Clinical Trial RiskRisks to our investment thesis include failure of clinical trials, regulatory requirements for additional clinical studies, and an untested commercialization strategy.
Commercialization UncertaintyThere is uncertainty regarding the potential approval and commercialization of the Hemopurifier in the oncology and organ transplant markets.
Revenue RecognitionDespite clinical progress and financial discipline, AEMD did not recognize any revenue during the F3Q25 quarter, and no revenue is forecasted for FY25 or FY26.