On April 30, 2020 ImmuPharma plc (LSE:IMM), (Euronext Growth Brussels: ALIMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its final results for the twelve months ended 31 December 2019 (the "Period") (Press release, ImmuPharma, APR 30, 2020, View Source [SID1234556801]).
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Key Highlights (including post Period review)
Stable financial performance over the Period
– Cash balance of £1.4 million (31 December 2018: £4.9 million)
– Loss for the period of £6.1 million (31 December 2018: £7.2 million)
– Research and development expenses of £2.7 million (31 December 2018: £4.7 million)
– Administrative expenses of £1.8 million (31 December 2018: £1.7 million)
– Share based expense of £2 million (31 December 2018: £1.8 million)
– Basic and diluted loss per share of 3.99p (31 December 2018: 5.19p)
– 2 successful fundraisings, completed in June 2019 and March 2020, securing in total approximately £4.2 million spread over 24 months
– Dual listing on Euronext Growth Brussels in December 2019
‘Autoimmunity’: Lupuzor
Open label extension study – following completion of Lupuzor’s Phase III trial, an open label extension study undertaken. Analysis of results announced on 28 June 2019
– 62 eligible patients enrolled throughout the US/EU completing 24-week treatment period
– Primary endpoint successfully achieved confirming safety profile of Lupuzor
– No ‘serious adverse events’ related to Lupuzor reported
– Insights into the Phase III data allow optimised Lupuzor phase III design to progress
Licence and development agreement signed in November 2019 with Avion Pharmaceuticals
– Exclusive rights for US with Avion
– Avion to fund new ‘optimized’ international Phase III trial, up to $25m
– Milestones up to $70m & tiered double-digit royalties up to 17%
– Data from Phase III trial allows approvals in key ex-US markets
– Avion to explore peptide’s potential in other auto-immune diseases for US market
– Discussions continue with potential partners for Lupuzor outside of US in key territories
Post review period
– Avion strengthened advisory team for Lupuzor Phase III trial, including collaboration with leading lupus patient group and formation of KOLs – all senior respected consultants within lupus and autoimmune community in US/EU
Proof of Concept study planned for Lupuzor in CIDP patients – potential Orphan Drug designation
Other program developments: Nucant and Peptide program combined to form Ureka Pharma SAS
Three therapy areas: Cancer, Metabolism and (new) Anti-Infectives (Anti-Viral, Anti-Bacterial, Anti-Fungal) – these programs include:
– Anti-Infective: new BioAMP-B (Anti-Fungal) product for lung infections
– Metabolism: new BioGlucagon product – rescue therapy for low sugar events in diabetes
– All programs provide future partnering opportunities
Incanthera plc oncology specialist in which ImmuPharma retains 11.9% shareholding, listed on Aquis Stock Exchange ("AQSE", formerly NEX Exchange) in February 2020