17 June 2025

Genflow Biosciences Plc

Genflow Biosciences Provides Half Year Corporate Update on SIRT6 Programs, IP Progress and Strategic Partnerships

Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"), the only publicly listed longevity company in Europe, is pleased to provide an update on the continued advancement of its core programs focused on the SIRT6-centenarian gene and its potential to slow aging and delay the onset of age-related diseases.

Since the start of the year, the Company has made meaningful progress across its research and development initiatives. These advancements have been supported by a strengthened leadership network of world-class academic collaborators and laboratories. Combined with the continued support of international institutional investors and previously awarded government grants, this ecosystem has played a vital role in accelerating Genflow's scientific and clinical development.

As part of its strategic execution, Genflow has signed a Master Service Agreement (MSA) with CER Groupe, a trusted long-term partner and leading Belgian research center specializing in integrated bioproduction and pre-clinical services. CER operates in a fully regulated ISO and GxP-compliant environment and will provide a robust R&D framework to support the advancement of Genflow's pre-IND gene therapy programs.

In parallel, the Company continues to expand its global intellectual property portfolio. In February, Genflow's exclusively out-licensed European Patent Office (EPO) application titled "Variants of SIRT6 for Use in Preventing and/or Treating Age-Related Diseases" advanced through the Supplementary European Search Report without objections, allowing it to proceed to the national phase-a key step toward securing protections across major European markets.

Similarly, the Japanese Patent Office has progressed the same SIRT6-related application (Application No. JP 2024515284) to the national examination phase, marking another important milestone in establishing global IP coverage for Genflow's innovative gene therapy technology.

Originally filed on 13 May 2022, the patent is jointly owned by the University of Rochester, The Trustees of Columbia University in the City of New York, and Albert Einstein College of Medicine. Genflow holds the exclusive worldwide license to this intellectual property.

To support the intellectual property costs associated with entering into the national phase in the U.S., Canada, Europe, Japan, Australia, China, Genflow has applied for a PATEX-2 grant in connection with its patent application PCT/EP2023/084840, titled "SIRT6 Variants for NASH," filed on December 8, 2023. This patent is fully owned by Genflow Biosciences.

Below is a status update on each of our programs, reflecting significant progress at the mid-year point:

MASH (GF-1002): We completed an initial production test with our CDMO partner, Exothera SA, for the GMP manufacturing of GF-1002. The results exceeded our expectations, with a yield notably higher than anticipated-a promising outcome for the upcoming manufacturing phases.

We are currently conducting the two pivotal studies to support our filing for Clinical Trial Application (CTA) for GF-1002 in MASH. These studies are being carried out independently by two reputable Contract Research Organizations (CROs): Physiogenex and Accelera.

Genflow signed an MSA with Heureka Labs, a medical AI company spin-off from Duke University. Heureka will provide Genflow with access to its proprietary artificial intelligence ("AI") platform, which specializes in the analysis of high-dimensional genomic data including RNA sequencing and gene expression profiles. The application of Heureka's AI technology is expected to enhance Genflow's ability to interpret complex biological datasets, enabling deeper insights into gene regulatory networks and systemic biological responses. These insights will be key to optimising therapeutic design and anticipating patient-specific outcomes. Genflow will retain all IP rights under the agreement. Our MASH program receives support through a research grant awarded by the regional government of Wallonia - Belgium Service Public de Wallonie.

Werner Syndrome (GF-1003): We have developed a proprietary liver organoid model derived from human cells of patients with Werner syndrome. This innovative system allows us to test our drug candidate, GF-1003, directly in a disease-relevant human tissue model. The approach offers several advantages: it reduces the need for animal testing and provides deeper insight into the efficacy and safety of GF-1003 in a synthetic organ created from the cells of three Werner syndrome patients. As a result, this model significantly enhances the predictive value of our preclinical data for the potential success of future clinical trials in Werner patients.

