REG - Sareum Holdings PLC - Half-Year Report for Six Months Ended 31 Dec 2025
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RNS Number : 3116W Sareum Holdings PLC 12 March 2026
Sareum Holdings PLC
("Sareum" or the "Company")
Half-Year Report for the Six Months Ended 31 December 2025
Cambridge, UK, 12 March 2026 - Sareum Holdings plc (AIM: SAR), a
clinical-stage biotechnology company developing next-generation kinase
inhibitors for autoimmune disease and cancer, announces its unaudited results
for the six months ended 31 December 2025.
Sareum also provides a broader update on operational activities and pipeline
progress, highlighting the restart of the Phase 2-enabling toxicology
programme for SDC-1801, its lead TYK2/JAK1 inhibitor being developed for a
range of autoimmune diseases with an initial focus on psoriasis, following the
successful completion of the Phase 1 clinical trial and a sufficient cash
runway to advance the programme towards Phase 2 clinical development.
OPERATIONAL HIGHLIGHTS - INCLUDING POST-PERIOD UPDATES
SDC-1801 (autoimmune disease)
· Strong Phase 1 data and continued positive momentum across the
TYK2/JAK1 field reinforce the Company's conviction that SDC‑1801 has the
potential to become a differentiated, once‑daily oral therapy for autoimmune
diseases.
· Post-period, Sareum restarted the Phase 2-enabling toxicology
programme for SDC-1801 with a leading global contract research organisation
(CRO) with extensive experience in long-term toxicology studies. All
subjects have commenced dosing.
· Together with ongoing chemistry, manufacturing and controls (CMC) and
formulation development activities, these efforts position SDC‑1801 for
Phase 2 clinical development, with psoriasis expected to serve as the initial
proof‑of‑concept indication.
· The restart followed discontinuation of the previous 16-week GLP
study after unexpected findings were observed more frequently in control-group
animals that did not receive SDC-1801 following safety findings observed by
the third party provider of the study. Subsequent analysis confirmed the
findings were unrelated to SDC-1801.
· Ahead of the restart of the trial, the Company completed a short
pharmacokinetic study to assess tolerability and exposure across different
formulations, enabling selection of a suitable vehicle with precedent in
long-term studies.
· The toxicology programme is being conducted using the Company's
existing cash resources and previously manufactured toxicology batch of
SDC-1801. The dosing phase is expected to complete in mid-2026, with the full
Phase 2-enabling regulatory package anticipated to be complete by year-end.
· Work to optimise the capsule formulation of SDC-1801 is nearing
completion, aimed at enhancing drug release at higher doses and reducing the
number of capsules required per dose in future clinical trials.
· The full dataset from the Phase 1 clinical trial, has been submitted
to an academic journal and is currently undergoing peer review.
SDC-1802 (cancer immunotherapy)
· Translational studies with SDC-1802 have been completed, providing a
solid data package to support potential further development.
· The strongest cancer response was seen in cancers with a significant
level of unmet medical need including indications affecting relatively small
patient populations, which are best suited to targeted development approaches.
· The Company has concluded that this asset will be best progressed by
a partner and preparations are being made to identify the best route forward.
SRA737 (cancer)
• Targeted business development initiatives continue to support
partnering discussions for SRA737 as part of the Company's broader
value‑creation strategy.
• The Company continues to explore partnering opportunities for
SRA737, building on positive Phase 1/2 data that demonstrated good
tolerability as monotherapy and promising activity in combination with
low-dose gemcitabine in anogenital cancers, an area of significant unmet
medical need.
• Sareum holds the licence for SRA737 on significantly improved
economic terms, securing 63.5% of all future revenues compared to 27.5% under
the former agreement, at no cost to the Company.
• The Company has maintained an Investigational New Drug (IND)
application with the United States Food and Drug Administration (FDA) to
conduct a Phase 1 trial in patients with acute myeloid leukaemia and
myelodysplastic syndromes and retains sufficient stock of SRA737 capsules to
conduct a trial.
• Notice of Allowance received from US Patent and Trademark Office
for an application protecting the crystal form of SRA737 drug substance,
extending patent protection until at least April 2041.
TYK2 Neuroscience Discovery programme
· Sareum is progressing a collaboration with Receptor.AI to accelerate
discovery of blood-brain barrier (BBB)-penetrant, selective TYK2/JAK1
inhibitors for potential use in neuro-inflammatory indications such as
multiple sclerosis and Parkinson's disease. This builds on earlier preclinical
work from the Company's SKIL platform, which demonstrated blood-brain barrier
permeability of selected TYK2/JAK1 molecules.
