Genflow Biosciences Share Discussion Threads

[moneymunch] 08/4/2024 07:55

Supply and demand, the majority of free float is now very tightly held for bigger and better things to come....On and UP!!! Gl :-)

[steg] 08/4/2024 07:27

Can’t buy in any quantity at all anyone else the same?

[moneymunch] 07/4/2024 22:06

Courtesy of Porter on Lse, an excellent and informative interview and very encouraging on prospects and potential going forward. Exciting times ahead. Gla :-)

US fast track trials

Interview with Zak Mir:



- US fast tracking Nash trials

- 100,000 patients on liver transplant list in US alone

- talk of further US institutions coming in

- delivering Nash treatment like a vaccination - think how much money was made on covid…

[moneymunch] 07/4/2024 18:32

Plenty to look forward to Northeast, but momentum was lost in September 2023 update confirming the Human Clinical Trials for Nash wouldn't be for at least 18 months ( 2025 ) with many pi's selling up looking for more immediate returns, but at least the trials will be carried out on Nash patients rather than healthy volunteers and I guess Genflow had to meet further criteria from the EMA associated with manufacturing/dosage and delivery etc, but as you say, Eric will want everything covered and every chance the patent could be approved and granted by then which will be massive news, and highly significant and of major interest to any potential partners. Exciting times and fully expect to see the share price heading UPwards from this new financial year, with plenty of money flooding back into the market and any cut in interest rates will be very well received. Gl :-)

[northeast14] 07/4/2024 17:06

Money,
Genflow has the mice trial results to show the FDA before publication! No one else has done anything like this. We are well ahead of the game as data is always needed. I’m not 100% sure why we aren’t going into Human trials this year. I guess like Eric has said from day 1 he wants to have everything covered and do it correctly. This patent will be a game change.

Not to mention we have the other two programs moving along nicely too. News can come on any front now

[moneymunch] 07/4/2024 16:19

You can't imagine Madrigal acquiring or partnering one of the big players and so Genflow could be on their radar, given the compelling potency and importance of Sirt6 in multiple disease targets and involvement and influence/activation over incretin-modulatiion, highlighted in the above article, and also includes GLP-1's currently in development as obesity therapies which are thought to have a high chance of being of medical benefit to Nash etc. Gla :-)


.........


These findings establish the involvement of SIRT6 in the inflammatory pathways of diabetic atherosclerotic lesions and suggest its possible positive modulation by incretin, the effect of which is associated with morphological and compositional characteristics of a potential stable plaque phenotype.

[moneymunch] 07/4/2024 16:09

MASH/NASH market predictions

Following FDA’s authorisation, “future therapies will now have to meet or outperform efficacy and safety data generated from resmetirom’s Phase III MAESTRO studies,” Sravani Meka, Senior Pharma Analyst at GlobalData explained.

“According to GlobalData estimates, the NASH/[metabolic dysfunction associated steatohepatitis] (MASH) market is anticipated to reach $25.7 billion in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan).

“With competitor assets projected to launch during the forecast period from 2024 to 2032, including but not limited to Novo Nordisk’s semaglutide, [Eli] Lily’s tirzepatide, and Viking’s (THR)-β agonist VK-2809, Rezdiffra’s approval gives Madrigal the opportunity to reap the benefits of the first-to-market therapy for patients with MASH with stages F2 to F3 fibrosis.

“Prior to the approval, a significant point of contention in the industry revolved around the potential requirement for a biopsy, which sparked concerns that the requirement of this procedure could restrict access to Rezdiffra”

“However, it remains to be seen how long Madrigal will be able to hold this lead as we see the entry of the incretin-modulating therapies into MASH during the forecast period. According to Madrigal, FDA has approved the prescription of Rezdiffra without the requirement of a liver biopsy for diagnosis.

“Prior to the approval, a significant point of contention in the industry revolved around the potential requirement for a biopsy, which sparked concerns that the requirement of this procedure could restrict access to Rezdiffra.”

Meka also suggested that an M&A deal in the NASH treatment landscape could be in the pipeline: “As Madrigal continues its journey in commercialising resmetirom, it would not be surprising if the company is also looking to position itself for an acquisition or partnership.”

[northeast14] 07/4/2024 10:02

It’s all beginning to point in a great direction yet again for us Steg. Really hope you get your extra cheap shares before it moves. Hopefully there will be a lot of new investors with ISA money this coming week. FDA meeting should be this quarter also. That could now be an even bigger meeting for Genflow. Hopefully it’s after the European meeting. Big Pharmaceutical will be keeping an even closer eye on us now

[steg] 06/4/2024 20:54

I can’t believe the market hasn’t woken up to this yet, well some have 😀 the potential here is mind blowing and all the signs are extremely positive, mind you the longer it takes the better I still have another couple of mil to accumulate at the current beyond belief bargain price, market cap 4m. I would suggest that any potential investor look at the market cap of the us company which has had the first ever approved Nash treatment, multi billion market cap and just raised 600 million dollars and the whole value of the company appears to be on one program and we have 3 with in human trials 2025 and going by the public information kindly posted by north east it’s a really key area with fast track approval from October which we already have from the European agency next stop fda. The European agency didn’t allow Genflow to go straight to human trials for no reason.We are bound to be of interest to major pharmas already as they are always watching companies developing projects but this should provide some laser focus and put a major spotlight on little old Genflow gla

[moneymunch] 06/4/2024 17:37

Great find Northeast and exciting news for Genflow. Gl :-)


First in human proof-of-concept Phase I/ II Trial in NASH

NASH or Non-Alcoholic Steatohepatitis is a liver disease with a significant unmet medical need. Effecting an estimated 35 million people worldwide, it is the most chronic liver condition in the West and patient numbers are growing rapidly. It is the leading cause of liver transplants due to the lack of approved therapies with the market for NASH therapy expected to reach $27.2B by 2029.

