Company Announcements

ImmuPharma plc        

Chairman's Statement

Chairman's Report

The first part of 2024 has been a period of progress for ImmuPharma, with our late-stage pipeline assets, specifically within our P140 autoimmune technology platform, where we have gained new insights into the MOA which is strengthening  our discussions with potential partners.

There has also been continuing significant attention to tight financial management and stability over the period, which is highlighted in the key financial highlights. But in summary, this is  reflected in the operating loss for the period reducing to £0.4m down from £0.8m for the previous period.  

P140 / SLE & CIDP

Preparation for a new international, dose-range, Phase 3 study in systemic lupus erythematosus ("SLE") is underway with Simbec-Orion, our appointed Contract Research Organisation ("CRO").

There are a number of  significant improvements in the new Phase 3 study design compared to the one completed by ImmuPharma in 2018. Of particular note are dose levels of P140, administered through subcutaneous injection, which will be significantly higher.  

Our second major clinical study addresses chronic idiopathic demyelinating polyneuropathy ("CIDP"), a high medical need autoimmune disease. The Company received positive feedback from the Food and Drug Administration (FDA) at a Pre-Investigational New Drug Application (pre-IND) meeting for a late-stage Phase 2/3 adaptive clinical program. CIDP is a rare disease and qualifies as an orphan indication.  

An IND application is now being prepared for submission to the FDA, incorporating all guidance points and Simbec-Orion has been appointed as the CRO for this program.

New insights into P140's mechanism of action ("MOA") explain why it is the only non-immunosuppressing therapy in clinical development in the industry for autoimmune diseases. P140's MOA supports its potential as a therapy for patients suffering from a multitude of autoimmune diseases that are caused by the same underlying malfunction. This agrees with preclinical animal models where P140 has demonstrated efficacy in several autoimmune diseases, for example, asthma (acute and chronic), gout, periodontitis, IBD and Sjogren's disease.

Centre National de la Recherche Scientifique (CNRS)

ImmuPharma continues to have important collaboration arrangements with the Centre National de la Recherche Scientifique ("CNRS"), the French National Council for Scientific Research and the largest basic research organisation in Europe.

Anti-Infection

Anti-infection (antifungal and antibacterial) was chosen as a core therapy focus because of the continual emergence and threat of new and drug-resistant fungi and bacteria.   

The innovative peptide technology at ImmuPharma Biotech has been a huge success and very recently has given rise to two novel development programs, out of which we have identified two core programs, in pre-clinical development: BioAMB and BioCin, which we believe have the best commercial opportunity and speed to market. The new entities include BioAMB (a new antifungal based on amphotericin-B) and BioCIN (a new antibacterial based on vancomycin) and will be fully patent protected.

Interest in Incanthera Plc

On 3rd June 2024 the Company sold its investment in shares in Incanthera plc. All of the 9,904,319 shares held at the year end were sold at 15p per share realising gross proceeds of £1.5 million. ImmuPharma continues to hold 7,272,740 warrants in Incanthera plc. As of 6 September 2024, the warrants have been extended to 31 March 2025. See announcement issued on 9 September 2024 for further information.

Current Activities and Outlook

We remain committed as a Board, on the development of P140 in SLE and CIDP, our two key late-stage clinical assets, together with securing additional partnering for P140. We have made significant scientific progress over the last period, including refinement of the protocols for the SLE and CIDP studies and new insights into the MOA of P140, and as a result, we have a high level of confidence of the success of these new studies.

We will also continue to concentrate on securing further commercial and partnering deals, on which we have made significant progress over the last 6 months.

On an operational level, we have continued our focus on tight cost controls and maximising the use of outsourcing to keep our committed overhead costs to the minimum. This is illustrated very clearly in the reduction of our operating loss for the period to £0.4m down from £0.8m for the same period last year. We have also strengthened the balance sheet and extended our cash runway by successfully selling our shareholding in Incanthera, whilst still retaining a further 7.3 million warrants.

We look forward to providing further updates on the progress of our pipeline and commercial deals throughout the remaining period of 2024 and moving into 2025.

In closing, we would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including CNRS and Avion.

Tim McCarthy                   

Chairman & CEO

6^th September 2024