Speculative M&A Transaction Analysis, page-755

The key drivers of value are breakthrough therapy designation and accelerated approval from CPACS, which largely depend on anti-cancer efficacy/synergy, the number of indications (both cancer types and anthracycline combinations), and the cardioprotective effect. If RAC can prove that Bisantrene synergizes effectively to provide significant improvement in anti-cancer efficacy in over 75% of cancer indications and anthracyclines while offering cardioprotection similar to that of dexrazoxane (approximately a 65% decrease in cardiac events), then I believe it easily meets the criteria for accelerated approval. Given the significant issue of anthracycline-induced cardiotoxicity, Bisantrene might not need to be this effective to achieve breakthrough therapy designation or accelerated approval, but it could be a matter of patient numbers—50 from Phase 1a/b and 100 from Phase 2 might be sufficient. A good example is Trilaciclib, an IV CDK4/6 inhibitor that reduces chemotherapy-induced myelosuppression. It was approved based on three Phase 2 trials in 159 patients, and while there was an improvement in myelosuppression rates, there wasn't much improvement in efficacy. Bisantrene could potentially achieve both safety and efficacy, a world first.



The next key driver is competition. Many factors can influence this, but one approach is to focus on using a company's biggest and best drugs and demonstrating that Bisantrene can enhance their efficacy. This is an easy example to consider, as it’s already summarized in a table, hah. Acquired resistance rates for immune checkpoint blockade (ICB) therapies are a significant issue. Simply compare the column for Overall Response Rate (ORR) to the Estimated acquired resistance rate. If Bisantrene can demonstrate synergy with drugs like Keytruda and Opdivo across a broad range of cancer types, leading to reduced rates of acquired resistance, it could create a highly competitive scenario. Bisantrene has already been shown to overcome ICB resistance in a very aggressive mouse melanoma model, the same model that revealed changes in macrophage activity. If Bisantrene can achieve similar results with ICBs and other targeted therapies owned by large pharmaceutical companies, where it has already shown synergy, this could set the stage for competition among potential buyers.



A competitive buyout is 100% the best outcome for shareholders, and I think the board changes are aligning with that strategy. Get the people in that can get the job done.