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Based on the MTD of the mice models for ava6k, we are currently not even close to the expected MTD in humans. Even more so if (as implied by AS) ava6k is more targeted in humans than in mice (due to the lower free floating FAPa levels in humans than mice). So another increase of 40mg is unlikely to find an MTD either...it would likely take a number of additional cycles, and months or even years to the study.

Avacta (and the doctors) would have known the expected MTD before the trial started...under the assumption that it worked and that mice were a good representation of human for this drug. Obviously, they couldn't just assume this and jump to high doses right away, these are human trials after all (i'm impressed that they started at 90% of dox equivalent), so they need to build up carefully. Optimum doses can be found in later studies. If high doses of dox (twice the standard dox and times 3 or 4 for the tumour focus, so ~6-8x) are already in the TME and little side effects are found, there is little reason to increase by another 40mg or so. imho anyway.

@Groot. Watch the video above posted by Energy. This is what Third Bridge do. They set up their clients (typically large investment funds) with an expert, in this case a former Avacta employee. They are all well aware of the laws regarding what can and cannot be communicated and Third Bridge watch on to make sure nothing dubious is said.

Agreed!

Ah, thanks Energy, this makes more sense now. So this won't be a public interview, so no info given to PIs. Rather this is for specialist investors...perhaps a company is thinking about investing big in Avacta?

Still not sure how Livedata found out about this (and hence, whether this is actually true), but if true, this sounds like a good way for the big boys to find out details about Avacta.

Can you give a bit more info?

Oddly, the linkedin post by Avacta still mentions that FMcL will be providing a 'key update'. You'd think they would take this down asap, if it wasn't true. Very strange I must say...

They would have applied for this speaking slot months ago, when they couldn't have known whether the P1a trial was going to be finished by this date. It is normal within science to apply with a holder presentation, i.e., to speak about data that you know that you are going to have at the time, and then update your presentation/results if new data is available in time. This looks to be such a case.

The placing was for ~10% of the amount of the loan (i.e., bond). It seems to me a standard agreement by the lender that some (small) fraction of the required funds would be provided by the company, to show good faith in the agreement (shared risk).

@DTW much obliged! Thanks!

Hi everyone, does anyone know how to take advantage of the 95p offer through a standard Barclays investing account? Thanks!

Could be. A somewhat overlooked statement by AS is that in addition to their pipeline of Precision products, they are also looking to license out the platform to companies to develop pro-versions of their (under patent) chemotherapies.

A pro-version of Keytruda announced to the world would be (obviously would still need to go through trials, but presumably on Merck's dime), would set the entire industry alight.

@Energyshares, another possible RNS to add to the growing list.

I actually found it to be somewhat informative. Obviously it is poorly researched and the conclusions that it draws are ignorant. However, it may go someway to explaining the currently absurd stock price, something that I have struggled to get my head around. This author likely represents the perspective of at least some investors out there, who only look at the revenues/cash burn and continue to see Avacta as little more than a covid company. My guess is that this is actually quite a common misconception outside of this BB and a handful of PIs. Imagine their surprise over the next few weeks.

The fundamental shift, that will see this surging well past previous highs, will be when Avacta are seen as the future of cancer care, with a diagnostics business on the side.

@Timster, not Phase 2, but rather Phase 1b (which is the phase expected to begin later this quarter).

Of course they won't have full efficacy data, as the cohorts are simply too small to give a statistically meaningful result. However, they will be able to say whether or not ava6k cleaves in the TME, i.e., if the mechanism of action (MoA) of confirmed, and the severity (or lack thereof) of the side effects. As stated many times, ava6k is only a delivery mechanism, not a new treatment, dox works well and has decades of studies behind it. So once the MoA is confirmed and no unexpected side effects are seen (i.e., the leaving group is leaving without further negative interactions), that is as good as confirmation of the efficacy.

This is what makes this P1a data release for ava6k so meaningful, relative to the average Phase 1 results release in biotech.

