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ReNeuron Group

The rise of the exosome

Update | Pharmaceutical & healthcare | 22 May 2018

ReNeuron introduced its exosome nanomedicine programme at its recent capital markets day. While being a preclinical programme, it has three significant advantages. First, it gives ReNeuron the potential to expand into new therapeutic indications. Second, it opens up the potential for collaborations in diagnostics and drug delivery. Third, it builds on its wealth of experience and IP and on its CTX cell line on which ReNeuron’s existing products and the exosome platform are built.

ReNeuron Group

Consolidation confusion?

Update | Pharmaceutical & healthcare | 14 Feb 2018

ReNeuron’s recent 100 for 1 share consolidation was a benign and cosmetic ‘tidy up’ of its historical capital structure. The share price of ReNeuron is trading at 52-week lows and the recent consolidation may have been an unrelated or an unintended cause for concern for some investors. ReNeuron’s valuation is now below its c GBP 40m cash position. In this update, we offer some possible thoughts on this overreaction and, in the absence of operational newsflow, our forecasts and valuation are largely unchanged.

ReNeuron Group

Biblical aspirations

Update | Pharmaceutical & healthcare | 21 Dec 2017

ReNeuron’s interim results for the six months to 30 September 2017 showcased a crucial juncture in the company’s history. With the first of two US placebo-controlled, late-stage studies in chronic stroke starting in 2018 and dosing ongoing in the US Phase I/II study in retinitis pigmentosa, ReNeuron’s stem cell therapies are aimed at helping the disabled walk and the blind see. ReNeuron reported a loss of GBP 9.6m for the six months (vs GBP 7.7m in H117). In 2018 ReNeuron’s profile will increase further as it conducts two clinical studies and opens an operational base in the US.

ReNeuron Group

Milestones expected as pipeline progresses

Update | Pharmaceutical & healthcare | 06 Jul 2017

The highlight of FY17 was positive Phase II efficacy data from ReNeuron’s PISCES II clinical trial. As this and its other clinical programmes in ophthalmology and its earlier stage exosome platform progress, ReNeuron is entering a period of potentially significant milestones over the next 12 to 18 months. We maintain our valuation of GBP 291m, adjusting for FY17 cash and rolling the model forward, which is offset by moving out the clinical timeline for the Phase III pivotal trial in stroke, now expected to start in early 2018 (vs H217).

ReNeuron Group

Global clinical pipeline strategy update

Update | Pharmaceutical & healthcare | 02 May 2017

ReNeuron continues to prepare for its Phase III chronic stroke study (due to start in H217) and has indicated that it is making progress with the US/EU regulatory authorities. It intends to submit an IND in the US in Q217 and shortly after in the EU. ReNeuron also announced that it now plans to expand its ongoing Phase I/II retinitis pigmentosa (hRP cells) study to 20 patients in Phase II and commence a Phase II study in a new indication: cone-rod dystrophy (CRD). As a result, it will not continue development of CTX in critical limb ischaemia (CLI). We maintain our rNPV at £291m.

ReNeuron Group

Clinical pipeline progressing as planned

Outlook | Pharmaceutical & healthcare | 23 Mar 2017

ReNeuron reported in December 2016 positive Phase II trial data for its CTX cells in chronic stroke patients, despite not meeting the three-month time frame of a two-point improvement in its primary outcome measure, the Action Research Arm Test (ARAT). As a result, the company has confirmed that it will progress to a pivotal controlled clinical study in 2017. Beyond CTX, we expect safety and efficacy data from its retinitis pigmentosa (RP) trial in 2017 and Phase I data from its critical limb ischaemia (CLI) trial. Our rNPV has increased to £291m.

