Member Info for HotblackDesiato

I wish I had some inside scoop for you, elcap, but I'm just a regular punter with no special knowledge.

Although the BIO-Europe meeting gets a mention here http://www.sareum.com/news/events/ it doesn't look like we've got our name down for it yet - http://events.ebdgroup.com/bioeurope/core/participating-companies2022.php

Is there a license deal on the horizon and therefore we no longer need to shmooze?

There probably is some element of the CTA news being priced in but there has to be some uplift in sp once the RNS comes out. With people buying on speculation, I wonder if whatever the sp rises to on the CTA RNS, it will hold fairly steady as we may have another RNS in a few weeks if GSK get their act together on 737.

Morning Leggster - the HNWs would be aware of what they were letting themselves in for i.e. directly funding the company to get the 1801 ball rolling and if the sp dips then maybe/probably buy more on the open market.

With the warrants they can either exercise them as soon as possible (to perhaps help fund 1802 into P1a) or they could wait until the sp is significantly higher, take up their options and then immediately sell them for a fast, large profit.

If the HNWs have millions in spare change to invest in SAR then they can ride out any dips with a casual shrug. Smart people, these rich buggers!

Sorry, first line should have read

32142855 6428571 0.05 321429

I'd divided the original figure by 3 rather than 5 (too late in the day for doing homework!).

Total potential raise is therefore £3,860,173.

Right, here're the sums. Note the final subscription gets one and a quarter five-year warrants, hence 5 lines in my calcs.

Original subscription - Number due under Warrant - Original Warrant Price - Net Cost

32142855 10714285 0.05 £535,714
30000000 10000000 0.07 £700,000
14285714 14285714 0.09 £1,285,714
12121212 12121212 0.1025 £1,242,424
3030303 3030303 0.1025 £310,606

Total of £4,074,458 if all warrants are taken up.

I've not done the arithmetic as each subscription had different terms re the warrants -

1. 32,142,855 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 2.8p per share (the "Subscription Price") (the "Subscription"). The Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every five Subscription Shares issued (the "Subscription Warrant"), which can only be exercised following the Company's the closing middle market share price being above 5p per Ordinary Share for five consecutive days.

2. a subscription for 30,000,000 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 4.9p per share (the "Subscription Price") (the "Subscription").
This subscription is by the same high net worth individual who subscribed to shares to the value of £900,000 as announced by the Company on 1 June 2021 (the "Subscriber").
Under the terms of the Subscription, the Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every three Subscription Shares issued (the "Subscription Warrant"), which can only be exercised following the Company's closing middle market share price being above 7p per Ordinary Share for five consecutive days.

3. 14,285,714 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 7p per share (the "Subscription Price") (the "Subscription").
Under the terms of the Subscription, the new Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrant"), which can only be exercised following the Company's closing middle market share price being above 9p per Ordinary Share for five consecutive days.

4. 12,121,212 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 8.25p per share (the "Subscription Price") (the "Subscription").
Under the terms of the Subscription, the new Subscriber will also be issued one and a quarter five-year warrants, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrants"), which can only be exercised following the Company's closing middle market share price being above 10.25p per Ordinary Share for five consecutive days.

Hi Mafuta - just looked and the 4 warrants are at 5p, 7p, 9p & 10.25p.

Hi SOG, whilst the final spend on P1a will be on a need to know basis, the half-year report (next Feb?) should outline what we have left in the coffers and we can maybe work backwards from there.

I'll keep an eye on those sites I listed in case our trial shows up and we can at least see what payments volunteers get. We should also be able to see how 1801 is to be monitored e.g. if volunteers have a single stay overnight or how often they need to attend for blood samples.

At least the sp should start heading north with some consistancy. Lots to come in quick succession - CTA, 737 progress and maybe even an update on 1802.

