REG - Sareum Holdings PLC - Half-Year Report
22/03/2023 07:15
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RNS Number : 7796T Sareum Holdings PLC 22 March 2023
Sareum Holdings PLC
("Sareum" or the "Company")
Half-Year Report for the Six Months Ended 31 December 2022
Cambridge, UK, 22 March 2023 - 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 2022.
Sareum also provides a broader update on its operational activities and
pipeline progress.
The Company will hold a virtual presentation for all existing and potential
investors today, 22 March at 12:30 GMT, via the Investor Meet Company
platform. Please click the following link to register to attend:
https://www.investormeetcompany.com/sareum-holdings-plc/register-investor
(https://www.investormeetcompany.com/sareum-holdings-plc/register-investor) .
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.
· After the period end, Sareum submitted an application to perform
Phase 1 clinical studies on SDC-1801 in Australia under the Clinical Trial
Notification (CTN) scheme.
· Approval by the Human Research Ethics Committee (HREC) and acceptance
of the CTN by Australia's medicines regulator, the Therapeutic Goods
Administration (TGA), is expected in Q2 2023. Subject to this approval, Sareum
plans to start the trial as soon as possible.
· Preparatory work for the trial is complete, including synthesis of
the SDC-1801 drug substance under GMP conditions and GMP-compliant
manufacturing of the SDC-1801 capsules.
SDC-1802 (cancer immunotherapy)
SDC-1802 is a TYK2/JAK1 inhibitor being developed for cancer immunotherapy.
· Sareum continues to work on the translational studies needed to
support development of SDC-1802, defining the optimal cancer application prior
to completing toxicology and manufacturing studies.
· Expertise and experience gained through SDC-1801 will support Sareum
in optimising its planning and maintaining cost discipline.
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, on 6 March 2023, Sierra Oncology, Inc.
("Sierra") (a subsidiary of GSK plc ("GSK") completed the return of the
Clinical Study Reports and other associated documents and data associated with
SRA737 to Sareum's co-development partner, the CRT Pioneer Fund LP ("CPF").
· Sareum is evaluating the potential development opportunities for this
asset with CPF and will provide further updates as appropriate.
· Sareum also notes the expansion of the patent estate relevant to
SRA737, with US patent number 11596637, "CHK1 (SRA737)/PARPi combination
methods of inhibiting tumor growth" being granted on 7 March 2023.
FINANCIAL HIGHLIGHTS
• Cash at 31 December 2022 of £2.9m (£5.6m as of 31 December 2021
and £4.3m as of 30 June 2022).
• Loss on ordinary activities after taxation for the six months
ended 31 December 2022 of £1.4m, reflecting investment in preparatory work
for a clinical trial application (2021: loss of £0.9m).
• R&D tax credit of £0.4m received in December 2022.
Dr Tim Mitchell, Chief Executive Officer of Sareum, commented:
"We are pleased to have submitted an application to conduct Phase 1 clinical
studies on our lead molecule, SDC-1801, for the treatment of autoimmune
diseases in Australia.
"We have identified Australia as the ideal location for these studies for a
number of reasons, including its thriving research and development ecosystem,
diverse patient population, internationally recognised regulatory authorities
and supportive R&D tax credits system. We are confident that Australia's
regulatory process will enable us to move forward efficiently and effectively.
"The continued commercial momentum building around the TYK2/JAK1 space
supports our confidence in progressing SDC-1801, and we look forward to
beginning clinical development. We remain committed to maintaining a lean
business model and controlling costs. By doing so, we can ensure that our
resources are directed towards developing high-quality therapeutics that can
help address patient needs."
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO 01223 497700
Alex Harrison, Investor Relations ir@sareum.co.uk
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)
Claire Noyce 020 3764 2341
Consilium Strategic Communications (Financial PR)
Jessica Hodgson / Davide Salvi / Stella Lempidaki 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, and is planned to
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 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%3Ablank)
CHAIRMAN'S STATEMENT
Sareum is focused on advancing its next generation kinase inhibitors for
autoimmune disease and cancer into clinical development.
An application to initiate Phase 1 clinical studies on SDC-1801 in Australia
under the Clinical Trial Notification (CTN) scheme was submitted to a Human
Research Ethics Committee (HREC) in Australia. Approval by the HREC and
acceptance of the CTN by Australia's medicines regulator, the Therapeutic
Goods Administration (TGA) is expected in Q2 2023. Subject to this approval,
Sareum plans to start the trial as soon as possible.
Australia offers state-of-the-art research facilities and an efficient
approval process, making it an attractive location for research and
development. Moreover, the country provides significant tax incentives for
companies that conduct their research there, allowing them to claim up to
43.5% of their eligible R&D expenditure as a cash payment. As such, Sareum
has established the required local presence by setting up a legal entity in
Australia.
