The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
@OilNovice - your concern would be valid if there was a single big pharma company that controlled everything. However, in reality there are many companies, all trying to take market share away from their competitors (and also trying to increase the size of the market). This is why new drugs continue to be developed, which replace older drugs over time, if they are more efficacious.
Thanks Estura, that's what I remembered, that he was pretty sure of the date but that he couldn't say more than that at the moment. The follow up also supports this, a recording describing the results, as us normal folk wouldn't be allowed it to any conference.
@Moneysponge: And if we want "maximum affect", that is surely a large high profile conference, along with a press release to the media. This would make a much larger splash than simply a publication (even in a high profile journal).
As for the C1-C6 (including as much of C7 as possible) data release, the comments from the results presentation, along with the email exchange betweeen AS and EmilyKate suggest that a specific date was pencilled in long ago. This likely corresponds with some external factor. For exciting results to be presented to the world, conferences are the most common. There are dozens of oncology conferences in December (2023), but none of them appear to be very high profile. There is a big one (JP Morgan Healthcare Conference) in January (8th-11th) which is often used to announce big results. Obviously that wouldn't be Q4 though...
Agreed BV. As the bi-weekly dosing will be a new trial, I expect them to RNS when 1) it is approved (or given the green light) and 2) when the first patient is dosed.
@BV - to be fair, you can't "stand by that" because you don't know what the real situation is. We are all guessing from the sidelines. There is every chance that AS did present the real situation, and that nothing has changed except some PIs are (as always) becoming impatient. PL presented his view a month or so back (when we also had this discussion about the wording), so not much changing there.
@Timster - if the RNS comes tomorrow I would be very disappointed. The US is closed for Thanksgiving, so releasing an RNS designed to gain the attention of BP, large funds and large privative investors would be a big wasted opportunity.
Ha...great minds. I was referring to PL's view from a few weeks ago that he posted.
I liked PL's take on this. The bi-weekly trial will begin whenever FDA give approval. This is expected to be relatively quickly (i.e., a couple months compared to the average ~6 month wait) and if it is given before the end of C7 then they will begin, so the two trials will be in parallel. If approval comes after C7 completes then it won't be in parallel. The approval timescale is not in Avacta's hands (although presumably they are in contact with the FDA about the trial and changes to P2, and likely breakthrough status).
Good point Largo, I guess that rules out data release on Thursday/Friday.
My bad.
@BITL - to be fair the SP has been falling pretty steadily since Nov. 7th. And in this case, I don't think anyone actually believed that Nov. 21st was a real possibility...this was all tongue in cheek.
Nope. Sujood just picked the date out of thin air a few weeks ago. Hence, it has become a joke that the 21st is the big day.
With the data release expected imminently (Q4) it's worth thinking about expectations and possibilities. From my perspective, the data by itself is unlikely to lead to any significant change in the share price (SP). The reason is that it will be largely technical, so not aimed at the average investor. However, the data may open the doors to large fund investors (likely US based) and/or large pharma/biotech companies. If these types of institutions do become involved, I would expect a few day to few week delay between data release and significant buying.
But the other side of the data release will be "case studies", i.e., details and personal stories of individuals who responded on the trial. If these case studies are good enough to make it into the main stream media, this will drastically elevate Avacta in the investor community (first in the UK, perhaps beyond as well) and will bring in a larger investment base.
So what might we expect from the case studies. The first is the obvious one, that we have already been told about, the STS patient with a dramatic shrinkage (that continues) in their tumour. But we were also told about other, non-STS patients that have shown signs of efficacy as well. As part of the data release we should find out the tumour types of all the patients so far (like we did for C1-C4 at Science Day). If a breast or lung patient (or other common cancer) is also included as a case study, this would dramatically increase the impact of the data release. And the more case studies, the better.
As the median number of cycles (at least in C1-C4) received by patients is just 2, my guess (and it's only a guess) is the STS patient with a dramatic reduction in tumour size was from C5, simply because it often takes a few cycles of dox before tumour shrinkage occurs (not always, but often). This opens the possibility of some great case studies coming out of C6 and C7, due to the higher dosage.
So I would expect the case studies to draw in more private investors while the data itself will be more relevant to the big players. I expect both to be very strong.
@LL - yes, except at the science day deck we were not given the equivalent results (biopsies and concentrations) for straight dox. What the numbers below the table show was the expected IC50 rate for dox, but this was in a petri dish, not in a human. And while one should expect them to be close, biology is such that surprises are common.
But even with this, I realise that concentration of dox in the tumour for ava6k and straight dox are not directly comparable at a single time point (24 hours after infusion in this case) due to the different PK properties between ava6k and straight dox. Dox from ava6k might be lower in the tumour than straight dox at a given time point, but if it last for longer the cumulative amount of dox in the tumour could be much higher.
