Member Info for Moneymunch

6/1/25

Dog Aging (GF-1004): We are initiating a life extension clinical trial for aging dogs in collaboration with our contract research partner, Syngene. This six-month study will assess the potential of a veterinary version of our gene therapy to extend both the health span and lifespan of dogs. We expect to complete the full analysis of the trial by the end of 2025. Based on the outcomes, we may explore partnership opportunities or licensing agreements with veterinary specialty pharmaceutical companies.

14th October 2024

"There's a very large appetite from the veterinary industry for life extension for our dog companions. Therefore, we'll provide proof of concept. We're starting this very soon, and once this proof of concept is finished, that should trigger an out-licensing deal with our partner in veterinary. "

Chairman's Statement- 30/4/25

During 2025, the Company plans to continue advancing its existing research programs, along with embarking on an exciting clinical trial focused on aged dogs. In early 2025, we commenced a proof-of-concept clinical trial to evaluate the safety and efficacy of our proprietary SIRT6-centenarian gene therapy targeting age-related decline in dogs.

28th March 2025

Genflow begins SIRT6 gene therapy trial in dogs

Trial aims to demonstrate capacity to extend healthspan in older animals as company continues to progress towards human trials.

Longevity biotech Genflow Biosciences has commenced a gene therapy trial aimed at addressing age-related decline in dogs. The trial is designed to evaluate the safety and efficacy of the company’s SIRT6 gene therapy in extending healthspan in older canines.

By targeting the SIRT6 gene, which has been linked to extended lifespan in centenarians, Genflow hopes to generate insights that could inform future treatments for both veterinary and human applications. The trial’s launch was announced in conjunction with a recent investment of ~$560,000 from an institutional backer to accelerate the company’s research programs.

The study involves 28 dogs aged ten years and older and is being conducted in collaboration with Syngene, a contract research organization. Over the course of a year, dogs receiving the therapy via intravenous injections will be compared to an untreated control group. Researchers will assess biological age using the GrimAge methylation clock, monitor changes in muscle mass and strength, evaluate mitochondrial function, track coat condition and measure overall well-being. The six-month treatment period will be followed by a six-month observation phase to assess lasting effects. The results of the trial are expected by the end of 2025.

“As a devoted dog owner myself, I have a 9-year-old golden retriever, I know firsthand the desire we all share for more happy, healthy years of with our beloved pets,” said Genflow CEO Dr Eric Leire. “Our goal is not just to extend their lifespan, but to enhance their quality of life. By targeting biological aging in dogs, we also can unlock groundbreaking insights that could revolutionize both veterinary and human medicine. This research has the potential to reshape the way we approach aging, offering hope for longer, healthier lives for all.”

Proactive:

In fact, you raised €4 million in funding commitment. That was from the Wallonia region for your GF-1002 development. You've also had some equity funding, so you have managed to put the funds in place to take your programs forward?

Dr Eric Leire:

Yes, it's a vote of confidence in the company. Again, we could have decided to freeze everything due to uncertainty in biotech, but the results are so good that we made the decision to move on — also with the dog study. That study is important.

What I’d like to point out for investors is that yes, times are uncertain and we're moving forward. But we’re not moving forward blindly. The MASH program is a long-term investment due to the highly regulated nature of human clinical trials. In animal health, the regulatory burden is lower. So we’re doing a proof-of-concept study in dogs, and the timeline for a potential exit is much shorter.

We’ve initiated the study, which will take six months plus analysis. That means we could have a business development deal, licensing, or sale of the product within a year. It could also be a source of non-dilutive funding — similar to a grant — through an upfront payment.

We’re obviously not an animal health company. We don’t have that expertise. So it makes sense to demonstrate proof-of-concept and then partner or license. The study is being run by Syngene, a major CRO. It’s comparative, randomized, with multiple valid endpoints.

https://www.proactiveinvestors.com/companies/news/1070648/genflow-biosciences-moves-forward-on-mash-trial-icymi-1070648.html

I have no problem with Eric's fees, £215k down £15k on last year, and the 4 directors receiving only £27.5k each, down from £30k previous year.

