Member Info for B2HS2L

Kong -

o Read out of two-weekly and three-weekly dose escalation study data in late Q2 2024;

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To me that means both are in progress

From RNS "Proposed Fundraise to progress Therapeutics" today -

"The next steps with AVA6000 involve optimising the patient population, dose and schedule in order to increase efficacy and tolerability of doxorubicin treatment via pre|CISION? targeting.

Given the favourable safety data from the three-weekly Phase 1a dosing study, a two-weekly dosing study, which is now screening patients with high FAP levels in the USA, will assist in optimising the schedule and dose for a Phase 2 study (dose expansions are expected to begin in H2 2024 in the USA, **subject to funding and FDA approval**).

The Company would, dependent on the data obtained during the Phase 1a and Phase 2 trials, anticipate commencing a potential Phase 3 trial in Q1 2026 for AVA6000 (also subject to **funding and regulatory approval**)."

Can we assume that the funding here is about the company having sufficient funds to complete a trial, rather than the company having previously made a 'Going Concern' announcement at the previous audited financial results.

So can the FDA stop a trial starting, because they check for evidence of sufficient company funding to complete the trial before providing approval?

**subject to funding and FDA approval** does not appear in any prior RNS when discussing FDA Approval.

FDA approval does.

If FDA checked Avacta had sufficient funds to complete phase 1a (I believe 4 Cohorts), before approval was given, then because of the extra cohorts, we definitely blew that budget.

Agree Icecool, I'm expecting a short attack a week for as long as it takes to get a response from the CEO.

The shorters are relying on continual sp rebounds to buy as soon as they sell.

Rinse and repeat, I'm sure that's the term I am looking for.

It's taken less than half an hour for calls for Alistair's head on a plate to return.

Does his future as a CEO rest on the sp being above or below 70p tonight?

It didn't happen last week at the 75p price point either.

65p next Wednesday? - time to chill out.

RNS 21 Jul 2022

AffyXell Successfully Completes Funding Round

AffyXcell has successfully completed a funding round to advance its lead mesenchymal stem cell (MSC) programme towards the clinic, and to develop its wider pre-clinical pipeline of cell therapies.

The proceeds of the fundraise, which remain undisclosed for reasons of confidentiality, from existing and new financial and strategic investors, will allow the company to progress through significant value inflection points. The funds will be used to support **Investigational New Drug (IND)** enabling studies which will underpin a regulatory filing to take its lead programme into the clinic. The funding will also allow AffyXell to develop the broader pipeline of cell therapies to address a wide range of immune diseases with high unmet needs, and to reinforce its platform IP portfolio.

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21 months later, can we expect an AffyXcell IND application soon?

In time for deal discussions, - highlighting Affimer utility.

IMO would only strengthen Simon's hand in negotiations.

We'll see, apologies if discussed before.

Doing some research and found this in the 28.09.2023 RNS, that may answer one or two posters' recent queries concerning Avacta's holding in AffyXcell.

"Avacta has successfully developed and characterised Affimer® proteins against the second target of interest for AffyXell and has filed a patent application for the associated intellectual property triggering the second milestone in the agreement during the reporting period. The second milestone will result in an increase in Avacta's shareholding in AffyXell, which currently stands at 19%. The exact shareholding will be determined, as with the first milestone payment which was achieved in April 2022, following a formal valuation of AffyXell and is expected to be approximately 25%."

So no longer 19% holding, but nearer 25%.

Jive - Does this perhaps lean toward a low strength weekly dose regimen.

Unsure if anyone may have tried this with strait Doxorubicin.

If this type of therapy were to result in holding cancer in check medium term,

AVA6000 would be able to address all high FAP lesions throughout the body, including in-operable areas.

Sounds feasible from where I'm standing, but what do I know?

🚀 Thanks for sharing gmcc, I'd appreciate a link if poss. 🚀

If you go to the trouble of hiring the likes of

Simon Bennett - deal specialist,

and appoint the likes of Shaun Chilton to the board - significant commercial and corporate development experience,

and you hire Christina Coughlin to take charge of R&D, who has recently been pivotal in driving the clinical development strategy for AVA6000

and you :

* hired them in good time

* are not discounting all their advice each time they open their mouth

* have funds in the bank to keep the lights on, pay everyone, and continue R&D for the near future

* are waiting to see how PFS data matures for many trial patients, who might by now have passed away if they weren't on ALS-6000-101

* are awaiting grade 3 and 4 toxicity data for cohorts 5, 6 and 7 and arm 2

* and you make no announcements concerning progress of any sort after you provided a large update 2 months ago,

* await the finance rectifying deals you seek, that are being discussed negotiated and developed, with multiple interested parties (so we are advised)

Why would you then change track and agree a placing:

* because journalists / message board posters / social media 'twitterati' (so far no 'X' equivalent) outside the company feel the time is ripe?

