Intercytex Group plc (LSE: ICX), a developer of regenerative medicine products, today announces its results for the year ended 31 December 2008. The Company also reports new clinical data on its regenerative medicine products; VAVELTA® and ICX-TRC.
On 20 February 2009, Intercytex announced that following the decision to discontinue the development of Cyzact®, the Board has determined to evaluate all strategic options for the Company. Options being considered include the possible merger or sale of the business.
PRODUCT SUMMARY
VAVELTA® - natural repair for damaged skin
• VAVELTA® made commercially available to small group of UK specialists from June 2008
• Over 120 patients treated by Clinical Practice Group (CPG) since launch and CPG now expanded to 16 clinics
• Positive final data from two Phase II trials of VAVELTA® presented at the FACE congress in June 2008
• Announced today eight Epidermolysis Bullosa patients treated with VAVELTA®. Remarkable and rapid healing responses seen in all of the five patients evaluable to date
• Phase II trial for burns scars (including contractures) on hold to refocus resources
SHEF-1 - age-related macular degeneration
• Preclinical development programme obtained via the acquisition of Axordia in December 2008
• SHEF-1 licensed to The London Project to Cure Blindness for treatment of age-related macular degeneration, the leading cause of blindness in the elderly
• Development fully funded by The London Project to Cure Blindness
ICX-TRC - hair regeneration
• Positive data from Phase II trial announced today - increase in hair count in the majority of evaluable subjects observed at 48 weeks
ICX-SKN - skin grafts for acute wounds
• Phase I study in excisions showed integration of graft in all 12 patients persisting for up to 6 months
• Product being reformulated for burns application as part of the AFIRM grant award
Cyzact® - chronic wounds
• Cyzact® discontinued after failure of Phase III venous leg ulcer trial in February 2009
CORPORATE AND FINANCIAL SUMMARY
• Loss before tax for the year slightly reduced at £11.53m (2007: £11.63m)
• Cash and cash equivalents and liquid investments at 31 December 2008 of £4.86m (2007: £12.50m)
• Placing of new shares in September 2008 raised £2.75m gross
• Awarded US$1.5m over 5 years from US Armed Forces Institute of Regenerative Medicine (AFIRM) to support development of ICX-SKN for burns
• Awarded grant from the Technology Strategy Board of £285k over 3 years to assist with development of strategies for preservation and storage of cell therapy products
• Acquisition of embryonic stem cell company Axordia Limited (Axordia) for £1.68m in shares in December 2008
• Restructuring announced in January 2009 to significantly reduce cash burn
• Strategic review announced on 20 February 2009. The Board continues to explore options to maximise shareholder value, and the Company is now in discussions with a number of parties which may or may not lead to an offer being made for the Company
BOARD
• Appointment of Max Herrmann ACA as Chief Financial Officer replacing Richard Moulson
• Appointment of Lee Woodward ACA as Company Secretary and Financial Controller (previously Financial Controller)
Nick Higgins, CEO of Intercytex, commented: “Following the discontinuation of development of Cyzact, all our efforts are focused on maximising the value of the rest of our broad portfolio of highly innovative regenerative medicine products. Vavelta® continues to gain patient and clinician acceptance with more than 120 people having now been treated in a commercial setting. Today we have announced promising results from use of Vavelta in the devastating skin condition epidermolysis bullosa, and final Phase II results of ICX-TRC which have demonstrated good hair regeneration. The recent acquisition of Axordia has provided Intercytex with world class stem cell technology and a leading collaboration with the London Project to Cure Blindness. With ICX-SKN, our skin graft replacement for burns and acute wounds, fully funded by the US Armed Forces Institute of Regenerative Medicine (AFIRM), we have a significant portfolio of regenerative medicine products.”
