REG - Sareum Holdings PLC - Subscription to raise £2,364,000

Sareum HoldingsAnnouncement

11/10/2024 07:00

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RNS Number : 7894H  Sareum Holdings PLC  11 October 2024

THIS ANNOUNCEMENT (THE "ANNOUNCEMENT") AND THE INFORMATION CONTAINED HEREIN IS
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THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR ISSUE OR THE
SOLICITATION TO BUY, SUBSCRIBE FOR OR OTHERWISE ACQUIRE ANY SECURITIES.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF
THE MARKET ABUSE REGULATION (EU) 596/2014 AS IT FORMS PART OF UK DOMESTIC LAW
BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 ("MAR"), AND IS
DISCLOSED IN ACCORDANCE WITH THE COMPANY'S OBLIGATIONS UNDER ARTICLE 17 OF
MAR.

 

Sareum Holdings PLC

 

("Sareum" or the "Company")

 

Subscription to raise £2,364,000

Proceeds to fund preparation of SDC-1801 for Phase 2 studies

Update on 1801 trial progress

 

Cambridge, UK, 11 October 2024 - Sareum Holdings plc (AIM: SAR), a
clinical-stage biotechnology company developing next-generation kinase
inhibitors for autoimmune disease and cancer, is pleased to announce that it
has completed a fundraise of £2.364 million (before expenses), from certain
high net worth individuals, corporates and an institution, via a subscription
for a total of 11,820,000 new ordinary shares of 1.25 pence each in the
capital of the Company ("Ordinary Shares") at a price of 20 pence per new
Ordinary Share (the "Subscription Price") (the "Subscription"). This funding,
alongside a A$ 1.9 million (c. £1 million) tax credit received on 8(th)
October 2024, from Australia for running the Phase 1 clinical development of
the Company's lead candidate SDC-1801, will enable the Company to conduct
further development of SDC-1801, including longer-term toxicology studies, to
prepare the asset for Phase 2 clinical trials thereby enhancing its potential
value.

 

Under the terms of the Subscription, each subscriber will also be issued one
five-year warrant, exercisable at the Subscription Price, for every
Subscription Share issued (the "Subscription Warrants"). The Subscription
Price represents a discount of approximately 27 per cent. to the closing
middle market price for Sareum shares on 10(th) October 2024.  In the event
that the Company completes a future equity fundraise while the warrants remain
exercisable at a price lower than 20p per new Ordinary Share, the exercise
price of the unexercised Subscription Warrants will be automatically rebased
to an exercise price equivalent to such lower issue price.

Use of funds and Trial Progress

The net funds will be utilised by the Company to further develop its lead
candidate SDC-1801, a dual inhibitor of JAK family kinases TYK2 and JAK1,
culminating in longer-term toxicology studies required to support Phase 2
clinical trials in patients. Successful completion of such studies would
represent a significant milestone in advancing SDC-1801 towards Phase 2
readiness, building upon the highly encouraging results from the recently
completed Phase 1 clinical trial.

The Phase 1 trial of SDC-1801, which concluded in July 2024, demonstrated a
favourable safety profile and achieved blood plasma levels significantly
exceeding the predicted therapeutic exposure, with a long half-life of up to
20 hours. No serious adverse events attributable to SDC-1801 were observed.

Based on the unblinded data now available, the Company is pleased to report
that the frequency of adverse events (all mild or moderate) was similar in the
active and placebo groups. No clinically significant effects were observed on
any component of blood (including red blood cells, haemoglobin, reticulocytes,
platelets or neutrophils) which have been affected by earlier generation JAK
inhibitors.

Analysis of blood samples from subjects who received SDC-1801 for 10 days in
the multiple ascending dose cohorts demonstrated clear, dose responsive,
reductions in three biomarkers of JAK1 and/or TYK2 activity. This provides
strong evidence that safe blood levels of SDC-1801 were able to significantly
inhibit major inflammatory pathways.

The planned toxicology studies are designed to further validate the safety and
tolerability of SDC-1801 over an extended period, providing essential data for
regulatory submissions to conduct future clinical studies.

The Company anticipates that these studies will substantially enhance the
compound's attractiveness to potential out-licensing partners, should it
choose to pursue this strategic option for Phase 2 development.

Through this additional development work, Sareum intends to position SDC-1801
as a best-in-class TYK2/JAK1 inhibitor for autoimmune diseases, with an
initial focus on psoriasis-a condition affecting over 60 million adults
worldwide, representing a market opportunity exceeding US$30 billion.

 

Admission, Total Voting Rights and other terms

 

The Company has applied for 11,820,000 new Ordinary Shares to be to be
admitted to trading on AIM ("Admission") by 8.00 a.m. on or around 16 October
2024.

 

The new Ordinary Shares will, when issued, be credited as fully paid and will
rank pari passu in all respects with the existing Ordinary Shares of the
Company including the right to receive all dividends or other distributions
made, paid or declared in respect of such shares after Admission. Admission is
conditional on all funds having been received from Subscribers pursuant to the
Subscription.

 

Following Admission, the total number of Ordinary Shares in issue will be
119,765,783 and the total number of voting rights will thereafter be
119,765,783 and this figure may be used by shareholders as the denominator for
the calculations by which they will determine if they are required to notify
their interest in, or a change to their interest in, the share capital of the
Company under the FCA's Disclosure Guidance and Transparency Rules.

 

Dr Stephen Parker, Executive Chairman of Sareum, commented:

"We are delighted to secure this funding which, together with the tax credit
from Australia, enables us to progress our lead programme, SDC-1801, towards
Phase 2 readiness. The recent successful completion of our Phase 1 trial,
demonstrating SDC-1801's favourable safety profile, combined with impressive
pharmacokinetics and biomarker effects, has reinforced our confidence in its
potential as a best-in-class TYK2/JAK1 inhibitor.

"With sustained high blood levels, positive side-effect profile and absence of
changes to blood components, SDC-1801 demonstrates significant advantages in
the competitive landscape of autoimmune disease treatments. The planned
longer-term toxicology studies are critical next steps, not only for
regulatory purposes but also to enhance SDC-1801's value proposition for
potential out-licensing partners.

"We believe SDC-1801 has the potential to offer increased efficacy compared to
existing therapies in a number of autoimmune conditions where there is a
serious unmet medical need. This funding brings us closer to realising that
potential and potentially delivering a new, more effective treatment option
for millions of patients worldwide."

 

- Ends -

 

For further information, please contact:

 Sareum Holdings plc

 Stephen Parker, Executive Chairman               01223 497700

                                                  ir@sareum.co.uk

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                      020 7409 3494

 Hybridan LLP (Corporate Broker)

 Claire Noyce                                     020 3764 2341

 ICR Consilium (Financial PR)

 Jessica Hodgson / Davide Salvi / Kumail Waljee   0203 709 5700

 

About Sareum

 

Sareum Holdings (AIM:SAR) is a clinical-stage 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, including
psoriasis, and has completed Phase 1 clinical development.

 

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 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
(about:blank)

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