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Genflow Biosciences PLC Announces Clinical Readiness Acceleration
Clinical Readiness Accelerates Across Genflow Biosciences Lead Programs
LONDON, UK / ACCESS Newswire / July 24, 2025 / Genflow Biosciences Plc (LSE:GENF)(OTCQB:GENFF) ("Genflow" or "the Company"), the only publicly listed longevity company in Europe, is pleased to report key preclinical activities in two of its lead programs.
GF-1002
In preparation for a submission for European Clinical Trial Authorisation (CTA), the EU's regulatory equivalent to the U.S. FDA's IND process, Genflow is continuing to advance key development activities. To support this process, the Company has initiated Chemistry, Manufacturing, and Controls (CMC) work in collaboration with its CDMO partner, Exothera, to ensure clinical supply production meets Good Manufacturing Practice (GMP) standards. In parallel, pivotal efficacy studies are underway with Genflow's independent CRO partners, Physiogenex and Accelera, evaluating GF-1002 in both early and advanced stages of MASH.
GF-1004
Genflow has submitted a first protocol amendment to its ongoing proof-of-concept clinical trial in aged dogs to clarify the administration of its investigational product, GF-1004. The amended protocol now specifies the intravenous (IV) dose rate to ensure consistent and controlled delivery, minimizing the risk of infusion-related adverse events and reinforcing patient safety. This randomized, controlled trial initiated in March in collaboration with the renowned CRO, Syngene is designed to evaluate the safety and efficacy of Genflow's proprietary SIRT6-centenarian gene therapy in addressing age-related decline in dogs.
Dr. Eric Leire, CEO of Genflow, commented: "This update reflects the growing maturity of our pipeline and our continued commitment to advancing science-backed therapies in healthy aging. The combination of expected non-dilutive funding, strategic partnerships, and supportive regulatory tailwinds puts Genflow in a strong position to accelerate both our programs."
Contacts
Genflow Biosciences | Harbor Access |
Dr Eric Leire, CEO | Jonathan Paterson, Investor Relations |
+32-477-495-881 | +1 475 477 9401 |
Corporate Broker |
Capital Plus Partners |
Jonathan Critchley |
+44 0207 432 0501 |
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. Genflow's 12-month proof-of-concept clinical trial evaluating their SIRT6-centenarian gene therapy in aged dogs began in March 2025. Other programs planned for 2025, include a clinical trial that will 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 and follow the Company on LinkedIn and 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 [email protected] or visit www.rns.com.
SOURCE: Genflow Biosciences PLC
View the original press release on ACCESS Newswire
A.Malone--AMWN