Preliminary results

AGI Therapeutics, plc

Preliminary financial results for the year ended 31 December 2010

AGI announces new lead programme and provides business update

Enters into development agreement with Aerogen

Dublin, Ireland, 23 March 2011 - AGI Therapeutics, plc ("AGI" or the "Company"), a specialty pharmaceutical company, today reports preliminary financial results for the year ended 31 December 2010, and provides a business update to shareholders.

Financial highlights

·; Cash and short-term deposits at 31 December 2010 of $10.0 million, (2009: $12.0 million)

·; Research and Development (R&D) spend of $1.4 million (2009: $8.3 million)

·; Reduced net loss of $3.6 million (2009: $10.6 million)

·; Loss per ordinary share of 5.3 cents (2009: 15.8 cents)

Operational Summary

In 2010, AGI announced that it would re-focus its research and development efforts in the area of specialty indications with unmet medical needs, with particular focus on treatments for conditions which qualify for Orphan Drug status.

During the year the Company evaluated a number of potential products, both internal and external, which met this criteria. The R&D costs of $1.4 million incurred in 2010 reflect these efforts, which included conducting a number of feasibility studies on potential new pipeline candidates to validate and support further development. Today, as a result of these efforts, AGI is pleased to announce that it has identified a promising new lead product candidate, AGI-350, for which a programme of pre-clinical testing has commenced.

New Lead Development Candidate

AGI-350 is a novel presentation of an existing marketed drug which AGI will develop to treat a significant unmet medical need in the critical care setting. AGI-350 is specifically formulated to allow effective and efficient delivery of the drug directly to the lung to treat a life-threatening, lung-related, condition. There are currently no formulations of the drug available for inhaled delivery, and AGI believes that AGI-350 will represent the first such approved use of the drug to treat the target critical care population.

AGI expects that AGI-350 will qualify for Orphan Drug status, which, if granted, should provide seven to ten years exclusivity post approval in key markets. AGI anticipates the pre-clinical development phase, which includes testing in an established disease model, will be completed during H2, 2011. Depending on the outcome of these studies, AGI plans to prepare and file an Investigational New Drug (IND) application with a view to commencing a proof of concept clinical trial in patients during H1, 2012.

For commercial and intellectual property reasons, the drug name and target indication cannot be disclosed at this time.

Collaboration with Aerogen

AGI is also pleased to announce today that it has entered into a development agreement with Aerogen Limited, to provide specialised aerosol technology for the administration and delivery of AGI-350 to ventilated patients in the Intensive Care Unit (ICU) setting. This collaboration will involve the customisation of Aerogen's proprietary technology for use with AGI-350 in the target patient population.

Commenting on the results, Dr. John Devane, CEO of AGI, said:

"During 2010 we completed a process of rigorous technical and commercial due diligence and identified a new lead programme and direction for the Company. We are also pleased to enter into a collaboration with Aerogen in support of AGI-350 and we look forward to providing further updates on the progress of this programme during the course of this year".

Contact Information:

For further information: 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 treatments for conditions which qualify for Orphan drug status.

The Company's lead programme, AGI-350, is being developed to treat a significant unmet medical need in the critical care setting, in particular for patients who require ventilation support.

AGI's common shares are listed on the Alternative Investment Market of the London Stock Exchange (AIM) and on the Enterprise Securities Market (ESM) of the Irish Stock Exchange as AGI.

For further information please see www.agitherapeutics.com.

About Aerogen Limited

Aerogen is a specialty medical device and drug delivery company with leading expertisein the design, manufacture and marketing of aerosol drug delivery systems aimed at the critical care respiratory market. Aerogen is focused on creating and commercializing novel, superior devices based on its proprietary OnQ™ Aerosol Generator. Aerogen's patented OnQ™ micropump technology sets a new performance standard for pulmonary drug delivery by efficiently producing consistently sized, high-quality respirable aerosols which can be optimized for a specific indication. Aerogen's gold-standard products are sold in more than 50 countries worldwide and include; the Aeroneb® Pro reusable nebulizer, The Aeroneb® Solo, single patient use disposable nebulizer, the Aeroneb® Go homecare nebulizer and the Aeroneb® Lab clinical nebulizer. Aerogen also partners with biotech and pharma companies to develop and deliver specialty aerosol drug solutions utilizing its proprietary OnQ™ technology platform.

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.

