with mainland Europe beginning to generate revenues resulting from new dedicated business development support for this territory. On a standalone basis, Contract Research Services' contribution increased year on year by 28% to £0.25m. Investment in our Novel Therapies (including Biomarkers) and central administration increased year on year by £0.3m, to £1.5m, due to increased headcount in senior management and production cost investment in our protein therapeutics. The loss reported for the financial year (net of a £0.2m R&D tax credit) was £1.0m (2006: £0.9m). Headcount in the Company is now 30 (2006: 29). The Company was admitted to the UK LSE: AIM market on 4 April 2007 raising £3.0m (2.5m net of listing expenses) at a listing price of £1.24. Demand for the Company's stock has remained firm and the stock has subsequently out-performed the market indices. Cash balances at the June 2007 financial Year End were £2.3m. The Company annual Audit was completed in October 2007 by HW, Chartered Accountants, and their Audit report is included in the annual accounts. Contract Research Services The Contract Research Services division provides specialist epithelial testing for companies wishing to evaluate their cancer, GI and dermatological drugs against a wide range of both normal and diseased epithelial tissues including lung, colon, breast, prostate and skin, all of which have been well characterised, over many years, by the Company. The Contract Research Services team has built an enviable record of working with major international pharmaceutical and biotechnology companies. During 2007, the Contract Research Services team saw the initiation of the Company's first major contract with the US National Institute of Health (NIH) to test treatments for radiation sickness following a nuclear terrorist attack. Epistem is the major provider of these services, which identify novel drugs that can improve the repair of the GI tract following exposure to radiation. There are currently no medications approved by the FDA to treat this condition. Epistem is an established provider of similar GI services for oncology supportive care. The contract with the US NIH is expected to develop further over the forthcoming year. The tests performed by Epistem are also likely to identify agents with oncology supportive care applications. These agents will reduce mucositis - severe ulceration and diarrhoea experienced by patients during radio- and chemotherapy. Product development remains a vital part of our specialist assay service and the Company is currently developing novel stem cell services for drug efficacy testing. The division is also extending its Inflammatory Bowel Disease portfolio of assays to meet with increased customer demand. The 2007 year saw greater visibility and awareness of the Company's assays and services, which resulted in an increase in the number of contractual service agreements with our pharmaceutical and biotechnology partner companies. Increased awareness of the Company's core expertise and know-how is still unfolding and customer numbers are set to grow further in 2008. Biomarkers The Company's biomarker technology is based on gene expression profiles which measure how a single plucked hair can provide a means of evaluating how effectively a drug is targeting a particular gene or set of genes in a signal pathway. Epistem's biomarker technology is at the forefront of cancer drug development and provides an innovative approach to quickly assessing cell and tissue exposure to a drug. Epistem commenced its first biomarker feasibility studies during 2007 with a number of pharmaceutical partners. Biomarker demand continues to build and this has been further buoyed by the US FDA's efforts to find effective biomarkers for cancer therapeutic development. There are inevitable risks in the development of this technology as it is positioned to measure the effectiveness of cancer therapeutic agents, but we are confident, based on recent developments, that we will pioneer a new approach to help guide oncology-based drug development. We expect to see the first preclinical and clinical results of our efforts in the fourth quarter 2007. We also forecast an increased revenue contribution for the forthcoming financial year arising from our developments and collaborations in this new business area. Novel Therapies Epistem is focused on the discovery of novel protein therapeutics to control the production of epithelial cells. The Company has focused its high resolution gene expression technology on the discovery and development of novel therapeutics which regulate cell production, including inhibition. The development of these protein cell regulators will initially target the disease areas of oncology, oncology supportive care (mucositis), GI and other epithelial disorders such as wound healing. During the year, the Company identified and selected a core group of 250 proteins