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| 22-10-09 | RNS |
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RNS Number : 1823B AGI Therapeutics plc 22 October 2009 AGI Therapeutics plc Changes to Executive Team Dublin, Ireland, 22 October 2009 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, announces today that Dr David Young, President of US Operations, and Dr Sian Bigora, Vice President, Clinical Research and Regulatory Affairs, are to leave the Company in the next few weeks. Dr Young will remain as a director of the Board of AGI Therapeutics, plc. Dr John Devane, CEO of AGI Therapeutics, commented: "We want to thank both David and Sian for their contribution to all aspects of our business and wish them every success in the future. We are particularly pleased that David will remain on our Board which will ensure we continue to receive his counsel on our US regulatory strategy for products being developed as part of our new business plan. We continue to make good progress on developing the operational plans and intellectual property positions that will support those projects which will be the focus of our development efforts over the coming years." End Contact Information:
David Kelly, Chief Financial Officer
Jonathan Birt/John Dineen
Niamh Lyons
Neil Mackison Will Carnwath
John Frain For further information please see www.agitherapeutics.com. Notes to Editors: About AGI Therapeutics plc AGI is a specialty pharmaceutical company which is focused on the development and commercialisation of differentiated specialty drug products to treat unmet medical needs, including conditions which qualify for Orphan drug status. The company has a portfolio of product candidates derived from its Known Molecular Entity (KME*) approach to drug re-profiling and development and aims to bring its products to the market either directly or through out-licensing or other partnering arrangements. 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. 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. This information is provided by RNS The company news service from the London Stock Exchange END
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| 22-09-09 | AFX UK Focus |
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DUBLIN, Sept 22 (Reuters) - Ireland's AGI Therapeutics will widen its focus beyond gastro intestinal disorders and develop alternative uses for its flagship Rezular product after disappointing clinical trials earlier this year.
(Reporting by Carmel Crimmins; Editing by Jon Loades-Carter) Keywords: AGITHERAPEUTICS/ (carmel.crimmins@reuters.com; +353 1 500 1529; Reuters Messaging: carmel.crimmins.reuters.com@reuters.net)
COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. More |
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| 22-09-09 | AFX UK Focus |
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DUBLIN, Sept 22 (Reuters) - AGI Therapeutics Plc:
board.
medical need. out-licensing to or partnering with established pharmaceutical companies
COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. More |
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| 22-09-09 | RNS |
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This news article is displayed preformatted as it may contain results tables
RNS Number : 4279Z
AGI Therapeutics plc
22 September 2009
AGI Therapeutics
Interim financial results for the six months ended 30 June 2009
New business strategy announced
Dublin, Ireland, 22 September 2009 - AGI Therapeutics plc ("AGI" or "the Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, today announces interim financial results for the six months ended 30 June 2009.
The Company also today announces that, following a comprehensive review of the business by management, it has implemented a revised business strategy which has been endorsed by the Board.
Financial summary
* Cash and short-term deposits at 30 June 2009 of $15.1 million (31 December 2008: $23.6.million). Net of short-term liabilities: $12.4 million (31 December 2008: $21.0 million)
* R&D spend $7.8 million (2008: $8.3 million)
* Loss per ordinary share $0.14 cents (2008: $0.13 cents)
Operational summary
* In May, the top line results of ARDIS1, the Phase III efficacy study of Rezular* in diarrhea-predominant irritable bowel syndrome (IBS-D), the Company's lead development programme, were announced
* The study did not show a statistically significant difference between drug and placebo in the primary endpoint of patient-reported adequate relief of IBS symptoms
* Statistically significant evidence favouring Rezular treatment was achieved in a number of secondary endpoints and in particular those relating to GI motility and diarrhea symptoms as well as quality of life
* In March, positive results in a Phase II proof-of-concept study of AGI-004 in the control of chemotherapy-induced diarrhea (CID) were announced. AGI-004 is a once-daily controlled release transdermal patch containing the nicotinic antagonist mecamylamine
* The results showed a statistically significant difference between drug and placebo in the primary endpoint of reducing the incidence of patient-recorded diarrhea
* The primary endpoint was supported by a statistically significant difference in the secondary endpoint of patient-recorded severity of diarrhea
Business strategy review
Following the announcement on May 15th that AGI was discontinuing the development of Rezular in the broad indication of IBS-D, the Company commenced a full review of its business strategy, including a fundamental review of its pipeline products, and an extensive post-hoc analysis of the data from the ARDIS 1 study and the ARDIS 3 safety study of Rezular. That business review has now been completed and a new business strategy, prepared by management, has been approved by AGI's Board of Directors.
