ReNeuron Group plc - AGM Trading Update

ReNeuron Group plc (AIM: RENE), a global leader in the development of cell-based therapeutics, is pleased to provide a trading update ahead of today’s Annual General Meeting (“AGM”).

We are very pleased to report that patient dosing has now commenced in the US in the expanded Phase 2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa (RP) patients. The expanded study will enable the treatment of up to a further nine patients (beyond the ten Phase 2a patients already treated) at a higher dose level, under a revised protocol at clinical sites in both the US and the UK. 

RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.  We have previously announced positive efficacy data from patients in this study at all time-points including, for the first patient treated, out to 18 months follow-up. 

As announced in the Company’s preliminary results statement on 20 July 2020, we expect to present further data from the expanded Phase 2a clinical trial during the next twelve months. We expect this expanded Phase 2a study to generate sufficient data to enable the Company to seek regulatory approval in the second half of 2021 to commence a single pivotal clinical study with our hRPC cell therapy candidate in RP.  The pivotal study will be designed to demonstrate further the efficacy of this treatment and, assuming a successful outcome, to enable ReNeuron to seek marketing approvals for its hRPC cell therapy candidate in RP in selected major markets.  

This RP programme has been granted Orphan Drug Designation in both Europe and the US, as well as Fast Track designation from the FDA in the US.  Orphan Drug Designation provides the potential for a significant period of market exclusivity once the therapy is approved in those territories.  Fast Track designated products may also be eligible for accelerated approval and priority review programmes offered by the FDA.

On 31 July 2020, we were pleased to announce that the US Patent and Trademark office (USPTO) had completed its examination of the Company’s patent application (14/379,239), entitled: “Phenotype profile of human retinal progenitor cells” and issued a notification of allowance for the issuance of a patent.  The allowed patent protects the composition of our hRPC cell therapy candidate for retinal diseases and adds further intellectual property protection to the hRPC technology, which already has patent protection in a number of other major territories including Europe, Japan and Australia.

Our exosome technology is being exploited as a novel vector for delivering third party biological drugs and this partnering strategy reflects increasing industry interest in exosomes. 

We stated in our preliminary results statement that we anticipated further collaborations with pharmaceutical/biotechnology companies to commence over the coming months.  We are pleased to report that we have subsequently signed a further research evaluation agreement with a leading biotechnology company in connection with the use of the Company’s proprietary exosomes for the delivery of novel therapeutics.  In addition, we expect to be able to sign further collaboration agreements, currently under negotiation, in the near term. 

Our exosomes are derived from our CTX human neural stem cell line. They have a natural ability to cross the blood brain barrier and can thus be used to deliver therapeutics for diseases of the brain.  These exosomes can be produced through a fully qualified, xeno-free, scalable process and the clinical-grade source cell-line ensures consistent exosome product.  The exosomes can be loaded with a diverse range of potential therapeutics, such as siRNA/mRNA/miRNA, CRISPR/Cas9, antibodies, peptides and small molecules.

On 12 August 2020, we announced the planned reconfiguration of the non-executive membership of the Board of the Company, which will take effect from the conclusion of today’s AGM.  John Berriman and Simon Cartmell OBE (having served for nine years and thereby having become non-independent under the QCA code of corporate governance) have expressed their intention not to seek re-election at the AGM and they and Dr Claudia D’Augusta will retire with effect from the close of today’s meeting.  We reiterate our thanks to our retiring colleagues for their contributions to the Company.

Co-incident with the above, Dr Tim Corn, an existing non-executive director of the Company, will become Chairman of the Board and will also chair the Company’s Remuneration Committee.  Professor Sir Chris Evans OBE will chair the Nominations & Corporate Governance Committee.  As previously announced on 12 August 2020, Mark Evans, the chairman of Obotritia Capital KGaA (“Obotritia”), will be appointed as a non-independent non-executive director of the Company in recognition of Obotritia’s significant shareholding and ongoing support for the Company.  Mark will also chair the Company’s Audit Committee given his extensive finance background.  We welcome Mark to his new position.

Today’s AGM will take place at 10.00am at the Company's offices at Pencoed Business Park, Pencoed, Bridgend CF35 5HY.  As previously announced, in light of the restrictions imposed due to the COVID-19 pandemic, the AGM this year will not be open for shareholders to attend in person.  The results of voting on the AGM resolutions will be announced later today.