ReNeuron Group

Executive Interview - ReNeuron

Edison TV: | Pharmaceutical & healthcare | 19 Dec 2016

ReNeuron is a UK clinical-stage biotech company developing allogeneic cell-based therapies. CTX neural stem cells are in development for ischaemic stroke disability (Phase II) and critical limb ischaemia (Phase I), and human retinal progenitor cells (hRPC) are being studied for retinitis pigmentosa (Phase I/II). ReNeuron is one of the pioneers in the field of stem cells, having developed proprietary technology platforms, notably based on the CTX neural stem cell line, derived and immortalised from a single donor cell. It is developing these multipotent adult stem cells specifically for allogeneic administration (as opposed to autologous procedures). The final product can be cryopreserved, stored and transported, with a simple procedure to prepare the cells for injection, so offering a genuine off-the-shelf, cell-based therapy. There is a clear clinical and commercial appeal, in that rather than addressing the symptoms of a disease, stem cell therapy seeks to address the cause of the condition, to effect repair or reversal of the disease through the regeneration of the affected tissue.

ReNeuron Group

Positive Phase II stroke data

Update | Pharmaceutical & healthcare | 07 Dec 2016

ReNeuron has presented positive Phase II trial data for its CTX cells in chronic stroke patients. Reported data included 15 out of 21 patients having a clinically relevant and sustained response on at least one efficacy measure. This confirms the potential for long-term benefits from treatment with its CTX neural stem cells and has led to the decision to progress to a pivotal controlled clinical study in 2017. Beyond CTX, we expect safety and efficacy data from its retinitis pigmentosa (RP) trial in 2017. Our rNPV has increased to GBP 278m (vs GBP 249m) as we have increased the probability of the stroke programme’s success to 25% (from 20%) and updated cash.

ReNeuron Group

PISCES-I long-term data published in The Lancet

Update | Pharmaceutical & healthcare | 05 Aug 2016

ReNeuron has announced the publication of long-term Phase I stroke clinical trial (PISCES-I) data in The Lancet. The data indicate improvements in neurological status and limb function compared with pre-treatment baseline performance within three months of treatment and throughout long-term follow up. Alongside this there were no cell-related or immunological adverse events across the four ascending dose levels in the study. This is positive as the data from the first stroke study continue to demonstrate safety, tolerability and functional improvement from the CTX cell therapy treatment. Investor focus is currently on the three-month readout of ReNeuron's Phase II stroke disability study (PISCES-II) with its CTX cells, due in Q416. We maintain our rNPV at £249m.

ReNeuron Group

Progressing toward a pivotal moment

Outlook | Pharmaceutical & healthcare | 27 Jul 2016

Investor focus is currently on the readout of ReNeuron's Phase II stroke disability study with its CTX cells, due in Q416. Alongside this there are a number of other data readouts and progression of its pipeline potentially in the near term. ReNeuron has significant financial resources to support its broad clinical development programme over the next two to three years. Adjusting for cash, strengthening of the $:£ exchange rate and revised clinical timeline for CTX in stroke (patient recruitment completed in June 2016), we raise our rNPV to £249m (vs £233m).

ReNeuron Group

First patient treated in first US clinical study

Update | Pharmaceutical & healthcare | 24 Mar 2016

ReNeuron has treated the first patient in its US Phase I/II clinical trial with its cell therapy candidate for the blindness-causing disease retinitis pigmentosa (RP). This is a significant step given we estimate peak sales of $445m for the programme, which could move straight into a pivotal Phase II/III study in H217, pending positive data in the Phase I/II by end-2016/early 2017. The next major valuation inflection point is now the Phase II stroke disability study data (with its CTX neural stem cells), due in mid-2016.

ReNeuron Group

Banking on progress

Update | Pharmaceutical & healthcare | 29 Oct 2015

ith significant financial resources able to support an extensive clinical development programme over the next three to four years, ReNeuron is well-positioned to determine the true value of its cell-based technology platforms. While near-term focus is rightly on the readout of the Phase II stroke disability study in H116 with its CTX neural stem cells, we view the imminent start of a US Phase I/II study using hRPCs for retinitis pigmentosa as significant given the market opportunity. Adjusting for cash and revised clinical timelines, our rNPV rises to £230m (vs £134m).