No idea and very disappointing, especially that it wasn't a placing as such, but an equity investment by an Institutional Investor giving Genflow an extra £435 in the bank towards the Dog trial ( proof of concept ), although lack of transparency on who has bought 41m shares probably hasn't helped. Genflow is still very much under the radar but the recent news on the AI partnership resulted in an influx of buying volume along with the AI ramping brigade, who all appear to have sold out after their efforts to get the sp moving on the AI hype didn't go to plan and so their selling impacted on what was already a fragile sp, someone even sold 1m at 0.85p on Friday!!! Nevertheless, Genflow have bags of potential and great prospects going forward and so hopefully the performance in sp will improve soon enough and recover fair value at the very least. Gl.:-)

What I’d like to point out for investors is that yes, times are uncertain and we're moving forward. But we’re not moving forward blindly. The MASH program is a long-term investment due to the highly regulated nature of human clinical trials. In animal health, the regulatory burden is lower. So we’re doing a proof-of-concept study in dogs, and the timeline for a potential exit is much shorter.

We’ve initiated the study, which will take six months plus analysis. That means we could have a business development deal, licensing, or sale of the product within a year. It could also be a source of non-dilutive funding — similar to a grant — through an upfront payment.

We’re obviously not an animal health company. We don’t have that expertise. So it makes sense to demonstrate proof-of-concept and then partner or license. The study is being run by Syngene, a major CRO. It’s comparative, randomized, with multiple valid endpoints.

Proactive:

Eric, apart from the dog study, what else should investors be looking out for as 2025 progresses?

Dr Eric Leire:

There’s a very important piece of the puzzle: intellectual property. In biotech, patents are essential. Our patents on MASH and the SIRT6 gene are moving to the national phase. That means we've passed all initial steps and are now filing country by country.

We’ve just submitted the Japanese patent. Once patents are issued at the national level in multiple countries, it puts us in a different category as a company. We expect the company’s valuation to increase accordingly.

Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) outlined recent developments across its pipeline following the release of its 2024 results.

The company said it had made progress on multiple fronts, including its core MASH program, additional indications such as Werner syndrome and sarcopenia, and a newly initiated proof-of-concept study in dogs.

The company said it received positive feedback from the US Food and Drug Administration, which will allow it to initiate clinical trials in MASH patients rather than healthy volunteers.

Chief executive officer Dr Eric Leire told Proactive about it.

Proactive:

Eric, very good to speak with you. You're out with your 2024 results this week. It looks like you've made good progress across your research programs. Take us through some of the highlights.

Dr Eric Leire:

Yes, you're right. We've made some very good progress. We've mostly broadened our portfolio of programs. We are focusing on MASH and decided to also move on with different programs. As you know, the biotech index (XBI) is not doing great. As a biotech company, we have the choice — either to wait for the storm to pass and conserve our cash, or to move forward. Because in preclinical, we got some very encouraging and promising results on a centenarian Sirtuin 6 (SIRT6), we decided to move on. We're progressing not only with MASH, but also with Werner syndrome, sarcopenia with partners, and the dog study.

Proactive:

And in fact, you got some very positive feedback from the FDA on MASH, Eric. So what's the next step?

Dr Eric Leire:

The next step is to prepare for the clinical trial. The bulk of this preparation is about having a product manufactured under GMP (good manufacturing practice) conditions — exactly the same as the commercial product. It’s a long and costly process, and we're doing it with the help of a grant.

The good thing is, rather than starting with Phase 1 in healthy volunteers — which only establishes safety and not efficacy — we’ll be allowed to start directly with MASH patients. That’s very positive because demonstrating safety alone doesn't increase a company’s valuation significantly. A glass of water is safe, but it’s not valuable unless it does something. If it cures cancer, it becomes very valuable. So that’s where we are on MASH.

Proactive:

In fact, you raised €4 million in funding commitment. That was from the Wallonia region for your GF-1002 development. You've also had some equity funding, so you have managed to put the funds in place to take your programs forward?

Dr Eric Leire:

Yes, it's a vote of confidence in the company. Again, we could have decided to freeze everything due to uncertainty in biotech, but the results are so good that we made the decision to move on — also with the dog study. That study is important.

