Business
Company Update
Company Update.
About this update from Genflow Biosciences Plc
[{"type":"text","content":"\n\n \n20 September 2023\nGenflow Biosciences Plc\n \n(\"Genflow\" or \"the Company\")\n \nSuccessful first regulatory interaction with the Federal Agency for Medicines and Health Products (FAHMP)\n \nAnd\n \nInternal Debt Restructuring\n \n \nFirst regulatory agency interaction results in recommendation to commence Phase I/II Clinical Trial in NASH Patients\n \nThe 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.\n \nThe Company's NASH clinical trials are scheduled to begin in approximately 18 months following dialogue and subsequent agreement with the European Medicine Agency.\n \nEric 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.\n \nWe are hopeful that these trials will showcase the ability of longevity gene-therapy assisting patients with life-limiting illnesses.\n \nThe 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.\"\n \nInternal Debt Restructuring\n \nIn 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.\n \nThis 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 ass...