The key elements of the new business strategy are as follows:
Business focus
* While AGI has focused to date on products for gastro-intestinal (GI) indications, the Company's approach to development of differentiated products based on Known Molecular Entities (KMEs) is equally applicable to other therapeutic areas
* Under the new business plan, the Company will focus on the development of specialty products where there is an unmet medical need. In some cases these products will be developed for Orphan indications
* The Company will focus its primary efforts on the US market where it has the most experience and which offers the greatest commercial potential
* By focusing on products targeting unmet medical needs in specialty indications the Company will execute development programmes in a timely and cost effective manner and will aim to bring products to the market either directly or through out-licensing to or partnering with established pharmaceutical companies
* The Company's immediate focus will be to maximize the value of its existing pipeline of products, as well as adding new product opportunities where appropriate
Product pipeline
* Applying criteria based on the new business strategy, AGI has completed a comprehensive review of its product pipeline and associated indications
* A comprehensive review of the data from ARDIS 1, AGI's Phase III clinical efficacy study of Rezular in IBS-D, has been conducted. The analysis has confirmed that Rezular offers a potential treatment for chronic diarrhea symptoms, particularly those associated with altered gut motility. Furthermore the analysis, based on extensive and extended drug exposure in ARDIS 1 and ARDIS 3 supports the excellent safety profile of the drug. (A separate press release setting out in more detail the results of this analysis is issued today.)
* Following the review, AGI has identified a number of potential diarrhea-associated indications for Rezular that could be appropriate for further development. Some of these indications may qualify for Orphan drug status and approval. For competitive and intellectual property protection reasons, AGI does not intend to reveal these indications until priority has been established. AGI estimates that if Rezular was ultimately successfully developed, approved and launched in all these indications, peak sales could be in excess of $1.0 billion
* In addition, based on the unique pharmacology of Rezular, AGI has identified a new indication that is not diarrhea-related and is not in the GI therapeutic area, but which is an established Orphan indication where Rezular may have particular and unique benefit. If successfully developed in this indication AGI estimates potential peak global sales of $0.5 billion
* The management team has also determined that AGI-004, transdermal mecamylamine for the treatment of Chemotherapy Induced Diarrhoea (CID), meets the criteria of AGI's new business strategy and will be considered for further development
* A detailed operational plan is now being developed around these core products, Rezular and AGI-004, that prioritises the programmes for further direct investment by AGI. Co-funding or funding through strategic industry alliances may be considered for certain programmes
* AGI has three other products in development, AGI-010, AGI-022 and AGI-006. The Company recently announced that it has reached mutual agreement with Axcan Pharma Inc. to terminate the joint-development of AGI-010, controlled-release omeprazole, without any further financial obligations on either party. AGI has now regained full rights to this product and intends to seek pharmaceutical partners to fund the further development of AGI-010. A similar approach will be taken with AGI-022, a targeted and controlled-release aminosalicylate and AGI-006, an upper-GI prokinetic agent
New products
* In addition to building value based on its core products, Rezular and AGI-004, the business review has made provision for adding new products to add to the pipeline, including through partnerships and/or alliances with other companies. These new opportunities will be evaluated against the same criteria as those being pursued in-house, i.e. targetting unmet medical needs, in specialist indications and potential Orphan indications
Cost structure and cash
In the June 11 AGM statement, AGI announced that it expected to have cash resources of approximately $12.0 million at the end of Q2 2009. Cash on hand at 30 June 2009 was $15.1 million, before current liabilities of $2.7 million, most of which related to close out costs on the ARDIS programme and restructuring costs. These liabilities are due to be discharged in the third quarter of 2009, leaving pro-forma cash reserves of $12.4 million available as of the end of June for the execution of the new business strategy. The Company has moved to reduce its cost base which will allow for future clinical programmes to be funded to ensure it can rebuild value in its pipeline. The Company envisages that it will have sufficient cash resources for at least two years.
