Member Info for Saxondale

Here you go mate
https://www.faron.com/sites/default/files/2022-06/Faron%20Corporate%20deck%20June%2016%202022%20ver2.pdf

Warning - science gobbledygook below that may be miles off target .

Still no mention from Faron as to what this patent published 6 months ago alludes to .
https://patents.justia.com/patent/20210371865
The invention relates to use of TLR9 antagonist in a method for treating cancer and/or chronic infection by downregulating Clever-1 expression on alternatively activated immunosuppressive macrophages.
*TLR9 agonist was found to reduce rapidly Clever-1 expression.
*TLR9 agonists can be used as Clever-1 inhibitors in the treatment of cancers and/or chronic infections in an individual.

New article published last month regarding Toll Like Receptors , and targeting them .
https://www.sciencedirect.com/science/article/pii/S2590098622000033
Their conclusion -
TLRs are aberrantly expressed in various human cancer cells, including colorectal cancer [25], gastric cancer [26], breast cancer [27], pancreatic cancer [28] and melanoma [29
TLR-based therapy serves as a dual regulatory effect in cancer immunotherapy. TLR activation on tumor cells not only promotes the differentiation of MDSCs and Treg, induces the secretion of immunosuppressive factors, but also enhances tumor invasion and metastasis.

However , its a complicated subject - with many types of TLRs

TLR9 can work both ways -
On the one hand, the activation of immune cells producing anti-tumor effects via TLR9 agonist stimuli, such as CpG can induce strong antitumor immunity by triggering T cell priming and tumor infiltration of CD8+ T cells.
But overly expressed TLR9 may lead to a number of unfavorable effects, increasing tumor cell proliferation and migration

It's a cutting edge science at the moment , and you get the impression that at this level , the patients own make up is key to which treatment will suit them best , as everybody is different .

The patent says
Especially, it has been observed that TLR9 agonist comprising CpG ODN downregulates Clever-1 expression on alternatively activated immunosuppressive macrophages.

The recent article talkes of 4 generations of TL9a's , each getting more efficient and less toxic .
The first generation of natural CpG ODN is easily degraded by nucleases ( is this the one Faron used ? )
latest generation use synthetic nanoparticle technology -
In clinical studies, a synthetic CpG oligonucleotide (SD-101) was approved by FDA for a phase I clinical trial of pancreatic cancer .

Starting to get a bit complicated - and well beyond my understanding .
But perhaps this connection Faron have made - will allow them to make further discoveries about Clever-1 .

https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-to-acquire-forty-seven-for-49-billion

That's an interesting case study .
Looks to have been snapped up at a very early stage - P1b trial ongoing when they were bought , with approx 400 patients having been treated in various cohorts .
It does seem like they had some cracking data in one area that led to fast track approval through FDA and orphan status for AML . In their trial of 46 patients , 92% responded with 50% having a complete response .
SP had been as low as $7 . Then up to about $40 on the good data , then $95 for the sale .
Looks like they hit the jackpot in data early on - that led to Gilead jumping on them .
I think Faron differs in the way that Matins was investigating such a wide range of cancers , to narrow down the best targets and also gather data on biomarkers etc .
What they know now puts them in a much better place going into P3 trials - the ORR should be much higher if they can target low IFN gamma patients for example .
At PI stage with Bex , I don't think the picture was clear enough to warrant any company making a silly high bid for it .
Looking at FortySevens position before they got sold - they reported that they had $329 m in cash , and were financed for the next year or so to proceed on their own . Then a month later they got sold .
So they had a bit more cash in the bank than Faron - not sure how that arose , but they obviously got an offer good enough to sell .

Interesting that in March 2020 , the time when this deal was done , our SP jumped from £2.60 to over £5.00

I wonder if that was down to speculation that we ( being a similar company ) , were going to get a similar style bid .
We didn't really get any massive news that month to double our SP .
Might explain the rise ?

Upshot is - whatever we may have been worth back in 2020 , we should be worth a whole lot more now .

Farons June presentation had these two examples in it -
Significant licensing and M&A activity in the macrophage field recently
Pre-clinical/early clinical deals (TREM2, LILRB2) ranging from $100 – 200
million up-fronts and billion-dollar milestones
With Phase II data Gilead acquired FortySeven Inc for $5 billion and
Pfizer Trillium for $2 billion, both targeting CD47

But do you sell Bex outright in the next year to one company , or work a deal with someone to keep ownership , but start licensing out Bex to multiple companies for their particular field of treatment ( in order to fund further studies and build up bigger value - Bexcombo PD1/PDL1 - a successful data set there is worth billions on its own ) .
By selling Bex soon , Faron may miss the added potential .