AGI Therapeutics, plc

Chairman's and Chief Executive's review:

2010 was a year of transition for AGI. During the first six months of the year the restructuring of AGI's business continued. AGI has reset its cost base to more closely align it with that of an early-stage development company. We closed our US office and reduced other costs in an effort to conserve cash reserves for future R&D investment. As a result, the loss for 2010 was substantially reduced, to $3.6 million from $10.6 million in 2009. As this loss includes significant non-cash items our actual cash expense for the year was reduced to $2.0 million, leaving $10.0 million cash on our balance sheet at year end.

During 2010, the management team's efforts were directed primarily to identifying and evaluating new opportunities for the business. We focused on opportunities that met our investment criteria, i.e. that they be in a specialist niche market, preferably for indications that would qualify for Orphan Drug status in the U.S. and/or Europe, that they represent areas of unmet medical need with attractive commercial sales potential and that they be capable of being developed by AGI to a significant value-generating inflection point. We believe that by focusing on this type of opportunity, we will maximise the return to shareholders on the use of the company's resources.

The AGI team evaluated a number of potential product candidates, both internal and external, which met these criteria. The R&D costs of $1.4 million incurred in 2010 reflect these efforts, including conducting a number of feasibility studies on potential new pipeline candidates to validate and support further development. Today, as a result of these efforts, we are very pleased to announce that we have identified a promising new lead product candidate, AGI-350, for which a programme of pre-clinical testing has commenced.

New Lead Development Candidate

AGI-350 is a novel presentation of an existing marketed drug which AGI will develop to treat a significant unmet medical need in the critical care setting. AGI-350 is specifically formulated to allow effective and efficient delivery of the drug directly to the lung, to treat a life-threatening, lung-related, condition. There are currently no formulations of the drug available for inhaled delivery, and AGI believes that AGI-350 will represent the first such approved use of the drug to treat the target critical care population.

We believe that AGI-350 has the potential to significantly improve therapy for the target patient population compared to current standards of care and represents a highly attractive market opportunity for us. We expect that AGI-350 will qualify for Orphan Drug status, which, if granted, should provide 10 years of market exclusivity in Europe, Japan and other selected markets, and 7 years exclusivity in the US, following regulatory approval. In addition, we anticipate that an Orphan drug designation for AGI-350, along with the established efficacy/safety of the drug in non-inhaled forms may reduce the burden of pre-clinical and clinical evidence to support a New Drug Application (NDA).

We anticipate that the pre-clinical development phase, which includes testing in an established disease model, will be completed during H2, 2011. Depending on the outcome of these studies, we anticipate preparing and filing an investigational new drug (IND) application with a view to commencing a proof of concept clinical trial in patients during H1, 2012.

For AGI-350, we have determined that the optimal route of delivery for the relevant patient population will be by aerosol delivery directly to the lung. While a number of companies supply nebulisation technology, Aerogen Ltd. is a recognised leader in high performance aerosol delivery devices in the ICU setting. Aerogen's systems are partnered with many of the leading providers of medical equipment to ICU's including GE Healthcare, Phillips Respironics, Covidien, Maquet, Hamilton and others. We have therefore entered into a development agreement with Aerogen to provide specialized aerosol technology for the administration and delivery of AGI-350 in the ICU setting. This collaboration will involve the customization of Aerogen's proprietary technology for use with AGI-350.

We are confident that the AGI management team has the required experience and skills to achieve our aims for the business. Our management has considerable expertise in drug reformulation, delivery and development. The team originally held senior management positions in the drug delivery division of Elan Corporation where they were responsible for the successful development and NDA approval of a number of products. More recently, at AGI, they have managed a variety of programmes from proof of concept through to Phase III clinical testing, including meeting with and agreeing the design of such programmes with the US regulatory agency, the FDA.

We believe there may be other opportunities to develop products for use in the ICU setting. We are continuing to identify and evaluate further products which may have utility in patients in the critical care environment, in particular where there are currently no available therapies or where current standard of care can be improved.

Outlook

We believe that the development of our AGI-350 product candidate in the critical care environment will lead to significant benefits for patients. Our collaboration with Aerogen, combined with our experience in drug delivery and development has exciting potential. In 2011 our efforts will focus on the pre-clinical development of AGI-350 and preparation for clinical trials in 2012 and we look forward to keeping our shareholders informed of our progress.

Dr. Ronan Lambe Dr. John Devane

Chairman Chief Executive Officer

Dublin, 22 March 2011

AGI Therapeutics, plc

Financial review

for the year ended 31 December 2010

At the end of 2010 AGI had a cash balance of $10.0 million (2009: $12.0 million) which it intends to invest in a new development pipeline and progress a selected number of projects to a stage where they will have tangible worth that will enhance shareholder value.

