Date: 2012-04-27
Type of information: Private placement
Company: ReNeuron (UK)
Investors:
Amount: £5.4 million (€6.6 million) + £0.7 million (€0.85 million)
Funding type: private placement and open offer
Planned used: The proceeds from the Placing and Open Offer will be used to fund the pre-clinical and clinical development costs of the Company’s core therapeutic programmes and other general business costs, including anticipated completion of the PISCES stroke clinical trial and commencement of a Phase I/II clinical trial with the Company’s ReN009 therapy for critical limb ischaemia.
Others: On 3 April 2012, the Board of ReNeuron has announced the details of a Placing and Open Offer. On April 27, 2012, The Company has raised gross proceeds of approximately £5.4 million by means of a Placing through the issue of 134,037,500 Placing Shares at 4p per share. In addition the Company provided all qualifying shareholders with the opportunity to subscribe, also at 4p per share, for an aggregate of up to 99,744,494 Open Offer Shares. The Open Offer has now closed in accordance with its terms, the Company having received valid acceptances under the Open Offer in respect of 17,387,116 Open Offer Shares from Qualifying Shareholders, representing a take-up of approximately 17.43% of the total Open Offer Shares being offered and providing gross proceeds of approximately £0.7 million (€0.85 million). The Placing Shares have been admitted to trading on AIM and application has been made for the 17,387,116 New Ordinary Shares under the Open Offer to be admitted to trading on AIM with dealings expected to commence at 8.00 a.m. on 3 May 2012. Based on the above progress, the Company expects that the remaining high-dose patient cohorts in the PISCES study will have been treated within the next twelve months, leaving the Company on-track to submit an application to commence a Phase II study with ReN001 next year. The Company’s other therapeutic programmes continue to progress to plan. The Company and its academic collaborators have now completed pre-clinical studies successfully confirming the positive results from earlier pre-clinical efficacy studies with the Company’s ReN009 stem cell treatment for critical limb ischaemia, the end stage of peripheral arterial disease. Long term pre-clinical safety studies with ReN009 have also now been successfully completed. On this basis, the Company remains on track, later this year, to file for approval to commence a substantial multi-centre Phase I/II combined safety and efficacy study with ReN009 in critical limb ischaemia patients. The Company’s ReN003 collaborative programme for diseases of the retina continues to make progress, with further pre-clinical efficacy studies planned under the Company’s partnership with the US Schepens Eye Research Institute as well as with further academic centres both in the US and UK. Subject to a successful outcome from these pre-clinical efficacy studies, the Company intends to commence GMP cell banking and long-term pre-clinical safety studies with its proprietary hRPC retinal cell product, ahead of an initial clinical trial filing for ReN003 in the latter part of 2013 in patients with the blindness-causing disease, retinitis pigmentosa.
A Phase I clinical trial with the Company’s ReN001 stem cell therapy for stroke is currently being conducted in Scotland (the PISCES study), with the treatment being administered in ascending dose cohorts to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. To date, five patients have been treated in the PISCES stroke study – all three in the first dose cohort and two in the second dose cohort. Two patients have reached their 12 month follow-up visits, one patient has reached 9 month follow-up and the remaining two are through their 3 month follow-ups. All five patients have shown some measure of improvement in outcomes compared with their stable pre-treatment baseline performance, including some reduction in both neurological impairment and spasticity of the affected limbs as measured by NIHSS and Summated Ashworth scores, respectively. These improvements were sustained in those patients who have reached longer term follow-up points. Interim data from the trial will be presented by the Glasgow clinical team in scientific conference later this year, including longitudinal radiological data (such as functional MRI) to identify potential biomarkers of change in neurological function in the brains of the treated patients. The final patient in the second dose cohort is scheduled for treatment this month. Eligible patients have already been pre-screened at the Glasgow site for all of the next dose cohort and part of the final dose cohort. Further, to ensure a steady flow of eligible patients for the PISCES study and for a Phase II study in due course, the Company is currently in the process of seeking approval to open the trial to two other clinical sites in England. To this end, the Company is pleased to announce that the PISCES study has recently been adopted by the National Institute for Health Research (NIHR) Stroke Research Network. The NIHR is the UK public body responsible for promoting and enabling clinical research through the NHS infrastructure. Adopted studies benefit from a number of measures to streamline and coordinate the set-up and monitoring of clinical sites and patient recruitment.
Therapeutic area: Cardiovascular diseases - Regenerative medicine
