reports
- Andy Smith
ReNeuron Group - Biblical aspirations
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 £9.6m for the six months (vs £7.7m in H117). In 2018 ReNeuron’s profile will incr...
- Dr Linda Pomeroy
Milestones expected as pipeline progresses
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 £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 exp...
- Dr Linda Pomeroy
Global clinical pipeline strategy update
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 contin...
- Dr Linda Pomeroy
Clinical pipeline progressing as planned
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 is...
Ford Equity International Rating and Forecast Report
Ford Equity International Research Reports cover 60 countries with over 30,000 stocks traded on international exchanges. A proprietary quantitative system compares each company to its peers on proven measures of business value, growth characteristics, and investor behavior. Ford's three recommendation ratings buy, hold and sell, represent each stock’s return potential relative to its own country market.. The rating reports which are generated each week, include the fundamental details behind...
- Dr Linda Pomeroy
Positive Phase II stroke data
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) tria...
Outlook: Progressing toward a pivotal moment
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 recruitm...
Update: First patient treated in first US clinical study
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 ste...
Update: Banking on progress
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 f...
Update: Supportive PISCES data
ReNeuron presented two-year follow-up data from the PISCES study in disabled stroke patients, which confirm the potential for long-term benefits from treatment with its CTX neural stem cells. Improvements in stroke disability scores observed after 12 months were mostly maintained at 24 months. Beyond CTX, ReNeuron recently filed an IND to commence a Phase I/II study in the US with its human retinal progenitor cells (hRPC) to treat retinitis pigmentosa, an orphan hereditary disease that can lead ...
Update: Poised for a pivotal year
ReNeuron is facing a potentially transformational year in 2015, with key clinical data and relocation to a new cell manufacturing/research facility. Its allogeneic, CTX neural stem cell product is the primary valuation driver, and Phase II data in H215 for stroke disability are the key event. Positive outcomes would signal a prospective breakthrough therapy for these patients and likely spark fresh investor/partnering interest. And with new legislation in Japan to accelerate the approval of stem...
Initiation: Renewed confidence through robust approach
ReNeuron operates off solid fundamentals as it seeks to advance its novel stem cell technology. Last year’s £25.3m fundraise coupled with a £7.8m grant from the Welsh government to build a new manufacturing facility for its neural CTX stem cells (to complete Q215) allows management to guide ReNeuron to several value inflection points. Clinical data from ReN001 for stroke (Phase II – robust trial design) and ReN009 for critical limb ischaemia (Phase I) are expected in 2015. We value ReNeuro...
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