Dublin, Ireland, 11th June 2009
AGM Statement
AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, will hold its Annual General Meeting today at the Company's offices in Dublin. During the meeting, the Company will provide shareholders with the following update.
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 confiirms 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.
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Jonathan Birt/John Dineen
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Niamh Lyons
Tel: +353 1 663 3602
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
For further information please see www.agitherapeutics.com.
Notes to Editors:
About AGI Therapeutics plc
AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastro-intestinal (GI) diseases and disorders. AGI's common shares are listed on the Alternative Investment Market of the London Stock Exchange (AIM) and on the Irish Enterprise Exchange of the Irish Stock Market (IEX) as AGI.
The Company has a portfolio of product candidates derived from its Known
Molecular Entity (KME™) approach to drug re-profiling and development.
The Company's lead product candidate, RezularTM, is an orally administered
multiple mechanism intestinal regulator, a first-in-class mechanism for
the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).
KME is a re-profiling methodology used by the Company to identify existing
therapeutic drugs which typically have been marketed for a number of years,
have established safety profiles and can be developed for new clinical
indications or with improved profiles in their existing clinical indications.
In this way, the Company seeks to reduce the risk, time and cost of new
product development as compared to the development of new chemical entities.
AGI is developing a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, dyspeptic symptoms, gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) and diarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). The Company is targeting areas of the GI therapeutic drug products market for its product candidates where there are currently unmet medical needs or where the effectiveness of existing drug therapies can be further improved.
The Company has five active clinical stage product candidates which are either isomers or novel drug delivery formulations of existing approved drugs and which have established safety and tolerability profiles in their currently approved clinical indications.
For further information please see www.agitherapeutics.com
Statements contained within this press release may contain forward-looking comments which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this press release are subject to the satisfactory progress of research which is, by nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.