TIDMSAR
RNS Number : 7081V
Sareum Holdings PLC
11 August 2020
(AIM: SAR) 11 August 2020
Sareum Holdings PLC
("Sareum" or the "Company")
Pre-Close Trading Statement
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 2020. Sareum expects to report its full audited
annual results in October 2020.
A presentation to the investment community will take place on 14
August 2020 at 10.00am via the Investor Meet Company platform -
please click on this link to register to attend:
https://www.investormeetcompany.com/sareum-holdings-plc/register-investor.
OPERATIONAL HIGHLIGHTS
Selective TYK2/JAK1 Inhibitors in Autoimmune Diseases and
Cancer
Sareum is continuing to advance its proprietary selective dual
tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through
preclinical development as potential once-daily, oral immunotherapy
candidates, targeting autoimmune diseases (SDC-1801) and cancers
(SDC-1802). Both molecules demonstrate high selectivity for TYK2
and JAK1 kinases, promising early safety data as well as compelling
activity in relevant disease models. In addition, both programmes
represent unique licensing opportunities for pharmaceutical
partners as there are currently no marketed products with the
selectivity profile of these molecules.
Key Objectives
-- Complete preclinical (IND-enabling) studies with at least one candidate by the end of 2020.
-- Decide on the initial target indications during 2H 2020 as
part of preparation for first-in-human studies.
-- Build a robust preclinical data package to support ongoing partnering activities.
-- Continue and advance initial discussions with potential
partners to secure commercial licences for its assets when they
reach late preclinical or early clinical stages.
SDC-1801 (autoimmune diseases)
SDC-1801 and related molecules have shown promising activity in
autoimmune disease models, including psoriasis, rheumatoid
arthritis, inflammatory bowel disease and systemic lupus
erythematosus (SLE).
-- SDC-1801 has demonstrated excellent tolerability in
toxicology studies in rodents and work is continuing towards
completing the dose-finding and longer-term toxicology studies
ahead of human trials.
-- A robust manufacturing route has been developed to produce
active ingredient under GMP (Good Manufacturing Practice)
conditions for both preclinical and clinical studies.
-- A formulation that will successfully deliver a therapeutic
dose level has been identified, however the Company is required to
deliver very high doses to SDC-1801 in order to identify a toxic
dose level (maximum tolerated dose), and formulation studies for
this are still ongoing.
-- Encouraging preclinical data reported with Sareum's TYK2/JAK1
inhibitors in SLE disease models. These studies were conducted by
co-development partner SRI International (Menlo Park, CA, USA)
under a US Department of Defense (DoD) grant and recently published
on the website of the Defense Technical Information Center.
SDC-1802 (cancer immunotherapy)
SDC-1802 and related TYK2/JAK1 inhibitors have shown encouraging
anti-tumour activity in multiple cancer disease models. Sareum
retains global commercialisation rights for TYK2/JAK1 inhibitors
with profiles optimised for oncology and immuno-oncology
applications.
-- SDC-1802 is advancing behind SDC-1801 in preclinical
development. Formulation work for oral dosing is complete and
toxicology studies and further manufacturing work are planned over
the coming months.
-- In October 2019, Sareum presented new findings showing that
SDC-1802, dosed orally as a monotherapy and in combination with
chemotherapy, significantly reduces tumour growth in models of
solid tumours and blood cancers. SDC-1802 was found to act through
a novel immunotherapeutic mechanism of action. These findings were
presented at the American Association for Cancer Research (AACR)
National Cancer Institute (NCI) European Organisation for Research
and Treatment of Cancer (EORTC) International Conference.
TYK2/JAK1 Inhibitors for treating symptoms of Covid-19
In its Half-Yearly report published on 26 March 2020, the
Company noted that it would investigate grant funding opportunities
to assess the potential use of its TYK2/JAK1 inhibitors to address
the severe inflammatory responses (the "cytokine storm") and
potentially fatal respiratory symptoms of Covid-19 and other viral
infections.
-- A grant application to fund preliminary laboratory studies
designed to investigate the ability of its TYK1/JAK2 inhibitors to
modulate (down-regulate) the overactive immune system in relevant
cellular and mouse disease models has been submitted to UK Research
and Innovation (UKRI) and a response is expected by the end of
October 2020.
-- These preliminary studies have been designed as a potential
first step towards clinical studies, pending success and further
funding.
FLT3+Aurora Inhibitors
On 26 March 2020, Sareum announced it entered a global licensing
deal for its FLT3+Aurora kinase inhibitor programme targeting blood
cancers with a China-based specialty pharmaceutical company (the
"Licensee"). The Licensee will fund all future development
activities for licensed FLT3+Aurora kinase inhibitors and has been
granted the sole rights to commercialise any resulting products
worldwide.
Sareum received a small upfront payment and is eligible for
c.GBP0.90m due on certain milestones being achieved within nine
months of signing and receipt of programme data by the Licensee,
with a subsequent payment due on the achievement of a pre-specified
development milestone. The Licensee confirmed receipt of the
programme data on 7 April 2020 and research is ongoing. Sareum is
also eligible to receive further revenues upon the
commercialisation of any resulting products. However, there can be
no certainty that the milestones will be achieved and/or that any
further payments will become due.
