Date: 2015-08-25
Type of information: Private placement
Company: Reneuron (UK)
Investors: new and existing investors including Woodford Investment Management (UK)
Amount: £68.4 million (€ 93 million)
Funding type: private placement
Planned used: The funds will provide working capital for Reneuron\'s core cell-based therapeutic programmes and new exosome nanomedicine programme in oncology through to first half of 2019. They will also be used to support stroke and retinitis pigmentosa programmes through to market authorisation application based on existing clinical development plans. Reneuron has a Phase II programme in stroke; a Phase I programme in critical limb ischaemia, a serious and common side-effect of diabetes; and approval to commence a Phase I/II study in the US in retinitis pigmentosa. The ongoing Phase II clinical trial for stroke continues to enrol patients. Following a recent change to the study protocol and discussions with key opinion leaders in the field, Reneuron intends to curtail the Phase II study after the first patient cohort, where dosing is expected to have completed by the end of the year with a read out in the first half of 2016. At this point, the Company intends to file an application to commence a controlled, pivotal Phase II/III clinical trial in the target stroke patient population. Reneuron\'s Phase I critical limb ischaemia clinical trial also continues to enrol patients. The Company intends to curtail this study at the middle dose level of 50 million cells and focus resources on initiating a Phase II placebo-controlled clinical trial. The Phase I study is expected to have completed dosing by the end of the year and the Company expects to have commenced the Phase II study in the middle of 2016.
Reneuron has also filed an application with the FDA to commence a Phase I/II clinical trial in the US in retinitis pigmentosa patients. This application has since been approved by the FDA and the Company expects to be able to commence the study before the end of this year. Subject to the outcome of the Phase I/II study, a pivotal Phase II/III clinical trial is planned to commence in 2017.
The net proceeds of the Placing together with the Company’s existing cash resources will, in the opinion of the Directors, provide the Company with sufficient working capital out to the first half of 2019, sufficient to fund the following milestones (subject to final protocol designs and regulatory approvals not already received):
• Phase II/III data with stroke programme
• Phase I/II and Phase II/III data with retinitis pigmentosa programme
• Phase I and Phase II data with critical limb ischaemia programme
• Phase I data with exosome programme
• Welsh facility on-stream as cell manufacturing/exosome centre of excellence
• Sufficient clinical data and financial resources to provide the business with the option to pursue high value partnering deals or to take its core cell-based programmes through to clinical proof of-concept stage and, in the case of the stroke and retinitis pigmentosa programmes, through to market authorisation application stage.
Others: * On August 25, 2015, ReNeuron, a UK-based cell therapy company, announced on 21 August 2015 that shareholders had approved all the resolutions in connection with the Placing of £68.4 million before expenses announced in July. As expected, Admission of the Placing shares became effective this morning and dealings commenced at 8.00 a.m. The Company has 3,156,239,639 Ordinary Shares in issue, all with voting rights. The Company holds no Ordinary Shares in treasury. The figure of 3,156,239,639 Ordinary Shares may be used by shareholders as the denominator for the calculation by which they will determine if they are required to notify their interest in, or a change in their interest in, the Company under the FCA’s Disclosure and Transparency Rules. Capitalised terms in this announcement have the same meaning as in the announcement of 10 July 2015 and the circular posted to shareholders on 29 July 2015 except where otherwise indicated. * On August 21, 2015, Reneuron announced that shareholders approved the details of a placing in which it had conditionally raised proceeds of £68.4 million before expenses. As a consequence of the passing of the Resolutions which included the Rule 9 Waiver, Woodford Investment Management will hold a total of 1,119,883,005Ordinary Shares, representing 35.5 per cent. of the issued share capital of the Company following Admission. It is expected that Admission will become effective and dealings will commence at 8.00 a.m. on Tuesday, 25 August 2015. Following Admission, the Company will have 3,156,239,639 Ordinary Shares in issue, all with voting rights. The Company holds no Ordinary Shares in treasury. * On July 10, 2015, ReNeuron announced that it has raised a total of £68.4 million, before expenses, through a conditional placing that will enable the Company to build on the recent progress achieved across its therapeutic programmes. The Company has conditionally placed 1,367,411,939 new Ordinary Shares at 5 pence per share with existing and new investors to raise approximately £68.4 million before expenses. In connection with the Placing, the Company and Cenkos have entered into a placing agreement (the “Placing Agreement”) pursuant to which and conditional upon, inter alia. Application will be made to the London Stock Exchange for the Placing Shares to be admitted to trading on AIM. Assuming that the Resolutions are passed, it is expected that Admission of the Placing Shares will become effective and dealings in the Placing Shares will commence at 8.00 a.m. on 24 August 2015.
Therapeutic area: Regenerative Medicine
