AGI Therapeutics
Interim financial results for the six months ended 30 June 2008
-- ARDIS-1 now 75% enrolled --
Dublin, Ireland, 9 September 2008 - AGI Therapeutics plc ("AGI" or
the"Company") (AIM, IEX: AGI), a speciality pharmaceutical development
company focused on gastrointestinal drug products, today reports
interim financial results for the six months ended 30 June 2008.
The Company also announces that enrolment into ARDIS-1, the first of
two pivotal Phase III efficacy studies of RezularTM, AGI's lead
programme for the treatment of diarrhoea-predominant irritable bowel
syndrome (IBS-D) remains on schedule and has now reached 75% of its
target enrolment.
Financial highlights:
. Cash and short term deposits at 30 June 2008 of USD32.8 million (31
December 2007: USD45.5 million)
. R & D spend of USD8.3 million (2007: USD7.0 million)
. Loss per ordinary share of USD0.13 cent (2007: USD0.12 cent)
Operational highlights:
. The initiation in February of a Phase II clinical study of AGI-
004, a transdermal mecamylamine patch being developed for the
treatment of chemotherapy-induced diarrhoea (CID)
. The release on 21 February of the key findings of a study to
assess the pharmacokenetic profile of RezularTM and the
subsequent presentation of mechanism-of-action and Phase II
clinical data on RezularTM at the Digestive Disease Week
conference in San Diego in May
. The key findings, announced on 2 April, of a clinical study to
assess the pharmacokinetic profile of arbaclofen (AGI-006),
which is being developed for the treatment of upper
gastrointestinal (GI) disease such as gastroparesis, a
significant gastric disorder amongst diabetics
Highlights post period-end:
. In July the Company announced that the US Food and Drug
Administration (FDA) agreed the statistical plan to be used
to analyse the ARDIS-1 study data, allowing AGI to revise
the target enrolment in the study to 680 patients. The FDA
also re-affirmed the previously agreed key parameters of
the RezularTM Phase III programme, and in particular the
acceptability of the current primary endpoint of patient
global relief
Commenting on the interim results, Dr. John Devane, Chief Executive of
AGI, said:"The first six months of 2008 have been dominated by our efforts
to
ensure that the Phase III programme for RezularTM remains on track as
we work to acieve our goal of reporting of clinical data for the
ARDIS-1 study in the first half of 2009. Finalising the road map with
the FDA for the development of the RezularTM new drug application was a
hugely important step for us. We believe that RezularTM can be the
first new widely-used and effective treatment to come to market for
IBS-D, a disease that affects over 10 million people in the US alone
and for which there are currently few safe and effective treatments.
This is a large and as yet untapped market with a potential to generate
new product sales in excess of USD2 billion annually in the US and we
anticipate that RezularTM will be well-placed to garner a significant
portion of that market."
Outlook
Commenting further on the outlook for the rest of 2008, Dr. Devane
added:"During the remainder of this year and into 2009 we will remain
focused
on completing enrolment into the ARDIS-1 and ARDIS-3 studies with the
goal of reporting ARDIS-1 results in H1 2009. In that context we are
encouraged that enrolment into ARDIS-1 is now at 75% of the target. We
will also seek to progress our discussions with potential partners for
RezularTM in anticipation of ARDIS-1 data next year.
In addition to our expected report on RezularTM in 2009, we also look
forward to having data early in 2009 from our Phase II study of AGI-004
in patients with chemotherapy-induced diarrhoea, which will allow us to
engage with the FDA to further define the development and regulatory
pathway for this product."
-- Ends --
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/Lara Mott
Financial Dynamics - Ireland Tel: +353 1 663 3607
Aisling Garvey
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 1 614 8761
John Frain
For further information please see www.agitherapeutics.com.
Notes to Editors:
About RezularTM (AGI-003)
RezularTM (AGI-003) is an orally administered triple-action intestinal
regulator, a first-in-class mechanism for the treatment of IBS-D.
