Immupharma Regulatory News (IMM)

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ImmuPharma PLC

("ImmuPharma" or the "Company")

FINAL RESULTS ANNOUNCEMENTfor the year ended 31 December 2022

ImmuPharma PLC (LSE:IMM), ("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 2022 (the "Period").

Key Highlights (including post Period review)

Financial

· Loss for the Period of £3.8m (2021: £8.2m)

· Research and development expenses of £2.0m (2021: £3.7m)

· Administrative expenses of £0.8m (2021: £1.0m)

· Exceptional items of £nil (2021: £1.4m, representing corporate reorganisation costs)

· Cash balance at 31 December 2022 of £0.7m (31 December 2021: £1.6m)

· Successful subscription and placing, raising in total £2.0m (gross) - August 2022

· Lanstead derivative financial asset of £0.3m (2021: £0.9m)

· Incanthera financial asset of £0.7m (2021: £1.2m)

· Warrants financial asset of £0.001 (2021: £0.2m)

Product Development

· P140 Pharmokinetic ("PK") study successfully completed in April 2022 with key findings shared with the FDA*

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

· Type C meeting confirmed with FDA for 7 June 2023 for consideration of the new protocol of the Phase 2/3 adaptive study for Lupuzor™ in SLE patients

· Pre-IND meeting confirmed with FDA for 16 May 2023 for feedback on the new protocol of the Phase 2/3 adaptive study for CIDP

· Collaboration with Orano - ImmuPharma peptide technology as a vector for cancer radiotherapy - an initial collaboration for 12 months

*FDA (Food and Drug Administration)

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

"As a Board, we remain focused on bringing our two key late stage clinical assets, Lupuzor™ for lupus and CIDP closer to the market. We now have a clinical roadmap for Lupuzor™ and remain on track to commence the Phase 2/3 adaptive trial in H2 2023, with potentially CIDP moving into clinical studies in parallel. This illustrates the potential franchise we have within our P140 autoimmune platform.

We will also continue to concentrate on further commercial and partnering opportunities. In conjunction with the above objectives, we continue to take prudent measures on managing our cost base.

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 ENGLISH LAW BY VIRTUE OF THE EUROPEAN (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.

ImmuPharma plc

Chairman's Report

2022 was a year of further transition for ImmuPharma as we continued to focus on progressing our late-stage pipeline assets as well as dealing with some complex regulatory processes, in conjunction with our partner Avion Pharmaceuticals ("Avion") and in discussions with the US Food and Drug Administration ("FDA").

In 2022, ImmuPharma continued its primary focus on progressing our late-stage program, Lupuzor™ (P140), in conjunction with our US partner, Avion. During the second half of 2021, ImmuPharma started preparations for the commencement of a clinical pharmacokinetic ("PK") study, as guided by the US Food and Drug Administration ("FDA"). The PK study was successfully completed in April 2022 with guidance from the FDA in respect to progressing Lupuzor's clinical program, announced in early 2023. This confirmed that in conjunction with Avion, we have agreed that the optimum route forward for Lupuzor™ is for a dose ranging Phase 2/3 adaptive study. Our current target is to commence this trial in H2 2023.

The PK study findings also contributed to progressing an additional autoimmune clinical program for a new disease indication, CIDP (Chronic Idiopathic Demyelinating Polyneuropathy).

In June 2022, our share capital structure was reorganised and in August 2022, we concluded a successful fundraising of £2.04m (gross). ImmuPharma continued to explore opportunities with other potential commercial partners ex-US for P140 in lupus. Global partnerships are also being sought for P140 in CIDP and anti-infective assets from the Company's R&D pipeline.

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™ and Avion Pharmaceuticals | Background

On 28 November 2019, ImmuPharma and Avion signed an exclusive Trademark, License and Development Agreement for Lupuzor™/P140, with Avion agreeing to fund a new international Phase 3 trial and commercialising Lupuzor™/P140 in the US. The agreement also provides Avion an option on any other P140 indications. Since then, there have been two guidance meetings with the FDA on the lupus program. At the first meeting the FDA requested ImmuPharma complete a clinical PK study of P140. Following successful completion of the PK study in 2022 the FDA guided on a new dosing regimen which has been built into a new Phase 2/3 adaptive clinical trial design.