from which to find those responsible for controlling cell production. These proteins have advanced through development and the initial subset has now been selected for testing through the Company's established disease efficacy models. Over the next few months, the Company expects to identify a number of emerging lead candidates with activity and efficacy relevant to our targeted disease areas. It is expected that these leads, the Company's discovery programme and our high resolution gene expression platform will form part of a partnership collaboration to identify and develop protein therapeutics targeting cancer stem cells. There are risks associated with our therapeutic discovery programme, primarily in relation to an extended timescale for the identification of robust protein therapeutic activities. To mitigate these risks, the Company has undertaken to identify and develop the 250 proteins via a number of routes to maximise the probability of its success. It will also seek to minimise any development timescale exposure by identifying complementary pharmaceutical or biotechnology partners to co-develop its protein regulators and other elements of its novel therapeutic programme. Epistem's protein therapeutic discovery strategy is to develop its protein leads to late stage preclinical validation and then license and/or co-develop these novel therapeutics with its pharmaceutical and biotechnology partner companies. During 2007, the Company entered its first out-licencing agreement, including milestone payments, for a small molecule in the area of GI and oncology supportive care. Intellectual Property Traditionally, Epistem has provided its know-how and expertise on a fee-for-service basis. The biomarker technology is proprietary to the Company and any intellectual property emerging in relation to this technology will be secured, as appropriate, by the Company. Provision for control over biomarker intellectual property arising out of biomarker commercial contracts will also be secured by the Company. With a pipeline of novel proteins now emerging, the Company will also secure its valuable intellectual property rights in relation to these proteins as they advance through development on a case-by-case basis. The company's protection of normal mucosal tissues patent in relation to its first out-licence is currently undergoing patent examination. Outlook Epistem is developing its technology, lead therapies and contract services whilst rapidly growing its revenues and expertise. This requires a careful management approach, good communication and a close relationship with our investor base. We have a globally recognised and experienced management team with strengthening commercial expertise. We are confident that the year ahead will see a substantial increase in our forecast revenues, supported by our Contract Research Services and Biomarker growth alongside our Novel Therapies' emerging lead candidates. The Company will also consider other complementary technology acquisitions and in-licensing where appropriate to underpin its growth ambitions. Finally, I would like to thank the Board, management and employees for their continued commitment in building the success of Epistem, as well as both our established and new investors for their continued close support of our exciting company. It has been my privilege to join the board of Epistem and it is our ambition to significantly build shareholder value by providing the next generation of cancer and GI therapies, by exploiting our know-how and expertise in epithelial stem cells. Matthew H Walls Chief Executive Officer Consolidated Income Account For the year ended 30 June 2007 2007 2006 £000 £000 Revenue 1,357 901 Contract research costs (1,112) (711) Discovery and development costs (1,034) (823) General administrative costs (452) (410) Operating loss (1,241) (1,043) Interest receivable 49 50 Interest payable and similar charges (5) (5) Loss on ordinary activities before taxation (1,197) (998) Tax credit on loss on ordinary activities (160) (130) Loss for the financial year (1,037) (868) Earnings per share (pence) (22)p (22)p Consolidated Balance Sheet As at 30 June 2007 2007 2007 2006 2006 £000 £000 £000 £000 Non-current Assets Intangible assets 59 63 Plant and equipment 368 292 427 355 Current Assets Trade and other receivables 357 323 Tax receivables 160 131 Cash and cash equivalents 2,395 681 2,912 1,135 Liabilities Current Liabilities Trade and other payables 395 214 Obligations under finance leases 81 63 Bank overdrafts and loans 129 5 Net current assets 2,307 853 Total assets less current liabilities 2,734 1,208 Non-current liabilities Obligations under finance leases (137) (113) Net Assets 2,597 1,095 Capital and reserves Called-up equity share capital 98 - Share premium account 7,402 2,532 Share options reserve 453 399 Reverse acquisition reserve (2,484) - Profit and loss account (2,872) (1,836) Total