Member Info for jive_turkey

And £2M+ of options. do some basic research.

Yes, the C7 data should be remarkable. But they won't RNS the data. As we were told in the Q&A, they are holding data back in order to present the at a major oncology conference. One can only assume that they are holding back the best data, to maximise the chance of an oral presentation (as opposed to a poster presentation) as well as to make the largest possible splash in the community (if not the media).

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.

Timster - indeed, P1a now has two arms. Arm 1 is C1-C7. Arm 2 is the bi-weekly dosing. So no, P1a is not complete, but should be mid-year (if we believe that timeline...although I am quite surprised that the first cohort (all 3 patients) has started yet).

@Timster - why? They openly said that they held things back from the Dec. presentation in order to have 'new material' to present at upcoming conferences. Examples include case studies of C6 and C7 patients (where we expect the largest effects, both in terms of dose level and, C7, hopefully patients with less previous treatments), lack of cardiotoxicity (a major point that just happened to not be discussed in december), quality of life of the patients, detailed biospy data, etc. I think they already had more than enough for an oral presentation in December...and definitely enough by the early Feb. final deadline (and of course new data can be included after this point...it just won't be in the abstract).

Which is likely to be an ADC. Those are the best currently available approved therapies. Typically don't use a monarch to try out new (unapproved) therapies.

The Precision platform patent does not cover Affimers. Affimers are unrelated to Precision, two separate platforms.

@FS - If ava6k would take the standard route to market (standard FDA approval), it would be expected to gain approval in mid/late 2026. It would be this quick due because a Phase 3 is not required (pro-drug forms of approved drugs often don't need P3), making the upcoming Phase 2 'pivotal'. However, given the results so far, specifically the safety profile and early efficacy signals, in addition to the Orphan Drug Designation status, there is good reason to believe that ava6k would be a candidate for accelerate approval or breakthrough therapy status. In these cases, it could be brought to market (temporary FDA approval) much earlier, and would gain full FDA approval at the end of P2. This could happen at the end of arm 2 of the P1a study, which is expected in mid-2024.

As has been stated many times Hurst, what Novartis mean by precision is gene sequencing, nothing to do with Avacta's Precision. That is their focus, pretty much a 180 degrees away from Avacta's Precision (i.e., patient specific treatments based on their genes rather than a broad chemotherapy with general utility).

That's not to say that they wouldn't be potentially interested in Avacta's Precision in the future, but that is not their focus now.

@LDA - no, I can't imagine a FSTE 100 CEO starting that, but by the same token, I can't imagine a FTSE 100 (or Nasdaq listed company) stating that they have drastically reduced side effects of a potent chemotherapy, thereby allowing for 2-3x more doses, with clear efficacy signals in humans and that the drug was working much better than imagined possible, and then the stock price going down.

That is not the CEOs fault, that is the market behaving irrationally (i.e., traders controlling the market). Should Avacta get off AIM? Of course. However, the resources and time for moving exchanges are significant, and of course there are tradeoffs with the move (i.e., moving to a real exchange is not only sunlit uplands). Should deals be made? Of course, but negotiations take time and can be subject to events outside the control of Avacta.

@CTSFO - Avacta need to buy standard dox from somewhere in order to make ava6k. So the current producers of standard dox won't need to change their business model (or look to partner), as it seems likely that much more dox will need to be produced due to ava6k than is currently made. So the current makers are actually set for relatively big gains. All they need to due to strike a procurement deal with Avacta (or whoever Avacta partners with make ava6k).

@starbright - actually, biotech companies often/typically use conferences to announce major results. The reason is that the majors and press are present, so it’s a great forum to make a splash.

Of course, calling out any and all vaguely oncology focussed conference is pointless, so those posts should obviously be ignored. The difference here is the statement in the Q&A response that they have held back data explicitly to present at a major conference. The pre-eminent oncology conference is the AACR, coming up in April, which matches timescales.

@cemented - nope. As per the Q&A responses, data was held back to enable presentation at a major oncology conference. Likely AACR in early april.

HG4- it was in the Q&A answers.