Commenting on the announcement today, John Devane, CEO of AGI stated; "We are pleased to have completed a rigorous business strategy and portfolio review, which provides a realistic route for rebuilding value in our pipeline, using the assets and resources available to us. In recent months we have spent considerable time identifying assets that will benefit best from further internal development and those better monetised by out-licensing. Over the next year we will concentrate our efforts on building value based on clinical and other scientific evidence in those indications where we see the greatest value for AGI."
- Ends -
Conference Call:
Please note that AGI will hold a conference call to discuss these results today, beginning at 11:00 BST.
To participate, please call +353 1 486 0922 (Ireland) or +44 (0) 20 7806 1951(UK) quoting the confirmation code 8869040. A slide presentation accompanying this call will be available in the Investors/Publications section of the AGI website 15 minutes before the call commences, or by following this link:
http://phx.corporate-ir.net/phoenix.zhtml?c=196905&p=irol-reports
Contact Information:
AGI Therapeutics plc. Tel: +353 1 449 3254
David Kelly, Chief Financial Officer
Financial Dynamics - UK Tel: +44 (0) 20 7269 7182
Jonathan Birt/John Dineen
Financial Dynamics - Ireland Tel: +353 1 663 3607
Niamh Lyons
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 1 614 8761
John Frain
Notes to Editors:
About Rezular* (AGI-003)
RezularTM (AGI-003) is an orally administered multiple action intestinal regulator. Rezular contains arverapamil, a single enantiomer moiety of the racemic drug verapamil.
About AGI Therapeutics plc
AGI is a specialty pharmaceutical company which is focused on the development and commercialisation of differentiated specialty drug products to treat unmet medical needs, including conditions which qualify for Orphan drug status.
The Company has a portfolio of product candidates derived from its Known Molecular Entity (KME*) approach to drug re-profiling and development and aims to bring its products to the market either directly or through out-licensing or other partnering arrangements.
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.
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.
Chairman's and Chief Executive's review
The first half of 2009 was dominated by activities associated with progressing AGI's lead product, Rezular, for the treatment of diarrhoea-predominant irritable bowel syndrome, (IBS-D). Two Phase III studies, ARDIS 1 and ARDIS 3 were underway during the first half of 2009. ARDIS 1 was a randomised, double-blind, placebo-controlled, parallel-group, Phase III study in IBS-D patients (both men and women). There were four treatment arms (placebo and three dose levels of Rezular) and patients were treated for 12 weeks of double-blind therapy. A total of 711 patients were randomised in 123 clinical centres in the United States, Europe and South America. Of the total patients randomised, 63% were in the United States. ARDIS 3 was an extended safety study, designed to track at least 100 patients exiting ARDIS 1 for a total exposure of one year on active drug.
The Company received the top-line results from ARDIS 1 in mid-May. In summary;
* The study did not show statistically significant differences between drug and placebo in the primary endpoint of patient-reported adequate relief of IBS symptoms
* Statistically significant evidence favouring Rezular treatment was achieved in a number of secondary endpoints, particularly those relating to aspects of diarrhoea e.g. stool form (as assessed by the Bristol Stool Scale), stool frequency and in the majority of sub-categories of quality-of-life (IBS-QOL) scores and in the overall IBS-QOL score
* There were no statistically significant differences between treatments in adequate relief of pain/discomfort or change in severity of pain
* Based on this preliminary data analysis, AGI did not believe that the results of ARDIS-1 would meet the current regulatory requirements for an effective therapy for the broad IBS-D population and therefore ceased development of Rezular in this indication
This was a disappointing result for the Company, shareholders and IBS-D patients for whom no effective therapy to address all their symptoms exists. Having made the decision to discontinue the ARDIS programme, AGI commenced a review of its business strategy, including a fundamental review of its pipeline products and a post-hoc analysis of the data from the ARDIS 1 & 3 studies of Rezular. The Company 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 results of that review are made public today and form the basis of AGI's plans to re-build value in the Company.
