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ReNeuron Group Plc: THE INVESTMENT CASE

ReNeuron eyeing data rich period as it progresses four opportunities

Early 2016 looks to be data-rich for stem cell group ReNeuron as it progresses its clinical portfolio on multiple fronts.
ReNeuron eyeing data rich period as it progresses four opportunities
INVESTMENT OVERVIEW: RENE The Big Picture
Last year saw good momentum with the first recruitment into the firm's first US clinical trial and a £68.4mln fundraise, which means it can afford to progress all its programmes at the same time

Early 2016 looks to be data-rich for stem cell group ReNeuron (LON:RENE) as it progresses its clinical portfolio on multiple fronts.

The biotech, which recently relocated to South Wales, is focused on developing cell lines for "off the-shelf" therapies to treat serious conditions where there is unmet medical need, and is developing four platforms.

Last year saw good momentum with the first recruitment into the firm's first US clinical trial and a £68.4mln fundraise, which means it can afford to progress all its programmes at the same time.

And 2016 has kicked off well - the firm won a £2.1mln grant by a government agency to fund further research into the use of stem cells for regenerative medicine.

Firstly, its most advanced programme is the CTX therapy candidate for stroke, where a phase II trial is ongoing, with data expected during the first half of 2016 (namely to end March).

A pivotal phase II/III trial is expected to kick off in the second half of 2016 ahead of potential marketing of the candidate.

Secondly, first data is also expected in the first half from the ongoing phase I trial for critical limb ischaemia, while a  second  clinical trial is planned to start  in the second half of 2016.

Also ongoing is the group's retinitis pigmentosa programe. This is examining treatment for a group of diseases which lead to blindness.

Fifteen patients have now been recruited into a phase I/II clinical trial in Boston,  USA - the firm's first trial stateside after regulator FDA  fast-tracked the treatment.

Results are expected in the second half of 2016 and if successful, ReNeuron will file for a Phase II/III clinical trial in 2017.  The work is expected to be the basis for subsequent marketing authorization filings in both the US and Europe.

ReNeuron chief executive  Olav Hellebø is excited about this trial, along with the others the firm is progressing, and its implication for patients.

"There hasn't been much going on in the field (retinitis pigmentosa) for a long period and in the last few years, that has changed dramatically," he told Proactive.

The fourth programme is its exosome nanomedicine platform - a new nanomedicine targeting cancer, which is a potential new delivery system in gene therapy, where promising pre-clinical data had been shown.

The July fundraise was very large by the UK biotech sector standards, notes Hellebø, who added it meansthe firm can progress all four of its opportunities - rather than just one, which  was better and unusual in the sector.

"Success in any single one of these is worth a multiple of our current market cap," he highlighted.

Losses for the half year to end September were £4.5mln (£4.1mln) reflecting the development spending.

ReNeuron ended the half year to September with cash of £72mln. 



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Article
January 11 2016

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