Immupharma Regulatory News (IMM)

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PRELIMINARY RESULTS ANNOUNCEMENTfor the year ended 31 December 2011

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 2011.

Key Highlights:

·; All rights regained to our lead compound, LupuzorTM, from Cephalon, Inc following its acquisition by Teva Pharmaceuticals

·; LupuzorTM received approval from the US Food and Drug Administration to start a Phase III trial with a Special Protocol Assessment as well as obtaining Fast Track designation

·; ImmuPharma is now in discussions with a number of companies to agree a new licensing deal for this Phase III asset

·; ImmuPharma's anti-cancer compound IPP-204106, with a novel and promising mechanism of action has made encouraging progress with promising early results in its Phase I/IIa trial where 21% of patients demonstrated disease stabilisation for more than 6 months

·; Strong cash position of £12.2 million as at 31 December 2011 (2010: £15.6m)

·; Loss for the year of £3.35 million (2010 : £1.98 million)

·; Basic and diluted loss per share of 4.12p (2010: 2.44p) 

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

·; Continued successful relationships with the CNRS, Centre Nationale de la Recherche Scientifique with a strong pre-clinical pipeline which includes three novel drug candidates in inflammation, pain and MRSA

Commenting on the year's performance and outlook Richard Warr, Chairman, said: 

"2011 has been an important year for ImmuPharma. We regained rights to our lead compound, LupuzorTM, from Cephalon following its acquisition by Teva Pharmaceuticals. Substantial progress was made with LupuzorTM, with the approval from the FDA to start a Phase III trial with a Special Protocol Assessment as well as the grant of Fast Track designation. Our cancer programme also made encouraging progress with promising early results in its Phase I/IIa trial.

 "Our key objectives for 2012 are to secure a new licensing partner for LupuzorTM, to advance our cancer programme and to continue to develop the rest of our asset base. We also continue to value and build our key relationship with the Centre National de la Recherche Scientifique (CNRS). As in previous years, these objectives are to be achieved with solid financial management and carefully controlled expenditure."

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ImmuPharma plc

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

2011 has been an important year for ImmuPharma. We reacquired our lead compound, LupuzorTM, from Cephalon, Inc (Cephalon) following their acquisition by Teva Pharmaceuticals. Cephalon had made substantial progress with LupuzorTM, obtaining approval from the US Food and Drug Administration (FDA) to start Phase III with a Special Protocol Assessment (SPA) as well as obtaining Fast Track designation. ImmuPharma is now in discussions with a number of companies to agree a new licensing deal for this Phase III asset. Our cancer programme, IPP-204106, has made encouraging progress with promising early results in its Phase I/IIa trial. Its continued clinical development remains a key priority. Our cash position remains strong providing a solid basis for re-licensing LupuzorTM and our Phase II trial for cancer.

ImmuPharma entered into an option agreement with Cephalon in 2008 while in the middle of a Phase IIb study, which ImmuPharma designed, managed and funded. Cephalon paid ImmuPharma $15m before the results of the Phase IIb study for the exclusive option to enter into the worldwide license. Following positive results of the ImmuPharma Phase IIb study in early 2009, Cephalon exercised its option by paying a further $30m for an exclusive worldwide license. This was part of an agreement worth $500m in cash milestone payments plus royalties on product sales. Upon completion of the license agreement, Cephalon assumed all responsibilities and costs for the development and commercialisation of Lupuzor™.

In May 2011, Cephalon agreed to a takeover bid by Teva. The acquisition was finalized on 14 October 2011. Given the fact that Teva Pharmaceuticals has a competing drug candidate for Lupus (laquinimod) and the existence of key provisions of the agreement between ImmuPharma and Cephalon, Immupharma requested and was granted the return of the rights for Lupuzor™. ImmuPharma regains LupuzorTM at an exciting stage in its development. The FDA has granted LupuzorTM approval to start Phase III with a Special Protocol Assessment (SPA) with Fast Track designation.