Revenue

During 2009, AGI entered into a license agreement with a UK company, Myotec Therapeutics Limited (Myotec), granting Myotec access to data relating to AGI-001, s-pindolol. In consideration, Myotec paid AGI a license fee of $67,000 during 2010 (2009: $31,000).

2009 revenues also included $289,000 earned in respect of a license agreement, initially entered into in September 2006, with Axcan Pharma Inc, (Axcan), a Canadian headquartered specialty pharmaceutical company with a focus on gastro-intestinal diseases. As part of this agreement, an initial milestone payment of $1.5 million has been recognised on a straight line basis over approximately three years, in conjunction with the term of the underlying development programme. In August 2009, Axcan and AGI terminated this agreement and all product rights have reverted to AGI.

Research and development expenses

R&D expenses for the year ended 31 December 2010 were $1.4 million (2009: $8.3 million).

In 2010, the R&D activities were limited to exploratory studies on new product opportunities for the company. In 2009, R&D costs were substantially higher and were dominated by costs associated with the phase III clinical programme of Rezular™ for the treatment of IBS-D (ARDIS). ARDIS was terminated in May 2009 when headline data from the ARDIS study showed that Rezular had not met its primary efficacy endpoint.

General and administrative expenses

General and administrative (G&A) expenses in 2010 were $1.2 million (2009: $2.6 million).  The reduction in G&A expenses is due to the company's efforts to reduce its cost base following the termination of the ARDIS programme.

AGI Therapeutics, plc

Operating and financial review (continued)

Restructuring and impairment charges

A charge of $1.1 million was recognised in 2010, primarily relating to the write off of all intellectual property associated with Rezular. The company made considerable efforts to develop new indications for Rezular and to partner other programmes in its pipeline. Previously, the company carried certain intangible assets and know-how on its balance sheet associated with these programmes. Because the ultimate success of these programmes is uncertain, AGI wrote off the carrying value of its intangible assets associated with Rezular and other programmes, which resulted in a non-cash impairment charge of $1.1 million in the year ended 31 December 2010.

The remaining intangible assets, associated with ongoing early stage development programmes, amounted to $0.3 million at 31 December 2010. The recoverable amount of the intangible assets is based on value-in-use calculations. The company has prepared projections for these assets which support the carrying value of the intangibles at the balance sheet date.

In 2009, the company incurred $321,000 relating to the termination of certain positions, as well as the impairment of certain acquired patents and computer and office equipment, in conjunction with the closure of its US office.

Interest income and expense

The company earns interest on its cash balances. This amounted to $58,000 (2009: $140,000). The decline in interest income reflects both the declining interest rates available for deposits as well as the declining cash balances on deposit year-over-year.

Other (expense)/income comprises foreign exchange losses of $50,000, (2009: gains of $53,000).

Taxation

The company has incurred losses to date, and no tax charge arises for 2010 or 2009.

Share based compensation expense

During 2010, the company issued 4,200,000 (2009: 3,830,000) share options to certain employees. The company accounts for the fair value of option grants as a charge in the income statement, using the Black-Scholes option-pricing model. A charge of $0.5 million (2009: $0.8 million) was recognised in 2010 in respect of share based compensation expense, disclosed within research and development and general and administration expenses.

Balance sheet and cash flows

Cash and cash equivalents at 31 December 2010 amounted to $10.0 million, a decrease of 16% as compared to $12.0 million at 31 December 2009. The decrease in cash and cash equivalents was attributable to operating cash outflows of $2.0 million (2009: $11.8 million), which primarily comprised the net loss for the year (adjusted to exclude non-cash items) and a decrease in working capital balances.

AGI Therapeutics, plc

Condensed, consolidated income statement

for the year ended 31 December 2010

Note 2010 2009

$'000 $'000

Revenue - continuing operations 67 320

______ ______

Operating expenses

Research and development expenses

(share based payment charge of $278,000

(2009: $330,000)) (1,391) (8,271)

General and administrative expenses

(share based payment charge of $242,000

(2009: $477,000)) (1,157) (2,559)

Restructuring and impairment charges 3 (1,129) (321)

______ ______

Loss from operating activities - continuing

operations (3,610) (10,831)

______ ______

Finance income and expense

Interest income 58 140

Other (expense)/income (50) 53

______ ______

Net finance income 8 193

______ ______

Loss before income tax (3,602) (10,638)

Income tax - -

______ ______

Net loss for the year - attributable to equity

holders of the company (3,602) (10,638)

Loss per ordinary share

Basic and diluted loss per ordinary share

($ cents) 4 (5.3) (15.8)

The accompanying notes are an integral part of this financial information.

