Sareum Regulatory News (SAR)

(AIM: SAR) 17 December 2019

Sareum Holdings plc

("Sareum" or the "Company")

AGM Statement

Sareum Holdings plc (AIM: SAR), the specialist cancer drug discovery and development business, will hold its Annual General Meeting today, at 10:00 a.m. at the offices of Citigate Dewe Rogerson, 8th Floor, Holborn Gate, 26 Southampton Buildings, London WC2A 1AN. The Company's Chairman, Dr Stephen Parker, will make the following statement:

"2018-19 has been a year of mixed fortunes for the UK life sciences sector and Sareum has not been immune from its effects. Saying that, we have been successful in raising additional funds during the year against a generally difficult climate for financing listed companies in the sector.

These funds are being deployed to advance our proprietary TYK2/JAK1 projects through preclinical development and the Board is pleased to report significant progress has been made with these projects during the year. We also remain cautiously optimistic about the future development of our out-licensed Chk1 project SRA737 with Sierra Oncology, Inc ("Sierra"). This view is based on the encouraging preliminary clinical and preclinical results reported during the year, while recognising that Sierra has reprioritised its resources on the Phase 3 development of momelotinib and is seeking strategic solutions that will enable the further development of SRA737.

In June 2019, Sierra announced preliminary clinical data from two on-going Phase 1/2 studies with SRA737 at the American Society of Clinical Oncology ("ASCO") annual meeting. Of particular note was the combination study of SRA737 and low-dose gemcitabine (LDG), which demonstrated positive efficacy in anogenital cancers, a group of virus-associated cancers for which there are few current therapy options. This trial remains ongoing and is due to finish in the first half of 2020. At the time, Sierra noted that, given the level of unmet medical need in anogenital cancers, one further trial at a cost of about US$10 million could be sufficient to generate a data package that could be submitted for approval.

Earlier in the year, Sierra announced preclinical data on the effects of a triple combination of SRA737, LDG and anti-PD-L1 immunotherapy in a mouse model of small-cell lung cancer at the American Association of Cancer Research ("AACR") annual meeting in April 2019. We are very excited by these data and the potential of SRA737 being developed as part of the growing armamentarium of oncology and immuno-oncology compounds.

At a presentation to analysts at ASCO, Sierra made it clear that SRA737 is no longer core to its future plans and that it is seeking "non-dilutive strategic options" to enable further development. Subsequently, it has further clarified that its preferred solution is to on-license the drug to a third party, and we understand that a licensing exercise has been launched. At this stage, we have no immediate visibility on the state of progress, nor any terms which might be sought in the on-licensing deal. We have had to conclude, however, that timing of two near-term milestone payments - disclosed by Sierra for the first time in August 2019 and, together, worth approximately US$5 million to Sareum - are likely to be delayed, possibly beyond the end of this financial year. The Board and Management team are evaluating our options and making plans accordingly.

Our primary focus is to advance the development of our two TYK2/JAK1 programmes: SDC-1801 targeting autoimmune diseases and SDC-1802 targeting cancer. Both programmes have made good progress in the year, with the manufacturing process of SDC-1801 being completed and early toxicology studies undertaken. Post-reporting period, we were particularly happy to present a poster of preclinical data for SDC-1802 against several cancer indications at the AACR-NCI-EORTC* international cancer conference in November 2019. These data suggest that in SDC-1802 Sareum has a potent, orally-available, small molecule contributor to the immune-oncology field, which could prove advantageous over the biological approaches that currently dominate. Subject to successful progress and financing, human trials are targeted to start in late-2020.

The Company continues to engage with potential partners with a view to securing commercial licences for all its products and programmes and we will, of course, keep shareholders updated in this regard as appropriate.

The Company ended its fiscal year 2018/2019 with a loss of £1.45 million and cash of £0.92 million, which was increased through a placing in July 2019 of £0.78 million. The Board is actively monitoring the working capital position and has taken steps to maximise the runway, constantly ensuring that the two TYK2/JAK1 compounds take priority in resource allocation.

The Board believes that, despite the delays in the SRA737 programme described above, good progress has been made with the proprietary TYK2/JAK1 programmes and we will continue to drive the development of these assets forward. I 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 2020.

*American Association of Cancer Research ("AACR") National Cancer Institute ("NCI") European Organisation for Research and Treatment of Cancer ("EORTC") International Conference.

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Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune disease. 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 (SDC-1801) and cancers (SDC-1802). The Company is targeting first human clinical trials in each indication in 2020.

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 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 Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology, in a $328.5m plus royalties licence deal, with Sareum eligible to receive 27.5% of all payments to CPF under the agreement.

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.co.uk.

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