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This likely won't apply to Avacta. For new drugs (as opposed to biologics) the criteria to be included are: "For CDER [drugs], products must be intended to treat rare neurodegenerative conditions, including those of rare genetic metabolic etiology."

The alternative, new biologics [which doesn't include ava6k as we don't use biologics] "must be a gene or cellular therapy ".

@Bella - a company can always delay an announcement, by a few days or weeks. They company can take time to 'fully understand' the implications of a result, or simply delay the sign off by the necessary person in the company. This is why major results for most companies are announced earlier in the week, and bad results tend to be released late on Friday.

@RMFatGB - exactly. I would not be surprised by an announcement of a small deal to co-develop Precision-ADCs with a partner. I doubt it will be affimer based (too many new things to develop and dest), but attaching Precision to a known (approved?) ADC would be a great target.

As we know, ADCs are the bees knees when it comes to new cancer therapies. This is where the buzz is. The field is growing at an exponential rate as every major player (nearly) is jumping on the band wagon.

There was a 400% in deal growth for ADCs from 2017 - 2022, and 2023 and 2024 have blown the 2022 results out of the water.

https://www.biopharma-reporter.com/Article/2023/10/26/adc-licensing-deals-reached-peak-of-16.6-billion-in-2022

But of course, ADCs are not new. The first one was approved in 2000, and a number were approved between 2010 - 2020 (I believe there are 13 currently approved). And many of the assets that are being picked up today, started pre-clinical or clinical studies 5 years ago or more.

So why weren't ADC companies bought out or licensed earlier? Why is there a rush of LDs and M&A now? Why didn't BP buyout these companies years ago for lower prices? Technology has enhanced of course, but a big reason is simply trends within the field. New M&As and LDs spur further deals as no one wants to fall behind. So there are even fads within biotech.

In my view, Avacta are a next generation cancer therapy, ADCs are the present. So Avacta's position today is the equivalent of where ADCs were in say 2015 or so. Yes, there were M&As and LDs for ADCs in 2015, but the real excitement was elsewhere at the time. For those companies that bought into ADCs in 2015, they got big rewards. So big, in fact, that now everyone is trying to jump into the field to try to replicate those results. But they are late to the party.

The excitement in biotech is generally not generated by the cutting edge. It is a few years behind. I guess because it is never clear which of the cutting edge technologies is going to be the next big thing. But if you wait a few years, it becomes clearer,

as many fall away, so there is less risk.

Avacta could be taken out tomorrow in an M&A, as there were ADC deals happening in 2015. But it may also take a few years as the technology matures and awareness gets out. Currently, BP's eyes are focussed on ADCs (and immunotherapies). It's easier to justify a strategy to shareholders and the board of just chasing the pack, i.e., going after the next ADC deal. It's harder to justify going in a new direction and going after a new technology. The potential gains are much bigger in the latter, but it's a bigger risk. The novartis CEO recently said as much, they won't be chasing the ADC band wagon, they'll be looking for the next big thing. Could be Avacta, or another of a number of cutting edge tech.

O&W - I do not believe that is true. I have never seen or heard of a situation where a published paper has any impact on the share price nor the external valuation. Presentations and announcements, on the other hand, drive valuation. Journal publications are for record keeping, rather than for announcing results in the pharma industry. And indeed, it is premature for an article, it would likely be submitted after the full P1 or even after the full trial.

@BV - I would also like to see the graph of the UPS patient (and others) of the size of the tumour vs. time. But i doubt that this will appear in the published article...as I've never seen such a graph for any cancer treatment (I'm not saying that this is never shown, only that it is not a standard figure, so it is uncommon).

The Undifferentiated pleomorphic sarcoma (UPS) patient, who I believe is likely to become the first "complete response" patient on the ava6k trial, began their ava6k treatment in Feb. 2023. Their tumours are sensitive to dox, but if they were given straight dox, they would only be allowed 6 cycles, meaning that their treatment would have ended after 18 weeks, which would have been in June or July. Progression free survival of sarcoma patients after ending their dox treatment is just 2 or 3 months (it is 6-7 months from the beginning of streatment).

Instead of progression, his tumours continue to shrink. At the November 2023 cutoff, the tumours at shrunk by 65%. By the Jan. 2024 cutoff it had shrunk to nearly 80%. So it is the fact that ava6k can be given for much longer periods that is going to be the game changer here.

Just a reminder that many tumours are sensitive to dox, but that 6 cycles is simply not enough to wipe them out. In fact, the tumours are often just starting to show significant shrinkage when the treatment stops. Precision will upend this, drastically improving response rates and improving the quality of life at the same time.

