Member Info for Saxondale

At least with the SP anchored well and truly in the mud , we have weathered the recent turbulence in the markets .
But..
Bexmab has been primed now - has been something of a side story to the main Bex project - but this has the potential to be a fastpass to perhaps an EUA and commercialisation for Bex , even before the Matins pivotal trials get agreed on with FDA later in Summer .

If first data from Bexmab patients shows to be positive - things could move very fast .

This sales process really does seem to have so many moving parts .
But having the 'hydrogen' guy on board will surely speed up any negotiations involving that arm .
We sometimes forget that it's part of EUAs future .

At the bottom of their RNS's -

A parallel business development strategy based on the Hydrogen Economy forms a new development arm of the Company.

Isn't this guy already connected to EUA in that hydrogen project ?
I'm sure he was discussed a while back . Was involved in some meetings in Japan etc I think .
So he knows EUA very well .
https://www.youtube.com/watch?v=rcc76O_e01o

Artem Matyushok served in senior M&A roles with major Natural Resource companies: total value of M&A deals executed is over $100bn
Right man to help them get this monster over the line .

Nice

Yep been trying to buy - unable to at this level

Two updates on the NIH Clinical trial site - just to bring them up to date with what we were told .

HIBISCUS -Terminated (The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time)
RENACOL - Withdrawn (Since no patients have been enrolled in RENACOL, and safety and tolerability data is rapidly accumulating in another ongoing study, sponsor considered that RENACOL study is no longer needed to assess the safety profile of bexmarilimab)

Good to read that they have so much safety and tolerability data 'rapidly ' being acquired .

So next update ?

The new Interferon trial ( DofD partnered for Ischemia Reperfusion Injury ? )
BEXMAB - first dosing - or trial site additions/ monotherapy additional arm ( perhaps in USA)
Updated Staining data for Bex
Updated biomarker data for Bex
Updated dosing frequency results for Bex
Update on ideal dosing levels for Bex
Soluble Clever-1 data findings from increased dosing frequency patients.
US Nasdaq listing ( take your time there please - no rush lol )

Yes Luck , Markku mentioned that there will be news shortly regarding Bexmab trial - something about a USA connection too . Not sure why the delay in first dosing news - perhaps they wanted the ex vivo data published first ?
But once underway - yes they will know ' very soon' .
And that would kick off some fireworks for sure .
Any of the big boys waiting on the sidelines may have to show their hand .

Something tells me that they perhaps want this as a US based trial - hence the delay on the trial below ( which was set up last year ) . But I'm just guessing on that .
Either way - its an open label trial - so no big delays in them getting results they can tell us about .

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002104-12/FI

I remember the Redeye analysis of Faron last month highlighted that one side of the Bex story was proving that Clever-1 was an important target .
Well , here's some more.
Bodes well for Bexmab ..

Can't understand why we are still so under the radar ?!

"These results reinforce the strong scientific rationale behind our focus on Clever-1 and the potential of bexmarilimab, either alone or in combination with standard of care, to treat blood cancers," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "High Clever-1 expression is associated with poor survival in certain blood cancer patients and bexmarilimab provides a novel treatment approach for these patients, downregulating Clever-1 expression and igniting an effective immune response. We look forward to the imminent start of our hematology cancer clinical trial program to further explore these promising findings."

Had a few grand at 12.24 .
Wasn't hoping for another opportunity really , but like you say - rude not to .
In a year's time , these won't be 12p that I am fairly sure of .

We are looking for a proactive and dedicated person to join Faron as CMC SPECIALIST

The CMC (Chemistry, Manufacturing and Controls) Specialist will focus on process development and GMP manufacturing activities. The person we are looking for will have deep knowledge of and/or experience in developing mammalian cell culturing or deep knowledge/experience in various purification techniques based on chromatography for biological/biotechnological products. The goal of Faron CMC is to work consistently and with precision to advance our development programs and we hope to find a likeminded professional join our team.

https://www.pharmarelations.com/available-positions?jobid=1776

Not exactly news to us here , as we got hold of this last week from Hollmen Labs . However , I guess all this just builds the foundations for what is to come . For some , they are just learning about Bex , so it's helpful to at least back up these trials with the historic science behind the whole program .
When you are looking at multi billion dollar deals , you need to be able to confirm that from start to finish , you have the science nailed down , which is what Faron/Hollmen have been doing .

