ImmuPharma remain focussed on achieving full regulatory approval of Lupuzor with US partner Avion

ImmuPharma plc (LON:IMM), the specialist drug discovery and development company, is pleased to announce its final results for the twelve months ended 31 December 2019.

Key Highlights (including post Period review)

·    Stable financial performance over the Period

o Cash balance of £1.4 million (31 December 2018:  £4.9 million)

o Loss for the period of £6.1 million (31 December 2018:  £7.2 million)

o Research and development expenses of £2.7 million (31 December 2018: £4.7 million)

o Administrative expenses of £1.8 million (31 December 2018: £1.7 million)

o Share based expense of £2 million (31 December 2018: £1.8 million)

o Basic and diluted loss per share of 3.99p (31 December 2018: 5.19p)

o 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

o  62 eligible patients enrolled throughout the US/EU completing 24-week treatment period

o  Primary endpoint successfully achieved confirming safety profile of Lupuzor™

o  No ‘serious adverse events’ related to Lupuzor™ reported

o  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

o Exclusive rights for US with Avion

o Avion to fund new ‘optimized’ international Phase III trial, up to $25m

o Milestones up to $70m & tiered double-digit royalties up to 17%

o Data from Phase III trial allows approvals in key ex-US markets

o Avion to explore peptide’s potential in other auto-immune diseases for US market

o Discussions continue with potential partners for Lupuzor™ outside of US in key territories

·      Post review period

o 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:

o Anti-Infective: new BioAMP-B (Anti-Fungal) product for lung infections

o Metabolism: new BioGlucagon product – rescue therapy for low sugar events in diabetes

o 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

Commenting on the statement and outlook Tim McCarthy, Chairman, said: “The Board has been focused on delivering a business strategy, which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, knowhow, collaborations and funding.  In the medium term, we remain focussed on achieving the full regulatory approval of Lupuzor™ in conjunction with our US partner, Avion, which we believe has the potential to be a ground breaking drug for lupus patients with blockbuster potential in commercial terms. Both companies are focused on expediting Lupuzor™ into a new optimised international Phase III study. Avion’s strengthening of its team of advisors to include a collaboration with a leading lupus patient group and the formation of KOLs, all of whom are senior respected consultants within the lupus and autoimmune community in the US and Europe, only enhances this strategy. In parallel, discussions are continuing with a number of potential commercial partners for Lupuzor™ outside of the US.

“Within the P140 Lupuzor™ platform and having confidence in the data gained from the lupus trials already completed, we can see real opportunities by expanding the disease targets and are now focussing our efforts on a Proof of Concept study in CIDP patients.

“In also broadening our R&D programs we are excited by the potential of our anti-fungal Bio-AMP-B therapy and our new BioGlucagon program, both have the potential of progressing quickly through initial bio-equivalence trials whilst in parallel opening up discussions for potential partnering opportunities. These initiatives continuing to create further opportunities in the medium to long term to enhance shareholder value.

“We are in a new chapter within ImmuPharma’s history, with the investment thesis for the Company and specifically Lupuzor™ being repositioned and we look forward to providing further updates on progress with shareholders over the next period.

“Lastly, the Board would like to thank its shareholders including Lanstead for their support as well as its staff, corporate and scientific advisers and our partners including Simbec-Orion, CNRS and our new partner for Lupuzor™, Avion, for their continued efforts and collaborative expertise.”

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