RezularTM contains arverapamil, a single enantiomer moiety of the
racemic drug verapamil. Unlike the currently available commercial forms
of racemic verapamil (a mixture of two enantiomers), RezularTM shows a
dominant activity in treating the symptoms of IBS-D without the
traditional cardiovascular actions of the racemic drug. The efficacy
and safety of RezularTM in IBS patients has already been established in
a Phase II trial, the preliminary results of which were reported by the
Company in 2006.
About ARDIS
ARDIS is the Phase III programme for RezularTM (AGI-003) in the
treatment of IBS-D and consists of three pivotal studies.
ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel
group, Phase III study in IBS-D patients (both men and women). There
are four treatment arms (placebo and three dose levels of Rezular) and
patients will be treated for 12 weeks of double-blind therapy. At the
end of double-blind therapy in ARDIS-1, patients will be eligible to
continue treatment with RezularTM through enrolment into ARDIS-3.
ARDIS-2 is a confirmatory Phase III efficacy/safety study to be
conducted in IBS-D patients upon completion of ARDIS-1.
ARDIS-3 is an open-label safety study designed to capture 1 year
extended safety in approximately 100 patients on continuous RezularTM
therapy.
About IBS-D
Irritable bowel syndrome (IBS) is a functional disorder that comprises
a cluster of gastrointestinal symptoms which are likely to be life long
and which affect between 10% and 20% of the population in developed
markets. IBS remains the most common diagnosis made by
gastroenterologists and can lead to a substantial reduction in
patients' quality of life, accompanied by considerable socio-economic
and psychological consequences. Altered intestinal motility is a major
component of IBS and patients are diagnosed and sub-typed according to
their predominant symptom of bowel disturbance. Diarrhoea-predominant
irritable bowel syndrome (IBS-D) is estimated to occur in one-third of
all IBS patients. IBS-D represents a significant unmet medical need as
there are currently few safe and effective therapeutic options
available to these patients.
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 triple-action 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
(IBS), 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 new 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.
Chairman's and Chief Executive's review
During the first half of 2008 AGI's operational priority was the
ongoing execution of ARDIS, our Phase III programme for RezularTM, the
Company's lead programme for the treatment of diarrhoea-predominant
Irritable Bowel Syndrome, (IBS-D). AGI currently has two Phase III
studies ongoing from this programme, ARDIS-1 and ARDIS-3, and it is
anticipated that ARDIS-2 study will commence once data from ARDIS-1 is
available next year. Both studies are progressing well and we look
forward to reporting clinical data from the first Phase III study,
ARDIS 1, in the first half of 2009.
In addition to RezularTM we continue to advance other products in our
portfolio. In particular, in February we initiated a Phase IIa clinical
study in February of AGI-004, a transdermal mecamylamine patch, in
patients suffering from chemotherapy induced diarrhoea (CID). We
believe AGI-004 has the potential to address a significant need for a
more effective anti-diarrhoeal therapy for patients undergoing
chemotherapy.
With financial markets in a state of turmoil in recent months we have
been careful to manage our cash resources to ensure that they are
concentrated on those programmes with the potential to deliver clinical
data in the near to medium term, i.e. RezularTM and mecamylamine. We
believe it is important for the Company to manage its business
prudently and set out to maintain a medium-term cash positive outlook
until these key development milestones are met and further funding
options can be explored if necessary. We have therefore not initiated
additional Phase II work on our other programmes in the first half and
we expect to move these programmes into the next stage of clinical
development when we have greater visibility into our existing studies.
Review of key clinical research programmes
RezularTM (arverapamil, AGI-003) in IBS-D
RezularTM is being developed in an oral dosage form for the treatment
of IBS-D in both men and women. In late 2007, following the filing and
acceptance of an Investigational New Drug (IND) application by the FDA,
we commenced our Phase III programme for RezularTM, which we have named
ARDIS.
ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel
group Phase III study in IBS-D patients (both men and women). There are
four treatment arms (placebo and three dose levels of RezularTM) and
patients will be treated for 12 weeks of double-blind therapy. At the
end of double-blind therapy in ARDIS-1, patients will become eligible
to enrol into ARDIS-3. It is planned to randomise 680 patients into
ARDIS-1. We currently have over 500 patients enrolled in ARDIS-1 at
study sites in the US, Europe and Latin America.
ARDIS-2 is a confirmatory Phase III efficacy/safety study to be
conducted in IBS-D patients. This study will commence following the
completion of ARDIS 1.
ARDIS-3 is an open-label safety study designed to capture 1 year
extended safety in approximately 100 patients on continuous RezularTM
therapy. Currently approximately 80% of patients completing ARDIS-1 are
rolling over into ARDIS-3.
Our activities around RezularTM in the first half of 2008 were focused
in four important areas:
1. We have worked closely with our CRO to ensure that the current
ARDIS-1 and ARDIS-3 studies are executed as efficiently as
possible. This has included preparation of regulatory and
investigator documentation, site and investigator selection,
monitoring and replacement of underperforming sites and
territories, and ensuring timely availability of clinical supplies
to all study sites
2. We met with the FDA's Division of Gastroenterology Products to
finalise a number of aspects of the RezularTM development
programme, including the specific statistical approach to the
analysis of efficacy data for ARDIS-1, the ongoing Phase III
efficacy study which began in late 2007. This has allowed the
revision of target enrolment to 680 patients in the ARDIS-1 study.
We now expect the last patient to be enrolled in Q4 2008 or Q1
2009, with preliminary data anticipated in H1 2009. The FDA also
agreed on the statistical plan to be used to analyse the ARDIS-1
data. Most importantly, the FDA reaffirmed the previously agreed
key parameters of all Phase III efficacy studies, and in particular
the acceptability of the current primary endpoint of patient global
relief
3. Since commencing ARDIS we have initiated discussions with a number
of pharmaceutical companies with the sales and marketing
capabilities necessary to commercialise a product with the market
potential of RezularTM. Our objective is to build commercial
partnerships with one or more companies to further develop,
register and market RezularTM in key global markets.
4. During this first half year, we initiated a scientific information
campaign to inform the scientific and medical communities of our
findings to date with RezularTM as a potential new treatment for
IBS-D. On 21 February, we announced the key findings of a clinical
study to assess the pharmacokinetic profile of RezularTM, which
study supported the important safety attributes of arverapamil, the
R-isomer of verapamil, over racemic verapamil. In May we presented
these findings, as well as other data on the mechanism of action of
RezularTM and more detailed data from our previously completed
Phase II clinical study, at Digestive Disease Week (DDW) in the US,
the leading annual scientific meeting on GI disease
Mecamylamine (AGI-004) in chemotherapy-induced diarrhoea (CID)
AGI believes that this controlled release mecamylamine product has the
potential to be an effective agent in diarrhoeal states characterised
by a high frequency of watery stools. Given the mechanism of action of
mecamylamine on nicotinic acetylcholine receptors (nAChR) and the
pathophysiology of certain diarrhoeal states which are not satisfied by
current therapy, AGI has identified CID as an area of unmet clinical
need where mecamylamine CR may have therapeutic benefit.
The current standard of care for CID patients usually involves multiple
oral daily doses of an opioid agent such as loperamide. However, many
patients who receive loperamide continue to experience significant and
debilitating diarrhoea which may require reduction, delay or even
withdrawal of chemotherapy. AGI-004 is a controlled release transdermal
patch containing the nicotinic antagonist mecamylamine. The patch
involves a new anti-diarrhoeal mechanism via selective blockade of
enteric nicotinic acetylcholine receptors (nAChR) and offers a
significant advantage to current CID therapy via its convenient,
once-daily transdermal form.
AGI previously reported data demonstrating a statistically significant
improvement in stool consistency in patients with functional diarrhoea.
The new Phase II study initiated in February is a randomised,
double-blind, placebo-controlled evaluation of AGI-004 in cancer
patients experiencing National Cancer Institute (NCI) grade 1 or 2 CID.
