On June 5, 2024 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its Final Results for the twelve months ended 31 December 2023 (the "Period") (Press release, ImmuPharma, JUN 5, 2024, View Source [SID1234644124]).

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Key Highlights (including post Period review)

Financials

Loss for the Period of £2.9m (2022: £3.8m)
Research and development expenses of £2.0m (2022: £2.0m)
Administrative expenses of £1.0m (2022: £0.8m)
Share based expense of £0.14m (2022: £0.16m)
Cash balance of £0.2m at 31 December 2023 (31 December 2022: £0.7m)
Lanstead derivative financial asset of £0.6m (2022: £0.3m)
Basic and diluted loss per share of 0.81p ( 2022: 1.26p)
Incanthera financial asset: shares of £0.6m (2022: £0.7m) – warrants of £1 (2022: £1k)
Fundraising in September 2023, comprising gross proceeds of £130,683 in addition to £1.35 million being raised in a Subscription and Direct Subscription
Portfolio

SLE/Lupus

A Phase 3 dose-range study of P140, rather than a Phase 2/3 adaptive study, is the preferred design.
Importantly, the direct Phase 3 route is faster to filing for approval whilst also incorporating the FDA’s request for demonstration of a dose-ranging in the pivotal program
The 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
Dosing will be significantly higher and subcutaneous injection, once a month, will be administered with a highly convenient and patient friendly autoinjector. The doses are safe and well tolerated.
Two planned interim analyses during the study will allow early detection of the effectiveness of P140
Simbec-Orion appointed as the Contract Research Organisation ("CRO")
CIDP

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
This 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 close to submission to the FDA, incorporating all guidance points
An application for Orphan Drug status for CIDP will be also submitted in parallel
Simbec-Orion, has been appointed as the CRO for this program
P140 technology platform

Recent further insights into P140’s mechanism of action ("MOA") confirms its position as the only non-immunosuppressing molecule in clinical development in the industry
The favourable impact of P140 on immune system homeostasis also support P140 as a new potential standard of care not only for SLE sufferers, but for patients suffering from a multitude of autoimmune diseases that are caused by the same underlying 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
Anti-infectives | Bio-AMB

After multiple in vivo studies assessing the Pharmacokinetic/Pharmacodynamic ("PK/PD") and safety profile of BioAMB, the dose-effect relationship has now been assessed in Part 1 of a new dose-range pharmacodynamic study in an aspergillosis rat model. Part 1 has now been completed – no toxicity related to BioAMB was observed at the active dose
Part 2 of the study will further evaluate the safety of BioAMB at the active dose and confirm the advantage of BioAMB over the other forms of AMB
Cancer

In March 2023 a collaboration with Orano SA on ImmuPharma’s peptide technology was established
Partnering

Active discussions are ongoing with new potential corporate partners across the P140 platform and anti-infective programs.
Corporate

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

On 3 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 £1.4 million. ImmuPharma continues to hold 7,272,740 warrants in Incanthera plc.
Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:

"As a Board, we remain focused on the development of our two key late stage clinical assets, P140 (SLE) and P140 (CIDP), and on securing additional partnering deals for each. .We have made significant scientific progress over the last year, including further refinement of the protocol for the P140 (SLE) study and new insights into the MOA of P140, and as a result, we have a high level of confidence of the success of the new study.

We look forward to providing further updates on the progress of this study, together with progress on P140 (CIDP) and our earlier stage programs throughout 2024.

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."