· A first batch of compounds has been designed, synthesised and
completed early-stage testing in biochemical and ADME assays. Building on the
data obtained, a further batch of compounds has been designed and is currently
being synthesized prior to early-stage testing.
Business Development
· With a clear operational roadmap, active business development
initiatives and sufficient financial resources, the Company is well positioned
to deliver further progress in the period ahead.
· As part of a broader value-realisation strategy, Sareum has engaged a
specialist US-based business development consultancy to actively broaden and
accelerate ongoing partnering discussions for SDC-1801 and SRA737. We are
already seeing some impact from the consultancy's activities.
FINANCIAL HIGHLIGHTS
· Cash at 31 December 2025: £2.5 million (£3.5 million as of 30 June
2025).
· Administrative expenses (including R&D): £1.8 million; R&D
spend: £1.4 million.
· Loss before tax: £1.9 million (£4.9 million as of 30 June 2025).
· £0.5 million cash raised in the period by the exercise of warrants.
· R&D tax credits received in the period: £0.1 million (£1.2
million as of 30 June 2025).
Dr Stephen Parker, Executive Chairman of Sareum, commented:
"Sareum has made solid progress during the period, most notably with the
restart of the Phase 2-enabling toxicology programme for SDC-1801, our lead
asset. This programme is central to advancing SDC-1801 into Phase 2
development and we are encouraged by the immediate progress."
"This builds on the strong Phase 1 data and continued positive momentum across
the TYK2/JAK1 field, reinforcing our confidence in SDC-1801's potential as a
differentiated, once-daily oral therapy for autoimmune diseases. In parallel,
we continue to progress value-creation opportunities across the wider
portfolio, including SRA737 and our TYK2 neuroscience collaboration, supported
by the engagement of a specialist US-based business development consultancy to
broaden and accelerate partnering discussions. With clear milestones ahead, we
remain confident in the Company's direction and prospects."
- 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 also owns 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
EXECUTIVE CHAIRMAN'S STATEMENT
The first half of the year has been defined by steady operational execution,
particularly in relation to SDC‑1801. Following the strong Phase 1 results,
which confirmed that the molecule was generally well tolerated and
demonstrated PK/PD characteristics consistent with once‑daily dosing, we
moved quickly to re‑establish the Phase 2‑enabling toxicology programme.
The earlier GLP study was halted after unexpected findings were observed more
frequently in control‑group animals, and subsequent analysis confirmed that
these findings were unrelated to SDC‑1801. Before restarting the programme,
we completed a short pharmacokinetic study to compare formulations and
identify a vehicle suitable for long‑term studies. With dosing now underway
and formulation optimisation progressing, the programme continues to move
forward, with psoriasis planned as the initial proof‑of‑concept
indication.
Work on SDC‑1802 has also reached an important point. Translational studies
have concluded and provide a solid foundation for further development,
particularly in cancers with significant unmet need. Given the Company's focus
on SDC‑1801 and the nature of the opportunity for SDC‑1802, we have
determined that the most appropriate next step is to progress this asset
through a partner, and preparations to support this approach are in progress.
In oncology, SRA737 remains an important component of our portfolio. The
licence continues to be held on significantly improved economic terms,
providing the Company with 63.5% of all future revenues at no cost. Previous
clinical data have shown good tolerability as monotherapy and encouraging
activity in combination with low‑dose gemcitabine in anogenital cancers. The
programme also retains an active IND with the FDA for a potential Phase 1
trial in AML and MDS, supported by sufficient capsule stock. Business
development efforts, including the engagement of a specialist US‑based
consultancy, are ongoing to broaden and accelerate discussions with potential
partners.
Beyond these clinical and translational programmes, we continued to advance
our TYK2 neuroscience discovery collaboration with Receptor.AI. Early‑stage
biochemical and ADME testing has been completed for the first set of
compounds, and a second set is now in synthesis. This work builds on earlier
findings from our SKIL platform demonstrating blood-brain barrier permeability
of selected TYK2/JAK1 molecules and supports the potential application of this
approach in neuro‑inflammatory conditions.
Financially, we maintained a disciplined approach to resource allocation. The
loss after tax for the period was £1.7 million, and the Company ended the
half‑year with £2.5 million in cash, supported by warrant exercises and
R&D tax credits. All core activities, including the toxicology programme
for SDC‑1801 and the neuroscience collaboration, continue to be funded from
existing cash resources.
As we move through the remainder of the year, our efforts will remain centred
on advancing the Phase 2‑enabling work for SDC‑1801, supporting partnering
processes for SDC‑1802 and SRA737, and continuing progress within our TYK2
neuroscience programme. The Board remains focused on delivering against these
priorities in a measured and responsible manner.
