In its preliminary results statement, ReNeuron Group (LON:RENE) said that it made “very substantial progress” in the financial year to 31 March 2010. The company reduced its losses compared to the previous year to £3.9m from £4.4m, and ReNeuron said the result reflects its leaner and tightly-controlled underlying cost base.
Also during the period ReNeuron completed a number of fundraisings with a £7.8m share placing, a £5m equity finance facility and the £2.5m capitalisation of all outstanding convertible loan notes.
London-based stockbroker Daniel Stewart & Co issued a positive note in response, highlighting that FY10 had exceeded its expectations beating the broker's loss projection. The broker noted that the adjusted pretax loss was now £1m lower year-on-year.
"We have a clear strategy to leverage the significant competitive advantages and therapeutic potential we believe our stem cell products bring to the field, with the aim of benefiting patients as well as generating a meaningful return to our shareholders”, ReNeuron chairman Professor Trevor Jones commented.
“The progress ReNeuron has made in the period ... positions ReNeuron as a front-runner in its areas of focus, with proven stem cell technologies capable of translation into clinical-stage therapies for very significant and poorly-served medical conditions."
From an operational perspective, ReNeuron achieved several key milestones in respect of their stem-cell therapy treatment.
Patient recruitment is now underway in the landmark first-in-man clinical trial of ReN001 stem cell therapy for stroke. Additionally, it received positive data from three pre-clinical efficacy studies of ReN009 stem cell therapy for peripheral arterial disease.
Among the other achievements, ReNeuron received an industrial grant from a major US healthcare company to fund the ReN003 stem cell therapy collaboration aimed at retinal disease therapies; Eight peer-reviewed papers were published in the period; positive data was presented post-year-end, from three further pre-clinical studies in stroke; and the ReN001 stroke therapy won the Breakthrough of the Year at 2010 European Mediscience Awards.
At the 31 March 2010, the company had cash and cash equivalents of £5.5m (FY09: £0.9m), with further £4.9 million available from an equity finance facility.
ReNeuron is a UK-based adult stem cell company whose primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.
The ReN001 treatment for stroke is the company’s most advanced therapy, and the first-in-man trials are now underway, with 12 patients set to receive the ReN001 therapy from between six and twenty-four months after their stroke. If ultimately shown to be safe and effective clinically, ReN001 should become a significant new treatment option for stroke survivors, offering the potential for a degree of recovery of function in disabled stroke patients.
The PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In the Phase I trial, ReNeuron's ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial.
In a separate broker note, entitled “ReNeuron: A Clinical Stage Company”, Daniel Stewart highlighted ReN001’s blockbuster potential in the treatment of stroke.
According to Daniel Stewart, stroke is the largest cause of adult disability in the developed world, with half of all stroke survivors left with some form of permanent disability, and ReNeuron’s ReN001 stem cell therapy offers the potential for a degree of recovery of function in disabled stroke patients.
“Given that the annual global health and social costs of caring for patients with stroke disability is estimated to be in excess of US$100 billion, we believe that if ReN001 were successful, it would enter a market of major unmet medical need. As such, we estimate that ReN001 could qualify as a blockbuster treatment”, Daniel Stewart stated.
Furthermore, the stockbroker stated that: “Not only is ReNeuron moving a first-of-its kind stem cell therapy into the clinic, but the group is rapidly deploying an ever expanding preclinical pipeline.”
Among the other treatments under development, Daniel Stewart highlighted the ReN009 stem cell therapy for peripheral artery disease (PAD), and the ReN003 programme for diseases of the retina, as being significant to the investment case. Daniel Stewart said that the ReN009 preclinical programme is progressing rapidly with clinical trials on-track to get underway in 2012, and noted that the ReN003 partnered preclinical programme recently received further external financing.