27th Jun 2007 07:01
ReNeuron Group plc27 June 2007 Guildford, UK: 27 June 2007 ReNeuron Group plc Preliminary Results for the Year Ended 31 March 2007 Operational Highlights • Application filed in November 2006 to commence initial clinical trialin the US with lead ReN001 stem cell therapy for stroke o Further FDA guidance recently received, clarifying additional data requirements in support of application o Submission of further data in support of application on track for Q4 2007 • Prestigious grant awarded by the Michael J Fox Foundation for ReN004 Parkinson's disease programme • Research collaboration initiated with Schepens Eye Research Institute (Harvard Medical School) for ReN003 retinal disease programme • Insulin-producing islet cells generated in ReN002 diabetes programme • Worldwide market launch of ReNcell(R) neural stem cell lines for non-therapeutic applications and collaboration signed to develop ReNcell(R) liver cell products • Key European patent granted covering neural stem cell lines Financial Highlights • Equity fundings raise £8.1 million before expenses • Cash and short term investments at 31 March 2007 of £7.7 million (2006: £5.1 million) • Loss for the year of £5.2 million (2006 restated: £6.4 million, after exceptional items of £1.2 million) • Net cash outflow before management of liquid resources and financing items £5.4 million (2006: £4.6 million) Commenting on the results, Professor Trevor Jones, Chairman, said: "The period under review has been a significant one for ReNeuron, with ourReN001 stroke therapy having progressed to the point of an initial regulatoryfiling with the FDA in the US. We are currently supplementing this filing withfurther data and we remain highly confident of achieving our primary near-termobjective of commencing a Phase I clinical trial with ReN001, followingregulatory approval. Beyond ReN001, we have made steady progress with our othertherapeutic programmes and other activities in the period, as well as furtherstrengthening our patent estate and financial resources. We look forward toreporting further progress across all aspects of our business over the course ofthe current financial year." For further information: Michael Hunt, Chief Executive Officer ReNeuron Group plc +44 (0)1483 302560 David Yates Financial Dynamics - Europe +44 (0)20 7831 3113 Jonathan Birt, John Capodanno Financial Dynamics - US +1 (212) 850 5755 Chairman's and Chief Executive Officer's Joint Statement Review of Operations ReN001 stem cell therapy for stroke ReNeuron's most advanced therapeutic programme is its ReN001 stem cell therapyfor stroke. This treatment is targeted at patients who have suffered a strokeand have been left disabled by it. During the period, we filed our firstInvestigational New Drug (IND) application with the US Food and DrugAdministration (FDA) to commence initial clinical trials with ReN001 in the US.This filing represents the world's first such application concerning a neuralstem cell treatment for a major neurological disorder. Subsequent to the IND filing, and in accordance with established procedure, theFDA placed the application on clinical hold and confirmed its questions andrequests for further information regarding the application. We are currentlyworking to conclude a number of additional pre-clinical studies in support ofthe data package required to address the FDA's requests. The most important of these is a study examining the long-term safety profile ofReN001 in a specialised rodent stroke model. We had anticipated the possibleneed for such a study and therefore initiated it last year with an experiencedcontract research organisation in the US. This study is currently approachingits end-point, with no significant or unusual adverse safety effects having beenidentified thus far in either control or treatment groups. We have been greatlyencouraged by the results from this study to date, given its importance to theregulatory submission and to our overall knowledge base concerning the long-termsafety characteristics of ReN001. We have received recent guidance from the FDA providing further clarification ofthe data requirements in support of the IND application, and we intend tomaintain our constructive dialogue with the reviewers as we finalise the datapackage. Based on this guidance, and on our internal timetables, we remain ontrack to submit the data package to the FDA in Q4 2007. Based on the above progress, and following regulatory approval, we remain highlyconfident of achieving the key near-term objective of taking our first stem celltherapy into man in an area of significant unmet medical need. As well as demonstrating the safety and efficacy of a potential stem celltherapy, it