REG - Sareum Holdings PLC - Sareum Half-Year Report
25/03/2025 07:00
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RNS Number : 9310B Sareum Holdings PLC 25 March 2025
Sareum Holdings PLC
("Sareum" or the "Company")
Half-Year Report for the Six Months Ended 31 December 2024
Cambridge, UK, 25 March 2025 - Sareum Holdings plc (AIM: SAR), a biotechnology
company developing next generation kinase inhibitors for autoimmune disease
and cancer, announces its unaudited results for the six months ended 31
December 2024.
Sareum also provides a broader update on its operational activities and
pipeline progress.
OPERATIONAL HIGHLIGHTS - INCLUDING POST-PERIOD UPDATES
SDC-1801 (autoimmune disease)
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.
· Successfully completed Phase 1 clinical trial for SDC-1801 with
single ascending dose ("SAD"), multiple ascending dose ("MAD") and food effect
studies.
· SDC-1801 achieved blood plasma levels significantly exceeding
predicted therapeutic exposure with a half-life of 17-20 hours, confirming the
potential for once-daily dosing. Significant dose-responsive biomarker effects
were observed.
· No deaths or serious adverse events due to SDC-1801 were reported,
with frequency of adverse events (all mild or moderate) similar in active and
placebo groups.
· The Clinical Study Report was received in December 2024.
· Strengthened intellectual property position with:
o US Patent and Trademark Office granted a patent (US Patent No. 12,187,716)
on SDC-1801's chemical structure, its use in treating inflammatory diseases,
and certain methods of chemical synthesis.
o Patent allowance in China protecting certain crystalline forms of SDC-1801
and methods of their preparation with a similar Decision to Grant that was
recently received from the Japanese Patent Office.
SRA737 (cancer)
SRA737 is a clinical-stage oral, selective Checkpoint kinase 1 inhibitor that
targets cancer cell replication and DNA damage repair mechanisms.
· After the period end, Sareum successfully acquired the licence for
SRA737 following the termination of a licensing agreement between CRT Pioneer
Fund ("CPF") and a US-based licensee in December 2024.
· Sareum renegotiated significantly improved economic terms, securing
63.5% of all future revenues compared to 27.5% under the former agreement.
· SRA737 has completed two phase 1/2 studies in patients with advanced
cancers, one as a single agent and the other in combination with low-dose
gemcitabine. An Investigational New Drug ("IND") application has now been
approved by the US Food & Drug Administration.
SDC-1802 (cancer immunotherapy)
SDC-1802 is a TYK2/JAK1 inhibitor being developed for cancer immunotherapy.
· The additional funding secured in October 2024 has enabled further
translational and preclinical development studies on SDC-1802.
FINANCIAL HIGHLIGHTS
• Cash at 31 December 2024 of £4.1m (£0.4m as of 31 December 2023
and £1.5m as of 30 June 2024).
• Loss on ordinary activities after taxation for the six months
ended 31 December 2024 of £1.2m, in line with expectations given the clinical
trial activity (2023: restated loss of £1.7m).
· After the period end, Sareum successfully raised £1.07m through a
subscription of 8,560,000 new ordinary shares at 12.5 pence per share.
Dr Stephen Parker, Executive Chairman of Sareum, commented:
"Sareum has made strong progress this period, marked by the successful
completion of our Phase 1 clinical trial for SDC-1801. The trial confirmed a
favourable safety profile and pharmacokinetics, reinforcing its potential as a
once-daily treatment for autoimmune diseases such as psoriasis. To support its
progression to Phase 2 trials, we are preparing the necessary toxicology
studies, supported by our strengthened financial position following a
successful fundraising round.
"Beyond SDC-1801, we have also strengthened our patent portfolio and secured
the licence for SRA737 on significantly improved economic terms - important
strategic advances that enhance our pipeline. With a clear development path
ahead, we remain confident in delivering value to shareholders as we advance
these promising therapeutic candidates."
- 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
Oberon Capital (Joint Broker)
Mike Seabrook / Nick Lovering 020 3179 5300
Hybridan LLP (Joint Broker)
Claire Noyce 020 3764 2341
ICR Healthcare (Financial PR)
Jessica Hodgson / Davide Salvi 020 3709 5700
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 cancer immunotherapy.
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
(about:blank)
EXECUTIVE CHAIRMAN'S STATEMENT
We continue to make good progress with SDC-1801, highlighted by the successful
completion of our Phase 1 clinical trial, which, coupled with the additional
funding secured during the period provides us with the resources to advance
SDC-1801 towards Phase 2 clinical trials. In parallel, we continue to develop
our promising cancer immunotherapy candidate, SDC-1802.
Since the period end, we have further strengthened our position by acquiring
the licence for SRA737, which significantly increases our economic interest to
63.5% of all future revenues. We believe SRA737 remains a valuable asset, and
gaining control of the licence puts us in a stronger position to explore
potential partnerships or development opportunities. Given the existing
clinical and preclinical data, we remain optimistic about identifying a path
forward that maximises SRA737's value, particularly as it received IND
approval from the US Food and Drug Administration (FDA) last year, which could
enable the start of clinical trials in the USA.
