Clinical Trial Failures: Evaxion's success hinges on the positive outcomes of its clinical trials, which are inherently uncertain and prone to high failure rates at any stage, potentially leading to significant delays or discontinuation of product candidates.

Regulatory Approval Uncertainty: Obtaining necessary regulatory approvals for its drug candidates is a lengthy, complex, and highly uncertain process, and any delays or outright rejections would prevent market access and revenue generation.

Funding and Capital Requirements: The company requires substantial ongoing capital to fund its extensive research, development, and clinical programs, and its ability to secure additional financing on favorable terms in the future is not guaranteed, potentially leading to dilution or operational curtailment.