Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Annual General Meeting Statement

Cambridge, UK, 19 December 2024 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next-generation kinase inhibitors for autoimmune disease and cancer, publishes an update on operations and pipeline progress ahead of its Annual General Meeting ("AGM") taking place today at 10.00am GMT at 88 Wood Street, London, EC2V 7QR.

During the AGM, the Company's Executive Chairman, Dr Stephen Parker, will provide an update on Sareum's progress.

The Company made good progress in 2024 with SDC-1801, its lead programme, announcing the successful completion of its Phase 1 clinical trial, including both single ascending dose and multiple ascending dose stages.

SDC-1801 (autoimmune disease)

SDC-1801, Sareum's TYK2/JAK1 inhibitor, continues to demonstrate promising therapeutic potential for a range of autoimmune diseases with a potential initial focus on psoriasis, an autoimmune condition affecting the skin.

As announced on 1 July 2024, dosing in the Phase 1 clinical trial of SDC-1801 (Trial ID: ACTRN12623000416695) was successfully completed in Melbourne, Australia. This was a randomised, placebo-controlled trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects.

The Phase 1 trial demonstrated that SDC-1801 achieved blood plasma levels significantly exceeding the predicted therapeutic exposure, with a half-life of 17-20 hours suggesting once-daily dosing will be possible. Importantly, no deaths or serious adverse events due to SDC-1801 were reported, and based on the unblinded data, the frequency of adverse events (all mild or moderate) was similar in the active and placebo groups. No clinically significant effects were observed on any component of blood (including red blood cells, haemoglobin, reticulocytes, platelets or neutrophils) which have been affected by earlier generation JAK inhibitors.

The Clinical Study Report for the trial was received on 18 December 2024.

The recently announced additional funding of £3.4 million through share subscriptions and in addition the receipt of a A$1.9 million (c. £1 million) Australian tax credit, will support the next steps in the programme. This includes preparing the asset for Phase 2 clinical trials by undertaking additional drug product synthesis and toxicology studies. These studies, expected to conclude by mid-2025, are designed to meet regulatory requirements for longer dosing periods.

The Company has also strengthened its intellectual property position with two key patent milestones being achieved:

· A Notice of Allowance from the US Patent and Trademark Office for a patent offering substantial protection on SDC-1801's chemical structure, its use in treating inflammatory diseases, and certain methods of chemical synthesis. This completes protection for the chemical structure of SDC-1801 in all of the major territories.

· A patent allowance in China protecting certain crystalline forms of SDC-1801 and methods of their preparation, marking the first patent allowance protecting crystalline forms in any territory.

SDC-1802 (cancer immunotherapy)

Sareum continues to advance development of SDC-1802, its second TYK2/JAK1 inhibitor designed specifically for cancer and cancer immunotherapy applications.

The funding secured in October 2024 will enable further translational and preclinical development studies on SDC-1802. The Company looks forward to reporting progress on these studies during the current period.

Licensed Programme - SRA737: A Selective Chk1 inhibitor

SRA737 is a clinical-stage oral, selective Checkpoint kinase 1 inhibitor that targets cancer cell replication and DNA damage repair mechanisms.

On 2 January 2024, Sareum announced that the Company's co-development partner, the CRT Pioneer Fund ("CPF"), entered into a development and commercialisation licence agreement for SRA737 (the "Licensing Agreement") with a private biopharma company based in the United States (the "Licensee Company"). Sareum received a US$137,500 upfront fee payable under the Licensing Agreement.

An additional fee of up to US$1.0 million cash and 500,000 shares in the Licensee Company may be payable to CPF, of which Sareum is entitled to a 27.5% share, upon the sooner of 12 months following the signing of the Licensing Agreement, or the event of the Licensee Company achieving certain commercial and material financing objectives.

Summary

Sareum's management remains optimistic about its strong pipeline of kinase inhibitors and their potential to provide significant benefits to patients. The recent funding will enable the Group to conduct further development of SDC-1801, including the longer-term toxicology studies required to prepare the asset for Phase 2 clinical trials and undertake further translational and preclinical development on its SDC-1802 cancer immunotherapy programme thereby enhancing their potential values.

We would like to thank our shareholders and other stakeholders for their continued support.

AGM Webcast

A live webcast to the investment community will be made available online via the Investor Meet Company platform. Existing and potential investors wishing to participate in the presentation can register on www.investormeetcompany.com/sareum-holdings-plc/register-investor. Questions can be submitted before the event via the Investor Meet Company dashboard or at any time via the live presentation via the "Ask a Question" function. Responses from the Q&A session will be published at the earliest opportunity on the IMC platform.

Shareholders are reminded that attendance online will not constitute attendance at the AGM and shareholders will not be able to vote on the day.

- Ends -

For further information, please contact: 

About Sareum

Sareum Holdings (AIM:SAR) is a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer.

The Company is focused on developing next generation small molecules which modify the activity of the JAK kinase family and have best-in-class potential. Its lead candidate, SDC-1801, simultaneously inhibits TYK2 and JAK1. SDC-1801 is a potential treatment for a range of autoimmune diseases, including psoriasis, and has completed Phase 1 clinical development.

Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential application for cancer immunotherapy.

Sareum Holdings plc is based in Cambridge, UK, and is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company's website at www.sareum.com