* because the sp is under pressure, and more than normally erratic, and currently the lowest for many months?

AS has advisors who will advise if / when a placing is appropriate

With the above currently the case, IMO the CEO should ignore the noise and let his plans mature.

Alastair Simon and Shaun long ago agreed the optimum timing of deals, and I hope trial results will help to make deals arrive in a timely fashion.

Apologies if posted before, - found this but was looking for evidence that FDA were interested in increasing the speed of drug / platform development, which I did not find.

https://www.ajmc.com/view/unlocking-the-benefits-of-fda-s-orphan-drug-designation

Not previously aware of 'access to specialized regulatory assistance from the FDA’s Office of Orphan Products Development (OOPD)'

Q - When AS says he will wait to make it more impactful at an oncology conference, how so?

attempted answer - Could he not have released the info months ago and then said it again at a conference.

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Impact can only occur once.

Any subsequent utterance is confirmation, but advising what you have already announced.

But you know this.

Not willing to discuss thank you, no response required.

B_V - were you referring to this from Fiona regarding patents:

"This is a question for Fiona : You have mentioned a few times now that you are gaining new insights into FAP, potential active and non active forms for example. Can you elaborate on this and explain how, if at all, these findings affect the potential use of the platform? Thanks.

This is an important question. We are exploring this but these insights potentially constitute new IP which we need to protect before we can discuss them publicly. We look forward to discussing this in the future."

No clue when IP protection started though.

J_t "From this perspective it is worth noting that they did not mention cardiotoxicity in the December presentation, which is note worthy as this is the limiting factor in using standard dox. Also no real discussion of quality of life, alopecia, or any comments on efficacy for patients in C6 or C7. It's going to be one hell of a presentation."

They did not mention Cardiotoxicity directly.

However, from CC when discussing 59 yo Mr 65% - "What’s critically important here is not just the deepness of the response also the deepening meaning over time the response has continued to increase. We’re actually seeing now a duration of the response that is more than six months and this gentleman is now approaching ten months on the trial. He continues to receive AVA 6000 and is doing well. You’ll recall I mentioned at the beginning that standard dose Doxorubicin is only administered for six cycles or eighteen weeks, so four and a half months. However, given the limited exposure that we’ve seen in the bloodstream in this patient and others at this dose level of 160 migs, we are going to be able to dose this patient a further seven additional cycles if his tumour doesn’t progress and this represents up to another five months of therapy which would bring him up to a total of fifteen months on AVA 6000. This represents three times the length of time that this patient could be treated if he was receiving standard dose Doxorubicin."

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No cardiotoxicity here, but at 160 migs dose strength, many more doses could be provided than available via 75migs Doxorubicin doses.

Have encouraged Novacyt to get involved with the following:

It concerns encouraging government to act to improve Anti Microbial Resistance activities, mentioning future POC capabilities.

https://www.bivda.org.uk/Portals/0/documents/External_Affairs/BIVDA%20AMR%20Consensus%20Statement%20Final.pdf?ver=IcdF3HfhVEEjnR-rvH5hiw%3d%3d dated 26.02.2024

Novacyt are full members of BIVDA (British In Vitro Diagnostics Association), and would hope that provides an 'IN' to future sales and marketing plans.

Our own brokers haven't research the difference either Ben.

And you need to research the difference between a new drug, and a new

safer, less toxic platform to deliver a succesfull tried and tested old drug.

FWIW, If one party is considered by the court to have interpreted English Law correctly, the opposition would have to have interpreted it incorrectly, so a clear winner would emerge.

There has been significant arbitration, but no settlement (yet).

English law may be open to interpretation in it's present form (unlikely but possible), hence no clear winner.

This situation leads me to conclude there will be a court case, but I could be wrong.

Agree 100% Wilson.

If both sides differ in their interpretation of English Law, the only place to decide who is right is in court.

I'd rather have Twigger on my side than the oppositions.

I can imagine Al treading harder on Simon's balls.

"I'll get kettle on. You peddle list of deals faster son."

"As in MUCH faster"

"sp won't wait for you to slack off now, - breakfast my a*se"

Supplied for Info.

I'm thinking the use of the term 'Going Concern' is not as important as some posters surmise.

Investopedia - What Does Going Concern Mean?

https://www.investopedia.com/terms/g/goingconcern.asp#:~:text=Going%20concern%20is%20an%20accounting%20term%20used%20to%20identify%20whether,auditor%20audits%20their%20financial%20statements.

"Going concern is not included in the generally accepted accounting principles (GAAP) but is included in the generally accepted auditing standards (GAAS)"

Make what you will of the info on this web page.