Business Strategy
The Company intends to leverage its strength in product development by focusing on specialty products in areas where unmet medical needs exist. This means that AGI intends to concentrate its efforts on market segments where the clinical and regulatory route to approval may be less costly and where commercialisation can be successfully undertaken by a smaller and more focused specialty company. Some of these indications will, the Company believes, meet the criteria for Orphan drug status under regulations of the US Food and Drug administration (FDA).
While the therapeutic focus of the Company up until now has been on GI diseases, AGI's approach to development and experience is applicable to numerous therapeutic areas. AGI now intends to pursue products that fit with the Company's revised business strategy rather than being limited to a single therapeutic area.
Of the current pipeline products, AGI intends to concentrate its future development efforts on alternative applications for Rezular and on AGI-004, AGI's transdermal patch containing mecamylamine where we believe significant additional value can be created for our business and shareholders.
AGI has identified a number of potential new indications for Rezular and intends to prioritise, design and execute value-creating clinical trials in these indications. Where appropriate, study design and endpoints will be reviewed with the FDA. Rezular is discussed in more detail below. AGI-004 has already established clinical proof-of-concept in Chemotherapy Induced Diarrhoea (CID) and AGI is exploring the optimal study design for the next stage of this product's development.
While it is AGI's intention to advance these programmes using its own resources, the Company may consider co-development partnerships or strategic alliances with other pharmaceutical companies.
Non-core products will be monetised and developed through out-licensing or other partnership arrangements. Based on its current financial resources, AGI believes that the most productive way to advance AGI-010 controlled-release omeprazole, AGI-022, a targeted and controlled-release aminosalycilate, and AGI-006, an upper-GI pro kinetic agent, will be through partnering. This will allow these products to be financed externally, providing cash and/or future value to AGI. The Company will pursue the establishment of such partnerships over the next year. The Company has already started the process of identifying and meeting with potential partners.
It is the Company's intention to allocate some of its cash resources to the development of new products if suitable candidates are identified. These should meet the criteria of being directed to specialty markets where unmet medical needs exist.
Rezular*
Based on the comprehensive analysis of the ARDIS data including a variety of post-hoc analyses, the Company reached the following key conclusions in relation to the efficacy of Rezular in IBS-D:
* The analysis has confirmed the preliminary findings that Rezular at the medium (112.5mg per day) and high dose (225mg per day) showed a clear effect to normalise the loose/watery stool pattern of the IBS-D patients (measured by improvements in stool form using the BSS scale)
* Rezular improved stool frequency and quality of life (QOL) and also showed trends to improve urgency * Certain post-hoc analyses did suggest an improvement in pain severity under certain circumstances
Overall, the analysis has confirmed the view of AGI that Rezular may offer an effective treatment for chronic diarrhea in a variety of conditions, particularly those associated with altered gut motility.
The immediate focus for AGI is to develop and implement a detailed operational plan that is consistant with the new business strategy approved by the Board. Ultimately we are confident that this new strategy will create increased value in the business.
Dr. Ronan Lambe Dr. John Devane
Chairman Chief Executive Officer
Dublin, 22 September 2009
Financial review
Basis of preparation and International Financial Reporting Standards (IFRS)
The financial information for the six months ended 30 June 2009 has been prepared in accordance with IFRS as adopted by the European Union.
Functional Currency
Commencing on January 1st 2008, AGI has adopted the US Dollar as the functional currency for the Company. This decision is based on the fact that the Company's primary market for its products under development are in the US, the majority of the Company's costs are denominated in US dollars, and it is likely that most future revenues, whether in the form of license fees, development fees, royalties or product sales, are likely to be earned in dollars. Previously the Company's functional currency was the euro as most of its costs were euro-denominated and its funding was raised in euro.
