On outlook Tim McCarthy, Chairman Immupharma PLC (LON:IMM), said: “ImmuPharma is focused on ensuring the successful development of the late stage clinical development of Lupuzor(TM) through its pivotal Phase III trial. The key milestone this year is the completion of the recruitment of the 200 Lupus patients with top line results announced by the end of 2017, and management will continue to communicate on a regular basis with shareholders as this trial progresses.
The Board would like to thank its shareholders, both those longstanding and those who participated in the recent fundraising, for their support, as well as its staff, corporate and scientific advisors including Simbec-Orion and the CNRS for their continued collaboration.”
ImmuPharma PLC (LSE:IMM) the specialist drug discovery and development company, has told DirectorsTalk its preliminary results for the year ended 31 December 2015.
Key Highlights:
Lupuzor(TM)
— Pivotal Phase III clinical trial for Lupuzor(TM) , the Company’s lead programme for the potential breakthrough compound for Lupus, is progressing, in conjunction with Simbec-Orion, an international clinical research organisation (“CRO”) conducting the study, in 10 centres in US and 35 centres across Europe, with recruitment underway to enrol 200 patients
— Phase III trial is fully funded following GBP8.4 million placing in February and March 2016 (post-period end)
— An Investigators Meeting was held in Paris in December bringing together key specialists in the field of Lupus actively involved as clinical investigators in the Phase III Lupuzor(TM) pivotal trial
-- First US sites commenced dosing Lupus patients in February 2016 (post-period end)
Wider program developments
— ImmuPharma, in conjunction with the Centre National de la Recherché Scientifique (“CNRS”), continues to focus on expanding its Forigerimod (Lupuzor’s chemical name, or P140) auto immune pipeline
o A new patent has been filed outside of Lupus, which has the potential for Orphan Drug designation
— The Company’s Cancer Nucant program, IPP-204106, demonstrated within its Phase I/IIa dose-finding adaptive study that the maximum tolerated dose was 9 mg/kg, which was the primary objective of the study. A number of options are under review to further progress this program
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
Further notable events
-- Tim McCarthy appointed as Non-Executive Chairman -- Dr Stephane Mery appointed as Non-Executive Director
— Prof. Sylviane Muller, inventor of Lupuzor(TM) , awarded ‘The CNRS Medal of Innovation’ for discoveries made on the mechanism of action of Lupuzor(TM) and its applications to other autoimmune diseases
GBP8.4 million fundraising and EIS/VCT qualifying status (post-period end)
— In February and March 2016, the Company completed a GBP8.4 million fundraising to principally progress the pivotal Phase III trial for Lupuzor(TM) as well as providing working capital requirements into 2018
-- Advance assurance received from HMRC for VCT and EIS qualifying status
Financial Summary
-- Cash position as at 31 December 2015 of GBP0.8m (2014: GBP5.4m) -- Loss for the period of GBP3.9m (2014: GBP2.9m) -- Basic and diluted loss per share of 4.40p (2014: 3.43p)
Announced Today: Prof. Sylviane Muller: London Lupuzor Symposium June 8 & 9, 2016
— A number of key symposiums will be hosted during this two day event where Prof. Muller will present on the unique ‘Mechanism of Action’ of Lupuzor(TM), also known by its chemical name ‘Forigerimod’ or ‘P140’. Prof. Muller will also provide further evidence of the role the P140 molecule can take in the potential treatment of other autoimmune diseases. For more information please email lisa.baderoon@immupharma.com
