FOR IMMEDIATE RELEASE                                              30 SEPTEMBER 2016

 

 

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

INTERIM RESULTS ANNOUNCEMENT
for the six months ended 30 June 2016

 

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 2016 (the "Period").

 

Key Highlights (including post Period review)

 

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

o  Pivotal Phase III trial is progressing on track with development partner Simbec-Orion

§ Total 11 sites now active in US

§ Five European countries now recruiting Lupus patients in Czech Republic, France, Germany, Hungary and Poland

§ Two final European countries, UK and Italy, to open within the next few weeks

§ New Mauritius site opened and over 10 Lupus patients pre-screened prior to dosing

 

·     Prof. Sylviane Muller, inventor of Lupuzor, held a number of key symposiums hosted in London, 8-9 June 2016, where she presented on the unique 'Mechanism of Action' of Lupuzor™, also known by its chemical name 'Forigerimod' or 'P140'.

o  Prof. Muller provided further evidence of the role the P140 molecule can take in the potential treatment of other autoimmune diseases, including those which are Orphan indications

o  A new patent has been filed outside of Lupus in conjunction with the Centre National de la Recherché Scientifique ("CNRS"), its collaboration partner

 

·     £8.4 million fundraising completed in February and March 2016

o  The Company successfully raised £8.4 million (gross) to fund the pivotal Phase III Lupuzor^TM trial and to support the Company's working capital requirements

o  New and existing shareholders participated in the fundraising, including all of the Directors, Simbec-Orion, Aviva, Alto Invest and Lanstead Capital

o  Advance assurance received from HMRC for VCT and EIS qualifying status

 

 

·     Wider program developments

o  A number of options are under review to further progress ImmuPharma's Cancer Nucant program, IPP-204106 following a Phase I/IIa dose-finding adaptive study which showed that the maximum tolerated dose was 9 mg/kg, the primary objective of the study

o  ImmuPharma and CNRS have filed a new co-owned patent controlling the Company's peptide platform technology, with Type II diabetes being the first therapeutic area to be targeted. 

o  An additional patent has been filed by ImmuPharma to protect certain peptides (GLP1 analogues) demonstrating outstanding properties in terms of duration of action.

 

·     Northland Capital Partners appointed as joint broker

 

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

o  Net assets of £6.2 million (31 December 2015 £1.7 million).

o  Loss for the period of £3.7m (H1 2015:  £1.5m)

§ Research and Development expenses of £2.5 million (H1 2015: £0.9 million)

o  Basic and diluted loss per share of 3.35p (H1 2015: 1.74p)

 

 

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

 

"Successfully raising £8.4 million and commencing our pivotal Phase III Lupuzor™ trial are two significant milestones for ImmuPharma over the first half of 2016.

 

"We are delighted by the continued progress of our Lupuzor™ Phase III trial having recently announced that the US now has 11 sites active and five countries across Europe are currently recruiting Lupus patients with two further countries including the UK to open in the near future. The opening of a new additional site in Mauritius clearly illustrates the positive profile Lupuzor™ is gaining within key cross sections of Lupus patient groups and within the specialist rheumatologist community.

 

"We remain confident of reaching our key milestone of recruiting the full 200 patients in 2016 with top line results in 2017 and look forward to providing further positive updates on this Lupuzor™ Phase III study as it progresses throughout the end of this year and 2017.

 

"The Board would like to thank its shareholders for their support, as well as its staff, corporate and scientific advisors and the CNRS for their continued 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	+ 44 (0) 20 7152 4080
Tim McCarthy, Chairman
Dimitri Dimitriou, Chief Executive Officer
Tracy Weimar, Vice President, Operations and Finance
Lisa Baderoon, Head of Investor Relations	+ 44 (0) 7721 413496
Panmure, Gordon & Co., NOMAD & Broker	+44 (0) 20 7886 2500
Freddy Crossley, Duncan Monteith, Corporate Finance
Charles Leigh-Pemberton, Corporate Broking
Northland Capital Partners Limited, Joint Broker	+44 (0) 20 3861 6625
Patrick Claridge, David Hignell, Corporate Finance
Rob Rees, Corporate Broking

 

 

CHAIRMAN'S STATEMENT

 

 

The first half of 2016 was dedicated to the progress of our lead programme, Lupuzor^™ (a breakthrough treatment for the auto-immune disease Lupus), as it commenced its pivotal Phase III trial and the dosing of Lupus patients in the US and across Europe. This was combined with the strengthening of our financial position by completing a successful placing and subscription raising £8.4 million before expenses in February and March.