ImmuPharma and its US partner Avion co-developed and successfully completed a clinical PK study of P140 which was announced on 13 April 2022. The study was a Phase 1, open-label, single dose pharmacokinetic study of P140 after subcutaneous and intravenous administration in healthy male volunteers. Patients received a single subcutaneous injection of 200μg or 800μg P140 or a single intravenous injection of 800μg P140. There was a clear time and dose-related PK profile, which is detectable in the blood of human volunteers and applicable for all potential clinical dosing regimens of P140. In-line with all human dosing to date, P140 was safe and well tolerated across all doses and in all subjects.

In the first half of 2022 ImmuPharma provided progress updates to the market in respect to guidance meetings between the FDA and Avion. This concluded with the FDA providing a detailed response in September 2022 to Avion with significant guidance on next steps for the clinical programme. This included advice on the dosing regime. In addition, the FDA also provided further significant improvement guidance on the study protocol.

In February 2023, ImmuPharma confirmed that, with its partner Avion, they had agreed on an adaptive Phase 2/3 study for Lupuzor™ in Systemic Lupus Erythematosus ("SLE") patients. This is a one-protocol pivotal study which allows exploration of a dose-range in the Phase 2 part of the study, followed by seamless progression into the Phase 3 part of the study at the chosen dose. The overall timelines for the Lupus clinical program are shorter as one avoids the need for stopping and starting two independent trials, regulatory checks, ethics approvals and site set-ups. It is also expected to be less costly overall. There is also an opportunity, through an interim analysis in the Phase 3 part of the study, to stop the study earlier if an efficacy signal is reached after a certain percentage of patients have been treated.

This new study design incorporates guidance from the FDA which advised exploration of higher dose levels than have been used in the clinical program to date. A clean safety profile has already been established at higher doses.

In April 2023, ImmuPharma confirmed that the FDA had a set date of 7 June 2023 for a type C meeting to consider the new Phase 2/3 study protocol, which remains on track to commence in H2 20223.

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 meeting date of 16 May 2023, to consider a Phase 2/3 adaptive trial study protocol.

This will be the first pivotal stage clinical study of P140 in patients with CIDP: a rare neurological disease with high medical need.

A new Investigational New Drug ("IND") submission is required, as this will be the first time that P140 is to be studied in humans for the indication of CIDP. An application for Orphan Drug status will be submitted following the pre-IND meeting.

The CIDP market is expected to reach global sales of US$2.7bn by 2029 (source: Data Bridge Market Research, Dec 2022).

Potential Distribution Agreement with Avion

As announced in November 2022, we have agreed to explore the opportunity of a mutually beneficial route to allow ImmuPharma to introduce certain Avion products into the European market. If this is successful, this would generate top-line product sales revenue for the first time in ImmuPharma's history and contribute net positive cash flow to the Company.

We in turn have identified an established European partner who could provide the infrastructure to market and distribute the products.

Lupus ABC Consortium

The FDA's Center for Drug Evaluation and Research 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.

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. 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 

There is a depth of scientific knowledge and innovation within the R&D team in Bordeaux which is focusing on those product developments (see below) which offer the highest probability of both scientific and commercial success.

Management continues to concentrate on identifying and concluding commercial collaborations and licensing deals across the product portfolio.

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 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.

Autoimmunity & Inflammation

P140's mode of action is relevant to many autoimmune and inflammatory diseases which provides a number of opportunities for ImmuPharma and its partners to explore in the near future. The therapeutic potential of P140 goes beyond just Lupus, with Chronic Inflammatory Demyelinating Polyneuropathy ("CIDP") being the next step. P140's application across numerous disease states stems from the research partnership between the Company and Prof. Sylviane Muller, inventor of P140 and Emeritus Research Director CNRS, France. Key highlights within the progression of the P140 platform are summarized below:

o  P140 - Lupuzor™ successfully completed PK study in 2022. A Phase 2/3 adaptive study is planned to commence in H2 2023. This is a one protocol pivotal study which allows exploration of a dose range in the Phase 2 part of the protocol.

