ImmuPharma PLC “Pivotal Phase III trial is progressing on track”

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.”

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, this morning announced 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

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’.

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

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

The Company successfully raised £8.4 million (gross) to fund the pivotal Phase III LupuzorTM trial and to support the Company’s working capital requirements

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

Advance assurance received from HMRC for VCT and EIS qualifying status

 

 

·     Wider program developments

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

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. 

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

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

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

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

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

 

 

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