Interim results announcement

RNS Number : 2533P

Immupharma PLC

30 September 2011

 

Immupharma plc

INTERIM RESULTS ANNOUNCEMENT

For the six months ended 30 June 2011

ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the "Group"), the specialist discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2011.

INTERIM HIGHLIGHTS

·     Cephalon, Inc (Cephalon), ImmuPharma's licensee for Rigerimod (Lupuzor^TM),  continues to progress its Phase IIb trial in US and European lupus patients.  This study has been designed to provide US-based investigators and the US FDA with clinical data obtained mainly in the USA.  This data will be part of the package submitted to the FDA and other regulatory authorities for approval.  We plan to provide an update on this trial in conjunction with Cephalon announcing these results.  Positive Phase IIb data from outside the USA has previously been announced.  ImmuPharma look forward to providing an update on Lupuzor^TM's progress following the finalisation of the acquisition of Cephalon by Teva Pharmaceuticals.

·     The Phase I/IIa trial of IPP-204106, ImmuPharma's anti-cancer compound with a novel and promising mechanism of action, continues to progress in cancer patients.  A scientific paper on IPP-204106 was published in the prestigious medical journal of the American Association for Cancer Research

·     Strong cash position of £14.3m

·     Basic and diluted loss per share were 2.59p and 2.59p respectively (30 June 2010:  basic and diluted loss per share 0.10p and 0.10p respectively)

Commenting on the progress to date and the outlook for ImmuPharma, Dimitri Dimitriou, Chief Executive Officer, said:

"The first half of 2011 has seen ImmuPharma build on the success of 2010 with Cephalon, our licensee for Lupuzor^TM, moving ahead with a large trial in the US.  We look forward to providing an update on Lupuzor^TM's progress once Teva's acquisition of Cephalon is complete.  In parallel, we are focusing our own efforts on our promising cancer drug and are pleased to have seen encouraging results so far and to have achieved publication in the journal of the American Association for Cancer Research.  We look forward to building on this success during the rest of 2011 and in the coming years."

Richard Warr, ImmuPharma's Chairman added:

"ImmuPharma has two potential blockbuster drugs in the clinic, Lupuzor^TM and our cancer compound, IPP-204106.  We look forward to providing an update on Lupuzor^TM following the imminent finalisation of Teva's acquisition of Cephalon.  Moreover, ImmuPharma is pleased to report a strong balance sheet, controlled expenditure and a robust cash position."

For further information, please contact:

Statement from the Chairman and Chief Executive Officer

 

INTERIM HIGHLIGHTS

Summary

We are pleased to report our interim results for the six months ended 30 June 2011.  Building on the progress made in 2010, the first six months of 2011 have seen the announcement of substantial and exciting progress of IPP-204106, our cancer programme.  In February, ImmuPharma announced preliminary results of our ongoing Phase I/IIa trial in cancer patients.  In May, a scientific paper on IPP-204106 was published in the prestigious American Association for Cancer Research, a momentous landmark for our collaboration partner, the CNRS and ImmuPharma.  Lupuzor^TM, our drug candidate for systemic lupus erythematosus which is licensed to Cephalon, Inc. (Cephalon), continues to progress through its Phase IIb trial in patients in multiple centres in the USA and Europe. 

Our pipeline includes 5 lead compounds.  The most advanced, Lupuzor^TM, has been licensed to Cephalon, Inc. which has taken over responsibility for its development and all associated costs.  Our next priority program is IPP-204106 for the treatment of cancer.  It continues to progress in its Phase I/IIa trial in cancer patients.  It has 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

·    Lupuzor^TM

Since licensing Lupuzor^TM to Cephalon in 2009, ImmuPharma has placed a priority on developing a good working relationship with our licensee.  Cephalon has a Phase IIb trial in progress in the USA and Europe.  This study was designed to allow US-based investigators and the FDA to evaluate Rigerimod (Lupuzor^TM) as a treatment for lupus on the basis of data derived mainly from the USA.  A large number of centres are involved and the data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval.  In addition to the US trial and in order to prepare for the commercial development in Japan, Cephalon has also initiated development of Lupuzor^TM in Japan through its partner Symbio Pharmaceuticals.  Under the agreement, Cephalon retains all commercialisation rights to Rigerimod (Lupuzor^TM) in Japan, and Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of Rigerimod (Lupuzor^TM) with Japanese regulatory bodies.  Cephalon is currently in the process of being acquired by Teva Pharmaceuticals.  Once the acquisition clearance process is complete (expected Q4 2011), we look forward to providing a further update on Lupuzor^TM and its progress. 

·     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.  In February, ImmuPharma reported progress on the Phase I/IIa trial in cancer patients.  This trial is ongoing with plans for Phase IIb in development.

Statement from the Chairman and Chief Executive Officer

Development Pipeline (continued)

·     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 £14.3 million (£15.6 million at 31 December 2010).  Basic and diluted loss per share were 2.59p and 2.59p respectively (30 June  2010: 0.10p and 0.10p).  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 £1,568,140 (£2,521,050 for the six months ended 30 June 2010).  Research and development expenditure was £579,195 (£975,454 for the six months ended 30 June 2010) reflecting primarily the activities for the development of IPP-204106, our anti-cancer compound.  Administrative expenses were £993,474 (£1,545,713 for the six months ended 30 June 2010).  Finance costs for the period were £572,779 which is attributable to adverse foreign exchange movements during the period. 

Outlook

With a strong cash position and controlled expenditure, the focus of the Group is on continuing the development of our strong relationship with Cephalon, our license partner for Lupuzor^TM, and the development of our other pipeline candidates, in particular our promising cancer compound, IPP-204106.  We are looking forward to providing an update on Lupuzor^TM after the clearance process for the Teva acquisition of Cephalon is complete (Q4 2011) and to announcing the preliminary results of our Phase IIa trial for IPP-204106 in the coming months.  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.

Richard Warr, MA, Chairman                        Dimitri Dimitriou, MSc, Chief Executive Officer

29 September 2011 

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 2011 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 5.

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 half-yearly 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 2011 is not prepared, in all material respects, in accordance with the requirements of the AIM rules.

 

                                                                                                                                                              25 Moorgate

                                                                                                                                                              London

Nexia Smith & Williamson                                                                                                            EC2R 6AY

Statutory Auditor                                                                                                                             

Chartered Accountants                                                                                                                    29 September 2011

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2011

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2011

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (continued)

FOR THE PERIOD ENDED 30 JUNE 2011

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2011

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2011

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 2011.

The accounting policies applied are consistent with those that will apply to the financial statements for the year ending 31 December 2011.

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 2010 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 2010 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 2011 and 30 June 2010 is unaudited.

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

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2011

(continued)

2              EARNINGS PER SHARE

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

 

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2011

(continued)

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