Immupharma Regulatory News (IMM)

ImmuPharma PLC

INTERIMS RESULTS ANNOUNCEMENT

For the six months ended 30 June 2012

ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the "Group"), the specialist drug discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2012.

INTERIM HIGHLIGHTS

·; LupuzorTM, our candidate for the treatment of lupus which has been granted approval by the US Food and Drug Administration to begin Phase III trials under Special Protocol Assessment with Fast Track designation, continues to be the subject of licensing discussions with a number of possible partners

·; IPP-204106, ImmuPharma's cancer programme, has begun dosing in a new clinical trial with the next generation of 'polyplexed Nucant'. This 'polyplexed Nucant' formulation has shown an impressive efficacy of about 10 times over the previous Nucant version in pre-clinical cancer models and represents a newly discovered form using the previous Nucant version together with a specific excipient that forms micro/nano structures (see separate announcement released today)

·; IPP-204106, final results are available for the Phase I/IIa clinical trial where 6 out of the 14 patients had proven stabilisation with stabilisation lasting more than 6 months in 2 of the 6 patients. No serious drug related adverse events were reported

·; Received the New Economy award for Best Medical Research and Development Company Europe 2012

·; Strong cash position of £10.1 million

·; Basic and diluted loss per share 2.17p and 2.17p respectively (30 June 2011: 2.59p and 2.59p).

Commenting on the progress to date and the outlook for ImmuPharma, Richard Warr, Chairman, said:

"The first half of 2012 has seen ImmuPharma initiate licensing discussions with a number of potential partners for LupuzorTM following the regaining of rights from Cephalon, Inc as result of their acquisition by Teva Pharmaceuticals. At the same time, we are delighted to report substantial progress with our Nucant cancer programme as announced separately today. Furthermore, we are pleased to announce that dosing has commenced in the next cancer clinical trial. We are committed to building on this success and to providing further updates on an ongoing basis. The Board recognises and appreciates the continuing support of our shareholders which has been instrumental in these achievements."

For further information, please contact:

Statement from the Chairman and Chief Executive Officer

Summary

We are pleased to report our interim results for the six months ended 30 June 2012. The first six months of 2012 have been a busy time for ImmuPharma. LupuzorTM has been approved by the US Food and Drug Administration (FDA) to start Phase III trials under Special Protocol Assessment and has been granted Fast Track status. Since regaining the rights to LupuzorTM from Cephalon, Inc (Cephalon) in late 2011 following its acquisition by Teva Pharmaceuticals, we have been in discussions with a number of possible partner companies for LupuzorTM. IPP-204106, our cancer programme, continues to make exciting progress with the first patients dosed in trials of our new formulation. The final report of the Phase I/IIa trial has been produced showing that 6 out of the 14 patients had proven disease stabilisation with stabilisation lasting for more than 6 months in 2 out of the 6 patients. We were also delighted to be awarded the New Economy award for Best Medical Research and Development Company Europe 2012.

Our pipeline includes 5 lead compounds. The most advanced, LupuzorTM, has been granted approval by the US FDA to start Phase III trials under Special Protocol Assessment with Fast Track status designation. Our next priority program is IPP-204106 for the treatment of cancer. The first patients in the next clinical trial have just begun dosing. It has previously been awarded grants totalling €1.15m by French government organisations which are supporting its development process. Three other earlier stage programmes are in preclinical development for - inflammatory disorders, moderate to severe pain and serious hospital infections. In addition to our lead compounds, our long-term pipeline includes a patented chemical library of over 300,000 small molecules and a technology for converting small peptides to drugs that can potentially be applied to generate further compounds for the Company.

Development Pipeline

·; LupuzorTM

ImmuPharma regained the rights to LupuzorTM from Cephalon following its acquisition by Teva Pharmaceuticals (Teva). As Teva already had a compound in development for Lupus, ImmuPharma was able to regain the rights to LupuzorTM. LupuzorTM has been granted Fast Track status by the US FDA and approved to start Phase III under Special Protocol Assessment. ImmuPharma has been in discussions with a number of possible partner companies to progress LupuzorTM's development and commercialisation. 

·; IPP-204106, treatment for cancer

IP-204106 is ImmuPharma's lead compound for cancer. The rights for this compound have been obtained through the Group's ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France's leading scientific research organisation. The molecule is a nucleolin antagonist and has a promising and novel mechanism of action, acting both in preventing angiogenesis as well as proliferation. Preclinical data has shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types. Results from a Phase I/IIa trial in cancer patients demonstrated that it met its safety endpoints and showed stabilisation of disease in 6 out of 14 patients. ImmuPharma has just begun dosing patients in the next trial in this promising cancer programme. 

