RCS - Genflow Biosciences - Strengthening of Pre-Clinical Efforts

Genflow BiosciencesAnnouncement

27/06/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240627:nRSa0280Ua&default-theme=true

RNS Number : 0280U  Genflow Biosciences PLC  27 June 2024

 

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO
CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE MARKET ABUSE REGULATION
(EU) NO. 596/2014 AS IT FORMS PART OF UK DOMESTIC LAW PURSUANT TO THE EUROPEAN
UNION (WITHDRAWAL) ACT 2018, AS AMENDED. UPON THE PUBLICATION OF THIS
ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS
CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 

27 June 2024

 

Genflow Biosciences Plc

 

Genflow Biosciences Strengthens Pre-Clinical Efforts

with FDA Guidance and CDMO and CRO Selection

 

Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company")
an emerging leader in the field of longevity research, focused on developing
therapeutic solutions for the prevention of age-related diseases is pleased to
report advancements in its pre-clinical programs.

 

Genflow has initiated a feasibility study with a Contract Development
Manufacturing Organization (CDMO), Exothera S.A, to assess the ability to
produce its future MASH clinical lot in accordance with Good Manufacturing
Practices (GMP).

 

Genflow is also in the process of selecting Contract Research Organizations
(CROs) to conduct its upcoming dog clinical trial, aimed at studying its
promising drug candidate, GF-1004. The Company is currently evaluating
requests for proposals (RFPs) and is working diligently to finalize a
definitive agreement next month.

 

In addition, Genflow has received research guidance from the FDA's Initial
Targeted Engagement for Regulatory Advice on CBER Products (INTERACT). The
Company submitted a comprehensive briefing package detailing all preclinical
(in vitro and in vivo) studies conducted with its lead drug candidate,
GF-1002, for the treatment of Metabolic Associated Steatohepatitis (MASH).

 

The FDA has encouraged Genflow to proceed with its plans to identify
appropriate animal models through pilot proof-of-concept (POC) studies. These
studies will inform the definitive POC, toxicology, and biodistribution
studies necessary for eventual clinical trials. Detailed summaries of the
products used in each animal study and their comparability to the intended
clinical product are to be included.

 

Dr. Eric Leire, CEO of Genflow commented: " We are excited by the momentum we
have built in moving forward with our pre-clinical programs and the guidance
received from the FDA. This encouragement reinforces our commitment to
developing effective therapeutic solutions for age-related diseases. As we
move forward with our dog clinical trials, we remain focused on our mission to
improve healthspan."

 

Contacts

 

 Genflow Biosciences  Harbor Access
 Dr Eric Leire, CEO   Jonathan Paterson, Investor Relations
 +32-477-495-881      +1 475 477 9401
                      Jonathan.Paterson@Harbor-access.com

 

 Joint Corporate Brokers
 Capital Plus Partners Ltd
 Keith Swann, +44 0203 821 6169
 Jon Critchley, +44 0203 821 6168

 

 

About Genflow Biosciences

 

Founded in 2020, Genflow Biosciences Plc. (LSE:GENF) (OTCQB:GENFF), a
biotechnology company headquartered in the UK with R&D facilities in
Belgium, is pioneering gene therapies to decelerate the aging process, with
the goal of promoting longer and healthier lives while mitigating the
financial, emotional, and social impacts of a fast-growing aging global
population. Genflow's lead compound, GF-1002, works through the delivery of a
centenarian variant of the SIRT6 gene which has yielded promising preclinical
results. Scheduled to begin in 2025, Genflow's clinical trial aims to explore
the potential benefits of GF-1002 in treating MASH (Metabolic
Dysfunction-Associated Steatohepatitis), the most prevalent chronic liver
disease for which there is no effective treatments. Please visit
www.genflowbio.com (http://www.genflowbio.com)   and follow the Company on
LinkedIn and Twitter/X.

 

DISCLAIMER

The contents of this announcement have been prepared by, and are the sole
responsibility of, the Company.

This announcement may contain forward-looking statements. The forward-looking
statements include, but are not limited to, statements regarding the Company's
or the Directors' expectations, hopes, beliefs, intentions or strategies
regarding the future. In addition, any statement that refers to projections,
forecasts or other characterisations of future events or circumstances,
including any underlying assumptions, is a forward-looking statement. The
words "anticipate", "believe", "continue", "could", "estimate", "expect",
"intend", "may", "might", "plan", "possible", "potential", "predict",
"project", "seek", "should", "would" and similar expressions, or in each case
their negatives, may identify forward-looking statements, but the absence of
these words does not mean that a statement is not forward-looking.

Forward-looking statements include all matters that are not historical facts.
Forward-looking statements are based on the current expectations and
assumptions regarding the Company, the business, the economy and other future
conditions. Because forward-looking statements relate to the future, by their
nature, they are subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict. Forward-looking statements are
not guarantees of future performance and the Company's actual financial
condition, actual results of operations and financial performance, and the
development of the industries in which it operates or will operate, may differ
materially from those made in or suggested by the forward-looking statements
contained in this announcement. In addition, even if the Company's financial
condition, results of operations and the development of the industries in
which it operates or will operate, are consistent with the forward-looking
statements contained in this announcement, those results or developments may
not be indicative of financial condition, results of operations or
developments in subsequent periods. Important factors that could cause actual
results to differ materially from those in the forward-looking statements
include regional, national or global, political, economic, social, business,
technological, competitive, market and regulatory conditions.

Any forward-looking statement contained in this announcement applies only as
of the date of this announcement and is expressly qualified in its entirety by
these cautionary statements. Factors or events that could cause the Company's
actual plans or results to differ may emerge from time to time, and it is not
possible for the Company to predict all of them. The Company expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained in this announcement to
reflect any change in its expectations or any change in events, conditions or
circumstances on which any forward-looking statement contained in this
announcement is based, unless required to do so by applicable law, the
Prospectus Regulation Rules, the Listing Rules, the Disclosure Guidance and
Transparency Rules of the FCA or the UK Market Abuse Regulation.

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAKZGZVKVFGDZM