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Crumbs thanks, yes, good to see some positive news this morning.

Sorry Crumbs, not with you. Why would approval of the SA trial trigger Cliff's exit?

Anyway, excellent news that Scancell can now crack on with the Covidity trial.

Shareguard - it will be interesting to see what tomorrow brings. Some media from Lindy and a show of support from Vulpes/Redmile would be useful

GF123

Jeez - what is so hard to understand?

1) I'm not passing any judgement whatsoever on how/why CH has departed. I was simply saying that if this was all a happy, mutual decision then the communication of it has been poor because the RNS does not paint that picture. It was a quick one liner response to WTP and I have no idea why you're making such an issue of it.

2) I'm actually on the side of wait and see, you're the one putting me on the side of 'this is a problem'

3) I don't 'claim' to know why I've invested here - I know exactly why. What an odd comment

GF123 - I'm sorry but that's not right. WTP asked whether this had all been mutual and cordial and I responded that if it was then I don't think it's been very well handled - and I stand by that because the RNS didn't send out that message. IMO.

Balerno - you'd be surprised at how quickly large corporates can move when it comes to 'releasing' directors!

The RNS didn't make it clear whether Lindy's appointment was temporary or not or whether she would continue on a part time basis. It would be good to get some clarity from Scancell.

GF123,

Yes you're absolutely right, I should have added IMO.

Just to be clear, I haven't made any presumptions at all regarding the reason for Cliff's departure.

GF123,

Since you've asked, I'll give you an honest reply.

Firstly, my comment should be viewed within the context it was made - an answer to a specific question from WTP in his 20.59.

In my experience, both professionally and as an investor, when there is a change in the leadership at the top, the best and least disruptive path is a smooth, pre-planned and well executed handover of power. An out of hours RNS announcing the sudden and immediate departure of the CEO and a replacement with the CSO does not suggest that has taken place. If it has then the RNS certainly hasn't conveyed that message and that was the point of my comment in reply to the question from WTP.

Sorry but I just don't believe Cliff will be involved with Zakari. The RNS made it clear that he was stepping down as CEO and board member of Scancell and IMO that must surely include any subsidiaries. He may still be listed at Companies House as a director of Zakari but he's also still listed as CEO of Scancell - there obviously hasn't been time yet for Scancell to register the changes.

Also this was the last sentence of the main body of the RNS from John Chiplin:-

'"We are very grateful to Cliff for all his hard work over the last three years at Scancell. The Company is now on a sound financial footing with the infrastructure in place for the next stage of its growth. The Board and I wish Cliff all the best for the future."

Sounds pretty final to me and would be more than a little disingenuous to issue tonight's RNS and then appoint Cliff to run Zakari.

WTP

If it was a mutual decision then I don't think it's been very well handled!

WTP,

Redx's CEO remains the same and Redmile appear to be very supportive. They do however have a non-exec director on the Board who was appointed over a year after their initial investment.

shareguard,

Cliff Holloway didn't leak any info. re. Zakari Therapeutics. All details were in the public domain the moment the company was incorporated and listed on Companies House website.

IMO the RNS makes it clear that Cliff has moved on and will play no futher part in the future of Scancell or any of its subsidiaries. For sure, he leaves the Company in a much better financial position than when he joined and I'm sure we all wish him well for the future.

Balerno,

Some pretty big assumptions in there - perhaps you should add IMO

Falsedawn - not sure there's any way of knowing until the next annual report.

WTP

They couldn't have run any clinical trials without CMC work and data - they'd never have been given regulatory approval to dose a single patient without it. So yes, it has been going on and it's part and parcel of all drug development. As for who previously carried out the work, I'm not sure whether Scancell contracted any of it out, but if not, Sally Adams and her small team were probably covering it.

There have been many (justified) comments on this bb re. the apparent bottleneck when it comes to translating Lindy Durrant's innovation into hard products and taking them into the clinic. This is the one area, that was most in need of funding and hopefully will be transformed by Redmile's investment. It's going to take time but you can see by the positions being recruited that Scancell clearly have recognised the need.

Worth noting that one of the first things Scancell did after the second, large round of funding from Redmile was to go out and recruit Dr Gillies O'Bryan-Tear as Chief Medical Officer and Dr Robert Miller as Medical Director - both of whom have a wealth of clinical development experience. I'm sure they'll be instrumental in building the required infrastructure to improve upon the clinical development of Scancell's products.

By the way, still a baby bio in my books but with the potential now to become something more.

WTP

CMC stands for Chemistry, Manufacturing, and Controls, it's an integral part of all stages of drug development and is all about safety and quality control of the actual drug product - ie. the composition and characteristics, the testing, the manufacture etc.

When Scancell submits a clinical trial application they have to submit lengthy and detailed CMC information. This will include things like, characterisation of the drug, the formulation, the manufacture, dose, stability testing etc. etc. They'll have to submit this info. for each and every application, for every stage of clinical trial and to all regulators, whether it's the FDA, MHRA or SAHPRA. It's an important role that can make all the difference between a smooth and bumpy path when it comes to dealing with the regulators, so it's vital to get it right .

A shareholder motion to propose what?

Another strong trading update today from Ergomed. Good to see new acquisitions contributing as expected, but also to see organic growth as well as acquisitive growth.

https://www.proactiveinvestors.co.uk/companies/news/956036/ergomed-deliver-double-digit-revenue-growth-as-well-as-operational-progress-956036.html

Yes, excellent news that results in patients with Wnt-ligand driven cancers are good enough to warrant continued development of RXC004 as a monotherapy. Looking forward to reading more detailed phase I results, which I assume will be released via RNS when they're presented at ESMO in a few weeks.

Great to see Redx cracking on with their clinical studies despite current Covid difficulties.

Chester,

Without more detail about the design of the South African study, I think it's almost impossible to even guess. For instance the following unknowns could all impact timescales for results:-

1) Dosing regime - how many doses (assume 2) and interval between doses. A 3 week interval between doses will obviously produce results much quicker than a 12 week gap.
2) How many patients? Recruiting 20 patients will clearly be quicker than 120
3) Which needle-free delivery methods are involved - are they already approved proprietary devices or completely novel systems in development? If any specialist equipment is required such as a jet gun, what is the lead time for supplying, shipping and training staff?
4) Is the vaccine now fully manufactured and how soon can it be shipped to SA?
5) How quickly can the CRO set up the trial, train staff etc.

It would be good to hear much more from Scancell regarding this trial - hopefully we won't have long to wait.

Ivy,

Thanks for that - some real challenges ahead. I'm sure the solutions will be practice changing and the clinical trials landscape across all medical disciplines may emerge from this pandemic in a better state than it started. You can only hope.

In the meantime, it highlights the advantages of Scancell's approach of going down the road of carrying out trials in the booster setting - much easier to run randomised studies by simply going head to head with approved vaccine boosters or no boost vaccinated control groups.