Member Info for PCS1954

Good evening SOG

Not sure you have pulled my post apart, perhaps highlighted some poor grammar on my part - “for efficacy to continue in phase 2” - perhaps I should have stated “ phase 2 for efficacy to continue”.

As we know, a clinical trial never ceases as many drugs make it to market with stated added side effects, so “to continue” seemed appropriate choice of wording, my apologies if you feel differently!

Other than that, you opinionated some financial scenarios, same as anyone else - no problem.

GLA

Putting a pragmatic “business” head on, I would have found it strange for the BoD to progress this far without some form of financial “funding” plan ( they surely learnt from the RF debacle what happens when you get to “zero” pot ).

They also stated they were “advised” to get to Phase2 ready and that it was the intention to on license/deal rather than go alone, albeit, it would remain an alternative.

There is a misconception on here, if people think that week 16 is the “tick box” for SDC-1801, it’s only the dosing period - data analysis, evaluation and reporting of GLP on all matters relating to that dosing to be scrutinised before regulatory submission to MHRA for efficacy to continue into Phase2 trials.

So on reflection, I’m going back to my original thought process that we’ve been pushed to get to Phase2 ready with financial “avenues” hovering.

As for SRA737, I again go back to my original thinking and it’s outside the above, a separate “funding” opportunity.

I just can’t see SP or the BoD relying on some cashed in warrants and/or a hopeful HNWI “punt” at this stage of the game.

I know people can pull above to pieces (and probably will), but, as I said just putting a “business” head on.

GLA

HBD, don’t worry, you do enough research - I’m comfortable with your statement and that things are ongoing, just a wee baffled at the timelines of anything “financial” over the last 6 months!

GLA

Https://endpoints.news/biopharma-ma-maintains-strength-even-as-large-deals-wane/

GLA

HBD, think Google may well have 😉

All touch and go in my opinion, unless with have been guided with a financial “incentive” at the outset as you and I have mentioned, it seems “finances” are being left late again - I was a strong believer that SRA737 would be our “driver” - I still feel it’s on as we gained the patent extension, but, it seems to be taking an eternity.

With all the potential talk of pharma funding, M & A ‘s etc. (I’ill ping another separately) - really hope we’re not letting the “finances” drift and knock ourselves out of “competitive” negotiations!!

GLA

Morning HBD

Below, as per Google AI

“Sareum Holdings plc (AIM: SAR) currently has two primary groups of outstanding share warrants, totaling an estimated 16 million potential shares, alongside several million historical warrants.

The primary outstanding warrants are:October 2024 Subscription Warrants: These are \(1-1\) warrants issued during late 2024 fundraising. Due to a clause allowing for adjustments if a lower-priced fundraise occurs, these warrants had their exercise price adjusted down to \(12.5\) pence. They hold an expiration date of October 2029 and account for approximately \(11.1\) million shares.

2021 Introductory Service Warrants: Issued to providers who facilitated past share subscriptions, these cover up to \(29\) million shares with an exercise price of \(5\) pence. These warrants are conditional upon the stock trading at or above \(7\) pence for five consecutive days and carry an expiration date of May 31, 2026.

Historical Director & Consultant Warrants: A smaller batch of about \(580,000\) warrants remains outstanding with an exercise price of \(2.50\); these only become exercisable if the share price hits \(3.50\) for five days.

Investors actively monitor these updates, as frequent blocks of warrants have been exercised at \(12.5\) pence.”

Be interesting how the “2021 warrants” are handled as they are due to expire in two weeks, but, were introduced as a “thank you” - if they expire, with no consequences, and as a business option, I agree with Potnak’s thoughts of perhaps generating a low key cash raise on the back of successful completion of Toxicity Studies- that would then cover the “fat that we need to leave on the table” to progress a deal to fruition.

All opinions on where we’re going, but, let’s hope the BoD are engaged on at least one of them for betterment of our abysmal shareholder value, given what our “stated” pipeline is!

Enjoy your Sunday.

GLA

Hi potnak, yep have all that in the thought process - I see both ways with it all.

Regarding warrants, my belief is the HNWI’s allocations of 2021 will expire this year before being able to exercise.

Have a good weekend.

GLA

…. It will be very disappointing after reading the general availability of funding in the Pharmaceutical world, the stated aim of the BoD’s business model if we go down yet another dilutive route, given the link below.

I fully understand that the “deal” needs to be right, however, if what we are being told by the “Lab” and the “Marketing” departments of Sareum is as stated, common business sense says we should be in “discussions” with a least someone who wants some if not all of “us” !!

The Edison report in itself states looking at “avenues” before the requirement of dilutive funding, that said it may be the only option the BoD have which is a little bewildering given they intended not to go along with Phase2 themselves.

https://endpoints.news/ma-isnt-just-for-big-pharma-mid-size-companies-are-stepping-up-deal-hunts/

Just my view, appreciate others possibly read a different scenario - that said, here’s to completion of a successful Toxicity Studies, otherwise, the above is of an irrelevance to any current opinions.

