Immupharma Regulatory News (IMM)

RNS: RELEASE | 31 August 2023

ImmuPharma PLC

("ImmuPharma" or the "Company")

INTERIM RESULTSfor the six months ended 30 June 2023

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 2023 (the "Period").

Key Highlights (including post Period review)

Financials

· Loss for the Period of £0.8m (30 June 2022: £1.7m)

· Research and development expenses of £0.8m (30 June 2022: £1.0m)

· Administrative expenses of £0.4m (30 June 2022: £0.6m)

· Share based expense of £0.1m (30 June 2022: £0.1m)

· Cash balance of £0.2m as at 30 June 2023 (31 December 2022: £0.2m)

· Derivative financial asset of £0.6m as at 30 June 2023 (31 December 2022: £0.6m)

· Basic and diluted loss per share of 0.25p (30 June 2022: 0.58p)

· Successful fundraising - see separate announcement today

Portfolio

· In February 2023 an adaptive Phase 2/3 study for Lupuzor™ in SLE/Lupus patients was agreed with US partner, Avion Pharmaceuticals.

· In March 2023 a collaboration with Orano SA on ImmuPharma's peptide technology was announced.

· In May 2023, ImmuPharma received positive guidance from the Food and Drug Administration ("FDA") following the Pre-Investigational New Drug ("PIND") meeting supporting a Phase 2/3 adaptive clinical study of P140 in CIDP.

· In June 2023, confirmation that following receipt of comprehensive guidance from the FDA, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor™) in patients with Lupus will commence in H2 2023.

· Established discussions with new potential corporate partners across the P140 platform and anti-infective programmes.

Corporate

· In August 2023, the Board was strengthened with two NED appointments: Dr Laurence Reilly & Dr Sébastien Goudreau.

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

"We continue to make positive progressive steps for ImmuPharma. As a Board, we remain focused on bringing our two key late stage P140 clinical assets in Lupus and CIDP through their final clinical trials and to the market.

The drive to conclude further commercial and partnering deals will be accelerated over this next period and which is now bolstered by the recently announced new Board appointments.

The Board would like to take this opportunity to thank its shareholders for their continued patience and support, as well as its 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 2023

ImmuPharma plc

Chairman's Statement

The first part of 2023 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 platform.

Most recently in June, the Company announced that, after receiving comprehensive guidance from the Food and Drug Administration ("FDA") on the new Phase 2/3 adaptive clinical trial protocol for the lead programme for the treatment of patients with systemic lupus erythematosus ("SLE/Lupus"), it is moving forward with the study, together with its US partner Avion Pharmaceuticals ("Avion").

Positive progress was also announced in May for a second high medical need disease, chronic idiopathic demyelinating polyneuropathy ("CIDP"). The Company received positive feedback from the FDA at a pre-IND meeting for a late-stage Phase 2/3 adaptive clinical program in patients, which is a further debilitating auto-immune condition within the Company's P140 platform.

In parallel with advancements in the late-stage clinical developments, the Company is also actively in discussions with a number of potential commercial partners for programmes across the Company's development portfolio.

Lupuzor™/P140 - opportunity and next steps

There are an estimated five million people suffering from Lupus, with approximately 5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America). The prevalence in China may be 2-3 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 Lupuzor™/P140 has the potential to be a novel specific drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in most Lupus patients. It has a unique mechanism of action and is not an immunosuppressant like other drugs. Lupuzor™/P140 normalises the over-activity of T-cells which are involved in the immune response leading to Lupus disease. Lupuzor™ taken over the long term may have the potential to prevent the progression of Lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.

A new major opportunity for P140 is CIDP, a rare acquired autoimmune disorder of peripheral nerves. It is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. CIDP is a potential orphan drug indication which would provide patent life extension of 7 years post-approval. 

The Board is confident that there is a route to market for P140 in Lupus and CIDP including further corporate collaborations.

Lupuzor™ Phase 2/3 Adaptive Study

As announced in June 2023, following the receipt of comprehensive guidance from the FDA, in conjunction with our US partner Avion, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor™) in patients with Lupus will commence in H2 2023.

The trial design and protocol is substantially different from previous clinical trials that ImmuPharma has completed and includes maintaining subcutaneous dosing but at much higher concentrations and significant changes to patient inclusion criteria and primary and secondary clinical endpoints.

The detailed protocol and key elements of the clinical trial design will be communicated at a later stage once the details of the trial are available on clinicaltrials.gov (a comprehensive database of privately and publicly funded clinical studies conducted around the world).

Lupus ABC Consortium

The FDA's Center for Drug Evaluation and Research ("CDER") has partnered with the Lupus Research Alliance ("LRA") to launch the Lupus Accelerating Breakthroughs Consortium ("Lupus ABC"), a first-of-its-kind public-private partnership focused on addressing challenges impacting Lupus clinical trial success. 

