Member Info for Saxondale

For those not up to speed on the Steroids subject :
RNS 6th FEb 2020

Following feedback from the FDA regarding the design of the next Traumakine study and receipt of agreed meeting minutes, Faron has updated the proposed study design and has submitted the amended trial protocol to the FDA. The trial protocol has been amended to reflect the FDA's feedback that further studies with interferon-beta (IFN-beta) should exclude the use of overlapping steroids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient outcomes. Faron will continue to work in close collaboration with the FDA to achieve final approval for the next study.



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.



A recent descriptive study published in The Lancet3 on the 2019 novel coronavirus (2019-nCoV) outbreak in Wuhan, China reports that 17% of the 99 patients with 2019-nCoV pneumonia developed Acute Respiratory Distress Syndrome ("ARDS") and 11% worsened in a short period of time and died of multiple organ failure. 19% of patients in the study received corticosteroids, a treatment option no longer recommended by the WHO.



Dr. Markku Jalkanen, Faron's CEO, said: "With no currently approved pharmacological treatments available, ARDS remains a significant problem for patients and healthcare systems. We are pleased to note that the WHO has recognised the risk of using corticosteroids on patients with coronavirus, which aligns with our findings from post-hoc analysis of the INTEREST study.

They are doing a good job again of making some investors either bored or thinking they can pop elsewhere for a few weeks and get back for the action . Been there once .
For those who bought in over £4 its a bit frustrating , and short term holders may just cut and run to try their luck elsewhere.

Luckily those who know the story and are used to how this share works are not surprised at all as to how the share is sitting at the moment . It's a great time to start your journey as a LTH . Ok , 2 years ago would have been better , but the plane hasn't left the runway yet . 2 years ago the plane didn't have an engine . Now its got 2 and they're warming up nicely.

Hardly worth repeating all the facts about where we are .
Plus it would take too long .
I dare anyone to read the last 10 RNS updates and not get excited .

Rick thats the old 2017-8 Interest trial - that post hoc analysis showed that steroids interfered with results .
We are so far down the road from there mate .
WHO new guidance
FDA approved new trials

So its old news .

If you watch a few interviews with Markku on Proactive - you will be brought up to speed on the situation

SNG is same IFN beta 1a as ours - but in a nebulized form

Different patent , different delivery method and dosage ( much higher)
We have a rack of patents involved with ARDS , the diagnosing / dosing of IFN beta 1a , and the freeze drying patent for global distribution .

Somebody more experienced than me can give you the exact details , but basically we target the problem from the inside , with much more accuracy , intravenously , rather than a large dose breathed in .

I hope theirs works too , but 95% of my pharma share money is here .

Can they please repeat this price dip every day , maybe at 10.30am for the big dip , so I can buy a few more whilst enjoying a coffee and a biscuit , rather than waiting in all morning ?

Could be great timing Copper .
The Clevegen program now coming on strong at a time when cancer immunotherapy is becoming a leading biotechnology force .
Traumakine program reaching its final test stage before launch - during a worldwide pandemic.

Small free float of shares , with growing institutional holdings .

I'm trying not to get carried away , and always look on this share from a distance once a week , to make sure I'm not getting too emotionally attached to it . Every time I do that , it still makes sense .
It could be a steady increase in SP with Matins updates , more II holdings etc .
or..
That mythical incoming RNS is still there as a possibility . One that's getting a bit more possible every week .

Exciting times CB - you've been waiting longer than me , but its great to see it all coming together !

Not particularly pleasant reading from a moral standpoint , but this article highlights the profits that drug companies will make with any Covid therapy . Govt subsidies may be needed to maintain availability to all those in need . Supply and Demand though .
Sirpa Jalkanen herself pointed out that the therapies targeting unmet medical needs are the most profitable .
Multi billion dollar market.

https://www.theguardian.com/world/2020/may/11/soaring-drug-prices-could-bar-access-to-future-coronavirus-treatments

Part of a consortium , so shared knowledge and state of the art characterization of the responses they find.
Points again towards this use of Clevegen as a combi drug across the board .

Was it Leiwo who mentioned personalized therapies - looks like he was right there .

Clevegen to be studied in experimental combinations with anti-cancer molecules from other consortium members.

Cracking !

Not bad , nearly a million euros chucked at them to help them do what they were doing anyway .
Another big show of confidence in the Clevegen program
Well done Faron team

They also have patent in for screening pregnant women for complications or estimating risk of complications , linked to Ovarian cancer and the use of Clevegen .
If they pick up on high levels of Clever 1 expression - they have a very poor outcome with current treatments.
Ties in well , as they announced that Ovarian cancer would be their second cohort back in Jan 27th.
Having the diagnostics to screen the patients will give them much better understanding - as it will screen those who need/ would benefit from treatment , and help them to prove up what they know .

Patent Jan 7th 2020

https://patents.justia.com/patent/10526607

From the RNS 27th Jan : Ovarian cancer is a tumour type known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). It presents a high unmet medical need with few available treatments for patients. Large transcript analysis of ovarian tumours indicates significant outcome differences between patients with either high or low Clever-1 expression. Patients with high Clever-1 expression have short life expectancies under current treatment options.

Investors , armchair boffins , and real boffins - loads to look forward to .

Browsing the AGC Biologics website , they seem to have extensive experience of producing mammalian based lines.
Beta 1a is produced from Hamster ovary cells I believe , which AGC do with their CHEF1 Expression platform .

Have we found our new Traumakine manufacturing partner already ?

