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Rather awkward here how it can confuse ie trial results have been peer reviewed in the question, then in the answer Clinical Trial study report wont be peer reviewed.

Then they will submit, after putting a manuscript of, to a peer reviewed Journal and if that's accepted.

lots of ifs, imaginationss probably, sure and a not sure. How do you submit a non peer reviewed report to a peer reviewed journal?

45 days out of the window the BJP a tad different to the BMJ.

Nothing overly important here

Agree nothing to be communicated until notification that trial has started.

3rd quarter does look favourable for at least preliminary results.

Just added a thought and 4 month tox study would I believe be 4 months of treatment plus follow up period afterwards that would contribute to finalisation of results.

It is what it is

Regards

Potnak. 16 weeks plus a month from commencenent of trial, Tim did not appear to tell me anything about timelines as it was Stephen Parker, (I dont know where you got that notion from as I posted this information in relavent post).

AS I put put before i asked post closing of the meeting so not recorded or edited out after the meeting.

Potnak at what moment in time does your reliance on JR states 6 months come into effect? Last year? Last month? Last week? Next week week after? next month. month after next?

These timelines are all fine but when does JR's start?

The only reliable timeline we have is 16 weeks plus a month for results.

These results will be preliminary

But we need and indication just acknowledging progress and looking to a tox study test start in such and such time.

Sareum still does not seemed to have learned that the need communicate.

My opinion for what it is worth is that trial data will not be published by BMJ in 45 days. Very little benefit and you are paying somebody to interpret the data which is nothing more in effect than a salesman.

Coeliac disease.

not surprising that the aging Tofacitinib is being pushed in Coeliac disease..

Area of urgent need. Squeezed out of other indication areas by the like s of Deucravacinib and the dreaded Jaki tarbrushing.

Nice little niche market 600 million a year forecast to rise to 1.3 billion by 2032.

Of course in this market it consists mainly of gluten free foods.

From patent description re 1801

2.15 A compound of formula (2) or a salt thereof as defined in any one of Embodiments 1.38 to 1.105 for use in a method of treating a disease or condition in a subject in need thereof, wherein the disease is any one or more diseases or conditions selected from:

(a) skin inflammation due to radiation exposure;

(b) asthma;

(c) allergic inflammation;

(d) chronic inflammation;

(e) an inflammatory ophthalmic disease;

(f) dry eye syndrome (DES, also known as keratoconjunctivitis sicca or dysfunctional tear syndrome);

(g) uveitis (e.g. chronic progressive or relapsing forms of non-infectious uveitis);

(h) insulin- dependent diabetes (Type I);

(i) Hashimoto's thyroiditis;

(j) Graves' disease;

(k) Cushing's disease;

(l) Addison's disease (which affect the adrenal glands)

(m) chronic active hepatitis (which affects the liver);

(n) polycystic ovary syndrome (PCOS);

(o) coeliac disease;

(p) psoriasis;

(q) inflammatory bowel disease (IBD);

(r) ankylosing spondylitis;

(s) rheumatoid arthritis;

(t) systemic lupus erythematosus;

(u) myasthenia gravis;

(v) transplant rejection (allograft transplant rejection); and

(w) graft-versus-host disease (GVDH);which method comprises administering to the subject an effective TYK2 inhibiting amount of the compound of the formula (2) or a salt thereof as defined in any one of Embodiments 1.38 to 1.105.

Very interesting Krone and as you may be aware Type 1 diabetes is in the patent description of SDC1801.

Jak inhibitor far safer than the synthetic insulin in my opinion

Https://www.bms.com/about-us/responsibility/transparency/policy-and-advocacy-engagement-and-political-contributions.html

No problem Celtic007

There is a link below. You can scroll down about halfway and read from the header ' Discussion'

I will add that from the preliminary data no changes in plasma levels were observed. This will include the 300 mg per day.

The concern is major adverse cardiovascular events. Ie strokes and heart attack or risk of.

What to note of course is that many people with an auto immune disease are more at risk of major adverse serious events from the specific disease itself Rheumatoid Arthritus being one.

Interestingly talking to Tim about the differences between 1801 and 1802 is the reduction in Jak content in 1801 in which his decision to lower the jak content allowing acceptable level of safety.

We can't allow treatments that have an off target effect in auto immune that would be allowable in the treatment of cancers.

Hence we have 1801 and 1802 and of course we know that 1802 has patent protection for use I auto immune.

Some auto immune conditions are quite debilitating.

Have a read yourself and these MACE concerns have been pushed through comparatively recently 2021 to 2023.

Very convenient for Deucravacitinib as Tyk2 only.

