Immupharma Regulatory News (IMM)

INTERIM RESULTS ANNOUNCEMENTfor the six months ended 30 June 2015

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its interim results for the six months ended 30 June 2015 (the "Period").

Although we are pleased to report our interim results, we are saddened by the passing of our Chairman, Richard Warr, in late July.

Key Highlights (including post-Period):

· LupuzorTM

o Phase III pivotal trial has started with development partner Simbec-Orion

o Registration live with the US National Institute of Health with progress trackable on ClinicalTrials.gov website

o A new patent has been filed (co-owned with CNRS) to cover other autoimmune indications - some of which have the potential for Orphan Drug designation

· Nucant program IPP-204106

o The Phase I/IIa results confirmed that ImmuPharma, from a regulatory perspective, can commence Phase II studies in pancreatic cancer and other indications using an authorised dose

o Nucant program has shown modulation of angiogenesis with multiple indications in addition to cancer

o Grant funded preclinical study of ophthalmological indication of age-related macular degeneration underway

o Composition of matter patent provides longer exclusivity, additional protection of the Nucant program and a multitude of other indications in addition to cancer.

· Peptide Technology Collaboration Platform

o In collaboration with CNRS, Institut National de la Santé et de la Recherche Medicale (INSERM) and the Institut Européen de Chimie et Biologie (IECB) at the University of Bordeaux, ImmuPharma filed a new patent controlling a breakthrough peptide technology called UrelixTM

o Allows the mimicry of long natural peptides in the configuration used to bind their receptor

· Further notable events:

o Appointment of Tim McCarthy as Non-Executive Chairman (see separate announcement)

o Dr Stephane Mery was appointed as Non-Executive Director

o Dr Sylviane Muller, inventor of LupuzorTM, awarded Centre National de la Recherche Scientifique (CNRS) Medal of Innovation for work on both LupuzorTM's mechanism of action and its applicability to other autoimmune indications

o ImmuPharma was awarded the New Economy Award for Most Innovative Drug Licensing and Development Company

· Financials

o Cash position as at 30 June 2015 of £3.29m (H1 2014: £5.18m)

o Term sheet signed for a proposed financing of up to $14 million - final agreement under negotiation.

o Loss for the Period of £1.54m (H1 2014: £1.83m)

o Basic and diluted loss per share of 1.74p (H1 2014: 2.23p)

Commenting on the highlights, Dimitri Dimitriou, Chief Executive Officer said: 

"2015 has been a year of many changes for the Company. We entered into a collaboration with a prestigious development organisation, Simbec-Orion and started the pivotal Phase III trial for LupuzorTM. We strengthened the Board and our team of advisors. Of important significance we were honoured by the award of a prestigious medal to the inventor of LupuzorTM, with the discovery of new molecules and new potential indications for LupuzorTM. Finally, we sadly lost our Chairman and good friend, Richard Warr."

For further information please contact:

ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer

INTERIM HIGHLIGHTS

Summary

Although we are pleased to highlight our interim results for the six months ended 30 June 2015, we are saddened by the passing of our Chairman, Richard Warr. Richard was one of the three co-founding executive directors of ImmuPharma. In the short term, our senior non-executive director, Franco di Muzio, has been acting as Interim Chairman. In a separate announcement issued today, Tim McCarthy, an experienced healthcare director, has been appointed Non-Executive Chairman with immediate effect. We have further strengthened the Board by the appointment of Dr Stephane Mery, an experienced scientist, investor and industry executive, as a Non-Executive Director.

During 2015, we have made exciting progress on all of our key programs. We have begun the pivotal Phase III trial for LupuzorTM (P140), a breakthrough treatment for the auto-immune disease lupus, with our development partner, Simbec-Orion. Our Nucant program, IPP-204106, is progressing with combination therapy approaches and grant-funded ophthalmological indications. We announced in February that the Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate demonstrate that the maximum tolerated dose was 9 mg/kg. This was the primary objective of the study. These Phase I/IIa results now allow ImmuPharma, from a regulatory perspective, to commence a Phase II study. Separately, our peptide technology collaboration at the University of Bordeaux is now well established and moving forward.