Another example is Redx - they had a deal with upfront payment then milestone payments . Current SP today is 10 x what is was the month before the deal was announced .

To progress into next year at this accelerated pace - one thing is clear - it needs big financing .

Faron tell us they have a plan . A couple of months and we'll get to hear about it .

While the tumbleweed is blowing , two minor tweaks to the Matins Bex trial .
They just updated the intervention headings , replacing FP1305 with Bexmarilimab as the main name of the drug .
This was done partly in June , and also today .
Just wording , but someone at least is tinkering to make sure everything is just right .
The Bexmab trial had a minor update in July too , just adding detail to the secondary trial outcomes regarding disease progression definition .

One would like to think this is just somebody making sure all the I's are dotted and T's crossed before inking a nice multi billion dollar deal .

It's probably not.

Looking on another share today where some interesting new trademarks have been registered , I thought I'd have a look at what Faron have .
I'm assuming that back in 2018 when they thought Traumakine was going to market , they registered it as a trademark . It's still live
They also registered Faron as a service trademark ( also live )
Clevegen is also registered as a trademark name ( in 2016 )
https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4805:4grl84.2.1
No sign of Bex being registered . Not sure if Clevegen will be used for that given that its the same thing ?

One new trademark that appeared last month was Haematokine . It was filed last year , but now getting close to being registered . ( published June 7 2022 - for opposition , i.e lets anyone object ) .
Rather large description of its nature covering all bases by the looks of it - including this blurb -
pharmaceutical preparations for the treatment of hematological malignancies, bone marrow dysfunction or suppressions; Synthetic peptides for pharmaceutical purposes for the treatment of hematological malignancies, bone marrow dysfunction or suppressions; Pharmaceutical products for treating respiratory diseases; Pharmaceutical compounds for treating respiratory diseases; Pharmaceutical preparations for treating respiratory diseases; Pharmaceutical compounds for treating correlated pulmonary syndromes; Pharmaceutical preparations for treatment and prevention of ischemic conditions, inflammation and organ damages resulting from tissue traumas, reperfusion injuries, cancer, cancer metastasis, inflammatory conditions and allergic conditions; Pharmaceutical preparations for treatment and prevention of multi-organ failure, acute lung injury and acute respiratory distress syndrome in adults, adolescents, children, infants and neonates

The Faron trademark was filed in 2018 , but only registered in June last year 2021 .
It's also live
https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4807:htp7yg.4.1

Anyway - good to know these things are going on in the background , and encouraging that Haematokine , which they will be submitting for IND approval in the near future , is already in the trademark arena .

No problem Drac .
I'm as confident as I can be that we are on track for some kind of major deal this year.
Having sifted through Faron's work for 4 years now , its clear all the parts of the jigsaw are coming together now .

Putting the SP aside , every RNS/interview we get shows calculated and logical progress towards Big Pharma partnership . The recent placing for example and the EGM to allow shares to be placed in holding . All strategic moves to keep them in the driving seat , and not to get boxed in by some funding requirement that they cannot easily achieve .
Add in positive backing by groups such as LLS TAP ( recent investment , after first patient dosed , and showing no adverse reactions ) just adds to the confidence . Normally that would have been done prior to a trial starting , often in order to fund it . These guys seem to have jumped in , and invested at market price ( albeit without sending SP higher due to it being a placing )

They seem to have just about enough data on Matins to pretty much know what is going to happen . And BOD seem happy enough to put more skin in the game .

In the mean time we await updates on Traumakine . Funny that both SNG and Faron have an IFN Beta 1a treatment , hailed as the possible saviour , and neither are currently in any trial , be it their own or a platform . ( we can't count Remap as I'm pretty sure that's paused for us too ).
Wouldn't it be amazing if the two therapies got their own platform trial , with steroids being banned , and run as SOC before any other treatment . One can dream !

The ncbi article studied the use of TLR9 along with PDL1 therapy with Hepatocellular carcinoma , and saw a benefit .
That cancer was one of Farons strongest cohorts in Matins with Bex ( 40% response rate )
As that is one of the cancers with high Clever1 positivity .

It shows that there is still a major unmet need for treatments of these cancers.

This blurb does highlight how much of a breakthrough Bex ( or even TLR9 agonists ) could become .

Bex is showing up to 40% response ( as opposed to 20% or less in current treatments ) , and also is starting to provide some amazing 12 month survival data ( whereas current treatments struggle to provide even 4 months ).
Just puts into context - how important we may be .

