Immupharma Regulatory News (IMM)

ImmuPharma PLC

("ImmuPharma" or the "Company")

INTERIM RESULTS ANNOUNCEMENTfor the six months ended 30 June 2017

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 2017 (the "Period").

Key Highlights

· Lupuzor™: is the Company's lead program for the potential breakthrough compound for Lupus a potential life threatening auto-immune disease

§ Total 11 sites active in US with 70 patients

§ Five European countries with 81 Lupus patients taking part in the trial: Czech Republic, France, Germany, Hungary and Poland

§ One Mauritius site with 49 Lupus patients included in trial

· Most recent update on progress of Lupuzor™ trial announced on 21 September 2017

· Top line results on track to report in Q1 2018

· As announced on 26 September 2017, first steps initiated for Lupuzor's™ regulatory submissions

· £4.1 million fundraising (before expenses) successfully completed in March 2017

· Northland Capital Partners appointed as sole broker and NOMAD

· Stable financial performance over the Period, in line with market expectations

o Net assets of £6.4 million (31 December 2016: £5.5 million)

o Loss for the Period of £3.0 million (H1 2016: £3.7million)

§ Research and Development expenses of £2.3 million (H1 2016: £2.5 million)

o Basic and diluted loss per share of 2.34p (H1 2016: 3.35p)

· New employee share option plan implemented in March 2017 to continue to attract and retain key individuals

· 'Investor' Event on 30 June 2017

o ImmuPharma successfully hosted a technology symposium on Friday 30 June following the Company's AGM. The event attended by institutional and private investors included presentations from key management on the three core technology platforms. The video of the presentation can be seen on http://www.immupharma.co.uk/media/events

· New ImmuPharma website launched: www.immupharma.co.uk

Commenting on the Interims and outlook Tim McCarthy, Chairman, said:

"Ensuring that our pivotal Phase III Lupuzor™ trial progresses on track remains a key focus for ImmuPharma.

"We recently announced that all patients in the study have now passed the six months stage, with over 26% of patients having now completed the full 12 months. With a continued robust safety record, we are looking forward with confidence and planning for a successful outcome of the study with all patients completing the treatment protocol in the coming months and to reporting top-line results in Q1 2018.

"Having successfully completed a £4.1 million fundraising (before expenses) in March, the Board would like to thank its shareholders for their continued support, as well as its staff, corporate and scientific advisors and the CNRS for their ongoing collaboration."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")

For further information please contact:

ImmuPharma plc

Chairman's Statement

INTERIM HIGHLIGHTS

The first half of 2017 saw the continued progression of our lead program LupuzorTM, for the treatment of Lupus, through significant milestones in its pivotal Phase III trial. The most recent update to the trial as announced on 21 September 2017 confirmed that as at 15 September 2017:

· all patients in the study have passed the 6 months stage, and

· 52 patients (26%) have completed the full 12 months of the study

Importantly there continues to be a robust safety record which remains consistent with Lupuzor™'s product profile as shown in its previous Phase IIb study.

As announced on 26 September 2017, with the trial progressing on track, ImmuPharma is planning ahead in anticipation of the trial's successful outcome. In consultation with our regulatory advisors, we are now progressing the completion of the regulatory dossiers in preparation for submission to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes the finalisation of the Drug Master File (DMF) and in particular the manufacture of commercial batches of the LupuzorTM drug. These will be manufactured according to described procedures in the DMF, to be ready for inclusion in the Company's regulatory submissions. ImmuPharma expects to have the first set of batches ready by the end of Q1 2018 in line with Lupuzor'sTM Phase III top line results being announced.

We were also pleased to have successfully completed an oversubscribed £4.1 million fundraising (before expenses) in March 2017. The funds raised strengthened the Company's Statement of Financial Position and have also supported further investment in ImmuPharma's earlier stage portfolio, in particular its P140 peptide platform.

Lupuzor™ Phase III Trial - Progress through H1 2017

Lupuzor™ received approval from the US Food and Drug Administration (FDA) to start Phase III with a Special Protocol Assessment (SPA) and Fast Track designation, perceived as the 'Gold Standard' from the FDA. Under the SPA, the necessary number of patients for the Phase III programme is much lower than other Lupus development candidates in previous clinical trials and underpins the significant efficacy and safety profile shown by Lupuzor™ in its clinical development program to date. Importantly, this means that the total cost and time to completion of Phase III is significantly reduced.