But all that uncertainty is behind us now, the risk is gone, efficacy has been demonstrated and as has been noted (but under-appreciated in my view) is that even for very successful drugs efficacy isn't seen in P1a (due to the patient pool). So that fact that we see it now (so much so that the P1b has been dropped), so clearly, means that ava6k is looking very special indeed.
FWIW, I think that there was still significant risk that ava6k wasn't "working" during C1-C4, even maybe including C5. Yes, the biopsies that were taken showed significant dox levels in the tumours, and this was a big signal that it was working. But there was still a chance that due to the different PK properties of ava6k vs. straight dox, that the concentrations reached would not be high enough to really help destroy the tumour. For example, ava6k should dampen the big early spike of dox in the blood when given as straight dox. Ok great, but if ava6k was cleaved at too low a rate in the tumours, it is possible that there wouldn't be enough dox around to kill the tumour. As AS has stated, until a few months ago, there weren't any clear efficacy signals in the patients. That wasn't entirely unexpected (given the patient pool that comprises P1a studies), but it meant that it was still a risk.
But we now have clear efficacy signals in multiple patients. So this risk has been removed. AS and FMcL have recently stated that there is now little risk involved for ava6k and that everyone in the know thinks that ava6k will work and be approved. The only risk mentioned is one that they are on top of, namely making sure that the P2 study is well designed (i.e., sub-types used).
For common tumour types (e.g., breast, lung, ovarian, etc) there are many drugs that have been approved, so there is is certainly competition between the different makers to get their drugs used more often. But that hasn't stopped many of these drugs from becoming blockbusters (>>$1B in sales). So competition is unlikely to be a significant hurdle either, even before one considers the special position that ava6k finds itself in, i.e., an effective drug with drastically reduced side effects (and no cardiotox!).
That's a good point PL. My hope, however, is that these new retail investors won't be traders for the most part, but rather normal Brits who are investing for the future. Traders seem to love AIM, while investors seem to shun it, by and large.
I think that there will be three causes of SP after data release. The first, like others have said, is if we get a large fund or a large pharma to take a large stake in the company. And making the data public (assuming it is as good as it has been implied) increases the likelihood of this enormously. Secondly, the published data make the possibility of a license deal much more likely. It is these two that will see the SP much closer to the deserved level.
The third is if the data release contains info that can be picked up by the main stream media. "Terminal cancer case gets miracle cure"...that kind of headline. This would introduce Avacta to the public at large, and will double or triple the retail investment base overnight. But this of course requires making the front pages of the newspapers and onto the headline stories of BBC news.
The latter, by itself, would probably put at us ATHs (300p+), but the former (first two) is where the true value lies (1000p+).
Excellent point CTSFO. I asked ChatGPT "Are case studies usually given with Phase 1 oncology results?" and this was the response:
Case studies are not typically presented alongside Phase 1 oncology clinical trial results. Phase 1 clinical trials are primarily focused on assessing the safety, tolerability, and dosage of a new drug or treatment in a small group of patients. These trials are designed to determine the maximum tolerated dose (MTD) and evaluate the drug's side effects.
Case studies, on the other hand, are typically detailed examinations of individual patients or a small number of patients, often conducted in a clinical setting. They provide in-depth information about the medical history, treatment, and outcomes of specific patients. Case studies can be valuable for illustrating unusual or unique clinical scenarios and are often used for educational or research purposes.
Phase 1 clinical trial results are generally reported as aggregate data, summarizing safety, dosage, and early efficacy data for the entire study population. These reports are important for regulatory and scientific purposes and provide the foundation for advancing to Phase 2 and 3 trials.
As clinical trials progress to later phases (Phase 2 and Phase 3), more extensive data on the efficacy of the treatment is collected, and case studies may be included in the discussion of these later-phase results to provide additional context or insights into individual patient responses. However, they are not a standard component of Phase 1 trial reporting.
@Timster - Good point about inclusion of C7. Avacta are collating and QCing all the data for C1-C6 (a process we are told is non-trivial and very time consuming) and the inclusion of C7 data may complicate matters. On the other hand, one could image the inclusion of C7 data that does not require detailed QCing, i.e., side-effect profile. And if we want to be very optimistic one could imagine (due to the higher dose level than C5/C6) that a patient or two might be experiencing significant tumour reduction in C7 who could make excellent case studies.
@CTSFO - I fully agree. Avacta are really talking up the P1a results from all angles, so definitely not your standard results.
@RMFatGB - nope. This morning it is at $1.99 which is £1.65. Compared to the £1.36 price in the UK (before the markets opened).
It's also at 17% above the UK price.