Company Announcements

Chairman's Report

The year 2024 was a period of further progress for ImmuPharma as we continued to focus on progressing our late-stage pipeline assets specifically, within our P140 autoimmune technology platform. This positive progress, I am pleased to say, has continued into the first period of 2025.

In January 2025, we announced innovative groundbreaking advancements in our preclinical research program focused on P140 and the pathogenesis of autoimmune diseases. This new discovery, conducted by the Company's R&D subsidiary ImmuPharma Biotech, has yielded data that provides novel insights into autoimmune disease mechanisms. Importantly for our autoimmune therapy P140, these findings pave the way for earlier and more accurate diagnostics; identifying patients most likely to respond to P140 therapy; and improved monitoring of the patient's response to treatment with P140

In March 2025, we announced a significant milestone in evidencing for the first time key hypotheses in the unique mechanism of action ("MOA") of our P140 autoimmune technology platform. Importantly, these new discoveries highlight that: P140 has a unique MOA, P140 is non‐immunosuppressive, and P140 is effective and safe.

The favourable impact of P140 on immune system homeostasis also supports P140 as a new potential standard of care for patients suffering from a multitude of autoimmune diseases, that are caused by the same underlying malfunction. This also agrees with many preclinical animal models of autoimmune diseases where P140 has clearly demonstrated efficacy.

Based on this recent  progress and insights into P140's MOA and autoimmune disease, the Company is actively in discussions with a number of potential global commercial partners. 

P140 - SLE New dose strategy, study design and MOA clarity

There are an estimated 1.5 million people suffering from SLE in the US (source: Lupus Foundation of America), and an estimated 5 million globally. The prevalence in China may be 3-4 times that seen in the US. Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited efficacy, with over 60 per cent of patients not adequately treated.

ImmuPharma believes P140 has the potential to be a novel specific drug therapy for the treatment of SLE by specifically restoring an imbalanced immune system and halting disease progression in many autoimmune diseases, of which SLE is a well-known example.

The P140 program was re-examined in 2021/22, and the Board decided that it required a completely different approach. The result of this was to redesign all future clinical studies creating a superior product offering and target product profile. The three pillars of strength and confidence in our new program are dose, design and MOA.

After three FDA guidance meetings in previous years, further human and animal pharmacokinetics studies and reconciliation with efficacy demonstrated in the animal models, it was concluded that the previous dose used in clinical studies was significantly too low. The new  dose will be up to 20 times higher than the 200 micrograms used previously.

We expect no adverse events that could lead to product label warnings seen with all other approved drugs and standard of care. In addition, a key objective will be to taper the use of steroids which are currently the standard of care.

The lack of immunosuppression is explained by our refined MOA. All other molecules currently in development possess varying degrees of immunosuppression, which give rise to side effects and limit the dose that can be used to achieve efficacy.

The use of oral steroids in most SLE patients as standard of care (SoC) therapy is contrary to the action of P140 and will modify the efficacy of most drugs being tested. Therefore, because P140 restores the immune system to normal, there should be no need for steroid use. Consequently patients will have their oral steroid therapy adjusted down. Downward adjustment or 'titration' by the study physician, should be easier in the P140 treated group than the placebo group and as such will allow even greater delineation of benefit from P140.

New MOA evidence highlight:

·      P140 has a unique MOA: The results provide direct evidence for the first time of a major key hypothesis of the unique MOA of P140.

·      P140 is non-immunosuppressive: Unlike the most advanced therapies currently available for the treatment of autoimmune diseases, these findings indicate that P140 does not reduce or block the body's ability to mount a specific immune response.

·      P140 Immune Signature: These findings confirm P140's potential as a safe and effective treatment for patients suffering from systemic lupus erythematosus (SLE).

These discoveries result from a new preclinical study designed by ImmuPharma Biotech's team and conducted at a world leading Laboratory in the USA. While detailed data will be released in due course, these findings allow ImmuPharma to further expand its intellectual property portfolio, with additional new patents, strengthening the commercial viability of the P140 technology platform.

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. This is where P140 platform was invented by Prof. Sylviane Muller, Emeritus Research Director at the CNRS. Through this partnership, the CNRS will be entitled to receive from ImmuPharma low double-digit royalty payments of funds received by ImmuPharma from Avion through the Licence and Development Agreement and through further commercialisation deals for territories outside of the US.

Pipeline Overview 

ImmuPharma is a biopharmaceutical company that specialises in the usage and development of biopolymers, specifically peptides.

Our research strategy is based on two strategic axes: research based on external collaboration aimed at discovering new active ingredients, which has led to the development of our most advanced project in terms of clinical development: P140, an active peptide against autoimmune diseases including SLE and internal research based on the use of molecular programming technologies, which has notably led to the development of the BioAMB (antifungal) and BioCIN (antibacterial) projects.

This research, for original biopolymer-based active compounds, has led us to collaborate with the world-renowned Centre National de la Recherche Scientifique, (CNRS) in France. This collaboration enables us to access innovative research with substantial embedded value and to work with many leading scientists and clinicians.

ImmuPharma has exclusive rights to all of its intellectual property assets. Since a major Board and management restructuring in 2021, the team has refocused its key pipeline portfolio to maximise long-term shareholder value.

Our late-stage to preclinical pipeline is focused on two core therapeutic areas; autoimmunity and anti-infectives.

Autoimmunity

P140 is a peptide discovered by Professor Sylviane Muller and licensed to the Company by our long standing collaboration partner, the CNRS. Due to its "restorative" action on the immune system, P140 is a technology platform that can be applied across many autoimmune diseases. The Company is currently in clinical development of P140 for the treatment of SLE and CIDP with a view to expanding the clinical program into other selected autoimmune diseases

P140  for SLE

P140 is a peptide technology platform that targets autoimmune diseases such as SLE. Like all autoimmune diseases there is currently no cure against SLE. There are 2 approved monoclonal antibody treatments that are prescribed for SLE patients but most cases are treated with steroids. Overall, the treatments are mainly immunosuppressants which can have significant side effects.

