REG - Sareum Holdings PLC - Restart of Phase 2-enabling toxicology programme

Sareum HoldingsAnnouncement

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RNS Number : 2341T  Sareum Holdings PLC  17 February 2026

Sareum Holdings PLC

("Sareum" or the "Company")

Restart of Phase 2-enabling toxicology programme for SDC-1801

Cambridge, UK, 17 February 2026 - Sareum Holdings plc (AIM: SAR), a
clinical-stage biotechnology company developing next-generation kinase
inhibitors for autoimmune disease and cancer, is pleased to announce that it
has restarted the Phase 2-enabling toxicology programme for SDC-1801, a
selective TYK2/JAK1 inhibitor being developed as a potential treatment for a
range of autoimmune diseases, with an initial focus on psoriasis.

The Company has appointed a leading global contract research organisation
(CRO), with extensive experience in long-term toxicology studies to conduct
the programme following the discontinuation of a previous study, as announced
on 10 October 2025.

Before restarting, the Company completed preliminary pharmacokinetic (PK) work
to evaluate tolerability and exposure levels across different formulations
 allowing selection of a vehicle with some precedence in long-term studies.

The toxicology programme is being conducted using the Company's existing cash
resources and toxicology batch of SDC-1801. Completion of this programme,
together with ongoing CMC and formulation development activities, will form
the Phase 2-enabling regulatory package, positioning the programme for Phase 2
clinical development. The dosing phase of the toxicology studies is expected
to complete in mid-2026, with the full Phase 2-enabling package expected to be
complete by year-end.

As previously reported, the Phase 1 clinical study of SDC-1801 in healthy
volunteers met its primary objectives and characterised a pharmacokinetic
profile consistent with once-daily dosing. No safety concerns were identified.

Dr Stephen Parker, Executive Chairman of Sareum, said: "Generating a full
Phase 2 enabling toxicology package is an important step forward for SDC-1801.
The appointment of an experienced global CRO and the successful completion of
the preliminary PK study give us confidence as we advance through this
important phase of development. Combined with the strong Phase 1 data, these
studies will further support SDC-1801's potential to become a best-in-class,
once-daily oral therapy for autoimmune diseases. We look forward to providing
further updates as the programme progresses."

- ENDS-

For further information, please contact:

 Sareum Holdings plc

 Stephen Parker, Executive Chairman                  01223 497700

                                                     ir@sareum.co.uk
 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                         020 7409 3494

 Singer Capital Markets (Joint Corporate Broker)     020 7496 3000

 Phil Davies

 Oberon Capital (Joint Corporate Broker)             020 3179 5300

 Mike Seabrook / Nick Lovering

 ICR Healthcare (Financial PR)                       020 3709 5700

 Jessica Hodgson / Davide Salvi

 

About Sareum

Sareum (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, with a planned
initial focus on psoriasis.

Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential
application for certain haematological cancers and has recently initiated a
preclinical programme to develop TYK2/JAK1 inhibitors for neuroinflammatory
diseases such as multiple sclerosis and Parkinson's disease

The Company has recently acquired the license for SRA737, a clinical-stage
Checkpoint kinase 1 inhibitor that targets cancer cell replication and DNA
damage repair mechanisms.

Sareum Holdings plc is based in Cambridge, UK, and is quoted 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
(http://www.sareum.com)

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