Competitive And Enrollment RiskCompeting therapies advancing in the same treatment setting, pushed-back interim data, and ongoing BCG shortages could slow enrollment, complicate comparative positioning, and delay clarity on clinical benefit.
Financial RunwayRising research and development spending and high cash burn heighten the risk that limited cash resources will require additional financing and could pressure operations.
Trial Benchmarking UncertaintyAllowing investigator choice of intravesical chemotherapy in the control arm rather than a direct BCG comparator creates uncertainty about how TARA-002 will be benchmarked against the historical standard of care.