RENE.L Regulatory News (RENE)

5 Apr 2006 09:08

ReNeuron Group plc05 April 2006 ReNeuron announces intention to raise funds through international placing Guildford, UK, 5 April 2006 - ReNeuron Group plc (AIM: RENE) announces that itproposes to raise up to £8.5 million via a non pre-emptive placing of newordinary shares and American Depositary Shares (ADSs) (the "Placing"). TheCompany intends that institutional investors (including US and certain existinginstitutional shareholders) will participate in the Placing. The proceeds of thePlacing will be used to fund the Company's lead ReN001 programme for stroke asit progresses to the clinic, and also to fund the Company's other therapeuticprogrammes based on recently announced progress made. The Directors believe that the Placing will enable ReNeuron to widen its USshareholder base and enhance the Company's profile in the US, where much of theCompany's activities concerning its lead ReN001 stroke programme are currentlyfocussed. The Directors further believe that an enhanced profile in the USmarket will provide greater liquidity in the Company's shares and serve toincrease the overall value of the Company in the medium to longer term, to thebenefit of all shareholders. To this end, the Directors intend to considerlisting the Company's shares in the US in due course, subject to marketconditions, the ability of the Company to meet applicable listing requirementsand the Directors then judging that such a listing is in the best interests ofthe Company and its shareholders as a whole. ReNeuron has made significant progress with its stem cell programmes since itsAdmission to the London AIM Market last August, as outlined below: • confirmation of the Company's pre-clinical development programme for its ReN001 stroke therapy, following the formal pre-IND1 meeting between the Company and the US Food and Drug Administration (FDA) in July 2005. Based on the results of this programme thus far, the Company expects, in the second half of 2006, to file for approval to commence initial clinical trials in the United States with ReN001; • repeat positive efficacy and dose-response pre-clinical data generated for ReN001, together with first results from late pre-clinical safety studies indicating that the ReN001 stem cells do not form tumours following implantation; • completion of the manufacturing scale-up of both master and working cell banks for ReN001 to Good Manufacturing Practice (GMP) standards. These cell banks contain the material from which the Company expects all future clinical and in-market supplies for ReN001 will ultimately be drawn; • manufacturing contract entered into with Angel Biotechnology Holdings plc to scale up production of ReNeuron's ReN005 stem cell line for Huntington's disease. This contract initially covers the production of a GMP-compliant master cell bank; • initial pre-clinical data for the Company's ReN004 candidate stem cell lines generated showing them to have attributes that may favour the reversal of the neurological deficits seen in Parkinson's disease; and • key functional data concerning the Company's second generation ReNcell hepatocyte (liver) cell lines generated, indicating their high potential utility as a drug toxicology testing and screening tool. Commenting on the Company's plans Michael Hunt, Chief Executive Officer ofReNeuron, said: "Since ReNeuron's flotation on AIM last summer, we have made steady progress inboth our therapeutic and ReNcell programmes. Although our current financialresources will fund the Company's activities well into 2007, we believe that itis appropriate to seek a judicious amount of further funding at this time. Thiswill allow us to build quickly on recent progress across our therapeuticprogrammes as well as furthering our investor profile in the US, which we regardas an important factor in the Company's future success." ReNeuron is today calling an extraordinary general meeting (EGM) to propose aSpecial Resolution permitting the Company to issue new ordinary shares and ADSsfor cash on a non pre-emptive basis. The EGM will be held on 28 April 2006 at2:30pm at the offices of Morrison & Foerster, 7th Floor, CityPoint, OneRopemaker Street, London EC2Y 9AW. As at today's date, no agreement has yet been entered into committing theCompany to issue, or any person to subscribe for shares as part of, the proposedPlacing. In particular no underwriting agreement has been entered into inrespect of the proposed Placing. In addition, the Placing is conditional uponshareholder approval. This press release shall not constitute an offer to sell or the solicitation ofan offer to buy, nor shall there be any sale of the ordinary shares or ADSs inany jurisdiction in which such offer, solicitation or sale would be unlawful.The ordinary shares and ADSs to be offered in the Placing have not been and willnot be registered under the U.S. Securities Act of 1933 and may not be offeredor sold in the United States absent registration or an applicable exemption fromregistration requirements. 1 Investigational New Drug application Enquiries: ReNeuronMichael Hunt, CEO Tel: +44 (0)1483 302 560 Financial DynamicsDavid Yates Tel: +44 (0)20 7831 3113Sarah Macleod Notes to Editors ReNeuron is a leading, UK-based adult stem cell therapy business. The Companyis applying its novel stem cell platform technologies in the development ofground-breaking stem cell therapies to serve significant and unmet or poorly-metclinical needs. ReNeuron has used its c-mycERTAM technology to generate genetically stableneural stem cell lines. This technology platform has multi-national patentprotection and is fully regulated by means of a chemically-induced safetyswitch. Cell growth can therefore be completely arrested prior to in vivoimplantation. The Company's lead stem cell therapy, ReN001 for chronic stroke disability, isin late pre-clinical development. Subject to successful completion ofpre-clinical testing, the Company plans to file for approval to commence initialclinical trials in stroke later this year, with trials commencing as soon aspossible thereafter. The Company has also generated pre-clinical efficacy data with its ReN005 stemcell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder which affects around 1 in 100,000 people. Thisprogramme is in pre-clinical development. In addition to its stroke and Huntington's disease programmes, ReNeuron isdeveloping stem cell therapies for Parkinson's disease, Type 1 diabetes anddiseases of the retina. ReNeuron has also leveraged its stem cell technologies into non-therapeuticareas - its ReNcell range of cell lines for use in drug discovery applicationsin the pharmaceutical industry. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L,and its warrants are traded under the symbol RENW.L. Further information on ReNeuron and its products can be found atwww.reneuron.com. 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" or "the Company" refer to ReNeuron Group plc and itssubsidiary undertakings. This announcement is not for distribution in the United States, Canada, Japan orAustralia. This information is provided by RNS The company news service from the London Stock Exchange