I may be barking up the wrong tree however as I have no proof that any of this is relevant , but to a novice investigator it looks promising .

https://cdn2.hubspot.net/hubfs/1924513/PDFs/CMC_CHEF1_2016.pdf

Digging deeper , AGC Biologics used to be called CMC Biologics , and a search on their news history throws up quite a few manufacturing contracts for lyophilized powders .

http://www.agcbio.com/resource-center/news/cmc-biologics-in-commercial-supply-agreement-with-emergent-biosolutions-for-fda

Thats enough Columbo for today - see what the next news is .

haven't looked at it too closely GK but guess maybe that if you don't have the patent for IV delivery of Beta 1a , its not worth your while doing a trial on it . So maybe the company involved in sponsoring that trial is a Beta 1b player .
The Remap guy in early April said they would expect some clear results in 3-4 months .
Who knows what the next update will be . Could be a Manufacturing update for T . If there isn't a leak they will want to have everything in line before any REMAP findings .
The fact a 14 million Euro placing came out of the blue , indicates to me , like Zen said , that the partnering discussions were not looking juicy enough , and with fast track status now looking much more likely for C , the timeframe to market would be that much shorter , and so the possibility of going it alone across the finishing line becomes achievable .
At the moment Traumakine & Clevegen are wholly owned .
Demand for a lung treatment is and will be off the charts for years to come .
No panic now to sign up for a low ball offer .
Despite all this , I'm still curious to know more about the secret weapon . Work must be ongoing there , and i'd love to hear more about that .

REMAP website had a bit of an update on numbers .
Now showing 902 total randomised patients , 408 with Covid .

160 sites over 14 countries - and looks like the UK is leading the way , although the UPMC trials in the US lead by Dr Angus is only showing as 1 site ( and they have 40 hospitals alone ) so in reality I reckon there are more .

Considering Farons phase 3 trial was only looking for 200-300 patients , we should be well on our way to getting some good data , albeit we are sharing the patient numbers , but as drugs such as hydroxychloroquine fall out of favour , so ours should be pushed up the leader board .

Exciting times !

https://www.remapcap.org/

Quite a bit I think rick , which isn't a bad thing , as ours is the most immunogenic form of Interferon , made using hamster ovary cells . Beta1b is made from E.Coli bacteria .
So almost chalk and cheese in scientific terms .

Its odd that although Intereforn beta has been used to treat MS for years , they still don't seem to know why it works .

At least with Traumakine - the studies and science know exactly how it works , and what it does .

Our time is coming . IFN Beta 1a - delivered intravenously , on its own as a therapy , distributed globally in a lyophyllised form along with a patented kit to monitor the condition for dosing .

Not 100% relative to us but if it produces more media about Interferon thats a positive.

They are talking about Interferon Beta 1b delivered by injection . Traumakine is Interferon beta 1a delivered by I/V .

Differences shown here -
https://pediaa.com/what-is-the-difference-between-interferon-beta-1a-and-1b/

Mary Moo asked the other day about FPHAF .
Looks like it has been set up as an OTC ( over the counter) share in the US . Currently at $4.75
Can't see much detail and doesn't show much history so guess its a recent thing .

Maybe a little teaser so at least any US investors can see Farons details listed .

Also , Lago Kapitals initial 3 month agreement to be the liquidity supplier for Nasdaq First North ended on 3rd March , and from then on they have been on a 1 month rolling contract .
The intention was to promote liquidity into the share.
I wonder how long that will continue . Anyone have experience of whether they would be needed an an ongoing requirement ? Do these agreements run and run with a dual listing like this , as a method of maintaining a flow of shares to avoid spikes .

Morning CB . Not rushing to make a quick buck on this share ( already there on that one like you :-) ) , be great to see how this plays out over the next year .

Great presentation Magic , perhaps you should send your CV over to Greatland too . Top job

I agree Leiwo , stability is what the big boys are after once this has re-rated .
Many will cash out early on ( albeit a lot richer ) - but the institutions will build their holdings and enjoy years of profit and dividends .
If T or C go big , I'm sure they have their eye on Nasdaq main market for starters .

I can't remember how I even came across this share , I think it was literally one morning I decided to have a punt on 2 random pharma shares , based on what had been RNS'd that day on VOX . The other one was Redx , which sank from 14p to about 4p , then I sold 2 months ago and the next week it went back to 14p . Over the previous year I think there were 2 RNS's for that share ( both dull) . They bored me into submission .
Faron started as a punt , but every month we got juicy tidbits of progress . There was this Z guy who was manning the board like a slightly crazed lighthouse keeper , keeping the flame burning while ships passed by . I was hooked .
And slowly people started realising that this company actually had something. Every RNS showed substantial progress , and every interview backed it up and didn't set off the bullsh*tometer .
But still we were so far under the radar that you needed a periscope to check the share price .
I suppose 10 years of burning cash and still not getting anywhere concrete wasn't exciting yet for investors .
Then something clicked , and from mid last year you could start to feel the excitement and positive vibes growing with every new update .
Anyway - roll on nearly 12 months and what a position we are in .
The lighthouse now has many keepers , and a fine bunch they all are .
Not long to wait now till our ship comes in !

And to think all this from a random punt - could have so easily missed it and gone elsewhere.
Anyway enough rambling - have a great weekend all - looking forward to more news !

Seems a long time ago since we had a good surge in share price .
March 19-20th we went up 50% - not on the back of an RNS , and it was a few days after the proactive interview .
Sure - we will go mental on a Covid/partner RNS , but this share can do it out of the blue on its own sometimes .

I feel like a geologist looking at seismic data - we've had some recent tremors , and a minor quake on March 19th-20th , but the charts are telling us we are due a biggie any day now .