Reneuron Regulatory News (RENE)

ReNeuron Group plc

("ReNeuron" or the "Company")

Year-end update and results notification

ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, announces a year-end business update ahead of its preliminary results for the year ended 31 March 2019, which will be announced on Thursday 11 July 2019.

Clinical programmes

hRPC for retinal disease

ReNeuron has made significant progress advancing the clinical development of the Company's human retinal progenitor cell (hRPC) therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP). Most recently, on 26 April 2019, the Company reported positive preliminary data in the first cohort of the Phase 2a part of its study of hRPC in RP. All three subjects in the cohort demonstrated a rapid and sustained improvement in vision compared with their pre-treatment baseline. 

Dosing of the second patient cohort in the study is now complete. The second cohort comprised three patients with a greater baseline level of visual acuity than those patients earlier in the study. The clinical protocol for the study allows for up to 12 patients (four cohorts of three patients each) to be treated in the Phase 2a part of the study. We expect to treat the final six patients in the study this summer and to report data from all 12 of the Phase 2a subjects in the second half of this calendar year. These results will form the basis of the Company's interactions with the European and US regulatory authorities regarding the remaining clinical development path of hRPC for the treatment of RP.

ReNeuron's RP clinical programme benefits from Orphan Drug Designation in both Europe and the US, as well as Fast Track designation from the US Food and Drug Administration (FDA).

CTX for stroke disability

ReNeuron is continuing to progress the clinical development of its CTX cell therapy candidate for stroke disability. In January 2019, the Company announced that patient dosing had commenced in PISCES III, a randomised, placebo-controlled, Phase 2b clinical trial in 110 patients at up to 40 clinical trial sites in the US.

ReNeuron is currently evaluating the optimum global development plan for the CTX cell therapy candidate for stroke disability. Subject to relevant regulatory approvals, the ongoing PISCES III study may be expanded to include clinical sites in China. On 9 April 2019, the Company announced the signing of an exclusive licence agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma") for the development, manufacture and commercialisation of ReNeuron's CTX and hRPC cell therapy programmes in the People's Republic of China. Potential expansion of the PISCES III study into China would be conducted in conjunction with Fosun Pharma.

Subject to finalisation of the clinical development plan for CTX, and based on current patient recruitment and resource planning, ReNeuron expects to report top-line data from the PISCES III study during the second half of 2020, later than the original guidance of early 2020. The Company expects the PISCES III clinical trial, if positive, to be one of two pivotal studies required to support marketing authorisations for CTX in stroke disability.

Exosome technology

ReNeuron is pursuing opportunities to capitalise on the significant scientific and life sciences industry interest in exosomes by forming near-term, value-generating, business partnerships covering the Company's exosome technology. ExoPr0, the first CTX-derived exosome candidate arising from this technology, is being developed as a novel vector for delivering third party biological drugs.

In January 2019, ReNeuron signed a collaboration agreement with a US-based biopharmaceutical company to explore the use of the Company's exosome technology to create delivery vehicles for synthetic oligonucleotides used in gene therapy. ReNeuron is in active early discussions with other commercial third parties regarding potential collaboration agreements for the Company's exosome technology.

Business development activities

ReNeuron's technologies and therapeutic programmes have increasingly attracted the interest of commercial third parties, as demonstrated by the Company's recent licence agreement with Fosun Pharma. The Company is in discussions with other commercial third parties regarding potential collaboration and/or out-licensing deals across ReNeuron's programmes.

Financial results

ReNeuron's unaudited financial results for the year ended 31 March 2019 remain in line with the Board's previous expectations.

The Company had unaudited cash, cash equivalents and bank deposits totalling £26.39 million at 31 March 2019 (31 March 2018 audited: £37.41 million). The Directors expect that the Company's current financial resources, combined with the £6.0 million upfront fee and near-term milestone income from the above-mentioned licence agreement with Fosun Pharma, will be sufficient to support operations for at least the next 12 months from the date of this announcement. 

Notification of preliminary results

ReNeuron will announce its preliminary results for the year ended 31 March 2019 on Thursday 11 July 2019. A meeting for analysts will be held at 10.00am BST on the morning of the announcement, at the offices of Buchanan, 107 Cheapside, London EC2V 6DN. Further details regarding the analyst meeting will be announced in due course.

Olav Hellebø, Chief Executive Officer of ReNeuron, said:

"We are greatly encouraged by the progress we have made with our cell therapy clinical development programmes for retinitis pigmentosa and stroke disability since our interim financial results update last December. Both the hRPC and CTX studies are expected to continue to yield meaningful clinical data during the course of 2019 and 2020. We are pleased to be working with Fosun Pharma as our partner for China and are encouraged by the level of interest other potential collaborators are showing in all of our programmes. We look forward to continuing to advance our clinical and business development activities in the months ahead."

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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 clinical-stage candidates are in development for disability as a result of stroke and for the blindness-causing disease, retinitis pigmentosa. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. For further information visit www.reneuron.com.