AGI Therapeutics plc Financial results for the year ended 31 December 2005
Dublin, Ireland, 20th April 2006: AGI Therapeutics plc ("AGI" or the "Company"), a speciality pharmaceutical company focused on gastrointestinal drug products, today reported the audited financial results for AGI Therapeutics Research Limited, formerly AGI Therapeutics Ltd, for the year ended 31 December 2005. AGI Therapeutics Research Limited is the operating subsidiary of AGI Therapeutics plc which was created as a holding entity prior to the Company's recent flotation.
The admission document for AGI Therapeutics plc, issued on 21 February 2006, included audited results for the years ended 31 December 2004 and 2003 and unaudited results for the nine months ended 30 September 2005 for AGI Therapeutics Research Limited.
AGI’s listing on the AIM market of the London Stock Exchange and the IEX market of the Irish Stock Exchange on 27 February 2006 raised gross proceeds for the Company of €42.5 million (£29.2 million) through the placing of 33,730,159 ordinary shares at €1.26 (86.5p) per ordinary share.
2005 Operating Highlights
- Established the formulation, manufacturing methods and sources of supply, and manufactured clinical trial supplies for all six clinical product candidates
- Completed enrolment of Phase II trial in 132 patients for AGI-001 (espindolol) in functional dyspepsia
- Completed enrolment of Phase II trial in 128 patients for AGI-003 (arverapamil) in non-constipation dominant irritable bowel syndrome
- Completed enrolment of Phase II trial in 67 patients for AGI-001 (espindolol) in irritable bowel syndrome
- Initiated two further Phase II trials for AGI-004 (mecamylamine) in functional diarrhoea and AGI-006 (arbaclofen) in functional dyspepsia
- Grant of US Patent No. 6,849,661 for AGI-003
Post Period End Highlights
- Dr Ronan Lambe appointed non-executive Chairman (January 2006)
- Successful admission to trading on the AIM market of the London Stock Exchange and the IEX market of the Irish Stock Exchange raising net proceeds of €39.6 million (February 2006)
- Completed enrolment of Phase II trial in 82 patients for AGI-004 (mecamylamine) in functional diarrhoea (March 2006)
- Positive results in human pharmacokinetics trial of AGI-022 (4-aminosalicylate sodium), confirming the target controlled release and delivery (March 2006)
- Preliminary results from human pharmacokinetics and pharmacodynamics trial of AGI-010 (omeprazole) confirming controlled release profile. Profile will now be further optimized to target nocturnal acid breakthrough in gastro-esophageal reflux disease (March 2006)
- Mr. David G. Kelly appointed as Chief Financial Officer, effective as of 2 May 2006 (see separate announcement today)
Commenting on the 2005 results and on the outlook for 2006, Dr. John Devane, Chief Executive Officer of AGI, said:
"This has been a very pleasing period of progress for the Company, highlighted by our successful flotation earlier this year. During the last 12 months, we have initiated five Phase II clinical trials and a further two human pharmacokinetics and pharmacodynamics studies on our six clinical stage products. During 2006 we expect to complete and report on our five Phase II clinical trials and we can look forward to a significant stream of clinical news through the remainder of the year."
Contact Information
AGI - Tel: +353 1 449 3254
David G. Kelly, Chief Financial Officer
Financial Dynamics – UK Tel: +44 (0) 20 7831 3113
Sarah MacLeod
Financial Dynamics - Ireland Tel: +353 1 663 3607
Aisling Garvey
For further information please see www.agitherapeutics.com
About AGI Therapeutics
AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastrointestinal (‘‘GI’’) diseases and disorders.
The Company has a portfolio of product candidates derived from the Known Molecular Entity (‘‘KME’’) approach to drug re-profiling and development. 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 has developed a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. 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 six clinical stage product candidates which are either isomers or new drug delivery formulations of existing approved drugs, and which have established safety and tolerability profiles in their currently approved clinical indications. These product candidates are all in clinical development, including five Phase II trials.
AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate Phase III development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.
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.
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