is also critical, in order to establish a commercially viabletreatment, to be able to show scalability of the cell product and consistency ofquality throughout the scale-up process. Using ReNeuron's unique and highlyefficient c-mycER stem cell expansion technology, we have now successfullyscaled up our ReN001 product into a series of clinical and commercial gradebanks of cells, manufactured and tested to full Good Manufacturing Practice(cGMP) standards. It is from these pre-existing cell banks that all futureReN001 clinical and market product can be derived. We believe that the ability to scale our ReN001 therapy readily to the volumesnecessary to serve the large numbers of eligible stroke patients will greatlyenhance ReN001's attractiveness to future commercial development partners. Other therapeutic and non-therapeutic programmes Our other therapeutic programmes continued to progress well during the period.A key milestone in the ongoing successful development of these programmes willbe to show, initially in pre-clinical testing, that our c-mycER platformtechnology can generate a safe, effective and scalable stem cell product acrosseach of the cell types we are using to address the diseases targeted. We arecurrently working to generate the requisite pre-clinical data for each of theseprogrammes, in conjunction with our academic and commercial technologycollaborators. With our ReN005 therapy for Huntington's disease, we have now successfullyproduced a master cell bank to cGMP standard for ReN005, from which all futureclinical and commercial product will be derived. During the period, weinitiated a collaboration with the Schepens Eye Research Institute at HarvardMedical School in the US to progress our ReN003 programme for disorders of theretina. Also in the period, we were awarded a prestigious grant by the US-basedMichael J. Fox Foundation for Parkinson's Research to develop our ReN004 therapyfor Parkinson's disease. We were delighted to be awarded this grant which weregard as an important independent validation of the therapeutic approach we areadopting with our ReN004 programme. More recently, we announced significantprogress with our ReN002 programme for Type 1 (juvenile) diabetes patients,having used our c-mycER platform to develop functional insulin-producing isletcells for subsequent pre-clinical testing. We have made good progress during the period with our ReNcell(R) products fornon-therapeutic applications in research and in the pharmaceutical industry.Our first generation ReNcell(R)CX and ReNcell(R)VM neural cell lines wereofficially launched onto the market through US-based Millipore Corporation. Apaper describing the characteristics of these cell lines was recently publishedin the on-line journal, BMC Neuroscience. We have also progressed developmentof our second generation ReNcell(R)HEP hepatocyte (liver) cell line for use as adrug toxicology testing and screening tool. This cell line is currently underevaluation by a number of commercial parties. In the period, we initiated acollaboration with Japan-based CellSeed Inc. to develop novel, liver cellculture systems using the ReNcell(R)HEP cell line in conjunction with CellSeed'stemperature-sensitive polymer technology. Other activities During the period, we became a participant in a research project to developregenerative, cell-based therapeutic "units" for implantation into strokepatients. The project involves academic groups in the UK and US and is fundedunder the US National Institutes of Health Quantum Grant Programme. We alsoinitiated a research collaboration with King's College London during the period,to further develop our c-mycER stem cell expansion technology. This project ispart-funded by the UK government under its Knowledge Transfer Partnershipscheme. In February 2007, we entered into a revenue-sharing agreement with the LudwigInstitute of Cancer Research (LICR) and the US-based Dana-Farber CancerInstitute, concerning research conducted by these institutions on certaingene-based cell expansion technology. This technology has been licensed to acommercial partner and ReNeuron's entitlement to revenues generated from thelicence stems from an earlier agreement between ReNeuron and the LICR. We have continued to strengthen our intellectual property position during theperiod and thereafter. Significantly, in April 2007, we received notificationof grant from the European Patent Office concerning a patent application thatcovers the composition, manufacture and use of three of our key human neuralstem cell lines, including those lines that constitute our ReN001 and ReN005therapies for stroke and Huntington's disease, respectively. A key advantage ofour c-mycER stem cell