7. Preclinicalactivities ongoing
·Preclinical studies aiming to elucidate the mechanism of action of bisantrene cardio protective effects seemingly unchanged from the August strategy update (which would hopefully imply this work hasn’t been disrupted in any material way)
·FTO biomarker development with CoH and Monash is notably absent from the updated strategy – need to understand the reasoning behind this? It looks like RAC will be unable to fulfil its obligations to CoH and will be liable for penalty fees.
I think it isimportant, and a nice-to-have, rather than a must-have, to continueinvestigating the MoA of bisantrene’s cardioprotection so I’m glad this programis continuing. I think it can only provide additional value in terms of physician’swillingness to uptake bisantrene, and be comfortable continuing to useanthracyclines (perhaps even at higher doses and longer durations than they donow) with an understanding of how it works.
8. City of HopeContractual Obligations
·The CoH deal was signed by previous management, assumingly under the proviso of RAC adhering to the August Strategic Update. It would seem to me that the updated strategy puts RAC in jeopardy of the below deadlines.
I don’t see it beingwithin the realm of possibility to have dosed a patient in a P3 FTO-relatedtrial of bisantrene prior to July 8 2027, given the P2 trial readout isestimated in 2029. Marketing approval for an FTO-related indication inUSA/EU/CN/AU may be possible prior to July 8 2029 if fast-track designationsand breakthrough therapy designations are achieved and the P2 solid tumourtrial is completed ahead of the estimated timelines above. But I would also putthis as quite a low likelihood. So it will be important to understand theliability RAC has to CoH under this agreement, and whether this agreement isactually still viable under the new strategy. What implication does this haveon our access to CoH FTO data and for the future success of bisantrene and thedevelopment of FTO biomarkers?
