ReNeuron Group Plc (LON:RENE) is a clinical-stage cell therapy development company focused on its flagship CTX stem cell therapies.
As of September, all patients had been treated in a Phase II clinical trial to treat motor disability as a result of ischaemic stroke, the most common form.
The three month follow-up data will be available in December and will be a “key clinical milestone” for the group.
It then expects to file an application in the first quarter of 2017 to commence a randomised, controlled Phase II/III clinical trial with CTX.
Next key clinical milestone
Elsewhere, its CTX cell therapy candidate for critical limb ischaemia (CLI) is currently in a Phase I clinical trial in the UK.
CLI is a condition that results in loss of blood flow to the lower limb that can lead to amputation, common in diabetics.
Well-funded
“ReNeuron remains well-funded to advance all of its therapeutic programmes through to further significant clinical milestones and we look forward to reporting further progress in the months ahead,” said chief executvie Olav Hellebø in September.
ReNeuron’s principal strategy is to gain clinical validation for its cell therapy programmes through well-designed clinical trials in well-regulated territories.
Ultimately, the group expects to realise value for its therapies by out-licensing to commercial development partners at later stages of development.
Exosomes
Recently the group has made notable progress with its exosome platform.
Exosomes are nanoparticles secreted during the expansion of stem cells and containing a number of biologically active proteins with potential therapeutic benefits for a number of diseases.
The group is developing “off-the-shelf” stem cell therapies.
Unlike conventional drug treatments that address the symptoms, stem cell treatments have the potential to address the underlying causes of the target disease.
Its flagship CTX cell line has been taken through a full manufacturing scale-up and quality-testing process.
CTX now represents a standardised, clinical and commercial-grade cell therapy product that can be used to treat all eligible patients with the targeted diseases, without the need for additional immunosuppressive drug treatments.
Waiting for data
As well as data from the CTX stem cell therapy candidate phase II for stroke, phase I for critical limb ischaemia there is a phase I/II trial for human retinal progenitor cells for eye disease retinitis pigmentosa.
“Positive data from each would be a share price catalyst and offer significant upside potential,” said analysts at N+1 Singer.
Significantly undervalued
“As one of the most promising global stem cell therapy companies we believe ReNeuron remains significantly undervalued,” said analysts at Stifel.
“We believe ReNeuron's tech value of £21mln (with cash of £66mln as of 31 March 2016) significantly undervalues the business and places it at an unwarranted discount to its peers.”