Evidenced by the recent fundraise of £1.07m, we are delighted by the
continued support from our shareholders as we look to build value within the
Company. With our strengthened patent portfolio and clear development pathway
for our lead programmes, we are well-positioned to build on this momentum in
the second half of the year and beyond. We remain focused on advancing our
pipeline of next-generation kinase inhibitors to address significant unmet
needs in autoimmune disease and cancer.
PROGRAMME UPDATES
SDC-1801
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.
Sareum has the successfully completed the Phase 1 clinical trial of SDC-1801
(Trial ID: ACTRN12623000416695
(https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385555)
), including both SAD and MAD stages. The randomised, placebo-controlled
trial investigating the safety, tolerability, pharmacokinetics and
pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects, was
conducted at a clinical unit in Melbourne, Australia and demonstrated that
SDC-1801 achieved blood plasma levels well above the predicted therapeutic
exposure, and induced significant dose-dependent biomarker changes
No deaths or serious adverse events were reported due to SDC-1801, and based
on the unblinded data, the frequency of adverse events (all mild or moderate)
was similar in the active and placebo groups. As a consequence, we believe
that the safety and PK profile gives us a potential best-in-class advantage
over similar products in development.
The Company also made significant progress in expanding its intellectual
property protection for SDC-1801 during the period. This included securing
patent allowances in key markets, with the US Patent Office approving claims
covering the compound's structure and therapeutic applications, while Chinese
authorities granted protection for specific crystalline forms of the molecule.
After the period end, the Company also received a Decision to Grant letter
from the Japanese Patent Office for similar crystalline form protection. These
patents substantially strengthen Sareum's competitive position and commercial
potential for this promising therapy.
SRA737
SRA737 is a clinical-stage oral, selective Checkpoint kinase 1 inhibitor that
targets cancer cell replication and DNA damage repair mechanisms.
After the period end, Sareum successfully acquired the licence for SRA737
following the termination of a licensing agreement between CPF and a US-based
licensee in December 2024. The Company renegotiated 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.
We remain encouraged by the potential to secure a promising development path
for the compound, given the data from the Phase 1/2 studies, where SRA737 was
well tolerated as a monotherapy. Additionally, in combination with low dose
gemcitabine, SRA737 demonstrated promising activity in anogenital cancers,
where there is significant unmet medical need.
Preclinical data in disease models also indicate that SRA737 may be effective
in combinations with Wee1 or PARP targeted therapies in ovarian cancers, and
with low-dose gemcitabine and immunotherapy in lung and colon cancers.
SDC-1802
SDC-1802 is a TYK2/JAK1 inhibitor being developed for cancer and cancer
immunotherapy applications.
The additional funding secured in October 2024 enabled further translational
and preclinical development studies on SDC-1802. The Company continues to
advance this programme in parallel with its lead asset, leveraging the
expertise gained through the development of SDC-1801.
FINANCIAL REVIEW
Following the 2024 fundraises, on 31 December 2024 Sareum had cash of £4.1m
(2023: £0.4m). The loss on ordinary activities after taxation for the six
months ended 31 December 2024 was £1.2m (2023: restated loss of £1.7m),
reflecting ongoing clinical trial costs.
Post-period end, Sareum received UK R&D tax credits of £0.2m and
successfully raised £1.07 m through a subscription of 8,560,000 new ordinary
shares at 12.5 pence per share, representing a discount of approximately 24%
to the closing mid-market price on 12 March 2025.
OUTLOOK
The Company's focus for the remainder of the financial year and beyond is
advancing its strong pipeline of next-generation kinase inhibitors. Our focus
remains on completing the manufacture of new drug product to allow the
additional toxicology studies for SDC-1801 to commence by mid-2025, enabling
preparation for Phase 2 clinical trials in psoriasis and potentially other
autoimmune indications.
Sareum is now well positioned to realise the potential of the pipeline while
maintaining flexibility to respond to new opportunities that may arise in the
constantly evolving therapeutic landscape for kinase inhibitors.
The board of Sareum continues to apply a rigorous approach to capital
allocation for the development of our assets, particularly in the current
challenging economic environment, and maintains a clear focus on bringing
these medicines to patients as efficiently as possible, while maximising value
for shareholders.
