Genflow Biosci Regulatory News (GENF)

4 April 2023

Genflow Biosciences Plc

("Genflow" or "the Company")

Company Update

The board of Genflow is pleased to provide an update to investors on the Company's progress during a busy first quarter of 2023. 

Genflow is the first longevity company listed in Europe, and is well placed to take advantage of the recent resurgence of interest in the longevity sector [1]. 

Group Financial Position

The outlook for the Company is positive as it is in a secure financial position.

Genflow's current cash, and grant funding, allows for a 2 year runway until March 2025 (based on the Company's current, planned expenditure). This puts Genflow in a more favourable financial position compared to many other biotechnology companies. 

Group Update

Genflow continues with the research, development and safe implementation of its two longevity programs:

1. NASH (Non-Alcoholic Steatohepatitis) where 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 [2] ; and

2. Werner Syndrome where the Company is seeking to improve the life of patients with this accelerated ageing disease. The Company is seeking to ensure swift first-in-human trials.

In furtherance of the Group's programs mentioned above, notable progress includes:

· The completion of a detailed application dossier for the Chemistry, Manufacturing, and Controls (CMC) of the Group's medical treatment of NASH. This will be presented to the Belgian regulatory authorities (FAMHP/FAGG) in early June 2023.

The Directors believe that this presentation is a significant milestone for the Group, allowing it direct interaction with national regulatory authorities, and thus, paving the way for the Group to commence clinical trials on an accelerated pathway (given there is currently no known medical treatment for NASH). 

· In collaboration with Dr. Manlio Vinciguerra, (a Company Scientific Advisory Board member based at the University of Liverpool), Genflow has gained a significantly deeper understanding of the biochemical changes that occur in the treatment of NASH using its centenarian SIRT6. This research has led to the Company clearly identifying the workings of its drug candidate and its potential benefits for NASH patients. As a result, Genflow has accumulated important data and is currently exploring additional IP opportunities.

As validation, part of these results have been published in a peer controlled journal (reference: Human centenarian-associated SIRT6 mutants modulate hepatocyte metabolism and collagen deposition in multilineage hepatic 3D spheroids - PubMed (nih.gov)) with the Company's CEO and members of its Scientific Advisory board listed as co-authors.

· The Company has initiated in-vivo evaluations of its centenarian SIRT6 gene therapy in four different NASH mice models in conjunction with three leading partners in the field:

(a) The University of Liverpool, UK

(b) The University of Rochester, US; and

(c) Physiogenex, France (www.physiogenex.com).

These studies have been wide reaching and have included the analysation of over 700 mice, with the intention of understanding the efficacy and safety of the Company's drug candidate in animal models with NASH.

These studies have generated essential information which will be used to seek authorisation for clinical trials in humans.

· The Company has conducted targeted biodistribution studies of its SIRT6-AAVs (the means by which gene therapy is delivered to the body) with its partners IVEX , in Estonia and Articles in Belgium.

These studies demonstrate the absorption and distribution of the Company's drug candidates in the human body. The data from these studies, which is owned by the Company, will form a significant part of its presentation to the regulatory authorities mentioned above.

· After conducting rigorous in-house studies, the Company has achieved consistent and satisfactory delivery of its drug candidate to the required, targeted human cells, with optimal levels of expression. Referring to the picture below, investors can see how the Company has developed the aforementioned consistency and delivery over the period of the studies:

This significant milestone marks a crucial (and necessary) first step in determining the most effective dosage for cSIRT6 gene therapy in human trials.

· The Company's partnership with Exogenus Therapeutics in Portugal, has uncovered a promising opportunity for a new patent application related to the encapsulation of AAVs into exosomes. The understanding of the means of delivery of drug candidates to cells and tissues, whilst reducing the damage to the human immune system, is key in all areas of medicine.

If successful, this-then patent protected delivery method could have significant positive implications for the field of gene therapy and beyond. Based on this work, further IP opportunities are also being explored.

· The Group has recently expanded its intellectual property portfolio through a provisional patent application focussing on the ability to edit its SIRT6 gene. This gene has been shown to play a role in longevity and age-related diseases. If successful, the patent will represent a significant breakthrough in the field of gene editing, with potential implications for longevity and other forms of gene therapy.

The Board looks forward to updating shareholders on further progress in due course.

The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2014.

Footnotes:

[1]  How to age well: Can we stay healthy for longer?" - BBC News: Published on 1 October 2022.

"Could living to 1000 become a reality?" - The Telegraph: Published on 16 February 2021.

"Longevity drugs: Are we getting closer to unlocking the secrets to a longer life?" - The Independent: Published on 10 August 2022.

"The race for longevity: How scientists are extending our healthy lifespans" - The Guardian: Published on 12 July 2021.

"Why I believe we will live to 150 within our lifetimes" - Wired UK: Published on 13 March 2021.

[2] Sources: Pais R, Barritt AS 4th, Calmus Y, Scatton O, Runge T, Lebray P, Poynard T, Ratziu V, Conti F. NAFLD and liver transplantation: Current burden and expected challenges. J Hepatol. 2016 Dec;65(6):1245-1257. And Vlad Ratziu, Sven Francque, Arun Sanyal, Breakthroughs in therapies for NASH and remaining challenges, Journal of Hepatology, Volume 76, Issue 6, 2022)

For further information please contact:

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