AGI Therapeutics, plc

Condensed, consolidated statement of comprehensive income

for the year ended 31 December 2010

2010 2009

$'000 $'000

Net loss for the year (3,602) (10,638)

______ ______

Total comprehensive loss for the year -

attributable to equity holders of the company (3,602) (10,638)

AGI Therapeutics, plc

Condensed, consolidated balance sheet

at 31 December 2010

Note 2010 2009

$'000 $'000

Non-current assets

Property, plant and equipment - 2

Intangible assets 3 271 1,549

______ ______

Total non-current assets 271 1,551

______ ______

Current assets

Other current assets 38 75

Cash and cash equivalents 9,965 11,972

______ ______

Total current assets 10,003 12,047

______ ______

Total assets 10,274 13,598

Shareholders' equity

Share capital 992 992

Share premium 75,194 75,194

Share based compensation reserve 5,514 4,994

Retained deficit (71,668) (68,066)

______ ______

Total shareholders' equity 10,032 13,114

______ ______

Current liabilities

Trade and other payables 242 484

______ ______

Total current liabilities 242 484

______ ______

Total liabilities 242 484

______ ______

Total shareholders' equity and liabilities 10,274 13,598

The accompanying notes are an integral part of these financial statements.

AGI Therapeutics, plc

Condensed, consolidated statement of cash flows

for the year ended 31 December 2010

2010 2009

$'000 $'000

Loss for the year (3,602) (10,638)

Adjustments to reconcile loss to net cash used in

operating activities:

Depreciation of property, plant and equipment 2 22

Amortisation of intangible assets 98 143

Interest income (58) (140)

Foreign currency (gain)/loss 50 (53)

Impairment of intangible assets and property,

plant and equipment 1,180 111

Share based payment expense 520 807

______ ______

Operating cash outflow before changes

in working capital (1,810) (9,748)

Decrease in other current assets 37 89

Decrease in trade and other payables (242) (2,138)

______ ______

Cash absorbed by operations (2,015) (11,797)

Interest received 42 139

______ ______

Net cash outflow from

operating activities (1,973) (11,658)

______ ______

Net decrease in cash and cash equivalents (1,973) (11,658)

Cash and cash equivalents at the beginning

of the year 11,972 23,577

Effect of foreign exchange rate changes (34) 53

______ ______

Cash and cash equivalents at the

end of the year 9,965 11,972

NOTES TO THE CONDENSED CONSOLIDATED PRELIMINARYFINANCIAL INFORMATION

For the year ended 31 December 2010

1 BASIS OF PREPARATION

The condensed consolidated preliminary financial information, included in the preliminary financial results announcement, which should be read in conjunction with the 2009 Annual Report, has been derived from the consolidated financial statements for the year ended 31 December 2010, which have been prepared in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union ("EU") and effective as at 31 December 2010.

The condensed consolidated preliminary financial information presented herein does not constitute the company's statutory financial statements for the years ended 31 December 2010 and 2009, within the meaning of Regulation 40(1) of the European Communities (Companies: Group Accounts) Regulations, 1992 of Ireland, insofar as such group accounts would have to comply with disclosure and other requirements of those Regulations.  The statutory financial statements for the year ended 31 December 2010, together with the independent auditor's report thereon, will be filed with the Irish Registrar of Companies following the Company's Annual General Meeting and will also be available on the Company's website, http://www.agitherapeutics.com. Statutory financial statements for the year ended 31 December 2009 have been filed with the Irish Registrar of Companies. The auditor's report on those financial statements was unqualified.

The consolidated financial statements and the condensed consolidated preliminary financial information were approved by the Board of Directors on 22 March 2011.

The financial information is presented in US dollars rounded to the nearest thousand, being the functional currency of the parent company and its subsidiaries. It has been prepared on the historical cost basis of accounting, except for share based payments, which are based on fair value determined at the grant date of the relevant share option.

The condensed consolidated preliminary financial information includes the results and financial position of the Company and all of its subsidiary undertakings. All significant intercompany account balances, transactions, and any unrealised gains and losses or income and expenses arising from intercompany transactions have been eliminated in preparing the financial information.

