Sareum Regulatory News (SAR)

 Sareum Holdings PLC

("Sareum" or the "Company")

Application in Australia for the Clinical Development ofTYK2/JAK1 Inhibitor SDC-1801

Cambridge, UK, 15 March 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, announces today that it has initiated an application to perform Phase 1 clinical studies on SDC-1801 in Australia under the Clinical Trial Notification (CTN) scheme.

SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. Documents required to initiate the trial under the CTN scheme have been submitted to a Human Research Ethics Committee (HREC) in Australia. A decision on approval by the HREC and acceptance of the CTN by Australia's medicines regulator, the Therapeutic Goods Administration (TGA), is expected in Q2 2023.

Sareum, working alongside specialist consultants, contract research organisations (CROs), and clinical units, has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to regulatory approval being granted, Sareum plans to commence a Phase 1a trial as soon as possible to investigate the safety and tolerability of an oral formulation of SDC-1801 in ascending doses administered to healthy subjects. If the safety data proves satisfactory, the Company intends to commence a Phase 1b clinical study in psoriasis patients in 2024.

Australia offers state-of-the-art research facilities and an efficient approval process, making it an attractive location for research and development. Moreover, the country provides significant tax incentives for companies that conduct their research in Australia, allowing them to claim up to 43.5% of their eligible R&D expenditure as a cash payment. As such, Sareum has established the required local presence by setting up a legal entity in Australia.

Further clarity requested by Sareum from the UK Medicines and Healthcare Products Regulatory Authority (MHRA) regarding its original clinical trial authorisation application has not been received. In parallel, the Company has evaluated alternative options and has decided to transfer the clinical trial to Australia to progress the development of SDC-1801.

Preclinical development activities required for the application have been successfully concluded. Synthesis of SDC-1801 drug substance under Good Manufacturing Practice (GMP) conditions has also been completed successfully, with a surplus of material for the planned Phase 1 clinical trials. GMP-compliant manufacture of capsules of SDC-1801, for use in the Phase 1 trial, is also complete.

Dr Tim Mitchell, CEO of Sareum, commented: "This application is an important step for Sareum in advancing SDC-1801, our lead TYK2/JAK1 inhibitor, into clinical development. Australia is an ideal location for these studies and we look forward to reporting further progress in due course."

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About Sareum

Sareum Holdings (AIM:SAR) is a 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, which, is planned to enter clinical development with an initial focus on psoriasis.

Sareum has an economic interest in SRA737, a clinical-stage Chk1 inhibitor which it originally developed in collaboration with several Cancer Research UK-related organisations. SRA737 has shown promising safety and efficacy in two Phase 1/2 clinical trials.

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