Sareum Holdings plc announced that at its Annual General Meeting to be held on 14 December 2023, the Company made good progress in 2023 with its lead programme, SDC-1801, with a Phase 1a clinical trial underway in Australia. SDC-1801 (autoimmune disease) SDC-1801, Sareum's TYK2/JAK1 inhibitor, continues to demonstrate promise as a potential new treatment for autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. The Phase 1a clinical trial, evaluating SDC-1801 in healthy subjects, commenced in May 2023 at a specialist clinical unit in Melbourne, Australia.

Following approval by the safety review committee, based on preliminary data from the initial cohorts in the single ascending dose part of the study, dosing began in the multiple ascending dose escalation phase of the study in September 2023. The Company has also recently started a food effects study for the compound. This part of the study will inform whether the drug should be taken with food or on an empty stomach, optimising its potential benefits while potentially minimising any possible side effects.

Full safety data from the Phase 1a clinical trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained and subject to financing and regulatory and recruitment preparations, the Company plans to initiate a Phase 1b clinical study, aiming to recruit up to 24 psoriasis patients. This study is expected to be completed before the end of 2024. Also in 2023, the first patent for SDC-1801 was granted by the China National Intellectual Property Administration.

This expansion effectively broadens the compound's protective reach beyond its primary focus in immuno-oncology. Sierra Oncology Inc, a subsidiary of GSK plc, has completed the return of the Clinical Study Reports and other associated documents and data related to SRA737 to Sareum's co-development partner, the CRT Pioneer Fund LP ("CPF"). CPF is actively engaged in evaluating potential further development opportunities for SRA737.

Further updates will be provided as soon as possible. Sareum drew down an additional PS0.3 million as the Second Deposit under this Facility on 23 November 2023. If fully drawn down, the Facility, together with anticipated tax incentives of PS1.6 million (of which PS0.4 million has already been received), should enable the completion of the Phase 1a/b clinical development of SDC-1801, expected to be a catalyst for driving shareholder value, and for general working capital to fourth quarter 2024.

Summary In conclusion, the Board remains optimistic about Sareum's pipeline of kinase inhibitors. Shareholders are reminded that attendance online will not constitute attendance at the AGM and shareholders will not be able to vote on the day.