Member Info for Saxondale

I've only got a small holding here , did top up on Friday at 80p , should have done it Thurs , just couldn't understand the disconnect between SP and the placing price . In the end I think it was just an overlooked opportunity for us lot to buy in cheap .
I have dipped in and out here , but this time I will just hold .
The thought of not being in here if and when some high grade drill results land would be too painful .
Either way , steady growth through the recovery of POG , and Pure Golds expansion means , barring an asteroid strike or world war 3 , from here on it should be a pretty safe investment .

Faron seem to be confident too.
They are booked to give a presentation at the Macrophage - directed Therapy Summit in Sept 2021 Day 2 2pm
https://macrophage-directed-therapies.com/program/agenda/day-two/
Dr Juho will present( our charismatic ' One ring to rule them all ' guy )
In the description , part of Farons presentation is : Insights into dose escalation studies and demonstrating proof of concept in tumor specific expansion cohorts.

Dose escalation is the most recent change to the study , and what we are eager to see the findings of .

Why would you book yourself into an event in Sept to discuss findings if they weren't good ?

Thank you two for that . That was an hour well spent ! Despite being invested here for quite a while , I actually learnt a whole lot more tonight .
Thanks to your insight , and for showing us what gems lay under the surface of last weeks Newcrest update , and for explaining them so well .
It's almost as if they don't want us to know how big this monster is going to be yet .
And finally I have got my head around the layout of all these zones , with the 3d models , as to where they all sit in relation to each other .
Having someone talk you through it makes it so much easier , and adds a lot of value to me .
So thanks again .

https://www.proactiveinvestors.co.uk/register/event_details/337

Yep looks the same .

Yes Cov maybe epic wasn't the right word , rebound maybe . The epic rise will come if and when they actually get a proper deal.
I think we could be excused for getting a bit more optimistic this year , with what has been revealed to date about Bex .
If they were just working on one P2 cohort , I would be a bit nervous . But the fact they have 6 or 7 and counting , all providing positive data , plus this universal soluble Clever 1 additional findings , and they've booked a Proactive Forum evening on the 20th , makes me think there's some good news just around the corner .
And as for deals , we are in that stage of development where Pharma companies do deals . I know we have hung on Markkus every word for the last year , but he has said many times recently that partners are just wanting to see this P2 data before progressing .
All this commercial manufacturing set up . Soft loans , grants . Institutional funds placing . CFO buying in more shares .
No selling of any shares by major holders .
Options and recent placing at higher SP than today .
Recent additions to board , some high profile US connections.
Further patent applications .
FDA approving tweaks to trials .
Some of the BOD like Frank Armstrong for example bought a lot of shares at over £7 .
And that was back in the day when Clevegen hadn't even got going .

New minor discoveries that excite the scientists will give us another rebound.
But we really must be getting close to that Carlsberg RNS we are all hoping for !!

Does anyone know how many machines they may have ?
250 is a lot of staff .

From the Faron website .
In the trial, Traumakine will be used prior to the current practice of corticosteroid treatment, to prevent systemic inflammatory response syndrome (SIRS) and ARDS, to improve clinical condition and reduce patient death

From which my take is that they expect EVERY patient to be given corticosteroids during the trial anyway , as its part of standard care now , and they can't get away from that fact . It's just that in their trial , Traumakine gets first dibs , then after the 6 days its back to standard care . That way , they get data on Traumakine in what will be a real world setting .

Dex has shown to be effective in these sort of patients ( ie needing hospitalisation ) . Not so much for those that don't need respiratory assistance .
Faron have always said they didn't mind the use of steroids , just not at the same time , and I assume , preferably after .

So they are obviously confident enough with the science that they are prepared to throw Traumakine into this trial , knowing that the Interferon will show good data , and that any steroid use afterwards will not adversely affect the Traumakine patient , in fact they seem to think it will actually be complimentary and bolster the results in our favour .

Otherwise it would have been simpler to just run a Calibre type trial with no steroids at all .

Worth noting that this trial will get the serious end of the Covid patients , not the mild ones , so mortality is a possibility , and Faron obviously feel that running Traumakine and then steroids will give the best patient outcome .

Below is the data from RECOVERY last year for steroids .
It shows that although effective - dex isn't a wonder drug - plenty of patients still dying despite taking them .
So definitely room for Faron to show added value by putting IFN Beta1a in first .

Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021). There was no benefit among those patients who did not require respiratory support (1.22 [0.86 to 1.75]; p=0.14).

Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.

