High Cash BurnConsistent, large negative operating and free cash flows require ongoing external financing and create dilution risk. Cash burn that materially outpaces revenue weakens financial flexibility, constrains sustained investment in trials and commercialization, and heightens execution risk over months.
Accumulated Losses / Weak Capital BaseSignificant accumulated losses and volatile equity undermine balance-sheet resilience and raise the probability of future equity raises. This structural weakness can force unfavorable financing terms, dilute shareholders, and limit long-term strategic flexibility for product development.
Regulatory And Clinical DelaysStopping the original FDA pathway and expanding a new pivotal study delays commercialization, increases trial and development costs, and extends time to reimbursement and scale. These structural delays raise execution and funding risk until pivotal data and regulatory clearance are achieved.