2023 was a busy and productive year for Genflow Biosciences Plc (“Genflow) marked by significant advancements in our mission to pioneer novel therapeutics for a longer, healthier life. The groundbreaking gene therapies that we are working on alongside our co-collaborators are being engineered to target both the ageing process, and reduce and delay the onset of age-related diseases. Our mission remains to lower healthcare expenditures while easing the emotional and social challenges associated with an ageing population.
We’ve made numerous strategic moves this year as a part of our ongoing efforts to strengthen our company, financial and market position. Our balance sheet remains strong, and we are in a solid financial position. To comply with the updated requirements of the existing grant from the Wallonia region, and to be eligible for future grant funding, we undertook an internal debt re-organization without dilution. This puts us in a favorable financial position compared to many other biotechnology companies.
We diligently continue to pursue the research, development, and safe implementation of our two pivotal programs centered on NASH (Non-Alcoholic Steatohepatitis) and Werner Syndrome and have made significant progress this year.
- NASH. We are pleased to report that our NASH program, which afflicts an estimated 35 million individuals worldwide and ranks among the leading causes of chronic liver disease with the urgent need for life-saving liver transplants, is progressing to plan. This program is advancing steadily, underscoring our firm commitment to combatting this pressing global health issue. In collaboration with Dr. Manlio Vinciguerra, (a Genflow Scientific Advisory Board member based at the University of Liverpool), are gaining a significantly deeper understanding of the biochemical changes that occur in the treatment of NASH using the centenarian SIRT6. This research has led to us clearly identifying the workings of our lead drug candidate, GF-1002 and its potential benefits for NASH patients. As a result, we have accumulated important data and filed a new patent application on this specific activity. Additionally, NASH clinical trials are expected to begin in Q1-Q2 2025 following dialogue and subsequent agreement with the European Medicine Agency.
- Werner Syndrome. Simultaneously, we are making progress targeting Werner Syndrome, an accelerated ageing disease. Here, our vision is clear: to enhance the quality of life for affected patients and expedite the path towards swift and successful first-in-human trials under orphan drug designation. Our lead compound GF-3001, is a topical delivery of SIRT6 to the skin.
Key Milestones
- Q1 2023: Issued a shareholder update on the Company’s progress, highlighting our expanded intellectual property portfolio through a provisional patent application focusing on the ability to edit the SIRT6 gene, shown to play a role in longevity and age-related diseases as well as our solid cash position.
- Q2 2023: Expanded our intellectual property portfolio through a provisional patent application focusing on the ability to edit the SIRT6 gene, shown to play a role in longevity and age-related diseases. If successful, the patent will represent a significant breakthrough in the field of gene editing, with potential implications for longevity and other forms of gene therapy;
Genflow started trading on the OTCQB Venture Market in the US under the ticker GENFF. This move aligns with our strategic emphasis on the US due to its significant advancements in longevity and our ongoing collaborations with US-based institutions;
The Company appointed Prof. Dr. Sven Francque on our Scientific Advisory Board. Prof. Francque is currently Chairman of the Department of Gastroenterology and Hepatology of the University Hospital Antwerp and Full Professor of Medicine at the Faculty of Medicine and Health Sciences of the University of Antwerp in Belgium. He has a longstanding interest and expertise in nonalcoholic fatty liver disease and conducted [basic] research focusing on steatosis. His research unit continues to study pathophysiological mechanisms of NASH. He also conducts clinical research, and his unit is a partner in several research consortia supported by the European Commission. - Q3 2023: Received positive comments from the Federal Agency for Medicines and Health Products (FAHMP) of Belgium regarding the design of our upcoming Phase I/II clinical trials of our lead drug candidate, GF-1002 with patients suffering from NASH. Following our encouraging results from in-vitro human cell and in-vivo rodent studies, the Agency concurred with Genflow’s proposal to commence clinical trials directly with NASH patients, thereby bypassing Phase I trials with healthy volunteers;
Appointed Harbor Access, a strategic Investor Relations firm with offices in the US and Canada to provide investor relations support and investor outreach. - Q4 2023: Appointed Capital Plus Partners Ltd (“CPP”) to act as Joint Broker, alongside Clear Capital Markets Limited. The addition of CPP is expected to bring additional expertise to the Company, strengthen our position and improve access to the capital;
Appointed Prof. Dr. Mary E. Rinella, Director, Metabolic and Fatty Liver Disease Department at the University of Chicago. She has investigated a broad range of topics within fatty liver disease, including the use of non-invasive measures to minimize the use of liver biopsy and the study of new therapies to treat fatty liver disease, since there is still no FDA approved treatment. Dr. Rinella has published nearly 150 peer-review articles in prestigious journals, such as Nature Reviews Gastroenterology & Hepatology, Gastroenterology, Hepatology, Journal of the American Medical Association (JAMA), The Lancet and others.
Heading into 2024, Genflow is well placed to take advantage of the recent resurgence of interest in the longevity sector. We continue to monitor opportunities, and to prioritize marketing efforts to expand our investor audience in North America and Europe. Our commitment to innovation and improving lives remains steadfast, as we navigate the opportunities and challenges that lie ahead. Together, we envision a future where our pioneering work redefines possibilities, bringing hope and transformative solutions to those who need it most.
Dr. Eric Leire
Founder and CEO
Genflow Biosciences Plc
January 25, 2024