shareholders' equity 2,597 1,095 Consolidated Statement of Cash Flows For the year ended 30 June 2007 2007 2007 2006 2006 £000 £000 £000 £000 Cash flows from operating activities Loss for the year (1,241) (1,043) Depreciation, amortisation and impairment 109 74 Share based payment expense 55 242 Operating profit before changes in working capital (1,077) (727) and provisions (Increase)/decrease in trade and other receivables (34) 7 Increase/(Decrease) in trade and other payables 181 (155) Net cash outflow from operations (930) (875) Interest paid (5) (5) Interest received 49 50 Tax received 131 7 175 52 Net cash (outflow) from operating activities (755) (823) Cash flow from investing activities Acquisition of fixed assets, net of lease (63) (82) financing Net cash (outflow) from investing activities (63) (82) Cash flows from financing activities Proceeds from issue of share capital 3,091 119 Expenses of share issue (608) (33) Repayment of borrowings (75) (23) Net cash inflow from financing activities 2,408 63 Net increase/(decrease) in cash equivalents 1,590 (841) Cash and cash equivalents at beginning of period 676 1,517 Cash and cash equivalents at end of period 2,266 676 Analysis of Net Funds Cash at bank and in hand 2,394 681 Bank overdrafts (128) (5) Net Funds 2,266 676 Notes to the Preliminary Results to 30 June 2007 1. A Summary of Accounting policies Basis of accounting The financial statements have been prepared under the historical cost convention, modified to include the revaluation of financial instruments and in accordance with applicable accounting standards. The consolidated financial statements consolidate those of the Company and its subsidiary (together referred to as the 'Group'). The consolidated financial statements have been prepared and approved by the Directors in accordance with International Financial Reporting Standards as adopted by the EU ('Adopted IFRSs'). Basis of consolidation On 16 March 2007, Epistem Holdings Plc merged with Epistem Limited, and on that date the shareholders of Epistem Limited exchanged their shares for equivalent shares in Epistem Holdings Plc. As Epistem Holdings Plc was newly incorporated at the time of the transaction under the terms of IFRS 3 'Business Combinations', this transaction has been accounted for as a reverse acquisition, on the basis that the shareholders of Epistem Limited gained a controlling interest in the Group. The financial statements therefore represent a continuation of the financial statements of Epistem Limited. Impact of IFRS 2 - share based payments The Group has adopted IFRS 2 from 1 July 2006 whereby the value of share options based upon fair value at their grant date is calculated. As a result of the adoption of IFRS 2 the results for the year ended 30 June 2006 have been restated to reflect the fair value of share options and share warrants issued but not vested at 1 July 2005. Revenue recognition The Company generally invoices and reports as sales, 50% of the value of a new contract on signature. This policy is designed to recognise that, in negotiating contracts for new studies, the Company performs specific pre-contract work to establish the parameters of the study work. When the final report is issued to the client the remainder of the contract is invoiced and recognised as income, at that date. In other cases where the contract does not provide for income recognition on signature, revenue is recognised as the work is invoiced. Research and development Research and development expenditure is written off in the year in which it is incurred. Amortisation Amortisation is calculated so as to write off the cost of an asset, less its estimated residual value, over the useful economic life of that asset as follows: Intellectual property - 5% straight line basis Depreciation Depreciation is calculated so as to write off the cost of an asset, less its estimated residual value, over the useful economic life of that asset as follows: Plant & machinery - 25% reducing balance Fixtures & fittings - 25% reducing balance Equipment - 25% reducing balance Taxation Current tax is provided at amounts expected to be paid (or recovered) using the tax rates and laws that have been enacted, or substantially enacted, by the balance sheet date. 2. Loss per share The basic loss per share is calculated by dividing the earnings attributable to ordinary shareholders for the year by the weighted average number of ordinary shares in issue during the year. The weighted average number of shares in issue during the year was 4,635,934 (2006: 4,028,883) For diluted loss per share, the weighted average number of ordinary shares in issue is adjusted to assume conversion of all dilutive potential ordinary shares. Since the Group is loss-making there is not a dilutive impact. This information is provided by RNS The company news service from the London Stock Exchange

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