expansion technology is its ability to generate individualcell lines which we can then seek to patent in their own right. These celllines represent the prototypes of distinct, patent-protected cell-basedtherapies or products that can therefore be more readily licensed to commercialpartners in due course. In the wider context, we were greatly encouraged by the European Parliamentvote, in April 2007, to provide an integrated regulatory framework for theauthorisation and post-marketing vigilance of advanced therapy products, such asthe stem cell therapies ReNeuron is developing. The Regulation has subsequentlybeen agreed to by the EU Council of Health Ministers, and should be formallyadopted later this year. This development provides regulatory clarity forbusinesses like ours, creating a workable regulatory system which will assessthe efficacy and safety of advanced therapies in a consistent manner acrossEurope. During the period, we also secured our near-term financial position by raisingfurther equity funding totalling £8.1 million, before expenses. This wasachieved through a combination of the placing of new shares and the exercise ofoutstanding warrants over the Company's shares. Summary of results In the year ended 31 March 2007, turnover was £49,000 (2006: £9,000),representing initial income from the Group's non-therapeutic licensingactivities. Net operating expenses before exceptional items increased in the period to £6.2million (2006 restated: £5.9 million). Of this increase, £0.2 million relatesto non-cash charges arising from the Group's adoption of Financial ReportingStandard 20, "Share based payments". The balance of the net increase in costsrelates to a provision of £0.1 million against intangible assets acquired, thecomparative charge of £0.9 million being treated as an exceptional item in theprior period. The balance of the overall operational cost base stayed broadlyequivalent across the two periods. Net operating expenses including exceptional items decreased in the period to£6.2 million (2006 restated: £7.1 million). There were no exceptional chargesin the period (2006: £1.2 million), and no interest payable (2006: £0.25million). Other operating income and interest received in total were broadlyequivalent in both periods at £0.5 million. Tax credits booked against researchand development expenditure were also broadly constant in both periods at £0.5million. The resulting net loss for the period decreased to £5.2 million (2006restated: £6.4 million), largely as a result of there being no exceptionalcharges in the period. Net cash outflow before use of liquid resources and financing increased in theperiod to £5.4 million (2006: £4.6 million). This was due largely to debtor andcreditor balances decreasing in the period by £43,000 and £0.5 millionrespectively, compared to respective prior period increases of £0.2 million and£0.7 million. During the period, short term creditors and accruals decreasedfrom £1.3 million to £0.8 million, due primarily to payments made in the periodto pre-clinical contract research organisations for work undertaken that wasaccrued for in the prior period. At the Annual General Meeting in September 2006, a resolution was passed tosubdivide each 10p ordinary share in the Company into one new ordinary share of1p nominal value and one deferred share of 9p nominal value. In order to leavethe total number of issued ordinary shares in circulation unchanged after thesubdivision, the deferred shares so created were repurchased by the Company for1p in aggregate consideration, and cancelled. A capital redemption reserve of£9.0 million was consequently created, representing the aggregate nominal valueof the cancelled deferred shares. As at 31 March 2007, the Group had cash balances totalling £7.7 million (2006:£5.1 million). During the period, the Group raised £0.7 million and £5.5million, before expenses, in two share placings, and outstanding warrants overthe Company's shares were also exercised in the period to raise a further £1.9million. The directors estimate that the Group's current cash resources aresufficient to meet expenditure requirements for at least the next twelve months.Consequently, the going concern basis has been adopted in the preparation ofthese financial statements. Summary and outlook The period under review has been a significant one for ReNeuron, with our ReN001stroke therapy having progressed to the point of an initial regulatory filingwith the FDA in the US. We are currently supplementing this filing with furtherdata and we remain highly confident of achieving our primary near-term objectiveof commencing a Phase I clinical trial with ReN001, following regulatoryapproval. Beyond ReN001, we have