Member Info for Saxondale

Reassuring update .
All things going ahead as best as can be expected given the upside down world we are in .
Savvy to hold reserves for future.
I bet silver miners wished they had that option.

Confident statements in here .
I know they are just words , but the expectation of success is almost assumed here in this RNS .

New date in calendar Thurs 6th Oct - Proactive Investor Forum live event.

The FDA has suggested that the required information would constitute a major amendment to the New Drug Application .

We need more info before blaming anyone , as to what this information is ?

Why didn't they need this information last time , in which case POLX would know it was required ?

Sounds more like FDA asking for more info that POLX and manf partner were not aware they needed to provide.

Oh well , at least this has been brought up before deadline day - and extension will allow it to be resolved .

Last top up done today . Amazed that SP hasn't built much , but happy to take the opportunity .
Odds are heavily weighted in our favour for positive FDA decision .
Plenty of time to address the points , and why would you re submit , unless you had addressed those points .
Yes , always chance of a curve ball again , but I have no doubt that POLX have done what is needed , and are fully confident now that this will go commercial .
New hirings to the board , and progress with the research side of things all positive .
Plenty of demand out there for this technology still .
Perhaps the lack of interviews etc this time has dampened the buzz , but I think they are keeping their heads down , making sure they get this across the line this time without any egg on face .

Link to a recent HC Wainwright meeting -
https://www.faron.com/investors/most-recent-presentations ( link is 2nd down on right)

20 minutes of good insight .
This was a week ago , but the team seemed upbeat at what they were discovering .
Again , the excitement around Bexmab is palpable . The pre clinical studies on bone marrow , along with what they know about Clever-1 in AML , all point to Bex being able to make a difference .
Everyone is very relaxed and confident .

It's a positive move, in my opinion , to have other members of the team take a bigger role in interviews and forums .
It puts a fresher feel to the message .
Jonathan Knowles today was a good example .
Markku will always be the face of Faron , but MLF , Maija , Juho and Toni all add their own expertise , and remind us that there is a big machine working behind the scenes to get Bex ( and T&H )across the finish line .

Exactly , you don't make a deal when you haven't even got the next stage agreed with FDA .
They still have data to come , and the meeting to agree dosing for next stages .
That's when they have a package that can be made into a deal.
Plus they are literally weeks away from initial Bexmab data - which if positive could bring a whole new accelerated revenue stream.

So - one of the most positive Faron webcasts I've watched - the important data is all building on their initial findings , making the FDA meeting alot easier to prove their case .
Super strong biomarker and staining data.
Super data showing immune system activation in responders.
Great life expectancy data
Top of class in tolerability at huge dosing levels , that give them combi friendly status.
Funding options from multiple sources
US centric future trials and investment potential.
Multi arm therapy with options for spin of licensees , both geographically and clinically .
Patents in place .
And two other therapies ( T& H) - that could be monetised at some point in the future.

The Faron team is really coming together it feels . Maija is growing in her role . MLF will be key working in the US .
And lets hope along with JK , Anne Whitaker and Eric O are busy priming the US side for whats to come .

I know the SP stinks , but just look around at other AIM shares . Even some of the most promising ones are in the gutter at the moment .

Final words from JK -" If you think PD1 was big - just wait for this - it's going to be bigger ."

Pretty bullish statement , considering his status and his first appearance .

Jonathan Knowles - why haven't we had this guy on before - what a star !

MLF doing deep dive into P2 data - highlighting who responded , and the biomarkers signalling who is best suited.
Staining for Clever-1 in the tumour samples - patients responded best who had clever-1 in the tumours .
Very excited about this .
Bexmab -dose escalation expected Oct 2022 . US sites by end of 2022 .
Abstract in Dec 2022
Part of the TAP ( therapy acceleration program)

Maija doing a great job of explaining the bex development story , with who benefits best , why , and how to select patients.
Not the easiest job , but for anyone new to the subject , its about as clear as you are going to get.

https://faron.videosync.fi/2022-bexmarilimab-development-update

Nas up 8% .
UK can't buy any quantity on my platform , but can sell all for 191.5
Rises here are always delayed ( sometimes by days) .
Lets see what the BOD give us in the webcast - and what these expected milestones are .

Some great stuff in here , reinforces all their current thinking .

Higher baseline Clever-1 levels in the tumors was associated with increased clinical benefit and could become an essential component as a diagnostic tool for patient selection

Accurate patient selection is key to increasing success rates - and FDA approval .

Looks like they have made substantial progress on dosing .

30mg tolerated , even on weekly cycle , and best benefit seen at 1mg ( at weekly and 3 weekly) - so huge safety margin .
Big signal that combi treatments will be well tolerated too.

Clinical benefit seen at all dosing levels and reduced soluble clever-1 in the blood with majority of dosing levels ( more frequent and higher dose levels ? )

3-4 fold increase in survival time ( and these were on refractory last line patients)

More data to come on clinical benefit imminently - then FDA meeting .

Looking forward to Tuesday .
Been here 4+ years , and I've never seen them wheel out Jonathan Knowles - so this will be more than a few little updates I feel .
It may be just more of the same , but as soon as I saw that RNS , it had a different feel to it .
Are we finally getting ready for something big ?
SP can't grind much lower you'd think , so fingers crossed.

Good find Itsall . Here's the abstract - a fair bit of work gone into this.

https://www.utupub.fi/bitstream/handle/10024/154589/Annales%20D%201642%20Tadayon%20DISS.pdf?sequence=1&isAllowed=y

In this thesis work, we showed that lymphocyte entry into the spleen is not a
passive process forced by blood flow, but rather an active process regulated by
Clever-1. We also discovered that lymphocytes preferentially enter the spleen via
the vessels in the red pulp (RP) rather than marginal zone (MZ) sinuses or the white
pulp (WP) vessels. These findings change the long-lasting dogma since 1973, which
stated that lymphocytes enter the spleen via the MZ sinuses. We also identified
Clever-1 as the first molecule that regulates lymphocyte migration into the spleen
via the vasculature in the red pulp. In addition, we discovered that Clever-1 is
expressed on peripheral lymphatic vessels and its absence reduces DC
transmigration. Moreover, Clever-1, expressed on lymphatic endothelial cells
(LECs), down-modulates DC activation and subsequently regulates the magnitude
of antigen-specific T-cell responses in lymph nodes. In summary, this thesis work
identified Clever-1 as a unique molecule that controls the migration of lymphocytes
and DCs into secondary lymphoid organs, along with its crucial role in regulating
antigen-specific immune responses.

Well that really is a great achievement .
Last worry now flattened and gone .
Future secured - we are safely on trajectory for success .

FUNDED !?! oooh !

I guess you have to pay for quality .
Should pay GGP back in multiples though for their expertise and reputation.
Great stuff