The Phase III trial is a double-blind, randomised, placebo-controlled trial. The study involves patients being dosed for one year, receiving 0.2mg once every month subcutaneously. Significant progress was made toward completion of the trial. 293 patients were screened illustrating the demand from physicians for a new, safe and effective treatment for Lupus. Of these, the required 200 patients have been successfully recruited and randomised (dosed). Patients are participating in the trial in 7 countries across 28 sites.

In the United States the trial has been approved by a major Central Institutional Review Board (IRB) which is allowing several sites to participate through a single IRB. In Europe, the study is approved through the centralised Voluntary Harmonisation Procedure (VHP). Through the EU VHP the study is taking place in Germany, France, Czech Republic, Hungary and Poland.

ImmuPharma was also requested to open a new site in Mauritius. CAP Research, a major clinical research organisation in Mauritius, is leading the trial and 49 patients have been recruited. Mauritius, with a population of around 1.2 million, has a high proportion, approximately 300 of Lupus patients currently diagnosed. Top line data is expected during Q1 2018. Progress of the trial can be seen at: www.clinicaltrials.gov (search term 'Lupuzor').

Lupus - Opportunity

There are an estimated five million people globally suffering from Lupus, with approximately 1.5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America). Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited effectiveness, with over 60% of patients not adequately treated. GSK's Benlysta is the first Lupus drug approved in many years and paves the path to market for Lupuzor™. Based on conservative estimates, and taking into account that Benlysta is priced currently at approximately US$30,000 per patient per year, Lupuzor™ would be entering a market with the potential for multi-billion dollar sales.

Lupuzor™ has the potential to be a novel specific first-line drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in a substantial proportion of patients. Lupuzor™ has a unique mechanism of action that modulates the activity of CD4 T-cells which are involved in the cell-mediated immune response which leads to the Lupus disease. Lupuzor™, taken over the long term, as indicated in earlier stage clinical trials, has the potential to prevent the progression of Lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.

There will be a number of routes to market for Lupuzor™ which could include: a global licensing deal; ImmuPharma partnering with regional distributors, or an outright sale of Lupuzor™ or the Company. The prime objective of any strategy would be to maximise shareholder return. 

Pipeline Overview

LupuzorTM - Forigerimod / P140 Auto-Immune Platform

Lupuzor™, is also known by its chemical name 'Forigerimod' or P140.

ImmuPharma, in conjunction with the CNRS, is working hard on expanding the P140 auto immune pipeline, which is supported by Lupuzor™'s strong efficacy and safety profile and by its mechanism of action.

An important patent has been granted in key countries (USA, EU, China, India and Japan) covering LupuzorTM up to 2032 and its use in the treatment of a majority of autoimmune diseases such as Sjogrens, rheumatoid arthritis, Crohn's and CIDP.

Additionally, a new patent has been filed (co-owned with CNRS) to cover non-autoimmune indications. Further preclinical work continues at the CNRS with the objective of further indications moving into the clinic in due course.

Nucant Platform

Our Cancer Nucant program, IPP-204106, is focused on combination therapy approaches and ImmuPharma is reviewing a number of options to further progress this program. In 2016, a grant was awarded by the EU to different EU partners (€7 million total with €430k awarded to ImmuPharma) to develop the Nucants in combination with cytotoxic drugs linked to a solid support. The concept has been validated in pre-clinical studies. As indicated in many high-level scientific journals (Cancer Research), Nucants can be used to selectively target cancer cells and deliver on target highly cytotoxic drugs. Further, it has been proven that Nucants are drastically enhancing the effects of cytotoxic drugs at the tumour level (factor 3) allowing thereby improved efficacy and/or reduction of side effects for the same efficacy. The product, subject to funding, is ready for Phase II development.

The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications. The preliminary results are very encouraging and the product could be ready for clinical assessment provided sufficient funding is secured.

