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Evening Billy - although 75p would get the m/cap back to pre-RF levels, it doesn't take into account the progress made since then i.e. completion of SAD & food effect stages without adverse effects and the intention to jump forward to P2a rather than P1b. Each of those steps should add to that notional 75p per share so maybe £1 is nearer the mark.

They might not need to fundraise as the Edison Report (see below) notes, "we expect the company is likely to seek non-dilutive funding in the form of a partnership".

https://www.edisoninvestmentresearch.com/?ACT=18&ID=33426

Hi Basil - and just to add, recent RNS make reference to the SAD/MAD/food element of the trial and also P2a. No mention at all of P1b. Coupled with what they've told us regarding being able to reach concentrations in the blood where it could be therapeutic, we have a pretty nailed-on certainty that good news is on the horizon.

Damion - I'm afraid I can't say I agree with anything in your second paragraph. But at least "...or maybe they just haven't got a clue what and are just bouncing from pillar to post" was comedy gold.

Enjoy the rest of your weekend.

Hi Damion - even without reaching a maximum tolerated dose (a good problem to have, as JR has said), the known results so far note:

· Preliminary blinded safety, tolerability and pharmacokinetics data from the trial indicate a favourable profile and support once daily oral dosing of patients.

· These preliminary results indicate that SDC-1801 has the potential to achieve therapeutically effective dose levels with no serious adverse events.

This tells us that irrespective of a MTD being found, the dose levels used this far should be sufficient to cause a response in psoriasis patients. Remember, the P1 trial is mainly about safety - 1801 is safe! The P1b is to see if there is a positive effect on the disease compared to a placebo. The related RNS didn't suggest there wasn't enough data, in fact it told us that things were progressing so well that we can jump ahead to P2a. That is a big step and we can only imagine the damage it would do to the company if the BoD were trying to circumvent established protocol for clinical trials i.e. they'll know better than anyone here if 1801 can progress or not with respect to an unestablished MTD.

I'm sure you've done your own research on this topic so please share what you found.

Afternoon Damion - clearly the BoD wouldn't know how 1801 would do in the trial before it started so they had to plan for a P1b. I used an AI tool to ask when you can skip a P1b trial and head for a P2a trial. Answer below -

"A drug can skip a Phase 1b trial and move directly to a Phase 2a trial under specific circumstances, primarily when there is a high degree of confidence in the safety and pharmacokinetics of the drug based on previous studies or data. This is not a common practice and is generally reserved for drugs that have already undergone extensive preclinical testing and have shown promising results in early clinical trials.

Phase 1b trials are typically designed to further evaluate the safety and pharmacokinetics of a drug at higher doses than those tested in Phase 1a trials. They are crucial for determining the maximum tolerated dose (MTD) and for understanding the drug's pharmacokinetics in a larger group of participants. However, if the drug has already demonstrated a favorable safety profile and pharmacokinetics in Phase 1a trials, and there is strong evidence supporting the drug's efficacy, it may be possible to proceed directly to Phase 2a trials.

Phase 2a trials, which are part of the broader Phase 2 trials, are designed to evaluate the drug's efficacy and safety in a larger group of participants. These trials are often divided into Phase 2a (dose-finding) and Phase 2b (efficacy) trials. Phase 2a trials are particularly important for determining the optimal dose of the drug that balances efficacy with safety.

The decision to skip Phase 1b and proceed directly to Phase 2a trials is made by the drug development team, often in consultation with regulatory authorities like the FDA. This decision is based on a thorough review of the drug's development history, including preclinical studies, early clinical trials, and any available data on the drug's safety and pharmacokinetics. It's important to note that skipping Phase 1b trials is a significant decision that requires careful consideration of the drug's development history and the potential risks associated with moving directly to Phase 2a trials."

Hi SOG - see below for another paper citing 737. Published on 25th April (apologies if someone has already posted re this one) - Therapeutic Targeting of DNA Repair Pathways in Pediatric Extracranial Solid Tumors: Current State and Implications for Immunotherapy.

https://www.mdpi.com/2072-6694/16/9/1648#B42-cancers-16-01648

Hi Billy, very true but I'm reminded of a thing Clement Freud once said. He loved horse racing and would always gamble a large enough amount that it would cause him some physical pain when he lost. That way if he won, it felt like the whole universe was smiling upon him.

Call me shallow but I have a specific financial goal in life and if this hits anything north of about £3.80 a share then I'll be one happy lad. That isn't far off where we once were, albeit the world was a different place back then. With so many LTHs still invested after all these years it's either a case of Stockholm syndrome or they also think the sp has some way to go yet.

I don't want to put you on the spot but you must have some notion of what would be an acceptable sp if everything works out - care to share?

In the world of pharma, failure is always an option but I can live with that.

