Genflow Biosciences plc 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.