We expect to complete this study by the end of the year and report
preliminary data in Q1 2009.
CHRONAB-omeprazole (AGI-010) for nocturnal acid breakthrough (NAB) in
GERD
We are developing a modified release formulation of the proton pump
inhibitor drug (PPI), omeprazole, based on our CHRONAB technology which
we believe will be effective in treating NAB, a prevalent aspect of
current PPI therapy of GERD. GERD is the most prevalent of the major
gastrointestinal disorders and is most commonly treated with PPI drugs
which achieve global annual sales in excess of EUR15 billion. NAB is
estimated to occur in at least 50 per cent of GERD patients on PPI
therapy.
AGI entered into a co-development and license agreement for North
American markets with Axcan Pharma Inc. ("Axcan") in September 2006 to
jointly develop a modified release omeprazole product based on AGI's
CHRONAB formulation approach. We announced on 17 March 2008 the
completion of the optimisation phase of development. As part of the
optimization phase of development, AGI completed a number of studies in
healthy human volunteers. These studies characterized the drug release
profile, the pharmacokinetics of omeprazole and the intra-gastric pH
following administration of a number of prototype formulations of
AGI-010. Based on the outcome of these studies, a formulation has been
identified which could have the potential to control intra-gastric pH
during the night.
We are currently in discussions with our partner, Axcan, to determine
how best to progress this programme to the next stage of development.
Arbaclofen (AGI-006)
The results of a 64 patient exploratory Phase II trial of arbaclofen in
functional dyspepsia reported in early 2007 demonstrated statistically
significant improvements across a range of endpoints, including patient
global severity, bloating, nausea, condition specific Quality-of-Life
(QOL) and use of rescue antacids. AGI determined that the profile of
activity of arbaclofen matches well with the desired profile of a
therapy for a range of upper GI symptoms. This opens up the potential
for arbaclofen to be used in a variety of GI conditions including the
dyspeptic symptoms of gastroparesis. Diabetic gastroparesis is the most
common manifestation of these symptoms, however effective and
well-tolerated therapy options are extremely limited for these
patients.
On 2 April 2008 we reported the results of work we carried out on the
pharmacokinetic exposure profile of arbaclofen in healthy human
subjects, under both fasted and fed conditions. In addition, this study
compared the fasted exposure of AGI-006 in terms of both R- and
S-isomers of baclofen with the fasted exposure following a single 10mg
dose of Lioresal® (a marketed form of racemic baclofen). The results
of this work support the Company's belief that the development of AGI-
006 can follow a similar clinical/regulatory pathway to RezularTM.
We have recently undertaken market research on the potential use of
arbaclofen in a number of upper GI conditions. This research will allow
us to identify the product's market potential and the appropriate
clinical/regulatory development strategy for this product.
4-ASA (AGI-022) in ulcerative colitis
AGI is developing a modified release oral formulation of
4-aminosalicylate sodium (4-ASA) for the induction and maintenance of
remission of mild to moderate ulcerative colitis (UC). UC is a chronic,
recurrent, relapsing and remitting inflammatory disease of the colon
and/or rectum. AGI believes that its 4-ASA product may offer certain
advantages compared with current 5-ASA based therapies which are
commonly used to treat UC, including a superior tolerability profile,
and a more reliable delivery to the target sites of action in UC
leading to a higher efficiency of therapy with potential dosing
advantages.
In March 2006, AGI reported on the outcome of a human pharmacokinetics
trial in 16 human subjects designed to characterise the in vivo drug
release profile and pharmacokinetics of three delayed release/
controlled release formulations compared with a reference solution of
4-ASA. The study demonstrated delayed and controlled in vivo release
profiles consistent with targeted colonic delivery.
During 2007, having selected a lead formulation, AGI developed a high
unit-dose, once-daily, modified release tablet of this product and has
designed a Phase II clinical study to further investigate the efficacy
of this product in UC patients. AGI hopes to initiate this study in
late 2008 or early in 2009, depending on the progress of other
projects, particularly RezularTM.
