Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-473

What I find interesting is BOTs determination that 5% QD is the preferred dose. They’re basing this on the combined data outcome but when you look at the best singular performer across both countries, 5% BID in Australia had the highest percentage reduction in both Inflammatory (43.1%) and non inflammatory (39.5%) lesions with statistically significant separation from the Aus vehicle in both cases; particularly in non-inflammatory (34% better) which Management have stated was the more challenging lesion to treat. If you consider their comments and concerns in the presentation around the multiple batches of CBD produced in the US, it just makes me wonder if the apparent reliability of the CBD used on the Australian cohort makes 5% BID a better option. From a commercial standpoint, if you can justify a higher dose getting better results, you’d sell more product.

I think the QD vs BID results show how poor the US batch consistency and quality may have been. Every single dose rate in the US performed worse than in Australia; the 2.5% QD and 5% BID were significantly worse so could it be that the batch they used in the US for 5% QD was just by chance better quality? If they’d used that batch in the 5% BID would that have resulted in a significantly better outcome for BID over QD in the US and therefore deemed the preferred dose? The more I look at the results, the more I suspect the trial data from the US cohort is unreliable which in turn means the combined data is largely invalid and the Australian data is a more reliable measure of how the drug and placebo really performed - not only because of the unexplainably high vehicle outcome in the US but also the variability in performance of BTX in the US trial when compared to Aus.

Management are restricted by the ASX in what they can say but reading between the lines, I think they’ve looked at the US data and gone OK, we don’t know why the vehicle performed so well, let’s call that out and investigate why that happened, but the US CBD performance reflects inconsistent quality, hence their remarks around this issue in the presentation and the emphasis around having addressed the problem for the Atopic Dermatitis Ph2 trial.