The preparation of the condensed consolidated preliminary financial information 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 this financial information, the significant judgements made by management in applying the Company's accounting policies and the key sources of estimation uncertainty are the same as those that applied to the consolidated financial statements as at and for the year ended 31 December 2009.

The accounting policies applied in the condensed consolidated preliminary financial information are the same as those applied in the consolidated financial statements as at and for the year ended 31 December 2009, as set out on pages 29 to 33 of the 2009 Annual Report. There were no new standards or amendments to standards which were mandatory for the first time for the financial year beginning 1 January 2010 which had a significant impact on the financial information.

2  Going concern

During 2010, the restructuring of AGI's business continued. The company has reset its cost base to more closely align it with that of an early-stage development company. In early 2010, AGI's US office was closed and the company reduced other costs in an effort to preserve cash reserves for future R&D investment. As a result, the loss for 2010 was substantially reduced, from $10.6 million in 2009 to $3.6 million in 2010. As this loss includes significant non-cash items the actual cash expense for the year was reduced to $2.0 million, leaving $10.0 million cash on the balance sheet at year end.

During 2010, the management team's efforts focused primarily on finding new product development opportunities for the business. A new lead programme, AGI-350, has been identified and is now in pre-clinical development.

The directors are satisfied that the company has sufficient cash resources to support its research programmes for a period of twelve months from the date of approval of this financial information and therefore the company can continue to trade during this period. Consequently, the directors have adopted the going concern basis in the preparation of the financial information.

3 Restructuring and impairment charges

2010 2009

$'000 $'000

Severance and other (adjustments)/expenses (51) 210

Impairment of intangible assets 1,180 101

Impairment of property, plant and equipment - 10

_____ _____

Total restructuring and impairment charges 1,129 321

A charge of $1.1 million was recognised in 2010, primarily relating to the write off of all intellectual property associated with Rezular. The company made considerable efforts to develop new indications for Rezular and to partner other programmes in its pipeline. Previously, the company carried certain intangible assets and know-how on its balance sheet associated with these programmes. Because the ultimate success of these programmes is uncertain, AGI wrote off the carrying value of its intangible assets associated with Rezular and other programmes, which resulted in a non-cash impairment charge of $1.1 million in the year ended 31 December 2010.

The remaining intangible assets, associated with ongoing early stage development programmes, amounted to $0.3 million at 31 December 2010. The recoverable amount of the intangible assets is based on value-in-use calculations. The company has prepared projections for these assets which support the carrying value of the intangibles at the balance sheet date.

In 2009, the company incurred $321,000 relating to the termination of certain positions, as well as the impairment of certain acquired patents and computer and office equipment, in conjunction with the closure of its US office.

4  Loss per ordinary 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, on an as-if-converted basis.

The following table sets forth the computation for basic and diluted loss per share for the years ended 31 December 2010 and 2009:

2010 2009

$'000 $'000

Numerator:

Loss attributable to ordinary shareholders (3,602) (10,638)

_________ _________

Denominator:

Denominator for basic & diluted/weighted average shares 67,412,783 67,412,783

_________ _________

Basic and diluted loss per share ($ cents) (5.3) (15.8)

  ========= ========

For the years ended 31 December 2010 and 2009, there was no difference in the weighted average number of ordinary shares used for the basic and diluted loss per ordinary share computation, as the effect of all potentially dilutive shares are anti-dilutive due to the existence of net losses of the group. At 31 December 2010, there were share options outstanding of 10,776,948 (2009: 6,576,948) which could potentially have a dilutive impact in the future, but which were anti-dilutive in 2010 and 2009.

5 Related-party transactions

Remuneration of key management personnel

The key management personnel ("KMP") of the group and company are the executive directors. The amounts reflect the costs for the group.

2010 2009

$'000 $'000

Wages, salaries and bonuses 683 1,067

Post employment benefits - contributions to defined

contribution pension plan 88 122

Share-based compensation expense 520 628

_____ _____

Total remuneration of key management personnel 1,291 1,817

Frank Kenny, John O'Sullivan and Peter Sandys are non-executive Directors of the Company and are board nominees of Delta Partners, ACT Venture Capital and Seroba Bioventures respectively. Fees of $11,326 annually are paid by the Company to each of Delta, ACT and Seroba in respect of their nominees' appointments.

6 Subsequent events

There were no significant events after the balance sheet date which would require the adjustment of, or disclosure in, this preliminary financial information.

7 Approval

The condensed consolidated preliminary financial information was approved by the directors on 22 March 2011.