Member Info for Thompi

Morning Fevertree, I followed your suggestion and checked out Swansinger. It seems clear on LinkedIn that he finished at DxTerity in April and started at AGL in May. You might have to revise your opinion on that one.

https://www.linkedin.com/in/brett-swansiger-a9a1645

Hi Tim - “I believe AS mentioned breast cancer as a target at the AGM (or have I imagined that)”. Yes, breast cancer was discussed in the Q&A session of the AGM. Alistair answered the question initially and then Fiona stepped in. The answer was basically - yes they are interested in breast cancer but due to the cost etc not until after phase 1b.

The below is Alistair’s answer, Fiona’s reply was more lengthy.

It’s about 01:01:58 into the presentation if you are interested.

Question

What are the minimum milestones you would need to progress a second indication for AVA6000? For example, breast cancer, given the size of the market versus STS what point would you look to do that?

Alistair

Yeah, I mean, obviously, there's resource constraints, because to take it into another clinical trial in an indication like breast and ovarian would, and again, I'll look to Elliot and Fiona to come up, would be far more expensive than going into soft tissue sarcoma. So yes, I mean, we certainly are thinking about what those other indications are that we can go into. I would say post phase 1b when we have a good efficacy signal I hope from from patients in soft tissue sarcoma, then we can think about opportunities to go into other indications.

https://www.investormeetcompany.com/investor/meeting/post-agm-presentation-and-investor-qa

There was an interesting question asked in the afternoon session of the AGM.

Question from Audience

With straight doxorubicin treatment there is a lifetime cumulative maximum you can give. How do you calculate that with AVA6000?

Andrew Saunders

So we look at the exposure and periphery in the plasma as a percentage of what we would expect with standard dox and based on our computation we can work out how many cycles that patient could have before they would reach that threshold of standard equivalent standard doxorubicin exposure. Typically, the limit on doxorubicin is 450/m2, typically thats six cycles. Now many patients in the real world don't get the six cycles. Why? Because we scan them after two cycles. If they don't have stable disease or response, we tend to stop the drug because it's not working. The other reason they stopped is they don't tolerate the drug. So a lot of patients don't get the six cycles, but those that do tend to stop with six, some trials have gone to eight but typically six and stop to minimise the risk of heart failure essentially.

Hi WeAreGroot, I agree Covid related revenues were discounted from the buy price of Launch Diagnostics. But I remembered something Tony Gardiner said about a possible deferred payment, although this was not anticipated to happen. I checked back and this, just for completeness, is what he said at the prelims in April:

“In terms of the Launch acquisition £24 million pounds was an upfront payment. There is deferred consideration of up to £13 million to do with the future sale of COVID products which exceed £2 million pounds in any of the next three years. Our assessment at the end of this year is that there is unlikely to be more than £2 million of COVID sales in any one of these years. And so we do not envisage paying any more of the £13 million deferred consideration.”

Thanks GMCC, once again some excellent research.

“Surely good enough will be good enough. Taking longer seeking a finite limit could cost lives.” I understand where you are coming from Donkey, but I would also argue that the higher the dose the greater the potential longer life expectancy for patients. So continuing trying to find MTD (or highest RP2D) could ultimately in the mid-long term save more lives.

Thanks Doggy, an interesting article. And I agree Gje - “that's the kind of license deal we may soon wake up to”.

Goldstandard, I agree. My point is that we have had no confirmation of the specific start date. To start putting dates on various aspects of the trial is speculation and can raise people’s hopes. I think we can all agree that patience is needed. I am adding to my holding .

Greedo, I too saw something on Twitter. Rah estimated (based on cohort 3 taking 64 days) that the “23rd August is therefore the earliest it’s possible to find an MTD within C6.”

Rah’s figure must be based on C6 starting on the 20th June (23/8/23 minus 64 days = 20/6/23). I have the utmost respect for Rah, he is very well researched, but the tweet is based on an assumption of a C6 start date stated in a factual manner and this can be misleading. It is extremely likely C6 is underway, but we have had no confirmation of the actual start date and I think that should be caveated in people’s posts.

Wyn & Touk,

I agree that AS has said that the MTD may never be achieved and that in the words of Wyn “It looks to me that the goalposts have been moved quite a bit from only a few months ago as to what is trying to be achieved now.” I also agree time costs money. BUT the bigger picture is that it is a positive - AVA6000 has exceeded expectations and surely (and very importantly) the higher the dose the greater the benefit for cancer patients.

AS explained at April’s prelims presentation the reason for the change in the increase to the number of cohorts and how it is a positive:

“When we designed the original clinical trial, we designed it for four cohorts. We have not in the first four cohorts reached the maximum tolerated dose, which is obviously better than we could have hoped and extremely promising. So we've now progressed on to the fifth cohort.”

There was also a related question during the prelims Q&S session:

Question

“Why is the company continuing to dose escalate in its Phase 1a trial to find a Maximum Tolerated Dose when enough doxorubicin is getting into the tumour in cohort 4?”

Answer AS

“Yeah, it's a good question. And I mean, the first point is that the MTD, the maximum tolerated dose, is critical to define the dose range for ALL future studies, you know whether that's us or by our partners as we just discussed. So we need to be able to define the maximum dose range so that people can in future plan their clinical development of the assets.

