Clinical Trial Failures Risk: The success of Soligenix depends heavily on its drug candidates successfully completing clinical trials, and failure at any stage could lead to significant delays or discontinuation of development programs.

Regulatory Approval Uncertainty Risk: Even with positive clinical trial results, SNGX's drug candidates must receive regulatory approval (e.g., FDA, EMA), and a rejection or lengthy review process could severely impact commercialization plans.

Insufficient Capital and Funding Risk: Developing biopharmaceutical products is capital-intensive, and SNGX may require significant additional funding through equity offerings or debt, which could dilute existing shareholders or impose burdensome terms.