2011 was also a time of promising progress for our anti-cancer nucleolin/nucleophosmin antagonist ("Nucant") peptide programme. Having received approval from Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) and initiated a Phase I/IIa study in three hospitals in France, we reported promising early results. The trial is now completed and the data are being analysed. 21% of patients demonstrated disease stabilisation for more than 6 months. The clinical development programme continues to be a key priority for ImmuPharma during 2012. It is planned to focus on patients with glioblastoma (brain tumour), melanoma and other cancers where nucleolin plays a key role. Recent scientific publications have demonstrated that by reducing nucleolin a strong growth inhibition of cancer cells was observed confirming our initial results.

Additionally, we have been working to raise ImmuPharma's profile in the investment community and strive to maintain an effective dialogue with our investors. We have therefore been pleased to have built upon our blue-chip investor shareholder base, including M&G Investments, ING, Pictet and Aviva.

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. 

Our key objectives for 2012 are to secure a new licensing partner for LupuzorTM, to advance our cancer programme and to continue to develop the rest of our asset base. We continue to value and to seek to enhance our key relationship with the Centre National de la Recherche Scientifique (CNRS). As in previous years, these objectives are to be achieved with solid financial management and carefully controlled expenditure. 

ImmuPharma is looking forward to another promising year in 2012. 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.

Richard Warr Dimitri F. Dimitriou Dr Robert Zimmer

Chairman Chief Executive Officer President

ImmuPharma plc

Financial Review

The year ended 31 December 2011 was a year of steady progress with focus on our cancer programme and the reacquisition of rights to LupuzorTM from Cephalon, Inc. 

Income Statement

The overall loss for the year ended 31 December 2011 was £3.35m (2010: £1.98m). During 2011, research and development expenditure was £1.6m which is roughly in line with that incurred in 2010. Administrative expenses were £2.2m, down from £2.6m in 2010. The Group posted a £0.16m gain on foreign exchange in 2011 compared to a gain of £1.69m on foreign exchange in 2010. This arises from the translation of the US dollar balance held by the Group's French subsidiaries. To date, the Group has not entered into any formal hedging arrangements to protect against such fluctuations. Total comprehensive loss for the period was £3.6m (2010: £2.5m), £0.3m greater than the loss for the year as a result of exchange differences on translation of foreign operations.

As 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 £146,834 which represents the current year charge for options granted. This is a notional amount stipulated by IFRS2 (and calculated using a statistical model) as a result of granting the options. 

Balance Sheet

Cash and cash equivalents at 31 December 2011 amounted to £12.2m (2010: £15.6m). Financial borrowings were £969k (2010: £807k). This is primarily the conditional advance, from the French Government, for use in the development of our cancer programme. No interest is payable. 

Results

The Group recorded a loss for the year of £3.35m (2010: £1.98m). Basic and diluted loss per share were 4.12p (2010: 2.44p). 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

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE YEAR ENDED 31 DECEMBER 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE YEAR ENDED 31 DECEMBER 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2011

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

They were signed on its behalf by:

Richard Warr Dimitri Dimitriou

Director Director

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2011

ImmuPharma plc

NOTES TO THE PRELIMINARY RESULTS

FOR THE YEAR ENDED 31 DECEMBER 2011

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 2011 or 31 December 2010.

The financial information has been extracted from the statutory accounts for the years ended 31 December 2011 and 31 December 2010. 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 2011 and 31 December 2010 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 2010 have been delivered to the Registrar of Companies, whereas those for the year ended 31 December 2011 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 2011 and the statutory accounts for the year ended 31 December 2010, which have been prepared in accordance with International Financial Reporting Standards ("IFRS").

The financial information is for the year ended 31 December 2011 and the comparatives are for the year ended 31 December 2010.

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

NOTES TO THE PRELIMINARY RESULTS

FOR THE YEAR ENDED 31 DECEMBER 2011 (continued)

ImmuPharma plc

NOTES TO THE PRELIMINARY RESULTS

FOR THE YEAR ENDED 31 DECEMBER 2011 (continued)

ImmuPharma plc

NOTES TO THE PRELIMINARY RESULTS

FOR THE YEAR ENDED 31 DECEMBER 2011 (continued)