Have a good weekend to all.

GLA

At this moment in time, I read the Edison report as quoting SRA737 being a potential avenue of funding - doesn’t mean it will be, but, reads as an option whilst Toxicity Studies still in progress and covered to end of.

Nothing to stop HNWI contributing to keep the lights on and I seem to recall SP stating a preferred non-dilutive route - that said business is business.

Have a good weekend all.

GLA

Fair point potnak, I would add though we have allegedly been speaking with regard to SRA737 for over 15 months and still none the wiser!

GLA

Morning

Let’s not get into silly spats, we all know the score - funding will be needed at some point, hopefully, non dilutive through potential “deal” of SRA737 and/or SDC-1802 ( this case, possibly unlikely until Toxicity Studies concluded) or wishful thinking a T/O, otherwise it’s a “dilutive raise”.

A heavy dilutive raise has many consequences for both shareholders and BoD alike, so I’d like to think behind all the “cryptic” soundbites of “interested parties”, “talking to” etc .. something actually is progressing on a non dilutive solution and there is deliverance of that much “promised” shareholder value - current shareholders intended!!

Time will tell!

GLA

Hi HBD

Direct access, unfortunately, like IR doesn’t always register a reply - that said, I know the message in this case has been read !

GLA

HBD

Sent message direct to SP, let you know if any response!

GLA

Opening ok at the moment, albeit, last day or two had to have a couple of attempts to connect as saying site not connected to server 🤷🏻‍♂️

GLA

Hi HBD, fair comment re: peer review 👍, bb at it’s best!

GLA

Sorry for double post 🤷🏻‍♂️

GLA

Hi HBD, trust you’re well and yes understand all the “potential” of the route we have taken as discussed at the AGM with some BoD members and other shareholders - yes 16 week “provides” better information regarding toxicity/efficacy etc.. , however, my point is we are a very small biotech, with apparently fingers in many pies, many others are in the kitchen too - we need to get something on the picnic table very soon!

Also, the peer review has only been submitted not accepted to review as far as I’m aware - that, then provides the justification of our Phase1a data.

Chairman’s Corner due in a week or two, hopefully, some positive “enlightenment” on matters Sareum!

GLA

Hi HBD, trust you’re well and yes understand all the “potential” of the route we have taken as discussed at the AGM with some BoD members and other shareholders - yes 16 week “provides” better information regarding toxicity/efficacy etc.. , however, my point is we are a very small biotech, with apparently fingers in many pies, many others are in the kitchen too - we need to get something on the picnic table very soon!

Also, the peer review has only been submitted not accepted to review as far as I’m aware - that, then provides the justification of our Phase1a data.

Chairman’s Corner due in a week or two, hopefully, some positive “enlightenment” on matters Sareum!

Totally agree potnak, we are at the stage where first we need good “chronic” toxicity studies data to propel us up the “pack”, then good negotiation (accepting we will have to leave some fat on the table) to get a good financial scenario to accelerate us along, rather than the “glacial” progression we appear to take.

There’s obviously a reason for bypassing Phase1b and “sub chronic” 13 week toxicity with SDC-1801, let’s hope all comes to fruition in the very near future!

Time to get a fair deal and pass the baton - the “big” numbers come with “big” dilution, is my thinking!

GLA

Again, I appreciate it’s AI, but, below seems to “suggest” we were guided into 16 weeks - crucial 3 weeks ahead and hopefully successful completion 🤞

In the UK and Europe, a 13-week toxicity study is a standard sub-chronic, repeated-dose study (typically OECD 408/ICH S7A) designed to support medium-term human clinical trials, while a 16-week study is not a standardized, conventional regulatory requirement and is often a bespoke design for specific pharmaceutical or, more commonly, monoclonal antibody (mAb) studies to identify novel toxicities.

Key DifferencesStandardization vs. Bespoke Duration: The 13-week study is the conventional "90-day" sub-chronic study used to identify target organs and set safe doses. A 16-week study (or studies ranging 12–16 weeks) is often used for biopharmaceuticals, where longer duration allows better identification of novel toxicities in chronic studies.

Purpose: 13-week studies are standard for IND-enabling packages to support clinical trials, identifying potential preneoplastic lesions or toxicities. A 16-week study duration can serve to reduce the incidence of unexpected findings in later chronic studies (6 months or longer), as longer 12-16 week studies are better at predicting these risks.

Regulatory Focus: The 13-week studies often inform the need for long-term chronic studies. Research into mAb toxicology has shown that 12-16 week studies provide higher confidence for identifying toxicities that might otherwise be missed in shorter (1–4 week) studies.

Study Design: While both look at hematology, pathology, and clinical chemistry, a 16-week study may include specialized recovery groups or be designed to specifically bridge the gap between sub-chronic and chronic toxicity for specific biopharmaceuticals.

Both study durations are aimed at understanding toxicities beyond the 4-week acute phase, generally adhering to GLP (Good Laboratory Practice) and OECD guidelines for safety assessment.

GLA