made steady progress with our othertherapeutic programmes and other activities in the period, as well as furtherstrengthening our patent estate and financial resources. We look forward toreporting further progress across all aspects of our business over the course ofthe current financial year. Professor Trevor Jones Michael HuntChairman Chief Executive Officer 27 June 2007 ReNeuron Group plc consolidated profit and loss account for the year ended 31March 2007 Year ended 31 March Year ended 31 March 2007 2006 Unaudited Note Unaudited Restated £'000 £'000 ______ ______Turnover 49 9Cost of sales - - ______ ______Gross profit 49 9 ______ ______Net operating expenses excluding exceptional items 2 (6,223) (5,941)Exceptional operating costs 3 - (1,167) ______ ______Net operating expenses including exceptional items (6,223) (7,108)Other operating income 263 270 ______ ______Operating loss (5,911) (6,829)Interest receivable and similar income 192 197Interest payable and similar charges - (250) ______ ______Loss on ordinary activities before taxation (5,719) (6,882)Tax credit on loss on ordinary activities 523 513 ______ ______Loss for the financial year 6 (5,196) (6,369) ______ ______ Loss per 1p ordinary share Basic and diluted 4 (4.9p) (8.8p) ______ ______ All results arise from continuing operations. Statement of total recognised gains and losses for the year ended 31 March 2007 Year ended 31 March Year ended 31 March 2007 2006 Note Unaudited Unaudited Restated £'000 £'000 ______ ______Loss for the period (5,196) (6,369) ______Total recognised losses for the period (5,196) (6,369) ______Prior year adjustment - Share based payment 1 (56) ______Total recognised losses since last annual report (5,252) ______ Reneuron Group plc consolidated balance sheet as at 31 March 2007 Note As at 31 March 2007 As at 31 March 2006 Unaudited Unaudited Restated £'000 £'000 ______ ______Fixed assetsNegative goodwill 5 (1,233) (1,421)Tangible fixed assets 1,042 1,208 ______ ______ (191) (213) ______ ______Current assetsDebtors - due after one year 125 81Debtors - due within one year 879 946Cash at bank and in hand 7,676 5,134 ______ ______ 8,680 6,161Creditors: amounts falling due within one year (782) (1,320) ______ ______Net current assets 7,898 4,841 ______ ______Total assets less current liabilities 7,707 4,628 ______ ______Net assets 7,707 4,628 ______ ______ Capital and reservesCalled up share capital 6 1,377 9,355Share premium account 6 12,974 5,472Capital redemption reserve 6 8,964 -Warrant reserve 6 113 436Other reserves 6 365 365Profit and loss reserve 6 (16,086) (11,000) ______ ______Total shareholders' funds 6 7,707 4,628 ______ ______ ReNeuron Group plc consolidated cash flow statement for the year ended 31 March2007 Note Year ended 31 March Year ended 31 March 2007 2006 Unaudited Unaudited Restated £'000 £'000 ______ ______Net cash outflow from operating activities 7 (6,034) (4,995) ______ ______Returns on investments and servicing of financeInterest received 192 179 ______ ______Net cash inflow from returns on investments and servicing 192 179of finance ______ ______ TaxationUK corporation tax -- research and development tax credits 503 329received ______ ______ Capital expenditurePurchase of tangible fixed assets (32) (92) ______ ______Net cash outflow from capital expenditure (32) (92) ______ ______Net cash outflow before use of liquid resources and (5,371) (4,579)financing ______ ______ Management of liquid resourcesDecrease in short term investments - 361FinancingIncrease in loans - 1,000Issue of ordinary share capital 8,106 9,500Share issue costs (193) (1,218) ______ ______Increase in cash in the period 2,542 5,064 ______ ______ Notes to the preliminary results for the year ended 31 March 2007 1. Basis of preparation These preliminary results do not constitute financial statements within themeaning of Section 240 of the Companies Act 1985. Results for the year ended 31March 2007 have not been audited. Results for the year ended 31 March 2006 havebeen extracted and restated, as noted below, from the statutory financialstatements of the Group that have been filed with the Registrar of Companies andupon which the auditors reported without qualification. The restated results forthe year ended 31 March 2006 have therefore also been marked as unaudited inthese preliminary results. The statutory accounts and audit report for the yearended 31 March 2007 have not yet been approved by the directors or the auditorsrespectively. These preliminary results for the year ended 31 March 2007 have been prepared inaccordance with the accounting policies set out in the consolidated statutoryaccounts for ReNeuron Group plc for the year ended 31 March 2006, except asnoted