Operating performance
Revenue
AGI received an initial milestone payment of $1.5 million from Axcan Pharma Inc. in 2006 related to a co-development agreement for AGI-010, Chronab omeprazole. This upfront fee has been recognised on a straight line basis over three years, an estimate of the likely term of the underlying development programme. For the six months to June 30 2009 a total of $0.3 million was recognised as revenue (2008: $0.3 million). As of 30 June 2009 the full amount of $1.5 million has been recognised. In August 2009 AGI announced that, by mutual consent, AGI and Axcan have terminated this co-development and all associated intellectual property and ownership of the asset has reverted to AGI. There are no further financial obligations on either party associated with this termination.
Research and Development expenses
Total Research and Development expenses for the six months to June 30 2009 were $7.8 million (2008: $8.3 million). R&D costs in both 2008 and 2009 were dominated by the ARDIS Phase III clinical programmes associated with Rezular. As a result of the Company's decision to discontinue ARDIS in May 2009, all significant remaining costs associated with ARDIS were accrued in June 2009 and therefore R&D costs will be substantially lower in the second half of 2009.
General and Administrative expenses
General and Administrative expenses in the first six months of 2009 were $1.5 million (2008: $2.0 million). This decrease is attributable to the elimination of salary bonus payments in 2009, a reduced share-based compensation charge as well as other cost containment measures. As a result of continuing measures to contain costs AGI expects G&A costs to decline further in the second half of 2009.
Interest Income and other income
The Company earned interest on its cash balances amounting to $0.1 million in the first six months of 2009 (2008: $0.7 million). Interest income has fallen as cash balances have reduced and interest rates for cash deposits declined in 2009 compared to 2008. This category also includes an unrealised loss of $21K in 2009 (2008: $469K unrealised gain) arising from the translation, of those cash balances AGI still holds in euro into dollars at the period end.
Reorganisation expense
A charge of $0.4 million has been recognised in the first half of 2009 to account for costs associated with making certain positions redundant and the costs of writing down certain intellectual property. There was no comparable charge in 2008.
Taxation
The Company has had a loss to date and continues to incur losses. Because of these losses no charge for tax arose in the first six months of 2009, although there was a small charge of $0.1 million for the comparable period of 2008.
Share based compensation expense
The Company issues share options to certain employees on an annual basis. While the options were issued at a strike price equal to the market price of the Company's shares on the date of grant, a calculation is required of the potential expense to the Company of issuing those options which is determined using the Black-Scholes option-pricing formula. A total amount of $0.6 million was expensed during the first half of 2009 (2008: $0.8 million) for these share based compensation charges, divided between Research and Development and General and Administration expenses.
Operating cash flow
Net cash outflow from operating activities in the period was $8.5 million (2008: $12.5 million), which consisted principally of the loss from operations and changes in working capital balances. At June 30, 2009, AGI had cash and short-term deposits of $15.1 million, (2008 $32.8 million). The Company also had short tem liabilities consisting of trade payables and accruals in the amount of $2.7 million at 30 June 2009 a large portion of which related to Rezular. These liabilities are due to be fully discharged in the third quarter of 2009. The Directors have considered the Company's cash position and are satisfied that it is sufficient to meet the Company's financial obligations for at least the coming twelve months.
