Immupharma Regulatory News (IMM)

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PRELIMINARY RESULTS ANNOUNCEMENTfor the year ended 31 December 2010

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its preliminary audited results for the year ended 31 December 2010.

Key Highlights:

·; Lead candidate for the treatment of Lupus "LupuzorTM": with license partner, Cephalon, Inc. progressing with further Phase IIb trials in US and Europe with interim analysis expected in 3Q 2011. This trial complements the successful phase IIb study by ImmuPharma in 2009

·; ImmuPharma's anti-cancer compound with a novel and promising mechanism of action announced early encouraging results from its Phase I/IIa trial. Final results to be announced around the end of 1H 2011. Phase IIb trials to start later in 2H 2011 in patients with glioblastoma (brain tumour), hormone-resistant prostate cancer and pancreatic cancer

·; Strong cash position of £15.6 million (as at 31 December 2010) 

·; Loss for the year of £1.98 million (2009: profit of £8.1m principally due to receipt of a licensing payment from Cephalon, Inc.)

·; Basic and diluted loss per share were both 2.44p (31 December 2009: basic and diluted earnings per share10.46p and 9.99p respectively)

·; Blue-chip investor base including M&G Investments, ING, Pictet and Aviva

·; Continued successful relationships with the CNRS, Centre Nationale Recherche Scientifique

·; Strong pre-clinical pipeline which includes three novel drug candidates in inflammation, pain and MRSA

·; Received Best Drug Development Company in Europe award at The New Economy Pharmaceutical and Healthcare Awards 2010

Richard Warr, Chairman, said: "We are pleased to report our results for 2010, a year of steady, positive progress for ImmuPharma. Following our successful licensing of LupuzorTM to Cephalon our focus has been on our promising cancer programme. Early results of our cancer programme are encouraging, and we look forward to reporting on further developments during 2011. We also look forward to interim results of Cephalon's Phase IIb trial in LupuzorTM expected in 3Q 2011. With the full support of the CNRS we are confident in the potential of LupuzorTM irrespective of recent developments surrounding our licensing partner. We are in a strong financial position and remain confident in our pipeline and plans for the future."

For further information please contact:

ImmuPharma plc

Report of the Chairman, the Chief Executive Officer and the President

We are pleased to report on a year of steady, positive progress for ImmuPharma. Our lead compound, LupuzorTM, continues to make progress with Cephalon, Inc (Cephalon), who took an exclusive, worldwide license to LupuzorTM during 2009. Furthering the work undertaken in our Phase IIb study, Cephalon are conducting a Phase IIb study in lupus patients in the US and Europe. Our promising cancer program has made important strides forward with an ongoing Phase I/IIa study with further results expected in 2011. Furthermore, the rest of our development portfolio, our continued relationship with the Centre Nationale Recherche Scientifique (CNRS) and our strong cash position provide us with a solid basis for future growth.

During 2010, Cephalon has moved forward with its comprehensive development plan for LupuzorTM. Our own Phase IIb study showed LupuzorTM achieve statistically significant improvement in the moderate to severe patient sub-group with 62% of patients taking LupuzorTM in addition to steroids or other "standard care" treatment, improving their SLEDAI score (Systemic Lupus Erythematosus Disease Activity Index) by more than 4 points compared to 41% of patients who were taking only steroids or other "standard care" treatment. Cephalon is conducting a further Phase IIb study in lupus patients in the US and Europe in a trial designed to allow US-based investigators and the FDA to evaluate LupuzorTM as a treatment for lupus before commencing a Phase III clinical trial. A large number of centres are involved. The data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval. According to Cephalon, interim analysis of this Phase IIb trial will be available during 3Q 2011. We are delighted with Cephalon as a partner and seek to support its development plans.

2010 was a time of exciting progress for our anti-cancer nucleolin/nucleophosmin antagonist ("Nucant") peptide programme. Having received approval from AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante), we began our Phase I/IIa study in 3Q 2010. Early results from this ongoing trial indicate that around half of the cancer patients who have undergone treatment with IPP-204106 are in stable condition without any other drug treatment. The trial is taking place in two hospitals in Paris and one hospital in Dijon in France and is expected to complete in the coming months. We hope to start a Phase IIb programme later this year in patients with glioblastoma (brain tumour), hormone-resistant prostrate cancer and pancreatic cancer.

Our strategic objectives for 2011 and beyond centre on the maintenance of a positive relationship with Cephalon for LupuzorTM, the focus on the development of our cancer programme, and the development of the rest of our asset base. We also seek to add value and build upon our key relationship with the CNRS. This is to be achieved with solid financial management and careful control of expenditure.

Following the two notable awards received in 2009, ImmuPharma received the Best Drug Development Company in Europe award at The New Economy Pharmaceutical and Healthcare Awards 2010. We are proud to have our achievements recognised in this way. 

The Company continues to strive to incorporate best practice corporate governance guidelines for AIM companies in a manner that is most appropriate and effective for the size and complexity of ImmuPharma. The Quoted Companies Alliance published new guidelines for AIM companies in September 2010. The Corporate Governance section included in the annual report provides more information regarding how ImmuPharma applies these guidelines.

ImmuPharma is looking forward to another promising year in 2011. The Board would like to thank its shareholders for their ongoing support as well as its scientific advisors and the Centre Nationale de la Recherche Scientifique in France for their collaboration.

