Member Info for Saxondale

Interesting that the 30m euro finance package was not even mentioned .
A nice introduction to Marie Louise .
You feel that the emphasis on combi use of Bex now is really gaining importance - and with combis , comes the potential for licensing and income .
Lots of options going forward .

Probably not one of the best days to announce some good news to the market given the current global situation , but I had a small top up at £2.51 .
10m euro loan , paid off over 5 years , with a further 20m on hand if needed .

I don't see this as a 100% go it alone plan , but as a way to strengthen their hand in future Partner negotiations . They have the facility now in place to go for perhaps 2 years , right at crucial pivotal trial stages .
Within this year , there will be data coming in from the combi trials and further matins data within next quarter .
And also they have that superb update on mortality and 91% biomarker accuracy already in the bag .

5 presentations in March , hiring new staff , building up team in US , and we aren't even takling about the Traumakine R&D day that will come along soon .

IPF would need to see a legitimate pathway for Faron to repay this loan .
Plenty of due diligence , and this must have taken some detailed analysis to sort .
Well done Toni . Other than the soft loan from Business Finland for Traumakine manufacture , this is the first real step away from the usual share dilution .
A great signal I think , as they know that by entering into debt agreement , the onus on now becoming a cash generator has been crystalized . If the future was still unclear , we may have expected just another 5m raise to keep us going .
But this is a big step .
Hopefully we get an interview .

Looking on IPF website - and at their current investments , at 30m euro , we will be one of their biggest investments .
https://ipfpartners.com/portfolio/

30 million euro debt funding then with IPF partners !
10 million now to see us through 2022 - then 5 and another 15 dependent on certain criteria .

Lots to absorb here , but looks like we are now funded well into the future .

"This funding agreement strengthens our financial position and adds flexibility to our funding strategy by adding a debt instrument into our funding tools," said Toni Hänninen, Chief Financial Officer of Faron. "We are excited to be working with IPF Partners, one of the leading alternative financing providers focused on the healthcare sector, and thank them for their partnership."

No these are just my thoughts . Not assuming anything other than what has been put out officially .
Synairgen would have been well aware of Faron's steroid debacle back in 2018 .
Their 2020 P2 trial would have had to have been a compromise over time vs how specific protocols they could run .
Perhaps they had enough data gleaned from previous studies for them to decide that it didn't disable the efficacy when delivered through nebulizer rather than bloodstream .
The P2 success was good enough to warrant a £80 million raise and a super quick P3 .
And even then , steroids were not mentioned on protocol , so you'd assume it was not seen as a serious barrier to efficacy , otherwise they'd have been nuts to carry on .

I think its more complicated - a mix of various issues around the SOC provided . Perhaps even the change of Delta to Omicron , or something else we haven't even thought of . Steroids may be in there somewhere for sure , but I don't think its the sole culprit as was the case for Faron

Synairgen have years of data from COPD patents too , loads of In vitro data too .

Covid has been a slippery eel of a virus however , acting very differently in patients .
And IFN B s effect also varies wildy depending on the patient , and the timing of its administration .

At the moment , I'm running on my gut instinct , and Polygons renewed buying .

Just to correct myself - I'd invested in this horse before P2 , but after P2 came out , it seemed to be the favourite to win the IFN B race , because of the lack of steroid interference noted .
People were still aware and cautious that steroids may interfere , but as late 2020 came , steroids were emerging as about the only readily available and affordable drug that was being recommended . Plenty of doctors were noted expressing their worry ( especially in India ) , but for whatever reason they just kept being pushed , and the likes of Ivermectin etc were being suppressed .
This where we enter the unseen meddling hand debate , but that's for another day .

