TIDMSAR
RNS Number : 0737J
Sareum Holdings PLC
19 August 2021
Sareum Holdings PLC
("Sareum" or the "Company")
Trading Statement
Cambridge, UK, 19 August 2021 - Sareum Holdings plc (AIM: SAR),
the specialist drug development company delivering targeted small
molecule therapeutics to improve the treatment of cancer and
autoimmune diseases, provides the following trading update ahead of
its full year results for the year ended 30 June 2021. Sareum
expects to report its full audited annual results in October
2021.
OPERATIONAL HIGHLIGHTS
SDC-1801 for treating symptoms of Covid-19
As noted in the Company's RNS announcement of 1 July 2021, the
UKRI-funded Covid-19 research project for SDC-1801, a novel,
TYK2/JAK1 inhibitor, was completed on schedule, with the final
results confirming the initial encouraging results as noted in the
Company's Interim Results, published on 23 April 2021.
The project found that SDC-1801 reduced the levels of cytokines
associated with Acute Respiratory Distress Syndrome (ARDS) in human
lung cells infected with SARS-CoV-2 and demonstrated a profile that
was superior to the anti-inflammatory steroid dexamethasone and
similar to baricitinib, a JAK1/JAK2 inhibitor.
The in-vivo studies that have now been completed support the
initial cellular results and provide strong evidence that
expression of Type 1 interferons (IFNa and IFNb) is reduced by
SDC-1801 treatment in a dose-responsive manner. The studies also
showed that viral loads did not increase after SDC-1801
administration, which is a potential concern when anti-inflammatory
agents are used to dampen down an over-active immune response
The Company aims to commence Phase 1 clinical trials for
SDC-1801 in early 2022, subject to successful completion of the
ongoing preclinical toxicology studies, gaining the requisite
approval and financing. The timing and design of the clinical
trials for Covid-19 applications will be determined following
consultations with experts in the field.
SDC-1801 (autoimmune diseases)
Recent delays in compound supply mean that SDC-1801 is now
scheduled to commence its final preclinical studies at the
beginning of Q4 2021 but the Company still aims to file a Clinical
Trial Application (CTA) by the end of Q4, subject to no further
delays. First clinical trials - safety studies in healthy
volunteers - may commence in early 2022, subject to gaining the
requisite approval and funding.
SDC-1802 (cancer immunotherapy)
Sareum continues to work on the design of the translational
studies needed to define the optimal cancer application prior to
completing toxicology and manufacturing studies.
The Company announced, on 30 July 2021, that a notice of
allowance had been received from the US Patent and Trademark Office
in respect of a patent (Application no. 16/343,639) protecting
SDC-1802 and its use in treating certain cancers. Subject to
certain formalities being completed, the patent is expected to be
granted within three months.
Licensed Programme - SRA737: A Selective Chk1 inhibitor
The Company continues to monitor licence holder Sierra
Oncology's activities as it explores options to fund the future
development of SRA737. Sareum continues to believe that the amended
licensing agreement between Sierra and CRT Pioneer Fund (CPF) could
expedite the advancement of the SRA737 programme in a timely
manner.
Post period-end, during an Investor Presentation on 6 August
2021, Sierra announced the in-licencing of the BET inhibitor,
AZD5153, from AstraZeneca and noted potential combinations with
SRA737 as a possible pipeline expansion opportunity.
Financial highlights (subject to audit)
-- Raised GBP2.37m before expenses in June 2021 through two
subscriptions to a high net worth individual.
-- Loss on ordinary activities (after taxation) for the year
ended 30 June 2021 is expected to be approx. GBP1.6m (2020: loss of
GBP0.96m), reflecting the increased R&D expenditure required
for preclinical development.
-- Cash at bank as at 30 June 2021 expected to be approx.
GBP2.7m (GBP1.3m as at 31 December 2020; GBP1.8m as at 30 June
2020).
-- Post period-end, in July and August 2021, raised a further
GBP2.18m (before expenses) through a share subscriptions to two
additional high net worth individuals plus an exercise of
warrants.
Salary Deferral Scheme
The salary deferral scheme, as announced by the Company on 17
December 2019 and updated on 1 July 2020, will end in August 2021,
with a total of GBP155k, representing all amounts outstanding,
being settled in cash, following the significant c.GBP4.5m
improvement in the Company's financial position arising from the
recent share subscriptions and warrant exercise.
Dr Tim Mitchell, CEO of Sareum, commented :
"The past year has seen Sareum advance the preclinical
development of our proprietary dual TYK2/JAK1 inhibitor programmes,
with the goal of completing preclinical development of SDC-1801 and
filing for clinical trials approval by the end of 2021. We are
particularly pleased to have raised substantial additional funding
during the period, which will be deployed to advance these
programmes into clinical development and build a robust data
package to support our ongoing partnering activities for these
exciting and differentiated assets."
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO 01223 497 700
Strand Hanson Limited (Nominated
Adviser)
James Dance / James Bellman 020 7409 3494
Hybridan LLP (Nominated Broker)
Claire Noyce 020 3764 2341
MEDiSTRAVA Consulting (Financial
PR)
Mark Swallow / David Dible 020 7638 9571
About Sareum
Sareum is a specialist drug development company delivering
targeted small molecule therapeutics to improve the treatment of
cancer and autoimmune diseases. The Company aims to generate value
through licensing its candidates to international pharmaceutical
and biotechnology companies at the preclinical or early clinical
trials stage.
Sareum is advancing internal programmes focused on distinct dual
tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through
preclinical development as therapies for autoimmune diseases,
including the 'cytokine storm' immune system overreaction to
Covid-19 and other viral infections, (SDC-1801) and cancer
immunotherapy (SDC-1802).
Sareum also has an economic interest in SRA737, a clinical-stage
oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets
cancer cell replication and DNA damage repair mechanisms.
Preliminary Phase 2 and comprehensive preclinical data suggest
SRA737 may have broad application in combination with other
oncology and immune-oncology drugs in genetically defined
patients.
SRA737 was discovered and initially developed by scientists at
The Institute of Cancer Research in collaboration with Sareum, and
with funding from Sareum and Cancer Research UK. SRA737 was
licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra
continues to explore options that would enable the development of
SRA737 to advance.
Sareum Holdings plc 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
- Ends -
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