Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

AGM Statement

Cambridge, UK, 16 December 2022 - 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 a.m. at the offices of Peel Hunt LLP, 7th Floor, 100 Liverpool Street, London EC2M 2AT. The meeting will also be webcast via the Investor Meet Company ("IMC") platform.

At the AGM, the Company's Non-Executive Chairman, Dr Stephen Parker, will make the following comments.

The Company made good progress in the financial year to 30th June 2022 and remains confident in its future despite some recent setbacks.

SDC-1801 (autoimmune disease)

SDC-1801 is Sareum's 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.

As announced on 8 November 2022, the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") informed Sareum that it has not been able to approve the Clinical Trial Authorisation ("CTA") to evaluate the safety and tolerability of SDC-1801. The Company can confirm that it provided a robust preclinical data package to support the CTA application, in collaboration with several world-leading, internationally recognised contract research organisations.

The MHRA has indicated that it requires an additional review by the UK Good Laboratory Practice (GLP) Monitoring Authority of part of the pre-clinical data included in the application to approve the clinical study. Sareum and its advisers have sought additional clarification from the MHRA and UK GLP on the next steps. 

In parallel with seeking clarification with the MHRA, the Company is also assessing regulatory opportunities in other countries. Sareum remains committed to SDC-1801 and is focused on finding the quickest and clearest pathway to obtaining authorisation to commence clinical studies for the asset.

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis and we believe this asset has great potential. This week we have seen evidence of the continued commercial interest in the TYK2 class following the announcement by Takeda of plans to acquire Nimbus Lakshmi Inc., a unit of Nimbus Therapeutics for an upfront consideration of US$4 billion. We believe this underscores the great potential of this class.

SDC-1802 (cancer immunotherapy)

Sareum continues to work on the translational studies for SDC-1802 needed to define the optimal cancer application prior to completing toxicology and manufacturing studies.

Planning for such studies will incorporate what we have learnt from our experience with SDC-1801.

Licensed Programme - SRA737: A Selective Chk1 inhibitor

As announced on 12 October 2022, Sareum has been informed by Sierra Oncology, Inc. (a subsidiary of GSK plc) that it intends to return the rights for SRA737, a selective Checkpoint kinase 1 inhibitor, to Sareum's co-development partner, the CRT Pioneer Fund LP ("CPF"). The SRA737 licence agreement has a 90-day notice period for termination and therefore the Company expects the rights to be formally returned in January 2023.

Sareum is evaluating the potential development opportunities for this asset with CPF and will provide further updates as appropriate.

SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, with funding from Sareum and Cancer Research UK.

Summary

In conclusion, the Board believes Sareum has a strong pipeline of kinase inhibitors which have the potential to provide great benefit to patients. The Company is committed to advancing SDC-1801 into clinical development and is focused on finding the quickest and clearest pathway to obtaining authorisation to commence clinical studies for the asset, whether it be in the UK via the MHRA or other countries.

The Company also remains confident in the potential for SRA737 and now has the opportunity to be more closely involved in planning its future development.

We would like to thank our shareholders, suppliers, contractors 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 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.

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About Sareum

Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases. The Company aims to generate value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum is focused on advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors into clinical development as potential new therapies for autoimmune diseases (with an initial focus on psoriasis), respiratory symptoms arising from viral infections and cancer immunotherapy. Sareum is also eligible to receive certain milestone payments and future royalties on SRA737, a clinical-stage, oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. SRA737 was licensed to Sierra Oncology, which was acquired by GSK in June 2022.

Sareum Holdings plc 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