Genflow Biosciences Share Discussion Threads

[moneymunch] 28/3/2024 13:12

Cheers steg, we know Eric is very keen to get institutional investors on board, and so hopefully all in the pipeline along with more positive news on proceedings. The current rockbottom low will soon be a distant memory with any luck, and I had a few first thing this morning in anticipation. Gl :-)

[steg] 28/3/2024 12:56

Great research money paves the way for institutional investment, I would say game on 👍

[moneymunch] 28/3/2024 12:48

Genflow and exosome-focused biotech EXO Biologics are embarking on a three-year scientific program focusing on mRNA delivery. Supported by a grant of €1.55 million, the initiative will explore an approach using exosomes to encapsulate and transport Genflow’s SIRT6 gene therapy.

[moneymunch] 28/3/2024 12:38

27-MAR-2024

Liver fibrosis, non-parenchymal cells, and the promise of exosome therapy

Peer-Reviewed Publication

FIRST HOSPITAL OF JILIN UNIVERSITY

[moneymunch] 28/3/2024 12:32

Healthy Returns: The first drug for a common, deadly liver disease is here – and more are coming

PUBLISHED TUE, MAR 19 2024



In a landmark decision on Thursday, the Food and Drug Administration approved Madrigal Pharmaceuticals' drug "Rezdiffra," to be used along with diet and exercise. The company expects the medicine to be available next month with a hefty price tag of $47,400 per year before insurance and other rebates.

The agency's approval is also a big deal because it means Madrigal has succeeded in an area where several other drugmakers have failed – or are still trying to crack.

That gives Madrigal an edge in a market that could be huge: The MASH industry could be worth nearly $26 billion by 2032 across the U.S., France, Germany, Italy, Spain, the U.K. and Japan, according to an estimate from data analytics firm GlobalData.

Madrigal's drug is setting the bar for efficacy and safety for MASH treatment, while also opening the door for medicines still in development.

There's one important detail in the approval that could bode well for the entire MASH space: The FDA isn't requiring patients to get a liver biopsy to determine their eligibility for Madrigal's drug.

That refers to a procedure in which a doctor removes a small piece of liver tissue from a patient so they can examine it under a microscope for signs of damage or disease.

"The absence of liver biopsy requirement in Rezdiffra's label should buoy biotech stocks" of companies developing MASH treatments and "potentially accelerate and broaden patient access," William Blair analyst Andy Hsieh wrote in a note on Friday.

[steg] 28/3/2024 12:06

Classic transferring of weak share holders to the better informed going on, not convinced we will see these lows again, 2024 will provide big news in the UK and I suspect in the US followed by NASH in human trials in 2025, as they say you got to be in it to win it. Latest tr1 is just the start and the free float is getting tighter gla

[moneymunch] 28/3/2024 11:11

March 2024 Company Presentation

[northeast14] 27/3/2024 16:43

Not that I’m aware of

[cyberbub] 27/3/2024 12:15

Is rezdiffra a SIRT6 drug also?

[northeast14] 25/3/2024 17:53

Steg,
Fantastic post, my valuation of genflow has gone up. If our trials go as well as I think Eric believes we will be sailing into the pounds.

[bri15] 24/3/2024 10:35

This and Geni are both worth investing in,both massively undervalued,both funded for foreseeable future,and both waiting on share price changing news.

[moneymunch] 24/3/2024 08:20

Cheers Steg and ditto, my thoughts exactly. Gl ;-)

"Besides the launch effort, the money could be used for everything from R&D to potential acquisitions or licensing deals"

[steg] 23/3/2024 22:19

Great posts and find Money. I think this drug has a positive effect on 2 stages of the disease where Genflow have early positive indication on 4 stages with trials involving around 36 patients in human trial scheduled for 2025. Most interesting is the market cap of Madrigal at a cool $5 billion. It’s not without the realms of possibility that the company may try and take out any other companies that could potentially both jeopardise the millions invested and the billions in future projected revenues and also to ensure they dominate the NASH space. If it was my business I would have Genflow as both a risk and opportunity. Very very interesting, I had a target of 300 million valuation for Genflow £1 a share but this would suggest if we are successful this would completely undervalue the company, a long way to go yet and patience is key but for sure at a 4 million market cap we are ludicrously undervalued. Our latest major shareholder announced this week may I suspect have similar ideas on the future potential.

[moneymunch] 23/3/2024 15:17

The numbers are huge, maybe little old Genflow would be a nice addition to Madrigal's R&D!!?? Gla :-)


PHARMA

After monumental MASH nod, Madrigal plots $600M stock sale to support Rezdiffra launch

Mar 19, 2024


Just a few days ago, Madrigal Pharmaceuticals made history by winning FDA approval for its metabolic dysfunction-associated steatohepatitis (MASH) med Rezdiffra. Now that the launch is in sight, the company aims to raise hundreds of millions of dollars to help fuel its commercialization efforts.

The drugmaker is pricing 750,000 shares of its common stock at $260 apiece, plus it's selling pre-funded warrants to buy around 1.56 million shares for roughly the same price.



In all, Madrigal expects to raise some $600 million to support the launch of its recently approved MASH therapy Rezdiffra, which on Friday scored the first FDA nod for the disease.

The offering was upsized by $100 million after Madrigal originally proposed a $500 million offering on Monday.

Besides the launch effort, the money could be used for everything from R&D to potential acquisitions or licensing deals, the company said in a recent press release. The offering is expected to close March 21.

Madrigal is gearing up to launch the groundbreaking med during the second quarter of this year, the drugmaker said in a recent filing.

