To your point @Scoonie there is a lot of research in prostate cancer (and cancer generally) that could disrupt both TLX and CU6. The Pfizer Phase 1 results for mevrometostat which is being tested against metastatic castration resistant prostate cancer (mCRPC) is just one example. Drugs that target mCRPC have priority disease status with the FDA due to the lack of effective treatments and high prevalence and impact of the disease. Hence the approval path is quicker, but it could still take 5-10 years to get from pre-clinical to approval, so it's a relative thing.

I have a dog in this fight to declare and a reason I have been hesitant to invest in TLX and CU6. I am a part time CFO with a Biotech which has a small molecule candidate for mCRPR but it is pre-clinical and unlisted. We are obviously a long way from being in market, and based on average success rates it's only about a 5% chance we will make it to FDA approval,

BUT the potential of our candidate (and potentially other candidates in the small molecule space) is a business killer for TLX and CU6. Subject to verification of safety and efficacy (the point of clinical studies), the cost to provide the treatment is much lower, there is no need for specialised equipment like is required with radiopharmaceuticals to manufacture, nor does it require specialised lab work to match to or modify for specific patients like genetic treatments or the currently popular CART cell therapies. It would be an of the shelf pill and unlikely to require expert administration to be effective.

Now to the point about risk, TLX and CU6 are risky, but far less risky that the Pfizer candidate which is less risky again compared to the candidate the company I work for has. It will be interesting to see how much "time in market" drugs/treatments are also impacted by AI accelerating rates of development. Normally a drug would have a 20-year patent, of which at least 10years would be spent in the clinic, so at best another 10 years generating sales on patent (note it's usually a lot less time in market before the original patent expires, but extensions via supporting patents are common, or may be allowed for priority diseases), but the arrival of a superior treatment is going to cut that short again, so calculating the value is very very hard given the extent of these unknows.

Regarding the diagnostic offering that TLX and CU6 have, these are very important, but probably more at threat of disruption. Diagnostics are usually quicker to get FDA approval because the clinical trial requirements are easier to achieve (generally you can test a new diagnostic without denying a patent the current best practice without compromising the test which you can't do with treatments and it is unethical to deny a patent the existing best practice treatment just so you can test your new one, hence combination treatment testing like Pfizer did with mevrometostat by combining with Xtandi).

Back to the company I work for, the small molecule treatment candidate we have has potential as a diagnostic also (with a similar logic that is the case for the TLX therapy/diagnostic). So it is likely that we would progress both a diagnostic and therapeutic path with a view to commercialise the diagnostic well before the therapeutic was approved.

For some context the Prostate Cancer market is valued around US$15.9b, of which around 56% is for therapeutic treatments and 46% is for diagnostics. So diagnostics is a massive market and if you have an offering that is far superior to alternatives plus it's patented then you get a very large chunk of that market.

The Cancer treatment and diagnostic market has been a focus of large pharma and much of their funding for research for many decades and what is interesting is how much money chases just incremental improvements with a real solution out of reach. Pfizer's mevrometostat results show the median progression-free survival increase from 6.2 to 14.3 months. So on average patients are getting an extra 8 months - it isn't a cure, it's an extension and if successful will be worth 10's of billions.

Not to understate the importance the increase in life represents, the real disruptor would be a cure - one that leads to remission rather than a period of progression-free. Now I note we are talking mCRPC here, which currently doesn't have an effective treatment. This is the stage/status of prostate cancer you basically get to once other therapies prove in effective, so we are talking late stage and hard to treat.

I suppose my point on this is that there are lot's of parts of the market and puzzle, all have competitive and disruptive threats like other businesses, but the thing to really look out for is a fully effective treatment. We will probably see it first developed for hard-to-treat conditions like mCRPC, which is a regulatory supported path to market so quicker and cheaper way to FDA approval, but will be the ultimate threat to other treatments and potentially diagnostic providers across all forms of prostate cancer and potentially a range of cancers.