Peptide Platform

ImmuPharma's subsidiary 'Ureka' has initiated the development of a novel and innovative peptide technology platform through the Company's collaboration with 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). Jointly, ImmuPharma and CNRS have filed a new co-owned patent controlling this breakthrough peptide technology. The first therapeutic area being targeted is diabetes with glucagon-like peptide -1 agonists, a class of drugs for the treatment of diabetes, as well as initiating the development of novel peptides as glucagon antagonists - one of the novel approaches to treat Type I and Type II diabetes. A consequence of this approach is the development of long acting peptides to treat NASH (Non-Alcoholic Steato-Hepatitis), one of the most important challenges for public health in the future. ImmuPharma has received non-refundable grants of approximately €600,000 to develop this technology with application to peptides used to treat diabetes as well as to peptides which allow the control of protein/protein interactions (cancer, targeting P53 interactions).

Investor Symposium on 30 June 2017

ImmuPharma held a technology symposium in London on 30 June 2017 following the Company's AGM. Over forty investors attended the event which included both institutions and private investors. The key objective of the event was to give further insight into ImmuPharma's three core technology platforms:

· Lupuzor™ / P140 : Auto Immune Diseases

· Nucants : Oncology / Opthamology

· Peptides : Metabolic Disorders

Vadim Alexandre, Healthcare Analyst at Northland Capital Partners also provided his view on the investment case for ImmuPharma centred on Lupuzor™, an overview of the Auto-Immune sector and competitive landscape.

The video of the presentation can be seen on http://www.immupharma.co.uk/media/events.

Financial Review

ImmuPharma's cash balance at 30 June 2017 was £3.13 million (£1.88 million at 31 December 2016, £0.66 million at 30 June 2016). Further to the Lanstead sharing agreement entered into in February 2016, the Company also has £0.94 million as a derivative financial asset (£1.55 million at 31 December 2016, £3.14 million at 30 June 2016). The sharing agreement with Lanstead includes the provision for 18 monthly tranches of proceeds from the derivative financial asset depending on the share price performance versus an agreed benchmark price. At 30 June 2017, there were 3 monthly tranches outstanding, therefore the sharing agreement will shortly be coming to an end. The Company also has an asset in respect of a prepayment of £0.80 million of advanced fees to Simbec-Orion at 30 June 2017 (£1.24 million at 31 December 2016, £1.75 million at 30 June 2016). Basic and diluted loss per share were 2.34p and 2.34p respectively (30 June 2016: 3.35p and 3.35p). In line with the Company's current policy, no interim dividend is proposed.

Operating loss for the Period was £3.2 million (£3.2 million for the six months ended 30 June 2016). Research and development expenditure in the Period was £2.3 million (£2.5 million for the six months ended 30 June 2016) reflecting primarily the significantly increased expenditure related to the LupuzorTM Phase III clinical trial. Administrative expenses were £0.93 million during the Period (£0.73 million for the six months ended 30 June 2016).

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 significant investment in the form of clinical trial expenditure in addition to maintaining the infrastructure of the Group.

Current Activities and Outlook

The Board are excited by ImmuPharma's medium and long term potential. We are focused on the late stage clinical development of Lupuzor™ through its pivotal Phase III trial and are looking forward with confidence to announcing top-line data by the end of the first quarter of 2018. We will also continue to communicate on a regular basis with shareholders as this trial progresses.

ImmuPharma will also continue to look at ways to create further value in its assets as it progresses its other earlier stage pipeline candidates whilst exploring other opportunities around Lupuzor's™ mechanism of action and its applicability to other autoimmune conditions.

The Board would like to thank its shareholders, both longstanding and those who participated in the more recent fundraisings, for their support as well as its staff, corporate and scientific advisers including Simbec-Orion and the CNRS for their continued collaboration.

Tim McCarthy

Chairman

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2017

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE PERIOD ENDED 30 JUNE 2017

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2017

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2017

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2017

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017

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 to be adopted by the European Union and applicable as at 31 December 2017. The Group has chosen not to adopt IAS 34 "Interim Financial Statements" in preparing the interim financial information.

The accounting policies applied are consistent with those that were applied to the financial statements for the year ending 31 December 2016.

Non-Statutory accounts

The financial information set out in this interim report does not constitute the Group's statutory accounts, within the meaning of Section 434 of the Companies Act 2006. The statutory accounts for the year ended 31 December 2016 have been filed with 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 2017 and 30 June 2016 is unaudited.

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

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017

(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.

The group has granted share options in respect of shares to be issued.

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017

(Continued)