In July 2022, Sareum submitted an application for a Clinical Trial
Authorisation (CTA) to the UK Medicines and Healthcare Products Regulatory
Agency (MHRA) based on a robust preclinical data package produced in
collaboration with several world-leading, internationally recognised contract
research organisations (CROs) to evaluate the safety and tolerability of
SDC-1801. However, in November of the same year, the MHRA informed the Company
that the application could not be approved until an additional review of
certain preclinical data by the UK Good Laboratory Practice (GLP) Monitoring
Authority was conducted. Despite stipulating this requirement, the MHRA has
not, to date, requested this review by the UK GLP. In parallel with seeking a
response from the MHRA on multiple occasions, the Company has assessed
alternative locations to conduct its clinical trial and identified Australia
as the optimal route to progress its lead asset.
Whilst the decision of the MHRA and lack of response to Sareum's requests were
disappointing, we are pleased to have identified a clear and attractive
alternative path for the clinical development of SDC-1801.
Sareum remains confident in the potential of dual inhibition of both TYK2 and
JAK1 for treating autoimmune diseases. In recent months, mounting evidence has
supported this, including the approval of Sotyktu™(deucravacitinib), the
first selective TYK2 inhibitor approved by the US Food & Drug
Administration (FDA), signalling a growing scientific and commercial
confidence in this approach.
With its clear and differentiated offering in SDC-1801, Sareum is eager to
explore the potential efficacy and safety benefits in clinical development.
While 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.
Following the return of the Clinical Study Reports and other associated
documents and data on SRA737 to CRT Pioneer Fund LP (CPF), Sareum now has the
opportunity to participate in planning its future development. The promising
preclinical and early clinical data generated by SRA737 reinforces our
confidence in its potential for cancer treatment. Sareum will work with CPF to
evaluate further development options, including re-licensing the programme to
a third party, and will provide updates when appropriate.
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.
The preclinical development activities necessary to apply to perform a Phase 1
clinical trial have been completed and, consistent with the Company's clinical
development plan, an application to perform the trial in Australia under the
Clinical Trial Notification scheme has been submitted.
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 specialist consultants, contract research
organisations (CROs), and clinical units, has designed a Phase 1a/b clinical
trial with SDC-1801 in healthy subjects and psoriasis patients. As soon as
regulatory approval is granted, Sareum plans to commence a Phase 1a trial to
investigate the safety and tolerability of an oral formulation of SDC-1801 in
ascending doses administered to healthy subjects. If the safety data proves
satisfactory, the Company intends to commence a Phase 1b clinical study in
psoriasis patients in 2024.
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 potentially in patients with the acute respiratory symptoms of
viral infections should the Company decide to progress such trials.
Provided satisfactory safety data is obtained from this initial safety and
dosing study, and subject to additional funding, a Phase 1b clinical study
will commence in psoriasis patients.
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, for use in the
Phase 1 trial, is also complete.
SDC-1802
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.
SRA737
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.
SRA737 was licenced to Sierra Oncology in 2016. Following its acquisition by
GSK in 2022, Sierra has returned the rights for SRA737 to CPF. The return of
the Clinical Study Reports and other associated documents was completed in
March 2023. CPF and Sareum will evaluate potential options for future
development opportunities for SRA737 and evaluate its next steps accordingly.
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 has been reported to support the
potential for SRA737 in combination with other anti-cancer agents against
hard-to-treat cancers.
The patent estate covering SRA737 was recently expanded by the granting of a
patent in the US (no. 11596637) that describes the combination of SRA737 with
a PARP inhibitor and its effectiveness in inhibiting tumour growth.
We remain confident, based on preclinical and early clinical data, that SRA737
holds strong promise for the treatment of cancer, particularly in combination
settings and are confident in the potential of this molecule.
FINANCIAL REVIEW
At 31 December 2022 Sareum had cash of £2.9m (2021: £5.6m).
The loss on ordinary activities after taxation for the six months ended 31
December 2022 was £1.4m (2021: loss of £0.9m), reflecting ongoing clinical
trial preparation costs.
In December 2022 the Company received £0.4m (2021: £0.2m) in R&D tax
credits.
OUTLOOK
Sareum has submitted an application to conduct a Phase 1 clinical trial of
SDC-1801 in Australia, and pending regulatory approval, we hope to begin
dosing as soon as possible in 2023.
Our preclinical findings and the growing commercial and scientific momentum
building around the TYK2/JAK1 class, support our continued excitement about
the potential for SDC-1801 to be a superior option to approved oral therapies
for the treatment of autoimmune diseases.
Following the return of SRA737 by CPF, we will evaluate the potential for
future development opportunities. 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 Board of Sareum continues to apply a rigorous approach to capital
allocation to 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 Income Statement for the six months ended 31 December 2022
Notes Unaudited Unaudited Audited
Six months ended
Six months ended
Year
31 Dec 22
31 Dec 21
ended
30 Jun 22
£'000 £'000
£'000
Revenue - - -
Other operating income - - -
Operating expenses (1,748) (1,017) (2,577)
Share of loss of associate - - (3)
Operating loss (1,748) (1,017) (2,580)
Finance income 17 - 1
Loss before tax (1,731) (1,017) (2,579)
Tax 3 285 160 407
Loss on ordinary activities after taxation (1,446) (857) (2,172)
Basic and diluted loss per share (pence) 5 (2.1)p (1.3)p (3.2)p
Consolidated Statement of Comprehensive Income for the six months ended 31
December 2022
Unaudited Unaudited Audited
Six months ended
Six months ended
Year
31 Dec 22
31 Dec 21
ended
30 Jun 22
£'000 £'000
£'000
Loss for the period (1,446) (857) (2,172)
Other comprehensive income - - -
Total comprehensive income for the period (1,446) (857) (2,172)
Total comprehensive income attributable to:
Owners of the parent (1,446) (857) (2,172)
Consolidated Balance Sheet as at 31 December 2022
Unaudited Unaudited Audited
As at As at As at
31 Dec 2022 31 Dec 2021 30 Jun 2022
£'000 £'000 £'000
Non-current assets
Computers and equipment 1 3 2
Investment in associate 23 25 23
24 28 25
Current assets
Debtors 380 236 500
Cash and cash equivalents 2,941 5,613 4,261
3,321 5,849 4,761
Creditors: amounts due within one year (460) (231) (455)
Net current assets 2,861 5,618 4,306
Net assets 2,885 5,646 4,331
Equity
Called-up share capital 851 851 851
Share premium 20,925 20,925 20,925
Share-based compensation reserve 325 325 325
Retained earnings (19,216) (16,455) (17,770)
Total equity 2,885 5,646 4,331
Consolidated Statement of Changes in Equity for the six months ended 31
December 2022
Share capital Share premium Share-based compensation reserve Retained earnings Total
£'000
£'000 £'000 £'000 £'000
As at 30 June 2021 (audited) 833 17,235 362 (15,635) 2,795
Issue of share capital (net) 18 3,690 - - 3,708
Transfer in respect of options exercised - - (37) 37 -
Loss for the period - - - (857) (857)
As at 31 December 2021 (unaudited) 851 20,925 325 (16,455) 5,646
Issue of share capital (net) - - - - -
Transfer in respect of options exercised - - - - -
Loss for the period - - - (1,315) (1,315)
As at 30 June 2022 (audited) 851 20,925 325 (17,770) 4,331
Issue of share capital (net) - - - - -
Transfer in respect of options exercised - - - - -
Loss for the period - - - (1,446) (1,446)
As at 31 December 2022 (unaudited) 851 20,925 325 (19,216) 2,885
Consolidated Cash Flow Statement for the six months ended 31 December 2022
Unaudited Unaudited Audited
Six months ended
Six months ended
Year ended
31 Dec 2022
31 Dec 2021
30 Jun 2022
£'000 £'000 £'000
Net cash flow from operating activities
Continuing operations:
Loss before tax (1,731) (1,017) (2,580)
Add back:
Depreciation 1 - 2
Finance income (17) - (1)
Share of loss of associate - - 3
(1,747) (1,017) (2,576)
(Increase)/decrease in trade and other receivables (3) 73 56
Increase/(decrease) in trade and other payables 5 (53) 171
Cash used in operations (1,745) (997) (2,349)
Tax received 408 218 218
Net cash outflow from operating activities (1,337) (779) (2,131)
Cash flows from investing activities
Purchase of tangible fixed assets - (2) (3)
Interest received 17 - 1
Investment in associate - - -
Net cash inflow/(outflow) from investing activities 17 (2) (2)
Cash flows from financing activities
Net proceeds from issue of share capital - 3,708 3,708
Net cash inflow from financing activities - 3,708 3,708
(Decrease)/increase in cash and equivalents (1,320) 2,927 1,575
Cash and cash equivalents at start of period 4,261 2,686 2,686
Cash and cash equivalents at end of period 2,941 5,613 4,261
NOTES TO THE UNAUDITED RESULTS FOR THE SIX MONTHS ENDED 31 DECEMBER 2022
1. Financial information
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
2022 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.
2. Basis of accounting
The accounting policies adopted are consistent with those of the financial
statements for the year ended 30 June 2022, as described in those financial
statements. As at the date of approving the interim financial statements,
there are no new standards likely to materially affect the financial
statements for the year ending 30 June 2023.
Going concern
The Group made a loss after tax for the period of £1.4 million (2021: £0.9
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.
3. Taxation
No liability to for corporation tax arises for the six-months ended 31
December 2022. Research and development tax credits, receivable as cash, are
estimated to be £285,000 for the period.
4. Dividends
The directors do not propose the payment of a dividend in respect of the six
months ended 31 December 2022.
5. Loss per share
Basic loss per share is 2.1 pence (2021: 1.3 pence). The basic loss per
ordinary share is calculated by dividing the Group's loss for the six months
of £1,446,000 (2021: £857,000) by 68,069,416 (2021: 67,282,760), 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 2022 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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