ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce its interim results for the six months ended 30 September 2019.
hRPC stem cell therapy candidate for retinal disease:
· Positive top-line efficacy data presented from Phase 2a patients in ongoing US Phase 1/2a clinical trial in retinitis pigmentosa
· Ongoing Phase 2a study to be expanded to allow for subsequent potential single pre-approval clinical study and shorter route to market
· Further top-line efficacy data from expanded Phase 2a study expected to be presented during 2020
CTX stem cell therapy candidate for stroke disability:
· Clinical trial protocol amendments and other initiatives in place to accelerate patient recruitment in ongoing US Phase 2b clinical trial
· Significant increase planned in overall number of patients to receive CTX therapy as opposed to placebo procedure in Phase 2b study
· Overall size of Phase 2b study increased from 110 to 130 patients, with top line data expected in mid-2021
Exosome and iPS cell technologies:
· Grant-funded collaboration initiated with European Cancer Stem Cell Research Institute to enable delivery of therapeutic nucleic acids using CTX-derived exosomes
· New data presented, supporting use of CTX-derived iPSCs (induced pluripotent stem cells) to develop new immortalised cell lines as potential therapeutic agents for subsequent licensing to third parties
Increased business development activity:
· Exclusive out-licence agreement signed with Fosun Pharma to develop and commercialise hRPC and CTX programmes in China
o ReNeuron to receive upfront, near term and estimated success-based milestone payments of £80.0 million plus double-digit royalties on sales
· Discussions ongoing with other commercial third parties regarding potential out-licence deals across all of ReNeuron’s programmes
· Reduced loss for the period of £3.90 million (2018: loss of £5.36 million)
· Reduced cash consumed by operations of £5.15 million (2018: £7.54 million)
· Upfront payment of £5.40 million, net of withholding tax, received pertaining to licence agreement with Fosun Pharma
· Cash, cash equivalents and bank deposits at 30 September 2019 of £21.27 million (31 March 2019: £26.39 million)
Commenting on the results, Olav Hellebø, Chief Executive Officer, said:
“The period under review has been marked by significant progress across our various clinical and research programmes. During the period, and subsequent to it, we presented very encouraging positive efficacy data from the Phase 2a patients in the ongoing US Phase 1/2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa. We have taken advantage of these early results to amend our clinical development strategy with the aim of shortening the overall time to market approval application for this therapeutic candidate.
“During the period, we have instigated a number of protocol amendments and other initiatives to accelerate patient recruitment into the ongoing US Phase 2b clinical trial of our CTX cell therapy candidate in chronic stroke disability. These amendments will result in a greatly increased number of CTX-treated patients in the study. Additionally, we have been very encouraged to see the potential of our exosome and iPS cell technologies emerge further during the period.
“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. We hope to be able to announce further deals with commercial third parties across our various programmes in the months ahead.”