Dr. Ronan Lambe Dr. John Devane
Chairman Chief Executive Officer
Dublin, 8 September 2008
Financial review
Basis of preparation and International Financial Reporting Standards
(IFRS)
The financial information for the six months ended 30 June 2008 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 Group. 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.
In the attached financial statements, comparable results and balance
sheet have been translated into dollars at a rate of 1 euro to 1.47
dollars, the rate in effect at 1 January 2008.
Operating performance
Revenue
AGI received an initial milestone payment of USD1.5 million from Axcan
Pharma Inc. in 2006 related to a co-development agreement for Chronab
omeprazole. This upfront fee is being 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 2008 a
total of USD0.3 million was recognised as revenue (2007: USD0.3 million).
Research and Development expenses
Total Research and Development expenses for the six months to June 30
2008 were USD8.3 million (2007: USD7.0 million). The significant
increase in R&D costs reflects the increased number of clinical
programmes associated with the Company's products in development,
particularly the ongoing ARDIS Phase III programme for RezularTM.
General and Administrative expenses
General and Administrative expenses in the first six months of 2008
were USD2.0 million (2007: USD1.8 million). This increase is
attributable to the general increase in the operational activities of
the Company.
Interest Income and other
The Company earned interest on its cash balances, primarily the
proceeds of the IPO during 2006. This amounted to USD0.7 million in the
first six months of 2008 (2007: USD1.1 million). Interest income has
fallen as cash balances have reduced and interest rates for dollars
deposits, now the predominant currency held by AGI, are lower than
those available on Euro deposits, which were held in the prior period.
This category also includes unrealised gains arising from the
conversion, for reporting purposes, of those cash balances we still
hold in euro into dollars at the period end..
Taxation
While the Company has had a loss to date, not all of this is available
for offset against the interest income referred to above. Therefore AGI
incurred a tax charge of USD0.1 million for the year (2007: USD0.2
million).
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 USD0.8 million was expensed
during the first half of 2008 (2007: USD0.7 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 USD12.5
million (2007: USD3.8 million), which consisted principally of the loss
from operations and changes in working capital balances. At June 30,
2008, AGI had cash and short-term deposits of USD32.8 million, (2007
USD55.0 million). The Directors have considered the Company's cash
position and are satisfied that they are 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
Notes Period Period
ended ended
30 June 30 June
2008 2008
USD'000 USD'000
Revenue 288 288
_____ _____
Research and development expenses 8,340 7,056
(share based payment charge of USD439
(2007: USD307))
General and administrative expenses
(share based payment charge of USD400 2,016 1,769
(2007: USD392)) _____ _____
Total operating expenses 10,356 8,825
_____ _____
Operating loss (10,068) (8,537)
Interest income and other 1,121 1,071
_____ _____
Loss before tax (8,947) (7,466)
Income tax (59) (161)
_____ _____
Loss for the period (9,006) (7,627)
_____ _____
Basic loss per ordinary share:
Basic loss per share (USD cents) 3 (13.3) (11.8)
_____ _____
UNAUDITED CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
30 June 31 December
2008 2007
USD'000 USD'000
Non-Current Assets
Property, plant and equipment 53 71
Intangible assets 1,865 1,715
Total Non-Current Assets 1,918 1,786
Current Assets
Other current assets 538 628
Cash and cash equivalents 32,783 45,504
Total Current Assets 33,321 46,132
Total Assets 35,239 47,918
______ ______
Current Liabilities
Trade and other payables 3,869 8,381
Total Current Liabilities 3,869 8,381
Total Liabilities 3,869 8,381
_____ _____
Shareholders' Equity
Share capital 992 992
Share premium 75,194 75,194
Forign currency translation reserve 87 87
Other reserves 3,488 2,649
Retained loss (48,391) (39,385)
Total Shareholders' Equity 31,370 39,537
Total Shareholders' Equity and Liabilities 35,239 47,918