And a reminder that this is all having to be explained because Bex really is a ' pioneering treatment ' .

"This research underlines the strength of the science behind our bexmarilimab program. It is widely known that tumor progression is profoundly influenced by interactions of the cells within the tumor microenvironment, which makes it a critical area of focus for the development of new immunotherapies," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "With bexmarilimab, targeting the Clever-1 protein on tumor-associated macrophages, we have an opportunity to switch their activity from being immunosuppressive to become immune-stimulating, enabling them to both mount an immune response of their own and activate other immune cells to infiltrate the tumor. Our ongoing clinical development program will enable us to further understand this potentially pioneering approach of harnessing the immune system to fight cancer".

If the role of Clever1 really is 'systemic ' , and Bex can remove that immune suppression it causes ( which it appears to ) , then we really do have the perfect neoadjuvant therapy , and mono-therapy .
Again , it is the dosing frequency that may be key . That is perhaps why despite 15 months , they are taking their time to make sure they have it nailed down .

Back in Jan 2021 -
They announced that increased dosing frequency changes were underway to counter the high levels of soluble clever 1 .
Although soluble Clever 1 levels were greatly reduced after one dose , by the third week , the levels had risen again , hinting that they may need to dose weekly to maintain suppression.
So they have had well over a year now to study this !
The high baseline Tregs discovery also showed great predictability of success potential . Much like the recent IGN gamma levels . Both the opposite of what is found in other CPI predictions . Making Bex even more unique .

From that RNS -
Latest scientific observations from the trial include the identification of a new role for soluble Clever-1, related to its capacity to control T-cell activation. This suggests that the inactivation of Clever-1 as an immune suppressive molecule could be even broader and more important than previously thought as the immune-stimulating effects are not only limited to tumour associated macrophages (TAM) but may also act systemically.
Never during my career have I seen that a high baseline count of regulatory T cells (Tregs) predicts a good response to a therapy. Until now, it has always been the opposite. This is remarkable. Such observations now provide us with a much better understanding of the next steps required for bexmarilimab’s clinical development in pivotal studies and support its potential as a breakthrough therapy to deliver optimal clinical results in patients with hard to treat cancers.

“The new discovery of the role of soluble Clever-1 as an immune suppressive molecule is striking, indicating the soluble part of this receptor could cause systemic inhibition of T-cells in all locations of body, therefore controlling the general immune capacity in cancer patients. We hope to be able to overcome this inhibition just by increasing the dosing frequency of bexmarilimab to provide maximal binding and the removal of Clever-1 from body fluids and tissues, including tumours.”

We may also get news on the following shortly -
1.) First dosing in Bexmab study ( Leukemia patients ) - that could also lead to a very quick analysis as they will know fairly soon whether it is doing what they hope .
2.) Expansion of Bexmab sites into the US ( at Redeye event Markku said that was being worked on so expect news shortly )

3.) Staining data from tumours update - more data here to unveil .
4.) Further biomarker data - additional and confirmatory results ?
5.) Two abstracts being posted at ASCO 2022 ( American Society of Clinical Oncology) June 3-7th Chicago.
One on -Promising clinical benefit rates in advanced cancers alongside potential biomarker correlation in a phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy.
One on - Modelling treatment benefit for bexmarilimab (an anti-Clever-1 antibody and a novel macrophage reprogrammer) using phase I/II first-in-man trial data.

6.) Dosing frequency findings . The weekly dosings have been in place for months now . Over 200 patients now been treated . Will we finally get the soluble Clever1 data ?? The Hollmen report seemed to hint that as Bex gets cleared from the system fairly quickly , more frequent doing would be beneficial .
This is possibly the biggest piece of the jigsaw that they need to get finalised before meeting the FDA .

