Ann: Updated Strategy and Investor Presentation, page-321

In fairness to the Race management at the time, the 2023 Three Pillar approach is very innovative. The conventional approach is to advance Bisantrene primarily as an anticancer drug with cardioprotection properties. This involves picking a late stage cancer indication (say triple negative breast cancer) and then running a conventional 3+3 dose escalation Phase 1 trial followed by a standard Phase 2 in that indication with anticancer activity as the endpoint. It is not possible to measure cardioprotection conventionally until Phase 3 as you require around 2000 patients in total.

This conventional approach works, but it takes a long time and costs a great deal as it is very difficult to recruit the narrow patient population required so you have to have many, many sites and track the patients until their cancer progresses. Recruiting the large number of patients in the Phase 3 becomes very difficult as you have to do it within the same narrow patient population. The other major hurdle is you have to make the decision to run the Phase 3 trials without knowing if the drug offers cardioprotection in the clinic. My best estimate is such a program is going to cost north of US$500 million and take 12-15 years to get to approval as accelerated approval is not a possibility.

By inverting the design to cardioprotection first and using VO2Peak you can avoid all of this as you get proof-of-concept data on cardioprotection from Phase 1 in a broad population and gold standard, randomised, placebo-controlled, double-blinded data from Phase 2 that can support accelerated approval. With luck you also get gold standard anticancer efficacy data, but if not, you pick it up early in the post-approval Phase 2b/3 trial. This is not a conventional approach, but it gets you to your destination a lot faster and cheaper.

All of this is not really about ego, but different visions for Race.