Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Trading Statement

Cambridge, UK, 19 August 2021 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, provides the following trading update ahead of its full year results for the year ended 30 June 2021. Sareum expects to report its full audited annual results in October 2021.

OPERATIONAL HIGHLIGHTS

SDC-1801 for treating symptoms of Covid-19

As noted in the Company's RNS announcement of 1 July 2021, the UKRI-funded Covid-19 research project for SDC-1801, a novel, TYK2/JAK1 inhibitor, was completed on schedule, with the final results confirming the initial encouraging results as noted in the Company's Interim Results, published on 23 April 2021.

The project found that SDC-1801 reduced the levels of cytokines associated with Acute Respiratory Distress Syndrome (ARDS) in human lung cells infected with SARS-CoV-2 and demonstrated a profile that was superior to the anti-inflammatory steroid dexamethasone and similar to baricitinib, a JAK1/JAK2 inhibitor.

The in-vivo studies that have now been completed support the initial cellular results and provide strong evidence that expression of Type 1 interferons (IFNa and IFNb) is reduced by SDC-1801 treatment in a dose-responsive manner. The studies also showed that viral loads did not increase after SDC-1801 administration, which is a potential concern when anti-inflammatory agents are used to dampen down an over-active immune response

The Company aims to commence Phase 1 clinical trials for SDC-1801 in early 2022, subject to successful completion of the ongoing preclinical toxicology studies, gaining the requisite approval and financing. The timing and design of the clinical trials for Covid-19 applications will be determined following consultations with experts in the field.

SDC-1801 (autoimmune diseases)

Recent delays in compound supply mean that SDC-1801 is now scheduled to commence its final preclinical studies at the beginning of Q4 2021 but the Company still aims to file a Clinical Trial Application (CTA) by the end of Q4, subject to no further delays. First clinical trials - safety studies in healthy volunteers - may commence in early 2022, subject to gaining the requisite approval and funding.

SDC-1802 (cancer immunotherapy)

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

The Company announced, on 30 July 2021, that a notice of allowance had been received from the US Patent and Trademark Office in respect of a patent (Application no. 16/343,639) protecting SDC-1802 and its use in treating certain cancers. Subject to certain formalities being completed, the patent is expected to be granted within three months. 

Licensed Programme - SRA737: A Selective Chk1 inhibitor

The Company continues to monitor licence holder Sierra Oncology's activities as it explores options to fund the future development of SRA737. Sareum continues to believe that the amended licensing agreement between Sierra and CRT Pioneer Fund (CPF) could expedite the advancement of the SRA737 programme in a timely manner.

Post period-end, during an Investor Presentation on 6 August 2021, Sierra announced the in-licencing of the BET inhibitor, AZD5153, from AstraZeneca and noted potential combinations with SRA737 as a possible pipeline expansion opportunity.

Financial highlights (subject to audit)

· Raised £2.37m before expenses in June 2021 through two subscriptions to a high net worth individual.

· Loss on ordinary activities (after taxation) for the year ended 30 June 2021 is expected to be approx. £1.6m (2020: loss of £0.96m), reflecting the increased R&D expenditure required for preclinical development.

· Cash at bank as at 30 June 2021 expected to be approx. £2.7m (£1.3m as at 31 December 2020; £1.8m as at 30 June 2020).

· Post period-end, in July and August 2021, raised a further £2.18m (before expenses) through a share subscriptions to two additional high net worth individuals plus an exercise of warrants.

Salary Deferral Scheme

The salary deferral scheme, as announced by the Company on 17 December 2019 and updated on 1 July 2020, will end in August 2021, with a total of £155k, representing all amounts outstanding, being settled in cash, following the significant c.£4.5m improvement in the Company's financial position arising from the recent share subscriptions and warrant exercise.

Dr Tim Mitchell, CEO of Sareum, commented:

"The past year has seen Sareum advance the preclinical development of our proprietary dual TYK2/JAK1 inhibitor programmes, with the goal of completing preclinical development of SDC-1801 and filing for clinical trials approval by the end of 2021. We are particularly pleased to have raised substantial additional funding during the period, which will be deployed to advance these programmes into clinical development and build a robust data package to support our ongoing partnering activities for these exciting and differentiated assets."

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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 advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases, including the 'cytokine storm' immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).

Sareum also has an economic interest in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.

SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to explore options that would enable the development of SRA737 to advance.

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 

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