We were honoured to see our collaborator, Dr Sylviane Muller, the key inventor of LupuzorTM and Research Director at the Centre National de la Recherche Scientifique (CNRS), receive 'The CNRS Medal of Innovation' for her discoveries made on the mechanism of action of LupuzorTM and its applications to other autoimmune diseases. In addition, ImmuPharma was delighted to have been awarded the New Economy Award for Most Innovative Drug Licensing and Development Company.

Development Pipeline Highlights

· LupuzorTM

LupuzorTM also referred to as IPP-201101 or P140 is a potential treatment for lupus (or Systemic Lupus Erythematosus), a chronic, potentially life-threatening auto-immune disease, LupuzorTM has a novel mechanism of action aimed at modulating the immune system and has the potential to halt the progression of the disease in a substantial proportion of patients. A certain number of patients suffering from other autoimmune diseases may, according to preclinical data generated by the group of Sylviane Muller (CNRS), benefit from P140. A Phase II/III study for an orphan indication is expected to be filed this year and may benefit from US and/or French funding or loans.

LupuzorTM has been granted Fast Track status by the US FDA and approval to start a pivotal Phase III trial under Special Protocol Assessment (SPA). This SPA was subsequently amended due to its strong safety and efficacy profile to allow for a reduced number of patients in the Phase III trial thereby reducing the projected cost of development considerably. 

Together with our development partner, Simbec-Orion, this pivotal Phase III trial has begun and is due to recruit patients. The trial's progress can be tracked on 'Clinicaltrials.gov' and is entitled: 'A 52 week, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200 mcg Dose of IPP-201101 Plus Standard of Care in Patients with Systemic Lupus Erythematosus'. 

ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)

· IPP-204106, Nucant program

IPP-204106 is ImmuPharma's lead compound for cancer and other indications. The rights for this compound have been obtained through the Group's ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS). The molecule is a nucleolin antagonist and has a promising and novel mechanism of action, acting on modulating 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 the initial Phase I/IIa trial in cancer patients demonstrated that it met its safety endpoints and showed stabilisation of disease in 21% of patients. The further Phase I/IIa clinical trial designed to assess safety of increasing doses and to identify the optimal dose for treatment that had been ongoing in France and Belgium has been completed. 

While safe doses have been established for the stand alone use of these compounds, we are investigating the possibility that the compounds have promising potential as combination therapies. The Nucant's ability to bind selectively to membrane nucleolin that is seen only in proliferating cells has led us to develop a Nucant-based selective targeting system to safely deliver cytotoxic drugs. In addition, we have been granted new composition of matter patents surrounding an 'optically pure' version of ImmuPharma's Nucant family which broadens our usage into other indications in addition to cancer. This new patent family covers millions of peptide constructs and also expands the potential uses to include angiogenesis related conditions such as age-related macular degeneration, diabetic retinopathy and wound healing as well as cancer selective targeting systems. 

ImmuPharma has been awarded a grant to investigate the Nucant program's applicability to this ophthalmological indication and progress is underway.

· Peptide technology platform collaboration

ImmuPharma has also initiated the development of a novel and innovative peptide technology platform through the collaboration with our longstanding and successful research partner, CNRS, thereby gaining access to pioneering research centred on novel peptide drugs at the University of Bordeaux and the Institut Européen de Chimie et Biologie (IECB). IECB is an international and interdisciplinary research incubator, placed under the joint authority of the CNRS, INSERM (Institut National de la Santé et de la Recherche Medicale) and the University of Bordeaux. Through its network, IECB hosts 15 international and multi-disciplinary research teams including the CNRS team of Dr Gilles Guichard, one of the scientific founders of ImmuPharma and a leading researcher in peptides. Additionally, ImmuPharma has established a significant research entity located within the IECB campus comprising 3 PhDs from Dr Guichard's lab and ETH Zurich as well as state-of-the-art equipment. 

