TIDMSAR
RNS Number : 4212J
Sareum Holdings PLC
16 August 2023
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum updates on financial and operational progress
-- Equity Prepayment Facility of up to GBP5.0 million agreed
with RiverFort Global Opportunities PCC Ltd which provides funding
towards the Phase 1 trial of SDC-1801
-- Phase 1a clinical trial of lead programme SDC-1801 progressing well in Australia
-- Multiple Ascending Dose escalation phase expected to commence
in Q3 2023, subject to Safety Review Committee approval
Cambridge, UK, 16 August 2023 - Sareum Holdings plc (AIM: SAR),
a clinical-stage biotechnology company developing next generation
kinase inhibitors for autoimmune disease and cancer , today
provides a business update ahead of its full year results for the
year ended 30 June 2023, and updates on the progress of its
SDC-1801 Phase 1a clinical trial and other operations.
Dr Tim Mitchell, CEO of Sareum, commented:
"With a newly agreed funding facility designed to support Sareum
through the Phase 1 study of its lead programme, SDC-1801, and good
initial progress on the Phase 1a part of the trial, Sareum has
begun the new financial year with significant momentum.
"Pending the continuing good progress of the single ascending
dose stage and review of the results by the safety review
committee, we expect Part 2 of the trial, the multiple ascending
dose, to commence in Q3 2023.
"We remain fully focused on bringing SDC-1801 to patients and
are encouraged both by the growing commercial momentum around the
TYK2/JAK1 space and by the progress of our trial. We look forward
to progressing into the next phase of this trial as soon as
possible and will update investors accordingly. "
OPERATIONAL HIGHLIGHTS - STRONG CLINICAL PROGRESS
SDC-1801 (autoimmune disease)
SDC-1801 is a 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.
SDC-1801 is currently undergoing a Phase 1a clinical trial
designed to investigate the safety, tolerability, pharmacokinetics
and pharmacodynamics of an oral formulation of SDC-1801 in healthy
subjects (trial ID ACTRN12623000416695p). This is a randomised,
placebo-controlled trial, with single and multiple ascending oral
dose studies.
Recruitment of participants has been progressing to plan and the
trial safety committee will make a decision shortly as to whether
the study can progress to Part 2 of the Phase 1a trial, the
multiple ascending dose stage. Subject to a positive decision, this
is expected to commence in Q3 2023. The safety committee will also
establish the maximum dose to move forward into cohort A of Part 2,
based on the safety and pharmacokinetic data observed to date in
Part 1 (single ascending dose stage). Part 2 will begin in parallel
with additional planned dose escalation in Part 1 of the study.
Full safety data from the Phase 1a trial are expected to be
available during the first half of 2024 and, provided satisfactory
results continue to be obtained, and funding is available under the
RiverFort Equity Prepayment Facility or otherwise, a Phase 1b
clinical study is expected to commence as soon as possible
thereafter in psoriasis patients, with a readout expected before
the end of 2024, subject to recruitment and progress.
Psoriasis is an autoimmune dermatological condition affecting
more than 60 million adults worldwide, with a market size for
potential treatments estimated to be worth more than US$30.0
billion. Sareum believes that TYK2/JAK1 inhibition offers potential
for increased efficacy in psoriasis, compared with existing
approved therapies.
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a
healthy immune system and has strong clinical validation in
psoriasis and psoriatic arthritis.
SDC-1802 (cancer immunotherapy)
Sareum continues to work on the translational studies needed to
define the optimal cancer application prior to completing
toxicology and manufacturing studies.
PATENT UPDATES
In June 2023, the Company announced that The China National
Intellectual Property Administration (CNIPA) has officially issued
patent number CN113056456, safeguarding SDC-1801 and medical
applications of it in treating inflammatory or immune disorders.
This is the first patent grant issued to Sareum for SDC-1801 in any
territory. Patent applications in Europe (EP3864009), the US
(US2021387981) and other territories are still under review.
The Company also announced in June 2023 that the United States
Patent and Trademark Office (USPTO) has formally granted patent
number US 11,673,870 specifically covering the treatment of
autoimmune disorders with SDC-1802 and several analogues. While
Sareum has previously secured international patents providing
comprehensive protection for the compound SDC-1802, this patent
extends its scope in the US beyond immuno-oncology.
This follows the granting of a patent, in April 2022, for
protecting the SDC-1802 molecule and pharmaceutical preparations
thereof as a therapeutic to treat T-cell acute lymphoblastic
leukaemia (T-ALL - a cancer of a particular type of white blood
cell called a T lymphocyte) and other cancers that are dependent on
TYK2 kinase for survival.
SRA737: A Selective Chk1 inhibitor
As announced in March 2023, Sierra Oncology, Inc ("Sierra"), has
completed the return of the Clinical Study Reports and other
associated documents and data related to SRA737 to Sareum's
co-development partner, the CRT Pioneer Fund LP ("CPF").
As the major partner, CPF is taking the lead in evaluating
potential further development opportunities for SRA737 and further
updates will be provided as appropriate.
STRENGTHENED CASH POSITION AND RESULTS FORECAST
Sareum had a cash position of approximately GBP1.0 million as at
30 June 2023 (cash of GBP 2.9 million as at 31 December 2022 and
GBP4.3 million as at 30 June 2022). In August 2023, Sareum agreed
terms on an Equity Prepayment Facility of up to GBP5.0 million with
RiverFort Global Opportunities PCC Ltd (the "Facility"), and as
part of this, received an initial deposit of GBP2.0 million, net of
associated costs, on 4 August 2023.
The Company intends to use the Facility, if fully drawn,
together with the receipt of anticipated tax credits, estimated to
be in the region of GBP1.6 million, to complete the Phase 1a/b
clinical development of the Company's lead candidate SDC-1801,
which is expected to be a primary catalyst for driving shareholder
value, and for general working capital to Q4 2024.
Whilst still subject to audit, the loss for the year to 30 June
2023 is expected to be around GBP3.3 million after tax, (2022:
GBP2.2 million), which is in-line with market expectations and
reflects the increased costs associated with setting up for and
commencing clinical studies.
- Ends -
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO 01223 497700
Strand Hanson Limited (Nominated Adviser)
James Dance / James Bellman 020 7409 3494
Peel Hunt LLP (Joint Corporate Broker)
James Steel / P atrick Birkholm 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 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 and has entered Phase
1a/b clinical development with an initial focus on psoriasis.
Sareum has an economic interest in SRA737, a clinical-stage Chk1
inhibitor which it originally developed in collaboration with
several Cancer Research UK-related organisations. SRA737 has shown
promising safety and efficacy in two Phase 1/2 clinical trials.
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
UPDFLFERTFIELIV
(END) Dow Jones Newswires
August 16, 2023 02:00 ET (06:00 GMT)
Sareum (LSE:SAR)
過去 株価チャート
から 4 2024 まで 5 2024
Sareum (LSE:SAR)
過去 株価チャート
から 5 2023 まで 5 2024