Sareum Holdings plc (AIM: SAR), the specialised small molecule drug development business, announces its results for the year ended 30 June 2019 and provides an update of significant post-period events. The Company will host a conference call today at 10.00 a.m. (see details below).
The Company expects to publish its Annual Report and Accounts in November 2019.
Proprietary Selective TYK2/JAK1 Inhibitors in Autoimmune Diseases and Cancer
· Advancing two distinct molecules selected from proprietary dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) programmes as potential once-daily, oral immunotherapies for autoimmune diseases (SDC-1801) and cancers (SDC-1802)
o SDC-1801 has demonstrated excellent tolerability in toxicology studies in rodents and has progressed into longer-term toxicology and dose-finding studies, which would form part of the regulatory documentation needed to apply to begin human trials
o Additional research to refine the Company’s clinical plans, including prioritisation of indications, is continuing, with detailed profiling of SDC-1801 in human tissue, and of SDC-1802 in immune-competent mouse models of cancer
o Positive preclinical data demonstrating the anti-tumour activity of SDC-1802 via novel immunotherapeutic mechanism of action to be presented at the upcoming 2019 AACR-NCI-EORTC International Cancer Conference
o Human clinical trials are targeted to start in late-2020, subject to successful progress and financing
o Programmes continue to attract interest from international pharmaceutical companies
SRA737 – Chk1 inhibitor in Multiple Cancer Indications Exhibiting Defined Genetic Profiles
· In June 2019, Sierra Oncology (“Sierra”), the licence holder of SRA737 (an oral selective Chk1 inhibitor), announced promising preliminary efficacy and safety data at the annual meeting of the American Society of Clinical Oncology (ASCO) from two ongoing Phase 1/2 clinical trials. These trials were evaluating SRA737 across multiple indications, both as a monotherapy and as a combination, potentiated by non-cytotoxic low-dose gemcitabine (LDG)
· In June 2019, following its ASCO presentation, Sierra announced it was exploring non-dilutive strategic options to support the next stages of development of SRA737, as it had decided to prioritise the development of its Phase 3 myelofibrosis candidate, momelotinib
· The ongoing SRA737 monotherapy and SRA737+LDG combination Phase 1/2 studies continue with completion expected in the first half of 2020
· Sierra also presented evidence at international congresses highlighting the potential of combining SRA737 with other novel therapeutic approaches that are gaining traction as mainstays of targeted cancer treatment, including PARP inhibition (PARPi) and immune checkpoint blockade
Corporate update – Board of Directors strengthened
· Dr Michael Owen and Mr Clive Birch were appointed as Non-Executive Directors in November 2018, bringing significant experience in the development of innovative biopharmaceutical products and in financial management and corporate governance
Financial highlights (subject to audit)
· Raised £850,000 before expenses in November 2018, through a placement of 130,769,231 new ordinary shares at 0.65p per share, to progress internal drug development programmes as well as for working capital purposes
· Raised £781,484 before expenses through a placement and offer of 195,371,000 new ordinary shares at 0.4p per share that completed in July 2019, to progress the Company’s TYK2/JAK1 drug development programmes as well as for working capital purposes
· Loss on ordinary activities (after taxation) of £1.45m (2018: loss of £1.47m)
· Cash at bank as at 30 June 2019 was £0.92m (excluding the £0.78m raised in the placing that completed in July 2019) (£1.54m as at 31 December 2017; £1.38m as at 30 June 2018)
Dr Tim Mitchell, CEO of Sareum, commented:
“We are very pleased with the progress of our proprietary dual TYK2/JAK1 programmes. We believe these offer a novel oral immunotherapy approach to addressing unmet needs in autoimmune diseases and cancer and that their mechanism is gaining increasing interest from the pharmaceutical industry. In line with our business model, we continue to engage with potential partners with a view to securing commercial licences when they reach late preclinical or early clinical stages.
“We also remain optimistic that Sierra will be successful in finding a non-dilutive solution that will enable the development of SRA737 to advance. The positive clinical results presented in June and the exciting preclinical findings presented throughout the year from combining SRA737 with advanced cancer therapies suggests that SRA737 has significant value. In addition, the advancement of SRA737 in its clinical studies could result in Sareum receiving significant milestone payments in due course.
“We expect to report on continued progress across our active portfolio during the coming year and beyond, which we believe will result in important value generation for our shareholders.”