Lupus ABC will convene people living with Lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to address scientific hurdles that are beyond the capacity of any single entity. By connecting those with lived experience with all parties involved in Lupus treatment research, CDER hopes to advance the development of urgently needed treatments for Lupus. 

This can only be extremely good news for Lupus patients worldwide, including ImmuPharma, our partners and our peers, in bringing new safe Lupus drugs to the market, sooner rather than later.

CIDP / P140

For P140 in CIDP we announced in April 2023 that we had received confirmation from the FDA for a pre- Investigational New Drug ("PIND") meeting date of 16 May 2023, to consider a Phase 2/3 adaptive trial study protocol.

In May 2023, ImmuPharma received positive guidance from FDA following the PIND meeting that confirms the route for a Phase 2/3 adaptive clinical study of P140 in CIDP.

The FDA feedback recognises that P140 is suitable to be studied in another disease indication in addition to SLE and this strongly supports the underlying science and mechanism of action of P140 across several auto-immune/inflammatory diseases and is a significant breakthrough for the P140 platform.

The Phase 2/3 adaptive clinical trial will be the first pivotal stage study of P140 in patients with CIDP: a rare neurological disease with high medical need.

An IND application is now being prepared for submission to the FDA, incorporating all guidance points. An application for Orphan Drug status for CIDP will be also submitted in parallel to the full IND application.

The CIDP market is expected to reach global sales of US$2.7bn by 2029.

Anti-Infection

The innovative peptide technology at ImmuPharma Biotech has been a huge success and very recently has given rise to a number of novel development programs, out of which we have identified two core programs: BioAMB and BioCin, which we believe have the best commercial opportunity and speed to market. 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.

o  BioAMB, a novel peptide-based drug that offers a potential improvement on the limiting side effects and poor administration regime of current Amphotericin-B ("AMB") formulations. AMB is one of a last line of agents against serious and life-threatening fungal infections caused by the aspergillus family of fungi.

o  BioCin, a novel peptide-based drug based on an existing potent antibacterial, vancomycin, used in high medical need cases and in many cases the last line of defense. BioCin has the potential to offer improved safety and administration benefits.

Pipeline Overview 

Our therapeutic focus is on two core areas; Autoimmunity/Inflammation and Anti-infection. We also look for valuable deals for non-core assets as evidenced by a collaborative deal, signed in March 2023, with Orano SA on ImmuPharma's peptide technology as a vector for cancer radiotherapy. The initial collaboration is for 12 months, and a small undisclosed upfront payment was paid to ImmuPharma.

Commercial Activities

Management has established discussions with new potential corporate partners across the P140 platform and anti-infective programmes. The drive to conclude further commercial and partnering deals will be accelerated over this next period and which is now bolstered by the recently announced new Board appointments.

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 Lupuzor™ /P140 platform was invented by Prof. Sylviane Muller, Emeritus Research Director at the CNRS.

Interest in Incanthera Plc

As at 30 June 2023, ImmuPharma had a 12.7% interest in oncology specialist, Incanthera plc, which trades on Aquis Stock Exchange ("AQSE") under the ticker (TIDM:INC).

ImmuPharma also has 7,272,740 warrants in Incanthera at an exercise price of 9.5p. As most recently announced in August 2023, the term of these Warrants has been extended by 12 months to 6 September 2024.

As announced in Incanthera's interim report in December 2022, the Company continues to concentrate upon furthering discussions to capitalise on the potential for various applications of its skincare portfolio for commercial success.

As a major shareholder, ImmuPharma remains supportive of Incanthera.

Capital subscription post period end

The Company has undertaken a successful fundraising post period ended; see the separate announcement issued today.

Current Activities and Outlook

"We continue to make positive progressive steps for ImmuPharma. As a Board, we remain focused on bringing our two key late stage P140 clinical assets in Lupus and CIDP through their final clinical trials and to the market.

The drive to conclude further commercial and partnering deals will be accelerated over this next period and which is now bolstered by the recently announced new Board appointments.

The Board would like to take this opportunity to thank its shareholders for their continued patience and support, as well as its staff, corporate and scientific advisers and our partners including CNRS and Avion."

Tim McCarthy

Chairman & Chief Executive Officer

31 August 2023

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2023

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE PERIOD ENDED 30 JUNE 2023

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2023

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 2023

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2023

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 2022. 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 2022.

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 2022 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 2023

(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 2023

(Continued)

ImmuPharma plc

NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2023

(Continued)

5 Issued share capital

At 30 June 2023, the Company had no limit on its authorised share capital.

6. Subsequent events

Successful fundraising, see separate announcement issued today