The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
The last time the sp was at this low was 6 months ago, a Company Update was released followed by the Final Results which saw the stellar rise in sp from sub 2p to 5p plus, and so let's see what happens on the release of the Half Year Results expected end of this month, which no doubt will have substantial detail on proceedings, including the status of the planned Werner Syndrome, accelerated clinical trials and maybe a further UPdate on the two non-dilutive research grants mentioned by Eric in his interview, which will see Genflow fully cashed for 80% of their R&D well into 2026. Gla Holders. Gla Holders...Fill ya Boots at this rockbottom bargain low.....this will bounce big in the coming days imho.....On and eventually UP!!! ;-)
Today's Rns was probably released because of Eric's disclosure in his interview with Proactive Investors on Monday, and looks like a bit of tree shake before the release of the Half Year Results expected end of next week, which will mo doubt have substantial detail on progress made, with every chance of confirmation of the two non-dilutive research grants mentioned by Eric in his interview, also news on the status of the planned accelerated Werner Syndrome clinical trials and maybe news on patents etc...News of a Major investor and or JV partner could also be in the pipeline...Genflow's current low offers tremendous near term upside...On and UP!!! :-)
Eric confirmed in his recent interview Genflow are in negotiation for two non-dilutive research grants which would provide funds for 80% of R & D for an additional 3 years, fully cashed well into 2026, and so confrmation news in the pipeline along with an update on their Werner Syndrome accelerated clinical plans. Gla Holders.....a Major investor or JV partner could pop UP at anytime. ;-)
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The Company is headquartered in London and has a Belgian R&D subsidiary, Genflow Biosciences SRL (“Genflow BE”) that was established in 2020. Genflow BE’s location enables it to benefit from the relatively low operating costs and from substantial (non diluting) grants that support its research and development that are available from Belgium’s Wallonia region.
In addition to pre-clinical activities, Genflow seeks an earlier path to revenue with respect to Werner Syndrome, a rare progressive disorder characterised by the appearance of unusually accelerated ageing.
Genflow intends to conduct a European Phase I/II clinical trial with Werner Syndrome patients. The Company believes that positive clinical data will be the source of significant value creation through, potential acquisition or licensing arrangements. Moreover, a trial in Werner Syndrome will support the path to a specific aging indication.
RNS Number : 9615M
Genflow Biosciences PLC
20 September 2023
20 September 2023
Genflow Biosciences Plc
("Genflow" or "the Company")
Successful first regulatory interaction with the Federal Agency for Medicines and Health Products (FAHMP)
And
Internal Debt Restructuring
First regulatory agency interaction results in recommendation to commence Phase I/II Clinical Trial in NASH Patients
The Company (LSE:GNF) (OTCQB:GENFF), today announces the receipt of written comments from the Federal Agency for Medicines and Health Products (FAHMP) of Belgium. The Company is pleased with the advice received from the FAHMP to commence clinical trials of its drug, GF-1002, with patients suffering from NASH [*] (rather than in healthy volunteers). This follows promising results from the Company's research in in-vitro human cells and in-vivo rodent studies.
The Company's NASH clinical trials are scheduled to begin in approximately 18 months following dialogue and subsequent agreement with the European Medicine Agency.
Eric Leire, CEO of Genflow, commented; "We are thrilled that the FAHMP has recommended Genflow to commence Phase I/II clinical trials in NASH patients rather than with healthy volunteers. We hope that this will provide a first signal of efficacy in humans more speedily. We will continue to seek guidance and recommendations from the FAHMP to develop an appropriate program in conducting our proposed clinical trial in humans.
We are hopeful that these trials will showcase the ability of longevity gene-therapy assisting patients with life-limiting illnesses.
The current financial outlook for the Company remains positive as it is in a secure financial position. Genflow Biosciences has sufficient cash reserves until March 2025 and continues to seek further non-dilutive funding in the form of research grants."
Internal Debt Restructuring
In order to comply with the updated requirements of the existing grant from the Wallonia region, and to be eligible for future grant funding, Genflow recently undertook an internal debt re-organization.
This was completed by means of the benefit of the receipt of the existing loans between the Company and its ultimate subsidiary entity, Genflow Biosciences SRL ("Genflow BE"), being assigned to Genflow Biosciences, Inc ("Genflow US"), the Company's immediate subsidiary. This was then followed by a capital restructure within Genflow BE, resulting in an increase to this entity's net assets within the parameters and requirements of the possible grant providers. The overall debt position within the Group, therefore, remains unchanged.
Whilst this does not provide any assurances relating to the granting of non-dilutive funding in the Company's favor, it allows the Company to be considered for the same.