UNAUDITED CONDENSED CONSOLIDATED INTERIM INCOME STATEMENTS
For the six months ended 30 June 2009
Notes Period ended Period ended
30 June 2009 30 June 2008
$'000 $'000
Revenue 288 288
Research and development 7,824 8,340
expenses
(share based payment charge
of $322 (2008: $439))
General and administrative 1,467 2,016
expenses
(share based payment charge
of $242
(2008: $400))
Reorganisation expense 380 -
Total operating expenses (9,671) 10,356
Operating loss (9,383) (10,068)
Interest income and other 100 1,121
income
Loss before tax (9,283) (8,947)
Income tax - (59)
Loss for the period (9,283) (9,006)
Basic loss per ordinary share:
Basic loss per share ($ cents) 3 (13.8) (13.3)
UNAUDITED CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
30 June 31 December
2009 2008
$'000 $'000
Non-Current Assets
Property, plant and equipment 21 34
Intangible assets 1,618 1,793
Total Non-Current Assets 1,639 1,827
Current Assets
Other current assets 189 163
Cash and cash equivalents 15,073 23,577
Total Current Assets 15,262 23,740
Total Assets 16,901 25,567
Current Liabilities
Trade and other payables 2,675 2,622
Total Current Liabilities 2,675 2,622
Total Liabilities 2,675 2,622
Shareholders' Equity
Share capital 992 992
Share premium 75,194 75,194
Other reserves 4,751 4,187
Retained loss (66,711) (57,428)
Total Shareholders' Equity 14,226 22,945
Total Shareholders' Equity and Liabilities 16,901 25,567
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
30 June 2009 30 June 2008
$'000 $'000
Loss for the period (9,283) (9,006))
Adjustments to reconcile loss to net cash used in
operating activities:
Depreciation of property, plant and equipment 13 18
Amortisation and writedown of intangibles 175 70
Interest income (100) (652)
Income tax - 59
Share-based compensation 564 839
Operating cash outflow before changes in working (8,631) (8,672)
capital
Increase in other current assets (36) (84)
Increase/(decrease) in trade and other payables 51 (4,544)
Cash used by operations (8,616) (13,300)
Interest received 110 826
Tax refunded/(paid) 2 (25)
Net cash outflow from operating activities (8,504) (12,499)
Investing activities
Acquisition of intellectual property and other - (221)
investments
Net cash used by investing activities - (221)
Net (decrease) in cash and cash equivalents (8,504) (12,720)
Cash and cash equivalents at the beginning of 23,577 45,503
period
Cash and cash equivalents at the end of the 15,073 32,783
period
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
Number Ordinary share Share Other Reserves Retained deficit Total
of Shares Capital Premium $'000 $'000 Amount
$'000 $'000 $'000
Balance at 31 December 2007 67,412,783 992 75,194 2,649 (39,225) 39,610
Loss for the period - - - - (9,006) (9,006)
Share-based compensation - - - 839 - 839
Balance at 30 June 2008 67,412,783 992 75,194 3,488 (48,231) 31,443
Loss for the period - - - - (9,197) (9,197)
Share-based compensation - - - 699 - 699
Balance at 31 December 20087 67,412,783 992 75,194 4,187 (57,428) 22,945
Loss for the period - - - - (9,283) (9,283)
Share-based compensation - - - 564 - 564
Balance at 30 June 2009 67,412,783 992 75,194 4,751 (66,711) 14,226
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM
FINANCIAL STATEMENTS
1 BASIS OF PREPARATION
These unaudited condensed consolidated interim financial statements (the interim financial statements) have been prepared in accordance with IFRS that are adopted by the European Union (EU) and effective at 30 June 2009. The interim financial statements do not include all of the information required for full annual financial statements.
These interim financial statements are presented in US Dollar rounded to the nearest thousand, being the functional currency of the parent company and the group companies. They are prepared on the historical cost basis, except for share based payments, which are stated at fair value.
The accounting policies applied by AGI in these interim financial statements are the same as those applied by AGI in its consolidated financial statements as at and for the year ended 31 December 2008.
The preparation of interim financial statements requires management to make judgements, estimates and assumptions that affect the application of policies and reported amounts of assets and liabilities, income and expenses. Actual results could differ materially from these estimates. In preparing these interim financial statements, the significant judgements made by management in applying our accounting policies and the key sources of estimation uncertainty were the same as those that applied to the consolidated financial statements as at and for the year ended 31 December 2008.
These interim financial statements do not constitute Statutory Financial Statements of the Group within the meaning of Regulation 40 of the European Communities (Companies: Group Accounts) Regulations, 1992. Statutory Financial Statements for the year ended 31 December 2008 have been filed with the Companies Office. The auditor's report on those financial statements was unqualified.
2 FUNCTIONAL CURRENCY
On 1 January 2008, the functional currency of the Company changed from Euro to US Dollars as the Company's cost structure became primarily US Dollar based. The Company's principal clinical trials are carried out in the United States and billed in dollars. In addition the Company earns only US Dollar revenue. The US Dollar is the currency of the primary economic environment in which the Company operates. At 1 January 2008 the Company translated its financial statements at 31 December 2007 to US Dollars at the exchange rate prevailing at that date.