Rezdiffra is the first therapy cleared to treat MASH, also known as nonalcoholic steatohepatitis (NASH). Specifically, the drug’s label (PDF) covers MASH patients with moderate to severe liver fibrosis consistent with stages F2 and F3 of the disease.

MASH is estimated to impact some 5% of adults in the U.S., but it has been a notoriously tough field to break into. Intercept Pharmaceuticals appeared closest to an FDA approval before Madrigal, but the company was forced to change course after a second rejection for its treatment candidate last year.

Other biopharma players including Pfizer, Bristol Myers Squibb and Genfit have all tried to get into the NASH field as well. Madrigal’s offering, meanwhile, was the first to meet the goals of both MASH resolution and fibrosis improvement in a phase 3 study.

The company is pricing Rezdiffra at a wholesale acquisition cost of $47,400 before discounts. Analysts at Evercore ISI have previously pegged peak global sales at $5.5 billion, and the analyst team expects the drug to generate about $2.6 billion in 2030.

Crucially, the FDA’s approval comes without the requirement of a liver biopsy to determine patient eligibility. That was a major point of contention among investors ahead of the approval, as the invasive procedure would have constrained wide access to the med.

[moneymunch] 23/3/2024 13:42

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

1,546 followers
3d

Genflow Biosciences (LON:GENF) (OTCQB:GENFF) is glad to see the mounting interest in Nonalcoholic Steatohepatitis (NASH). The field was notably understudied until recently, when Genflow Biosciences and fellow pioneers began developing promising new treatments revolving around #SIRT6.

Our CEO, Dr Eric Leire, points to a recent EMBO Press report as an example of the growing attention, which also lends support to our research in #NASH.

Read the report here:

[moneymunch] 23/3/2024 13:22

FDA approves Madrigal’s Rezdiffra as first drug for fatty liver disease NASH

Over six million people in the US are affected by NASH with moderate-to-advanced liver scarring

19th March 2024


The US Food and Drug Administration (FDA) has approved Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) to treat adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis, alongside diet and exercise.

Based on results from the MAESTRO-NASH trial, the accelerated approval marks Rezdiffra as the first treatment option available to address notable liver scarring and liver damage.

[northeast14] 21/3/2024 07:17

What a morning! Huge news! Congratulations to all holding! And then the TR1 to top it all off!! Boom time

[moneymunch] 21/3/2024 07:09

TR1 - Major Holdings Notification

Name

Jonathan Mark Swann

City of registered office (if applicable)

rickmansworth

Country of registered office (if applicable)

United Kingdom

[moneymunch] 21/3/2024 07:01

RNS Number : 6661H
Genflow Biosciences PLC
21 March 2024




21 March 2024



Genflow Biosciences Plc

Announces Publication of a Key European Patent in Partnership with University of Rochester, New York, et al.



Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"), an emerging leader in the field of longevity research, focused on developing therapeutic solutions for the prevention of age-related diseases, is pleased to announce a significant milestone in its journey. Genflow's collaborative partners, including the University of Rochester, The Trustees of Columbia University in the City of New York, and Albert Einstein College of Medicine, have received confirmation that their European patent application was published today by the European Patent Office, bearing the reference number EP 4 338 267.



Innovation in Age-Related Disease Prevention and Treatment



The patent, titled "Variants of SIRT6 for Use in Preventing and/or Treating Age-Related Diseases," enhances the understanding and potential treatment of diseases associated with aging by focusing on the SIRT6 gene/protein, known for its critical role in DNA repair, metabolism, and longevity.



SIRT6 regulates DNA damage repair, specifically double strand breaks (DSB) and prevents or delays aging of cells. Genflow's lead drug candidate, GF-1002, delivers a centenarian variant of the SIRT6 gene. Genflow is currently undertaking key Investigational New Drug (IND)-enabling development activities that will help define the pharmacological and toxicological properties of GF-1002 and its potential benefits, initially, for non-alcoholic steatohepatitis (NASH) patients.



In 2023, the Company received positive feedback from the Federal Agency for Medicines and Health Products in Belgium and expects a follow-up meeting in Q2 2024 to finalise design of Phase/II clinical trials. NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD) characterized by excessive fat deposits in the liver, is usually a silent disease with few, if any, symptoms, and effective treatments.



Dr. Eric Leire, CEO of Genflow commented: "This approval from the European Patent Office highlights the innovative spirit of our collaborative team and we are incredibly proud to be part of this pioneering research alongside such respected institutions." He continued, "This patent represents a leap forward in our understanding and capabilities in treating age-related conditions and marks a significant step forward in our mission to develop effective therapies for NASH and other age-related diseases."

[northeast14] 20/3/2024 18:38

There hasn’t been an updated share register in over a year. Rumour is we will see a TR1 tomorrow as someone has gone above 3%. I was working out rough calculations off what I know people hold and I don’t actually think there’s a bit free float. Definitely been a few people buying up all these sells

[cyberbub] 19/3/2024 23:56

Don't worry, found it via a web search - doesn't seem easy to find on their site.So about 60% held by insiders, and a further 13% by Jarvis... Such a large Jarvis holding, with no other nominees showing up, must surely mean that represents a group of large-ish investors with perhaps 1-2% each?A low float can be positive if there's any good news pops up... But it also means that minority shareholders/PIs have little influence if the directors try tricks like taking the company private...

[cyberbub] 19/3/2024 23:33

Anyone know who the big shareholders are, apart from Eric? I couldn't find AIM Rule 26 info on their website. Thx

[moneymunch] 09/3/2024 09:52

Eric's presentation. Gla ;-)


Genflow Biosciences Plc (OTCQB: GENFF | LSE: GENF): Virtual Investor Conferences

[moneymunch] 01/3/2024 22:08

Hats off !!! :-)))