Member Info for Saxondale

Wow , literally the first patent dosed in trial is now a complete responder!
They must be super happy with that .
And this is just the start.

Partial responder becomes complete responder with complete remission of blasts in blood and bone marrow followed by normalization of blood counts
Second patient demonstrated a partial response
Stable disease observed in the other treated patients

Separating company achievements from SP performance , 2022 was a pivotal year for GGP.
You don't need to be much of a financial guru to see how things are going to pan out in 2023 for the company .
Happy days ahead .

Brings the worlds top Clever-1 expert 'in house' now .
This adds value to ' Faron' as an entity .

Great new - Maija now joins Faron as Chief Scientific Officer.
Make sense , but also signals confirmation that Bex and the program is on the up .

Quite the turnaround !
Has to some confidence out there for this to be picking up so relentlessly .

Pretty sure one of the slides they had recently valued its potential at $2-5 billion , given what it could do for other drugs in combination.
And what's it worth to stop your competitor taking it and making their product better .

Mcap in the old days before Traumakine failed launch was about £240m I think , which would give us roughly £4 SP with current shares.
I think we only had about 30m shares then , so today we are nudging £6 in old money .

£1 billion Mcap gives us about £16 SP .

Good starting point for negotiations lol

340 showing at the moment for me .
Not sure if buying pressure is coming from Naz . I think it is .
They rise , then we follow .
This is quite an amazing rise really , given that all we've had is a off the cuff sentence that none of us can understand lol .

The inclusion of irORR seems logical as these newer immunotherapy treatments can have slightly different observable results compared to more standard treatments .
From searching internet - this new method allows for differing time scales on efficacy ( ie small immediate improvement - but leads to bigger long term one ( ie extended life) , and in some cases the tumour size may even increase before reducing .
So looks like FDA have allowed them to adopt the more modern response measurement techniques.

To evaluate antitumor responses to chemotherapeutic agents, investigators would typically rely upon Response Evaluation Criteria in Solid Tumors (RECIST) or modified WHO criteria, which do not comprehensively capture responses with immunotherapeutic agents. In the December 1, 2009, issue of Clinical Cancer Research, Wolchok and colleagues reported their development of novel criteria, designated “Immune-related Response Criteria” (irRC), designed to better capture the response patterns observed with immunotherapies. Broad use of the irRC since then has allowed for a more comprehensive evaluation of immunotherapies in clinical trials, indicating that their concepts can be used in conjunction with either RECIST or WHO, and has shown irRC to be a powerful tool for improved clinical investigation.

New update to Matins trial on Clinical website .

The primary outcome detail was changed from
The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. ORR will be reported as the proportion of subjects of all evaluable subjects.

to
The objective response rate (ORR), clinical benefit rate (CBR) and immune-related ORR (irORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency will be reported separately.

Not sure exactly what this might signal , but looks like they will report more detailed outcomes by various factors rather than in one total batch .

https://clinicaltrials.gov/ct2/show/NCT03733990?term=faron&draw=2&rank=5

Not a bad day again !
Both mkts up about 12%
Either Markku's cyrptic comment has got everyone excited , or something may finally be arriving to cheer us up before Christmas .

Naz 315 , with 3 times the volume than us .
£2.58 to sell , and NT to buy .
This does have the hallmarks of another move up shortly .
Q4 FDA meeting - surely must have occurred already.

One thought I had over Bexmab and AML , concerns how it may help children .
Leukemia is the most common cancer in children and teens ( 1 out of 3 cancer patients )
Although AML only accounts for about 25% of those , thats still a lot of patients .

Bexmab , and most trials I guess , can only recruit adults over 18yrs .

I wonder what rules and regulations have to be met in order to get approval to treat minors if or when it gains medical approval ?
Looking online , it seems many drugs remain unlabelled in that area , probably for legal reasons.

But things may be improving , and for Bex with such low doses and virtually zero poor side effects , it may be well suited to help all age groups .