Outlook for 2025

Our key objectives for 2025 are:

· Continuing to identify suitable grant funding to support the Group's project pipeline.

· Undertake key Investigational New Drug (IND)-enabling development activities that will help define the pharmacological and toxicological properties of our lead drug candidate, GF-1002, and its potential benefits for MASH patients.

· Select site and QMS framework for clinical readiness, expected by the end of 2025 for the MASH program.

· Commence preliminary discussions with the European Medicines Agency (EMA) on Mechanism of Action (MoA) data for Orphan Drug Application (ODA) for our second compound GF-3001, targeting Werner Syndrome.

· Work with selected Contract Development and Manufacturing Organization (CDMO) for advancing the GMP manufacturing of the MASH clinical lot of lead drug candidate, GF-1002.

· Develop and implement project management, budgeting and governance for collaborative partners, in line with clinical and pre-clinal activities that will enable IND applications.

· Move key patent applications under the Patent Cooperation Treaty (PCT) to the national phase, while further expanding our development pipeline with new products and new indications.

· Complete and analyse results of our clinical trial in aged dogs with the objective of a licensing out agreement with an Animal Health pharmaceutical company.

· Initiate the development program for eye pathologies with an ophthalmology partner.

Funding

In October 2024, we received official confirmation from the Wallonia region of this continued support for our MASH project in the form of €4,026,525 in non-dilutive financial support, subject to the Company meeting certain conditions, which will continue to fund the ongoing development of Genflow's lead gene therapy for the treatment of MASH. The Wallonia region's financial support highlights the growing recognition of Genflow's innovative work in gene therapy.

The financial support comprises non-reimbursable research grants and a recoverable advance, repayable to the Wallonia region upon commercialisation. This funding, is expected to cover three years of Genflow's development program for GF-1002, with the first instalment being received as working capital and is receivable subject to Genflow meeting certain capital requirements.

Further strengthening the Company's financial position and increasing its institutional investor base, the Company completed a placing and subscription of £715,000 (before expenses) in April 2024. We were privileged to have Premier Miton, a well-known UK institution, participate in this fundraise.

The Company completed a further fund raise in March 2025 with a major institution for an equity investment totalling £434,083 (before expenses), in order to accelerate the Company's planned 2025 programs including launching a clinical trial in aged dogs.

2025

During 2025, the Company plans to continue advancing its existing research programs, along with embarking on an exciting clinical trial focused on aged dogs. In early 2025, we commenced a proof-of-concept clinical trial to evaluate the safety and efficacy of our proprietary SIRT6-centenarian gene therapy targeting age-related decline in dogs.

In addition to this, we will shortly launch a new development program in ophthalmology, focused on advancing a novel gene therapy which utilizes a specially designed non-viral vector engineered for precise delivery of Genflow's SIRT6 to the eye. The therapy is designed to combat ocular problems including several pathologies of the cornea and glaucoma.

Chairperson's Report

Dear Shareholders,

Introduction

I am pleased to present my statement as the Chairperson of Genflow Biosciences Plc (GENF) (the "Company").

The Company is a preclinical biotechnology company focused on the development of innovative biological interventions (namely gene therapies) which are aimed at tackling the effects of aging, potentially slowing or halting the aging process and so reducing the incidence of age-related diseases thereby increasing life span.

During 2024, the Company made significant progress with its two core research programmes, MASH (Metabolic Dysfunction-Associated Steatohepatitis) and Werner Syndrome, and was pleased to report that it has entered into further collaborations with world-class researchers and laboratories on two new research programmes.

Most notably, our MASH study is advancing into the pre-IND phase of preclinical development (a critical stage where companies discuss their product development with the FDA), and we have partnered with Exothera SA for GMP (good Manufacturing Practise) manufacturing of the clinical lot, utilising its state-of-the-art facilities in Belgium.

