Sareum Holdings PLC
(“Sareum” or the “Company”)
Final Results for the Year Ended 30 June 2022
Cambridge, UK, 24 October 2022 – Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, announces its audited results for the year ended 30 June 2022.
Sareum also provides a broader update on operational activities and pipeline progress.
OPERATIONAL HIGHLIGHTS – INCLUDING POST-PERIOD UPDATES
SDC-1801 (autoimmune disease)
SDC-1802 (cancer immunotherapy)
Dr Tim Mitchell, CEO of Sareum, commented:
“We close this financial year with growing excitement around the potential for our portfolio of differentiated TYK2/JAK1 inhibitors.
“Our lead programme, SDC-1801, is a TYK2/JAK1 inhibitor which we believe has significant potential for superior efficacy in autoimmune disease compared to oral therapies currently available and in development. We have submitted a Clinical Trial Authorisation (CTA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and, subject to the required approval, hope to begin clinical trials in healthy volunteers before the end of 2022, with a psoriasis trial planned for 2023. This comes against a background of increased recognition around the potential for the TYK2/JAK1 class, and we have been encouraged by the recent FDA approval of BMS’s Sotyktu, the first approved TYK2 therapeutic, and the interest building around the space.”
“Our expertise in kinase inhibition, alongside momentum in our translational work, also supports confidence in SDC-1802, our immunotherapy programme targeting cancer. We are working to further define an appropriate patient population for clinical work and look forward to continued progress with this and our other programmes.
“We are pleased to have clarity on SRA737 and to be able to plan the next steps for SRA 737 together with CPF. We continue to believe that SRA737 has great potential for the treatment of cancer, particularly in combination settings.”
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO
Strand Hanson Limited (Nominated Adviser)
James Dance / James Bellman
020 7409 3494
Peel Hunt LLP (Joint Corporate Broker)
James Steel / Oliver Duckworth
020 7418 8900
Hybridan LLP (Joint Corporate Broker)
020 3764 2341
Consilium Strategic Communications (Financial PR)
Jessica Hodgson / Davide Salvi / Stella Lempidaki
020 3709 5700
Sareum Holdings (AIM:SAR) is a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer.
The Company is focused on developing next generation small molecules which modify the activity of the JAK kinase family and have best-in-class potential. Its lead candidate, SDC-1801, simultaneously inhibits TYK2 and JAK1. SDC-1801 is a potential treatment for a range of autoimmune diseases, which, subject to MHRA approval, will shortly enter clinical development with an initial focus on psoriasis.
Sareum has an economic interest in SRA737, a clinical-stage Chk1 inhibitor which it originally developed in collaboration with several Cancer Research UK-related organisations. SRA737 has shown promising safety and efficacy in two Phase 1/2 clinical trials.
Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential application for cancer immunotherapy.
Sareum Holdings plc is based in Cambridge, UK, and 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
Sareum is making exciting progress in advancing its programme of next generation kinase inhibitors for autoimmune disease and cancer into clinical development.
The Company has emerged strongly from the challenges of the COVID-19 pandemic with a new focus on autoimmune disease and particularly psoriasis, an area of high unmet need and one with significant commercial potential.
Management believes that dual inhibition of both TYK2 and JAK1 has the potential to offer superior efficacy, in comparison to other small molecule approaches, for the treatment of autoimmune diseases, and that the Company has a compelling and differentiated offering.
With this goal in mind, for much of the year, the Company has been focused on preparatory work to begin clinical development. All preliminary work, including toxicology studies, drug manufacture and formulation, and regulatory submission, is now complete and we look forward to advancing into the clinic soon, subject to approval from the MHRA.
Although SDC-1801 is the Company’s primary focus, translational studies are also progressing in SDC-1802, an immunomodulating molecule that has demonstrated good efficacy in preclinical models of cancer.
Post-period, Sareum was advised that Sierra intends to return the rights for SRA737 to CPF. The Company and CPF will discuss the potential options for future development opportunities for SRA737 and evaluate its next steps accordingly.
Sareum continues to believe that, based on preclinical and early clinical data, SRA737 holds strong promise for the treatment of cancer, particularly in combination settings and are confident in the potential of this molecule.
Sareum is a clinical-stage small molecule drug development company which is focused on advancing inhibitors of the JAK kinase family into clinical development for autoimmune disease and cancer. It is led by a highly experienced team with expertise in kinase inhibition and decades of experience in R&D and public company management.
Sareum’s pipeline is focused on TYK2/JAK1 inhibitors, which are involved in signalling pathways that are deregulated in multiple autoimmune diseases. Inhibition of TYK2 and JAK1 has the potential to yield a superior efficacy compared with agents that block just one of these two kinases and with a superior safety profile than “first generation” JAK family inhibitors that also modulate JAK2 and JAK3.
Our approach is to discover and develop programmes to late preclinical or early clinical stages before licensing or partnering.
We maintain a lean cost base with a small, highly specialised team and use trusted third-party providers to maximise return on investment.
SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin.
Preclinical development activities required to apply for the CTA have been concluded and, consistent with the Company’s clinical development plan, an application for a CTA has now been filed with the MHRA for the development of SDC-1801.
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers the potential for increased efficacy in psoriasis, compared with existing approved oral therapies.
Sareum, working alongside a specialist contract drug development organisation, has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to regulatory approval from the MHRA, the Phase 1a trial is planned to commence in Q4 2022 and will investigate the safety and tolerability of an oral formulation of SDC-1801 in ascending doses administered to healthy subjects. In addition, the trial will evaluate the effect of SDC-1801 on certain biomarkers of autoimmune disease that could be predictive of efficacy when tested in patients.
The Phase 1a part of the trial is expected to provide safety and dosing information applicable for any future trials in patients with other autoimmune diseases and the acute respiratory symptoms of viral infections, including COVID-19, should the Company decide to progress such trials.
Provided satisfactory safety data is obtained from this initial study, and subject to additional funding, a Phase 1b clinical study will commence in psoriasis patients in 2023. The Clinical Research Organisation conducting and managing the studies has extensive experience in conducting trials in inflammatory diseases and up to 120 subjects will be recruited at a site in Manchester, UK.
Synthesis of SDC-1801 drug substance under GMP conditions has been completed successfully, with a surplus of material for the planned Phase 1 clinical trials. GMP-compliant manufacture of capsules of SDC-1801, intended for use in the Phase 1 trial, is also complete, and the capsules are undergoing rigorous quality control checks before delivery to the clinical unit.
SDC-1802 is a TYK2/JAK1 inhibitor being developed for cancer and cancer immunotherapy applications.
Sareum continues to work on the translational studies needed to define the optimal cancer application prior to completing toxicology and manufacturing studies.
In April 2022, the Company was granted a new patent, protecting the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat T-cell acute lymphoblastic leukaemia (T‑ALL – a cancer of a particular type of white blood cell called a T lymphocyte) and other cancers that are dependent on TYK2 kinase for survival.
SRA737 is a clinical-stage oral, selective Chk1 inhibitor that targets cancer cell replication and DNA damage repair mechanisms.
The asset was originally developed by Sareum in collaboration with several Cancer Research UK-related organisations, including CPF with whom the Company entered a co-development agreement in 2013. Under the terms of the agreement, Sareum is entitled to a 27.5% share of any commercialisation revenues.
CPF has been informed by Sierra Oncology that it intends to terminate the SRA737 licence agreement and return the rights for SRA737. Sareum will discuss with CPF the potential options for future development opportunities for SRA737 and evaluate its next steps accordingly. The SRA737 licence agreement has a 90-day notice period for termination, therefore the Company expects the rights to the programme to be returned to CPF during January 2023 and further updates will be made in due course, as and when appropriate.
Sierra had reported positive preliminary efficacy and safety data in two clinical trials evaluating it as a monotherapy and in combination with chemotherapy in 2019, and preclinical data have been reported that support the potential for SRA737 in combination against hard-to-treat cancers.
We continue to believe that, based on preclinical and early clinical data, SRA737 holds strong promise for the treatment of cancer, particularly in combination settings and are confident in the potential of this molecule.
Sareum ended the full year to 30 June 2022 with a robust cash position following subscriptions in July, August and December 2021 that raised £3.6m after expenses.
As a result, the cash at the bank as of 30 June 2022 was £4.3m (£2.7m as of 30 June 2021).
The Company also received an R&D tax credit of £0.2m in December 2021 and expects to receive £0.4m in R&D tax credit in December 2022.
Loss on ordinary activities (after taxation) for the year ended 30 June 2022 was £2.2m (2021: loss of £1.5m), which reflects the increased R&D investment required for late preclinical development and preparation for clinical trials.
Sareum plans to initiate clinical trials for SDC-1801 by the end of 2022 to provide critical safety and dosing information, with a planned trial in psoriasis patients in 2023. Preparatory work has largely concluded, and we look forward to advancing this study as soon as possible.
Our preclinical work, combined with the growing commercial and scientific momentum building around the TYK2/JAK1 class, gives us growing optimism about the commercial potential for this molecule and we are excited to be nearing clinical development.
Our experienced team continues to advance translational studies around SDC-1802, which we believe has attractive potential in cancer immunotherapy. We have a robust data package to support partnering activities for both these assets.
Following its acquisition by GSK, Sierra informed SRA737 co-development partner, CPF, of its intention to return the rights to SRA737. Sareum plans to discuss the potential for future development opportunities with CPF. While it is too early to comment on future strategy, we continue to believe that there is strong potential for this molecule in ‘hard-to-treat’ cancers. The Company currently expect these rights to revert in January 2023 and we will update the market accordingly.
The Board and management of Sareum continue to apply a rigorous approach to capital allocation to the development of our assets, particularly in the current challenging economic environment, and maintain a clear focus on bringing these medicines to patients as efficiently as possible, while maximising value for shareholders.