Genflow Biosciences PLC Company Update (9615M)
2023年9月20日 - 3:00PM
RNSを含む英国規制内ニュース (英語)
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RNS Number : 9615M
Genflow Biosciences PLC
20 September 2023
20 September 2023
Genflow Biosciences Plc
("Genflow" or "the Company")
Successful first regulatory interaction with the Federal Agency
for Medicines and Health Products (FAHMP)
And
Internal Debt Restructuring
First regulatory agency interaction results in recommendation to
commence Phase I/II Clinical Trial in NASH Patients
The Company (LSE:GNF) (OTCQB:GENFF) , today announces the
receipt of written comments from the Federal Agency for Medicines
and Health Products (FAHMP) of Belgium. The Company is pleased with
the advice received from the FAHMP to commence clinical trials of
its drug, GF-1002, with patients suffering from NASH [*] (rather
than in healthy volunteers). This follows promising results from
the Company's research in in-vitro human cells and in-vivo rodent
studies.
The Company's NASH clinical trials are scheduled to begin in
approximately 18 months following dialogue and subsequent agreement
with the European Medicine Agency.
Eric Leire, CEO of Genflow, commented; "We are thrilled that the
FAHMP has recommended Genflow to commence Phase I/II clinical
trials in NASH patients rather than with healthy volunteers. We
hope that this will provide a first signal of efficacy in humans
more speedily. We will continue to seek guidance and
recommendations from the FAHMP to develop an appropriate program in
conducting our proposed clinical trial in humans.
We are hopeful that these trials will showcase the ability of
longevity gene-therapy assisting patients with life-limiting
illnesses.
The current financial outlook for the Company remains positive
as it is in a secure financial position. Genflow Biosciences has
sufficient cash reserves until March 2025 and continues to seek
further non-dilutive funding in the form of research grants."
Internal Debt Restructuring
In order to comply with the updated requirements of the existing
grant from the Wallonia region, and to be eligible for future grant
funding, Genflow recently undertook an internal debt
re-organization.
This was completed by means of the benefit of the receipt of the
existing loans between the Company and its ultimate subsidiary
entity, Genflow Biosciences SRL ("Genflow BE"), being assigned to
Genflow Biosciences, Inc ("Genflow US"), the Company's immediate
subsidiary. This was then followed by a capital restructure within
Genflow BE, resulting in an increase to this entity's net assets
within the parameters and requirements of the possible grant
providers. The overall debt position within the Group, therefore,
remains unchanged.
Whilst this does not provide any assurances relating to the
granting of non-dilutive funding in the Company's favor, it allows
the Company to be considered for the same.
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2014.
Footnote :
[*] NASH is an acronym for Non-Alcoholic Steatohepatitis. The
Company is seeking to reverse ageing fibrotic livers to normal
functionality. NASH affects an estimated 35 million people globally
and is one of the leading causes of chronic liver disease and liver
transplants .
For further information please contact:
Genflow Biosciences Plc
Dr Eric Leire
Chief Executive +32 477 495 881
-----------------
Clear Capital Markets
-----------------
Corporate Broker +44 203 869 6080
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About Genflow Biosciences
Genflow is a UK-based biotechnology company established in 2020.
The Company is developing gene therapies designed to target the
aging process and to reduce and delay the incidence of age-related
diseases. This will be done through novel therapeutics targeting
aging in humans by using adeno-associated virus ("AAV") vectors to
deliver copies of the Sirtuin-6 ("SIRT6") gene variant that is
found in centenarians into cells.
Its mission is to increase our understanding of the factors that
control and impact lifespan. Genflow researches, develops, and
commercialises therapeutic solutions to lengthen health span, the
amount of time we live in good health, creating biological
interventions that enable longer and healthier lives. Genflow is
dedicated to the development and commercialisation of novel
therapeutics targeting aging in dogs and humans. By treating aging,
Genflow can contribute to a decrease in healthcare costs and lessen
the emotional and societal burden that comes with an aging
population.
To learn more visit www.genflowbio.com
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September 20, 2023 02:00 ET (06:00 GMT)
Genflow Biosciences (LSE:GENF)
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から 4 2024 まで 5 2024
Genflow Biosciences (LSE:GENF)
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から 5 2023 まで 5 2024