Clinical Trial Failure Risk: The development of drug candidates is highly uncertain and subject to the risk that they may not demonstrate efficacy or safety in clinical trials, potentially leading to delays or discontinuation of development programs.

Regulatory Approval Uncertainty Risk: Even with positive clinical trial results, there is no guarantee that Tenax Therapeutics' drug candidates will receive necessary regulatory approvals from health authorities like the FDA, which could prevent commercialization.

Financial Sustainability Risk: Tenax Therapeutics is a development-stage company with no current revenue from product sales and relies on equity or debt financing to fund operations, posing a risk to its long-term financial viability and potential for significant shareholder dilution.