In June 2024, we received positive feedback from the FDA encouraging Genflow to proceed with its plans to identify appropriate animal models through pilot, proof-of-concept studies. This has emboldened us on our journey and provides encouragement that we may receive further positive feedback from the FDA once the Company has submitted a comprehensive briefing package conducted on our lead drug candidate, GF-1002, for the treatment of MASH.

An update on the status of each of our research projects has been detailed in the Strategic Report on page 5.

On 18 January 2024, we commenced two collaborations with world-class researchers and laboratories which allowed us to receive the support of two non-diluting and non-reimbursable research grants from the Government of Wallonia in Belgium, as follows;

· Sarcopenia research program with Revatis SA - focusing on the development of muscle progenitor cells loaded with Genflow's proprietary SIRT6, for the prevention and treatment of sarcopenia, the age-related loss of muscle mass and function.

· Exosome-mRNA project with EXO Biologics - which aims to deliver a therapeutic product composed of exosomes encapsulating an AAV or mRNA encoding SIRT6, designed to target MASH and Werner Syndrome.

During 2024, the Company has received grant funding totalling €777,281 in respect of 50% these projects, with the further 50% financial support committed in the first half of 2026, subject to spending over the working capital requirements. In 2024, other operating income totalling £320,471 has been recognised in the Consolidated Statement of Comprehensive Income in relation to these grants.

Funding

Lol, Good Evening mannan are you in??? Massive UPside potential with plenty of positive newsflow expected on multiple fronts in the coming days, weeks and months. A major re-rate is fast approaching, i reckon. Gl :-)

This is a very intricate landscape of gene expression and regulation.

At Genflow, we generate a lot of data through our preclinical program. Almost 700 mice—we did RNA sequencing, we did genomic, we did proteomic. When we don’t use AI, we understand maybe 10% of the message, and 90% of the patterns go unidentified. AI helps us to do that. It helps us identify mechanisms of action—which is very important in our relationship with the regulators. It allows us to fine-tune our approach in terms of interaction with other genes. It also helps us identify the patients most likely to respond.

You know that when you receive a drug, on average it might work at, say, 30% efficacy. That means nothing. As an individual, that’s just the average for a large population. In reality, there are people who don’t respond to a drug, and people who do. Now, most of the regulators want to see some biological tests—biomarkers—that allow us to identify the most likely responders, so people don’t get gene therapy if they’re not likely to respond. AI can play a major role in that. So it’s crucial—and it has the potential to unlock significant value for Genflow.

Proactive: So Eric it will be initially supporting your lead candidate. That's GF-1002. That's the SIRT-6 gene therapy targeting MASH (metabolic dysfunction-associated steatohepatitis). Take us through the first steps.

Dr Eric Leire: Yes. MASH is important because we have discussions with the regulators, and all this in-depth analysis of the preclinical results for MASH will be extremely useful in our discussions with the regulators—FDA and the European Agency.

But more importantly, it's a tool we need. And that's why we have this master service agreement. It's a partnership with Heureka. And the size of Genflow and the size of Heureka allow us to have this kind of partnership. It will be used for all the programs and the synergies between the programs, because the mechanism of action we discover through AI, through the liver program, can be used for the eye, can be used for the muscle.

That's why you see, for example, Sam Altman from OpenAI investing a major amount of money in biotech companies like Retro Biosciences. Retro Biosciences is the biotech company of Sam Altman, if you will. But it's not the only one. Every biotech in gene therapy should have an AI component. If you don't have that, you miss a critical tool to unlock value for your shareholders.

Proactive: Eric, I hope you'll keep us posted on progress with that program. Thank you very much for speaking with us today.

Genflow Biosciences PLC - AI boosts Genflow’s drug research capabilities -

CEO Dr Eric Leire talked with Proactive about the company’s new strategic partnership with US-based Heureka Labs, a spinoff of Duke University, to enhance its gene therapy research using AI technology.

Leire said, “Every biotech in gene therapy should have an AI component. If you don't have that, you miss a critical tool to unlock value for your shareholders.” He stressed the need for a multi-omics approach—genomic, transcriptomic, and proteomic—to better understand gene expression and drug response, which traditional analysis methods struggle to fully capture.