below: Change in accounting policy During the year, the Group adopted Financial Reporting Standard 20, 'Share basedpayments' (FRS 20) and the related Urgent Issues Task Force ('UITF') No.44, 'Group and Treasury Share Transactions'. The comparative numbers have beenrestated to reflect the change in accounting policy. FRS 20 requires the fair value of employee share options to be charged to theprofit and loss account over the period the employee becomes entitled to theaward. The Group has taken advantage of the transitional arrangements in FRS 20and only applied the requirements to options granted after 1 April 2006, theeffective date for the Group. The impact of adopting FRS 20 is a charge of £110,000 to the profit and lossaccount in the current year in respect of share options granted. A charge of£56,000 has been reflected in the restated profit and loss account for the prioryear. The adoption of FRS 20 has also resulted in a charge of £113,000 to the profitand loss account in the current year in respect of warrants issued during theyear. There has been no impact in respect of warrants on the comparative period. Going concern The financial statements have been prepared on the going concern basis. Thedirectors estimate that cash held by the Group at the date of approval of thepreliminary announcement will be sufficient to continue funding the tradingactivities of the Company and the Group for at least a further twelve monthsfrom the date of approval of the preliminary announcement. Share based payments The Company issues equity settled share based payments to certain employees.Equity settled share based payments are measured at fair value at grant date.Fair value is measured using the Black-Scholes model, taking into account theterms and conditions upon which the instruments were granted, including theimpact of any non-market based vesting conditions. The total amount to be expensed over the vesting period is determined byreference to the fair value of the equity instruments granted and the number ofequity instruments which eventually vest. A corresponding credit is made toequity. At each balance sheet date, the Company revises its estimate of the number ofequity instruments that are expected to vest. It recognises the impact of therevision of original estimates, if any, in the income statement, and acorresponding adjustment to equity over the remaining vesting period. Where the Company has granted options over the Company's shares to employees ofits subsidiaries, a capital contribution has been deemed to be made by theCompany and no charge arises in the profit and loss account of the Company. Where warrants have been issued as recompense for services supplied these areconsidered equity settled share based payments. The fair value of warrants,calculated using the Black-Scholes model, is charged to the profit and lossaccount and a corresponding credit is made to the warrant reserve. Warrants Where warrants have been issued together with ordinary shares, the proportion ofthe proceeds received that relates to the warrants is determined by reference tothe relative market values of the warrants. The proportion of the proceeds thatrelates to the warrants is credited to a warrant reserve within shareholders'funds. Where warrants have been issued as recompense for services supplied these areconsidered equity settled share based payments and are accounted for inaccordance with FRS 20. See share based payment accounting policy above. 2. Net operating expenses excluding exceptional items Year ended 31 March Year ended 31 March 2007 2006 Unaudited Unaudited Restated £'000 £'000 ______ ______Administrative expenses 1,858 1,608Research and development expenditure 4,365 4,333 ______ ______Net operating expenses excluding exceptional items 6,223 5,941 ______ ______ 3. Exceptional operating costs Year ended 31 March Year ended 31 March 2007 2006 Unaudited Unaudited Restated £'000 £'000 ______ ______Exceptional administrative expenses:Share option compensation charge - 273Exceptional research and development expenditure:Provision against intangible assets acquired - 894 ______ ______ - 1,167 ______ ______ Share option compensation charge In the prior year, a net charge of £273,000 was made to the profit and lossaccount in accordance with Urgent Issues Task Force Abstract 17, "Employee shareschemes" (UITF 17), and identified as exceptional. The charge of £110,000relating to share based payments in the current year is not consideredexceptional and has been included in operating costs. Provision against intangible assets acquired In July 2005, ReNeuron entered into licence and subscription and share exchangeagreements with StemCells, Inc., whereby the Group was