Sareum Holdings PLC

("Sareum" or the "Company")

Sareum updates on financial and operational progress

·    Equity Prepayment Facility of up to £5.0 million agreed with RiverFort Global Opportunities PCC Ltd which provides funding towards the Phase 1 trial of SDC-1801

·    Phase 1a clinical trial of lead programme SDC-1801 progressing well in Australia

·    Multiple Ascending Dose escalation phase expected to commence in Q3 2023, subject to Safety Review Committee approval

Cambridge, UK, 16 August 2023 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, today provides a business update ahead of its full year results for the year ended 30 June 2023, and updates on the progress of its SDC-1801 Phase 1a clinical trial and other operations.

Dr Tim Mitchell, CEO of Sareum, commented:

"With a newly agreed funding facility designed to support Sareum through the Phase 1 study of its lead programme, SDC-1801, and good initial progress on the Phase 1a part of the trial, Sareum has begun the new financial year with significant momentum.

"Pending the continuing good progress of the single ascending dose stage and review of the results by the safety review committee, we expect Part 2 of the trial, the multiple ascending dose, to commence in Q3 2023.

"We remain fully focused on bringing SDC-1801 to patients and are encouraged both by the growing commercial momentum around the TYK2/JAK1 space and by the progress of our trial. We look forward to progressing into the next phase of this trial as soon as possible and will update investors accordingly."

OPERATIONAL HIGHLIGHTS - STRONG CLINICAL PROGRESS

SDC-1801 (autoimmune disease)

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.

SDC-1801 is currently undergoing a Phase 1a clinical trial designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). This is a randomised, placebo-controlled trial, with single and multiple ascending oral dose studies.

Recruitment of participants has been progressing to plan and the trial safety committee will make a decision shortly as to whether the study can progress to Part 2 of the Phase 1a trial, the multiple ascending dose stage. Subject to a positive decision, this is expected to commence in Q3 2023. The safety committee will also establish the maximum dose to move forward into cohort A of Part 2, based on the safety and pharmacokinetic data observed to date in Part 1 (single ascending dose stage). Part 2 will begin in parallel with additional planned dose escalation in Part 1 of the study.

Full safety data from the Phase 1a trial are expected to be available during the first half of 2024 and, provided satisfactory results continue to be obtained, and funding is available under the RiverFort Equity Prepayment Facility or otherwise, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients, with a readout expected before the end of 2024, subject to recruitment and progress.

Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments estimated to be worth more than US$30.0 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis.

SDC-1802 (cancer immunotherapy)

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

PATENT UPDATES

In June 2023, the Company announced that The China National Intellectual Property Administration (CNIPA) has officially issued patent number CN113056456, safeguarding SDC-1801 and medical applications of it in treating inflammatory or immune disorders. This is the first patent grant issued to Sareum for SDC-1801 in any territory. Patent applications in Europe (EP3864009), the US (US2021387981) and other territories are still under review.

The Company also announced in June 2023 that the United States Patent and Trademark Office (USPTO) has formally granted patent number US 11,673,870 specifically covering the treatment of autoimmune disorders with SDC-1802 and several analogues. While Sareum has previously secured international patents providing comprehensive protection for the compound SDC-1802, this patent extends its scope in the US beyond immuno-oncology.

This follows the granting of a patent, in April 2022, for protecting the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat T-cell acute lymphoblastic leukaemia (T-ALL - a cancer of a particular type of white blood cell called a T lymphocyte) and other cancers that are dependent on TYK2 kinase for survival.

SRA737: A Selective Chk1 inhibitor

As announced in March 2023, Sierra Oncology, Inc ("Sierra"), 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").

As the major partner, CPF is taking the lead in evaluating potential further development opportunities for SRA737 and further updates will be provided as appropriate.

STRENGTHENED CASH POSITION AND RESULTS FORECAST

Sareum had a cash position of approximately £1.0 million as at 30 June 2023 (cash of £2.9 million as at 31 December 2022 and £4.3 million as at 30 June 2022).  In August 2023, Sareum agreed terms on an Equity Prepayment Facility of up to £5.0 million with RiverFort Global Opportunities PCC Ltd (the "Facility"), and as part of this, received an initial deposit of £2.0 million, net of associated costs, on 4 August 2023.

The Company intends to use the Facility, if fully drawn, together with the receipt of anticipated tax credits, estimated to be in the region of £1.6 million, to complete the Phase 1a/b clinical development of the Company's lead candidate SDC-1801, which is expected to be a primary catalyst for driving shareholder value, and for general working capital to Q4 2024.

Whilst still subject to audit, the loss for the year to 30 June 2023 is expected to be around £3.3 million after tax, (2022: £2.2 million), which is in-line with market expectations and reflects the increased costs associated with setting up for and commencing clinical studies.

- 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 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