PROGRAMME UPDATES
SDC-1801
SDC-1801 is a selective TYK2/JAK1 inhibitor being developed as a potential new
therapeutic for a range of autoimmune diseases, with an initial focus on
psoriasis. Psoriasis is a chronic autoimmune condition affecting more than 60
million adults worldwide, with the global market for psoriasis therapies
valued at over US$30 billion. Sareum believes that dual TYK2/JAK1 inhibition
offers the potential for enhanced efficacy while maintaining an attractive
safety profile compared with existing therapies.
Post-period, Sareum restarted the Phase 2-enabling preclinical toxicology
programme for SDC-1801, marking an important step towards advancing the
programme into Phase 2 clinical development. The studies are being conducted
by a leading global contract research organisation with extensive experience
in long-term toxicology programmes. Ahead of restarting, the Company completed
a short pharmacokinetic study to assess tolerability and exposure across a
range of formulations, enabling selection of a vehicle with appropriate
precedent for long-term studies. The programme is being undertaken using the
Company's existing cash resources and previously manufactured toxicology batch
of SDC-1801, with the dosing phase expected to complete in mid-2026 and the
full Phase 2-enabling regulatory package anticipated to be completed by
year-end.
The restart follows the discontinuation of a previous 16-week GLP toxicology
study in October 2025 after unexpected findings were observed more frequently
in control-group animals. Subsequent analysis confirmed that the control
animals were not dosed with SDC-1801 and that the findings were unrelated to
the compound.
Sareum previously reported positive results from the Phase 1 clinical trial of
SDC-1801 in healthy volunteers conducted in Australia. The study included both
single ascending dose (SAD) and multiple ascending dose (MAD) cohorts and was
designed to assess safety, tolerability, pharmacokinetics (PK) and
pharmacodynamic (PD) biomarker responses.
· Safety and tolerability: SDC-1801 was generally well tolerated
across all doses tested, with no serious adverse events attributed to the
compound.
· Pharmacokinetics: PK analysis demonstrated a half-life of
approximately 17-20 hours, supporting once-daily oral dosing.
· Pharmacodynamics: PD biomarker analysis showed dose-dependent
reductions in relevant cytokine signalling pathways, consistent with selective
TYK2/JAK1 inhibition and sustained target engagement.
In parallel with the toxicology programme, CMC and formulation development
activities are progressing to support future clinical studies. Together, these
activities are intended to position SDC-1801 for Phase 2 clinical development,
with psoriasis expected to serve as the initial proof-of-concept indication.
SDC-1802
SDC-1802 is a TYK2/JAK1 inhibitor being developed for cancer and cancer
immunotherapy applications. Translational studies have been completed and
demonstrated the strongest validation in haematological cancers such as T-ALL
and B-cell lymphoma, areas of significant unmet need. The programme has shown
potential both as a single agent and in combination with existing therapies.
· Reflecting its portfolio priorities and the near-term opportunity
represented by SDC-1801, the Company has concluded that SDC-1802 will be best
progressed by a partner. Internal resources remain focused on advancing
SDC-1801 and building value across the broader portfolio.
SRA737
SRA737 is a clinical-stage oral, selective inhibitor of checkpoint kinase 1
(Chk1), that targets cancer cell replication and DNA damage repair mechanisms.
During the period, the Company continued to hold the licence for SRA737 on
significantly improved economic terms, securing 63.5% of all future revenues
compared to 27.5% under the former agreement, at no cost to the Company.
The Company continues to explore partnering opportunities for SRA737, building
on positive Phase 1/2 data that demonstrated good tolerability as monotherapy
and promising activity in combination with low-dose gemcitabine in anogenital
cancers, where there is significant unmet medical need. Sareum has maintained
an Investigational New Drug (IND) application with the FDA to conduct a Phase
1 trial in patients with acute myeloid leukaemia and myelodysplastic syndromes
and retains sufficient stock of SRA737 capsules to conduct such a trial.
TYK2 neuroscience Discovery Programme (post-period)
Sareum's TYK2 neuroscience programme, conducted in collaboration with
Receptor.AI, is focused on accelerating the discovery of blood-brain barrier
(BBB)-permeable, isoform-selective TYK2/JAK1 inhibitors for potential use in
neuro-inflammatory conditions such as multiple sclerosis and Parkinson's
disease. The collaboration builds on earlier work from the Company's SKIL
platform, which demonstrated blood-brain barrier permeability of selected
TYK2/JAK1 molecules.
