ReNeuron Group plc has announced its preliminary results for the year ended 31 March 2015.
• CTX stem cell therapy candidate for stroke:
- Long term Phase I data presented confirming good safety profile and sustained improvements in neurological status and limb function
- Phase II clinical trial ongoing - data expected during H1 2016
- Phase II/III clinical trial planned to commence in H2 2016
• CTX stem cell therapy candidate for critical limb ischaemia:
- Phase I clinical trial ongoing - data expected during H1 2016
- Phase II clinical trial planned to commence in mid 2016
• hRPC stem cell therapy candidate for retinitis pigmentosa:
- Orphan Drug Designation granted in both Europe and the US
- Fast Track Designation granted in the US
- Regulatory approval obtained post year-end to commence Phase I/II clinical trial in the US
- Phase II/III clinical trial planned to commence in 2017
• Exosome nanomedicine platform generating promising early pre-clinical data in cancer, and research collaboration extended with Benitec Biopharma to utilize exosomes as delivery system for gene therapy targeting cancer
• Olav Hellebø appointed as CEO, bringing substantial pharmaceutical, commercial and business development experience
• Strengthening of senior management team with appointments of Chief Medical Officer, Head of Regulatory Affairs, Head of Research and VP Development & General Manager, Wales.
• Placing announced to raise £68.4 million, before expenses, funding lead therapeutic programmes through late-stage clinical development over next three years
• Loss for the year of £8.91m (2014: £7.07m); cash outflow from operating activities of £8.25m (2014: £6.00m); cash, cash equivalents and bank deposits at 31 March 2015 of £12.38m (31 March 2014: £20.92m).
Commenting on the results, Olav Hellebø, ReNeuron’s CEO, said: “During the year under review, we have commenced dosing of patients in two new clinical trials in stroke disability and critical limb ischaemia, representing further significant milestones in the clinical development of ReNeuron’s CTX cell therapy candidates. Importantly, we have since gained regulatory approval to commence our first clinical trial in the US, a Phase I/II clinical trial of our hRPC cell therapy candidate for retinitis pigmentosa. We are also encouraged by the early pre-clinical data generated with our exosome nanomedicine platform, targeting cancer.
“As the business continues to progress its therapeutic programmes towards commercialization, we have also expanded senior management capability within the business to meet future operational needs. In this regard, we look forward to the relocation of the business to our new, world-class cell manufacturing and research facility in South Wales early next year.
“Finally, as a result of the fundraising announced today, the business benefits from a very strong balance sheet, the backing of high calibre institutional investors and an experienced management team focused on the delivery of clinical data and associated value generation across all of the Company’s therapeutic programmes over the next three years. We continue to look forward to the future with high confidence.”