This is indeed the quandary, SOG. I will have similar funds available very soon but not sure if I should buy more having already used up this year's ISA allowance, wait to see if there's a further WRAP that will include Halifax customers or just sit tight with what I've already got and stick my money in Premium Bonds/local guitar emporiums.

Difficult to judge as there are so many unknowns -

Will a partner come along to take 1801 through P2 without any cash payment to us and no share dilution but they take a chunky percentage ownership of 1801? We'd then need to raise cash later for 1802 progress.

Will someone license 1801, giving us say, £10m upfront and much larger milestone payments meaning the BoD won't need to raise any more cash for 1802?

Will someone buy 1801 outright and the cash would pay for 1802 development and also allow either some sort of dividend or allow the BoD to buy back some shares in order to cancel them reducing the recent massive dilution?

Knowing my luck we'll get news on P1 the day before the funds hit my bank account and the sp will rocket, rather like running for a train only to see it pulling away!

Fair point, Potnak.

Aber - I'm always a bit wary of posters using the company name in their moniker.

Lsesar - each time RF requested more shares they will have had to provide evidence that they had sold their previously issued shares and the selling price in order to work out how many more shares they were due. The latest RNS more or less tells us RF had been selling their shares at a loss and have now been given a final number to pay off the remaining balance.

You initially seemed quite positive about the share but now you're throwing some doubt in here, hmmmmmm.

Hi AOTD - I suspect those dates were simply chosen as suitable 'place holders' when completing the trial docs. They would push the dates out far enough to build in any potential slippage since they couldn't possibly know how many volunteers would sign up and when. The last advert looking for recruits was taken off the Nucleus Network website around 6th Jan. so I'd expect them to have enrolled the final subjects by the end of that month.

Hi Eazy - although that would be the sensible thing to do, RF have sold immediately so all notions of 'investing' go out the window. They look as if they need cash to help their rto of another company so rather than playing the long game, I was thinking they might just go for a quick profit and exercise their warrants very soon instead of waiting for the sp to hit £1+.

Thanks all for the swift replies.

SOG - re those initial warrants at 147p, under the terms of the agreement (or 'shafting' to use a more appropriate term), aren't they reduced to 10p due to the subsequent WRAP/Subscription?

I suppose it's all fairly moot now anyway and a potential partner would review all aspects of the company & compound before entering into a deal.

RF dumped their shares as soon as they got them (or even before!) so what are the chances that they'll shortly cash in their warrants to make a quick return now that the sp is over 30p?

Would any prospective partner for 1801 want them out of the picture completely or wouldn't it matter to them?

Any thoughts?

Only posting this to illustrate our compounds are known by at least one big pharma. Whilst the patents only mention 1801/2 in the context of myriad other compounds, at least we're not flying totally under the radar. I came across the patents by searching the WIPO site for anything referencing SDC-1801 and then based on those results, limited it to results with "Gilead or MiroBio" AND "SDC-1801" -

https://patentscope.wipo.int/search/en/result.jsf?_vid=P12-LVCGCV-13961

MiroBio was an Oxford spinout acquired by Gilead for £332m - https://www.ox.ac.uk/news/2022-08-04-oxford-spinout-mirobio-acquired-gilead-sciences-405m

Onwards!

Knew I'd find it somewhere - https://apps.dtic.mil/sti/pdfs/AD1087498.pdf

5. CHANGES/PROBLEMS:

We received a no cost extension for this project in April 2018. The PI on this project, Dr. Abhishek

Trigunaite, had to travel to his home country (India) for immigration related issues (VISA stamping).

Because of the unanticipated length of the processing time, he was required to stay in India for nearly

3 months and only able to return close to the termination date of the project. This loss of effort meant

that we were unable to perform the long-term dosing studies prior to the termination date of the grant.

Additionally, at the beginning of this award we had only proposed to look at only one strain of lupus

prone mice ((NZBxNZW) F1 mice) but later during the scientific review of the proposal, it was

decided to include a second mouse model (MRL/lpr) in the study. This increase in the animal number

for the short term (4-6 week) treatment did not leave us with enough funds to perform a long-term

survival study.

Hi Celtic - the trial was with 1802 and the lead researcher had to return to India due to their visa running out or family issues so the work was never completed.

https://www.pharmiweb.com/press-release/2020-07-24/encouraging-preclinical-results-generated-with-sareum-s-tyk2jak1-inhibitors-in-a-disease-model-of-lupus

I'll try and find the actual project doc on the US Military site.

Hi Aber - I'm not saying the rise is down to Parker at all. All I'm suggesting is a number of shareholders will have made money out of the situation.

If life hands you lemons, squirt lemon juice back in life's eyes.

Even if there's an outside chance of a Monday morning RNS I expect a further surge tomorrow afternoon as FOMO kicks in.