10th February 2025
Cardiogeni
PLC
("Cardiogeni" or the "Company")
Signing of Memorandum of
Understanding with the UAE Private Office of Sheikh Al
Qassimi
Cardiogeni (AQSE: CGNI), a UK
clinical stage biotechnology company founded by 2007 Nobel Laureate
Sir Martin Evans to advance novel heart failure medicines through
human trials, is pleased to announce the signing of a memorandum of
understanding (the "MoU") with the Private Office of Sheikh Al
Qassimi for direct investment and the funding of the Company's
clinical trials.
The funding will be through the
formation of a joint venture ("JV") with a total funding amount of
GBP £20 million to complete research, development and clinical
trials in the United Arab Emirates ("UAE").
Principal Transaction Terms
The MoU includes the following
principal terms:
· £20m in funding in
the period covering 2025 to 2027;
· £5m coming via an
initial investment in H1,2025 with the remainder being supplied to
fund the clinical development of Cardiogeni's heart failure
medicines through Phase 2b/3 clinical trials;
· The establishment
of a UAE joint venture corporation to complete R&D, specialist
manufacturing, Phase 2b/3 clinical trials and the commercialisation
of Cardiogeni's heart failure medicines in the Gulf Cooperation
Council ("GCC") states including the UAE, Saudi Arabia, Oman and
Bahrain;
· The JV agreement
will include the relevant governmental and family offices
sponsorship to expedite the development of Cardiogeni's heart
failure medicines in the GCC; and
· The MoU is
non-binding, and the Parties will negotiate a legally binding
licence agreement in good faith, throughout February 2025 and will
aim to sign the binding agreement by March 31st, 2025.
Following formation of the Joint
Venture and the completion of the initial investment, the Company
intends to disclose details of the clinical development program,
forward funding schedule and the anticipated timelines for
expedited development.
The Company will provide
shareholders with further updates regarding this transaction as
appropriate.
Dr
Darrin M Disley OBE, Executive Chairman of Cardiogeni
commented:
"Following our recent admission to AQSE we are delighted to be
able to share news of such a meaningful development for the
Company. The receipt of the initial funding will facilitate
advancement of our innovative heart failure medicines through the
ongoing Randomised Controlled trial (RCT) in Europe and, via the JV
to be formed, through pivotal P2b/3 human trials in a region that
has both an excellent medical research eco-system and access to a
market with a significant unmet need due to a high prevalence of
heart failure."
ENDS
About Cardiogeni
Founded by Nobel Laureate, Professor
Sir Martin Evans, the Cardiogeni Group is developing a new class of
life-saving cellular medicines. The Group's platform technology
enables the creation of unique (living) cells that are engineered
with a specific therapeutic function.
The Group's lead product, CLXR-001,
is a patented engineered cellular medicine to treat heart failure
patients which is administered during coronary artery bypass
grafting surgery. The Group's novel epigenetic cellular
reprogramming technology was developed in-house by Professor Sir
Martin Evans and the platform along with the pipeline of medicines
in development are protected by a portfolio of ~100 international
patents and trademarks.
CLXR-001 targets heart failure which
will affect 1 in 4 people in their lifetime and is not reversible
or curable. CLXR-001 consists of a novel allogeneic (off-the-shelf) cell type, iMP
cells, engineered for cardiac regeneration whose mechanism of
action is to regenerate damaged heart tissue and restoration of
improved heart function improving both the life expectancy and
quality of life of patients.
CLXR-001 targets the cardiac market
niche of CABG surgery with ~400,000 patients per year in the US
alone. The Group's two follow-on products target larger cardiac
market segments of stent treatment (over two million patients per
year) and myocardial infarction (heart attack, over one million
patients per year). Each of the products has the potential to
become a first or best-in-class blockbuster ($1B in annual sales)
medicine.
CLXR-001 has successfully completed
an EU Phase II investigator sponsored clinical trial in which
patients showed a statistically significant (P<0.05) improvement
in all end-point targets including heart function, reduction in
heart scarring and an improvement in quality of life.
CLXR-001 has received regulatory
approval to begin a randomized controlled trial from the national
regulatory authority of a European Union member country and this
trial has begun dosing patients with interim data expected to
read-out within 18 months of Admission.
The Company's admission document is
available to view on its website: www.cardiogeni.com
The directors of Cardiogeni accept
responsibility for this announcement.
For further information please contact:
Cardiogeni PLC
|
Dr Darrin M Disley OBE, Executive
Chairman
|
Via First Sentinel
|
First Sentinel Corporate Finance Limited
Corporate Adviser
|
Brian Stockbridge
Gabrielle Cordeiro
|
+44 (0) 7858 888007
|