Highlights

1. Advancements in Longevity Treatments: Genflow Biosciences has made notable progress in developing therapies for age-related diseases, specifically Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Werner Syndrome.

2. Regulatory Engagement: The company submitted a comprehensive briefing package for its lead drug candidate, GF-1002, to the US FDA, initiating its participation in the INTERACT programme for regulatory guidance.

3. Innovative Research Approaches: Development of three-dimensional liver organoids has been achieved, enhancing the accuracy of testing for the company’s SIRT6-based gene therapies.

Genflow Biosciences PLC {OTC:GENFF} a London-listed biotechnology firm, has reported significant advancements in its primary longevity programmes and improved financial stability during the first half of 2024. The company's ongoing efforts focus on addressing the unmet medical needs associated with MASH and Werner Syndrome, both of which are age-related diseases.

In June, Genflow submitted a detailed briefing package to the US Food and Drug Administration for GF-1002, its lead candidate for treating MASH. Through the FDA's Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) programme, the company is set to receive valuable regulatory guidance. While awaiting feedback, the FDA has encouraged the firm to proceed with pilot proof-of-concept studies to identify suitable models for further development.

In a strategic move to minimize reliance on animal testing, Genflow has developed functional three-dimensional liver organoids derived from cells of patients with Werner Syndrome. These lab-grown organs mimic human tissue structure and function, offering a more accurate testing environment for the efficacy of the SIRT6-based gene therapy.

The company has also initiated a feasibility study with Exothera SA, focusing on the production of clinical batches of GF-1002 in compliance with Good Manufacturing Practices. Furthermore, the selection of contract research organizations for an upcoming clinical trial of GF-1004, a simplified version of its SIRT6 drug candidate, is underway.

Genflow's research initiatives have received a boost from non-dilutive grants from the Government of Wallonia, totaling €777,281 for two projects aimed at addressing age-related conditions. The company posted a loss during the reporting period, reflecting its commitment to research and development, while maintaining cash reserves of over £1.1 million. Chairman Tamara Joseph emphasized the importance of collaboration and FDA feedback in reinforcing the company's mission to improve healthspan.