granted a licence tocertain intellectual property and patents owned by or exclusively licensed toStemCells, Inc., and pursuant to which the Company issued, as part considerationfor the licence, a total of 8,939,493 ordinary shares of 10p each to StemCells,Inc. Due to the early stage nature of the underlying technology, the directorscarried out an impairment review of the intangible asset so created, andconsidered that it was appropriate to provide against the asset in full. Thecharge in the prior year was considered exceptional, but an equivalent charge of£139,000 in the current year is not. 4. Loss per share The basic and diluted loss per share is calculated by dividing the loss for thefinancial year attributable to ordinary shareholders by the weighted averagenumber of ordinary shares in issue during the year. The loss for the financialyear ended 31 March 2007 is £5,196,000 (2006 restated: £6,369,000) and theweighted average number of 1p ordinary shares in issue during the year ended 31March 2007 is 106,455,554 (2006: 72,532,756). During the prior year, ordinaryshares had a nominal value of 10p; as a result of the share split in September2006, as disclosed in Note 6, the nominal value was amended to 1p. No change in the number of shares has occurred. Potential dilutive instruments, such as options and warrants, are not treated asdilutive as the Group has made a loss in each year. 5. Amortisation of negative goodwill Negative goodwill arose during the period ended 31 March 2004 on the acquisitionof ReNeuron (UK) Limited by ReNeuron Holdings Limited. The amount of negativegoodwill arising on acquisition was £2,916,000. The amount that was in excess ofthe fair values of non-monetary assets acquired was immediately amortised to theprofit and loss account. The remaining negative goodwill of £1,883,000, beingequal to the fair values of non-monetary assets acquired, is being amortisedover a period of 10 years, the period over which the non-monetary assets areexpected to be recovered. 6. Share capital and reserves Share Share premium Capital Warrant capital account redemption reserve account reserve £'000 £'000 £'000 £'000 ______ ______ ______ ______At 1 April 2006 9,355 5,472 - 436Issue of new ordinary shares 986 7,259 - -Costs of share issue - (193) - -Subdivision of ordinary shares (8,964) - 8,964 -Exercise of Warrants - 436 - (436)Issue of warrants - - - 113Recognition of share based payment - - - -Loss for the financial year - - - - ______ ______ ______ ______At 31 March 2007 1,377 12,974 8,964 113 ______ ______ ______ ______ 6. Share capital and reserves (continued from table above) Other Profit and Total reserves loss shareholders' account funds £'000 £'000 £'000 ______ ______ ______At 1 April 2006 365 (11,000) 4,628Issue of new ordinary shares - - 8,245Costs of share issue - - (193)Subdivision of ordinary shares - - -Exercise of Warrants - - -Issue of warrants - - 113Recognition of share based payment - 110 110Loss for the financial year - (5,196) (5,196) ______ ______ ______At 31 March 2007 365 (16,086) 7,707 ______ ______ ______ On 26 April 2006, a resolution was passed at an Extraordinary General Meetingauthorising the issuance of up to 170,000,000 new ordinary shares of 10p. On 28 June 2006, the Company raised £715,000 via a placing of 5,500,000 10pordinary shares at 13p each. At the same time, 556,767 shares were issued inaccordance with the licence and subscription and share exchange agreements withStemCells, Inc. On 21 September 2006, a resolution was passed at the Annual General Meetingauthorising the subdivision of each 10p ordinary share into one new ordinaryshare of 1p nominal value and one deferred share of 9p nominal value. A capitalredemption reserve was created with the value of the deferred shares. Thedeferred shares, amounting to 99,604,700 in total and with a nominal value of£8,964,423, were thereafter repurchased in aggregate by the Company for 1p, andwere cancelled. The repurchase of the deferred shares was financed from theproceeds of the issue of one ordinary share at nominal value. On 21 September 2006, a resolution was passed at a Warrant Holders Meetingauthorising an amendment of the price payable on exercise of the warrants from30p to 10p, and an amendment to the last date for exercise of the warrants from12 February 2007 to 12 December 2006. A total of 18,919,400 warrants wereexercised at a price of 10p each, and 18,919,400 ordinary shares of 1p wereconsequently issued on 19 December 2006. Warrants totalling 80,600 were notexercised by the expiry date and lapsed. The warrant reserve created on issue ofthe warrants was released to share premium. On 12 February 2007, the Company placed 18,333,333 new ordinary shares of 1p ata price of 30p, raising £5,500,000 before expenses of £193,000. In conjunctionwith the placing, warrants to subscribe 688,145 ordinary 1p shares, exercisableat a price of 30p per share, were issued to Collins Stewart Limited, theCompany's nominated adviser and broker. At the same time 771,368 shares wereissued in accordance with licence and subscription and share exchange agreementswith StemCells, Inc. On 19 February 2007, a further 62,543 shares of 1p were issued to StemCells,Inc. in final satisfaction of the Company's obligation to issue shares under thelicence and subscription and share exchange agreements. 