Intercytex beefs up management; reports progress on cell therapy product pipeline

After a month as a listed company cell therapist Intercytex reported a pre-tax loss for 2005 of £7.2m, a widening of 41% compared to 2004, as it moves forward on its R&D programme.

Chairman Ian Kent (pictured) said that in 2005 "we made considerable progress in developing our product pipeline, management team and financial base and are now well-positioned for the future."

Operating cash outflow for the year was £6.3m, compared with £4.8m in the previous year. The net cash inflow was £3.9m resulting in year-end cash on hand of £5.7m, which was subsequently boosted by £13.7m raised from its listing on AIM on 1st February this year.

"Intercytex now has sufficient cash to fund its development through a series of milestones which should add considerable value to the Company," Mr Kent said.

The company uses its proprietary expertise in cell therapy to develop products that harness the innate ability of human cells to regenerate and repair the body. It has four products in the pipeline in two business areas. In wound care it has ICX-PRO, designed to stimulate active repair in chronic wounds, and ICX-SKN, being developed as a durable and robust skin replacement.

In aesthetic medicine it has ICX-TRC, a hair regeneration product and ICX-RHY, a facial rejuvenation product.

It says that all its products are derived from unmodified, human cells.

Mr Kent said the impact of newly appointed - in January - CEO Nick Higgins (from Acambis) and VP Medical Affairs John St.Clair Roberts (from Microscience) "has been substantial" and has enabled founder Paul Kemp "to apply his unique cell therapy experience full time as Chief Scientific Officer".

The company said the increase loss reflected higher R&D costs, due in particular to the transition of ICX-PRO to Phase III trials, greater effort on ICX-SKN and the establishment of the ICX-RHY programme. General and administrative costs were also higher mainly as a consequence of fundraising costs and the expanded management team.

Product progress

During 2005 Intercytex completed a Phase IIb clinical trial of ICX-PRO, its lead product for the treatment of chronic ulcers. The trial indicated good efficacy and benefits and the company began a multi-centre Phase III trial in the US, UK and Canada which is expected to be completed during the first half of 2007.

Its baldness treatment product, ICX-TRC completed a Phase I safety trial in which five out of seven subjects showed an increase in hair numbers. Mr Kent said this is a medical first. The company is now preparing applications to start a Phase II clinical efficacy programme, initially in the UK.

Its facial rejuvenation product, ICX-RHY was conceived during the first half of the year, and by early 2006 the first volunteer had consented to a Phase I trial being undertaken in the UK.

Its living skin substitute for immediate closure of wounds, ICX-SKN has moved quickly from early stage research in 2004 to GMP manufacturing process validation by 2006. So far it has demonstrated skin-like tertiary collagen structure, tensile strength and sufficient toughness to take sutures. It is planned to start a phase I trial later this year.

Intercytex started up in 2000 and employs around 65 staff.

The share price was down 1p on the day. With its share price at 115.5p, the company's market capitalisation is £54.5m.

8th March 2006

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