Transactions in currencies other than the functional currency of the entities are recorded at the rate of exchange prevailing on the date of the transactions. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are retranslated into the respective functional currencies of Group entities at the rate of exchange prevailing at the balance sheet date.
3 LOSS PER SHARE
Basic loss per share is computed by dividing the loss for the period available to ordinary shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is computed by dividing the loss for the period, by the weighted average number of ordinary shares outstanding and, when dilutive, adjusted for the effect of all potentially dilutive shares, including stock options, warrants, and convertible debt securities on an as-if-converted basis.
The following table sets forth the computation for basic and diluted loss per share for the six months ended 30 June 2009 and 2008:
30 June 2009 30 June 2008
$000 $000
Numerator:
Loss attributable to ordinary shareholders (9,283) (9,006)
Denominator:
Denominator for basic-weighted average number of shares 67,412,783 67,412,783
Basic loss per share:
Basic loss per share (US$ cents) (13.8) (13.3)
Potentially dilutive instruments, such as share options have not been treated as dilutive as the Group made a loss in both periods.
4 RELATED PARTY TRANSACTIONS
(a) Transactions with founding members and shareholders
Frank Kenny, John O'Sullivan and Peter Sandys are Directors of the Company and are board nominees of Delta Partners, ACT Venture Capital and Seroba Bioventures respectively. Fees of $25,000 annually are paid by the Company to each of Delta, ACT and Seroba in respect of their nominees' appointment.
5 APPROVAL
The unaudited condensed consolidated interim financial statements were approved by the directors on 17 September, 2009
This information is provided by RNS
The company news service from the London Stock Exchange
END
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| 22-09-09 | RNS |
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RNS Number : 4278Z AGI Therapeutics plc 22 September 2009 AGI Therapeutics Completed analysis of ARDIS data for Rezular* Dublin, Ireland, 22 September 2009 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, today announced that it has completed the data analysis of ARDIS-1 and-3 , it's Phase III clinical studies of Rezular* in diarrhoea-predominant irritable bowel syndrome (IBS-D). ARDIS 1 study design: ARDIS-1 was a double-blind, placebo-controlled, parallel-groups, dose-response study of Rezular in IBS-D patients. A total of 708 patients make up the intent-to-treat (ITT) safety population. Patients were treated for 12 weeks following a baseline/run-in period of 2 weeks. Measures of efficacy were typically reported daily by patients. In addition, there were three physician visits during therapy, at weeks 4, 8 and 12. Vital signs and laboratory tests were performed at all visits and ECG measurements taken at weeks 4 and 12. In addition to placebo (P n=174) there were 3 different doses of Rezular treatment, 15mg t.i.d. (45mg/day (R 45mg n=179)), 37.5mg t.i.d (112.5mg/day (R 112.5mg n=177)) and 75mg t.i.d (225mg/day (R 225mg n=178)). ARDIS 1 efficacy data: Based on a comprehensive analysis of the data, including a variety of post-hoc analyses, the following are the key conclusions in relation to the efficacy of Rezular in IBS-D: 1. Based on the protocol-defined end-points, the analysis has confirmed the preliminary findings that Rezular at the medium (R 112.5mg) and high dose (R 225mg) showed a clear effect to normalise the loose/watery stool pattern of the IBS-D patients (measured by improvements in stool form using the BSS scale). Furthermore, Rezular improved stool frequency and also showed trends to improve urgency and also quality of life (QOL). However this analysis, based on historically applied end-points, also indicated that Rezular showed no improvement in pain relief or improvement in pain severity compared to placebo, in the broad IBS-D population. 2. In April 2009, at the Endpoints and Outcomes Conference held in Milwaukee, USA and organised by the ROME Foundation to specifically address issues in IBS, the US Food and Drug Administration (FDA) indicated their intent in the future to focus primarily on changes from baseline in symptom severity in both pain and stool function rather than the historical binary global end-point (e.g. adequate relief of IBS symptoms). They also proposed the application of a standardised definition of clinical response (possibly a one point change from baseline on these symptom scales). 