Just to add to SOG's figures, below are some websites showing current trials and what volunteers could earn.

https://rewardingresearch.co.uk/current-studies/

https://researchforyou.co.uk/current-studies/

https://www.weneedyou.co.uk/current-trials/

Maybe they've finally accepted that the CTA followed (hopefully!) next month by GSK announcing 737 plans proves we're heading for the big leagues. They did what they could but we must be pretty much unstoppable now.

However I'm sure one or two here will still complain that whatever positive RNS comes out, it'll not be quite sparkly enough for them.

Fair point, Num4.

Hi Baton, I think we're a month away from any official word from GSK on 737. Even then, they might choose to keep a lid on their plans for it.

My own preference would be for a Monday am RNS detailing trial start date and likely timescale for P1a. Once we have safety data in early 2023 and know what other indications 1801 might target, that's when we can likely call the shots on a license deal.

If the BoD have had official approval from the MHRA - Ydoow's excellent find probably confirms it - then there can only really be two reasons for not announcing it yet:

1. The BoD might still be awaiting word on a start date from the chosen CRO in Manchester. The CRO will need to confirm that they are still able to fulfill the CTA's requirements and they'll also need to know when they can expect delivery of the capsules etc.

And/Or

2. With the CTA approved, that may be the hurdle that we needed to clear in order for a license agreement to be signed. With this week's turmoil in the markets, a potential partner may need a little bit of extra time before they sign on the line.

If the CTA has been approved then I can't think of any reason not to announce it other than the above. As SOG (I think) has mentioned, the CTA would need to detail the source of all the required funding for the whole P1 trial, so whatever the BoD have committed to must have been acceptable to the review panel.

Hopefully I'm in the right ballpark and we can sit back and wait for a cracker of an RNS.

Hi Ahfam - looks like there are a few candidates in Manchester to choose from. I posted this one a wee while back https://meu.org.uk/cro-services/

I've also kept an eye on this site just in case our trial in healthy patients pops up ahead of the official RNS - https://clinicaltrials.gov/ct2/results?cond=Healthy&cntry=GB&city=Manchester&Search=Apply&recrs=b&recrs=a&age_v=&gndr=&type=&rslt=&phase=0

Regards.

The other thing to keep in mind is that whilst it's currently cheaper for a US buyer to acquire us thanks to a weaker pound, that shouldn't have any impact on the BoD's asking price and therefore is of no consequence to your average punter.

Even if the pound sank below parity with the dollar, I don't think anyone here would be complaining if the BoD agreed a sale at £50 per share!

Welcome Geste - I'm no economist (neither is the Chancellor, it seems) but the fact the sp has not dropped over the recent days may confirm that pharma/bio stocks are relatively well insulated from the wider market. It would be different if we were exporting widgets but intellectual property is another matter.

As the last RNS stated, 'Sareum will update on the regulatory progress of SDC-1801 in due course.'

Assuming we've received full approval, I guess the BoD might now take a day or two to confirm with the clinic running the trial when they can start. The clinic should already have a register of healthy people willing to take part in drug trials (Manchester must have a high population of students looking to earn a bit of easy money!) so whenever the RNS lands it should hopefully announce a bit more than just "we've now got approval".

Just some further info - https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#assessment-of-your-submission

Hi Bailiff - the following website states, "The statutory timeframe for initial assessment of a CTA application is 30 days with an MHRA internal target of an average of 14 days for assessment of phase 1 applications.

Currently, MHRA conducts an initial assessment of phase 1 applications within approximately 12 days and within approximately 22 days for all other phases. When GNA points are raised it can add up to 21 days to the final approval time for a phase 1 application and 23 days for other phases, depending on the time taken for the applicant to submit their response and MHRA assessment of that response.

Whilst these timeframes remain competitive and are well within the statutory 60 day period for final determination of a CTA application for a clinical trial of a general medicinal product, reducing any avoidable delays to the authorisation of a clinical trial is of benefit to trial sponsors and, ultimately, patients."

https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications

Can't be much longer now, can it? :-(