I'm not a chartist at all , but if you are looking for patterns , and understand how Pharmas do work to a sort of cycle of news , then the last year has shown 2 two 3 month slides , then a short painful dip followed immediately by an epic rise .
We've now had the third 3 month slide . If we get a 20p dip on no news , I'd get the champagne on ice .

Oh , if only life was that predictable .

My take on it was that from the outset of announcing Hibiscus , Markku wanted to address the steroid issue face on .

This is because we have a conundrum :
1.) Steroids have a negative effect on Traumakines effectiveness when used together at the same time .
2.) Most hospitals now have steroid as the standard care for patients once hospitalised.

So even if Traumakine passes HIBISCUS with flying colours , it's still going to have an uphill battle being adopted by the medical world because they will still want to be giving the patients a dose of steroids on admittance .

I believe Markku wants to show that they can use the steroids 'after' Traumakine rather than first , as either a back up if the Interferon fails , or as a general anti inflammatory , once the Interferon has 'put out the fire' so to speak.

If he can prove that theory , then it will open up a lot more doors .
They obviously intend to try and prove it hence the patent applications .
This was in the Aug 2020 RNS : The study ( HIBISCUS) will test Traumakine against both placebo and dexamethasone, which is now a part of the standard of care in the US.

Clinicaltrial.gov info just shows placebo - so perhaps they have either had to simplify the trial for speed/ numbers , and the dex comparison will be done later on if the trial is a success ?
Thats why I was wondering where the dex was today , as that had seemed a key component of the HIBISCUS plan ?

Or perhaps the DofD , who are obviously bankrolling a large part of this , wanted the trial to be more simple and straightforward to show that Traumakine can help with severe lung issues , and major organ failure .

However , I see that this trial is listed as a Phase 2 .
So perhaps after the 70 patient readout , the proper Phase 3 trial will have the placebo and dex incorporated.

Yes 8 x 5000 buys that I can see today .
Then a push down on the price late PM on the Nas ( -3-4%)
I got a small buy in at £3.29 .
Mind you , there's sea of red out there on the stock market today , so might just be going with the flow .
Buts it's getting to that time again when I start thinking we are due some news .

To be honest , I have so many so called ' buying opportunities ' now in my portfolio , I'm spoilt for choice .
Looking forward to later in the year when I may have a ' selling opportunity' lol

Sorry to keep posting , but after all the talk of Hibiscus pitting Traumakine vs Steroids , I don't see any noting of Steroids being run here , just a placebo . Not sure if they will just record what other drugs are given to the patients after the Traumakine dosings ?
I'm not a clinician , but I assume after the Traumakine 6 days , if patient is still in need of help , they will then offer steroids too ?

Looking forward to Markku explaining all .

January RNS -
Dr. Markku Jalkanen, Faron's CEO, said: "We are pleased to have received approval from the FDA to commence our phase II/III HIBISCUS trial of intravenous IFN beta-1a in COVID-19 patients. IFN beta-1a has previously demonstrated a compelling scientific rationale as the body's first line of defense against viral infections and might be advantageous over current standard of care when given intravenously to patients suffering from COVID-19 induced ARDS. This trial will allow us to gain important insights into Traumakine's potential in this particular setting and we believe that this sequential administration of intravenous interferon beta, before corticosteroids, could become a standard of care in the future and as such have filed a patent application to protect the commercial opportunity.

Faron also covering themselves having applied for patent to cover using Traumakine and then steroids as a complimentary therapy .
Traumakine will only be administered for 6 days .

From January RNS
Company seeking patent protection for the sequential use of IV interferon beta-1a and corticosteroids.

The details tie in exactly with the Hibsicus RNS posted on 26th January .

The study will recruit 140 hospitalised COVID-19 patients with 1:1 randomisation assessing Traumakine against placebo with a primary endpoint of clinical status (WHO 9-point ordinal scale) at day 14. Secondary endpoints are clinical status at day 28, and in-hospital mortality at day 28 and day 90. The study protocol will have an interim analysis once 70 trial subjects have been assessed for the primary efficacy endpoint (clinical status at day 14). A further assessment of the conditional power will also be conducted in the interim analysis based on the observed result and the sample size will be adjusted accordingly, allowing completion of the study with confidence for regulatory compliance.

Interim analysis at 70 patients - and sample size adjustment .
Patients who have had steroids within 7 days prior to hospitalisation - EXCLUDED.

Patients must have respiratory symptoms requiring hospital care .

So finally - we have a trial about to run with the steroids excluded - patients ill enough with respiratory illness that they need hospital treatment .
This is about a good a chance as Traumakine is going to get with proving itself .

