Sareum Holdings PLC – SAR – Final Results

Sareum Holdings PLC – SAR – Final Results

Cambridge, UK, 13 October 2020 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, announces its results for the year ended 30 June 2020.

The Company will be holding a presentation to investors on 16 October 2020 at 10.00 a.m. via the Investor Meet Company platform - please click on this link to register to attend: https://www.investormeetcompany.com/sareum-holdings-plc/register-investor.

The Company expects to publish its Annual Report and Accounts, along with the Notice of the Company's Annual General Meeting, in November 2020.

OPERATIONAL HIGHLIGHTS (including post-period updates)

Proprietary Programmes - Selective TYK2/JAK1 Inhibitors in Autoimmune Diseases and Cancer

SDC-1801 (autoimmune diseases)

·      A new formulation specifically designed to deliver higher exposure levels of SDC-1801 has recently been developed by the Company, which is suitable for progressing into the further toxicology studies needed prior to applying to investigate SDC-1801 in human trials.

·      SDC-1801 has demonstrated excellent tolerability in initial toxicology studies in rodents. A formulation that is predicted to deliver a therapeutic dose level has also been identified.

·      If progress is successful, the application to commence first human trials is expected to be made during Q1 2021.

SDC-1802 (cancer immunotherapy)

·    Formulation work for oral dosing of SDC-1802 is complete and toxicology studies and further manufacturing work are planned over the coming months.

·    In October 2019, Sareum presented new findings showing that SDC-1802, dosed orally as a monotherapy and in combination with chemotherapy, significantly reduces tumour growth in models of solid tumours and blood cancers.

·    In October 2020, the Company received a Notice of Allowance for its US patent covering SDC-1802, the grant of which will complete the patent protection of this compound in all major territories.

TYK2/JAK1 Inhibitors for treating symptoms of Covid-19

·    A grant application has been submitted to UK Research and Innovation (UKRI) to fund preliminary laboratory studies investigating the potential of Sareum's TYK2/JAK1 inhibitors to address the severe inflammatory responses (the "cytokine storm") and potentially fatal respiratory symptoms of Covid-19 and other viral infections.

·    A response is expected by the end of October 2020 which, if successful, will enable initial studies to begin shortly thereafter.

Licensed Programmes

FLT3+Aurora Inhibitors (haematological cancers)

·    On 26 March 2020, Sareum announced it entered a global licensing deal for its FLT3+Aurora kinase inhibitor programme targeting blood cancers with a China-based specialty pharmaceutical company (the "Licensee").

·    Sareum received an upfront payment and is eligible to receive an additional c.£0.90m should certain milestones be achieved by January 2021, being within nine months of signing and receipt of programme materials by the Licensee. Sareum is also eligible to receive a further development-based milestone, and revenues upon the commercialisation of any resulting products.

 SRA737: A Selective Chk1 inhibitor (solid cancers)

·    The licence holder for SRA737, Sierra Oncology Inc. ("Sierra"), stated in August 2020 that it was exploring internal and external options to support the continued development of SRA737.

·    As of 25 September 2020, Phase 1/2 trials of SRA737 as a monotherapy and in combination with low dose gemcitabine were both reported to be complete.

·    In March 2020, new research published in Cancer Research highlighted the anti-cancer effect of SRA737 in multiple human lung and colorectal cancer cells, when used in combination with small molecules that block DNA replication and repair (B-family DNA polymerases), further adding to the encouraging data generated on SRA737.

AUDITED FINANCIAL HIGHLIGHTS

·      As previously indicated, R&D Tax Credit of £0.23m was received in January 2020.

·      Raised £1.02m (gross) in June 2020 through a placing by Hybridan LLP in conjunction with an offer via PrimaryBid to progress the Company's TYK2/JAK1 drug development programmes as well as for working capital purposes.

·      Loss on ordinary activities for the year ended 30 June 2020 (after taxation) of £0.99m (2019: loss of £1.45m), reflecting the Company's careful management of cash resources.

·      Cash at bank as of 30 June 2020 was £1.80m (£1.0m as of 31 December 2019; £0.92m as of 30 June 2019).

·      As announced on 17 December 2019, the Company confirmed that all directors had entered a voluntary salary deferral scheme, whereby 33% of directors' salaries were being deferred until further notice. On 1 July 2020, the Company announced an update to the Salary Deferral Scheme and announced the settlement of directors' deferred salary through the issue of new ordinary shares. The Company also agreed to reduce the terms of CEO Dr Tim Mitchell's salary deferral from 33% to 20% of his salary going forward. All other directors agreed to continue to defer 33% of their salaries until further notice.

Dr Tim Mitchell, CEO of Sareum, commented:

"Sareum has continued to make good progress with the preclinical development of our proprietary dual TYK2/JAK1 inhibitor programmes. Most recently, we have overcome an important formulation challenge with SDC-1801, which will now be advanced into the toxicology studies needed to complete our preparations for clinical trials.

"In addition, we are pleased to have raised additional funding during the period, which will be deployed to advance our proprietary programmes towards clinical development and build a robust data package to support our ongoing partnering activities for these exciting and differentiated assets.

"We were pleased to sign a global licensing deal for our FLT3+Aurora inhibitor programme targeting blood cancers with a China-based specialty pharma company during the period. Progress is being made by the Licensee in line with its development plan. Further good progress would enable us to receive a success-dependent milestone payment by January 2021 from this agreement.

"Regarding SRA737, we continue to monitor Sierra Oncology's activities as it explores options to fund the future development of this novel compound. We were pleased to note that as of 25 September 2020, the website www.clinicaltrials.gov is reporting that the Phase 1/2 trials of SRA737 as a monotherapy and in combination with low dose gemcitabine in solid cancers are complete. We look forward to the results of these completed trials being disclosed. We will provide further updates on this and other programmes when appropriate."

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