AGM Trading Update
News Sep 25, 2015
ReNeuron Group plc has provided 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 authorization.
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 on stream 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.’’