Member Info for Saxondale

CFO unable to attend as too busy .
Very diplomatic answer .
I do recall the CFO being photo'd with EIC group people about a month ago , all very positive comments such as ' with the EIC's help we can get Bex across the finish line' etc .

The EIC have pumped alot of money into Faron's development , along with taking a near 5% holding . They want us to succeed as much as we do . Helping us through to authorisation , and allowing Faron to still maintain 100% ownership of Bex will provide much larger long term financial benefit .

In auction - I grabbed a grand at 33p . Lets see if that was a bit hasty

Now 23.2%

Although I'll add that if rise is purely down to Ukraine shennanigans , I'm not gloating .
But the similar fall in Bitcoin seems to highlight how gold is starting to remind people that it really is one of the few trusted safe havens in times of instability .

Always nice to wake up and see Gold on a rise .
That's added a fair bit of value to the treasure down below .

Video now available
https://faron.videosync.fi/r-and-d-day

Seems to be the norm that the SP doesn't react much now to these updates .
But also , past history has shown that quite often a few days later ( usually at mid morning ) , the SP can do a sudden rerate .
Either way , we are getting to be fair and square in that window of partnering , licensing , or sale , in a year when Big Pharmas has over $1.7 trillion burning a hole in its pocket .
Plans to grow the team to double figures in the US , and with Marie Louise focusing on the best pathway to authorisation , is all great news and shows their confidence .
Just two big factors that remain unknown and hence SP stagnation
The main one is Funding
The other is the dosing data ( and I include Soluble Clever 1 in that )

I think that is why the pin hasn't been pulled yet .
Once dosing and soluble question is answered ( and also the final P2 analysis with biomarkers etc ) , then I think the funding situation will get announced .
One will lead to the other .

But then , they have T & H on the other side , plus their relationships with the EIC and DoD .
So there are many options that may pop up .

All in all - looking good and very happy with the feel of yesterdays meeting .

Markku finishing off - ambitious goals . Hiring new people to execute the goals .
Additional info will be forthcoming , and R&D day on T & H to come .

So no giveaways - but they do seem like a team on the move now . I like the sound of extra team members in US - close to the important players .
Still perhaps T may be funding Bex ? who knows .

One thing I took from this is that with Marie Louise onboard - they would be wasted doing any deals until the final P2 data and dosing etc is all known - biopsies , etc , and wasting her expertise .
Once she has taken the P2 data to its conclusion -
That is one point at which they could place a true value on the Bex package up to that point .

Partnerships - with Marie Louise - really want to take the trial to P2 data completion - that will bring the next big inflection value point .
Even until the end maybe ... ( but then he said 'or we'll see' )
Constantly having discussions .
Survival data does take longer - hence the timescale has been stretched .

Anticipate - by next year - 5-10 people in US . COO to coordinate activity . Global activity .

They are dosing 2 weekly and weekly 1-10mg/kg too at the moment
And regarding authorisation
Looking at maybe one large study to get FDA approval - a P2 than runs into a P3 .

Ive asked too about how these trials will be funded .

Seems to be quite science related - but lets hope they answer

To get a drug approved - you need to show overall survival rates...
This data has now been produced - huge difference - but what were the prior therapies these patients were on .
Its proved that they were having treatments ( unsuccessfully) - but then did have success with Bex .
Biomarkers to select the responsiveness - via blood test - with several markers together - almost perfect diagnosis of predicting responsiveness -91% outstanding .
Also - Tumour staining for Clever 1 - to show progress of Bex
60 pairs of biopsies taken too - soon to be examined to see what is occuring .

Most data by Q2 . By Q3 should set dosing for P3 and how to move forward .

Patients who had Immunotherapy but then stopped responding - given Bex , and then showed response- tumour stabilisation ( when IFN y levels were raised too ) . Supports their theory .

Next steps - 2 pathways , more data could decide which way to go - should be finalised in Q2

Lots of potential for combinations in Leukemia - already approved by Finnish FDA - start treating Q2 2022

BEXCOMBO - this will be the PD1 combi trial - Bex can ignite the immune system - then treat with PD1
Want to run with 1-2nd line with modest ORR , also with patients who haven't stopped responding to PD1 already
Flexible trial - can run with 4-5 types of cancer .

