ReNeuron Group plc (AIM: RENE.L), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce its preliminary results for the year ended 31 March 2020.

Operational highlights

hRPC stem cell therapy candidate for retinal disease: Positive and sustained top-line efficacy data at all time-points from Phase 2a patients in ongoing US Phase 1/2a clinical trial in retinitis pigmentosa

Regulatory approval received in US and UK to expand ongoing Phase 2a study to allow for subsequent potential single pre-approval clinical study and shorter route to market

Further readouts from expanded study expected over next 12 months, leading to intention to file application in second half of 2021 to commence pivotal clinical study

Exosome and iPS cell technologies

Grant-funded collaboration initiated with European Cancer Stem Cell Research Institute to enable delivery of therapeutic nucleic acids using Company's exosomes

New data presented supporting use of Company's iPSCs (induced pluripotent stem cells) to develop new immortalised cell lines as potential therapeutic agents for subsequent licensing to third parties

Collaboration agreements signed with major pharmaceutical/biotechnology companies post year-end to explore the potential of the Company's exosomes to deliver therapeutic agents to the brain

Proprietary exosome developed for the potential delivery of COVID-19 vaccines

CTX stem cell therapy candidate for stroke disability

Positive data from PISCES II Phase 2a clinical trial of CTX in stroke disability published in peer reviewed journal

Post year-end decision to continue stroke disability programme through regional partnerships

Fosun Pharma to develop and commercialise hRPC and CTX programmes in China under e xclusive out-licence agreement signed in April 2019

PISCES III Phase 2b stroke study to remain suspended in US, following earlier COVID-19 restrictions at clinical sites

CTX cell therapy candidate available for licensing in all territories in other indications

Publication of new positive non-clinical data demonstrating ability of CTX cells to rescue deficits associated with Huntington's disease

Intention to reconfigure non-executive Board membership to reflect the Company's new emphasis on retinal diseases and commercial partnerships

As part of this reorganisation, the Board has approved in principle a request from substantial shareholder Obotritia Capital KGaA to nominate a non-executive director to the Board

Commenting on the results, Olav Hellebo, Chief Executive Officer, said: 'During the period under review, and subsequent to it, we have continued to generate encouraging positive efficacy data from the ongoing US Phase 2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa. We are pleased to have recently received regulatory approvals in both the US and the UK to pursue this study in further patients at a higher dose level and we look forward to presenting further data from this extended study in due course.

'Additionally, we have been very encouraged to see the potential of our exosome and iPS cell technologies emerge during the period, with further collaboration agreements expected in the near term to complement the agreements we have already signed with major pharmaceutical/biotechnology companies regarding our exosome programme.

'The decision we have recently taken to focus our in-house activities on our retinal disease and exosome-based programmes provides the Company with significant near-term opportunities to deliver value-enhancing data and commercial partnerships. Our stroke disability programme will continue through regional partnerships and we are pleased to be working with Fosun Pharma as our partner for China, following the signing of the exclusive licence agreement for both our CTX and hRPC programmes in that territory during the period.'

Contact:

Tel: +44 (0)20 3819 8400

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 clinical-stage candidates are in development for the blindness-causing disease, retinitis pigmentosa, and, via regional partnerships, for disability as a result of stroke.

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.

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.

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