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ReNeuron up as it highlights significant near term opportunities, reduces full year losses

The biotech said its hRPC stem cell therapy candidate for retinal disease has delivered “positive and sustained top-line efficacy data” in an ongoing US Phase 1/2a clinical trial

ReNeuron Group PLC - ReNeuron highlights significant near term opportunities, reduces full year losses

ReNeuron Group PLC (LON:RENE) shares rose on Monday after the firm said a decision to focus in-house activities on its retinal disease and exosome-based programmes will provide “significant near-term opportunities to deliver value-enhancing data and commercial partnerships” as it updated on the progress of its various treatments.

In its results for the year ended March 31, 2020, the cell-based therapeutics firm said its hRPC stem cell therapy candidate for retinal disease had delivered “positive and sustained top-line efficacy data” in an ongoing US Phase 1/2a clinical trial, with further readouts from an expanded study expected over the next 12 months, leading to intention to file an application in the second half of 2021 to commence a pivotal clinical study.

READ: ReNeuron treatment for degenerative eye condition “meaningful effect” for all points measured up to 18 months

The company also said it has received regulatory approval in the US and UK to expand the Phase 2a study to allow for a subsequent potential single pre-approval clinical study and shorter route to market.

Meanwhile, ReNeuron said it has developed a proprietary exosome for the potential delivery of coronavirus vaccines, and that post-year end it has signed collaboration deals with major pharmaceutical and biotechnology companies to explore the potential of its exosomes to deliver therapeutic agents to the brain.

The group also highlighted positive data from a PISCES II Phase 2a clinical trial of its CTX cell therapy candidate for stroke disability, and said that post-year it has decided to continue the stroke disability programme through regional partnerships.

In its figures for the full-year, ReNeuron reported a loss of £11.4mln, narrowed from a £14.3mln loss in the prior year, while it had received an upfront licence fee of £5.4mln as part of a partnership with Fosun Pharma to develop and commercialise its CTX therapy candidate.

"The decision we have recently taken to focus our in-house activities on our retinal disease and exosome-based programmes provides the company with significant near-term opportunities to deliver value-enhancing data and commercial partnerships”, said ReNeuron chief executive Olav Hellebø in the results statement.

“Our stroke disability programme will continue through regional partnerships and 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", the CEO added.

In morning trade on Monday, ReNeuron shares were 1.8% higher at 139.25p.

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Quick facts: ReNeuron Group PLC

Price: 115 GBX

LSE:RENE
Market: LSE
Market Cap: £36.63 m
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ReNeuron's Michael Hunt says key focus now is to build dataset for retinal...

ReNeuron Group PLC's (LON:RENE) Michael Hunt speaks to Proactive London's Andrew Scott on the back of its results for the year to the end of March 2020. He says one of the main highlights has been the continuation of the retinal disease clinical study in the US. A recent update showed the...

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