o  P140 - CIDP a rare autoimmune disorder of peripheral nerves. CIDP is a potential orphan drug indication which would provide patent life extension of 7 years post-approval. A Phase 2/3 adaptive trial is planned with IND/FDA guidance and orphan drug designation application underway.

o  P140 - Second generation. Our pre-clinical team in Bordeaux, 'ImmuPharma Biotech' has commenced work to develop a pharmacologically improved version of P140, a second-generation product that aims to further strengthen the IP position and provide therapies with different improved administration modalities, yet still maintaining P140 as the active moiety.

o  P140 - Other indications. Further clinical applications based on further preclinical investigation include asthma, Sjogrens syndrome, renal inflammation in diabetes, periodontitis and gout.

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, 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.

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.

Interest in Incanthera Plc

As at 31 December 2022, ImmuPharma had a 12.97% 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 options in Incanthera at an exercise price of 9.5p pence, being the price at which new shares were issued in the Placing accompanying Incanthera's listing in 2020.

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 restructure

At the Annual General Meeting on 28 June 2022, the shareholders approved the subdivision of the Company's ordinary share capital, whereby each existing Ordinary Share with a nominal value of 10p was subdivided into 1 new Ordinary Share of 1p and 1 Deferred Share of 9p. The Deferred Shares have no significant rights attached to them and carry no right to vote or to participate in distribution of surplus assets and are not admitted to trading on the AIM market of the London Stock Exchange plc. The Deferred Shares effectively carry no value.

Capital subscription

On 03 August 2022 ImmuPharma announced a subscription and placing to raise c£1.1m through the issue of 21,018,182 new ordinary shares of 1 pence each in ImmuPharma at a price of 5p per ordinary share ("Issue Price"). This was followed on 11 August 2022 by the completion of the associated Broker Option, which raised £0.95m through the issue of 19,000,000 new ordinary shares of 1p each in the Company at a price of 5p per ordinary share.

The monies raised included a £1.0m subscription for 20,000,000 new ordinary shares with Lanstead Capital Investors LP ("Lanstead"), at an Issue Price of 5 pence per share, together with a related Sharing Agreement.

The £1.0 million gross proceeds of the Lanstead subscription was followed by the Sharing Agreement with Lanstead for 100% of these shares with a reference price of 6.67p per share ("Benchmark Price"). The Sharing Agreement is for a 24 month period and the Company will receive 24 monthly settlements, as measured against the Benchmark Price. The actual consideration is variable depending upon ImmuPharma's share price and provides the opportunity for ImmuPharma to benefit from a positive future share price performance or conversely to receive less proceeds if there is negative future share price performance.

The Company also agreed to issue Lanstead 1,400,000 ordinary shares in connection with entering into the Sharing Agreement ("Value Payment Shares").

The Company also issued 200,000 new Ordinary Shares ("Fee Shares") at an issue price of 5 pence per share to SPARK Advisory Partners Ltd in lieu of fees. 

The Issue Price of 5 pence represented a 21.38% percent discount to the closing mid-market price (of 6.36p) of the Ordinary Shares on 02 August 2022, the latest business date prior to the Subscription and Placing.

Warrants

The Company agreed to issue Lanstead 30,000,000 warrants in return for Lanstead foregoing the entitlement to increase the benchmark price in 2021 sharing agreement from 14.666p to 22p. The warrants are exercisable for 10 years at an exercise price of 5.5 pence.

The Company also issued 2,500,000 and 500,000 warrants to Stanford Capital Partners "SCP" and SI Capital in lieu of fees. The warrants are exercisable for 10 years at an exercise price of 5 pence.

During 2022, L1 Capital Global Opportunities Master Fund ("L1") exercised Options over 6,000,000 new ordinary shares of 1p each ("Ordinary Shares") at an exercise price of 5p per share, for a consideration of £300,000.

Current Activities and Outlook

As a Board, we remain focused on bringing our two key late stage clinical assets, Lupuzor™ and CIDP closer to the market. We now have a clinical roadmap for Lupuzor™ and remain on track to commence the Phase 2/3 adaptive trial in H2 2023, with potentially CIDP moving into clinical studies in parallel. This illustrates the potential franchise we have within our P140 autoimmune platform.