·; Other Pipeline Compounds

More modest progress has been made on ImmuPharma's other pipeline compounds for inflammation, pain, MRSA and other hospital-acquired infections during the period. The Group remains committed to their development either alone or with a partner.

Financial Review

ImmuPharma's cash balance remains strong at £10.1 million (£12.2 million at 31 December 2011). Basic and diluted loss per share were 2.17p and 2.17p respectively (31 December 2011: 4.12p and 4.12p). In line with the Company's current policy, no interim dividend is proposed.

ImmuPharma continue to emphasise prudent and controlled expenditure. Operating loss for the period was £1,968,657 (£1,568,140 for the six months ended 30 June 2011). Research and development expenditure was £806,141 (£579,195 for the six months ended 30 June 2011) reflecting primarily the activities for the development of IPP-204106, our anti-cancer compound. Administrative expenses were £1,162,516 (£993,474 for the six months ended 30 June 2011). Finance income for the period was £200,895 which is attributable to favourable foreign exchange movements during the period.

Given the stage of ImmuPharma's development, the fact that losses have continued to be made is to be expected since there is minimal revenue and business activity is concerned with clinical trial expenditure, maintaining the infrastructure of the Group and, importantly, seeking a license partner for LupuzorTM.

Outlook

With a strong cash position and controlled expenditure, the focus of the Group is on confirming a solid partnership for LupuzorTM and the development of our other pipeline candidates, in particular our promising cancer compound, IPP-204106. Furthermore, in an effort to maximise the value of our development pipeline, ImmuPharma continues to be in discussions with a number of pharmaceutical and biotech companies for potential collaborations.

Independent Review Report to ImmuPharma plc

Introduction

We have been engaged by the Company to review the condensed set of financial statements in the interim report for the six months ended 30 June 2012 which comprises the Consolidated Income Statement, the Consolidated Statement of Comprehensive Income, the Consolidated Statement of Financial Position, the Consolidated Statement of Changes in Equity, the Consolidated Statement of Cashflows, and the related notes 1 to 4.

We have read the other information contained in the interim report and considered whether it contains any apparent misstatements or material inconsistencies with the financial information in the condensed set of financial statements.

This report is made solely to the Company in accordance with the terms of our engagement to assist the Company in meeting the requirements of the AIM Rule 18. Our review has been undertaken so that we might state to the Company those matters we are required to state to it in this report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company for our review work, for this report or for the conclusions we have reached.

Directors' responsibilities

The interim report is the responsibility of, and has been approved by, the directors. The directors are responsible for preparing the interim report in accordance with AIM Rule 18.

As disclosed in note 1, the annual financial statements of the Group are prepared in accordance with IFRS as adopted by the European Union. It is the responsibility of the directors to ensure that the condensed set of financial statements included in this interim report have been prepared on a basis consistent with that which will be adopted in the Group's annual financial statements.

Our responsibility

Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the interim report based on our review.

Scope of review

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures.

A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the interim report for the six months ended 30 June 2012 is not prepared, in all material respects, in accordance with the requirements of the AIM rules.

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2012

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE PERIOD ENDED 30 JUNE 2012

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2012

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2012

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2012

ImmuPharma plc

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2012

1. ACCOUNTING POLICIES

Basis of preparation

The interim financial information in this report has been prepared using accounting policies consistent with IFRS as adopted by the European Union. IFRS is subject to amendment and interpretation by the International Accounting Standards Board (IASB) and the IFRS Interpretations Committee and there is an ongoing process of review and endorsement by the European Commission. The financial information has been prepared on the basis of IFRS that the Directors expect to be adopted by the European Union and applicable as at 31 December 2012.

The accounting policies applied are consistent with those that will apply to the financial statements for the year ending 31 December 2012.

Income tax

Taxes on income in the interim periods are accrued using the tax rate that would be applicable to expected total annual earnings.

Non-Statutory accounts

The financial information for the year ended 31 December 2011 set out in this interim report does not constitute the Group's statutory accounts for that period. The statutory accounts for the year ended 31 December 2011 have been delivered to the Registrar of Companies. The auditors reported on those accounts; their report was unqualified, did not contain a statement under either Section 498 (2) or Section 498 (3) of the Companies Act 2006 and did not include references to any matters to which the auditor drew attention by way of emphasis. The financial information for the 6 months ended 30 June 2012 and 30 June 2011 is unaudited.

Copies of this statement will be available on the Company's website - www.immupharma.com.

2. EARNINGS PER SHARE

Share options have not been included in the calculation of diluted loss per share as they are anti-dilutive.

3.

4. SUBSEQUENT EVENTS

There have been no subsequent events since 30 June 2012.