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11-Jul-2019

Preliminary Results for the year ended 31 March 2019

ReNeuron Group plc (AIM: RENE), 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 2019. 

Operational highlights 

hRPC stem cell therapy candidate for retinal disease: 

• Positive preliminary efficacy data from first three Phase 2a patients in ongoing US Phase 1/2a clinical trial in retinitis pigmentosa 

• Top line results from all treated Phase 2a patients to be presented at the American Academy of Ophthalmology Annual Meeting in October 2019 

CTX stem cell therapy candidate for stroke disability:   

• Patient dosing commenced in placebo-controlled US Phase 2b clinical trial

• Top line data from Phase 2b study expected in late 2020 

Exosome platform:

• Programme primarily focused on use of exosome technology as a drug delivery vehicle

• First collaboration agreement signed with US company to explore use of exosome technology as a delivery vehicle in gene therapy 

Increased business development activity reflecting interest from third parties: • Exclusive out-licence agreement signed post-year end with Fosun Pharma to commercialise hRPC and CTX programmes in China  o ReNeuron to receive upfront, future near term and estimated success-based milestone payments of £80.0 million plus doubledigit royalties on sales • Discussions ongoing with other commercial third parties regarding potential out-licence deals 

Financial highlights  

• Reduced loss for the year of £14.3 million (2018: loss of £17.6 million) 

• Reduced cash used in operating activities of £12.0 million (2018: £14.9 million) • Cash, cash equivalents and bank deposits at 31 March 2019 of £26.4 million (2018: £37.4 million).   • Upfront payment of £5.4 million, net of withholding tax, received post-year end pertaining to licence agreement with Fosun Pharma 

Commenting on the results, Olav Hellebø, Chief Executive Officer, said: 

“The past year has been a transformational one for ReNeuron.  During the period, we commenced patient dosing in the US placebo-controlled Phase 2b clinical trial of our CTX cell therapy candidate in chronic stroke disability.  This was followed shortly afterwards by the announcement of strongly positive preliminary efficacy data from the first three Phase 2a patients in the ongoing US Phase 1/2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa.  We look forward to delivering further significant clinical data in our stroke and retinitis pigmentosa programmes over the next 18 months. 

“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.  We are also encouraged by the level of interest other potential collaborators are showing in all of our programmes, including our exosome technology which is being developed as a novel system for delivering third party drugs.   

“We look forward to providing further updates on our clinical and commercial progress in the months ahead.” 

Analyst meeting and webcast: 

A presentation meeting for analysts will be held at 10.00am BST today at the offices of Buchanan, 107 Cheapside, London, EC2V 6DN.  

For a webcast of the analyst presentation, please log on to the following web address approximately 5 minutes before 10.00am:  

https://webcasting.buchanan.uk.com/broadcast/5d011332221579216107d918  

For further details please contact Buchanan on 020 7466 5000 or email reneuron@buchanan.uk.com

A recording of the webcast will be made available on ReNeuron's website, www.reneuron.com.

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Last Updated: 11-Jul-2019