Member Info for B2HS2L

Page 27 -

Affimers: Multiple Critical Advantages for Drug Delivery Over Monoclonal Antibodies

Avacta doing further product / attribute differentiation.

Https://avacta.com/wp-content/uploads/2024/06/Targeting-the-tumor-microenvironment-June-2024.pdf

Page 14 Capping Groups?

Robsaunders99 -

...or is this Avacta ensuring all interested parties can access a baseline document containing baseline info, in the format Avacta are happy with.

This dated today.

My feedback, as provided post presentation.

1 There is a need for investors to see / possibly meet and question present board members as a new board has assumed control. That cannot happen remotely.

2 Lyn dodged the question when are Novacyt going to be profitable. Spent too much time talking about £4M savings and not stopping at £5M.

Shareholders deserve more news about breakeven timelines, and especially about new Primerdesign products.

There is no visibility about Primerdesign creating bespoke primers or assay development for special requirements, and we might have to go deep into the numbers for evidence of that activity.

There is no prior visibility of new Primerdesign products, Lyn announced no fewer than nine new products retrospectively. I assume it's because the customers are all RUO entities, but investors need to know where the companies wins are - and the details - you know like other companies do. Else they are invested in a black hole.

As for integration, it's clear that process is not complete, and it should be.

What has James McCarthy been doing since September?

3 It's clear Yourgene has met and are meeting success with their products, but it's not happening fast enough.

With past and present attendance at trade fairs etc, I expect announcements to be made via RNS to keep investors informed.

Hi Poidster.

It would be good to know which of the DHSC labs had which of these instruments.

The IFU (dated 29.06.2020) contains the following :

"7.Real-Time PCR instruments

The exsig™ COVID-19 Direct (CE IVD) assay has been validated

with the following Real-Time PCR instruments:

• Applied Biosystems® 7500 Real-Time PCR System (software version 2.3)

• Roche® LightCycler 480 II (software version 1.5.1.62 SP3)

• Bio-Rad CFX Connect™ Real-Time PCR Detection System (Maestro™ software version 1.1)

• FluoroCycler® XT (FC XT 101, Bruker Hain Lifescience)

• QuantStudio 5 (ThermoFisher Scientific, QuantStudio Design & Analysis Software v 1.4.3)"

No mention of IT-IS Q16 / Q32 instruments here, but see

RNS - R&D Update

Mon, 27th Jul 2020

for Q16 & Q32 coverage.

+++

Which instrument was Portsmouth lab using?

If dhsc labs reporting processing failures were using the same instrument, that might have meaning, but you would expect an assay manufacturer to have switched on to that fact.

++++

Also see https://www.linkedin.com/in/cameron-littlefield-007678195/ to show continuous improvement capabilities on assays as at March 2021 and beyond.

+++

ref https://www.diagnocine.com/Content/Upload/Product/datasheets/Path-exsig-COVID-19%20Direct-CE-IFU%20Issue%201.0.pdf

re your

"....doing a root cause analysis of failure would be to immediately look to user error

before even considering a faulty test."

Might page 16 of the IFU be a problem for the labs reporting processing failures?

Para's 12.2, 12.3 and particularly cooling requirements of :

12.4 genesig® Easy RNA Internal extraction control (IEC) preparation

• The genesig® Easy RNA Internal extraction control (IEC) can be added during the sample

preparation to provide an RNA template control, detect PCR inhibition and confirm the integrity

of the PCR run.

• Precautions: This reagent should be handled with caution in a dedicated nucleic acid handling

area to prevent possible contamination.

• Upon receipt, the dried IEC can be stored at -20ºC for up to 18 months or the expiry date,

whichever occurs first.

• Using aseptic technique, resuspend the dried IEC in 1000µl of Template preparation buffer, mix

gently. Resuspended IEC is stable for up to six months when stored at -20ºC.

• Freeze/ thaw cycles should be minimised and not exceed 5 freeze/thaws. The reagent once

resuspended can be aliquoted into smaller volumes if required and stored at -20ºC.

Room for user error with IEC yes, but the IFU states what is required.

The contract included training, and it was provided according to Ajan Reginald.

This is still available under his experience on LinkedIn:

Chief Operating Officer

Indirect Contract

Mar 2020 - Jan 2021 · 11 mos

"During the COVID-19 Pandemic, led the ~50 FTE NHS team deploying and training 90+ NHS hospitals at the peak of the pandemic to utilise rapid PCR tests for urgent patient and staff testing."

Trainers would have insisted on clean lab conditions.

The syllabus would have included that the IEC - Internal Extraction control - had been designed to detect a compromised sample and invalid result, requiring the sample to be re-analysed.

Definitely not the name of the game in busy labs.

From Para 8. As to the case on robustness more generally, the defendants say that there is no contractual requirement of robustness which is itself a vague term. The IEC has been designed to detect a compromised sample and invalid result and, therefore, an "IEC failure" cannot evidence a flaw in the test kit. On the defendants' case, it follows that the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.

++++

FWIW, this seems the crux:

'no contractual requirement of robustness'. - Robustness not defined (or used) in the contract.

