Immupharma Regulatory News (IMM)

RNS: RELEASE | 9 September 2024

ImmuPharma PLC

("ImmuPharma" or the "Company")

INTERIM RESULTSfor the six months ended 30 June 2024

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its interim results for the six months ended 30 June 2024 (the "Period").

Key Highlights (including post Period review)

Financials

· Loss for the Period of £0.4m (30 June 2023: £0.8m)

· Research and development expenses of £0.5m (30 June 2023: £0.8m)

· Administrative expenses of £0.3m (30 June 2023: £0.4m)

· Share based expense of £0.03m (30 June 2023: £0.1m)

· Cash balance of £1.1m as at 30 June 2024 (30 June 2023: £0.2m)

· Derivative financial asset of £0.5m as at 30 June 2024 (30 June 2023: £0.3m)

· Basic and diluted loss per share of 0.09p (30 June 2023: 0.25p)

Portfolio

P140 technology platform

· New insights into P140's mechanism of action ("MOA") confirms its position as the only non-immunosuppressing therapy in clinical development in the industry for autoimmune diseases

· P140's MOA support its potential not only for SLE sufferers, but for patients suffering from a multitude of autoimmune diseases that are caused by the same underlying immune system malfunction

· In April 2024, the Company announced that it has initiated a new intellectual property strategy to significantly enhance the patent life and commercial value for its P140 technology platform

SLE (Lupus)

· A Phase 3 dose-range study of P140 continues preparation in collaboration with Simbec-Orion, the designated Contract Research Organisation ("CRO")

· The new international SLE Phase 3 dose-range study design and protocol is substantially different from the previous Phase 3 clinical trial completed by ImmuPharma in 2018

· The monthly dose level administered by subcutaneous injection will be significantly higher

CIDP

· A Phase 2/3 adaptive clinical study of P140 in CIDP is planned following positive guidance from a Pre-Investigational New Drug (PIND) meeting with the FDA last year

· An IND application is now close to submission to the FDA, incorporating all guidance points

· Simbec-Orion, has been appointed as the CRO for this program

Preclinical Portfolio

· The core anti-infective program with antifungal (BioAMB) and antibacterial (BioCIN) candidates are progressing through pre-clinical studies

· The non-core anticancer collaboration with Orano SA is ongoing

Incanthera

· On 3 June 2024 ImmuPharma divested its investment in shares in Incanthera. 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.

· Announced today: As confirmed by a separate announcement issued today, the warrants of 7,272,740 held in Incanthera have been extended to 31 March 2025. See separate announcement for full details of the transaction.

Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:

"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."

Market Abuse Regulation (MAR) Disclosure

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

A copy of the interim report is available on the Company's website www.immupharma.co.uk

ImmuPharma plc

INTERIM RESULTS

FOR THE SIX MONTH PERIOD ENDED 30 JUNE 2024

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

6th September 2024

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2024

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE PERIOD ENDED 30 JUNE 2024

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2024

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2023

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2024

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024

1 ACCOUNTING POLICIES

Basis of preparation

The interim financial information in this report has been prepared using accounting policies consistent with IFRS as adopted by the United Kingdom. IFRS is subject to amendment and interpretation by the International Accounting Standards Board (IASB) and the IFRS Interpretations Committee and there is an ongoing process of review and endorsement by the UK Endorsement Board. The financial information has been prepared on the basis of IFRS expected to be adopted by the United Kingdom and applicable as at 31 December 2023. The Group has chosen not to adopt IAS 34 "Interim Financial Statements" in preparing the interim financial information.

The accounting policies applied are consistent with those that were applied to the financial statements for the year ended 31 December 2023.

Non-Statutory accounts

The financial information set out in this interim report does not constitute the Group's statutory accounts, within the meaning of Section 434 of the Companies Act 2006. The statutory accounts for the year ended 31 December 2023 have been filed with Registrar of Companies. The auditors reported on those accounts; their report was unqualified, did not contain a statement under either Section 498 (2) or Section 498 (3) of the Companies Act 2006 but did include emphasis of matter paragraph relating to the carrying value of Parent Company's investment in subsidiaries and receivables due from group undertakings, and a reference to which the auditor drew attention by way of emphasis without qualifying their report in respect of going concern.

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024

(Continued)

2 LOSS PER SHARE

There is no difference between basic loss per share and diluted loss per share as the share options and warrants are anti-dilutive. Deferred shares are excluded from the loss per share calculation as they have no attributable earnings.

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024

(Continued)

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024

(Continued)

5 Issued share capital

At 30 June 2024, the Company had no limit on its authorised share capital.

6. Subsequent events

On 6 September 2024, the 7,272,740 warrants held in Incanthera Plc were extended from 6 September 2024 to 31 March 2025 for a consideration of £75,000.