ReNeuron Group plc

("ReNeuron" or the "Company")

First subject treated at Oxford Eye Hospital in Phase 2a RP trial

Oxford University Hospitals NHS Foundation Trust activated as ReNeuron's first UK study site

ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, provides a further update on the progress of its Phase 2a clinical evaluations for the treatment of retinitis pigmentosa ('RP'), an inherited, degenerative eye disease.

Following the positive news announced on 1 October 2021 regarding regulatory approval for the continuation of the study in all geographies, the Company can now confirm that the first UK subject has been treated at the Oxford Eye Hospital, part of Oxford University Hospitals NHS Foundation Trust. The remaining study subjects are expected to be treated by the end of 2021.

ReNeuron's hRPC therapeutic candidate is undergoing Phase 2a clinical evaluations for the treatment of retinitis pigmentosa ('RP'), which affects 1 in 4,000 people in the US and worldwide. The expanded study encompasses four sites worldwide, with two sites in the US as well as the recently activated sites in the UK and in Spain.

The study uses a cryopreserved human retinal progenitor cell line ('hRPC') formulation, enrolling subjects with advanced RP with some remaining central vision. The 2 million cell dose used in this study extension represents a doubling of the earlier dose level, where good product safety and efficacy signal were seen in subjects followed out to 12 months.

As previously announced, the Company expects to present early efficacy data from the extension segment of the Phase 2a study in Q1 2022. ReNeuron remains on track for advancing the programme into the next clinical trial by the end of 2022.

Prof. Robert MacLaren, Professor of Ophthalmology, University of Oxford, said: "We are delighted that Oxford University Hospitals NHS Foundation Trust has become the first UK centre to perform photoreceptor transplantation in this exciting new clinical trial in collaboration with ReNeuron. Photoreceptor loss is a common cause of untreatable blindness in the UK and this trial represents the first step towards a potential new treatment for many of my patients. So far the transplantation surgery has gone extremely well and we look forward to seeing the results in due course."

Olav Hellebø, Chief Executive Officer, commented: "We are extremely pleased to see the first subject dosed in the UK in this Phase 2a clinical evaluation for our hRPC therapeutic candidate and expect to complete dosing of the remaining subjects in the expanded segment of the study by the end of 2021. We are proud to be working with the University of Oxford, a team globally renowned for cutting edge retinal disease research. We look forward to updating the market in Q1 next year on early efficacy data from the expanded Phase 2a study."

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About ReNeuron

ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments, without the need for immunosuppressive drugs. The Company's lead cell therapy candidate is in clinical development for the blindness-causing disease, retinitis pigmentosa. 

ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that treat diseases of the brain.  The Company also has the ability through its conditionally immortalised induced pluripotent stem cell (iPSC) platform to make any tissue cells of choice; in-house programmes are focused on treatments for blood cancers and diabetes.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.  For further information visit www.reneuron.com