3. AGI has analysed the ARDIS data on the basis of these new metrics. This analysis re-confirmed the strong profile of response in stool-related measures, e.g. stool form and frequency, and also suggested an improvement in pain severity in certain post-hoc analyses and in certain sub-populations particularly in those patients with the higher baseline pain severity. 4. Overall, the analysis has confirmed the view of AGI that Rezular offers an effective treatment for chronic diarrhea symptoms, particularly in conditions associated with altered gut motility such as IBS-D. Furthermore, the analysis suggests a possible combined activity on stool function and pain. AGI will seek an opportunity to discuss these findings with the FDA in the coming months. ARDIS 1 safety data: Overall Rezular was well tolerated and showed a good safety profile. There were no deaths or cardiovascular-related serious adverse events (SAE's). The incidence of treatment-emergent SAE's was 1.7% (P), 0.6% (R 45mg), 2.8% (R 112.5mg) and 0.6% (R 225mg) and discontinuations related to AE's were 9% (P), 8%( R 45mg), 12% (112.5mg) and 11% (R 225mg). The most common AE-related discontinuation was constipation with rates of 1.7% (P), 1.7% (R 45mg), 1.7%(R 112.5mg) and 2.8% (R 225mg). Average changes in cardiovascular function (blood pressure, heart rate and ECG) from baseline were minimal. ARDIS 3 safety data: In addition to the safety profile established in ARDIS-1 over 3 months dosing, a long-term, open-label safety study (ARDIS-3) which enrolled 349 patients directly from ARDIS-1 has been completed. Based on an analysis of the data from ARDIS-1 and a preliminary analysis of ARDIS-3, the safety profile of Rezular in ARDIS-3 was similar to that reported for ARDIS-1. In particular there were no deaths or cardiac related SAE's. There was no case of ischaemic colitis in either ARDIS-1 or ARDIS-3. Overall, the safety data from both ARDIS-1 and ARDIS-3 confirmed the generally well tolerated and safe profile of Rezular and also confirms the successful disassociation of the previously dominant cardiovascular effects of racemic verapamil from the desired intestinal effects provided by Rezular. Commenting on the analysis, Dr John Devane, CEO of AGI Therapeutics, said: 'Despite the disappointment of not meeting the pre-defined efficacy end-point (Adequate Relief) in ARDIS-1, our further data analysis leaves us in no doubt that Rezular has demonstrated a profile of desirable efficacy improving diarrhea-related symptoms in IBS-D patients. Furthermore, the ability of Rezular to improve other symptoms (e.g. pain) in certain circumstances is intriguing and merits follow up discussions with the FDA. The safety profile of Rezular and in particular the absence of any clinically meaningful cardiovascular activity validates the use of Rezular as a unique drug with its own profile of therapeutic activity distinct and clearly dissociated from that of racemic verapamil'. Contact Information:
David Kelly, Chief Financial Officer
Jonathan Birt/John Dineen
Niamh Lyons
Neil Mackison Will Carnwath
John Frain For further information please see www.agitherapeutics.com. Notes to Editors: About Rezular* (AGI-003) RezularTM (AGI-003) is an orally administered multiple action intestinal regulator. Rezular contains arverapamil, a single enantiomer moiety of the racemic drug verapamil. About AGI Therapeutics plc AGI is a specialty pharmaceutical company which is focused on the development and commercialisation of differentiated specialty drug products to treat unmet medical needs, including conditions which qualify for Orphan drug status. The company has a portfolio of product candidates derived from its Known Molecular Entity (KME*) approach to drug re-profiling and development and aims to bring its products to the market either directly or through out-licensing or other partnering arrangements. 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. 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. This information is provided by RNS The company news service from the London Stock Exchange END
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RNS Number : 4716Y AGI Therapeutics plc 03 September 2009 AGI Therapeutics PLC Notification of Results AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company, will be announcing its interim results for the six months ended 30 June 2009 on Tuesday, 22 September 2009. Contact Information:
David Kelly, Chief Financial Officer
Jonathan Birt/John Dineen
Niamh Lyons
Neil Mackison Will Carnwath
John Frain 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 gastrointestinal (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. For further information please see www.agitherapeutics.com This information is provided by RNS The company news service from the London Stock Exchange END
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