ImmuPharma plc

Financial Review

The year ended 31 December 2010 was a year of solid progress with an increasing change in focus from LupuzorTM to our cancer programme and other assets. With our license partner, Cephalon, responsible for LupuzorTM's ongoing development, Immupharma has been able to focus its development efforts primarily on our promising cancer programme. Our financial statements reflect this change in focus and progression from the successful licensing of LupuzorTM in 2009.

Income Statement

The overall loss for the year ended 31 December 2010 was £1.98m (2009: profit of £8.1m principally due to receipt of the license payment from Cephalon). During 2010, research and development expenditure was £1.6m which is down from £4m for the year ended 2009. The difference is primarily attributable to reduced development expenditure on LupuzorTM which was licensed to Cephalon in 2009 and to lower remuneration costs. Administrative expenses were £2.6m (2009: £3.6m). The reduction is due to a number of factors including lower remuneration costs and legal fees. The Group posted a £1.7m gain on foreign exchange in 2010 compared to a loss of £1.3m on foreign exchange in 2009. This arises from the translation of the US dollar balance held by the Group's French subsidiary, Immupharma France SA. To date, the Group has not entered into any formal hedging arrangements to protect against such fluctuations. Total comprehensive loss for the period was £2.5m (2009: profit of £6.5m), £0.6m greater than the loss for the year as a result of exchange differences on translation of foreign operations.

In previous years, IFRS2, relating to share-based payments has had an impact on the Group's results. There is a charge in the accounts of £201,770 which represents the current year charge for options previously granted. This is a notional amount stipulated by IFRS2 (and calculated using a statistical model) as a result of granting the options. A further £158,446 is due to be charged in next year's accounts under IFRS2, being the remainder of the fair value charge.

Balance Sheet

Cash and cash equivalents at 31 December 2010 amounted to £15.6m (2009: £22.5m). £4.3m is held on short term deposits. £9.6m is held in US dollar denominated assets, representing 62% of total cash. Trade payables decreased from £5.3m in 2009 to £0.6m in 2010 primarily due to the payment of the amount due to the CNRS arising from the license payment received from Cephalon. Financial borrowings were £807k (2009: £458k). This is primarily the conditional advance from the French Government for use in the development of our cancer programme. No interest is payable. The issued share capital increased by 441,000 shares as a result of the exercise of options and now amounts to 81,532,463 shares.

Results

The Group recorded a loss for the year of £1.98m (2009: profit of £8.1m). Basic and diluted loss per share was 2.44p (2009: basic earnings per share of 10.46p) and diluted loss per share was 2.44p (2009: diluted earnings per share 9.99p). No dividend is proposed.

Treasury Policy

The policy continues to be that surplus funds of the Group are held in interest-bearing bank accounts on short or medium maturities, until commitments to future expenditure are made, when adequate funds are released to enable future expenditure to be incurred. The Group's Treasury Policy and controls are straightforward and approved by the Board. The Group does not engage in speculative transactions and continues to believe that this represents the most prudent approach in spite of the impact of exchange rate movements in the accounts.

Financial Strategy

The overall strategy is to maintain a tight control over cash resources whilst enabling controlled development of the potential product portfolio

Tracy Weimar

Vice President, Operations and Finance

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE YEAR ENDED 31 DECEMBER 2010

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE YEAR ENDED 31 DECEMBER 2010

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2010

The financial statements were approved by the Board of Directors and authorised for issue on 

They were signed on its behalf by:

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2010

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2010

ImmuPharma plc

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEAR ENDED 31 DECEMBER 2010

1 ACCOUNTING POLICIES

The financial information set out in this announcement does not comprise the Group's statutory accounts for the year ended 31 December 2010 or 31 December 2009.

The financial information has been extracted from the statutory accounts for the years ended 31 December 2010 and 31 December 2009. The auditors reported on those accounts; their reports were unqualified and did not contain a statement under either Section 498(2) or Section 498(3) of the Companies Act 2006 in respect of the years ended 31 December 2010 and 31 December 2009 and did not include references to any matters to which the auditor drew attention by way of emphasis. 

The statutory accounts for the year ended 31 December 2009 have been delivered to the Registrar of Companies, whereas those for the year ended 31 December 2010 will be delivered to the Registrar of Companies following the Company's Annual General Meeting.

The accounting policies are consistent with those applied in the preparation of the interim results for the period ended 30 June 2010, which have been prepared in accordance with International Financial Reporting Standards ("IFRS").

The Directors have considered the accounting policy with respect to the treatment of foreign exchange gains and losses on foreign currency cash balances and consider it appropriate to change the policy to reflect such foreign exchange gains and losses within Finance Income and Finance Costs respectively rather than within Administrative Expenses. The Directors consider that this presentation provides more relevant information about the group's financial performance. This adjustment has decreased Administrative Expenses and increased Finance Costs for the year ended 31 December 2009 by £1,257,212. This has had no impact on the profit for the year ended 31 December 2009 or on the total equity of the group as at that date.

The financial information is for the year ended 31 December 2010 and the comparatives are for the year ended 31 December 2009.

The Group's financial statements incorporate the financial statements of ImmuPharma plc and other entities controlled by the company ("the subsidiaries"). Control is achieved where the company has the power to govern the financial and operating policies of an investee entity so as to obtain benefits from its activities.

ImmuPharma plc