Any jaki inhibitor irrelevant of selectivity is found guilty until proven otherwise.

So l sit confident myself with what l know and looking at the pros and cons, other inhibitors performance, selectivity and safety and those that discontinue further trials in an indication.

https://pmc.ncbi.nlm.nih.gov/articles/PMC10442954/#:~:text=The%20US%20Food%20and%20Drug,conditions%20(FDA%2C%202023).

Certain Indications require a lifetime of treatment. How does a pharma become satisfied that a compound that they may be intersted in is satisfactory for use over long albeit low dose treatment regime.

There are many many new inhibitors in development most will fail.

Stastically they put phase 2 at the biggest phase of drug failure.

Brepocitinib ceased development in 7 Indications.

All down to safety and much harder with these recent MACE concerns and FDA required warnings.

It is what it is for the time being.

Regards

Good morning Celtic007.

I asked when are these toxicology studies likely to start?

Early in the New Year.

Definitions run from Jan to March and January to June.

These fefinitions are from early in the year and to me is different to early in the New Year.

Now how long after the AGM has Sareum appointed the CRO?

Not many working days left in the yearnot a problem if the CRO has access to the required animals.

May take a while however if we use non human primates. Animals need to be settled in and not stressed.

So prep work is in progress?

If these animals are required to be imported then this takes time and as the CRO have not been appointed this indicated a delay that could have been prevented if this is the case.

Annoying attributes of Sareum

A statement is made to likely start date of which they say early in the New Year.

No explanation as to the reasonings.

January is early part of New year and so is March by definition.

I may be wrong and we receive RNS next week but personally am looking at late Feb to be my estimate.

Regards

Interested parties keen on establishing if yellow box free.

That will be part of negotiation.

Of course once established up goes the value of SDC1801 considerably a billion plus is not out of the question. Take it into context of Deucravacitinib ball park figure.

Fearg, krone.

Good morning, the importance here if the toxicology studies here can not be over estimated.

In effect what it would allow is potential lifelong treatment with a compound that has satisfactory efficacy in an indication.

Indications have not itemised but there are numerous.

Our nearest competitor Breprocitinib cannot have this freedom due to its safety profile.

They come under the yellow boxed warnings.

In this case never will become first line treatment.

The value is down to the toxicology study results and interpretation of the data.

We have bypassed phase 1b having no planned toxicology studies to go into phase 2 in whatever indication is decided.

No Indications given at the AGM

I doubt take it that thus is immaterial as satisfactory tory tox results sufficient for us to escape the yellow label warnings is enough.

No need for trial into Psoriasis, UC, crohns, GVH, SLE or one of many others.

A pharma can take on the compound and basically do whatever it wants in any indication or indications it chooses content in the knowledge that their are not long term usage restrictions.

Add on robust patent protection to the early 2040's and this indeed looks extremely commerciable.

As an interesting point how many noted that GSK undertook a buyout of Sierra Oncology and yet all the other pipeline products were returned?

It was not just 737. They also had a very promising WEE1 inhibitor that SO were looking to combo with 737.

Regards

Not sure if this has been posted before, but worth a listen.

https://www.edisongroup.com/edison-tv/sareum-holdings-executive-interview/34181/

At AGM l asked how long for phase 2 toxicology results would take.

Stephen Parker replied with from commencement 16 week trial plus a month to gather data.

Now as John Reader stated previously that you are looking at a minimum of 6 months.

Prep work and trial planning is in progress and has been for a month or so.

The question l put and of course not recorded was post closure of the meeting. They were all sitting at the table.

Should toxicology start beginning of Feb then you are looking at July for preliminary data.

Finalisation will of course take a little longer.

Stephen Parker 4 months plus a month from trial start.

Blockbuster1

I suggest have a read through all previous RNS,s.

Have you carried out any research yourself?

You put:-

'So why do we sit at just 0,045p a share if what you say is true?'

There is no'if' about about it Blockbuster1 !

What I have stated is true.

It is called market sentiment.

When you understand what market sentiment is and what affects it then you will understand.

As I have said many times before the pharmaceutical sector especially AIM has been absolutely hammered due to lack of investment. It is not just Sareum. All pharmas spiked around the Covid period.

Look at companies like Rolls Royce, BAE systems that have jumped 5 fold in value since mid 2021. That is where investment is funnelled.

Virtually no risk at all here with a US western orchestrated creation of the Russian SMO in Ukraine.

Who sits at the top of the tree ?

Companies like Blackrock sit at the top. These are the people that control governments! With over 10 trillion dollars in assets. They dont accrue that much wealth in a short period of trime by being nice.

