After the announcement on May 15th that AGI was discontinuing the development of Rezular in diarrhoea-predominant Irritable Bowel Syndrome (IBS-D), the Company has commenced a review of its business strategy, including a fundamental review of its pipeline products and post-hoc analysis of the data from the ARDIS 1 study of Rezular. The Company has moved quickly to limit the close out costs of the ARDIS Phase III programme as well as other project commitments in order to maximise the cash available to the business pending completion of the strategy review.
The ongoing data analysis of the ARDIS-1 clinical data confirms that Rezular has clinically meaningful activity on gut motility and diarrhoea symptoms. This profile of activity may have utility in indications in which patients suffer chronic diarrhoea as a dominant symptom which is not adequately treated with current therapies. AGI has had discussions with its medical advisory board and intends to undertake further analysis to identify appropriate clinical indications, to define the regulatory pathway and to determine the commercial feasibility of pursuing development programmes in these various indications.
Once completed the results of these analyses, combined with the analysis of the other portfolio products, will be incorporated into a new business plan to be presented to the Board of Directors for their approval. The outcome will be communicated to all shareholders at the appropriate time. The Company is committed to providing the Board with the new business plan as quickly as possible. During the review period, the Company has targeted reduction of all elements of cash burn that are not judged critical to any revised business plan.
Based on current estimates, the Company expects to have cash resources of approximately $12 million by end Q2 2009, after provision for the close out costs of ARDIS 1 and 3 and certain restructuring provisions. AGI is committed to aligning its cost base to the requirements of the new business plan to ensure that shareholder value is maximised.
AGM:
The AGI Therapeutics plc AGM will take place on Thursday, 11th June, 2009 at 2.00 pm at its offices at Adelaide Chambers, Peter Street in Dublin.
Copies of the Company's Annual Report and Accounts for the year ended 31 December 2008 and Notice of the Annual General Meeting were posted to shareholders on May 12th, and are also available to view on the Company's website; www.agitherapeutics.com, under the heading Investors/Publications.