I'm still thinking about the comment Markku made - about whether a partner deal would be achieved .
"That day will come . I know it already "
That comment implies ( to me ) that he has some sort of assurance that a deal will be forthcoming . What isn't clear is what the value of that deal is . As investors we were asked to be patient for another Quarter or two .
He is very confident . Chucked some more of his own cash in last month .
You can just feel the momentum building .

Yes just read this too . Interesting .
Their trial halved hospitalisations when given early .
Effect seen in Omicron too .
Dr Juho commented on twitter - ' Because finally used early enough and without steroids!'

Just come across this - not sure if it's been mentioned here as I haven't been on here much recently .

Bodes well for all other interferon early treatments perhaps .
Non hospitalized early dosing ( like Activ2 ?) gave great results .

Synairgen mentioned here too .
Interesting.
https://www.science.org/content/article/interferon-therapy-shows-striking-results-against-covid-19?utm_source=sfmc&utm_medium=email&utm_campaign=DailyLatestNews&utm_content=alert&et_rid=79504704&et_cid=4227910

Proof that you actually can print gold

Good job you kept 50% . Lets hope it comes good - I'm pretty sure it will .
Even Markku just added £70k the other week , and he already owns about 6% of the company .
Anyway - just watched the RedEye presentation tonight . Just a quick one , but shows that we are on the cusp of signing deals . A question regarding licensing - Faron want to be careful to try not to limit themselves to just one agent , they feel Bex would be best attracting several candidates to show how it can be effective . Markku quote - "That day will come . i know it already " . Quite telling ?
Q regarding Hollmen Lab description of Bex . Important to showcase what Bex is and how it was discovered , and that the patents that cover Bex are almost all approved worldwide now - with China now - they have about 90% of the market tied up until 2037 . Again - very important when it comes to how much a deal is worth .
Q regarding US listing . It is a common pattern for a company like Faron to follow this path . They are building up the team in Boston to be closer to regulators , but also to gain access to Wall St . Expect something concrete to be announced later this year .

Also from Redeye -
Patient numbers now over 200
IHC staining of cells - showing higher Clever 1 positivity is associated with clinical benefit - expect to hear more within 1st H 2022.
FDA and EMA meetings scheduled .
Bexmab - commencing soon in Europe and also will be in the US - expect and announcement about that soon .

In my experience , the period before deals is often either terribly volatile ( where rumours /ramping/shorting run riot as they know people are looking at huge gains and there are games being played non stop ) , or the share goes dead flat ( like here and others ) where there isn't the day trading element , and also the fizz has worn off from the initial excitement .
Yes , we've had years now of 'SSV around the corner ' , ' partner discussions ' etc . Often probably to facilitate fund raises .

We were never a hot share at the best of times . Now we are just another pharma with a promising drug .
But for those who follow closely , things really ' are' coming together now .
I would never recommend having 100% of your money in a share like this , but personally I'm very happy with my holding , and where it may go from here .
Well funded - new CMO , much better focus , US developments , and all the P2 data with biomarkers getting better and better . IR managers in US and Europe. FDA & EMA meetings . Patents all in place . Commercial manf agreements in place .
Multiple trials set up , and Traumakine also being redirected back into action with 3rd party financing .
EIC investment and share buying . IPF financing of 10 million euro with another 20 million available .
I could go on , but upshot - We are in a good place - and ready to take advantage of the next developments .

Brings to mind thethe definition of a gold miner - ' a liar standing next to a hole '.
Either way , I've invested a fraction into ARV , just for the ' what if ' factor .
I know they big up everything . I'm just a sucker for the small guy hitting it big story ( like GGP was in the early days )
They do have some other good projects , and are funded to bang in plenty of holes in that area this year .

First 5 holes no intercepts of Gold , but the 5th one that was in the dyke area only got to 241m , and that was the only hole in a 1.5km area stretching across the dyke.
Disappointing , but not unexpected . Big distances between holes , and they are only going 6-800m .Six major targets to drill at this year , so lets see where that takes us .
Main benefit here is that the SP doesn't have any value pinned to the Patterson area yet , and the Carlow and Chapman projects are doing well , so they have that core value . So its as you were until the next results from these two .

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02517880-6A1090327?access_token=83ff96335c2d45a094df02a206a39ff4