Just spotted this on Clinical Trials site - NEW listing for HIBISCUS !

https://clinicaltrials.gov/ct2/show/NCT04860518?term=faron&draw=2&rank=1

Start date May2021 - says not yet recruiting ( although I expect to hear news of first dosing soon )

Just added another pile thanks.
Another dip and I'll have another bite .
I really didn't think we'd get a chance at sub 20 again this far into the year .
Because I'm in buying mode , this is the only share at the moment where I get happy if it goes up or down .

Yes don't think the SNG home trial showed much info for us , other than more data to bolster the theory that Interferon beta needs to be administered just as patient is starting to get ill , be that breathless , or losing the ability to produce their own interferon defense.
Hibiscus really should prove us up one way or the other , assuming the patients will be ones coming into hospital in need of oxygen etc , rather than those on the SNG home trial who had just tested positive and were showing some mild symptoms .

Luckily we have the DoD investigating other uses for T , and the highly anticipated Bex cohort news which should arrive at latest before the May 20th Proactive Forum.

I really can't get too excited about REMAP anymore . They are blinkered by using steroids , and have essentially sidelined the Immune domain . They seem to be looking for big numbers of patient data , and they just won't deliver that for Faron , even if the small data set we get is good .

The old addage comes to mind , if you want to do it properly , do it yourself .

I always saw the home trial really as a way mainly to prove that the therapy could be delivered at home .
In that regard it was a great success.
It showed a successful way for the patient to self treat , and also an effective method of monitoring the patients progress.
I'm sure that they knew the small percentage of mild sufferers that go onto be serious cases was small , but it was worth doing even if they only gained experience and data for the home delivery method itself .
Like others have said - the uptake was slow - and it was probably only very pro active ( or SNG knowledgeable folk ) who actually enrolled . Much different from a hospital setting where you are approached by the doctors to ask if you want to partake .
It's a shame that the cases were so mild for the trial to show up good data , but it certainly didn't throw up any bad data .

Post hoc analysis can be very useful . In the case of Faron , a failed trial with IFN Beta1a threw up the fact that corticosteroids were interfering with the drugs efficacy . FDA accepted the post hoc analysis and new protocols for a new P3 trial were designed and agreed .

Synairgens trial results don't need anything drastic like that , but it shows that protocols and targets can change during the development of a drug , as more findings are made .

Finally had time to listen to presentation . Not sure if it was the whole thing , I think it was edited as this was only 19 minutes long.

From comments yesterday I was expecting some sort of car crash event , so unless they edited all the huffing and puffing out , it wasn't too bad at all .
I remember the P2 hospital trial result was delivered in the same subdued straightforward manner and nobody complained back then . Like others have said - this was just to lay out the results and conclusions , it wasn't an Investors evening Q&A .

Slide23 showed how if targeted to those in actual need ( ie suffering from breathlessness ) it delivers superb results .

Richard didn't seem too downbeat at all in my edited version , explaining how this confirms their conviction that breathlessness is an important indicator for targeting this drug , where it shows great effectiveness .

They were all obviously disappointed that the bulk of the trial patients were mostly mild cases ( 40% on level 1 ) , not their fault , but still gave them valuable extra data , plus it showcased how the therapy could be delivered in a home setting .


So to me , given the patients we were given , the results were entirely predictable , and in line with how Synairgen see the drug too .

Long Covid data will be very interesting - not essential , as the initial effectiveness will be good enough to see this drug to market , but logic says if you are preventing patients from prolonged lung injury to start with , longer term their symptoms and issues should be less than those on the placebo .

Activ 2 - I have no idea if these findings will be able to affect that side . I guess the patients who are at home all get picked before showing WHO 3-4 issues , but perhaps the larger numbers will help them catch some more serious cases that develop at home . Either way - if it eventually throws up the same data set - it will just reinforce the premise for using SNG001 on those who are most in need .

Phase 3 going well - so just a few months to wait ( unless they pull a rabbit out of the hat on the US side ) to confirm their findings on the right condition patients .

I totally understand the SP drop . That's the stock market . I was too slow to make hay there , although I did lower my average by topping up a bit .

So apart from a bruised SP , we are still on track for a bumper reward here .

If todays RNS had been a real mega Carlsberg one , I probably would have top sliced a fair bit on the inevitable spike .
As it was , I had a nice top up , and actually averaged down a tad .
Will now hold until P3 results - with a slightly bigger holding .
Ignore the noise etc . P3 hospital trial results WILL be good enough to get SNG001 marketed I'm sure .
And anything that comes before that will be a bonus .