Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) announced significant progress in its primary longevity programmes and bolstered its financial position during the first half of 2024, according to the company's half-year results statement.
The London-listed biotechnology firm has been making strides in developing treatments for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Werner Syndrome, both of which are age-related diseases with substantial unmet medical needs.
In June, Genflow submitted a comprehensive briefing package to the US Food and Drug Administration for its lead drug candidate, GF-1002, aimed at treating MASH.
The company anticipates receiving guidance through the FDA's Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) programme. While awaiting feedback, the FDA has encouraged Genflow to proceed with pilot proof-of-concept studies to identify suitable models.
In a move that reduces reliance on animal testing, Genflow has developed functional three-dimensional liver organoids derived from cells of patients with Werner Syndrome.
These lab-grown miniature organs mimic the structure and function of human tissues, providing a more accurate model for testing the efficacy of the company's SIRT6-based gene therapy in a human-like environment.
In the update, investors were told Genflow initiated a feasibility study with Exothera SA, a contract development and manufacturing organisation.
The study aims to assess the production of clinical batches of GF-1002 in compliance with Good Manufacturing Practices. At the same time, the company is in the process of selecting contract research organisations to conduct an upcoming clinical trial in dogs for GF-1004, a simplified naked DNA version of its centenarian SIRT6 drug candidate.
Genflow's research efforts have been further supported by collaborations backed by non-dilutive grants from the Government of Wallonia in Belgium.
During the reporting period, the company received grant funding totaling €777,281 for two projects. The first is a sarcopenia research program with Revatis SA, focusing on developing muscle progenitor cells loaded with Genflow's proprietary SIRT6 to prevent and treat age-related muscle loss.
The second is an exosome-mRNA project with EXO Biologics, aiming to create a therapeutic product composed of exosomes encapsulating an adeno-associated virus or mRNA encoding SIRT6. This therapy targets liver fibrosis associated with MASH and Werner Syndrome.
In April, Genflow Biosciences SRL received an additional €350,000 from the regional government of Wallonia, representing the second tranche of a grant awarded in 2023. These funds are expected to further accelerate the company's research initiatives.
Strengthening its financial standing, Genflow raised £715,000 through a share placing and subscription during the period.
Notably, Premier Miton, a well-known UK-based investment firm, participated in the fundraising round. The influx of capital not only boosts the company's resources but also reflects growing institutional interest in Genflow's approach to combating age-related diseases.
Genflow posted a £524,259 loss for the six months ended June, reflecting its investment in research and development. More importantly, it exited the period with just over £1.1 million of cash reserves.
"Our commitment to pioneering therapeutic solutions for longevity has been strengthened by the support of our collaborative partners and promising feedback from the FDA during the six-months to 30 June 2024," said chairman Tamara Joseph.
"This encouragement reinforces our commitment to developing effective therapeutic solutions for age-related diseases. We remain focused on our mission to improve healthspan, and I look forward to providing you with further updates as we progress through our work programs, including clinical dog trials."