·      P140 has the potential to be a new standard of care therapy for the treatment of SLE.

·      P140 has a unique MOA: Recent results provide direct evidence for the first time of a major key hypothesis of the unique MOA of P140.

·      P140 is extremely safe, well-tolerated and patient friendly, and potentially can be self-administered through a subcutaneous injection, twice monthly for SLE.

P140 for CIDP

P140 shows compelling pre-clinical data in Chronic Inflammatory Demyelinating Polyneuropathy ("CIDP"), a progressive inflammatory condition of the nerves.

P140's efficacy has been proven in early pre-clinical models of CIDP.

Applications for full FDA IND and orphan drug designation will be submitted in due course.

P140 offers the potential to:

·      reduce the frequency of CIDP disease flares

·      reduce the need for hospital Intravenous Immunoglobulin Therapy (IVIg) therapy

·      convenience of a simple auto-injection twice monthly by patient at home

·      reduce costs for patient and healthcare system

P140 - Other indications

A number of additional autoimmune-related indications have already been identified in pre-clinical studies for the P140 platform. They all share the same common cause at the mechanistic level of the cell. Pre-clinical studies have confirmed P140 activity in asthma (acute and chronic), gout, periodontitis and IBD. There have been no new significant drug classes addressing these indications for many years.

What next?...

ImmuPharma has built up invaluable scientific knowledge by developing a peptide compound which can potentially treat a range of autoimmune diseases. Building on this experience, we are developing a new active peptide, targeting specific autoimmune pathologies. This new research programme is perfectly aligned with our strategic priorities. It's a very exciting project that should create further opportunities for the Company.

P140 for CIDP (continued)

Anti-Infection

Anti-infectives were chosen as a core therapy focus because of the ever-looming threat of new and resistant organisms, with few significant new products or even classes having been discovered or developed now for many years.

The innovative peptide technology at ImmuPharma Biotech has been a huge success and has given rise to a number of 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. Despite the preclinical stage, these programs are based on existing drugs that have been used for decades so the PK, efficacy and safety of those drugs is well understood. They will also be patent protected.

BioAMB | for systemic fungal infections

BioAMB is a groundbreaking amphotericin-B variant that promises both efficiency and safety.

Although AMB is highly effective, currently marketed AMB formulations may cause serious kidney toxicity and other severe reactions. BioAMB is not a typical reformulation but a Bio-drug entity which releases AMB as the active agent.

BioAMB aims to:

·      Significantly reduce toxicity and improve tolerance to amphotericin-B therapy

·      Use a simple injection vs IV infusion

·      Improve the frequency & duration of therapy

·     Provide a more powerful alternative to existing 1st line azole antifungal therapy where there is increasing resistance.

BioCIN | for severe bacterial infections

BioCIN is an innovative vancomycin-based treatment for efficient, safe, anti-infection treatment.

Vancomycin, a generic drug, is a last resort therapy for the treatment of sepsis and lower respiratory tract, skin, and bone infections caused by Gram-positive bacteria and the killer bug methicillin-resistant Staphylococcus aureus (MRSA).

Marketed since 1954, it is poorly absorbed from the gut and currently requires carefully controlled IV therapy over many hours.

BioCIN aims to:

·      Significantly reduce toxicity and improve tolerance to vancomycin therapy

·      Use a simple injection &/or oral admin vs IV infusion

·      Improve the frequency & duration of therapy

·      Improve efficacy through improved tolerance

Interest in Incanthera Plc

On 3rd June 2024 the Company sold its investment in shares in Incanthera plc, which trades on Aquis Stock Exchange ("AQSE") under the ticker (TIDM:INC). All of the 9,904,319 shares were sold at 15p per share realising gross proceeds of £1.5 million.

As at 31 December 2024, ImmuPharma held 7,272,740 warrants options in Incanthera plc. The warrant options have an exercise price of 9.5p pence. As announced in September 2024, the term of these Warrants had been extended by 6 months to 31 March 2025, being the same price at which new shares were issued in the Placing accompanying Incanthera's listing in 2020.

More recently on 1 April 2025 ImmuPharma agreed with Incanthera to further extend the exercise period in the Warrant Instrument, to 30 September 2025.

ImmuPharma shall pay Incanthera a profit share ("Profit Share") upon exercise of the Warrants, equal to 30% of the difference between the Subscription Price and the closing market price of Incanthera Shares on AQSE, on the day of exercise of the Warrants or, if the Warrant Shares are contracted to be sold within 10 days of exercise, then the Company shall pay to Incanthera a profit share of 30% of the difference between the Subscription Price and the contracted market sale price.

Other than the change in the expiry period to 30 September 2025 and the introduction of the Profit Share mechanism, as detailed above, all other provisions in the Warrant Instrument remain the same.

Current Activities and Outlook

We have made significant scientific progress over 2024 and into 2025, most importantly, announcing innovative groundbreaking advancements on P140 and the pathogenesis of autoimmune diseases. Importantly paving the way for earlier and more accurate diagnostics; identifying patients most likely to respond to P140 therapy; and improved monitoring of the patient's response to treatment with P140

In addition, we also announced a significant milestone in evidencing for the first time key hypotheses in the unique mechanism of action ("MOA") of our P140 autoimmune technology platform. Importantly, these new discoveries highlight that: P140 has a unique MOA, P140 is non‐immunosuppressive, and is effective and safe.

As a Board, we remain focused on bringing P140  to the market, and  securing additional partnering deals for P140 as well as other assets within our portfolio.

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