A first batch of compounds has been designed, synthesised and completed
early-stage testing in biochemical assays to assess potency against the JAK
kinases, and in ADME assays to evaluate the potential for blood-brain barrier
penetration, as well as metabolic stability and other assays predictive of
pharmacokinetics. Data arising from these assays was fed into the design of a
further batch of compounds which are currently undergoing synthesis.
FINANCIAL REVIEW
The loss on ordinary activities after taxation for the six months ended 31
December 2025 was £1.7 million (year ended 30 June 2025: loss of £4.4
million). Sareum ended the period with cash at bank of £2.5 million (30 June
2025: £3.5 million), including £0.5 million cash raised in the period by the
exercise of warrants. The Group received R&D tax credits of £0.1 million
in the period (year ended 30 June 2025: £1.2 million).
During the period, the Company's principal expenditure related to the restart
of the Phase 2-enabling toxicology programme for SDC-1801, ongoing CMC and
formulation development activities, and the central nervous system (CNS)
discovery collaboration with Receptor.AI. The Company continues to manage its
resources prudently, with all current core activities funded from existing
cash resources.
OUTLOOK
Sareum expects continued progress in the second half of the year as it
advances the Phase 2-enabling toxicology programme for SDC-1801. The dosing
phase is expected to complete in mid-2026, with the full regulatory package
anticipated by year-end, positioning the programme for Phase 2 clinical
development.
The strong Phase 1 data, together with positive readouts across the TYK2/JAK1
field, continue to reinforce the Company's conviction that SDC-1801 has the
potential to become a best-in-class, once-daily oral therapy for autoimmune
diseases.
In parallel, the Company intends to progress the broader portfolio through
targeted business development and partnerships. The engagement of a specialist
US-based business development consultancy continues to support partnering
discussions for SDC-1801 and SRA737. The Company is also reviewing options for
further development of SDC-1802, and the TYK2 neuroscience collaboration with
Receptor.AI continues to advance.
With a clear operational roadmap, active business development initiatives, and
sufficient financial resources, the Board is confident of delivering further
progress in the period ahead.
Consolidated Statement of Comprehensive Income for the six months ended 31
December 2025
Notes Unaudited Unaudited Audited
Six months ended
Six months ended
Year
31 Dec 25
31 Dec 24
ended
30 Jun 25
£'000 £'000
£'000
Revenue - - -
Administrative expenses (1,820) (1,346) (3,382)
Share of profit/(loss) of associate - (2) 2
Operating loss (1,820) (1,348) (3,380)
Finance income 31 20 77
Financing charge in respect of warrants granted (63) - (1,600)
Loss before tax (1,852) (1,328) (4,903)
Tax 2 200 167 465
Loss on ordinary activities after taxation (1,652) (1,161) (4,438)
Other comprehensive income/(expense)
Exchange gains/(losses) arising on translation of foreign operations - (45) (70)
Total comprehensive expense for the period (1,652) (1,206) (4,508)
Loss attributable to owners of the parent (1,652) (1,161) (4,438)
Total comprehensive expense attributable to owners of the parent (1,652) (1,206) (4,508)
Basic and diluted loss per share (pence) 4 (1.2)p (0.9)p (3.6)p
Consolidated Balance Sheet as at 31 December 2025
Note
Unaudited Unaudited Audited
As at As at As at
31 Dec 2025 31 Dec 2024 30 Jun 2025
£'000 £'000 £'000
Non-current assets
Computers and equipment - - -
Investment in associate - 7 -
- 7 -
Current assets
Trade and other receivables 747 553 684
Cash and cash equivalents 2,488 4,145 3,546
3,235 4,698 4,230
Current liabilities
Warrant liability 1,638 - 1,600
Trade and other payables 403 375 353
2,041 375 1,953
Net current assets 1,194 4,323 2,277
Net assets 1,194 4,330 2,277
Equity
Called-up share capital 1,726 1,561 1,680
Share premium 29,431 28,012 29,020
Share-based compensation reserve 525 291 413
Foreign exchange reserve (50) (25) (50)
Retained earnings (30,438) (25,509) (28,786)
Total equity 1,194 4,330 2,277
Consolidated Statement of Changes in Equity for the six months ended 31
December 2025
Share capital Share premium Share-based compensation reserve Foreign exchange reserve Retained earnings Restated
£'000
£'000 £'000 £'000 £'000 Total
£'000
As at 30 June 2024 (audited) 1,349 24,802 312 20 (24,369) 2,114
Issue of share capital 212 3,302 - - 3,514
Costs of issue (92) (92)
Transfer in respect of options expired - - (21) 21 -
Arising on consolidation (45) (45)
Loss for the period - - - (1,161) (1,161)
As at 31 December 2024 (unaudited) 1,561 28,012 291 (25) (25,509) 4,330
