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 2018.
Operational Highlights
- CTX stem cell therapy candidate for stroke disability:
– Long term data from Phase II clinical trial presented, showing sustained improvements in motor function and reduced levels of disability and dependence
– IND application approved by FDA to commence a Phase IIb, placebo-controlled clinical trial in the US
– Patient recruitment expected to commence shortly leading to top-line data at the end of 2019 - hRPC stem cell therapy candidate for retinal diseases:
– Four patient cohorts treated in ongoing US Phase I/II clinical trial in retinitis pigmentosa (RP)
– Phase I/II study to be expanded to target patients with less-impaired vision
– Top line Phase I/II data now expected in mid-2019
– Phase II study planned in cone-rod dystrophy patients, to run in parallel with planned Phase IIb study in RP - Exosome nanomedicine platform:
– Positive pre-clinical data with ExoPr0 exosome therapy candidate demonstrates potential of ExoPr0 to target multiple diseases
– Initial clinical trial application planned for 2019 in oncology - US office established in Boston, reflecting the Company’s increasing clinical activity in the US
- Increased business development activity in the period due to third party interest in Company’s core therapeutic programmes
– Active discussions ongoing with a number of commercial third parties - Increased collaborative work in the period to exploit technology platforms beyond core therapeutic programmes
Financial Highlights
- Loss for the period of £17.6 million (2017: loss of £15.6 million)
- Cash used in operating activities of £14.9 million (2017: £12.6 million)
- Cash, cash equivalents and bank deposits at 31 March 2018 of £37.4 million (31 March 2017: £53.1 million)
- 1 for 100 Share Capital Reorganisation completed in the period
- Three further government grants awarded in the period and post-period end, providing funding towards £5.0 million of collaborative work programmes across the Company’s therapeutic development programmes
Post-period end
- Further positive pre-clinical data demonstrates that ExoPr0 exosome therapy candidate significantly reduces tumour volume in a variety of in vivo models of cancer
- Exclusivity agreement signed with US-based specialty pharmaceutical company regarding potential out-licensing of hRPC technology platform and therapeutic programmes
Commenting on the results, Olav Hellebø, Chief Executive Officer, said: “During the period, our therapeutic development programmes have continued to progress well. The regulatory approval from FDA to commence a Phase IIb clinical trial in the US with our CTX cell therapy candidate for stroke disability was a significant milestone for ReNeuron and we look forward to dosing the first patient in this study. Dosing has progressed during the period in our ongoing US Phase I/II study with our hRPC cell therapy candidate for retinitis pigmentosa and we have continued to generate and present encouraging pre-clinical data with our ExoPr0 exosome therapy candidate in oncology.
“We now have a physical presence in Boston, US, one of the world’s leading biotechnology hubs, where our new US office reflects ReNeuron’s increasing clinical activity in this territory. Further, our cell-based technologies and therapeutic programmes have attracted the interest of a number of commercial third parties, leading, initially, to yesterday’s separate announcement of an exclusivity agreement with a US specialty pharmaceutical company regarding our hRPC retinal stem cell technology and therapeutic programmes. We hope to be able to conclude a definitive agreement with this company later this year.
“Our cash position remains robust and we are positioned to deliver significant clinical milestones across our therapeutic programmes during each of the next three years.”
reneuron
