Reneuron Regulatory News (RENE)

24 September 2015 AIM: RENE

ReNeuron Group plc

 AGM Trading Update

Guildford, UK, 24 September 2015:  ReNeuron Group plc (the "Company") (AIM: RENE), a leading UK-based stem cell therapy company, is pleased to provide a trading update ahead of today's Annual General Meeting.

In the Company's July preliminary results statement, we reported substantial progress across all of our therapeutic programmes. We also announced a £68.4 million placing, the proceeds from which have now been received. This major financing provides the funding to enable us to take all of our current therapeutic programmes into clinical development and, subject to future clinical data and regulatory approvals, to enable us to take our therapeutic programmes in stroke and retinitis pigmentosa through late-stage clinical development to the point of first application for market authorisation.

Our CTX stem cell therapy candidate for disability caused by ischaemic stroke is currently in a UK Phase II clinical trial, with data expected in the first half of 2016. At that point, and subject to an overall assessment of the collective data from the Phase I and Phase II studies, we are planning to submit an application to commence a controlled, pivotal Phase II/III clinical trial in chronically disabled stroke patients.

Our CTX cell therapy candidate for critical limb ischaemia is currently in a Phase I clinical trial and we expect safety data from this study to enable us to move this programme into Phase II clinical development towards the middle of 2016.

We are excited to have received regulatory approval to undertake our first clinical trial in the US, with our hRPC stem cell therapy candidate for retinitis pigmentosa. Preparations for this Phase I/II clinical trial are well advanced, with first patient dosing expected before the end of this year. Subject to the outcome of this study, we are planning to file an application to commence a pivotal Phase II/III clinical trial with this candidate in 2017.

Elsewhere in the business, our exosome nanomedicine programme is proceeding well, with pre-clinical studies continuing in order to further elucidate the mechanism of action and utility of this therapeutic platform in a range of potential cancer indications. We also remain on track to commence the phased relocation of our existing business operations to our new facility in South Wales in the early part of next year, with cell production suites planned to come onstream at a later date, once qualified for use and licensed for clinical and commercial manufacture.

Finally, we announced in April of this year that Mark Docherty, a non-executive director of the business since the Company's flotation on AIM in 2005, will step down from the Board at today's Annual General Meeting. We further announced that Dr John Sinden, Chief Scientific Officer, a co-founder of ReNeuron and a Board member since the inception of the business, will also step down from the Board at today's Annual General Meeting. Dr Sinden's continuing role as Chief Scientific Officer at ReNeuron will focus on the Company's collaborations and other externally facing activities.

Olav Hellebø, Chief Executive Officer of ReNeuron, said:

"Our business has made great strides over the past year and we are now funded to deliver key clinical milestones across all of our therapeutic programmes over the next three years.

"I would like to thank Mark Docherty for his long and distinguished service on the Board of ReNeuron and to also recognise John Sinden's remarkable and continuing contribution to our Company as Chief Scientific Officer.''

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About ReNeuron

ReNeuron is a leading, clinical-stage cell therapy development company. Based in the UK, its primary objective is the development of novel cell-based therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered "off-the-shelf" to any eligible patient without the need for additional immunosuppressive drug treatments. The Company's therapeutic candidates for stroke disability and critical limb ischaemia are in clinical development and its cell-based treatment for the blindness-causing disease, retinitis pigmentosa, is about to commence clinical development in the US.

ReNeuron is also advancing a proprietary platform technology to exploit nanoparticles (exosomes) secreted by stem cells as potential new drug candidates targeting a range of cancers.

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 at www.reneuron.com.

This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.