 

To focus initially on the fundraising it was a sign of widespread support that as part of the completion of the £8.4 million funding round key participators included:

•    All of the Directors

•    Simbec-Orion, our development partner

•    Aviva, our longstanding major institutional investor

•    New institutions including Alto Invest, a specialist Healthcare fund, and Lanstead Capital

•    Longstanding private client shareholders

 

As part of the fundraising exercise, ImmuPharma also received confirmation of advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme. These assurances were important for attracting a significant proportion of new shareholders into the recent fundraising.

 

Lupuzor™ Phase III Trial - Progress through H1 2016

 

As background to the study, we stated that recruitment would occur in up to 45 investigator sites, 10 sites in United States and 35 in Europe, to ensure the screening of 270 potential patients, in order to recruit the required 200 patients for the trial. The Phase III trial is a double-blind, randomised, placebo-controlled trial. The study will involve patients dosing for one year, receiving 0.2mg once every month subcutaneously.

 

Current Status

 

We can now confirm that we have 11 sites opened in the US.  In Europe we have sites open in five countries - France, Hungary, Poland, Czech Republic and Germany.  A further two countries, UK and Italy, will open in the next few weeks. Further details on the trial and updates on recruitment can be seen at: www.ClinicalTrials.gov.

 

New Site in Mauritius: post review period

 

On 7 September we announced the opening of a new site in Mauritius. This was a new country allocation due to the request from the Mauritian Government based on the high incidence of Lupus sufferers, approximately 3000, in this region. We have indicated that around 30 Lupus patients will be included in the current Lupuzor Phase III trial.

 

 

Lupuzor™ Symposium

 

In June, ImmuPharma organised a number of presentations attended by investors, sell side analysts and media, hosted by Prof. Muller, the inventor of Lupuzor™ in which she presented on the unique 'Mechanism of Action' of Lupuzor™, also known by its chemical name 'Forigerimod' or 'P140' and provided further evidence of the role the P140 molecule can take in the potential treatment of other autoimmune diseases. A video of the presentation is available to view on the Company's website on: http://www.immupharma.org/events/2016.

 

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 $35,000 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 be: 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

 

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.

 

A new patent has been filed (co-owned with CNRS) to cover other autoimmune indications, outside of Lupus, some of which have the potential for Orphan Drug designation. Further preclinical work continues with the objective of further indications moving into the clinic in due course.

 

Nucant Platform

 

The Company's Cancer Nucant program, IPP-204106, is focused on combination therapy approaches. The Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate demonstrated that the maximum tolerated dose was 9 mg/kg, which was the primary objective of the study.  ImmuPharma is now reviewing a number of options to further progress this program.  A grant was awarded by the EU to develop the Nucants in combination with cytotoxic drugs linked to a solid support.  The concept has been validated in pre-clinical studies.

 

The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications.

 

 

 

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.  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).

 

 

Financial Review

 

ImmuPharma's cash balance at 30 June 2016 was £0.66 million (£0.83 million at 31 December 2015, £3.3 million at 30 June 2015).  Further to the Lanstead sharing agreement entered into in February, the Company also has £3.1 million as a derivative financial asset.  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, with 15 tranches outstanding at the 30 June 2016.  The Company also has an asset in respect of a prepayment of £1.75 million of advanced fees to Simbec-Orion at 30 June 2016.  Basic and diluted loss per share were 3.35p and 3.35p respectively (30 June 2015: 1.74p and 1.74p).  In line with the Company's current policy, no interim dividend is proposed.

 

Operating loss for the period was £3.2 million (£1.5 million for the six months ended 30 June 2015).  Research and development expenditure in the period was £2.5 million (£0.87 million for the six months ended 30 June 2015) reflecting primarily the significantly increased expenditure related to the Lupuzor^TM Phase III clinical trial.  Administrative expenses were £733,893 during the Period (£677,111 for the six months ended 30 June 2015).  Consistent with the reclassification of expenses between research and development and administration undertaken for the accounts for the year ended 31 December 2015, the expenses for the 6 months ended 30 June 2015 have also been reclassified to aid comparability.

 

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 continues to be excited by ImmuPharma's potential. We are focused on the late stage clinical development of Lupuzor^™ through its pivotal Phase III trial through to its results, which we are confident of announcing in respect of the top-line data by the end of 2017, and to communicate on a regular basis with shareholders as this trial progresses. We are now also beginning to have dialogue with a number of Lupus patient groups, both in the UK and the USA, and we will increase our efforts within this important and powerful community throughout this year and beyond.

 

ImmuPharma will also progress 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 recent fundraising, 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

29 September 2016