The partnership with Heureka Labs, which integrates deep AI and biological expertise, will initially support Genflow’s lead candidate, GF-1002, a SIRT-6 gene therapy targeting MASH (metabolic dysfunction-associated steatohepatitis). AI will help the company analyse complex preclinical data, including insights from nearly 700 mice tested, to understand mechanisms of action and identify likely responders, crucial in discussions with regulators such as the FDA and EMA.

Leire also emphasised that the collaboration is scalable across Genflow’s pipeline, helping unlock synergies between programs in liver, muscle, and eye diseases.

Proactive: Eric, very good to speak with you. You've announced a strategic partnership with Heureka Labs in the US to use their AI platform. Tell us more about Heureka Labs and what this collaboration will entail?

Proactive: Heureka Labs is a spinoff of Duke University. We have a long relationship with Duke University through Professor Dr Matthew Hirschey. What's very interesting in Heureka Labs is that they have really focused not only on AI, but on biology—to really understand biology. Now having AI is a collaboration between AI and biology. It's not an advantage for biotech, it's a necessity. So we are quite happy with this relationship with Heureka Labs—major players in AI and biology.

Proactive: So how will you use their AI technology to enhance your own research, Eric?

Dr Eric Leire: AI now has the potential to play a critical role in analyzing increasingly complex and large genomic data. If I come back to biology—not that long ago—we sequenced the genome. We understood the gene, the DNA. We thought we had all the solutions, that we understood all the biology. And then we realized it was more complex. You had to understand the entire sequence. It’s because DNA—a gene in itself—does nothing. It has to go on to code for protein. So you have to look at the DNA, then look at the mRNA, and then at the protein. That’s what we call a multi-omics approach: genomic, transcriptomic, proteomic. And the amount of data is huge.

In addition to that complexity, we now understand that it’s impossible to grasp the function of a gene in isolation. Gene expression is—or rather, it’s regulated—among all the genes. This is a very intricat

4m late reported buy!!! All bodes well. Gla ;-)

This should be back to 2p plus soon enough and then on to new highs as more positive news is delivered. Amazing upside potential from this bargain basement low. Gla holders...On and UP!!! :-)

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)

1,912 followers

5h

Check out Genflow Biosciences (LON:GENF) (OTCQB:GENFF) latest presentation! Learn about #GENF's impressive financials, recent milestones in its #SIRT6 studies, and exciting future plans.

See it here: https://loom.ly/RsxnFCE

#GENF #GENFF #Biotech #MASH #WernerSyndrome #Sarcopenia #Aging

Eric did say in his interview with Proactive Investor's after the announcement, the investment was bring in credible investors from outside the UK, including the US , and so perhaps the Institutional Investor is representing several investors who have participated , but all under the 3% reporting threshold, and so collectively no TR1 is required.??? Although, with another 41m shares in issue, the % holding of Genflow's existing major shareholders might require a TR1 or two . Hopefully we'll find out very soon. :-)

"The investment supporting the trial, although limited in size, is seen as a strategic vote of confidence, bringing in credible investors from outside the UK, including the US. Leire described the initiative as a major step that could generate near-term revenue and redefine the company’s biotech positioning."

We should have a TR1 very soon I reckon. Gl:-)

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following Admission the enlarged issued share capital of the Company will comprise 391,047,942 ordinary shares. For the avoidance of doubt, this excludes any intended equity participation by Eric Leire.

The Company does not hold any shares in treasury. The above figure may be used by Shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Tamara Joseph, Chair of the Company, commented "We are extremely pleased to have been approached by an institution who wishes to support Genflow in its journey in pioneering gene therapies to decelerate the aging process. The use of these proceeds will accelerate the Company's proposed studies and trials in aged dogs, an issue which has attracted a great deal of press coverage, including in recent weeks."

All bodes well and now expecting a TR1 this week confirming who has made the 10% equity investment for £435k cash in the bank for Genflow. Plenty more non-dilutive grant money expected this year from the €4m announced October 2024 and a further €700m from the remainder of the €1.5m announced April 2024. In Eric we trust and shouldn't be too long before this re-rates significantly. Gla holders...On and UP!!!:-)