AGI Therapeutics, plc Interim financial results for the six months ended 30 June, 2006
Dublin, Ireland, 7th September 2006: AGI Therapeutics plc ("AGI" or the "Company"), a speciality pharmaceutical company focused on gastrointestinal drug products, today reports interim financial results for the six months ended 30 June, 2006.
Financial highlights:
- Cash and short term deposits at 30 June 2006 of €40 million
- R & D spend of €1.6 million
- Net loss of €2.3 million
- Loss per ordinary share of €0.04 cent
Corporate Highlights:
- Completed a successful listing on the AIM Market of the London Stock Exchange and the IEX Market of the Irish Stock Exchange on 27 February 2006, raising gross proceeds of €42.5 million (£29.2 million)
- Strengthened the management team and Board through the addition of Dr. David Young, President of U.S. Operations and David Kelly as Chief Financial Officer
After the period end:
- Added Dr Chris Blackwell, Chief Executive of Vectura Group plc, to the Board as a non-executive director
Operating highlights:
- Reported positive, preliminary results of a Phase II trial of arverapamil (AGI-003) in non-constipation predominant irritable bowel syndrome (IBS), showing statistically significant superiority versus placebo
- Completed enrolment and treatment in a Phase II trial in 82 patients for mecamylamine (AGI-004) in functional diarrhoea; preliminary results expected in H2 2006
- Reported results from a human pharmacokinetics and pharmacodynamics trial of delayed/controlled release omeprazole (AGI-010) for the treatment of nocturnal acid breakthrough (NAB) in gastro esophageal reflux disease (GERD) demonstrating a controlled and extended release profile
After the period end:
- Completed enrolment of a Phase II trial in 68 patients in functional dyspepsia for arbaclofen (AGI-006)
Commenting on the interim results, Dr John Devane, Chief Executive of AGI, said:
"The first six months of 2006 was a pivotal period for AGI. Having completed a successful flotation, providing the Company with substantial resources to fund our future growth, we subsequently completed and announced results for a series of our most advanced clinical programmes which will be the basis for that growth. We have also continued to strengthen our management team and operating capabilities. We expect the pace to continue in the second half as we build further on the positive clinical results already reported and as we seek to maximise the value of our R&D portfolio."
Outlook
Commenting further, on the outlook for the remainder of 2006, Dr. Devane added:
"Once we have completed the current phase of clinical development activity we shall determine the best commercial options for our broad portfolio to establish both strategic licensing partnerships and a robust internal pipeline of clinical development programmes. While our initial strategy of advancing all our product candidates through key clinical proof of concept trials internally is now nearing completion, we look forward in the longer term to securing strong marketing positions for our resulting products, both in collaboration with pharmaceutical partners and through retaining marketing rights for certain of our products in important niche market segments."
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.
|
Home