REG - Sareum Holdings PLC - AGM Statement

Sareum HoldingsAnnouncement

16/12/2022 07:00

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RNS Number : 9185J  Sareum Holdings PLC  16 December 2022

Sareum Holdings PLC

("Sareum" or the "Company")

AGM Statement

Cambridge, UK, 16 December 2022 - Sareum Holdings plc (AIM: SAR), a
biotechnology company developing next generation kinase inhibitors for
autoimmune disease and cancer, publishes an update on operational activities
and pipeline progress ahead of its Annual General Meeting ("AGM") taking place
today at 10.00 a.m. at the offices of Peel Hunt LLP, 7th Floor, 100 Liverpool
Street, London EC2M 2AT. The meeting will also be webcast via the Investor
Meet Company ("IMC") platform.

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

The Company made good progress in the financial year to 30(th) June 2022 and
remains confident in its future despite some recent setbacks.

SDC-1801 (autoimmune disease)

SDC-1801 is Sareum's 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.

As announced
(http://www.sareum.com/news/press-releases-and-news/2022/update-sdc-1801-cta-application/)
on 8 November 2022, the UK Medicines and Healthcare Products Regulatory Agency
("MHRA") informed Sareum that it has not been able to approve the Clinical
Trial Authorisation ("CTA") to evaluate the safety and tolerability of
SDC-1801.  The Company can confirm that it provided a robust preclinical data
package to support the CTA application, in collaboration with several
world-leading, internationally recognised contract research organisations.

The MHRA has indicated that it requires an additional review by the UK Good
Laboratory Practice (GLP) Monitoring Authority of part of the pre-clinical
data included in the application to approve the clinical study. Sareum and its
advisers have sought additional clarification from the MHRA and UK GLP on the
next steps.

In parallel with seeking clarification with the MHRA, the Company is also
assessing regulatory opportunities in other countries.  Sareum remains
committed to SDC-1801 and is focused on finding the quickest and clearest
pathway to obtaining authorisation to commence clinical studies for the asset.

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune
system and has strong clinical validation in psoriasis and psoriatic arthritis
and we believe this asset has great potential. This week we have seen evidence
of the continued commercial interest in the TYK2 class following the
announcement by Takeda of plans to acquire Nimbus Lakshmi Inc., a unit of
Nimbus Therapeutics for an upfront consideration of US$4 billion. We believe
this underscores the great potential of this class.

SDC-1802 (cancer immunotherapy)

Sareum continues to work on the translational studies for SDC-1802 needed to
define the optimal cancer application prior to completing toxicology and
manufacturing studies.

Planning for such studies will incorporate what we have learnt from our
experience with SDC-1801.

Licensed Programme - SRA737: A Selective Chk1 inhibitor

As announced
(http://www.sareum.com/news/press-releases-and-news/2022/update-sar737/) on 12
October 2022, Sareum has been informed by Sierra Oncology, Inc. (a subsidiary
of GSK plc) that it intends to return the rights for SRA737, a selective
Checkpoint kinase 1 inhibitor, to Sareum's co-development partner, the CRT
Pioneer Fund LP ("CPF"). The SRA737 licence agreement has a 90-day notice
period for termination and therefore the Company expects the rights to be
formally returned in January 2023.

Sareum is evaluating the potential development opportunities for this asset
with CPF and will provide further updates as appropriate.

SRA737 was discovered and initially developed by scientists at The Institute
of Cancer Research in collaboration with Sareum, with funding from Sareum and
Cancer Research UK.

Summary

In conclusion, the Board believes Sareum has a strong pipeline of kinase
inhibitors which have the potential to provide great benefit to patients.
The Company is committed to advancing SDC-1801 into clinical development and
is focused on finding the quickest and clearest pathway to obtaining
authorisation to commence clinical studies for the asset, whether it be in the
UK via the MHRA or other countries.

The Company also remains confident in the potential for SRA737 and now has the
opportunity to be more closely involved in planning its future 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 in due course.

AGM Webcast

A live webcast to the investment community will be made available online via
the Investor Meet Company platform. Existing and potential investors wishing
to participate in the presentation can register on
www.investormeetcompany.com/sareum-holdings-plc/register-investor
(http://www.investormeetcompany.com/sareum-holdings-plc/register-investor) .
Questions can be submitted before the event via the Investor Meet Company
dashboard or at any time via the live presentation via the "Ask a Question"
function. Responses from the Q&A session will be published at the earliest
opportunity on the IMC platform.

Shareholders are reminded that attendance online will not constitute
attendance at the AGM and shareholders will not be able to vote on the day.

 

- Ends -

 

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO / Alex Harrison, Investor Relations   01223 497700

 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       0203 709 5700

 

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 focused on advancing internal programmes focused on distinct dual
tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors into clinical
development as potential new therapies for autoimmune diseases (with an
initial focus on psoriasis), respiratory symptoms arising from viral
infections and cancer immunotherapy. Sareum is also eligible to receive
certain milestone payments and future royalties on SRA737, a clinical-stage,
oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell
replication and DNA damage repair mechanisms. SRA737 was licensed to Sierra
Oncology, which was acquired by GSK in June 2022.

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)

 

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