Full transcript from Eric's interview. Gla :-)
https://www.proactiveinvestors.com/companies/news/1026930/genflow-biosciences-ceo-reveals-the-secrets-of-longevity-an-exclusive-interview-with-dr-eric-leire-1026930.html?rel=scroll
Genflow is somewhat under the radar, and small cap Bio's along with many Aim listed stocks mostly require official Rns confirmation these days to get the sp moving, positive material news and funding, without dilution should do the trick, and usually best to get in on the low before any potential news that could add value is delivered imho. Gl :-)
A great interview with Eric, who confirms drtsils of Genflow's recent meeting with the European Health Agency will be announced soon and intimated that they have their full support along with the FDA. Also confirmed was their current 18 month cash runway but Eric stated they're in negotiations for two additional Funding Grants that would cover 80% of their R&D for an additional 3 years, fully cashed up until 2026. Very exciting stuff and looking forward to the Update/results. Gla :-)
Nice one Troajan. :-)
A very exciting period ahead as we eagerly await the next UPdate/results on progress made, and given Sirt6 is believed to be fundamental and the most potent and important gene for longevity, healthspan and multiple disease targets, every chance of a Major investor and or JV partner wanting in early, which would be truly transformational for all concerned. Gla holders. :-)
The next Longevity Investors Conference will be held in Gstaad on September 27-29 2023
About Longevity Investors Conference (LIC)
The Longevity Investors Conference is bringing together the world's leading longevity key opinion leaders and scientists, institutional and private investors, wealthy private individuals, family offices, and investment funds. The main aim of the event is to discuss the latest trends and opportunities but also to provide relevant insights into the longevity and rejuvenation industry. As an investors-only conference, the event is fully focused on investors.
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/fourth-longevity-investors-conference-held-130000286.html
Last chance to get in at this current lowly low, UPdate/ Results excepted this month which will add significant value imho!!! Gla holders...On and UP!!! :-)
Ps...or cumulatively across multiple stocks, these tiny trades , presumably generated by some sort AI trading bot, could be returning decent profit with little risk??? Still a pain in the rear, and should be banned!!!
No idea, but the sp will rise sharply on decent buying volume and I assume the tiny trades are generated by some sort of Trading Bot, a pain in the backside as far as I'm concerned, but I've witnessed these tiny trades on other stocks recently, and maybe some sort of trial before whoever is behind them, decides to increase the value from tiny to worthwhile????
Something similar for Genflow, highly likely. Gla :-)
Rejuveron lands $75m to advance healthy aging portfolio; expands focus in Middle East
2 HOURS AGO
Longevity biotech opens strategic Abu Dhabi office as Mubadala Capital joins Series B investment round.
Longevity biotech company Rejuveron Life Sciences has successfully closed a dual-tranche Series B equity and convertible loan financing round, raising a total of $75 million.
The funding was co-led by Catalio Capital Management and Apeiron Investment Group, the family office and private investment firm of entrepreneur Christian Angermayer.
The round was also joined by new investor Mubadala Capital, a subsidiary of Mubadala Investment Company, the $280 billion sovereign investor group headquartered in Abu Dhabi, UAE.
htTps://longevity.technology/news/rejuveron-lands-75m-to-advance-healthy-aging-portfolio-expands-focus-in-middle-east/amp/
A compelling watch. Gla :-)
WHAT TOP Scientists Say About SIRT6: The KEY to LONGEVITY??
9.9K views · 2 months ago
htTps://youtu.be/3F6l2ZZIgJo?si=m8-yf7g1gNYbn_6G
Exciting times ahead on several fronts, and the FDA has recently given approval for another longevity clinical trial for dogs, and so all bodes well for Genflow. Gl :-)
New tricks: Loyal’s companion dog longevity study receives FDA protocol concurrence.
Loyal, a clinical-stage veterinary medicine company developing drugs intended to extend the healthspan and lifespan of dogs, has announced it has received protocol concurrence from the FDA for its companion dog longevity study.
Longevity.Technology: Loyal is on a mission is to help dogs everywhere live longer, healthier lives – and that means taking on the development of the first FDA-approved drugs explicitly intended to extend lifespan and healthspan. On the path to FDA approval, Loyal must run a clinical trial that objectively and robustly demonstrates that its drug extends dogs’ healthy lifespan – and does so safely. However, no-one has developed a dog – or human – longevity drug before, so Loyal is building the path to FDA approval largely from scratch.
Today, Loyal has announced that last week it learned from the FDA that the company has received protocol concurrence for its companion dog longevity study. This is good news for the longevity biotech sector, especially welcome as it comes on the same day that tech lender Silicon Valley Bank collapsed and was put under the control of the US Federal Deposit Insurance Corporation – news that left biotechs and VCs reeling.
Loyal’s protocol concurrence means the FDA has reviewed the scientific design of its study and determined that it meets their high quality standards, and will validate whether Loyal’s drug does indeed extend canine lifespan and healthspan.
