Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery

What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful therapy was on track but faced an unclear future. Overseeing the human trials of a refined second-generation drug candidate, Amy had led the company back from the “valley of death” after Cleave’s initial offering resulted in off-target toxicity. Still, after completing multiple dose escalation cohorts, Cleave’s scientists told Amy that they could not draw any definitive conclusions about the benefits of the drug. Amy and her team knew the importance of speed and capital in the high-risk business of oncology drug development where success often takes more resources and time than expected and competitors lurk. Nearing the close of a five-year investment window, should the thinly staffed Cleave 2.0 continue to recruit patients and clear dosing cohorts at a rapid rate, or should Amy prioritize funding and partnership discussions? This case is suitable as a general business case for undergraduate and MBA students of any level on strategy, entrepreneurship, health care innovation, biopharma, cancer, FDA’s role in biopharma, funding early-stage biopharma ventures, biopharma clinical trials, and the healthcare industry.