Guildford, UK, 13 September 2013: ReNeuron is pleased to provide a trading update ahead of today’s Annual General Meeting.
As reported in the Company’s July preliminary results statement, all patients in the PISCES Phase I clinical trial have been dosed with the Company’s ReN001 stem cell therapy for stroke disability. The patients in the highest dose cohort are through their short term follow-up period, with no cell-related or immunological adverse events reported. Since then, the independent Data Safety Monitoring Board for the study has reviewed all available data from the study and has supported the ReN001 therapy’s progression to a Phase II clinical trial utilising the highest dose from the Phase I study. Further, the proposed Phase II stroke study has been through formal ethical review since the preliminary results statement with no material issues arising.
In collaboration with the contract research organisation selected to manage the ReN001 Phase II clinical trial, we have identified and are evaluating additional UK clinical sites in order to ensure patient recruitment targets are met for this study. Last month, we were also pleased to announce that the Company had been awarded a £1.5 million grant from the Technology Strategy Board (TSB) under its Supporting Regenerative Medicines and Cell Therapies Competition. This grant will part-fund the Phase II clinical trial.
We are currently in the process of completing the validation of two new European contract manufacturing sites for the CTX cells to be used in both the Phase II study with our ReN001 therapy for stroke and the proposed Phase I study with our ReN009 therapy for critical limb ischaemia. Pharmacell B.V., based in Holland, will manufacture CTX drug product and Roslin Cells Ltd., based in Scotland, will initially manufacture further cryopreserved CTX cell banks from which future drug product is derived. Based on encouraging recent in-house evaluation data, we have extended the validation plan to include a cryopreserved variant of the CTX drug product in addition to the existing non-cryopreserved variant.
On the basis of the above developments, and subject to final regulatory approvals, we expect both the Phase II clinical trial with ReN001 and the Phase I clinical trial with ReN009 to be open for patient recruitment by the end of the year. We therefore maintain our previously stated guidance regarding future Phase II clinical trial completion dates for these programmes, being mid-2015 for Phase II with ReN001 and H2 2015 for Phase II with ReN009 (assuming a successful Phase I read-out next year). As noted in the preliminary results statement, these completion dates fall well within the three year period to the third quarter of 2016 for which the Company is now financed.
Our ReN003 programme, based on our human retinal progenitor (hRPC) cells, continues to plan, initially targeting the blindness-causing disease, retinitis pigmentosa. Our academic collaborators at the UCL Institute of Ophthalmology in London have recently confirmed earlier pre-clinical data demonstrating that the hRPC cells are able to enhance visual acuity in a standard rodent model of blindness caused by the loss of photoreceptors in the retina. We were also pleased to recently announce that the ReN003 therapy has been granted Orphan Drug Designation in both Europe and the US. Treatments with this designation benefit from significant commercial and regulatory advantages, such as market exclusivity for 10 years from approval in the disease concerned, against other treatments offering no greater therapeutic advantage. For this reason, orphan status diseases are an increasing area of therapeutic and commercial focus by the mainstream pharmaceutical industry.
As reported at in the preliminary results statement, we are currently developing the protocol for an initial Phase I/II clinical trial with our ReN003 therapy in the UK and US, in retinitis pigmentosa patients. We have commenced our interactions with the US FDA regarding pre-filing regulatory advice on this programme, with a view to filing for regulatory approvals for the initial clinical study in the middle part of 2014.
The £33 million financing package we announced at the time of the preliminary results statement will allow us to take all of our therapeutic programmes through Phase II proof-of-concept clinical studies over the next three years. Included within this financing was a £7.8 million grant package from the Welsh Government to establish a cell manufacturing and development facility in South Wales for late stage clinical and commercial product requirements. Planning for this initiative is well underway, with a number of sites currently under evaluation.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“Ahead of today’s Annual General Meeting, we are delighted to report continuing progress across all aspects of our operations. Our therapeutic programmes are progressing to plan and we now have the opportunity, through the Welsh grant package, to both enhance and take full control over the manufacture of our stem cell therapy candidates as they get closer to market. The recently completed equity financing has given the business a very high quality institutional and specialist life science investor base, with the business now fully funded to pursue its development plans to value inflection over the next three years.”
ReNeuron +44 (0) 1483 302560
Michael Hunt, Chief Executive Officer
Buchanan +44 (0) 20 7466 5000
Mark Court, Fiona Henson, Sophie Cowles
Cenkos Securities +44 (0) 20 7397 8900
Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
ReNeuron is a leading, clinical-stage stem cell business. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional immunosuppressive drug treatments. ReNeuron’s lead candidate is its ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This therapy is currently in clinical development. The Company is also developing stem cell therapies for other conditions such as critical limb ischaemia, a serious and common side-effect of diabetes, and blindness-causing diseases of the retina such as retinitis pigmentosa.
ReNeuron has also developed a range of stem cell lines for non-therapeutic applications – its ReNcell® products for use in academic and commercial research. The Company’s ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Merck Millipore.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.
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 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.