In a nutshell, this means that if Loyal’s study demonstrates that its dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the US.
“Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…” – FDA Center for Veterinary Medicine
https://longevity.technology/news/first-longevity-clinical-study-design-fetches-fda-approval/amp/
Wow!!! A great find Poerter, a mega multi-bag in a blink. Gl :-)
First in human proof-of-concept Phase I/ II Trial in Werner Syndrome
Genflow Biosciences is on the fast track to become a top performing biotechnology longevity powerhouse. An aggressive clinical development plan is underway. A team of seasoned industry leaders leads with confidence knowing there is short-term milestone potential.
Leveraging major unmet needs within communities affected by issues related to ageing is a key factor for aligning with Genflow Biosciences.
First in human proof-of-concept phase I/II trial in Non-Alcoholic Steato Hepatitis (NASH) and Werner Syndrome in patients that will be conducted in Sardinia. We will apply to Orphan drug designation for this indication. Werner syndrome is a heritable human premature ageing disease. As a classical premature ageing disease, etiological exploration of WS can shed light on the mechanisms of normal human ageing and facilitate the development of interventional strategies to improve health span.
First in human proof-of-concept Phase I/ II Trial in NASH
NASH is a liver disease that affect an estimated 35 million people globally with an increasing prevalence. NASH is becoming one of the leading causes of chronic liver disease and liver transplant and remains a significant unmet medical need with no approved therapies. The adipogenesis, anti-fibrotic and anti-tumoral effects discovered in our recent pre-clinical program make GF-1002 a promising candidate for the treatment of NASH. The choice of NASH as potential indication for GF-1002 allows Genflow to benefit of clear regulatory accelerated development pathway and a potential conditional fast track approval.
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Lots of potential positive material newsflow in the pipeline to add significant value, expected soon. Gla :-)
The potential to extend healthy lifespan with groundbreaking science
The SIRT6 gene is recognized as a master regulator of healthy ageing. SIRT6 overexpression has been shown to lead to a healthy lifespan extension in both male and female mice. Genflow Biosciences intends to promote healthy ageing by providing extra copies of a variant of the Human SIRT6 gene found in centenarians. Genflow Biosciences is developing an ethical, safe and efficient gene delivery system to deliver this centenarian variant of SIRT6 gene.
THE PRODUCTS PIPELINE
Our Lead Compound GF-1002
A 120-minute infusion of AAV vectors allows a safe transient episomal expression of extra copies of a centenarian variant of the SIRT6 gene without integration into the DNA, without risk of self-replication, without transfer of bacterial genetic material, without immunogenic or mutagenesis concerns.
Pre Clinical Stage GF-1002
GF-1002 is a suspension of an AAV vector-based gene therapy for intravenous infusion and intends to improve DNA maintenance by delivering extra copies of the Centenarian Variant. The AAV gene therapy works by modifying (or ‘recombining’) a natural AAV to produce a safe and efficient vector to deliver a transgene into cells. The transgene is the ’gene of interest’ (“GOI”) to be provided to the cells. In the case of GF-1002, the GOI is the coding sequence of the Centenarian Variant.
Pre Clinical Stage GF-4001
GF-4001 is a non-Human version of GF-1002 anti-ageing gene therapy developed for veterinary use (dogs).
Pre Clinical Stage GF-3001
GF-3001 is an formulation of andeno-associated viral vector-based gene therapy. It is a recombinant AAV with fibroblast tropism containing a transgene encoding the cDNA portion of a variant of the human SIRT6 gene found in centenarians for delivery to the dermal fibroblast.
‘Elixir of life’ on the horizon thanks to longevity gene in naked mole rats
SEPTEMBER 6 2023
ROCHESTER, N.Y. — The naked mole rat is bringing modern medicine one step closer to creating the “elixir of life.” Researchers have successfully transferred a longevity gene from the species into a mouse. This groundbreaking procedure has potential implications for promoting longer, healthier lives in humans.
The naked mole rat, despite its less-than-appealing appearance, boasts a remarkable lifespan and a significant resistance to age-related diseases. Researchers from the University of Rochester in New York are optimistic about the insights this provides into the mysteries of aging and potential lifespan extension for society.
For context, naked mole rats are mouse-sized rodents that live up to 41 years, nearly 10 times the lifespan of rodents of comparable size. Distinctly, they show little to no signs of neurodegeneration, cardiovascular disease, arthritis, or cancer as they age. In this research, a gene from the mole rat was introduced into mice, leading to enhanced health and increased longevity in the mice.
“Our study provides a proof of principle that unique longevity mechanisms that evolved in long-lived mammalian species can be exported to improve the lifespans of other mammals,” says Vera Gorbunova, the Doris Johns Cherry Professor of biology and medicine at Rochester, in a university release.