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world and the second leading cause of cancer-related death 1. Currently, treatments for early-stage HCC include surgical resection, liver transplantation and local radiofrequency (RF) ablation 2, but their efficacy remains limited. Molecular targeted therapies such as the small-molecule multikinase inhibitor sorafenib (first-line use) 3, regorafenib (second-line use) 4 and lenvatinib (first-line use) 5 have been approved by the US Food and Drug Administration (FDA) for the treatment of advanced HCC. However, these drugs only extend the median overall survival of advanced HCC patients by no longer than 4 months, and the overall response rate is extremely low 6. Immune checkpoint blockade (ICB) has yielded considerable clinical benefits in patients with different tumors by enhancing T cell responses and maintaining prolonged antitumor activity 7-10. The anti-PD1 therapy approved for HCC treatment has achieved a 20% response rate 11. However, treatment with pembrolizumab or nivolumab failed to meet the primary endpoints of the KEYNOTE-240 and CheckMate-459 HCC clinical trials. Therefore, there is an urgent need to improve the therapeutic effect of ICB and develop more effective combination therapies.

I'm still yet to hear a mention of this from Faron .
https://patents.justia.com/patent/20210371865
Yet on reading this patent , it seems like quite a big deal .
'Now, the inventors have surprisingly discovered that a Toll-like receptor 9 (TLR9) agonists can be used to downregulate the expression of Clever-1 on alternatively activated macrophages. TLR9 agonist was found to reduce rapidly Clever-1 expression.'
Patent was filed Nov 2019 - published Dec 2021 ( so only 6 months ago )

I just keep thinking - what further research is going on here . Patent mentions that it could be used in combination . Experiments on mice bone marrow samples were used . And also human tumour cells .
As with Bex , it suggests screening for Clever 1 positivity .
So much of the claims seem similar to the patents for Bex .
The patent inventor was Maijia Hollmen .
So are Hollmen labs working on this ? Haven't heard much from them this year .

Further -
Here an article here in 2020 shows that a study with TLR9 and PD1 / PDl1 therapy - Therefore, combination therapy with a TLR9 agonist and an anti-PD-1 antibody or anti-PD-L1 had much better antitumor efficacy than either monotherapy in HCC.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255037/

Anyway - interesting that this patent is out there .

One other thing to note regarding Bexmab , is that unlike some trials where they are going in fresh from pre clinical to clinical , Faron have approx 200 patients who have provided them with blood samples , from which they have formed an opinion as to how Bex will work in the bloodstream .
Also the dosing in Matins will have greatly informed dosing in Bexmab ( hence the 1week / 2 week set up perhaps)

I think this is perhaps why the trial protocol was so detailed and specific , as they have a very good idea of what they are expecting to see , as they have already seen it , just not in Leukemia patients .

The splitting of Bexmab into 3 arms may also be very calculated . 3 different sets of patients with different variety of specific illness .
Rather than grouping them all together and having to pick through the data post trial , they have 3 separate arms that may show different degrees of efficacy . One arm showing a clear success would stand out more than a mixed bag .

Anyway , I've talked myself into one last top up .

It's hold tight now , sit on hands for a few months and see what develops .

Yes superb report thanks .
We are still in the game - Activ 2 , a new platform trial . Long Covid data . COPD/Asthma
SNG001 is still there as one of the best candidates as a non invasive , variant agnostic , all purpose antiviral treatment for respiratory illness .
Huge amount of data gathered from various trials .
Professional team of experts pushing the program .
Not sure its totally 'bottom drawer' material .
May be a long road , but could be some nice surprises along the way .
Just waiting for its day in the sun .

LLS have been instrumental in nearly every breakthrough in blood cancer treatment - their words .
I guess their panel saw what Faron were doing , and decided that they had better get involved , as if Bex can suppress Clever 1 and ignite the immune system to be more receptive to the current treatments , then it's a real breakthrough .
They were obviously aware of what Faron were doing .

As a reminder - this is the situation with AML patients - many patients have poor outcomes from the current drugs and show drug resistance and poor response .
Bex can help with this - by doing what it does with Clever 1 , it allows better immune activation , shown by the increased antigen presenting molecule (HLA-DR) , which is what basically helps the body identify and kill cancer cells , so when used as a combi with azacytidine and / or venetoclax , the treatment will be far more effective .
venetoclax can actually inhibit the HLA-DR , but with Bex , that effect is nullified , and even reversed .

First patient dosed on or before 8th June . 3 weeks ago . First run is a 1 week dosing , then 2 weekly dosing . 28 day cycle .

I see there are 3 arms for different type patients :
Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML
Newly diagnosed AML patients non-fit for induction therapy
Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML

6 primary outcomes -including ORR , Dose toxicity and Minimal Reduction of disease for newly diagnosed AML patients
Plenty of possible results here that could prove successful .
And all 6 are recordable after 30 days post trial.