Bella - dox is a generic drug, made by multiple companies, hence this will not be a limiting factor (i.e., a manufacturer who 'calls the shots'). Most likely, as in any drug production, multiple dox manufacturers will be contracted to provide that drug as part of ava6k, so as not to have a single point of failure. Now, who makes ava6k is anyone's guess. It almost certainly won't be Avacta. But looking at currect dox manufacturers is unlikely to play a major role in the calculus.

Also, more frequent dosing of dox is an age old idea, so this was almost always certainly on the cards. This wasn't a new idea by a major. Take away or reduce the side effects, and it was always the goal to reduce the time between dosings. It has been shown multiple times in clinical trials, that more frequent dosing leads to better results. The problem is simply that at the same time, there is more damage to the body (white blood cell counts specifically and knock on effects) which means that on balance, the patient is worse off.

The completion of a cohort is a fairly nebulous concept. There may be an official end (as LL suggests, which seems reasonable to me), but little changes at this point. The patients still get dosed, still get monitored, etc. after this point.

And to be a pedant (sorry BV, I beat you to it), P1a ends with the bi-weekly study sends - i.e., arm 2, not when c7 completes.

Given that nothing changes at the official end of c7, I don't expect to get an RNS on this. We definitely won't see any data from c6 or c7 until the big release presentation.

@cj - what exactly are you expecting to hear? We only heard about the 'end' of previous cohorts because we were moving on to the next cohort. This is not the case with c7. We know that they will continue to dose patients after the official completion and continue to follow their progress. So I doubt we will get an update for c7 until whenever they present the full Phase 1a arm1 results. Perhaps when we hear that patients have been dosed in c1 of arm2 there may be a mention that c7 is officially done (although with patients still being dosed), but I would guess that would be about it.

@Timster - The way it works for such conferences is that Avacta will apply for a 'presentation', where they give an abstract and possibly a general summary of the results. Typically, there are many more requests for presentations slots than can be accommodated by the schedule. The organisers of the conference (a panel of specialists) then choose which applicants will be given an oral presentation and which will be given a poster slot. So assuming the AACR is the place where Avacta are going to present the P1a data, they will have already applied for a presentation slot, and the organisers should decide if Avacta get a poster or oral slot sometime in Feb or March, and I guess we would hear a week or two before the conference.

Normally, Phase 1 data are not exciting enough to get an oral slot at a major conference. However, as we know, these are not typical Phase 1 results. So with the results presented so far, and knowing that some (much?) data have been held back explicitly in order to be able to apply for presentations and major conferences, I would assume that Avacta get an oral presentation. Last year Allogene Therapeutics got an oral presentation at the AACR (https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-presents-interim-phase-1-data-allo-316), so it's definitely not unheard of.

Good discussion, and indeed seems like a lot of hints are being dropped. Disappointing though when they get the basics wrong, i.e., going into Phase 1b and that Precision was developed in Leeds. You can see where the confusion comes from (it's arm 2 of P1a and affimers are coming from Leeds, not Precision), but easy to check and correct.

@Profcheese - Thanks for your kind words. My post wasn't about Avacta management or the ability to commercialise a product. Both are, of course, very important and I'm sure that we (i.e., the BB) could have a constructive discussion on both. My point was only related to the seemingly constant suggestion that it is Heights that is responsible for the SP drop. Simply looking at the numbers shows that this isn't the case (even under the additional added theory - without evidence - the Heights forward sells the shares). Instead, this narrative that the repayments are important to the SP play directly into the traders hands. And as this share is, in my opinion, already over-controlled by traders (thereby reducing the possibility of the share obtaining a representative value) it's worth calling this out as BS.

Again, the drop has little or nothing to do directly with Heights. ~3 million shares is nothing. Since the beginning of January, the average day has seen volumes of ~700-800k in trades. So even *if* Heights forward sells, it is just a small fraction of the total market. And the SP has been dropping since the beginning of November, so this would be ~3 months to absorb the sale. So it simply isn't relevant in the overall picture.

What is relevant is the traders who are playing off this irrational fear. Just like the obsession with 'shorts', which when at the few percent level have no effect on a share.