Clinical Trial Failure Risk: The success of DKN-01, their lead product candidate, depends entirely on positive results from ongoing and future clinical trials, and any negative outcomes could severely impact the company's prospects.

Future Financing & Dilution Risk: Leap Therapeutics has a history of operating losses and will require significant additional capital to complete the development and commercialization of DKN-01, which may lead to further stock dilution for existing shareholders.

Regulatory Approval Uncertainty: Even if DKN-01 demonstrates positive clinical results, there is no guarantee that regulatory authorities like the FDA will grant marketing approval, a process that is lengthy, expensive, and highly uncertain.