Bit from an article online I found from Scientific American -

The first hurdle is the term itself. “Off-label doesn’t mean the drug is experimental or doesn’t work or that there’s no evidence for it,” says Kathleen Neville, a pediatrician at Children’s Mercy Hospital in Kansas City, Mo., and the policy statement’s lead author. Very common drugs such as ampicillin and many children’s cancer drugs, for example, are prescribed off-label. “It just means there’s not labeling yet,” usually because studies have not been done specifically with children for FDA approval. A drug will only have labeling for use in kids if the FDA has specifically determined the drug’s safety and effectiveness for particular conditions in children based on the data provided during the drug’s approval process or through post-licensure submissions to the FDA. The label, or package insert, lets doctors know how to prescribe the medication, but labels may also simply alert clinicians that the drug is ineffective or unsafe in children.

Could this be the case with Bexmab ?
AML leukemia has one of the highest unmet medical need for new therapies in the cancer world.

This means that potentially drugs may be marketed even before full phase trials are completed ( given conditions concerning safety etc are met ) should they show efficacy at early stages .

The buyout or M&A scenario may even have run out of time also , if Faron decide to try and market it themselves .

Back in the day , they weren't going to sell Traumakine - but market it themselves .

Is the AML market is possibly niche enough for them to handle it themselves ?

Globally its a $1billion market , but USA is only about $200m , so it's not out of the question , given they still have EUR20m of funding from IPF in hand potentially plus EIC etc / Leukemia society LSS , to get it done alone .

They have the commercial manufacturing set up with AGC Biologics in place .

Who knows , just tossing an idea about , all over one cryptic sentence lol

Other Faron News - from their twitter page the other day
Faron has been chosen to participate in the @EUeic
Investor Day with @CUF_academicC
, the largest private operator of healthcare in Portugal, in Lisbon next week.
https://eic.eismea.eu/community/stories/open-call-eic-x-cuf-day-healthcare-pitch-best-innovations-lisbon

This event is tomorrow and Weds ( 29th & 30th Nov )
All part of this EIC funding program - but you have to apply and the a few are selected to actually pitch .
The EIC team heads were also at the SLUSH event the other day ( that Faron were at ) .

Again , getting themselves in front of more of the right kind of financial investing partners .

EIC-funded companies will be selected by an exclusive investor jury from top European VCs & CVCs with notable investments in the healthcare sector. The selected companies will have the opportunity to pitch in front of these top European VCs & CVCs and meet them in private one-to-one meetings alongside more networking opportunities. 

Reminds me of the Irish baked bean eating contest winner who managed 239 cans . Asked whether he thought he could manage one more , said no , that would be 240 . ( best said in a broad Irish accent )

He also talked of getting more data on more partial and full responders in Bexmab .
Its been running a fair while now , so I'm sure they must be getting a feel of how its going with the other 4 patients who are building up data .
Confident words for Markku - remember this trial is running in four hospitals in Finland at present and is an open study .

"Lets put it this way , every meeting before now has been run out of partnering times , that's the current status of our activities , so it looks really promising indeed "

Still not sure I got it right - but its a positive statement - so perhaps he means that every meeting has been run ( ie built around ) partnering times (ie when can we partner with you )

You'd hardly say we've run out of partners , which is good lol

Share price seems to like it anyway

Another Red Eye interview posted yesterday.
https://www.redeye.se/video/event-presentation/865582/faron-pharmaceuticals-infocus-interview-with-ceo-markku-jalkanen-at-redeye-life-science-day-2022?utm_source=video&utm_medium=email

Again super confident and excited about Bexmab .

At the end he was asked about US - and says that they have been very warmly received over there , and will have no problem in adding sites . Plans to perhaps expand staff in US to 10 in 2023 . (Total Faron is 44 at present in total)

Also says something about partners at the end , saying they are in a good position now . But I can't work out the exact wording of what he says .

Anyway - good to see it chugging up again .

Someone seems in a hurry to get themselves some shares this week .
Having been here for a while , I'm only just over my buy in price .
For many , they'll have to go a lot higher for me to even think about selling any .
And since this share isn't a day traders dream , I'm leaning towards the ' no smoke without fire ' theory .

Looking good , perhaps a breakthrough at last