7. Reconciliation of operating loss to net cash outflow from operating activities Year ended Year ended 31 March 2007 31 March 2006 Unaudited Unaudited Restated £'000 £'000 ______ ______Operating loss (5,911) (6,829)Depreciation of tangible fixed assets 198 265Amortisation of negative goodwill (188) (188)Impairment of intangible fixed assets acquired 139 894Share option compensation charge - 273Share-based payment charges 223 56Decrease / (increase) in debtors 43 (199)(Decrease) / increase in creditors (538) 733 ______ ______Net cash outflow from operating activities (6,034) (4,995) ______ ______ 8. Reconciliation of movement in net funds At 31 March 2007 At 1 April 2006 Unaudited Restated Unaudited Cashflow £'000 £'000 £'000 ______ ______ ______Cash at bank and in hand 5,134 2,542 7,676 ______ ______ ______Net funds 5,134 2,542 7,676 ______ ______ ______ Notes to Editors ReNeuron is a leading, UK-based stem cell therapy business. It is applying itsnovel stem cell platform technologies in the development of ground-breaking stemcell therapies to serve significant and unmet or poorly-met clinical needs. ReNeuron has used its c-mycER technology to generate genetically stable neuralstem cell lines. This technology platform has multi-national patent protectionand is fully regulated by means of a chemically-induced safety switch. Cellgrowth can therefore be completely arrested prior to in vivo implantation. ReNeuron has filed for approval to commence initial clinical studies in the USwith its lead ReN001 stem cell therapy for chronic stroke disability. Thisrepresents the world's first such filing concerning a neural stem cell treatmentfor a major neurological disorder. There are an estimated 50 million strokesurvivors worldwide, approximately one half of which are left with permanentdisabilities. The annual health and social costs of caring for these patientsis estimated to be in excess of £5 billion in the UK and in excess of US$50billion in the US. ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem celltherapy for Huntington's disease, a genetic and fatal neurodegenerative disorderthat affects around 1 in 10,000 people. This programme is in pre-clinicaldevelopment. In addition to its stroke and Huntington's disease programmes,ReNeuron is developing stem cell therapies for Parkinson's disease, Type 1diabetes and diseases of the retina. ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -its ReNcell(R) range of cell lines for use in research and in drug discoveryapplications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX andReNcell(R)VM neural cell lines are marketed worldwide under license by MilliporeCorporation. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found atwww.reneuron.com. Data sources: UK Stroke Association; American Stroke Association. This announcement contains forward-looking statements with respect to thefinancial condition, results of operations and business achievements/performanceof ReNeuron and certain of the plans and objectives of management of ReNeuronwith respect thereto. These statements may generally, but not always, beidentified by the use of words such as "should", "expects", "estimates","believes" or similar expressions. This announcement also containsforward-looking statements attributed to certain third parties relating to theirestimates regarding the growth of markets and demand for products. By theirnature, forward-looking statements involve risk and uncertainty because theyreflect ReNeuron's current expectations and assumptions as to future events andcircumstances that may not prove accurate. A number of factors could causeReNeuron's actual financial condition, results of operations and businessachievements/performance to differ materially from the estimates made or impliedin such forward-looking statements and, accordingly, reliance should not beplaced on such statements. The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement referto ReNeuron Group plc and/or its subsidiary undertakings, depending on thecontext. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
RENE.L