With LSS onboard , they obviously approve of the goals that Faron have set themselves , and have put their name to the project .

Interesting read about who and what LLS TAP is .
They are the world's largest voluntary (nonprofit) health organization dedicated to funding blood cancer research and providing education and patient services.
They have staff in over 80 offices in the US .
We are their latest investment . One of 20 partnered companies now in their program .
https://www.lls.org/research/faron-pharmaceuticals

Being part of their program seems to provide access to expert specialists , their patient network , and the channels to accelerate drug candidates through to market .
They have 4 drugs that they have partnered with that have been given FDA approval since 2017 .

You couldn't ask for a better addition to the program , than having the worlds leading Leukemia Society put their backing behind you . Their experts must have seen some fairly compelling reasons to invest in Faron and Bexmab . They are not some Investment group looking for a quick profit . They have an outstanding reputation in the Leukemia field , and the number of companies competing for their investment must be huge .

For any company , this is a major moment in their program's development .

The website blocker seems very temporary to me , as if they are having to comply to some rule , but surely they can't expect people to go through that hurdle every time they check in . ( It doesn't seem to remember your selections ).

Bexmab could produce data in approx a month from patient dosing . Very quick . Open trial .
LLS jumping in . Timo filling his boots . Markku adding a big chunk .
It's all very bullish .

Took two chunks late on in the 5.3's .
Wow this is getting daft .
We were above this pre suspension !
Averaging down exercise for me , and to be honest I'm getting a lot of shares for my money at the moment .
Can wait years for the outcome .
Already been here years .
Like GGP , the shares moving from the impatient to the patient , and the jittery to the confident .

Thanks .
The CFO also tweeted today - 'Busy weeks past us. Very happy to bring this to finish line and especially to have @LLSusa
support. - responding to Farons tweet about the placing .

Toni H doesn't tweet much , so this must be another milestone in his remit that he is proud to have reached .

I like the words ' finish line ' - one could speculate that it sounds like we are almost there .

Yes thanks all for the updates .
Still so many opportunities . Good to see the team are still all together and working hard .

Just clicked on Faron website , and for first time ever , it asked me my country of residence and where I was logging in from .
I've encountered similar situation on a few US based websites where they have asked to confirm what country you are from .
Not sure if this is just me . Maybe nothing , or could just be a slight tweak to website in preparation for dealing with visitor(investors) from US ?

In the Placing registration RNS - this paragraph was inserted . Never seen it before after previous placings .

Possibly again , just a tweak of their reporting , to make sure they are doing it all by the book ?

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO "QUALIFIED INSTITUTIONAL BUYERS" AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

Just catching up with RNS news . Disregard current SP . It will be what it will be until big news gets announced .

But as for what we are seeing develop , I believe its all following the plan that the BOD have envisaged .

They have the FDA meeting in Autumn , at which point they will have all the PII data , along with biomarker data , staining results , and presumably dosing data all wrapped up . It's at this point that the Bex package ( for solid tumours ) , is ready to be partnered for maximum shareholder value .

We have had all the planning going ahead for Wall st US listing / Investment , with the EGM in July to allow 11 million shares to be held by the company for future use .

This placing allows further acceleration of all the Bex programs , and specifically gives a hint of the importance of Bexmab with the LLS TAP coming onboard .

Markku buys a further £84,000 worth of shares , and the new BOD members taking token amounts to show willing .

But Timo , who is no fool , increases his stake again towards 20% . I have no thoughts that he wants to go to 30% , doesn't seem part of the plan . He obviously sees value in increasing his holdings , and I fully expect that this ' low ' share price , allowing a placing at market price , is no ' accident' .

The SP has been carefully managed to allow for this increase . Not hard considering there is zero trading activity pushing this around . They just set the price and we accept it . Nobody seems interested in intervening , so they have managed to just flatten the SP .

So now we are more funded , enough to keep up the accelerated development .
By Q4 2022 , Markku has suggested that 'something important ' will occur .

All the activity suggests that is what they are aiming for .

Bexmab data may catch us out as , if good , that could stir things up sooner .

But either way , reading the RNS , I'm just seeing it all play out as expected , and that's reassuring .
Markku is making sure they have funds available , and Toni and Erik are now putting their plans into action .

Just don't think the SP has to react to these RNS's .

The whole market is in the dumps . Just look at AVCT for example- cracking RNS and ends up about 7% up .

So long as the news is good , and it doesn't seem dodgy , then all is good .

The fact that Timo ( to a massive amount ) , and Markku and Toni have added is just added comfort that things are going well .

Keep it up - just added another chunk . Ridiculous lol