Originally in mid 2020 the WHO put out a document recommending NOT to use steroids automatically . This was great news for Faron as that backed up their experience when trialing I/V IFN B .
From an RNS - Feb 2020
The Company notes with interest a recent recommendation by the World Health Organization (WHO) that steroids should not be used on coronavirus infected patients1. One of the main first lines of defence against viral infection is endogenous IFN-beta production2. Blocking endogenous IFN-beta production using steroids may be deleterious to treatment outcomes in these patients. Therefore, exogenous IFN-beta (like Traumakine) can strengthen further this endogenous IFN-beta action and provide maximal protection against viral infections but it has to be administered without concomitant corticosteroids, which have the capacity to disturb or block IFN-beta action.
https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1
The link however doesn't exist anymore as they removed it .
Shortly after , WHO brings out another document saying they ' did' recommend using steroids . Very confusing , but I guess data was emerging .
By Sept 2020 they issued this document - https://apps.who.int/iris/rest/bitstreams/1299344/retrieve
Recommending steroids for severe cases , but not for mild cases .
This was possibly due to the increase in cases of black lung etc .

Either way - steroids were being used everywhere from then on ( and it seems with great success) . On REMAP CAP platform trial - Steroids became SOC , so it became almost impossible to have any control group without steroids , and next to impossible to enroll a large number of steroid free patients onto a trial in any sensible timeframe .

As a Faron shareholder , it was infuriating . When SNG P2 data came out showing success despite steroids , I decided to back this horse too , as that had been Farons Achilles heel .

Hopefully with Activ2 , things should be different . There will be steroids involved , but only to the point where patients had been on them for other ailments . In fact , to be on the trial , you'd assume they were instructed what they could or couldn't take that would jeopardize the results . Obviously if they got too ill and required hospital care then they would , but other than that , the biggest worry with Activ 2 was that they may not be enough 'ill' patients .
The fact that we progressed to Activ2 P3 , and the protocols for eligibility were changed to ' breathless ' does bode well however .

I remember when Operation Warp speed was announced , its main raison d'etre was to smash the old clunky Clinical trial approach . Tear up the rule book so to speak . If something works , find a way to prove it , rather than just stick with the established ' one strike and you're out ' trial set up .
Lots of conjecture , and I haven't even got started about the meddling hand of Big Pharma & Govts lol

Oh forgot to mention , after that failed P3 , Faron got $6 million grant from the Department of Defence to run the new trial , and also 2.5 million euro grant from Business Finland ( Finnish Govt investment body ) to develop new maufacturing process for their Interferon Beta drug , along with further investment from the European innovation Council .
Yes their SP got annihilated at the time ( down over 80% on the day ) , but they came back fighting .
If you can prove the science , and under what conditions the drug works , then as the CEO says , you cannot take that data away .

Sorry to keep using Faron as an example , but it does illustrate the point .
Interview here with CEO after failed P3 - talking about data
Finnish accent does make it hard to grasp , but you'll get the gist .
https://www.youtube.com/watch?v=z4AJJ-TgAbg

This was done in Feb 2020 , again , before Covid really became a ' thing ' .

The problem Faron have had with steroids since then however , is that they are used almost globally as SOC , so getting steroid free cohorts has been painfully slow .

With Synairgen however , we don't know for sure that steroids ' are ' the problem .
P2 had plenty of them , and actually didn't make any difference .
My hunch is that as the SOC in general is better now ( as RM mentioned ) , the target group of patients where we will show efficacy in hospital will be a subset / number of subsets ( those getting severely ill perhaps / old / with low IFN production ) All this will come out in the analysis .
And the Activ2 trial will throw up another set of patients ( as generally no SOC administered )

All this data together will influence the next steps .

I think everyones been hit these last few weeks with market jitters , fears of economic woes and incoming bad news allround .
Faron normally fare better than most in these times ( one of our advantages of not being a highly traded stock)
But also - pharma / mining shares have all had the wind sucked out of them recently .
Also we have 70% more shares in circulation than we did a couple of years ago . If we still had 30m shares ( as per 2019) , we'd have an SP of £4.50 approx . But that's just academic .
I think the main reason the SP doesn't budge anymore at breakthrough data here , is that Faron have relentlessly pursued the ' do it ourselves' policy , and not taken the cash from any Partner .
That may soon change ( and will have to if they want to crack on )
Big Pharma have a lot of dosh , and need to acquire fresh blood to keep their profits coming in .
We are just the sort of potential cash cow they are after .
But until Markku gives the market a clear signal that they really are pulling the pin on a deal , then the big money will sit on the sidelines.

