ImmuPharma PLC (LSE:IMM), (Euronext Growth Brussels: ALIMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its final results for the twelve months ended 31 December 2020 (the "Period").
Key Highlights (including post Period review)
· Stable financial performance over the Period
o Cash balance of £5.9m (31 December 2019: £1.4m)
o Derivative financial asset of £1.2m (31 December 2019: £2.3m)
o Incanthera financial asset of £1.8m (£0.7m at 31 December 2019) and warrants financial asset of £0.6m (£Nil at 31 December 2019)
o Convertible loan notes of £0.6m (£Nil at 31 December 2019)
o Loss for the period of £6.9m (31 December 2019: £6.1m)
o Research and development expenses of £2.4m (31 December 2019: £2.7m)
o Administrative expenses of £1.8m (31 December 2019: £1.8m)
o Share based expense of £1.6m (31 December 2019: £2m)
o Finance cost of £1.7m (31 December 2019: £0.5m) due to loss on derivative financial asset
o Basic and diluted loss per share of 3.43p (31 December 2019: 3.99p)
o £1.5m subscription agreement through the issue of 15,000,000 new ordinary shares - March 2020
o Funds raised from US healthcare investors of £2.4m/$3m (face value) - June 2020
o US healthcare investors converted part of their loans into equity, resulting in 7,437,226 ordinary shares issued in 2020
o Placing of new ordinary shares of £6.5m (gross) - September 2020
· Licence and development agreement with Avion Pharmaceuticals progress:
o Avion has had a number of progressive discussions with the FDA over 2020 culminating in a Type 'A' meeting on 4 December 2020
o Based on positive guidance and feedback from FDA there is now a clear regulatory pathway to commence the Phase III trial in H2 2021
o Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™, prior to the commencement of the Phase III study
o Final guidance meeting between Avion and the FDA anticipated in Q2 2021
o Discussions continue with potential partners for Lupuzor™ outside of US in key territories
· Proof of Concept study planned for Lupuzor™ in CIDP patients - potential Orphan Drug designation
Other program developments through Ureka Pharma SAS
· Three therapy areas: Anti-Infectives, Metabolism and Cancer - these programs include:
o Anti-Infective: BioAMB (Anti-Fungal) - lead optimisation completion
o Metabolism: BioGlucagon - rescue therapy for low sugar events in diabetes
o Cancer: Nucant, IPP-204106
o All programs provide potential future partnering opportunities
Incanthera plc, oncology specialist where ImmuPharma retains 13.37% shareholding
· Listed on Aquis Stock Exchange in February 2020
· Successful study results for 'Sol', its skin cancer technology and positive data from Sensitisation study
Audited Annual Report and Accounts
· The Annual Report for the year ended 31 December 2020, will today be published on the Company's website. Copies of this Report, including the Notice of Annual General Meeting, will be posted to shareholders in the near future. To view the Report please go to: www.immupharma.co.uk.
Commenting on the statement and outlook Tim McCarthy, Chairman, said: "Despite the continuing disruption of the Covid -19 pandemic, we remain focused, in collaboration with our partner Avion, on expediting Lupuzor™ into a new optimised, international Phase III study in Lupus patients in H2 2021. The most recent positive feedback from the FDA confirms our envisaged roadmap forward.
"In parallel, we continue to progress our other R&D programs which includes our anti-fungal BioAMB therapy, which has the potential of progressing quickly through initial bio-equivalence trials. Discussions for potential partnering opportunities are continuing. These initiatives create further opportunities in the medium to long term.
"In response to strong investor interest last year, we were delighted to welcome new and returning institutional and private investors as part of three successful capital raisings. This has created a robust financial position with an anticipated cash runway until the end of 2023.
"As we move our key asset, Lupuzor™ into a new international optimised Phase III trial and continue to progress our development pipeline, the investment thesis of ImmuPharma continues to strengthen and we look forward to providing further value enhancing progress updates over the next period to create long term shareholder value for our shareholders.
"Finally, the Board would like to take this opportunity to t