Scancell Holdings Share Chat (SCLP)

… doesn’t read too badly !

“ Scancell Holdings PLC - Nottingham, England-based cancer immunotherapies developer - Reports pretax profit of GBP2.5 million for six months to October 31, swinging from loss of GBP4.4 million year-on-year. Firm gets boost from GBP7.2 million gain on substantial modification of convertible loan notes. Says firm is well-funded and strong cash position should allow it to "pursue multiple clinical programmes". "The funding received in the last financial year will also provide the company with further flexibility regarding the development plans for its existing therapies, to ensure both optimal development and commercialisation strategies can be pursued, and to limit the potential impact on the company of economic pressures caused by Covid-19," it says.”

Makes a change from the headline being losses !?

Take care all ..

Careful aimbig, the elusive diggle wiggle probability comes with the obligatory blow back as you are obviously well versed in.

£1.80p?
Yes, I think that is a realistic possibility.

it will soon be 10 years but still belive this is one of the few shares i own with a very relistic chance to go at least 10x
Each one of the 4 products we have could end up worth £1b each

I used to email cliff and get an answer but I dont have JC or LD email.

i think it would be intresting to ask if the 16 patients is correct.
Very strange no one has started since the Proactive presentation!!!
Also has patient 1 had all four jabs?

Now, if ever there was a day to suggest maybe a DD RNS might soon appear I would have thought it would be today.
I'm not saying there will be one, but it is a possibility.
There, a little speculative idea.
AIMO

Konar/Chester,

Think we have to be a bit careful here. Unless I'm mistaken, we were only told that 16 patients had been recruited on 3rd Dec during Lindy Durrant's Proactive One2One presentation. No patients have been recruited since but
we haven't been told that recruitment has been halted/suspended/stopped. All we know is that no patients have been dosed over the past few weeks. We've been told this is largely due to Omicron and of course Christmas fell in the middle of that period. For all we know they have still been actively trying to recruit but have been unable to get any patients through screening - worth noting the inclusion criteria for the trial. It's not just that patients can not have been infected themselves, but also they must have had no known exposure to SARS-CoV-2 virus in the last 14 days. So if they have had any contact with anyone who tested positive for Covid in the last 2 weeks, they have to be excluded.

I agree it's disappointing, but unless there was a conscious decision to officially halt the trial, I'm not sure there was any obligation (moral or regulatory) on Scancell to either inform the market or amend the study status from recruiting. Worth noting that the University of CapeTown Lung Institute still has an appeal for patients to join the trial on its website and the SAHPRA still shows the study as recruiting.

What's matters now is how quickly they can get recruitment back up to speed and how quickly they can move onto dosing with SCOV2 and move towards commencing the UK arm.

Not a good one either

Not a bad day all round}

I recorded an adverse event whilst reading your post Burble.
Only joking :-)

So there are five main levels of adverse events when running clinical trials - Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)

AEs - are unfavourable and unintended signs, including abnormal results, symptoms or disease associated with treatment. These are recorded in case report forms and in the patient notes.

AEs can be classified as serious or non-serious, expected or unexpected, study related, possibly study related or not study related. Minor AEs are reported in bulk to the sponsor and generally are noted and submitted later but are reviewed at regular stages through a trial.

AEs are generally reported in grades
1 - Mild AE (asymptomatic or mild symptoms, no intervention required)
2 - Moderate AE (minimal, local or non-invasive intervention may be needed)
3 - Severe AE (not immediately life threatening, but medical intervention required)
4 - Life threatening/disabling AE (urgent intervention required)
5 - Death related to AE

Throughout a trial generally you will have a reasonable amount of Grade 1 and Grade 2 AEs, but these generally include things like 'patient experienced a headache after injection' or 'pain and reddening at site of injection'. Generally clinical trial results often report the number of Grade 3 or Grade 4 adverse events. Depending on the nature of these, a trial may be halted temporarily or stopped all together if severe enough.

ARs - are adverse events but casually related to the investigational product. So any untoward and unintended response in a subject to an investigational product.

SAEs - are any untoward medical occurrence that at any dose results in death, hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity or a congenital anomaly or birth defect. These must be reported immediately to the sponsor. Example TGN1412 clinical trial.