Recent pre-clinical programs have highlighted the adipogenic, anti-fibrotic, and anti-tumoral effects of GF-1002 positioning it as a promising treatment candidate for NASH.

By targeting NASH, Genflow Biosciences stands to benefit from a clear regulatory pathway that could lead to accelerated development and the potential for conditional fast-track approval.

[northeast14] 06/4/2024 08:18

The European Medicines Agency (EMA) said in a new reflection paper that it will consider granting conditional marketing approval to sponsors developing treatments for non-alcoholic steatohepatitis (NASH) based on the use of intermediate endpoints to address a high unmet need for these products.

The paper addresses non-cirrhotic NASH, fibrosis stage 2 and 3, and cirrhotic NASH (fibrosis stage 4).

EMA said the paper outlines a “preliminary” development strategy for these products, as their experience in this space is still evolving.

EMA said that NASH “is considered the progressive, necro-inflammatory phenotype of non-alcoholic fatty liver disease (NAFLD), which itself is the most prevalent chronic liver disease worldwide with an estimated prevalence in the Western world of around 25%, and it is estimated that about 20-50% of these suffer from NASH.”

Despite the prevalence of the disease, there are no approved treatments for NASH in the EU. In the US, the Food and Drug Administration (FDA) on 14 March approved Madrigal Pharmaceuticals Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis).

EMA said that “due to the unmet medical need in the field, a strategy to obtain an early, conditional approval (conditional marketing authorisation; CMA) of new compounds based on these intermediate endpoints could be considered.”

This strategy will only be acceptable if an unmet need is still present, a positive benefit-risk ratio can be concluded, and the applicant can provide comprehensive data post-marketing.

For non-cirrhotic NASH, fibrosis stage 2 and 3, acceptable intermediate endpoints would be:

The resolution of NASH – with the presence of any grade of steatosis, and no ballooning, only minimal (grade 1) lobular inflammation and no worsening of the stage of fibrosis.


The improvement of fibrosis by at least 1 stage without any worsening of NASH, and no worsening of ballooning and lobular inflammation, and no more than 1 grade increase in steatosis.

For cirrhotic NASH, fibrosis stage 4, or compensated cirrhosis, the reversal of cirrhosis can be considered an intermediate endpoint. “The endpoint would need to exclude the occurrence of any decompensation event, an increase in MELD [Model for End-Stage Liver Disease] as well as a deterioration (or re-occurrence) of features of NASH activity (inflammation, ballooning, and fat) at the same time (Improvement of cirrhosis by at least one fibrosis grade without occurrence of a decompensation event and without deterioration of MELD and NAS-score).


The paper will go into effect on 1 October 2024.

[cyberbub] 04/4/2024 14:23

This is slightly disappointing, as we'd been led to believe that the company was fully funded for 2 years. To be honest I thought they might need a top up at some point, but thought it would be at a higher price later in the year, to minimise dilution. Still it seems that they've tried to keep the amount raised as small as possible at these levels. Let's hope any further raises are at significantly higher prices following news, by which I mean double figures!! :-)

[moneymunch] 04/4/2024 11:46

It's all good, and now look forward to a run of positive newsflow. Gla :-)

[northeast14] 04/4/2024 06:49

I want to know how much Premier Milton bought. Could be 1 share for all we know

[babbler] 04/4/2024 06:38

Placing done. 1.25p with 2p warrants. Onwards....

[moneymunch] 03/4/2024 12:06

Yep, an absolute steel at current share price and Genflow are still set for a great year ahead imho Gla holders:-)

[andymunchkin] 03/4/2024 10:23

dUmp phAse

[moneymunch] 02/4/2024 07:01

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

1,558 followers
7h

The first #NASH treatment is FDA approved! Despite its growing rates, the disease went largely understudied for decades - until now. Genflow Biosciences (LON:GENF) (OTCQB:GENFF) and its peers are developing life saving medicine to change the lives of millions.

Read more:

[steg] 28/3/2024 17:49

Don’t think the game plan is to take it private but you are right about the uk market, watch this space for action stateside, think the next 3 to 6 months will shape the future for us, the USA would value us more favourably but we are close to invisible for the time being. If we get a big US inst in that would pave the way, I do think because of all the excitement around Nash we will start to get traction especially if the 2025 Nash trials are in the USA, big news could come at any time. Easier said than done but patience is key, watch this space as the story starts to unfold

[cyberbub] 28/3/2024 17:23

Er ...just checked the shareholder register again, which has now been updated for Jonathan Swann so must be up to date... and Jarvis Nominees, who were shown as a 13% holding on 19th March, has vanished?? Are they the big seller?

[cyberbub] 28/3/2024 17:04

Hopefully :-)My main worry here is whether the large holders might despair at the pathetic valuation on the AIM cesspit, and decide to take the company private as a concert party. We need to see Mr Market start to give it a proper valuation, to avoid this. Hopefully this will happen once the big seller is out soon...

[moneymunch] 28/3/2024 15:38

Hopefully great timing cyberbub. Gl :-)

[cyberbub] 28/3/2024 13:49

I have bought in. I have no objection to insti money coming in, it will give confidence and help to reduce the large holders' influence as well. However it will have to be at much higher prices than 1.5p, I trust the management are clear on that!