REG - Sareum Holdings PLC - AGM Statement

Sareum HoldingsAnnouncement

16/12/2021 07:00

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RNS Number : 8159V  Sareum Holdings PLC  16 December 2021

SAREUM HOLDINGS PLC

("Sareum" or the "Company")

AGM Statement

Cambridge, UK, 16 December 2021 - Sareum Holdings plc (AIM: SAR), the
specialist drug development company delivering targeted small molecule
therapeutics to improve the treatment of autoimmune diseases and cancer, will
hold its Annual General Meeting ("AGM") today at 10.00 a.m. at The City
Centre, 80 Basinghall Street, London EC2V 5AG. The AGM will also be relayed as
a live webcast via the Investor Meet Company (IMC) platform.

As announced on 7 December 2021, shareholders wishing to join the AGM remotely
and participate in the Q&A session should register with IMC at:
www.investormeetcompany.com/sareum-holdings-plc/register-investor
(http://www.investormeetcompany.com/sareum-holdings-plc/register-investor) .

At the AGM, the Company's Non-Executive Chairman, Dr Stephen Parker, will make
the following statement:

"The Board is pleased with the progress Sareum has made in the past 12 months,
despite this being a challenging period for business due to the ongoing impact
of Covid-19. SDC-1801 continues to advance towards first clinical trials and
we believe the Company to be in a robust position financially following
several share subscriptions by high-net-worth individuals during 2021. In
addition, the Board is highly optimistic about the future of its out-licensed
asset SRA737, which is expected to enter new clinical trials in 2022 under the
guidance of Sierra Oncology, the licence holder for this exciting candidate.

SDC-1801 is a selective dual tyrosine kinase 2 ("TYK2") / Janus kinase 1
("JAK1") inhibitor, discovered by Sareum. We have been advancing SDC-1801
through preclinical development and preparing for clinical trials to
investigate its potential for treating autoimmune diseases, such as psoriasis,
lupus, inflammatory bowel diseases, rheumatoid arthritis as well as severe
respiratory symptoms of Covid-19.

We are pleased to report that the final toxicology and safety studies required
to file for an exploratory Clinical Trial Authorisation ("CTA") have been
completed and we expect the finalised reports in the first quarter of 2022.
The data from these studies will be crucial to the progression of this CTA,
which we remain on track to submit during mid-2022. While data analysis is
still in progress, we are confident that the studies have met their objectives
of identifying any organs or tissues that might be susceptible to high-dose
toxicity and determining the appropriate first-in-human dose. The results
received to date fully support our plan to submit this CTA for SDC-1801.

As we reported in the Company's full year results on 25 October 2021, we have
appointed consultants to advise on the design of these first clinical trials,
which would investigate the safety of SDC-1801 in healthy volunteers during
which time the Company will continue to assess the initial indications for
further study.

The synthesis of SDC-1801 drug substance under GMP conditions, intended for
use in the planned Phase 1 clinical trial, continues to progress to plan with
delivery expected during the first half of 2022.

We have also initiated the process to develop drug product for these trials as
an oral capsule formulation rather than orally dosed solutions or suspensions
as previously planned. This step will require additional time, but the Board
believes it to be a good use of resources that will add value to the programme
by improving the quality of the data generated in the Phase 1 trial and remove
the need to develop capsules at a later stage.

Importantly, this first clinical trial could also support the clinical
development of SDC-1801 as a potential treatment for the severe respiratory
symptoms of Covid-19. As a reminder, during 2021 we completed a six-month
project, funded in part by a UK government grant, demonstrating that SDC-1801,
in infected lung cells and in vivo disease models, reduces levels of key
inflammatory agents known to play a role in the serious and potentially
life-threatening hyper-inflammatory response (the "cytokine storm") that
affects some Covid-19 patients.

We are now considering how we might make use of the UK government's AGILE
clinical trial platform, or other equivalent programmes, to provide additional
funding and support for clinical trials with SDC-1801 for Covid-19
applications and potentially accelerate its development.

