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Small Talk: Stem cell firm set for heart-to-heart talks

Nick Clark
Monday 04 February 2008 01:00 GMT
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ReNeuron Group executives will be hoping that love is in the air when they sit down for talks with US regulators on St Valentine's Day.

The Guildford-based stem cell company has suffered this year as uncertainty has continued to drag around one of its therapies in the US, but last week it said that the Food and Drug Administration had set 14 February for a face-to-face meeting.

ReNeuron, which operates from Los Angeles as well as the UK, uses patented technology to generate genetically stable neural cell lines to be used to treat neurological disorders. It said the technology is fully regulated by a chemically induced safety switch: "Cell growth can therefore be completely arrested prior to in vitro implantation."

The group is developing stem cell therapy to treat chronic stroke disability. There are some 50 million stroke survivors worldwide, and half of those are left with permanent disabilities. The annual health and social costs of caring for these are over £5bn in the UK and over $50bn in the US.

ReNeuron made an Investigational New Drug application to start clinical trials in the US in September after completing successful pre-clinical trials. The filing for its ReN001 stem cell therapy was the first for approval of neural stem cell treatment for a major neurological disorder.

Yet that's as far as ReNeuron came. Last month the AIM-listed group was told by the FDA that its application was on clinical hold, because the regulator had concerns about approving the treatment. Shares in ReNeuron have been on the slide since November, when they were 23.5p. Investor unease has since led the stock down to 15.75p on Friday, its lowest point for over a year.

ReNeuron now has a date to sit down with the FDA for what is called a Type A meeting. It hopes to address the concerns raised and secure approval. Michael Hunt, chief executive, said: "We are grateful to the FDA for allowing us the opportunity to meet with them in the near term to clarify and resolve the remaining clinical hold issues regarding our ReN001 stroke therapy."

Meanwhile, the company is continuing its preparations for the clinical phase of the development of the therapy, and the market will know the results of the talks within 30 days of the meeting.

The group, which is also developing stem cell therapies for Parkinson's disease, Huntington's disease and type one diabetes, was founded in 1997, to commercialise technology developed by its founders, who were scientists at the Institute of Psychiatry at King's College London.

Angle turns corner

There are signs that the fortunes of Angle, the intellectual property and technology commercialisation company, are starting to turn. After six months of restructuring and cost-cutting, interest has emerged from outside the group.

Last week, Angle announced a strong set of results for the six months to the end of October, and revealed that it had been approached over a potential deal. Talk in the market was of a full takeover offer, causing Angle's share price to bounce 36 per cent on Thursday, from 28.5p to 38.75p.

Angle's board, which is being advised by Collins Stewart Europe, said that it would evaluate the approach on its merits and update shareholders. It stressed that there could be no certainty that this approach will lead to an offer.

Angle's chairman, Garth Selvey, said the company had made strong progress in the first half of the year, operationally and financially. He said that over the last six months overheads had been cut and the group's portfolio had been restructured, as it looked at maximising investment return.

The company reported it had turned around losses of £4.9m from the first half of 2006, to report a pre-tax profit of £2.8m.

Mr Selvey added that the second half had started well, and the group expects to deliver positive results for the year in its investment portfolio and themanagement servicesbusiness.

Humberts up on bid talk

The estate agency and surveyor Humberts is another company that saw its share price rally on the back of takeover speculation last week.

It has been a woeful year for the firm, which fell along with the rest of the sector, culminating in the resignation of the chairman, Tim Jones, and chief executive, Max Ziff, last month.

Humberts listed five years ago at 60p. This year has seen the value smashed from 107p a year ago to as low as 7p last week.

On Wednesday, after it said it had received a "preliminary approach", the share price doubled to 15.25p at the close, but that remains scant consolation for any investor holding the shares longer than two weeks.

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