Aptose Biosciences Inc (APTO)

[dcaf7]

In general, today's presentation was not positive. They had an EOP1 meeting with FDA. As a result, FDA told them not to use 120 mg as a RP2D and to stick with 80 mg. It is consistent with the results of dose-escalation study, but it is not what Aptose wanted. The meeting didn't bring any clarity on what ORR and mDoR they need to beat in their single arm study. They need to conduct a natural history study and to find out it by themselves. Rice said it is difficult. I guess it is easier to do for Flt3i failures but not for TP53mut and other patient populations. As an alterative, they are thinking about Tusp vs Tusp/Ven trial, where Tusp arm is a control. Not a bad idea but trial will be more expensive and possibly will require preliminary dose-finding. Finally, initiation of a single arm registrational study disappeared from their timeline slide. This is the most annoying thing to learn. Delay after delay after delay. Typical for Aptose. Some hope is on slide 35 where you can find "Large Biotech/Pharma Type Agent". Give it to large pharma.