It can vary for different studies, but for ava3996 it was expected to take "just over a year":
https://twitter.com/tom_the_bomb__/status/1541322156927229952

After a week of financial news from the company, I thought it would be good to turn back towards the science and regulatory approval process. Assuming that the Phase 1a results are similar to that of the pre-clinical animal models, what are the next steps in the process, and what are the chances of approval/sales?

I found an interesting article on this from 2019: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6868302/

The authors state: "Determining the safety of an agent remains the mainstay of phase I clinical trials; however,.....the majority of phase I trials could have a therapeutic aim, even in the first-in-human setting....Drug development in oncology is being transformed by the arrival of agents with well-defined mechanisms of action and targets, and hence with potential efficacy that can be unveiled rapidly via innovatively designed phase I trials enrolling hundreds of patients. Accordingly, in the past few years, the FDA has approved investigational drugs on the basis of results from phase I studies."

Hence, if Phase 1b goes well, and clear benefits to the treatment (overall response rate and/or lack of serious side effects) there is precedence for the FDA to approve the drug for treatment before Phase II. In this case, presumably other trials of ava6k would continue, i.e., using it as part of polytherapy, and investigating other types of cancer, etc. Recent examples of FDA approval after Phase 1 are ceritinib and pembrolizumab. These drugs had an overall response rate (the percentage of people in a study or treatment group who have a partial or complete response to the treatment within a certain period of time) of just 58% and 38%, respectively.

In the ongoing ava6k trial, a secondary objective is "Objective response rate" (ORR - which I believe is effectively the same as "Overall response rate"). I'm not sure if Avacta will announce the ORR of the Phase 1a study, or if they will wait until the completion of Phase 1b. If the ava6k ORR is >15%, the chance for FDA approval is 76% and if the ORR is >30%, then the chances of FDA approval is 89%.

I don't think Avacta published the ORR for the pre-clinical studies (but I could be wrong), but given that the overall survival fraction of the mice after 6 months with ava6k was 100%, presumably the ORR was very high.

I guess they would keep at least 50% of TMAC if they did sell RX. While I'm sure they would like to see 'full value', that is likely 5+ years off (i.e., full value will be when a number of Precision products are on the market). So to me, I think that this (selling off Rx for a metric sh*t ton of cash) is possible, at least in principle. But equally, I can see them pushing on with Precision themselves for now.

I agree Timster and MrR that shorters definitely affect the psychology of many PIs, which is likely why it is discussed so much on this (and other) BBs.

We also seem to agree that the shorts appear to have little or no effect the share price. You argue that this is due market manipulation, and I suggest that this is due to shorts have a small effect on the share.

In the case of Point Bio (which is on Nasdaq) are you suggesting manipulation there as well? I would assume that this would be much more difficult on Nasdaq (although I admit that the way that AIM behaves sometimes, it may happen here at times).

From what I can see, way too much is being made of the importance of 'shorting'. Half of the shorts for Avacta (over 0.5%) have now been closed, and it has had little or no effect on the share price. Especially for Avacta, where the shorters making up a tiny fraction (about 1% or less, now) of the market cap.

Compare this to Point Bio. On Sept. 15, 2022, shorters had 18% of the market cap. By Sept. 30th, this had dropped to only 7%. A huge change, right? And what did the share price do? It dropped by ~15% (and has continued to drop slowly after this).

The take away, for me anyway, is that for healthy companies, shorting has little or no effect on the share price, and that way too much is made of it.

@MB53, while there will eventually be a paper on the ava6k results, that will be on a very different timescale, i.e., months or even a year or more after the P1a results. The paper would likely not contain just the 1a results, but likely the P1b and possible P2 results.

A summary of the results are likely to be released in an RNS, followed (potentially the same day) with a presentation where AS and/or others walk investors and the general public through the results and their significance. If the results mirror that found in the pre-clinical studies, then on the day of the RNS release, I also expect a media release with graphics and talking points that hopefully will echo throughout the media.