From Para 4 - 'IFU advised users to only use tests where IEC (Internal Extraction Control) Cq result is less than 27'.

From Para 8 'The IEC has been designed to detect a compromised sample and invalid result and, therefore, an "IEC failure" cannot evidence a flaw in the test kit. On the defendants' case, it follows that the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.'

+++

If the court agrees robustness is not a term that is applicable to the DHSC complaint, then ....the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.

+++

I intend to reread and develop further understanding, but Para 8 seems important.

A_g glad to hear from you again.

The one aspect was I believe the only aspect with which dhsc could achieve the required full value of its claim without winning the court case. In effect dhsc were trying to say we dont need a court case because the court has been given all that is needed to make a judgement in dhscs favour without a court case.

If the case were so good, why did dhsc bring the summary judgement many months after the court case dates were finalised?

DHSC gave it their best shot when that shot should have been fired many months ago, and the court knows it. The court refused the summary judgement.

With their best shot fired, it is now for the dhsc legal team to prove their case against Twiggers defence and counter claim.

Good luck with that, better to accept defeat gracefully.

Poidster, I recall one of the reasons you stopped posting was because your posts often disappeared.

Regardless, I hope we here from you more often now this dispute has entered the 'interesting' stage.

Someone hasn't turned up for their shift this morning.

Perhaps they're on a Microsoft teams call, getting a b*llocking because the sp drop has stalled.

I'm not missing them and I'm sure you guys aren't.

Not only are Novacyt defending a suit for £134.6 million from DHSC, but they are counter-claiming for £81.5 Million.

So any pragmatic solution has twice the complications.

Twigger wants to defend and counterclaim in court, (which would be best for NCYT's situation if they win, - and he might not be saying that if JW weren't advising him so).

JW has splashed out on the best defence he can, to retain his own business credentials, across a considerable number and type of business interests.

Personally, from the information that was and is in the public domain, I don't see why any compromise should be considered given the DHSC case.

On 30 April, we appear to have seen the best of the claim they have.

My thoughts are how long might Primerdesign and Novacyt have to wait for their cash.

BITL - The latest we have I fear, - sdtand to be corrected:

https://avacta.wistia.com/medias/b74537ezmn 14:05

Waterfall Graph with asterisk on far right. - Asterisked patient is ongoing at the data cut-off date.

From slide at @ 8:00 - data cut-off date 11.03.2024.

"....60 year old gentleman, with a right sided popliteal mass. This is an undifferentiated, pleomorphic sarcoma "

His last scan was January 2024, so I'm hoping for an update re his cancer reduction, but will now probably have to wait for images to appear in a presentation (sometime soon I hope).

SDMC review now well overdue.

RNS 30.04.2024 -

· The Board will also evolve to meet the increased demands of being a clinical stage oncology company alongside the need to more clearly communicate with shareholders and other key stakeholders. An individual with sector, commercial and listed company experience will be the ideal addition.

C'mon CC - don't wait for a new appointment, - spill the beans now.

Https://twitter.com/Smiffy_O/status/1786395117596651908

Dunno what to make of that.

"deutsche bank initiates avacta with 'sell' - target 40 pence"

....must try harder.

https://www.lse.co.uk/news/avct/london-broker-ratings-astrazeneca-target-raised-anto***asta-lowered-mvtpe9gxuw0obw1.html

Of the six companies short listed, are the other five for a drug,

whilst ours is for a platform from which to launch drugs.

Targeted therapy that spares healthy tissues is a holy grail of oncology drug development .

Will there be recognition that the holy grail has at last been found.

Whatever, well done Avacta for some great market disrupting tech.

Hope we get to commercialise it (thus bringing a better price for the platform/company)

before the IP rights and know how get sold off.

Thanks for a good find gmcc, and thanks for sharing.

WeAreGroot -

I think most are agreed we need a new CFO, someone who CC is satisfied with, and doesn't publish an RNS proving simple arithmetic is an issue.

Someone perhaps with experience gained in USA, with US contacts and has knowledge of rules / regs and trading on US exchanges, as CC must recognise some of AIM's limitations and problems by now.

You mention CC '....presented the best proposed strategy and credentials'.

If she did, she may have presented to members of the present board, and some of these people may soon find themselves applying for other jobs.

Intriguing

We Are Groot -

"the evolution of the board. There are some critical competencies here that we know are needed, and this is ongoing, has been ongoing in parallel with the CEO search."

If there is to be strategy reform as you mentioned, it would need to be done with the new BoD in place,

as it doesn't make sense for that to happen before.

CC - "And fourth, which I haven't touched on, but you saw in the RNS this morning, is the evolution of the board. There are some critical competencies here that we know are needed, and this is ongoing, has been ongoing in parallel with the CEO search. We know that there is board evolution needed to take Avacta into this next chapter that I told you a little bit about today."

Many here thought they wanted a business brain to lead Avacta, now the techie founder has retired.

As CC has become CEO, might she still lead R&D, or has that post become vacant.

Does CC wish to lead R&D, but in partnership with a deputy who carries out her wishes.

I know we'll wait and see, but I'm with others here, I want a business brain in charge.