Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Annual General Meeting Statement

Cambridge, UK, 14 December 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, publishes an update on operational activities and pipeline progress ahead of its Annual General Meeting ("AGM") taking place today at 10.00 am at 85 Gresham Street, London EC2V 7NQ.

At the AGM, the Company's Non-Executive Chairman, Dr Stephen Parker, will provide the following overview:

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 patent safeguards the use of SDC-1801 for medical applications in treating inflammatory or immune disorders. Additionally, after receiving a Notice of Allowance from the Japan Patent Office in November, the patent for SDC-1801 has now been formally granted in Japan.

SDC-1802 (cancer Immunotherapy)

Sareum continues to work on the translational studies required to support the development of SDC-1802 as a candidate for cancer immunotherapy. These studies are aimed at identifying the most appropriate cancer application for SDC-1802, an important step before proceeding to toxicology and manufacturing studies.

In June 2023, the United States Patent and Trademark Office granted a new patent that encompasses the treatment of autoimmune diseases with SDC-1802 and several of its analogues. This expansion effectively broadens the compound's protective reach beyond its primary focus in immuno-oncology.

Licensed Programme - SRA737: A Selective Chk1 inhibitor

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.

Equity Prepayment Facility with RiverFort

As announced on 3 August 2023, Sareum agreed terms on an Equity Prepayment Facility (the "Facility") of up to £5.0 million with RiverFort Global Opportunities PCC Ltd. The Company received an initial deposit of £2.0 million prior to associated costs, on 4 August 2023. Sareum drew down an additional £0.3 million as the Second Deposit under this Facility on 23 November 2023.

If fully drawn down, the Facility, together with anticipated tax incentives of £1.6 million (of which £0.4 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 Q4 2024.

Summary

In conclusion, the Board remains optimistic about Sareum's pipeline of kinase inhibitors. The focus remains on advancing SDC-1801 into further clinical development, supported by a strong intellectual property foundation and a prudent approach to financial planning.

CPF is taking the lead in evaluating potential further development opportunities for SRA737 and further updates will be provided as soon as possible.

We would like to thank our shareholders and other stakeholders for their continued support and look forward to providing further updates on progress in due course.

AGM Webcast

A live webcast to investors 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.

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 and has entered Phase 1a/b 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

- Ends -