RAC - Charts & Price Action, page-247

Brequinar is being repurposed (new indication) by Clear Creek Bio, which is different to what we are doing with Bisantrene resurrected (same indication).

The trial Clear Creek are running in collaboration with COH has nothing to do with FTO, they are using it as a repurposed drug, targeting, in combination with ribavirin, dihydroorotate dehydrogenase [1].

Brequinar is not a serious competitor to bisantrene, not least because bisantrene has two mechanism of actions in AML (high and low dose). FTO is only overexpressed in a small fraction of AML cancers - about 5% to 6% from my investigations. Brequinar has none of the historical data supporting its use in cancer (it failed in the past in Phase II)[2]. It really is right back at the start of the drug development process.

From the paper COH are not planning on doing FTO trials with bisantrene or brequinar, they are planning on making variants of bisantrene and hope to start clinical trials with their new compound in a couple years (assuming they can find a new drug that works against FTO and gets around our patents). They are starting right at the beginning of the drug development process (unless they work with us of course).

I think many people here have missed the significance of slide 16 (AML - a crowded market) from the June investor update. There are so many new drugs being developed for AML at the moment that it is not practicable to recruit enough patients to complete a Phase III trial. If you have a new drug you have none of the safety data you need to reassure the FDA your drug is safe and efficacious. You can show your drug is efficacious from Phase II trials, but showing safety requires testing your drug in a large numbers of patients (i.e Phase III trials). We have the data to show it is safe from the historical trials and we can collect the data to show it is efficacious purely from Phase II. This really is a rapid path to market in a crowded field.

The bottom line is bisantrene is a lot more valuable than most of the Australian sharemarket thinks. Those in the industry know much better.

1. https://clinicaltrials.gov/ct2/show/NCT03760666
2. https://en.wikipedia.org/wiki/Brequinar