Licensed Programme - SRA737: A Selective Chk1 inhibitor
SRA737 is a potent, highly selective, orally bioavailable small
molecule inhibitor of Checkpoint Kinase 1 (Chk1), a key regulator
of important cell cycle checkpoints and central mediator of the DNA
Damage Response (DDR) network.
SRA737 is licensed to Sierra Oncology Inc. ("Sierra"), which has
presented positive safety & efficacy data of the combination of
SRA737+low-dose gemcitabine (LDG) from a broad Phase 1/2 clinical
development programme potentially supporting development in
anogenital cancer. Sierra has also presented compelling preclinical
data supporting the use of SRA737 in combination with novel
targeted therapeutic approaches, including PARP inhibitors and
immune checkpoint blockade.
In June 2019, Sierra announced it was exploring non-dilutive
strategic options to support the next stages of development of
SRA737. Sierra appointed a new Chief Executive Officer, Dr Stephen
Dilly, on 1 June 2020. In the notes to Sierra's most recent 10-Q
Quarterly Report, dated 6 August 2020, it stated that it is
exploring options to support the continued development of SRA737.
However, there can be no assurance that Sierra will obtain the
funding or support necessary to advance SRA737 or, even if it does
secure funding, that any funding will ultimately be used to advance
SRA737. The Company will continue to monitor the public statements
released by Sierra and will update the market should there be any
meaningful developments.
-- In March 2020, new research published in the peer-reviewed
journal Cancer Research highlighted the anti-cancer effect of
SRA737 in multiple human lung and colorectal cancer cells, when
used in combination with small molecules that block the function of
a family of proteins involved in DNA replication and repair
(B-family DNA polymerases).*
*R.F. Rogers et al. CHK1 inhibition is synthetically lethal with
loss of B-family DNA polymerase function in human lung and
colorectal cancer cells. (2020) Cancer Research
https://cancerres.aacrjournals.org/
Impact of Covid-19 on operations
The Company has been following UK government advice to minimise
risk to staff. At present, Sareum remains fully operational,
although management's effectiveness may be impacted if restrictions
are increased. To date there has been minimal impact on the
Company's network of Contract Research Organisations, with some
minor delays in the delivery of chemical intermediates and
solvents. While this has not so far affected the Company's
timelines, there may be delays if further restrictions on work and
movement are added.
Salary Deferral Scheme
As announced on 17 December 2019, the Company confirmed that all
directors had entered a voluntary salary deferral scheme, whereby
33% of directors' salaries were being deferred until further notice
(the "Salary Deferral Scheme").
On 1 July 2020, the Company announced an update on the Salary
Deferral Scheme and announced the settlement of directors' deferred
salary through the issue of new ordinary shares of 0.025p each in
the capital of the Company.
The Company also agreed to reduce the terms of Dr Tim Mitchell's
salary deferral from 33% to 20% of his salary going forward. All
other directors agreed to continue to defer 33% of their salaries
until further notice.
Financial highlights (subject to audit)
-- As previously indicated, R&D Tax Credit of GBP0.23m received in January 2020.
-- Raised GBP1,022,222 before expenses in June 2020 through a
fundraising comprising a placing by Hybridan LLP in conjunction
with an offer via PrimaryBid, to progress the Company's TYK2/JAK1
drug development programmes as well as for working capital
purposes.
-- Loss on ordinary activities (after taxation) of GBP0.96m
(2019: loss of GBP1.45m), reflecting the Company's careful
management of cash resources.
-- Cash at bank as at 30 June 2020 was GBP1.8m (GBP1.0m as at 31
December 2019; GBP0.92m as at 30 June 2019).
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 at least one
candidate by the end of 2020. We are particularly pleased to have
raised additional funding during the period, which will be deployed
to advance these programmes towards clinical development and build
a robust data package to support our ongoing partnering activities
for these exciting and differentiated assets.
"We were pleased to sign a global licensing deal for our
FLT3+Aurora inhibitor programme targeting blood cancers with a
China-based specialty pharma company during the period. Sareum is
potentially eligible to receive a success-dependent milestone
payment during Q1 2021 from this agreement, as well as future
revenues pending successful progress.
"We continue to monitor Sierra's activities as it explores
options to fund the future development of SRA737 and we will
provide further updates on this and other programmes when
appropriate."
The information contained within this announcement is deemed by
the Company to constitute inside information under the Market Abuse
Regulation (EU) No. 596/2014
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO 01223 497 700
Strand Hanson Limited (Nominated Adviser)
James Dance / Richard Tulloch 020 7409 3494
Hybridan LLP (Nominated Broker)
Claire Noyce / John Beresford-Peirse 020 3764 2341
Citigate Dewe Rogerson (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). The Company is targeting completion of
IND-enabling studies for at least one of these candidates in
2020.
The Company's preclinical FLT3+Aurora inhibitor programme
targeting haematological cancers is licensed to a China-based
specialty pharma company.
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 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
is currently exploring options to obtain the funding or support
necessary to advance the future development of SRA737.
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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END
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