Over 20 trillion of natural resources in Ukraine. Black Rock had their eyes on this for ages.

Look at the recent development of a company by Blackrock involved in planning and rebuilding companies for infrastructure.

No risk of losses here!

All about sentiment of course.

As you claim to have been accumulating stock over the past 15 years, why have you not sold some at highs and bought on lows? i find it odd that someone who claims to have accumulated stock 15 years ago is now becoming so concerned as to its future. It does not add up to me.

In effect, what is your problem?

If you have accumulated 15 years ago you are still sitting on a profit.

Regards

Yes Joey5000 and you have nothing constructive to contribute as usual.

How long you been invested here?

What do you know about SAR and the potential?

Come on lets have a little chat

Blockbuster1, over the past 15 years the stock has risen from lows of 0.18p or less to over 5050 fold increase. phenomenal rises have been made after periods of substained low sp.

We now have our own wholly designed SDC1801 moecule in state of preparation for phase 2 clinical trials.

Our safety profile betters that of our closest competition, Our ADMET prformance is first class and our efficacy although yet not proven in clinical trial albeit ticks ( or should that be Tyks) the boxes in many, but not all indications with the

relavent Jak Stat pathways.

We are predominently Tyk2, I am sure you understand the importance of this.

I take it over the past 15 years you have experienced ample opportunity to sell, we are much further advanced however the AIM businesses have been decimated over the past 3 years and companies have suffered with many leaving or going to the wall caused by lack of investment.

My confidence grows by a magnitude of order (in my opinion of course) over your daily clamied lessening of confidence.

You state boom or bust?

Boom it can but what on earth will make it go bust when we already have superior dose escalation results over our nearest competitor?

The purpose of the toxicology studies is to establish a satisfactory safety profile for use as a long term treatment, not to determine whether the drug is not suitable for use per se.

i welcome your comments on this.

Regards

What is your expectation from SDC1801 Surfie1961?

Dont be surprised if the price drops Bailiff.

Damion, the MHRA never rejected approval, they were unable to authorise which is definately not the same.

Sareum have written to MHRA requesting reasons for not approving, and as yet the MHRA have not replied.

They will not reply as would have to admit they were at fault.

Only one person believed to be handling CTA's in the UK.

All preclinical work carried out to GLP procedures in line with MHRA requirements.

My own theory on this matter is that, at some stage long term toxicology studies became a requirement to have these long term studies (with two non rodent animals of which one is a dog and the other a non human primate) due to increased events being recorded post covid with JAK inhibitors with the now mandatory yellow boxed warning.

The regulations and requirements pertaining to these toxicology studies to comply have also tightened.

Changes are introduced over a period of time and whilst Sareum had covered studies with animals in preclinical testing over 3 years ago they did however comply with authorising body requirements.

Sickening when you think that there was a poster on here spreading the fear factor of, there must be something wrong with it or it would not be refused, neither are correct.

I have stated time and time again that there will not be any problems with SDC1801 with the SAD and MAD dosing.

Was I correct?

Several on here want to find fault,no need to name as they know who they are, but there are very few that will at least have the courtesy to accept that on certain aspects i am right.

Now if Sareum or indeed the CRO involved were at fault then tell me why then has the MHRA not replied.

Regards

Most certainly Krone.

Early tox results great.

Long term will give us a value. If we are similar with regards to safety as Deucravactinib due to the low Jak content, then what value can you you place on SDC1801.

The only person of any credibility was TM at circa 800 million.

The compound 1801 is designed and made by him, he is aware of the competitors and also deals that have gone ahead.

Where the SP sits at the moment is immaterial, unless of course you want to raise funds.

Now, surely Sareum would be looking to raise funds post tox testing preliminary results as opposed, prior to where our SP sits on no news.

What do you think would be the result of the corresponding SP should the long term safety data be as good as the SAD and MAD results?

Personally, I dont think we will be here in 2026 as will be bought out 750 million plus in H2. That price being an absolute bargain to any pharma. The BoD like many of us here are getting on in years.

Anyone care to put an arguement against please feel free and give your reasonings.

The Company has also strengthened its intellectual property position with two key patent milestones being achieved:

· A Notice of Allowance from the US Patent and Trademark Office for a patent offering substantial protection on SDC-1801's chemical structure, its use in treating inflammatory diseases, and certain methods of chemical synthesis. This completes protection for the chemical structure of SDC-1801 in all of the major territories.

· A patent allowance in China protecting certain crystalline forms of SDC-1801 and methods of their preparation, marking the first patent allowance protecting crystalline forms in any territory.