So I think you also need to remember that as we do this and we reach an MTD, we're getting a very detailed picture of safety, tolerability, PK, pharmacodynamics and all of that is the first time that the pre|CISION platform itself has been into human. And therefore all of the data that we're gathering is tremendously valuable in terms of the value of the platform and partnering and so on. So it's really important that we fully explore the dose range, even though it's taking longer than we originally thought, but that's a really positive thing because we're way above where we thought we would get to in terms of dosing.”

In response to Wyn’s earlier query, this is the reason given at the AGM for NOT running AVA6000 phase 1a & 1b in parallel.

Alistair Smith

“In terms of the Phase 1b, we still have to complete the Phase 1a, and I'm sure there'd be a question about that. But you know, it makes it makes no sense to start an efficacy study when we don't know what the dosing should be in that efficacy study. It would be a reckless use of funds to start what could be a suboptimal Phase 1b.”

AS later read out a submitted online question:

“Given AVCT suspect they have found their RP2D already. Why isn't Phase 1a and Phase 1a B being run in parallel? Other companies do so, eg Shasqi. So given the importance of speed to market why has Avacta not taken this approach?”

Answer from AS

“Okay, so there's obviously a very good answer for that. I don't think we should be suspecting that we found our RP2D by the way. I don't think that would pass muster when we move forwards. And we certainly haven't made any decisions on what our dosing levels or dosing regimen should be for the Phase 1b at this point. But the substantive question is why don't we run Phase 1a and Phase 1b in parallel? And that question has been asked a lot, so it's useful to deal with that one. And I think I touched on it when I was speaking. So to say other companies do so, Andrew, correct me if I'm wrong, that's not true. I mean, it's a rare occurrence that companies go into an efficacy study without having completed the dose finding phase of the work. 

 

I have no idea why Shasqi took that approach. Presumably is a sensible reason for that, but in my opinion, certainly the team's opinion, it would be reckless to go into a Phase 1b which was potentially suboptimal because we don't know how high a dose we can give, and to then spend a considerable amount of money doing that and run the risk of not getting the outcome that we want. All for the sake of waiting for another cohort or two, whatever it turns out to be. So the answer to the question is yes, it's true to say that companies have very occasionally in the past run these two types of studies in parallel. That's not appropriate for us.”

Andrew Saunders was in agreement with AS and concluded his answer by saying:

“So you can either rush to a suboptimal dose and maybe failure or you can do it in a more rigorous way. Which I think we are doing, the more traditional way, but do it as steadily and as fast as you can do. But choose the optimal dose and schedule because once that is done, it's really difficult to go back.”

I didn’t attend the AGM, but I have heard a recording of the afternoon session and have a transcript.

Ref the Diagnostic Division, I agree with the comments regarding synergies. AS concluded the Diagnostics session by saying:

“So, as I said earlier, our immediate focus is about gaining the synergies from both businesses [Coris & Launch]. It's not on further M&A activity, I mean the Board is absolutely aware of the need to allocate capital across the group. That's something that we talk about all the time and just to be clear, we're not heading down any further acquisitions anytime soon.”

Thank you for the feedback from those that attended, especially the excellent Jive_Turkey.

Just on the subject of the AGM, the cut off for voting on the proposals is 23rd June. I have voted against the remuneration proposal on principle. It was very simple to do on my brokers website.

I thought the LTIP options announcement for AN & IG was a shocker. There is, imo, no justification for any potential awards unless the SP hits at least last year’s 80p placement price. I appreciate there is five year lock in, but the thought that AN & IG may potentially benefit whilst many of their LTH’s are still substantially in the red doesn’t sit right with me at all.

The remuneration vote is only advisory, but it is a good indicator of shareholders views so I do hope people vote.

We could do with some contract/partnership news to act as an SP catalyst, attract new investment and reassure LTH’s who have taken a right battering over the last year.

The daily trade volume is very low. Take Monday for example, there was only 10 trades and the combined TOTAL value was under £6k (if anyone is interested LSE lets you look back at the last five days trade).

We could also do with some evidence of II interest. IG said at the Investor Meet presentation that they had plans to attend “numerous investor conferences and we've got quite a few coming up over May and June in the UK and the US with the European and US investors. And we're encouraged with the meeting schedules that we've got and potential new investors, including some large ones where we've had ongoing dialogue.” So we could definitely do with some signs of progress in attracting this type of investment.

Plenty going on in Twitter tonight.

I have no idea if the rumours are true, but it might give the SP a lift tomorrow.

Does anyone know please what the significance (if any) is of the low single digit trades? They have cropped up a few times recently over the last week, including today. For example -

Time Qty. Buy/Sell

12:32:48 5 Sell

12:44:20 2 Sell

12:54:34 4 Sell

13:04:13 1 Buy

Thanks Soup for the explanation. What a lot of pointless effort for little or no return.

I agree Trans - good riddance. I have lost count of how many NFX P&D’s I have seen over the last three 3+ years, there has been a lot of them.

One thing I don’t understand is why target a share with such a wide spread? Why not go for something with a bit more trade volume and and a 2% spread? I still haven’t got my head round that one.

At least someone stuck up for the LSE LTH’s on the Telegr*m group. I find it very strange Dan is on there.

“Dan, with respect a lot of the investors on LSE are LTH’s who are heavily in the red but have still stuck by the company, despite the numerous board changes and the catastrophic SP. I should know because I used to be one of them.

I still hold a few now, but disillusionment set in a long time ago.”

Thanks RD, for clarifying my badly put P1a explanation and apologies.