Issue of share capital 119 1,068 - - - 1,187
Costs of issue (60) (60)
Transfer in respect of share options granted - - 122 - - 122
Arising on consolidation - - - (25) - (25)
Loss for the period - - - - (3,277) (3,277)
As at 30 June 2025 (audited) 1,680 29,020 413 (50) (28,786) 2,277
Issue of share capital 46 411 - - - 457
Costs of issue - - - - - -
Transfer in respect of share options granted - - 112 - - 112
Arising on consolidation - - - - - -
Loss for the period - - - - (1,652) (1,652)
As at 31 December 2025 (unaudited) 1,726 29,431 525 (50) (30,438) 1,194
Consolidated Cash Flow Statement for the six months ended 31 December 2025
Unaudited Unaudited Audited
Six months ended
Six months ended
Year ended
31 Dec 2025
31 Dec 2024
30 Jun 2025
£'000 £'000 £'000
Net cash flow from operating activities
Continuing operations:
Loss before tax (1,852) (1,328) (4,903)
Add back/ (deduct):
Charge for the period in respect of options issued 112 - 122
Financing charge re warrants issued 63 - 1,600
Finance income (31) (20) (77)
Foreign exchange differences - (45) (70)
Share of result of associate - 2 (2)
Operating cash flows before movements in working capital (1,708) (1,391) (3,330)
(Increase)/decrease in trade and other receivables 41 (116) (104)
Increase/(decrease) in trade and other payables 25 (278) (300)
Cash used in operations (1,642) (1,785) (3,734)
Tax received 96 1,029 1,183
Net cash outflow from operating activities (1,546) (756) (2,551)
Cash flows from investing activities
Interest received 31 20 77
Investment in associate - - 12
Net cash inflow/(outflow) from investing activities 31 20 89
Cash flows from financing activities
Proceeds from issue of share capital 457 3,514 4,701
Costs of issue - (92) (152)
Net cash inflow from financing activities 457 3,422 4,549
(Decrease)/increase in cash and equivalents (1,058) 2,686 2,087
Cash and cash equivalents at start of period 3,546 1,459 1,459
Cash and cash equivalents at end of period 2,488 4,145 3,546
NOTES TO THE UNAUDITED RESULTS FOR THE SIX MONTHS ENDED 31 DECEMBER 2025
1. Basis of financial information and accounting policies
These interim financial statements are unaudited and do not constitute
statutory financial statements within the meaning of Section 434 of the
Companies Act 2006. The Annual Report and Accounts for the year ended 30
June 2025 has been delivered to the Registrar of Companies and is available
from Sareum's web site, www.sareum.com. The report of the auditor on those
accounts was not qualified and contained no statement under Section 498 of the
Companies Act 2006.
The accounting policies adopted are consistent with those used for the
financial statements for the year ended 30 June 2025, as described therein. As
at the date of approving these interim financial statements, there are no new
standards likely to materially affect the financial statements for the year
ending 30 June 2026.
The Group made a loss after tax for the period of £1.7 million (year ended 30
June 2025: loss of £4.4 million), as it continued to progress its research
and development activities. These activities, and the related expenditure, are
in line with the budgets previously set and are funded by regular cash
investments.
The Directors consider that the cash held at the period end, together with
that projected to be received, will be sufficient for the Group to meet its
forecast expenditure for at least one year from the date of approving the
interim financial statements. If there is a shortfall, the Directors will
implement the required cost savings to ensure that the cash resources last for
this period of time. For these reasons, the interim financial statements
have been prepared on a going concern basis.
2. Taxation
No liability to corporation tax arises for the six-months ended 31 December
2025. Research and development tax credits, receivable as cash, are estimated
to be £0.2 million for the period (year ended 30 June 2025: £0.5 million).
3. Dividends
The Directors do not propose a dividend in respect of the six months ended 31
December 2025.
4. Loss per share
The basic loss per share is 1.2 pence (2024: 0.9 pence), calculated by
dividing the Group's loss for the six months by 137,715,273 (2024:
124,825,601), the weighted average number of shares in issue during the
period. There is no dilutive effect in respect of share options during the six
months to 31 December 2025 because the Group generated a loss in that period.
5. Availability of Half-yearly Report
This Half-yearly Report, including the interim financial statements, is
available on request from the Company by writing to: Unit 2a, Langford Arch,
London Road, Pampisford, Cambridge CB22 3FX or can be downloaded from the
Company's website www.sareum.co.uk.
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