Consolidated Statement of Comprehensive Income for the six months ended 31
December 2024
Notes Restated
Unaudited Unaudited Audited
Six months ended
Year
31 Dec 24 Six months ended
ended
31 Dec 23
30 Jun 24
£'000
£'000 £'000
Revenue - - -
Other operating income - - 22
Operating expenses (1,346) (2,536) (4,596)
Share of profit/(loss) of associate (2) 4 (60)
Operating loss (1,348) (2,532) (4,634)
Finance income 20 19 32
Loss before tax (1,328) (2,513) (4,602)
Tax 3 167 765 1,182
Loss on ordinary activities after taxation (1,161) (1,748) (3,420)
Total comprehensive income for the period (1,161) (1,748) (3,420)
Total comprehensive income attributable to:
Owners of the parent (1,161) (1,748) (3,420)
Basic and diluted loss per share (pence) 5 (0.9)p (2.5)p (4.2)p
Consolidated Balance Sheet as at 31 December 2024
Note Restated
Unaudited Unaudited Audited
As at As at As at
31 Dec 2024 31 Dec 2023 30 Jun 2024
£'000 £'000 £'000
Non-current assets
Computers and equipment - - -
Investment in associate 7 46 9
7 46 9
Current assets
Debtors 553 1,513 1,299
Cash and cash equivalents 4,145 408 1,459
4,698 1,921 2,758
Creditors: amounts due within one year (375) (789) (653)
Net current assets 4,323 1,132 2,105
Total assets less current liabilities 4,330 1,178 2,114
Creditors: amounts due after one year - - -
Net assets 4,330 1,178 2,114
Equity
Called-up share capital 1,561 878 1,349
Share premium 28,012 22,675 24,802
Share-based compensation reserve 291 312 312
Foreign exchange reserve (25) 10 20
Retained earnings (25,509) (22,697) (24,369)
Total equity 4,330 1,178 2,114
Consolidated Statement of Changes in Equity for the six months ended 31
December 2024
Share capital Share premium Share-based compensation reserve Foreign exchange reserve Restated Restated
£'000
£'000 £'000 £'000 Retained earnings Total
£'000 £'000
As at 30 June 2023 (audited) 851 20,925 325 14 (20,962) 1,153
Issue of share capital (net) 27 1,750 - - 1,777
Transfer in respect of options exercised - - (13) 13 -
Arising on consolidation (4) (4)
Loss for the period - - - (1,748) (1,748)
As at 31 December 2023 (unaudited) 878 22,675 312 10 (22,697) 1,178
Issue of share capital (net) 471 2,127 - - - 2,598
Arising on consolidation - - - 10 - 10
Loss for the period - - - - (1,672) (1,672)
As at 30 June 2024 (audited) 1,349 24,802 312 20 (24,369) 2,114
Issue of share capital (net) 212 3,210 - - - 3,422
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
Consolidated Cash Flow Statement for the six months ended 31 December 2024
Restated Audited
Year ended
Unaudited Unaudited
30 Jun 2024
Six months ended
Six months ended
31 Dec 2024
31 Dec 2023 £'000
£'000 £'000
Net cash flow from operating activities
Continuing operations:
Loss before tax (1,328) (2,513) (4,602)
Add back/ (deduct):
Depreciation - 1 1
Finance income (20) (18) (32)
Foreign exchange differences (45) (4) 5
Share of result of associate 2 (4) 60
Operating cash flows before movements in working capital (1,391) (2,538) (4,568)
(Increase)/decrease in trade and other receivables (116) (149) 42
Increase/(decrease) in trade and other payables (278) (77) (213)
Cash used in operations (1,785) (2,764) (4,739)
Tax received 1,029 378 820
Net cash outflow from operating activities (756) (2,386) (3,919)
Cash flows from investing activities
Purchase of tangible fixed assets - - -
Interest received 20 18 32
Licence fee received from associate - 88 -
Investment in associate - (83) (23)
Net cash inflow/(outflow) from investing activities 20 23 9
Cash flows from financing activities
Net proceeds from issue of share capital 3,422 1,777 4,375
Net cash inflow from financing activities 3,422 1,777 4,375
(Decrease)/increase in cash and equivalents 2,686 (586) 465
Cash and cash equivalents at start of period 1,459 994 994
Cash and cash equivalents at end of period 4,145 408 1,459
NOTES TO THE UNAUDITED RESULTS FOR THE SIX MONTHS ENDED 31 DECEMBER 2024
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 2024 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 2024, 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 2025.
The Group made a loss after tax for the period of £1.2m (2023: restated
£1.8m), 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. Prior period figures
The comparative figures for the six months ended 31 December 2023 have been
adjusted to remove the notional impact of the Riverfort Facility financing
charge that might have been payable since all amounts due under that facility
were subsequently settled by the issue of shares.
3. Taxation
No liability to corporation tax arises for the six-months ended 31 December
2024. Research and development tax credits, receivable as cash, are estimated
to be £0.2m (2023: £0.8m) for the period.
4. Dividends
The Directors do not propose a dividend in respect of the six months ended 31
December 2024.
5. Loss per share
The basic loss per share is 0.9 pence (2023: restated 2.5 pence), calculated
by dividing the Group's loss for the six months by 124,825,601 (2023:
70,221,589), 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 2024 because the Group generated a loss in that period.
6. 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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