On May 24, 2019 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is reported its final results for the twelve months ended 31 December 2018 (the "Period") (Press release, ImmuPharma, MAY 24, 2019, View Source [SID1234536567]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Key Highlights (including post Period review)
Stable financial performance over the Period
– Cash balance of £4.9 million (31 December 2017: £2.7 million)
– Loss for the period of £7.2 million (31 December 2017: £6.2 million)
– Research and development expenses of £4.7 million (31 December 2017: £5.1 million)
– Basic and diluted loss per share of 5.19p (31 December 2017: 4.75p)
– A successful, £10 million (gross) fundraising completed in January 2018
– Acquired a 15% stake in Incanthera Limited for £2 million
Lupuzor
Top line results of the Company’s pivotal Phase III trial of Lupuzor were announced on 17 April 2018– key highlights include:
Lupuzor demonstrated a superior response rate over placebo (52.5% vs 44.6% "responders") in the primary analysis on the Full Analysis Set of all 202 patients. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met
Across the whole study population, in those patients who had anti-dsDNA autoantibodies, Lupuzor demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) Lupuzor plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218)
The study confirmed the outstanding safety profile of Lupuzor, with no serious adverse events reported
Follow-on ‘extension’ open label study
– A total of 62 eligible patients from the original Phase III trial recruited
– The study is anticipated to report results in Q2 2019
Discussions continue with potential corporate partners as well as consulting with regulatory advisors on potential pathways to market. Whilst these activities continue, the commencement of the Managed Access Program for Lupuzor is postponed, until further clarification on these activities gained
As announced on 7 May 2019, a renewed focus on developing the P140 platform within different auto-immune indications outside of lupus – following encouraging pre-clinical data
Other program developments
Within our two further platforms, Elro Pharma (Nucant) and Ureka Sarl (Peptide), ImmuPharma is exploring options to license, divest or ‘spin-off’ the technologies of both of these subsidiaries to unlock future potential and enhance value to shareholders – as announced on 7 May 2019
All negotiations with Incanthera Limited on the Nucant cancer programme and broader collaboration discussions have now terminated – as announced on 7 May 2019
Advisors appointments
– Spark Advisory Partners Limited appointed as Nominated Advisor in December 2018
– Stanford Capital Partners and SI Capital appointed as Join Brokers in September 2018
Commenting on the statement and outlook Tim McCarthy, Chairman, said: ‘We are pleased to report our results for 2018 as well as the key highlights for our programs. Following on from the Phase III results, we are focused on progressing Lupuzor and the P140 autoimmune platform. Our plans to combine and either divest, spin off or license Elro Pharma (Nucant) and Ureka (Peptide Platform) are planned to unlock value for shareholders. We look forward to reporting on these developments in the coming months. We would also like to take this opportunity to thank our shareholders, scientific advisors, corporate collaborators and the CNRS.’
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")