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16-Sep-2019

AGM Trading Update

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

We continue to progress the clinical development of our human retinal progenitor cell (“hRPC”) therapy candidate in the blindness-causing disease, retinitis pigmentosa (“RP”).  A Phase 1/2a open-label clinical trial is ongoing to evaluate the safety, tolerability and preliminary efficacy of our hRPC stem cell therapy candidate in patients with advanced RP.

Dosing of the third cohort of three subjects in the Phase 2a element of the study is complete and dosing of the remaining cohort is underway.  These later cohorts include patients with a greater baseline level of visual acuity than those patients earlier in the study, as we seek to assess preliminary efficacy in patient groups with differing levels of remaining vision.  

We expect to report preliminary data next month from all treated Phase 2a subjects at the American Academy of Ophthalmology 2019 Annual Meeting in San Francisco, which is being held on 12-15 October 2019.  These results will form the basis of our future interactions with the regulatory authorities in Europe and the US regarding the future clinical development path of hRPC for the treatment of RP.      

Our CTX cell therapy candidate for stroke disability is currently being evaluated in the PISCES III clinical study, a randomised, placebo-controlled, Phase 2b clinical trial in 110 patients in the US.  Due to the nature and complexity of the study, patient recruitment has been slower than anticipated and we are pursuing or evaluating a number of further initiatives to address this.  These include potential amendments to the clinical trial protocol as well as various patient recruitment initiatives to better target eligible patients for the study. 

As a result of the above, we anticipate that the time to PISCES III clinical trial read-out will be extended by approximately 3-6 months, in the first half of 2021. 

Our exosome technology is being exploited as a novel vector for delivering third party biological drugs.  In August 2019, we announced a new grant-funded collaboration with the European Cancer Stem Cell Research Institute at Cardiff University to develop novel systems to enable the delivery of therapeutic nucleic acids across the blood brain barrier using ReNeuron’s CTX stem cell-derived exosomes.  In July 2019, we announced the grant of a number of key patents in Europe, Japan, China and South Korea covering our neural stem cell-derived exosomes and their methods of production.

Following the licence agreement signed with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma”) in April 2019, we are working closely with Fosun Pharma as it pursues the development, manufacture and commercialisation of our cell therapy programmes in the People’s Republic of China, with the CTX programme being the initial focus of activities. 

We remain in discussions with other commercial third parties regarding potential collaboration and/or out-licensing deals across our programmes.

Olav Hellebø, ReNeuron’s Chief Executive Officer, will give a brief presentation at the AGM. The slides accompanying the presentation will be made available at the start of the AGM in the Investor section of the Company’s website at www.reneuron.com/investors/presentations.

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Last Updated: 16-Sep-2019