I sold half on the Monday , but bought it all back on Thurs , and more on Friday .
So I now have more shares than I did a week ago .

A failed P3 is not the end of the road if there is post hoc analysis that can show that given new protocols or end points , it would have shown efficacy .
Close to home is the P3 INTEREST trial that Faron did in 2017/18 ( 600 odd patients ) . It failed , but straight away they saw that the steroids were causing issues .
What followed were meetings with the FDA to explain this , and draw up a new study protocol to prove their thesis .
From a Faron RNS -
The FDA accepted Faron's proposed study protocol for the new Traumakine trial, which excludes the use of concomitant corticosteroids and which will be split in two steps. The first step will commence with INTEGRITY, a pilot randomised and placebo controlled study, which will serve as final adjustment for adequate statistical powering and sample size justification for the pivotal second step, CALIBER.

That was in 2019 , and was about to get underway , when Covid blew up . That put a spanner in the works for normal trials in 2020 , but Faron got involved in two platform trials , that were a waste of time , and hence then had further meetings with FDA and redesigned the trial again - to focus on Covid - called HIBISCUS . This would pitch their drug directly up against Dexamethasone in a small P2/3 trial again ( funded by the Department of Defence ) .

Anyway - the gist of this is that if there is good data in amongst SPRINTER , then the FDA will more than likely be willing take post hoc analysis into consideration .
This may result in a smaller trial to just prove the point ( 70-150 patients with new protocols ) , or consider it along with all the other trial data , and ACTIV2 P2 data to make further recommendations .

Also , with the increasing research being published on IFN B and Covid , further biomarkers / patient types may be discovered that also make the diagnosis of likely responders even more clear .

For example , Faron also have another drug they are trialing , and P2 data has thrown up 4 biomarkers which gives an AUC of 0.917 ( 91% accuracy of targeting a likely responsive patient before therapy )

All this kind of stuff can come out off the data analysis . Synairgen will have a huge set of data now , so no surprise we haven't had any update yet .

Looks like a mix up with Oruser mining , although GGPs Shaun will be there too .
Shame they didn't put ' Greatland Golds CEO James Bond ' lol

any other week we would be assuming a deal RNS is on its way .
my senses are frazzled this week - can't work out up from down , but I know its a good sign whatever

Making a nice profit on what I bought yesterday , but why is it with EUA I can never bring myself to sell the damn things ?

only 3 trades today so far - but all buys and totaling £42k
and not Mr 5000 either .
Given that a few of my other shares are in death spirals or in the Mariana trench , I'm quite content with some stagnation here while we wait for news .

Five presentations at conferences now booked in the Faron calendar :

8th March - Redeye Investor Forum
10th March - Biocapital Europe 2022
15-16th March - 32nd Oppenheimer Annual Healthcare conference
15th March - Carnegie Nordic virtual healthcare seminar 2022
23rd March- Swiss Nordic Bio Invitation 25 Jan 2022

From memory , only one was there last week , maybe 2 .

More news coming ?

Didn't sell out any yesterday , in fact added a few £k
Learnt this year to always keep some dry powder for those extreme averaging down moments .
Never thought it would go much below 10 , so my timing wasn't great , but can sit on these for years if necessary .
That's why we call it investing .

Might be a bit of an issue trying to 'ditch' 47 million shares quietly .
That sort of off load can take months , and its very painful to the SP ( see 4D Pharma )
My hunch is that whether by informed research , or slightly better knowledge of the inner workings of this industry , and its mechanics , they have decided that SNG will make them money , be it through a sale , or through Activ2 results/FDA discussions that will enable SNG001 to move forward .
Timescales may be more fuzzy , but be it weeks/months down the road , I'm following the money on this one .