______ ______
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
30 June 30 June
2008 2007
USD'000 USD'000
Loss for the period (9,006) (7,627)
Adjustments to reconcile loss to net cash used in
operating activities:
Depreciation of property, plant and equipment 18 12
Amortisation of intangibles 70 45
Interest income (652) (1,071)
Income tax 59 161
Share-based compensation 839 699
_____ _____
Operating cash outflow before changes in working (8,672) (7,781)
capital
Increase in other current assets (84) (237)
(Decrease)/increase in accounts payable (2,528) 72
(Decrease)/increase in accrued and other (2,016) 3,073
liabilities _____ _____
Cash used by operations (13,300) (4,873)
Interest received 826 1,026
Tax (paid)/refunded (25) -
Net cash outflow from operating activities (12,499) (3,847)
_____ _____
Investing activities
Acquisition of intellectual property and other (221) -
investments
Acquisition of property, plant and equipment - (6)
_____ _____
Net cash used by investing activities (221) (6)
_____ _____
Net (decrease)/increase in cash and cash (12,720) (3,853)
equivalents _____ _____
Cash and cash equivalents at the beginning of 45,503 58,895
period
Cash and cash equivalents at the end of the period 32,783 55,042
_____ _____
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN
SHAREHOLDERS' EQUITY
Number of Ordinary Share Other
Shares share Premium Reserves
Capital
USD'000 USD'000 USD'000
Balance at 31 December 2006 67,412,783 992 75,194 1,171
Loss for the period - - - -
Share-based compensation - - - 699
_____ _____ _____ _____
Balance at 30 June 2007 67,412,783 992 75,194 1,870
Loss for the period - - - -
Share-based compensation - - - 779
_____ _____ _____ _____
Foreign currency reserve
arising on change in functional
currency - - - -
_____ _____ _____ _____
Balance at 31 December 2007 67,412,783 992 75,194 2,649
Loss for the period - - - -
Share-based compensation - - - 839
_____ _____ _____ _____
Balance at 30 June 2008 67,412,783 992 75,194 3,488
_____ _____ _____ _____
(continued from table above)
Foreign
currency Retained Total
translation Loss Amount
reserve
USD'000 USD'000 USD'000
Balance at 31 December 2006 - (18,614) 58,743
Loss for the period - ( 7,627) (7,627)
Share-based compensation - - 699
_____ _____ _____
Balance at 30 June 2007 - (26,241) 51,815
Loss for the period - (13,144) (13,144)
Share-based compensation - - 779
_____ _____ _____
Foreign currency reserve
arising on change in
functional currency 87 - 87
_____ _____ _____
Balance at 31 December 2007 87 (39,385) 39,537
Loss for the period - (9,006) (9,006)
Share-based compensation - - 839
_____ _____ _____
Balance at 30 June 2008 87 (48,391) 31,370
_____ _____ _____
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 2008. 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 financial instruments and 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 2007.
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 2007.
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
2007 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 Group changed from
Euro to US Dollars as the Group's cost structure became primarily US
Dollar based. The Group's principal clinical trials are carried out in
the United States and billed in dollars. In addition the Group earns
only US Dollar revenue. The US Dollar is the currency of the primary
economic environment in which the Group operates. At 1 January 2008
the Group 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 2008 and 2007:
30 June 30 June
2008 2007
USD000 USD000
Numerator:
Loss attributable to ordinary shareholders (9,006) (7,627)
Denominator:
Denominator for basic-weighted average
number of shares 67,412,783 67,412,783
_____ _____
Basic loss per share:
Basic loss per share (USUSD cents) (13.3) (11.8)
_____ _____
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
In January 2008 the Group acquired intellectual property from J. Dev, a
company owned and controlled by John Devane, a director of the Group,
for consideration of USD0.2 million.
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 USD25,000 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 September 8th, 2008
This information is provided by RNS
The company news service from the London Stock Exchange
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