ImmuPharma PLC (LON:IMM), the specialist drug discovery and development company, has today provided its final results for the twelve months ended 31 December 2016 (the “Period”).
Key Highlights (including post Period review)
· Lupuzor™: is the Company’s lead program 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 active in US with 70 patients
§ Five European countries with 81 lupus patients taking part in trial: Czech Republic, France, Germany, Hungary and Poland
§ One Mauritius site with 49 lupus patients included in trial
o Most recent update on progress of Lupuzor™ trial announced on 17 May 2017
o Top line results anticipated in Q1 2018
· Prof Sylviane Muller, inventor of P140, held a number of key symposiums hosted in London, 8-9 June 2016, where she presented on the unique ‘Mechanism of Action’ of P140, the scientific name of LupuzorTM, also known by its chemical name ‘Forigerimod’.
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 have Orphan indications
· Three successful, value accretive fundraisings – to support Lupuzor™’s Phase III trial and working capital requirements
o £8.4 million (gross) fundraising completed in February and March 2016 at 26 pence per share
o £1 million (gross) in October 2016 associated with a £3.5 million Vendor Placing at 35 pence per share
o £4.1 million (gross) fundraising in March 2017 at 52 pence per share
o All three fundraisings were supported by existing long term shareholders together with the addition of new blue chip institutions
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 Cancer Research, the prestigious medical journal of the American Association for Cancer Research (“AACR”), has published a fundamental scientific paper highlighting the unique mechanism of action of IPP-204106 (announced 16 November 2016)
o ImmuPharma and CNRS have filed a series of new co-owned patents controlling the Company’s peptide platform technology URELIX, with Type II diabetes and NASH (Non-Alcoholic-Steato-Hepatitis) being the first therapeutic areas to be targeted. This technology allows inter alia outstanding properties in terms of duration of action.
· Northland Capital Partners appointed as sole broker and NOMAD
· Stable financial performance over the Period, in line with market expectations
o Net assets of £5.5 million (31 December 2015: £1.7 million).
o Loss for the period of £5.3 million (31 December 2015: £3.9 million)
§ Research and development expenses of £5.3 million (31 December 2015: £3 million)
o Basic and diluted loss per share of 4.54p (31 December 2015: 4.40p)
· Prof. Sylviane Muller – Finalist for the European Inventor Award 2017: ‘Invention’ Category “Treating Lupus by Targeting T-cells”
§ Forthcoming ‘Investor’ Event on 30 June 2017
o ImmuPharma will be hosting an Investor Presentation and luncheon immediately following the Company’s Annual General Meeting, currently scheduled for Friday 30 June, in the City of London. Further details will be disclosed when ImmuPharma’s Report and Accounts are posted to shareholders in the next week. Please contact Lisa Baderoon at lisa.baderoon@immupharma.com if you would like to attend this event.
Commenting on the statement and outlook Tim McCarthy, ImmuPharma PLC Chairman, said: “We have achieved a number of significant milestones during this period including three successful and share price accretive fund raisings.
“We are delighted by the continued progress of our LupuzorTM Phase III study having recently announced that all 200 patients have passed the three month stage, 28 patients have passed the full 12 months of the study and over 80% of patients having had exposure to LupuzorTM for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile. We remain on track to report top line results in Q1 2018.
“The Board would like to thank its shareholders both long-standing and new for their support, as well as its staff, corporate and scientific advisors and the CNRS for their ongoing collaboration.”