It is evident that that there is still a clear need for new therapies to treat
severe respiratory inflammation arising from viral infections such as Covid-19
despite the success of vaccination programmes and the availability of the
first new, mainly antiviral, therapies. With TYK2 acknowledged as a key
therapeutic target for severe Covid-19 in an article published in December
2020 in the leading scientific journal, Nature, we believe that SDC-1801 could
have a role to play in this area in the future and we look forward to updating
shareholders on further progress.

With regards to our second TYK2/JAK1 inhibitor candidate, SDC-1802, we
continue to advance the preclinical development of an oral formulation and
have designed and initiated translational studies to define the optimal cancer
application prior to completing toxicology and manufacturing studies.

Turning now to our out-licensed asset SRA737; we have been highly encouraged
by recent disclosures from Sierra Oncology ("Sierra"), the licence holder of
this promising clinical-stage Checkpoint Kinase 1 ("Chk1") inhibitor, relating
to its possible advancement.

In August 2021, Sierra in-licensed the BET inhibitor AZD5153 (now known as
SRA515) from AstraZeneca and noted how it might combine SRA515 with SRA737 as
a potential pipeline expansion opportunity. Sierra has subsequently referred
to its plans to initiate additional clinical studies in the first half of 2022
with pipeline agents including SRA737 in other haematologic and solid tumour
indications. Specifically, reference was made to a potential role for SRA737
in combination studies with novel agents in solid tumours, including
pancreatic cancer, where patients have become resistant to a class of drugs
called PARP inhibitors.

The dosing of the first patient with SRA737 in any clinical trial would
trigger a $2.0m payment from Sierra under the amended $290m licensing deal on
SRA737 between Sierra and CRT Pioneer Fund LP ("CPF") signed in November 2020.
Under the amended agreement, Sareum is eligible to receive a 27.5% share of
this and any future milestone payments.

Sareum continues to believe that, based on preclinical and early clinical
data, SRA737 holds great promise for the treatment of cancer, particularly in
combination settings, and looks forward to Sierra providing further updates on
its progress.

Looking at the Company's financial position: Sareum ended the fiscal year to
30 June 2021 with a robust cash position having raised £2.37m (before
expenses) from two subscriptions by a high-net-worth individual in June 2021.
A further £2.18m (before expenses) was raised in July and August 2021 with
two further share subscriptions by new high-net-worth individuals plus an
exercise of warrants, bringing the total raised to approximately £4.6m to
fund the further development of SDC-1801 and SDC-1802. Sareum's cash position
as at 30 September 2021 was approximately £4.4m.

The Company reported a loss after tax during the fiscal year ended 30 June
2021 of £1.5m, reflecting the increased R&D expenditure required for
preclinical development, versus a loss of £0.99m in 2020.

Sareum continues to deploy its funds to advance SDC-1801 and SDC-1802 and
build a robust data package and patent portfolio to support ongoing partnering
activities for these differentiated assets. For both TYK2/JAK1 inhibitor
programmes, the Directors will continue to review the potential higher value
of a later-stage licensing deal versus the requirement for any additional
funding.

The Board and management continue to employ rigorous capital allocation in the
development of internal assets and the overall business, with a clear focus on
generating value for shareholders.

Finally, the Board would like to take this opportunity to inform shareholders
that it is considering undertaking a share consolidation in the new year. The
Board is of the opinion that the high number of shares outstanding (over 3.3
billion) and the low absolute share price negatively affects investors'
perception of the Company and considers a share consolidation to be in the
best interests of the Company and its shareholders. A consolidation would
reduce the number of shares outstanding and increase the relative price, which
could be more attractive to a broader range of institutional investors and
other members of the investing public. A proposal regarding the terms of a
share consolidation will be put to shareholders for approval at an
Extraordinary General Meeting, which will be convened early in 2022.

So, overall, we are looking forward with optimism to 2022, during which time
we expect to report on continued progress both with our proprietary
programmes, in particular the advancement of SDC-1801 into clinical trials,
and with our partnered asset SRA737 should Sierra advance its development.

We would like to thank our shareholders, suppliers, contractors and other
stakeholders for their continued support and look forward to providing further
updates on progress as we move forward into 2022."

 

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

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel                                020 7418 8900

 Hybridan LLP (Joint Corporate 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 (http://www.sareum.com)

- Ends -

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