The use of more sophisticated organoid models reflects Genflow's strong commitment to minimizing animal suffering wherever possible. While this approach involves higher costs and longer development timelines, it aligns with our core values and ethical commitment to respecting animal welfare. By prioritizing human-relevant, non-animal models, Genflow demonstrates that scientific progress and compassion can go hand in hand.

Our Werner program receives support through a research grant awarded by the regional government of Wallonia.

Dog Aging (GF-1004): In March, we commenced a proof-of-concept clinical trial to evaluate the safety and efficacy of its proprietary SIRT6-centenarian gene therapy targeting age-related decline in dogs. The Company is treating the dogs for 6 months and assess the safety and efficacy of our therapy for the following 6 months. This is a randomized, controlled trial with 28 dogs aged 10+ years, conducted with the renowned CRO, Syngene.  Genflow will compare recipient dogs of intravenous injections of proprietary SIRT6 gene therapy versus untreated control group.  Endpoints will include biological age estimation (via GRIM methylation clock), muscle strength, muscle mass, mitochondrial function, coat quality and overall health indicators.

Sarcopenia (GF-1005): Our sarcopenia program, aimed at combating age-related muscle loss, continues to progress positively with GF-1005-myoblast progenitor cells engineered to express the centenarian variant of SIRT6 (centSIRT6). This project is being carried out in collaboration with our partners at Université libre de Bruxelles (ULB) and Revatis.

Building on this foundation, Genflow has identified three additional sirtuin genes that may act synergistically with centSIRT6. This has led to the development of four drug candidates: GF-10051, which expresses centSIRT6 alone, and GF-10052, GF-10053, and GF-10054, each co-expressing centSIRT6 with one of the three potentially synergistic sirtuin genes. We have successfully achieved stable dual gene expression-a technically challenging feat due to the large size of the combined genetic constructs. This milestone highlights Genflow's advanced capabilities in gene therapy development.

We are now fine-tuning functional assays, with a particular focus on mitochondrial function, to further evaluate the therapeutic potential of these candidates.

Our sarcopenia program receives support through a research grant awarded by the regional government of Wallonia.

Ophthalmology: Genflow launched a new development program in ophthalmology, focused on advancing a novel gene therapy leveraging its proprietary centenarian SIRT6 (centSIRT6). This therapy will utilize a specially designed non-viral vector engineered for precise delivery of Genflow's centSIRT6 to different compartments of the eye. The therapy is designed to combat ocular problems including several pathologies of the cornea and glaucoma. This initiative is part of Genflow's continued efforts to optimize its gene therapy and proprietary centenarian SIRT6.

As part of this effort, Genflow has signed a Material Transfer Agreement (MTA) with a leading ophthalmology company, to collaborate on the design and development of the eye-targeted centSIRT6 non-viral vector to target ocular diseases. These therapies will leverage Genflow's proprietary centSIRT6 Centenarian gene technology, in combination with an advanced vector delivery system.

Guided by our mission to improve healthspan, updates will be provided on our current programs, such as the clinical dog trials, as they progress.

Contacts

About Genflow Biosciences

Founded in 2020, Genflow Biosciences Plc. (LSE:GENF) (OTCQB:GENFF), a biotechnology company headquartered in the UK with R&D facilities in Belgium, is pioneering gene therapies to decelerate the aging process, with the goal of promoting longer and healthier lives while mitigating the financial, emotional, and social impacts of a fast-growing aging global population. Genflow's lead compound, GF-1002, works through the delivery of a centenarian variant of the SIRT6 gene which has yielded promising preclinical results. Genflow's 12-month proof-of-concept clinical trial evaluating their SIRT6-centenarian gene therapy in aged dogs began in March 2025. Other programs planned for 2025, include a clinical trial that will explore the potential benefits of GF-1002 in treating MASH (Metabolic Dysfunction-Associated Steatohepatitis), the most prevalent chronic liver disease for which there is no effective treatments. Please visit www.genflowbio.com  and follow the Company on LinkedIn and X.