So looks like they have done some tweaking - but she seems to have taken charge of the tasks , and there are some decisions to be made in the next few months on the clear direction .

Marie Louise now on .
RENECOL - one dose of Bex . no safety data needed as plenty available . So closing it down .
Now...
MATINS - ongoing - currently exploring higher doses and frequency dosing
BEXMAB - starting Q2 2022
BEX COMBO - PD1 combo -planned
BEX LUNG - to be run in Texas I think ( slide changed ) Investigator sponsored ?

It going well .
Markku excited
Dr Curiel gave a nice Q&A with Markku , about how Farons work is important
Maija now giving good summary of Bex up to date

Markku said that Traumakine would possibly have its own R&D day in the short future , as there is a lot going on there .
Interesting .
Also Haematokine getting close to clinic - just finalising the compounds that work best . News will be forthcoming

Maybe they see value in Activ2 ?
Happy either way - bought my half back today so will just roll with it now and see where it goes .
Anything is a bonus from here - but who knows ??

Yes , the funding is going to be the question .
Markku is against dilution .
P2 side trials is one thing - P3 is altogether a bigger fish again .
But Faron talk of accelerated , ambitious plans .
Perhaps this latest biomarker data and mortality data will be the tipping point for Big Pharma to write a cheque or two ?

To go it alone across these trials would be almost impossible .

I'm sure they have a plan - lets see how much they share with us later .

Just looking at the biomarker info , and the ROC and AUC numbers , these 4 markers have given Faron a real advantage going forward .
To put it in context -
In general, an AUC of 0.5 suggests no discrimination (i.e., ability to diagnose patients with and without the disease or condition based on the test), 0.7 to 0.8 is considered acceptable, 0.8 to 0.9 is considered excellent, and more than 0.9 is considered outstanding.

The AUC using these biomarkers is 0.9107

Considered - Outstanding

I think the $value of Bex just went up a bit ;-)

Misread the RNS - one of the biomarkers is actually tumor necrosis factor alpha (TNFa) , not IFN a .
Quick google didn't help much lol , but it does seem to be related to cancer , but usually the other way round ( high levels)

Yep Santhi . I think we will come good . We sure needed some good news this week , and this is good indeed .

Good news again !
70% survival rate for Bex responders compared to 26% for non responders .
4 biomarkers now identified ( IFN y and a , and IL6 and IL8) - easy simple blood test .
Safety data still excellent
One dose of Bex ignites the IFNy levels

Patient selection using these markers could/should blow the success rate much higher .

Really great data . Biomarker targeting is key , and we ( they) have identified four !!

Well done Faron - Think today's meeting will be very optimistic

I think many of us are in the same boat - some more severe than others financially , but all to some extent still in a bit of shock .
Yesterday was terrible . Humbling , and a big reality check . I was numb for about an hour .
I've had big losses before , but this one was harder as it was like a punch in the guts . Not just the money , but the whole premise of the drug and its potential - seemingly evaporating into thin air .
I haven't tried over analysing it yet , i will wait for RM to do that .
I don't think this the end of the road by any means , theres just too much potential for future use to be just discarded .
But it may take some time , and some compromises with what value we think this could bring us .
I'm not pinning hopes on some miracle turnaround somehow , but I think something may come out of this that will keep the story going , and get Inhaled Interferon back in the mix .
Be that Activ 2 P2 , or some detailed post hoc analysis that convinces the FDA that we have something concrete .
I did sell half of what I had left at 29p yesterday . But I have decided I will probably buy it back tomorrow , more out of principle . Its not much , but I have done so much research and read so many articles about Interferon , that I think that even if it is 2 years down the line , somehow it will get proven to be effective , be that COPD , Asthma or a new Covid epidemic .

I didn't beat myself up too much yesterday . I told the missus straight , and she was Ok . That helped , to have support . We had a laugh in the end . Today I feel somewhat better . I've got other shares and still liquid , just not a millionaire yet .

I feel for those who also had a bad day yesterday . And I feel for the SNG team , for whom this was the culmination of a lifes work for many . But there are some clever people at Synairgen , and they won't be taking this lying down I'm sure .

Its been a hard life lesson this week , that nothing in this life is certain . It sure tests your mental strength , but if you can come through this intact and positive , then you will be a better person for it .