We will also continue to concentrate on further commercial and partnering opportunities. In conjunction with the above objectives, we continue to take prudent measures on managing our cost base.

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

Financial Review

The financial results of the ImmuPharma Group in this report cover the year ended 31 December 2022. The Group's principal activity is that of research and development of novel drugs to treat serious medical conditions.

Income Statement and Statement of Comprehensive Income

The operating loss for the year ended 31 December 2022 was £3.0 million, down from £6.6 million for the year ended 31 December 2021. The research and development expenditure was £2.0 million, down from £3.7 million in 2021. The decrease is a direct result of the corporate reorganisation in the prior year.  Administrative expenses were £0.8 million (2021: £1.0 million). The operating loss for the prior year included exceptional costs of £1.4 million in respect of corporate reorganisation, including the departures of Board members (including Dr Robert Zimmer and Dimitri Dimitriou) and respective settlement agreements. No such costs have taken place during the year ended 31 December 2022. 

Finance income has increased from £1k in 2021 to £29k in 2022. Finance costs amounted to £1.5 million, down from £2.4 million in 2021, caused largely by the comparative fair value calculations on the Lanstead derivative financial asset and fair value loss on issue of warrants of £219k (2021: £nil). The loss after tax for the year was £3.8 million, a decrease from £8.2 million in 2021.

The amounts recognised directly in the Statement of Comprehensive Income include the total fair value loss of £0.7 million (2021: fair value loss of £1.0 million) which comprises the following components: fair value loss on shares held in Incanthera plc of £520k (2021: fair value loss of £584k) and fair value loss on Incanthera's warrants of £206k (2021: fair value loss of £418k). Total comprehensive loss for the year was £4.5 million, a decrease from £9.2 million in 2021.

Statement of Financial Position

The Group cash and cash equivalents at 31 December 2022 amounted to £0.7 million (2021: £1.6 million) with the decrease caused by the operating losses including research and development expenditure related to PK study offset by cash inflows from financing activities. Trade and other payables decreased to £1.5 million (2021: £1.6 million) and was largely due to PK study related expenditure. The total value of the financial asset equated to £0.7 million, comprising of shares in Incanthera of £0.7 million (2021: £1.2 million) and warrants in Incanthera of £0.001 million (2021: £0.2 million). At 31 December 2022 the Lanstead derivative financial asset amounted to £0.3 million (2021: £0.9 million). The decrease was a result of the fair value calculation performed at year end, reflecting the decrease in ImmuPharma's share price.

Results

The Group recorded a loss for the year of £3.8 million (2021: £8.2 million). Basic and diluted loss per share was 1.26p (2021: 3.25p). In accordance with the Group's loss making position, no dividend is proposed.

Capital restructure

At the Annual General Meeting on 28 June 2022, the shareholders approved the subdivision of the Company's ordinary share capital, whereby each existing Ordinary Share with a nominal value of 10p was subdivided into 1 new Ordinary Share of 1p and 1 Deferred Share of 9p. The Deferred Shares have no significant rights attached to them and carry no right to vote or to participate in distribution of surplus assets and are not admitted to trading on the AIM market of the London Stock Exchange plc. The Deferred Shares effectively carry no value.

Total Voting Rights & Warrants

The Company had a total of 618,388,048 ordinary shares in issue at 31 December 2022. The Company's issued share capital now comprises 333,403,115 Ordinary Shares with one voting right each and 284,984,933 deferred shares with no rights to vote. Total warrants outstanding equal: 151,450,908.

Treasury Policy

The policy continues to be that surplus funds of the Group are held in interest-bearing bank accounts on short or medium maturities, until commitments to future expenditure are made, when adequate funds are released to enable future expenditure to be incurred. The Group's Treasury Policy and controls are straightforward and approved by the Board.

Financial Strategy

The overall strategy is to maintain a tight control over cash resources whilst enabling continued progress of the Company's development assets.

On behalf of the Board

Tim McCarthy

Director

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2022