The longstanding collaboration with the CNRS under Dr Guichard and ImmuPharma has resulted in the filing of a new co-owned patent controlling the breakthrough peptide technology codenamed 'Urelix', allowing the mimicry of long, natural peptides particularly in the configuration used to bind to their receptor, the potential improvement of their stability against enzymatic degradation (breakdown of peptides into amino acids) and greater efficacy. 

ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)

· Peptide technology platform collaboration (continued)

The first therapeutic area being targeted is diabetes with glucagon-like peptide -1 agonists or GLP-1 agonists, a class of drugs for the treatment of type 2 diabetes and is initiating the development of novel peptides as glugacon antagonists, one of the novel approaches to treat Type I and Type II diabetes. According to Research and Markets (August, 2011), this family represents a potential market of approximately $10 billion. The potential of this technology is substantial and diverse and is one of the key reasons ImmuPharma has established its own research team working in close collaboration with Dr Guichard and his CNRS team. These developments also involve our patented chemical library of over 300,000 peptide-like small molecules. 

ImmuPharma's subsidiary, Ureka sarl, was awarded a grant of approximately €400,000 to support this work.

Financial Review

ImmuPharma's cash balance at 30 June 2015 was £3.29 million (£5.42 million at 31 December 2014). Basic and diluted loss per share were 1.74p and 1.74p respectively (31 December 2014: 3.43p and 3.43p). In line with the Company's current policy, no interim dividend is proposed.

ImmuPharma continues to emphasise prudent and controlled expenditure. Operating loss for the Period was £1,537,274 (£1,818,412 for the six months ended 30 June 2014). Research and development expenditure in the Period was £494,567 (£820,357 for the six months ended 30 June 2014) reflecting primarily the activities for the development of the UrelixTM peptide technology collaboration and the Nucant program. Administrative expenses were £1,056,266 during the Period (£998,055 for the six months ended 30 June 2014).

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 and maintaining the infrastructure of the Group.

Current Activities & Outlook

We have concentrated our efforts over the last period of progressing Lupuzor™ through the initial regulatory and feasibility stages of the Pivotal Phase III process to the point where we are now starting to recruit patients within Europe and USA.

ImmuPharma in conjunction with the CNRS are also working hard on progressing the P140 auto immune pipeline, based on LupuzorTM's strong efficacy and safety profile and illustrated by its mechanism of action as lauded by the inventor Dr Sylviane Muller. We hope to be able to share further data on preclinical studies of other indications of P140 later this year together with plans for progressing a number of indications into clinical studies.

ImmuPharma plc

Statement from the Interim Chairman, President and Chief Executive Officer (continued)

Current Activities & Outlook (continued)

In summary, the focus of the Group is on ensuring the smooth progress of the late stage clinical development of LupuzorTM, exploring other opportunities around LupuzorTM's mechanism of action and its applicability to other autoimmune conditions with Orphan Drug Status together with progressing ImmuPharma's other pipeline candidates.

We look forward to providing further progress updates over the next period.

Dr Franco di Muzio, Interim Chairman and Senior Non-Executive Director

Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer

Dimitri Dimitriou, MSc, Chief Executive Officer

29 September 2015

Independent Review Report to ImmuPharma plc

Introduction

We have been engaged by ImmuPharma plc ("the Company") to review the condensed set of consolidated financial statements in the interim report for the six months ended 30 June 2015 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 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 2015 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 2015

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2015

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE PERIOD ENDED 30 JUNE 2015

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2015

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2015

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2015

ImmuPharma plc

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2015

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 2015.

The accounting policies applied are consistent with those that were applied to the financial statements for the year ending 31 December 2014.

Non-Statutory accounts

The financial information set out in this interim report does not constitute the Group's statutory accounts. The statutory accounts for the year ended 31 December 2014 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 2015 and 30 June 2014 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 2015

(continued)

2 LOSS PER SHARE

There is no difference between basic loss per share and diluted loss per share as the share options and warrants are anti-dilutive.

ImmuPharma plc

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2015

(continued)