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ReNeuron - Preliminary Results for the Year Ended 31 March 2011


6/30/2011 10:05:51 AM

June 30, 2011 -- Operational Highlights

- Commencement of landmark PISCES clinical trial of ReN001 stem cell therapy for stroke:

- First dose cohort of three patients now treated with no safety issues arising

- Data Safety Monitoring Board to review first dose cohort follow-up data in August

- Clinical protocol amendments approved to widen patient eligibility criteria

- Additional efficacy evaluation measures planned based on early observations in first dose cohort

- Emerging data from PISCES trial and extensive pre-existing data package drives decision to accelerate testing of ReNeuron’s lead CTX stem cell line in other categories of stroke and other major neurological conditions including Alzheimer’s disease

- Further positive pre-clinical efficacy data presented with ReN009 stem cell therapy for peripheral arterial disease

- License agreement recently signed with US-based Schepens Eye Research Institute to develop and commercialise ReN003 retinal stem cell therapies

- Applications to commence clinical trials planned across all of the Company’s therapeutic programmes in second half of 2012 to build emerging clinical pipeline of high value stem cell therapies

- Further pre-clinical data presented regarding the multiple mechanisms by which CTX stem cells may promote recovery from brain damage caused by stroke and other conditions

- Stem cell contract manufacturing arrangements expanded through deal with NHS Blood and Transplant, with further cell manufacturing deals planned in the US

- Senior management strengthened, with further hires at senior management and non-executive Board level planned

Financial Highlights (Unaudited)

- Share placing and share subscription in the year raised £10 million, before expenses, providing pre-clinical and clinical development funding for core therapeutic programmes to late 2012

- Loss for the year increased to £6.1 million (2010: £3.6 million pre-exceptional items; £5.9 million post-exceptional items), reflecting initial clinical costs in stroke programme, increased late pre-clinical activity on other core therapeutic programmes and non-recurring legal and professional fees

- Cash used in operations increased to £5.5 million (2010: £3.3 million), reflecting the above cost increases

- Cash and cash equivalents at 31 March 2011 of £9.7 million (2010: £5.5 million), reflecting the above financing activities Commenting on the results, Professor Trevor Jones, Chairman, said:

“The year under review has been a landmark one for ReNeuron. The commencement of patient dosing in the PISCES clinical trial of our ReN001 stroke therapy has placed ReNeuron at the forefront of the development of treatments for disabled stroke patients using neural stem cells. The therapy appears to be well-tolerated by the first dose cohort of patients in the clinical trial and we look forward to providing further updates later in the year.

“Our other core therapeutic programmes continue to make good progress towards the clinic and we are pursuing further opportunities to exploit the therapeutic potential of our lead CTX stem cell line in other neurological conditions. As we gather further clinical data from the PISCES stroke trial over the coming year and complete the pre-clinical development of our other therapeutic programmes, we intend to focus our resources on an emerging clinical pipeline of stem cell therapies offering the greatest potential for clinical benefit, commercial development and consequent value generation for the business.”

Enquiries:

Michael Hunt, Chief Executive Officer - ReNeuron +44 (0) 1483 302560

Dr John Sinden, Chief Scientific Officer - ReNeuron

Lisa Baderoon, Mark Court, Isabel Podda

Buchanan Communications +44 (0) 20 7466 5000

Antony Legge, Oliver Rigby +44 (0) 20 7776 6550

Daniel Stewart & Company plc

James Gallagher, Steve Waterman +44 (0) 20 3206 7000

Matrix Corporate Capital LLP


Read at BioSpace.com

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