SSARs - are any ARs considered consistent with information about the investigational product. These must be reviewed at regular intervals to see if the profile of the investigational medicinal product has changed.

SUSARs - are any events suspected to be caused by the trial drug, but which are not consistent with information about the product. (These are the most serious and are subjected to expedited reporting). An example of this was the SUSAR which occurred with the AZ Covid-19 vaccine resulting in temporary pause of the trial.

So when SCLP say no safety concerns - read this as none of the following:
- AEs - Grade 3, 4 or 5
- ARs
- SAEs
- SSARs
- SUSARs.

Hope that helps. It's quite a complex part of clinical trials and have many reporting lines with how quick things need reporting and to who. Hence for every clinical trial you have a clinical trials unit who deals on nearly a 24/7 basis with the appropriate reporting and actions.

I agree that expecting trial data today was expecting too much, and that mid February was always more likely.

My big frustration here is that:

1 - We weren't told about this sooner. Its been nearly 3 months since we were told 16 patients were recruited, and the suspension of recruitment is significant.
2 - The BoD must have known this was the last date that they could push out disclosure of this materially significant news. Why did they not have a pre-booked interview with the likes of pro-active, to explain the situation and what they are doing about it? To me it just seems like they have kept this information hidden, and then failed to explain it or justify it.

I imagine I am like a lot of shareholders, I am getting increasingly frustrated by the continuous moving timelines and the failure to deliver meaningful trial data (whilst also being sympathetic to the global situation). Take this line for example:

"The Directors believe that the Company is well-funded and its diverse pipeline, based upon its proprietary platforms, is on track to deliver multiple value inflection points over the next 18 months."

This statement (or a version of it) has been in every financial update for as long as I can remember! Way past time to actually deliver on this - imvho.

An example would be something like Injection Site Inflammation and Soreness. Is it a side effect? Yes. Is it a safety concern? No. It is a common reaction when injecting someone.
To me, a safety concern would be something unexpected or something that could lead to long term harm to the person. But as I said in my original post, Burble would no doubt be able to advise.

Either way though - no safety concerns is very significant.

Konar surely side effects would fall under the safety concern umbrella.

Neither mentioned in the update so we should assume all is going as well as planned.

I am really amazed that we were told 16 volunteers were enrolled by Prof. Durant back at the end of November and then the next day the trial enrollment stopped.

Obviously Scancell cannot dictate to the clinic in South Africa, how they have had to deal with their Omicron infections is under their responsibility .

The very thing that Covidity may impact upon is stopping trial.

From what has been said the trial should be back up and running ASAP.
For those that keep on pointing the finger at Scancell for the delays it shows a complete lack of the facts, in fact it shows a misunderstanding of the difficulties of running such a trial in the middle of a pandemic.

I always thought the Covidity safety read out would be by the middle of February so the fact we still have 24 volunteers to enrol is just an unforeseen delay.

MODI1 First patient dosed will probably land mid February as well.

Chester.

Martin,
Bad news: I'm afraid they already have - been waiting 9 years for one now.

Morning all. Long term holder but hope the 18 month inflection points don’t keep get extended. :)

Thank you Ivy…
ATB

True - but at least while slower than expected, it's continuing anyway - thank goodness!

Konar,
Sorry you are quite right about SCIB1 first patient dosed.
The good thing about a senile fading memory is that regurgitated news seems fresh and exciting.
Plus I've forgotten how long I've been invested (I think it was last week) so can't get impatient.

@RW - "No safety concerns" is indeed positive and not to be overlooked. It is a major positive outcome of a phase 1 trial. But afaik "no safety concerns" isn't the same as "No side effects" which is what you seem to be implying. Burble may be able to clarify.

Hasiba,
Won’t make any further comment on here but well done on ARB.

The emphasis on 'only 16 patients dosed' should also take into account the vital and very encouraging words 'no safety concerns.' Not 'minimal' or 'minor' - none. That's good.

That's right Konar - Nov 19th I see...
I wonder why ProActive headlined on it now ? Never mind.

How is scib1 first patient dosed news?? It happened in November