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 2020.
Operational highlights
hRPC stem cell therapy candidate for retinal disease: Further positive and sustained top-line efficacy data at all time-points from Phase 2a patients in ongoing US Phase 1/2a clinical trial in retinitis pigmentosa ('RP')
Ongoing Phase 2a segment of the study expanded in US and UK to allow for a single pivotal Phase 3 clinical study before marketing approval application
Further readouts from expanded Phase 1/2a clinical trial expected over next 12 months, leading to planned commencement of pivotal clinical study in H2 2022
Exosome and iPSC platforms
Three collaboration agreements signed with major pharmaceutical/biotechnology companies to explore the potential of the Company's exosomes to deliver therapeutic agents to the brain
New immortalised, licensable cell lines generated from the Company's iPSC (induced pluripotent stem cell) platform as potential therapeutic agents for cancer immunotherapy and type 1 diabetes
Commenting on the results, Olav Hellebo, Chief Executive Officer, said: 'During the period under review, and subsequent to it, we have continued to generate encouraging positive efficacy data from the ongoing US Phase 2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa. Having received regulatory approvals in both the US and the UK to expand the ongoing study, we have recently commenced treating patients at a higher dose level and we look forward to presenting further data from this extended study over the coming year. The enhanced data set will inform the design of the subsequent pivotal Phase 3 study required for marketing approval. Our exosome and iPSC platforms have also progressed well during the period, with multiple industry-based collaborations now in progress across both platforms and the prospect of pre-clinical proof-of-concept data over the coming months.
'Our decision earlier this year to focus the Company's resources on our retinal disease programme and our exosome and iPSC platforms has resulted in significantly lower operating costs, as reflected in the interim results for the period under review. This renewed clarity of focus, together with the Fundraise announced separately yesterday, will enable us to reach important, data-driven value inflection points across our programmes over the next 12 months and beyond.'
Contact:
Tel: +44 (0) 20 3819 8400
About ReNeuron
ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments, without the need for immunosuppressive drugs. The Company's lead cell therapy candidate is in clinical development for the blindness-causing disease, retinitis pigmentosa.
ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that treat diseases of the brain. The Company also has the ability through its conditionally immortalised induced pluripotent stem cell (iPSC) platform to make any tissue cells of choice; in-house programmes are focused on treatments for blood cancers and diabetes.
This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as 'should', 'expects', 'estimates', 'believes' or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking also statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.
RENEURON GROUP PLC 
