10 million placing to fund first human stem cell trial in major CNS disease
Not for release or distribution or publication in whole or part in or into the United States, Canada, Japan or Australia.
Guildford, UK, 12 July 2005: ReNeuron Group plc (“ReNeuron” or the “Company”), the UK-based adult stem cell research and development company, today announces its intention to list on AIM via an institutional placing. Collins Stewart is acting as nominated advisor and broker to the Company.
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company is applying its novel stem cell platform technologies in the development of ground-breaking stem cell therapies to serve significant and unmet or poorly-met clinical needs. The Company is also exploiting the non-therapeutic potential of its technologies with the intention of generating sustainable near-term revenue streams to contribute to the funding of its therapeutic programmes. The Company is planning to file for approval to commence initial clinical trials with its stem cell therapy for stroke in the first half of 2006, and hopes to commence these trials as soon as possible thereafter. The Company believes that this would be the first such trial using human neural stem cells for this condition.
The Company was formerly listed on AIM and was taken private in mid 2003 by Merlin Biosciences. Since that time, ReNeuron has made significant progress in applying its proprietary and highly efficient c-mycERTAM stem cell expansion technology to the development of therapies for a number of significant disease conditions.
ReNeuron has used its c-mycERTAM technology to generate genetically stable stem cell lines. This technology platform has multi-national patent protection and is fully regulated by way of a chemically-induced safety switch. Cell growth can therefore be completely arrested prior to in vivo implantation.
The Company has tested a number of its neural stem cell lines in a series of validated pre-clinical efficacy models of stroke, Huntington’s disease and dementia, with positive results. The efficacy data are being prepared for publication in a leading peer-reviewed journal and were presented at the Society of Neuroscience and American Neurological Association meetings in October 2004. To the best of the Directors’ knowledge, this was the first disclosure of positive pre-clinical data in stroke using stable, expanded neural stem cells, thus providing evidence of the Company’s strong competitive position in the field.
As a result of this progress, the Company’s lead stem cell therapeutic program, ReN001 for chronic stroke disability, has now moved into late pre-clinical development. The ReN001 cell product has been banked to Good manufacturing Practice (GMP) standards, and pre-clinical safety studies are underway. Initial feedback from the US Food and Drug Administration has been encouraging. ReNeuron plans to file for approval to commence initial clinical trials in stroke in the first half of 2006, with trials commencing as soon as possible thereafter.
In addition to its ReN001 stroke programme, ReNeuron is pursuing stem cell programmes to address Huntington’s disease, Parkinson’s disease, Type 1 diabetes and diseases of the retina.
The Company recently announced that it had entered into an agreement with StemCells, Inc., a leading US adult stem cell development company, giving that company exclusive access to ReNeuron’s c-mycER technology for use in the development of therapies for certain diseases targeted by StemCells. In return, ReNeuron gains exclusive access to StemCells’ adult neural stem cell patent portfolio for the development of its own neural stem cell therapies. The agreement provides for reciprocal royalties and milestone payments on the achievement of various goals under the cross- licence.
The potential market for stem cell products is estimated to exceed $10 billion by 2013* and the diseases targeted by ReNeuron are chiefly characterised by large patient populations representing a major healthcare cost in terms of existing patient care. For most of the Company’s targeted indications, there are currently no effective cures or treatments addressing the underlying cause of the condition.
ReNeuron is seeking to raise gross proceeds of £10 million through a placing with institutional investors. The indicative pre-new money price range of £15 million to £20 million corresponds to a market capitalisation for the Company of £25 million to £30 million on Admission (assuming gross proceeds from the placing of £10 million). The offering is expected to be completed during the second half of July. The net proceeds will be used to fund ongoing pre-clinical work and the initial costs of the first clinical trials with respect to the ReN001 stroke programme, ongoing research and pre-clinical development of the Company’s other therapeutic programmes, and other working capital requirements.
Commenting on the announcement, Michael Hunt, CEO of ReNeuron, said:
“ReNeuron has made significant progress over the past two years, placing the Company in an advantageous competitive position within the stem cell field. We plan to file for approval to take our ReN001 stroke programme into the clinic in the not-too-distant future and our technology shows promise in the other therapeutic and non-therapeutic applications that we have targeted. Our agreement with StemCells Inc., is an endorsement of ReNeuron’s technology approach and opens the way to further collaborative activity between the two companies.
“We believe ReNeuron is well placed to achieve its goals of bringing stem cell therapies to patients suffering from chronic stroke damage and other diseases for which there are currently no cures, as well as delivering significant value for shareholders in the future.”
*Tissue Engineering & Stem Cell Technology Report 2003-2013, Visiongain, 2003.
Notes to editors
ReNeuron is a leader in stem cell research and development. The Company has proprietary stem cell technologies from which it is seeking to develop ground-breaking cell therapy products. ReNeuron’s focus is on cell therapy treatments designed to reverse the effects of major diseases such as stroke and diabetes.
ReNeuron believes that its unique stem cell expansion technologies confer significant advantages over competitor technologies, in terms of the Company’s ability to generate stable, functional cell lines with the characteristics necessary for scale-up to a viable cell therapy product capable of treating large patient populations.
ReNeuron has demonstrated positive efficacy data in a pre-clinical model of stroke, and its ReN001 stem cell therapy for stroke is now in late pre-clinical development. ReNeuron has broadened its product pipeline by initiating programmes to develop stem cell therapies for Type 1 diabetes, Parkinson’s disease, Huntington’s disease and diseases of the retina. ReNeuron has also leveraged its stem cell technologies into non-therapeutic areas such as drug discovery – its ReNcellTM product.
Tel: 0207 523 8700
Michael Hunt, CEO
John Sinden, CSO
Tel: 01483 302 560
Tel: 020 7831 3113
This announcement does not, and no part of it shall, constitute or form part of any offer for sale or subscription of securities, or any solicitation of any such offer, not shall it, or any part of it, form the basis of or be relied upon in connection with any contract or commitment whatsoever. Any eventual acquisition of, or application for, shares in ReNeuron Group plc should be made solely on the basis of information contained in the admission document relating to ReNeuron Group plc to be issued in due course in connection with the proposed admission to trading of its shares (issued and to be issued) (the “Shares”) to AIM, a market of the London Stock Exchange.
This announcement is not for release, publication or distribution, in whole or in part, in or into the United States of America, Canada, Japan, the Republic of Ireland or Australia or any jurisdiction where such announcement would be unlawful.
These written materials are not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration under the US Securities Act of 1933 (the “US Securities Act”) or an exemption therefrom. ReNeuron Group plc has not and does not intend to register any Shares under the US Securities Act. The Shares will not be offered or sold to the public in the United States.
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