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
LONDON, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Genflow Biosciences Plc (“Genflow” or “the Company”) (LSE:GENF) (OTCQB:GENFF), today announced 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 |
| Harbor Access | |
| Jody Kane Investor Relations | +1 475 477 9402 |
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
