Sareum Regulatory News (SAR)

Sareum Holdings plc

("Sareum" or "the Company")

AGM Statement

Sareum Holdings plc (AIM: SAR), the specialist small molecule drug development business, will be holding its Annual General Meeting today, at 10:00 at the offices of Citigate Dewe Rogerson, 3 London Wall Buildings, London Wall, London EC2M 5SY. The Chairman, Dr Stephen Parker will make the following statement:

"The Board is pleased to report on another year of substantial progress for Sareum. Our active development portfolio now comprises three compounds targeting important kinases in diseases for which there remain significant levels of unmet medical need: SRA737 (out-licensed to Sierra Oncology), SDC-1801 and SDC-1802. We have recruited two new Non-Executive Directors, Michael Owen, Ph.D and Clive Birch, each of whom has exceptional experience of direct relevance to your Company as it moves forward. These appointments have allowed us to create Nominations & Governance, Audit & Risk and Remuneration Committees, which further enhances our corporate governance, in accordance with the QCA guidelines.

During the year and thereafter, our partner for SRA737, Sierra Oncology ("Sierra"), continued to make good progress, refining the trials as new data emerged and prioritising development on high-grade serous ovarian cancer ("HGSOC"). Sierra presented preclinical data showing efficacy of SRA737 monotherapy in in vivo models of human ovarian cancer at a recent cancer congress, where it also confirmed that HGSOC appears an attractive disease target for combination therapy approaches. This reprioritising and enlarging of the ongoing Phase 1/2 studies has meant that the publication of clinical trial data is now expected to take place in mid-2019, with Sierra suggesting that these data will be submitted for presentation at the ASCO annual conference at the end of May/early June.

Patients in the SRA737 monotherapy trial are currently being dosed in 15 cancer centres in the UK; completion is estimated to be in April 2020. The current combination trial with SRA737 and low-dose gemcitabine is active in six centres in Spain and a further 14 in the UK, and is currently estimated to complete in June 2020. We also await the commencement of a combination study of SRA737 with niraparib, a PARP inhibitor, in metastatic castration-resistant prostate cancer("mCRPC"), and we note with interest the recent data presented by Sierra showing effective synergy when SRA737 is combined with cancer immunotherapy in models of small cell lung cancer, a disease for which cancer immunotherapy has had limited efficacy.

The focus on our TYK2 programme in 2018 was rewarded with the selection of two distinct compounds, SDC-1801 for auto-immune diseases and SDC-1802 for cancer indications, both TYK2/JAK1 inhibitors. We have commenced formal preclinical programmes for each compound with a view to entering the clinic in each of the indications in 2020. Additional research is ongoing to refine the clinical plans. In the meantime, the data arising from some of the work leading to the compound selection are being prepared for submission to a peer-reviewed publication and a conference presentation.

In line with our business model, the Company continues to engage with potential partners with a view to securing commercial licences for its products and programmes, including seeing early interest in the Aurora/FLT3 programme, into which we have discontinued further investment while we find a licence partner.

In addition, Sareum is exploring new research programmes from its in-house drug discovery platform, as well as external early stage opportunities that can be potentially in-licensed and progressed into the clinic.

The Company ended its fiscal year 2017/2018 with a loss after taxation of £1.470 million and cash of £1.375 million. We continue to manage cash carefully and in October, the Company raised a further £850,000 in a placing. This has further strengthened the working capital position, whilst we assess the long-term capital requirements for maximising the value of the TYK2 assets and the Company.

As mentioned earlier, we are delighted to welcome Dr Mike Owen and Mr Clive Birch to the Sareum Board. We are aware that the climate and requirements for relevant and firm governance is ever increasing and Mike and Clive's careers speak to their ability to ensure that we continue to run your Company appropriately and optimally. Mike's experience as head of biopharmaceutical research at GSK will be especially valuable as we select the target indications for SDC-1801 and SDC-1802.

The Board of Directors believes that 2018 has consolidated the progress and increasing maturity reported last year. I would like to thank our shareholders, collaboration partners, suppliers, contractors and other stakeholders for their continued support and look forward to providing further updates on progress in 2019."

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Notes for editors: 

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

Sareum's leading clinical-stage programme, SRA737, a novel Checkpoint kinase 1 (Chk1) inhibitor licensed to NASDAQ-listed Sierra Oncology, is in Phase 2 clinical trials targeting ovarian and other advanced cancers. The key role of Chk1 in cancer cell replication and DNA damage repair suggests that SRA737 may have broad application as a targeted therapy in combination with other oncology and immune-oncology drugs in genetically defined patients.

Sareum is also advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) /Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases and cancers. TYK2 and JAK1 have roles in pro-inflammatory responses in autoimmune diseases (e.g. psoriasis, rheumatoid arthritis, inflammatory bowel diseases and lupus) and tumour cell proliferation in certain cancers (e.g. T-cell acute lymphoblastic leukaemia and some solid tumours). The Company is targeting first human clinical trials in each indication in 2020.

The Company also has an Aurora+FLT3 inhibitor targeting haematological cancers, which is at the preclinical development stage.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit www.sareum.co.uk

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