Hi BV, I'm not sure, as I did not think that [18F]FAPI-74 could be used as a therapeutic. 18F is a radioactive nuclide, and when it decays it emits a positron (like Ga in normal PET imaging). Positrons don't cause much damage, which is why they are used in imaging. My understanding is that this could be turned into a therapeutic by putting on a different radioactive nuclide, i.e., an alpha or gamma ray emitter or something like that.

Great find. Interesting though that sarcoma is not included...

Bicycle Therapeutics just raised $550M in a private placing, which represented ~67% of the total market cap. A huge dilution, right? Well, the stock jumped up ~19% on the news. But of course this is on NASDAQ with real investors instead of being dominated by day traders.

https://ifamagazine.com/bicycle-therapeutics-announces-555-million-private-placement-equity-financing/

On AIM, you raise ~20% of your mcap, and you drop ~50% of your value. Crazy. This is why biotechs don't want to be associated with London.

Ava6k is not being trialed for breast cancer (at the present time)

In reality, all the BOD would need to do to block a buyout that they think is too low (be it £3 or £5 or whatever) is to say "We do not recommend this offer, as we believe a higher offer will be made imminently." It is very rare that shareholders accept a bid that is not recommended by the BOD. Why? Simply because it is reasonable to believe that the BOD have a better understanding of the value of the company.

The opposite can happen (see Point), where the BOD recommends an offer, but the shareholders want more, and therefore don't accept (for some time).

@Rambo - I fully agree.

Yes, I know the interview that you mention with AS, but I thought it was pretty clear that the cohorts needed to be sequential, while the patients within a cohort could be done in parallel. The SMDC is overseeing both the US and UK arms of the study, so the UK arm can't just start at Cohort 2 dose levels (which will be the dose level of the 4th cohort in the 3 weekly arm) until the SMDC approves the safety of Cohort 1 (bi-weekly). The UK can 'back fill' the cohorts though...meaning that additional patients can be enrolled in Cohort 1 (during or after the US Cohort 1 has been approved).

@Icecool - I didn't read the message that you are responding to, as they are filtered. But I believe that in fact they cannot move on to the 2nd cohort until the 1st cohort finishes. The "parallel" refers to the fact that they can dose all 3 patients in a cohort at the same time. This is unlike what was done in the 3 weekly study, where the patients needed to be dosed sequentially. So each cohort can, in principle, run much quicker than in the 3 weekly study. But the SMDC need to sign off on the safety of the cohort before moving on to the next cohort (i.e., moving up dosage).

What we don't know if whether the SMDC have already signed off and the 2nd cohort has started and that we will only be told once the 3rd patient has been dosed. Or if something happened in the 1st cohort which has delayed the process (i.e., a patient dropping out...which is common and not necessarily linked to ava6k). I had hoped for better communication, meaning that we would be told we were moving to the next cohort and then another RNS when the 3rd patient was dosed. But given that we didn't hear about the 1st cohort until the 3rd patient was dosed, it seems very possible (likely even) that we will only hear about cohort 2 when the 3rd patient is dosed.

This is an excellent comparison. Perspective Tx started their Phase 1 last year and the first results were out in late 2023 or early 2024. The first cohort had a decent safety profile and the SDMC recommended to move on to the 2nd dose cohort in mid-Jan 2024. Since then, the SP has gained ~300%. The platform was partially proven, hence the investment was significantly de-risked so the SP grew. This is the problem with AIM, such rational responses are simply not seen.

The only real difference that I can see is that Perspective Tx does seem to present at nearly every health/oncology conference under the sun. Whereas, Avacta appear to be very conservative on where/when to present.

Spot on. Found this on cancer research uk:

-Incidence rates for soft tissue sarcoma in the UK are highest in people aged 80-84 (1996-2010).

What more data do you think they will release? They give us continued updates on the patients still on trial...but is there something you don't think that they have released yet that they should?

@PL - yeeeehawww!

After the 2QW trial ends, so likely late summer or early fall.

Interesting idea Bella. Definitely possible that the 'important announcement' that it is the sale or spinoff of Dx. However, I don't agree with the rest of the theory. They will never pay off the bond with cash. The cash is always better used to fund the pipeline. Getting new money (either through a sale or a raise), to pay off other debts is simply not something that young biotechs do. They are always cash hungry.

@GoSushi - not sure. But my guess is that we could use the Keytruda Melenoma study as an example...so 150-200 or so?

@GoSushi - that's true, a Phase 1 study with n=173 patients.